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Aneurin Bevan University Health Board Medicines & Therapeutics Committee PRESCRIBING enewsletter archive at: http://www.wales.nhs.uk/sites3/page.cfm?

Formulary: ABHB FORMULARY UPDATES ABHB s Drug Formulary is at: http://aneurinbevanhb.inform.wales.nhs.uk/ November 2013

The MTC has followed AWMSG advice and designated aclidinium a Green drug (non specialist initiation appropriate). Full prescribing information on this new LAMA is at: http://www.medicines.org.

00 Aclidinium bromide (Eklira Genuair) 375mcg BD DPI 60 343.20 Tiotropium bromide (Spiriva handihaler refill pack) 18mcg OD DPI 30 418.44 Tiotropium bromide (Spiriva Respimat) 2.

1 Aneurin Bevan University Health Board Medicines & Therapeutics Committee PRESCRIBING enewsletter archive at: Dear Gwent Prescriber At its last two meetings (5 th September and 17 th October) ABUHB s Medicines & Therapeutics Committee made the following decisions in relation to the ABUHB Formulary: ABHB FORMULARY UPDATES ABHB s Drug Formulary is at: November 2013 BNF section ACLIDINIUM bromide ( Eklira Genuair ) inhalation powder for COPD ADDED as an option for use in adults with COPD in accordance with AWMSG advice The MTC has followed AWMSG advice and designated aclidinium a Green drug (non specialist initiation appropriate). Full prescribing information on this new LAMA is at: LAMA Options Type of device No of puffs per inhaler Annual cost based on 12 inhalers Glycopyrronium bromide (Seebri Breezhaler) 44mcg OD DPI Aclidinium bromide (Eklira Genuair) 375mcg BD DPI Tiotropium bromide (Spiriva handihaler refill pack) 18mcg OD DPI Tiotropium bromide (Spiriva Respimat) 2.5 mcg 2 puffs OD Prices based on Drug Tariff October 2013 BNF section PERAMPANEL ( Fycompa ) tablets for adjunctive treatment of partial onset seizures ADDED as an option for restricted use where the Wales Patient Access Scheme (WPAS) applies in accordance with AWMSG advice Having now confirmed that the WPAS will apply across Primary and Secondary Care in Wales the MTC has designated perampanel an Amber without Shared Care drug (i.e. specialist initiation only but without the need for Shared Care arrangements for GP repeat prescribing) for the approved indication. Full prescribing information on perampanel at: BNF sections AND DEMECLOCYCLINE Don t use as an antibiotic The MTC agreed to restrict demeclocycline s ABUHB s Formulary inclusion to its licensed indication for the treatment of chronic hyponatraemia associated with the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) secondary to malignant disease (where water restriction is ineffective and the patient does not have concomitant cirrhosis) only and that it should not be available in section Antibacterial drugs/tetracyclines. The MTC reached this decision for the following reasons: Page 1 of 8

2 1. The high cost of demeclocycline ( for 28 x 150mg capsules) compared to other oral tetracyclines available on the Formulary ( 1.11 for 8 doxycycline 100mg capsules and 6.22 for 28 lymecycline 408mg capsules), 2. That expert micobiological view was that there was no particular advantage offered by demeclocycline in its antibacterial effect as compared to other tertracyclines available on the Formulary and 3. That only 11 practices had prescribed demeclocycline in the most recent 6 month period of prescribing data (42 items at a total cost of 17,700). Full prescribing information on demeclocycline is at: BNF section INSULIN DEGLUDEC ( Tresiba ) for diabetes mellitus NOT CONSIDERED In the absence of a submission from Novo Nordisk, Tresiba cannot be endorsed by AWMSG for use in accordance with its licensed indication, as a technology appraisal by AWMSG (or NICE) has not been undertaken. The medicine should NOT be prescribed routinely within NHS Wales for this indication. BNF section Linagliptin/metformin ( Jentadueto ) tablets for T2DM ADDED as an option for type 2 diabetes mellitus in accordance with AWMSG advice The MTC has designated Jentadueto an Amber without Shared Care drug (i.e. specialist initiation only but without the need for Shared Care arrangements for GP repeat prescribing). Although the two individual components were designated Green the MTC felt this was the only option considering that since the loss of exclusivity with Takeda s Actos (pioglitazone) the fixed does pioglitazone metformin combination (Competact ) has remained at for 28 days treatment (compared to between 1.64 and 2.40 for 28 days of pioglitazone). Full prescribing information on Jentadueto at: BNF section ULIPRISTAL 5mg ( Esmya ) for uterine fibroids ADDED as an option for the pre operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age in accordance with AWMSG advice The MTC has designated ulipristal 5mg a Red drug (specialist prescribing only) in accordance with the consensus view from ABUHB s Obs & Gynae consultants and in consideration that the duration of treatment with Esmya is limited to 3 months. Cost of Esmya is for 28 tablets. Prescribers should note that ulipristal 30mg (ellaone ) for emergency contraception remains a Green drug. Full prescribing information on Esmya at: BNF section INGENOL MEBUTATE ( Picato ) for actinic keratosis ADDED as an option for non hyperkeratotic, non hypertrophic actinic keratosis in accordance with AWMSG advice In considering AWMSG s view on the appropriate place for prescribing ingenol mebutate gel the MTC felt that: Page 2 of 8

