November 2018 Review date: November 2020

Transcription

1 November 2018 Review date: November 2020

2 Executive Summary 3 Introduction 4 Background 4 Scope 5 Resources to implement this policy 6 Policy review 6 Table of items with formulary indication 7 Co-proxamol 7 Dosulepin 7 Doxazosin modified release 8 Immediate release fentanyl 8 Glucosamine and Chondroitin 9 Herbal therapies 9 Homeopathy 9 Lidocaine plasters 10 Liothyronine 11 Lutein and antioxidants 12 Omega 3 Fatty acids compounds 13 Oxycodone and naloxone combination products 14 Paracetamol and tramadol combination products 14 Perindopril arginine 15 Rubefacients 15 Tadalfil once daily 16 Travel Vaccines 17 Trimipramine 17 Appendix A : Dosulepin/Trimipramine audit Appendix B : Doxazosin modified release review 20 Appendix C : Lidocaine patches Appendix D: Perindopril arginine 23 Appendix E : Exception reporting form 24

3 Executive Summary This policy sets out the strategy to ensure prescribing spend is rationalised and medication with low clinical or cost effectiveness are not prescribed. Inclusion Criteria for items that should not be routinely prescribed in primary care: Products of low clinical effectiveness where there is lack of robust evidence of clinical effectiveness or there are significant safety concerns Products that are clinically effective but where more cost effective products are available, including products that have been subject to excessive price inflation Products which are clinically effective but due to the nature of the product are deemed a low priority for NHS funding This policy is a localised version of the NHSE guidance on items that should not be routinely prescribed in primary care and highlights the red (secondary care/specialist) status of any drug as per Sandwell & West Birmingham CCG s formulary. This policy also provides practical guidance on how to manage deprescribing and provides switching information advice. Clinicians should exercise their clinical judgement in making decisions appropriate to the individual patient s circumstances and in exceptional circumstances can deviate from this policy where it is in the best interest of the patient. Clinicians should only prescribe medicines that are known to be clinically effective and provide health benefits to the patient. Sandwell and West Birmingham CCG advises that only treatments that are clinically effective and provide a clear health benefit to patients should be prescribed on NHS prescriptions In the case of treatments which can be prescribed on NHS prescriptions, there are some which provide limited health benefit. They should be considered as a low priority and not suitable for prescribing unless patients fall into an exception category Items that should not be routinely prescribed in primary care V1 November of 24

4 1.0 Introduction This policy has been developed in line with NHSE s guidance on Items which should not be routinely prescribed in primary care: Guidance for CCGs Publication Sandwell and West Birmingham CCG spent approximately 78 million on prescribing in the financial year 2017/18. Out of this spend, 1 million was spent on items that have no cost or evidence base. It is inappropriate to direct NHS resources towards products that do not have proven efficacy or safety in preference to licensed medicines. This policy highlights the formulary status of the 18 drugs listed in the NHSE guidance. SWB CCG encourages clinicians to refer to the local health economy formulary and guidelines, accessible at: As a CCG, we have a finite budget which we use to commission healthcare that meets the reasonable requirements of our patients. This policy aims to rationalise the use of resources so that cost and clinically effective medication are used to achieve greater benefits for our patients. Sandwell and West Birmingham CCG considers all lives of all patients whom it serves to be of equal value and, in making decision about funding treatments for patients, will not discriminate on the grounds of sex, age, sexual orientation, ethnicity, educational level, employment, marital status, religion or disability save where a difference in the treatment options made available to patients is directly related to the patient s clinical condition or is related to the anticipated benefits to be derived from a proposed form of treatment. The policy will help reduce health inequalities and allow fair and equitable treatment for all our patients. 2.0 Background A clinical working group consisting of NHS clinical commissioners, NHSE, NICE, the Royal College of General Practitioners, the Royal Pharmaceutical Society and others made recommendations on 18 items listed under the scope section of this policy. The 18 items were chosen on the basis that they have limited evidence base for clinical effectiveness or there are safety concerns, are clinically effective however more cost effective products are available or are costly or deemed low priority for NHS funding. The recommendations were subject to a national public consultation for a period of 3 months (July-October 2017) and a local SWB CCG public consultation (23 rd March 2017 to 13 th July 2017). The NHSE guidance has also been presented to the Drugs and Therapeutics Committee at Sandwell & West Birmingham Hospital so specialists are aware of national guidance including prescribing of liothyronine and lidocaine plasters. Items that should not be routinely prescribed in primary care V1 November of 24

