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Issue 17, July 2015 Current Issues............................................................................................................................................................................. 1 Topic of the Month ..................................................................................................................................................................... 1 Drug Tariff .................................................................................................................................................................................. 3 Safety ......................................................................................................................................................................................... 5 Current Issues Prescription requirement changes for temazepam As of 1st June 2015, prescriptions for temazepam must fully comply with the prescription writing requirements for Schedule 3 controlled drugs. Prescriptions for temazepam must now contain the following information: dose form strength (where appropriate) total quantity of the preparation in both words and figures Topic of the Month STRONG OPIOIDS AND TRANSDERMAL PATCHES Strong opioids Pain can be mild, moderate or severe. It can be treated using different strengths of painkiller, depending on the level of pain experienced by the patient. The World Health Organisation (WHO) Pain Ladder(1) shows each level of pain and the type of painkillers that are best to control it: 1. Mild pain - Step one includes non-opioid drugs e.g. paracetamol and anti-inflammatory drugs (ibuprofen, naproxen). 2. Moderate pain - Step two includes weak opioid drugs e.g. dihydrocodeine, codeine phosphate or tramadol. 3. Moderate to severe pain - Step three includes strong opioid drugs e.g. morphine, fentanyl and oxycodone. Adjuvant drugs such as anti-depressants or anti-consultants may also be used to control pain. Pain management When starting a painkiller remember: Mouth - use the oral route where possible, even for opioids. By the clock - for persistent pain, provide medication at regular set intervals (around the clock) rather than when required. Use the WHO Pain Ladder (see diagram). 1 WHO Pain Ladder Key Messages Oral analgesics are generally preferred as first line therapy in chronic non-cancer pain. Buprenorphine patches at lower doses (BuTrans®) are broadly as effective as codeine or tramadol but are much more expensive. NICE guidance recommends oral morphine as the first-line strong opioid for palliative care(2). Buprenorphine patches cost several times more than oral morphine in equivalent doses. The patches are unsuitable for acute or unstable pain due to the need for slow titration of doses; it may take up to 72 hours to achieve a stable blood level after a change in dose. Patches containing buprenorphine (Transtec®, BuTrans®) are an alternative to oral opioid analgesics. Buprenorphine patches are generally not recommended as a first-line analgesic and should not be used for unstable pain. Analgesic patches are considerably more expensive than oral therapy. Circumstances when patches may be considered preferable to oral products include if the patient: • • • • • has difficulty/inability to swallow, or the oral route is inappropriate is intolerant of oral analgesics or is experiencing unacceptable side-effects with oral analgesics has poor absorption from the gastrointestinal tract has renal impairment has compliance problems – supervised patch changes will assist this. Cost of patches (28 days)3 Buprenorphine 5mcg/hr (BuTrans®) Buprenorphine 10mcg/hr (BuTrans®) Buprenorphine 20mcg/hr (BuTrans®) Buprenorphine 35mcg/hr (Trantec®) Buprenorphine 52.5mcg/hr (Transtec®) Buprenorphine 70mcg/hr (Transtec®) - £17.60 - £31.55 - £57.46 - £27.65 - £41.49 - £55.30 2 Prescribing data Prescribing data for buprenorphine patches in the last year (April 14- March 15): Wirral spent a total of £113,346 on buprenorphine patches; 10% of this cost was as a result of prescribing the weaker strength patch BuTrans®, which has a similar analgesic effect to co-codamol or tramadol. References: 1. World Health Organization (2009). WHO’s Pain Relief Ladder www.who.int/cancer/palliative/painladder/en/ 2. NICE CG140 Opioids in palliative care: safe and effective prescribing of strong opioids for pain in palliative care of adults. http://publications.nice.org.uk/opioids-in-palliative-care-safe-and-effective-prescribing-of-strong-opioids-for-pain-in-palliativecg140/recommendations 