Download Prescribing Formulary – February 2013

Prescribing
Formulary
th
15 Edition – February 2013
Version 15
Version date: 28 Feb 2013
Somerset CCG - Prescribing Formulary – February 2013
Introduction
This formulary has been developed and reviewed by the Somerset CCG Medicines Management team, in liaison with Secondary Care NHS Trusts.
It is intended to guide evidence-based and cost-effective prescribing across Somerset. Key points to note with regard to the formulary are:

It is intended to only cover first and in some cases second-line drug choices (other than where stated) in uncomplicated patients

It is expected that practices will find the options provided are appropriate for the treatment of most new patients

It is acknowledged that patients who are intolerant / unresponsive to formulary drugs, may require alternatives which are non-formulary

It is anticipated that medication reviews will provide an opportunity to transfer appropriate patients from non-formulary to formulary drugs

New products will by default be non-formulary initially and prescribers are thus asked to refrain from prescribing new drugs until they have been assessed and
approved for addition to the formulary either by the Prescribing Forum or Drugs and Therapeutics Committee.

Drugs which are classified as amber under the Somerset Traffic Light System are not generally included in the formulary. They should be initiated by (or on the
advice of) an appropriate specialist. There may be arrangements for Shared Care.

The formulary is primarily aimed at prescribing for adults, guidance on prescribing for children can be found in the BNF for children.

Full prescribing information about products in the formulary is available in the BNF, available online or as an app for many mobile devices.
It is acknowledged that to be effective the formulary needs to be accessible and thus an electronic rather than paper format is preferred by many. To aid decision
support at the point of prescribing, this formulary will therefore be made available on general practice clinical systems. It is expected that this formulary will then be
set as the default for all users within practices, including partners, retained doctors, locums and non-medical prescribers.
The formulary will be reviewed at approximately six-monthly intervals, taking account of emerging evidence, product availability, and pricing. Prices quoted in this
edition are taken from the most recent editions of the Drug Tariff and Chemist & Druggist monthly price list.
There are often cost-effective alternatives to pharmaceutical specials, including crushing tablets or prescribing licensed liquid preparations of similar medicines.
Guidance on the use of pharmaceutical „specials‟ is available on the Medicines Management web page. Prescribers may also contact the Prescribing & Medicines
Management Team with any queries.
By rationalising the choice of drugs prescribed in Primary Care through adoption of the formulary, and by improving liaison with Secondary Care, it is hoped that
prescribing across the Somerset health community can become more rational, cost-effective and seamless. In further support of this objective, the Out of Hours
formulary is reproduced as an appendix to this document, and the Palliative Care handbook can be found here.
Somerset CCG Medicines Management Team
Feb 2013
We believe the information in this document is correct at the time of production.
Please notify the Medicines Management Team of any errors.
[email protected] Team Administrator
Introduction
Page 1
ADMISSION AND DISCHARGE PROCESSES
Poor communication of information at transition points is responsible for as many as 50% of all medication errors and up to 20% of adverse drug
events in hospital. Practices should have a process for medicines reconciliation before admission and after discharge from secondary care and a
means of identifying patients at high risk of medicines related adverse events.
Please see the following two NHS Somerset guidance documents:
From Primary to Secondary Care
Provision of patient information on admissions from Primary Care
Reconciliation of patient information post-discharge
From Secondary to Primary care

Complete patient details

Complete patient details

The presenting condition plus co-morbidities

The diagnosis of the presenting condition plus co-morbidities

A list of all the medicines currently prescribed for the patient with
indications

Dose, frequency and route of all the medicines listed

Any OTC medicines or supplements the patient takes

Medicines stopped and started, with reasons

Dose, frequency and route of all the medicines listed

Length of courses where appropriate

An indication of any medicines that are not intended to be continued
(eg.acute prescriptions)

Details of increasing or decreasing regimes

Known allergies

Known allergies

Known previous side effects
Suggestions for Drug Monitoring in Adults in Primary Care
The monitoring parameters cited in the formulary are derived from a range of guidelines, reference sources, and expert opinion and must
therefore be considered suggestions only. Adherence to them will not ensure a successful outcome in every case. The ultimate judgement
regarding a particular clinical result must be made by the doctor in light of the clinical data presented by the patient and the diagnostic and
treatment options available. Please see the Suggestions for Drug Monitoring in Adults in Primary Care document.
Admission and discharge processes
Page 2
Contents
BNF Therapeutic Chapter
Page
Page
Ch. 1 Gastro-intestinal system
Helicobacter pylori eradication
Ch. 2
6-12
8
Guidance on assessing dehydration in children under 5 years
Cardiovascular system
10
13-45
Summary Drug Treatment for Hypertension
20
Summary of drug interactions for Dabigatran & Rivaroxaban
34
NICE Care Pathway for Hypertension
21
Implementation priorities for Dabigatran & Rivaroxaban
35-36
22-26
Lipid-Regulation Guidance
Heart Failure Guidance
Heart Failure prescribing Guidelines flowchart
27
Primary Prevention in CVD (based on NICE CG 67)
40
Guidelines for the Treatment of Chronic Stable Angina Pectoris
29
Secondary Prevention of CVD (based on NICE CG 67)
41
Management of coumarin induced haemorrhage
32
Ch. 3
Respiratory system
COPD Guidance
Ch. 4
Summary of drug-statin interations
42
46-62
57
Assessing and managing symptoms in COPD
Central nervous system
59
75-84
Hypnotics
63
Migraine
75-80
Antipsychotics
64-65
NICE: CG150 Diagnosis of migraine, cluster & tension type headache
77
Antimanic drugs
65
Epilepsy
80-81
Antidepressants
66-69
Substance Dependence: Smoking & Opioid
81-83
Analgesia
70-73
Drugs in dementia
84
Opioid conversion table
74
Ch. 5
Infections
85-95
Influenza vaccines
88
Urinary tract infections
90-91
Management of infection guidance
89
Gastro-intestinal tract infections
91
Upper respiratory tract infections
90
Genital tract infections
92
Lower respiratory tract infections
90
Skin / soft tissue infections
92-93
Menigitis
90
MRSA decolonistation policy
95
Table of contents
Page 3
BNF Therapeutic Chapter
Ch. 6
Page
Page
Endocrine system
96-116
Diabetes
Sex hormones
Summary chart for the treatment of diabetes
97
Hormone replacement therapy
106
Insulin therapy in diabetes guidance
98
Male sex hormones and antagonists
108
Blood glucose monitoring guidance
104
Drugs affecting bone metabolism
109
Thyroid and anti-thyroid drugs
105
Summary of NICE TAG 160: Primary Prevention of
Osteoporosis
111
Corticosteroids
105
Summary of NICE TAG 161: Secondary Prevention of
Osteoporosis
112
Ch. 7
Obstetrics, gynaecology, and urinary-tract disorders
Contraceptives
Emergency hormonal contraception
Ch. 8
118-19
Treatment of Urinary Dysfunction
121-23
120
Treatment of erectile dysfunction
123-24
Malignant disease and immunosuppression
Prostate cancer & Gonadorelin analogues
Ch. 9
117-123
125
125
Somerset Prescribing Forum statement on endometriosis & fibroids
Nutrition and blood
125
126-128
Ch. 10 Musculoskeletal and joint diseases
129-134
Non-steroidal anti-inflammatory drugs (NSAIDs)
129
Gout
131
Rubefacients and topical NSAIDs
130
Guidance on the management of osteoarthritis (OA)
132-134
Ch. 11 Eye
134-135
Ch. 12 Ear, nose and oropharynx
136-138
Nasal allergy
137
Decolonisation of nasal MRSA
Ch. 13 Skin
137
139-146
Emollients
139-41
Acne
145
Topical corticosteroids
142-43
Anti-infective skin preparations
146
Vitamin D analogues
144
Table of contents
Page 4
BNF Therapeutic Chapter
Page
Page
Ch. 15 Anaesthesia
Antagonists for central and respiratory depression
147
147
Appendix 1 Borderline substances
Food supplements
MUST Nutritional Screen
148-146
148
Gluten-free foods
148
149
Pathways for Replacement Milk Formula for Cow‟s Milk
allergy/intolerance
a) Breast Fed Infants
b) Formula Fed Infants
Prescribing Quantities Formula Milks
150
151
Appendix 2 Dorset & Somerset Out of Hours Service
152
154-157
Somerset Community Pharmacies holding Palliative Care Drugs
154-55
List of Palliative Care Drugs held by Community Pharmacies
156-57
Useful links

Prescribing & Medicines Management intranet pages

Traffic Light System

Palliative Care Handbook

Somerset Prescribing Forum

Drug & Therapeutics Committees

Prescribing & Medicines Management Group (PAMM)
Table of contents
Page 5
Therapeutic area
Formulary choices
Cost for 28 unless stated
Rationale for decision / comments
BNF Chapter 1: Gastro-intestinal system
Top
1.1 Dyspepsia & gastro-oesophageal reflux disease
Antacids
Asilone
Suspension: £2.00 (500ml)
A combination of magnesium and aluminium antacids, plus an antiflatulent, also
low in sodium. Available OTC
Mucogel
Suspension: £1.71 (500ml)
Low sodium and cost-effective treatment for dyspepsia.
At dose of 10-20ml tds & at bedtim provides equivalent magnesium intake
required for hypomagnesaemia as an alternative to magnesium
glycerophosphate.
Alginates
Peptac
Aniseed and
peppermint flavour
Gaviscon Advance
Aniseed and
peppermint flavour
Liquid: £1.95 (500ml)
Contains 3.1mmol of sodium per 5ml so should be avoided in patients where
restriction of sodium intake is desirable. Available OTC
Liquid: £4.54 (500ml)
Chewable tablets: £2.72 (60)
Recommended dose: 10ml
Contains 2.3mmol sodium & 1mmol potassium per 5ml dose
Acidex Max
Strength
Aniseed and
peppermint flavour
Liquid:
(500ml)
Gastrocote
Suspension: £2.67 (500ml)
Tablets: £3.51 (100)
®
Gastrocote liquid contains 1.8mmol of sodium per 5ml and may therefore be
®
more appropriate than Peptac in patients where restriction of sodium intake is
®
desirable. Gastrocote tablets contain 1mmol Sodium per tablet. Both
suspension and tablets available OTC
Severe hypomagnesaemia has been reported infrequently in patients treated
with PPIs, although the exact incidence is unknown.
Where this is a clinical concern prescribers may also decide to use a magnesium
containing product such as magnesium trisilicate or Gastrocote (with alginate).
NB Magnesium salts tend to be laxative in effect.
Gastro-intestinal System
Page 6
Therapeutic area
Formulary choices
Cost for 28 unless stated
Rationale for decision / comments
Mebeverine
135mg tablets: £4.81 (100)
Avoid prescribing as Colofac IBS as this is the OTC pack and more expensive.
1.2 Antispasmodics
Antispasmodics
®
1.3 Antisecretory drugs
Related guidance: NICE Clinical Guideline CG17 (2004): Dyspepsia
H2 - receptor
antagonists
Ranitidine
150mg tablets: £2.01 (60)
300mg tablets: £2.06 (30)
75mg/5ml S/F
oral solution: £9.09 (300ml)
Ranitidine is recommended as first line treatment for mild-moderate GORD in
the majority of patients.
Ranitidine is available OTC, but only as 75mg tablets
1.3.5 Proton pump inhibitors
Based on licensed indications and availability of both as generic capsules, omeprazole and lansoprazole are now considered joint first line PPIs and
the need to use other PPIs should therefore be limited. Pantoprazole is the preferred PPI for patients who specifically require a tablet formulation.
NB. Refer to NICE
guidance on use of
PPIs
Lansoprazole
capsules
15mg capsules: £1.19
30mg capsules: £1.72
Avoid prescribing Lansoprazole orodispersible tablets (Zoton FasTabs) as the
cost is greater than generic capsules, except as an alternative to costly special
liquid formulations.
Omeprazole
capsules
10mg capsules: £1.27
20mg capsules: £1.31
As Mepradec
10mg capsules: £1.12 (28)
20mg capsules: £1.14 (28)
Avoid prescribing Omeprazole dispersible tablets (Losec MUPS ), as they cost
about five times more than generic capsules, except as an alternative to costly
special liquid formulations and where lansoprazole orodispersible tablets are not
an acceptable alternative.
Where Omeprazole 20mg once-daily is not effective, increasing dose to 2x20mg
daily (not 1x40mg) or using Lansoprazole 30mg daily is recommended.
®
For patients currently taking Nexium tablets who are unable to change to
omeprazole, lansoprazole or pantoprazole, product should be prescribed as
EMOZUL capsules (esomeprazole capsules 20mg and 40mg)
Pantoprazole
tablets
20mg tablets: £1.14
40mg tablets: £1.60
Pantoprazole has been included for circumstances where a tablet formulation is
necessary.
Severe hypomagnesaemia has been reported infrequently in patients treated
with PPIs, although the exact incidence is unknown.
Where this is a clinical concern prescribers may also decide to use a magnesium
containing product such as magnesium trisilicate, magnesium hydroxide (not
suitable for patients with short bowel syndrome) or Mucogel.
Gastro-intestinal System
Page 7
Therapeutic area
Formulary choices
Cost for 28 unless stated
Rationale for decision / comments
Helicobacter pylori eradication – Please refer to Infection Management Guidance.
First line:
PPI (as opposite)
+ Metronidazole
+ Clarithromycin
all for 7 days
or
PPI (as opposite)
+ Amoxicillin
+ Clarithromycin
all for 7 days
400mg BD
250mg BD
Helicobacter pylori eradication is indicated in GU, DU and MALT lymphoma,
whereas evidence of value in GORD and NUD is inconsistent. Recommended
PPI regimes for H. pylori eradication are either Omeprazole capsules 20mg
bd or Lansoprazole capsules 30mg bd.
1g BD
500mg BD
The combination of a PPI + Clarithromycin and Metronidazole is now a
recommended as first line therapy for H. pylori eradication. However the use of
Clarithromycin or Metronidazole should be avoided if they have been used in the
previous year for the treatment of any other infections as this significantly
increases the likelihood of H Pylori being resistant.
NB. Different doses of Clarithromycin indicated in the two regimes.
Second line:
See opposite or seek
specialist advice
Where patients require a second course of eradication, a regime should be
chosen which does not include antibiotics given previously, see BNF for
guidance or seek specialist advice.
1.4 Acute diarrhoea
Avoid anti-motility agents in children. See page 10 for assessment of dehydration in under 5s in line with NICE CG84

Oral rehydration
Electrolade
£1.97 (6 sachet)
£4.99 (20 sachet)
Available as multipack containing mixed flavours, less expensive than Dioralyte .
Available OTC.

Antimotility
agents
Loperamide
capsules
2mg capsules: £0.94 (30)
Available OTC as generic loperamide, various own-brand products and as
Imodium. Do not prescribe as branded version owing to high cost.
Codeine
15mg tablets: £1.19
30mg tablets: £1.49
(avoid packs of 30 pack as
these are twice the cost)
Just 3 days of codeine containing medicines can lead to addiction – The PCT
strongly recommends that prescribers discuss the risk of addiction when
initiating new patients on any opioid containing medication and that this
discussion is recorded in the patient notes.
Watch for increasing frequency of requests for prescriptions
Gastro-intestinal System
®
Page 8
Therapeutic area
Formulary choices
Cost for 28 unless stated
Rationale for decision / comments
1.5 Chronic bowel disorders
Chronic diarrhoea
First line:
In line with national guidance it is recommended that Mesalazine is prescribed by brand name.
For all mesalazine preparations monitor renal function as recommended in SPC.
®
Mesalazine as
Octasa MR
400mg tablets: £19.50 (90)
Where 400mg tablets are required Octasa tablets are recommended as first line
as they are considered to be bioequivalent to the original product Asacol but at
a lower cost. 800mg Octasa cost more than 2 x 400mg so for cost-effective
dose we recommend using 400mg tabs
Mesalazine as
c
Pentasa SR
500mg tablets £30.74 (100)
1g tablets £36.89 (60)
Where 500mg tablets are required Pentasa tablets are recommended.
®
Asacol 800mg tablets are not recommended
Mesalazine
1g sachets £30.74 (50)
®
Salofalk sachets:

As Salofalk
1.5g sachets £48.85 (60)
3g sachets £97.70 (60)
Mesalazine as
1g suppositories £29.62 (28)
2g/100ml enema £29.92 (7)
Salofalk
Second line:

1.5g equivalent to 2g pentasa or 2.4g Octasa or Asacol
3g equivalent to 4g Pentasa or 4.8g Octasa or Asacol
Mesalazine as
®
Mezavant XL
1.2g tablets: £62.44 (60)
Consultant initiation only. All patients should have evaluation of renal function
prior to initiation and at least twice yearly whilst on treatment.
Budesonide
3mg capsules £77.05 (100)
2mg/100ml Rectal Foam
£57.11 (14)
Capsules enclose enteric coated granules which release budesonide into the
ileum and ascending colon.
Extraintestinal symptoms, e.g. involving the skin, eyes or joints, are unlikely to
respond to Budenofalk 3mg because of its local action.
Initial dose is 3mg tds for a maximum of 8 weeks. During week 7, dose should
be reduced to two capsules daily and in week 8, reduce to one capsule daily.
Budesonide (and conventional glucocorticosteroid) should not be used to
maintain remission NICE CG152
1.5.2
Corticosteroids
as Budenofalk
Gastro-intestinal System
Page 9
Assessing dehydration in children under 5 years for use during remote and face-to-face assessments
Adapted from ‘Diarrhoea and vomiting in children’ (NICE clinical guideline 84). The quick reference guide and full guidance are available from: www.nice.org.uk/CG84
Increasing severity of dehydration
Clinical dehydration
Signs
(face-to-face assessments)
Symptoms
(remote and face-toface assessments)
No clinically detectable
dehydration
may indicate children at
increased risk of progression
to shock
Risk Factors for Dehydration:
Clinical shock (one or more
signs/symptoms present.
(-) features do not specifically
indicate shock

Children younger than 1 year, especially those younger than
6 months

infants who were of low birth weight

children who have passed six or more diarrhoeal stools in the
past 24 hours

children who have vomited three times or more in the past
24 hours
children who have not been offered or have not been able to
tolerate supplementary fluids before presentation
Appears well
Appears to be unwell or
deteriorating
–
Alert and responsive
Altered responsiveness (for
example, irritable, lethargic)
Decreased level of
consciousness

Normal urine output
Decreased urine output
–

infants who have stopped breastfeeding during the illness

children with signs of malnutrition.
Skin colour unchanged
Skin colour unchanged
Pale or mottled skin
Warm extremities
Warm extremities
Cold extremities
Alert and responsive
Altered responsiveness (for
example, irritable, lethargic)
Decreased level of
consciousness
Skin colour unchanged
Skin colour unchanged
Pale or mottled skin
Warm extremities
Warm extremities
Cold extremities
Eyes not sunken
Sunken eyes
Moist mucous membranes
(except after a drink)
Dry mucous membranes
(except for „mouth breather')
X Box 1 x
Suspect hypernatraemic dehydration if there are any of the
following:

jittery movements

increased muscle tone

hyperreflexia
–

convulsions
–
 drowsiness or coma.
Laboratory investigations:
Normal heart rate
Tachycardia
Tachycardia

Do not routinely perform blood biochemistry.
Normal breathing pattern
Tachypnoea
Tachypnoea

Measure plasma sodium, potassium, urea, creatinine and
glucose concentrations if:
- intravenous fluid therapy is required or
Normal peripheral pulses
Normal peripheral pulses
Weak peripheral pulses
Normal capillary refill time
Normal capillary refill time
Prolonged capillary refill time
Normal skin turgor
Normal blood pressure
Reduced skin turgor
Normal blood pressure
–
Hypotension (decompensated
shock)
- there are symptoms or signs suggesting hypernatraemia.
Measure venous blood acid–base status and chloride
concentration if shock is suspected or confirmed.
Interpret symptoms and signs taking into account risk factors for dehydration (see box 1).
Gastro-intestinal System
Page 10
Therapeutic Area
Formulary choices
Cost for 28 unless stated
Rationale for decision / comments
1.6 Laxatives
Related guidance: NICE Clinical Guideline CG99 (2010): Constipation in children and young people
Bulk-forming
laxatives
Ispaghula Husk
Stimulant laxatives
Senna
7.5mg tablets: £2.83 (60)
7.5mg/5ml SF liquid: £2.69
(500ml)
Available OTC.
Glycerol
suppositories
1g: £0.94 (12)
2g: £0.94(12)
4g: £2.15 (12)
Glycerin suppository sizes:
3.5g sachets: £2.20 (30)
Prescribe generically. Available OTC.
3.4g sachets (e.g. Regulan) are more expensive at £2.44 per 30

1g = infant

2g = child
 4g = adult
All available OTC
Osmotic laxatives
1st Line
Macrogol
Sachets:£5.34 (30)
as Laxido Orange
Sugar-free
or
2nd Line
Lactulose
Gastro-intestinal System
3.35g/5ml solution: £3.16
(500ml)
NICE Cochrane QP review in June 2010 concluded that polyethylene glycol
(macrogol) should be used in preference to lactulose for chronic constipation.
Using polyethylene glycol in preference to lactulose is likely to improve the
quality of patient care by reducing the use of a less effective treatment.
Course of treatment for chronic constipation not normally > 2 weeks.
A stimulant laxative should be added if disimpaction is not achieved after 2
weeks.
Efficacy requires adequate fluid intake. Contains Na+, care in patients with
hypertension / heart failure. Laxido® replaces Movicol® as lower cost brand
equivalent.
Takes 2 to 3 days to exert effect, “prn” use ineffective; should be taken with
additional fluid. Therapeutic dose for adults 15ml twice daily. Available OTC.
Page 11
Therapeutic Area
Formulary choices
Pre-op Bowel
Cleansing
Solutions
N/A
Peripheral opioidreceptor antagonist
Methylnaltrexone
Injection
12mg/0.6ml
Cost for 28 unless stated
Rationale for decision / comments
Bowel cleansing medicine may modify the absorption of regularly prescribed
medications. Urea and Electrolytes shou;d be checked in all patients to
minimise the risk of electrolyte imbalance particularly patients taking the
following medications:
Diuretics, corticosteroids, cardiac glycosides, NSAIDs, tricyclics, SSRIa,
antipsychotics, carbamazepine.
See NPSA Alert and local guidelines for details.
£21.05 (single vial)
£147.35 (7 vial pack)
Injection for opioid-induced constipation in terminally ill patients, when response
to other laxatives is inadequate. Used in addition to existing laxative therapy.
Not licensed for use in any other circumstance.
1.7 Local preparations for anal and rectal disorders
Rectal soothing
agents
Anusol
Cream: £2.15 (23g)
Ointment: £2.15 (25g)
Suppositories: £2.02 (12)
Available as cream, ointment and suppositories.
Available OTC.
Rectal
corticosteroids
Scheriproct
Ointment: £2.94 (30g)
Suppositories: £1.38 (12)
Scheriproct is recommended over the traditionally widely used Proctosedyl , as
the latter is one of the most costly preparations of its type at £10.34 per tube.
Preparations for
anal fissures
Rectogesic
(Glyceryl Trinitrate
Ointment 0.4%)
Ointment: £34.80 (30g)
Glyceryl Trinitrate for the management of anal fissure should be prescribed as
®
Rectogesic , which is the only available licensed product for this indication.
Prescriptions for other strengths will require the dispensing of “specials” which
are unlicensed, often have a short shelf life and usually cost in excess of £100
per pack.
Maximum duration of use: 8 weeks
All external preparations of diltiazem are unlicensed specials and are nonformulary. Acute trust commissioned to provide full treatment course.
Gastro-intestinal System
®
®
Page 12
Therapeutic Area
Formulary choices
Cost for 28 unless stated
Rationale for decision / comments
BNF Chapter 2: Cardiovascular system
Related guidance: NICE Clinical Guideline CG127 (2011): Hypertension: Clinical management of primary hypertension in adults
NICE Clinical Guideline CG36 (2006): Atrial fibrillation
NICE Clinical Guideline CG48 (2007): MI: secondary prevention
NICE Clinical Guideline CG107 (2010): Hypertension in pregnancy
NICE Clinical Guideline CG108 (2010): Chronic heart failure
NICE Technology Appraisal TAG210 (2010): Clopidogrel and modified-release dipyridamole
Top
Given the wide overlap between many drug groups and clinical indications and vice-versa, the indications for which each drug is included in the formulary are
clearly stated in the comments section. Recommendations and local guidelines for the management of specific cardiovascular conditions are provided as inserts.

Hypertension

Heart Failure

Primary Care Guidelines for the Treatment of Chronic Stable Angina Pectoris

Management of anticoagulant-induced haemorrhage

Primary Prevention of CVD

Secondary Prevention of CVD

Drug – statin interactions table
2.1 Positive inotropic drugs
Cardiac glycosides
Cardiovascular system
Digoxin
62.5mcg tablets: £1.60
125mcg tablets: £0.95
250mcg tablets: £0.96
Digoxin is included in the formulary for use:

Atrial fibrillation: but not paroxysmal AF

Heart failure: where symptoms persist (due to LVSD) despite optimum
therapy including ACEIs, B-Blockers and diuretics.
U&Es should be checked at least 6-monthly, or when drug treatment is
changed. Monitoring serum potassium is particularly important in patients‟
taking digoxin or an aldosterone antagonist. A serum digoxin level should be
measured within 8-12 hours of the latest dose only if toxicity or non-adherence
is suspected.
Page 13
Therapeutic Area
Formulary choices
Cost for 28 unless stated
Indapamide
2.5mg tablets: £1.13
Rationale for decision / comments
2.2 Diuretics
Thiazides and
related diuretics

Hypertension: indapamide 2.5mg daily is considered the optimal dose
for hypertension
NB People treated with bendroflumethiazide whose blood pressure is
stable & well controlled should continue on bendroflumethiazide

Heart failure: bendroflumethiazide may have a limited role in mild heart
failure or where patients are intolerant of loop diuretics.
1.5mg MR tablets: £3.40 (30)
Bendroflumethiazide
Loop diuretics
Aldosterone
Antagonists
Furosemide
Spironolactone
Eplerenone
Cardiovascular system
2.5mg tablets £0.74
20mg tablets:£0.71
40mg tablets: £0.71
25mg tablets: £1.32
50mg tablets: £1.98
25mg tablets: £42.72
50mg tablets: £42.72
Furosemide is included in the formulary for use

Heart failure: to provide relief of symptoms. Patients‟ who do not
respond to 80mg/day will require further specialist advice.

Hypertension: For treatment of resistant hypertension at Step 4 where
BP remains sub-optimally controlled despite standard therapies.
Spironolactone is included in the formulary for :

Heart failure: for patients with NHYA Grade III-IV who remain
symptomatic despite optimisation of therapies such as ACE inhibitors
and Beta-blockers. Spironolactone is the aldosterone antagonist of
choice in this situation; Eplenerone is considered an alternative only for
specialist initiation.

Hypertension: For treatment of resistant hypertension at step 4 if blood
potassium is ≤ 4.5mmol/l

Regular monitoring (maintenance): U&E at 6, 9 & 12 months,
thereafter every 6 months.
Used, in addition to standard therapy, to reduce the risk of cardiovascular
mortality and morbidity after recent myocardial infarction in stable patients with
left ventricular dysfunction and clinical evidence of heart failure, as an
alternative to spironolactone, where sex hormone mediated adverse effects
experienced.
Page 14
Therapeutic Area
Formulary choices
Cost for 28 unless stated
Rationale for decision / comments
100mg tablets: £1.50
200mg tablets: £2.01
Treatment should only be initiated by a hospital specialist and only for the
treatment of severe rhythm disorders not responding to other therapies.
Prescribing at initial loading dose should be limited to 2 weeks.
Amiodarone therapy requires monitoring of:
2.3 Anti-arrhythmic drugs
Drugs for
arrythmias
Amiodarone

LFTs and TFTs at baseline and then every 6 months.
 Ophthalmic examination at baseline and then twelve-monthly
The long half-life of amiodarone (~50 days) means the therapeutic and adverse
effects persist for long periods after discontinuation of therapy.
WARNING Do not exceed Simvastatin 20mg in patients taking amiodarone
and monitor lipid levels to ensure lowest dose necessary of atorvastatin is
used.
Dronedarone
Cardiovascular system
400mg tablets: £67.50 (60)
Although effective in treating atrial fibrillation and flutter, dronedarone is not as
effective as amiodarone. However, the different side effect profile has led to its
use in patients for whom amiodarone may be contraindicated or otherwise
unsuitable. See the Shared Care Agreement or NICE TAG
Page 15
Therapeutic Area
Formulary choices
Cost for 28 unless stated
Rationale for decision / comments
2.4 Beta-adrenoreceptor blocking drugs
Beta blockers may be considered as initial therapy for hypertension particularly if intolerant or C/I to ACEI/ARB for:

younger people (under 55)

women of childbearing age

people with evidence of increased sympathetic drive

at Step 4 if further diuretic therapy is not tolerated, C/I or ineffective
Evidence suggests the combination of beta-blocker and thiazide increases risk of Type 2 DM and this is generally considered to be dose related.
Cardioselective beta-blockers may be used in well-controlled asthmatic patients, or COPD without significant reversible component for Heart Failure or following
an MI. Treatment should be initiated at a low-dose & the patient monitored carefully for adverse effects.
Recent evidence-based guidance for angina states that beta-blockers should be the first line therapy for the long-term prevention of angina.
Patients with heart failure should only be prescribed with beta-blockers licensed for this indication.
Beta-blockers
Bisoprolol
Atenolol
Metoprolol
Cardiovascular system
1.25mg tablets: £2.03
2.5mg tablets: £1.52
3.75mg tablets: £2.71
5mg tablets: £1.09
7.5mg tablets: £4.66
10mg tablets: £1.23
25mg tablets: £0.71
50mg tablets: £0.72
100mg tablets: £0.77
50mg tablets: £1.05
100mg tablets: £1.15
Bisoprolol is included in the formulary for:

Heart failure: Patients‟ with heart failure should be prescribed a betablocker licensed for heart failure. Bisoprolol is first line drug, initiated at
1.25mg and titrated according to guidelines.

Hypertension: in line with NICE guidance. Alternative to Atenolol or
Metoprolol

Angina: as alternative to Metoprolol

Post-MI: as alternative to Metoprolol
Atenolol is included in the formulary for:

Hypertension: in line with NICE guidance. Atenolol dose for
hypertension should not normally exceed 50mg daily.

Angina: for prophylaxis of symptoms, some additional benefit may be
obtained by increasing the dose to 100mg.
Metoprolol is included in the formulary for:

Hypertension: in line with NICE guidance. Alternative to Atenolol or
Bisoprolol

Angina: as alternative to Bisoprolol

Post-MI: as alternative to Bisoprolol
Page 16
Therapeutic Area
Formulary choices
Cost for 28 unless stated
Rationale for decision / comments
2.5 Drugs affecting the renin-angiotensin system and other antihypertensives
ACE-inhibitors (ACEIs) should be used in line with NICE / PCT guidance for hypertension and heart failure. All should be prescribed in a single daily dose where
possible. Lisinopril and Ramipril are the recommended first line options. Monitoring requirements U+Es at baseline, repeated 1-2 weeks after each dose increase
for heart failure and after final dose increase in hypertension, annually thereafter.
Patients exhibiting ACE cough on first choice ACEI should trial a second choice ACEI before an ARB.
ACE-inhibitors
or
Cardiovascular system
Lisinopril
Ramipril capsules
2.5mg tablets: £0.83
5mg tablets: £0.91
10mg tablets: £0.89
20mg tablets: £1.02
1.25mg capsules:£0.96
2.5mg capsules: £1.01
5mg capsules: £1.10
10mg capsules: £1.20
Lisinopril is included in the formulary for:

Hypertension: in line with NICE guidance. Usual dose range 2.5mg 20mg daily. May be commenced at dose of 10mg daily in patients
without renal impairment and not on diuretics.

Post-MI: titrated to 5-10mg daily if possible

Heart failure: as guidelines, titrated to 35mg if possible

Diabetic nephropathy: initially 2.5mg once daily, adjusted to achieve
sitting diastolic BP of < 75mmHg in normotensive IDDM and < 90mm
Hg in hypertensive NIDDM, usual range 10- 20mg once daily
Ramipril is included in the formulary for:

Hypertension: 1.25mg to 10mg daily, in line with NICE guidance.

Post-MI: titrated to 10mg daily if possible

Heart failure: as guidelines, titrated to 10mg if possible
Page 17
Therapeutic Area
Formulary choices
Cost for 28 unless stated
Rationale for decision / comments
ARBs should only be used in patients with persistent troublesome ACEI induced cough. The percentage of patients‟ reporting a cough was between 2-10% in
randomised controlled trials. ACEIs have a better evidence base and are more cost-effective.
ARBs should be used in line with NICE / PCT guidance for hypertension and heart failure.
Patients exhibiting ACE cough on first choice ACEI should trial a second choice ACEI before switching to an ARB.
Dual therapy ACEI+ARB is not recommended for any indication, other than under specific conditions for patients with heart
failure . (NICE CG108 (2010): Chronic heart failure)
Angiotensin-II
receptor blockers
(ARBs)
First line:
Losartan
Following
consideration of
available evidence
at Somerset
Prescribing Forum
March 2010 it was
agreed that generic
versions of losartan
may be used for all
indications
Second line:
Third line:
Cardiovascular system
Candesartan
Valsartan capsules
25mg tablets: £1.49
50mg tablets: £1.50
100mg tablets: £1.84
Losartan is included in the formulary for:

Hypertension: (where intolerant to ACEI except for people of African or
Caribbean origin at step 2where ARB are oreferred to ACE) in line with
NICE guidance, dose range 25-100mg once daily

Renal protection in Type 2 DM with nephropathy: (where intolerant to
ACEI) initially 50mg daily, increased after one month to 100mg daily
according to blood pressure

Heart failure: (>60 yrs; ACE intolerant; LVEF <40% & clinically stable).
Patients with heart failure who have been stabilised with an ACE
inhibitor should not be switched to losartan. Initially 12.5mg, titrated at
weekly intervals to usual maintenance dose of 50mg, as tolerated by
patient.
2mg tablets:£4.53 (7)
4mg tablets:£1.24 (7)
8mg tablets:£3.07
16mg tablets: £3.96
32mg tablets: £4.68
Candesartan is included in the formulary for:
40mg capsules:£2.39
80mg capsules:£2.63
160mg capsules:£3.35
Valsartan is only included in the formulary for:

Hypertension: (where intolerant to ACEI) in line with NICE guidance,
dose range 2-16mg daily

Heart failure: (where intolerant to ACEI) as per guidelines, titrated to
32mg daily if possible.

Post-MI: (where symptomatic heart failure and intolerant to ACEI),
initially 20mg bd, titrated to 160mg bd where tolerated

Not included for hypertension
Page 18
Therapeutic Area
Formulary choices
Cost for 28 unless stated
Rationale for decision / comments
Centrally acting
antihypertensive
drugs
Methyldopa
125mg tablets: £35.37 (56)
250mg tablets: £6.78 56)
500mg tablets: £9.51 (56)
Methyldopa is included in the formulary for:
200mcg tablets: £3.22
300mcg tablets: £3.56
400mcg tablets: £3.98
Moxonidine is included in the formulary for:
1mg tablets: £0.82
2mg tablets: £0.84
4mg tablets: £1.17
Doxazosin is included in the formulary for:
Moxonidine
Alpha-blockers
Doxazosin
®
as Doxadura brand
Cardiovascular system
1mg tablets: £0.74
2mg tablets: £0.84
4mg tablets: £1.05


Hypertension in pregnancy
Hypertension: For treatment of resistant hypertension at Step 4 where
BP remains sub-optimally controlled despite standard therapies.

Hypertension: For treatment of resistant hypertension at Step 4 where
BP remains sub-optimally controlled despite standard therapies.

