National Pharmacovigilance Systems: Ensuring the Safe Use of Medicines. August 16–18, 2010 Nairobi, Kenya
(2010; 13 pages)


Medicines-related problems can be the result of several different types of challenges (e.g., poor product quality, previously unidentified adverse drug reactions, and medication errors). In addition to these issues, the increasing availability of new essential medicines as a result of several global initiatives (including the U.S. President's Emergency Plan for AIDS Relief [PEPFAR]) and the safety data that can better inform decisions in treatment guidelines have highlighted the need for an increased awareness of pharmacovigilance systems at the local level.

Pharmacovigilance systems include all organizations, institutions, and resources that contribute to ensuring medicine safety through efficient and timely collection, assessment, and communication of risks and benefits to support decision making at various levels of the health care system. Comprehensive pharmacovigilance systems are those that use both passive (e.g., spontaneous reporting) and active (e.g., cohort event monitoring) surveillance methods to achieve these goals. Such systems, when implemented nationally, will help to ensure that signals of public health importance generated through spontaneous reporting mechanisms can be evaluated with active surveillance methods and that subsequent harm can be prevented through risk management practices.

The U.S. Agency for International Development-funded Strengthening Pharmaceutical Systems Program advocates that countries should establish national, comprehensive pharmacovigilance systems to best protect public health.

Until recently, most global pharmacovigilance initiatives have focused on supporting passive surveillance systems, such as the World Health Organization (WHO) Programme for International Drug Monitoring. These systems add value by encouraging the reporting of pharmacovigilance data, compiling these (mostly voluntary) reports from around the world, and sharing this information widely. This data aggregation has been valuable as countries with limited resources have struggled to staff and fund their own national programs. However, sentiment suggests that more locally developed approaches to pharmacovigilance would complement the global initiatives and lead to better risk management; for example, providing information about the total number of patients (that is, the denominator of the ratio) exposed to the medicine and determining the incidence of adverse events. There is currently momentum for augmenting spontaneous reporting with active systems for collecting, analyzing, and using information directly in the country or region.

SPS has been collaborating with WHO and donors (USAID, the Global Fund to Fight AIDS, Tuberculosis and Malaria) to provide assistance in developing comprehensive country-owned, national pharmacovigilance systems focused on adding active surveillance mechanisms to complement the local passive surveillance strategies. As part of this work, a conference entitled National Pharmacovigilance Systems: Ensuring the Safe Use of Medicines was held August 16–18, 2010, in Nairobi, Kenya, to provide a platform for discussion of national strategies for comprehensive pharmacovigilance implementation. More than 100 participants representing Ministries of Health, medicines regulatory authorities, nongovernmental organizations (NGOs), donors, universities, and other partners from more than 30 different countries participated in the conference, which was conducted in English with simultaneous French translation.

The Nairobi conference began with a discussion of global pharmacovigilance initiatives, and then focused on systems-based approaches to comprehensive strategies. Country, disease, and methodological examples of pharmacovigilance initiatives and the lessons learned from these were then discussed. Next, participants generated information about country-level barriers, opportunities, stakeholder roles, and sustainability issues in the realm of pharmacovigilance. Donor perspectives were also addressed with particular emphasis on how countries can include pharmacovigilance activities in their Global Fund applications and how USAID can support activities for Global Fund recipients. Finally, an outline for a step-wise plan of action for transitioning to national, comprehensive pharmacovigilance systems (described hereafter) was developed.

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