Download Draft Minutes of the Formulary Sub Group (FSG

Minutes of the Formulary Subgroup (FS) Meeting
Tuesday 19 August, Ante Room, John Dewar Building, Inverness
Present:
Wendy Nganasurian, Chair
Evelyn Cromarty, Formulary Pharmacist
Mairi Dunbar, Senior Pharmacist, Woman & Child Directorate (deputising for Peter Mutton)
Dr Moray Fraser, GP
Dr Duncan Gray, Associate Specialist, Care of the Elderly
Joan Greig, Patients’ Council
Heather Harrison, Prescribing Support Pharmacist, Argyll & Bute (videoconferencing)
Findlay Hickey, Mid Highland CHP Lead Pharmacist
Dr Simon Hurding, GP
Jenny Jack, Practice Nurse
Dr Stewart Lambie (deputising for Dr Peel)
Dr Alistair Michie, GP
Apologies:
Katrina Flannigan, Respiratory Nurse Specialist
Arthur Harris, HealthVOICES Representative
Peter Mutton, Head of Pharmaceutical Specialist Services
Christine Smith, Plastic Surgery Specialist Nurse
Dr Robert Peel, Consultant Nephrologist
In attendance: Dr Stephen Cross, Consultant Cardiologist
Alison MacDonald, Area Antimicrobial Pharmacist
Roberta Kerr, Formulary Assistant
1.
Welcome and Apologies
The Chair welcomed Dr Stephen Cross, Consultant Cardiologist, to the meeting for the discussion
on the resubmission of ivabradine (originally submitted to Formulary Subgroup (FS) in September
2007).
2.
Minutes of the meeting held on 3 June 2008
The minutes were approved subject to amendments on page 1 and page 4.
3.
Approve follow-up report on actions agreed at meeting on 3 June 2008
a)
Appendix 3: Emergency treatment of poisoning
It was confirmed that European Viper Venom Antiserum is effective against UK viper venom.
b)
Antivirals for HIV review
Dr McKenna has confirmed the validity of the draft guidance.
c)
Obesity review
The algorithm has been amended in line with FS recommendations.
d)
Pain review
NSAIDs will be discussed as a separate agenda item.
e)
Obstetrics & Gynaecology review
Text has been amended in line with FS recommendations. It was confirmed that Depo-Provera is
effective for 12 weeks and that there is no thrombotic risk with HRT patches.
f)
Recent SMC advice
The report has been finalised and posted on the website.
g)
Prescribing of non-Formulary medicines in Raigmore Hospital outpatient clinics
Pharmacy students at Raigmore investigated outpatient prescribing in the Eye Clinic. There was a
general increase however this was probably a result of locum staff in Ophthalmology being
unfamiliar with the Formulary. Overall, non-Formulary prescribing has decreased and Formulary
prescribing has improved. Non-Formulary drugs are being used appropriately (second-line to
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Formulary drugs). Locums are not given the same induction as permanent medical staff and
therefore do not have the Formulary explained to them.
h)
Adoption of Highland Joint Formulary by Western Isles NHS Board
EC has been in contact with the Principal Pharmacist in Western Isles. They have been sent 30
copies of the Formulary but will access it mainly via the intranet. They will have input into future
review groups.
i)
Highland Joint Formulary User Survey 2008
The results of the 2008 user survey have been processed and a report will be presented at the
next meeting.
j)
Proposed change to name of Formulary
At a recent patient participation event the title ‘Joint’ Formulary caused confusion among patients
who thought that it was a Formulary of drugs for musculoskeletal disorders. It was suggested that
the term ‘joint’ is now obsolete and a recommendation should be made to ADTC that it is dropped
from the next edition. The Subgroup was happy with this suggestion.
4.
Consider for approval updated Formulary sections and guidelines
Appeal by Dr Cross for the inclusion of ivabradine (Procoralan) in the Formulary
(original submission September 2007)
SC declared a personal, non-specific interest in Servier Laboratories Ltd.
a)
There was discussion around what has changed since the original submission. Many patients are
intolerant of conventional drugs eg beta blockers. Ivabradine controls the heart rate in angina, SC
emphasised symptomatic control. Ivabradine could be used on an ad hoc basis for patients having
CT coronary angiographs to lower the heart rate. SIGN 96 recommends nicorandil, which is
already on the Formulary. SIGN guidance only considers written evidence however there is some
new published evidence suggesting that ivabradine is equivalent to beta-blockers for the treatment
of angina but the new evidence is in abstract form and therefore has not been peer-reviewed.
Ivabradine will be used in addition to nicorandil, not as a replacement.
