LANARKSHIRE AREA DRUG & THERAPEUTICS COMMITTEE
Minute of the meeting held on Wednesday 15th August 2012 at 10am in, NHS Lanarkshire HQ, Kirklands,
Bothwell
PRESENT:
2012/106
2012/107
2012/108
Dr Stephanie Dundas
Mrs Christine Gilmour
Dr Harpreet Kohli
Mr George Lindsay
Dr Philip McMenemy
Mr John Milne
Dr Colin Ooi
Ms Karen Patterson
Mrs Gail Richardson
Mr James Smith
Dr Vijay Sonthalia
Mr Alastair Thorburn [Chair]
Mrs Lesley Ritchie [Admin Support]
Apologies
Linda Johnstone, Frances Leckie, Dr Alwaly Majumdar
Minute of previous meeting
The minute of the previous meeting held on Wednesday 18th July was accepted as a true record
subject to the following amendments:
Item 2012/93 (e) Podiatry requests to GPs for dressing for ongoing care - ‘He also advised that
the majority of dressings are not licensed medicines so there is no restriction as such on
podiatrists providing these dressings to patients on a continuing basis unless the dressing is a
POM’ should be changed to ‘He also advised that the majority of dressings are not POMs so
there is no restriction as such on podiatrists providing these dressings to patients on a continuing
basis unless the dressing is a POM’
Item 2012/100 (i) Formulary – general update – ‘There have been discussions at the Wound
Management Formulary meetings on the possibility of simplifying the dressings that appear on
the formulary’ should be changed to ‘There have been discussions at the Wound Management
Formulary meetings on the possibility of pulling together a list of simple dressings for the
eFormulary for Vision’.
Matters arising from the previous meeting
(a) IPTR / unlicensed medicines update
KP advised no new IPTRs have been received over the summer period. There has been some
use of Ozurdex and Bevacizumab continues to be prescribed as an unlicensed medicine.
(b) Biologic drugs – request for written protocol for drug choice
AWT has again written to the Consultant Rheumatologists but there has been no further
communication from them. AWT has also spoken to Dr T Reilly who has agreed to speak to the
Consultant Gastroenterologists. GR reiterated the request to Dr Murphy when they met recently
regarding another matter. PMcM & CG are meeting with the Board MD and Finance colleagues
tomorrow and will raise this matter with them and highlight the importance of having a protocol
on the use of anti TNF drugs.
(c) ADHD draft protocol - update
The next date of the ADHD Working Group Committee is set for 17 th September 2012 – an
update will be received after this meeting.
(d) Guidance on the cost effective treatment of depression where drugs are indicated
No further update. Work still in progress.
(e) Triptorelin review protocol (West of Scotland) update
Dr Khan has advised that this item will be discussed at their next meeting which was scheduled
for w/c 13th August. The matter will be brought to the attention of the Acute Medical Director if
no response has been received from the Urologist by the September meeting of the ADTC.
(f) Remote prescribing
GL met with Billy Lang and Maria Gilfedder this week. It was noted that within Mental Health
some remote prescribing does take place and the GMC have altered their statements to advise
that remote prescribing can occur in certain circumstances. An update is also expected from
NMC. Discussions are taking place around the governance issues of this prescribing within
Mental Health to ensure that it happens safely. VJ asked if the discussions could also take
account of the community hospitals as remote prescribing by primary care colleagues also
happens in these areas. GL will feed back progression at the September meeting.
(g) ADTC Terms of Reference – annual review – August 2012
AWT advised that the terms of reference are due to be reviewed. Members agreed to study the
current document and discussions will take place at the September meeting.
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Action
PMcM / CG
GL
ALL
1
2012/109
2012/110
(h) ADTC chair from September 2012
AWT advised members that the September meeting would not be quorate if there was no chair
or vice chair present. Since the current chair, AWT, is retiring on 17th August and the vice
chair, PMcM, is unable to attend the September meeting members nominated CG as vice chair
with a view to CG chairing the September meeting.
