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.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Sodium zirconium cyclosilicate (Lokelma®) has been accepted for restricted use, following a resubmission, for use in the treatment of hyperkalaemia in adult patients. The restriction limits use to patients with hyperkalaemia (defined as a serum potassium of >6.0mmol/L) with chronic kidney disease stage 3b to 5 and/or heart failure, who would otherwise need to down-titrate or discontinue their renin-angiotensin-aldosterone system inhibitor (RAASi) therapy to maintain a clinically acceptable serum potassium level. It should be noted the NICE Guidance exists for England and Wales that contains similar restrictions.
Esketamine nasal spray (Spravato®) has been accepted for use in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI), for adults with treatment-resistant Major Depressive Disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.
Cannabidiol (Epidyolex®) has been accepted for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome, in conjunction with clobazam, for patients 2 years of age and older. It is noted that this advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower. As such it would be expected that prescribing would occur in secondary care.
Cannabidiol (Epidyolex®) is accepted for use as adjunctive therapy of seizures associated with Dravet syndrome, in conjunction with clobazam, for patients 2 years of age and older. It is noted that this advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower. As such it would be expected that prescribing would occur in secondary care.
Semaglutide (Rybelsus®) has been accepted for restricted use in the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise. The restrictions limits use to being in addition to other oral anti-diabetic medicines, or as an add-on to basal insulin, as an alternative glucagon-like peptide-1 receptor agonist option.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
During August 2020 Clinical Knowledge Summaries were published or updated in the following areas.
All of the topics have been reviewed and undergone minor restructuring. The Appendicitis topic has been significantly restructured in the Diagnosis section. The HIV infection and AIDS topic has been updated to include iformation on the use of pre-exposure prophylaxis.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.