Quality deviations of medicines: identification, evaluation and responses
Keywords:
Vigilância de produtos, vigilância de evento sentinela, recall de medicamento, retirada de medicamentos baseada em segurançaAbstract
Medicines are produced following technical specifications of high quality control determined by National Agency of Sanitary Surveillance. Pharmacosurveillance is the monitoring of drugs actions already on the market, through the identification, assessment and prevention of problems with them.
Objetives: Identify and evaluate the records of complaints relating to misuse of technical quality of products during a year in a private hospital in Porto Alegre.
Methods: Data were obtained notifications made using an internal program of non-conformity of products and processes registration between April/2010 to March/2011. The technical complaints were classified according to the type of problem presented.
Results: Were processed 169 reports, where 112 of technical defect and 57 adverse drug reaction. The most frequent deviation (51.4%) is related to problems encountered with packaging. The inpatient unit was responsible for 36 notifications, 34 per Pharmacy. Records of chemotherapy, 15% were not reported to the industry, 62% were resolved, 23% were ongoing. By notifications resolved, 62% reimbursed the Hospital through the products substitution and 38% through a credit on next purchase. Only three industries reported sent reports of product quality demanded.
Conclusion: These records represent a upgrade in the process of health regulation of medicines in order to ensure better products to market more safely to patients and health professionals. There isn’t still regulation guiding National Agency of Sanitary Surveillance industries on how to redress these products health institutions.
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