(i) Podiatry – supply of dressings following nail surgery
Following further discussions R Peat has confirmed that the podiatry service do supply
dressings for patients following nail treatments but advised that patients may need to contact
their GP for dressings if they need more than podiatry have provided. VS advised this is not
consistent with the emails that have been sent from R Peat to the LMC and suggested that the
podiatry service issue guidance on the procedure that should be followed. PMcM agreed to take
this item forward with R Peat, asking the podiatry service to clarify the position with their own
staff and GPs.
(j) Buccolam v Epistatus
AWT advised that colleagues in the paediatric unit at Wishaw General Hospital have advised
that there may be some confusion about the prescribing of midazolam for seizure control. It
was agreed by the ADTC at previous meetings that Epistatus would continue to be used for
patients and this is supported by colleagues in paediatrics, Yorkhill Hospital and SNAP.
(k) Gemscript – ‘specials’ prescriptions
It was noted that in the recent update to the Gemscript drug dictionary that a number of parallel
import products were being listed in the drop down menu when selecting a drug that is still
under patent. It should be noted that GPs have been advised by the IT facilitators to select the
first option in the drop down menu when there is a choice like this. The parallel import drugs
will be removed in the next drug dictionary update from Vision.
There was a short discussion around ‘specials’ prescriptions and AWT advised that they can be
prescribed on GP10 and can be found in Gemscript if the prescriber unticks’ the checkbox for
formulary and ticks the checkbox for specials. It was agreed to disseminate this information to
all GPs.
Following the introduction of the Gemscript drug dictionary it was agreed that FG should check
that the formulary guidelines tab in the consultation manager screen is still working as before.
Electronic Prescribing
Work is progressing. There may be some issues regarding clearing aged invoicing before the
update, 5.01, to the JAC system. Further update at the September meeting. Go live date is still
anticipated for October.
Scottish Medicines Consortium Advice
(a) Full submissions:
CG
PMcM
LR (J
Milligan)
FG
CG
1. Vemurafenib 240mg film-coated tablet (Zelboraf®) Roche Products Ltd (No 792/12)
Not Recommended
vemurafenib (Zelboraf®) is not recommended for use within NHS Scotland.
Indication under review: as monotherapy for the treatment of adult patients with BRAF V600
mutation-positive unresectable or metastatic melanoma.
A phase III, open-label study has demonstrated a significant improvement for the co-primary
endpoints of overall survival and progression free survival for vemurafenib relative to an
intravenous single agent chemotherapy regimen, in patients with previously untreated
unresectable stage IIIC or stage IV melanoma with V600E BRAF mutation.
The submitting company did not present a sufficiently robust economic analysis and in addition
their justification of the treatment’s cost in relation to its health benefits was not sufficient to
gain acceptance by SMC.
The committee endorsed the SMC recommendations.
2. Tegafur/gimeracil/pteracil 15mg/4.35mg/11.8mg and 20mg/2.8mg/15.8mg hard capsules
(Teysuno®) Nordic Pharma Ltd (No 802/12) Accepted Restricted
tegafur/gimeracil/oteracil (Teysuno®) is accepted for restricted use within NHS Scotland.
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Indication under review: tegafur/gimeracil/oteracil is indicated in adults for the treatment of
advanced gastric cancer when given in combination with cisplatin.
SMC restriction: tegafur/gimeracil/oteracil is restricted to use in patients with advanced gastric
cancer who are unsuitable for an anthracycline, fluorouracil and platinum triplet first-line
regimen.
In a multicentre, randomised, open-label clinical study in adult patients with advanced gastric
cancer, tegafur/gimeracil/oteracil in combination with cisplatin was non-inferior to an
intravenous fluoropyrimidine plus cisplatin with respect to overall survival.
The committee endorsed the SMC recommendations.
3. Colecalciferol 800 international units (equivalent to 20 micrograms vitamin D3)
capsules (Fultium- D3®) Internis Pharmaceuticals Limited (No 801/12) Accepted
colecalciferol (Fultium-D3®) is accepted for use within NHS Scotland.
Indication under review: In adults, the elderly and adolescents for the prevention and treatment
of vitamin D deficiency and as an adjunct to specific therapy for osteoporosis in patients with
vitamin D deficiency or at risk of vitamin D insufficiency.
The therapeutic use and safety profile of colecalciferol as a treatment for vitamin D deficiency
and as an adjunctive treatment in osteoporosis is well established. There are no comparative
data for Fultium-D3® as it is the first licensed oral vitamin D monotherapy formulation.
