Download (BCHCFT) Formulary - Birmingham Community Healthcare

Drug Application Process
& BCHCFT Formulary
Version 1.0
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ensure that it is the most recent version. The most
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Drug application Process & BCHCFT Formulary v1.0 July 2016
Bilkis Islam-Ali (Clinical Training & Policy Development Pharmacist)
Page 1 of 21
Commencement of Consultation
Date: November 2015
Consultation History:
The following Committees, groups or individuals have been consulted in the development
of this version of this Formulary:
Name:
David Harris (Chief Pharmacist)
Johanne Deeks (Learning Disabilities Pharmacist)
Melanie Dowden (Lead Pharmacist Community Health)
Sudha Balakrishnan (Rehabilitation Consultant)
Karen Mitchell-Meades (Head Pharmacist Moseley Hall Hospital)
Carol Eadie (Head Pharmacist West Heath Hospital)
Neal McCathie (Consultant Community Paediatrician)
Dr Falope (Rehabilitation Consultant)
Dr Chit Ko Ko (Consultant Physician in Rehabilitation Medicine)
Rebecca Martin (Service Lead Tissue Viability)
Andrea Richards (Consultant Oral Physician)
Harriet Anstey (Consultant Oral Surgeon)
Olayinka.M.Fadahunsi-Oluwole (Speciality Doctor Community
Paediatrics)
Medicines Management Committee
Date:
November 2015
December 2015
January 2016
January 2016
January 2016
January 2016
February/May 2016
February 2016
February 2016
March 2016
April 2016
April 2016
April 2016
March, April, May,
June, July 2016
Previous Version History
Version No.
NA
Lead
Date Change Implemented
Reason for Change
New for BCHCFT
This replaces
consolidated
Formulary (2014) and
Community Hospitals
Formulary (2012)
Consultation Process
Lead Clinicians are an integral part of the formulary development process and will provide
expert clinical advice and support when a new drug formulary application is made. This
information will be submitted to the Medicines Management Committee (MMC) in the first
instance for first approval.
Relevant Divisional Committees
Proposed drugs to be considered for addition to BCHCFT formulary may be consulted at
divisional committees before bringing to MMC for consideration.
Area Prescribing Committee (APC)
For medicines that BCHCFT services prescribe on FP10 or would like GPs to prescribe
require final consultation and approval at the APC. Medicines must be approved by
Medicines Management Committee prior to taking to the APC for consideration.
Drug application Process & BCHCFT Formulary v1.0 July 2016
Bilkis Islam-Ali (Clinical Training & Policy Development Pharmacist)
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Section
Page
1.
Purpose
4
2.
Scope
4
3.
Responsibilities of Clinicians
4
4.
Drug Application Process & BCHCFT Formulary
4.1
Formulary Revision Process
4.2
New Drug Application Process
4.3
BCHCFT Formulary
4
4
5
References/Evidence/Glossary/Definitions
12
5.
Appendices
1.
Example of an APC Drug Application Form
13
Drug application Process & BCHCFT Formulary v1.0 July 2016
Bilkis Islam-Ali (Clinical Training & Policy Development Pharmacist)
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1. Purpose
The aim of the formulary is to encourage safe, rational and cost-effective prescribing,
and to have a unified choice of treatment for patients. It will ensure seamless
transition of care for patients between Birmingham Community Healthcare
Foundation Trust (BCHCFT) and General Practice.
It is a locally maintained document and it also sets out the process to be followed
when requests are made for a medicine to be added to the formulary.
2. Scope
This formulary will apply across the whole of BCHCFT within all divisions.
3. Responsibilities of Prescribers
All prescribers are expected to take into account whether the medicine they intend to
prescribe is on the formulary. BCHCFT prescribers should consult the Area
Prescribing Committee Formulary and BCHCFT Formulary.
