The September issue of the Drug Tariff will contain several amendments to the Selected List Scheme (SLS) for drug used in the treatment of erectile dysfunction.
The SLS lists items that may only be prescribed under certain conditions. Changes in legislation made in August have removed sildenafil from the SLS list but added avanafil and Viagra®.
These changes essentially mean that generic sildenafil can now be prescribed to all men with erectile dysfunction. Patients who are prescribed avanafil (Spedra®), tadalafil (Cialis®), vardenafil (Levitra®) or the Viagra® brand must still meet the SLS criteria and the prescription must be endorsed 'SLS' by the prescriber.
Action: Clinicians should be aware of these changes. Men who are currently prescribed sildenafil can be transferred to NHS prescriptions. Men currently prescribed an alternative on a private prescription may present requesting an NHS prescription for sildenafil.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Colestilan (BindRen®) has been rejected for the treatment of hyperphosphataemia in adult patients with chronic kidney disease (CKD) stage 5 receiving haemodialysis or peritoneal dialysis. The manufacturer did not present sufficiently robust clinical and economic analysis to gain acceptance.
Dapagliflozin and Metformin (Xigduo®) has been accepted for restricted use in the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:
- in patients inadequately controlled on their maximally tolerated dose of metformin alone
- in combination with other glucose-lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products
- in patients already being treated with the combination of dapagliflozin and metformin as separate tablets
The restriction limits use to patients where a combination of dapagliflozin and metformin is an appropriate choice of therapy.
Lubiprostone (Amitiza®) has been rejected for the treatment of chronic idiopathic constipation and associated symptoms in adults, when response to diet and other non-pharmacological measures (e.g. educational measures, physical activity) are inappropriate. The manufacturer did not present sufficiently robust clinical and economic analysis to gain acceptance.
Olodaterol solution for inhalation (Striverdi Respimat®) has been rejected for use as a maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease. The manufacturer did not present sufficiently robust clinical and economic analysis to gain acceptance.
Racecadotril (Hidrasec®) has been rejected for complementary symptomatic treatment of acute diarrhoea in infants older than three months and in children, together with oral rehydration and the usual support measures, when these measures alone are insufficient to control the clinical condition. The manufacturer did not present sufficiently robust clinical and economic analysis to gain acceptance.
Umeclidinium / Vilanterol (Anoro®) has been rejected for use as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. The manufacturer did not present sufficiently robust clinical and economic analysis to gain acceptance.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for August 2014 (PDF).
The drug safety section in this issue advises clinicians of a recent European review of emergency contraceptives. The relationship between increasing body weight or BMI and efficacy of emergency contraceptives was considered. Concerns have been raised that emergency contraceptives may be less effective as body weight or BMI increases but this review found that the available data are inconclusive. The overall conclusion was that emergency contraceptives are suitable for all women regardless of body weight or body mass index. Readers are reminded that emergency contraceptives should be used as soon as possible after unprotected sex or contraceptive failure to prevent unintended pregnancy and should not be used to replace a regular contraceptive method.
This issue also advises that the learning module on anticoagulants has been launched. Responding to feedback on previous learning modules, this one is reported to be much more interactive.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.