BERKSHIRE EAST CCGs Medicines Optimisation Prescribing Update Contact Details for the Medicines Optimisation Team Volume 2 Issue 1 April 2013 Contents of this issue CCG Support Pharmacists: Head of Medicines Optimisation Team Page no: High cost drugs excluded from the payment by results (pbr) tariff (change in commissioning arrangements 2 Scheriproct Ointment 2 -----Bracknell & Ascot Melody Chapman 07826 533736 Email: melody.chapman@nhs.net -----Maidenhead/Windsor/Ascot Dawn Best 07793 007976 dawnbest@nhs.net ------Slough Tim Langran 07775 010727 Email: tim.langran@nhs.net TheraBite- a jaw motion rehabilitation system for the treatment of trimus. 3 XCLAIR® cream 3 Flutiform 4 Unlicensed medicines - when Is It Appropriate To Crush Tablets Or Open Capsules? 4 -----Practice Support Pharmacist Sundus Bilal 07909 505658 Email: sundusbilal@nhs.net ------ Simvastatin-Amlodipine Interaction: Reminder Of National And Local Advice Catriona Khetyar 07500 606169 Email: catriona.khetyar@nhs.net Calcium And Vitamin D3 Supplementation For Mobile Care Home Patients Aciferol® – New Vitamin D Liquid Available East Berkshire Joint Formulary now available online Hypnotics: Support For Reducing Prescribing Prescribing Support Pharmacist Caroline Pote 01753 636845 Email: caroline.pote@nhs.net 1 HIGH COST DRUGS EXCLUDED FROM THE PAYMENT BY RESULTS (PbR) TARIFF (CHANGE IN COMMISSIONING ARRANGEMENTS) PbR is the rules-based payment system in England under which commissioners pay healthcare providers using national tariffs. There are a number of high cost drugs that are excluded from the PbR tariff which are typically specialist, and concentrated in a relatively small number of centres rather than evenly across all trusts and would therefore not be fairly reimbursed if they were funded through the tariff. Changes to prescribing In differentiating which activity should be commissioned by CCGs and that which the NHS CB should commission directly, there will need to be some changes in the way in which drugs are prescribed across primary, secondary and tertiary care to improve consistency of practice and cost effectiveness in standardising prescribing arrangements. Many specialist drugs and devices are excluded from Tariff. Specialised services commissioning will be operationally delivered via ten nominated Local Area Teams (LATs); funded directly via a finite budget that will be set by the NHS CB, rather than on a subscriptions basis funded by CCGs and is therefore completely separate to the funding that will be available for CCGs. To help remove wide variations in pricing, from 1 April 2013 there will be one single provider contract managed by a single LAT, legally held by the NHS CB as the statutory body and 2013.14 will be a preparatory year in order to avoid destabilisation. How does this affect primary care? As described above, specialist PbR excluded drugs for certain disease areas will now be managed through LATs. There has been a disparity of supply; for example some patients prescribed PbR excluded drugs for cystic fibrosis are supplied through the hospital Home Care supply chain and recharged to the PCT, whilst others through FP10 via their GP surgery prescribing budget. If you are asked to prescribe any of the drugs on the list attached, please do not start prescribing, but refer the clinician to the specialised contracting arrangements through LATs from April 2013/14. Scriptswitch will flag these medicines as “Red”. We are currently in the position that secondary and tertiary care costs from specialised PbR excluded drugs will be paid through the NHS CB budget, but arrangements do not allow primary care to charge the same drug costs to the same budget. For patients currently prescribed these drugs by GPs on FP10 we have been asked not to return to secondary and tertiary centres immediately due to the danger of destabilisation, but do intend to identify patients over 2013.14 and gradually return to secondary and tertiary centres to enable them to transfer the drug costs to the relevant LAT. Attached separately is a draft copy of the 2013/14 Drugs list for NCB commissioning (PbR excluded drugs). SCHERIPROCT OINTMENT Supplies of both the ointment and suppositories are unavailable and the manufacturers are unable to advise when stocks will return. Please use Anusol-HC ointment as the locally recommended cost effective alternative. Scriptswitch messages have been amended to reflect this advice. 