October 2012 UPDATE1 A summary of the Joint Prescribing Committee key recommendations following the meeting on 19 September 2012 is provided below: BULLETIN / PAPER RECOMMENDATIONS / INFORMATION PRIMARY CARE OR INTERFACE PRESCRIBING ISSUES Dabigatran and Rivaroxaban for
Prescribing of Dabigatran and Rivaroxaban for the
prevention of stroke or systemic
prevention of stroke and systemic embolism in atrial
embolism in patients with AF.
fibrillation is recommended in line with NICE Technology
Appraisal Guidance (TA 249 and TA 256) only.
“Hospital Initiation generally recommended”
The East of England Priorities Advisory Committee (PAC) guidance to support implementation of NICE TA 249 and NICE TA 256 was supported (with amendments) noting that this guidance does not and should not over-ride the NICE TAs. A clinician may choose to initiate dabigatran or rivaroxaban for any patient meeting the Technology Appraisals’ criteria, if clinically appropriate.
• Dabigatran and Rivaroxaban should generally be initiated
by a secondary care consultant (haematologists, cardiologist or stroke physician as appropriate) with the support of their anticoagulant clinic. Prescribing can then be passed to the GP with shared care advice. Initiation of Prescribing by GPs with special expertise in anticoagulation (e.g. GP with special interest) is also acceptable.
Exenatide twice daily (Byetta®) as
The revised bulletin and following recommendations were agreed:-
an adjunctive therapy to basal
The use of Exenatide twice daily (Byetta®) as an adjunctive
insulin with or without metformin
therapy to basal insulin with or without metformin and/or
and/or pioglitazone in adults with
pioglitazone in adults with poorly controlled type 2 diabetes
poorly controlled type 2 diabetes
mellitus is supported in accordance with agreed initiation
mellitus. “Prescribing under shared care recommended”
The use of the combination therapy (as outlined above) is subject to audit to be undertaken by the Hospital Trusts
1 There has been a minor update made to the recommendations relating to bulletin 124 - the
amendments are in bold italics and relate to group 2 driving licence holders.
and presented to the JPC in September 2013.
The current JPC recommendation on the addition of insulin to patients who are already receiving Exenatide remains negative.
Specialist initiation, with GP to take over prescribing under shared care arrangements.
The Exenatide shared care guideline will be updated to reflect the recommendations.
Bedfordshire Community
The JPC agreed further amendments to the wording in these
Antimicrobial Prescribing
documents replacing references to ‘true penicillin allergy’ with
Guidelines– Pelvic Inflammatory
‘serious penicillin allergy’ and giving more detailed information
Disease (PID) and Neisseria
relating to the reconstitution of ceftriaxone injection.
gonorrhoeae, uncomplicated
With the above amendments, the documents were approved.
Guidelines on the frequency of self-
The JPC agreed to update Bulletin 124 to include and support the
monitoring of blood glucose in non-
current advice from the DVLA with respect to self-monitoring of
insulin dependent (Type 2) diabetic
blood glucose in people with non-insulin treated diabetes mellitus
patients for maintaining glycaemic
holding group 1 and group 2 driving licences.
control (Bulletin 124) 1
The summary recommendations below relate only to self blood glucose monitoring for people with diabetes who are not on “Updated Patient information leaflet” treatment with insulin.
For the full list of other requirements / needs of notification etc and detailed guidance, please refer to the DVLA document: “At a glance guide to the current medical standards of fitness to drive” (May 2012) available at http://www.dft.gov.uk/dvla/medical/ataglance.aspx Group 1 Licences (car/motorbike)
To recommend that those who take tablets that carry a risk of hypoglycaemia (such as sulfonylureas and glinides e.g. repaglinide, nateglinide) and who have or are applying for a Group 1 driving licence should be advised that “It may be appropriate to monitor blood glucose regularly and at times relevant to driving to enable the detection of hypoglycaemia”. The DVLA guidance also states that these patients “Must be under regular medical review”.
In addition, the JPC recommend that the decision as to which patients fit this criteria should be made on a case by case basis, by the prescriber, taking individual circumstances into consideration.
The DVLA does not make any recommendations regarding blood glucose monitoring for patients who take tablets other than those which carry a risk of hypoglycaemia or use non-insulin injectable medication.
Blood Glucose Testing Strips to be issued by GPs in line with
1 There has been a minor update made to the recommendations relating to bulletin 124 - the
amendments are in bold italics and relate to group 2 driving licence holders.
