Análise da qualidade de antidepressivos contendo fluoxetina 20 mg dispensados pela rede pública.

Abstract

Good manufacturing practices for drugs establish the minimum requirements to ensure and achieve pharmaceutical products of good quality. The pharmaceutical industry must guarantee proven parameters of efficacy, safety and quality for all pharmaceutical products prior to commercialization. Accordingly, the public sector drug procurement, for example, plays an important role on defining technical and legal requirements for selection of suppliers. Even though the purchase of medicines is done by bidding the lowest price, it is reasonable to include criteria that could guarantee the quality of drugs acquired, as well as proper terms elaboration, knowledge of current legislation, proper evaluation of bids and monitoring these drugs through quality control testing and pharmacovigilance activities. The aim of this study was to analyse the quality of fluoxetine 20 mg acquired by bidding process and distributed by public health care of Region Vale do Rio Pardo/RS, checking if they are in accordance with pharmacopoeial requirements for tests of weight variation, disintegration, uniformity of dosage units and assay. The results showed only one batch of fluoxetine 20 mg with a deviation in quality from the uniformity of dosage units test. In conclusion, monitoring drugs that are dispensed from municipal pharmacies is a measure of great importance to ensure access of good-quality, safe and effective medicines.