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Issue 2, February 2014 Halton ........................................................................................................................................................................................ 1 Pan Mersey Area Prescribing Committee ................................................................................................................................... 2 Current Issues............................................................................................................................................................................. 4 Drug Tariff .................................................................................................................................................................................. 5 Safety ......................................................................................................................................................................................... 6 Halton NEWS Past Prescribing Incentive Scheme monies As the end of the financial year approaches please ensure you have claimed for any outstanding incentive scheme monies from financial years 11/12 and 12/13 by 31st March 2014. Please contact the medicines management team if you are unsure of how much you have outstanding. Fentanyl Patches to be prescribed as Fencino brand It has now been agreed that Halton CCG will start to prescribe fentanyl patches as the brand Fencino first line, with the view to switching all generic scripts over to Fencino and look at switching Durogesic D Trans to Fencino where appropriate. Fencino is the cheapest available Fentanyl patch on the market, all local hospitals are able and willing to hold stocks. There are no supply issues, the manufacturer guarantees that all the major wholesalers will have ample stock, and prices are guaranteed. Fencino patches are bio-equivalent to Durogesic DTrans. A prescription written as the generic ‘fentanyl patch’ can result in either a reservoir or a matrix style patch being dispensed and therefore largely depends on what product the pharmacist has in stock. As a result of this there have been a large number of patient safety incidents reported to NHS England and therefore CQC and NICE support the branded prescribing of Fentanyl patches. Fencino are a matrix patch and so carry less risk of accidental overdose and offer less potential for abuse than the reservoir system. Potential annual savings for Halton CCG assuming 100% switch to Fencino patches£27,000. Your medicines management team will be in touch in the next few weeks to discuss support regarding this project. The team will also ensure that local community pharmacies are made aware of the project before it is rolled out within each practice. Quetiapine modified release – 5 Boroughs Partnership (5BP) Drug and Therapeutics Committee statement Since the patent for Seroquel® expired in 2012, generic quetiapine has been available in two dosage forms: immediate release (IR) and modified release (MR). Routinely, the IR formulation is administered twice daily, and the MR formulation once daily. There is a significant, 30-fold difference in price (Drug Tariff January, 2014): • Quetiapine IR 300mg tablet £0.09 per tablet • Quetiapine MR 300mg tablet £2.83 per tablet In response to this, the 5BP Medicine Management Committee has approved guidance to ensure that quetiapine MR is only prescribed where appropriate. This guidance can be summarised as follows: • The quetiapine IR formulation must be routinely prescribed / recommended as per the Trust formulary. • The MR formulation to be reserved for rapid treatment initiation only. • If the MR formulation is initiated, then patients to be switched to the IR formulation once considered stable. • Switching not to be made mandatory as clinicians are reminded to consider the needs of individual patients when considering a switch. • If, when reviewed, the continued use of quetiapine MR is deemed appropriate, this should be clearly documented in the medical notes AND in GP correspondence (Form 8M / Discharge letter). Failure to notify the GP is likely to result in a request for clarification • The information in the guidance can also be used by the clinicians at 5BP to consider a switch for patients who are currently stable on quetiapine MR where appropriate Action: The Medicines Management Team plans to review prescribing of quetiapine MR early in 2014/15 to ensure stable patients are being reviewed and have been considered for a switch to quetiapine IR tablets. Pan Mersey Area Prescribing Committee RECOMMENDATIONS Fluocinolone acetonide intravitreal implant (Iluvien®▼) The Pan Mersey APC recommends fluocinolone acetonide intravitreal implant (Iluvien®▼) as an option for treating chronic diabetic macular oedema (DMO) only in line with NICE TA301. http://www.panmerseyapc.nhs.uk/recommendations/documents/PS35.pdf Ranibizumab 10mg/ml solution for intravitreal injection (Lucentis®▼) in choroidal neovascularisation The Pan Mersey APC recommends the prescribing of ranibizumab 10mg/ml solution for intravitreal injection (Lucentis®▼) as an option for treating visual impairment due to choroidal neovascularisation only by ophthalmologists experienced in the use of intravitreal injections and in accordance with NICE TA298. 