2 THERABITE – A JAW MOTION REHABILITATION SYSTEM FOR THE TREATMENT OF TRIMUS We have received a number of queries recently, whereby TheraBite has been recommended to be prescribed to patients by Speech and Language Therapy. This prescribable device has not been commissioned locally and an evidence based review has not been submitted to confirm its place in treatment. It currently should be treated as a non-formulary and the Medicines Optimisation team will work with speech and language to ascertain it's place in the treatment pathway for trimus. XCLAIR® CREAM There have recently been a few requests from local private oncology clinics asking GPs to prescribe XCLAIR® cream for radiation dermatitis. XCLAIR® cream costs £17.00 per 50g tube and there is very little information available regarding its effectiveness and how it compares to other hydrating emollients commonly used to treat radiation dermatitis within the NHS. After seeking specialist information from The Royal Marsden Hospital, oncologists at The Royal Marsden recommend the use of Aqueous cream for skin which is intact and dry. If the skin is broken and moist (moist desquamation), Hydrogel would be more effective. E45 cream is not recommended as it contains lanolin which can be sensitizing, and it’s also not a good hydrator. Aloe Vera gel (99% or higher) may help with the burning and stinging of radiation dermatitis although it is not effective as a hydrating product. You can find out more about skin reactions due to radiotherapy from Sister Ellen Trueman’s work at the following link: http://www.aspenmedicaleurope.com/Downloads/EWMA_Understanding_Managing_Radioth erapy_Induced_Skin_Reactions_150L_05.11_XS300.pdf (Ellen Trueman is radiotherapy sister at the Leeds Teaching Hospitals Trust and winner of the Cancer Nurse Leader Award in the Nursing Times Awards 2011). SUMMARY Follow the South Central Priorities Guidance for prescribing post private referral: offer the patient aqueous cream or Hydrogel for skin with moist desquamation, as per NHS policy. XCLAIR® cream, should be obtained via a private prescription via the patient's consultant FLUTIFORM This is a newly marketed combined steroid inhaler, which contains the corticosteroid, fluticasone propionate and LABA, formeterol fumarate. It is available in 3 strengths and licensed for asthma only, for patients not adequately controlled with inhaled corticosteroids and 'as required' inhaled short-acting β2 agonist. Or for patients already adequately controlled on both an inhaled corticosteroid and a longacting β2 agonist. The 50/5 and 125/5 micrograms inhalers are indicated for 12 years and older, the 250/10 micrograms in 18 years and over. The inhaler is due to be reviewed by the Drug and Therapeutics committee and a statement will be issued shortly after. In the meantime please do not prescribe it and continue to use 3 Fostair as the 1st choice "step three" combined steroid inhaler; the cost of Flutiform and Fostair being comparable. UNLICENSED MEDICINES When Is It Appropriate To Crush Tablets Or Open Capsules? Special-order medicines are unlicensed and expensive and should only be used if there are no alternatives. Pharmaceutical specials are unlicensed medicines that have not been assessed for safety, quality or efficacy by the relevant licensing authorities and are not required to be manufactured to the same standards of Good Manufacturing Practice (GMP) that is normal for pharmaceuticals. The prescriber takes responsibility for the quality of the medicine and any adverse effects experienced by the patient when prescribing 'specials'. Prescribers and pharmacists have a responsibility to ensure that ‘specials’ are only prescribed and dispensed where there is no suitable licensed alternative available. Unlicensed medicines represent a considerable cost to the NHS and many would not pass the NICE QALY criteria for clinical / cost effectiveness if it were to be applied. A STEP wise approach to prescribing unlicensed medicines is recommended. STEP 1: Is the medication essential? It might, in some instances, be more