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Issue 7, July/ August 2014 News .......................................................................................................................................................................................... 1 Current Issues............................................................................................................................................................................. 2 QIPP Key Messages: Minocycline ............................................................................................................................................... 4 Topic of the month: Diabetes ..................................................................................................................................................... 5 Drug Tariff .................................................................................................................................................................................. 6 Safety ......................................................................................................................................................................................... 8 News Medicines Management Education Event Details have been sent out of the Medicines Management Education Event for prescribers which is being held on Thursday 25th September 2014 1pm – 4.30pm The afternoon will consist of a brief medicines management update followed by four breakout clinical education sessions – prescribers are able to attend two out of the four sessions. Details of the sessions are: • Novel Oral Anticoagulants • Strong Opioid prescribing including use of transdermal opioids • New diabetes drugs and their place in therapy • Antidepressant prescribing including switching between drugs and current issues In order to facilitate planning of the event, it is important that Prescribers let us know the 2 sessions they would like to attend during the afternoon. Could you please confirm your attendance and session choices by Wednesday 10th September 2014 to [email protected] and also notify us of any special dietary requirements. We are aware that this is on the same date as a pre-existing In House PLT date, and as such this may pose a problem for some practices who already have pre-booked training in place. However, we are intending to hold another event later in the year to ensure all prescribers have the opportunity to attend a session if they wish. NPSA Rapid Response Report NPSA/2008/RRR05 - Reducing dosing errors with opioid medicines Due to further incidents with regards to prescribing of opioids we would like to remind everyone about the recommendations in the 2008 rapid response alert around prescribing of opioids. http://www.nrls.npsa.nhs.uk/resources/type/alerts/?entryid45=59888&p=3 When opioid medicines are prescribed, dispensed or administered, in anything other than acute emergencies, the healthcare practitioner concerned, or their clinical supervisor, should: • Confirm any recent opioid dose, formulation, frequency of administration and any other analgesic medicines prescribed for the patient. This may be done for example through discussion with the patient or their representative (although not in the case of treatment for addiction), the prescriber or through medication records. • Ensure where a dose increase is intended, that the calculated dose is safe for the patient (e.g. for oral morphine or oxycodone in adult patients, not normally more than 50% higher than the previous dose). • Ensure they are familiar with the following characteristics of that medicine and formulation: usual starting dose, frequency of administration, standard dosing increments, symptoms of overdose, common side effects. Healthcare organisations should ensure local medicines and prescribing policies, including Standard Operating Procedures, are reviewed to reflect this guidance. Prescribers are also advised to be cautious when picking the appropriate drug from clinical system picking lists as they can be confusing and this has recently contributed to an error – where a particular risk has been identified we will be working with the system supplier to rectify the problem. It is recommended that prescribers’ double check the prescription generated to ensure the intended item, strength and dose has been chosen. Pharmacists should always dispense off the prescription rather than off a pharmacy generated label in case an incorrect product has been selected. If you have any queries please contact your medicines management team for advice. Current Issues Levonorgestrel and ulipristal remain suitable emergency contraceptives for all women, regardless of bodyweight The MHRA have sent a letter to healthcare professionals to advise that Levonelle® (levonorgestrel) and ellaOne® (ulipristal acetate) can be used for emergency hormonal contraception in all women regardless of weight or BMI. This follows a Europe-wide review, triggered because the product information for one levonorgestrel containing emergency contraceptive approved in the rest of the EU (but not approved in the UK) was amended to suggest that it is less effective with increasing body weight. However, the review of all the available studies conducted with levonorgestrel and ulipristal acetate concluded that the data is not robust enough to establish that there is a reduction in efficacy of emergency contraceptives with increase in weight or BMI. The letter from the MHRA can be accessed through the link below: https://www.cas.dh.gov.uk/ViewAndAcknowledgment/viewAttachment.aspx?Attachment_id=101945 2 When should medication be prescribed on the NHS following a private referral? Patients who request to be referred privately are expected to pay the full cost of any treatment they receive in relation to the