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.

From the Uppsala monitoring centre: a review of viewpoint part 1 and part 2.

The core task of the Uppsala Monitoring Centre (UMC) is the collection and processing of adverse drug reaction reports from member countries of the WHO Programme for International Drug Monitoring to detect early signals of potential drug hazards. Also a high priority is the communication of information about drug safety issues to the widest possible professional and general audiences in order to improve patient safety and welfare. The publication of the two parts of the publication Viewpoint represents a pioneering effort to provide easily accessible information on international pharmacovigilance for lay and specialist readers.

Protecting the people?: risk communication and the chequered history and performance of bureaucracy.

The history and characteristics of bureaucracy1 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.2.

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.

Embedding 'speaking up' into systems for safe healthcare product development and marketing surveillance.

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.

The challenge of effectively communicating patient 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.

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

The core task of the Uppsala Monitoring Centre (UMC) is the collection and processing of adverse drug reaction reports from member countries of the WHO Programme for International Drug Monitoring to detect early signals of potential drug hazards. Also a high priority is the communication of information about drug safety issues to the widest possible professional and general audiences in order to improve patient safety and welfare. The publication of the two parts of the publication Viewpoint represents a pioneering effort to provide easily accessible information on international pharmacovigilance for lay and specialist readers.