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 (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. may occur in people with and without pre-existing liver disease. Rare cases of cholestasis, , 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, 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 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 can result from serious medical conditions or from medication (e.g. ciclosporin, , , phenobarbitone, , combined oestrogen- replacement therapy). For women who choose removal therapy, laser treatment or electrolysis is recommended. For pharmacological therapy, consider: Oral contraceptives for the majority of women, adding an anti-androgen after 6 months if the response is suboptimal.

Approved MOPB June 2017, updated December 2019, next review December 2021

If a local decision is taken to fund the treatment of hirsutism after failure of self-care and lifestyle measures, restrict eflornithine treatment to use in women for whom alternative therapy, e.g. co-cyprindiol, is contraindicated, ineffective, or considered inappropriate (e.g. post- menopausal women or where severe or multiple risk of venous thromboembolism may constitute a contraindication for co-cyprindiol).

In women with moderate or severe hirsutism, test for elevated androgen levels. Eflornithine cream should only be used in patients with a raised free androgen index associated with an androgenic disease e.g. polycystic syndrome.

Clinical Knowledge Summary (CKS) provides guidance on the management of hirsutism in premenopausal and postmenopausal women: Premenopausal women (with or without polycystic ovary syndrome) - Encourage weight loss in women who are overweight or obese. - Discuss cosmetic methods of hair reduction and removal as these will remain an important part of management. - If hirsutism is mild and does not significantly interfere on the women’s quality of life, consider no additional treatment. The NICE CKS also states that a subjective approach is generally appropriate in primary care to assess severity of hirsutism, using the woman's own perception of her condition and the extent it impacts on her quality of life. - If additional treatment is required, offer co-cyprindiol. Co-cyprindiol is licensed for the treatment of moderately severe hirsutism but should be stopped after three or four menstrual cycles after the woman’s hirsutism has completely resolved because of an increased risk of venous thromboembolism - Advise women that treatment may take at least 6 months to work - If combined oral contraceptives (COCs) are contraindicated or have not worked offer women topical eflornithine. - If additional treatment is required, consider topical eflornithine. - Benefit should be noted in 6-8 weeks and eflornithine should be discontinued if no benefit is seen within 4 months of starting treatment. - If improvement is seen, continued treatment is necessary to maintain the benefits. Once the cream is discontinued, hair growth returns to pre-treatment levels within about 8 weeks.  NICE Clinical Knowledge Summary. Hirsutism. Accessed 19/10/13 via http://cks.nice.org.uk/ hirsutism

Coughs and colds Codeine linctus, simple linctus, Tixyilix®, pholcodeine linctus These products fall under our OTC guidance and patients should be sign- posted to the community pharmacy to purchase these as part of the self- care policy.

Evidence There is little evidence to support the prescribing of cough and cold remedies and simple home remedies are found to be more effective.

Approved MOPB June 2017, updated December 2019, next review December 2021

Action No new initiations for prescriptions for cough and cold remedies Review patients prescribed these medications, discuss the evidence and suggest patients visit their community pharmacy if they wish to continue on the medication where appropriate.  https://www.england.nhs.uk/wp-content/uploads/2018/03/otc-guidance-for-ccgs.pdf Complementary Therapies Homeopathic remedies, herbal products and vitamins

Evidence These items are not licensed Drugs under the Medicines Act, so there is no approved summary of product characteristics (SmPC) for prescribers to consult. (N.B. prescribers are only indemnified by a drug company if there is a SmPC and if the drug is used within licensed indications). This concurs with the CCG OTC guidance

Action Review the patients being prescribed these products and consider sign-posting the patient to the community pharmacy to purchase further supplies  https://www.england.nhs.uk/wp-content/uploads/2019/08/items-which-should-not- routinely-be-prescribed-in-primary-care-v2.1.pdf

Silicone scar gels and sheets (e.g. Dermatix®, ScarSil ®gel, SilDerm® Scar Gel) A full list of products is available on the Drug Tariff June 2017 Evidence Silicone gels or sheets are used on healing skin (not open wounds) to reduce redness and try to minimise hypertrophic or keloid scars. There is limited evidence to support their use to prevent or treat hypertrophic and keloid scarring. The evidence that is available is weak and from small trials. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD003826.pub3/pdf

Action Silicone scar gels and dressings should not be routinely prescribed for management of hypertrophic and keloid scars. Prescribing may only be considered in exceptional circumstances as those outlined in the scar revision section of West Essex service restriction policy.

