Pharmacovigilance Among Surgeons and in Surgical Wards: Overlooked or Axiomatic?

To review the status of pharmacovigilance system among surgeons and in surgical wards with recommendations. Literature search using MEDLINE, cross-reference of published data and review of World Health Organization—Pharmacovigilance transcripts. Pharmacovigilance system is still in its infancy among surgeons and in surgical wards. No major studies have been published addressing this issue, till date. Surgeons are professionals least likely to report adverse drug reactions. Moreover widespread and irrational antibiotic use is contributing towards high incidence of adverse events apart from multidrug resistance. Lack of interest, funding and knowledge pose challenges in effective post marketing drug surveillance in surgery. A three tier proactive pharmacovigilance system in surgical wards is suggested along with specific recommendations. The pros and cons of adverse drug reporting among the surgeons are discussed. With growing awareness of pharmacovigilance in various fields of medicine, surgery can no longer remain an exception. In the transition from medical school to surgery clinic a subtle shift must occur from emphasizing pharmacokinetics to appreciating pharmacodynamics. This change in philosophy will occur at the level of instruction when the surgeons of tomorrow are motivated through regulatory and institutional means at school level to adopt pharmacovigilance in their clinical practices along with the practicing surgeons

Farmacovigilância: elementos para a discussão e perspectivas Drug surveillance: topics for discussion and prospects

A vigilância de medicamentos subdivide-se em dois grupos. O primeiro consiste nas ações de registro e fiscalização, que são as mais conhecidas da sociedade. O segundo grupo consiste nas ações de farmacovigilância, que são as de pesquisa e monitoramento de reações adversas. Essas últimas estão previstas na legislação federal do setor saúde que vigora desde a década de 70. Do mesmo modo, uma portaria recente prevê a criação do sistema nacional de monitoramento. O texto aborda de maneira panorâmica elementos da história, dos conceitos, das definições, da classificação, dos mecanismos de ação e do diagnóstico de reações adversas. São descritos os objetivos e as fontes de informação para os estudos de farmacovigilância, bem como a experiência nacional no campo.<br>Drug surveillance can be grouped into two areas. The first includes registration and inspection, activities that are more familiar to society at large. The second involves research and monitoring of adverse effects. Brazilian legislation has regulated this subject since 1970. A recent directive also provides for a national pharmaceutical surveillance system. This current article provides an overview of the history, definitions, pharmacological concepts, classification, and diagnosis of the adverse effects of drugs. An analysis is presented of the goals and sources of information for drug monitoring as well as some Brazilian experience in this field