2 http://www.panmerseyapc.nhs.uk/recommendations/documents/PS34.pdf Lixisenatide solution for injection (Lyxumia®▼) in combination with insulin The Pan Mersey APC recommends the prescribing of lixisenatide solution for injection (Lyxumia®▼) in combination with insulin for the management of type 2 diabetes mellitus following specialist initiation or recommendation ONLY WHERE BOTH EXENATIDE AND LIRAGLUTIDE ARE UNSUITABLE, NOT TOLERATED OR PRESCRIBING WOULD BE OUTSIDE OF THEIR PRODUCT LICENCES. http://www.panmerseyapc.nhs.uk/recommendations/documents/PS33.pdf Azithromycin in COPD The Pan Mersey APC recommends the prescribing of Azithromycin in COPD at the request of respiratory specialists for the prevention of exacerbations in COPD and bronchiectasis in selected high risk patients. http://www.panmerseyapc.nhs.uk/recommendations/documents/PS9.pdf Additional strength of Triptorelin The Pan Mersey APC recommends the addition of 22.5mg injection to the formulary in addition to the 11.25mg strength injection. http://www.midmerseymmb.nhs.uk/recommendations/documents/11_63_triptorelin_201111.pdf Bitmaprost with Timalol single dose eye drops (Ganfort®) The Pan Mersey APC recommends the prescribing of Bitmaprost with Timalol (Ganfort®) preservative free eye drops in addition to non-preservative free products when requested by a specialist. http://www.panmerseyapc.nhs.uk/formulary/documents/11-00-00_eye.pdf Renavit for renal dialysis The Pan Mersey Area Prescribing Committee recommends the use of Renavit (Vitamin B complex and C water soluble Vitamins) for vitamin supplementation in renal dialysis. http://www.panmerseyapc.nhs.uk/formulary/documents/09-00-00_nutrition_blood.pdf Finasteride tablets The Pan Mersey APC recommends finasteride as the 5-alpha reductase inhibitor of choice for men with lower urinary tract symptoms (LUTS) who have prostates estimated to be larger than 30 g or a PSA level > 1.4 nanogram/mL, and who are considered to be at high risk of progression (for example, older men). http://www.panmerseyapc.nhs.uk/recommendations/documents/PS36.pdf Lixisenatide injection (Lyxumia®▼) The Pan Mersey Area Prescribing Committee recommends the prescribing of lixisenatide injection (Lyxumia®▼) for the treatment of adults with type 2 diabetes mellitus ONLY WHEN BOTH EXENATIDE AND LIRAGLUTIDE ARE UNSUITABLE OR NOT TOLERATED and in accordance with the recommendations in NICE Clinical Guideline 87 and NICE TA203. http://www.panmerseyapc.nhs.uk/recommendations/documents/PS32.pdf Clopidogrel for prevention of occlusive vascular events The Pan Mersey Area Prescribing Committee recommends the prescribing of Clopidogrel for prevention of Transient Ischemic Attacks which is not covered in the NICE TA as it is an unlicensed indication. http://www.panmerseyapc.nhs.uk/guidelines/documents/G3.pdf Levonorgestrel Emergency Hormonal Contraception (Upostelle®) The Pan Mersey Area Prescribing Committee recommends the prescribing of the Upostelle as Emergency Hormonal Contraception. http://www.panmerseyapc.nhs.uk/formulary/documents/07-00-00_obs_gynae_ut.pdf Linaclotide for Irritable Bowel Syndrome The Pan Mersey Area Prescribing Committee recommends that LINACLOTIDE (Constella®▼) is considered as an alternative second line treatment option to tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs) in adults with moderate to severe IBS-C, who do not respond adequately to or cannot tolerate an adequate trial of first-line treatment with antispasmodic agents and/or laxatives. Although linaclotide is specifically licensed for IBS-C, it has been positioned second line due to a lack of evidence against other therapies recommended first line in the NICE guidelines for IBS, its black triangle status and cost. http://www.panmerseyapc.nhs.uk/recommendations/documents/PS18.pdf Antimicrobial guidance and management of common infections in Primary care The Pan Mersey Area Prescribing Committee has reviewed and consolidated Mid Mersey and North Mersey antimicrobial guidelines incorporating them into one document. This document has been ratified however the section on Urinary Tract Infections is still undergoing discussion and is not yet included. Prescribers should continue to follow previous published guidance on antibiotics in UTIs until superseded. http://www.panmerseyapc.nhs.uk/formulary/documents/05-00-00_infections.pdf Current Issues NEWS New product: Noyada® (captopril) 5mg/5ml and 25mg/5ml oral solution The UK’s first licensed oral solution formulation of captopril has been launched for use in heart failure, hypertension, type I diabetic nephropathy and post myocardial infarction. QUERY CORNER If a patient with COPD needs codeine for pain relief can a low dose be used with caution? The BNF states that opiates should be used with caution in patients with impaired respiratory function - avoided in COPD and acute asthma attacks. Patient information leaflets for both the 8mg and 30mg strengths of co-codamol advise patients not to take if they have asthma or any other breathing problems. The American Hospital Formulary Service Drug