Benign prostatic hyperplasia: See section 7
®
NB. Doxazosin MR (Cardura XL ) tablets are specifically not recommended for
maintenance in hypertension and maximum licensed dose for other indications
is 8mg. Stabilised hypertensive patients on Doxazosin MR tablets should be
switched to standard 4mg tablets:

Doxazosin MR 4mg one daily → Doxazosin 4mg one daily

Doxazosin MR 8mg one daily → Doxazosin 4mg two daily
Page 19
Summary of
Antihypertensive
Drug Treatments
Step 1
Aged under 55 years
Step 3
Step 4
Resistant
hypertension
Cardiovascular system
(NICE CG127)
ACE inhibitor or ARB
(sartan)
Calcium channel blocker (CCB)
(Choose a low cost ARB)
(a CCB is preferred but consider a thiazide-like diuretic if CCB
not tolerated or person has oedema, evidence of HF or high risk
of HF) [New 2011]
*If choosing an ARB (sartan)
choose a low cost
Step 2
Aged over 55 years or black
person of African or
Caribbean origin of any age
ACE inhibitor or ARB (sartan)
+ Calcium channel blocker
(CCB)
ACE inhibitor or ARB (sartan)
+ Calcium channel blocker
(CCB)
+ Thiazide-like diuretic
ACE inhibitor or ARB (sartan)
+ Calcium channel blocker (CCB)
For black people of African or Caribbean
origin, consider an ARB (sartan) in preference
to an ACEI, in combination with CCB [new
2011]
If diuretic treatment is to be initiated or
changed, offer a thiazide-like diuretic such as
indapamide 1.5mg MR or 2.5mg daily in
preference to conventional thiazide diuretics
[new 2011]
Consider a low dose of spironolactone (25mg once
daily) if blood K is ≤4.5mmol/l or higher doses of a
thiazide-like diuretic if >4.5mmol/l. [New 2011]
+ Thiazide-like diuretic
+ consider further diuretic or alpha-
At the time of publication (August 2011) spironolactone did
not have a UK marketing license for this indication.
Informed consent should be obtained and documented
blocker or beta-blocker
Consider seeking expert advice
Consider an α-blocker or β-blocker if further
diuretic therapy is not tolerated, or
contraindicated or ineffective
Page 20
Cardiovascular system
Page 21
Prescribing Guidelines for HEART FAILURE
This guidance is not intended to replace NICE CG108 Chronic heart failure (August 2010), but provides primary care prescribers with a summary of key
points relevant in practice.
Aims of treatment
 To relieve symptoms
 To improve exercise tolerance
 To reduce incidence of acute exacerbations
 To reduce hospitalisations
 To reduce mortality
First-line treatment
Offer both angiotensin-converting enzyme (ACE) inhibitors and beta-blockers licensed for heart failure, to all patients with heart failure due to left ventricular
systolic dysfunction (LVSD). Clinical judgement should guide which drug to start first.
ACE Inhibitors (first-line treatment)
An ACE inhibitor is recommended for ALL patients with asymptomatic LVSD or symptomatic heart failure (unless contra- indicated).
Start with a low dose and titrate upwards at short intervals (e.g. not less than 2 weeks). Where possible, ACE inhibitor treatment should be titrated up to the
highest licensed dose which is tolerated. GPs considering initiating ACE inhibitor therapy should consider specialist supervision and/or particularly careful
monitoring for those patients:

receiving multiple or high dose diuretics (≥ furosemide 80mg)

with hypovolaemia

with hyponatraemia (<130mmol/l)

with pre-existing hypotension (systolic < 90mm Hg)

with unstable heart failure

with renal impairment (creatinine > 150mmol/l)

receiving high-dose vasoldilator therapy

aged 70 years or more
NB: A small dose of an ACE inhibitor is better than no ACE inhibitor at all.
Because of the risk of hypotension, especially in patients with hypovolaemia, consideration should be given to withholding or reducing the dose of diuretics for
24 hours prior to commencement of an ACE inhibitor. Where possible all ACE inhibitors should be used in a single daily dose to aid compliance and costeffectiveness.
Formulary recommended ACE inhibitors;

LISINOPRIL initially 2.5-5mg ONCE DAILY, titrated up to 30-35mg ONCE DAILY, or

RAMIPRIL initially 2.5mg ONCE DAILY (1.25mg if already prescribed a diuretic), titrated up yo 10mg ONCE DAILY
Monitoring: serum urea, creatinine, electrolytes and eGFR at initiation and after each dose increment
Cardiovascular system
Page 22
Beta-blockers (first-line treatment)
Offer beta-blockers licensed for heart failure to all patients with heart failure due to left ventricular systolic dysfunction, including:
•
•
older adults and
patients with:
o peripheral vascular disease
o erectile dysfunction
o diabetes mellitus
o interstitial pulmonary disease and
o chronic obstructive pulmonary disease (COPD) without reversibility.
Beta-blocker therapy should be initiated by those experienced in the management of heart failure and should commence at a very low dose and titrated up by
doubling doses at intervals of not less than two weeks. Heart rate, blood pressure and clinical status should be assessed after each titration. Symptoms may
deteriorate initially, calling for adjustment of concomitant therapy, such as temporary increase in dose of diuretics.
Stable patients who are already taking a beta-blocker for a comorbidity (for example, angina or hypertension), and who develop heart failure due to left
ventricular systolic dysfunction, should be switched to a beta-blocker licensed for heart failure.

Formulary recommended
beta-blocker for heart failure;

BISOPROLOL initially 1.25mg ONCE DAILY, titrated according to response and tolerability to 10mg ONCE DAILY
Where an alternative to bisoprolol is required, for example where there is intolerance or concern that unopposed beta-blockade may be undesirable;
Carvedilol should be considered as the appropriate alternative beta-blocker for heart-failure patients. There is also a stronger evidence base for carvedilol in
those patients with higher grades of heart failure and its use may be preferred in this situation. Prescribers should be aware that carvedilol requires twice-daily
dosing and the implications of this for compliance with therapy should be taken into account when selecting a beta-blocker for heart failure.
NB. Although doses of beta-blockers should be titrated to the maximum tolerated, a small dose of a beta-blocker is better than no beta-blocker at all.
Second-line treatment
Seek specialist advice and consider adding one of the following if a patient remains symptomatic despite optimal therapy with an ACE inhibitor and a betablocker:
•
•
•
an aldosterone antagonist licensed for heart failure (especially if the patient has moderate to severe heart failure [NYHA class III–IV] or has had an MI
within the past month) or
an angiotensin II receptor antagonist (ARB) licensed for heart failure (especially if the patient has mild to moderate heart failure [NYHA class II–III]) or
hydralazine in combination with nitrate (especially if the patient is of African or Caribbean origin (not including mixed race) and has moderate to
severe heart failure [NYHA class III–IV])
Cardiovascular system
Page 23
Aldosterone antagonists (second-line treatment)
Formulary recommended aldosterone antagonist for heart failure;

SPIRONOLACTONE initially 25mg each morning, reducing to 12.5mg daily or 25mg on alternate days if necessary
Monitoring: serum potassium, creatinine, & eGFR required at baseline, week 2, week 4, and monthly thereafter
Although the doses of spironolactone recommended for use in heart failure are much lower than those used for ascites, there is still a significant risk of
electrolyte disturbance.
Patients who have had an acute MI and who have symptoms and/or signs of heart failure and LVSD, should be prescribed an aldosterone antagonist licensed
for post-MI treatment. This should be initiated within 3–14 days of the MI, preferably after ACE inhibitor therapy.
Formulary recommended aldosterone antagonist for signs or symptoms of heart failure post-MI;

EPLERENONE initially 25mg ONCE DAILY, increased within 4 weeks to 50mg ONCE DAILY
Monitoring: serum potassium, creatinine, & eGFR required at baseline, week 2, week 4, and monthly thereafter
Angiotensin Receptor Blockers (ARBs) (second-line or alternative first-line treatment)
The weight of evidence supporting use of ARBs in heart failure is not as robust as it is for use of ACE inhibitors and therefore an ARB can only be
recommended for those patients who are intolerant of ACE inhibitor therapy due to intractable cough.
On the basis of the currently available evidence, candesartan and losartan are the only ARBs licensed for use in heart failure.
The combination of an ACE-inhibitor, a potassium-sparing diuretic (e.g. spironolactone), and an ARB is not recommended and should be considered only
after careful consideration of the potential benefits and risks.
Formulary recommended ARB;


LOSARTAN initially 12.5mg ONCE DAILY, increased at 1 - 2 weekly intervals, to 50mg ONCE DAILY
CANDESARTAN initially 4mg ONCE DAILY, doubling the dose at intervals of no less than 2 weeks, to 32mg ONCE DAILY
Monitoring: serum potassium, creatinine, & eGFR required at baseline, week 2, week 4, and monthly thereafter
The triple combination of Valsartan, ACE inhibitor and beta-blocker should be avoided, based on current evidence.
As with ACE inhibitors, it is recommended to exert particular care when using ARBs in the patient groups who are at greater risk of complications and
consideration given to specialist input where appropriate.
Hydralazine in combination with a nitrate (alternative first-line treatment)
Hydralazine in combination with nitrate can be considered for patients with heart failure due to LVSD who are intolerant of ACE inhibitors and ARBs. Seek
specialist advice.
Cardiovascular system
Page 24
Third-line treatment
Digoxin is appropriate for patients with atrial fibrillation and any degree of heart failure. It is also recommended for those with worsening or severe heartfailure due to LVSD who remain symptomatic despite treatment with an ACE Inhibitor and a beta blocker.
Digoxin may improve symptoms, exercise tolerance and reduce hospitalisations. Digoxin has not been shown to reduce mortality. Hypokalaemia predisposes
to digoxin toxicity so careful monitoring of U&Es is required, especially where patients are also prescribed loop or thiazide diuretics, particularly if an ACE
inhibitor, ARB or spironolactone is not co-prescribed.
Formulary recommendation;

DIGOXIN 62.5mcg - 125mcg ONCE DAILY (higher doses are rarely appropriate in heart failure not associated with AF)
Monitoring: serum urea & electrolytes, particularly potassium, creatinine, & eGFR required
Diuretics
A diuretic is usually required by most patients with heart failure to reduce symptoms of fluid overload, reduce hospitalisation due to acute exacerbation and
increase exercise tolerance. The dose should be titrated (up and down) according to need following the initiation of subsequent heart failure therapies.
Formulary recommended loop diuretic;

FUROSEMIDE 20mg - 40mg ONCE DAILY (in the morning), titrated according to symptomatic response
Monitoring: serum urea & electrolytes, creatinine, & eGFR required
A thiazide diuretic may be of benefit in patients with mild heart failure and good renal function; however thiazides are ineffective in patients with poor renal
function.
Formulary recommended thiazide diuretic;

BENDROFLUMETHIAZIDE 2.5mg ONCE DAILY (in the morning)
Monitoring: serum urea & electrolytes, creatinine, & eGFR required
If diuresis with one diuretic is insufficient, a combination of loop diuretic and thiazide may be tried.
Metolazone may still be recommended but has been discontinued in the UK. AMBER in TLS.
Indapamide combined with furosemide has been found to be effective in a small trial of patients with massive oedema although this is an unlicensed use.
(Tanaka M et al. The Na+-excreting efficacy of indapamide in combination with furosemide in massive edema. Clinical and Experimental Nephrology, June
2005, vol./is. 9/2(122-126)
Cardiovascular system
Page 25
Calcium channel blockers
No Calcium channel blocker is licensed for the treatment of heart failure.
The use of calcium channel blockers with a direct effect on cardiac contractility i.e. verapamil or diltiazem should be specifically avoided in heart failure.
For those patients who develop heart failure or are at high risk of heart failure NICE 127 recommends they should be changed to a thiazide-like diuretic in
place of a CCB.
Where continuation of a dihydropyridine calcium channel blocker is considered essential for control of hypertension or angina, this may be justified where use
of other therapies such as beta-blocker, ACE-inhibitor and diuretic has been optimised.
Ivabradine
Initiation only for patients on maximum therapy & with heart rate > 75 beats per minute
NICE TA 267 Ivabradine for Treating Chronic heart failure - recommends ivabradine as a possible treatment for people with chronic heart failure provided the
following conditions are all met.
o New York Heart Association (NYHA) class II to IV stable chronic heart failure with systolic dysfunction
o who are in sinus rhythm with a heart rate of 75 beats per minute or more
o who are given ivabradine in combination with standard therapy including beta-blocker therapy, angiotensin-converting enzyme (ACE) inhibitors and
aldosterone antagonists, or when beta-blocker therapy is contraindicated or not tolerated (after 4 week period of stabilisation on these meds)
o with a left ventricular ejection fraction of 35% or less
Initiation may be by GPwSI or heart failure specialist nurse.
Cardiovascular system
Page 26
NHS SOMERSET: Heart Failure Prescribing Guidelines
Algorithm adapted from NICE CG108 by the Medicines Management team, October 2010
For further details please refer to the full PCT guidance above and to NICE Clinical Guideline 108: Chronic heart failure
STANDARD TREATMENT FOR
PATIENTS WITH HEART FAILURE
DUE TO LVSD
OR
WITH PRESERVED EJECTION
FRACTION
New diagnosis of heart failure
with preserved ejection fraction
New diagnosis of heart failure
due to left ventricular systolic dysfunction
Manage comorbid conditions such as
high blood pressure, ischaemic heart
disease and diabetes mellitus in line
with relevant NICE guidance
FIRST LINE TREATMENT
Start ACE-inhibitor OR beta-blocker licensed for heart failure
Clinical judgement should guide which to start first
e.g. Lisinopril or Bisoprolol, and titrate upwards
If ACE-inhibitor not tolerated, trial a second ACE-inhibitor
If second ACE-inhibitor not tolerated, considering an ARB (Losartan)
If ARB not tolerated, consider hydralazine plus a nitrate
Offer rehabilitation and education
Diuretics should be prescribed for
the relief of congestive symptoms
and fluid retention.
Start ACE-inhibitor OR beta-blocker licensed for heart failure
Which ever is not yet prescribed, and titrate upwards
The dose should be titrated up and
down according to the patients’
need following initial and
subsequent heart failure therapies
Ensure both therapies are prescribed at maximum tolerated dose
Specialist
assessment
Ivabradine – option
For consultant initiation only for
patients on maximum therapy &
with heart rate > 75 beats per
minute, in sinus rhythm – see
p.26
Cardiovascular system
SECOND LINE TREATMENT
If patient remains symptomatic, seek specialist advice and consider
adding spironolactone, an ARB (Losartan), or hydralazine plus a
nitrate.
THIRD LINE TREATMENT
If symptoms persist, consider digoxin
Page 27
Therapeutic Area
Formulary choices
Cost for 28 unless stated
Rationale for decision / comments
2.6 Nitrates, calcium channel blockers and potassium channel activators
Nitrates
Glyceryl trinitrate
(GTN) spray
400mcg: £3.29 (200 dose)
400mcg: £2.63 (180 dose) as
®
brand Nitromin
Glyceryl trinitrate is included in the formulary for:
ISMN First line:
Isosorbide
mononitrate
Standard tablets
10mg: £1.74 (56)
20mg: £1.83 (56)
40mg: £2.14 (56)
ISMN second line:
Sustained-release
Isosorbide Mononitrate is included in the formulary for:
Angina: for prophylaxis of symptoms as monotherapy where intolerance or
C/I to use of a beta-blocker or rate-limiting CCB. As combination therapy
with beta-blocker or CCB where monotherapy provides insufficient control.
First line is to prescribe standard Isosorbide mononitrate tablets asymmetrically
to ensure a nitrate free period is maintained to reduce nitrate tolerance e.g.
20mg bd at 6-8am and 2-4pm.
If patients cannot comply with this regime, MR preparations should be
prescribed by brand (Tardisc XL for 60mg) and only given once-daily to reduce
nitrate tolerance.
Where Isosorbide mononitrate has been added to provide symptom control
pending angioplasty or CABG, consideration should be given to cautious
withdrawal after successful completion of and recovery from the procedure
Tardisc XL tablets
60mg: £3.49 (28)
 Angina: for as required use for relief of symptoms
Note that GTN tablets are now significantly more costly than spray
ISOSORBIDE DINITRATE is NON-FORMULARY except where initiated by a
specialist for left ventricular failure
Cardiovascular system
Page 28
Cardiovascular system
Page 29
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
Calcium channel blockers – Dihydropyridines
First line:
Amlodipine
®
as Amlostin brand
5mg tablets: £0.87
10mg tablets: £94
NB. Avoid short-acting dihydropyridines in BP, CHD and CCF.
5mg tablets: £0.78
10mg tablets: £0.85
Amlodipine is first line CCB, with lercanidipine as a second line option for:

Hypertension: in line with NICE guidance

Second line:
Lercanidipine
10mg tablets: £1.64
20mg tablets: £2.11
Angina: as monotherapy where intolerance or C/I to use of a betablocker or rate-limiting CCB. As combination therapy with beta-blocker
where monotherapy provides insufficient control.
NB: When prescribing Amlodipine generically, this should be as plain
®
Amlodipine. Prescriptions for Amlodipine besilate will result in the supply of Istin
and incur significantly greater costs.
Calcium channel blockers - Rate limiting
Prescribe by brand
Diltiazem M/R
as Slozem
120mg m/r capsules: £7.00
180mg m/r capsules: £7.80
240mg m/r capsules: £8.20
300mg m/r capsules: £8.50
Diltiazem MR (as Slozem) is included in the formulary for:

Angina: as monotherapy where intolerance or C/I to use of a betablocker. In combination with a beta-blocker where monotherapy provides
insufficient control. - NB. caution required due to risk of bradycardia and
heart-block.

Hypertension: For treatment of resistant hypertension at Step 4 where
BP remains sub-optimally controlled despite standard therapies.
NB. Prescribing Diltiazem MR as the formulary preferred Slozem brand ensures
continuity of supply, as recommended nationally.
Verapamil
40mg tablets: £1.69 (84)
80mg tablets: £2.22 (84)
and
Prescribe by brand

Angina: as monotherapy where intolerance or C/I to use of a betablocker.

Hypertension: For treatment of resistant hypertension at Step 4 where
BP remains sub-optimally controlled despite standard therapies.
Verapamil M/R
as Half-Securon SR
or
Securon SR
Cardiovascular system
Verapamil is included in the formulary for:
120mg m/r tablets: £7.71
240mg m/r tablets: £5.55
NB. Verapamil should not be combined with a beta-blocker for any indication
due to high risk of bradycardia and heart-block
Page 30
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
2.6.3 Other antianginal drugs
Potassium Channel
Activator
Nicorandil
10mg: £5.49 (60)
20mg: £10.53 (60)
Where Nicorandil has been added for symptom control pending angioplasty or
CABG, strong consideration should be given to cautious withdrawal after
successful completion of and recovery from the procedure.
Nicorandil is associated with oral, anal, gi & para-stomal ulceration & delayed
wound healing. Addition of a PPI is ineffective to promote healing – cessation of
the drug is needed.
Sinus Node
Regulator
Ivabradine
5mg: £40.17
7.5mg: £40.17
GREEN for medical management of Stable angina: in line with NICE CG126
See guide p.29
AMBER for management of heart failure (see guidelines page 26)
QT prolongation may be exacerbated by heart rate reduction. The ue of
ivabradine with other drugs which prolong QT interval eg citalopram, diltiazem,
should be avoided.
If the combination appears necessary, close cardiac monitoring is needed.
Hypokalaemia and hypomagnesaemia can increase the risk of arrhythmia
especially in patients with long QT interval, whether congenital or substanceinduced eg with potassium-depleting diuretics (thiazide diuretics and loop
diuretics). Caution & careful monitoring is needed.
Other
Ranolazine
375mg: £48.98 (60)
500mg: £48.98 (60)
750mg: £48.98 (60)
Included for medical management of Stable angina: in line with NICE CG126
See guide p. 29
2.6.4 Peripheral vasodilators and related drugs
Related guidance: NICE Technology Appraisal TA223 (2011): Treatment of intermittent claudication in people with peripheral vascular disease
Vasodilators
Cardiovascular system
Naftidrofuryl
100mg capsules: £6.16 (84)
Naftidrofuryl oxalate is recommended as an option for the treatment of
intermittent claudication in people with peripheral arterial disease for whom
vasodilator therapy is considered appropriate after taking into account other
treatment options (NICE TA223)
Cilostazol, pentoxifylline and inositol nicotinate are not recommended for the
treatment of intermittent claudication in people with
peripheral arterial disease.
Page 31
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
2.8 Anticoagulant drugs
Parenteral
anticoagulants
Related guidance: NICE Clinical Guideline CG92 (2010): Venous thromboembolism – reducing the risk
A Shared Care agreement is available for the use of Enoxaparin in pregnancy
Enoxaparin
Pre-filled syringes
20mg/0.2ml: £22.72 (10)
40mg/0.4ml: £30.27 (10)
60mg/0.6ml: £45.65 (10)
80mg/0.8ml: £64.86 (10)
100mg/1ml: £80.33 (10)
120mg/0.8ml: £97.70 (10)
150mg/1ml: £111.01 (10)
Enoxaparin is licensed for the prophylaxis and treatment of venous
thromboembolism; treatment of unstable angina, non-Q-wave myocardial
infarction, acute ST-segment elevation myocardial infarction (STEMI); prevention
of thrombus formation in the extracorporeal circulation during haemodialysis.
NB. Dalteparin is licensed for treatment of symptomatic VTE and prevention of
its recurrence, in patients with solid tumours.
Management of haemorrhage: haemorrhage is the main adverse effect of all oral anticoagulants. Checking the INR and omitting doses is essential. If the
anticoagulant is stopped but not reversed, the INR should be checked again after 2 to 3 days to ensure that it is falling. The following recommendations apply to
patients taking Warfarin and are based on the result of the INR and whether there is major or minor bleeding:
Major bleeding: stop Warfarin; give Phytomenadione (Vitamin K1) 5-10mg by slow intra-venous injection; give prothrombin complex concentrate (factirs II, VII,
IX and X) 30-50units/kg (or if no concentrate available) fresh frozen plasma 15ml/kg.
INR> 8.0, no bleeding or minor bleeding: stop Warfarin, re-start when INR < 5. If there are other risk factors for bleeding, give Phytomenadione (Vitamin K1)
500mcg by slow intra-venous injection or 5mg by mouth, (for partial reversal of anticoagulation give smaller oral doses of Phytomenadione e.g. 0.5mg –
2.5mg, using the intravenous p reparation orally); repeat dose of Phytomenadione if INR still too high after 24 hours.
See Chapter 9 for details of Phytomenadione preparations on the formulary.
Management of patients on warfarin should be in line with the National Enhanced Service specification.
Oral anticoagulants
Coumarins
(continued on next
page)
Cardiovascular system
Refer to National Patient Safety Agency (NPSA) guidance on safe practices around use of anticoagulants.
Warfarin
500mcg tablets: £1.49
1mg tablets: £0.75
3mg tablets: £0.78
5mg tablets: £0.85
Warfarin is included in the formulary for the following indications (with target
INRs):

Atrial fibrillation: target INR = 2.5

Treatment of DVT or PE: target INR = 2.5

Recurrent DVT or PE: target INR = 3.5

Mechanical prosthetic heart valves: target INR dependent on type and
location of valve. Generally a target INR of 3 is recommended for
mechanical aortic valves and a target INR of 3.5 for mechanical mitral
valves
Page 32
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
Dabigatran
75mg capsules: £65.90 (60)
75mg only for after
elective knee & hip surgery
in some patients – RED in
TLG
110mg capsules:£65.90 (60)
150mg capsules:£65.90 (60)
Dabigatran is included for the prevention of stroke & systemic embolism for
people with non-valvular atrial fibrillation where patients fit the criteria in NICE
TA249. See Implementation priorities p35
10mg tablets: £63.00 (30)
10mg only for after
elective knee & hip surgery
– RED in TLG
Rivaroxaban is included for the prevention of stroke & systemic embolism for
people with non-valvular atrial fibrillation where patients fit the criteria in NICE
TA256. See p36 for implementation priorities.
and
Treatment of DVT and prevention of recurrent DVT and PE as per NICE TA261
Oral anticoagulants
(continued)
Direct thrombin
Inhibitor
Direct inhibitor of
activated Factor X
Rivaroxaban
15mg tablets: £58.80 (28)
20mg tablets: £58.80 (28)
Apixaban
2.5mg tablets: £102.90 (60)
5mg tablets: £64.50 (56)
See note below for use post elective hip & knee replacement.
See note below for use post elective hip & knee replacement.
Apixaban is included for the prevention of stroke and systemic embolism in adult
patients with non-valvular atrial fibrillation, with one or more risk factors, as for
Dabigatran & Rivaroxaban NICE TA275
RED Indication in TLG: Primary prevention of venous thromboembolic events in
adult patients after elective total hip replacement surgery or total knee
replacement surgery.
The full course should be supplied when the procedure is carried out & there
should be no requirement to prescribe for either 10mg rivaroxaban or 75mg
dabigatran in primary care.
See TA157 Dabigatran, TA170 Rivaroxaban & TA245 Apixaban
Cardiovascular system
Page 33
Rivaroxaban & dabigatran are “black triangle drugs” ie subject to intensive monitoring by CHM & MHRA. Reports of any adverse drug reactions
(however minor) are encouraged.
Following is extracted from SPC for the drugs on electronic Medicines Compendium last updated 18/6/2012 (rivaroxaban) & 23/7/12 (dabigatran)
Medication
Rivaroxaban
Dabigatran
Any other anticoagulant – (limited experience) ↑bleeding risk
↑bleeding risk. Contra-indicated except when
switching treatment
Systemic Azoles e.g. ketonconazole,
itraconazole
AVOID ↑bleeding risk
AVOID ↑bleeding risk
HIV protease inhibitors eg ritonavir
AVOID ↑bleeding risk
Not studied – combination not recommended
Ciclosporin, tacrolimus
AVOID ↑bleeding risk
Dronedarone
AVOID
AVOID
Strong CYP34A Inducer eg.Rifampicin,
phenytoin, carbamazepine, St Johns Wort
CAUTION ↓rivaroxaban plasma levels
AVOID ↓dabigatran plasma levels
Amiodarone
Verapamil, quinidine
CYP3A4 inhibitors (e.g Clarithromycin)
Caution ↑dabigatran plasma levels (especially
in renal impairment)
Caution & reduce doseof dabigatran
↑dabigatran plasma levels (especially in renal
impairment)
↑rivaroxaban plasma levels, not considered clinically Monitor for signs of bleeding, especially if
relevant but Caution if renal impairment
renal impairment
SSRIs/SNRIs/NSAID/platelet aggregation
inhibitors
Caution
These products typically increase bleeding risks.
Care is to be taken.
Cardiovascular system
Caution ↑bleeding risk
Page 34
DABIGATRAN IMPLEMENTATION PRIORITIES: FOR PATIENTS WITH NON VALVULAR AF and 1 or more RISK FACTORS





RISK FACTORS
Previous stroke, TIA or systemic embolism
Left ventricular ejection fraction below 40%
Symptomatic heart failure of New York Association (NYHA)
class 2 or above
Age 75 Years or older
Age 65 years or older with one of Diabetes, Coronary
artery disease or hypertension
EXCLUSIONS
DABIGATRAN IS A POWERFUL ANTI-COAGULANT WHICH CAN’T BE REVERSED BY
VITAMIN K
BEFORE CONSIDERATION PATIENTS MUST HAVE AN UP TO DATE RENAL FUNCTION
TEST:
 Creatinine clearance <30ml/min (eGFR <30) =>
use of Dabigatran is contra-indicated do not proceed
 Contra-indicated with ketoconazole, cyclosporine, itraconazole and
tacrolimus (see SPC for full list)
An online eGFR calculator is available at: http://www.renal.org/eGFRcalc/GFR.pl
 Mechanical Heart Valve – contra-indicated
All new and existing Non Valvular AF patients should discuss with their clinician the risks
and benefits
of swallow
dabigatran
compared
to–warfarin
before initiation or switching
Patient
unable to
whole
capsules
do not proceed

1st
2nd
3rd
4th
Patients with elevated liver enzymes (>2 ULN) were excluded in studies. Use
of dabigatran not recommended in this population.
Patients newly diagnosed with Non Valvular AF – with good medicine
compliance. Dabigatran is NOT suitable for patients using MDS
systems because product must remain in original packaging.
Age < 80yrs 150mg BD
Age >80yrs 110mg BD
Patients fitting Criteria currently receiving no preventative treatment
Patients fitting Criteria receiving just aspirin – Aspirin offers little
protection against stroke in AF compared to warfarin or dabigatran
Patients with unstable INR on Warfarin or Phenindione. Starting with
those patients most commonly out of treatment range
House Bound
patients
requiring
remote
monitoring of
INR
When clinically relevant bleeding occurs,
treatment should be interrupted. Bleeding can
occur at any site during therapy with
dabigatran. An unexplained fall in haemoglobin
and/or haematocrit or blood pressure should
lead to a search for a bleeding site
Caution - Concomitant administration of
strong P-gp inhibitors (such as amiodarone,
verapamil, quinidine, ketoconazole and
clarithromycin) is expected to result in
increased dabigatran plasma concentrations
and potential increase in bleeding risk
Dabigatran can be given as soon as INR is < 2.0
5th
Patients with stable INR on Warfarin or Phenindione - the risks/
benefits of dabigatran compared to warfarin should be discussed as it
may be appropriate for stable patients to remain on warfarin
Cardiovascular system
FURTHER PRESCRIBER GUIDANCE: electronic Medicines Compendium
and information on renal function, tests & relationship between
creatinine clearance & eGFR here
Page 35
RIVAROXABAN IMPLEMENTATION PRIORITIES FOR PATIENTS WITH NON VALVULAR AF and 1 or more RISK FACTORS





RISK FACTORS
Previous stroke, TIA or systemic embolism
Left ventricular ejection fraction below 40%
Symptomatic heart failure of New York Association (NYHA) class
2 or above
Age 75 Years or older
Age 65 years or older with one of Diabetes, Coronary artery
disease or hypertension
EXCLUSIONS
RIVAROXABAN IS A POWERFUL ANTI-COAGULANT WHICH CAN’T EASILY BE
REVERSED (prothrombin complex concentrate is an option)
BEFORE CONSIDERATION PATIENTS MUST HAVE AN UP TO DATE RENAL FUNCTION
TEST:
 Creatinine clearance <15ml/min (eGFR <20) =>
use of Ribaroxaban is contra-indicated do not proceed
 Contra-indicated with ketoconazole, voriconazole, itraconazole and
dronedarone (see SPC for full list)
An online eGFR calculator is available at: http://www.renal.org/eGFRcalc/GFR.pl
 Mechanical Heart Valve – contra-indicated
Patient
unable of
to rivaroxaban
swallow whole
capsulesto–warfarin
do not proceed
All new and existing Non Valvular AF patients should discuss with their clinician therisks
and benefits
compared
before initiation or switching
 Patients with elevated liver enzymes (>2 ULN) were excluded in studies. Use
of dabigatran not recommended in this population.
1st
If a dose is missed the patient should take
Patients newly diagnosed with Non Valvular AF – with good medicine
rivaroxaban immediately and continue on the
compliance. Rivaroxaban is suitable for patients using MDS systems
following day with the once daily intake as
Dose 20mg ONCE DAILY for all ages
recommended. The dose should not be doubled
Dose 15mg ONCE DAILY if creatinine clearance 15-49 ml/min
within the same day to make up for a missed
dose.
2nd
House Bound
Patients fitting Criteria currently receiving no preventative treatment
patients
requiring
remote
Pregnancy
monitoring of
3rd
Safety and efficacy of rivaroxaban have not
Patients fitting Criteria receiving just aspirin – Aspirin offers little
INR
been established in pregnant women. Studies
protection against stroke in AF compared to warfarin or rivaroxaban
in animals have shown reproductive toxicity
and rivaroxaban passes the placenta.
Patients with unstable INR on Warfarin or Phenindione. Start with
Contraindicated during pregnancy
4th
those patients most commonly out of treatment range.
Rivaroxaban can be given as soon as INR is < 3.0
5th
Patients with stable INR on Warfarin or Phenindione - the risks/
benefits of rivaroxaban compared to warfarin should be discussed as
it may be appropriate for stable patients to remain on warfarin
Cardiovascular system
FURTHER PRESCRIBER GUIDANCE: electronic Medicines Compendium
and information on renal function, tests & relationship between
creatinine clearance & eGFR here
Page 36
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
2.8 Antiplatelet drugs
Related guidance: NICE Technology Appraisal TAG210 (2010): Clopidogrel and modified-release dipyridamole
Anti-platelet drugs
Aspirin
75mg dispersible tablets:
£0.69
ATT meta-analysis : Aspirin for primary prevention of CVD
Aspirin is not licensed for the primary prevention of vascular events but there
remains the possibility for particular sub-groups of individuals at higher CV risk
(including conditions such as diabetes) that the risk:benefit of aspirin is
favourable. Until more evidence is available, the use of Aspirin 75mg for
primary prevention should be based on an individual risk assessment.
Aspirin is included in the formulary for:

Secondary prevention of CV events: see notes regarding use in
combination with Dipyridamole or Clopidogrel below
NB There is evidence that:
 Aspirin doses >75mg daily increase GI toxicity and general bleed risk
Enteric-coated Aspirin does not reduce GI events and may be less effective
Dipyridamole m/r
200mg m/r capsules: £10.06
(60)
Modified-release dipyridamole alone is recommended by NICE as an option to
prevent occlusive vascular events;
 for people who have had an ischaemic stroke only if aspirin and clopidogrel
are contraindicated or not tolerated or
 for people who have had a transient ischaemic attack only if aspirin is
contraindicated or not tolerated.
®
Dipyridamole m/r
(with Aspirin) as
Asasantin Retard
Continued on next page
Cardiovascular system
200/25mg m/r capsules:
£9.84 (60)
Modified-release dipyridamole in combination with aspirin (as Asasantin Retard )
is recommended by NICE as an option to prevent occlusive vascular events;
 for people who have had a transient ischaemic attack or
 for people who have had an ischaemic stroke only if clopidogrel is
contraindicated or not tolerated.
Non modified-release dipyridamole products, e.g. dipyridamole liquid,
should NOT be prescribed as evidence shows no clinical benefit.
Page 37
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
Anti-platelet drugs
Clopidogrel
75mg tablets: £1.91 (30)
Clopidogrel is recommended by NICE as an option to prevent occlusive vascular
events;
(Continued from previous
page)
Following
consideration of
available evidence
at Somerset
Prescribing Forum
Sep 2009 it was
agreed that
generic versions
of clopidogrel may
be used for all
indications

for people who have had an ischaemic stroke or who have peripheral
arterial disease or multivascular disease or TIA (by local agreement)

for people who have had a myocardial infarction only if aspirin is
contraindicated or not tolerated.
Clopidogrel is also included in the formulary for:

Patients with true aspirin allergy who require secondary prevention of
cardiac or vascular disease

In combination with Aspirin 75mg daily following acute coronary
syndrome (ACS) for a period of 12 months

In combination with Aspirin 75mg daily following insertion of drug-eluting
stent for a period of 12 months

In combination with Aspirin 75mg daily following insertion of non-drugeluting stent for a period of 1 month

In combination with Aspirin 75mg daily following a STEMI for a period of
28 days (secondary care provision)
In all cases where Clopidogrel is initially used in combination with Aspirin, when
the Clopidogrel is stopped, anti-platelet therapy continues with Aspirin 75mg
daily alone.
Patients requiring treatment with clopidogrel and PPI should avoid omeprazole
and esomeprazole which may reduce the effects of clopidogrel on platelet
function and lead to poorer long-term patient outcomes (death and readmission).
The effect of clopidogrel is also antagonised by calcium-channel blockers and
some statins.
Prasugrel
Prescribers should
ensure that all
prescriptions for
prasugrel have a
stop date and that
no repeats are
issued after that
date.
Cardiovascular system
5mg tablets: £47.56
10mg tablets:£47.56
Prasugrel in combination with aspirin is recommended as an option for
preventing atherothrombotic events in people with acute coronary syndromes
having percutaneous coronary intervention, only when:
• immediate primary percutaneous coronary intervention for ST-segmentelevation myocardial infarction is necessary or
• stent thrombosis has occurred during clopidogrel treatment or
• the patient has diabetes mellitus.
Treatment should continue for 12 months unless discontinued earlier, e.g. for
side effects (NICE TA182: Acute coronary syndrome - prasugrel)
Page 38
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
Ticagrelor
£54.60 (56)
Ticagrelor in combination with low-dose aspirin is recommended for up to 12
months as a treatment option in adults with acute coronary syndromes (ACS) as
follows:
• with ST-segment-elevation myocardial infarction (STEMI) or
• with non-ST-segment-elevation myocardial infarction (NSTEMI) or
• admitted to hospital with unstable angina – defined as ST or T wave changes
on electrocardiogram suggestive of ischaemia plus one of the characteristics
defined in guidance.
Before ticagrelor is continued beyond the initial treatment, the diagnosis of
unstable angina should first be confirmed, ideally by a cardiologist.
Prescribers should
ensure that all
prescriptions for
ticagrelor have a
stop date and that
no repeats are
issued after that
date.
See NICE TA236: Ticagrelor for the treatment of acute coronary syndromes
Hyperglycaemia in ACS
Hyperglycaemia is common in people admitted to hospital with ACS. Hyperglycaemia at the time of admission with ACS is a powerful predictor of poorer survival
and increased risk of complications while in hospital, regardless of whether or not the patient has diabetes.
All patients with hyperglycaemia after ACS and without known diabetes tests for should be tested for • HbA1c levels before discharge and • fasting blood glucose
levels no earlier than 4 days after the onset of ACS.
GPs should offer at least annual monitoring of HbA1c and fasting blood glucose levels to people without known diabetes who have had hyperglycaemia after an
episode of ACS
Cardiovascular system
Page 39
2.12 Lipid-regulation
Primary prevention of CVD (based on NICE Clinical Guideline CG67 (2008): Lipid modification)
 For primary prevention of CVD in primary care, a systematic strategy should be used to identify people aged 40–74 likely to be at high risk.
 People should be prioritised on the basis of an estimate of their CVD risk before a full formal risk assessment. Their CVD risk should be estimated using CVD
risk factors already recorded in primary care electronic medical records.
 The Framingham 1991 10-year risk equations1 should be used to assess CVD risk.
 People should be offered information about their absolute risk of CVD and about the absolute benefits and harms of an intervention over a 10-year period.
This information should be in a form that:
 presents individualised risk and benefit scenarios
 presents the absolute risk of events numerically
 uses appropriate diagrams and text (See www.npci.org.uk)
 Before offering lipid modification therapy for primary prevention, all other modifiable CVD risk factors should be considered and their management optimised if
possible. Baseline blood tests and clinical assessment should be performed, and comorbidities and secondary causes of dyslipidaemia should be treated.
Assessment should include:
 smoking status
 alcohol consumption
 blood pressure (see NICE CG127: Hypertension)
 body mass index or other measure of obesity (see NICE CG43: Obesity)
 fasting total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides (if fasting levels are not already available)
 fasting blood glucose
 renal function
 liver function (transaminases)
 thyroid-stimulating hormone (TSH) if dyslipidaemia is present
 Statin therapy is recommended as part of the management strategy for the primary prevention of CVD for adults who have a 20% or greater 10-year risk of
developing CVD. This level of risk should be estimated using an appropriate risk calculator, or by clinical assessment for people for whom an appropriate risk
calculator is not available or appropriate (for example, older people, people with diabetes or CKD or people in high-risk ethnic groups) (see NICE TA94:
Cardiovascular disease – statins)
 Treatment for the primary prevention of CVD should be initiated with simvastatin 40 mg. If there are potential drug interactions, or simvastatin 40 mg is
contraindicated, a lower dose or alternative preparation such as pravastatin may be chosen.
1
Anderson KM, Odell PM, Wilson PW et al. (1991) Cardiovascular disease risk profiles. American Heart Journal 121: 293–8.
Cardiovascular system
Page 40
Secondary prevention of CVD (based on NICE Clinical Guideline CG67 (2008): Lipid modification)
 For secondary prevention, lipid modification therapy should be offered and should not be delayed by management of modifiable risk factors. Blood tests and
clinical assessment should be performed, and co-morbidities and secondary causes of dyslipidaemia should be treated. Assessment should include:
 smoking status
 alcohol consumption
 blood pressure (see NICE CG127: Hypertension)
 body mass index or other measure of obesity (see NICE CG43: Obesity)
 fasting total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides (if fasting levels are not already available)
 fasting blood glucose (see NICE CG87: Type 2 diabetes – newer agents (a partial update of CG66)
 renal function (see NICE CG73: Chronic kidney disease)
 liver function (transaminases)
 thyroid-stimulating hormone (TSH) if dyslipidaemia is present
 Statin therapy is recommended for adults with clinical evidence of CVD (see NICE TA94: Cardiovascular disease – statins)
 Offer statins to people with CKD for secondary prevention of CVD irrespective of baseline lipid values
 Offer antiplatelet drugs to people with CKD for secondary prevention of CVD
 Treatment for the secondary prevention of CVD should be initiated with simvastatin 40 mg. If there are potential drug interactions, or simvastatin 40 mg is
contraindicated, a lower dose or alternative preparation such as pravastatin may be chosen.
 Any decision to offer a higher intensity statin should take into account informed preference, comorbidities, multiple drug therapy, and the benefit and risks of
treatment.
 There is an increased risk of myopathy associated with high-dose (80mg) simvastatin. The 80mg dose should be considered only in patients with severe
hypercholesterolaemia and high risk of cardiovascular complications who have not achieved their treatment goals on lower doses, when the benefits are
expected to outweigh the potential risks. (see MHRA Drug Safety Update May 2010; 3 (10))
 People with acute coronary syndrome should be treated with a higher intensity statin. Any decision to offer a higher intensity statin should take into account the
patient's informed preference, comorbidities, multiple drug therapy, and the benefits and risks of treatment.