The committee endorsed the SMC recommendations. FG to add to NHSL Formulary
following publication on the SMC website, 10th September 2012.
(b) Resubmission:
1. Tocilizumab 20mg/mL concentrate for solution for infusion (RoActemra®) Roche
Products Ltd (No 774/12) Accepted Restricted with PAS
tocilizumab (RoActemra®) is accepted for restricted use within NHS Scotland.
Indication under review: Tocilizumab monotherapy is indicated in patients who are intolerant
to methotrexate or where continued treatment with methotrexate is inappropriate, for the
treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have
either responded inadequately to, or who were intolerant to, previous therapy with one or more
disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF)
antagonists.
SMC restriction: tocilizumab is restricted for use in accordance with British Society for
Rheumatology guidance on prescribing TNFα blockers in adults with rheumatoid arthritis
(2005).
In a randomised, double-blind, controlled study conducted in patients who were intolerant to
methotrexate, or for whom methotrexate was inappropriate, tocilizumab monotherapy was
superior to a TNF antagonist for several clinically relevant outcomes (DAS28 scores, DAS28
remission, ACR response rates).
This SMC advice takes account of the benefits of a Patient Access Scheme that improves the
cost-effectiveness of tocilizumab. This SMC advice is contingent upon the availability of the
Patient Access Scheme in NHS Scotland.
The committee endorsed the SMC recommendations.
2 .Fingolimod (as hydrochloride) 0.5mg hard capsules (Gilenya®) Novartis
Pharmaceuticals UK Ltd (no 763/12) Accepted Restricted with PAS
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fingolimod (Gilenya®) is accepted for restricted use within NHS Scotland .
Indication under review:
As single disease modifying therapy in highly active relapsing remitting multiple sclerosis
(RRMS) for the following adult patient groups:
 Patients with high disease activity despite treatment with a beta-interferon.
These patients may be defined as those who have failed to respond to a full and
adequate course (normally at least one year of treatment) of beta-interferon. Patients
should have had at least one relapse in the previous year while on therapy, and have
at least nine T2-hyperintense lesions in cranial magnetic resonance imaging (MRI) or
at least one gadolinium-enhancing lesion.
A “non-responder” could also be defined as a patient with an unchanged or increased
relapse rate or ongoing severe relapses, as compared to the previous year.
or
 Patients with rapidly evolving severe RRMS defined by two or more disabling relapses
in one year, and with one or more gadolinium enhancing lesions on brain MRI or a
significant increase in T2 lesion load as compared to a previous recent MRI.
SMC restriction: restricted to use as single disease modifying therapy in highly active RRMS in
adult patients with high disease activity despite treatment with a beta-interferon with an
unchanged or increased relapse rate or ongoing severe relapses, as compared to the previous
year.
Fingolimod reduced the annualised relapse rate significantly more than a beta-interferon in
patients with clinically active RRMS. An indirect comparison also demonstrated similar efficacy
to another disease modifying therapy in established use in RRMS.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves
the cost-effectiveness of fingolimod. This SMC advice is contingent upon the continuing
availability of the patient access scheme in NHS Scotland.
The committee endorsed the SMC recommendations. It was agreed to bring this to the
attention of the Chair of the PMB to discuss a service level agreement and approval
process for patients being commenced on this drug.
2012/111
2012/112
2012/113
2012/114
2012/115
SMC Budget Impact Templates – for info
1. Tegafur/gimeracil/oteracil (Teysuno)
Colecalciferol (Fultium-D3) 1 template for treatment and maintenance
Colecalciferol (Fultium-D3) 1 template for osteoporosis
Tocilizumab (RoActemra) (with PAS)
Tocilizumab (RoActemra) (without PAS)
Fingolimod (Gilenya) (with PAS)
Fingolimod (Gilenya) (without PAS)
NICE Technology Appraisals / NHSQIS Comments on Guidance
Nil
Drug & Therapeutics Bulletin (BMJ) –
Link circulated.
AD&TC Bulletin – No 60 August2012
Circulated for info.
