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A Retrospective Observational Study of Adverse Drug Reactions (ADR) Reported to ADR Monitoring Centre from 2010 to
Akila Srinivasan1, Sandhiya Selvarajan2, Santhosh Shivabasappa2
1Department of Pharmacology, Mahatma Gandhi Medical College and Research Institute (MGMCRI), Sri Balaji Vidyapeeth, Pondicherry, India.
Background:
Adverse Drug Reactions (ADR) are one of the common causes of hospital admissions and pose a significant clinical and economic burden on the healthcare system. The Adverse Drug Reaction Monitoring Centre (AMC) in JIPMER functioning under the Pharmacovigilance Programme of India (PvPI) plays a vital role in ensuring medication safety by routinely detecting and monitoring ADRs. Hence, this study aimed to assess the characteristics of ADR reported from 2010 to 2020 in AMC JIPMER and to detect signals, if any.
Objective:
To study the characteristics of Adverse Drug Reactions (ADR) reported to a regional ADR monitoring center from 2010 to 2020 and to detect signals of disproportionate reporting (SDRs) if any from the reported ADRs.
Materials And Methods:
A total of 6007 ADR reports with a single suspect drug were included for analysis from 2010 to 2020. The characteristics of these reports, including patient's age and gender, Number and percentage of ADRs, the causality of ADR using WHO UMC (World Health Organization-Uppsala Monitoring Centre) scale, the seriousness of the ADR, and outcome were collected from the ADR reports. MedDRA (Medical Dictionary for Regulatory Activities) Preferred Terms (PT) were used to classify adverse drug reactions. Causality analysis using the Naranjo Algorithm and Preventability using Modified Schumock and Thornton criteria were performed for the ADRs. The number and percentage of severe ADRs were analyzed. The System Organ class of all the ADRs was enumerated. ADRs not mentioned in the US FDA (United States Food and Drug Administration) product label (unlabelled reactions) were documented. Unlabeled reactions with ≥3 ADR reports were included for signal detection by disproportionality analysis.
Results:
Antineoplastic drugs, followed by antimicrobials, anticonvulsants, Anti snake venom, and NSAID were the most common drugs implicated in ADRs. Skin and subcutaneous tissue disorders were the most common System Organ Class (SOC) involved in the ADRs. Among the 6007 reports, 19.2% were serious ADRs. Most of the ADR reports were of possible causality followed by probable and certain as per WHO UMC and Naranjo causality scales. Only ten ADRs were preventable and one reaction (Tamoxifen-induced neuropathy) was eligible for signal detection. Disproportionality analysis using a 2x2 contingency table showed insignificant signal detection using the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR).
Conclusion:
Analysis of ADRs from an ADR Monitoring center functioning in a tertiary care hospital shows antineoplastic drugs to be the most common drugs associated with adverse drug reactions, with rash being the most common adverse effect. The majority of the ADRs were not preventable. No Signals of Disproportionate Reporting (SDR) were detected in our study.
Insights
This study found antineoplastic drugs were most frequently linked to adverse drug reactions (ADRs), with rash being common. Most ADRs were not preventable, and no significant safety signals were detected.
Area of Science:
- Pharmacovigilance
- Drug Safety Monitoring
- Clinical Pharmacology
Background:
- Adverse Drug Reactions (ADRs) are a major cause of hospitalizations, incurring significant healthcare costs.
- The Adverse Drug Reaction Monitoring Centre (AMC) at JIPMER, part of the Pharmacovigilance Programme of India (PvPI), is crucial for medication safety.
- This study analyzed ADR characteristics and potential safety signals from 2010-2020.
Purpose of the Study:
- To characterize Adverse Drug Reactions (ADRs) reported to a regional monitoring center between 2010 and 2020.
- To identify potential safety signals of disproportionate reporting (SDRs) from these ADR reports.
Main Methods:
- Analysis of 6007 ADR reports with single suspect drugs from 2010-2020.
- Assessment of patient demographics, causality (WHO UMC, Naranjo), seriousness, and outcomes.
- Classification of ADRs using MedDRA Preferred Terms; analysis of unlabelled reactions for signal detection.
Main Results:
- Antineoplastic drugs were the most frequent cause of ADRs, followed by antimicrobials and anticonvulsants.
- Skin and subcutaneous tissue disorders were the most common System Organ Class (SOC).
- 19.2% of ADRs were serious; most had possible causality. No significant safety signals were detected.
Conclusions:
- Antineoplastic drugs are commonly associated with ADRs, often presenting as rash.
- The majority of reported ADRs were not preventable.
- No Signals of Disproportionate Reporting (SDRs) were identified in this decade-long analysis.
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