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Revista Cubana de Farmacia

versión impresa ISSN 0034-7515versión On-line ISSN 1561-2988

Resumen

JIMENEZ LOPEZ, Giset et al. Cross of quality and safety data of national drugs starting from the automated databases: First semester 2006 . Rev Cubana Farm [online]. 2007, vol.41, n.3. ISSN 0034-7515.

Within the system of postmarketing surveillance, the cooperation between centres is crucial. That's why, the Quality Division of Quimefa, which rules the vigilance of the quality of the national industry products, and the National Coordinating Pharmacovigilance Unit of the Center for Pharmacoepidemiology Development that coordinates the National Monitoring System of Adverse Reactions Suspicions produced by drugs, established a database consultation system. The Product Quality Vigilance System runs in an Access database, and the suspicions of adverse reactions in an Excel sheet with database functions. Every month, there is a data cross between both systems, based on the product, batch, manufacturer, place of report, etc., and, this way, the two systems feedback themselves. A monthly meeting is also held to check the results of the systems. In the first semester of 2006, the subsystem processed more than 800 quality complaints from drug stores, which led to the establishment of 11 retention notice plans and 28 product removal plans. On the other hand, the system of report of adverse reactions has received 4 254 notifications and 9 records have been created for products with adverse reactions to drugs. All the information is sent to the postmarketing system of the State Center for Drug Quality Control

Palabras clave : Pharmacovigilance; adverse reaction to drugs; adverse effects; drug surveillance.

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