There was discussion about the lack of an established evidence-base for ivabradine however it
was felt that there would be a small patient group for whom this drug would be appropriate. It is
expensive but the niche of patients using it will restrict cost. It was agreed that there would be a
place for ivabradine as a ‘specialist initiation’ drug for symptom control in patients intolerant to
beta-blockers and rate-limiting calcium-channel blockers. On this basis it was agreed to revise the
previous decision and accept ivabradine for inclusion in the Formulary.
b)
Cardiovascular review group
FH declared a lapsed interest in Eli Lilly. SC declared a personal, non-specific interest in GSK
and WN declared a non-personal, non-specific interest in GSK.
Bisoprolol
Changing bisoprolol to first choice in Section 2.4 (Beta-adrenoceptor blocking drugs) will have cost
implications, however figures have not been confirmed. Bisoprolol will be first choice wherever a
beta-blocker is required in cardiovascular disease. Switching from atenolol to bisoprolol resolves
side-effects such as tiredness and shortness of breath, which patients often perceive as symptoms
of their condition, and reduces the need for chest x-rays, exercise tests etc. in these patients. The
Subgroup accepted this change.
It was suggested that it might be helpful in future to factor in costings for such changes for
information.
Simvastatin
There was extensive discussion regarding the suggested statement ‘The 80mg dose may be
associated with a higher incidence of side-effects and interactions’ (significant interaction with
diltiazem and increased risk of rhabdomyolysis). It was felt that it would be difficult to find
evidence to back up this statement and that the side-effects are dose-related. The issue of the
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lack of evidence was discussed. Government-driven targets for reducing cholesterol were
discussed. SC would be happy to recommend simvastatin 40mg for secondary prevention, but
would prefer to use a more potent statin rather than a higher dose of a less potent one.
Agreement was not reached and the it was referred back to the review group for further discussion
prior to the next Formulary Subgroup meeting.
The Subgroup was happy with all other suggested changes to the chapter.
Chapter 2: Guidelines
(DG joined the meeting).
Step up management of hypertension in diabetic patients
It was suggested that the bullet point on avoiding use of verapamil and diltiazem with betablockers should be bold for greater emphasis. The Subgroup agreed with this suggestion.
Drug treatment of stable angina
The place of ivabradine in this guideline was discussed however it was decided that it was
specialist use and the patients should be referred to Cardiology by that stage.
Embolism prophylaxis for patients with persistent or permanent atrial fibrillation (AF)
It was suggested that a statement should be added about upper limits/controlling blood pressure
when using aspirin/warfarin; it was agreed to add a box at the bottom of the page with a statement
‘All usual contra-indications need to be considered’. The changes were approved.
Drug use in secondary prevention following myocardial infarction
The rationale for stating ‘3 to 12 months’ for aspirin /clopidogrel in non-ST elevation MI is that NHS
Greater Glasgow recommend 3 to 12 months and NHS Highland 9 to 12 months. The changes
were approved.
Use of lipid-lowering medication in the prevention of atherosclerosis
It was suggested that in the second box, potential candidates for treatment should be adults over
40 years. This will be added to the text.
There was considerable discussion around the choice of therapy if simvastatin 40mg did not
achieve cholesterol targets. It was agreed that as this issue was not resolved the guideline would
be referred back to the review group for further discussion and revisited at the next Formulary
Subgroup meeting.
(SC left the meeting).
Changes to the following guidelines were also approved:
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Step up management of essential hypertension
Drug treatment of heart failure due to left ventricular systolic dysfunction (LVSD)
Anticoagulant advice
Cardiovascular MCN guidelines
c)
Blood products
Information was circulated to the Subgroup via email regarding issues around the inclusion of
these products in the Formulary.
A proposed national process for the procurement of Blood Products, which will provide support for
Formulary management of these products, is being discussed by the Scottish Directors of
Pharmacy and the NHS Board Chief Executives. Until national agreement is reached EC feels it is
too early to look at this issue for the Formulary and suggests waiting for national guidance.
SPCs (Summary of Product Characteristics) for blood products are available on the internet and
local advice is available from the Blood Transfusion service and from haematologists. It was
suggested that it might be useful in the short-term to list products that Pharmacy and Blood
Transfusion keep in stock and give brief instructions on how to get them so that doctors on the
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wards have a ready source of information, especially as these items are usually required urgently.
It was agreed that such a list would be useful, but with the caveat ‘not assessed by SMC’. EC
asked MD if this was something that the Pharmacy department in Raigmore might consider.
Action
To compile a list of blood products and their availability
5.
EC/MD
Consider addition to Formulary
a)
Dabigatran etexilate (Pradaxa) 75mg & 100mg hard capsules
There were no declarations of interest.
