Principles and Considerations for Responsible Sharing of Safety Information Via the Medical Information Channel

The approach used by medical information services in answering unsolicited safety-related questions from health care professionals regarding prescription medicines varies widely across the pharmaceutical industry. A significant amount of information is available in the public domain, but this can be difficult to filter and determine what is most appropriate for a given situation. A team representing the medical information group MILE (Medical Information Leaders Europe) and European Federation of Pharmaceutical Industries and Associations Pharmacovigilance Expert Group have partnered to develop principles and considerations on how to answer unsolicited safety questions. Essentially two key principles are important in ensuring success: (1) Effective collaboration between medical information and patient safety teams is important for an optimal outcome providing accurate, useful, and timely information. This article discusses considerations for an effective, efficient collaboration between medical information and patient safety and suggests a way of working. (2) Collaborating teams will need to evaluate and select the most appropriate sources of information to answer the question. Sources of information that may or may not be in the public domain are discussed. Adoption of principles and considerations discussed in this article may be expected to improve current safety information–sharing practices that tend to be conservative and risk averse. In addition, this presents the opportunity to initiate discussions with regulatory authorities to realize the benefits that will come through greater transparency and communication to support safe and effective use of medicines.