Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - June 2017

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.

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SMC Update - June 2017

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.

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Strontium ranelate discontinued

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.

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CKS Updates - May 2017

During May 2017 Clinical Knowledge Summaries were updated in the following areas.

The following topics were all reviewed:

The topics have undergone minor restructures. The most significant change is to the Parvovirus B19 infection topic which has ben renamed from slapped cheek syndrome, it has all had significant restructuring in the Scenarios.

Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.

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Drug Safety Update - May 2017

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for May 2017 (PDF).

This issue contains information about an association between finasteride 1mg and depression and, in rare cases, suicidal thoughts. Finasteride is used for male pattern baldness at a dose of 1mg daily and for benign prostatic hyperplasia at 5mg daily. It is therefore recommended that patients taking finasteride 1 mg are advised to stop this medication and inform a healthcare professional should they develop symptoms of depression.

This issue also signposts a new set of free e-learning modules to find out more about how and when to report suspected adverse drug reactions. Doctors completing these modules will also earn CPD credits.

There is also a summary of letters sent to healthcare professionals in April including a reminder that retigabine (Trobalt®) has been withdrawn and will not be available from the end of June 2017. Other letters include a warning of the risk of medication errors with oral solution presentations of levetiracetam and a change to dosing recommendations for Amoxil® in patients undergoing haemodialysis.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.

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