4. Drug Application Process & BCHCFT Formulary
4.1
Formulary Revision Process
Drugs on the current BCHCFT formulary do not need to go through the drug
application process. If there is any change to the way a drug is prescribed this would
then need to go through the application process outlined below (4.2).
The BCHCFT Formulary and the Drugs List (page7) should be reviewed at least
every two years. A representative from each division should be present at Medicines
Management Committee to review the drugs for their specialist area. If there are any
significant changes, the appropriate information and evidence to support this will be
required and bought to committee using the documentation in Appendix 1.
4.2
New Drug Application Process
The following algorithm sets out how new drugs will be considered for addition to the
formulary for use within BCHCFT and for prescribing in primary care by GPs.
Applications for the inclusion of a medication to the BCHCFT Formulary must be
initiated by a consultant or other appropriate senior healthcare professional.
Requests for products to be added to the formulary require approval from the
Medicines Management Committee (MMC) followed by the APC approval process. If
relevant a new drug application can be discussed at a divisional committee (e.g.
Dental Drugs and Therapeutics Committee) prior to consultation at MMC. Medicines
Drug application Process & BCHCFT Formulary v1.0 July 2016
Bilkis Islam-Ali (Clinical Training & Policy Development Pharmacist)
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for use within BCHCFT services only are not required to go through the APC
application process.
Flow chart showing BCHCFT & APC Drug Application Process
Complete
Formulary
Application
(See APC*)
Medicines
Management
Committee
Not Approved
Approved for BCHCFT use
Is APC approval required?
(i.e. Do GPs want to prescribe this drug
or is it for BCHC prescribing only?)
* Application form to be obtained
from [email protected]
See Appendix 1 as an example
No
** Complete ESCA or RICAD if
necessary. APC can provide more
information - see APC website
Add to BCHCFT
approved list of
medicines
APC: Area Prescribing Committee
RICAD: Rationales for Initiation, Continuation and Discontinuation
ESCA: Effective Shared Care Agreement
4.3
Yes
APC**
Not Approved
Approve
d
BCHCFT Formulary
Birmingham Community Healthcare Foundation Trust is a community trust providing
treatment to patients in community settings, hospitals and specialist care. In the
majority of cases, drug treatments will have already been initiated by the patient’s
GP or by another trust and if appropriate BCHCFT will continue.
The BCHCFT Formulary comprises of two elements: (i) the Birmingham, Sandwell,
Solihull and environs Joint Formulary otherwise referred to as the Area Prescribing
Committee (APC) Formulary (ii) specified drugs in List A and B (page 7 to 12).
The APC Formulary represents the drugs that Trusts and Clinical Commissioning
Groups across the region have jointly agreed to prescribe in preference to other
treatment options. It is expected the majority of prescribing will follow the APC
formulary but this does not restrict a trust to prescribe or administer other such drugs
where this is clinically indicated.
The APC Formulary can be accessed here:
http://www.birminghamandsurroundsformulary.nhs.uk/default.asp
Drug application Process & BCHCFT Formulary v1.0 July 2016
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Any prescriber who wishes to use a product outside of formulary should either make
a formal application for it to be considered at APC or request an individual funding
request (IFR) to the commissioner. Prescribers should note that if a non-formulary
medicine is commenced without the necessary approval, the Trust could be charged
the ongoing costs.
All drugs included in the APC Formulary are allocated a traffic light status. The red
amber green ratings offer guidance on where clinical and prescribing responsibilities
lie in regard to the initiation and maintenance of prescribing.
Key to APC Formulary Recommendations
Initiation and maintenance of prescribing by Specialists, GPs and other qualified
clinicians
Initiation and maintenance of prescribing by Specialists and transfer to Primary Care
prescribing when appropriate, or initiation and maintenance of prescribing in Primary
Care following recommendation from a Specialist. Some amber medicines require
agreement with the local (internal) medicines committee prior to initiation; others may
require a framework to support safe transfer and maintenance of care such as a RICaD
or ESCA. The Formulary will be annotated to reflect these requirements.