episode of care provided privately: consultation fees, drugs prescribed or treatment provided by a clinician in the course of the private consultation. Patients should be informed of this expectation prior to referral. If a private consultation identifies a long term condition or a need for medication which is available as routine NHS treatment, this should be provided as such by the patients usual GP. However the NHS doctor would only be obliged to prescribe in line with NHS and the local Pan Mersey guidance and formulary. There is no obligation on behalf of the GP to prescribe the recommended treatment if it is contrary to his/her normal clinical practice. Covert Administration of medicines in Care Homes Following a number of recent queries about covert administration of medication we have put together some guidance for prescribers: • Covert administration of medicines is a complex issue and involves the administration of a medicine disguised in food or drink to a patient without their knowledge or consent. • A clear distinction should be made between those patients who have mental capacity to refuse a medicine and whose refusal should be respected, and those who lack this capacity. • Prescribers should always assume that care home residents have the mental capacity to make decisions about their treatment. Care home residents should have the same opportunities to make decisions about their medicines as people who do not live in care homes. • Covert administration should only be used in exceptional circumstances after exploring alternative ways of administering medication e.g. a change of formulation or timing of administration, if clinically appropriate. Administration of medicine covertly carries risks that the patient may not receive the full dose, the medicine may degrade in food or drink and crushing a tablet is an unlicensed activity all of which have to be balanced against the risks of not giving the medicine at all. • If covert administration of medicines is being considered, health and social care practitioners should ensure that the process for covert administration of medicines to adults resident in care homes includes: 1. Assessing mental capacity of the resident in line with appropriate legislation (e.g. the Mental Capacity Act 2005) 2. Holding a best interests meeting involving care home staff, the health professional prescribing the medicine, pharmacist and family member or advocate to agree whether administering medicines to the resident covertly is in their best interests. 3. Recording the reasons for presuming mental incapacity and the proposed management plan along with details of how each medicine will be administered without the resident knowing. The suitability of each medicine for covert administration must be assessed separately. 4. Regularly reviewing whether covert administration is still needed. If you have any further queries please contact our care home pharmacist via email [email protected] or on 01928 593452 3 Fluticasone furoate with vilanterol Inhaler (Relvar Ellipta®▼) We are aware drug reps are currently promoting fluticasone furoate with vilanterol inhaler (Relvar Ellipta®▼ ). Prescribers are reminded Pan Mersey APC does not currently recommend the prescribing of fluticasone furoate with vilanterol inhaler (Relvar Ellipta®▼) for the treatment of asthma or Chronic Pulmonary Airways Disease (COPD): http://www.panmerseyapc.nhs.uk/recommendations/documents/PS31.pdf The New Medicines Subgroup is currently reviewing the evidence and any change to the status of the drug will be communicated to prescribers. Medicines Management work plan A summary of the work the Medicines Management Team are currently working on or plan to start in the next few weeks is detailed below: Asthma patients on combination inhalers (ICS/LABA) reviewed for stepping down Erectile dysfunction review –NHS patients on vardanafil/ tadalafil for switch to sildenafil. Special unlicensed meds review Vitamin B Co review Clopidogrel, Prasugrel & Ticagrelor review Insulin/needles/lancet/ strips- review of quantities Stoma prescribing audit Nexium review – switch to generic QUERY CORNER Sunscreens – who can I prescribe for? Formulary products Sunsense® Ultra lotion factor 50 and Uvistat® cream factor 30 and 50 are prescribable as drugs as advised by the Advisory Committee on Borderline Substances (ACBS) for the following conditions: Abnormal cutaneous photosensitivity resulting from genetic disorders Photodermatoses, including vitiligo and those resulting from radiotherapy Chronic or recurrent herpes simplex labialis Patients requesting prescriptions for sun cream for other conditions such as eczema, following surgery for skin cancers or who experience allergies to regular sun cream should be advised to purchase these products, which are readily available over the counter. For optimum protection, sunscreen preparations should be applied thickly and frequently (approximately every 2 hours). In photodermatoses, they should be used from spring to autumn. As maximum protection from sunlight is desirable, preparations with the highest sun protection factor should be prescribed. QIPP Key Messages: Minocycline Minocycline Prescribing There is no clear evidence to support the preference of minocycline over other oral antibiotics in the treatment of inflammatory acne or rosacea. 