Bruce Hugman

When rumours derail a mass deworming exercise

The role of misleading or scaremongering news media reports in causing drug crises is well known. Pharmacovigilance systems can play an important educational and preventive role through safety monitoring of products and effective communication about safety issues with health professionals and the general public. That failure to use an existing pharmacovigilance system in implementation planning and weaknesses in communications about medication could lead to mass hysteria and civil unrest might thus seem implausible. But this reaction happened in several regions of Ghana on Feb 12, 2007.

The challenge of effectively communicating risk-benefit information

SummaryAlthough the techniques involved in drug safety monitoring (pharmacovigilance) have dramatically improved in recent years, communication of these issues to health professionals and the public lags far behind. Several measures need to be taken in order to address this discrepancy.A climate of greater openness concerning the basis of merit assessments must be created. We need to develop merit-assessment formulations that are more accurate and helpful when treating individual patients in clinical situations. All of the involved groups must be educated about the nature of drugs and drug therapy, and the possibilities and limitations of such therapy. More effective techniques and systems have to be developed in order to stimulate higher rates of high quality spontaneous reporting of adverse effects. More conscientious and purposeful attention to the theory and practice of communications, in order to ensure the effective delivery of optimal benefits to patients, clinicians and society at large, would also be advantageous.We must ensure that where issues of public health and confidence in the medical profession are at stake, we employ the very best communications practices.

The erice declaration : The critical role of communication in drug safety

The Erice Declaration on Communicating Drug Safety Information, first published in September 1997, provides a vision of vigorous, open, ethical, patient-centred communications in drug safety that the world has yet to achieve. The Declaration is reprinted here as a further stimulus to all parties to renew their commitment and to add new momentum to the improvements which have undoubtedly taken place in the past few years. The content of the Declaration is briefly reviewed, and some of the continuing communications challenges and problems are outlined.

The challenge of effectively communicating pateint safety information

Rational use of drugs and patient safety are seriously compromised by a lack of good information, education and effective communication at all stages of drug development and use. From animal trials through to dispensing, there are misconceptions and opportunities for error which current methods of drug information communication do not adequately address: they do not provide those responsible for prescribing and dispensing drugs with the data and information they need to pass on complex and often changing messages to patients and the public. The incidence of adverse reactions due to the way drugs are used; the variable impact of regulatory guidelines and warnings on prescribing behaviour; drug scares and crises suggest a great gap between the ideals of the safe use of medicines and the reality in homes, clinics and hospitals around the world. To address these challenges, the authors review the several levels at which safety information is generated and communicated, and examine how, at each stage, the content and its significance, and the method of communication can be improved.

Risk perception and communication in sub-Saharan Africa.

In this narrative review, a brief summary of theoretical approaches to risk perception is followed by an analysis of some of the special factors influencing risk perception and risk communication in sub-Saharan Africa. Examples of recent and emergent local medicines and vaccine controversies in several countries are given along with evidence and analysis of how they were managed. These demonstrate, among other things, the extent to which ethnic, religious and cultural issues influence popular perception, and the power of rumour and anecdote in shaping public opinion and official responses to events.Where safety monitoring systems exist, they are in their infancy, with limited capacity for data collection, credible scientific review, effective public communication and robust crisis management. Although increasing democratic freedoms, including less restricted media, and evolving health systems are addressing the challenges and give hope for further progress, there are still deep and intractable issues that inhibit transparent and effective risk communication and stand in the way of African populations comprehending medicines and their risks in safer and more balanced ways.Some proposals for future change and action are offered, including the pursuit of a deeper understanding of local and national values, assumptions and beliefs that drive risk perception; tailoring public health planning and communications to specifically-targeted regions and populations; strengthening of safety surveillance and data-collection systems; giving higher priority to medicines safety issues in healthcare training and public education.

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/

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

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Protecting the People

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.

Embedding ‘Speaking Up’ into Systems for Safe Healthcare Product Development and Marketing Surveillance

The history and characteristics of bureaucracy are examined with a view to understanding the impact of the bureaucratic mindset on medicines’ regulation, the pharmaceutical industry and healthcare delivery with a focus on risk communication, pharmacovigilance and patient safety. Controversies and allegations relating to common, negative effects of bureaucratic regulatory and management systems are reviewed and examples of creative and effective practice provided. Strategic directions and specific actions for reform are proposed.

From the Uppsala Monitoring Centre A Review of Viewpoint Part 1 and Part 2

Robust, active cooperation, and effective, open communication between all stakeholders is essential for ensuring regulatory compliance and healthcare product safety; avoiding the necessity for whistle-blowing; and, most essentially, meeting the transparency requirements of public trust.The focus here is on what can be done within a healthcare product organization (HPO) to achieve actionable, sustainable policies and practices such as leadership, management, and supervision role-modelling of best practice; ongoing process review and improvements in every department; protection of those who report concerns through robust policies endorsed at Board level throughout an organization to eliminate the fear of retaliation; training in open, non-defensive team-working principles; and mediation structure and process for resolution of differences of opinion or interpretation of contradictory and volatile data.Based on analyses of other safety systems, workplace silence and interpersonal breakdowns are warning signs of defective systems underlying poor compliance and compromising safety. Remedying the situation requires attention to the root causes underlying such symptoms of dysfunction, especially the human factor, i.e. those factors that influence human performance. It is essential that leadership and management listen to employees’ concerns about systems and processes, assess them impartially and reward contributions that improve safety.Fundamentally, the safety, transparency, and trustworthiness of HPOs, both commercial and regulatory, can be judged by the extent of the freedom of their staff to ‘speak up’ when the time is right. This, in turn, consolidates the trust of external stakeholders in the safety of a system and its products.The promotion of ‘speaking up’ in an organization provides an important safeguard against the risk of poor compliance and the undermining of societal confidence in the safety of healthcare products.