Clinical Protocols for the Introduction of New Drugs
(a) Dexmedetomidine hydrochloride (Dexdor®)
GR advised that pharmacy colleagues have been heavily involved in drawing up this protocol.
The committee endorsed this protocol.
Lanarkshire Formulary Update
(a) Appeals - Nil
(b) Deletions - Nil.
(c) Additions - Nil
(d) Formulary section review updates –
Obesity in patients with type 2 diabetes – A reply has been received from Dr Arnott, on behalf
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PMcM
AWT
4
2012/116
2012/117
2012/118
2012/119
of the MCN, indicating that GLP1 analogues should not be included in the obesity section of the
formulary. FG will ask the Diabetes MCN if they would like any additional information on the
management of obesity in the diabetic section of the formulary.
(e) Wound Management formulary – Nil
(f) Formulary amendment requests – Nil
(g) SMC submissions update
(i) Linagliptin No 746/11 – to be included in the formulary as 3rd line use. Vildagliptin to be
removed from formulary.
(ii) Exenatide once weekly No 748/11 – Exenatide daily to be included in the formulary as 1 st
line option. Bydureon and liraglutide to be used as 2 nd line options. FG to compare cost
comparison for Exenatide daily and weekly preparations.
(h) Formulary app for smart phones update – Figures show that there have been 762 hits on
the site for the app for the I-phone and 52 hits for android phones.
PMcM agreed to notify GPs that the app is now available for android phones also.
FG advised that there have been some problems with the calculators, therefore Softaware have
removed them from the app until the new National calculators are available in October.
FG will organise to advertise the app on the NHSL screensaver for all NHSL employees.
(i) Vision update – FG has been updating the system from a practice within Carluke as she is
unable to access vision on her PC.
(j)
General updates –
(i) Gluten free products – Need agreement on formulary items for Vision for over 12 years old.
FG to liaise with Maureen Lees. GR will also speak to Maureen at the next meeting of the Food
Fluid Nutrition Group but this is not until the end of Sept, beginning of Oct.
(ii) Lipid guidelines – FG to liaise with Cardiologists to review the guidelines.
(iii) EMIS – The practice in Biggar who use EMIS should have the formulary exported to them
this week.
(iv) Steroids – AWT advised that dermovate and eumovate should be prescribed by their brand
name to avoid errors when choosing the correct generic description from the Gemscript drug
dictionary.
Medication and Clinical Risk in Lanarkshire
1. Medication incident reporting – Nil
2. NPSA reports – Nil
3. MHRA – Vol 6 Issue 1 – August 2012–
Link circulated.
Regional Cancer Prescribing Advisory Group
JM provided the committee with an update. WoSCAN cancer protocols are now available from
FirstPort under quick links.
Correspondence
(a) Ticagrelor – letter from Astra Zeneca Ltd
Circulated for info. Ticagrelor is available in NHSL and can be used as per the SMC
recommendations. Concerns raised in the letter have been noted. No further action.
(b) Antimicrobial reports – CDI Heat Target
CDI HEAT targets for Acute division. It was noted that NHSL have achieved each of the
individual targets. Not yet recommended for step down as targets have not been met
consistently. This is mainly as the collection of the data was late in being started.
(c) SMC non recommended medicines – Yasmin – correspondence from family planning
service
A request, by the family planning service, has been made to notify GPs to discontinue the use of
Yasmin in Primary Care as there is no clinical benefit to using the drug. GPs were advised last
year to discontinue this drug and it was agreed to include an article in the ‘Prescribing Notes’ to
reiterate this information and provide comparable costs with current recommended drugs.
(d) Eltrombopag
Noted following a GP enquiry that this is a highly specialist drug requiring close monitoring by
Haematologists and dispensing of the drug should remain with the hospital pharmacy
department and not with primary care.
AOCB
It was noted that AWT was retiring from NHSL on 17th August and would therefore no longer
be Chairing the ADTC meetings. PMcM along with committee members thanked AWT for his
contribution and guidance over many years and PMcM presented a small gift as a token of
appreciation.
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FG
FG
FG
PMcM
FG
FG / GR
FG
FG
LR / A Auld
5
2012/120
Date of next meeting
Wednesday 19th September 2012 at 10am in the Board Room, Ground Floor, Kirklands
Hospital.
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