appropriate to stop therapy, either temporarily or long term STEP 2: Can the medication be given in a different licensed formulation? e.g. dispersible/soluble tablets, liquid preparations, patches, suppositories or injections. STEP 3: In some cases a different medicine within the same class can be prescribed that does not need to be swallowed whole or is available as an alternative formulation. STEP 4: Use a licensed medicine in an unlicensed manner, for example by crushing / dispersing tablets in water or by opening capsules. To check if a medicine is suitable for administration in this way please check with the medicines optimisation team who use medicines information resources and The Newt Guidelines for Administration of Medication to Patients with Enteral Feeding Tubes or Swallowing Difficulties to advise you. STEP 5: In the few situations where there is no licensed option, consider using a ‘special’. Special-order (‘special’) medicines are unlicensed and expensive and should only be used if there is no licensed medicine that meets the patient’s needs. CARE HOMES: Care staff may only administer medicines in an unlicensed manner on the instruction of the prescriber. A written direction to crush or disperse tablets or to open capsules must be documented in the patient’s care plan. The medicines optimisation team are able to supply practical directions to support crushing / opening capsules for individual cases. Patients administered medication in a crushed form must always be informed that the medication has been opened or crushed for ease of swallowing and consent obtained from the patient before administering. This is different to COVERT administration. 4 CALCIUM AND VITAMIN D3 SUPPLEMENTATION FOR MOBILE CARE HOME PATIENTS The use of combined calcium and vitamin D3 supplementation has been found to reduce fracture rates in older people in residential/nursing homes and sheltered accommodation. Those at higher risk of falls and fracture, such as those in nursing or residential homes, or patients receiving long term corticosteroids, should be considered for additional supplementation with calcium and vitamin D, at evidence-based doses (1g per day for calcium and around 800 units per day for vitamin D). Importantly, this includes those on a bisphosphonate or other osteoporosis treatment, as all of the trials for these drugs were conducted in people with optimal calcium and vitamin D intake. There are a number of licensed preparations that will supply the evidence-based doses of 1g per day for calcium and around 800 units per day for vitamin D, and practitioners should ensure that this is the case when prescribing, dispensing or administering this treatment. Berkshire East formulary currently recommends Adcal D3 chewable tablets (1 twice daily) or Accrete D3 Caplets, (1 twice daily) for those patients who prefer caplets. ACCRETE D3® – A COST-EFFECTIVE CALCIUM AND VITAMIN D CAPLET Accrete D3 is a caplet containing 600mg Calcium and 400iu Vitamin D per caplet. The recommended dose is “one caplet twice daily”. This is equivalent to Adcal D3 chewable tablets but may be preferable for patients who don’t like the chewable tablets. It is also lower cost than Adcal D3. It has been added to the local formulary. N.B. Please note that this product does contain gelatin. If a patient requires a gelatin-free product then Adcal D3 caplets can be prescribed. Adcal D3 caplets are certified Halal and Kosher. Product Content per dose unit Dose Accrete D3 caplet Adcal D3 chewable Adcal D3 caplet Calcium 600mg + Vitamin D 400iu Calcium 600mg + Vitamin D 400iu Calcium 300mg + Vitamin D 200iu ONE caplet TWICE daily Cost per 28 days £2.75 ONE tablet TWICE daily £3.65 TWO caplets TWICE daily £3.65 ______________________________ NICE, Clinical Guideline 21: Falls: The assessment and prevention of falls in older people, November 2004 . [http://www.nice.org.uk/nicemedia/live/10956/29583/29583.pdf] MeRec rapid review, Feb 2010. ACIFEROL® – NEW VITAMIN D LIQUID AVAILABLE Some new Colecaliferol liquid formulations have become available: Product Aciferol D3 2000iu/ml liquid Aciferol D3 3000iu/ml liquid Baby D 1000iu/ml liquid Size 100ml 100ml 30ml Cost £18.00 £24.99 £4.50 5 These are significantly lower cost than prescribing