5 3.0 Scope The 18 items that should not be routinely prescribed in primary care are: Co-proxamol Dosulepin Modified release doxazosin Immediate release fentanyl Glucosamine and chondroitin Herbal treatments Homeopathy Lidocaine plaster Liothyronine Lutein and anti-oxidants Omega-3 fatty acids Oxycodone and naloxone combination product Paracetamol and tramadol combination product Perindopril arginine Rubefacients (excluding topical NSAIDs) Tadalafil once daily Trimipramine The policy applies to: All clinicians working within GP practices at Sandwell & West Birmingham CCG who prescribe for patients. Out of hours and extended hours primary care providers NHS community providers Acute trusts as well as outpatients clinics Independent providers Opticians Dentists No new patients should be commenced on any of the items included in this policy. We recognise that for patients who have been established on an item for some time, it may be necessary to explore further options, or seek further management advice prior to de-prescribing. We also recognise that there will be exceptional circumstances whereby the prescriber considers no alternative medicine or intervention is clinically appropriate and available for the patient. These exceptions should be reported using the exception reporting form in Appendix E. The application of the policy does not override the professional responsibility of the health professional to make a clinical judgement based on any policy recommendations and in conjunction with the individual needs of the patient. Items that should not be routinely prescribed in primary care V1 November of 24

6 4.0 Resources to implement this policy The Sandwell & West Birmingham CCG formulary and Optimise Rx messages have been updated in line with the policy. Patient letters and information leaflets produced by PrescQIPP have been uploaded onto emis Web and SystmOne. They can also be accessed at: Searches for the 18 items have been produced and uploaded onto the PCCF standard 9 file on emisweb and SystmOne. The NHSE guidance on items that cannot be routinely prescribed in primary care can be accessed at Audit tools are available for downloading from the PrescQIPP s website, which can be availed to practices on request to the medicines quality team. Regional medicines optimisation committee s guidance on Liothyronine published November 2018, which can be accessed at Liothyroinine-Guidance-v2.0-final.pdf 5.0 Policy review This policy will be reviewed and updated when NHSE update their guidance for items that should not be routinely prescribed in primary care. Items that should not be routinely prescribed in primary care V1 November of 24

7 6.0 Table of items that should not be routinely prescribed in primary care The table summarises all of the 18 items with rationale for inclusion in the policy, recommendations and exceptions where applicable. Item Rationale Recommendation Exception Co-proxamol (dextropropoxyphene+ paracetamol) Co-proxamol is an analgesic previously licensed in the UK until being fully withdrawn from the market in 2007 due to safety concerns and all use is now on an unlicensed basis. Since 1985 advice aimed at the reduction of co-proxamol toxicity and fatal overdose has been provided and were not effective, resulting in withdrawal of co-proxamol by the MHRA. Since the withdrawal further safety concerns have been raised which have resulted in co-proxamol being withdrawn in other countries. No new patients should be initiated on co-proxamol De-prescribe co-proxamol in existing patients; patient s pain should be ideally reassessed and appropriate analgesia initiated. In the interim, patient could be prescribed paracetamol and a weak opioid separately. Where it has proven difficult to de-prescribe co-proxamol, consider referral to facilitate this change. Dosulepin (Dothiepin) Dosulepin (formerly known as dothiepin) is a tricyclic antidepressant. NICE CG90: Depression in Adults has a do not do recommendation, Do not switch to, or start, dosulepin because evidence supporting its tolerability relative to other antidepressants is outweighed by the increased cardiac risk and toxicity in overdose. No new patients should be initiated on dosulepin De-prescribe dosulepin in all patients with support from specialist services if needed. See Appendix A for more information. Dosulepin should not be stopped suddenly; the dose should be tapered over three to four weeks to prevent discontinuation symptoms. For more information on stopping or switching, see In exceptional circumstances if there is a clinical need for dosulepin to be prescribed in primary care, the decision should be undertaken with a multi-disciplinary team and/or other health professional. Items that should not be routinely prescribed in primary care V1 November of 24