Initiation and maintenance of prescribing by BCHCFT Specialists only.
Positive NICE TA; awaiting local clarification on place in therapy.
Non Formulary; may be prescribed following approval by individual hospital Medicines
Management Committees for specific patients.
(The term 'Specialist' refers to Consultants, Non-Medical Prescribers and General Practitioners with a
Specialist Interest)
Medicines listed in the tables below are for use within this Trust only so that
prescribing or administration remains with BCHCFT clinicians. There are two lists of
medicines:
List A: Medicines not on the APC formulary but approved for prescribing or
administration within BCHCFT e.g. anaesthetics, unlicensed medicines. These
medicines cannot be prescribed by GPs unless approved by the APC.
List B: Medicines currently part of the APC formulary but used within BCHCFT for
an unlicensed indication or off-label e.g. beclometasone inhaler for oral ulcerative
conditions; erythromycin as a prokinetic agent. Some unusual forms of
administration may require an APC application if Specialists would like GPs to
prescribe.
Prescribing may be declined by a GP on the grounds they are not sufficiently familiar
with the drug treatment to accept clinical responsibility for agents that are used off
label or are unlicensed.
Drug application Process & BCHCFT Formulary v1.0 July 2016
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Note: These drug lists are correct at the time of writing. Please cross reference with
the APC formulary for the most up to date information.
List A: Medicines not in the APC Formulary approved for use in BCHCFT
Name of drug approved in
BCHCFT formulary
Service Area
Indication/Notes
Adrenaline injection
Articaine
Atracurium injection
Atropine injection
Adults, Dental
Dental
Dental
Adults, Dental
AS Saliva Orthana
Dental
Benzocaine 20% gel (Ultracare Oral
Bubble Gum )
Baclofen liquid (some strengths)
BioXtra Gel and Mouthrinse
Dental
Acute anaphylaxis
Anaesthetic
Neuromuscular blockade
Premedication; Intra-operative
bradycardia;
Control
of
muscarinic
side-effects
of
neostigmine
in
reversing
neuromuscular blockade
Xerostomia, Sicca Syndrome/
Sjogren’s Syndrome, following
Radiotherapy
Topical anaesthesia
Botulinum toxin B
Budesonide nasal spray
Bupivacaine 0.5%
Calcium chloride injection
Adults, Rehab
Dental
Adults, Rehab,
Dental
Dental
Adults, Rehab,
Dental
Adults
Carnoy’s solution (ethanol,
chloroform, glacial acetic acid)
Chloracetic acid crystals in solution
Dental
Chlorhexidine gluconate 2.5 mg
(Periochip)
Chlorhexidine gluconate surgical
scrub (Hydrex)
Chlorhexidine sachets (Unisept)
Chlorhexidine 2% in Isopropyl
Alcohol 70% (ChloraPrep)
Co-codamol 8/500
Dental
Dantrolene injection
Dehydated alcohol
Adults
Skeletal muscle relaxant
Xerostomia, Sicca Syndrome/
Sjogren’s Syndrome, following
Radiotherapy
Spasmodic torticollis;
masseteric hypertrophy
Oral ulcerative conditions
Anaesthetic
Hyperkalaemia,
hypocalcaemia
Odontogenic keratocyst
Dental
Treatment of hard corns and
verrucae
Antimicrobial treatment for
chronic periodontal disease
Surgical scrub
Dental
Dental
Skin disinfection
Skin disinfection
Adults, Rehab,
Dental
Dental
Dental
Analgesic
Malignant hyperthermia
Trigeminal neuralgia
Drug application Process & BCHCFT Formulary v1.0 July 2016
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Diphtheria tetanus pertussis
(acellular) and hib vaccine
Dopamine
