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Drug Safety Update - September 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for September 2020 (PDF).

This month readers are advised of new recommendations following a review of the risks of dependence and addiction associated with prolonged use of opioid medicines (opioids) for non-cancer pain. Before prescribing opioids it is advised that clinicians discuss with the patient the risks and features of tolerance, dependence and addiction as well as agreeing together a treatment strategy and plan for end of treatment. In addition to this advice the CHM has recommended that fentanyl transdermal patches are contraindicated in opioid-naive patients in the UK. Clinicians are further advised to counsel on correct use of the patches when they are prescribed as well as warning patients and carers of the signs and symptoms of fentanyl overdose and actions to take should these signs and symptoms be recognised.

This issue also advices of new measures to reduce risk of fatal overdose due to inadvertent daily, instead of weekly, dosing with methotrexate. This includes packaging changes and the introduction of patients cards and educational materials. Safety reports are still being logged despite recommendations from the NPSA in 2006.

Clinicians are also reminded of the risk of cutaneous amyloidosis at injection site of all insulin products. Amyloid deposits can interfere with insulin absorption and therefore glycaemic control. Rotating the injection sites within the same body region can reduce or prevent the risk of cutaneous amyloidosis and other skin reactions including lipodystrophy.

The summary of letters to healthcare professionals were all regarding product recalls or supply disruptions.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.