The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for November 2020 (PDF).
This month readers are advised that modafinil potentially increases the risk of congenital malformations when used in pregnancy. Modafinil should not be used during pregnancy and women of childbearing potential must use effective contraception during treatment and for 2 months after stopping modafinil.
Additionally, pirfenidone (Esbriet®) has been linked with an increased risk of serious liver injury. Updated advice on liver function testing has been issued that recommends monthly checks during the first 6 months of treatment and every 3 months thereafter.
Ferric carboxymaltose (Ferinject▼®) has been linked with an increased risk of symptomatic hypophosphataemia leading to osteomalacia and fractures. Additional monitoring of phosphate levels is recommended for patients requiring multiple administrations at higher doses, on long-term treatment or with pre-existing risk factors for hypophosphataemia.
Finally in drug safety news, bupropion (Zyban®) has been associated with several cases of serotonin syndrome, especially when used with other serotonergic drugs or in cases of overdose. It is recommended that patients are informed about the milder symptoms of serotonin syndrome at initiation of treatment. If serotonin syndrome is suspected the dose of bupropion should be decreased or treatment withdrawn depending on the severity of the symptoms.
The summary of letters to healthcare professionals were generally regarding product recalls or supply disruptions.
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.
Patiromer (Veltassa®) has been rejected for use in the treatment of hyperkalaemia in adults. The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC. It should be noted the NICE Guidance exists for England and Wales that contains specific recommendations for use.
Romosozumab (Evenity®) has been accepted for restricted use in the treatment of severe osteoporosis in postmenopausal women at high risk of fracture. The restriction limits use to women who have experienced a fragility fracture and are at imminent risk of another fragility fracture (within 24 months).
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
During October 2020 Clinical Knowledge Summaries were updated in the following areas.
All of the topics have been reviewed and updated in keeping with current NICE guidance with minor layout changes. The Gastroenteritis topic has undergone major restructuring, with several nodes merged to improve clarity and navigation.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.
The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of October 2020. This month there are three guidelines that impact upon primary care.
The COVID-19 rapid guideline: managing symptoms (including at the end of life) in the community guideline has been updated. It aims to provide recommendations for managing COVID‑19 symptoms for patients in the community, including at the end of life. It also includes recommendations about managing medicines for these patients, and protecting staff from infection. The updated has amended recommendations on taking into account a patient’s existing medicines with reference to the MHRA advice on warfarin and other anticoagulants.
The Rheumatoid arthritis in adults: management guideline has been updated. It covers diagnosing and managing rheumatoid arthritis. It aims to improve quality of life by ensuring that people with rheumatoid arthritis have the right treatment to slow the progression of their condition and control their symptoms. This update amended the 'treat to target' recommendations to clarify that multiple disease-modifying anti-rheumatic drugs can be offered one after the other to achieve treatment targets.
The Behaviour change: digital and mobile health interventions guideline has been published. It covers interventions that use a digital or mobile platform to help people eat more healthily, become more active, stop smoking, reduce their alcohol intake or practise safer sex. The interventions include those delivered by text message, apps, wearable devices or the internet. The guideline only includes those that are delivered by the technology itself and not by healthcare professionals using technology to deliver interventions.
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 published Drug Safety Update for October 2020 (PDF).
This month readers are advised of new guidance that has been published on monitoring of patients on warfarin and other anticoagulants during the COVID-19 pandemic. In particular it is noted that acute illness may exaggerate the effect of warfarin and necessitate a dose reduction. Patients taking anticoagulants should be encouraged to report if they have symptoms of, or confirmed, COVID-19 infection to allow more careful monitoring of INR and bleed risk.
This issue also highlights that it is Medicines Safety Week from the 2nd until the 8th November 2020. The week long event will promote social media activity (#MedSafetyWeek) and discussion with colleagues and patients to highlight the importance of reporting suspected adverse drug reactions. Clinicians are encouraged to remain vigilant for suspected adverse drug reactions and report them.
The summary of letters to healthcare professionals were generally regarding product recalls or supply disruptions.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
