Informer May 2017 Pregabalin switch to Alzain brand Over the next few months you will see prescriptions from Doncaster GP practices for generic Pregabalin capsules switched to the brand Alzain. Key Information: Alzain is bioequivalent to Lyrica. 1 Patient cohort – pain in adults. Note: may include existing off-label indications. Exclusions - epilepsy, generalised anxiety disorder, patented indications. Opportunity will be taken to optimise to twice daily dosing. Supply – Dr Reddy’s have provided assurance they can meet demand. Pharmacy staff may wish to review their stock levels of generic Pregabalin and Alzain to avoid over/ under stocking. Electronic Repeat Dispensing Update to nystatin dose in BNF and BNF for Children Electronic Repeat Dispensing (ERD) continues to roll out across Doncaster GP practices. Pharmacies have been very helpful during this implementation phase and can continue to support ERD by nominating and reminding patients to request a new prescription at their second to last and last ERD prescriptions. Nystatin dose for oral candidiasis in BNF has historically reflected posology recommendations (PRs) in Nystan® SPC. Following discussions with MHRA, the dose has been updated (live in digital versions of BNF from March 2017) and now reflects current PRs for generic nystatin products. https://www.medicinescomplete.com/mc/bnf/current/PHP7390nystatin.htm?q=nystatin&t=search&ss=text&tot=37&p=6#_hit Canagliflozin may increase the risk of lower-limb amputation Canagliflozin may increase the risk of lower-limb amputation (mainly toes) in patients with type 2 diabetes. Evidence does not show an increased risk for dapagliflozin and empagliflozin, but the risk may be a class effect. Pharmacists should continue to provide advice to patients with diabetes on the importance of preventive foot care and refer patients to prescribers where required. Advice for healthcare professionals: carefully monitor patients receiving canagliflozin who have risk factors for amputation, such as poor control of diabetes and problems with the heart and blood vessels consider stopping canagliflozin if patients develop foot complications such as infection, skin ulcers, osteomyelitis, or gangrene advise patients receiving any sodium-glucose co-transporter 2 (SGLT2) inhibitor about the importance of routine preventive foot care and adequate hydration continue to follow standard treatment guidelines for routine preventive foot care for people with diabetes report any suspected side effect with SGLT2 inhibitors or any other medicine on a Yellow Card https://www.gov.uk/drug-safety-update/sglt2-inhibitors-updated-advice-on-increased-risk-of-lower-limbamputation-mainly-toes How to minimise the risks of medication errors with rivastigmine patches This Q&A aims to raise awareness on the types of medication errors reported with rivastigmine patches, as well as highlighting strategies to improve medication safety on the prescribing and administration of these patches. https://www.sps.nhs.uk/articles/how-tominimise-the-risks-of-medication-errorswith-rivastigmine-patches/ What should people do if they miss a dose of their medicine? As pharmacy staff are very aware, sometimes patients forget to take their medicines at the normal time. This may cause a problem because missing a dose may make the medicine less effective, but taking doses too close together may increase the risk of side effects. It is very difficult to give general guidance on what to do in these situations. Each situation needs to be looked at individually. However, this Medicines Q&A offers some general guidance, which may help patients who occasionally forget or delay a dose. It does not apply to patients who frequently miss doses. https://www.sps.nhs.uk/articles/what-should-people-do-if-they-miss-adose-of-their-medicine/ What legal and pharmaceutical issues should be considered when administering medicines covertly? Specialist Pharmacy Service This Medicines Q&A discusses some of the legal issues, pharmaceutical issues (e.g. absorption, incompatibility, interactions) and patient factors (e.g. acceptability) that need to be considered when deciding whether to administer medicines in this way. https://www.sps.nhs.uk/articles/what-legal-and-pharmaceutical-issues-should-be-considered-when-administering-medicines-covertly-2/ Resources to support the safety of girls and women who are being treated with valproate It is vital where valproate is prescribed & dispensed to girls and women of childbearing potential that they are made aware of the risks of taking the medication in pregnancy. The need for effective contraception planning must also be emphasised, along with the requirement for specialist oversight to safely change their medication if planning a pregnancy. MHRA have updated its valproate toolkit, providing a range of resources to support providers, staff and patients in the safe use of valproate. This alert asks all providers to undertake systematic identification of girls and women who are taking valproate, and to ensure the MHRA resources are used to support them to make informed choices. The guidance asks dispensing pharmacists: Whenever you dispense a medicine containing valproate (brand names Epilim, Depakote, Episenta) to a girl or woman of childbearing age, give her a Patient Card, unless she confirms that she already has one. Encourage her to read the card and enter her name and date to reinforce her own accountability to consider the information it contains. If you manage dispensing services in your organisation, ensure that processes are in place to allow these requirements to be met. www.gov.uk/government/publications/toolkit-on-the-risks-of-valproate-medicines-in-female-patients https://www.cas.dh.