Dobutamine solution for infusion
Dosulepin
Adults
Dental
Dental
LD, Dental
Ephedrine injection
Esomeprazole injection
Ethyl chloride spray
Dental
Adults
Dental
Ferric subsulphate 70% solution
(Monsel’s solution)
Flumazenil
Gaviscon Advance
Gelofusine infusion
Glandosane spray
Dental
Dental, Rehab
Adults
Dental
Dental
Glucose infusion
Glycopyrrolate
Guanfacine hydrochloride (Intuniv)
Hepatitis B vaccine
Dental
Rehab
Children
Adults
Human Papillomavirus vaccine
Children
Hydrocortisone /Chlorhexidine
/nystatin (Nystaform HC)
Influenza vaccine (inactivated and
live intranasal)
Intralipid
Isoflurane
Ketorolac injection
Levobupivacaine
Lidocaine injection
Lidocaine 2% in ethyl chloride
Lidocaine 5% ointment
Lidocaine + chlorhexidine
(Instillagel)
Lidocaine +/- adrenaline
Lidocaine+prilocaine (Oraqix, Emla)
Magnesium sulphate paste
Medical gases (e.g. oxygen, nitrous
oxide)
Measles Mumps Rubella vaccine
Dental
Adults/Children
Dental
Dental
Dental
Rehab
Rehab
Adults
Dental
Adults
Dental, Rehab
Dental
Rehab
Adults, Dental
Children
Immunisation
Inotropic agent
Inotropic agent
For Dental - facial pain:
Antidepressant
Sympathomimetic
Gastroesophageal disease
Topical anaesthetic; vitality
testing
Topical haemostatic agent
Conscious sedation
Gastrointestinal symptoms
Plasma substitute
Xerostomia, Sicca Syndrome/
Sjogren’s Syndrome, following
Radiotherapy
Hypoglycaemia
Hypersalivation
ADHD in children
Immunisation against hepatitis
B
Prevention of cervical cancer
and premalignant cervical
lesions
Oral ulcerative conditions
Prevention of seasonal flu
Reversal of local anaesthetic
overdose
Anaesthesia
Post operative pain
Anaesthesia
Anaesthesia
Anaesthesia
Anaesthesia
Catheterisation
Anaesthesia
Local anaesthetic
Superficial skin infections
Treatment of hypoxaemia;
anaesthesia
Prevention against measles,
mumps, rubella
Drug application Process & BCHCFT Formulary v1.0 July 2016
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Mepivacaine 3%
Meningococcal ACWY (MenACWY)
Adults, Dental
Adults
Midazolam1mg/1ml injection,
intranasal (+ lidocaine)
Midazolam 10mg/ml buccal
Minocycline 2% periodontal gel
(Dentomycin)
Neostigmine injection
Dental, Rehab
LD, Dental
Dental
Phenol Aqueous 6%injection
Phenol in Glycerol 5% injection
Phenol liquid
PEP (Kaletra, Truvada, raltegravir)
Rehab
Rehab
Adults
Dental
Pneumococcal polysaccharide
vaccine
Adults
Povidone Iodine 7.5% surgical
scrub/
Prilocaine
Prilocaine Hydrochloride with
Felypressin (Citanest)
Propofol
Pyrogallol 40% in WSP
Dental
Reversal of neuromuscular
blockade
Reversal of neuromuscular
blockade
Anaesthesia; sedation
Acute hypotension
Neuropathic pain
Diagnostic agent
Recurrent Aphthous
Stomatitis; Osteoradionecrosis
Nerve ablation
Intrathecal for spasticity
Ablation of the nail bed
Prevention of HIV needle stick
injury
Immunisation against disease
caused
by
Streptococcus
pneumoniae
Skin disinfection
Dental
Dental
Anaesthesia
Anaesthesia
Dental
Adults
Rocuronium injection
Salicylic acid 60% in WSP
Dental
Adults
Saliva Stimulating Tablets (SST)
Dental
Sativex spray
Rehab
Sevoflurane
Shingles vaccine (Zostavax)
Sodium bicarbonate injection
Sodium chloride mouthwash
Dental
Adults
Adults
Dental
Anaesthesia; sedation
Treatment of neurovascular
corns
Neuromuscular blockade
Treatment of hard corns and
verrucae
Xerostomia, Sicca Syndrome/
Sjogren’s Syndrome, following
Radiotherapy
Refractory
spasticity
in
patients with MS
Anaesthesia