8 Item Rationale Recommendation Exception Prolonged released Doxazosin ( also known as Doxazosin Modified release) Doxazosin is an alpha-adrenoceptor blocking drug that can be used to treat hypertension and benign prostatic hyperplasia. There are two oral forms (immediate release and prolonged) and both are taken once daily. Prolonged release doxazosin is approximately six times the cost of immediate release. (NHS Drug Tariff). NICE CG127 Hypertension in adults: diagnosis and management recognised that doxazosin should be used in treatment but does not identify benefits of prolonged release above immediate release. NICE CG97 Lower urinary tract symptoms in men: recommends doxazosin as an option in men with moderate to severe lower urinary tract symptoms. It does not identify benefits of prolonged release above immediate release. No new patients should be initiated on prolonged release doxazosin Review with a view of de-prescribing prolonged release doxazosin in all patients. Check that doxazosin has been prescribed appropriately in line with NICE hypertension or BPH guidance. Where doxazosin is an appropriate choice, switch to immediate release doxazosin. See Appendix B for more information. Immediate release fentanyl e.g. fentanyl lozenges, buccal and nasal spray Fentanyl is a strong opioid analgesic. It is available as an immediate release substance in various dosage forms; tablets, lozenges, films and nasal spray. Immediate release fentanyl is licensed for the treatment of breakthrough pain in adults with cancer who are already receiving at least 60mg oral morphine daily or equivalent. NICE CG140 Opioids in Palliative Care states Do not offer fast-acting fentanyl as first-line rescue medication. No new patients should be initiated on immediate release fentanyl De-prescribe immediate release fentanyl in all patients, with support from specialist services as needed. Consider alternative analgesics where there is an ongoing need. Fentanyl immediate release is a red drug on the formulary, i.e. prescribing should be initiated and maintained by palliative care. Items that should not be routinely prescribed in primary care V1 November of 24

9 Item Rationale Recommendation Exception Glucosamine and Chondroitin Glucosamine and Chondroitin are nutraceuticals used to improve pain associated with osteoarthritis. The BNF states the following about glucosamine: The mechanism of action is not understood and there is limited evidence to show it is effective. No new patients should be initiated on glucosamine/chondroitin De-prescribe glucosamine/chondroitin in all patients NICE CG177: Osteoarthritis care and management has the following do not do recommendation: Do not offer glucosamine or chondroitin products for the management of osteoarthritis Herbal treatments Under a Traditional Herbal Registration there is no requirement to prove scientifically that a product works, the registration is based on longstanding use of the product as a traditional medicine. No new patients should be initiated on herbal treatments De-prescribe herbal treatments in all patients Due to the lack of scientific evidence required to register these products with the MHRA, the above recommendation has been implemented. Homeopathy Homeopathy seeks to treat patients with highly diluted substances that are administered orally. A review conducted by the Specialist Pharmacy Service found that there was no clear or robust evidence to support the use of homeopathy on the NHS. No new patients should be initiated on homeopathic treatments De-prescribe homeopathic treatments in all patients Items that should not be routinely prescribed in primary care V1 November of 24

10 Item Rationale Recommendation Exception Lidocaine plasters Specialist initiation for post-herpetic neuralgia Lidocaine plasters can be applied for pain relief and are licensed for symptomatic relief of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN) in adults. NICE CG173 Neuropathic pain in adults: pharmacological management in non-specialist settings does not recommend lidocaine plasters for treating neuropathic pain. No new patients should be initiated on lidocaine plaster. De-prescribe lidocaine plaster in all patients, for indications other than postherpetic neuralgia. Consider alternative analgesic. See Appendix C for more information Patients who have been treated in line with NICE CG 173 Neuropathic pian in adults: pharmacological management in non-specialist settings, but are still experiencing neuropathic pain associated with post-herpetic neuralgia Items that should not be routinely prescribed in primary care V1 November of 24