Information text states that ‘respiratory depression is produced even with therapeutic analgesic doses of opiate agonists, but it is not usually clinically important in patients with normal respiratory capacity. The drugs should be used in extreme caution, if at all, in cor pulmonale, bronchial asthma, chronic pulmonary disease and in others with substantially decreased respiratory reserve’1. Consideration also needs to be given to the metabolism of codeine which is via CYP2D6. Genetic polymorphism of CYP2D6 means that although the majority of the population are ‘extensive metabolisers’ of codeine and convert 104 20% of the dose to morphine, ‘ultrarapid metabolisers’ (1-3% Northern Europeans, 10-30% North East Africans/Ethiopians) convert over 70%, and 5-10% caucasians are ‘poor metabolisers’ and experience no analgesic effect at all. Since this variability in the population is impossible to predict, caution is probably justified in the use of codeine in COPD although several small scale studies and a recent national prospective study of benzodiazepines and opiates in very severe respiratory disease2 have found no serious adverse events. 1. American Hospital Formulary Service Drug Information reference 2. Ekstrom M.P. et al. Safety of benzodiazepines and opioids in very severe respiratory disease: national prospective study. BMJ 2014;348:445 (published 30 January 2014) Acknowledgements to NW Medicines Information for their valuable contribution to this query Drug Tariff PRICE CHANGES Ondansetron prices Please note the variation in prices between the different formulations of ondansetron: Ondansetron 4mg tablets x 10 = £1.88 Ondansetron 8mg tablets x 10 = £37.06 Ondansetron 4mg oral lyophilisates sugar free x 10 = £35.97 Ondansetron 8mg oral lyophilisates sugar free x 10 = £71.94 Ondansetron 4mg orodispersible tablets x 10 = £37.76 Ondansetron 8mg orodispersible tablets x 10 = £75.53 Top ten price reductions since Dec 2013 Memantine 20mg tablets [1 x 28] £42.27 (-£26.05) Rizatriptan 10mg tablets [1 x 3] £1.58 (-£11.79) Isradipine 2.5mg tablets [1 x 56] £26.44 (-£11.03) Indapamide 2.5mg tablets [1 x 28] £3.88 (-£10.10) Nitrofurantoin 50mg tablets [1 x 28] £28.26 (-£9.85) Disopyramide 150mg capsules [1 x 84] £18.76 (-£8.82) Riluzole 50mg tablets [1 x 56] £51.35 (-£7.81) Isosorbide mononitrate 20mg tablets [1 x 56] £7.84 (-£6.69) Amantadine 100mg capsules [1 x 56] £3.30 (-£6.60) Isosorbide mononitrate 10mg tablets [1 x 56] £8.09 (-£4.44) Top ten price increases since Dec 2013 Trazodone 100mg capsules [1 x 56] £28.69 (+£10.96) Carbimazole 20mg tablets [1 x 100] £103.62 (+£8.00) Rivastigmine 2mg/ml oral solution sugar free [1 x 120] £95.77 (+£7.47) Sodium feredetate 190mg/5ml oral solution sugar free [1 x 500] £9.95 (+£5.13) Trazodone 150mg tablets [1 x 28] £18.59 (+£4.40) Ranitidine 300mg effervescent tablets [1 x 30] £18.26 (+£4.18) Ranitidine 150mg effervescent tablets [1 x 60] £18.27 (+£4.18) Primidone 250mg tablets [1 x 100] £39.21 (+£3.97) Modafinil 200mg tablets [1 x 30] £117.77 (+£3.60) Primidone 50mg tablets [1 x 100] £32.86 (+£3.32) Top 100 annual price reductions Top 100 price reductions since Jan 2013 http://www.panmerseyapc.nhs.uk/home/tariff_watch/partviiia_reductions_201401.pdf Top 100 annual price increases Top 100 price increases since Jan 2013 http://www.panmerseyapc.nhs.uk/home//tariff_watch/partviiia_increases_201401.pdfTop ten monthly price DRUG AVAILABILITY Senna tablets Due to supply problems with senna 7.5mg tablets, the price has increased from £2.83 for 60 tablets in January 2013 to £12.64 in February 2014. This represents a significant increase in spend for practices. Consider using bisacodyl 5mg tablets, an alternative stimulant laxative (£2.47 for 60 tablets) at the same dosing frequency as you would have used for senna. Other cost effective options include senna liquid (£2.69/500ml) or docusate 100mg capsules, which has both a stimulant and softening action and currently costs £2.09 for 30 capsules. Metformin 850mg and all strengths of valsartan NCSO has not yet been applied to metformin 850mg and all strengths of valsartan, although there are supply issues depending on wholesaler used. You may be asked to change prescriptions to the brand or other strengths/formulations to accommodate continued patient supply and avoid the pharmacy not being fully reimbursed. This is in line with the Pharmaceutical Services Negotiating Committee (PSNC) guidance which can be found under Frequently Asked Questions section at: http://psnc.org.uk/dispensing-supply/supply-chain/generic-shortages Action: these patients will need individual review to establish the most appropriate alternative. No Cheaper Stock Obtainable (NCSO) for February 2014 The following generic drugs have supply issues and are incurring increased costs. Please consider this before prescribing. Contact your Medicines Management Team for further advice on suitable alternatives. Note: gabapentin is still considerably less expensive than pregabalin. • Amiloride 5mg tablets (28) – £20.61 • Co-amoxiclav 250/125 tablets (21) – £3.50 • Co-amoxiclav 500/125 tablets (21) – £7.17 • Gabapentin 100mg capsules (100) – £5.00 • Gabapentin 300mg capsules (100) – £10.00 • Mebeverine 135mg tablets (100) – £18.00 • Prednisolone 5mg tablets (28) – £1.94 • Propranolol 10mg tablets (28) – £5.80 • Propranolol 40mg tablets (28) – £5.70 • Propranolol 80mg tablets (56) – £6.50 Safety Rosuvastatin: Crestor® all strengths Peripheral neuropathy has been added as a side effect. 