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.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Budesonide orodispersible (Jorveza®) has been accepted for restricted use in the treatment of eosinophilic oesophagitis (EoE) in adults (older than 18 years of age). The restriction limits use to patients unsuccessfully treated with proton pump inhibitors.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
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.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for August 2020 (PDF).
This month readers are advised that clozapine blood levels may need to be monitored more frequently in certain situations, for example if a patient starts or stops smoking, if taking concomitant medications that impact on blood levels or if pneumonia or another serious infection is present. Monitoring will usually be carried out by a specialist service.
Readers are also advised that denosumab 60mg (Prolia®), a treatment for osteoporosis, has been linked with an increased risk of multiple vertebral fractures after stopping or delaying ongoing treatment. It is recommended that risk factors are assessed before starting treatment, particularly in those with a history of vertebral fracture. It is noted that the optimal duration of denosumab treatment for osteoporosis has not been established and it is recommended that patients should not stop denosumab without specialist review.
Readers are also made aware of an increased risk of diverticulitis seen in patients taking baricitinib (Olumiant®▼), particularly when concomitantly taking medicines associated with an increased risk of diverticulitis (non-steroidal anti-inflammatory drugs, corticosteroids and opioids). It is recommended that patients on baricitinib to seek immediate medical care if they experience severe abdominal pain especially accompanied with fever, nausea and vomiting or other symptoms of diverticulitis.
This update also contains links to resources that promote awareness of the risk of severe and fatal burns in emollient users. The resources raise awareness to avoid naked flames and heat sources that may act as a source of fire ignition.
The summary of letters to healthcare professionals includes information regarding handling errors that have been reported with leuprorelin-containing depot medicinal products, potentially resulting in lack of efficacy. The manufacturers stress that the instructions for reconstitution and administration in the product information must be followed.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