11 Item Rationale Recommendation Exception Liothyronine and combinations e.g. Armour Thyroid (AT), Nature- Throid, Westhroid, Cytomel, NP Thyroid and ERFA thyroid) Specialist/Hospital prescribing only Liothyronine (sometimes known as T3) is used to treat hypothyroidism. It has a similar action to levothyroxine but is more rapidly metabolised and has a more rapid effect. It is sometimes used in combination with levothyroxine in products. The price of liothyronine has risen significantly and there is limited evidence for efficacy above Levothyroxine. The British Thyroid Association, in their 2015 position statement, state There is no convincing evidence to support routine use of thyroid extracts, L-T3 monotherapy, compounded thyroid hormones, iodine containing preparations, dietary supplementation and over the counter preparations in the management of hypothyroidism. Evidence that a cohort of patients who require liothyronine and there are some exceptions based on guidance from the British Thyroid Association. Do not initiate new prescriptions for Liothyronine or liothyronine containing products.requests from private consultants and other NHS consultants should NOT be accepted for primary care NHS prescribing, as Liothyronine is classed red( specialist prescribing) in our formulary Where a GP initiated the liothyronine, review the appropriateness of liothyronine and consider switching to the equivalent dose of levothyroxine (20-25 micrograms of Liothyronine is equivalent to 100 micrograms of levothyroxine). Seek endocrinology advice if needed. For patients whose liothyronine was initiated by an endocrinologist, the patient should be reviewed by the initiating endocrinologist with consideration given to switching to levothyroxine where clinically appropriate. Where a NHS endocrinologist assesses that there is a need for ongoing treatment with liothyronine, the specialist should maintain the prescribing within secondary care. Patients under a private endocrinologist should be referred back to the private service for private prescription of liothyronine or recommendation of an alternative treatment The British Thyroid Association (BTA) advise that a small proportion of patients treated with levothyroxine continue to suffer with symptoms despite adequate biochemical correction. These patients Liothyronine should be prescribed within secondary care. Liothyronine is also used for patients with thyroid cancer, in preparation for radioiodine ablation, iodine scanning, or stimulated thyroglobulin test. Here it is appropriate for patients to obtain their prescriptions from the specialist. Items that should not be routinely prescribed in primary care V1 November of 24

12 Item Rationale Recommendation Exception Lutein and Antioxidants e.g. Preservision_Lutein caps, Viteyes Orig for Plus Lutein Caps, Ocuvite_ Lutein Caps Lutein and antioxidants (e.g. vitamin A, C E and zinc) are supplements which are sometimes recommended for Age Related Macular Degeneration. A variety of supplements are available to purchase in health food stores and other outlets where they are promoted to assist with eye health. Two Cochrane Reviews have been conducted on this topic: Antioxidant vitamin and mineral supplements for preventing age-related macular degeneration 53.pub3/full The authors conclude There is accumulating evidence that taking vitamin E or beta-carotene supplements will not prevent or delay the onset of AMD. There is no evidence with respect to other antioxidant supplements, such as vitamin C, lutein and zeaxanthin, or any of the commonly marketed multivitamin combinations. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration 54.pub3/full The authors conclude People with AMD may experience delay in progression of the disease with antioxidant vitamin and mineral supplementation. This finding is drawn from one large trial conducted in a relatively well-nourished American population. The generalisability of these findings to other populations is not known. PrescQIPP CIC has issued a bulletin which did not find evidence to support prescribing of lutein and antioxidants routinely on the NHS. NICE have published draft consultation guidance on Age-Related Macular Degeneration and proposed that the effectiveness and cost-effectiveness of the use of lutein and antioxidants is currently a research recommendation. No new patients should be initiated on lutein and antioxidants De-prescribe lutein and antioxidants in all patients. Items that should not be routinely prescribed in primary care V1 November of 24

13 Item Rationale Recommendation Exception Omega-3 Fatty Acid Compounds There are essential fatty acids which can be obtained from the diet. They are licensed for adjunct to diet and statin in type IIb or III hypertriglyceridemia; adjunct to diet in type IV hypertriglyceridemia; adjunct in secondary prevention in those who have had a myocardial infarction in the preceding 3 months. e.g. Nebbaro, Omacor, Prestylon, Teromeg, EPA/DHA caps etc. NICE have reviewed the evidence and advised they are not suitable for prescribing by making Do not do recommendations Do not offer or advise people to use omega-3 fatty acid capsules/supplemented foods to prevent another myocardial infarction Do not offer omega-3 fatty acid compounds for the prevention of cardiovascular disease to any of the following: people who are being treated for primary prevention, people who are being treated for secondary prevention, people with chronic kidney disease, people with type 1 diabetes, people with type 2 diabetes. Do not offer the combination of a bile acid sequestrant (anion exchange resin), fibrate, nicotinic acid or omega-3 fatty acid compound with a statin for the primary or secondary prevention of CVD. Do not offer omega-3 fatty acids to adults with non-alcoholic fatty liver disease because there is not enough evidence to recommend their use. Do not use omega-3 fatty acids to manage sleep problems in children and young people with autism. People with familial hypercholesterolemia (FH) should not routinely be recommended to take omega-3 fatty acid supplements. Do not offer omega-3 or omega-6 fatty acid compounds to treat multiple sclerosis (MS). There is no evidence that they affect relapse frequency or progression of MS. No new patients should be initiated on omega-3 Fatty Acids De-prescribe Omega-3 Fatty Acids in all patients. Patients wishing to continue this treatment OTC should be advised they can purchase it OTC. If people choose to take omega-3 fatty acid capsules or eat omega-3 fatty acid supplemented foods, be aware that there is no evidence of harm. Items that should not be routinely prescribed in primary care V1 November of 24