6 Cosopt® (dorzolamide/timolol) preservative-free eye drops From 10th February 2014 a new interim container will be available for Cosopt® preservative-free eye drops, following safety concerns about the design of the current dropper which has a winged tip. Interface issues – reporting form The Pan Mersey APC safety sub-group has created a single form and logging system for interface problems related to medicines that have been identified by healthcare professionals and staff in the Pan Mersey area. Interface issues are any issues that may cause a problem in the medicines management of patients between different organisations. http://www.panmerseyapc.nhs.uk/safety.html http://www.panmerseyapc.nhs.uk/safety/interface_form.html Risk of Hypothermia in patients receiving continuous renal replacement therapy Following three recently reported patient safety incidents, including one fatality, this alert has been issued to warn that it is never safe to use continuous renal replacement therapy equipment without a fluid warmer even for short periods. https://www.cas.dh.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=102110 MHRA DRUG SAFETY UPDATES (JANUARY & FEBRUARY 2014) Prasugrel (Efient®): increased risk of bleeding—information on timing of loading dose New clinical trial information is available on the timing of the loading dose of prasugrel when used in patients with unstable angina or non-ST elevation myocardial infarction. In these patients, when coronary angiography is done within 48 hours after admission, the loading dose should only be given at the time of percutaneous coronary intervention. http://www.mhra.gov.uk/Safetyinformatio ... /CON364156 Ofatumumab: screen for hepatitis B virus before treatment All patients should be screened for hepatitis B virus infection before starting treatment with ofatumumab. Patients with active infection with this virus should not be treated with ofatumumab. http://www.mhra.gov.uk/Safetyinformatio ... /CON364166 Temozolomide: risk of hepatic injury, including fatal hepatic failure—updated warnings and monitoring guidance Hepatic injury, including hepatic failure with fatal outcome, has been reported in patients treated with temozolomide. Liver function should be tested before and during treatment with temozolomide. http://www.mhra.gov.uk/Safetyinformatio ... /CON364167 Capecitabine: risk of severe skin reactions—discontinue treatment Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported during treatment with capecitabine. Some cases were fatal. http://www.mhra.gov.uk/Safetyinformatio ... /CON364168 Cetuximab: importance of establishing wild type RAS (KRAS and NRAS) status before treatment of metastatic colorectal cancer In the treatment of metastatic colorectal cancer, inferior overall survival, progression-free survival, and objective response rates have been shown in people with RAS mutations (at exons 2, 3, and 4 of KRAS and NRAS) who received cetuximab in combination with FOLFOX4 (oxaliplatin-containing) chemotherapy versus FOLFOX4 alone. Cetuximab is now indicated for the treatment of people with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer in combination with irinotecan or oxaliplatin based chemotherapy or as a single agent. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON377644 Combined hormonal contraceptives and venous thromboembolism: review confirms risk is small—consider risk factors and remain vigilant for signs and symptoms The conclusions of the Europe-wide review were: • the risk of blood clots with all low-dose CHCs is small • there is good evidence that the risk of venous thromboembolism (VTE) may vary between products, depending on the progestogen • CHCs that contain levonorgestrel, norethisterone, or norgestimate have the lowest risk of VTE • the benefits of any CHC far outweigh the risk of serious side effects 8 • prescribers and women should be aware of the major risk factors for thromboembolism, and of the key signs and symptoms http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON377645 Abraxane (paclitaxel, formulated as albumin-bound nanoparticles): potential presence of strands in intravenous infusion bag—if visible, filtration advised There have been reports from Europe of thin, translucent or white-to-yellow proteinaceous strands (1–2 mm in length) being observed during visual inspection of bags of reconstituted paclitaxel suspension for intravenous infusion.There is no evidence of an increased risk of any adverse effect in patients treated with Abraxane containing strands. However, as a precaution we are advising that Abraxane with visible strands should be filtered http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON377646 The Halton Medicines Management Team is available from Monday to Friday between 9:00am and 5:00pm on 01928 593 452. The team also have a new generic email address that you can use to communicate with us [email protected]