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.
The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of October 2023. This month there are eight guidelines and two technology appraisals that impact upon primary care.
The following guidelines have all been updated in line with the standards for faster diagnosis of cancer:
The Thyroid disease: assessment and management guideline has been updated. It covers investigating all suspected thyroid disease and managing primary thyroid disease. The update highlights the potential for biotin in dietary supplements to affect the results of thyroid function tests.
The Acute Respiratory Infection in over 16s: Initial assessment and management guideline has been published. 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. It also covers the initial management of any infections and aims to support healthcare practitioners in making sure that people’s treatment follows the best care pathway.
The Pneumonia in adults: diagnosis and management clinical guideline has been updated. The update replaced the recommendation on lower respiratory tract infection with links to the new guideline on Acute Respiratory Infection in over 16s.
The Rimegepant for treating migraine technology appraisal has been published. This treatment is recommended as an option for the acute treatment of migraine with or without aura in adults, only if for previous migraines:
- at least 2 triptans were tried and they did not work well enough or
- triptans were contraindicated or not tolerated, and nonsteroidal anti-inflammatory drugs (NSAIDs) and paracetamol were tried but did not work well enough.
The Tirzepatide for treating type 2 diabetes technology appraisal has been published. This treatment is recommended for treating type 2 diabetes alongside diet and exercise in adults when it is insufficiently controlled only if:
- triple therapy with metformin and 2 other oral antidiabetic drugs is ineffective, not tolerated or contraindicated, and
- they have a body mass index (BMI) of 35 kg/m2 or more, and specific psychological or other medical problems associated with obesity, or
- they have a BMI of less than 35 kg/m2, and:
- insulin therapy would have significant occupational implications, or
- weight loss would benefit other significant obesity-related complications.
It is also noted that lower BMI thresholds (usually reduced by 2.5 kg/m2) should be used for people from South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family backgrounds.
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.
Atogepant (Aquipta®) has been accepted for restricted use for the prophylaxis of migraine in adults who have at least 4 migraine days per month. The restriction limits use to patients with chronic and episodic migraine who have had prior failure on three or more migraine preventive treatments.
Semaglutide (Wegovy®) has been accepted for restricted use as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of
- ≥30kg/m2 (obesity), or
- ≥27kg/m2 to <30kg/m2 (overweight) in the presence of at least one weight-related comorbidity.
This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS). In England, this product is recommended for use within a specialist weight management service.
Fenfluramine (Fintepla®) has been accepted for the treatment of seizures associated with Dravet syndrome as an add-on to other anti-epileptic medicines for patients 2 years of age and older. This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS). In England, this product is also subject to a commercial arrangement and as such it is expected prescribing would remain with a specialist.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
During September 2023 Clinical Knowledge Summaries were published or updated in the following areas.
The topics have all been reviewed and updated with minor structural and layout changes. The Bacterial vaginosis topic contains updated advice on screening for sexually transmitted infections and the advice for intravaginal gels has been updated based on the manufacturers' recommendations. The Cardiac arrest - out of hospital care topic now contains two new scenarios, 'Out of hospital post-resuscitation care' and 'Terminating resuscitation'. The Domestic Abuse topic has been renamed from 'Domestic Violence and Abuse' and the content has been updated in line with current evidence in the literature. The Hyperhidrosis topic contains updated management recommendations in line with the current literature.
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 September 2023 (PDF).
This issue notifies clinicians that there has been a very small number of reports of new-onset or aggravation of pre-existing myasthenia gravis associated with of statins. Based on the UK reports, the majority of patients recover fully on stopping treatment but it seems recurrence has also been reported when an alternative statin was trialled. It is recommended that all patients are advised to monitor for and report symptoms of myasthenia gravis when commencing treatment with statins.
Clinicians are also reminded to be alert for psychiatric reactions associated with the use of quinolone antibiotics. This reminder comes after the MHRA received a Coroner's report following the death of a patient who died by suicide after being treated with ciprofloxacin.
Lastly in this issue is a summary of letters to healthcare professionals in August. These generally related to supply issues and recalls with one letter covering recommended actions to address the global shortage of GLP-1 receptor agonists.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