14 Item Rationale Recommendation Exception Oxycodone and Naloxone Combination Product Oxycodone and naloxone combination product is used to treat severe pain and can also be used second line in restless legs syndrome. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut. PrescQIPP CIC have issued a bulletin and did not identify a benefit of oxycodone and naloxone in a single product over other analgesia (with laxatives if necessary). Due to the significant cost of the oxycodone and naloxone combination product and the unclear role of the combination product in therapy compared with individual products, it is not recommended for prescribing No new patients should be initiated on oxycodone and naloxone combination product Reviews existing patients and de-prescribe oxycodone and naloxone combination product in all patients. Consider prescribing morphine (or oxycodone if there is a clear indication for it) and a laxative instead. Advise that in exceptional circumstances if there is a clinical need for oxycodone and naloxone combination product to be prescribed in primary care this should be undertaken with a multi-disciplinary team and/or other health professional. Paracetamol and Tramadol Combination Product Paracetamol and tramadol combination products are more expensive than the products with the individual components. PrescQIPP CIC also issued a bulletin which did not identify any significant advantages over individual products, however it does recognise that some people may prefer to take one product instead of two. There are also different strengths of tramadol (37.5mg) and paracetamol (325mg) in the combination product compared to commonly available individual preparations of tramadol (50mg) and paracetamol (500mg), although the PrescQIPP CIC review found no evidence that combination product is more effective or safer than the individual preparations. No new patients should be initiated on paracetamol and tramadol combination product. Review existing patients with aim of prescribing either as separate medicines so that doses can be optimised and titrated individually, or switch to paracetamol and codeine. Items that should not be routinely prescribed in primary care V1 November of 24

15 Item Rationale Recommendation Exception Perindopril Arginine The perindopril arginine salt version was developed as it is more stable in extremes of climate than the perindopril erbumine salt, which results in a longer shelf-life. Perindopril arginine is significantly more expensive than perindopril erbumine and a PrescQIPP CIC review of the topic found there was no clinical advantage of the arginine salt. NICE CG 127 Hypertension guidance recommends that prescribing costs are minimised. Perindopril arginine is non-formulary so no new patients should be initiated on this. Switch perindopril arginine to perindopril erbumine in all patients. See Appendix D for more information on switching. Rubefacients Rubefacients are topical preparations that cause irritation and reddening of the skin due to increased blood flow. They are believed to relieve pain in various musculoskeletal conditions and are available on prescription and in over-the-counter remedies. They may contain nicotinate compounds, salicylate compounds, essential oils and camphor. The BNF states The evidence available does not support the use of topical rubefacients in acute or chronic musculoskeletal pain. NICE have issued the following Do not do recommendation: Do not offer rubefacients for treating osteoarthritis. Rubefacients are non-formulary. No new patients should be initiated on rubefacients (excluding NSAIDs); advise OTC purchase where appropriate. De-prescribe rubefacients (excluding NSAIDs) in all patients. Do not routinely offer topical NSAIDs instead of rubefacients. Consider alternatives e.g. topical NSAIDs for long term conditions, where appropriate. Items that should not be routinely prescribed in primary care V1 November of 24