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=102582 Mucodyne Paediatric Syrup 250 mg/5 mL (carbocisteine oral liquid) - new double-strength presentation Sanofi have launched a double strength Mucodyne Paediatric Syrup which has double the concentration of the active ingredient carbocisteine per mL compared with the previous formulation. The letter available via the link below warns healthcare professionals to ensure correct dosing. https://assets.publishing.service.gov.uk/media/58fa19a7ed915d06b00001a2/MucodynePaediatricReformulation_October_2016.pdf Hyoscine butylbromide (Buscopan) injection: risk of serious adverse effects in patients with underlying cardiac disease Hyoscine butylbromide (Buscopan), given intravenously or intramuscularly, is indicated in acute muscular spasm, as in renal or biliary colic; in radiology for differential diagnosis of obstruction and to reduce spasm and pain in pyelography; and in other diagnostic procedures where spasm may be a problem (e.g. gastroduodenal endoscopy). Prescribing information has been updated to help to minimise the risk of serious adverse reactions in patients with cardiac disease. Advice for healthcare professionals: hyoscine butylbromide injection can cause serious adverse effects including tachycardia, hypotension, and anaphylaxis these adverse effects can result in a fatal outcome in patients with underlying cardiac disease, such as those with heart failure, coronary heart disease, cardiac arrhythmia, or hypertension hyoscine butylbromide injection should be used with caution in patients with cardiac disease monitor these patients, and ensure that resuscitation equipment, and personnel who are trained how to use this equipment, are readily available hyoscine butylbromide injection remains contraindicated in patients with tachycardia Pharmacists should refer to the prescriber if they have any concerns over the prescribing of hyoscine butylbromide. https://www.gov.uk/drug-safety-update/hyoscine-butylbromide-buscopan-injection-risk-of-serious-adverse-effectsin-patients-with-underlying-cardiac-disease Shortage of Hyoscine Hydrobromide (Kwells) 150 and 300 microgram tablets Bayer is currently facing some technical issues relating to the manufacturing of, hyoscine hydrobromide and is thus not able to supply further stock for at least 6 months. This memo advises on alternative treatment options in the interim, with a focus on its off-label use for hypersalivation. https://www.sps.nhs.uk/articles/shortage-of-hyoscine-hydrobromidekwells-150-and-300-microgram-tablets/ Launch of RightBreathe internet resource This internet resource is designed specifically to help with the selection, prescribing, and on-going use of inhalers. It covers each and every inhaler and spacer device licensed in the UK for treating asthma and COPD. https://www.rightbreathe.com/ Apremilast (Otezla ▼): risk of suicidal thoughts and behaviour Apremilast (Otezla▼) is a phosphodiesterase-type-4 inhibitor for the treatment of moderate to severe chronic plaque psoriasis or active psoriatic arthritis in adults who have not responded to other systemic treatments. There is an increased risk that some patients may experience psychiatric symptoms with apremilast, including depression and suicidal thoughts. Advice for healthcare professionals: apremilast is associated with an increased risk of psychiatric symptoms, including depression, suicidal thoughts, and suicidal behaviours suicidal thoughts and behaviour, including completed suicide, have been reported in patients with or without a history of depression carefully assess the benefits and risks of starting or continuing treatment in patients with a history of psychiatric symptoms, or in those who are taking other medicines likely to cause psychiatric symptoms stop treatment if patients experience new psychiatric symptoms or if existing symptoms get worse advise patients to inform a healthcare professional if they notice changes in their mood Pharmacists should advise patients of the possible side effects and refer to the prescriber if any of these symptoms are reported. https://www.gov.uk/drug-safety-update/apremilast-otezla-risk-of-suicidal-thoughts-and-behaviour Glucose content of Lucozade Energy drinks to be