Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - December 2017

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

This issue advised that fingolimod (Gilenya®) can increase the risk of skin cancers and lymphoma and serious opportunistic infections. It is now recommended that patients on this treatment avoid UV light exposure and seek urgent medical advice if they notice any skin lesions. It is also recommended to seek urgent medical advice on the development of any symptoms or signs consistent with an infection, including up to 2 months after the end of fingolimod therapy. This treatment has also been associated with persistent bradycardia, which can increase the risk of serious cardiac arrhythmias. New contraindications have been introduced but patients currently on treatment should be reviewed should cardiac symptoms develop.

Lastly, the summary of letters sent to healthcare professionals in November includes a warning regarding a potential defect on midazolam (Buccolam®) oral syringes. An apparent fault with the syringe cap can prevent administration. If this occurs in use the e translucent tip cap needs to be manually removed to allow administration.

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

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SMC Update - December 2017

The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.

Aviptadil / Phentolamine (Invicorp®) has been accepted for restricted use in the symptomatic treatment of erectile dysfunction in adult males due to neurogenic, vasculogenic, psychogenic, or mixed aetiology. The restriction limits use to those patients who have failed on oral therapies (oral phosphodiesterase type-5 inhibitors) and other non-injectable formulations of erectile dysfunction medications. It is also likely that the existing SLS criteria will apply to this product.

Fulvestrant (Faslodex®) has been rejected for use in the treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy. The manufacturer failed to make a submission.

Tiotropium (Spiriva Respimat®) has been accepted for use as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD). This product was previously restricted use in patients who have poor manual dexterity but a price reduction has resulted in this restriction has been removed.

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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CKS Updates - November 2017

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

The following topics were all reviewed:

The majority of topics have undergone reviews and minor restructures.

The most significant changes are in Irritable bowel syndrome and Psoriasis topics. The Irritable bowel syndrome topic has been updated where the recommendations on the diagnosis and management of irritable bowel syndrome have been amended in line with current evidence, including the addition of linaclotide as a drug treatment option. The Psoriasis topic has been updated where recommendations on the diagnosis and management of psoriasis have been amended in line with current evidence, an additional node has been added to the Management section on Specialist investigations and treatment and the section on Topical corticosteroids has been replaced with a link to the CKS topic on Corticosteroids - topical (skin), nose, and eyes.

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 - November 2017

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

This issue reminds clinicians that quinine has a dose-dependent QT-interval-prolonging effect and should be used with caution in patients with risk factors, including taking other medicines that could prolong the QT interval, for QT prolongation or in those with atrioventricular block. Readers are also reminded that serum levels of phenobarbital or carbamazepine could become raised during concomitant use with quinine.

Clinicians are also reminded that oral tacrolimus products need to be prescribed and dispensed by brand name only in order to reduce the risk of toxicity and graft rejection. If brand switching is necessary then the patient should receive careful supervision and therapeutic monitoring by an appropriate specialist.

This issue also requests support for support for a second social media campaign to promote the reporting of suspected adverse drug reactions (ADRs) to the Yellow Card Scheme in support of the ADR awareness week taking place 20-24 November 2017. This year there is a focus on over-the-counter medicines.

Updated advice, that adds to the 3 risk-based categories, for the prescribing of anti-epileptic drugs recommends consideration of patient-related factors when deciding whether it is necessary to maintain continuity of supply for a specific product. For example, patient perception of differences in supply, for example differences in product presentations and also co-morbid conditions such as autism, mental health issues, or learning disability may make it more appropriate to prescribe either by specifying brand name or by using the generic drug name and name of the manufacturer.

This issue also notes that Public Health England has updated their guidance about live vaccination of infants born to a mother who received immunosuppressive biological therapy during pregnancy. It is recommended that children born of mothers who were on immunosuppressive biological therapy during pregnancy will not be eligible to receive rotavirus vaccine and will need to defer BCG, if indicated, for 6 months.

Lastly, the summary of letters sent to healthcare professionals in October includes a letter regarding Solu-Medrone 40 mg containing lactose derived from cows' milk and potentially milk proteins as reported in the update last month.

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

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NICE Guidance - November 2017

The National Institute of Health and Care Excellence (NICE) have published new or updated guidance for the month of November 2017. This month there are three guidelines that impact upon primary care.

The Bipolar disorder clinical guideline has been updated. It covers recognising, assessing and treating bipolar disorder (formerly known as manic depression) in children, young people and adults. The recommendations apply to bipolar I, bipolar II, mixed affective and rapid cycling disorders. It aims to improve access to treatment and quality of life in people with bipolar disorder. The guideline has been updated with footnotes containing current medication advice and some research recommendations have been stood down.

The Familial hypercholesterolaemia clinical guideline has been updated. It covers identifying and managing familial hypercholesterolaemia (FH), a specific type of high cholesterol that runs in the family, in children, young people and adults. It aims to help identify people at increased risk of coronary heart disease as a result of having FH. The evidence for case finding and diagnosis, identification using cascade testing, and management using statins has been reviewed and some recommendations have been amended.

The Glaucoma guideline has been published. It covers diagnosing and managing glaucoma in people aged 18 and over. It includes recommendations on testing and referral (case-finding) for chronic open angle glaucoma and ocular hypertension, and on effective diagnosis, treatment and reassessment to stop these conditions progressing.

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

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