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Jan 10 • Issue 26 Prescribing & Medicines Management Newsletter www.kirklees.nhs.uk ScriptSwitch: We start our post- Christmas ‘hangover cure’ bumper (well it’s actually the same size as usual) fun-packed (might get done by trades description for that one – Ed.) edition with news of the full launch of ScriptSwitch across the PCT. This program provides decision support at the point of prescribing/re-authorising and can be used for a wide range of initiatives including: Supporting patient safety e.g. National Patient Safety Alerts Providing reminders regarding the SWY APC ‘traffic light’ (RAG) status of a drug e.g. if it’s grey, green specialist initiation, amber or red. Prompting cost-effective drug choices to help practices meet local (e.g. PBC incentive scheme) & national (e.g. Better Care, Better Value) targets and stay within prescribing budget. Integration of local prescribing guidelines e.g. Antimicrobial A demo of the system in action can be found at: www.scriptswitch.com. Although the initial profile was produced by the medicines management team (MMT), the aim for future updates is a more collaborative approach with input particularly via PBC prescribing leads. Comments are welcome & can be fed back via your practice pharmacist/technician (where available); use of a feedback form (being distributed shortly) or to Su Pursell at the MMT office on: 01484 344352. New Drugs: Eslicarbazepine (Zebinix) : new antiepileptic launched as adjunctive therapy for the treatment of partial-onset seizures, with or without secondary generalisation, in adults. An active metabolite of oxcarbazepine (same mechanism of action as carbamazepine), the only apparent advantage over oxcarbazepine is once daily dosing but this comes at a significant cost - 800mg tablets £154.20/30 tabs (usual dose: 800-1200mg daily). Action: May be useful where compliance with twice daily oxcarbazepine is poor but changes to therapy should be secondary care led (oxcarbazepine is classified green with specialist initiation locally). Prasugrel (Efient): following on from the last edition, NICE has now issued guidance (TA182 Oct 09) which indicates that this new antiplatelet agent should be considered: • An option in combination with aspirin for patients who are treated by percutaneous coronary intervention (PCI) following ACS BUT that • this applies ONLY when they have had a ST-segment-elevation myocardial infarction (STEMI) OR •a blocked stent while on treatment with clopidogrel OR •have diabetes. The SPC recommends treatment continues for up to 12 months unless discontinuation is clinically indicated at an earlier time, perhaps due to side effects. Action: Locally prasugrel has been classified green with specialist initiation. In need of a New Year’s (Prescribing) Resolution? Why not choose one (or all) of the top tips for cost-effective prescribing in our 2010 Medicines Management Team ‘selection box’! To use simvastatin as my first choice statin (especially in primary CV prevention); To use AIIRAs (sartans) only in patients truly intolerant of ACE-inhibitors; To use omeprazole or lansoprazole gastro-resistant capsules as my first choice PPI; To prescribe plain prednisolone tabs rather than EC; To prescribe Mesren rather than Asacol; To prescribe Matrifen rather than Durogesic or generic fentanyl patches; To minimise my use of Grey Drugs; To develop closer working relationship with local community pharmacists (possibly integrate MURs into the clinical medication review process). Should generic clopidogrel be prescribed for ACS? Better Care, Better Value (BCBV) Q1 2009 data is now available at www.productivity.nhs.uk (NHS Institute for Innovation & Improvement): THE EAGERLY ANTICIPATED ‘SPECIALS’ BULLETIN WILL BE SENT OUT SHORTLY. NHSK: positions shown as: national (out of 152 PCTs) & local (out of the 14 PCTs in Yorkshire & Humber SHA); £ = savings available if to level of top quartile of PCTs Q1 2009/10) 3rd Quarter (Q3) 2008 1st Quarter (Q1) 2009 Increasing low cost prescribing for lipid modification (% simvastatin/pravastatin as all statins, including ezetimibe combinations) 118th / 9th (70.2% v 79%) £817,117 119th / 9th (70.3% v 79%) £874,100 Increasing low cost PPI prescribing (%lansoprazole/omperazole as all PPIs) 130th / 8th (85% v 92%) £315,790 132nd / 8th (85.6% v 92%) £258,424 Increasing low cost prescribing for drugs affecting the renin- angiotensin system (% ACEI as all renin-angiotensin drugs) 127th / 14th (67.7% v 74%) £388,933 128th / 14th (67.45% v 74%) £383,013 Unfortunately it does not paint a very pretty picture for NHS Kirklees (NHSK): • relatively poor performance against all 3 of these high priority DOH prescribing cost-effectiveness indicators (compared with other PCTs both locally & nationally - see table below) and • only limited signs of improvement since our last look at this data (Q3 2008). On a more positive note, the scope for LARGE COST SAVINGS remains (which could be vital in maximizing the number of patients who can be treated with these drugs in the current difficult economic climate) – target is to achieve level of top quartile of PCTs - REMEMBER: 1) These indicators are NOT about STOPPING prescribing they are about shifting it to agents of EQUAL EFFICACY but which are MORE COST-EFFECTIVE 2) Also that any improvement in the low cost lipid modification indicator will count towards practice achievement in the PBC local incentive scheme (LIS)!!! Practice pharmacists/technicians can aid surgeries in initiating BCBV action including the most appropriate use of available national support materials (NPC at: http://www.npci.org.uk/ reception_static.php#nsm). These cover all BCBV indicators but are due to be updated shortly. They include online and downloadable resources, and cover policy and guidance, therapeutics and implementation and monitoring at a local level. Another useful resource re BCBV is the latest Prescribing Review by NHS Prescription Services (formerly PPA): ‘July - Sept 2009 ACE Inhibitors and AIIRAs’ (www.nhsbsa.nhs.uk/2953.aspx) ACS was the most recent clopidogrel indication granted to Sanofi and is ‘restricted’ to branded Plavix for a period of time in the UK. It would seem unlikely that the antiplatelet activity of clopidogrel is any different in ACS (where generic clopidogrel is not licensed) compared to stable vascular disease (where it is) and the EMEA has indicated acceptance of the full bioequivalence of generic clopidogrel by granting Positive Opinions which included ACS on the continent. Although technically ‘off-label’ for ACS in the UK, prescribing generically for ALL indications (as ‘clopidogrel’) is: - Unlikely to involve added risk - Likely to be less complicated for prescribers, dispensers & patients alike - Likely to be a source of significant cost savings as the DT price of generic clopidogrel drops (it is already 7% less than Plavix) – a factor which has to be taken into consideration in the current economic climate. - A practice already adopted by a number of trusts/APCs nationally & locally. We have received reports of community pharmacy requests for addition of an indication to clopidogrel prescriptions, advice is that this should NOT be done as it sets an inappropriate precedent re other drugs/conditions.