reduced by 50% from April 2017 Pharmacy Guidance on Smoking & Mental Disorder The sugar and carbohydrate content levels of Lucozade Ribena Suntory drinks will be reduced by approximately 50%. Pharmacists advising people with diabetes to consume Lucozade Energy for the treatment of hypoglycaemia should advise that they check the label of any product purchased to ensure that they are aware of the correct quantity to consume. This guide from the Royal College of Psychiatrists, endorsed by the Royal Pharmaceutical Society, outlines how pharmacists can help reduce or stop smoking in people with mental health disorders as well as facilitating appropriate changes of medication doses. http://www.rcpsych.ac.uk/pdf/Pharmacy%20guidance%20smoking%20a nd%20mental%20health%202017%20update%20FINAL.pdf Launch of pilot reporting scheme for harms associated with illicit drugs, particularly new psychoactive substances MHRA is launching a pilot for healthcare professionals in UK to report suspected adverse reactions to illicit drugs (IDs), particularly new psychoactive substances. This will aid closer collaboration with Public Health England on safety issues affecting licensed medicines and IDs. New psychoactive substances (previously known as ‘legal highs’) pose potentially serious risks to public health. The number of new substances identified in recent years has increased rapidly, with greater availability over the internet. The pilot reporting website, the Report Illicit Drug Reaction form, will be available for 1 year for healthcare professionals across the UK who come into contact with patients experiencing harm associated with use of illicit drugs, particularly new psychoactive substances. The pilot aims to better collect data on harms from illicit drug use, to support provision of clinical guidance to professionals. The form is intended to be used by health professionals who work in emergency departments, general practice, drug treatment services, sexual health services, mental health services, and any other services who come into contact with people who have developed acute or chronic problems associated with use of new psychoactive substances. https://report-illicit-drug-reaction.phe.gov.uk/ Levetiracetam containing products 100 mg/mL oral solution presentations: Risk of medication errors associated with overdose Pharmacy staff should be aware of the following safety concern issued by UCB Pharma Limited in agreement with the European Medicines Agency and the MHRA: Summary Cases of an up to 10‐fold accidental overdose with Keppra (levetiracetam) oral solution have been reported. The majority of cases occurred in children aged between 6 months and 11 years. The use of an inadequate dosing device (e.g. confusion between a 1mL and a 10mL syringe, resulting in a 10‐fold overdose) was identified as an important cause. Physicians should always prescribe the dose in mg with mL equivalence based on the correct age. Pharmacists should ensure that the appropriate presentation of levetiracetam oral solution is dispensed. With every prescription, physicians and pharmacists should advise the patient and/or caregiver on how to measure the prescribed dose. With every prescription, physicians and pharmacists should remind patients or caregivers to use only the syringe delivered with the medicine. Once the bottle is empty the syringe should be discarded and not kept. https://assets.publishing.service.gov.uk/media/587f5894e5274a130300016c/Levetiracetam.pdf Safeguarding children and vulnerable adults: a guide for the pharmacy team CPPE e-learning The programme covers recognising types of abuse to identify victims for onward referral, who to contact for advice and how to report and record information. The aim of this learning resource is to give you the skills, knowledge and confidence to deal professionally with any safeguarding issues that may arise in the course of your practice. Completion of the programme and the associated Level 2 assessment will fulfil the safeguarding requirements at level 2 for pharmacists and pharmacy technicians as required for the Quality Payment Scheme and by the Intercollegiate Document: Safeguarding children and young people. Completion of the programme and the associated Level 1 assessment (available February 2017) will allow pharmacy support staff to prove their competence at Level 1 as required by the Intercollegiate Document: Safeguarding children and young people. https://www.cppe.ac.uk/programmes/l/safegrding-e-02 Licensed equivalents now available Instead of using Metformin 850mg/5ml oral solution and Metformin 1g/5ml oral solution, the following products which are licensed should ideally be considered: • Metformin 850mg/5ml oral solution sugar free (Colonis Pharma Ltd) • Metformin 1g/5ml oral solution sugar free (Colonis Pharma Ltd) The following special order products have all been discontinued: • Hydromorphone 10mg/1ml solution for injection ampoules (Special Order) • Hydromorphone 20mg/1ml solution for