The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for March 2015 (PDF). This month there are two updates pertinent to primary care.
A new e-learning module for corticosteroids has been created that aims to help clinicians understand how to identify, manage and avoid the
important side effects of these valuable and widely prescribed medicines - vital knowledge for optimising the use of corticosteroids.
Readers are also encouraged to report misleading medicines advertisements. Reports can be made to the MHRA at advertising@mhra.gsi.gov.uk or Prescription Medicines Code of Practice Authority (PMCPA) at complaints@pmcpa.org.uk.
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) has published new guidance for the month of March 2015. This month there are four guidelines and two technology appraisals that impact upon primary care.
The Medicines optimisation guideline offers best practice advice on the care of all people who are using medicines and also those who are receiving suboptimal benefit from medicines. The recommendations include topic areas such as medication review, medicines reconciliation and patient decision aids.
The Excess winter deaths and morbidity guideline makes recommendations on how to reduce the risk of death and ill health associated with living in a cold home. Clinicians may find this guideline useful when consulting vulnerable people.
The Maintaining a healthy weight guideline makes recommendations on behaviours that may help people maintain a healthy weight or prevent excess weight gain. The recommendations aim to:
- encourage people to make changes in line with existing advice
- encourage people to develop physical activity and dietary habits that will help them maintain a healthy weight and prevent excess weight gain
- encourage people to monitor their own weight and associated behaviours
- promote the clear communication of benefits of maintaining a healthy weight and making gradual changes to physical activity and diet
- ensure messages are tailored to specific groups
- ensure activities are integrated with the local strategic approach to obesity
The Depression in children and young people guideline has been updated in sections 1.5 and 1.6 where new recommendations on psychological therapies and antidepressants have been added.
The Empagliflozin technology appraisal recommends this treatment for type 2 diabetes, in combination with metformin, only if the person cannot take a sulfonylurea or is at significant risk of hypoglycaemia or its consequences. It can also be used in triple therapy in addition to metformin and a sulphonylurea or a glitazone, and finally use in combination with insulin, with or without other antidiabetic drugs is also allowed.
The Rivaroxaban technology appraisal recommends this treatment as an option within its marketing authorisation, in combination with aspirin plus clopidogrel or aspirin alone, for preventing atherothrombotic events in people who have had an acute coronary syndrome with elevated cardiac biomarkers. The risk of bleeding needs to be assessed before treatment is started and a decision on continuation of treatment should be taken no later than 12 months after starting treatment.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The manufacturer of Creon has written to healthcare professionals advising that Creon 40,000 capsules are temporarily unavailable due to manufacturing yield problems.
A letter from the manufacturer notes that Creon is a biological product and lower than expected yields of high-potency enzymes from porcine glands has impacted on the current availability of the 40,000 strength product. This issue does not impact upon the lower dose products and therefore Creon 25,000 and 10,000 remain available.
It is therefore recommended that an equivalent dose of a lower dose be used with a preference to use the 25,000 strength product to reduce the number of capsules taken by individual patients.
Action: Clinicians should be aware of this supply issue. It may be prudent to run clinical system searches to identify any patients who are currently prescribed this product to allow a review and an alternative to be arranged.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Apixaban (Eliquis®) has been accepted for use in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
NHS England has written to CCGs, pharmacies and GP practices regarding prescribing of generic pregabalin.
Pregabalin as the brand Lyrica® is licensed for epilepsy, generalised anxiety disorder and neuropathic pain. The patent for the neuropathic pain indication extends until July 2017. Generic versions of pregabalin are likely to be imminently available but are only licensed for epilepsy and generalised anxiety disorder due to this patent.
The manufacturer of Lyrica® is currently in a dispute with a number of generic pharmaceutical suppliers. The Court has required that NHS England issue guidance in relation to the prescribing and dispensing of pregabalin. This guidance states:
"Pregabalin should only be prescribed for the treatment of neuropathic pain under the brand name Lyrica®® (unless there are clinical contra-indications or other special clinical needs e.g. patient allergic to an excipient, branded product unavailable etc which apply to Lyrica®®, when you should not prescribe Lyrica®® or pregabalin)".
Action: Clinicians should be aware of this guidance. Consideration should be given to what measures need to be taken to protect against allegations of patent infringement.