Priya Bahri

Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies.

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.

Teaching Pharmacovigilance: the WHO-ISoP Core Elements of a Comprehensive Modular Curriculum

The importance of pharmacovigilance (PV) for safe medicines and their safe use has increasingly been recognised during the last few years [1]. PV has been subject of intense research and regulation. In particular, it has earned more and more importance and attention in low-resource countries. This is largely due to the globalisation of trade and the availability of new, highly effective but potentially harmful chemical medicinal products in those parts of the world where traditional treatments, in particular herbal or other complementary remedies, used to prevail. A plethora of publications, guidelines and information about newly observed or further investigated adverse drug reactions (ADRs) from all over the world creates a growing burden for people working with medicines or patients to keep abreast of this development. Largely due to the global availability of information through the Internet, patients are nowadays more and more critical and often concerned about, or even frightened of, potential ADRs of their medicines. This poses an additional demand on the up-todate capacities of their doctors and other healthcare professionals (HCPs). A particular challenge is the multidisciplinary character of PV which requires know-how in topics as different as molecular mechanisms of ADRs, clinical medicine, pharmacoepidemiology, information technology, pharmaceutical manufacturing, legal aspects, public health situations on various levels, and traditions in The views expressed in this article reflect a consensus reached between the personal views of all authors. They do not necessarily reflect the views of the authors’ employers or any institutions the authors are otherwise affiliated to.

Focusing on risk communication about medicines: why now?

Communication about the risks of medicines is not a new issue. Patients have long since sought advice about remedies, whether from family, healthcare workers or the wider community in traditional ways, or via websites and social media in today’s world. As pharmacovigilance professionals, interacting with patients, healthcare professionals, health policy makers, journalists and the general public has become part of our daily activity, in order to manage risks with medicines appropriately and reduce patient harm.

Communication in Drug Safety

Public communication on safety concerns over medicines and advice on how to preventmedicineinduced patient harm is a decisive challenge for the overall success of those responsible for pharmacovigilance. It was in this spirit that the topic of communication in drug safety was put on the agenda of the 10th Annual Meeting of the International Society of Pharmacovigilance (ISoP) in Accra, Ghana, on 5 November 2010, as a follow-up to the sessions on communications at previous annual meetings. The informal environment chosen this time was different and unusual but ideal for the topic at stake: an interactive debate involving all participants in the session with the objective of understanding the characteristics of effective communication. Around 30 participants from all over the world came together and presented views from their various perspectives: community and hospital pharmacy, academia, pharmacovigilance centres and regulatory agencies, as well as international bodies. Much is known in theory about good communication practices, particularly with regard to the need for clear messages targeted at different populations. But how to achieve this in practice? Reciprocity was defined as the starting point: an exchange of information based on mutual respect and shared interest. Two crude communication levels are to be distinguished: one-to-one communication between patients and healthcare professionals, versus mass communication – with smaller or larger audiences – by those investigating and regulating medicines. Independently of the level, the principles of reciprocity and interaction should apply, not least in the research and planning stage, before communication takes place. The interactive debate was a free-flowing discussion where almost all participants took the floor and presented examples, bringing the principles and challenges of their application to life. Patients’ misunderstandings as to the indication and adverse effects of medicines seem frequent. This was illustrated by examples, including one on women’s fears over adverse effects resulting in infertility and termination of pregnancy. The introduction of a communication protocol for thoroughly informing the women concerned in the presence of a third-party witness or supporter has solved the problem in the setting presented. Other examples related to communication over counterfeit medicines, another difficult area given that many people feel they do not have the financial means for, or easy access to, quality-assured products. MEETING REPORT Drug Saf 2011; 34 (10): 881-882 0114-5916/11/0010-0881/

Benefit-Risk Assessment, Communication, and Evaluation (BRACE) throughout the life cycle of therapeutic products

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Benefit-Risk Assessment, Communication, and Evaluation (BRACE) throughout the life cycle of therapeutic products : overall perspective and role of the pharmacoepidemiologist

Optimizing a therapeutic products benefit–risk profile is an on‐going process throughout the products life cycle. Different, yet related, benefit–risk assessment strategies and frameworks are being developed by various regulatory agencies, industry groups, and stakeholders. This paper summarizes current best practices and discusses the role of the pharmacoepidemiologist in these activities, taking a life‐cycle approach to integrated Benefit–Risk Assessment, Communication, and Evaluation (BRACE).

