Drug quality deviations: notifications in a sentinel hospital in Ceará
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.
Copyright (c) 2020 RBFHSS and the Authors
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
The authors hereby transfer, assign, or otherwise convey to RBFHSS: (1) the right to grant permission to republish or reprint the stated material, in whole or in part, without a fee; (2) the right to print republish copies for free distribution or sale; and (3) the right to republish the stated material in any format (electronic or printed). In addition, the undersigned affirms that the article described above has not previously been published, in whole or part, is not subject to copyright or other rights except by the author(s), and has not been submitted for publication elsewhere, except as communicated in writing to RHFHSS with this document.
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License (CC-BY-NC-ND) that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
This journal permits and encourages authors to post and archive the final pdf of the articles submitted to the journal on personal websites or institutional repositories after publication, while providing bibliographic details that credit its publication in this journal.