16 Item Rationale Recommendation Exception Tadalafil Once daily Tadalafil is a phosphodiesterase-5-inhibitor and is available in strengths of 2.5mg, 5mg, 10mg and 20mg used to treat erectile dysfunction. In addition 2.5mg and 5mg can be used to treat benign prostatic hyperplasia. Only 2.5mg and 5mg should be used once daily. 10mg and 20mg are used in a when required fashion. Tadalafil can be prescribed for erectile dysfunction in circumstances as set out in part XVIIIB of the Drug Tariff. Benign Prostatic Hyperplasia: NICE terminated their technology appraisal (TA273) due to receiving no evidence from the manufacturer. In NICE CG97: Lower Urinary Tract Symptoms in Men NICE state that there is not enough evidence to recommend phosphodiesterase inhibitors in routine clinical practice. Erectile Dysfunction: PrescQIPP CIC have reviewed the evidence for Tadalfil and although tadalafil is effective in treating erectile dysfunction, there is not enough evidence to routinely recommend once daily preparations in preference to when required preparations particularly as when required preparations are now available as a generic. Tadalafil once daily is non-formulary. No new patients should be initiated on tadalafil once daily De-prescribe tadalafil once daily in all patients. Switch to Sildenafil (if not tried before) or once weekly or PRN tadalafil (even if initiated by Urology) specialists), where there is ongoing need. Items that should not be routinely prescribed in primary care V1 November of 24

17 Item Rationale Recommendation Exception Travel Vaccines for travel purposes The following vaccines may still be administered on the NHS exclusively for the purposes of travel, if clinically appropriate, pending any future review: Cholera Hepatitis A Diphtheria/Tetanus/Polio Typhoid This guidance covers the following vaccinations which should not be prescribed on the NHS exclusively for the purposes of travel: No new patients should be initiated on vaccines exclusively for the purpose of travel Note this is a restatement of existing regulations and no changes have been made to the recommendation. ( for travel purpose) Hepatitis B Rabies Japanese Encephalitis BCG Meningitis ACWY Yellow fever Tick-borne encephalitis These vaccines should continue to be recommended for travel but the individual traveller will need to bear the cost of the vaccination.for all other indications, as outlined in Immunisation Against Infectious Disease the green book the vaccine remains free on the NHS. Trimipramine Trimipramine is a tricyclic antidepressant (TCA) however the price of trimipramine is significantly more expensive than other antidepressants. NICE CG90: Depression in Adults recommends selective serotonin reuptake inhibitor (SSRI) antidepressants first line if medicines are indicated as they have a more favourable risk: benefit ratio compared to TCA. However if a TCA is required there are more cost-effective TCAs than trimipramine available. No new patients should be initiated on trimipramine. Trimipramine is non-formulary. Review with a view of de-prescribing trimipramine in all patients, with support from specialist services if needed.if treatment is still indicated, consider switching to an alternative appropriate antidepressant. For patients under the care of a specialist, the specialist should be involved in the decision to switch. See Appendix C for more information. Items that should not be routinely prescribed in primary care V1 November of 24

18 Appendix A: Dosulepin / Trimipramine Audit Data collection form Patient no. Age Trimipramine/Dosulepin strength and dose Initiated by: Duration of use Concordance Action e.g. switch to alternative, refer to specialist, No longer indicated Items that should not be routinely prescribed in primary care V1 November of 24

19 Aim The aim of this audit is to review the prescribing of the antidepressants dosulepin or trimipramine. This is with a view to optimising safety/cost effective NHS prescribing. Method 1. Run the search for Dosulepin/Trimipramine, which is located under standard 9 of PCCF folder on emis Web and SystmOne. 2. For any patient under the age of 18 years on trimipramine, refer them to a specialist for a more suitable alternative. 3. Review the appropriateness of trimipramine in all other patients, review concordance to treatment and consider whether treatment is still indicated (based on the person s risk of relapse of depression in accordance with NICE). 4. If treatment is still indicated consider switching to an alternative appropriate antidepressant. For patients under the care of a specialist, the specialist should be involved in the decision to switch. 5. Patients prescribed dosulepin/ trimipramine for unlicensed indications other than depression in adults (e.g. anxiety, neuropathic pain, fibromyalgia or insomnia) should be considered for discontinuation of treatment or switched to a more appropriate alternative. 6. Communicate (involving patients in the decision making) and carry out the discontinuation or switch for all suitable patients, referring back to secondary care for advice, if necessary. Abrupt switching or cessation of treatment should be avoided due to the risk of withdrawal symptoms. For more information on stopping or switching Dosulepin, see Please refer to the Trimipramine Low Value Medicines Bulletin for guidance on gradual withdrawal or cross-tapering, accessible at 7. Communicate with local community pharmacies to ensure that they are able to respond appropriately to any patient queries. Monitoring Ensure that all patients (or their carers) fully understand how to manage their gradual discontinuation or managed switch to an alternative antidepressant to reduce the risk of withdrawal symptoms. All patients should be regularly reviewed during the switching process. A further review is recommended after switching/stopping to ensure compliance and appropriate response to treatment (if switched) or continued complete remission of symptoms if stopped. References: PrescQIPP resources for Dosulepin, accessed online on 18/10/18 at PrescQIPP resources for Trimipramine accessed online on 18/10/18 at Items that should not be routinely prescribed in primary care V1 November of 24

