Patient representatives are calling on the European Parliament to incorporate a clause specifically covering unlicensed medicines in the Pharmacovigilance Directive, which is currently under review.
Urgent measures are needed to protect patients, specifically in the wake of the recent company-led withdrawal of Avastin (bevacizumab) by Moorfields Pharmaceuticals, according to Jim Thomson, chair of the European Alliance for Access to Safe Medicines (EAASM), speaking on the eve of an event in the European Parliament held to discuss the issue.
The precautionary recall of 27 Avastin batches was issued after an increased number of reports of suspected sterile endophthalmitis, an inflammatory condition of the internal coats of the eye, usually caused by infection. The condition may also result from toxic agents or from retained native lens material after an operation.
There has been much debate about the widespread practice of using Avastin, which is licensed for the treatment of various cancers, as an unlicensed treatment in ophthalmology. A key argument against this use is that bacteria can be introduced during the compounding process, says the EAASM.
"We are not just heading for a healthcare system where economic factors are placed before patient safety and choice - we are already there," said Mr Thomson. "What we have here is a medicine, compounded by one of the world's leading eye hospitals, being used for a condition for which it is not licensed, in preference to the licensed alternative. This is about money, pure and simple, but at what price? Patient safety? What price is a patient's sight worth?"
The Alliance says urgent action is needed to address patient safety issues around the use of unlicensed and off-label medicines, which it says should only be used in cases where there is no licensed product available that meets the medical need.
The EAASM is also calling for: - establishment of a framework to research and publish the number of adverse events related to unlicensed or off-label use of medicines; - introduction of a professional Code of Practice to govern mandatory reporting of adverse events related to unlicensed or off-label use of medicines; and - action to improve public awareness, so that patients are aware of when they are prescribed an unlicensed or off-label medicine, know how to make sure that adverse events are reported and that they give their consent for those medicines to be used.
The Alliance is also concerned that the changes which the General Medical Council (GMC) in the UK is considering making to its guidance on the use of unlicensed medicines could allow doctors to make decisions based on cost. A draft of the GMC proposals released last year also suggest that, under the revised guidance which the Council plans to publish this year, doctors may not have to inform the patient being treated if they intended to use an unlicensed product.
"The very idea that a healthcare professional could prescribe an unlicensed medicine to a patient without his or her fully-informed consent is unthinkable. The EAASM is extremely concerned that there are so few safeguards in place currently, without removing those that there are," said Mr Thompson.
The Alliance has met recently with the Medicines and Healthcare products Regulatory Agency (MHRA), which assured the group that it plans to strengthen adverse drug reaction reporting requirements in this area, and this is very welcome, he said.
"We also plan to ask the European Parliament to incorporate a clause specifically dealing with unlicensed medicines within its Pharmacovigilance Directive, currently under review. Meanwhile, patients should, of course, be fully informed and, together with their healthcare professional, make choices that are based on the best treatment option, rather than the cheapest," he added.