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.

Downloads

Download data is not yet available.
Published
2020-09-21
How to Cite
CHAVES, E. F., GUIMARÃES, J. A., MORORÓ, A. M., MARTINS, B. C., & TEIXEIRA, A. F. (2020). Drug quality deviations: notifications in a sentinel hospital in Ceará. Revista Brasileira De Farmácia Hospitalar E Serviços De Saúde, 11(3), 489. https://doi.org/10.30968/rbfhss.2020.113.0489
Section
ARTICLES