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Page 1: Document

Jan 10 • Issue 26

Prescribing & Medicines Management Newsletter

www.kirklees.nhs.uk

ScriptSwitch: We start our post-Christmas ‘hangover cure’ bumper (well it’s actually the same size as usual) fun-packed (might get done by trades description for that one – Ed.) edition with news of the full launch of ScriptSwitch across the PCT. This program provides decision support at the point of prescribing/re-authorising and can be used for a wide range of initiatives including:

• Supporting patient safety e.g. National Patient Safety Alerts

• Providing reminders regarding the SWY APC ‘traffic light’ (RAG) status of a drug e.g. if it’s grey, green specialist initiation, amber or red.

• Prompting cost-effective drug choices to help practices meet local (e.g. PBC incentive scheme) & national (e.g. Better Care, Better Value) targets and stay within prescribing budget.

• Integration of local prescribing guidelines e.g. Antimicrobial

A demo of the system in action can be found at: www.scriptswitch.com. Although the initial profile was produced by the medicines management team (MMT), the aim for future updates is a more collaborative approach with input particularly via PBC prescribing leads. Comments are welcome & can be fed back via your practice pharmacist/technician (where available); use of a feedback form (being distributed shortly) or to Su Pursell at the MMT office on: 01484 344352.

New Drugs: Eslicarbazepine (Zebinix) : new antiepileptic launched as adjunctive therapy for the treatment of partial-onset seizures, with or without secondary generalisation, in adults. An active metabolite of oxcarbazepine (same mechanism of action as carbamazepine), the only apparent advantage over oxcarbazepine is once daily dosing but this comes at a significant cost - 800mg tablets £154.20/30 tabs (usual dose: 800-1200mg daily). Action: May be useful where compliance with twice daily oxcarbazepine is poor but changes to therapy should be secondary care led (oxcarbazepine is classified green with specialist initiation locally).

