NHS England has written to CCGs, pharmacies and GP practices with updated advice regarding prescribing of pregabalin.
In 2015, NHS England were required by the courts to issue advice that pregabalin must be prescribed a specific way when used for neuropathic pain due to the existence of a patent that applied to that licensed indication.
This update withdraws and replaces the previous advice and contains the following recommendation for prescribing clinicians:
"In our guidance of 2 March 2015 we asked you to consider amending the operation of any electronic prescription system that is within your power or control to ensure that practitioners were readily able to follow that guidance. If you made such an amendment, we now ask you to reverse it to reflect the revised guidance above as from 17 July 2017."
Action: Clinicians can now return to normal practice when prescribing pregabalin and no longer need to specify a brand name when prescribing for neuropathic pain.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Ciprofloxacin and dexamethasone ear drops (Cilodex®) have been accepted for restricted use in the treatment of acute otitis media in patients with tympanostomy tubes (AOMT) and acute otitis externa in adults and children. The restriction limits use in acute otitis media to patients with tympanostomy tubes.
Glycopyrronium (Sialanar®) has been accepted for use in the symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.
Saxagliptin and dapagliflozin (Qtern®) has been accepted for restricted use in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control when metformin and/or sulphonylurea and one of the monocomponents of Qtern is not adequately effective or when already being treated with the free combination of dapagliflozin and saxagliptin. The restriction limits use to a combination with metformin when a sulphonylurea is inappropriate.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The manufacturer of the NovoPen Echo® and NovoPen 5® has issued a safety alert notice advising that the insulin cartridge holder supplied with certain batches of these pens can become brittle and crack or break after exposure to household products resulting in reduced delivery of insulin.
Exposure to certain chemicals contained in household products including cleaning agents, sunscreen and food grease can affect the plastic and weaken it resulting in cracks and breaks. It is noted that if the cartridge cleaner is cleaned as described in the "Instructions of Use" that damage is extremely unlikely.
It is recommended that patients continue to use their existing treatment and contact the manufacturer online or via telephone on 0845 600 5055. If the pen in use is from an affected batch, a replacement cartridge holder will be supplied. The affected batch numbers have been made available by the manufacturer so the details can be checked before contacting them.
Action: Clinicians should be aware of this safety notice and direct concerned patients to contact the manufacturer.
The manufacturer of fluphenazine decanoate (Modecate®) injection has written to healthcare professionals advising that this product will be discontinued by the end of 2018.
The letter details unpredictable supplies of the active ingredient from the single global manufacturer as the reason for this decision. It is noted that this decision is not due to any safety concerns. Both injection strengths (25mg/ml and 100mg/ml) are being discontinued with manufacturing ceasing in mid-2018 with supplies in the United Kingdom expected to run out by the end of 2018.
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 June 2017 (PDF).
This issue contains recommendations following reports of osteonecrosis of the external auditory canal with denosumab (Prolia®). There have been 5 such reports worldwide and clinicians are advised to consider this possibility of osteonecrosis in patients receiving denosumab who present with ear symptoms including chronic ear infections or in those with suspected cholesteatoma. Risk factors include steroid use and chemotherapy, with or without local risk factors such as infection or trauma. Patients on treatment should be advised to report any ear pain, discharge from the ear or an ear infection during denosumab treatment. Any further cases should be reported via the Yellow Card Reporting Scheme.
This issue also notes that there have been reports of systemic cardiovascular effects including bradycardia, hypotension and dizziness after application of brimonidine gel (Mirvaso®). Some cases were reported after laser procedures to the skin. Patients should be advised to avoid application to irritated or damaged skin, including after laser therapy.
Additionally, this issue contains a review on the restriction on sales of pseudoephedrine and ephedrine which has indicated that these measures continue to be successful in managing the risk of misuse. It also encourages use the Yellow Card Reporting Scheme to support the safety of e-cigarettes and refill containers (e-liquids). Suspected side-effects, harm to children or non-users and safety issues or defects can all be reported.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
