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ADR in Journals: Are They Translated into Regulatory Frameworks?
Annapurna Kolupoti1, Ananya Chakraborty1, K Shahistha1
1Department of Pharmacology, Vydehi Institute of Medical Sciences and Research Center, Bangalore, India.
Current Drug Safety
|June 21, 2021
Summary
Most published adverse drug reaction (ADR) case reports lack reporting to regulatory authorities like Vigibase. Increased healthcare worker awareness and mandatory reporting criteria are needed to improve ADR surveillance and patient safety.
Area of Science:
- Pharmacovigilance
- Drug Safety Surveillance
- Clinical Pharmacology
Background:
- Adverse drug reaction (ADR) case reports are crucial for identifying drug risks.
- Many published ADR case reports do not document reporting to regulatory authorities.
- This study analyzes ADR case reports to assess their translation into regulatory frameworks.
Purpose of the Study:
- To analyze ADR case reports published in PubMed-indexed journals between January 2018 and June 2019.
- To determine if these reported ADRs are documented in regulatory databases (Vigibase) and package inserts.
- To identify deficiencies in ADR reporting to regulatory bodies.
Main Methods:
- Searched PubMed for ADR case reports published from January 2018 to June 2019.
- Extracted and categorized 158 ADR case reports based on drug class, geography, severity, and reporting status.
- Assessed completeness of ADR information and checked for inclusion in Vigibase and drug package inserts.
Main Results:
- Antibiotics, CNS drugs, and anticancer drugs were common in ADR reports.
- Causality assessment was performed for only 45% of ADRs, and 41.13% of patients required hospitalization.
- 14 ADRs were missing from Vigibase, and 32 were not mentioned in package inserts, indicating reporting gaps.
Conclusions:
- A significant deficiency exists in reporting suspected ADRs to regulatory authorities.
- Mandatory reporting criteria for ADR case reports should be considered.
- Enhanced awareness and training for healthcare workers on ADR reporting are essential.