Prasugrel (Efient): following on from the last edition, NICE has now issued guidance (TA182 Oct 09) which indicates that this new antiplatelet agent should be considered: • An option in combination with aspirin for patients who are treated by percutaneous coronary intervention (PCI) following ACS BUT that • this applies ONLY when they have had a ST-segment-elevation myocardial infarction (STEMI) OR •a blocked stent while on treatment with clopidogrel OR •have diabetes. The SPC recommends treatment continues for up to 12 months unless discontinuation is clinically indicated at an earlier time, perhaps due to side effects. Action: Locally prasugrel has been classified green with specialist initiation.

In need of a New Year’s (Prescribing) Resolution? Why not choose one (or all) of the top tips for cost-effective prescribing in our 2010 Medicines Management Team ‘selection box’! •To use simvastatin as my first choice statin (especially in primary CV prevention); •To use AIIRAs (sartans) only in patients truly intolerant of ACE-inhibitors; •To use omeprazole or lansoprazole gastro-resistant capsules as my first choice PPI; •To prescribe plain prednisolone tabs rather than EC; •To prescribe Mesren rather than Asacol; •To prescribe Matrifen rather than Durogesic or generic fentanyl patches; •To minimise my use of Grey Drugs; •To develop closer working relationship with local community pharmacists (possibly integrate MURs into the clinical medication review process).

Should generic clopidogrel be prescribed for ACS?

Better Care, Better Value (BCBV) Q1 2009 data is now available at www.productivity.nhs.uk (NHS Institute for Innovation & Improvement):

THE EAGERLY ANTICIPATED ‘SPECIALS’ BULLETIN WILL BE SENT OUT SHORTLY.

NHSK: positions shown as:national (out of 152 PCTs) & local (out of the 14 PCTs in Yorkshire & Humber SHA); £ = savings available if to level of top quartile of PCTs Q1 2009/10)

3rd Quarter (Q3) 2008

1st Quarter (Q1) 2009

Increasing low cost prescribing for lipid modification (% simvastatin/pravastatin as all statins, including ezetimibe combinations)

118th / 9th (70.2% v 79%)

£817,117

119th / 9th (70.3% v 79%)

£874,100

Increasing low cost PPI prescribing (%lansoprazole/omperazole as all PPIs)

130th / 8th (85% v 92%)

£315,790

132nd / 8th (85.6% v 92%)

£258,424

Increasing low cost prescribing for drugs affecting the renin-angiotensin system (% ACEI as all renin-angiotensin drugs)

127th / 14th (67.7% v 74%)

£388,933

128th / 14th (67.45% v 74%)

£383,013

Unfortunately it does not paint a very pretty picture for NHS Kirklees (NHSK): • relatively poor performance against all 3 of these high priority DOH prescribing cost-effectiveness indicators (compared with other PCTs both locally & nationally - see table below) and • only limited signs of improvement since our last look at this data (Q3 2008).

On a more positive note, the scope for LARGE COST SAVINGS remains (which could be vital in maximizing the number of patients who can be treated with these drugs in the current difficult economic climate) – target is to achieve level of top quartile of PCTs - REMEMBER: 1) These indicators are NOT about STOPPING prescribing they are about shifting it to agents of EQUAL EFFICACY but which are MORE COST-EFFECTIVE

2) Also that any improvement in the low cost lipid modification indicator will count towards practice achievement in the PBC local incentive scheme (LIS)!!!

Practice pharmacists/technicians can aid surgeries in initiating BCBV action including the most appropriate use of available national support materials (NPC at: http://www.npci.org.uk/reception_static.php#nsm). These cover all BCBV indicators but are due to be updated shortly. They include online and downloadable resources, and cover policy and guidance, therapeutics and implementation and monitoring at a local level.