The ISoP CommSIG for Improving Medicinal Product Risk Communication: A New Special Interest Group of the International Society of Pharmacovigilance

Optimizing a therapeutic products benefit–risk profile is an on‐going process throughout the products life cycle. Different, yet related, benefit–risk assessment strategies and frameworks are being developed by various regulatory agencies, industry groups, and stakeholders. This paper summarizes current best practices and discusses the role of the pharmacoepidemiologist in these activities, taking a life‐cycle approach to integrated Benefit–Risk Assessment, Communication, and Evaluation (BRACE).

How to Improve Communication for the Safe Use of Medicines

Communicating to patients and healthcare providers about the risks of harm with medicines and how to use medicines safely is vital to pharmacovigilance for fulfilling its objectives—there is no or little risk avoidance/mitigation or patient safety without risk communication. Communication about risk characteristics and factors should also enable patients and healthcare providers to make informed therapeutic choices. This requires discussing risks of medicines in the context of their benefits as well as the risks of deciding against medication. Usually medicines are meant to benefit the individuals taking them. In the area of infectious diseases, however, vaccines are aimed at protecting the vaccinee and also, through repressing or eradicating the disease, protecting vulnerable individuals who cannot be vaccinated. For a considerable time, guidance documents on communications have been available from international pharmacovigilance specialists [1–4] and some regulatory authorities (e.g. [5–8]). However, application of these documents in everyday pharmacovigilance has been a challenge. An issue of Drug Safety not long ago, dedicated to the theme of risk communication, discussed barriers to implementation and proposals for improving communication practices from worldwide experience [9–17]. There is much more research on medical information, communications and risk perception available, but every time a major safety concern arises with a medicine, designing a communication strategy and materials for avoiding and mitigating risks is perceived as a complex new challenge by both industry and regulatory authorities, and either the available evidence from the communication sciences is not fully applied or specific research to guide them is lacking. With rapidly changing communication tools, landscape and behaviour, it is not easy for research to catch up. However, communicating must be a paramount consideration whenever new safety information becomes available. Independently from which communication modalities are chosen, the content must be useful and understandable for those that should benefit from it (patients and healthcare providers), but also for other possible recipients like the general public and those in mediating roles such as drug information pharmacists and journalists. This On behalf of the ISoP CommSIG.

How to improve communication for the safe use of medicines?: Discussions on social marketing and patient-tailored approaches at the annual meetings of the WHO Programme for International Drug Monitoring.

Over the past decade, the annual meetings of national centres participating in the WHO Programme for International Drug Monitoring have increasingly included discussions on how to improve communication between national pharmacovigilance centres, patients, healthcare professionals, policy makers and the general public, with the aim of promoting the safe use of medicines. At the most recent meetings, working groups were dedicated to discuss possible applications and implementation of social marketing and patient-tailored approaches. This article provides the history and a summary of the recent discussions and recommendations to support progress in this respect at national and global level. Recommendations are made to investigate and pilot these approaches in small-scale projects at national pharmacovigilance centres. Applying elements from the social marketing and patient-tailored approaches to support behaviours of safe medicines use in patients and healthcare professionals should give the pharmacovigilance community new tools to achieve their goal to minimize risks with medicines and improve patient safety.

An Update on ISoP Special Interest Groups (SIGs)

Over the past decade, the annual meetings of national centres participating in the WHO Programme for International Drug Monitoring have increasingly included discussions on how to improve communication between national pharmacovigilance centres, patients, healthcare professionals, policy makers and the general public, with the aim of promoting the safe use of medicines. At the most recent meetings, working groups were dedicated to discuss possible applications and implementation of social marketing and patient-tailored approaches. This article provides the history and a summary of the recent discussions and recommendations to support progress in this respect at national and global level. Recommendations are made to investigate and pilot these approaches in small-scale projects at national pharmacovigilance centres. Applying elements from the social marketing and patient-tailored approaches to support behaviours of safe medicines use in patients and healthcare professionals should give the pharmacovigilance community new tools to achieve their goal to minimize risks with medicines and improve patient safety.