Over 100 delegates from 30 countries participated in the “National Pharmacovigilance Systems: Ensuring the Safe Use of Medicines” conference held in Nairobi, Kenya, August 16–18, 2010.  Organized by Management Sciences for Health’s (MSH) Strengthening Pharmaceutical Systems (SPS) program, which is funded by the U.S. Agency for International Development (USAID), the conference focused on the issue of medicine safety in the wake of increased access to medicines in the developing world through various global initiatives that promote treatment for HIV, malaria, and tuberculosis.  The forum aimed at providing participants with a framework for building, strengthening, and optimizing medicines safety and pharmacovigilance (PV) systems at the country level.

The event was opened by Mr. Mark Bor, Kenya’s Permanent Secretary from the Ministry of Public Health and Sanitation, who emphasized the significance of post-market surveillance of medicines to chronicle long-term effects of medicine that are unlikely to be observed during clinical trials. He noted that PV systems are beneficial for preventing drug-related morbidity and mortality, making savings on resources spent in health care costs and supporting better patient care. He also observed that many countries continue to be constrained in their medicine safety due to weak legal frameworks, lack of regulatory structures, and inadequate resources.

Regarding counterfeit medicines, Mr. Bor expressed concern about the difficulty in identifying such products.  He said that the enforcement of laws against counterfeits is the shared responsibility of the government, regulatory authorities, importing and exporting agencies, and even the media. 

The delegates who come from diverse geographical areas, cultures, and areas of expertise, including pharmacy, research, and logistics, shared their experiences in the evolving field of PV. Countries represented also provided a wide range  of experiences with PV systems with some being well developed, such as the United States, and others just beginning to  establish such systems, such as Lesotho.

Maseabata Ramoeletsi-Ramathebane from the National University of Lesotho represented the view of many conference participants when she expressed satisfaction at being able to share information and learn from a variety of countries, a number of which she had not previously interacted, such as China, Afghanistan, and various francophone African countries.

Professor Andy Stergachis from the University of Washington set the platform for deliberation when he drew the conference’s attention to the lack of emphasis on PV systems in countries.  Citing the World Health Organization’s (WHO) research on PV in developing countries, he noted that only 31 percent of Global Fund to Fight AIDS, Tuberculosis and Malaria Round 8 malaria proposals included a funding request for PV activities while 47 percent of the President’s Malaria Initiative Malaria Operational Plans for 2009 included a request for funding for PV. Professor Stergachis stressed the need for proactive direction to strengthen PV.

WHO’s Shanthi Pal noted that WHO is working closely with partners to ensure the integration of PV into health systems.  Referring to the Global Fund, she remarked that previous plans rarely took PV into consideration, whereas there is now technical guidance from WHO and greater collaboration with partners to jointly develop a global PV strategy.  With close to 25 percent of grant resources spent on medicine, it is undoubtedly in the interest of the Global Fund to ensure medicine quality and safety for proper care, Ms. Pal explained.

Participants welcomed the initiative of holding a PV conference. Gloria Abumere from Nigeria’s Federal Ministry of Health expressed optimism that the conference outcomes would go beyond the activities in Nairobi to country-specific advocacy and sensitization for PV.  She observed that the number of participants were significant to developing a blueprint to support PV awareness.

Dr. Elizabeth Ogaja-Ominde from Kenya’s Ministry of Health termed it an eye opener for persons at policy level and emphasized the need to have links between conference deliberations and practice.

Henry Fomundam of Howard University said that there is a push towards the development of national PV programs but expressed concern that not enough support is directed at the institutional level for effective PV systems. “Current focus is on reports but good quality reports will have to come from down.  From health care professionals— the people engaged in discussion on patient care. It is about change in mindset.”  He added that national systems are good for sharing and for making policies but require sustainable support from health care professionals.  Dr. Fomundam noted that the often cited human resource constraint in PV should be addressed by reorienting pharmacists towards PV while “task shifting” responsibilities to other personnel.  “It is about seeking practical approaches to solutions.”

In addition to the technical exchange process, delegates had the privilege of sampling the diverse cultures represented and especially the Kenyan culture and hospitality.

 MSH/SPS appreciates USAID, WHO, Global Fund, the Government of Kenya and all other stakeholders who made the conference a success.

 Conference materials (schedule, participant list and presentations) are available at the SPS website.

Photo: Permanent Secretary in the Ministry of Public Health and Sanitation Mr. Mark Bor addresses the conference as Dr. Fred Siyoi of the Pharmacy and Poisons Board and Dr. Mary Wangai, Chief of Party SPS/Kenya, look on.

Josephine Maundu is the Deputy Chief of Party, Pharmaceutical Services, for the SPS project at MSH.

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