Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - November 2018

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for November 2018 (PDF).

This issue advises of a small increased risk non-melanoma skin cancer seen in association with hydrochlorothiazine. The risk is cumulative and dose-dependent and as such is seen more after long-term use. Patients taking such medicines should be advised to regularly check for and report any new or changed skin lesions or moles. Sensible exposure to sunlight and UV rays, including using adequate protection should also be advised. Use in patients with a history of skin cancers should be reconsidered.

This issue also reports a small increased risk of aortic aneurysm and dissection, particularly on older patients, using fluoroquinolones. These antibiotics should only be used after careful consideration in patients at risk of aortic aneurysm and dissection, for example those with a family history, pre-existing aortic aneurysm or dissection and diseases that increase the risk such as Marfan syndrome, Ehlers-Danlos syndrome and hypertension.

It is also reported that a clinical study of sildenafil (Revatio® and Viagra®) in early-onset intrauterine growth restriction has been terminated early after reports of persistent pulmonary hypertension of the newborn (PPHN). It is noted that sildenafil is not licensed for this condition and that Revatio is not recommended in pregnancy unless strictly necessary while Viagra is not authorised for use in women.

A Europe wide campaign is running from 19–23 November 2018 to support the safe use of medicines in babies, children, and pregnant and breastfeeding women. Social media will be used to discuss the importance of reporting suspected side effects via the Yellow Card Scheme.

Also this month, the summary of letters to healthcare professionals includes information about expiry date extension of Jext® adrenaline autoinjectors, a reminder of the advice about phenytoin (Epanutin®) 30mg/5ml oral suspension supply disruption and shortage of sodium valproate modified release (Epilim Chronosphere®▼). CoaguChek Test Strips have also been found to give false high readings and it is recommended that readings above 4.5 are confirmed using a laboratory method or unaffected batches of test strips before adjusting treatment.

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

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Guidance on cannabis-based products

NHS England has issued guidance on the use of cannabis-based products for medicinal use.

Following high-profile news stories over the summer, the Home Office reviewed the legal status of cannabis-based products for medicinal use. In light of evidence of therapeutic benefit in certain medical conditions these products will be rescheduled.

The guidance document notes that cannabis-based products for medicinal use should only be prescribed:

  • for indications where there is clear published evidence of benefit or UK
    Guidelines
  • where there is a clinical need which cannot be met by a licensed medicine
  • where established treatment options have been exhausted
  • under the prescription or direction of a specialist doctor (listed on the Specialist Register of the General Medical Council)

Action: Clinicians should be aware of this guidance. It essentially rules out prescribing in primary care and places restrictions on specialist prescribing.

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Pregabalin and Gabapentin to be Controlled Drugs

The Home Office has announced that, following a consultation, Pregabalin and gabapentin are to be reclassified as Controlled Drugs with effect from April 2019.

Pregabalin and gabapentin have been associated with medicinal misuse, illegal diversion and addiction. Both drugs have seen increased use in recent years as well as increased numbers of fatalities related to drug related poisoning.

Both drugs will be reclassified as Schedule 3 controlled drugs meaning prescribers will now need to physically sign prescriptions which will only be valid in pharmacies for 28 days. As such they will no longer be sent electronically via EPS. The drugs will also be reclassified as class C making it illegal to possess pregabalin and gabapentin without a prescription and it will be illegal to supply or sell them to others.

These changes will come into force in April 2019 to allow time for healthcare systems and providers to implement the necessary changes to prescribing systems and processes.

Action: Clinicians should be aware of this change and ensure staff who aid in preparing prescriptions are notified. Systems for processing and handling controlled drug prescriptions may need to be reviewed and updated in light of this change.

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Drug Safety Update - October 2018

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for October 2018 (PDF).

This issue advises of an increased risk in all-cause mortality, thromboembolic and bleeding events in a clinical trial seen with rivaroxaban (Xarelto®) in a trial after transcatheter aortic valve replacement. Clinicians are reminded that direct-acting oral anticoagulants are not licensed or recommended for use in patients with prosthetic heart valves.

This issue also reports an interaction between ritonavir and levothyroxine leading to reduced thyroxine levels. Monitoring of thyroid-stimulating hormone (TSH) is recommended in patients treated with levothyroxine for at least the first month after starting and ending ritonavir treatment.

The issue also reports on cases of life-threatening and fatal opioid toxicity from accidental exposure seen with transdermal fentanyl patches, particularly in children. Since July 2014, there have been 5 reports of fatal incidents. It is recommended that patients and their carers are advised about safe use of fentanyl patches including:

  • not exceeding the prescribed dose
  • following the correct frequency of patch application, avoiding touching the adhesive side of patches, and washing hands after application
  • not cutting patches and avoiding exposure of patches to heat including via hot water (bath, shower)
  • ensuring that old patches are removed before applying a new one
  • following instructions for safe storage and properly disposing of used patches or those which are not needed

It is also suggested that patients and their carers are advised about the signs and symptoms of fentanyl overdose and seek medical attention immediately if overdose is suspected.

Also this month, the summary of letters to healthcare professionals includes a link to the supply disruption alert regarding EpiPen and EpiPen Junior.

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

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SMC Update - October 2018

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

Hydrocortisone granules (Alkindi®) have been accepted for restricted use in the treatment of adrenal insufficiency in infants, children and adolescents (from birth to <18 years old). The restriction limits use to first-line treatment of infants and young children with adrenal insufficiency aged from birth to less than six years of age for whom hydrocortisone must otherwise be individually prepared by manipulation such as by compounding (or crushing) or by production of special solutions in order to produce age-appropriate doses, or hydrocortisone given as off-label buccal tablets.

Cenegermin eye drops (Oxervate®) have been rejected for the treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults. The manufacturer failed to make a submission for this indication.

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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