3. Off-label use

7. Pharmacovigilance and off-label use

Directive 2001/83/EC requires the marketing authorisation holder (MAH) to report to the competent authorities ‘any other new information which might influence the evaluation of the benefits and risks of the medicinal product concerned’, including ‘data on the use of the medicinal product where such use is outside the terms of the MA’. So, if important safety information relating to ‘off-label’ use becomes available, this should be implemented in the SmPC. Further guidance is given by the European Medicines Agency (EMA) guideline on Good Pharmacovigilance Practices (GVP) and in an EMA Q&A presentation on Off-Label Use (January 2015).

With the popularity of social media and direct interaction across patient communities, patient organisations can play an instrumental role in extending and deepening the reach and effectiveness of pharmacovigilance. This is especially important in case of off-label use. Pharmaceutical companies are increasingly monitoring social media, and establishing formal interactions with patient organisations to follow up on the lifecycle of their products in other forms than Phase IV or post-marketing studies/trials. This also entails an increased level of responsibility on the side t of patient organisations so that they can keep this process under control, and observe safety and legal constraints. Promoting off-label use must be avoided, and pharmacovigilance on the side of the patient community is key for the future of any product, and the health and safety of patients.