3. Drug Tariff online July 2015 Drug Tariff PRICE CHANGES Top 10 monthly price reductions Methyldopa 125mg tablets [1 x 56] £116.27 (-£4.99) Dexamethasone 500microgram tablets [1 x 28] £58.83 (-£4.59) Aripiprazole 30mg tablets [1 x 28] £177.85 (-£3.56) Aripiprazole 10mg tablets [1 x 28] £88.93 (-£1.78) Aripiprazole 15mg tablets [1 x 28] £88.93 (-£1.78) Aripiprazole 5mg tablets [1 x 28] £88.93 (-£1.78) Isradipine 2.5mg tablets [1 x 56] £185.64 (-£1.63) Dexamethasone 10mg/5ml oral solution sugar free [1 x 150] £96.05 (-£1.61) Famciclovir 500mg tablets [1 x 14] £154.04 (-£1.08) Ibuprofen 10% gel [1 x 100] £4.92 (-£0.87) Top 10 monthly price increases Nitrofurantoin 25mg/5ml oral suspension sugar free [1 x 300] £260.46 (+£64.63) Trifluoperazine 1mg/5ml oral solution sugar free [1 x 200] £65.73 (+£32.87) Ampicillin 250mg/5ml oral suspension [1 x 100] £38.86 (+£31.47) Triamterene 50mg capsules [1 x 30] £41.90 (+£13.98) Amantadine 50mg/5ml oral solution sugar free [1 x 150] £103.25 (+£13.95) Chloral hydrate 143.3mg/5ml oral solution BP [1 x 150] £194.06 (+£13.45) Disopyramide 150mg capsules [1 x 84] £27.58 (+£8.82) Cloral betaine 707mg tablets [1 x 30] £110.06 (+£7.53) Prochlorperazine 3mg buccal tablets [1 x 50] £23.98 (+£5.76) Gentamicin 0.3% / Hydrocortisone acetate 1% ear drops [1 x 10] £11.98 (+£5.32) Top 100 annual price reductions http://www.panmerseyapc.nhs.uk/home/tariff_watch/partviiia_reductions_201506.pdf Top 100 annual price increases http://www.panmerseyapc.nhs.uk/home//tariff_watch/partviiia_increases_201506.pdf DRUG AVAILABILITY Drugs with long-term supply issues The following drugs have long-term supply issues. The table below shows the reason for the supply issue, where known, and possible return to stock dates. 3 Description Anusol Hc® suppositories x12 and x24 (Johnson & Johnson) Aptamil® lactose free milk powder x400g (Danone Nutricia) Caverject® Dual Chamber 20micrograms x2 (Pfizer) Colofac® tablets 135mg x100 (Bgp Products) Co-phenotrope tablets 2.5/0.025mg x100 (Amco Rwa / Mercury Pharma) Creon® 40 000 capsules x100 (Abbott Healthcare) Diclofenac sodium ec tablets 50mg (various makes) Freestyle® blood glucose test strips x50 (Abbott) Genticin® eye/ear drop 0.3% x10ml (Amco / Amdipharm) Hormonin® tablets x84 (Amco Rwa / Mercury Pharma) Methotrexate tablets 2.5mg x24 (Various brands) Modrasone® cream x50g (Teva) Due date Comment Supplier unable to confirm Manufacturing issue is causing a delay in supply Supplier unable to confirm Stock on allocation from supplier. January 2016 Supplier unable to confirm July 2015 January 2016 Supplier unable to confirm Limited supplies ongoing Supplier unable to confirm Limited supplies ongoing October 2015 July 2015 Sno Tears®eye drops 10ml (Bausch & Lomb) Supplier unable to confirm Synalar® cream x30g (Derma UK) Supplier unable to confirm Synalar® cream 1:4 x50g (Derma UK) Supplier unable to confirm Traxam® gel 3% x100g (Amco Rwa / Mercury Pharma) Traxam® pain relief gel x30g (Amco Rwa / Mercury Pharma) Unistik® 3 comfort lancet 28G X 1. 8mm x100 (Owen Mumford) Unilet® C touch lancets 28Gx0.38mm 100 VitA-POS® eye ointment x5g (Scope Opthalmics) Zidoval® vaginal gel 0.75% x40g (Meda Pharma) Zacin® cream 0.025% x45g (Teva) Manufacturing issue is causing a delay in supply. Medical Information Enquiries 0845 608 8866 Manufacturing issue is causing a delay in supply Supplier issue is causing a delay in supply. Manufacturing issue is causing a delay in supply. Market shortage is causing a delay in supply. Ongoing supply issue. Manufacturing issue is causing a delay in supply Supplier issue is causing a delay in supply Market shortage is causing a delay in supply Manufacturing issue is causing a delay in supply Manufacturing issue is causing a delay in supply Manufacturing issue is causing a delay in supply Manufacturing issue is causing a delay in supply February 2016 Supplier issue is causing a delay in supply February 2016 Supplier issue is causing a delay in supply July 2015 Supplier issue is causing a delay in supply Supplier unable to confirm Supplier issue is causing a delay in supply Supplier unable to confirm Supplier issue is causing a delay in supply August 2015 Supplier issue is causing a delay in supply Supplier unable to confirm Manufacturing issue is causing a delay in supply 4 Zovirax® 3% eye ointment supply problems There is a supply problem with Zovirax® 3% eye ointment (aciclovir 3% eye ointment) following a recall of contaminated