Drug quality deviations: notifications in a sentinel hospital in Ceará

Abstract

Objective: To characterize the drug quality deviation (DQM) notification and their financial impact of a sentinel network university hospital in Ceará. Methods: This is a cross-sectional observational pharmacovigilance study carried out in Fortaleza-CE, through spontaneous reports of DQM from January 2016 to June 2017. Data was obtained from the patient’s records, registered and analyzed using Excel spreadsheets. Results: A total of 49 (84.48%) reports were included in this study, with a monthly average of 2.72 notifications. These came mainly from the pharmacy (n=14; 28.57%) and medical clinics (n=12; 24.49%), with nurses (n=28; 57.14%) and pharmacists (n=13; 26.53%) being the largest notifiers. A total of 92 drugs were used, being blood substitutes and perfusion solutions (n=50; 54.35%), antibacterials for systemic use (n=12; 13.04%) and immunoglobulins (n=6; 6.52%) the most frequent. Injectable pharmaceutical formulations were more frequent (91,30%; n=84). The most frequently observed DQM were the presence of foreign body / material in suspension (n=16; 32.65%) and crack / bubble / leak (n=14; 28.57%). The supplier was contacted in em 65,31% (n=32), of the cases, with formal responses received in 65,62% (n=21) of them. The manufacturer took responsibility for DQM in 38,10% (n=8) of cases. The notification to the National Health Surveillance Agency (ANVISA) occurred in 20,41% of the cases. The reimbursement of the value of the drug by the producer laboratories contacted occurred in 25% (n=8) of the cases, corresponding to a value of R $ 4,254.97. Conclusions: The importance of conducting DQM notifications is evident since these can ensure better knowledge about health products on the market and safer products for patients and health professionals.