Group 2 Licences (Lorry/bus/taxis)
To recommend that those who take tablets that carry a risk of hypoglycaemia (such as sulfonylureas and glinides e.g. repaglinide,nateglinide) and who have or are applying for a Group 2 driving licence should be advised that they “Must regularly monitor blood glucose at least twice daily and at times relevant to driving”.
To recommend that patients who take tablets other than those that carry a risk of hypoglycaemia or use non-insulin injectable medication are advised to monitor their blood glucose regularly and at times relevant to driving. The DVLA guidance also states that these patients “Must be under regular medical review”.
Blood Glucose Testing Strips to be issued by GPs in line with the formulary.
The patient information leaflet supporting the bulletin has been updated to include a reference to DVLA advice and this was approved by the JPC.
Choice of statin for primary and
The JPC was asked to review the choice of statin for primary and
secondary prevention of
secondary prevention of cardiovascular disease in view of the
cardiovascular disease in adult patients
The following recommendations were agreed:-
Both atorvastatin and simvastatin may be considered as cost-effective choices of statin therapy for primary and secondary prevention of cardiovascular disease in adult patients.
For primary prevention, drugs of first choice are - Atorvastatin 10mg or Simvastatin 40mg daily (Pravastatin 40mg may be considered if there are potential drug interactions or if the patient is intolerant to Atorvastatin or Simvastatin).
Patients taking rosuvastatin who have never taken an alternative statin could be switched to an equipotent dose of atorvastatin. If the indication is familial hypercholesterolaemia, and atorvastatin has been tried but not tolerated or was ineffective, then rosuvastatin should be continued.
Simvastatin 80mg should not be used for any indication.
Further recommendations will be issued following the December JPC when the Committee will have had the opportunity to discuss the views of the Cardiac Network relating to more specialised indications. N.B. All atorvastatin and simvastatin prescriptions should be
1 There has been a minor update made to the recommendations relating to bulletin 124 - the
amendments are in bold italics and relate to group 2 driving licence holders.
generically written. Ulipristal acetate for Uterine fibroids The JPC agreed to support the use of ulipristal acetate for the pre- “Hospital Initiation, GP to continue”
operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. (Hospital initiation of prescribing, GP to continue). The total duration of treatment (primary and secondary care combined) is limited to 3 months. Daily tadalafil (Cialis®) for penile
The use of daily tadalafil for the treatment of penile rehabilitation
rehabilitation following radical
following radical prostatectomy, is not recommended.
prostatectomy “Not recommended” Dapagliflozin for the treatment of
Dapagliflozin is a competitive, reversible inhibitor of sodium-
Type 2 diabetes mellitus in adults
glucose co-transporter 2 (SGLT2), which has recently received a
positive opinion from the CHMP recommending its approval in the EU for the treatment of type 2 diabetes mellitus. The JPC was informed that local Specialists had not indicated any interest in prescribing this drug. In addition, there are still some outstanding safety concerns. The following Pre-Licensing Recommendation was therefore agreed:
The use of Dapagliflozin is not currently recommended. Recommendation to be reviewed when NICE has issued its guidance (estimated issue date – March 2013).
SECONDARY CARE PRESCRIBING/COMMISSIONING ISSUES – all items “Hospital Prescribing Only” Botulinum A Treatment Guidance
The JPC recommendations issued in 2009 have been updated to reflect the Bedfordshire and Hertfordshire Priorities Forum statement on the treatment of Focal Hyperhidrosis.
Photodynamic therapy (PDT) with
The PCTs have received an increasing number of Individual
verteporfin (Visudyne®)
Funding Requests (IFRs) relating to the use of PDT and verteporfin for a variety of ophthalmological indications. As verteporfin is now excluded from Payment by Results (PbR), the PCTs/CCGs need to agree policies for the use in these indications. The following recommendations were agreed:- •
To support the use of verteporfin/PDT in line with the NICE TAG i.e. for individuals who have a confirmed diagnosis of classic with no occult subfoveal CNV and best-corrected visual acuity (BCVA) 6/60 or better. (Accepting that Anti-VEGF treatment is now the recommended first-line treatment of CNV secondary to neovascular AMD,with PDT limited to circumstances in which this is contraindicated or refused by patients).
The use of PDT/verteporfin for Subfoveal CNV secondary to pathological myopia; Chronic central serous retinopathy; and Juxtafoveal telengiectasia is not supported.
