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.
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.
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.
During September 2018 Clinical Knowledge Summaries were published or updated in the following areas.
The following topics were all reviewed:
The majority of reviewed topics have undergone reviews and minor restructures.
The most significant changes were to the Impetigo topic where the duration of topical treatment has been reduced to 5 days based on recommendations by Public Health England and the Pelvic inflammatory disease topic where the role of Mycoplasma genitalium and antibiotic treatment is now detailed.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.
The Department of Health and Social Care have issued a Supply Disruption Alert regarding limited availability of EpiPen and EpiPen Junior. This situation is likely to last for the remainder of 2018.
Several suggestions are made that will aid effective supply in the coming months:
Due to the limited availability, prescriptions should only be issued where there is truly a need for a new prescription. Prescriptions should not be issued for people worried about the supply situation, but who have pens that are in date, as this will only add to the supply shortage.
The expiry date on the packaging indicates the end of the month when the product expires. Several batches as specified in the alert have also had the expiry date extended by 4 months so it may be prudent to ask for lot numbers before issuing scripts.
Switching between devices may be an option provided the alternatives can be supplied and patients can be instructed upon their use.
Prescribers and pharmacies are encouraged to work together to ensure appropriate items that are in supply are used and are directed to the Specialist Pharmacy Services website for additional updates to supply and clinical guidance.
Action: Clinicians should be aware of this supply situation and follow the recommended actions to relive some of the supply pressures.