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Treatment of Unproven Value the Medicines Listed Below Are Treatment of Unproven Value The medicines listed below are regarded as low priority, poor value for money or medicines for which there are safer alternatives Rubifacients Movelat®, Algesal®, Deep Heat®, Transvasin®, Balmosa® These topical medications are being prescribed for soft tissue disorders and topical pain relief Evidence There is a lack of evidence to support the use of rubefacients in acute or chronic musculoskeletal pain. A recently updated Cochrane review looked at salicylate-containing rubefacients for acute and chronic musculoskeletal pain in adults and found that any evidence of efficacy came from the older, smaller studies, while the larger, more recent studies showed no effect. Derry S, Matthews PRL, Wiffen PJ, Moore RA. Salicylate-containing rubefacients for acute and chronic musculoskeletal pain in adults. Cochrane Database of Systematic Reviews. November 2014, Issue 11. Art. No.: CD007403. DOI: 10.1002/14651858.CD007403.pub3 Accessed 27/02/2015. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD007403.pub3/abstract https://www.england.nhs.uk/wp-content/uploads/2019/08/items-which-should-not- routinely-be-prescribed-in-primary-care-v2.1.pdf Action Consider not initiating new patients on rubifacients, sign post patients to the community pharmacy to purchase these products. Review all patients currently on rubifacients. Consider recommending or prescribing an effective alternative treatment if still appropriate. If the patient wishes to continue with the previously prescribed treatment advise the patient the product can be purchased in the community pharmacy. Antifungal treatments (Amorolfine 5% nail lacquer (Loceryl®, Curanail®, Omicur®); Tioconazole 28% cutaneous solution (Trosyl®); Salicylic acid, tannic acid & boric acid paint (Phytex®) The above solutions are being prescribed for nail fungal infections Evidence Unsightly nails due to fungal infection are primarily a cosmetic problem. Self–care measures alone (incorporating good nail hygiene) are recommended if the person has few troublesome symptoms. Topical antifungal therapy offers very little benefit for the management of fungal nail infections. There is limited evidence for efficacy in dermatophyte infections. NICE Clinical Knowledge summaries (CKS) recommend that self-care may be appropriate for people who are not bothered by the infected nail or who wish to avoid the possible adverse Approved MOPB June 2017, updated December 2019, next review December 2021 effects of drug treatment. The British Association of Dermatologists (BAD) has produced guidelines on the management of nail infections. These are included in the NICE CKS on fungal nail infections. Recommendations include: - Topical treatment can only be recommended for treating superficial white onychomycosis (SWO), very early distal and lateral subungal onychomycosis (DLSO) or where systemic therapy is contraindicated e.g. liver or renal impairment. Topical treatment is inferior to systemic therapy in all but a small number of cases of very distal infection or in SWO. - Amorolfine (Loceryl or Curanail) nail lacquer is effective only in around 50% of fingernail and toenail dermatophyte infections. - Terbinafine is superior to itraconazole in dermatophyte onychomycosis, and should be considered as first-line treatment, with itraconazole as the next best alternative. Cure rates of 80–90% for fingernail infection and 70–80% for toenail infection can be expected. The most common adverse effects (mild and transient) associated with terbinafine are nausea, mild abdominal pain, diarrhoea, and dyspepsia. These normally resolve on stopping treatment. Hepatotoxicity may occur in people with and without pre-existing liver disease. Rare cases of cholestasis, hepatitis, jaundice, and liver failure have been reported. Serious skin reactions, such as Stevens-Johnson syndrome and lupus erythematosus-like rash have been reported. In cases of treatment failure the reasons for such failure should be carefully considered. In such cases either an alternative drug or nail removal in combination with a further course of therapy to cover the period of regrowth should be considered. - The NICE CKS3 states further that specialist advice is needed for children as fungal nail infection is rare in children, and the preferred treatments are not licensed for use in children. NICE Clinical Knowledge Summary. Fungal nail infection (onychomycosis) Accessed 10/11/13 via http://www.cks.nhs.uk/fungal_nail_infection https://www.england.nhs.uk/wp-content/uploads/2018/03/otc-guidance-for-ccgs.pdf Action If the fungal infection has been confirmed by positive microscopy or positive culture and the condition is severe and debilitating, painful or in patients with peripheral vascular