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Adverse Drug Reactions and quality deviations monitored by spontaneous reports
Marília Berlofa Visacri1, Cinthia Madeira de Souza1, Catarina Miyako Shibata Sato2
1Department of Clinical Pathology, Faculty of Medical Sciences (FCM), State University of Campinas, Alexander Fleming, 105, Zip Code 13083-881 Campinas, SP, Brazil.
Summary
This study analyzed Adverse Drug Reactions (ADRs) and quality deviations in a Brazilian hospital, finding quality issues more common than ADRs. Improved pharmacovigilance practices are needed to increase reporting.
Area of Science:
- Pharmacovigilance
- Drug Safety
- Healthcare Quality Management
Background:
- Spontaneous reporting systems are crucial for monitoring Adverse Drug Reactions (ADRs) and medication quality.
- Understanding the profile of these reports is essential for improving patient safety and healthcare practices.
- A Brazilian teaching hospital's 2010 data provides insights into ADR and quality deviation reporting.
Purpose of the Study:
- To determine the frequency and characteristics of spontaneous ADR and quality deviation reports.
- To propose a classification system for quality deviations.
- To inform pharmacovigilance practices in Brazil.
Main Methods:
- Descriptive, retrospective analysis of 68 spontaneous reports from 2010.
- Classification of ADRs by reaction mechanism, severity, and causality.
- Classification of quality deviations by type and drug market status.
Main Results:
- Quality deviations (60.3%) were more frequent than ADRs (39.7%).
- Anti-infectives were the most common cause of ADRs, with skin reactions being most frequent.
- Breaks, splits, and leaks were common quality deviations, often associated with generic drugs.
Conclusions:
- The proposed classification system for quality deviations was effective.
- Enhanced pharmacovigilance practices and policies are necessary to increase spontaneous report numbers.
- The study highlights the need for better drug safety monitoring and quality control.
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