The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for November 2023 (PDF).
This issue raises awareness that falsified Ozempic® and Saxenda® products have been found in the UK, including falsified pens containing insulin, which may lead to patient harm. Clinicians should be vigilant for symptoms linked to hypoglycaemia in patients who may have obtained a falsified product. Yellow Cards can be submitted and such products should be quarantined if possible. Patients who are concerned that the pens they have purchased might be falsified that they should not use the pens and report as a Yellow Card as well.
Clinicians involved in the prescription and supply of the COVID-19 treatment Paxlovid® (nirmatrelvir and ritonavir) are reminded of the risk of harmful drug interactions with the ritonavir component due to its inhibition of the enzyme CYP3A. As such it can interact with many commonly prescribed drugs. Prescribers should obtain a detailed patient history of current medications before prescribing.
Finally this month, healthcare professionals are reminded to remain vigilant for suspected adverse reactions and safety concerns associated with e-cigarettes and e-liquids, commonly known as vapes. Suspected adverse reactions should be reported to the Yellow Card scheme and patients should be encouraged to raise any safety concerns with a healthcare professional and can self-report using the Yellow Card scheme.
Lastly in this issue is a summary of letters to healthcare professionals in October. These generally related to supply issues and recalls.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of November 2023. This month there are four guidelines and one technology appraisal that impact upon primary care.
The Familial breast cancer: classification, care and managing breast cancer and related risks in people with a family history of breast cancer clinical guideline has been updated. It covers care for people with a family history of breast, ovarian or another related (prostate or pancreatic) cancer. The update removed the off-label warning for anastrozole in the recommendations on chemoprevention for women at moderate or high risk of breast cancer, in line with the MHRA licence variation.
The Acute Respiratory Infection in over 16s: Initial assessment and management guideline has been updated. It covers assessment of people aged 16 and over with symptoms and signs of an acute respiratory infection (both bacterial and viral) at first remote or in-person contact with NHS services. The update clarifies that the threshold for treatment or referral for further assessment may be lower for people with an acute respiratory infection who are more likely to have a poor outcome.
The Hypertension in adults: diagnosis and management guideline has been updated. It covers identifying and treating primary hypertension in people aged 18 and over, including people with type 2 diabetes. The update has amended the recommendations on measuring and managing postural hypotension. Tables have also been added to the section on monitoring treatment and blood pressure targets to summarise blood pressure targets.
The Transient loss of consciousness ('blackouts') in over 16s clinical guideline has been updated. It covers assessment, diagnosis and referral for people over 16 who have had a transient loss of consciousness. This update amended the guidance on assessment and referral for suspected postural hypotension.
The Empagliflozin for treating chronic heart failure with preserved or mildly reduced ejection fraction technology appraisal has been published. This treatment is recommended, within its marketing authorisation, as an option for treating symptomatic chronic heart failure with preserved or mildly reduced ejection fraction in adults.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Progesterone vaginal capsules (Utrogestan®) has been rejected for use in the prevention of preterm birth in women with a singleton pregnancy who have a short cervix and/or a history of spontaneous preterm birth. The manufacturer failed to make a submission for this indication.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
During October 2023 Clinical Knowledge Summaries were published or updated in the following areas.
The Sarcoidosis topic is new. The other topics have all been reviewed and updated with minor structural and layout changes. The Neck pain - acute torticollis topic contains a new short section detailing some complications which can arise in people with acute torticollis. The Pelvic inflammatory disease topic has been updated in line with current evidence and information on the antibiotic levofloxacin has been added to the Prescribing information section.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for October 2023 (PDF).
This issue introduces new safety measures when prescribing oral formulations of isotretinoin. It would be expected that treatment is initiated and supplied by a specialist. Primary care clinicians may wish to be aware of the suggested measures.
This issue also notes that from 6 to 12 November 2023 it will be the eighth annual #MedSafetyWeek social media campaign. This year the campaign will focus on the importance of reporting suspected adverse reactions to medicines and suspected problems with medical devices. Healthcare professionals are asked to support the campaign by talking to their patients and colleagues about the Yellow Card scheme.
This issue also advises that valproate containing medicines must now always be dispensed in the manufacturer’s original full pack unless there are exceptional circumstances. The aim of this recommendation is to ensure patient information resources reach the patient every time the medication is dispensed. Exceptions could include compliance packing although there should still be processes in place to make sure that the patient receives the Patient Information Leaflet.
Lastly in this issue is a summary of letters to healthcare professionals in September. These generally related to supply issues and recalls with one letter warning that the introduction of azathioprine tablets in new strengths of 75mg and 100mg strengths increases the risk of unintentional overdoses being prescribed or dispensed.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
