The Medicines and Healthcare products Regulatory Agency (MHRA) completed a public consultation in July 2009 into the legal position of practitioners mixing and administering medicines in palliative care.
The review concluded that changes were necessary:
- To allow doctors and dentists (who can already mix medicines themselves) to direct others to mix (other than a pharmacist under existing legislative provisions, or by a person holding a manufacturer’s licence)
- To allow non-medical prescribers to mix medicines themselves and direct others to mix (other than a pharmacist under existing legislative provisions, or by a person holding a manufacturer’s licence)
- To allow nurse and Pharmacist Independent Prescribers to prescribe unlicensed medicines for their patients on the same basis as doctors and supplementary prescribers
A statutory instrument (PDF) has now come into force that creates new exemptions from the restrictions imposed by sections 7 and 8 of the Medicines Act 1968.
It should be noted that the changes made do not currently extend to controlled drugs. However, the MHRA has already stated that it would not consider taking enforcement action for breaches of medicines legislation in the long standing accepted practice of prescribing and administering (and providing directions to others to administer) a mixture of licensed medication via a single injection or a syringe driver unless it would be in the public interest to do so.
Action: Clinicians can be reassured by this amendment to the law. It is hoped that the position with respect to controlled drugs will also be clarified.
The European Medicines Agency (EMEA) has announced (PDF) that they will be conducting a safety review for sibutramine (Reductil®) after cardiovascular safety concerns were raised.
The Sibutramine Cardiovascular OUTcomes (SCOUT) trial involved approximately 10,000 patients who were overweight or obese and had risk factors for cardiovascular disease for example diabetes or dyslipidaemia. The study aimed to assess the efficacy of drug assisted weight loss using sibutramine on cardiovascular outcomes in this higher risk population.
The EMEA are reviewing data that indicate an increased risk of serious cardiovascular events, such as stroke or heart attack. In the meantime clinicians and patients are reminded to use sibutramine-containing medicines with caution, and only in accordance with the currently approved product information. It is noted that the patients recruited to the SCOUT study would have been contraindicated in the majority of cases.
Clinicians should refer to the Summary of Product Characteristics and be aware of the following:
- Sibutramine is contraindicated in patients with a history of coronary artery disease, congestive heart failure, tachycardia, peripheral arterial occlusive disease, arrhythmia or cerebrovascular disease (stroke or TIA)
- All patients taking sibutramine should be regularly monitored for increases in blood pressure and heart rate
- Patients who do not lose at least 5% of their body weight within 3 months should stop treatment
- The maximum treatment duration should not exceed one year
Action: Clinicians should be aware of this review and use sibutramine cautiously until it is completed. Preferential use of orlistat, for the time being at least, would seem sensible.
