The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for July 2017 (PDF).
This issue contains information on the risk of severe liver injury in patients using Daclizumab (Zinbryta®). This drug is used to treat multiple sclerosis and during use monthly liver checks are recommended. These checks also need to continue for four months after stopping treatment. Liver injury should be monitored for and considered in patients on this treatment pending review by their consultant.
In the summary of letters sent to healthcare professionals in June it is noted that there have been several changes to prescribing information for enoxaparin (Clexane®). The strength will now be noted in milligrams and units, with 1mg equivalent to 100iu. The dosage in treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) has been clarified and use in end stage renal disease is not recommended unless to prevent thrombus formation in haemodialysis patients.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
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.
During June 2017 Clinical Knowledge Summaries were updated in the following areas.
The following topics were all reviewed:
The topics have undergone reviews and minor restructures. The most significant change is to the Adverse drug reactions topic which clarifies the recommendations for adverse drug reactions (ADRs) reporting in children. Previously it was recommended that all suspected reactions were reported but feedback suggested that this advice was impractical and deterred reporting and as such it is now recommended that reporting should occur in the same way as for adults.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.