[Challenges to the national network of sanitary surveillance laboratories: the case of manipulated drugs].
From the research on the "Status of Pharmacy Formulated Medicines (PFM) in health surveillance laboratories (HSL)" as result of an agreement between Ensp and Anvisa, we present and question issues that may contribute for reflections about the National Network of HSL organization in confronting analytical demands, having PFMs as discussion organizers. The Public Laboratories (PL) that evaluated PFMs from 2000 to 2005 were identified; its analysts and samples were scanned, and three laboratories were selected to be visited. Sample processing was analyzed from its entry till the final report's issuance. Samples study allowed identifying: applicants and sample's documents; HSL executors and how they receive, process and reply the analysis requests demands. Applicants are judiciary (20%) and the health surveillance (HS) (74%). Baseless claims represent 25%. Seven HSL analyzed PFMs. 45% of the samples previously passed by 15 PL; HR were insufficient to meet the claims' analytical complexity; little institutional culture in dealing with samples of PFM and HS; 31% of samples have no conclusion; 40% of the satisfactory reports and 23% of the unsatisfactory have not conducted adequate tests to answer the demand's reasons. In conclusion, HSLs must evaluate their working process.
Departamento de Administração e Planejamento em Saúde, Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz, Rio de Janeiro. anacelia@ensp.fiocruz.br
Ana Célia Pessoa
AC
da Silva
Catia Veronica dos Santos
CV
Oliveira
Maria Virginia Silva
MV
Cavalheiro
Maria do Carmo de Castro
Mdo C
Miranda
D001938:Brazil; D004345:Drug Industry / Q000592:standards*; D007753:Laboratories / Q000592:standards*; D011358:Product Surveillance, Postmarketing / Q000592:standards