‘Higher intensity statins’ are statins used in doses that produce greater cholesterol lowering than simvastatin 40 mg.
 For people with diabetes and existing or newly diagnosed CVD (or an increased albumin excretion rate) intensifying cholesterol lowering therapy with a more
effective statin (first line) or ezetimibe (second line) to achieve TC < 4 or LDL <2.
Cardiovascular system
Page 41
Drug – statin interactions
 No restriction
 Monitor
Atorvastatin (ATV)
Amiodarone
Monitor lipid levels to ensure lowest
dose ATV used

No interaction

No interaction

Recommended max dose 20mg
SMV

Amlodipine
No interaction

No interaction

No interaction

Recommended max dose 20mg
SMV

Ciclosporin
Recommended maximum dose
10mg ATV

Recommended start dose 20mg
PRV, titrate to max 40mg with
caution

Contraindicated

Recommended max dose 10mg
SMV

Clarithromycin
If on 40mg or 80mg ATV: reduce
dose or temporarily suspend ATV

Monitor

No interaction

Contraindicated

Diltiazem
Monitor lipid levels to ensure lowest
dose ATV used

No interaction

No interaction

Recommended max dose 20mg
SMV

No interaction
May increase risk of myopathy

No interaction
May increase risk of myopathy
Rosuvastatin (RSV)
 Dosing restrictions
Drug
Ezetimibe
Pravastatin (PRV)
 Contraindicated / not recommended

No interaction
May increase risk of myopathy
Simvastatin (SMV)

No interaction

May increase risk of myopathy
Gemfibrozil
Recommended start dose 10mg
ATV and clinical monitoring

Not recommended

Recommended start dose 5mg
RSV, max dose 20mg

Recommended max dose 10mg
SMV

Grapefruit juice
Large quantities of grapefruit juice
not recommended

No interaction

No interaction

Not recommended

Itraconazole
If on 80mg ATV: reduce dose or
temprorarily suspend ATV

No interaction

No dose restrictions recommended

Contraindicated

Protease inhibitors
Monitor lipid levels to ensure lowest
dose ATV used

No interaction

Not recommended

Contraindicated

Verapamil
Monitor lipid levels to ensure lowest
dose ATV used

No interaction

No interaction

Recommended max dose 20mg
SMV

Warfarin
More frequent INR monitoring

No interaction (usual INR
monitoring)

More frequent INR monitoring

More frequent INR monitoring

Fusidic acid
Contraindicated – suspend ATV
Eslicarbazepine
No interaction
No interaction

No interaction
Contraindicated – suspend SMV
No interaction

Eslicarbazepine reduces systemic
exposure to RSV when coadministered

Eslicarbazepine reduces systemic
exposure to SMV when coadministered

All data sourced from SmPCs for ATV, PRV, RSV, and SMV. Ezetimibe information taken from Stockley‟s Drug Interactions, accessed online on 28.10.2010.
Cardiovascular system
Page 42
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
2.12 Lipid-regulating drugs
Monitoring of statin treatment for primary and secondary prevention:
 People on a statin should be advised to seek medical advice if they develop muscle symptoms (pain, tenderness or weakness). If this occurs, creatine kinase
should be measured.
 Creatine kinase should not be routinely monitored in asymptomatic people who are being treated with a statin.
 Baseline liver enzymes should be measured before starting a statin. Liver function (transaminases) should be measured within 3 months of starting treatment
and at 12 months, but not again unless clinically indicated.
 People who have liver enzymes (transaminases) that are raised but are less than 3 times the upper limit of normal should not be routinely excluded from
statin therapy.
 If a person develops an unexplained peripheral neuropathy, statins should be discontinued and specialist advice sought.
It is recommended that attempts should always be made to get patients to national cholesterol levels with statin monotherapy, using all formulary statins, before
consideration is given to adding in or changing to another agent.
A summary of drug –statins interactions is given on p.42
Statins
First line:
Simvastatin
10mg tablets: £0.74
20mg tablets: £0.82
40mg tablets: £1.05
80mg tablets: £1.82
®
as Simvador
10mg tablets: £0.67
20mg tablets: £0.74
40mg tablets: £0.95
80mg tablets: £1.64
Simvastatin is first line statin for all new patients unless contra-indicated.
It is included in the formulary for:
 Hypercholesterolaemia
 Primary prevention of cardiovascular events (where 10year CVD risk ≥ 20%)
 Secondary prevention of CV events
Please note:
 Simvastatin should be prescribed at night to optimise effect.
 Simvastatin 10mg should only be prescribed for patients who cannot tolerate
a higher evidence-based dose of statin therapy
 Simvastatin doses should not exceed 20mg for patients on Amiodarone,
Verapamil, Amlodipine or Diltiazem
 See BNF or SPC for further information on interactions
 There is an increased risk of myopathy associated with high-dose (80mg)
simvastatin. The 80mg dose should be considered only in patients with
severe hypercholesterolaemia and high risk of cardiovascular complications
who have not achieved their treatment goals on lower doses, when the
benefits are expected to outweigh the potential risks. (see MHRA Drug Safety
Update May 2010; 3 (10))
Continued on next page
Cardiovascular system
Page 43
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
Atorvastatin
10mg tablets: £1.30
20mg tablets: £1.76
40mg tablets: £1.99
80mg tablets: £3.73
Atorvastatin is included as a second line choice, for use where there are
potential drug interactions with Simvastatin 40 mg or where it is contraindicated,
and as high intensity statin first line for:
Statins
Continued from previous page
2nd line:
Pravastatin
10mg tablets: £1.65
20mg tablets: £2.08
40mg tablets: £2.75

patients with Familial Hypercholesterolaemia

patients with Acute Coronary Syndrome (ACS)
It should be noted that the maximum reduction in total cholesterol which can be
expected from Pravastatin is 24%.
Higher intensity statins should not routinely be offered to people for the primary
prevention of CVD. A target for total or LDL cholesterol is not recommended for
people who are treated with a statin for primary prevention of CVD.
3rd line:
Other lipid
lowering drugs
Cardiovascular system
Rosuvastatin
5mg tablets: £18.03
10mg tablets: £18.03
20mg tablets: £26.02
40mg tablets: £29.69
Pravastatin and Rosuvastatin have a different metabolic pathway so may be
tolerated when Simvastatin or Atorvastatin are not.
In general, the evidence for an effect on outcomes is less robust than for statin therapy. Additional monitoring may be required,
particularly when Fibrates or Nicotinic Acid are used in combination with statins, due to increased risk of myopathy.
Page 44
Therapeutic Area
4th line
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
Ezetimibe
10mg tablets: £26.31
Ezetimibe is included in the formulary only for:

Use as monotherapy for patients intolerant to a minimum of two
formulary statins

Use in addition to a statin for patients not at target on statin
monotherapy, where higher doses of that statin and an alternative statin
have been tried and are not tolerated
The ENHANCE study showed the addition of Ezetimibe had no effect on
primary or secondary endpoints and emerging evidence contributes to
lack of positive cardiovascular outcomes with ezetimibe alone.
Note: Ezetimibe & Simvastatin combination (Inegy) is non-formulary due to its
greater cost compared to separate Ezetimibe and Simvastatin.
Other lipid lowering
drugs
Fenofibrate
micronized
as Supralip brand
Nicotinic acid
Anionic exchange
resins
Questran
Colestipol
Colesevelam
200mg capsules: £2.56
160mg capsules: £6.69
Specialist
recommendation
ONLY
Primary prevention of CVD: Fibrates should not be routinely offered but may be
considered if Statins are not tolerated.
Fibrates may be considered for the secondary prevention of CVD for patients
unable to tolerate statins.
Prescribe a fibrate (fenofibrate) if triglyceride levels remain above 4.5mmol/litre
despite attention to other causes.
If cardiovascular risk is high eg. Type 2 diabetes; consider adding a fibrate
(fenofibrate) to statin therapy if TG levels remain in the range 2.3-4.5mmol/litre
despite statin therapy.
These lipid lowering drugs are usually initiated in secondary care by clinical
biochemists for patients with complex dyslipidaemias.
Nicotinic acid should not be offered for the primary prevention of CVD. Nicotinic
acid may be considered for the secondary prevention of CVD for patients unable
to tolerate statins.
Tredaptive (Nicotinic acid + laropiprant) is not recommended. Product
withdrawn Jan 2013 as results of HPS2-THRIVE trial failed to show
reduced risk of CV events & incidence of serious adverse events in the
treatment group was higher.
Anion exchange resins may be considered for the secondary prevention of CVD
for patients unable to tolerate statins.
Note: A meta-analysis of 14 RCTs of omega-3 fatty acid supplementation in the secondary prevention of cardiovascular disease found it did not reduce the risk
of cardiovascular events or all-cause mortality. Therefore, omega-3-acid ethyl esters (Omacor) is now non-formulary and should no longer be prescribed for
secondary prevention after ischaemic events.
Cardiovascular system
Page 45
Top
BNF Chapter 3: Respiratory System
Related guidance:
NICE Technology Appraisal TAG138 (2008): Asthma (in adults) - corticosteroids
BTS / SIGN Guideline 101 (May 2011): British Guideline on the Management of Asthma
 Written personalised action plans as part of self-management education have been shown to improve health outcomes for people with asthma and
should be offered to all patients. Asthma Self Care Plan on NHS Somerset website
Note on inhaler devices
 Patients ability to use different devices varies; assessment of response to a prescribed treatment should include evaluation of inhaler technique as
demonstrated by the patient
 First line recommendation is an MDI plus spacer on grounds of cost
 Aerochamber Plus® spacer (medium-volume) has a flexible gasket & should fit all MDIs however SPC should be checked to ensure device is compatible
Correct inhaler technique is vital to ensure maximum benefit is obtained from inhaled therapies. Because the force of inhalation is different for MDI and
dry powder inhalers, where possible patients should have just one type of device i.e. all MDI or all DPI (see Types of Inhaler patient information leaflet)
Safer use of inhaled corticosteroids (ICS)
 ALL patients on high dose ICS (ie > 1000mcg beclomethasone or equivalent daily) should be issued with a Steroid Card.
 ICS can have serious side effects: one study has shown an increased risk of diabetes onset and progression. The risk increased with higher doses – patients
on ICS doses of 1000mcg fluticasone/day or more (2000mcg beclometasone) had a 64% increased risk of developing diabetes compared to no ICS use.
 Stepping-down asthma therapy helps reduce the ICS dose and can be considered in patients with complete asthma control (for at least 12 weeks). For patients
on combination therapy the preferred approach is to reduce the ICS by approximately 50% while continuing LABA at the same dose initially. See the asthma
step-down guide for combination ICS/LABA inhalers p.54/55
 Different ICS have different potencies and the equivalent dose can also vary between devices. Standard practice is to express the dose equivalent to
beclometasone dipropionate in the old CFC-containing inhalers (and now in Clenil Modulite®) as shown below.
Weight for weight, the inhaled steroid in Qvar®, Fostair® and all fluticasone inhalers deliver a much higher steroid dose. REDUCE DOSE ACCORDINGLY IN
THESE PREPARATIONS.
400mcg Clenil Modulite® = 400mcg BDP
200mcg Qvar®
= 400-500mcg BDP
200mcg Fostair®
= 500mcg BDP
400mcg budesonide (Pulmicort®/Symbicort®/Easyhaler®)
= 400mcg BDP
200mcg fluticasone (Flixotide®/Seretide®/Flutiform®)
= 400mcg BDP
Respiratory System – Bronchodilators
Page 46
Therapeutic Area
Formulary Choices
Cost per inhaler
unless stated
Rationale for decision / comments
3.1 Bronchodilators
Short acting
beta-2 agonist
bronchodilators
(SABAs)
First line:
Using TWO or more canisters of beta-2 agonist per month is a marker of poorly controlled asthma that puts
patients at risk of fatal or near-fatal asthma (BTS/SIGN 2008 revised 2011).
Salbutamol
Cfc-free MDI
100mcg/dose: £1.50
(200 dose inhaler)
First line: MDI (plus spacer if necessary) on grounds of cost
If patient cannot manage an MDI plus spacer, consider a breath-activated MDI
or a dry powder device.
Second line:
Breath actuated
cfc-free MDI
as Airomir
Autohaler
100mcg/dose: £6.02
(200 dose)
as Salamol
Easi-breathe
100mcg/dose: £6.30
(200 dose)
or
Dry powder inhaler
as Salbutamol
Easyhaler
100mcg/dose: £3.31
(200 dose)
200mcg/dose: £6.63
(200 dose)
Respiratory System – Bronchodilators
Page 47
Therapeutic Area
Formulary Choices
Long acting
Beta-2 agonist
bronchodilators
(LABAs)
In asthma LABAs should only be added if regular use of a standard dose ICS has failed to control asthma adequately and
should be discontinued if there is no response to treatment. LABA should only be started in patients who are already on inhaled
corticosteroids, and the inhaled corticosteroid should be continued. Consider stopping LABAs in well-controlled patients once inhaled
corticosteroid dose has been reduced (see step-down guidance p54)
In COPD, LABAs should be used in line with the local COPD guidance (page 57) If no benefit after trial period, stop treatment
First line:
Cost per inhaler
unless stated
Rationale for decision / comments
Formoterol
Dry powder inhaler
as Easyhaler
as OxisTurbohaler
12mcg: £23.75 (120 dose)
Formoterol is the first line LABA as Easyhaler. Maintenance dose is 12mcg
once or twice daily.
6mcg: £24.80 (60 dose)
Turbohaler formulation is second line Formoterol option. It costs 2-4 times per
dose more than an Easyhaler. 12mg and 6mg strengths cost the same so use 1x
12mcg bd rather than 2x6mcg bd. Licensed over age of 6 years.
12mcg: £30.06 (100 dose)
MDI version licensed for over age of 12 years
25mcg: £29.26
(120 dose inhaler)
Salmeterol is the second line LABA
Usual maintenance dose of Salmeterol is 50mcg bd so the cost of the MDI and
Accuhaler is the same at this dose. Licensed over the age of 4 years
MDI
as Atimos
Second line:
Salmeterol
as cfc-free MDI
as Accuhaler
Indacaterol
as Breezhaler
Short acting
anticholinergic
bronchodilators
Ipratropium
as cfc-free MDI
Respiratory System – Bronchodilators
50mcg: £29.26
(60 dose inhaler)
150mcg: £29.26
(30 dose inhaler)
®
300mcg: £29.26
(30 dose inhaler)
20mcg: £5.05 (200 dose
inhaler)
Indacaterol is indicated for maintenance bronchodilator treatment of airflow
obstruction in adult patients with COPD.
This is a cost neutral alternative to established treatments and may be
appropriate for patients for whom once-daily administration is appropriate,
especially those not requiring inhaled corticosteroids. It has been approved by
the SMC.
Ipratropium should not be co-prescribed with Tiotropium due to risk of increased
anticholingeric adverse effects
Page 48
Therapeutic Area
Formulary Choices
Long acting
anticholinergic
bronchodilators
Aclidinium
bromide
as Eklira Genuair ▼
Dry powder inhaler
Glycopyrronium
bromide
as Seebri
Breezhaler® ▼
Cost per inhaler
unless stated
400mcg: £28.60
(60 dose pack)
as Handihaler
Dry powder inhaler
Aclidinium is licensed for the maintenance treatment of COPD. The dose is
400mcg bd. The device may be suitable for some patients who are unable to use
a Handihaler®.
NB. Each 400 mcg metered inhalation of aclidinium bromide delivers 322 mcg of
aclidinium
50mcg: £27.50
(30 capsules plus device)
50mcg: £27.50
(30 dose refill pack)
Tiotropium

Rationale for decision / comments
18mcg: £34.87
(30 dose starter pack)
18mcg: £33.50
(30 dose refill pack)
Glycopyrronium is licensed for the maintenance treatment of COPD. The dose is
50mcg od.
Each 50 microgram capsule delivers a dose of 44 micrograms of glycopyrronium
Tiotropium is only licensed for use in COPD and should be prescribed in line
with the local COPD guidance, which is consistent with the NICE guidance, see
page57 for more information.
If no benefit after trial period, stop treatment.
Repeat prescriptions should only be for refill packs owing to cost.
Tiotropium should not be combined with Ipratropium due to increased risk of
anticholinergic side-effects
as Respimat ▼
2.5mcg: £35.50
(60 dose pack)
Tiotropium Respimat (mist inhaler) was included in the formulary for patient
choice, however MHRA advise Tiotropium delivered by a mist inhaler was
associated with a non-significant increase in all-cause mortality (vs placebo)
while Tiotropium Handihaler was associated with a decrease in all-cause
mortality (vs placebo). The reasons are unclear.
A more recent meta-analysis has provided further evidence of a possible
increased risk of all-cause and death from cardiovascular causes (compared to
placebo and other inhaled treatments) associated with tiotropium delivered by
the Respimat device.
Use the mist inhaler with caution in patients with known cardiac rhythm
disorder and do not exceed recommended once daily dose for either
preparation
Respiratory System – Bronchodilators
Page 49
Therapeutic Area
Formulary Choices
Cost per inhaler
unless stated
Theophylline
Theophylline MR
Reduce the dose of theophyline if macrolide or quinolones antibiotics (or other
drugs known to interact) are prescribed to treat an exacerbation.
®
as Nuelin SA
175mg tablets: £6.38 (60)
250mg tablets: £8.92 (60)
Offer theophylline only after trials of short- and long-acting bronchodilators, or to
people who cannot use inhaled therapy.
as Slo-Phyllin
60mg capsules: £2.76 (56)
125mg capsules: £3.48 (56)
250mg capsules: £4.34 (56)
Theophylline can be used in combination with beta2 agonists and muscurinic
antagonists. Please note, the risk of hypokalaemia is increased when
theophylline is given in combination with a beta2 agonist.
as Uniphyllin
®
Continus
200mg tablets: £2.95 (56)
300mg tablets: £4.77 (56)
400mg tablets: £5.65 (56)
Take care when prescribing theophylline to older people. Consider altered
pharmacokinetics, comorbidities, and interactions with other medicines;
Prescribe by brand.
The rate of absorption
from modified-release
preparations can vary
between brands. If a
brand name is not
specified on the
prescription,
pharmacists should
contact the prescriber
to establish which
brand is to be
dispensed.
Rationale for decision / comments
®

Plasma theophylline level is increased in heart failure, hepatic
impairment, viral infections, in the elderly, and by drugs that inhibit its
metabolism.

Plasma theophylline level is decreased in smokers, by alcohol
consumption, and by drugs that induce its metabolism.
Aminophylline
Aminophylline m/r
as Phyllocontin
®
Continus
Respiratory System – Bronchodilators
225mg tablets: £2.39 (56)
350mg tablets: £4.22 (56)
Page 50
Therapeutic Area
3.2 Corticosteroids
Inhaled
corticosteroids (ICS)
Formulary Choices
Cost per inhaler
Rationale for decision / comments
(See advice on safer use of inhaled corticosteroids p )
BTS / SIGN Guideline (101) on the management of asthma states: many children with recurrent episodes of viral-induced wheezing in
infancy do not develop chronic atopic asthma and do not require regular inhaled steroids.
NICE TAG138 states: for patients with chronic asthma in whom an ICS is appropriate, the least costly product that is suitable
for the individual, within its license, is recommended
Beclometasone
NB. Prescribe beclometasone MDIs by brand name to avoid confusion over
the product intended. Clenil Modulite and Qvar are not equipotent – see
p46
®
Children up to age 15 should use these products with a Volumatic .
CFC-free MDIs as
Clenil Modulite
50mcg: £3.70 (200 dose)
100mcg: £7.42 (200 dose)
200mcg: £16.17 (200 dose)
250mcg: £16.29 (200 dose)
as Qvar
50mcg: £7.87 (200 dose)
100mcg: £17.21 (200 dose)
Dry powder
®
as Easyhaler
200mcg: £14.93 (200 dose)
Breath-actuated
CFC-free MDI as
Qvar Easi-breathe
50mcg: £7.74 (200 dose)
100mcg: £16.95 (200 dose)
Budesonide
as Easyhaler
100mcg:£8.86 (200 dose)
200mcg £17.71 (200 dose)
400mcg: £17.71 (100 dose)
Licensed from age 6 years.
Therapeutic Area
Formulary Choices
Cost per inhaler
unless stated
Rationale for decision / comments
Respiratory System – Inhaled Corticosteroids
Qvar is not licensed in patients under 12yrs.
Page 51
Combination
long-acting
beta-agonist steroid
inhalers
NICE TAG 138 states that for patients with chronic asthma in whom an ICS and LABA is appropriate, the following apply:
-
Use of a combination device within license is recommended as an option to ensure that long-acting β2 agonists are not taken
without an inhaled steroid.
The decision to use combinations or separates should be made on an individual basis.
If a combination is chosen the least costly device that is suitable for the individual, within its license, is recommended
Flutiform ▼
(Fluticasone /
Formoterol)
CFC-free MDI
50mg/5mcg £18
125mg/5mcg £29.26
250mg/10mcg £45.56
(120 dose inhaler)
Licensed for asthma only at Step 3 or above of the BTS / SIGN guidelines.
Flutiform 50mcg and 125mcg are licensed for adults and children over 12 yrs..
The 250mcg strength is licensed for over 18 years only and is nonformulary owing to limited indication for high dose fluticasone in asthma
(estimated only 1% asthma patients should need such high dose
combination)
Fostair ▼
(Beclomethasone /
Formeterol)
CFC-free MDI
100/6mcg: £29.32
(120 dose inhaler)
OVER 18 YEARS ONLY
WARNING: beclomethasone 100mcg in Fostair is equivalent to 250mcg of
standard beclomethasone because of extra fine particle size – see p XX.
Patient should receive specific training and information leaflet on this issue.
Fostair is also licensed for combined maintenance and reliever therapy
(maximum 8 puffs per day). Any patient using this approach needs very careful
counselling and monitoring. Eight puffs is equivalent to a daily dose of
2000mcg standard BDP.
Fostair CFC-free MDI inhalers should be refrigerated until needed.
Each inhaler has a 5 month shelf-life once removed from cold storage.
Symbicort Turbohaler
(Budesonide /
Formoterol)
Dry-powder inhaler
100/6mcg: £33.00
(120 doses)
200/6mcg: £38.00
(120 doses)
400/12mcg: £38.00
(60 doses)
Some dosing flexibility is possible with Symbicort, it is still not as flexible as
ICS and LABA prescribed separately. Symbicort is the preferred combination
as Budesonide is equipotent to BDP and Formoterol has a faster onset of
action. It is licensed in COPD. The 100/6 strength is now licensed in age >6
yrs.
Symbicort Maintenance and Reliever Therapy (SMART). Patients over 18
years, at Step 3, who are poorly controlled may also use Symbicort 200/6 as
a rescue medication (maximum 12 puffs per day), with no Salbutamol. This
approach to treatment requires careful patient education and quantity of
inhalers used should be monitored.
Respiratory System – Inhaled Corticosteroids
Page 52
Therapeutic Area
Formulary Choices
Cost per inhaler
unless stated
Rationale for decision / comments
Seretide Evohaler
(Fluticasone /
Salmeterol 25mcg)
CFC-free MDI
50mcg: £18.00
(120 doses)
125mcg: £35.00
(120 doses)
250mcg: non-formulary
Seretide Evohaler 250mcg is non-formulary, due to cost and limited
need for high dose Fluticasone in asthma (estimated only 1% asthma
patients should need such high dose combination)
100mcg: £18.00 (60 dose)
250mcg: £35.00 (60 dose)
500mcg: £40.92 (60 dose)
Seretide 500mcg Accuhaler is included for moderate to severe COPD where
there is proven response to ICS. If no benefit after a trial period, stop
treatment.
Continued from previous page)
Seretide Accuhaler
(Fluticasone /
Salmeterol 50mcg)
Dry powder inhaler
Spacer devices
Medium volume:
Large volume:
Seretide 50mcg & 125mcg Evohalers included for asthma: for patients at
Step 3 or above of the BTS / SIGN guidelines. Note that the 50mcg Evohaler 
is licensed for adults and children over 4 years and the 125mcg inhaler for
adults and children over 12 years. This change is based on NICE guidance on
inhaled corticosteroid for treatment of children with chronic asthma which
states that the choice of product should be based on suitability for the
individual child, licensed indication and cost.
Patient‟s ability to use different devices varies; assessment of response to a prescribed treatment should include evaluation of inhaler
technique as demonstrated by patient. First line recommended is MDI plus spacer on grounds of cost.
AeroChamber Plus
standard adult (blue)
£4.69 (1)
adult with mask (blue)
£7.83 (1)
infant with mask (orange)
£7.83 (1)
child with mask (yellow)
£7.83 (1)
Volumatic

Respiratory System – Inhaled Corticosteroids
£2.91 (1)
The AeroChamber Plus is recommended as the spacer device of choice, in
view of its portability and flexible inhaler orifice, which permits most MDIs to be
used with it. MHRA advise that deposition and therefore effectiveness and
adverse effects may differ from Volumatic
AeroChamber Plus spacer devices should fit ALL MDI devices (inhaler
mouthpiece fits into flexible gasket.) but prescribers should check SPC .
®
Volumatic spacer device is only compatible with inhalers manufactured by
GSK or if mouthpiece has same specifications as inhalers manufactured by
GSK.
Page 53
Asthma Step-down Guide: Combination MDIs: Note: all doses are for asthma maintenance therapy, not asthma maintenance and reliever therapy
BTS/SIGN Step 4/5
Seretide
Evohaler
®
Flutiform®
inhaler
Seretide 250 Evohaler®
2 puffs bd
Seretide 125 Evohaler®
2 puffs bd
Seretide 50 Evohaler®
2 puffs bd
*(2000mcg/100mcg salmeterol)
NB. Non-formulary
*(1000mcg/100mcg salmeterol)
*(400mcg/100mcg salmeterol)
Flutiform®
250mcg/10mcg
2 puffs bd
*(2000mcg/40mcg formoterol)
NB. Non-formulary
BTS/SIGN Step 4
Fostair
Inhaler®
BTS/SIGN Step 3
Fostair® 100/6 Inhaler
2 puffs bd
*(1000mcg/ 24mcg formoterol)
Flutiform® 125mcg/5mcg
2 puffs bd
Flutiform® 50mcg/5mcg
2 puffs bd
*(1000mcg/20mcg formoterol)
*(400mcg/20mcg formoterol)
BTS/SIGN Step 3
Stepping down from Fostair is potentially problematic as there is only one
strength. Therefore either the device has to be changed or the LABA dose
reduced alongside the ICS.
OPTION 1:
Fostair 100/6 Inhaler 1 puff bd
®
BTS/SIGN Step 2
Prescribe an MDI
equivalent to 400500mcg BDP/day:
Clenil Modulite® 100mcg
2 puffs bd
OR
Qvar Easi-Breathe®
50mcg
2 puffs bd
OR
®
Qvar MDI 50mcg
2 puffs bd
OR
Fluticasone 50 Evohaler®
2 puffs bd
NB. Fluticasone inhalers
are non-formulary but are
included for comparison
*(500mcg/12mcg formoterol)
OPTION 2
Consider change to Flutiform® 50/5 2 puffs bd
Key (for both pages of step-down guide):
*(400mcg/20mcg formoterol)
*Total daily dose of inhaled corticosteroid, in terms of
beclometasone dipropionate (BDP) equivalent/ long
acting beta-agonist
OPTION 3
Consider change to separate corticosteroid and
LABA inhalers
Respiratory System – Inhaled Corticosteroids
Page 54
Asthma Step-down Guide – combination DPIs:
Note: all doses are for asthma maintenance therapy, not asthma maintenance and reliever therapy (e.g. not the SMART ® regime)
BTS/SIGN Step 3
Symbicort
Turbohaler
®
400/12
Symbicort
Turbohaler
®
200/6
BTS/SIGN Step 2
Symbicort 400/12 Turbohaler®
1 puff bd
Symbicort 100/6 Turbohaler®
2 puffs bd
*(800mcg/ 24mcg formoterol)
*(400mcg/24mcg formoterol
Prescribe a DPI
equivalent to 400500mcg BDP/day:
Symbicort 200/6 Turbohaler®
2 puffs bd
Symbicort 100/6 Turbohaler®
2 puffs bd
Easyhaler®
Beclometasone 200mcg
1 puff bd
OR
*(800mcg/ 24mcg formoterol)
*(400mcg/ 24mcg formoterol)
Easyhaler® Budesonide
200mcg
1 puff bd
OR
Symbicort 200/6 Turbohaler®
1 puff bd
*(400mcg/ 12mcg formoterol)
Symbicort
Turbohaler
®
100/6
Symbicort 100/6 Turbohaler®
2 puffs bd
®
BTS/SIGN Step 3
Seretide 500 Accuhaler®
1 puff bd
Seretide 250
Accuhaler® 1 puff bd
Seretide 100 Accuhaler®
1 puff bd
*(2000mcg/100mcg salmeterol)
*(1000mcg/100mcg salmeterol)
*(400mcg/100mcg salmeterol)
Respiratory System – Inhaled Corticosteroids
®
Fluticasone 100 Accuhaler®
1 puff bd
*(400mcg/ 24mcg formoterol)
BTS/SIGN Step 4/5
Seretide
Accuhaler
Budesonide Turbohaler
200mcg
1 puff bd
OR
NB. Fluticasone Accuhaler®
and budesonide Turbohaler®
are non-formulary but are
included here as some patients
on Seretide Accuhale®r or
Symbicort Turbohaler® may
benefit from stepping down to
the same device. Use formulary
devices where possible.
Page 55
Therapeutic Area
Formulary Choices
Cost per inhaler
unless stated
Rationale for decision / comments
3.3.2 Leukotriene receptor antagonists
Leukotriene receptor
antagonists
Montelukast
Chewable tablets
Tablets
Granules
Zafirlukast
Respiratory System – Inhaled Corticosteroids
4mg tablets: £25.69 (28)
5mg tablets: £25.69 (28)
10mg tablets: £26.97 (28)
4mg granules: £25.69 (28)
Included for add-on therapy according to BTS & SIGN guidelines for the
management of chronic asthma (BNF) and
BTS/SIGN 2008 revised 2011
20mg tablets: £17.75 (56)
Page 56
GUIDANCE FOR MANAGING COPD IN ACCORDANCE WITH NICE CLINICAL GUIDELINE CG101 (JUNE 2010)
ADAPTED BY NHS SOMERSET MEDICINES MANAGEMENT TEAM
FROM AN ORIGINAL PRODUCED BY SOMERSET LUNG CENTRE, MUSGROVE PARK, TAUNTON
CONSIDERATIONS
 STOP SMOKING, VACCINATIONS (pneumococcal, and annual influenza), THINK PULMONARY REHAB (MRC >3), PATIENT EDUCATION
 Remember, COPD is generally NOT a steroid-responsive disease, but:

There is evidence that some patients with more severe disease, or those who exacerbate frequently (more than twice a year), benefit from inhaled steroids. Trial
data shows an improvement in both exacerbation frequency and health status of these groups but patients are at increased risk of contracting pneumonia.

