Public Pharmacovigilance Communication

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.

Trends in use of antipsychotics in elderly patients with dementia: Impact of national safety warnings

“…Besides, content of the warnings may not have been optimal as they did not inform physicians with guidelines and alternatives for the management of BPSD. The lack of providing alternatives is a factor of poor efficacy for advisories (Bahri, 2010; Dusetzina et al, 2012). Indeed, recommendations for the management of BPSDs were only published by a separate agency (French Health Authority) in May 2009 and in between mixed signals have been sent to prescribers since risperidone was approved for BPSD in July 2008.…”

Listen to the public and fulfil their information interests – translating vaccine communication research findings into guidance for regulators

“…It had been recognized that in order to overcome potential mismatches between the delivered information about medicinal products and public information interests, regulators should understand their audiences 21. Listening mechanisms available to regulatory authorities include media monitoring and interacting directly with members of the public, and recently these mechanisms have increasingly been used in the EU.…”

“…Overall, the guidance draws from the concept for strategic health communication, which provides for objective‐focused planning of communication interventions and impact evaluation. This approach advocates for listening and understanding patients, healthcare professionals and others concerned, and then using this understanding for scoping medicinal product‐specific risk assessments and analysing communication options 21. This requires studying the real‐world use of medicines and its drivers, as well as the concerns and questions of those using medicines.…”

“…Forty‐five articles (full text or abstracts, as indicated in the references) were considered relevant for the recommendations 23, 24, 25, 26, 27, 28, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84. Additionally, EU reviews of the communication about 2009/10 (H1N1) pandemic influenza vaccines 22, 85 and key publications on medicines/vaccines communication were extracted 9, 21, 86, 87, 88, 89.…”

Relevance of a “Dear Doctor letter” to alert healthcare providers to new recommendations for vitamin D administration

“…Some of them explained that they did not believe necessary to do this, as a new pipette would soon be available (data not shown). This highlights the difficulty to make a message understood when many ideas coexist and argues for a critical review and analysis of the DDLs by a panel of the intended recipients and by psychologists [15]. However, despite the limited effectiveness of the DDL to convey information, postal letter remained for the responding health professionals the best way to issue a safety warning.…”