While the exact figure is difficult to ascertain, data published by the European Commission suggest the prevalence of off-label use of medicines is high across Europe. Positive results from such practices are often reported in academic literature, but less evidence is published on the adverse events.
In a new position paper on the off-label use of medicines, the Standing Committee of European Doctors (CPME) is recommending that measures are taken to encourage notification of adverse reactions related to off-label use of medicines at national and European level through the EudraVigilance database, in order to obtain objective data on risks and benefits.
The Committee, which represents national medical associations across Europe, is also recommending that off-label use should not be recommended before there is sufficient clinical evidence or at least, broad consensus that such use is beneficial.
The CPME says, where the off-label use of a drug is common and evidence-based, “it should be the responsibility of both the marketing authorisation holder and the responsible regulatory authority to take appropriate measures to address legal uncertainty and safety concerns regarding such medicines”.
The organisation says informed consent should be required before a drug is used outside of licensed indications.