Do NOT use oral corticosteroids routinely for maintenance therapy

Do NOT use oral corticosteroid reversibility tests to identify patients who will benefit from inhaled corticosteroids (ICS).
 Smoking cessation MUST be offered at every opportunity to people with COPD who still smoke, regardless of age.
 Combivent was discontinued in June 2008. Options are separate salbutamol/ipratropium inhalers (non-persistent symptoms), or a trial of tiotropium (persistent symptoms).
 Don‟t just assess on physiology. Use symptoms to determine inhaler benefit. Withdraw add on therapy if no benefit after trial.
Determining disease severity
Disability in COPD can be poorly reflected in the FEV1. A more comprehensive assessment should also include:

degree of airflow obstruction and disability

frequency of exacerbations

prognostic factors such as breathlessness (assessed using the Medical Research Council (MRC) scale, carbon monoxide lung transfer factor (TLCO), health status, exercise
capacity, BMI, partial pressure of oxygen in arterial blood (PaO2), and cor pulmonale.
Severity of airflow obstruction
Gold 1: Mild
≥ 80% predicted FEV1
Gold 2: Moderate
50-79% predicted FEV1
Gold 3: Severe
30-49% predicted FEV1
Symptoms should be present to diagnose
COPD in people with mild airflow obstruction
Symptoms
Respiratory System – Inhaled Corticosteroids
Gold 4: Very severe
< 30% predicted FEV1
Or FEV1 < 50% with respiratory failure
Choice of inhaled therapy in COPD
Page 57
SABA e.g. salbutamol or terbutaline, OR SAMA e.g. ipratropium as required.
SABA should continue through all stages of symptoms
Breathlessness
and/or exercise
limitation
FEV1 ≥ 50%
Exacerbations or
persistent
breathlessness
LABA
e.g. Formoterol, Salmeterol,
or Indacaterol
FEV1 < 50%
LAMA
e.g. Tiotropium
Aclidinium
Glycopyrronium
LABA + ICS
in a combination inhaler
Give LABA + LAMA if ICS
is declined or not tolerated.
Discontinue SAMA.
Give LAMA in preference
to regular SAMA.
Persistent
exacerbations or
breathlessness
LABA + ICS in a combination inhaler.
Discontinue SAMA.
Give LAMA in preference to
regular SAMA
LAMA
+
LABA + ICS in a combination inhaler.
Consider LABA + LAMA if ICS is declined or
not tolerated.
Definition of terms
LAMA
e.g. Tiotropium
Aclidinium
Glycopyrronium
Recommended product and daily dose
SABA
Short-acting beta2 agonist
Salbutamol (as Ventolin) 100mcg PRN, or up to QDS (max: 400mcg daily)
SAMA
Short-acting muscurinic antagonist
Ipratropium 20mcg PRN, up to QDS (max: 80mcg daily)
LABA
Long-acting beta2 agonist
Formoterol 24mcg BD via Easyhaler or Turbohaler
or Salmeterol 50mcg BD via MDI and spacer
Recommended trial period
Continue throughout
Stop if LAMA introduced
2 weeks
or Indacaterol 150-300mcg OD via Breezhaler
LAMA
Long-acting muscurinic antagonist
Aclidinium 400mcg bd via DPI
6-8 weeks
Glycopyrronium 50mcg daily via DPI
Tiotropium 18mcg daily via Handihaler (when initiating, discontinue ipratropium).
LABA + ICS
Inhaled corticosteroid
Symbicort Turbohaler 400/12: 1-2 actuations BD
3 months
or Seretide Accuhaler 500/50: 1 actuation BD
Respiratory System – Inhaled Corticosteroids
Page 58
Delivery systems
Inhalers
Spacers
Nebulisers

Hand-held devices are usually best, with a spacer if appropriate

If a person cannot use a particular device, try another

Teach technique before prescribing and check regularly

Ensure the spacer is compatible with the inhaler (aerochamber fits most inhaler devices)

Individuals should make single actuations of the inhaler into the spacer, and inhale as soon as possible, repeating as needed

Tidal breathing is as effective as single breaths

Do not clean spacers more than once a month

Clean with water and washing-up liquid and allow to air dry

Consider a nebuliser for people with distressing or disabling breathlessness despite maximum therapy with inhalers

Assess the individual and/or carers ability to use the nebuliser before prescribing and arrange appropriate support and maintenance of equipment

Allow the patient to choose either a facemask or mouthpiece where possible

Continue nebuliser treatment only if there is an improvement of symptoms, daily living activities, exercise capacity or lung function
Oral therapies

Corticosteroids are not normally recommended for maintenance therapy, but may be of use in some people with advanced COPD where corticosteroid
treatment cannot be stopped after an exacerbation

Keep dose as low as possible, monitor for osteoporosis and offer prophylaxis

Theophylline should be considered only after trials of short- and long-acting bronchodilators, or in people who cannot use inhaled therapy

Theophylline can be used in combination with inhaled beta 2 agonists and muscurinic antagonists

Take care when prescribing to older people because of pharmacokinetics, comorbidities and interactions with other medications

Reduce theophylline dose if macrolide or flouroquinolone antibiotics (or other drugs known to interact) are prescribed to treat an exacerbation
Mucolytic
therapy

Mucolytic therapy can be considered in people with chronic productive cough, and continued if symptoms improve

Do not routinely use to prevent exacerbations
Not
Recommended

Anti-oxidant therapy (alpha-tocopherol and beta-carotene supplements)

Anti-tussive therapy

Prophylactic antibiotic therapy
Corticosteroids
Theophylline
Respiratory System – Inhaled Corticosteroids
Page 59
Assess symptoms or condition and manage as described below
Breathlessness
and
exacerbations
Frequent
exacerbations
Cor pulmonale

Manage breathlessness and Fexercise limitation with inhaled therapy

For exacerbations or persistent breathlessness:
– use long-acting bronchodilators or LABA + ICS
– consider adding theophylline if still symptomatic

Offer pulmonary rehabilitation to all suitable people

Refer patients who are breathless, have a single large bulla on a CT scan and an FEV1 less than 50% predicted for consideration of bullectomy

Refer people with severe COPD for consideration of lung volume reduction surgery if they remain breathless with marked restrictions of their activities of
daily living, despite maximal medical therapy (including rehabilitation), and meet all of the following:
– FEV1 greater than 20% predicted
– PaCO2 less than 7.3 kPa
– upper lobe predominant emphysema
– TLCO greater than 20% predicted

Consider referring people with severe COPD for assessment for lung transplantation if they remain breathless with marked restrictions of their activities of
daily living despite maximal medical therapy. Considerations include:
– age
– FEV1
– PaCO2
– homogeneously distributed emphysema on CT scan
– elevated pulmonary artery pressures with progressive deterioration
– comorbidities
– local surgical protocols

Optimise inhaled therapy

Offer vaccinations and prophylaxis

Give self-management advice

Consider osteoporosis prophylaxis for people requiring frequent oral corticosteroids

Consider in people who have peripheral oedema, a raised venous pressure, a systolic parasternal heave, a loud pulmonary second heart sound

Exclude other causes of peripheral oedema

Perform pulse oximetry, ECG and echocardiogram if features of cor pulmonale

Assess need for LTOT

Treat oedema with diuretic

Angiotensin-converting enzyme inhibitors, calcium channel blockers, alpha-blockers are not recommended

Digoxin may be used where there is atrial fibrillation
Respiratory System – Inhaled Corticosteroids
Page 60
Assess symptoms or condition and manage as described below (continued)
Respiratory
failure

Assess for appropriate oxygen

Consider referral for assessment for long-term domiciliary NIV therapy
Abnormal BMI

Refer for dietetic advice

Offer nutritional supplements if the BMI is low

Pay attention to weight changes in older patients (especially > 3 kg)
Chronic
productive
cough

Consider mucolytic therapy
Anxiety and
depression

Screen for anxiety and depression using validated tools in people who:
– are hypoxic
– are severely breathless or

Refer to „Depression with a chronic physical health problem‟ (NICE clinical guideline 91).
Alpha-1
antitrypsin
deficiency

Offer referral to a specialist centre to discuss the clinical management of this condition

Alpha-1 antitrypsin replacement therapy is not recommended
Palliative setting

Opioids should be used when appropriate for the palliation of breathlessness in people with end-stage COPD unresponsive to other medical therapy

Use benzodiazepines, tricyclic antidepressants, major tranquillisers and oxygen to treat breathlessness

Provide access to multidisciplinary palliative care teams and hospices
–
have recently been seen or treated at a hospital for an exacerbation
Respiratory System – Inhaled Corticosteroids
Page 61
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
3.4.1 Antihistamines
Non-sedating
antihistamines
For nasal allergy and treatment with corticosteroid nasal sprays, please see Chapter 15.
First line:
Loratadine
10mg tablets: £1.03 (30)
5mg/5ml solution: £2.26
(100ml)
Loratadine is first line on basis of low rate of motor impairment and costeffectiveness. Loratadine is available OTC.
Second line:
Cetirizine
10mg tablets: £0.89 (30)
5mg/5ml solution: £1.78
(200ml)
Cetirizine is second line as more likely to impair motor function than Loratadine.
Cetirizine is available OTC.
Chlorphenamine
4mg tablets: £0.91
2mg/5ml SF solution: £2.49
(150ml)
Chlorphenamine is available OTC.
Sedating
antihistamines
3.7 Mucolytics
Mucolytics
Carbocisteine
as Mucodyne
®
Do not routinely use to prevent exacerbations.
375mg capsules:
£18.98(120)
125mg/5ml liquid: £5.08
(300ml)
250mg/5ml liquid: £6.59
(300ml)
Acetylcysteine
Respiratory System – Inhaled Corticosteroids
Carbocistine can be considered in patients with COPD with copious of tenacious
sputum. Trial carbocysteine 750mg tds for 4 weeks and stop if ineffective. If
effective reduce to bd.
Dose: initially 2.25g daily in divided doses,
then 1.5g daily in divided doses as condition improves
Acetylcysteine is unlicensed and for specialist prescribing only.
Erdocysteine is non-formulary
Page 62
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
BNF Chapter 4: Central nervous system
Top
4.1 Hypnotics and anxiolytics
Hypnotics
Temazepam
10mg tablets: £4.23
20mg tablets: £2.71
Patients should be advised to adopt better sleep hygiene and other lifestyle
changes, where appropriate. A leaflet advising on sleep hygiene measures is
available on PCT website. The National Prescribing Centre also produced a
useful document, The Good Relaxation Guide, which contains information that
can be printed off for patients.
Initial prescriptions for hypnotics should be limited to 7-14 days supply and not
transferred to repeat without re-assessment of the patient. Tolerance can
develop within 3 to 14 days of continuous use and long term efficacy is not
assured.
Patients who do not benefit from a first Z-drug are unlikely to benefit from
another.
In line with the NICE guidance on hypnotics the formulary does not
recommend the initiation of "Z" drugs, such as zopiclone and zolpidem.
NB. Whilst "Z-drugs" will continue to be used within T&ST (as a result of CD
issues), no patient will be discharged on these drugs unless prescribed them
prior to admission.
Different rules may apply to patients cared for by Somerset Partnership NHS
Foundation Trust.
Anxiolytics
Diazepam
2mg tablets: £0.73
5mg tablets: £0.74
Treatment should be limited to lowest dose for the shortest period of time.
Central Nervous System
Page 63
Therapeutic Area
4.2
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
Drugs used in psychoses and related disorders
Related guidance: NICE Clinical Guideline CG82 (2009): Schizophrenia (update)
NICE Technology Appraisal TA213 (2011): Aripiprazole for the treatment of schizophrenia in people aged 15 to 17 years
Antipsychotics
Antipsychotics are usually initiated within secondary care, following Somerset Partnership guidelines.
Prescribing responsibility may then be transferred to primary care in accordance with a Shared Care Agreement.
Regular combined treatment with two or more antipsychotic agents is not recommended
NICE CG82:
When deciding on
the most suitable
medication: consider
the relative potential
of individual
antipsychotics to
cause
extrapyramidal side
effects (such as
akathisia), metabolic
side effects (such as
weight gain), and
other side effects
(including
unpleasant
subjective
experiences).
Risperidone
1mg tablets: £0.83 (20)
2mg tablets: £1.61 (60)
3mg tablets: £1.84 (60)
4mg tablets: £1.79 (60)
Risperidone
long-acting
injection
®
(Risperdal Consta )
NB Cold chain must
be maintained.
25mg: £79.69 (1)
37.5mg: £111.32 (1)
50mg: £142.76 (1)
Olanzapine
2.5mg tablets: £1.17
5mg tablets: £1.82
7.5mg tablets: £2.17
10mg tablets: £2.67
15mg tablets: £3.54
20mg tablets: £4.81
Aripiprazole
5mg tablets: £96.04
10mg tablets: £96.04
15mg tablets: £96.04
30mg tablets: 192.08
Central Nervous System
Risperidone is licensed for the short-term treatment, up to six-weeks, of
persistent aggression in patients with moderate to severe Alzheimer‟s
dementia unresponsive to non-pharmacological approaches and when there is
a risk of harm to self or others.
NB 6 week restriction does not apply where risperidone is being
prescribed to treat acute or chronic psychoses or mania
All other antipsychotics are unlicensed for use in dementia and should only be
used when a person is a risk to themselves and others and all other methods
have been tried. Prescribers are reminded that all antipsychotics are
associated with an increased risk of serious adverse reactions in elderly
patients with dementia, (mortality, stroke, TIA and possibly cognition).
Aripiprazole is recommended as an option for the treatment of schizophrenia in
people aged 15 to 17 years who are intolerant of risperidone, or for whom
risperidone is contraindicated, or whose schizophrenia has not been
adequately controlled with risperidone (NICE TA213).
Page 64
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
Quetiapine
25mg tablets: £2.62 (60)
100mg tablets: £5.82 (60)
150mg tablets: £7.76 (60)
200mg tablets: £6.61 (60)
300mg tablets: £10.50 (60)
Where quetiapine is prescribed, the standard release formulation is preferred
for long term use on cost grounds (approx. 15 x price difference). This
approach is supported by Somerset Partnership Mental Health Directorate.
4.2.3 Antimanic drugs
Bipolar Disorder
Initiation of lithium therapy is the responsibility of Somerset Partnership NHS Foundation Trust after which care may be transferred to general practice under
shared care guidance. All healthcare organisations in the NHS where lithium therapy is initiated, prescribed, dispensed and monitored are asked to ensure that
by 31 December 2010:

Patients prescribed lithium are monitored in accordance with NICE guidance.

There are reliable systems to ensure blood test results are communicated between laboratories and prescriber.

At the start of lithium therapy and throughout their treatment patients receive appropriate ongoing verbal and wrttten information and a record book to
track lithium blood levels and relevant clinical tests.

Prescribers and pharmacists check that blood tests are monitored regularly and is is safe to issue a repeat prescription and/or dispense the prescribed
lithium.
 Systems are in place to identify and deal with medicines that might adversely interact with lithium therapy.
Suplies of record books and alert cards are available from:
Somerset Partnership Support Services,
Mallard Court, Express Park, Bridgwater, TA6 4RN
 01278 726964
Lithium
Lithium carbonate
Preparations vary widely in bioavailability:
®
+
For safety reasons inas Camcolit 250
250mg: £3.22 (100)
Li 6.8mmol/tablet
line with national
®
400mg: £4.30 (100)
Modified-release.
guidance lithium must as Camcolit 400
+
Li 10.8mmol/tablet
be prescribed by brand
®
as Liskonium 450mg
450mg: £2.88 (60)
Modified-release.
+
Li 12.2mmol/tablet
®
200mg: £2.30 (100)
Modified-release.
+
Li 5.4mmol/tablet
®
400mg: £3.35 (100)
Modified-release.
+
Li 10.8mmol/tablet
as Priadel 200mg
as Priadel 400mg
Central Nervous System
Page 65
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
4.3 Antidepressants
Do not routinely prescribe antidepressants for initial treatment of mild depression or persistent subthreshold depressive symptoms.
Do NOT initiate Dosulepin
Selective serotonin
re-uptake inhibitors
(SSRI)
Fluoxetine
20mg capsules: £0.84 (30)
As Oxactin
or
20mg capsules: £0.76
Fluoxetine, citalopram and sertraline are all included as first-line options for
SSRI. The long half-life of fluoxetine is a benefit on withdrawal, but a
drawback when switching drugs, e.g. to a TCA.
In elderly or with reduced hepatic function maximum dose of citalopam is 20mg
and maximum dose of escitalopram is 10mg.
See flowchart p.67 & p68 for options
Sertraline
or
50mg tablets: £1.06
100mg tablets: £1.22
NB. SSRIs are known to increase risk of GI bleeds especially if co-prescribed
with NSAIDs and in the very elderly.
Citalopram
10mg tablets: £0.90
20mg tablets: £0.88
40mg tablets: £1.05
Prescribers are reminded of the risk of serotonin syndrome with SSRI when
combined with other antidepressants, triptans, and opioids including tramadol.
Tricyclic and related
antidepressants
TCAs should be avoided for the treatment of depression in the elderly, due to increased risk of adverse effects,
e.g. cardiac especially in high doses.
First-line:
Lofepramine
70mg tablets: £11.71 (56)
Second-line:
Amitriptyline
10mg tablets: £0.73
25mg tablets: £0.74
50mg tablets: £0.82
Other
antidepressants
Mirtazapine
15mg tablets: £2.35
30mg tablets: £1.59
45mg tablets: £2.72
Oro-dispersible
tablets:
Lofepramine is the drug of choice in this group as it is safer and produces
fewer adverse effects than traditional tricyclics. NB: Lofepramine is now more
expensive than Fluoxetine.
Mirtazapine is a second-line line option, sedating properties may be useful
where insomnia is a problem.
15mg tablets: £1.99 (30)
30mg tablets: £1.83 (30)
45mg tablets: £2.30 (30)
(Continued on next page)
Central Nervous System
Page 66
Central Nervous System
Page 67
Central Nervous System
Page 68
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Other antidepressants
Venlafaxine
st
1 line:
Immediate release
37.5mg tablets: £2.60 (56)
75mg tablets: £2.96 (56)
Do not prescribe non M/R venlafaxine as Viepax brand (not cost-effective)
75mg tablets: £13.98
150mg tablets: £19.98
If modified release venlafaxine is prescribed, use tablets not capsules (on cost
grounds)
(Continued from page 66)
Rationale for decision / comments
See MHRA guidance
®
nd
2 line:
Venlafaxine
modified-release
as Viepax XL
®
Viepax XL or Venlalic XL are cost-effective brands for modified release
tablets
as Venlalic XL
as Depefex XL
Central Nervous System
75mg tablets: £11.20 (30)
150mg tablets: £18.70 (30)
225mg tablets: £33.60 (30)
There is no rationale for prescribing M/R products as a BD dose
75mg capsules: £10.40 (28)
150mg capsules: £17.40 (28)
Page 69
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
120mg: £31.63 (84)
Only to be prescribed in line with NICE guidance:
4.5 Drugs used in the treatment of obesity
Lipid absorption
inhibitors
4.7 Analgesics:
Orlistat

BMI > 30kg/m or > 28kg/m where other risk factors e.g. type 2 DM,
hypertension or hypercholesterolaemia

for patients who have lost ≥ 2.5kg by dietary control and increased physical
activity during previous month

only for individuals between 18 and 75 years

arrangements should exist for primary care staff (mostly practice nurses)
supported by community dieticians to offer advice, support and counselling
on diet, physical activity and behavioural strategies

treatment should continue beyond 3 months only if weight loss of >5%
from start of treatment

treatment should continue beyond 6 months only if weight loss is > 10%
from start of treatment

treatment should not usually continue beyond one year and never beyond
two years
2
Related guidance: NICE Clinical Guideline CG59 (2008): Osteoarthritis
2
Osteoarthritis management p.132
Avoid soluble formulations of Paracetamol and Co-Codamol because of high sodium content (the equivalent of up to 9g of salt per day at full dose) which may
contribute to or exacerbate hypertension or heart failure. These products are also more expensive.
Medication Overuse Headache All medications for treating headache can cause MOH in patients with a pre-existing primary headache disorder, even
if taking medicines for pain other than headache. Mean onest 1.7 years (triptans) to 4.8 years (analgesics)
Non-opioid
analgesics
First-line
Paracetamol
500mg tablets: £2.50 (100)
First choice drug in acute and chronic pain. If treatment is not effective check
that adequate dose is being used (i.e. 1g QDS) before adding other options.
Available OTC.
Paracetamol may be considered an option for treating agitation in people with
dementia where pain may be a factor. Husebo et al. (2011) Br Med J 343: d4065;
Husebo, Ballard, & Aarsland (2011) Int J Ger Psych 26: 1012-1018.
Central Nervous System
Page 70
Therapeutic Area
Weak opioid
analgesics
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
Buprenorphine Patches should NOT be prescribed. They are non-formulary as not a cost-effective use of NHS resources.
See note re effect of external heat sources p.70
The PCT strongly recommends that prescribers discuss the risk of addiction when initiating new patients on any opioid containing
medication and also on review. This discussion should be recorded in the patient notes.
Just three days of codeine or dihydrocodeine medicines can lead to addiction.
Codeine 30mg x
8/day provides
240mg codeine
equivalent to
Morphine 30mg
Codeine
15mg tablets: £1.19
30mg tablets: £1.49
60mg tablets: £2.40
Tramadol
First-line:
Immediate release
capsules
Weak opioid
analgesics (continued)
Second-line:
Modified release
as Marol
(twice-daily dosing)
as Tradorec XL
(once-daily
dosing)
50mg capsules: £3.20 (100)
Note that around 10% of the caucasian population lack the enzyme to
metabolize Codeine so derive little benefit from it, but still suffer the side effects
Prescribing Paracetamol and Codeine separately enables more appropriate
dose titration and enables patients to take more control of their own pain
management, e.g. taking Paracetamol regularly and adding Codeine as
required. Codeine alone is not considered a particularly effective analgesic.
Combinations may be appropriate for patients where there is concern over risk
of opiate abuse or where a fixed combination is known to be required regularly,
is effective and tolerated.
Tramadol may be considered as an alternative to Codeine where its efficacy or
tolerability is poor. MHRA advise short-term or intermittent treatment; caution
where history of addiction or seizure
Tramadol is considered first line opiate for osteoarthritis when opiate therapy is
appropriate NICE CG59
Tramadol may be most effective when given with full therapeutic doses of
Paracetamol (i.e. NOT as Tramacet which contains only 375mg paracetamol).
100mg tablets: £6.98 (60)
150mg tablets: £10.48 (60)
200mg tablets: £14.28 (60)
For patients with long term chronic pain responsive to tramadol but who suffer
significant side effects from the immediate release capsules a modified release
product may be prescribed.
100mg tablets: £14.10 (30)
200mg tablets: £14.98 (30)
300mg tablets: £22.47 (30)
For patients suffering long term chronic night time pain and pain on early
waking, Tradorec XL is a formulary option.
Maintenance dose for majority of patients is 200mg IN THE EVENING
Combination formulations that include tramadol as one of the ingredients (e.g. Tramacet) are non-formulary.
Central Nervous System
Page 71
Therapeutic Area
Formulary Choices
Combination
analgesics
The PCT strongly recommends that prescribers discuss the risk of addiction when initiating new patients on any opioid containing
medication and also on review. This discussion should be recorded in the patient notes.
Cost for 28 unless stated
Rationale for decision / comments
Just three days of codeine or dihydrocodeine medicines can lead to addiction.
Co-Codamol
(Codeine /
Paracetamol)
Co-codamol
30/500 x 8/day
provides 240mg
codeine equivalent
to Morphine 30mg
8/500mg tablets: £3.30 (100)
Evidence that Co-Codamol 8/500 offers significantly better analgesia than
Paracetamol alone is poor and many patients, especially the elderly,
experience troublesome constipation.
Co-Codamol 8/500 is available OTC.
30/500mg tablets: £4.57
(100)
Co-Codamol 30/500 is a potent analgesic carrying the full range of opioid side
effects e.g. constipation and sedation, requiring particular care in the elderly –
see BNF warning.
Prescribe as separate components if possible. NB. Co-Codamol 30/500 tablets
are >15% cheaper than capsules.
Management of opioid overdosage may require use of Naloxone: refer to Chapter 15 of the current BNF
Strong opioid
analgesics
First-line:
Note: There is no evidence of superior clinical analgesic effect of other opioids over morphine
Morphine
Solution
Strong opioid
analgesics
Modified release
capsules as
Zomorph
Central Nervous System
10mg/5ml solution: £4.95
(100ml)
10mg capsules: £3.47 (60)
30mg capsules: £8.30 (60)
60mg capsules: £16.20 (60)
100mg capsules: £25.65 (60)
200mg capsules: £51.30 (60)
Use oral solution for initial dose titration and breakthrough pain. Doses not to
be given at intervals of less than one hour.
Typical time to onset of therapeutic level –
Oral morphine solution:
20 – 30 minutes
Oxycodone solution:
60 minutes
Morphine tablets:
90 minutes
NB. Morphine 10mg/5ml is not subject to CD handwriting regulations.
Zomorph is the recommended modified-release morphine formulation.
Prescribe 12-hourly.
Subject to CD regulations.
Capsules can be opened and sprinkled on semi-solid food (e.g. yoghurt) or
given in water via NG tube.
Page 72
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Strong opioid
analgesics
Morphine (continued)
Modified release
tablets as
Morphgesic SR
10mg tablets: £3.85 (60)
30mg tablets: £9.24 (60)
60mg tablets: £18.04 (60)
100mg tablets: £28.54 (60)
Fentanyl
Fentanyl is only included for patients where morphine is contra-indicated or not tolerated or where there is
specific need for a non-oral route.
Patches as
12mcg £8.87 (5)
25mcg £12.68 (5)
50mcg £23.69 (5)
75mcg £33.03 (5)
100mcg £40.71 (5)
See MHRA DSU Vol.2 Issue 2 (Sep-08): Fentanyl patches: serious and fatal
overdose from dosing errors, accidental exposure, and inappropriate use.
Increases in body temperature and external heat sources may lead to
potentially fatal rises in serum fentanyl levels.
5mg capsules £11.43 (56)
10mg capsules £22.86 (56)
20mg capsules £45.71 (56)
5mg/5ml SF solution: £9.71
(250ml)
Oxycodone is included only for patients where morphine is contra-indicated or
not tolerated. Available data does not provide any evidence of oxycodone‟s
superiority to morphine.
5mg tablets: £10.63 (28)
10mg tablets: £21.24 (56)
20mg tablets: £42.48 (56)
40mg tablets: £84.98 (56)
80mg tablets: £169.97 (56)
Targinact is non-formulary: not a cost-effective use of NHS resources. No
long-term data, no comparison with other opioids with/without regular laxatives.
Second-line:
Matrifen
Third-line:

Oxycodone
Rationale for decision / comments
MR tablets as
Longtec
Buprenorphine Patches should NOT be prescribed. They are non-formulary as not a cost-effective use of NHS resources. There is a
lack of evidence of comparative efficacy with a clinically relevant treatment in the UK. The economic case has not been demonstrated.
Like other transdermal products, increases in body temperature (eg after bathing) and external heat sources may lead to increased
serum levels of active drug.
Central Nervous System
Page 73
OPIOID CONVERSION TABLE - St Margaret’s Hospice Guide to Opiod Dose Conversion
This is an approximate guide, comprehensive data are lacking and there is inter-individual variation.
In most cases, the calculated dose-equivalent of a new drug derived must be reduced by 25-50% to ensure safety. A dose reduction of at least 50% is
recommended when switching at high doses (ie. morphine or equivalent doses of 1g/24 hours or more), in elderly or frail patients, or because of intolerable
undesirable effects. A similar dose reduction is recommended when there has been a recent rapid escalation of the first opioid.
NB Reduction may not be appropriate if the original opioid failed to control pain.
The patient‟s clinical condition must be taken into account and breakthrough „prn‟ analgesia to make up any deficit while re-titrating to a satisfactory dose of the
new opioid.
(Converting from)
Current opioid
(Converting to)
New opioid and/or new route of administration
Divide 24 hour dose* of current opioid (col 1) by relevant figure below to
calculate initial 24 hour dose of new opioid and/or new route (column 2)
Example:
120mg oral morphine in 24 hours
subcutaneous diamorphine
Divide by 3
120mg/3 = 40mg subcutaneous diamorphine in 24 hours
ORAL TO ORAL ROUTE CONVERSIONS
oral codeine
oral morphine
oral tramadol
oral morphine
oral morphine
oral oxycodone
oral morphine
oral hydromorphone
ORAL TO TRANSDERMAL ROUTE CONVERSIONS
oral morphine
transdermal fentanyl
oral morphine
transdermal buprenorphine
ORAL TO SUBCUTANEOUS ROUTE CONVERSIONS
oral morphine
subcutaneous morphine
oral morphine
subcutaneous diamorphine
oral oxycodone
subcutaneous morphine
oral oxycodone
subcutaneous oxycodone
oral oxycodone
subcutaneous diamorphine
oral hydromorphone
subcutaneous hydromorphone
OTHER ROUTE CONVERSIONS (RARELY USED IN PALLIATIVE MEDICINE)
subcutaneous or intramuscular morphine
intravenous morphine
subcutaneous alfentanil
subcutaneous diamorphine
subcutaneous oxycodone
subcutaneous diamorphine
intravenous morphine
oral morphine
*
**
oral morphine
intramuscular morphine
Divide by 10
Divide by 7
Divide by 2
Divide by 7.5
Refer to manufacturer’s information**
Seek specialist palliative care advice
Divide by 2
Divide by 3
Divide by 1
Divide by 2
Divide by 1.5
Seek specialist palliative care advice
Divide by 1
Divide by 10 (specialist palliative care input: amber drug)
Divide by 1 – treat as equivalent up to doses of 60mg/24
hours – seek specialist advice
Multiply by 2
Divide by 2
The same units must be used for both opioids or routes, eg mg morphine to mg oxycodone
The conversion ratios of oral morphine : transdermal fentanyl specified by the manufacturer(s) vary from around 100:1 to 150:1
Central Nervous System
Page 74
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
4.7.3 Neuropathic pain
Related guidance: NICE Clinical Guideline CG96 (2010): Neuropathic pain – pharmacological management
NICE recommendation for the pharmacological management of neuropathic pain depends on diagnosed origin of the pain.





There is no need to change existing treatments for people whose neuropathic pain is well controlled

Do not start treatment with opioids (such as morphine or oxycodone) other than tramadol without an assessment by a specialist pain
service or a condition-specific service
All pharmacological treatments should be started at a low dose & titrated to maximum effective or tolerated dose
When switching to a new drug, consider overlapping treatments to avoid deterioration in pain control
When withdrawing, taper the dose to avoid discontinuation symptoms
If pain reduction is still unsatisfactory at maximum doses of first & second line treatments refer patient to a specialist pain and/or condition specific
service
Painful diabetic
neuropathy ONLY
First-line:
Duloxetine
60mg capsules: £27.72
or
Second-line:
Amitriptyline
10mg tablets: £0.73
25mg tablets: £0.74
50mg tablets: £0.82
Use amitriptyline if duloxetine is contra-indicated or has not been found
effective before using pregabalin.
Pregabalin
25mg capsules: £64.40 (56)
50mg capsules: £96.60 (84)
75mg capsules: £64.40 (56)
100mg capsules: £96.60 (84)
150mg capsules: £64.40 (56)
200mg capsules: £96.60 (84)
225mg capsules: £64.40 (56)
300mg capsules: £64.40 (56)
If pain reduction is unsatisfactory with first line options, offer treatment with
another drug instead of, or in combination with the first drug, depending on
outcome of informed discussion with patient.
Capsules:100mg £2.83 (100)
300mg £3.87 (100)
400mg £4.62 (100)
Pending review of CG96, gabapentin is included as an option.
Gabapentin
Central Nervous System
Because of price structure for pregabalin, ensure dose optimisation is carried
out.
Page 75
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
Amitriptyline
10mg tablets: £0.73
25mg tablets: £0.74
50mg tablets: £0.82
Amitriptyline should be considered as first option (unless C/I). If satisfactory
pain reduction is obtained with amitriptyline but patient experiences adverse
effects that cannot be tolerated, consider imipramine or nortriptyline as an
alternative.
If pain reduction is unsatisfactory with first line options, offer treatment with
another drug instead of, or in combination with the first drug, depending on
outcome of informed discussion with patient.
Other neuropathic
pain conditions
First-line:
or
Imipramine
10mg tablets: £1.22
25mg tablets: £1.09
or
Nortriptyline
10mg tablets: £34.51
25mg tablets: £56.11
or
Pregabalin
Prices as above
Third-line:
Tramadol capsules
(immediate release)
50mg capsules: £3.20 (100)
While awaiting referral tramadol may be considered instead of or in
combination with other treatments. More potent opiates are not recommended.
NB The combination of tramadol with amitriptyline, nortriptyline, imipramine or
duloxetine is associated with a low risk of serotonin syndrome.
Fourth-line:
Lignocaine
(Lidocaine) Patches
5% medicated plaster:
£72.40 (pack 30)
For the treatment of localised pain for people unable to take oral medication
because of medical conditions and/or disability.
All neuropathic pain
Central Nervous System
Page 76
Diagnosis of tension-type headache, migraine & cluster headache
Adapted from „Headaches‟ (NICE clinical guideline 150), available from http://www.nice.org.uk/CG150
Headache feature
Tension-type headache
Migraine (with or without aura)
Pain location1
Bilateral
Unilateral or bilateral
Pain quality
Pressing/tightening (non-pulsating)
Pain intensity
Effect on activities
Mild or moderate
Not aggravated by routine activities of
daily living
None
Other symptoms
Pulsating (throbbing or banging in
young people aged 12–17 years)
Moderate or severe
Aggravated by, or causes avoidance of,
routine activities of daily living
Cluster headache
Unilateral (around the eye, above the
eye and along the side of the
head/face)
Variable (can be sharp, boring, burning,
throbbing or tightening)
Severe or very severe
Restlessness or agitation
On the same side as the headache:
sound or nausea and/or vomiting.
Swollen eyelid
without headache and; are fully
reversible, develop over at least 5
minutes, last 5 - 60 minutes. Typical
aura symptoms include visual
symptoms such as flickering lights,
spots or lines and/or partial loss of
vision; sensory symptoms such as
numbness and/or pins and needles;
and/or speech disturbance.
Duration of headache
30 minutes–continuous
Frequency of
headache
< 15 days per month
≥ 15 days per month
for more than 3
months
Diagnosis
Episodic tensiontype headache
Chronic tensiontype headache2
eyelid
4–72 hours in adults 1–72 hours in
15–180 minutes
young people aged 12–17 years
< 15 days per month
≥ 15 days per month
1 every other day to 8
for more than 3
per day3, with
months
remission4 >1 month
1 every other day to 8
per day3 with a
continuous
remission4 <1 month
in a 12-month period
Chronic cluster
headache
Episodic migraine
Chronic migraine
Episodic cluster
(with or without
(with or without
headache
aura)
aura)
1 Headache pain can be felt in the head, face or neck. 2 Chronic migraine and chronic tension-type headache commonly overlap. If there are any features of migraine,
diagnose chronic migraine. 3 Frequency of recurrent headaches during a cluster headache bout. 4 The pain-free period between cluster headache bouts.
Central Nervous System
Page 77
Medication Recommendations from NICE CG 150: Headache (All recommendations - take account of preferences, comorbidities and risk of adverse events.
* Formulary triptans: 1st line – sumatriptan; 2nd line – zolmitriptan. If these are consistently ineffective, try one or more alternative triptans.
Tension Type
Headache
Acute treatment
Aspirin (not for
under 16 years association with
Reye’s Syndrome)
Paracetamol NSAID
Migraine with or without aura
Migraine associated with
Menstrual Cycle
Acute treatment
Acute treatment
oral triptan* + NSAID or
When standard treatment is
not effective:
oral triptan* + aracetamol
PLUS
Frovatripan 2.5mg bd or
Anti-emetic even in absence of nausea
Zolmitriptan 2.5mg two or
& vomiting
three times a day on the days
Consider nasal triptan for 12-17 year olds & migraine is expected
non-oral anti-emetic
Migraine in Pregnancy
Cluster Headache
Acute treatment
Paracetamol
Acute treatment
Oxygen 100% at flow rate at
least 12 litres/min with nonrebreathing face mask
and/or subcutaneous or
nasal triptan
DO NOT OFFER
Opioids
DO NOT OFFER
Ergots or derivatives
Opioids
DO NOT OFFER
Routinely prescribe
combined hormonal oral
contraceptive
DO NOT OFFER
DO NOT OFFER
Paracetamol
NSAIDs
Opioids
Ergots
Oral triptans
Prophylaxis
Prophylaxis: Review need to continue
prophylaxis 6 months after starting
Continue current regime for people on
existing effective migraine prophylaxis.
Propranolol or
Topiramate (pts under 18) – ensure
suitable contraception for females of
child bearing age (risk of foetal
malformation)
Second line:
Acupuncture: up to 10 sessions over 5-8
weeks
Or Gabapentin – up to 1200mg daily
Riboflavin 400mg once daily may be
effective to reduce migraine frequency &
intensity.
Prophylaxis
Prophylaxis
Prophylaxis
N/A
Seek specialist advice
Verapamil
Seek specialist advice if
cluster headache does not
respond to verapamil
Acupuncture: up to
10 sessions over
5-8 weeks
Central Nervous System
Consider triptan after
discussing need for
treatment and risks
Seek specialist advice for
cluster headache during
pregnancy
Use of medication in bold within this guidance is off-license for indication/age/dose
given. These were all approved for prescribing in Somerset at Prescribing Forum
November 2012.
Prescribers should follow relevant professional guidance & patient (or parent or carer)
should provide informed consent, which should be documented)
Page 78
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
Aspirin
300mg dispersible tablets:
£4.00 (100)
Evidence supports the efficacy of Aspirin at a dose of 900mg for acute
migraine. Available OTC.
Ibuprofen
200mg tablets: £3.01 (84)
400mg tablets: £3.01 (84)
600mg tablets: £6.57 (84)
For severe headache 400mg dose recommended. 200mg and 400mg tablets
available OTC.
Paracetamol
500mg tablets: £2.50 (100)
Soluble preparations may have a role for occasional use but have high sodium
content. Available OTC. Recommended dose 1000mg.
As above plus
Price as above
Analgesic plus anti-emetic combinations are the second line therapy option
when simple analgesia alone has proved inadequate. Combination products
eg. Migramax are significantly more expensive than separate prescriptions,
one component of which is available OTC.
Domperidone
10mg tablets: £1.04 (30)
30mg suppositories: £3.06
(10)
Metoclopramide
10mg tablets: £0.86
Prochlorperazine
5mg tablets: £1.10 (28)
3mg buccal tabs:£5.89 (10)
4.7.4 Antimigraine drugs
Acute management
of migraine
Simple analgesia
Simple analgesia
plus anti-emetic
prescribed
separately
Triptans
Metoclopramide causes more acute dystonic reactions than domperidone
particularly in younger patients.
1st-line
Sumatriptan
50mg tablets: £1.67 (6)
100mg tablets: £2.14 (6)
Sumatripan is included as the most cost-effective triptan. Evidence suggests
little additional benefit from doses above 50mg. If patients have been initiated
on injectable forms, a trial of oral sumatriptan is recommended.
2.5mg tablets: £3.47 (6)
2.5mg orodispersible tabs:
£3.65 (6)
5mg orodispersible tabs:
£16.19 (6)
Dose for migraine is 2.5mg – 5mg strength only for patients not achieving
satisfactory relief with 2.5mg dose.
nd
2 line:
Zolmitriptan
Central Nervous System
There is no evidence that oro-dispersible formulations have a faster onset of
action than conventional tablets.
Page 79
Therapeutic Area
Formulary Choices
Prophylaxis of
migraine
Consider prophylaxis when more than one or two attacks occur per month. See BNF for details.
The need for continuing migraine prophylaxis should be reviewed 6 months after starting.
Induction of drug overuse headache is possible for all triptans.
Risk becomes significant at 12 days per month of triptan intake, mean onest occurs after 1.7 years use.
st
1 line:
Propranolol
Cost for 28 unless stated
Rationale for decision / comments
10mg tablets: £0.78
40mg tablets: £0.79
80mg tablets: £1.07
Propranolol is the recommended first line prophylactic therapy for migraine.
Avoid using Propranolol MR products as significantly higher cost: Inderal-LA
(£1.91 pack of 28) and Half-Inderal LA (£5.40 pack of 28).
nd
Topiramate tablets
25mg tablets: £2.71 (60)
50mg tablets: £3.67 (60)
100mg tablets: £3.42 (60)
200mg tablets: £14.59 (60)
Topiramate is effective for migraine prophylaxis. Advise women & girls of
childbearing potential that topiramate is associated with a risk of foetal
malformations & can impair the effectiveness of hormonal contraceptives.
Ensure they are offered suitable contraception.
Prescribe as tablet formulation not capsule because of large price difference.
rd
Amitriptyline
10mg tablets: £0.73
25mg tablets: £0.74
50mg tablets: £0.82
NICE CG150 states that people whose migraine is well controlled with
amitriptyline should continue their current treatment.
2 line:
3 line:
4.8.1 Epilepsy
Related guidance: NICE CG137 The Epilepsies: diagnosis and management in adults and children in primary and secondary care
Brand Prescribing for Epilepsy
Brand prescribing is advised for carbamazepine (Tegretol) and phenytoin (Epanutin; in September 2012 renamed Phenytoin Sodium
Flynn Hard capsules) where there is evidence that bioavailability differences may have a clinical impact.
For all other anti epileptics prescribing should be generic where one exists and the prescriber, in consultation with the child, young
person, adult and their family and/or carers as appropriate, considers this not to be a concern.
NICE CG137 recommends use of controlled release preparations when prescribing Carbamazepine.
Central Nervous System
Page 80
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
0.5ml syringe (2.5mg dose):
£82
1ml syringe (5mg dose):
£85.50
1.5ml syringe (7.5mg dose):
£89.00
2ml syringe (10mg dose):
£91.50
Note:
Buccolamis currently the only licensed version of buccal midazolam and
should be the preferred product for new patients.
4.8.2 Drugs used in status epilepticus
Midazolam
Buccal solution
As Buccolam
10mg/2ml
Therapeutic Area
There may be a risk if existing patients are changed from „Epiststus‟ or other
unlicensed specials to Buccolam unless there has been clear communication
and training for the carer of the different strengths available
As Epistatus
(unlicensed product)
Price variable
Formulary Choices
Cost (per pack as stated)
Rationale for decision / comments
Patches - various
Gum - various
Lozenges - various
Nasal spray
Prescribing for the management of nicotine addiction should be in line with NICE
guidance
Evidence for all aids to smoking cessation indicates that motivational support
increase likelihood of successful quit attempt.
Decisions around appropriate aids to smoking cessation should be made in
agreement with the patient.
Combinations of NRT, bupropion and varenicline for smoking cessation should
not be used.
Decisions around route of administration for NRT should be made in agreement
with the patient.
Combinations of NRT products should be considered for those with a high level
of nicotine dependency or where previous attempts to stop smoking have been
unsuccessful.
Prescriptions should normally be for a sufficient to last until 2 weeks after the
target stop date, subsequent prescriptions should only be given to people who
demonstrate that their quit attempt is continuing.
4.10 Drugs used in substance dependence
Smoking Cessation
Nicotine
Replacement
Therapy (NRT)
Quickmist
Central Nervous System
Page 81
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Smoking Cessation
Bupropion
(Amfebutamone)
150mg tablets: £41.76 (60)
(continued from previous page)
Rationale for decision / comments
Prescribers should consider prescribing Bupropion a month at a time to minimise
waste and link with patients receiving ongoing behavioural support. Bupropion
should not be prescribed in pregnancy, lactation or to patients aged <18 years
Bupropion is contra-indicated in patients




with history of seizures
eating disorders
CNS tumour
experiencing acute symptoms of benzodiazepine or alcohol withdrawal
Bupropion should not be prescribed to patients with other risk factors for
seizures unless the potential benefits of smoking cessation clearly outweigh the
risk. Factors increasing seizure risk include:

