Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - January 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for January 2020 (PDF).

This month clinicians are invited to report suspected adverse reactions associated with use of e-cigarettes or vaping (including lung injury) to the MHRA via the Yellow Card Scheme. More than 2,600 cases of lung injury have been reported to the US Centers for Disease Control and Prevention (CDC) with 60 fatal cases. Clinicians should have a high index of suspicion in patients presenting with respiratory symptoms where there is a history of e-cigarette use or vaping in the past 30 days.

Clinicians are also notified of a small increased risk of oral clefts following use of ondansetron in the first 12 weeks of pregnancy. This information comes from epidemiological studies in the USA which have some limitations but are sufficiently robust to indicate an increased risk. Ondansetron is not usually used as a first line treatment in hyperemesis gravidarum. Where it is offered, women must be counselled on the potential benefits and risks of use, both to her and to her unborn baby and the final decision should be made jointly.

The summary of letters to healthcare professionals this month includes a further group of letters recalling ranitidine, a letter advising that three presentations of Insuman® are being discontinued and an update on the valproate Pregnancy Prevention Programme.

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

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Ingenol mebutate recalled

The manufacturer of ingenol mebutate (Picato®) has recalled all unexpired stock from wholesalers and pharmacies while investigations are ongoing into the concerns of the possible risk of skin malignancy.

Healthcare professionals are advised to:

  • Stop supplying the above products immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process
  • Stop prescribing Picato and consider other treatment options as appropriate. For patients who have recently been prescribed Picato, advise patients to be vigilant for any skin lesions developing and to seek medical advice promptly should any occur

Action: Clinicians should be aware of this recall and investigation. Alternatives will need to be issued during the remainder of the investigation.

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SMC Update - January 2020

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

Abiraterone (Zytiga®) has been accepted for use in combination with prednisone or prednisolone for the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer in adult men in combination with androgen deprivation therapy. 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. As such it would normally be prescribed by a specialist.

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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NICE Guidance - December 2019

The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of December 2019. This month there are two guidelines and two technology appraisals that impact upon primary care.

The Acute kidney injury: prevention, detection and management guideline has been published. It covers preventing, detecting and managing acute kidney injury in children, young people and adults. It aims to improve assessment and detection by non-specialists, and specifies when people should be referred to specialist services. This will improve early recognition and treatment, and reduce the risk of complications in people with acute kidney injury.

The Menopause: diagnosis and management guideline has been updated. It covers the diagnosis and management of menopause, including in women who have premature ovarian insufficiency. The guideline aims to improve the consistency of support and information provided to women in menopause. This update includes MHRA safety alert information regarding the risks of breast cancer.

The Cannabidiol with clobazam for treating seizures associated with Dravet syndrome technology appraisal recommends this treatment as an option for treating seizures associated with Dravet syndrome in people aged 2 years and older, only if:

  • the frequency of convulsive seizures is checked every 6 months, and cannabidiol is stopped if the frequency has not fallen by at least 30% compared with the 6 months before starting treatment
  • the company provides cannabidiol according to the commercial arrangement

The Cannabidiol with clobazam for treating seizures associated with Lennox–Gastaut syndrome technology appraisal recommends this treatment as an option for treating seizures associated with Lennox–Gastaut syndrome in people aged 2 years and older, only if:

  • the frequency of drop seizures is checked every 6 months, and cannabidiol is stopped if the frequency has not fallen by at least 30% compared with the 6 months before starting treatment
  • the company provides cannabidiol according to the commercial arrangement

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

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Drug Safety Update - December 2019

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for December 2019 (PDF).

This month clinicians are advice that domperidone is no longer licensed for use in children younger than 12 years or those weighing less than 35 kg. Results from a placebo-controlled study in children younger than 12 years with acute gastroenteritis failed to demonstrate any difference in efficacy at relieving nausea and vomiting compared with placebo. It is recommended that alternative treatments to domperidone are used in children younger than 12 years of age who need relief of symptoms of nausea and vomiting.

The summary of letters to healthcare professionals this month includes further links to letters recalling ranitidine, Emerade® adrenaline auto-injectors and several other pharmacy level drug recalls.

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

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