SUN SCREEN Anthelios®, Sunsense®, Uvistat® Sunscreens marked as ‘ACBS’ in the British National Formulary (BNF) are regarded as drugs when prescribed for skin protection against UV radiation in abnormal cutaneous photosensitivity.

Evidence

Approved MOPB June 2017, updated December 2019, next review December 2021

The European Guidelines for photo protection acknowledge the efficacy of broad-spectrum, high protection sunscreens in the prevention of PLE. However, they also report on the lack of compliance among patients suffering from photo dermatoses and that this may account for the variable effect of sunscreens. In one study, the median application thickness was found to be only 0.5mg/cm which reduced a declared SPF 50+ into an effective SPF of 2-3.  https://www.england.nhs.uk/wp-content/uploads/2018/03/otc-guidance-for-ccgs.pdf

Action The only ACBS approved indication is for skin protection against UV radiation in abnormal cutaneous photosensitivity. This includes genetic disorders, photo dermatoses, vitiligo from radiotherapy and chronic or recurrent herpes simplex labialis. Ensure all patients prescribed sunscreens on FP10 prescriptions meet the ACBS criteria. Patients who do not meet ACBS criteria should be advised to self-purchase sunscreen preparations with dual protection against UVB and UVA rays, with an SPF value minimum of 30. Advisory sunscreen because of risk of skin cancer is not a qualifying condition and should be regarded as routine sun protection

There is a need for thorough instructions in sunscreen application, amount used and effect from correct use. The ears, temples, posterior and lateral neck tend to be completely overlooked. The prescriber must ensure patients are counselled in the appropriate application of sunscreens.

AVEENO® CREAM, BATH AND SHOWER PRODUCTS Aveeno® cream and other colloidal oatmeal containing emollients are borderline substances & may only be prescribed in accordance with the ACBS criteria for endogenous and exogenous eczema, xeroderma, ichthyosis and senile pruritus associated with dry skin.

Evidence There is no evidence from controlled trials to support the use of one emollient over another therefore GPs should where possible select the emollient with the lowest acquisition cost from the formulary, taking into consideration patient acceptability, dryness of the skin and area of skin involved.

 NICE Clinical Knowledge Summaries: Dermatitis http://cks.nice.org.uk/dermatitis- contact#!prescribinginfosub:3 There is also no clinical evidence to support the use of shower gels and bath oils. The amount of emollient deposited on the skin during bathing/showering is likely to be far lower than with directly applied emollient creams/ointments. In addition, bath additive emollients will coat the bath and make it greasy; increasing the risk of slips and falls.

Action Aveeno products should be prescribed in accordance with ACBS criteria and only when cost effective options have failed.

Patients should be advised to use soap substitutes for washing instead of shower emollients. Most of the standard emollients on the formulary (except WSP 50%: LSP 50%)

Approved MOPB June 2017, updated December 2019, next review December 2021

are suitable to be used as a soap substitute or applied prior to bathing and then rinsed off. All ointments (except for WSP 50% and LSP 50%) can be added to bath water and used as a bath emollient. Care must be taken in the bath/shower, as emollients can make surfaces more slippery. Bath emollients can only be prescribed to wash dry scalps/ as soap substitutes where other emollients are unsuitable/ not tolerated. A patient information leaflet that explains appropriate emollients prescribing and use is available on the website.

 https://www.england.nhs.uk/wp-content/uploads/2017/11/annex-b-sps-evidence-review- bath-emollients.pdf

Approved MOPB June 2017, updated December 2019, next review December 2021