Good Pharmacovigilance Practices for the Americas, 2011

In preparing this paper, the Pharmacovigilance Group of the Pan American Health Organization’s Pan American Network for Drug Regulatory Harmonization (PANDRH) adopted the perspective of PAHO/WHO, which considers pharmacovigilance, an essential component of public health programs (3). Its intention was to facilitate the development of pharmacovigilance systems in the Region of the Americas and improve, strengthen, and promote the adoption of good practices to improve safety for patients and the general population, based on the needs of the Region.

The recommendations are based on WHO documents designed not only to improve the spontaneous reporting system for adverse events but also to promote active pharmacovigilance studies in Latin America and the Caribbean. Countries can select, adapt, or modify the recommendations in keeping with their needs and their legislation to ensure all stakeholders are included. For reference, this document is accompanied by an application guide.