Another useful resource re BCBV is the latest Prescribing Review by NHS Prescription Services (formerly PPA): ‘July - Sept 2009 ACE Inhibitors and AIIRAs’ (www.nhsbsa.nhs.uk/2953.aspx)

ACS was the most recent clopidogrel indication granted to Sanofi and is ‘restricted’ to branded Plavix for a period of time in the UK. It would seem unlikely that the antiplatelet activity of clopidogrel is any different in ACS (where generic clopidogrel is not licensed) compared to stable vascular disease (where it is) and the EMEA has indicated acceptance of the full bioequivalence of generic clopidogrel by granting Positive Opinions which included ACS on the continent. Although technically ‘off-label’ for ACS in the UK, prescribing generically for ALL indications (as ‘clopidogrel’) is:

- Unlikely to involve added risk- Likely to be less complicated for prescribers,

dispensers & patients alike- Likely to be a source of significant cost savings

as the DT price of generic clopidogrel drops (it is already 7% less than Plavix) – a factor which has to be taken into consideration in the current economic climate.

- A practice already adopted by a number of trusts/APCs nationally & locally.

We have received reports of community pharmacy requests for addition of an indication to clopidogrel prescriptions, advice is that this should NOT be done as it sets an inappropriate precedent re other drugs/conditions.

Page 2: Document

Produced by NHS Kirklees Medicines Management & Prescribing Team. This newsletter is available to download from the intranet: nww.kirklees.nhs.uk

The information contained in this newsletter is issued on the understanding it is the best available from the resources at our disposal at the time of going to print. For further information or to share any suggestions of your own please contact the Prescribing Team on 01484 344352.

More ‘Webbed Wonders’1) www.nelm.nhs.uk/en/Medicines-A-Z/Search/The prototype of the Medicines A-Z search engine has been launched on National electronic Library for Medicines (NeLM). The objective is that, for any particular medicine, you can see on a single web-page and be linked through to:

• relevant guidelines from NICE and CKS (formerly Prodigy);

• independent reviews undertaken by key organisations (eg UKMI, NPC, LNDG, SMC, AWMSG, MTRAC, DTB, Cochrane, DARE etc);

• key patient safety information (MHRA, EMEA and relevant systematic reviews from DARE – with possible extension to FDA in the future);

• clinically significant changes in product license; • relevant news and developments from their

news archive.Additionally users can link directly through to the relevant BNF monograph; SPC & PIL

2) http://trusttheevidence.net has the tag line ‘Discover the truth behind the research findings that affect everyday healthcare’. The site is funded by the Oxford based Centre of Evidence Based Medicine (CEBM) and is intended for anyone interested in evidence-based medicine.

3) http://www.sussexpartnership.nhs.uk/services-and-information/medication/professionals/documents/prescribing-and-related-guidance/?p=2

Although not official NHSK guidance, the Sussex Partnership NHS Foundation Trust have produced: ‘Behavioural problems in older people, management guidelines’ which may be a useful resource, particularly when auditing antipsychotic use in patients with dementia.

4) www.prescriber.org.uk/benzo_conversion.phpBenzodiazepine Converter: this spreadsheet application calculates conversion (to diazepam) and reduction schedules (based on 7 or 14 day intervals) for patients reducing and stopping benzodiazepine & Z-drug treatments. A disclaimer indicates: ‘The reduction schedules should be checked before treatment is changed and reductions should be supervised by a healthcare professional’ - it should also be noted that suggested reduction is at maximum recommended rate (speed should be determined by the patient and may need to be slower – some patients may prefer reduction based on the original drug).

5) www.nelm.nhs.uk/en/NeLM-Area/Health-In-Focus/NICE-Bites-December-0911/

NICE Bites – latest edition of this monthly bulletin (which handily summarises key prescribing points from NICE guidance) contains a table of contents with web links for all the 2009 editions.

Top 6 Medicines Management News Items Hit Parade: Our attempt to present (as concisely as possible and in no particular order) a selection of the rest of the more newsworthy ‘stories’ since our last edition:1. Ongoing controversy on whether aspirin has a role in PRIMARY CV prevention (including in

diabetes) – the PCT is currently assessing the evidence-base/seeking specialist advice with respect to diabetes, but MHRA comment (Drug Safety Update Oct 09) can be found at: http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON059804 and further info at: http://www.npci.org.uk/blog/?p=359 . Bottom-line: aspirin is NOT licensed for primary CV prevention and the risk of having a major bleed is likely to outweigh any benefit of treatment.

