The National Institute of Health and Care Excellence (NICE) has published new guidance for the month of September 2014. This month there are three clinical guidelines that impact upon primary care.
The Long-acting reversible contraception guideline has been re-issued with an addendum which updates the recommendations on progestogen-only subdermal implants. The new advice relates to information provided to women about these implants.
The Drug allergy guideline offers evidence-based advice on the diagnosis and management of drug allergy in adults, children and young people.
The Dyspepsia and gastro‑oesophageal reflux disease guideline offers evidence-based advice on the care and treatment of adults (aged 18 and over) with symptoms of dyspepsia, symptoms suggestive of gastro-oesophageal reflux disease (GORD), or both. It replaces CG17 that was published in August 2004 and contains new recommendations about investigation and referral, Helicobacter pylori eradication therapy, specialist management, and surveillance of Barrett’s oesophagus in people with dyspepsia.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that domperidone will no longer be available to purchase from pharmacies with effect from the 4th September 2014.
The Drug Safety Update from May 2014 warned of the risk of cardiac side effects especially in those with existing cardiac conduction conditions, impaired liver function or taking medication that may interact with domperidone.
It was noted that while community pharmacists are able to manage the majority of risks identified with this medicine, they would not routinely have access to a patient’s full medical history and would not quickly and accurately be able to assess which patients were at risk of cardiac side effects.
Action: Clinicians should be aware of this over the counter (OTC) drug withdrawal. Patients may present to GPs to enable continued access to this medication on prescription.
MTRAC issued an updated Commissioning Support guidance in August 2014. The review covers Avanafil (Spedra®).
This Commissioning Guidance (PDF) is an update to the review published in June.
This update still recommends restricted prescribing in primary care within the existing regulations imposed by the Department of Health for prescribing treatments for erectile dysfunction. It also highlights the availability of generic and off-patent formulations of other PDE-5 inhibitors.
Action: Clinicians should be aware of these reviews and use the recommendations to guide appropriate use of these medicines in current practice.
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.