3 As clinical data on the use of more than 1 course of ingenol mebutate gel for 2 or 3 consecutive days, or treatment of more than 1 area of 25cm 2 are not available and As local application site reactions (including erythema, blistering, crusting, erosion, exfoliation, pain and oedema) are all very common ( 1/10) ingenol mebutate gel should be designated Amber without Shared Care (i.e. specialist initiation only but without the need for Shared Care arrangements for GP repeat prescribing). Full prescribing information on Picato gel is at: SPC/ No current BNF listing TESTOSTERONE Skin Patch 300mcg/24hrs ( INTRINSA ) Non Formulary Prescribers should note that this formulation of testosterone (licensed for the treatment of hypoactive sexual desire disorder) apart from being Non Formulary is now also very costly. Intrinsa's UK license was voluntarily withdrawn back in 2012 but it has re appeared and is now significantly more expensive than its original 2007 cost of per pack. The current cost of a pack of 8 patches is 395. This increase has caught the attention of the national press: healthnews/ /drug companies accused of overcharging NHS face fraud inquiry.html See also: No current BNF listing DAPOXETINE ( Priligy ) for premature ejaculation Non Formulary Prescribers should note that the AWMSG have advised that in the absence of a submission from Menarini, dapoxetine ( Priligy ) cannot be endorsed for use within NHS Wales for the treatment of premature ejaculation in men aged 18 to 64 years old. ABHB would not be able to consider a formulary application to appraise dapoxetine locally whilst a Statement Of Advice stands. No BNF section MolluDab (5% potassium hydroxide) for molluscum contagiosum Non Formulary The fact that this new preparation is not classed as a Prescription Only Medicine means that 1. it will not be appraised at a national level by AWMSG 2. it can be bought over the counter from a pharmacy Point 1 above means that any ABUHB Formulary application will require a local appraisal of the evidence by the MTC. In the mean time prescribers should note: The level of evidence required for a medical device to added to Part IXA of the Drug Tariff (which lists MolluDab ) is less than that required for obtaining EU/MHRA marketing authorisation as a licensed medicine. A 2009 Cochrane Review of Interventions for cutaneous molluscum contagiosum ( onlinelibrary.wiley.com/doi/ / cd pub3/abstract) contains this plain language summary: Molluscum contagiosum, in healthy people, is a self limiting, relatively harmless viral skin infection. It affects mainly children and adolescents. It occurs worldwide but is much more frequent in certain geographic areas with warm climates. Molluscum contagiosum usually presents as single or multiple pimples filled with fluid. People may seek treatment for social and aesthetic reasons and because of concerns about spreading the disease to others. Treatment is intended to speed up the healing process. Eleven studies with 495 patients were included in this review. This review found that many common treatments for molluscum, such as physical destruction, have not been adequately evaluated. Several of the treatments that we studied are not part of daily practice. Limitations of several of these studies were: small numbers of patients, the investigators were not blinded, and patients who did not complete the study (which were numerous in some studies) were not included in the analysis. None of the evaluated treatment options were associated with serious adverse effects. Since most lesions will resolve within months, molluscum contagiosum can be left to heal naturally unless better evidence for the superiority of other treatment options emerges. Page 3 of 8

