Pharmacovigilance of drug quality deviation in the public health system

• Autor(a) principal: Cristiane Aparecida Menezes de Pádua
• Data de Publicação: 2017
• Outros Autores: Carolina Resende Bitencourt, Edson Perini
• Tipo de documento: Artigo de conferência
• Idioma: eng
• Título da fonte: Repositório Institucional da UFMG
• Texto Completo: https://doi.org/10.1002/pds.4275; http://hdl.handle.net/1843/46531
• topic: Farmacovigilância; Desvio da qualidade do medicamento; Farmacovigilância; Desvio da qualidade do medicamento

Background: Drug quality deviation (DQD) is defined as the disagreement with the parameters established for a pharmaceutical preparation at the registration process. Pharmacovigilance programs should be notified of DQD to support patient safety. Objectives: To describe DQD from public health system and its impact on the pharmaceutical care. Methods: Descriptive analysis of DQD recorded in public health care facilities at primary and secondary level in Belo Horizonte, Brazil. All notifications (n = 271) of quality deviations of drugs from the Municipal List of Essential Medicines recorded from April to September 2016 were analysed. Variables selected were type of DQD, pharmaceutical product, therapeutic class, notifying health unit, risk classification (potential consequences for drug, patient and pharmaceutical care), and reply of DQD notification by private and public drug suppliers and by Brazilian Health Surveillance Agency (ANVISA). Variables were described by estimating absolute and relative frequencies. Results: A total of 329 DQD was recorded, which led to a loss of 9,311 preparations, representing on average 0.2% of the acquired lot. Most DQD came from the primary health care level. Drug-related problems included deviations in package content (47%), package integrity (26%), label (5%), and pharmaceutical product itself (e.g. change in colour) (22%). DQD involving solid preparations was the most recorded (68.3%). Anti-infectives for systemic use and nervous system drugs accounted for 21.0% and 20.3% of DQD, respectively. Approximately, 70% of the DQD could lead to transient and reversible harm to patients (intermediate risk). Drug suppliers replied 83.6% of notifications, being the pharmaceutical manufactures more effective and faster in solving the complaints. None notification has been completely analysed by ANVISA until the end of the study. Conclusions: Pharmacovigilance is an important tool to minimize potential patient harm by managing DQD and improving the quality of dispensed drugs. The results highlight the need to strengthen this activity as well as extend it beyond the hospital settings where this practice is best established.