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.