Immunisation against shingles
Metabolic acidosis
Mucosal ulceration &
inflammation
Neostigmine/glycopyrronium
Nitrous oxide
Noradrenaline injection
Nortriptyline
Omnipaque (Iohexol)
Pentoxifylline
Dental
Anaesthesia
Vaccination against
meningococcal disease
Premedication/ conscious
sedation
Seizures
Chronic adult periodontitis
Dental
Dental
Dental
Dental, Rehab
Dental
Dental
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Sodium chloride infusion/injection
Sodium lactate infusion
(Hartmanns)
Sodium fluoride varnish/ tablet
Sugammadex (Bridion)
Dental
Dental
Fluid replacement/Flush
Hyperchloraemic acidosis
Dental
Dental
Suxamethonium injection
Sterile glycerin
Tetracaine gel (Ametop)
Tetrafluoroethane spray
Dental
Adults
Dental
Dental
Thiopental
Tiagabine
Tranexamic acid injection/oral
solution
Xerotin spray
Dental
LD
Dental
Prevention of dental caries
Reversal of neuromuscular
blockade
Neuromuscular blockade
Neutralisation of phenol
Local anaesthesia
Production of topical cryoanaesthesia in the oral cavity
Anaesthesia
Seizures
Fibrinolysis
during
dental
procedures; mouthwash
Xerostomia, Sicca Syndrome/
Sjogren’s Syndrome, following
Radiotherapy
Psychoses
Zuclopenthixol acetate (Acuphase)
injection
Dental
LD
List B: Medicines in the APC Formulary used for an unlicensed indication/offlabel approved for use in BCHCFT
Name of drug approved in
BCHCFT formulary
Service Area
Indication/Notes
Amantadine
Amitriptyline
Atropine eye drops
Azathioprine
Beclometasone dipropionate inhaler
(Clenil Modulite)
Beclometasone dipropionate nasal
spray
Betamethasone tablet
Rehab
Dental
Rehab
Dental
Dental
Neurostimulant
Facial pain
Hypersalivation
Severe ulcerative conditions
Mucosal
ulceration
and
inflammation
Oral ulcerative conditions
Betamethasone valerate cream and
ointment (Betnovate)
Bromocriptine
Dental
Carbamezepine
Dental
Dental
Rehab
Dental, Children
Oral inflammation and
ulceration (used as a
mouthwash)
Oral ulcerative conditions
Neurostimulant in prolonged
disorder of consciousness
minimally conscious state;
Treatment of apathy
symptoms after brain injury
Facial pain; mood stabiliser
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Citalopram
Children
Panic and anxiety
Clindamycin capsule
Dental
Clobetasone butyrate cream and
ointment (Eumovate)
Clobetasone
butyrate/nystatin/oxytetracycline
(Trimovate)
Colchicine
Dental
Severe bone infections;
antibiotic prophylaxis in
oncology patients
Oral ulcerative conditions
Dental
Oral ulcerative conditions
Dental
Clobetosol propionate cream and
ointment (Dermovate)
Clonidine
Co-careldopa
Cyclizine
Dapsone
Dental
Oral ulceration and
inflammation
Oral ulcerative conditions
Dexamethasone injection
Doxycycline
Erythromycin suspension
Fluoxetine
Fluticasone propionate
spray/nasules
Gelclair
Hyoscine patch
Hydroxochloroquine
Hydrocortisone cream with
miconazole (Daktacort)
Lamotrigine
Melatonin (note some
products/strengths are unlicensed
e.g. Kidnap)
Methylphenidate (including
Matoride)
Midazolam Oromucosal Solution
(Buccolam)
Mycophenolate
Ondansetron injection
Oxcarbazepine
Children
Rehab
Dental
Dental
Dental
Dental
Rehab
Dental
Dental
Dental
Children
Dental
Dental
Dental
Rehab, Children
LD, Children
LD
Dental
Dental
Dental
ADHD and Tourettes
Neurostimulant
Nausea/vomiting
Vesiculobullous
disorders,
Lichen Planus, Linear IgA
disease
Anti-inflammatory agent
Aphthous ulcers
Prokinetic agent
Facial pain
Oral ulcerative conditions
