The manufacturer of Bricanyl® Turbohaler has written to healthcare professionals, and also informed Asthma UK, advising that supplies of this inhaler are very low in the UK.
The reason behind this shortage is being investigated and it is currently expected that this issue will persist until the end of January 2019. Asthma UK is advising patients to check their inhalers and ensure they have adequate supply; it is also recommended to seek advice from a healthcare professional for a suitable alternative before their current inhaler runs out.
Switching to an alternative will require a change to salbutamol. Consideration should be given to the range of devices available including pressurised metered dose inhalers, breath actuated aerosols and dry powder inhalers. Provision of a spacer device may also be appropriate.
Action: Clinicians should be aware of this product supply shortage. 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.
The manufacturer of Cilest® (norgestimate and ethinyl estradiol) has written to healthcare professionals advising that this product will be discontinued with effect from July 2019.
The letter states that this was a commercial decision to exit the oral hormonal contraceptive market and it is stressed that the are no safety, efficacy or quality issues with the product. Current supplies are expected to last until mid-July 2019.
There are two alternative products that are currently available in the UK with the same active ingredients - Cilique® and Lizinna®.
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.
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.
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
- 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.
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.