2. Risk of hospital admission for bleeding in patients with acute MI increases with the number of antithrombotics (aspirin, clopidogrel & vitamin K antagonists (VKA) e.g. warfarin) used - not rocket science perhaps and with the inherent limitations of an observational study (offset by a large sample size: 40,812 patients), but in the absence of prospective trials, data which underlines the need for careful selection of anti-thrombotic drug combinations based on individual patient characteristics (especially in the elderly or others at already heightened GI risk) – NB asp + clopi should NOT be used in preference to clopi alone based on this data.

Antiplatelet therapy : Lancet 2009; 374: 1967-74 *

Asp Clopi VKAAsp + Clopi

Asp + VKA

Clopi + VKA

Asp + VKA + Clopi

Yearly bleeding incidence (%)

2.6 4.6 4.3 3.7 5.1 12.3 12

* www.thelancet.com/journals/lancet/article/PIIS0140-6736(09)61751-7/abstract

3. Additions to the list of adverse effects (ADRs) associated with STATIN use: sleep disturbances, memory loss, sexual dysfunction, depression and very rarely interstitial lung disease (leading to breathing problems) to be added to SPCs – based on a Europe-wide review of clinical trial data, ADR reports & published literature on the statins conducted by MHRA (see Nov 09 Drug Safety Update: http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON062553). Balance of risks and benefits of statins as a class remains positive, but healthcare professionals should be aware of the updated safety information.

4. Silver-donating antimicrobial dressings no more effective than non-silver low-adherence dressings in the treatment of venous leg ulcers (VULCAN randomised controlled trial in British Journal of Surgery Vol 96, Issue 10 (Oct 09) see: http://www.npci.org.uk/blog/?p=796). Neither primary (healing rate at 12 wks) nor secondary outcomes (assessing time to healing, quality of life and cost-effectiveness) were significant. Although there were some areas for methodological criticism, the results are consistent with recent systematic reviews that have failed to find any evidence of benefit with antimicrobial dressings. Higher costs were associated with use of silver dressings (average of £97.85 per patient). The authors therefore concluded that clinicians should use the ‘‘least expensive, inert dressings beneath compression therapy as standard care’.

5. Use of a Mediterranean-style diet (<50% of calories from carbohydrates and at least 30% from fat mainly as olive oil) in newly diagnosed type 2 diabetes delayed the need for hypoglycaemic drug therapy compared to a high carbohydrate low fat diet (<30% of calories from fat). It was also associated with greater weight loss and some improvement in cardiac risk factors. Ann Intern Med 2009; 151 306-14 (http://www.annals.org/content/151/5/306.abstract)

6. Controversy/investigation is ongoing into a potential link between cancer and long-acting human insulin analogue use - in particular insulin glargine (Lantus) - but the EMEA has advised that no changes to prescribing advice are necessary at present. Too much of a good thing?: Prescribing data suggests extensive use of insulin analogues despite NICE advice that they should be reserved for specific patient circumstances and NOT used routinely (≈ 1.2 million items of insulin glargine & 400,000 items of insulin detemir annually based on QE Dec 08 = ≈ 40% of ALL intermediate/long-acting insulin items in England). Whether or not the cancer link is confirmed, given that the costs per Quality Adjusted Life Year (QALY) are so large for these agents, prescribers may wish to review if their use is in line with NICE guidance (CG 15 updated Jun 09 & CG 87 May 09).

Is there a ‘smoking gun’ for your patient’s ADR? MHRA have highlighted how a patient’s smoking status may affect prescribing decisions due to clinically significant interactions with medicines (Drug Safety Update Oct 09 – http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON059804).

Antibiotic Prescribing (it can be très (C).Difficile!): • Although all antibiotics are able to pre-dispose a patient to C. Difficile superinfection, highest risk

is associated with quinolones, clindamycin and cephalosporins – please only prescribe these agents as indicated in the local antimicrobial guidelines (currently being updated – due Feb 2010: http://intranet.cht.nhs.uk/formulary/Web-Formulary_Files/Guidelines/APC/Primary%20Care%20Antibiotics.htm *).

• Prescribers are reminded of the need for care in choice of both antibiotic (AB) and preparation e.g. prescribing ORAL vancomycin purely on the basis of lab sensitivity for systemic/skin infections (e.g. MRSA) is pointless as vancomycin is NOT absorbed from the gut (the injectable form would be required - if considered necessary). [In contrast, for a GIT-only infection (C.Difficile), oral vancomycin is effective BUT locally oral metronidazole is preferred - see guidelines*].