Relieve the pain of oral
mucositis
Drying secretions
Oral mucosal inflammatory
conditions (Chronic ulcerative
stomatitis; Oral Lichen Planus)
Oral ulcerative conditions
Facial pain
Sleep problems in brain injury;
sleep problems in children
ADHD in adults and children
Seizures in adults
Lichen Planus, Pemphigus,
Pemphigoid, Orofacial
granulomatosis under
specialist supervision
Prevention nausea/vomiting
Treatment of trigeminal/
glossopharyngeal neuralgia
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Paroxetine
Phenytoin
Pizotifen
Prednisolone soluble
Dental
Dental
Dental
Dental
Facial pain
Neuropathic pain
Neuropathic pain
Oral ulceration & inflammation
Pregabalin
Dental
Trigeminal neuropathic pain
Propranolol
Children
Risperidone oral
Sodium valproate
Tacrolimus ointment
Tocopherol (Vitamin E)
Triamcinolone acetonide for
injection
Trihexyphenidyl
Venlafaxine
6.
Children
Dental, Children
Dental
Dental
Dental
Children
Dental
Anxiety and migraine
Aggressive behaviour
Facial pain; mood stabiliser
Severe ulcerative conditions
Osteoradionecrosis of the jaws
(in conjunction with
pentoxifylline)
Oral ulcerative conditions
Dystonia (e.g.
palsy)
Facial pain
in
cerebral
References/Definitions
Birmingham, Sandwell, Solihull and environs Formulary
Unlicensed use or off label use: licensed medicines used outside the terms of its
Marketing Authorisation e.g. medicine licensed specifically for adults but used in
children.
Unlicensed medicine: medicines that have no Marketing Authorisation (licence) for
use in the UK.
Drug application Process & BCHCFT Formulary v1.0 July 2016
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Appendix 1
Birmingham,Sandwell,Solihull and Environs Area Prescribing Committee
DRUG APPLICATION FORM
All essential information in support of this application must be attached to this application form with full
references provided electronically.
Applications from Trust or CCG Medicine Committees should be emailed to the APC Secretary:
[email protected]
To discuss application enquiries please call the APC Secretary at Midlands and Lancashire CSU who will signpost
you to an appropriate pharmacist. Phone: 0121 612 4109
Section 1: Information on the Medicinal
Product
a) Brand/generic name
b) Pharmaceutical form
c) Strength
d) Administration route
e) Dosage/ frequency
f) Course length, if applicable
g) Manufacturer
h) BNF section number
i) Licensed indication for use , in the
UK
j) Proposed indication for use and
dose (if different from license)
If product is unlicensed or to be used 'off label', provide references to support dosage
k) Brief summary of the condition
being treated (including morbidity,
quality of life and mortality
estimates)
Section 2: Evidence of Comparative Efficacy
a) Is the proposed medicinal product
covered by NICE technology
appraisal guidance? If so, which?
If the answer to section 2a is Yes then please go to section 8 and complete the declarations. If
the answer is No then please continue with the rest of the application.
b) Report clinical outcomes in preference to surrogate markers; absolute and relative
risk/hazard ratios; and numbers needed to treat (NNTs); quality-of-life measures as a minimum,
where available:
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Vs placebo
Vs current “best available therapy”
Vs other comparators
c) What are your views on the
efficacy of this medicinal product
compared to the available therapy?