Concomitant administration of drugs that lower seizure threshold eg.
antidepressants, antimalarials, antipsychotics, quinolones, sedating
antihistamines, systemic corticosteroids, theophylline and tramadol,
stimulants and anorectics
Alcohol abuse
History of head trauma
Diabetes



Varenicline▼
Starter pack: £27.30
0.5mg tablets (11)
1mg tablets (14)
0.5mg tablets: £54.60 (56)
1mg tablets: £27.30 (28),
£54.60 (56)
Note: Varenicline (Champix) is a Black Triangle▼drug, consequently all
adverse effects should be reported to the MHRA via the Yellow Card scheme.
The MHRA have advised that following reports of depression and suicidal
ideation:

Smoking cessation with or without pharmacotherapy may be associated
with an exacerbation of underlying psychiatric illness, including
depression. Care should be taken in such patients, who should be
advised of the risk

Patients should be made aware of the possibility that trying to stop
smoking might cause symptoms of depression

Patients who are taking varenicline who develop suicidal thoughts
should stop their treatment and contact their doctor immediately.
There are some concerns about cardiovascular risk with a warning from FDA issued in
June 2011. Patients should be instructed to notify their doctor of new or worsening
cardiovascular symptoms. The risk appears to be similar with bupropion
Central Nervous System
Page 82
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
Varenicline is approved for prescribing in Primary Care with the following advice

Varenicline should only be prescribed within its licensed indications for
smokers who have expressed a desire to quit smoking

Varenicline should normally only be prescribed as part of a programme
of behavioural support

Varenicline should not be prescribed in pregnancy, lactation or to
patients aged <18 years
Prescribers should consider prescribing the 12 week course of Varenicline
a month at a time to minimise waste in patients and link in with patients
receiving ongoing behavioural support.
Opioid dependence
Oral methadone and buprenorphine are recommended by NICE for maintenance therapy in the management of opioid dependence.
Patients should be committed to a supportive care programme including a flexible dosing regimen administered under supervision for at
least three months, until compliance is assured. In Somerset substance misuse services are provided by Turning Point Somerset
which offers a comprehensive program of supportive care through the central team and key workers.
Selection of methadone or buprenorphine should be made on a case by case basis, but methadone should be prescribed (as
®
Physeptone ) if both drugs are equally suitable.
Primary care prescribing of methadone 1mg/ml mixture or buprenorphine sublingual tablets for the treatment or maintenance of opioid
dependence is only recommended by GPs who undertaken the necessary RCGP training and in practices that have the relevant
shared-care arrangements in place with Turning Point Somerset.
Prescribing for the treatment or maintenance of drug addiction outside of shared-care arrangements is NOT recommended and could
lead to medico-legal implications for the prescriber in some circumstances.
Alcohol dependence
Methadone
1mg/1ml mixture
®
as Physeptone
1mg/ml: £6.42 (500ml)
1mg/ml sugar-free: £6.42
(500ml)
Prescribing by brand is recommended as the most cost-effective option.
NB: Sugar-free methadone liquid is thought to have more abuse potential, as it
causes fewer complications if injected intra-venously by abusers. SF
methadone mixture should be considered second-line. There is no evidence of
SF preparations being beneficial in the prevention of dental problems in opioid
dependence – dental decay is more likely to be attributed to lifestyle factors that
effect dental hygiene and the depressant effect of opioids on salivary secretion.
Buprenorphine
sugar-free
sublingual tablets
®
as Subutex
0.4mg: £1.60 (7)
2mg:£6.35 (7)
8mg: £19.05 (7)
Prescribing by brand is recommended as the most cost-effective option.
Naltrexone
50mg tablets: £22.34 (28)
For alcohol dependence, oral naltrexone is an AMBER drug, to be initiated at
Turning Point and continued by general practice.
Somerset Prescribing Forum approved use of generic naltrexone for this
indication.
Central Nervous System
Page 83
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
4.11 Drugs for dementia
Related guidance: NICE Technology Appraisal TA217 (2011): Donepezil, galantamine, rivastigmine and memantine for Alzheimer’s disease
When assessing the severity of Alzheimer‟s disease and the need for treatment, healthcare professionals should not rely solely on cognition scores in
circumstances in which it would be inappropriate to do so (see NICE TA217 for examples).
When using assessment scales to determine the severity of Alzheimer‟s disease, healthcare professionals should take into account any physical, sensory or
learning disabilities, or communication difficulties that could affect the results and make adjustments they consider appropriate. Healthcare professionals should
also be mindful of the need to secure equality of access to treatment for patients from different ethnic groups, in particular those from different cultural
backgrounds.
These should only be initiated by specialists in the care of dementia (psychiatrists, neurologists and physicians specialising in the care of older people).
Treatment should be continued only when it is considered to be having a worthwhile effect on cognitive, global, functional or behavioural symptoms. Patients who
continue on treatment should be reviewed regularly by an appropriate specialist team, or according to the locally agreed Shared Care Protocol. Carer‟s views on
the patients‟ condition should be sought at baseline and during follow-up.
Acetylcholinesterase
inhibitors
Donepezil
Galantamine
Modified release
Rivastigmine
Transdermal
patches
NMDA-receptor
antagonist
Memantine
Central Nervous System
5mg tablets: £1.69 (28)
10mg tablets: £1.98 (28)
8mg tablets: £59.29 (56)
12mg tablets: £74.10 (56)
8mg m/r capsules: £51.88 (28)
16mg m/r capsules: £64.90 (28)
24mg m/r capsules: £79.80 (28)
1.5mg capsules: £24.77 (28)
3mg capsules: £24.77 (28)
4.5mg capsules: £24.77 (28)
6mg capsules: £20.59 (28)
4.6mg/24hr patches: £77.97 (30)
9.5mg/24hr patches: £77.97 (30)
10mg tablets: £69.01 (28)
20mg tablets: £69.01 (28)
The acetylcholinesterase (AChE) inhibitors: Donepezil, Galantamine and
Rivastigmine are recommended as options for mild to moderate Alzheimer‟s
disease.
Treatment should be started with the drug of lowest acquisition cost.
However, an alternative agent could be prescribed if considered appropriate
when taking into account adverse event profile, expectations about
adherence, medical co-morbidity, possibility of drug interactions and dosing
profiles.
Oral formulations should be used except where patient has poor swallow or
experiences side effects with oral treatment which would lead to discontinuing
treatment.
Memantine is recommended as an option for people with;

Moderate Alzheimer‟s disease who are intolerant or, or have a
contraindication to AChE inhibitors, or

Severe Alzheimer‟s disease.
Page 84
Therapeutic Area
Formulary Choices
Cost (per pack as stated)
Rationale for decision / comments
BNF Chapter 5: Infections
Related guidance: NHS Somerset Infection Management Guidance (2010)
Top
5.1 Antibacterial drugs
Penicillins
Phenoxymethylpenicillin
(Penicillin V)
250mg tablets: £1.17 (28)
125mg/5ml SF solution:
£16.56 (100ml)
250mg/5ml SF solution:
£16.56 (100ml)
See Infection management guidance for appropriate clinical indications.
Flucloxacillin
250mg capsules: £1.76 (28)
500mg capsules: £2.53 (28)
125mg/5ml suspension:
£21.33 (100ml)
125mg/5ml SF suspension:
£21.87 (100ml)
250mg/5ml suspension:
£26.28 (100ml)
250mg/5ml SF suspension:
£26.87 (100ml)
See Infection management guidance for appropriate clinical indications.
Amoxicillin
250mg capsules: £1.23 (21)
500mg capsules: £1.48 (21)
125mg/5ml SF suspension:
£1.15 (100ml)
250mg/5ml SF suspension:
£1.42 (100ml)
See Infection management guidance for appropriate clinical indications.
Co-amoxiclav
250/125mg tablets: £2.73 (21)
500/125mg tablets: £3.41 (21)
125/31mg SF suspension:
£2.34 (100ml)
250/62mg SF suspension:
£2.37 (100ml)
See Infection management guidance for appropriate clinical indications.
Management of infection
Community use of Co-amoxiclav has been implicated in the causation
of Clostridium difficile in Somerset.
Page 85
Therapeutic Area
Formulary Choices
Cost (per pack as stated)
Rationale for decision / comments
Cephalosporins
Cefalexin
250mg capsules: £1.97 (28)
500mg capsules: £2.10 (21)
125mg/5ml suspension: £1.50
(100ml)
250mg/5ml suspension: £1.79
(100ml)
The Infection management guidance has a very limited role for
cephalosporins first line. Cefalexin is indicated for second line use in
UTIs where sensitivity is known and Trimethoprim or Nitrofurantoin are
not appropriate.
The spectrum of activity of Cefalexin and other oral cephalosproins
means they are generally inappropriate for RTIs and skin and soft tissue
infections.
RESTRICTED USE
ADVISED
Cephalosporins are commonly implicated in Clostridium difficile
infection
Tetracyclines
Doxycycline
100mg capsules: £1.03 (8)
See Infection management guidance for appropriate clinical indications.
Oxytetracycline has been removed from this section given probability of poor
compliance with dosing requirements, together with clinical and costeffectiveness of Doxycycline as viable alternative.
Macrolides
Erythromycin
250mg e/c tablets: £1.78 (28)
See Infection management guidance for appropriate clinical indications.
®
NB. Erythromycin capsules (such as Erymax ) are approximately 10 times
the price of the standard ec tablets.
per 100ml suspension:
125mg/5ml: £2.46
sugar free £3.08
250mg/5ml: £3.60
sugar free £4.07
500mg/5ml: £5.80
sugar free £9.20
Clarithromycin
Management of infection
250mg tablets: £3.73 (14)
500mg tablets: £3.27 (14)
125mg/5ml SF
suspension:£6.68 (70ml)
250mg/5ml SF
suspension:£13.28 (70ml)
Erythromycin & Clarithromycin are known inhibitors of cytochrome
P450 enzyme CYP3A4. Prescribers should be aware of the potential for drug
interactions with other medicines. Click on these links for more information.
See Infection management guidance for appropriate clinical indications.
®
Clarithromycin MR tablets (Klaricid XL ) are non formulary on grounds of
higher cost.
Page 86
Therapeutic Area
Formulary Choices
Cost (per pack as stated)
Rationale for decision / comments
Azithromycin
250mg tablets: £3.39 (4)
500mg tablets: £2.34 (3)
Azithromycin is recommended for treatment of Chlamydia where compliance
with other options may be poor.
AMBER (specialist initiation) for prevention of exacerbations of non-CF
bronchiectasis. ECG required before initiation & if prescribed continuously for
longer than 3 months, GP should consider periodic ECG to manage cardiac
risks.
Trimethoprim and
sulphonamides
Trimethoprim
100mg tablets: £1.05 (28)
200mg tablets: £0.93 (14)
50mg/5ml SF suspension:
£2.16 (100ml)
See Infection management guidance for appropriate clinical indications.
Metronidazole and
tinidazole
Metronidazole
200mg tablets: £1.13 (21)
400mg tablets: £1.24 (21)
200mg/5ml suspension:
£18.20 (100ml)
See Infection management guidance for appropriate clinical indications.
Quinolones
Ciprofloxacin
250mg tablets: £0.82 (10)
500mg tablets: £0.97 (10)
750mg tablets: £8.59 (10)
See Infection management guidance for appropriate clinical indications.
Ciprofloxacin has very poor activity against common RTI pathogens
and therefore should only be used on specialist advice for these
indications.
Quinolones are commonly implicated in Clostridium difficile infection.
Urinary tract
infections
Nitrofurantoin
100mg tablets: £5.75 (28)
50mg capsules: £3.66 (30)
100mg capsules: £6.91 (30)
100mg capsules m/r: £5.87
(14)
See Infection management guidance for appropriate clinical indications.
Consider Nitrofurantoin as an alternative to Trimethoprim as first line
treatment for uncomplicated UTIs. 50mg is associated with significantly less
nausea than 100mg.
Chapter 13: Skin
5.2 Antifungal drugs
For topical antifungal preparations, please refer to Chapter 13: Skin
Antifungals
Fluconazole
See Infection management guidance for appropriate clinical indications.
Voriconazole – RED
drug. NOT for
primary care
prescribing.
50mg capsules: £0.88 (7)
150mg capsule: £0.80 (1)
Itraconazole
100mg capsules: £6.90 (15)
See Infection management guidance for appropriate clinical indications.
Management of infection
Page 87
Therapeutic Area
Formulary Choices
Cost (per pack as stated)
Rationale for decision / comments
NB Transient or permanent hearing loss has been reported with itraconazole.
Terbinafine
250mg tablets: £1.86 (28)
See Infection management guidance for appropriate clinical indications.
Measure LFTs before treatment & after 4-6 weeks.
5.3 Antiviral drugs
For topical antivirals please refer to Chapter 13: Skin
Antivirals
Antiviral
treatments for
HIV, and
Valganciclovir are
RED drugs and
not for primary
care prescribing.
Influenza vaccine
First-line:
Aciclovir
Second- line:
Valaciclovir
First line:
®
Fluvirin
®
Enzira
®
Influvac
®
Fluarix
Shingles Vaccine
Management of infection
See Infection management guidance for appropriate clinical indications.
200mg dispersible tablets:
£2.58 (25)
400mg tablets: £5.12 (56)
800mg tablets: £6.00 (35)
Famciclovir is non-formulary, based on cost. Famciclovir 750mg daily
costs £148 per 7 day course i.e. around 16x higher than an equivalent course
of Aciclovir 800mg.
Valaciclovir is included in the formulary only for genital herpes for second line
use when Aciclovir is not appropriate.
250mg tablets: £123.28 (60)
500mg tablets: £16.31 (10),
£86.30 (42)
£5.55 per dose
£5.25 per dose
£5.22 per dose
£5.39 per dose
Companies offer a range of deals & discounts depending on service
package. The PCT has a duty to recommend that practices make best use
of the available NHS resources and purchase a vaccine that is both cost
effective and has a supplier who can provide sufficient practice support to
ensure good uptake by patients.
Given the choice of 4 different vaccines NHS Somerset see no reason for a
practice to choose a vaccine with an NHS price > £5.55
Non-Formulary
Supply is limited & prescribing not currently recommended on NHS.
The DH has confirmed that it intends to run a national vaccination programme
for those over 70 years of age, but until they have secured a sufficient supply
of the Zostavax vaccine and is able to implement the JCVI‟s
recommendations, GPs are currently advised not to give the vaccine.
Page 88
SOMERSET PCT - INFECTION MANAGEMENT GUIDANCE 2012/13
Aims



to provide a simple, empirical approach to the treatment of common infections
to promote the safe, effective and economic use of antibiotics
to minimise the emergence of bacterial resistance in the community
Principles of Treatment
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
This guidance is based on best available evidence and should be used alongside references such as the BNF, BNFc , and SPCs
Professional judgement should be used and patients should be involved in decisions about their treatment.
Unless otherwise stated, a dose and duration of treatment for adults is usually suggested, but may need modification for age,
weight and renal function. In severe or recurrent cases consider a larger dose or longer course.
Prescribe an antibiotic only when there is likely to be a clear clinical benefit.
Lower threshold for antibiotics in immunocompromised or those with multiple morbidities; consider culture and seek advice.
Consider a no, or delayed, antibiotic strategy for acute self-limiting upper respiratory tract infections including sore throat,
common cold, cough and sinusitis. (See No Antibiotic ‘Prescription’ Form)
Limit prescribing over the telephone to exceptional cases.
Use simple antibiotics prescribed generically whenever possible.
Avoid broad spectrum antibiotics (e.g. co-amoxiclav, quinolones and cephalosporins) when narrow spectrum antibiotics
remain effective, as they increase risk of Clostridium difficile, MRSA and resistant UTIs.
Avoid widespread use of topical antibiotics (especially those agents also available as systemic preparations, e.g. fusidic acid).
In pregnancy, AVOID tetracyclines, aminoglycosides, quinolones, high dose metronidazole (e.g. 2g STAT).
In pregnancy, short-term use of trimethoprim (theoretical risk in first trimester in patients with poor diet or if taking another
folate antagonist such as antiepileptic or proguanil), or nitrofurantoin (at term, theoretical risk of neonatal haemolysis) are
unlikely to cause problems to the foetus.
Clarithromycin is recommended in place of erythromycin (except in pregnancy) as it has less side-effects, greater compliance
(as twice rather than four times daily), and generic tablets are similar cost. In children erythromycin may remain preferable as
clarithromycin syrup is twice the cost.
For further advice contact the Microbiologists at Musgrove Park Hospital, out of hours via MPH switchboard  01823 333444
Jump to the infection group you want by clicking on the link below
UPPER RESPIRATORY TRACT INFECTIONS
LOWER RESPIRATORY TRACT INFECTIONS
MENINGITIS
URINARY TRACT INFECTIONS
GASTRO-INTESTINAL TRACT INFECTIONS
ILLNESS
GENITAL TRACT INFECTIONS
SKIN INFECTIONS
DENTAL INFECTIONS
EYE INFECTIONS
COMMENTS
DRUG
DOSE
DURATION
UPPER RESPIRATORY TRACT INFECTIONS: Consider delayed antibiotic prescriptions.
Influenza
HPA Influenza
Acute Sore
Throat
CKS
Annual vaccination is essential for all those at risk of influenza. For otherwise healthy adults antivirals not recommended.
Treat ‘at risk’ patients ONLY within 48 hours of onset AND when influenza is circulating in the community or in a care home
where influenza is likely. At risk: 65 years or over, chronic respiratory disease (including COPD and asthma) significant
cardiovascular disease (not hypertension), immunocompromised, diabetes mellitus, chronic neurological, renal or liver
disease. Use 5 days treatment with oseltamivir 75 mg bd or if there is resistance to oseltamivir use 5 days zanamivir 10 mg BD
(2 inhalations by diskhaler). For prophylaxis, see NICE. (NICE Influenza). Patients under 13 years see HPA Influenza link.
Avoid Antibiotics as 90% resolve in 7 days
without, and pain only reduced by 16 hours
If Centor score 3 or 4: (Lymphadenopathy; No
Cough; Fever; Tonsillar Exudate) consider 2 or
3-day delayed or immediate antibiotics
Antibiotics to prevent Quinsy NNT >4000
Antibiotics to prevent Otitis media NNT 200
Acute Otitis
Media
(child doses)
CKS
Optimise analgesia and Avoid Antibiotics 60%
are better in 24 hours, and 80% are better in 4
days without. They only reduce pain at 2 days
(NNT15) and do not prevent deafness
Consider 2 or 3-day delayed or immediate
antibiotics for pain relief if:
 < 2yrs with bilateral AOM NNT4 or
bulging membrane & ≥ 4 marked symptoms
 All ages with otorrhoea NNT3
phenoxymethylpenicillin
if allergic to penicillin:
clarithromycin
500 mg QDS
1G BD
(QDS when severe)
10 days
250-500mg BD
5 days
Child doses
amoxicillin
if allergic to penicillin:
erythromycin
40mg/kg/day in 3 doses
(max. 3g daily)
5 days
< 2yrs 125mg QDS
2-8yrs 250mg QDS
8-18yrs 250-500mg QDS
5 days
Abx to prevent Mastoiditis NNT >4000
Management of infection
Page 89
SOMERSET PCT - INFECTION MANAGEMENT GUIDANCE 2012/13
ILLNESS
Acute Otitis
Externa
CKS
COMMENTS
First use aural toilet (if available) & analgesia
CKS
First line:
acetic acid 2%
DOSE
DURATION
1 spray TDS
7 days
Second line:
neomycin sulphate with
corticosteroid
3 drops TDS
7 days min to 14
days max
Avoid Antibiotics as 80% resolve in 14 days
without, and they only offer marginal benefit
after 7 days (NNT15).
phenoxymethylpenicillin
500mg QDS
7 days
or amoxicillin
500mg TDS
1g if severe
7 days
Use adequate analgesia
if allergic to penicillin:
doxycycline
200mg stat/100mg OD
For persistent symptoms:
co-amoxiclav
625mg TDS
Cure rates similar at 7 days for topical acetic
acid or antibiotic +/- steroid
If cellulitis or disease extending outside ear
canal, start oral antibiotics and refer
Acute
Rhinosinusitis
DRUG
Consider 7-day delayed or immediate
antibiotic when purulent nasal discharge NNT8
In persistent infection use an agent with antianaerobic activity eg. co-amoxiclav
7 days
7 days
LOWER RESPIRATORY TRACT INFECTIONS
TOP
Low doses of penicillins are more likely to select out resistance. Do not use quinolone (ciprofloxacin, ofloxacin) first line due to poor pneumococcal
activity. Reserve all quinolones (including levofloxacin) for proven resistant organisms e.g. pseudomonas spp.
Acute cough,
Antibiotic little benefit if no co-morbidity
amoxicillin
500 mg TDS
5 days
bronchitis
Symptom resolution can take 3 weeks.
or
doxycycline
200
mg
stat/100
mg
OD
5 days
CKS
Consider 7-14 day delayed antibiotic with
NICE 69
symptomatic advice/leaflet
Acute
Treat exacerbations promptly with antibiotics
amoxicillin
500 mg TDS
exacerbation of if purulent sputum and increased shortness of
or doxycycline
200 mg stat/100 mg OD
COPD
breath and/or increased sputum volume
7 days (14 days
clarithromycin (if penicillin
500 mg BD
NICE 12
for frequent
Risk factors for antibiotic resistant organisms
GOLD
allergic
exacerbators)
include co-morbid disease, severe COPD,
nd
2 line
960mg BD
frequent exacerbations, antibiotics in last 3m
co-trimoxazole
CommunityUse CRB65 score to help guide and review:
IF CRB65=0: amoxicillin
500 mg TDS
7 days
acquired
Each scores 1: Confusion (AMT<8);
500 mg BD
7 days
pneumonia Respiratory rate >30/min;
or clarithromycin
treatment in
BP systolic <90 or diastolic ≤ 60;
200
mg
stat/100
mg
OD
7 days
or doxycycline
the community
Score 0: suitable for home treatment;
BTS 2009
Guideline
Score 1-2: hospital assessment or admission
Score 3-4: urgent hospital admission
Give immediate IM benzylpenicillin or
D
amoxicillin 1G po if delayed admission/life
threatening, and seek risk factors for
Legionella and Staph. aureus infection.
If CRB65=1 & AT HOME
amoxicillin
500 mg TDS
AND clarithromycin
500 mg BD
or doxycycline alone
200 mg stat/100 mg OD
7-10 days
7-10 days
Mycoplasma infection is rare in over 65s
MENINGITIS NICE fever guidelines
TOP
Transfer all patients to hospital immediately.
IV or IM benzylpenicillin
Age 10+ years: 1200 mg
IF time before admission, give IV
Children 1 - 9 yr: 600 mg
(only give IM if
benzylpenicillin, unless hypersensitive ie
Or
Children <1 yr: 300 mg
vein cannot be
history of difficulty breathing, collapse, loss of
IV or IM cefotaxime
Age 12+ years 1g
found)
HPA
consciousness, or rash
Child <12 yrs 50mg/kg
Prevention of secondary case of meningitis: Only prescribe following advice from Somerset Health Protection Agency accessible on
01823 287817 (Fax: 01823 287819) or out of hours via Musgrove Park switchboard on 01823 333444
TOP
URINARY TRACT INFECTIONS HPA UTI quick reference guide ESBLs CKS UTI
Amoxicillin resistance is common, therefore ONLY use if culture confirms susceptibility.
People > 65 years: do not treat asymptomatic bacteriuria; it is common (25% in ♀, 10% in ♂) but is not associated with increased morbidity
Catheter in situ: antibiotics will not eradicate asymptomatic bacteriuria; only treat if systemically unwell or pyelonephritis likely
Do not use prophylactic antibiotics for catheter changes unless history of catheter-change-associated UTI
UTI in
Women with severe or ≥ 3 symptoms: treat
trimethoprim
200mg BD
Women 3 days
men & women
Women with mild or ≤ 2 symptoms: use
or
nitrofurantoin
(no fever or
dipstick to guide treatment. Nitrite &
50-100mg QDS, or
Men 7 days
flank pain)
blood/leucocytes has 92% positive predictive
100mg m/r BD
HPA QRG
value ; -ve nitrite, leucocytes, and blood has a
76% NPV
Second line: perform culture in all treatment failures.
SIGN
Men:
send
pre-treatment
MSU
OR
if
Amoxicillin resistance is common; only use if susceptible
CKS, CKS
symptoms mild/non-specific, use –ve nitrite
Community multi-resistant Extended-spectrum Beta-lactamase E. coli are
and leucocytes to exclude UTI
increasing, but often remain sensitive to nitrofurantoin. Fosfomycin may be
an option on advice of microbiology,see guidance here
Suspected
meningococcal
disease
Management of infection
Page 90
SOMERSET PCT - INFECTION MANAGEMENT GUIDANCE 2012/13
ILLNESS
UTI in
pregnancy
HPA QRG
CKS
COMMENTS
Send MSU for culture & sensitivity and start
empirical antibiotics
Short-term use of nitrofurantoin in pregnancy
is unlikely to cause problems to the foetus
Avoid trimethoprim if low folate status or on
folate antagonist (eg antiepileptic or proguanil)
UTI in children
Child <3 mths: refer urgently for assessment
HPA QRG
CKS
NICE
Child ≥ 3 months: use positive nitrite to start
antibiotics. Send pre-treatment MSU for all.
Acute
pyelonephritis
CKS
Recurrent UTI
in women
≥ 3 UTIs/year
Imaging: only refer if child <6 months or
atypical UTI
NICE
HPA QRG
CKS
Symptomatic
relapse
Infectious
diarrhoea
CKS
Clostridium
difficile
DH & HPA
Travellers’
diarrhoea
CKS
First line: nitrofurantoin
DOSE
DURATION
50-100mg QDS, or
100 mg m/r BD
or trimethoprim
Second line:
if susceptible, amoxicillin
200mg BD (off-label)
Give folic acid if first
trimester
500 mg TDS
Third line: cefalexin
500 mg BD
Lower UTI: trimethoprim
or nitrofurantoin
if susceptible, amoxicillin
Second line: cefalexin
See BNFc for dosage
Upper UTI: co-amoxiclav
Second line: cefixime
All for 7 days
Lower UTI
3 days
Upper UTI
7-10 days
If admission not needed, send MSU for culture
& sensitivities and start antibiotics
If no response within 24 hours, admit
RCT data shows 7 days ciprofloxacin as good as
14 days co-trimoxazole.
ciprofloxacin
or co-amoxiclav
If susceptible trimethoprim
500 mg BD
500/125 mg TDS
200mg BD
7 days
14 days
14 days
Post-coital prophylaxis or standby antibiotic
trimethoprim
or nitrofurantoin
100 mg
50–100 mg
Post coital stat
(off-label)
Prophylaxis
OD at night
Nightly: reduces UTIs but adverse effects
nd
Nitrofurantoin 2 line due to potential
pulmonary toxicity.
GASTRO-INTESTINAL TRACT INFECTIONS
Eradication of
Helicobacter
pylori
DRUG
Eradication is beneficial in known DU, GU or
low grade MALToma
TOP
PPI is either omeprazole capsules 20mg BD or lansoprazole capsules 30mg
BD. H2RA is ranitidine 150mg BD or 300mg OD at night.
First line:
BD
PPI plus
250 mg BD
clarithromycin AND
400 mg BD
metronidazole
Consider test and treat in persistent
All for
OR
uninvestigated dyspepsia
7 days
PPI plus
BD
Do not offer eradication for GORD
clarithromycin AND
500mg BD
amoxicillin
1g BD
Do not use clarithromycin or metronidazole if
used in the past year for any infection
Second line:
Relapse
PPI plus
BD
or
MALToma
®
DU/GU relapse: retest for H. pylori using
bismuthate (De-nol tab )
240 mg BD
14
days
breath or stool test OR consider endoscopy for PLUS 2 unused antibiotics:
culture & susceptibility
1 g BD
amoxicillin
400 mg TDS
NUD: Do not retest, offer PPI or H2RA
metronidazole
500 mg QDS
tetracycline
Check travel, food, hospitalisation and antibiotic history (C. difficile is increasing). Fluid replacement is essential.
Refer previously healthy children with acute painful or bloody diarrhoea to exclude E. coli 0157 infection.
Antibiotic therapy not indicated unless systemically unwell.
If the patient is systemically unwell, or if pregnant, initiate treatment on advice of microbiologist.
If systemically unwell and campylobacter suspected (e.g. undercooked meat and abdominal pain), consider clarithromycin
250–500 mg BD for 5–7 days if treated early.
Please send stool specimens from suspected cases of food poisoning and after antibiotic use. Please notify suspected cases of
food poisoning to, and seek advice from, Somerset Health Protection Agency on  01823 287817 (Fax: 01823 287819) or out
of hours via the Musgrove Park Hospital switchboard on 01823 333444.
st nd
Stop unnecessary antibiotics and/or PPIs
1 /2 episodes
Triple therapy achieves an 85% eradication.
For NUD, the NNT is 14 for symptom relief
70% respond to MTZ in 5days; 92% in 14days
metronidazole (MTZ)
400 mg oral TDS
10-14 days
rd
Admit if severe: T >38.5; WCC >15, rising
3 episode/severe
creatinine or signs/symptoms of severe colitis
oral vancomycin
125mg oral QDS
10 -14 days
Avoid anti-motility anti-diarrhoeal agents such
as Loperamide or Codeine .
Only consider standby antibiotics for remote areas or people at high-risk of severe illness with travellers’ diarrhoea
If standby treatment appropriate give: ciprofloxacin 500 mg twice a day for 3 days (private Rx). If quinolone resistance high
(e.g. south Asia): consider bismuth subsalicylate (Pepto Bismol) 2 tablets QDS as prophylaxis or for 2 days treatment
Management of infection
Page 91
SOMERSET PCT - INFECTION MANAGEMENT GUIDANCE 2012/13
ILLNESS
COMMENTS
Threadworms
Treat all household contacts at the same time
PLUS advise hygiene measures for 2 weeks
(hand hygiene, pants at night, morning
shower) PLUS wash sleepwear, bed linen, dust,
and vacuum on day one.
CKS
DRUG
DOSE
DURATION
> 6 months: mebendazole
(off-label if < 2yrs)
100 mg
stat
3-6 mths: piperazine+senna
2.5ml spoonful
stat, repeat after
2 weeks
< 3mths: 6 wks hygiene
GENITAL TRACT INFECTIONS
STI screening
Chlamydia
trachomatis
SIGN
BASHH
HPA
CKS
Vaginal
candidiasis
TOP
People with risk factors should be screened for chlamydia, gonorrhoea, HIV, syphilis. Refer individual and partners to GUM
clinic or general practices with level 2 or 3 expertise in GUM. Risk factors: < 25y, no condom use, recent (<12mth)/frequent
change of partner, symptomatic partner.
Opportunistically screen all aged 15-25yrs
doxycycline
100 mg BD
7 days
Treat partners and refer to GUM service
or azithromycin
1g
stat
Pregnancy or breastfeeding: azithromycin is
Pregnant or breastfeeding:
the most effective option.
azithromycin
1g (off-label use)
stat
Due to lower cure rate in pregnancy, test for
or erythromycin
500 mg QDS
7 days
cure 6 weeks after treatment.
or amoxicillin
500 mg TDS
7 days
1A+
All topical and oral azoles give 75% cure.
clotrimazole
500 mg pess/ 10% cream stat
150 mg orally
stat
100 mg pessary at night
5 g intravaginally BD
6 nights
7 days
oral metronidazole
400 mg BD
or 2 g
5 g applicatorful at night
5 g applicatorful at night
7 days
BASHH
HPA
CKS
Oral metronidazole (MTZ) is as effective as
topical treatment but is cheaper.
Less relapse with 7 day than 2g stat at 4 wks.
Pregnant / breastfeeding: avoid 2g stat dose.
Treating partners does not reduce relapse.
Trichomoniasis
Treat partners and refer to GUM service.
metronidazole
BASHH
HPA, CKS
Pregnant/ breastfeeding: avoid 2g stat dose.
Consider clotrimazole for symptom relief (not
cure) if MTZ declined.
400 mg BD
or 2 g
5-7 days
stat
clotrimazole
100 mg pessary at night
6 nights
500 mg
400 mg BD
100 mg BD
stat
14 days
14 days
400 mg BD
400 mg BD
14 days
14 days
500 mg BD
200 mg BD
100mg BD
28 days
28 days
28 days
Pregnancy: avoid oral azole use intravaginal for
7 day.
Bacterial
vaginosis
Pelvic
Inflammatory
Disease
RCOG
BASHH, CKS
Acute
prostatitis
BASHH, CKS
CKS
Eczema
CKS
Erythema
chronicum
migrans
CKS
Cellulitis
CKS
3A+
or MTZ 0.75% vag gel
or clindamycin 2% crm
28% of gonorrhoea isolates now resistant to
quinolones. If gonorrhoea likely (partner has it,
severe symptoms, sex abroad) avoid ofloxacin
regimen.
If High Risk
ceftriaxone PLUS
metronidazole PLUS
doxycycline
or
metronidazole PLUS
ofloxacin
Send MSU for culture and start antibiotics.
4-wk course may prevent chronic prostatitis.
Quinolones achieve higher prostate levels.
ciprofloxacin
or trimethoprim
or doxycycline
Refer woman & contacts to GUM service.
Always culture for gonorrhoea & Chlamydia.
SKIN INFECTIONS
Impetigo
or oral fluconazole
1A+
clotrimazole
3A+
miconazole 2% cream
BASHH
HPA, CKS
stat
5 nights
7 nights
TOP
For extensive, severe, or bullous impetigo, use
oral flucloxacillin
500 mg QDS
7 days
oral antibiotics.
If penicillin allergic:
Reserve topical antibiotics for very localised
oral clarithromycin
250-500 mg BD
7 days
lesions to reduce the risk of resistance.
retapamulin
Topically BD
5 days
Reserve mupirocin for MRSA.
mupirocin (MRSA only)
Topically TDS
5 days
If no visible signs of infection, use of antibiotics (alone or with steroids) encourages resistance and does not improve healing.
In eczema with visible signs of infection, use treatment recommended in impetigo.
Associated with Lyme disease.
doxycycline
100mg BD
14 days
Send clotted blood for Lyme serology and treat Second line:
amoxicillin
500mg TDS
14 days
empirically. Microbiology will advise on
(especially for children,
positive results.
pregnancy &
See BNFc for children
breastfeeding)
under 5 years.
If patient afebrile and healthy other than
cellulitis, use oral flucloxacillin alone.
If river or sea water exposure, discuss with
microbiologist.
If febrile and ill, admit for IV treatment.
Management of infection
Flucloxacillin
if allergic to penicillin:
clarithromycin
nd
500 mg – 1g QDS
500 mg BD
2 line: doxycycline
200mg stat, 100mg od
facial: co-amoxiclav
500/125 mg TDS
All for 7 days.
If slow response
or patient
unable to take
st
nd
1 or 2 line
options contact
microbiology
Page 92
SOMERSET PCT - INFECTION MANAGEMENT GUIDANCE 2012/13
Leg ulcers
HPA QRG
CKS
Ulcers always colonized. Antibiotics do not
improve healing unless active infection.
If active infection, send pre-treatment swab.
Review antibiotics after culture results.
ILLNESS
Diabetic Foot
Infections
PVL S. aureus
HPA QRG
Bites
Human:
CKS
Cat or dog:
Mastitis
Scabies
CKS
Fungal infection
– skin
CKS body & groin
CKS foot
CKS scalp
Fungal infection
–fingernail or
toenail
CKS
Varicella
zoster/
chicken pox
CKS
&
Herpes zoster/
shingles
CKS
Cold sores
COMMENTS
See PEDIS grading & Treatment Options
Grade 1: No antibiotics
Grade 2: treat as per guidelines
Grade 2 + evidence of ischaemia, and above:
refer to secondary care.
Active infection if cellulitis/increased pain/pyrexia/purulent exudate/odour
If active infection:
Flucloxacillin
if allergic to penicillin:
or clarithromycin
DRUG
Flucloxacillin
500 mg – 1g QDS
As for cellulitis
500 mg BD
DOSE
DURATION
over 60kg
1g QDS
Under 60kg (or
problems with nausea)
500mg QDS
As for cellulitis
If no
improvement or
worse after 2
If allergic to penicillin
weeks refer to
If osteomyelitis is suspected, refer to
Clarithromycin
500mg BD
secondary care
secondary care
ASAP
Panton-Valentine Leukocidin (PVL) is a toxin produced by 2% of S. aureus and is associated with persistent pustules and
carbuncles or cellulitis. Can rarely cause severe invasive infections in healthy people. Send swabs if recurrent boils/abscesses.
At risk: close contact in communities (e.g. nursing homes) or contact sport, sharing equipment, poor hygiene and eczema.
Thorough irrigation is important.
Prophylaxis or treatment:
Assess risk of tetanus, HIV, hepatitis B&C.
co-amoxiclav
625 mg TDS
Antibiotic prophylaxis is advised.
If penicillin allergic:
Assess risk of tetanus and rabies.
metronidazole PLUS
400 mg TDS
All for 7 days
Give prophylaxis if cat bite/puncture wound;
doxycycline (cat/dog/man)
100 mg BD
bite to hand, foot, face, joint, tendon,
ligament;
AND review at 24 & 48hrs
Immunocompromised/diabetic/asplenic/
cirrhotic
Antibiotics are not always required. Self-help
flucloxacillin
500mg QDS
7 days
measures e.g. continuation of breastfeeding or
if allergic to penicillin:
expressing will aid resolution of mastitis.
7 days
500mg QDS
erythromycin
Treat all home & sexual contacts within 24h.
permethrin
5% cream
2 applications
Treat whole body from ear/chin downwards
If allergy:
1 week apart
and under nails.
malathion
0.5% aqueous liquid
If under 2 or elderly, also face and scalp.
Terbinafine is fungicidal, so treatment time
Topical terbinafine
BD
1-2 weeks
shorter than with fungistatic imidazoles.
or topical imidazole
BD
for 1-2 wks after
If candida possible, use imidazole.
healing
If intractable: send skin scrapings. If infection
(i.e. 4-6wks)
confirmed, use oral terbinafine/itraconazole.
Scalp: discuss with specialist.
Take nail clippings: start therapy only if
Superficial only amorolfine
1-2x/weekly
fingers 6 months
infection is confirmed by laboratory.
5% nail lacquer
toes 12 months
Terbinafine is more effective than azoles.
First line: terbinafine
250 mg OD
fingers 6 – 12 weeks
Liver reactions rare with oral antifungals.
toes 3 – 6 months
If candida or non-dermatophyte infection
Second line: itraconazole
200 mg BD
7 days monthly
confirmed, use oral itraconazole.
fingers 2 courses
For children, seek specialist advice.
toes 3 courses
Pregnant/immunocompromised/neonate: seek If indicated:
urgent specialist advice.
aciclovir
800 mg five times a day 7 days
Chicken pox: If started < 24h of rash & > 14y or
severe pain or dense/oral rash or 2° household
case or steroids or smoker consider aciclovir.
Shingles: treat if > 50 yrs and within 72 hrs of
rash (PHN rare if < 50yrs); or if active
ophthalmic or Ramsey Hunt or eczema.
Cold sores resolve after 7–10 days without treatment. Topical antivirals applied prodomally reduce duration by 12-24hrs.
TOP
DENTAL INFECTIONS
Dental
Infections
Local guidance
(Dental)
The primary treatment of dental infections should be drainage of pus and removal of the source of infection. This will
normally require attention by a dental practitioner. Urgent appointments (usually within 24 hours) can be obtained through
the dental helpline  0845 7697691. Antibiotics are of limited use and should not be prescribed except for patients who are
systemically unwell, or if there are signs of severe infection, e.g. fever, lymphadenopathy, cellulitis, or diffuse swelling.
Patients to seek dental advice if possible.
Dentists should follow local guidance.
Acute dental-alveolar infections:
amoxicillin
250mg TDS
Up to 5 days
If allergic to penicillin:
metronidazole
200mg TDS
Up to 3 days
Pericoronitis:
Management of infection
metronidazole
200mg TDS
3 days
Page 93
SOMERSET PCT - INFECTION MANAGEMENT GUIDANCE 2012/13
EYE INFECTIONS
Conjunctivitis
CKS
TOP
Most bacterial conjunctivitis is self-limiting.
65% resolve on placebo by day five.
Red eye with yellow-white mucopurulent, not
watery discharge.
Usually unilateral but may spread.
Management of infection
If severe:
chloramphenicol 0.5% drop
and 1% ointment
OR
1% ointment
2 hourly for 2 days then
4 hourly (whilst awake)
at night
All for 48 hours
after resolution
QDS
Page 94
SOMERSET PCT - INFECTION MANAGEMENT GUIDANCE 2012/13
Appendix 1
Methicillin Resistant Staphylococcus Aureus (MRSA)
Decolonisation Policy
If clinical infection is suspected medical staff must discuss treatment options with a Consultant
Microbiologist.
Where there is clinical infection, decolonisation treatment should be undertaken in addition to any
systemic treatment given.
Topical decolonisation treatment must be commenced immediately, using nasal and skin preparations as
below.
This is used for 5 days then stopped for 2 days and the patient is re-screened on day 8 to determine if the
patient is still MRSA positive
Mupirocin (Bactroban) Nasal Ointment: Three times daily to nostrils
PLUS
Skinsan*: Once daily wash, include at least one hair wash daily
OR
Octenisan*: Once daily wash, include at least one hair wash daily
* Although these may not be listed on all GP clinical system prescribing databases, they can be prescribed on FP10.
If the patient remains positive after the first course of decolonisation a further course of topical treatment
should be carried out as above, followed by a further screen. If the second course of decolonisation is
unsuccessful, the Somerset PCT Infection Control Team must be contacted to discuss further options.
The issues associated with the treatment for decolonising wounds is complex and should be discussed
with a member of the Somerset PCT Infection Control Team.
For patients in community hospitals, decolonisation therapy must be prescribed and staff must record
decolonisation as per the Topical Therapy Chart.
The Somerset PCT Infection Control Team can be contacted for further advice via the PCT switchboard
on 01935 384000.
Further advice (and documents, including topical therapy chart) is also available on the Infection control
page of the Somerset PCT website nww.somersetpct.nhs.uk
There is a separate pre-operative protocol for the management of patients attending Musgrove Park
Hospital for elective orthopaedic surgery. For information, contact Taunton & Somerset NHS Trust
Infection Prevention and Control team  01823 342611
Management of infection
Page 95
BNF Chapter 6: Endocrine System
6.1 Drugs used in diabetes
Top
Related guidance: NICE Clinical Guideline CG87 (2009): Type 2 diabetes
See summary chart on p.97
Before any pharmacological interventions are considered there should be a 3 month period of diet & lifestyle interventions.

