title: Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies.
abstract: As a contribution to the debate on how best to communicate information on the effective and safe use of medicines to patients, healthcare professionals and the general public, this article proposes to distinguish between communication and transparency purposes, and to test a strategic health communication approach. Any organization aiming to improve medicines use could adapt this approach to its remits and legal obligations. The approach includes agreeing measurable communication objectives through shared problem ownership of all concerned parties, evidence-based design and a cyclic process for planning, implementation and evaluation of communication as a public health intervention. The evidence base, which supplements risk assessment for product- and situation-specific communication on safety concerns, would be derived from research into drug utilization, medical decision making and risk perception, as well as from the participation of patients and healthcare professionals. It is crucial to address the practical questions and concerns of medicine users and to find out why unfavourable patterns of medicine use persist, in order to develop behaviour change models for overcoming these obstacles. For this purpose, appropriate models for facilitating the participation of medicine users in the risk management process will need to be explored. Such two-way communication would inform risk assessment as well as the analysis of risk minimization options, allow for agreement upon communication objectives and enable understandable, attractive communication materials to be designed. The communication programme should use mixed media and repetition of messages for long-term success. This would require cooperation within healthcare and medical information systems. An evaluation of the effectiveness of the communication should support the sustainability of the programme and provide lessons for the future. Given its mission, the pharmacovigilance community has the standing and duty to expand its scale of action and take the initiative in advancing risk management through a scientific approach to improving public communication for the safety of patients.
authors.affiliation: European Medicines Agency, London, UK. priya.bahri@ema.europa.eu
authors.forename: Priya
authors.initials: P
authors.lastname: Bahri
mesh_terms: D004346:Drug Information Services; D064420:Drug-Related Side Effects and Adverse Reactions; D055317:Evidence-Based Practice; D058015:Health Communication / Q000379:methods*; D006801:Humans; D009937:Organizational Objectives; D017891:Pharmacoepidemiology / Q000193:education*; D011358:Product Surveillance, Postmarketing; D024382:Professional Role