The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for September 2014 (PDF).
The drug safety section in this issue advises clinicians about updated recommendations to reduce the risk of osteonecrosis of the jaw (ONJ) associated with use of denosumab (Prolia® and Xgeva®). Dental examination and appropriate preventive dentistry are now recommended prior to initiating treatment to reduce the risk for both indications (osteoporosis and cancer).
This section also advises that nitrofurantoin now contraindicated in most patients with an estimated glomerular filtration rate (eGFR) of less than 45 ml/min. However, it can be used in patients with an eGFR of 30 to 44 ml/min to treat lower urinary tract infection with suspected or proven multidrug resistant pathogens when the benefits of nitrofurantoin are considered to outweigh the risks of side effects. This contraindication allows nitrofurantoin to be used in patients for whom it was previously not recommended. A renal function check should also be considered when choosing to treat with nitrofurantoin, especially in the elderly.
The yellow card scheme update advises clinicians that new guidelines for reporting suspected adverse drug reactions (ADRs) in children and adolescents aged under 18 years have been published. Previously, reporting was requested for all ADRs however it is now advised that yellow cards should be completed for:
- all suspected ADRs that are serious or result in harm. Serious reactions are those that are fatal, life-threatening, disabling or incapacitating, those that cause a congenital abnormality or result in hospitalisation, and those that are considered medically significant for any other reason.
- all suspected ADRs associated with new drugs and vaccines (identified by the black triangle symbol: ▼)
The stop press section reminds clinicians that domperidone is no longer available to purchase in pharmacies.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
The National Institute of Health and Care Excellence (NICE) has published new guidance for the month of September 2014. This month there is 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.