Education
provide structured education to every patient and/or their carer at and around the time of diagnosis and review annually.

Diet
provide individualised and ongoing specialist nutritional advice.

Lifestyle
encourage weight loss and exercise.
Blood Pressure Control
Evidence from UKPDS indicates that control of blood pressure in people with hypertension & Type 2 diabetes achieves a clinically
important reduction in the risk of deaths related to diabetes, complications related to diabetes, progression of diabetic retinopathy, and deterioration in visual acuity.
Guidance on the use of Blood Glucose Testing Strips is on page 104
The VADT, ACCORD and ADVANCE trials show that tight control of blood glucose in long standing Type 2 diabetics (reducing HbA1c to below 7%) may be
harmful. CG 87 agrees with this view and recommends:

Involve the person in decisions about their individual HbA1c target which may be above the general target of 6.5% especially in long standing diabetes.

Offer lifestyle advice and medication to help achieve and maintain the HbA1c target.

Inform patients with a higher HbA1c that any reduction towards the agreed target is advantageous to their health.
 Avoid pursuing highly intensive management to levels of <6.5%.
♦ Self-monitoring of blood glucose should be offered to a patient newly diagnosed with T2DM only as an integral part of his/her self- management education. Its
purpose should be discussed and there should be agreement how the results should be interpreted and acted upon.
♦ Eye and kidney damage should be screened annually.
NB DH require that HbA1c should always be measured in millimoles per mol (mmol/mol) as well as by percentage.
HbA1c of 6.5% is equivalent to 48 mmol/mol.
Guide to HbA1c values expressed as mmol/mol
Endocrine System - Diabetes
DCCT- HbA1c %
IFCC-HbA1c mmol/mol
6.0
42
6.5
48
7.0
53
7.5
58
8.0
64
9.0
75
Page 96
3 month trial of lifestyle interventions
97
HbA1c ≥ 6.5%
METFORMIN with active dose titration
and use of MR version if necessary to
minimise incidence of GI side effects.
HbA1c ≤ 6.5%
Monitor for
deterioration
HbA1c ≥ 6.5%
Metformin plus gliclazide
HbA1c ≤ 7.5%
Monitor for
deterioration
HbA1c ≥ 7.5%
Insulin + metformin + gliclazide
Adding insulin in preference to other oral
rd
hypoglycaemice should be normal 3 line
option unless there is a strong reason not
to, parrticularly if patient is markedly
hyperglycaemic
HbA1c ≤ 7.5%
Monitor for
deterioration
HbA1c ≥7.5%
Summary of NICE CG 87: Treatment of
Type 2 diabetes
Endocrine System - Diabetes
Consider gliclazide if:
i. Not overweight (tailor weight
assessment to ethnic group) OR
ii. Rapid therapeutic response is
required owing to hyperglycaemic
symptoms OR
iii. Metformin CI or not tolerated
Consider repaglinide before meals for
people with erratic lifestyle. Consider
substituting pioglitazone or gliptin for
gliclazide if there is significant risk of
hypoglycaemia (or its consequences)
or if sulphonylurea is CI or not
tolerated
Consider adding pioglitazone or gliptin
instead of insulin if insulin is not
acceptable for (see note p.94)
Consider adding exenatide or
liraglutide if:
 BMI≥ 35 kg/m2 in people of
European origin and there are
problems associated with high
weight
 BMI < 35 and insulin is
unacceptable because of
occupational implications andor
weight loss would benefit other
comorbidities
Increase insulin dose and intensify
regimen over time.
Consider pioglitazone with insulin if:
 Pioglitazone has previously had a
marked glucose-lowering effect or:
 Blood glucose control is inadequate
with high-dose insulin
For options i. and ii. consider Metformin
plus gliclazide
Gliclazide
HbA1c < 6.5%
Monitor for
deterioration
If metformin CI or not
tolerated:
Gliclazide + pioglitazone
OR
Gliclazide + gliptin
Metformin + pioglitazone
OR
Metformin + gliptin
HbA1c <7.5%
Monitor for
deterioration
HbA1c
≥ 7.5%
HbA1c ≥ 6.5%
HbA1c <7.5%
Monitor for
deterioration
HbA1c
≥7.5%
Metformin + gliclazide + pioglitazone
OR
Start
Insulin
Metformin + gliclazide + gliptin
OR
Metformin + gliclazide
+ exenatide or liraglutide
HbA1c < 7.5%
Monitor for
deterioration
HbA1c ≥ 7.5%
HbA1c ≥7.5%
HbA1c <7.5%
Monitor for
deterioration
Page 97
Insulin therapy in Type 2 Diabetes (based on NICE CG87, Type 2 Diabetes, May 2009)
When other measures do not keep HbA1c to < 7.5% (or other higher level agreed with the individual), discuss the benefits and risks of insulin therapy. Start
insulin therapy if the person agrees.
Note: Insulin may be considered unacceptable for employment, social, recreational or other personal issues, or obesity.
When starting insulin therapy, use a structured programme employing active insulin dose titration that encompasses:

structured education

continuing telephone support

frequent self-monitoring

dose titration to target

dietary understanding

management of hypoglycaemia

management of acute changes in plasma glucose control

support from an appropriately trained and experienced healthcare professional.
First-line: Human NPH insulin (intermediate-acting insulin) at bedtime or twice daily
OR: Long-acting insulin analogue (insulin detemir, glargine) once daily if:
 lifestyle and compliance factors make more frequent injections inappropriate
 the patient is unable to self-inject NPH insulin
target HbA1c is not reached or lifestyle is restricted because of hypoglycaemia
 significant hypoglycaemia occurs with NPH insulin
Alternative Options:
Biphasic human insulin (pre-mix) once or twice-daily particularly where HbA1c is above 9.0%.
Biphasic human insulin analogues (pre-mix) if:



immediate injection before a meal is preferred, or
hypoglycaemia is a problem, or
blood glucose levels rise markedly after meals .
Intensifying Insulin Therapy (HbA1c levels not controlled)
Monitor patients on:
NPH or long-acting insulin analogue to identify the need for injections of short-acting insulin before meals or pre-mixed insulin
Pre-mixed insulin once or twice daily to identify the need for injections of short-acting insulin before meals or a change to mealtime plus basal insulin
regime.
Endocrine System - Diabetes
Page 98
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Insulin aspart
(NovoRapid)
3ml cartridge: £28.31 (5)
10ml vial: £16.28 (1)
Insulin lispro
(Humalog)
3ml cartridge: £28.31 (5)
10ml vial: £16.61 (1)
Soluble Insulin
10ml vial: £7.48 (1)
Rationale for decision / comments
Insulins
Short acting:
(Human Actrapid)
Intermediate acting:
Long acting:
Needles
Biphasic Insulin
Aspart (NovoMix
30)
3ml cartridge: £28.84 (5)
Biphasic Insulin
Lispro
(Humalog Mix25)
3ml cartridge: £29.46 (5)
Isophane Insulin
(Human
Insulatard)
3ml cartridge: £22.90 (5)
10ml vial: £7.48 (1)
Insulin Glargine
(Lantus)
3ml cartridge: £41.50(5)
10ml vial: £30.68 (1)
Insulin Detemir
(Levemir)
3ml cartridge :£42.00 (5)
Omnican Fine
6mm/31 gauge £6.65 (100)
8mm/31 gauge £6.65 (100)
(10mm/30 gauge £6.65 (100)
12mm/29 gauge £6.65 (100))
Endocrine System - Diabetes
Choice of needle & lancet may be governed by specific insulin prescribed and
injection technique.
There is no clinical reason for recommending needles longer than 8mm in
adults or 6mm in children/adolescents.
Omnican Fine represents a cost-effective choice of needle where appropriate.
Page 99
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
This section specifically cover drugs used for management of blood glucose, however the majority of patients with diabetes should be considered to be at high
risk of CVD and hence should also be prescribed Simvastatin 40mg for primary prevention (unless C/I). For secondary prevention guidance see page 41
ATT meta-analysis : Aspirin for primary prevention of CVD
Aspirin is not licensed for the primary prevention of vascular events but there remains the possibility that for particular sub-groups of individuals at higher CV risk
(including conditions such as diabetes) the risk:benefit of aspirin is favourable. Until more evidence is available, the use of Aspirin 75mg for patients with
diabetes should be based on an individual risk assessment.
Biguanides
Metformin
st
1 line:
Immediaterelease
Sachets
Metformin should be;
500mg tablets: £0.77 (28)
850mg tablets: £1.11(56)

First line in Type 2 DM because of cardioprotective effect unless not
overweight, rapid therapeutic response required or metformin C/I

introduced at low dose and given with or after food to minimise GI
adverse effects e.g. 500mg daily and gradually titrated to 2g per day
(or 3g under specialist supervision).

continued in patients with Type 2 DM who require Insulin, as Metformin
reduces insulin requirements.

Use with caution in those at risk of a sudden deterioration in kidney
function
500mg sachets: £6.58 (60)
1000mg sachets: £13.16 (60)
Metformin sachets for patients with swallowing difficulties are much less
expensive than „special‟ liquid formulation.
500mg m/r tablets: £5.32
750mg m/r tablets: £6.40
1000mg m/rtablets: £8.52
Metformin MR is approved for patients who would otherwise stop Metformin
therapy due to GI side effects.
80mg tablets: £0.95 (28)
40mg tablets: £3.36 (28)
NICE CG87 1.5.2.4 Prescribe a sulfonylurea with a low acquisition cost (but
not glibenclamide) when a sulfonylurea is indicated.
nd
2 line:
Modified release
Sulphonylureas
Gliclazide
Normal third line option, if HbA1c remains at ≥ 7.5% HbA1c (or level agreed with individual) is to initiate insulin therapy (see page 98 in addition to
metformin and sulphonylurea (or other dual oral therapy) in preference to adding other drugs to control blood glucose unless there is strong
justification not to.
Endocrine System - Diabetes
Page 100
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
Glitazones (thiazolidinediones)
Prescribing of Pioglitazone should be in line with MHRA / EMEA advice (December 2007 & February 2008) and NICE guidance (May 2008):

Pioglitazone should not be started in people who:

The incidence of heart failure is increased when Pioglitazone is combined with insulin

Inform patient of risk of oedema and what to do if this happens. Closely monitor patients during treatment with pioglitazone for signs and symptoms of
fluid retention. Discontinue pioglitazone if heart failure develops.

Following consideration at Somerset Prescribing Forum (Nov 2011) it was agreed that generic versions of pioglitazone may be used for all indications
○
○
are at higher risk of fracture
have evidence of heart failure
Thiazolidinediones
Pioglitazone
DPP-4 inhibitors
DPP-4 inhibitor may be preferable to a glitazone:
Continue gliptin
only if there is a
reduction of
≥0.5% points in
HbA1c in 6
months (between
5 and 6
mmol/mol)
15mg tablets: £4.28
30mg tablets: £5.31
45mg tablets: £6.61
The PROACTIVE trial showed improvements in secondary outcomes.
Pioglitazone is licensed for use with insulin
Continue only if there is a reduction ≥ 0.5% points in HbA1c in 6 months
Pioglitazone might be preferable to a DPP-4 inhibitor if there is marked insulin
insensitivity, or if DPP-4 inhibitor is contraindicated or not tolerated.

To prevent weight gain

If the patient has not responded to, or not tolerated or has a contraindication to a glitazone
NB Group 2 (LGV/PCV) drivers are required to notify DVLA if taking combination of gliptin with sulphonylurea
Dose Adjustment in Renal Impairment
Sitagliptin
Mild – no dose adjustment needed
Moderate: creatinine clearance ≥30
to <50ml/min), use sitagliptin 50mg
once daily.
Saxagliptin
Reduce dose to 2.5mg in moderate to severe renal impairment
Linagliptin
No dose reduction required for linagliptin for patients with renal impairment
Vildagliptin
Reduce dose to 50mg once daily when CrCl <50ml/min
Endocrine System - Diabetes
CrCl <30ml/min or with end-stage renal disease requiring
haemodialysis or peritoneal dialysis, use sitagliptin 25mg
once daily.
Page 101
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Linagliptin
5mg tablets: £33.26 (28)
Rationale for decision / comments
Saxagliptin
5mg tablets: £31.60
2.5mg tablets: £31.60
Saxagliptin is is licensed for triple therapy with metformin &
sulphonylurea and with insulin +/- metformin
100mg tablets: £33.26
50mg tablets: £33.26
25mg tablets: £33.26
Sitagliptin is licensed for triple therapy with metformin & sulphonylurea
and with insulin +/- metformin
Vildagliptin
50mg tablets: £31.76 (56)
In dual combination with a sulphonylurea, the recommended dose of
vildagliptin is reduced to 50mg once daily administered in the morning.
In this patient population, vildagliptin 100mg daily was no more effective than
vildagliptin 50mg once daily
Repaglinide
500mcg tablets: £11.76 (90)
1mg tablets: £11.76 (90)
2mg tablets: £5.60 (90)
Repaglinide may have a role in patients who fail to achieve target HbA1c with
Metformin +/- Sulphonylurea, or when either of these two classes of drug are
contra-indicated or not tolerated.
Consideration should be given to a trial of Repaglinide before initiating a
glitazone.
Repaglinide may have a particular role in patients with an erratic lifestyle
/ irregular eating pattern. Repaglinide should be given in the 30 minute
period before a meal, up to TDS.
Acarbose
50mg tablets: £7.00 (90)
100mg tablets: £12.87 (90)
Acarbose may have a role for a person unable to use other oral glucose
lowering medications (contra-indicated or not tolerated) or in patients who fail
to achieve target HbA1c with Metformin +/- Sulphonylurea. Titrate dose slowly
to reduce incidence of GI adverse effects.
Sitagliptin
Other options:
Rapid acting
insulin
secretagogue
Endocrine System - Diabetes
Page 102
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
GLP-1 mimetic
Exenatide
5 mcg pre-filled pen: £68.24
10mcg pre-filled pen: £68.24
(60 doses in each pen)
Exenatide and Liraglutide administered either daily or weekly (at appropriate
dose) may be considered for triple therapy in addition to metformin and a
sulphonylurea in people whose HbA1c is above agreed level if;
Dietary advice
should be given
before starting
therapy with
these agents.
For all dose
regimens of
exenatide &
liraglutide
treatment should
be continued
only if there is a
reduction of ≥
1.0% points in
HbA1c in 6
months (between
10 and 11
mmol/mol)
AND
3% loss of initial
body weight in 6
months.
 BMI ≥ 35 kg/m in those of European descent (with appropriate adjustment
for other ethnic groups) & other specific psychological or medical problems
associated with high body weight, or
2
 BMI < 35 kg/m and insulin therapy would have significant occupational
implications, or where weight loss would benefit other significant comobidities such as sleep apnoea.
2
2mg vial : £73.36 (4)
NB Group 2 (LGV/PCV) drivers are required to notify DVLA if taking
combination of exenatide with sulphonylurea.
Liraglutide
6mg/ml pre-filled pens
3ml: £78.48 (2)
3ml: £117.72 (3)
Somerset Prescribing Forum approved the use of exenatide as adjunctive
therapy to basal insulin (with or without metformin and/or pioglitazone in
adults with Type 2 diabetes) Patients are expected to show 0.5%
(6mmol/mol) reduction in HbA1c after 6 months to justify continuation.
The addition of insulin to basal exenatide was rejected, patients where
weight & HbA1c reduction stipulated by NICE have not been achieved after 6
months on exenatide should have exenatide stopped as not cost-effective.
Liraglutide 1.2mg daily can be considered for dual therapy (in combination with
metformin or a sulphonylurea) only if either metformin or a sulphonylurea is
contraindicated or not tolerated, and a DPP-4 inhibitor is contraindicated or not
tolerated.
The combination of liraglutide with insulin is currently not commissioned for
prescribing in Somerset and any recommendation of this combination should
remain the responsibility of secondary care.
Endocrine System - Diabetes
Page 103
Guidance on the use of Blood Glucose Testing Strips based on NICE CG87
NICE national guidelines for the management of
blood glucose levels in people with type 2 diabetes May 2008
1.
2.
2.
4.
5.
In line with NICE guidelines, regular HbA1c testing (every two to six months) is the standard measurement. Pathology services in Somerset currently allow
a minimum interval of 3 months between tests. An individual target HbA1c should be set with every patient.
Blood glucose testing strips are primarily intended for people with diabetes treated with insulin. The frequency of testing should be as agreed between the
health professional and the individual with diabetes. (Those converting to insulin need to test more frequently during the dose titration phase, which is
usually managed by diabetes specialist nurses. Those with type 1 diabetes may need to test 4 or more times daily).
Self monitoring in patients with Type 2 diabetes, who are controlled by diet or oral hypoglycaemic agents, should only be instigated as an integral part of a
patient‟s self-management plan. The purpose of self-monitoring should be discussed along with agreement about how the results should be interpreted
and acted upon. eg:
To provide information on hypoglycaemia
To assess changes in glucose control resulting from medication and lifestyle changes
To monitor changes during illness
To ensure safety during activities such as driving
Urine glucose monitoring is an option if blood glucose monitoring is not acceptable.I
Frequency of self-testing is variable but is likely to be higher if a patient is unwell or titrating their medication. One pack of 50 strips will be
sufficient for 6-12 months for most patients in this group.
Practices should assess at least annually the continuing benefit of the intervention including:
Appropriate frequency of testing
Use made of results obtained
Impact on quality of life
Self-monitoring skills
Blood Glucose testing for Drivers when on insulin or oral medication carrying the risk of hypoglycaemia (DVLA)
Patients must not have had more than one episode of disabling hypoglycaemia within 12 months & must inform DVLA if they develop impaired awareness
of hypoglycaemia.
Cars & Motorcycles
For patients on sulphonylureas & gliptins there is no absolute requirement to test blood glucose. It may be appropriate to monitor blood glucose regularly
and at times relevant to driving depending on other patient factors.
Vocational Driving (Bus, coach & lorries)
Drivers should monitor blood glucose at least twice daily at times relevant to driving
Endocrine System - Diabetes
Page 104
Therapeutic Area
Formulary Choices
Cost for 28 unless stated
Rationale for decision / comments
25mcg tablets: £2.77
50mcg tablets: £1.67
100mcg tablets: £1.63
Monitoring requirements are for TFTs annually
100micrograms/5ml oral
solution sugar free: £80.05
(100ml)
Liquid is lactose free
Carbimazole
5mg tablets: £19.98 (100)
20mg tablets: £46.89 (100)
New patients should be counselled regarding warning signs of haematological
toxicity. Monitoring requirements are for FBC, LFTS and TFTs annually
Propylthiouracil
50mg tablets: £53.83 (56)
Propylthiouracil is included only for patients intolerant to Carbimazole.
Monitoring requirements are for FBC, LFTS and TFTs annually
6.2 Thyroid and anti-thyroid drugs
Thyroid hormones
Anti-thyroid
hormones
Levothyroxine
NB. Under no circumstances should Carbimazole and Propylthiouracil be
combined.
6.3 Corticosteroids
Glucocorticoid
therapy
Prednisolone
Prescribers are advised to use plain
prednisolone. Enteric coated
prednisolone has slower onset of action,
less consistent blood levels and no proven
evidence of GI protective effect.
1mg tablets: £0.78 (28)
5mg tablets: £0.96 (28)
Patients on long-term oral corticosteroids, should be provided with a steroid
warning card, these are available for practices to requisition from supplies at:
Somerset Partnership Support Services
Mallard Court
Express Park
Bridgwater
TA6 4RN
 01278 726964
Thyroid and Anti-thyroid drugs
Page 105
Therapeutic Area
Formulary Choices
Cost (per pack as stated)
Rationale for decision / comments
6.4 Sex Hormones
6.4.1 Hormone Replacement Therapy (HRT)

HRT should no longer be used a first line intervention to prevent osteoporosis. Preparations marked with an asterisk are those licensed for
osteoporosis as well as relief of menopausal symptoms, all other preparations are only licensed for menopausal symptoms.
 In view of increasing evidence that HRT may have harmful effects on CVD, this should be carefully discussed with patients at commencement and
annually at review.
 Oral preparations recommended 1st line on cost, although transdermal route may be more appropriate for some patients e.g. diabetics
 HRT should be prescribed by brand name to avoid confusion
Unopposed
1mg tablets: £5.04 (84)
Elleste Solo tablets are first line on cost grounds.
Elleste Solo
oestrogen
2mg tablets: £5.34* (84)
Cyclical combined
Continuous
combined:
Evorel
25mcg patch: £3.42 (8)
50mcg patch: £3.88* (8)
75mcg patch: £4.12* (8)
100mcg patch:£4.50* (8)
Evorel is recommended where a patch formulation is required, due to lower
cost, range of doses available and patient acceptability of matrix patches.
Elleste Duet
1mg tablets: £9.19 (84)
2mg tablets: £9.72* (84)
Elleste Duet tablets are first line on cost grounds.
Femoston
1/10mg tablets: £13.47* (84)
2/10mg tablets: £13.47* (84)
Femoston (Estradiol and Dydrogesterone) offers alternative with a C21
progestogen.
Kliovance
Tablets: £13.20* (84)
Kliofem
Tablets: £11.43* (84)
Continuous combined products should not be used until 12 months after the
menopause. Irregular bleeding patterns may occur for the first few months and
may persist for some women, requiring a move back to cyclical preparations
and/or investigation.
Femoston Conti
Tablets: £20.36* (84)
Kliovance has identical composition to Elleste Duet Conti, but at a lower cost
Tibolone is now non-formulary. It is expensive and benefits over HRT have
not been demonstrated for menopausal symptoms. The MHRA have
advised of increased risk of stroke in older women (LIFT study) and in
February 2009 noted the increased risk of recurrent breast cancer when
tibolone was used for vaso-motor symptoms in women with a history of
breast cancer (LIBERATE trial).
Sex Hormones
Page 106
Therapeutic Area
Formulary Choices
Cost (per pack as stated)
Rationale for decision / comments
Progestogens
Norethisterone
5mg tablets: £2.18 (30)
Norethisterone (15mg/day from days 5 to 26 of menstrual cycle) is an option
for management of heavy menstrual bleeding, however it is not recommended
as first line by NICE Clinical Guideline No.44. Norethisterone may cause more
androgenic effects than some other progestogens.
Medroxyprogesterone
2.5mg tablets: £1.84 (30)
5mg tablets: £1.23 (10)
10mg tablets: £2.47 (10)
Medroxyprogesterone may produce less androgenic adverse effects than
Norethisterone.
Sex Hormones
Page 107
Therapeutic Area
Formulary Choices
Cost (per pack as stated)
Rationale for decision / comments
250mg/ml amp: £2.45 (1ml)
Sustanon 250 is the testosterone injection of choice on grounds of costeffectiveness.
Second line is Testosterone Enantate 250mg given every 4 weeks. Trough
testosterone should be measured on the day of the 3rd Enantate injection to
make sure patients are not being overdosed – target is a testosterone in the
lower quartile of reference range, 8-13 nmol/L.
The Enantate dosing interval range of 3-6 weekly is longer than that for
Sustanon, which is usually 3-4 weekly.
6.4.2 Male sex hormones and antagonists
Testosterone
Sustanon 250
®
Testosterone
Enantate
250mg/ml amp: £13.33 (1ml)
Nebido
250mg/ml amp: £80.00 (4ml)
Testogel
50mg/5g gel sachet: £31.11
(30)
50mg/5g gel: £32.00 (30g)
Testim
Striant SR
2% testosterone gel (10mg per
application): £26.67 (60g)
30mg Mucoadhesive buccal
tablets: £28.00 (60)
Restandol
40mg capsules: £8.55 (30)
Tostran
5-Alpha Reductase
Inhibitors (5-ARIs)
®
If neither is available Nebido injection lasts for 10-14 weeks - measuring
trough testosterone weekly from 10 weeks will enable the dosing interval to be
determined using the target range above.
Nebido should be given with the patient lying in prone position
ALL Testosterone products are included (except Intrinsa) are included in the
formulary for the duration of the national shortage of injectable formulations.
For non-injectable alternatives please see BNF 62 6.4.2 or Choosing a
Testosterone Preparation information sheet for details.
Intrinsa for females remains NON-FORMULARY
Cross refer to section 7.4.1 for further details on the management of Lower
Urinary Tract Symptoms (LUTS) associated with benign prostatic hyperplasia
(BPH), for which 5-ARIs are indicated.
Finasteride
5mg tablets: £1.69 (28)
Finasteride is the only recommended 5-ARI, due to the weight of clinical
evidence and cost-effectiveness.
Dutasteride (Avodart) is non-formulary following rejection by the T&ST
D&TC
6.5 Hypothalamic and pituitary hormones and anti-oestrogens
6.5.2 Posterior pituitary hormones and antagonists
Posterior pituitary
hormones
Sex Hormones
Desmopressin
200mcg tablets: £10.96 (30)
Desmopressin tablets are included in the formulary only for the treatment of
nocturnal enuresis in line with NICE CG111: Nocturnal enuresis.
Page 108
6.6 Drugs affecting bone metabolism
Lifestyle interventions:
Investigations:

Nutrition (especially Calcium and Vitamin D intake)

FBC

Weight bearing exercise

Plasma viscosity,

Smoking cessation

Calcium, LFTs, creatinine,

Avoid excess alcohol

TSH,

Gamma GT,

? radiology to exclude other # causes.

Testosterone in males (sex hormone + SHBG)

Guidance on primary prevention of osteoporosis in postmenopausal women is provided in NICE TAG 160 See summary table p111

Guidance on secondary prevention of osteoporosis in postmenopausal women is provided by NICE TAG 161. See summary table p113

The March 2012 Somerset Prescribing Forum debated and then approved the off license use of Bisphosphonates (alendronate (1st) , risedronate(2nd)
rd
or ibandronate(3 ):
o Patients who have sustained fragility fractures but currently excluded by NICE criteria
o Patients deemed by clinicians at high risk of fragility fractures (including patients with Osteopenia if at high # risk)

The evidence of benefit from Bisphosphonate and Strontium therapy comes from trials which ensured patients had intake of therapeutic doses of
Calcium and Vitamin D, supplementation with Calcium and Vitamin D is therefore recommended for patients prescribed these drugs.

Where Calcium and Vitamin D is recommended, a formulation providing Calc.Carb. 1500mg and Vit D 400iu per tablet should be prescribed. A range of
products is included all now of similar price; the product chosen should be made according to patient preference & encourage concordance.