batches in November 2014. Although supplies were due to resume in April 2015, there are still very limited stocks available. UK licensed treatment options for managing herpes simplex keratitis are: • Ganciclovir 0.15% eye gel (Virgan®) – licensed for the treatment of acute herpetic keratitis (dendritic and geographic ulcers), given as ‘one drop five times daily’ until epithelial healing occurs. Treatment should not exceed 21 days. • A treatment course of oral aciclovir 400mg 5 times a day for 10 to 14 days. UK Medicines Information (UKMi) have issued the following guidance: http://www.medicinesresources.nhs.uk/en/Communities/NHS/SPS-E-and-SE-England/MedicinesInformation/Discontinuation-Supply-Shortage-Memos/Shortage-of-Zovirax-eye-ointment-3/ Creon® 40 000 capsules supply problems The manufacturer has stated that due to a lower than expected yield for this biological enzyme, there are supply constraints with the 40 000 strength of Creon® and they don’t have a stock availability date. However this should not impact on patient care as there is ample stock of the 10 000 and 25 000 strengths of Creon®. Patients who are prescribed Creon® 40 000 supplements should be switched to alternative strengths to ensure continuity of supply. Discontinued products- Co-danthramer (dantron/poloxamer 188 25mg/200 mg) and strong co-danthramer (dantron/ poloxamer 188 37.5mg/500 mg) capsules These have been discontinued by Napp. Stock of co-danthramer capsules is expected to last until the end of June 2015 and stock of strong co-danthramer capsules until the end of December 2015. Alternative suspension formulations of co-danthramer are available. For further information regarding supply problems, please contact Medicines Information. Safety Can breastfeeding mothers take paracetamol? Paracetamol has been widely used on prescription and over-the-counter since it launched in the UK in 1956. Paracetamol can be given therapeutically to infants (including premature infants from 28 weeks corrected gestational age) at a dose of 10-15mg/kg body weight every 8-12 hours for pain and pyrexia. It is also given to infants for post-immunisation pyrexia. Although paracetamol is widely used, the evidence for its safety in breastfed infants is based on mainly small, uncontrolled studies of single doses of paracetamol. However, it is considered to be compatible with breastfeeding and there appears to be no significant risk to the infant. There is a risk to the infant of hypersensitivity from low levels of exposure to paracetamol or its metabolites but it remains the choice of analgesia for breastfeeding mothers. Paracetamol has a relatively short half-life in adults of approximately two hours and the quantity of drug which passes in to the breast milk is very small. If the infant is pre-term, has a low birth weight or has an underlying medical condition, then further advice should be sought as it may affect the disposition and excretion of the drug. Full details are available from this link; http://www.evidence.nhs.uk/Search?q=%22Can+breastfeeding+mothers+take+paracetamol%22 5 MHRA DRUG SAFETY UPDATE SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin): risk of diabetic ketoacidosis Sodium glucose co-transporter 2 (SGLT2) inhibitors are licensed for use in adults with type 2 diabetes to improve glycaemic control. Serious and life-threatening cases of diabetic ketoacidosis (DKA) have been reported in patients taking SGLT2 inhibitors (canagliflozin, dapagliflozin or empagliflozin). When treating patients who are taking an SGLT2 inhibitor: test for raised ketones in patients with symptoms of diabetic ketoacidosis (DKA); omitting this test could delay diagnosis of DKA if you suspect DKA, stop SGLT2 inhibitor treatment if DKA is confirmed, take appropriate measures to correct the DKA and to monitor glucose levels inform patients of the symptoms and signs of DKA e.g. nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness. Advise them to get immediate medical help if these occur be aware that SGLT2 inhibitors are not approved for treatment of type 1 diabetes please continue to report suspected side effects to SGLT2 inhibitors or any other medicines on a Yellow Card Full details are available from this link https://www.gov.uk/drug-safety-update/sglt2-inhibitors-canagliflozin-dapagliflozin-empagliflozin-risk-of-diabeticketoacidosis Medicines Management Team contacts: Victoria Vincent (Wirral) [email protected] 0151 643 5319 For any feedback or suggestions on content, please email [email protected] 6