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Maggie Huff-Rousselle, MA, MBA, PhD, Social Sectors Development Strategies, Inc., 1411 Washington Street, No. 6, Boston, MA 02118, 617 421 9644, firstname.lastname@example.org, Oscar Simooya, MD, MS, Coperbelt University, P.O. Box 21692, Kitwe, Zambia, Violet Kabwe, Pharm BSc, HSSP Project (Zambia), Abt Associates, 4800 Montgomery Lane, Bethesda, MD 20814, and Ilyssa Hollander, MPH, SSDS, Inc, 1411 Washington St., Suite 6, Boston, MA 02118.
Partially jolted into action by the thalidomide tragedy, most major industrialized countries began to establish national pharmacovigilance systems for identifying and responding to the risk-benefit issues of marketed medicines – or pharmacovigilance systems – about 40 years ago. These systems have been focused on side effects, adverse reactions, and drug interactions. In developing countries, especially in Africa, the scope for pharmacovigilance is broader, because of the growing risk of having substandard and counterfeit drugs and the need to have a warning signal system for the development of resistance to the new essential drugs, e.g. Artemisinin-combination therapy (ACT) for malaria and Antiretrovirals for HIV/AIDS. Zambia learned important lessons from: 1) its own initial experiences in using ACT as a pathfinder, 2) the UK's “yellow card scheme,” and 3) Brazil's fledgling PV system for AIDS treatment. These lessons include: 1) the scope of PV must be clearly defined (in Zambia this includes product quality problems, counterfeit products, adverse reactions and interactions, and resistance); 2) the need for a broad program identity with multiple stakeholders, not a focus on one disease/therapy; 3) only essential information should be solicited and the reporting flow should be streamlined to encourage reporting; 4) reporting increases when consumers have an option to report directly to the government; 5) success of PV initiatives depends on the government's ability to create a “reporting culture” among providers, pharmacists and consumers; and, 6) new essential medicines are a sophisticated challenge requiring PV systems in unsophisticated contexts.
Keywords: Drugs, Information Systems
Presenting author's disclosure statement:
Any relevant financial relationships? No
The 134th Annual Meeting & Exposition (November 4-8, 2006) of APHA