Please provide the most recent and main peer reviewed papers with relevant supporting
literature, including efficacy, safety and cost effectiveness. Cite comparative studies to existing
therapies where available.
Section 3: Evidence of Comparative Safety &
Use
a) Please report the incidence of
adverse effects in both active and
comparator arms of trials, absolute
and relative risk increases and
number needed to harm (NNHs),
where available.
b) How does the safety of this
proposed drug compare to
treatment options currently in use?
c) What concerns are there over the safety of this product?
List the principal/ significant concerns for each part below:
i) Adverse effects
ii) Cautions
iii) Contra-indications
iv) Drug interactions
v) Toxicity
e.g. narrow therapeutic index
vi) Potential for misuse
d) How many clinical trials have you
assessed for this medicinal product?
e) Please indicate approximate
number of subjects who have been
exposed to the product during high
quality clinical trials.
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f) Were any significant patient
groups excluded from clinical trials?
g) Are there groups of patients for
whom the product is not suitable?
h) Please detail any specific pretreatment requirements
(e.g. baseline LFT)
i) What are the monitoring
requirements?
j) How and when would you propose
to audit/monitor use of the new
therapy?
k) Who will be responsible for
monitoring?
l) Would you recommend any
prescribing restrictions
e.g. microbiological advice,
consultant use only?
m) Are there any other processes or
approval required before use
e.g. microbiologists, safety groups?
n) Have prescribing guidelines been
produced (please attach) or do these
need to be developed to support
safe implementation of prescribing?
o) Will the drug complement
existing treatments? If yes, give
details
p) Please detail any relevant safety
concerns in relation to
storage/prescribing/preparation/
use/administration/disposal
q) What are your views on the
adverse drug reactions (ADRs) of this
medicinal product compared to the
available therapy?
Section 4:
Proposed position of therapy
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a) Will the proposed drug replace an
existing drug on the formulary? If
yes describe why it should be used
in preference.
b) What are the other treatment
options?
c) What are the patent expiry dates
of the products being replaced by
this proposed medicinal product?
d) Horizon Scanning: are similar
drugs likely to be licensed in the
near future?
e) Please indicate clearly, where
within the current drug treatment
pathway/algorithm the product
should be used (i.e. Options for 1st/
2nd/ 3rd tier treatments)?
f) Please indicate if there is a subgroup of patients in whom this
product has demonstrated particular
benefit or would be a preferred
option.
g) Is this medicine likely to be
prescribed in an out-patient setting?
h) Is Effective Shared Care
Agreement (ESCA) or a Rationale for
Initiation, Continuation and
Discontinuation (RICaD) required?
i) Has MTRAC ESCA Guidance been
issued? Confirm the outcome:
- Suitable for GP prescribing
- Effective Shared Care
Agreement (ESCA) required
Not appropriate for primary care
j) How would a change or
implementation of the new therapy
be communicated?
k) What is your proposed position in formulary? Please mark one response from below:
GREEN: Prescribable within primary and secondary care.
AMBER: Initiation by specialist, or recommendation for GP
initiation by specialist and conditions for safe transfer of
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prescribing to primary care eg RICAD, ESCA, place for monitoring.
RED: These drugs are for specialist prescribing only. Prescribing
retained in secondary care and should not be prescribed in
primary care.
Section 5: Expected level of use and potential expenditure across the Health
Community
Please provide information for both Secondary and Primary Care settings
a) Cost of product per patient per 28
days’ treatment at most common
dosage (or other if appropriate –
please specify)
b) Where appropriate, what is the
cost of the product(s) which this will
replace - per patient per 28 days’
treatment at most common dosage
(or other if appropriate, please
specify)
Primary Care (use standard drug tariff price or BNF cost):
Primary Care (use standard drug tariff price or BNF cost):
c) Cost of the product:£per annum, £per treatment course
d) Comparative cost of existing treatment £per annum, £per treatment course
e) Are there differences in non-drug
costs (or savings) associated with
use of the new product, for example
diagnostic tests, monitoring?
f) Estimated number of patients to
be treated per annum (based on
XXXX population of approx XXXXXX
giving consideration to incidence,
prevalence and expected place in
therapy)
population of approximately
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g) What is the financial cost/saving
resulting from the introduction of
the therapy?If there is a cost
pressure, how will this be funded?
h) Can the cost of this be covered by
a reduction in expenditure on
anything else? Please give details
i) Within your area of practice, what
else would you like to spend this
amount of money on?