injection ampoules (Special Order) • Hydromorphone 50mg/1ml solution for injection ampoules (Special Order) Instead of using these, the following licensed options, available from Napp Pharmaceuticals Ltd, should ideally be considered: • Palladone 10mg/1ml solution for injection ampoules (Napp Pharmaceuticals Ltd) • Palladone 20mg/1ml solution for injection ampoules (Napp Pharmaceuticals Ltd) • Palladone 50mg/1ml solution for injection ampoules (Napp Pharmaceuticals Ltd) Is there an interaction between erythromycin and statins? This updated Medicines Q&A evaluates the evidence for an interaction between erythromycin and statins. It concludes that if co-prescription with a drug that increases systemic exposure to statins is unavoidable, it is particularly important to start on the lowest statin dose. https://www.sps.nhs.uk/article s/is-there-an-interactionbetween-erythromycin-andstatins-2/ Glycopyrronium bromide 2mg/5ml oral solution & oral suspension has been removed from Part VIIIB of the March Drug Tariff Is there an interaction between bisphosphonates and proton pump inhibitors? Glycopyrronium bromide 2mg/5ml oral solution and oral suspension have been removed from Part VIIIB of the Drug Tariff. This is because a licenced alternative, Glycopyrronium bromide 400mcg/1ml oral solution sugar free, is now available and has been added to Part VIIIA effective from 1st March 2017. This updated Medicines Q&A from the Specialist Pharmacy Service (SPS) concludes that whilst there is not a recognised interaction between bisphosphonates (B) and PPIs, a common side effect of bisphosphonates is gastro-intestinal disturbance. Additionally the SPCs for B and PPIs highlight an increased risk of fractures The electronic Drug Tariff can be viewed here https://www.sps.nhs.uk/articles/is-there-an-interactionbetween-bisphosphonates-and-proton-pump-inhibitors-2/ Managing asthma in children: A booklet for parents, carers and family members Scottish Intercollegiate Guidelines Network have developed an information booklet which explains the recommendations in the SIGN/BTS clinical guideline for asthma. It details the medications used as treatment and gives advice on how parents and carers can help control their child’s asthma. http://www.sign.ac.uk/pdf/PAT153_Children.pdf Specialist Pharmacy Service Medicines Use and Safety Updates This report addresses the progress and activities of the Medicines Use and Safety Division of the Specialist Pharmacy Service. It includes links to recent resources, collaborative audits, and publications. https://www.sps.nhs.uk/wpcontent/uploads/2017/01/Medicines_Use_and_Safety_Update _-Mar_2017.pdf Be Clear on Cancer campaign resources available to order Community pharmacy teams can now pre-order their free campaign resources from Public Health England pharmacy order line for the Be Clear on Cancer Respiratory Symptoms campaign which launches on 18th May 2017. A toolkit has been created for pharmacies to support the campaign. https://campaignresources.phe.gov.uk/resources/campaigns/46/resources/1747 Controlled Drug Update CD Incident - Fraudulent Computer Generated Prescription A fraudulent computer generated prescription was recently identified by a Doncaster pharmacy. The prescription for Co-Codamol 30/50mg tablets and Zimovane 7.5mg did not look suspicious and was only identified when the pharmacist queried the number of tablets as he felt 56 days was excessive. On liaison with the GP practice it was confirmed that the practice had not issued the prescription. It is not yet known if there could be further fraudulent prescriptions, South Yorkshire Police are currently investigating the incident. Pharmacy staff should continue to be vigilant and contact the prescriber if they have any concerns regarding excessive quantities or validity of any prescriptions. Staff should report any prescriptions known or suspected to be fraudulent to the Police and NHS Protect, online via the link https://www.reportnhsfraud.nhs.uk/ or call the Fraud & Corruption Reporting Line Tel: 0800 028 40 60 Authorisation of CD Destruction Witnesses Pharmacies can now apply to the NHS England CD Accountable Officer to have staff authorised as witnesses for CD destructions. Requests for authorisation should be emailed to [email protected] Alternatively if you require an authorised witness to visit your pharmacy please email medicinesmanagementadmin@doncastercc g.nhs.uk or Tel: 01302 566229 for further information. Controlled Drug Incident Reporting The Controlled Drug Accountable Officer for NHS England Yorkshire & Humber is Gazala Khan. The Medicines Management Team continue to support the CD AO through delegated authority to implement the Controlled Drugs (Supervision of Management and Use) Regulations 2013. All CD incidents must be reported to NHS England by completing the incident form below & submitting via: Email: [email protected] NHS E CD Incident or by fax to 0113 245 1594 Form
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