The National Institute of Health and Clinical Excellence (NICE) has published new guidance for the month of June 2012. This month there are two clinical guidelines that impact upon primary care.
The Autism in adults clinical guideline offers evidence-based advice on the diagnosis and management of autism in adults. The guideline contains recommendations regarding assessment and diagnosis of autism in adult and interventions for core symptoms and challenging behaviour.
The Venous thromboembolic diseases clinical guideline offers evidence-based advice on the diagnosis and management of venous thromboembolic diseases. The guideline contains recommendations regarding assessment and treatment as well as the role of self monitoring of INR, investigations for cancer in patients with an unprovoked DVT or PE and the place of thrombophilia testing.
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 (MHRA) has published Drug Safety Update for June 2012 (PDF).
This update contains drug safety information reminding clinicians to prescribe oral tacrolimus by brand name. The growing number of brands available has increased the risk of inadvertent switches between products that may have different release profiles. Inadvertent switches have been associated with reports of toxicity and graft rejection. The currently available brands are:
- Immediate-release capsule taken twice daily (including Adoport®, Aletris®, Capexion®, Evenil®, Miloprosan®, Prograf®, Tacni®, Takon®, Taliximun®, Tamitect® and Vivadex®)
- Prolonged-release capsule taken once daily (Advagraf®)
- Granules for oral solution taken twice daily (Modigraf®)
The Stop Press section also reminds clinicians that tacrolimus ointment (Protopic®) may be associated with a possible risk of malignancy. Clinicians are reminded that this product should not be used in children under 2 years old and only the lower strength product should be used in children under 16 years old. Furthermore, the product should not be used on lesions that may be malignant or pre-malignant and used in individuals who are immunosuppressed through drug therapy or congenital or acquired disorders should not be prescribed this product.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
MTRAC has issued two new Commissioning Support reviews in June 2012. The reviews cover fampridine for walking disability in multiple sclerosis and dabigatran for stroke prevention in patients with atrial fibrillation.
Fampridine (Fampyra®) was considered unsuitable for prescribing in primary care and having a lower place in therapy with relatively weak evidence.
Dabigatran (Pradaxa®) was considered suitable for prescribing in primary care as an option. The committee recommended that warfarin remains first line with dabigatran having lower place in therapy despite relatively strong evidence. This lower place in therapy is made with regard to higher acquisition costs, unknown long-term safety and lesser opportunity to assess adherence to treatment.
Action: Clinicians should be aware of these reviews and compare current practice to the recommendations, making changes where appropriate.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Exenatide (Byetta®) has been accepted for use as adjunctive therapy to basal insulin with or without metformin and/or pioglitazone in adults with type 2 diabetes who have not achieved adequate glycaemic control with these agents.
Pregabalin oral solution (Lyrica®) has been accepted for restricted use in the treatment of peripheral and central neuropathic pain in adults and as adjunctive therapy in adults with partial seizures with or without secondary generalization. The solution should be used only for patients who find it difficult to or are unable to swallow tablets. It is also recommended that treatment in these conditions is started after trials of more established agents have provided inadequate response or not been tolerated. In the case of treating partial seizures treatment should be initiated by clinicians with experience in the treatment of epilepsy. Use in the treatment of Generalised Anxiety Disorder (GAD) in adults was rejected as the manufacturer failed to make a submission for this indication.
Tobramycin inhalation powder (TOBI Podhaler®) has been accepted for as a suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis.
Triptorelin pamoate (Salvacyl®) has been rejected for reversible reduction of testosterone to castrate levels in order to decrease sexual drive in adult men with severe sexual deviations. 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.
The MHRA has advised (PDF) that the manufacturer of Anapen® has recalled the product as a precautionary measure.
Anapen is an adrenaline auto-injector used for treating anaphylaxis in people with severe allergies. A possible issue has been identified that may result in inadequate doses of adrenaline being deliver and in the worst case none at all. There are currently no known cases where this has actually occurred.
It is recommended that patients in possession of an Anapen obtain an alternative from their doctor and then return the Anapen for appropriate destruction.
Action: Clinicians should be aware of this recall. It may be prudent to contact patients directly where adrenaline auto-injectors have been prescribed as the Anapen brand.