The manufacturer of dabigatran (Pradaxa®) has written to healthcare professionals to advise that the colour of the capsule is being changed in a move that is likely to improve patient safety.
Dabigatran is available in three strengths, 75mg, 110mg and 150mg. Previously the capsule shell was the same colour for all three strengths with the size and imprint text being different. The new colour will see the 75mg capsule coloured white, the 110mg will be light blue and the 150mg will be two-tone white and light blue. The size and text imprint will remain the same. The changes have also removed sunset yellow as a colouring agent.
Patient support materials are available from company representatives or direct from the company by emailing of calling 01344 742 579.
Action: Clinicians should be aware of this change. Patients who are concerned that their medication has changed in appearance can be reassured and advised to continue to take dabigatran as prescribed.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for March 2017 (PDF).
This issue contains updated advice on the increased risk of lower-limb amputation (mainly toes) associated with use of the SGLT2 inhibitor canagliflozin. The updated advice notes that the current evidence does not show an increased risk for dapagliflozin and empagliflozin, but warns the risk may be a class effect. As previously suggested, patients receiving canagliflozin should be monitored for risk factors for amputation such as poor diabetes control and vascular disease. Treatment should be stopped if foot complications such as infection, skin ulcers, osteomyelitis or gangrene develop. It is also noted that preventive foot care is important for all patients with diabetes and especially in those being treated with an SGLT2 inhibitor.
The issue also announces a year long pilot of a reporting scheme for healthcare professionals to report suspected adverse reactions to illicit drugs, particularly new psychoactive substances (or 'legal highs'). A new site is available containing the Report Illegal Drug Reaction form that also collects information about licensed medicine that may help identify common issues arising from combinations of specific licensed medicines and psychoactive substances.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The National Institute of Health and Care Excellence (NICE) have published new or updated guidance for the month of March 2017. This month there are two guidelines that impact upon primary care.
The Stroke and transient ischaemic attack in over 16s clinical guideline has been updated to give a definition of aspirin intolerance, rather than a link to a definition. The guideline covers interventions in the acute stage of a stroke or transient ischaemic attack (TIA). It offers the best clinical advice on the diagnosis and acute management of stroke and TIA in the 48 hours after onset of symptoms, although some interventions of up to 2 weeks are covered as well.
The Familial breast cancer clinical guideline has been updated after a review of the evidence for chemoprevention for women with no personal history of breast cancer. The guideline covers care for people with a family history of breast, ovarian or another related (prostate or pancreatic) cancer. It aims to improve the long-term health of these families by describing strategies to reduce the risk of and promote early detection of breast cancer (including genetic testing and mammography). It also includes advice on treatments (tamoxifen, raloxifene) and surgery (mastectomy).
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Department of Health announced in March that the price for an NHS prescription in England will increase by 20p to £8.60 with effect from the 1st April 2017.
The prices for 3 and 12 month pre-payment certificates are frozen and have remained the same at £29.10 and £104 respectively. For anyone requiring more than 3 items in 3 months or more than 12 in a year these certificates can provide significant savings.
Other NHS charges such as for dental work, wigs and fabric supports are also being increased in line with inflation.
Action: Clinicians should be aware of the current prescription charge and also the value for money represented by pre-payment certificates.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Lacosamide (Vimpat®) has been rejected for use as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent (16-18 years) patients with epilepsy. 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.