20 Appendix B: Doxazosin Modified release (MR) review Guidance and recommendations for clinicians Sandwell & West Birmingham CCG do not support the prescribing of Doxazosin modified release (MR) /Cardura XL/Doxadura XL or any other modified release products, and it is recommended that MR prescribing is changed to generic standard release. Dosing MR versus standard release It is essential to pay careful attention to the dosing regimens for doxazosin MR and doxazosin standard release. For hypertension: Doxazosin MR can be initiated at a 4mg OD, then dose can be increased to 8 mg OD after 4 weeks if necessary. The standard release doxazosin preparation is initiated at 1mg once daily, increasing after 1-2 weeks as necessary to 2mg once daily, and thereafter 4mg once daily, to a maximum of 16mg daily. For BPH: The maximum licensed daily dose of both doxazosin modified release and standard release doxazosin is 8mg daily Before conducting doxazosin MR to standard release switch, it would be beneficial to consider whether doxazosin prescribing is in line with NICE guidance, as well as assess patient compliance. NICE recommends α-blockers, such as doxazosin, are considered at step 4 of the treatment algorithm for patients with resistant hypertension, where further diuretic therapy is not tolerated, or is contraindicated or ineffective NICE recommends α-blockers, such as doxazosin for the management of moderate to severe lower urinary tract symptoms in BPH in men, if conservative management options have been unsuccessful or are not appropriate. NICE suggest considering offering a combination of an alpha blocker and a 5-alpha reductase inhibitor to men with bothersome moderate to severe lower urinary tract symptoms (LUTS) and prostates estimated to be larger than 30 g or a prostate specific antigen (PSA) level greater than 1.4 ng/ml. Patients currently prescribed doxazosin MR should be reviewed to assess whether they are suitable to have treatment changed to standard release doxazosin Items that should not be routinely prescribed in primary care V1 November of 24

21 Switching doxazosin MR to doxazosin standard release There are three potential change options, although clinicians may choose other options according to the clinical need of the patient. 1. Use the same dose (e.g. 4mg MR to 4mg standard release). Patients experiencing orthostatic hypotension may need a lower dose. 2. Use half the dose (e.g. 4mg MR to 2mg standard release). Some patients may need a higher dose subsequently. 3. Initiate therapy at 1mg daily of standard release doxazosin, increasing at weekly, fortnightly intervals as stated in the SPC as for new patients commenced on treatment. Monitoring Whichever dose is chosen, it is important to monitor blood pressure (about 2-4 weeks after the switch) and patient symptoms closely; adjust the dose if necessary. With any of these switches, patients may experience postural hypotension evidenced by dizziness, weakness or rarely syncope, particularly in the first few hours after doxazosin therapy is changed. Patients should be advised to sit or lie down if they feel dizzy or faint until they feel better and to seek medical attention if significantly affected. If the patient is affected, they should be advised to avoid situations where falls as a result of dizziness or faintness could result in injury. If patients are changed from MR to standard release, be aware that giving the same dose of the standard release formulation may result in a much higher peak and may increase the risk of hypotension. It may be better to give a lower dose and titrate upwards according to response, especially in older people. References UKMI & SPS June 2018 Switching from modified release doxazosin to standard release doxazosin in patients with hypertension, accessed online on 28/9/18 Hypertension in adults: diagnosis and management, NICE guidelines (CG127) Published date: August 2011,updated November 2016 Accessed online 28/9/18 at: Lower urinary tract symptoms in men: Management. (CG97) Published date: May 2010, updated June Accessed online on 28/9/18 Summary of Product Characteristics for Doxazosin and Cardura XL 4mg Tablets. Accessed online 28/9/18 at: Items that should not be routinely prescribed in primary care V1 November of 24