4 Five studies were included in the first 2006 version of the Cochrane Review with 6 more for the 2009 update. Two of the 11 studies assessed topical potassium hydroxide (at 5% and 10%). ABUHB WOUND HEALING PRODUCTS FORMULARY UPDATE ABUHB s Wound Healing Products Formulary is at: BNF section A5.2.4 AQUACEL & AQUACEL EXTRA Convatec has withdrawn the two dressing products Aquacel and Aquacel Ag Both presently on the Wound Healing Products Formulary They have been replaced by Aquacel Extra and Aquacel Ag Extra. These 'Extra' dressings are stronger and more absorbent than Aquacel but due to their extra cost were originally only available in Table 3 of the Formulary and reserved for highly exudating wounds only. The 'Extra' dressings have now been reduced in price to the same as the original dressings. It has been agreed by ABUHB s Wound Healing Group to amend the online version of the Wound Healing Products Formulary 2012 putting the Aquacel Extra dressing into Table 1 replacing the original Aquacel and Aquacel Ag Extra into Table 2 to replace the original Aquacel Ag dressing. Prescribers should note the potential for confusion as printed copies of the Formulary remain unchanged. ABUHB s Wound Healing Products Formulary is at: OTHER PRESCRIBING NEWS Weekly oral METHOTREXATE patients at risk? A review of the most recent quarter s WP10 prescribing data for methotrexate 10mg tablets showed that over 2,000 10mg tablets were dispensed across Gwent between May and July The MTC would like to remind prescribers and dispensers of the NPSA s Safe Practice Checklist in NPSA/2006/13 (at: particularly the points in the box below: All prescribers must avoid the use of as directed in prescribing a specific dose must be applied to each prescription. Bear in mind that patients often understand their dose by the number of tablets they take rather than mg. The required quantity and frequency of dose should be regularly discussed with the patient. Safe Dispensing practice: The strength of tablet supplied to the patient must stay consistent to prevent any confusion about the number of tablets they need to take, and the patient s monitoring document and Patient Medication Record should be checked to confirm the previous supply. It is the view of the MTC that patients receiving both the 2.5mg and 10mg tablets may be particularly at risk of confusion over the number of tablets to take, and the MTC advises that prescribers undertake a review of these patients. Any reasons for variance from the practice of prescribing/supplying solely as 2.5mg tablets should be documented. Note ABUHB acute services follow the policy of only supplying 2.5mg tablets for all weekly oral methotrexate prescriptions. The MTC also considers it good practice for prescribers to specify the day of the week on which the methotrexate should be taken as well as specifying the strength of methotrexate to be supplied. Page 4 of 8