generically as Colecalciferol liquid. Additionally, by specifying a brand we can be assured of getting a product of consistent quality. If a liquid is required short term for proven deficiency in a child then these products represent good choices. SIMVASTATIN-AMLODIPINE INTERACTION: REMINDER OF NATIONAL AND LOCAL ADVICE The MHRA has updated the interactions with simvastatin based upon a recent analysis of clinical trial data, spontaneously reported cases and drug- drug interaction studies. These interactions may increase plasma concentrations of simvastatin which is associated with an increased risk of myopathy and/or rhabdomyolysis. Key points to note are that: Simvastatin is now contraindicated with ciclosporin, danazol and gemfibrozil The maximum recommended dose for simvastatin in conjunction with bezafibrate, amlodipine or diltiazem is now 20 mg/day Recommendation: Any patient complaining of muscle aches or with indicative blood results, reduce the dose of simvastatin below 40mg or switch to atorvastatin 10mg or 20mg. Many practices will have a large number of patients co prescribed simvastatin 40mg and amlodipine, therefore it may be appropriate to review patients who are and have been for some time stable and without problem at their 6monthly/yearly review or opportunistically as seen in practice rather than immediately. For patients taking simvastatin for primary prevention there are no targets - reduce simvastatin to 20mg. For other patients either reduce the simvastatin dose to 20mg or consider replacing with a statin of equivalent potency such as atorvastatin 10/20mg. Avoid high cost rosuvastatin. If simvastatin is the only statin that a patient can tolerate then consider changing the amlodipine to an alternative calcium channel blocker that does not have the same interaction e.g. Felodipine, Lacidipine, Lercanidipine. N.B. The dose of simvastatin is limited to 20mg because the interacting drugs reduce simvastatin metabolism, potentially increasing its plasma concentration above that usually provided by a 40mg dose. This may mean that your patient receives better cholesterol lowering with the 20mg dose than usual. EAST BERKSHIRE JOINT FORMULARY NOW AVAILABLE ONLINE The medication formulary jointly agreed between the CCGs in East Berkshire and HWPH is now available publically on the internet. It is a useful resource for clinicians in the area because: It lists which medications are formulary and which are non-formulary locally. It gives the traffic light status of medications i.e. Red, Amber or Green. Over time local prescribing guidelines and pathways will be added so that all this information is available in one place. Freedom of information enquiries regarding medications and guidelines can be directed there. The formulary can be found here: 6 http://eastberks.formulary.co.uk/ or via a link on HWPH’s home page. 7 HYPNOTICS: SUPPORT FOR REDUCING PRESCRIBING There are significant risks associated with the prescribing of hypnotics (Nitrazepam, Temazepam, Zopiclone, Zolpidem, Lormetazepam, Loprazolam): Falls & fractures Accidents Dependence & withdrawal Cognitive impairment More recently, an association between higher prescribing rates and dementia and mortality have also been suggested. All hypnotics are licensed for maximum 2 to 4 weeks treatment and only if the insomnia is severe, disabling or causing extreme distress. N.B. Benzodiazepine or z-drugs are not recommended by NICE or BHFT for anxiety. For anxiety a SSRI should be used 1st line, followed by another SSRI, then Mirtazapine or Venlafaxine, then Pregabalin as 4th line. New prescriptions – Talking Therapies is available for patient with sleep disorders. Additionally, sleep hygiene measures can be effective. Medication should be last resort and, when prescribed, should be for a maximum of 14 days at a low dose. Established patients – Established patients cannot be ignored or labelled a “historic problem”, they must be addressed and every effort made to reduce their hypnotic use. A series of support materials have been produces by the Medicines Optimisation Team to aid review and step-down of long-term patients e.g. letters, algorithms for dose reduction, posters, patient leaflets. Please speak to your practice pharmacist about these. 8