The National Institute of Health and Care Excellence (NICE) have published new or updated guidance for the month of June 2017. This month there are two guidelines that impact upon primary care.
The Head injury clinical guideline has been updated to cross-reference other NICE guidelines and an outdated research recommendation was deleted. The guideline covers the assessment and early management of head injury in children, young people and adults.
The Spondyloarthritis in over 16s guideline has been updated to clarify the advice on what imaging should be done. The guideline covers diagnosing and managing spondyloarthritis that is suspected or confirmed in adults who are 16 years or older.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The manufacturer of fluphenazine decanoate (Modecate®) injection has written to healthcare professionals advising that this product will be discontinued by the end of 2018.
The letter details unpredictable supplies of the active ingredient from the single global manufacturer as the reason for this decision. It is noted that this decision is not due to any safety concerns. Both injection strengths (25mg/ml and 100mg/ml) are being discontinued with manufacturing ceasing in mid-2018 with supplies in the United Kingdom expected to run out by the end of 2018.
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 allow a review and arrangements made to identify a suitable alternative.
Update: At the end of 2020 it seems that Modecate Concentrate 100mg/ml is still being manufactured and distributed in the UK.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for June 2017 (PDF).
This issue contains recommendations following reports of osteonecrosis of the external auditory canal with denosumab (Prolia®). There have been 5 such reports worldwide and clinicians are advised to consider this possibility of osteonecrosis in patients receiving denosumab who present with ear symptoms including chronic ear infections or in those with suspected cholesteatoma. Risk factors include steroid use and chemotherapy, with or without local risk factors such as infection or trauma. Patients on treatment should be advised to report any ear pain, discharge from the ear or an ear infection during denosumab treatment. Any further cases should be reported via the Yellow Card Reporting Scheme.
This issue also notes that there have been reports of systemic cardiovascular effects including bradycardia, hypotension and dizziness after application of brimonidine gel (Mirvaso®). Some cases were reported after laser procedures to the skin. Patients should be advised to avoid application to irritated or damaged skin, including after laser therapy.
Additionally, this issue contains a review on the restriction on sales of pseudoephedrine and ephedrine which has indicated that these measures continue to be successful in managing the risk of misuse. It also encourages use the Yellow Card Reporting Scheme to support the safety of e-cigarettes and refill containers (e-liquids). Suspected side-effects, harm to children or non-users and safety issues or defects can all be reported.
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 / Formoterol (Symbicort® SMART) has been accepted for use as the regular treatment of asthma where use of a combination (inhaled corticosteroid and a long-acting β2 adrenoceptor agonist) is appropriate: patients not adequately controlled with inhaled corticosteroids and "as needed" short-acting β2 adrenoceptor agonists, or patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists. This advice relates to the extension of the license for Symbicort maintenance and reliever therapy (SMART®) to adolescents aged 12 to < 18 years.
Buprenorphine oral lyophilisate (Espranor®) has been accepted for restricted as a substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. This advice is contingent upon the continuing availability of Patient Access Schemes (PAS). The license would also usually limit prescribing to specialist clinics.
Obeticholic acid (Ocaliva®) has been accepted for use in the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid in adults with an inadequate response to ursodeoxycholic acid or as monotherapy in adults unable to tolerate ursodeoxycholic acid. This advice is contingent upon the continuing availability of Patient Access Schemes (PAS).
Safinamide (Xadago®) has been rejected for the treatment of adult patients with idiopathic Parkinson's disease (PD) as add-on therapy to a stable dose of Levodopa alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients. The manufacturer failed to make a submission.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The manufacturer of strontium ranelate (Protelos®) communicated the intention to cease supply of this medicines in May 2017. In that notification it was advised that production and distribution would cease at the end of August 2017.
Licensed for the treatment of severe osteoporosis it has been the subject of several safety alerts over the years including life-threatening allergic reactions, venous thromboembolism and increased risk of heart problems. The manufacturer has taken a strategic decision, for commercial reasons, to withdraw the product.
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 allow a review and arrangements made to identify a suitable alternative.