22 Appendix C: Lidocaine Patches Lidocaine 5% plasters are only licensed for neuropathic pain associated with previous herpes zoster infection (postherpetic neuralgia). Local neuropathic pathway have Lidocaine as an option for treatment of post herpetic neuralgia, where patients are intolerant to or found other oral treatments ineffective. See for more information. If prescribing/reviewing Lidocaine 5% patches: For those prescribed treatment for an unlicensed indication, review and discontinue treatment. If continued therapy is needed, consider alternative treatments appropriate to the indication. For those prescribed treatment for post-herpetic neuralgia, for whom treatment pathway has not been followed (including consideration or trial of appropriate alternatives), consider reviewing treatment with a view to restarting on treatment pathway. Individual review, including consideration of past treatments and comorbidities / contraindications etc., is essential. Ensure that Lidocaine patches are prescribed as the CCG s preferred cost effective brand Ralvo patches All patients should have at least a 12 hour treatment free period each day. Ensure patients are aware of the 12 hour treatment free period per day and document in notes. Ensure directions on prescriptions have the 12 hour treatment free period included. For people prescribed more than three patches per day - review and reduce number of patches used. This is because only up to three patches per day are licensed. Check also for over / under ordering Ensure all people prescribed lidocaine plasters are reviewed 4 weeks after starting treatment. Discontinue treatment if it is ineffective. If use is longer-term, ensure it is reassessed regularly. At review, consider reducing the number of plasters or increasing the interval between plasters. Consider a 'trial without' (treatment holiday), to assess ongoing need. Reduce the number of plasters or increase interval between plasters if the patient has been on therapy long term- with a view to eventually discontinuing treatment References: PrescQIPP resources/bulletin on Lidocaine patches, accessed online on 18/10/18 at lidocaine-plasters/ Items that should not be routinely prescribed in primary care V1 November of 24

23 Appendix D: Perindopril arginine Sandwell & West Birmingham CCG do not support the prescribing of perindopril arginine (Coversyl Arginine and Coversyl Arginine Plus ) for any indication as it is not a cost effective option. Perindopril is available as different salts, perindopril arginine (Coversyl Arginine ) and perindopril erbumine. Perindopril arginine has no clinical benefit over generic perindopril erbumine and no difference in safety profile but is more expensive for the NHS. The principal reason for the change in the Coversyl Arginine formulation originally (from erbumine to arginine salt) was improved stability which makes it better suited to extremes of (the Australian) climate. The improved stability increases shelf life from two to three years. This is of minor consequence in the UK. Commence new patients on perindopril erbumine, where perindopril is an appropriate angiotensin converting enzyme (ACE) inhibitor choice. Perindopril arginine (Coversyl Arginine ) and perindopril arginine with indapamide (Coversyl Arginine Plus ) are both non-formulary and should not be prescribed Review all patients on Coversyl Arginine and Coversyl Arginine Plus preparations for suitability for switching to generic perindopril erbumine.. The potential switch options from perindopril arginine (Coversyl Arginine ) to perindopril erbumine are shown in the table below with recommended dose equivalence. Current treatment Coversyl Arginine (perindopril arginine) 2.5mg once daily Coversyl Arginine (perindopril arginine) 5mg once daily Coversyl Arginine (perindopril arginine) 10mg once daily Switch to: Perindopril erbumine 2mg once daily Perindopril erbumine 4mg once daily Perindopril erbumine 8mg once daily For patients receiving Coversyl Arginine Plus which contains perindopril arginine 5mg and indapamide 1.25mg, there is not a direct switch. However prescribing perindopril erbumine 4mg plus an appropriate diuretic as a separate component is the best option. This provides greater flexibility of dosing. An appropriate diuretic would be indapamide 2.5mg once daily, according to the NICE clinical guideline for hypertension. References: PrescQIPP Bulletin 59. March V2.0. Perindopril arginine: Switching from Coversyl Arginine products (perindopril arginine) to perindopril erbumine tablets Accessed online 28/9/18 Items that should not be routinely prescribed in primary care V1 November of 24

24 Appendix E: Exceptions reporting form Exception report- items that should not be routinely prescribed in primary care Date of exception reporting Patient number Drug Reason why drug could not be stopped/switched Formulary classified 'red' drugs prescribing should be transferred to specialist and will not be excepted as an exception To be completed manually and returned to your locality medicines quality team by 31st March, Items that should not be routinely prescribed in primary care V1 November of 24

25 Sandwell and West Birmingham CCG Kingston House High Street West Bromwich B70 9LD Tel: Web: Items that should not be routinely prescribed in primary care V1 November of 24