Farmacovigilância dos desvios de qualidade na rede pública de saúde

Abstract

Drug quality deviation (DQD) is a type of technical complaint defined as the disagreement with the parameters established for a pharmaceutical preparation which should be notified to pharmacovigilance programs. The objective of this study was to describe the DQD from the public health system and its impact on the pharmaceutical assistance. A cross-sectional study of DQD recorded from primary and secondary public health care centers in Belo Horizonte was performed between April and September 2016. All notifications of DQD related to drugs from the Municipal List of Essential Medicines were analyzed. Variables selected were: type of quality deviation, pharmaceutical product, therapeutic class, notifying health unit, risk classification (potential consequences for drug, patient and pharmaceutical care - rated as minor, intermediate and major risk), financial cost, reply of notification suppliers and reply of the notification system of the Brazilian Health Surveilance Agency (NOTIVISA/ANVISA). Variables were described by estimating absolute and relative frequencies, measures of central tendency and of dispersion. The 271 notifications recorded during the study involved 329 quality deviations. 68.3% of them were solid preparations. Anti-infectives for systemic use (21.0%) and nervous system drugs (20,3%) were the main therapeutic class involved in quality deviation.Approximately 70% of DQD were classified as being of intermediate risk. Drug-related problems included deviations in package content (47%), package integrity (26%), pharmaceutical product itself (22%) and label (5%). DQD led to a loss of 9,311 pharmaceutical preparations, representing a cost of U$307.04 (R$994.82). The representativeness of the majority of the records was lower than 0.10%. No significant impact of DQD on the drug supply was observed. Drug suppliers replied 83.6% of notifications in an average of 50.4 days. None notification has been completely analysed by NOTIVISA/ANVISA until the end of the study. The incompleteness rate by ANVISA notification site was 34.3%. Pharmacovigilance is an important tool to minimize potential patient harm, to improve the quality of dispensed drug and to reduce financial losses. The results highlight the need to strengthen this activity as well as extend it beyond the hospital setting, where this practice is best established.