The European Alliance for Access to Safe Medicines (EAASM) is calling for authorities to act now to clarify the conditions under which medicines can be used outside of their approved status.
For example, the recent report from the US-based "CATT" study shows an increased risk of serious adverse events with the unlicensed (but widely-used) drug for wet AMD, when compared to the licensed (but more costly) drug. In the wake of the publication of a second, this time UK-based IVAN study report, and although the drugs were found comparably effective, the AMD Society commented that
"The trials cannot provide definitive safety information and the overall question of the safety of Avastin is, unfortunately, not answered to everyone's satisfaction by these trials.
"The use of Avastin will remain a matter of judgement for clinicians, with some satisfied with the evidence and others not."
Reacting to the study results, EAASM Chair, Jim Thomson, said:
"This is not an issue solely for the discretion of physicians. Of course it is a complex issue, with hard-pressed budgets involved, but that should not cloud the fact that patients deserve to be given the choice of the licensed medicine. We are talking about an elderly population and these patients should be fully informed and give written consent if they are to be treated with an unlicensed medicine.
There has been much debate about the widespread practice of using Avastin (a medicine licensed for the treatment of various cancers) as an unlicensed treatment in ophthalmology. Neither of these studies addresses a key argument against its use, that being that bacteria can be introduced during the preparation of Avastin for intra-ocular use. A single dose is drawn up from the larger vial, with the remainder of the contents potentially stored for future use, which has led to vials becoming contaminated. This has been proven to be a patient safety risk, with numerous patients blinded. Indeed The Department of Veterans Affairs - one of the largest healthcare providers in the world, now insists that if Ophthalmologists use Avastin, they must use a single vial per treatment having drawn up the required amount with the remainder of the vial's contents being discarded.
Of course, the CATT study points to increased risk of serious adverse events, regardless of that process."
Whilst the debate around the use of medicines outside of their approved status is bound to continue to rage, what remains extremely worrying is that there is very little formal regulation. The EAASM is one of a growing number of organisations campaigning to
- Establish a framework to research and publish the number of adverse events related to unlicensed or off-label use of medicines - Introduce a professional framework to govern mandatory reporting of adverse events related to unlicensed or off-label use of medicines - Improve public awareness so that patients are aware of when they are prescribed an unlicensed or off-label medicines, how to make sure that adverse events are reported, and that they give their consent for those medicines to be used
Jim Thomson comments: "The very idea that a healthcare professional could prescribe an unlicensed medicine to a patient without his or her fully informed consent, is unthinkable. We met with the MHRA recently and they assured us that they plan to strengthen the adverse drug reaction reporting requirements in this area. That is extremely welcome. Our recent report "When is a Medicine not a Medicine" highlighted two additional case studies - the reprocessing and re-use of single use medical devices and the use of unlicensed substances in pre-operative situations - that shouldn't be overlooked whilst attention is focused on the wet AMD debate. These are serious patient safety issues and right now, today, patients remain not only at risk but uninformed about those risks. The Lucentis / Avastin debate is just the tip of a barely visible patient safety iceberg and whilst any savings at all might seem on the surface to be attractive in the current economic climate, that isn't in itself reason enough to disregard two important factors.
First, there is a regulatory process for a very good reason. Second, 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."
Notes to editors
The European Alliance for Access to Safe Medicines (EAASM) was founded in 2007 with the aim of improving patient safety around Europe by fighting against unlicensed products and counterfeit medicines. The EAASM is a registered Community Interest Company (CIC) in the UK. This legal structure ensures that everything it does is specifically for community benefit or the wider public interest
For further enquiries or to request an interview contact:
Jim Thomson Chair, EAASM T: +44(0)1702-474230 M: +44(0)7901-800608 E: firstname.lastname@example.org
ots Originaltext: EAASM Im Internet recherchierbar: http://www.presseportal.de