Preparations such as Calcichew D3 or Calcium & Ergocalciferol BP do not provide evidence-based doses of the constituents and should normally not
be prescribed.
 Calcium and Vitamin D should be considered for all women over age of 75 yrs
The optimal period of treatment with bisphosphonates is not known, evidence of benefit has been measured for up to 5 years. NICE recommends research
into the long-term effects and prescribers should be aware of the possible adverse effects on bone quality when bisphosphonates are taken for extended
periods.
Bisphosphonate ‘drug holidays’ No formal guidance exists on this topic which is advocated by some secondary care centres. Local policy is to follow MHRA
alert & assess people individually. The absolute numbers of atypical stress fractures in patients on long-term bisphosphonates is very low; it is not at all clear
whether these are because of BPP therapy or simply random events.
Drugs affecting Bone Metabolism
Page 109
Patient group
Primary prevention
of osteoporosis in
postmenopausal
women
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
70mg tablets: £0.79 (4)
70mg/100ml solution: £22.80
(4x100ml)
Weekly alendronate is recommended first line for the primary prevention of
osteoporotic fracture in susceptible postmenopausal women where specified
combinations of BMD; age; independent risk factors or other indicator of low
bone mineral density apply.
The flow chart on p74 summarises the conditions.
Independent risk factors considered:
st
1 line:
Alendronic Acid
nd
See Summary of
NICE TAG 160 on
page 111
2 line
Risedronate 35mg
35mg tablets: £1.19 (4)
rd
3 line
Denosumab
January 2012
Somerset
Prescribing Forum
approved
Denosumab as
3rd line treatment
before strontium
for both primary &
secondary
prevention of
osteoporosis in
women
4th line:
Strontium Ranelate
60mg/ml prefilled syringe:
£183.00 (1)
120mg Injection NOT for
osteoporosis
2g sachets: £27.08 (28)
All with calcium
and vitamin D
supplement:
See p.129 for full
choice
Jan 2013 – costeffective product:
Accrete D3
Drugs affecting Bone Metabolism
Calcium carbonate 1500 mg)
and 10 micrograms of
colecalciferol (equivalent to
400 IU vitamin D3) tablets:
£2.95 (60)

Parental history of hip fracture

Alcohol intake > 3 units daily
 Rheumatoid arthritis
Indicators of low bone mineral density :

BMI < 22 kg/m2

Ankylosing spondylitis

Crohn‟s disease

Prolonged immobility
 Untreated premature menopause
Osteoporosis confirmed by DEXA scan is expected except by local agreement
for women over 75 with 2 independent risk factors or other indicator of low
BMD.
Risedronate and etidronate are recommended as alternatives where
alendronate is contra-indicated or not tolerated and
Strontium is recommended where treatment with a bisphosphonate is not
appropriate and specified BMD, age & risk factors apply.
Raloxifene is not recommended as a treatment option for primary prevention of
osteoporotic fractures.
Page 110
PRIMARY PREVENTION OF OSTEOPOROSIS IN
POSTMENOPAUSAL WOMEN
Based on NICE TA160 and NICE TA204
Clinical risk factors for fracture:
A. Parental history of # hip
B. Alcohol > 3 units daily (> 4 units if considering Denosumab)
C. Rheumatoid arthritis
AGE < 70 and 0 risk factors
DO NOT TREAT
AGE 75 +
Plus 2 risk factors
from A, B, C or other
indicator of low BMD
AGE 70 - 74
Plus 1 or more risk factors A, B or C or
indicator of low BMD
AGE 65 - 69
Plus 1 or more risk factors A, B or C
NO DEXA required
Refer for DEXA
T score – 2.5 or worse
Initiate weekly generic ALENDRONATE
Refer for DEXA
T score – 2.5 or worse
Initiate weekly generic ALENDRONATE
Alendronate C/I, intolerant or unable to
comply
Alendronate C/I, intolerant or unable to
comply
Initiate weekly
generic
ALENDRONATE
Alendronate C/I,
intolerant or unable to
comply – try
risedronate or
etidronate
C/I, intolerant or
unable to comply
with
bisphosphonates
REFER FOR
DEXA
T score- 4.0 or
worse OR -3.0 or
worse and 2 risk
factors try
Denosumab,
Zoledronate or
Strontium
NO risk factors
ONE risk factor
TWO risk factors
T score better
than - 3.5
DO NOT TREAT
T score - 3.0 or
worse try
risedronate or
etidronate
T score - 2.5 or
worse try
risedronate or
etidronate
NO risk
factors
DO NOT
TREAT
T score - 3.5 or
worse try
risedronate or
etidronate
C/I, intolerant or unable to comply with bisphosphonates
ONE risk
factor
T score -3.5
or worse try
risedronate
or
etidronate
NO risk factors
and T score - 4.5
or worse try
Denosumab,
Zoledronate or
Strontium
TWO risk
factors and T
score - 3.5 or
worse try
Denosumab,
Zoledronate or
Strontium
TWO risk
factors
T score
-3.0 or
worse try
risedronate
or
etidronate
C/I, intolerant or unable to comply with
bisphosphonates
NO risk factors
and T score > - 4.5
DO NOT TREAT
ONE risk
factor and T
score - 4.0 or
worse try
Denosumab,
Zoledronate or
Strontium
AGE < 65
Plus 1 risk factor from
A, B or C AND one
additional indicator of
low BMD
NO risk
factors
DO NOT
TREAT
ONE risk
factor and
T score - 4.5
or worse try
Denosumab,
Zoledronate or
Strontium
REFER FOR DEXA
T score – 2.5 or worse
Initiate weekly generic
alendronate
Alendronate C/I,
intolerant or unable to
comply
DO NOT TREAT
The NHS Somerset
Formulary allows
consideration of
monthly ibandronate
where compliance
issues would
otherwise prevent
patient taking
bisphosphonates
TWO risk
factors and
T score - 4.0 or
worse try
Denosumab,
Zoledronate or
Strontium
Page 111
Patient group
Formulary product
Secondary
prevention of
osteoporosis in
postmenopausal
women
(See Summary of
NICE TAG 161
on p.113)
1st line:
Alendronic Acid
2nd-line
Risedronate 35mg
Cost for 28 unless stated
st
70mg tablets: £0.79 (4)
70mg/100ml solution: £22.80
(4x100ml)
35mg tablets: £1.19 (4)
rd
3 line
Denosumab
January 2012
Somerset
Prescribing Forum
approved
Denosumab as
3rd line treatment
before strontium
for both primary &
secondary
prevention of
osteoporosis in
women
4th-line
Strontium Ranelate
or
Raloxifene 60mg
All with calcium
and vitamin D
supplement:
See p.128 for full
choice
Jan 2013 – costeffectice product:
Accrete D3
Drugs affecting Bone Metabolism
Rationale for decision / comments
60mg/ml prefilled syringe:
£183.00 (1)
nd
rd
Bisphosphonates (1 alendronate, 2 risedronate, 3 ibandronate) are
recommended first line for the secondary prevention of osteoporotic fracture in
women with confirmed osteoporosis who have also sustained a clinically
apparent osteoporotic fracture.
In addition, in March 2012, Somerset Prescribing Forum approved the off
license use of Bisphosphonates in patients with previous fragility fractures or
deemed by clinicians at high risk of fragility fractures for patients with
Osteopenia.
NB Local agreement for women over 75 – DEXA not required.
2g sachets: £27.08 (28)
Where bisphosphonate is not appropriate, denosumab, strontium or raloxifene
may be used again dependent on BMD, age & other risk factors.
60mg tablets: £17.06
Teriparetide is a treatment option following assessment in secondary care
where other therapies are not appropriate. Teriparetide is a RED drug under
the traffic light classification.
This information is summarised in the flow chart on p113
Calcium carbonate 1500 mg)
and 10 micrograms of
colecalciferol (equivalent to
400 IU vitamin D3) tablets:
£2.95 (60)
The FRAX algorithm is a tool to calculate 10 year probablilty of hip and other
major osteoporotic fractures using the same risk factors as NICE plus
glucocorticoid use and smoking status

http://www.shef.ac.uk/FRAX/?lang=en
Page 112
SECONDARY PREVENTION OF OSTEOPOROSIS
IN POSTMENOPAUSAL WOMEN
Clinical risk factors for fracture:
A. Parental history of # hip
B. Alcohol > 4 units daily
C. Rheumatoid arthritis
Based on NICE TAG161 and NICE TAG204 (Denosumab)
(1.6) Intolerance of alendronate, risedronate or etidronate is defined as persistent
upper GI disturbance occuring even though instructions for administration have
been followed correctly and sufficiently severe for treatment to be stopped.
Weekly generic Alendronate is recommended for
postmenopausal women who are confirmed to have
osteoporosis (central T score -2.5 or worse).
For women over 75 years DEXA not required.
(1.7) Intolerance of strontium is defined as persistent nausea or diarrhoea, either of
which warrants discontinuation of treatment.
(1.8) An unsatisfactory response is defined by a women having another fragility
fracture despite adhering fully to treatment for 1 year and there is evidence of a
decline in BMD below her pre-treatment baseline
If alendronate is not appropriate i.e. contraindicated, intolerant, unable to comply or
unsatisfactory response to treatment, options
depend on combination of age, T score and
independent clinical risk factors.
50 – 54
55 – 59
60 – 64
65 – 69
70 – 74
75 and
older
Refer for
DEXA
Refer for
DEXA
Refer for
DEXA
Refer for
DEXA
Refer for
DEXA
DEXA not
required
Alendronate not option: Treat
with risedronate or etidronate
0 risk factor
1 risk
factor
2 risk
factors
Not
recommended
- 3.0
- 2.5
- 3.0
- 3.0
- 2.5
- 3.0
- 3.0
- 2.5
- 3.0
- 2.5
- 2.5
- 2.5
- 2.5
- 2.5
- 2.5
- 2.5
- 2.5
* DEXA not required if indicators for low BMD exist, including:
Consider Denosumab or Zoledronic acid
Age
If T-score
not
available
(2.6) A fragility fracture is defined as a fracture sustained as the result of a force
equivalent to the force of a fall from a height equal to, or less than, the height of an
ordinary chair.
Alendronate, second
bisphosphonate, and Denosumab
or Zoledronic acid not option:
Treat with strontium or raloxifene
Strontium or raloxifene not option:
refer to secondary care assessment
for teriparatide
2 fragility
fractures or
less
Not
recommended
Not
recommended
Not
recommended
0 risk factors
1 risk
factor
2 risk
factors
More than 2
fragility fractures
Not
recommended
- 3.5
- 3.5
- 4.0
- 3.5
- 3.5
- 4.0
- 3.5
- 3.5
- 4.0
- 3.5
- 3.0
- 4.0
- 3.5
- 3.0
- 3.0
- 2.5
- 4.0
- 3.5
- 3.0*
- 2.5
- 2.5
- 4.0
- 3.5
Not recommended
- 4.0
- 4.0
2
Low BMI (< 22kg/m ), inflammatory conditions such as ankylosing spondylitis or Crohn‟s disease,
Conditions resulting in prolonged immobility, and untreated early menopause.
NHS Somerset Formulary allows consideration of monthly ibandronate where compliance issues would otherwise prevent patient taking bisphosphonates
Drugs affecting Bone Metabolism
Page 113
Patient group
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
Steroid induced
osteoporosis
(6 months at
>7.5mg
Prednisolone
equivalent)
Alendronic Acid
70mg tablets: £0.79 (4)
70mg/100ml solution: £22.80
(4x100ml)
To reduce the risk of osteoporosis doses of oral corticosteroids should be as
low as possible and courses of treatment as short as possible. The risk of
osteoporosis may be related to cumulative dose of corticosteroids; even
intermittent courses can therefore increase the risk. The greatest rate of bone
loss occurs during the first 6–12 months of corticosteroid use and so early
steps to prevent the development of osteoporosis are important. Long-term use
of high-dose inhaled corticosteroids may also contribute to corticosteroidinduced osteoporosis
Patients taking (or who are likely to take) an oral corticosteroid for 3 months or
longer should be assessed and where necessary given prophylactic treatment;
those aged over 65 years are at greater risk. Patients taking oral
corticosteroids who have sustained a low-trauma fracture should receive
treatment for osteoporosis. The therapeutic options for prophylaxis and
treatment of corticosteroid-induced osteoporosis are the same:
Plus calcium and
vitamin D
supplement:
See p.128 for full
choice
Jan 2013 – costeffectice product:
Accrete D3
Calcium carbonate 1500 mg)
and 10 micrograms of
colecalciferol (equivalent to
400 IU vitamin D3) tablets:
£2.95 (60)
 a bisphosphonate
 calcitriol [unlicensed indication]
 hormone replacement: HRT in women, testosterone in men
[unlicensed indication]
Breast cancer
treatment - induced
bone loss:
See: ‘Guidance for the management of breast cancer treatment-induced bone loss: A consensus position statement from a UK
expert group (2008)’
Drugs affecting Bone Metabolism
Page 114
Patient group
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
Osteoporosis in
Men
Alendronic Acid
70mg tablets: £0.79 (4)
70mg/100ml solution: £22.80
(4x100ml)
NB All young men with osteoporosis should be referred for specialist advice.
Denosumab
60mg/ml prefilled syringe:
£183.00 (1)
In Nov 2011 Somerset Prescribing Forum agreed to approve use of
denosumab in men when NICE criteria are fulfilled. Prescribers should ensure
that patients are aware that the product is being used outside of its licence.
Strontium
2g sachets: £27.08 (28)
Licensed for use in men at increased of fracture, and approved for use in men
with primary osteoporosis who cannot have, cannot tolerate or have failed oral
bisphosphonate treatment.
Plus calcium and
vitamin D
supplement:
See p.128 for full
choice
Jan 2013 – costeffectice product:
Accrete D3
Drugs affecting Bone Metabolism
Alendronate 70mg is not licensed in men, but is used outside of license for this
indication; prescribers should ensure that patients are aware of unlicensed
nature.
Calcium carbonate 1500 mg)
and 10 micrograms of
colecalciferol (equivalent to
400 IU vitamin D3) tablets:
£2.95 (60)
Page 115
Patient group
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
Primary Prevention
of osteoporosis
Frail elderly women
Calcium and
Vitamin D
supplement
See p.128 for full
choice
As above
Indicated for those at increased fracture risk e.g. patients in Nursing or
residential homes.
Jan 2013 – costeffectice product:
Accrete D3
Drugs affecting Bone Metabolism
Calcium carbonate 1500 mg)
and 10 micrograms of
colecalciferol (equivalent to
400 IU vitamin D3) tablets:
£2.95 (60)
Page 116
Therapeutic Area
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
BNF Chapter 7: Obstetrics, gynaecology, and urinary-tract disorders
Top
7.2 Treatment of vaginal and vulval conditions
Preparations for
vaginal atrophy
Estradiol
as Ovestin
0.1% cream £4.45 (15g)
as Vagifem
10mcg pessaries £16.72 (24)
Topical oestrogens should be used in the lowest effective amount to
minimize systemic absorption. Patients should be reviewed at least
annually to re-assess the need for continued treatment and to monitor
for symptoms of endometrial hyperplasia or carcinoma in women with a
uterus.
Patients should have the opportunity to choose a product suited to them
although there is no evidence of difference in effect.
Long term treatment may be required as symptoms can recur on
cessation of therapy
Vagifem 25mcg pessaries being discontinued February 2013
Vaginal and vulval
infections
Fungal
infections:
First line:
Fluconazole (oral)
150mg capsule: £0.80 (1)
Fluconazole is recommended as first line due to ease of use and costeffectiveness. Available as a generic.
Second line:
Clotrimazole
(intra-vaginal and/or
topical)
500mg pessary: £3.38 (1)
2% cream / 500mg pessary combipack: £5.21 (1)
1% Cream: £1.41 (20g)
Clotrimazole pessaries are second line due to higher cost.
NB: available OTC, often at cost lower than the NHS prescription
charge.
Gynaecology and Urinary-tract Disorders
Page 117
Therapeutic Area
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
7.3 Contraceptives
Women requiring contraception should be given information about and offered a choice of all methods including LARC (long-acting reversible contraception).
Interactions
The effectiveness of combined oral contraceptives, progestogen-only oral contraceptives, contraceptive patches, and vaginal rings can be considerably reduced
by interaction with drugs that induce hepatic enzyme activity (e.g. carbamazepine, eslicarbazepine, modafinil, nelfinavir, nevirapine, oxcarbazepine,
phenytoin, phenobarbital, primidone, ritonavir, St John’s Wort, topiramate, and, above all, rifabutin and rifampicin).
Hormonal contraceptives and antibacterials that do not induce liver enzymes
Advice on interactions between combined hormonal contraceptives and antibacterials that do not induce liver enzymes has been updated to take into account
the recommendations of the Faculty of Sexual and Reproductive Healthcare Clinical Guidance: Drug Interactions with Hormonal Contraception (January 2011).
Additional contraceptive precautions are no longer necessary when antibacterials that do not induce liver enzymes are taken with combined oral contraceptives,
(unless diarrhoea or vomiting occurs), contraceptive patches or vaginal rings. Click here for more information.
Some other interactions of hormonal contraceptives have been updated in Appendix 1 of the BNF: Interactions (under Oestrogens and Progestogens)
Gynaecology and Urinary-tract Disorders
Page 118
Therapeutic Area
Formulary product
Cost (per pack as stated)
Low strength
Loestrin 20
(Ethinylestradiol /
norethisterone)
20mcg/1mg tablets: £2.70 (63)
Standard
strength:
Ovranette
(Ethinylestradiol /
norgestrel)
30mcg/150mcg tablets: £2.20 (63)
Rationale for decision / comments
Combined
hormonal
contraceptives
as Rigevidon
®
Rigevidon is a cost-effective alternative to Ovranette.
Cilest
(Ethinylestradiol /
norgestimate)
35mcg/250mcg tablets: £7.16 (63)
Femodene
(Ethinylestradiol /
gestodene)
30mcg/75mcg tablets : £6.73 (63)
NB: Third-generation COCs containing the progestogens gestodene or
®
desogestrel (e.g. Femodene ) are associated with a higher risk of VTE.
as Millinette 30/75
30mcg/75mcg tablets: £4.85 (63)
Millinette 30/75 is a cost-effective alternative to Femodene
®
®Longtec
Cerelle 75mcg is a cost-effective alternative to Cerazette
Tri-Novum (triphasic)
(Ethinylestradiol /
norethisterone)
35mcg/500mcg, 35mcg/750mcg, &
35mcg/1mg: £3.46 (63)
Micronor
(Norethisterone
350mcg)
Tablets: £2.11 (84)
Femulen
(Etyndiol acetate
500mcg)
Tablets: £3.31 (84)
®
Progestogen-only
contraceptives
(POPs)
30mcg/150mcg tablets: £1.89 (63)
Gynaecology and Urinary-tract Disorders
®
®
Pfizer is discontinuing Femulen (ethynodiol diacetate) tablets 500mg 3 x
28 once current stocks are exhausted, expected to be by the end of
March 2013.
Page 119
Therapeutic Area
Formulary product
Long-acting
reversible
contraception
(LARC)
Medroxyprogesterone
®
as Depo-Provera
Etonogestrel
®
as Nexplanon
Emergency
Hormonal
Contraception
(EHC)
Cost (per pack as stated)
LARC methods are more cost-effective than COC pill even at one year.
150mg/ml prefilled syringe: £6.01 (1)
®
®
68mg implant: £79.46
Nexplanon is bioequivalent to Implanon (discontinued), it has the
®
same release rate and 3-year duration of action. Nexplanon also has a
different application device and insertion technique. Please visit
http://www.nexplanontraining.co.uk/ or contact MSD directly for training.
1500mcg tablet: £5.20 (1)
Available via PGD through many pharmacies across Somerset, free of
charge to those who are exempt from prescription charges and at the
standard prescription charge to those who are not exempt
Levonorgestrol 1500mcg is the first-line oral preparation for patients
presenting within 72 hours of UPSI or contraceptive failure.
Levonorgestrel
1500mcg tablet
as Levonelle 1500
Rationale for decision / comments
DO NOT PRESCRIBE AS THE OTC PREPARATION: Levonelle OneStep (as over twice the cost of the POM product.)
Pre-operative
treatment of uterine
fibroids
Ulipristal acetate
30mg tablet ▼
as EllaOne
30mg tablet: £16.95 (1)
Patients presenting between 72 hours and 120 hours may be offered the
choice of ulipristal acetate or intrauterine device and the risks and
benefits of each method should be discussed with the patient.
Ulipristal is licensed for emergency contraception within 120 hours (5
days) after unprotected sexual intercourse (UPSI).
Pregnancy should be excluded before ulipristal is taken.
Ulipristal acetate
5mg tablet ▼
as Esmya
5mg tablet: £ 125.71 (28)
Ulipristal acetate is indicated for pre-operative treatment of moderate to
severe symptoms of uterine fibroids in adult women of reproductive age
over the age of 18.
Approved at Somerset Prescribing Forum as an AMBER drug for a
maximum of 3 months treatment only with the acute trust to supply the
first month.
Pregnancy should be precluded prior to treatment and a non hormonal
contraceptive method is recommended during treatment
Gynaecology and Urinary-tract Disorders
Page 120
Therapeutic Area
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
7.4 Drugs for genito-urinary disorders
7.4.1 Drugs for urinary retention
Related guidance: NICE Clincal Guideline CG97 (2010): Lower urinary tract symptoms
Management of Lower Urinary Tract Symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH) involves:

Alpha-blockers – as below, cross refer to CV section for recommendations on use of alpha-blockers in hypertension
 5-alpha reductase inhibitors – cross refer to section 6.4.2. for details
Evidence from the MTOPS study which combined Finasteride with Doxazosin showed that dual-therapy provides additional symptomatic benefit for patients and
delays the progression of BPH, compared to monotherapy. Further guidance on management of LUTS associated with BPH is available on CD-ROM from the
British Association of Urological Surgeons.
Alpha-blockers
First-line:
Second-line:
Doxazosin
as modifiedrelease (m/r) (for
initiation only
Doxadura brand
4mg m/r tabs: £5.00 (28)
as standard
tablets for
continuation)
4mg tablets: £1.35 (28)
Doxadura brand
4mg tablets: £1.17
Tamsulosin MR
capsules
as Tabphyn MR
®
Gynaecology and Urinary-tract Disorders
Patients should be initiated on the 4mg MR preparation and then
switched to the more cost-effective standard 4mg tablet once
stabilised e.g. after one to two months therapy.
4mg m/r tabs £4.50
400mcg m/r capsules: £5.16 (30)
Tamsulosin has greater selectivity for the alpha-receptors predominant
in the urinary tract; however the clinical significance of this remains
debateable. In view of this and its greater cost, Tamsulosin should only
be used where there is intolerance to Doxazosin.
Generic Tamsulosin capsules are now available.
Available OTC.
400mcg m/r capsules: £4.39 (30)
Tamsulosin MR tablets (Flomaxtra XL) are not included in the
formulary
Page 121
Therapeutic Area
7.4.2
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
Drugs for urinary frequency, enuresis, and incontinence
Related guidance: NICE Clinical Guideline CG111 (2010): Nocturnal enuresis – the management of bedwetting in children and young people
Before initiating treatment a thorough investigation of the underlying cause of incontinence should be carried out and drugtreatments should be reviewed 4
weeks after starting. If there is no or suboptimal improvement or intolerable adverse effects change the dose, or try an alternative antimuscarinic drug, and
review again 4 weeks later.
Thereafter, treatments should be reviewed annually.
st
1 line:
Oxybutynin
(immediate release)
Tolterodine
(immediate release)
2.5mg tablets: £3.39 (56)
5mg tablets: £3.78 (56)
1mg tablets: £5.33 (56)
2mg tablets: £5.64 (56)
As per NICE guidance Oxybutynin (non-MR) is recommended as the
first line antimuscarinic for managing urinary incontinence as a result of
detrusor instability on the basis of its good efficacy and low cost.
Not recommended in frail, elderly women.
Research has shown that concordance after 3 years is less than 10%
regardless of class of drug use with little to differentiate treatment
options (Shamliyan T, et al. Benefits and harms of pharmacologic
treatment for urinary incontinence in women. A systemic review. Ann
Intern Med 2012; 156:861-74)
nd
2 line:
Oxybutynin MR
5mg m/r tablets: £13.77 (30)
10mg m/r tablets: £27.54 (30)
Tolterodine MR
4mg m/r capsules: £25.78 (28)
Trospium
(immediate release)
as Flotros®
20mg tablets:£18.20 (60)
TrospiumMR
as Regurin XL®
60mg tablets: £23.05
Propiverine
(immediate release)
15mg tablets: £18.00 (56)
Darifenacin
5mg tablets: £20.90 (28)
Gynaecology and Urinary-tract Disorders
Oxybutynin MR, Trospium & Trospium MR, Solifenacin and Tolterodine
MR are recommended as second line alternatives for use when
antimuscarinic adverse effects such as dry-mouth have are problematic
and affect patient compliance.
Page 122
Therapeutic Area
rd
3 line
Non oral therapy
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
Solifenacin
5mg tablets: £27.62 (30)
10mg tablets: £35.91 ( 30)
Evidence indicated that higher dose of solifenacin is more likely to cause
side effects than tolterodine MR or Trospium MR
Fesoterodine
4mg m/r tablets: £25.78 (28)
8mg m/r tablets: £25.78 (28)
Mirabegron
25mg tablets: £27.06 (28)
50mg tablets: £27.06 (28)
To use as an option where antimuscarinic drugs are contra-indicated or
clinically ineffective or side-effects are unacceptable, before surgery or
botox therapy
Lower dose used where hepatic or renal impairment exists
Oxybutinin Patches
Oxybutinin 3.9mg/24 hours: £27.20
(8)
Oxybutinin patches remain an option at any stage for those unable to
tolerate oral therapy or for patients with swallowing problems to avoid
the need for unlicensed liquid formulations.
Patches are applied twice weekly to clean, dry, unbroken skin on
abdomen, hips or buttocks.
For the use of desmopressin in the treatment of nocturnal enuresis, please refer to section 6.5.2 Posterior pituitary hormones and antagonists
7.4.5 Drugs for erectile dysfunction
The drugs for the treatment of erectile dysfunction in men listed below are considered appropriate for initiation in general practice, where patients meet the
following criteria for NHS prescribing and are endorsed as “SLS”:

Diabetes mellitus

Single gene neurological disease

Multiple sclerosis

Spina Bifida

Parkinson's disease

Spinal cord injury

Poliomyelitis

Dialysis for renal failure

Prostate Cancer

Radical pelvic surgery, prostatectomy or kidney transplant

Severe pelvic injury

Were receiving Caverject , Erecnos , MUSE , Viagra or Viridal for ED at NHS
expense on 14-09-1998
First-line:
Vardenafil
Gynaecology and Urinary-tract Disorders
5mg tablets: £7.56 (4)
10mg tablets: £14.08 (4)
20mg tablets: £23.48 (4)
®
®
®
®
®
NICE CG66 states that all PDE5‟s are effective and the evidence is not
sufficient to distinguish between them. Vardenafil is first line as most
cost effective option.
Page 123
Therapeutic Area
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
Second-line
Sildenafil
25mg tablets: £16.59 (4)
50mg tablets: £21.27 (4)
100mg tablets: £23.50 (4)
All PDE5 inhibitors are contra-indicated in patients taking nitrates.
Use after prostate surgery prophylactically: not considered to be in
accordance with Health Service Circular 1999/148 therefore cannot to
be prescribed on FP10
Treat as RED if recommended by a relevant specialist.
Third-line:
Tadalafil
10mg tablets: £26.99 (4)
20mg tablets: £26.99 (4)
Tadalafil is offered as a third line option for patients who are intolerant or
unresponsive to Sildenafil and Vardenafil. It should not be used in
patients taking nitrates.
Cialis Once Daily is non-formulary
Gynaecology and Urinary-tract Disorders
Page 124
Therapeutic Area
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
BNF Chapter 8: Malignant disease and immunosupression
Top
8.3 Sex hormones and hormone antagonists in malignant disease
Hormone
antagonists
Anastrazole
1mg tablets: £1.94 (28)
®
Prostate cancer &
Gonadorelin
analogues
First-line:
as Nastrosa
1mg tablets: £1.75 (28)
Letrozole
2.5mg tablets: £2.20 (14)
£84.68 (28)
Anastrazole is recommended as an adjuvant to early oestrogen-receptorpositive breast cancer and is supported by a Shared Care Protocol.
Monthly injections of triptorelin and goserelin were approved at the March 2010 meeting of the Somerset prescribing Forum for use
within licensed indications re: Breast Cancer – endometriosis and uterine fibroids.
Triptorelin
as Decapeptyl SR
Second-line:
Anastrazole is recommended as an adjuvant to early oestrogen-receptorpositive breast cancer and is supported by a Shared Care Protocol.

Goserelin
Malignant Disease and Immunosuppression
3mg (4.2mg) vial: £69.00 (1)
11.25mg (15mg) vial: £207.00 (1)
22.5mg (28mg) vial: £414.00 (1)
Decapeptyl SR is recommended as the first line GnRH anaologue within
its licensed indications for prostate cancer.
Patients with a life expectancy of >12 months who do not requiring 3monthly reviews should be considered for a switch from the 3-monthly
(15mg) to the 6-monthly (28mg) preparation.
3.6mg PFS: £65.00 (1)
10.8mg PFS: £235.00 (1)
Goserelin is considered as second line GnRH analogue for use within its
licensed indications, where Decapeptyl is not appropriate.
Page 125
BNF Chapter 9: Nutrition and blood
Top
9.1 Anaemias and some other blood disorders
Therapeutic Area
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
Iron deficiency
Ferrous fumarate
210mg tablets: £1.44 (100)
322mg tablets: £0.95 (28)
210mg Ferrous fumarate provides 68mg elemental iron, usual dose 210mg
tds.
322mg Ferrous fumarate provides 100mg elemental iron, usual dose
322mg bd
Ferrous sulphate is no longer included in the formulary as Ferrous
fumarate provides equivalent at lower cost. For reference 200mg Ferrous
sulphate tablets provide 65mg elemental iron.
Syrup
As Fersamal
as Galfer
Megaloblastic
anaemia

140mg/5ml: £3.73 (200ml)
140mg/5ml £5.33 (300ml)
Folic acid
400mcg tablets: £2.71 (90)
5mg tablets: £0.97 (28)
Hydroxocobalamin
1mg/ml injection: £2.83 (5)
400mcg daily is indicated for prevention of neural tube defects
9.2 Fluids and electrolytes
Potassium Salts
Oral rehydration
therapy
Potassium chloride
Electrolade

600mg m/r tablets: £1.90 (100)
Sachets: £1.97 (6)
Sachets: £4.99 (20)
Electrolade offers a lower cost alternative to Dioralyte
Chewable tablets: £7.25 (100)
Evidence for efficacy of Calcium supplements is in combination with Vitamin
D, there should be few situations where Calcium alone is indicated.
9.5 Minerals
Calcium
supplements
Nutrition and Blood
Calcium carbonate
as Adcal

Page 126
9.6 Vitamins
Vitamin D
Colecalciferol 800IU
as Fultium
as Desunin
Nutrition and Blood
800IU capsules: £3.60 (30)
Vitami D deficiency can occur in people whose exposure to sunlight is
limited and in those whose diet is deficient in vitamin D but there is little
agreement on what minimum blood levels should be and evidence base for
supplementation is poor (except rickets). Levels will be reduced during
winter months. Ergocalciferol or colecalciferol may be given in a dose of
20mcg (800IU daily by mouth.
Higher doses may be necessary for severe deficiency.If recommended by
secondary care there is an agreement that they will be responsible for
supplying the supplement for its whole duration and primary care should not
be asked to prescribe.
Capsules contain arachis oil and must not be taken by people with peanut
allergy, and gelatine
800IU tablets: £ 3.60 (30)
Tablet version of colecalciferol – included for option to capsules which may
be crushed for patients wih swallowing problems.
Dose equivalent to 20microgram vitamin D3

Page 127
Vitamin D
supplements with
Calcium
Calcium and vitamin D should be considered as an intervention to reduce fracture risk for all women over 75 yrs.
Calcium and
Vitamin D:
Calcium & Ergocalciferol tablets BP are non-formulary as they provide
an inadequate dosage for most patients.
st
1 line:
Accrete D3
Tablets: £2.95 (60)
A range of Calcium and Vitamin D products are included to provide a range
of flavours & formulation to encourage concordance.
Accrete is currently the most cost-effective choice however a range of
products is included for patient choice.
Chewable tablets:£3.65 (56)
£7.30 (112)
Caplet:
£3.65 (112)
Dose AdCal D3 caplets is 2bd

2nd line:
Adcal D3
or
Adcal D3 Dissolve
or
Soluble tablets: £4.99 (56)
Calcichew D3 Forte Chewable tablets: £4.24 (60)
or
Calceos
Chewable tablets: £3.58 (60)
®
Calcichew D3
Caplets: £7.43 (100)
More costly than other products in the class & provides lower dose of
colecalciferol.
Vitamin K1
Phytomenadione
10mg/ml ampoule: £3.78 (10)
2mg/0.2ml ampoule: £4.71 (5)
For use in the management of haemorrhage due to Warfarin, cross refer to
anticoagulant section of formulary.
MultiVitamin
Preparations
Dialyvit
Nutrition and Blood
Approved at May 2012 Prescribing Forum only for patients receiving renal
dialysis.
Unlicensed in UK – order supplies from USA
Page 128
Therapeutic Area
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
BNF Chapter 10: Musculoskeletal and joint diseases
Top
10.1 Drugs used in rheumatic diseases and gout
Related guidance: NICE Clinical Guideline CG59 (2008): Osteoarthritis (a summary of which can be found on page 132)
Non-steroidal antiinflammatory drugs
(NSAIDs)
NICE recommends cytoprotection with PPIs for patients who require systemic NSAIDs. Recommended PPIs are: Lansoprazole
15mg capsules; Omeprazole 20mg capsules or Pantoprazole 20mg tablets.
Risk of GI bleeds is higher for slow release formulations.
Note that all NSAIDs should be prescribed at the minimum effective dose for the minimum period in order to limit cardiovascular, renal
and GI toxicity.
Consider trial of topical NSAIDs before moving to systemic NSAID for Osteoarthritis.
First-line:
Ibuprofen
200mg tablets: £3.01 (84)
400mg tablets: £3.01 (84)
600mg tablets: £6.57 (84)
Ibuprofen is 1st choice on grounds of safety and cost
Second-line:
Naproxen
250mg tablets: £1.43 (28)
500mg tablets: £2.36 (28)
Naproxen EC tablets are non-formulary, evidence that EC reduces GI
events is poor and they are three times the price of standard tablets.
Diclofenac sodium
25mg ec tablets: £0.78 (28)
50mg ec tablets: £0.80 (28)
CV risks associated with diclofenac were statistically significantly
increased at both high and low doses this included doses less than 100
mg/day (close to the maximum recommended dose for over-the-counter
diclofenac products).If any NSAID is essential in patients with high CV
risk consider Ibuprofen or Naproxen instead. Diclofenac MR
preparations are non-formulary, on grounds of cost. Naproxen in a “bd”
regime may be alternative. Note all standard generic Diclofenac sodium tablets
are EC, there is no cost-premium for prescribing these.
Third-line:
COX-2 selective
NSAIDs
NICE recommends cytoprotection with PPIs for patients who require systemic COX-2s. Recommended PPIs are: Lansoprazole
15mg capsules or Omeprazole 20mg capsules
Note that all NSAIDs including COX-2s should be prescribed at the minimum effective dose for the minimum period in order to limit
cardiovascular, renal and GI toxicity. Consider trial of topical NSAIDs before moving to systemic COX-2 for Osteoarthritis.
First-line:
Meloxicam
7.5mg tablets: £1.25 (30)
15mg tablets: £1.48 (30)
Note Etoricoxib and Celecoxib are non-formulary
Musculoskeletal system
Page 129
Therapeutic Area
Formulary product
Cost (per pack as stated)
Rubefacients and
topical NSAIDs
Algesal
Cream: £1.21 (50g)
Transvasin
Cream: £1.43 (40g)
Ibuprofen as
Fenbid
5% gel: £1.50 (100g)
10% gel £4.00 (100g)
Piroxicam
0.5% gel: £5.06 (112g)
Rationale for decision / comments
NICE CG59 advises that Paracetamol and/or Topical NSAIDs should be
considered AHEAD of oral NSAIDs for OSTEOARTHRITIS
Topical NSAIDs should be considered for use in addition to core treatment for
knee or hand inflammation.
For patients using large volumes of topical NSAIDs, Fenbid 5%gel is the
most cost-effective.
Topical ketoprofen is no longer recommended following a Drug Safety Update
warning about the risk of photosensitivity reactions after exposure to direct
sunlight, uv lamps, etc.
Felbinac (Traxam) and Diclofenac (Voltarol) gels / foams are nonformulary
Capsaicin
Musculoskeletal system
0.025% cream £17.71 (45g)
0.075% cream £14.58 (45g)
Topical capsaicin should be considered as an adjunct to core treatment for
knee or hand osteoarthritis
Page 130
Therapeutic Area
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
Gout
Guidelines on management of gout available from The British Society for Rheumatology and British Health Professionals in
Rheumatology: http://rheumatology.oxfordjournals.org/cgi/reprint/kem056av1
Acute attacks:
First-line:
Second-line:
Naproxen
See p 129 for prices
Oral NSAIDs at maximum doses are the drugs of choice where there are no
contra-indications.
NICE recommends cytoprotection with PPIs for patients who require systemic
COX-2s. See above
Colchicine can be an effective alternative to NSAIDs, but has a slower onset of
action. To reduce risk of diarrhoea it should be used in doses of 500mcg bd to
qds.
Colchicine
500mcg tablets: £36.13 (100)
First-line
Allopurinol
100mg tablets: £1.00 (28)
300mg tablets: £1.06 (28)
Allopurinol is first line therapy for lowering uric acid. In uncomplicated gout,
therapy should be started if a second attack or further attacks occur within 1
year. Commence 1-2 weeks after inflammation of acute attack has settled.
Treatment should be initiated with 50-100mg/day and increased at 50-100mg
increments every few weeks, adjusted in necessary for renal function, until the
therapeutic target (Serum Uric Acid < 300mol/litre) is reached. Maximum in
severe conditions 900mg/day in divided doses.
If mild/moderate renal impairment: seek further advice.
Second-line:
Febuxostat
80mg tablets: £24.36 (28)
120mg tablets: £24.36 (28)
Febuxostat is recommended as an option for the management of chronic
hyperuricaemia in gout only when allopurinol is not tolerated at an effective
dose or for whom allopurinol is contra-indicated. NICE TA164
Sulfinpyrazone
100mg tablets: £41.25 (84)
200mg tablets: £79.00 (84)
Uricosuric therapy with Sulfinpyrazone (usually 200-600mg/day) may be an
appropriate second line option for patients with normal renal function who are
under-excretors of uric acid and those resistant to, or intolerant of, Allopurinol.
For those with mild/moderate renal impairment seek further advice.
Long term
control:
Musculoskeletal system
Page 131
Management of Osteoarthritis
NICE CG59 (2008): quick reference summary
Oral analgesics
Therapy options for OA are summarised in the following:
Healthcare professionals should consider offering paracetamol
for pain relief in addition to core treatment (see figure 2); regular
dosing may be required. Paracetamol and/or topical nonsteroidal anti-inflammatory drugs (NSAIDs) should be
considered ahead of oral NSAIDs, cyclo-oxygenase 2 (COX-2)
inhibitors or opioids.
oral NSAIDs
including COX-2
inhibitors
opioids
capsaicin
intra-articular
corticosteroid
injections
paracetamol
supports
and braces
topical
NSAIDs
education, advice,
information access
shockabsorbing
shoes or insoles
strengthening exercise
aerobic fitness training
assistive
devices
weight loss if
overweight/obese
TENS
manual therapy
(manipulation and
stretching)
Musculoskeletal system
local heat and
cold
joint
arthroplasty
If paracetamol or topical NSAIDs are insufficient for pain relief
for people with osteoarthritis, the addition of opioid analgesics
should be considered with Tramadol considered first line. Risks
and benefits should be discussed, particularly in elderly people.
If a strong opioid is needed, its use should be relatively short
term pending surgical or other specialist referral. Regular
follow-up is needed to assess analgesic efficacy and minimise
unwanted effects.
Topical treatments
Healthcare professionals should consider offering topical
NSAIDs for pain relief in addition to core treatment (see
figure 2) for people with knee or hand osteoarthritis. Topical
NSAIDs and/or paracetamol should be considered ahead of oral
NSAIDs, COX-2 inhibitors or opioids.
Topical capsaicin should be considered as an adjunct to core
treatment for knee or hand osteoarthritis.
Rubefacients are not recommended for the treatment of
osteoarthritis.
Page 132
NSAIDs and highly selective COX-2 inhibitors
Although NSAIDs and COX-2 inhibitors may be regarded as a single drug class of „NSAIDs‟, these recommendations continue to use the two terms for clarity, and
because of the differences in side-effect profile. The recommendations in this section are derived from extensive health-economic modelling, which included
December 2007 NHS drug tariff costs. This guideline replaces the osteoarthritis aspects only of NICE technology appraisal guidance 27. The guideline
recommendations are based on up-to-date evidence on efficacy and adverse events, current costs and an expanded health-economic analysis of cost effectiveness.
This has led to an increased role for COX-2 inhibitors, an increased awareness of all potential adverse events (gastrointestinal, liver and cardio-renal) and a
recommendation to co-prescribe a proton pump inhibitor (PPI).
Where paracetamol or topical NSAIDs are ineffective for pain relief for people with osteoarthritis, then substitution with an oral NSAID/COX-2 inhibitor should be
considered.
Where paracetamol or topical NSAIDs provide insufficient pain relief for people with osteoarthritis, then the addition of an oral NSAID/COX-2 inhibitor to paracetamol
should be considered.
Oral NSAIDs/COX-2 inhibitors should be used at the lowest effective dose for the shortest possible period of time.
When offering treatment with an oral NSAID/COX-2 inhibitor, the first choice should be either a standard NSAID or a COX-2 inhibitor (other than etoricoxib 60 mg).
In either case, these should be co-prescribed with a PPI, choosing the one with the lowest acquisition cost.
All oral NSAIDs/COX-2 inhibitors have analgesic effects of a similar magnitude but vary in their potential gastrointestinal, liver and cardio-renal toxicity; therefore,
when choosing the agent and dose, healthcare professionals should take into account individual patient risk factors, including age. When prescribing these drugs,
consideration should be given to appropriate assessment and/or ongoing monitoring of these risk factors.
If a person with osteoarthritis needs to take low-dose aspirin, healthcare professionals should consider other analgesics before substituting or adding an NSAID or
COX-2 inhibitor (with a PPI) if pain relief is ineffective or insufficient.
Nutraceuticals
The use of glucosamine or chondroitin products is not recommended for the treatment of osteoarthritis.
Intra-articular injections
Intra-articular corticosteroid injections should be considered as an adjunct to core treatment for the relief of moderate to severe pain in people with osteoarthritis.
Intra-articular hyaluronan injections are not recommended for the treatment of osteoarthritis.
Musculoskeletal system
Page 133
Therapeutic Area
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
BNF Chapter 11: Eye
Top
11.3 Anti-infective eye preparations
Antibacterials
Chloramphenicol
0.5% drops: £1.65 (10ml)
1% ointment: £1.62 (4g)
See Infection management guidance for appropriate clinical indications.
Chloramphenicol drops and ointment are now both available OTC at a cost lower
than NHS prescription charge but restrictions apply to sales.
®
Fusidic acid (Fucithalmic ) is non-formulary
Antivirals
Aciclovir
3% ointment: £9.34 (4.5g)
11.4 Corticosteroids and other anti-inflammatory preparations
Corticosteroids
Other
anti-inflammatory
products
As advised by secondary care
Sodium
cromoglicate
2% drops: £1.80 (13.5ml)
Available OTC.
Prescribe 13.5ml size.
5ml and 10ml pack sizes are OTC products, and are more expensive when
being used regularly.
11.5 Mydriatics and cycloplegics
Mydriatics and
cyloplegics
As advised by secondary care
11.6 Treatment of glaucoma
Glaucoma
As advised by secondary care
First line:
Latanoprost
Eyes
Where a prostaglandin analogue is indicated for reducing IOP, Latanoprost is
the recommended first line agent on grounds of cost (generic form available) and
ocular tolerability. Agreed by both T&S & YDH D&TC & Somerset Prescribing
Forum Sept 2012.
Patients currently using other forms of prostaglandin analogues may be
reviewed when seen routinely by secondary care.
Page 134
Therapeutic Area
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
0.3% drops £1.12
0.5% drops: £0.81 (10ml)
1% drops: £0.94 (10ml)
Treatment for dry eyes associated with tear deficiency should normally
commence with the least viscous agent e.g. Hypromellose 0.3% drops and work
through alternatives in increasing order of viscosity.
11.8 Miscellaneous ophthalmic preparations
Dry eyes:
Hypromellose
Lubricant
Carbomer 0.2% eye gel
Brand
Clinitas
Presentation
10g tube
Carmellose: 1% drops are significantly
less expensive than 0.5%
Carmize 1%
30 x 0.4ml single dose unit
60 x 0.4ml single dose unit
£3.00 reuse up to 12 hrs
£6.00 reuse up to 12 hrs
For 0.5% cost is least using CARMIZE
(£5.75) if patients are able to reuse vials
for more than one drop. If not Optive
becomes a cost-effective option.
Carmize 0.5%
30 x 0.4ml single dose unit
£5.75 reuse up to 12 hrs
£15.53 reuse up to 12 hrs
£7.49 up to 6 months
Hypromellose 0.5% eye drops (Pres)
Isopto Plain
90 x 0.4ml single dose unit
10ml
10ml (special container
maintains contents)
Hypromellose (Pres Free)
Lumecare Hypromellose 0.3% Eye Drops
Polyvinyl Alcohol 1.4% (Pres)
Polyvinyl Alcohol 1.4% (Pres-Free)
Sodium Hyaluronate (Pres)
Sodium Hyaluronate (Pres-Free)
Optive 0.5%
Cost is least using Clinitas SDU (£5.70) if
patients are able to reuse vials for more
than one drop. If not VisMed Multi
becomes a cost-effective option.
White Soft Paraffin with Liquid Paraffin
Cost
£1.49
Expiry once open
28 days
£0.81
28 days
30 x 0.5ml single dose unit
£5.72
reuse up to 12 hrs
Sno-Tears
Liquifilm Tears
10ml
30 x 0.4ml
£1.06
£5.35
28 days
single use
Blink Intensive Tears
Clinitas
10ml
30 x 0.5ml single dose unit
£4.98
£5.70
45 days
12 h
Vismed Multi
10ml (special container
maintains contents)
£6.81
3m
Lacrilube
3.5g
£2.51
28 days
Many of the preparations for dry eyes are classed as medical devices ie approved by private sector organisations called „Notified bodies‟, rather than medicines
which are directly approved by the MHRA. When prescribing, the variation in cost of these preparations should be considered.
Eyes
Page 135
Therapeutic Area
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
BNF Chapter 12: Ear, nose, and oropharynx
Top
12.1 Drugs acting on the ear
Otitis Externa
also see Chapter 5
First line:
Acetic acid
®
as EarCalm
2% spray: £4.10 (5ml)
Second line:
Betamethasone
with Neomycin
Drops: £2.39 (10ml)
See Infection management guidance for appropriate clinical indications.
Available OTC
Cure rates similar at 7 days for topical acetic acid or antibiotic +/- steroid.
Otitis media
Topical products not recommended for Otitis media
Removal of wax
For all preparations used in removal of ear wax patients should be advised to lie with affected ear uppermost for 5 minutes after
administration to ensure penetration of the ear canal.
Simple oils such as Olive (or Almond) oil should be used first line.
Available OTC
Olive Oil
Docusate Sodium
as Waxsol
Ear, Nose and Throat
See Infection management guidance for appropriate clinical indications.
0.5% drops: £1.81 (10ml)
Available OTC