This is a new drug which was accepted by SMC in May 2008 for primary prevention of venous
thromboembolic events (VTE) in adult patients who have undergone elective total hip or total knee
replacement surgery. Its advantage over low molecular weight heparin (LMWH) is that it is
administered orally and although it is slightly more expensive, the non-drug costs (eg routes of
administration, no requirement for monitoring) balance this out. A post-operative anticoagulation
protocol is being considered in Raigmore however there is no concrete guidance yet.
Dabigatran would not replace other DVT drugs outwith Orthopaedics and warfarin/enoxaparin
would still be used in patients with previous clotting issues. While it would be initiated from
hospital it was felt that guidance for GPs would be useful. The Subgroup decided to accept the
submission.
6.
Consider for approval updated Formulary sections and guidelines
a)
Antimicrobial Management Team
Alison MacDonald, Area Antimicrobial Pharmacist, attended the meeting for this agenda item.
This section was updated with comments from patient representative Liz Pritchard and was sent to
Dr De Villier at Inverclyde, who advises Argyll & Bute on infection management. The Subgroup
gave positive feedback on this section and the changes were approved.
b)
Skin review group
There were no declarations of interest.
Sue Ward of the National Eczema Society suggested that ointments are less acceptable to
patients and that this should be mentioned in the text. She also suggested adding a note that
tacrolimus used under wet wraps can cause problems.
EC agreed to investigate ongoing supply problems with Diprobase.
EC
Azelaic acid has been approved by SMC and is part of a new subsection on rosacea.
Chapter 13: Guidelines
Use of topical corticosteroids
It was pointed out that NICE recommends application of topical steroids once a day for children,
however this is an adult Formulary therefore children’s doses are not included. The Subgroup
approved changes to this guideline.
Methotrexate in dermatology: information sheet for general practitioners
This guideline is long and would benefit from bullet points. It was also felt that there should be
more specific/prescriptive advice on renal function. It was agreed that EC would liaise with SL to
amend this.
Some comment on rheumatology is also required. It is thought that there are some local guidelines
but that these may be out of date. It was agreed that EC would check with the rheumatology
department whether the information on their website is up-to-date and to ensure that the
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methotrexate guidance is consistent. It was suggested that more information on white blood count
would be useful. (SL left the meeting).
Methotrexate information sheet for patients
It was felt that this guidance contains too much technical wording, and that the average patient’s
reading age should be borne in mind. NPSA has a methotrexate patient leaflet which is simpler to
use and has a section for blood results etc. It was suggested that the review group might liaise
with the Patients’ Council/HealthVOICES and ask patient representatives to assist with
proofreading.
Management of chronic urticaria and angioedema
The Subgroup approved changes to this guideline but would like the length to be reduced if
possible.
It was generally felt that the dermatology guidelines were longer than the other guidelines and that
perhaps standardising the structure of guidelines might be useful.
Changes to the following guidelines were also approved:
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Adverse reactions to topical therapy
Use of emollients
Incontinence dermatitis
Management of pruritus
Management of eczema/dermatitis
Management of psoriasis
Management of acne.
Action
Investigate supply problems with Diprobase
Liaise with SL on renal section of methotrexate GP guideline
Liaise with rheumatology re website information
EC
EC
EC
7. Consider for approval amendments to the Formulary
Full submissions are required for valganciclovir and Glycophos Sterile Concentrate.
Parecoxib is the only Formulary item not approved by SMC. If it is removed all Formulary drugs
will be SMC-approved. The Subgroup agreed to its removal. All other recommended changes
were approved.
8. 10.1 NSAIDs/Acute pain – adult oral and rectal analgesic step ladder
Concern was expressed about ibuprofen being first-line with naproxen in the choices box. A major
problem with NSAIDs is gastro-intestinal effects. Low dose ibuprofen is consistently the least
problematic NSAID with respect to GI effects whilst risks with naproxen are intermediate. It was
agreed that low dose ibuprofen should be the first choice NSAID.
EC reported that the review group had not been happy with Subgroup feedback on the analgesic
stepladder and emphasised that it was developed by the Acute Pain team and therefore did not
focus on long-term pain control. Diclofenac is preferred as there are different routes of
administration available such as rectal, injection etc. and the objective in managing acute pain is to
aim high and titrate down. It was agreed that the word ‘acute’ would be emphasised in the title
heading.
9. Any other competent business
There was no essential AOCB and it was decided to defer the remaining agenda items until the
next meeting.
10. Date of next meeting
Tuesday 30 September 2008, Ante Room, Assynt House 12pm-2pm (lunch provided and
videoconferencing facilities available).
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