The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for September 2022 (PDF).
This issue advises clinicians that caution should be used if switching patients between different long-acting formulations of methylphenidate. Different instructions for use and different release profiles between the products may affect symptom management. It is recommended to specify a brand or manufacturer when prescribing. When considering a product switch consider patient preferences such as dosing frequency, discuss the change with the patient and cover the reasons for the switch, possible changes they may experience and provide instructions for use for the newly prescribed formulation, especially whether it should be taken with or without food.
This issue contains the latest COVID-19 vaccine and medicine information including confirmation of the authorisation of the Pfizer/BioNTech bivalent COVID-19 booster vaccine. It is further confirmed that COVID-19 vaccines are safe and effective during pregnancy and breastfeeding and there is substantial evidence to support this advice.
Lastly in this issue is a summary of letters to healthcare professionals in August. 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 September 2022. This month there are two guidelines that impact upon primary care.
The Obesity: identification, assessment and management guideline has been updated. It covers identifying, assessing and managing obesity in children (aged 2 years and over), young people and adults. The update reviewed the evidence on anthropometric measures for assessing health risks associated with overweight and obesity in adults and updated the recommendations on identifying and assessing overweight, obesity and central adiposity.
The Self-harm: assessment, management and preventing recurrence guideline has been published. It covers assessment, management and preventing recurrence for children, young people and adults who have self-harmed. It includes those with a mental health problem, neurodevelopmental disorder or learning disability and applies to all sectors that work with people who have self-harmed.
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.
Estradiol / micronised progesterone (Bijuve®) has been accepted for use as continuous combined hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women with intact uterus and with at least 12 months since last menses. It is noted that the experience in treating women older than 65 years is limited.
Apalutamide (Erleada®) has been accepted for restricted use in the treatment of adults with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT). This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement.
Delta-9-tetrahydrocannabinol and cannabidiol (Sativex®) has been accepted for use as a treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy. Based upon the need for an initial trial it is expected that treatment would normally be initiated by a specialist.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The manufacturer of Seroxat® suspension has written to healthcare professionals advised that this product will be discontinued globally with effect from October 2022.
The tablet formulations are unaffected by this announcement and the suspension has been discontinued for commercial reasons. There are no safety concerns.
There are currently no generic suppliers of the suspension. Pharmacies may be able to continue to supply this item through Specials Manufacturers or unlicensed imports. It would be expected that these alternatives would involve a higher cost.
Action: Clinicians should be aware of this product being discontinued. It would be prudent to run clinical system searches to identify any patients who are currently prescribed this product to assess if a suitable alternative can be arranged.
During August 2022 Clinical Knowledge Summaries were published or updated in the following areas.
The Integrated health and social care for people experiencing homelessness topic is new. All of the other topics have been reviewed and updated with minor structural and layout changes. The recommendations on non-melanoma lesions have been removed from the Melanoma topic. The Hypertension topic has been updated to be fully in line with the NICE guideline Hypertension in adults: diagnosis and management, and includes recommendations for adults with type 2 diabetes.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.