5 BNF ALDOSTERONE ANTAGONISTS in heart failure guidance on monitoring Local guidance on eplerenone (originally issued in Feb 2007 and then revised in Aug 2010 when eplerenone was changed from Red to Amber) has been significantly transformed into more general guidance on the monitoring of aldosterone antagonists (spironolactone and eplerenone) when used to treat left ventricular systolic dysfunction. Prescribers should note that eplerenone is now dually licensed (indication 2 below is new) and that the Amber Traffic Light designation of eplerenone has become less straightforward: 1. in addition to standard therapy including beta blockers, to reduce the risk of cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction (LVEF 40 %) and clinical evidence of heart failure after recent MI (within 3 to 14 days) specialist only initiation i.e. Amber without Shared Care Traffic Light designation. 2. in addition to standard optimal therapy, to reduce the risk of cardiovascular mortality and morbidity in adult patients with NYHA class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF 30%) suitable for non specialist initiation. i.e. Green Traffic Light designation. IN VIEW OF THE CONSIDERABLE DIFFERENCE IN ACQUISITION COSTS BETWEEN THE 2 ALDOSTERONE ANTAGO NISTS, USE OF EPLERENONE FOR THIS SECOND INDICATION SHOULD BE RESERVED FOR PATIENTS INTOLERANT OF SPIRONOLACTONE (E.G. GYNAECOMASTIA). The new guidance is at: ABHBguidelinesFINAL%5BSept2013%5D.pdf Key points to note: PATIENTS SHOULD BE INSTRUCTED TO STOP THEIR ALDOSTERONE ANTAGONIST DURING AN EPISODE OF DIARRHOEA OR WHILE LOOP DIURETIC THERAPY IS INTERRUPTED. CONCURRENT USE OF AN ALDOSTERONE ANTAGONISTS WITH ACE INHIBITORS, ANGIOTENSIN II ANTAGONISTS, HEPA RIN, LOW MOLECULAR WEIGHT HEPARIN OR OTHER DRUGS KNOWN TO CAUSE HYPERKALAEMIA, POTASSIUM SUPPLE MENTS, A DIET RICH IN POTASSIUM (E.G. SPINACH, DRIED APRICOTS AND BANANAS), OR SALT SUBSTITUTES CONTAINING POTASSIUM, (AS WELL AS CONCURRENT USE OF 2 ALDOSTERONE ANTAGONISTS) MAY LEAD TO SEVERE HYPERKALAEMIA. RENAL IMPAIRMENT HIGH RISK OF HYPERKALAEMIA. SEE NOTE ABOVE ABOUT PATIENTS WITH INTER CURRENT ILLNESS AND VOLUME DEPLETION/DEHYDRATION. CONCURRENT USE OF ALDOSTERONE ANTAGONISTS WITH NSAIDS (INCLUDES OVER THE COUNTER PRODUCTS) INCREASES RISK OF NEPHROTOXICITY. BNF Vitamin B Co STRONG & Vitamin B Co time to review? The recent increase in cost of Vitamin B Co (now for 28) has prompted a call for a wider review use of vitamin B in alcoholic liver disease. National guidance supports (NICE CG100 guidance.nice.org.uk/cg100 and CG115) supports the use of prophylactic oral thiamine in harmful or dependent drinkers, but not vitamin B Co or vitamin B Co strong. NICE CG100 recommends that thiamine should be given in doses toward the upper end of the 'BNF' range i.e mg daily in divided doses. Duration of prophylactic oral thiamine treatment? once an individual is alcohol free ABUHB advice is that oral thiamine can be stopped after 3 months. Updated ANTI INFECTIVE GUIDELINES for Primary Care This has recently been updated with new sections on dental infections and diverticulitis and the insertion of hyperlinks to children s doses for a range of common childhood infections The 9 page short version (without all the references) is now available as a Word document on the MTC website at: ABUHB%5BHPA%5DOct2013.doc Page 5 of 8

6 This local guidance is also available as a web based version (more easily viewed on a smart phone or tablet than the full document) at: QR code is: ANTIMICROBIAL RESISTANCE RCGP Toolkit In the UK, 80% of antibiotic prescribing occurs in Primary Care, with over half for respiratory tract infections. With the aim of reducing inappropriate use of antibiotics (and thereby reducing bacterial resistance) the MTC would like to make Primary Care prescribers aware of the following RCGP resources supporting antibiotic prescribing: Training resources Patient information leaflets Self assessment checklist and audit (in English and 5 other languages) Resources for clinicians Antibiotic management guidance External clinical resources All at: BNF Antiepileptic drugs categorised to help prescribers avoid switching risks New guidance on prescribing antiepileptic drugs (AEDs) has been issued by the MHRA to help prescribers and patients understand the potential risks from switching between branded and generic products or between different generic products. The MHRA has now classified all AEDs into 3 categories (using their therapeutic index, solubility and absorption: Category 1 Category 2 Category 3 Advice for doctors Doctors are advised to ensure that their patient is maintained on a specific manufacturer s product Doctors are advised to use their judgement (in consultation with their patient and/or their carer) to determine whether it would be advisable for them to be maintained on a specific manufacturer s product. Doctors are advised that it is usually unnecessary to ensure that their patients are maintained on a specific manufacturer s product. Antiepileptic drugs in category Phenytoin, carbamazepine, phenobarbital, primidone Valproate, lamotrigine, perampanel, retigabine, rufinamide, clobazam, clonazepam, oxcarbazepine, eslicarbazepine, zonisamide, topiramate Levetiracetam, lacosamide, tiagabine, gabapentin, pregabalin, ethosuximide, vigabatrin An information sheet for patients and carers may help in consultations, see: specificinformationandadvice/productspecificinformationandadvice A F/Antiepilepticschangingproducts/index.htm BNF BUCCOLAM (midazolam) two requests Prescribers are reminded that this licensed formulation of oromucosal midazolam is considered suitable for non specialist repeat prescribing (Amber without Shared Care Traffic Light designation) and are requested 1. Not to put Buccolam on repeat prescription but only to issue an acute script when family/carers have run out or Buccolam is about to reach its expiry date. 2. To add 'Please label individual syringes' to prescriptions as individual syringes can be held in different locations for the patient. Page 6 of 8