disease, diabetes or those who are immune-compromised consider oral treatment as first line due to improved outcomes. Topical therapy should only be considered if the infection is mild and superficial or where oral treatment therapy is contra-indicated or not tolerated e.g. hepatic or liver impairment. In these cases, patients should be advised to purchase over the counter (OTC) amorolfine 5% nail lacquer for the treatment of a maximum of 2 nails. Approved MOPB June 2017, updated December 2019, next review December 2021 Omega 3 fish oils Omacor® Evidence There are no good quality data for the use of omega 3 fish oils in prevention of dementia, pre-menstrual syndrome, attention-deficit hyperactivity disorder (ADHD), atrial fibrillation, eczema, osteoarthritis or age related macular degeneration. A systematic review and meta-analysis, published in late 2012, included data on cardiovascular outcomes in 63,030 patients. Omega-3 fatty acids had no effect on the primary outcome (a composite endpoint of MI, stroke or cardiovascular death). Omega-3 fatty acids also had no statistically significant effect on total mortality, coronary events, arrhythmias or cerebrovascular events. A borderline statistically significantly beneficial effect on vascular death was seen. A further systematic review published in 2012 also found no effect of omega-3 fatty acids on the secondary prevention of cardiovascular events. The meta-analysis included 14 randomized, double-blind, placebo-controlled trials involving 20,485 patients with a history of cardiovascular disease. Supplementation with omega-3 fatty acids did not reduce the risk of overall cardiovascular events, all-cause mortality, sudden cardiac death, myocardial infarction, congestive heart failure, or transient ischemic attack and stroke. A Cochrane systematic review, looking at the evidence for prevention and treatment of cardiovascular disease, search date 2004, included 48 randomised controlled trials (36,913 participants) and 41 cohort analyses. Pooled trial results did not show a reduction in the risk of total mortality or combined cardiovascular events in those taking omega 3 fatty acids. Trials varied in the doses used and trial design. NICE guidance recommends against prescribing omega-3 fatty acids for the primary prevention of coronary heart disease. Use in patients with schizophrenia is unlicensed and should be reviewed in conjunction with a specialist with a view to stopping prescribing if no benefit has been achieved. Patients should be advised to increase their dietary intake of omega-3 fatty acids. Kotwal S, Jun M, Sullivan D et al Omega 3 fatty acids and cardiovascular outcomes: Systematic review and meta-analysis Circulation: Cardiovasc Qual Outcomes 2012; 5: 808-818 Kwak SM, Myung S_K, Lee YJ et al for the Korean Meta-analysis Study Group Efficacy of Omega-3 Fatty Acid Supplements (Eicosapentaenoic Acid and Docosahexaenoic Acid) in the Secondary Prevention of Cardiovascular Disease: A Meta-analysis of Randomized, Double-blind, Placebo- Controlled Trials Arch Intern Med. 2012;172(9):686-694. Approved MOPB June 2017, updated December 2019, next review December 2021 Hooper L, Harrison RA, Summerbell CD, et al. Omega 3 fatty acids for prevention and treatment of cardiovascular disease. Cochrane Database of Systematic Reviews 2004, Issue 4. Art. No.: CD003177. Available from www.thecochranelibrary.com NICE lipid-modifying drugs updated September19 https://www.nice.org.uk/advice/ktt3 https://www.england.nhs.uk/wp-content/uploads/2019/08/items-which-should- not-routinely-be-prescribed-in-primary-care-v2.1.pdf Action Review all patients taking omega-3 fatty acid compounds. Consider switching patients taking omega-3 fatty acid compounds for hypertriglyceridaemia to a fibrate or statin. Consider stopping omega-3 fatty acid compounds in patients who have had an MI; such patients should be advised to consume two to four portions of oily fish or equivalent per week. Eflornithine Vaniqa® Prescribed for the treatment of hirsutism Evidence The treatment of hirsutism is considered cosmetic procedure which is low priority for funding by CCGs. If hirsutism is mild and does not significantly interfere with the woman’s quality of life, consider no additional treatment. Hirsutism is not usually associated with any significant medical abnormality Eflornithine 11.5% cream offers very little benefit for the management of facial hirsutism in women. There is limited evidence for efficacy and patient satisfaction with eflornithine. Action Review all patients prescribed Vaniqa in line with the guidance below and signpost where appropriate. It is important that the patient is properly assessed and underlying causes addressed (such as weight reduction if obese) before pharmacological therapy is considered as hirsutism
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