Which provides the greatest level of
benefit to patients?
j) Is this medicine excluded from
Payment by Results tariff (PbR)?
k) Other costs and considerations
l) Who will initiate prescriptions?
m) Who will undertake maintenance
prescribing?
n) Is there clinical trial evidence that
demonstrates resource benefit?
o) If there are comparative trials
against the standard therapy: was
there an additional
benefit/convenience?
p) What are your views on the costeffectiveness of this medicinal
product compared to available
therapy?
q) Please confirm the names of local
clinical leads in support of this
application (in your own or other
local Trusts or networks)
Section 7: Application Sponsor
By signing this application you are confirming that:
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a) You have agreement from Consultants within your directorate (and if appropriate other
directorates who may have an interest in using this product) regarding the proposed place in
the treatment pathway of this product as well any proposal you may have made to replace any
existing product.
b) You will cascade the result of this formulary application to your Directorate colleagues.
c) You understand that this application is for formulary approval across Birmingham, Sandwell
and Solihull area.
d) Your Clinical Director, and/ Directorate Pharmacist support the proposed clinical benefit of
this preparation.
e) The information supplied is correct to the best of your knowledge at the time of submission.
Section 8: Application details and declaration
a) Do you wish to attend the APC to
discuss application?
In person/representative:
b) Has the application been
discussed and supported by a Multidisciplinary Team (MDT) /other
forum within your trust or across the
area?
To avoid any concern that commercial interests might have influenced your request to the
Committee, you must indicate if you have an interest that may influence, or be perceived to
influence, your request.
c) Do you have any conflict of
interest to declare?
No - I have no conflict of interest
Examples include:
- Consultancy with the drug company;
- Department receives research funds from
the drug company;
- Staff within the department are funded by
the drug company;
- You or your staff receive funding for
attendance at scientific meetings from this
company
Yes - Please give details:
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d) Has the drug company been
directly involved in completing this
application?
No
Yes- Please confirm which companies have been
involved and state which sections the drug company has
helped to complete:
You must fully disclose: clinical trial work; other paid or sponsored research or audit (clinical or non clinical);
meeting(s) sponsored in part or whole; meeting attendances paid or sponsored in part or whole; Advisory panel or
consulting work or other employment; paid lecturing; gifts, meals, hotel accommodation or other hospitality; any
other potential conflict of interest (including shares held). Articles of low intrinsic value, i.e. less than £50, such as
diaries or calendars, need not be declared. Modest hospitality, such as meals, does not need to be declared
provided that the individual cost per year is less than £50. However, if more than one gift or meal is made from the
same or a related source within a 12 month period totalling more than £50, they should be declared. Declaration of
funding source should include financial interests over the three years to date, and should include prospectively
agreed research income for the next year. Declarations do not distinguish between personal payment and payment
to a Trust fund or research account and should include financial association of immediate family members. Circle/
code relationships as follows:i) >£50 and <£5,000ii) £5,000 - £20,000iii) >£20,000
Applicants Details / Counter-signatory Details
Name of requesting Clinician:
Job title:
Department / Specialty:
Work base:
Signature:
Date:
Name of sponsoring Clinical
Pharmacist:
Signature:
Date:
Name of Finance Lead:
Signature:
Date:
Name of Drugs and Therapeutics
Committee Chair (or Medical
Director)
Signature:
Date:
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Section 9: Decision summary
APC to complete Assessment Support Tool and record decision summary
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