4 Minocycline appears to be associated with a broader spectrum and higher incidence of adverse drug reactions than other tetracyclines. Minocycline is not included in the local formulary as a treatment option for inflammatory acne or rosacea. Minocycline is more expensive than other antibiotic treatment options. In an individual any possible benefits of minocycline must be carefully weighed against the risks. Topic of the month: Diabetes SELF-MONITORING OF BLOOD GLUCOSE IN PATIENTS WITH DIABETES MELLITUS Self-monitoring of blood glucose (SMBG) is essential for people with diabetes on insulin therapy and can be required for some people on other hypoglycaemic agents. Where SMBG is not serving a specific purpose in the management of the condition, it is a waste of NHS resources and may even worsen quality of life. 1,2 NICE recommend that SMBG should only be used in type 2 diabetes if it is going to be an integral part of the patient’s self-management education, and the continued benefit of SMBG should be assessed in a structured way each year. 3 In recent years the cost of prescribing blood glucose test strips (BGTS) has grown rapidly. In NHS Halton CCG in 2013/14, 18% of the spend on diabetes prescribing was for BGTS at a cost of £400,000. There has been a 0.5% increase in the number of items prescribed and a 6% increase in spend compared with this period last year.4 Background SMBG is an essential component in managing patients treated with insulin to help them to achieve tight blood glucose control and to prevent severe hypoglycaemia. The purpose of this is to allow a patient to make necessary adjustments to their insulin dose (applicable in type 1 diabetes) and also to make informed lifestyle changes. In noninsulin treated type 2 diabetes the benefits of regular SMBG are unclear. A Cochrane review found the overall effect of SMBG on glycaemic control in people with type 2 diabetes who were not using insulin was small up to 6 months after initiation, and subsided after 12 months. There was no evidence that SMBG affects patient satisfaction, general wellbeing or general health-related quality of life.5 It is recognised that patients treated with sulfonylureas are at risk of hypoglycaemia and SMBG may benefit people who are less able to identify early signs of hypoglycaemia. The usual method for monitoring blood glucose control is by measuring glycated haemoglobin (HbA1c) which gives an indication of the overall blood glucose control over the preceding three months. Guidance for reviewing the need to test for blood glucose Current prescribing of BGTS should be evaluated on an individual patient basis in discussion with the patient; if there is felt to be no need for SMBG, prescribing should be reduced or discontinued. 1. SMBG should only be provided routinely to people with type 2 diabetes not treated with insulin or sulfonylureas where there is an agreed purpose or goal to testing 2. Patients being treated with insulin or other diabetes agents that carry a risk of hypoglycaemia (sulfonylureas, glinides) must be prescribed BGTS to allow them to satisfy the level of testing stipulated by the Driver and Vehicle Licensing Agency (DVLA) 5 Table 1: Summary of DVLA requirements with regards to self-monitoring of blood glucose Insulin treated patients Patients managed by tablets which carry a risk of inducing hypoglycaemia (includes sulfonylureas and glinides) Group 1 Entitlement – Car, motorcycle There must be appropriate blood glucose monitoring. This is defined as 2 hours before the start of the first journey and every 2 hours while driving. It may be appropriate to monitor blood glucose regularly and at times relevant to driving to enable the detection of hypoglycaemia. Group 2 Entitlement – LGV/PCV (updated Dec 2011 & Apr 2012) Regularly monitors glucose at least twice daily and at times relevant to driving using a glucose meter with a memory function to measure and record blood glucose levels. Regularly monitors blood glucose at least twice daily and at times relevant to driving. Further guidance from the DVLA is available from the link below: https://www.gov.uk/government/collections/current-medical-guidelines-dvla-guidance-for-professionals 3. SMBG should be used to assist the optimisation of blood glucose control prior to conception and during pregnancy in Type 1 and 2 diabetes, including gestational diabetes7 4. SMBG should be used only within a care package, accompanied by structured education with regular review. The education should include clear instructions as to the place of monitoring and how results can be used to reinforce lifestyle change, adjust therapy or alert healthcare professionals 5. The quantity of test strips on prescription should reflect the frequency of testing required by the individual patient. Where testing is only required intermittently, prescriptions should be generated only when needed and not as a repeat prescription The Pan Mersey Diabetes Guidelines are available via the following link; http://www.panmerseyapc.nhs.uk/guidelines.html References 1. MeReC Extra Issue No. 34 July 2008 (www.npc.nhs.uk) 2. MeReC Extra Issue No. 35 September 2008 (www.npc.nhs.uk) 3. NICE Clinical Guideline CG87. Type 2 diabetes: the management of type 2 diabetes. May 2009 4. CMCSU Business Intelligence. Prescribing Analyst Team. Prescribing data for 12 months April 2012 to March 2013; and April 2013 to March 2014 5. Malanda UL et al. Self monitoring of blood glucose in patients with type 2 diabetes mellitus who are not using insulin. Cochrane Database of Systematic Reviews 2012, Issue 1. Art. No.: CD005060. DOI:10.1002/14651858.CD005060.pub3 6. Blood glucose test strips for patients with type 2 diabetes mellitus. NHS PrescQIPP Bulletin 46 August 2013 7. NICE Clinical Guideline CG 63. Diabetes in pregnancy. Management of diabetes and its complications from pre-conception to the postnatal period. July 2008 Drug Tariff DRUG AVAILABILITY Medication supply issues July 2014 The following generic drugs have supply issues and hence are incurring increased costs; they have been given a NCSO (no cheaper stock obtainable) status for July 2014. Please consider the costs of the following drugs before prescribing. Amiloride 5mg tablets (28) - £18.40 Fenofibrate micronised 200mg caps (28) - £14.23 6 Hydrocortisone 10mg