The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for June 2013 (PDF).
This issue contains drug safety advice informing clinicians of the new contraindications and warnings for diclofenac after a Europe-wide review of cardiovascular safety. This section also advises that a recent review of cyproterone acetate with ethinylestradiol (co-cyprindiol) has found that the balance of benefits and risks remains positive with a reminder that, while rare, healthcare professionals and patients should remain vigilant for signs and symptoms of venous thromboembolism.
The hot topic section reminds clinicians that the risk of foetal malformation with oral retinoids is extremely high, even when used at a low dose or for a short time during pregnancy. Women of child-bearing potential should have pregnancy excluded before starting treatment and while taking these medicines one or preferably two different forms of contraception must be consistently used.
Finally, the stop press section briefly details some new restrictions on the use of codeine as an analgesic in children and adolescents. Codeine should now only be used to relieve acute moderate pain in children older than 12 years and only if other painkillers such as paracetamol or ibuprofen alone cannot relieve it. The maximum daily dose is recommended as 240mg in split daily doses, used at the lowest effective dose for the shortest period and a maximum of 3 days before a review.
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 additional new guidance for the month of June 2013. There are two additional clinical guidelines and three new technology appraisals that impact upon primary care.
The Overactive bladder - mirabegron technology appraisal recommends this treatment when antimuscarinics do not work, are not suitable or have side effects that are unacceptable.
The Pulmonary embolism and recurrent venous thromboembolism - rivaroxaban technology appraisal recommends this treatment as a possible treatment for adults with pulmonary embolism and to prevent a further deep vein thrombosis or pulmonary embolism.
The Type 2 diabetes - Dapagliflozin technology appraisal recommends this treatment in dual therapy with metformin only if it is used as described for dipeptidyl peptidase‑4 (DPP‑4) inhibitors in Type 2 diabetes: the management of type 2 diabetes or in combination with insulin with or without other antidiabetic drugs. It is not recommended for use in triple therapy regimen in combination with metformin and a sulfonylurea unless this is part of a clinical trial.
The Ulcerative colitis clinical guideline provides evidence-based advice on the care and treatment of adults, children and young people with a diagnosis of ulcerative colitis.
The Familial breast cancer clinical guideline updates and replaces previous advice. It makes recommendations on genetic testing thresholds, surveillance and risk reduction and treatment strategies for people with a diagnosis of breast cancer and a family history of breast, ovarian or a related cancer.
Action: Clinicians should be aware of this month's additional new guidance and implement any necessary changes to practice.
The National Institute of Health and Care Excellence (NICE) has published new guidance for the month of June 2013. This month there are three clinical guidelines and one public health guideline that impact upon primary care.
The Falls guideline extends and updates guidance originally published in November 2004 and provides evidence-based advice on preventing falls in older people. This update now includes recommendations about preventing falls during a hospital stay.
The Idiopathic pulmonary fibrosis guideline provides evidence-based advice on the diagnosis and management of suspected idiopathic pulmonary fibrosis in adults. It includes a list of clinical features that may prompt consideration for a chest X‑ray or referral to a specialist.
The Stroke rehabilitation guideline provides evidence-based advice on the care of adults and young people aged 16 years and older who have had a stroke with continuing impairment, activity limitation or participation restriction.
The Tobacco harm reduction public health guideline provides recommendations to help people, particularly those who are highly dependent on nicotine, to minimise the harms from continued smoking. It is noted that stopping in one step (abrupt cessation) offers the best chance of lasting success but recognises that some people:
- may not be able (or do not want) to stop smoking in one step.
- may want to stop smoking, without necessarily giving up nicotine.
- may not be ready to stop smoking, but want to reduce the amount they smoke.
In such people this guideline recommends harm-reduction approaches which may or may not include temporary or long-term use of licensed nicotine-containing products.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The European Medicines Agency has completed a review of diclofenac. A positive benefit-risk balance has been confirmed but new contraindications and revised warnings have been recommended.
The review was started in October 2012 in response to a broader review of NSAIDs which identified a small increase in the risk of cardiovascular side effects with diclofenac compared with other drugs in the class. This more recent review has concluded that diclofenac increases the number of heart attacks by approximately 3 cases per year for every 1,000 people treated who are at moderate cardiovascular risk.
As such it is now recommended that, "Patients with certain cardiovascular risk factors such as high blood pressure, raised cholesterol, diabetes and smoking should only use diclofenac after careful consideration with their GP or pharmacist". It is also suggested that patients with an underlying heart condition who are currently taking diclofenac should speak to their GP or pharmacist at their next routine visit to consider alternative treatments.
Action: Clinicians should be aware of this review and the new advice. Non-NSAID options should be considered where possible. Where an NSAID is required the lowest effective dose should be used for the shortest possible duration.
Immunisation against Infectious Disease (more commonly known as the Green Book) has been updated by Public Health England to provide a complete current edition.
Individual chapters in the book are commonly updated with revisions to the entire book happening less frequently. At 543 pages, users are warned that it may take a while to download. For faster access it is recommended to access individual chapters.
Action: All clinicians involved in any aspect of immunisation should be aware of this publication and have access to an up to date copy.