Dispensers should consult with patient carers on whether the labelling of individual pre filled syringes of Buccolam is helpful and print further copies of the dispensing label to stick on to the

7 Dispensers should consult with patient carers on whether the labelling of individual pre filled syringes of Buccolam is helpful and print further copies of the dispensing label to stick on to the individual syringes if appropriate. Full prescribing information on Buccolam is at: BNF section 14.4 VARICELLA ZOSTER VACCINE (Zostavax ) A letter from the Chief Medical Officer / Chief Pharmaceutical Officer was issued on 25 th October 2013 see: The letter reminded prescribers that Zostavax, is a live attenuated vaccine and therefore contraindicated in patients on immunosuppressive therapy. This includes patients who have recently received or are currently being treated with biological therapies*. Key prescribing point: As biological therapies are usually administered in a hospital setting, treatment may not be immediately apparent from Primary Care records. * biological therapies include abatacept (Orencia), ustekinumab (Stelara), certolizumab (Cimzia), etanercept (Enbrel), adalimumab (Humira), inflixiamb (Remicade), golimumab (Simponi), rituximab (MabThera), tocilizumab (RoActemra) and anakinra (Kineret). They are commonly indicated for rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn's disease, ulcerative colitis and cancers. immunosuppressive therapies may not be cleared from the blood for several months. Full prescribing information on Zostavax is at: Reporting Adverse Drug Reactions (ADRs) Although the graph below of GP suspected ADR reports (Yellow Cards) in Wales ( ) is a little dated the declining level is a concern, and has led to a suggestion that the number of Yellow Cards submitted per GP practice and per Health Board become a National Prescribing Indicator for Reporting concerns about drug safety (i.e. suspected ADRs) is part of the GMC s ethical professional guidance on prescribing ( uk.org/guidance/ethical_guidance/14323.asp). The MTC would like to highlight extracts from the GMC s guidance below: Page 7 of 8

8 47. You must inform the MHRA about: a. serious suspected adverse reactions to all medicines and all reactions to products marked with a Black Triangle in the BNF and elsewhere using the Yellow Card Scheme. b. adverse incidents involving medical devices, including those caused by human error that put, or have the potential to put, the safety of patients, healthcare professionals or others at risk. These incidents should also be reported to the medical device liaison officer within your organisation. 48. You should provide patients with information about how they can report suspected side effects directly to the MHRA. The MHRA ( collects data on licensed and unlicensed prescription only, pharmacy and over the counter medicines Further guidance on reporting is available from the MHRA: Reporting Adverse Incidents at: bs/documents/publication/con pdf USEFUL LINKS: QR code link to Yellow Card online reporting: Online Yellow Card reporting for suspected ADRs Feedback on any item in this enewsletter is welcome. Suggested agenda items for the MTC are also welcome. Follow Trevor Batt Pharmacist & Professional Secretary to: Aneurin Bevan HB Medicines & Therapeutics Committee Aneurin Bevan Health Board Based at Victoria House, Corporation Rd, Newport NP19 0BH trevor.batt@wales.nhs.uk Tel: (DIRECT LINE) Page 8 of 8

Aneurin Bevan Health Board Medicines & Therapeutics Committee. enewsletter

Aneurin Bevan Health Board Medicines & Therapeutics Committee August 2013 enewsletter Dear Gwent Prescriber At its last two meetings (23 rd May and 11 th July) ABHB s Medicines & Therapeutics Committee