Sequential Use of biologics in
The current JPC guidance (issued April 2011) on sequential use of
patients with psoriasis
biological agents for the management of psoriasis was reviewed. The JPC concluded that there was only emerging clinical consensus evidence to support sequential use of biological agents in psoriasis and cost effectiveness was not demonstrated. Therefore, the current JPC recommendations remain unchanged.
Eviplera® for the Treatment of HIV
The JPC agreed to support the use of Eviplera® outside licensed
infection in non treatment naïve
indications as an option for the treatment of HIV in non treatment
1 There has been a minor update made to the recommendations relating to bulletin 124 - the
amendments are in bold italics and relate to group 2 driving licence holders.
patients (unlicensed indication)
naïve patients who experience side-effects to current treatments. A cost neutral position is assumed with respect to treatment costs.
East of England Priorities Advisory
The JPC noted the PAC draft minutes (June 2012),noted and
Committee (PAC)
adopted the Hepatitis C Guidance which has been produced to help support the implementation of NICE TA’s 252 and 253 and ratified the Tocilizumab guidance (this is in line with the JPC recommendations made at the last meeting relating to the use of biologics in the treatment of RA).
NICE Guidance The JPC Noted the following NICE Guidance:
Lapatinib or trastuzumab in combination with an aromatase inhibitor for the first-line treatment of metastatic hormone receptor-positive breast cancer that over expresses HER2, NICE TAG 257, Issued: June 2012. www.guidance.nice.org.uk/ta257
Erlotinib for the first-line treatment of locally advanced or metastatic EGFR-TK mutation-positive non-small cell lung cancer, NICE TAG 258, Issued June 2012. www.guidance.nice.org.uk/ta258 •
Abiraterone for castration resistant metastatic prostate cancer previously treated with a docetaxel-containing regimen, NICE TAG 259, Issued June 2012. www.guidance.nice.org.uk/ta259
Botulinum toxin type A for the prevention of headaches in adults with chronic migraine, NICE TAG 260, Issued June 2012. www.guidance.nice.org.uk/ta260
Rivaroxaban for the treatment of deep vein thrombosis and prevention of recurrent deep vein thrombosis and pulmonary embolism, NICE TAG 261, Issued July 2012,www.guidance.nice.org.uk/ta261
Adalimumab for the treatment of moderate to severe ulcerative colitis (terminated appraisal), NICE TAG 262, Issued July 2012.www.guidance.nice.org.uk/ta262
Bevacizumab in combination with capecitabine for the firstline treatment of metastatic breast cancer, NICE TAG 263, Issued August 2012. www.guidance.nice.ogr.uk/ta263
Proposed / Potential December 2012
Exenatide Shared Care Guidelines – Update
JPC items
Botulinum Toxin for OAB in men and women
LMWH for thromboprophylaxis during pregnancy – Shared Care Guidelines
Shared Care Guidelines for Immunosuppressive Therapy in Gastroenterology
If you are interested in commenting on any of these items, please contact [email protected] .
Website Access to JPC Documents: PCT Staff Log in to ‘Starfish’, select Directorates, then, BCCG, then Prescribing and Medicines Management, then Bedfordshire and Luton Joint Prescribing Committee Non PCT Staff We are currently experiencing problems in providing website access to JPC documents for non PCT staff for which we apologise. In the interim, we are uploading JPC Newsletters, List of JPC Documents and ‘Traffic Light’ documents to the NHS Bedfordshire and Luton Cluster website – this information will be freely available shortly without password protection at www.bedfordshireandluton.nhs.uk/publications/. If you wish to receive copies of any of the more detailed documents flagged in the Newsletters, please contact [email protected] or [email protected]. Going forward, it is hoped that the GP ref website (http://www.gpref.bedfordshire.nhs.uk) will become the repository for all JPC documents.
Comments are always welcome to [email protected].
1 There has been a minor update made to the recommendations relating to bulletin 124 - the
amendments are in bold italics and relate to group 2 driving licence holders.
Article 1 Le présent règlement est établi en application des dispositions des articles R. 3634-1 et R. 3634-2 du Code le la Santé Publique. Il remplacetoutes les dispositions réglementaires antérieures relatives à l’exercice du pouvoir disciplinaire en matière de lutte contre le dopage. Article 2 Aux termes de l’article L. 3631-1 du Code de la Santé publique : “Il est i