tablets (30) - £58.52 (new) Loperamide 2mg capsules (30) - £2.13 (new) Naftidrofuryl 100mg caps (84) - £18.99 Naproxen 500mg gastro- resistant tablets (56) - £10.10 Piroxicam 0.5% gel (112g) - £9.05 Pizotifen 500mcg tablets (28) - £7.50 (new) Pizotifen 1.5mg tablets (28) - £7.60 (new) Tamoxifen 20mg tablets (30) - £6.99 Valsartan 40mg capsules (28) - £9.28 Valsartan 80mg capsules (28) - £10.32 Valsartan 160mg capsules (28) - £11.50 Other drugs with long term supply issues include: Description Due Date Comments Accu-Chek Multiclix® lancets August 2014 A manufacturing issue is causing a delay in supply Allopurinol 100mg tablets Activis expect deliveries mid- A raw material issue is causing a delay in supply Zyloric® 100mg tablets August 2014 – see below for alternative options Chlordiazepoxide 5mg Supplier unable to confirm A manufacturing issue is causing a delay in capsules supply Cilest® tablets Limited supplies ongoing A market shortage is causing a delay in supply Duac Once Daily® gel No date given GSK Enquiries Call 0800 221 441 Eumovate® 0.05%cream No date given GSK Enquiries Call 0800 221 441 Loperamide 2mg capsules Manufacturer unable to A manufacturing issue is causing a delay in confirm supply Gentisone Hc ®Ear Drops August 2014 Temporary supply issue Maxitrol® 0.1% eye drops Limited supplies ongoing A market shortage is causing a delay in supply. Allopurinol 100mg – stock shortage There has been a long term manufacturing problem affecting the availability of allopurinol 100mg tablets. Stock was expected mid-July. However, based on the information supplied by the manufacturers, we now expect availability mid to late August. For patients requiring this strength an individual review will be required, and options to consider are: Review patients who have been on this long term with no flare ups and consider if treatment is still required. Check uric acid/urate levels and change to 300mg tablets (which can be halved to give a 150mg dose). Patients may need prophylaxis for gout flare ups if dose changes are being considered. For patients with renal impairment, a lower dose may be required (see table below). It may be necessary to prescribe an unlicensed special liquid in the short term - allopurinol 100mg/5ml oral suspension. Creatinine clearance: Dosage*: Over 20ml/minute Standard dose 10-20ml/minute 100-200mg daily 7 Under 10ml/minute 100mg daily or less frequently (*Information taken from Allopurinol (Actavis) SPC 300mg http://www.medicines.org.uk/emc/medicine/23723) Locorten Vioform® ear drops Locorten Vioform® branded ear drops have been discontinued but a generic preparation is available. This will need to be prescribed as Flumetasone pivalate 0.02% / Clioquinol 1% ear drops For any further information regarding supply problems please contact your Practice Pharmacist/Technicians or your local Medicine Management Team contact. (Details can be found on the last page of this newsletter) Safety Dexamethasone Injection Please be aware that there are at least 2 different strengths of this depending on the manufacturer. One generic make is 4mg/ml and another 3.3mg/ml. Please prescribe the dose as dexamethasone base. Dangers in changes to MAR charts in care homes A patient was admitted to Whiston hospital due to Insulin overdose in a care home. On the MAR chart the Insulin dose had been changed from “2 units daily” to “2 i.u.daily “and a nurse had interpreted this as 21 units daily. “ i.u.”( international units) should not be used as an abbreviation to denote unit doses due to the potential for error and this is just one example of medication errors caused by alteration / transcription of MAR charts. Immeasurable doses There have been recent hospital admissions where the patient has had medicines dispensed with inappropriate dosage instructions such as 0.08ml daily.(e.g. cholecalciferol liquid). Whereas they are not dosing errors, such doses cannot be measured to any degree of accuracy by a patient. Pharmacies should bear this in mind when dispensing and consider dilution where appropriate. MHRA DRUG SAFETY UPDATE JULY 2014 Drugs and driving: blood concentration limits to be set for certain controlled drugs in a new legal offence The Department of Transport has introduced a new offence of driving with certain controlled drugs above specified limits in the blood; this is likely to come into force on 2 March 2015. The list of drugs includes some licensed medicines. An information leaflet for patients is available on the MHRA website. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON432898 Intravenous dantrolene: risk of undissolved crystals—use a filter needle when drawing up reconstituted dantrolene solution Some newly issued vials of intravenous dantrolene may contain crystals of undissolved dantrolene sodium following reconstitution. Draw up the reconstituted solution with a filter needle to prevent these crystals from being administered to patients. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON432899 8 Transdermal fentanyl “patches”: reminder of potential for life-threatening harm from accidental exposure, particularly in children Accidental exposure to transdermal fentanyl can occur if a patch is swallowed or transferred to another individual. An information leaflet for patients is available on the MHRA website http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON432900 Administration errors with drugs for infusion: ensure appropriate checking procedures are in place Take care to ensure that checking procedures are in place to reduce the risk of administration errors with drugs for infusion. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON432901 Medicines Management Team contacts: Lucy Reid (Halton) [email protected] 01928 593 452 For any feedback or suggestions on content, please email [email protected] 9