The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Fluticasone/formoterol (Flutiform®) has been accepted for use in the regular treatment of asthma in children aged 5 to 12 years where the use of a combination product (an inhaled corticosteroid and a long-acting β2 agonist) is appropriate:
- for patients not adequately controlled with inhaled corticosteroids and 'as required' inhaled short-acting β2 agonist
- or for patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist
This product has already been accepted for use in adults and adolescents aged 12 years and above on the same basis.
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 May 2019 (PDF).
This issue only contains one item relevant to primary care and that is a request to help to reverse the decline in reporting of suspected adverse drug reactions (ADRs). 2018 saw a fall in the number of reported suspected (ADRs) to the Yellow Card Scheme and this was consistent across several reporter groups including GP, hospital pharmacists, community pharmacists, hospital doctors and nurses. Readers are reminded of the ways Yellow Cards can be submitted and are reminded that duplicate reports can be detected. So, to avoid under-reporting, send a Yellow Card, even if you think someone else has done it.
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.
Cariprazine (Reagila®) has been accepted for restricted use in the treatment of schizophrenia in adult patients. The restriction limits use to second-line therapy in patients where predominantly negative symptoms have been identified as an important feature.
Latanoprost and timolol (Fixapost®) has been accepted for restricted use for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues. The restriction limits use to patients who have proven sensitivity to preservatives.
Doxylamine succinate and pyridoxine hydrochloride (Xonvea®) has been rejected for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. The submitting company did not present a sufficiently robust clinical or economic analysis to gain acceptance by SMC.
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 April 2019 (PDF).
This issue warns that yellow fever vaccine (Stamaril®) must not be given to anyone who is immunosuppressed and extreme caution needs to be used people aged 60 years and older due an increased risk of life-threatening reactions. This follows two recent reports of fatal adverse reactions with suspected yellow fever vaccine-associated viscerotropic disease (YEL-AVD) shortly after administration of the vaccine.
This issue also advises that the Annual Risk Acknowledgement Form, which should be used during annual specialist review of all women and girls of childbearing potential on valproate medicines, has been updated. The updated form dated March 2019 should be used in future reviews.
Readers are reminded that pregabalin (Lyrica®) and gabapentin (Neurontin®) were rescheduled as controlled drugs with effect from the start of this month. It is recommended that healthcare professionals evaluate patients carefully for a history of drug abuse before prescribing pregabalin and gabapentin and observe patients for development of signs of abuse and dependence.
Finally this month, the summary of letters to healthcare professionals includes a letter advising of the new restrictions and precautions for use of fluoroquinolone antibiotics as covered in Drug Safety Update last month.
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.
Testosterone (Testavan®) has been accepted for restricted use as testosterone replacement therapy for adult male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests. The restriction limits use to patients requiring a transdermal delivery system and it is noted that this product is bioequivalent to another testosterone transdermal preparation and costs less.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