Page 136
Therapeutic Area
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
12.2 Drugs acting on the nose
Nasal Allergy
Nasal steroids
First-line:
Symptoms of nasal allergy are usually controlled with nasal corticosteroids and / or oral antihistamines.
Beclometasone
®
as Beconase
50mcg/spray: £2.19
(200 dose unit)
Beclometasone nasal sprays are available OTC, unbranded versions at less
than NHS prescription charge.
Do Not prescribe Beconase Hayfever or Beconase 180 dose preparations
as these are significantly more expensive.
Second-line:
Budesonide
®
as Rhinacort Aqua
64mcg/spray: £3.49
(120 dose unit)
Fluticasone Furoate
27.5mcg/spray: £6.44
(120 dose unit)
Mometasone
50mcg/spray: £7.68
(140 dose unit)
Triamcinolone
55mcg/spray: £7.39 (120dose
unit)
Anticholinergics
Ipratropium
21mcg/spray: £3.99
(180 dose unit)
Use Ipratropium only if rhinorhoea is main problem.
Decolonisation of
nasal MRSA
Mupirocin
Nasal ointment 2%: £3.54 (3g)
For use in decolonisation of nasal MRSA, standard regime is TDS nasal
application for 5 days. Where there is clinical infection, nasal decolonisation
treatment should be undertaken in addition to any systemic treatment given
Naseptin
(Neomycin 0.5% /
Chlorhexidine 0.1%)
Nasal cream £1.90 (15g)
Please refer to PCT Management of Infection Guidance and MRSA Policy for
further details (page137).
Ear, Nose and Throat
Note: Fluticasone propionate nasal sprays are non-formulary.
All patients currently prescribed Fluticasone propionate should be switched to
®
Fluticasone furoate nasal spray Avamys as significantly more cost-effective.
Page 137
Therapeutic Area
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
Benzydamine
0.15% mouthwash: £6.45
(300ml)
May be diluted with water if stinging occurs.
Available OTC
Hydrocortisone
2.5mg pellets: £4.24 (20)
Available OTC
12.3 Drugs acting on the oro-pharynx
Oral ulceration and
inflammation
Oropharyngeal antiinfectives
Preparations for oral candidiasis should be used after food and retained in the mouth for as along as is practical.
Oral candidiasis is often associated with the use of inhaled corticosteroids, use of spacer devices and rinsing the mouth with water after
using such inhalers may be helpful.
Miconazole
0.2% gel: £2.97 (15g)
£4.38 (80g)
Nystatin
®
as Nystan
100,000u/ml suspension: £1.80
(30ml)
Mouthwashes
Chlorhexidine
0.2% mouthwash: £3.32
(300ml)
Available OTC.
Dry mouth
Bioxtra
Spray: £3.94 (50ml)
Approved for NHS prescribing where they fulfil the borderline substances
criteria, for dry mouth caused by:
Salivix
Pastilles: £3.50 (50)
Ear, Nose and Throat
Miconazole gel is available OTC.
Use with caution if patient taking warfarin.

radiotherapy
 sicca syndrome
Prescriptions should accordingly be endorsed as ACBS.
All these products are available OTC, some at less than the NHS prescription
charge
Page 138
Therapeutic Area
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
BNF Chapter 13: Dermatological preparations
Related guidance: NICE Clinical Guideline CG57: Atopic eczema in children
SIGN National Clinical Guideline 125: Management of atopic eczema in primary care
Top
13.2 Emollient and barrier preparations

Always ensure that sufficient quantities are prescribed: liberal twice daily application to the whole adult body will use at least 500g per week. Total quantity of
emollient per week (based on “bd” application) for an adult: Face: 15-30g, Trunk: 400g, Both arms / legs: 100-200g, Both hands: 25-50g, Groins and
genitalia: 15-25g, Scalp: 50-100g

The more greasy an emollient the more effective it is but this needs to be balanced against cosmetic acceptability and compliance

Emollient creams and emulsifying ointment can be used as soap substitutes as well as moisturisers

Emollients should be applied by smoothing onto the skin in direction of any hairs (not by rubbing)

Regular re-application, especially after washing, with drying by patting not rubbing, will increase the effectiveness of all emollient therapy
13.2.1 Emollients
Gels
Creams - soap
substitute
Creams
Continued on next page
Dermatology
Doublebase
Gel:
Aquamax Wash
Cream wash: £2.99 (250g)
Non-foaming soap substitute. SLS & lanolin free.
Aquamax
Cream: £1.89 (100g)
£3.99 (500g)
SLS, Parabens & lanolin free. Most cost-effective preparation currently
available but not available in pump packs.
Cetraben
Cream: £1.40 (50g)
£3.98 (150g)
£5.99 (500g)
E45, Oilatum & Cetraben pump-packs are associated with less waste
than other pump-packs presentations and are preferred first choice options
on grounds of cost-effectiveness.
E45
Cream: £1.61 (50g)
£2915 (125g)
£4.85 (350g)
£5.96 (500g pump)
However patients should be encouraged to find a product they will use
regularly & achieve benefit from.
Oilatum
Cream: £2.46 (150g)
£4.99 (500ml)
Balneum
Cream: £2.80 (50g)
£9.80 (500g pump)
£2.65 (100g)
£5.83 (500g)
Contains 5% urea
Page 139
Therapeutic Area
Emollients
Formulary product
Balneum Plus

(Continued from previous page)
Cost (per pack as stated)
Rationale for decision / comments
Cream: £3.29 (100g)
£14.99 (500gpump)
Contains 5% urea, 3% lauromacrogols
Diprobase
Cream: £1.28 (50g)
£6.32 (500g pump)
Hydromol
Cream: £2.04 (50g)
£3.80 (100g)
£11.09 (500g)
Emulsifying
ointment
or
Ointment: £2.25 (500g)
White soft paraffin
Ointment: £2.85 (500g)
Liquid paraffin /
White soft paraffin
50/50
or
Ointment: £2.44 (500g)
Diprobase
Ointment: £1.28 (50g)
£5.99 (500g)
Hydromol
Ointment: £4.82 (500g)
Ointments
First-line:
Second-line:
Hydromol ointment has same ingredients as Epaderm and is cheaper.
Epaderm is non formulary.
Use preparations with antimicrobials only if infection present or strongly suspected
Emollients with
antimicrobials
Eczmol
®
Dermol Cream

Dermol 500
Dermatology
Cream: £3.70 (250ml)
Eczmol cream contains 1% chlorhexidine gluconate.
Cream £6.63 (500g)
Lotion: £6.04 (500ml)
Dermol contains 0.1% chlorhexidine dihydrochloride and 0.1% benzalkonium
chloride.
Page 140
Therapeutic Area
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
13.2.1.1 Emollient bath additives and shower preparations
Emollient bath
preparations
First-line:
Based on current evidence bath emollients may offer little or no benefit.
People who use them instead of directly applied emollients will unknowingly have substandard emollient therapy.
Dermalo
Bath emollient: £3.44 (500ml)
Dermalo is recommended first line as a cost-effective fragrance-free liquid
paraffin based bath additive.
Dermalo has similar constituents to Oilatum and is less costly,
Second-line:
Doublebase
Bath Emollient: £5.45 (500ml)
Shower Gel:
£5.21 (200g)
Diprobath
(lanolin-free)
Bath emollient: £6.71 (500ml)
E45
Emollient bath oil:
£3.19(250ml)
£5.11 (500ml)
Hydromol
Bath & Shower Emollient:
£3.61 (350ml)
£4.11 (500ml)
£8.19 (1 litre)
Oilatum
Bath additive:
£3.25 (250ml)
£5.10 (500ml)
Use preparations with antimicrobials only if infection present or strongly suspected
Emollient bath /
shower
preparations
with
antimicrobials
Dermol 200
Shower emollient: £3.55 (200ml)
or
Dermol 600
Bath emollient: £7.55 (600ml)
Or
Emulsiderm
Liquid emulsion: £3.85 (300ml)
Liquid emulsion: £12.00 (1ltr)
or
Oilatum Plus
Dermatology
Bath additive: £6.98 (500ml)
Page 141
Therapeutic Area
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
13.4 Topical corticosteroids
Topical corticosteroids
The Finger Tip Unit (FTU) is useful means of calculating approximate quantities required, as follows (1 FTU = 0.5g)
Face and neck: 2.5 FTU , Trunk: 7 FTU (front) and 7 FTU (back), One arm: 3 FTU, One hand: 1 FTU, One leg: 6 FTU, One foot: 2 FTU
Total quantities of topical steroids required per week based on “bd” application for an adult:
Face and neck: 15-30g, Trunk: 100g, Both arms: 50g, both hands: 15-30g, Both legs: 100g, Groins and genitalia: 15-30g
General note: Avoid prescribing dermatologicals that need to be made extemporaneously owing to the excessive costs of ‘special’ items. This does
not apply to ready made dilutions such as Betnovate RD
Topical
corticosteroids
Mild
Moderate
Most available as creams and ointments.
Patients with atopic eczema should be advised to apply topical corticosteroids once daily (SIGN CG125).
Twice weekly maintenance therapy should be considered in frequently relapsing moderate to severe atopic eczema (SIGN CG125).
NB Potency of a steroid is a product of the formulation as well as the corticosteroid
Hydrocortisone 1%
Cream: £1.07 (15g)
£2.14 (30g)
Ointment: £2.54 (30g)
Clobetasone
butyrate 0.05% as
Eumovate
Cream/ointment: £1.86 (30g)
£5.44 (100g)
Betamethasone
valerate 0.025%
Cream/ointment: £3.15 (100g)
Caution: Hydrocortisone butyrate is a potent steroid (Locoid)
as Betnovate RD
Fludroxycortide
0.0125%
Cream/ointment: £3.26 (60g)
as Haelan
(Continued overleaf)
Dermatology
(Continued overleaf)
Page 142
(Continued from previous
page)
Potent topical steroids should not be prescribed on repeat prescriptions.
Potent
First-line:
Betamethasone
valerate 0.1%
Second-line:
as Betnovate
Hydrocortisone
butyrate 0.1%
as Locoid
Mometasone
furoate 0.1%
Cream/ointment: £1.43 (30g)
£4.05 (100g)
Cream/ointment: £1.60 (30g)
£4.93 (100g)
as Elocon
Cream: £4.36 (30g)
£12.58 (100g)
Ointment: £4.32 (30g)
£12.44 (100g)
Fluticasone
propionate 0.05%
as Cutivate
Cream 0.05%/ointment 0.005%:
£2.27 (15g)
£4.24 (30g)
Fluocinolone
acetonide 0.025%
Cream/ointment: £4.14 (30g)
£11.75 (100g)
as Synalar
Very potent topical steroids should not be prescribed on repeat prescriptions.
Very potent
Clobetasol
propionate 0.05%
as Dermovate
Dermatology
Cream/ointment: £2.69 (30g)
£7.90 (100g)
Page 143
Therapeutic Area
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
13.5 Preparations for eczema and psoriasis
Vitamin D
analogues
Calcipotriol
®
as Dovonex
Ointment: £5.78 (30g)
Dovonex Cream was discontinued on 01/10/11
with
betamethasone
®
as Dovobet
Ointment: £61.43 (120g)
Gel:
£33.08 (60g)
£61.43 (120g)
For the treatment of stable plaque psoriasis on the body.
For the treatment of mild to moderate scalp and “non-scalp” psoriasis in
adults.
The gel is licensed for body and scalp application. UK market research
indicates the majority of patients prefer a gel formulation.
Regular emollient use may be considered to reduce fall of scales and help
with other symptoms, including itch.
Department of Dermatology Musgrove Park Hospital
Guidance for General Practitioners For patients prescribed calcipotriol / betamethasone dipropionate* preparations.
The recommended treatment period for Dovobet® Gel is 4 weeks for use on the scalp and 8 weeks for use on “non-scalp”. The recommended
treatment period for Dovobet® Ointment is 4 weeks. After these periods, treatment can be continued after medical review and under medical
supervision.
Dovobet Gel for body &
scalp psoriasis
Dovobet Ointment for body
psoriasis
Clearance is defined as no active psoriasis (flat, smooth, non-scaly & non-itchy). Patients should stop treatment at this point.
Any residual redness will improve without further treatment.
Dermatology
Page 144
13.6 Acne and rosacea
Therapeutic Area
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
13.6.1 Topical preparations for acne
Initial treatment should be based on whether the acne is predominantly inflammatory or comedonal, and its severity.
Keratolytics
Benzoyl Peroxide
as PanOxyl
Aquagel
2.5% gel: £1.76 (40g)
5% gel: £1.92 (40g)
Benzoyl peroxide may be effective for both comedonal and inflammatory
acne. Treatment should start with lower strength preparations, in an aqueous
base.
Topical
antibacterials
Clindamycin 1%
with Zinc
as Zindaclin Gel
Gel: £8.66 (30g)
Topical antibiotics are best reserved for patients with inflammatory acne who
do not wish to take systemic antibiotics or who cannot tolerate them.
Tretinoin Gel
0.01% gel: £5.28 (60g)
0.025% gel: £5.28 (60g)
Retinoids are useful in treating comedonal acne. Skin irritation often occurs
during the first few weeks of treatment.
Retinoids are contra-indicated in pregnancy and women of child bearing
age should take adequate contraceptive precautions.
100mg capsules: £1.03 (8)
Oral antibiotic treatment should be reviewed after 3 months, however
maximum benefit may only be seen after 4 to 6 months.
Oxytetracycline has been removed from this section given the possibility of
poor compliance with dosing requirements in long term use.
Lymecycline
408mg capsules: £6.22 (28)
£11.98 (56)
Minocycline is not recommended owing to safety concerns requiring LFT
monitoring when used >6 months, higher cost and lack of evidence of
superiority over Lymecycline in acne.
Co-Cyprindiol
2000/35mcg tablets: £4.82 (63)
The risk of VTE with Co-Cyprindiol is higher than with conventional low-dose
COCPs and recommend that:
Retinoids
13.6.2 Oral preparations for acne
Antibacterials
Doxycycline
or
Hormonal

it should only to be used after systemic antibiotics have failed or are
not tolerated

it should only be used in licensed indication

it should not be used solely for contraception

it should be discontinued 3-4 months after resolution of symptoms
The evidence in favour of co-cyprindiol over other oral contraceptives in
reducing acne lesion counts is limited.
Dermatology
Page 145
13.8 Photodamage
Therapeutic Area
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
Actinic keratosis
Ingenol
0.0015% gel £65.00 (3 x 0.47g)
Applied once daily to face or scalp for 3 days only
0.05% gel £65.00 (2 x 0.47g)
Applied once daily to trunk or extremeties for 2 days only
13.10 Anti-infective skin preparations
Avoid widespread use of topical antibiotics, especially those agents also available as systemic preparations.
Refer to PCT Management of Infection guidelines for indications
Antibacterials
Antifungals
Antivirals
Dermatology
Retapamulin
1% ointment: £7.89 (5g)
Refer to PCT Management of Infection Guidance for indications.
Mupirocin
2% cream/ointment: £4.38 (15g)
Reserve for MRSA. For nasal use see Chapter 12.
Amorolfine
5% nail paint: £11.35 (5ml)
Refer to PCT Management of Infection Guidance for indications.
Available OTC. Systemic treatment is more effective than topical for nail
infections BNF 13.10.2
Clotrimazole
1% cream: £1.41 (20g)
£3.53 (50g)
Refer to PCT Management of Infection Guidance for indications. Available
OTC
Miconazole
2% cream: £1.82 (30g)
Refer to PCT Management of Infection Guidance for indications. Available
OTC
Terbinafine
1% cream: £1.72 (15g)
£3.44 (30g)
Refer to PCT Management of Infection Guidance for indications. Available
OTC
Aciclovir
5% cream: £1.02 (2g)
£5.10 (10g)
For treatment of labial herpes simplex (cold sores), most effective if applied at
prodromal phase. Use 5x/day for 5 days Available OTC
Page 146
Therapeutic Area
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
BNF Chapter 15: Anaesthesia
Top
15.1.7 Antagonists for central and respiratory depression
Opioid overdose
Naloxone
400mcg/ml ampoule: £4.10 (1ml)
1mg/ml PFS: £8.36 (2ml)
Antagonists for Central and Respiratory Depression
Refer to Emergency treatment of poisoning section of current BNF for
guidance on management of opioid overdose / respiratory depression.
Page 147
Therapeutic Area
Formulary product
Cost (per pack as stated)
Rationale for decision / comments
Appendix 1 Borderline substances
Food supplements
Standard ACBS
indications: shortbowel syndrome,
intractable
malabsorption, preoperative preparation
of under-nourished
patients, proven
inflammatory bowel
disease following
total gastrectomy,
bowel fistulas, or
disease-related
malnutrition and
dysphagia
General Practitioners
are reminded that the
ACBS recommends
products on the basis
that they may be
regarded as drugs
for the management
of specified
conditions.
Gluten-free foods
Top
Assess nutritional status before starting use of food supplements and offer advice about enriching nutritional value of normal diet. Aim of
treatment should be recorded and record of weight kept.
Malnutrition Universal Screening Tool (MUST) is available on the Medicines Management section of the PCT intranet together with a
guide to developing a Nutrition Support Care Pathway (p.132) for patients in community & Care Home Settings.
A short leaflet produced by NHS Somerset dieticians is available advising on food fortification.
NAGE (Nutrition Advisory Group for Elderly People) produce a range of advice leaflets & posters – details available at:
www.bda.uk.com/Downloads/nage_updated_form_jan06.pdf or contact: NAGE, The British Dietetic Association, Cambertown House,
Commercial Road, Goldthorpe Industrial, Estate, Goldthorpe, Rotherham, South Yorkshire, S63 9BL. Helpline Number: 01709 889900
Fax Number: 01709 881673
Fresubin Powder
®
Extra
Available in:
Strawberry
Vanilla
Chocolate
Original
flavour
®
Resource Thicken
Up Clear
£5.60 (7 x 62g sachets)
(Sachets of powder requiring
preparation with fresh whole
milk.)
For patients who are able to add whole milk to a powder, or have a carer /
home staff.
Not suitable for lactose intolerant patients.
£8.46 (125g)
Used to thicken food & liquid for patients with swallowing difficulties.
The Prescribing Guide to Gluten Free foods indicating quantities of products appropriate for a range of people with coeliac disease is
available on the Medicines Management section of the PCT intranet. (The Coeliac Society Nov 2011)
Food supplements and Gluten-free foods
Page 148
Complete MUST Nutritional Screening
Develop a nutritional care plan considering the aims of the patient’s treatment
Must = 0 - Low Risk
Must = 1 - Medium Risk
Continue screening monthly or at
each review if patient is seen less
than monthly.
Continue screening
(as for low risk)
Ensure that patient has a tailored
nutritional care plan in place which
considers the patients preferences
and nutritional needs to provide an
optimal diet .
Follow pathway detailed for MUST
scoreof 1 for two weeks.
 Encourage regular meals and high
energy puddings
 Encourage 2-3 high energy snacks
per day
 Ensure patient receives food
fortification. Fortify foods using
butter, margarine, cream or
grated cheese
 Offer 2-3 glasses of full cream
milk/milky drinks (hot or cold)
Screen more frequently should there
be any clinical concerns, i.e.
unplanned weight loss (loose fitting
rings/clothes) impaired swallow,
altered bowel habit, prolonged
illness, ongoing poor appetite,
apathy or depression.
Improvement in nutritional
status after 1 month
If no improvement request a
prescription for Ist line Fresubin
Powder Extra twice a day in
between meals for 1 month.
Refer to Dietitian
2nd Line: ACBS approved 1.5kcal/ml milk based
supplement or fruit juice based for patients who
dislike or are intolerant to milk (seek advice from
Somerset Community Dietitians 01278 447407)
No improvement in
nutritional status after 1
month
Request a prescription for:
st
1 Line: Fresubin Extra twice a day between meals
2nd Line: ACBS approved 1.5kcal/ml milk based supplement or
fruit juice based for patients who dislike or are intolerant to
milk (seek advice from Somerset Community Dietitians 01278
447407)
Food supplements and Gluten-free foods
Patient is unsafe
and/or unable to
feed orally then
consider
appropriateness of
non-oral feeding
e.g. Naso-gastric
tube
Must = 2 or more - High Risk
If no improvement
in nutritional status
Referral to Somerset
Community Dietiitans
using the referral
form and faxing to
01278 431384 or
send to East Quay
Medical Centre
Bridgwater TA6 4GP
Page 149
Suspicion of cow’s milk protein allergy (CMPA)– Breast fed infants
Clinical assessment / findings
Family History
COLIC
Suspicion of milk moderate CMPA
Suspicion of severe CMPA
Gastrointestinal: loose frothy diarrhoea +/general distress with colic (crying for more
than 3 hours over more than 3 days over
more than 3 weeks)
One or more of the following:
Gastrointestinal: frequent regurgitation, vomiting,
diarrhoea, constipation, anaemia
Dermatological: atopic dermatitis,
General: persistent distress or colic more than 3 hours
over more than 3 days over more than 3 weeks
One or more of the following symptoms:
Gastrointestinal: failure to thrive due to chronic
diarrhoea, or vomiting, blood in stool, anaemia due to
occult or macroscopic blood loss, protein losing
enteropathy (hypoalbuminaemia), endoscopic or
histologically confirmed enteropathy, severe ulcerative
colitis
Dermatological: exudative or severe atopic dermatitis
Consider referral to breastfeeding specialist
for feeding advice
Maternal milk free diet whilst breast feeding continues for
2-4 weeks. Calcium supplement for mother will be
required (1000mg/d calcium).
eHF* formula for use in weaning e.g. Nutramigen (1 or 2)
or Milupa Aptamil Pepti (1 or 2).
Consider referral to Community Paediatric Dietetian
No improvement
Improvement
*eHF – Extensively hydrolysed formula
Reintroduce milk back
into maternal diet
If no symptoms
develop return to
normal diet
No improvement
Return to normal
diet and consider
paediatrician referral
If symptoms return, restart
maternal milk free diet. Or
Consider eHF* for use with
weaning solids and milk
free weaning diet
Consider maternal milk free
diet with a 2 week trial of
amino acid formula Neocate
or Nutramigen AA for use with
weaning solids
Referral to paediatrician plus
maternal milk free diet whilst
breastfeeding continues. Calcium
supplement for mother will be
required (1000mg/d calcium).
Amino acid formula for weaning e.g.
Neocate LCP or Nutramigen AA
Refer to paediatric dietitian for
specialist advice.
Specialist individual allergy and
challenge plan to be developed.
No improvement
At 1 year of age or after 6 months symptom free
undertake milk re-challenge at home as per written
plan
Food supplements and Gluten-free foods
Page 150
Suspicion of cow’s milk protein allergy (CMPA)– Formula fed infants
Clinical assessment / findings / Family History
Suspicion of mild to moderate CMPA
Suspicion of severe CMPA
One or more of the following:
One or more of the following symptoms:
Gastrointestinal: frequent regurgitation, vomiting, diarrhoea,
constipation, anaemia
Dermatological: atopic dermatitis, urticarial (unrelated to acute
infections or drugs)
Gastrointestinal: failure to thrive due to chronic diarrhoea, or vomiting,
blood in stool, anaemia due to occult or macroscopic blood loss, protein
losing enteropathy (hypoalbuminaemia), endoscopic or histologically
confirmed enteropathy, severe ulcerative colitis.
Respiratory: runny nose, chronic cough, wheeze (all unrelated to
infection)
Dermatological: urticaria, swelling (angioedema), exudative or severe
atopic dermatitis
General: persistent distress or colic more than 3 hours over more
than 3 days over more than 3 weeks)
Respiratory: acute laryngoedema or bronchial obstruction with
difficulty breathing
Systemic reactions: anaphylactic shock needs immediate hospital
management
Elimination diet: Extensively hydrolysed formula (eHF) for 2-4 weeks
e.g. Nutramigen 1 or 2, or Milupa Aptamil Pepti 1 or 2
Amino acid formula (AAF) e.g. Neocate LCP or
Nutramigen AA and milk free diet for 2-4 weeks
Improvement
Open challenge back on
cow‟s milk formula
If no
symptoms
develop,
return to
normal diet.
If symptoms return, restart
eHF and continue to avoid
milk for at least 6 months or
until over 1 year.
Give milk free dietary
advice and consider
referral to community
paediatric dietitian
At 1 year of age or after 6 months symptom
free undertake milk re-challenge at home as
per written plan
Food supplements and Gluten-free foods
No improvement
2 week trial of amino acid
formula (AAF)
Improvement
No improvement
Continue on AAF
and avoid milk for
at least 6 months or
until over 1 year.
Give milk free diet
pack
Return to normal
diet and
consider referral
to paediatrician
Improvement
Refer to paediatric dietitian
for specialist advice.
Specialist individual allergy
and challenge plan to be
developed by hospital team
No improvement
Paediatric
specialist
diagnostic
procedures
eHF or AAF should be continued until the age of 1
year at which point the child can change onto ready
to drink milk substitutes Alpro 1+ soya milk.
If milk and soya allergy, eHF or AAF should be
continued until the age of 2 years
Page 151
Suggested feeding table. Birth-12 months
PRODUCTS
Amino acid
formula
(AAF)
Preparation for single feeds
Approximate
age of baby
Approx
weight of baby
Level
scoops
Cooled, freshly
boiled water
Feeds in 24
hours
Neocate or
Nutramigen
AA
Extensively hydrolysed formula (EHF)
*Nutramigen 1 Nutramigen 2 *Aptamil Pepti 1
Birth to 6
months
6 months – 12
months
Birth to 6
months
Aptamil Pepti 2
6 months – 12 months
400g tins
900g tins
400g tins
**400g tins
400g tins
ml
fl. oz.
(approx)
3
90
3
6
6
6
Not suitable
6
Not suitable
9 1/4
4
120
4
6
8
8
Not suitable
8
Not suitable
4.7
10 1/4
5
150
5
5
8
8
Not suitable
8
Not suitable
4 months
6.5
14 1/4
7
210
7
5
11
11
Not suitable
11
Not suitable
6 months +
7.5
16 1/2
8
240
8
4
10
10
10
10
5
7 – 1 year
-
-
7
210
7
3
7
7
7
7
3
kg
lb
Birth - 2 wks
3.5
7 3/4
2 - 4 wks
4.2
2 months
SUGGESTED NUMBER OF TINS NEEDED PER MONTH
*Nutramigen 1 and Aptamil Pepti 1 may be used from birth – 1 year, although generally, once the child is 6 months old, they are moved to the appropriate
follow-on formula, either Nutramigen 2 or Aptamil Pepti 2 respectively. ** Aptamil Pepti 1 is also available as a 900g tin, reduce number of tins
accordingly.
Appendix 2: Out of hours formulary
Page 152
Appendix 2.
OUT OF HOURS
Appendix 2: Out of hours formulary
Page 153
SOMERSET COMMUNITY PHARMACY ENHANCED SERVICE TO PROVIDE PALLIATIVE CARE DRUGS
Bridgwater
ASDA Pharmacy
ASDA Superstore, East Quay, Bridgwater, TA6 5AZ
 01278 720400
Pharmacy open:
8am – 10pm Monday to Friday
8am – 9pm Saturday
10am – 4pm Sunday
Cheddar
Tout’s Pharmacy
Budgens Cheddar, Roynon Way, Cheddar, Somerset, BS27 3RB
 01934 744546
Pharmacy open:
7am to 11pm Monday to Friday
8am to 10pm Saturday
10am to 4pm Sunday
Frome
Sainsbury’s Pharmacy
Wessex Fields, Marston Road, Frome, BA11 4DH
 01373 473284
Pharmacy open:
7am to 11pm Monday to Friday
7am to 10pm Saturday
10am to 4pm Sunday
ASDA Pharmacy
Warminster Road, Frome, BA11 5LA
 01373 475200
Pharmacy open:
8am to 11pm Monday
7am to 11pm Tuesday to Saturday
10am to 4pm Sunday
 01458 834986
Glastonbury
Glastonbury Pharmacy
Feversham Lane, Glastonbury, BA6 9LP
Pharmacy open:
7am to 11pm Monday to Friday
7am to 7pm Saturday
9am to 1pm and 1.30pm to 5.30pm Sunday
Appendix 2: Out of hours formulary
Page 154
Minehead
Boots the Chemist
14-16 The Parade, Minehead, TA24 5UG
 01643 702004
Pharmacy open:
8.30am to 1.30pm and 2.30pm to 5.30pm Monday to Saturday
10am to 4pm Sunday
South Petherton
South Petherton Pharmacy
(John Ware Ltd)
Bernard Way, South Petherton, TA13 5EF
 01469 242269
Pharmacy open:
7pm to 11.59pm Monday and Friday
Midnight to 10pm Tuesday and Saturday
7am to 10pm Wednesday & Thursday
Taunton
ASDA Pharmacy
Creechbarrow Road, Taunton, TA1 2AN
 01823 448010
Pharmacy open:
9.45am to 12.30 and 2.30pm to 5pm Monday to Saturday.
11am to1pm and 2pm to 4pm Sunday
Yeovil
Asda Pharmacy
Preston Road, Yeovil, BA20 2HB
Pharmacy open:
7:30am to 11pm Monday - Friday
7am to 9pm Saturday
10am to 4pm Sunday
Boots the Chemist
37, Middle Street, Yeovil BA20 1LG
Pharmacy open:
8am to 1pm and 2pm to 10pm Monday - Sunday
Appendix 2: Out of hours formulary
 01935 709510
 01935 426673
Page 155
Part 2: Dorset and Somerset Palliative Care Drug Stock List:
Drug
Cyclizine 50mg/ml
Dexamethasone 4mg/ml
Dexamethasone 2mg
Diamorphine 10mg
Diamorphine 100mg
Diazepam 5mg/ml
Diazepam 10mg
Diclofenac 100mg
Domperidone 30mg
Fentanyl 25mcg
Fentanyl 50mcg
Fentanyl 75mcg
Fentanyl 100mcg
Glycopyrronium bromide 200mcg/ml
Haloperidol 5mg/ml
Hyoscine butylbromide 20mg/ml
Hyoscine hydrobromide 400mcg/ml
Levomepromazine 25mg
Levomepromazine 25mg/ml
Metoclopramide 5mg/ml
Midazolam 5mg/ml
Morphine sulphate 10mg/ml
Morphine sulphate 30mg/ml
Morphine sulphate (Oramorph) 10mg/5ml
Morphine sulphate (Oramorph) 100mg/5ml
Oxycodone 10mg/ml
Prochlorperazine 25mg
Sodium chloride 0.9%
Water for Injection
continued on next page
Appendix 2: Out of hours formulary
Form
Injection
Injection
Tablets
Injection
Injection
Injection
Rectal Tubes
Suppositories
Suppositories
Patches
Patches
Patches
Patches
Injection
Injection
Injection
Injection
Tablets
Injection
Injection
Injection
Injection
Injection
Oral Solution
Concentrated Oral Solution
Injection
Suppositories
Injection
Injection
Quantity
10 x 1ml
10 x 2ml
100
5
5
10 x 2ml
5
10
10
1x5
1x5
1x5
1x5
10 x 1ml
5 x 2ml
10 x 1ml
10 x 1ml
84
10 x 1ml
10 x 2ml
10 x 2ml
40 x 1ml
40 x 1ml
5 x 100ml
1 x 30ml
20 x 1ml
10
10 x 10ml
20 x 10ml
Page 156
Drug
Clexane 2000 units
Clexane 4000 units
Clexane 6000 units
Clexane 8000 units
Clexane 10000 units
Tamiflu 30mg
Tamiflu 45mg
Tamiflu 74mg
Tamiflu
Relenza 5mg
Appendix 2: Out of hours formulary
Form
Pre-Filled Syringes
Pre-Filled Syringes
Pre-Filled Syringes
Pre-Filled Syringes
Pre-Filled Syringes
Capsules
Capsules
Capsules
Suspension
Dry Powder for inhalation
Quantity
1 x 10 pfs
1 x 10 pfs
1 x 10 pfs
1 x 10 pfs
1 x 10 pfs
1 x 10
1 x 10
1 x 10
1 pack
1 pack
Page 157
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