The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for April 2013 (PDF).
This issue contains drug safety advice informing clinicians of the potential risk of error with insulin degludec (Tresiba®) due to it being available in two strengths. Clinicians are urged to ensure that the correct insulin product and strength is prescribed and pharmacists should check again when the product is dispensed. It is also advised that patients are trained on how to use the device in particular they should always visually verify the dialled units on the dose counter.
This section also warns of the risk of cardiovascular and bleeding events associated with use of cilostazol (Pletal®). This drug is licensed for use to improve walking distances in patients with intermittent claudication. A recent safety review has concluded that the benefits of treatment are worthwhile in some, but not all patients. It is recommended that cilostazol is now used as second line treatment to lifestyle interventions and that it should not be use in patients with:
- Unstable angina, recent myocardial infarction or coronary intervention (within 6 months)
- A history of severe tachyarrhythmia
- A prescription for two or more other antiplatelet or anticoagulant treatments
The hot topic section advises that clinicians remain vigilant to the potential for errors to occur as a result of drug name confusion. Recent examples of medicine names that have been confused resulting in medication errors include:
- Mercaptamine and Mercaptopurine
- Sulfadiazine and Sulfasalazine
- Risperidone and Ropinirole
- Zuclopenthixol decanoate and Zuclopenthixol acetate
Finally, the stop press section advises of emerging cardiovascular safety concerns related to strontium ranelate (Protelos®). This drug is already associated with an increased risk of venous thromboembolism but recent analysis of randomised controlled trial data has identified an increased risk of cardiovascular events including myocardial infarctions. A full assessment of the risks and benefits will be carried out. In the meantime it is recommended that use of this drug is restricted to cases of severe osteoporosis, it should be avoided in patients who already have a cardiovascular disease and should only be used after careful consideration in those with risk factors for cardiovascular disease.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
The National Institute of Health and Care Excellence (NICE) has published new guidance for the month of April 2013. This month there are four technology appraisals that impact upon primary care.
The Asthma (severe, persistent, patients aged 6+, adults) - omalizumab (Xolair®) technology appraisal recommends this treatment as an option for treating severe persistent confirmed allergic IgE‑mediated asthma in individuals who need continuous or frequent treatment with oral corticosteroids. This recommendation is made provided the treatment is made available with the discount agreed in the patient access scheme.
The Gout - canakinumab (Ilaris®) technology appraisal was terminated because no evidence submission was received from the manufacturer. As such the treatment cannot be recommended.
The Idiopathic pulmonary fibrosis - pirfenidone (Esbriet®) technology appraisal is recommended for patients with a predicted FVC between 50% and 80% and provided the treatment is made available with the discount agreed in the patient access scheme. Treatment should be stopped if the predicted FVC decline by more than 10% in 12 months.
The Rheumatoid arthritis - abatacept (2nd line) (Orencia®) technology appraisal recommends this treatment in combination with methotrexate as an option for treating rheumatoid arthritis in adults whose disease has responded inadequately to two conventional DMARDs. This recommendation is based upon it being used in accordance with the recommendations for other biological DMARDs as defined in TA130 and provided the treatment is made available with the discount agreed in the patient access scheme.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Medicines and Healthcare products Regulatory Agency has published guidance on patient specific directions (PSDs) in response to a number of enquiries about the use of PSDs in healthcare settings.
The guidance answers some frequently asked questions and includes a definition of a PSD. It also clarifies what information is needed on a PSD, how long they remain valid and the responsibilities and accountabilities of the prescriber who writes the PSD.
Action: Clinicians who make use of PSDs should be aware of this guidance and ensure that use of PSDs is in accordance with this guidance.
The 65th Edition of the British National Formulary has been published and it is currently being distributed in the NHS.
New or revised content in this version includes updated advice in the following areas:
- Updated guidance on pain management in palliative care
- Updated advice on the management of hereditary angioedema
- Revised guidance on the treatment of endocarditis
- Updated advice on the risk of malignancy with long-term use of calcitonin
- Several new drugs or indications have been added
The web version has already been updated but requires registration or an Athens account for continued access. The printed version is available for purchase.
Action: All clinicians should start using BNF 65 as soon as the print version arrives. The web version can be used to access the latest information if necessary.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Insulin degludec (Tresiba®) has been rejected for use in the treatment of diabetes mellitus in adults. The manufacturer failed to make a sufficiently robust economic case.
Insulin glargine (Lantus®) has been accepted for restricted use in the treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. The restriction recommends use in patients with Type 1 diabetes when efforts to achieve better glycaemic control result in unacceptable levels of nocturnal hypoglycaemia or to aid carer administration. In patients with Type 2 diabetes use is recommended for patients who experience recurrent episodes of hypoglycaemia or require assistance with their insulin injections.
Timothy grass pollen allergen (GRAZAX®) has been rejected for use as a disease-modifying treatment of grass pollen induced rhinitis and conjunctivitis in adults and children. The manufacturer failed to make a submission.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.