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  • Adverse Drug Reaction (Adr): Awareness, Attitude & Practice Of Adr Reporting Among Healthcare Students

  • Bundelkhand University, Jhansi Uttar Pradesh

Abstract

Adverse Drug Reactions (ADRs) are a significant cause of morbidity, mortality, and increased healthcare costs worldwide. Effective pharmacovigilance relies heavily on spontaneous reporting of ADRs by healthcare professionals. Healthcare students, as future professionals, play a crucial role in strengthening ADR reporting systems. The present study aimed to assess the awareness, attitude, and practice (AAP) of ADR reporting among healthcare students. A cross-sectional, questionnaire-based study was conducted using an online survey tool among undergraduate pharmacy students. Descriptive statistics were used to analyse the data. The findings revealed that although students had adequate awareness and a positive attitude toward ADR reporting, actual reporting practice was poor. Lack of training, limited practical exposure, and insufficient familiarity with national pharmacovigilance systems were identified as major barriers. The study highlights the need for structured educational interventions and hands-on training to improve ADR reporting practices among healthcare students.

Keywords

Adverse Drug Reaction, ADR Reporting, Healthcare Students, Patient Safety, Pharmacovigilance

Introduction

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An Adverse Drug Reaction (ADR) is defined by the World Health Organization (WHO) as a noxious and unintended response to a drug occurring at doses normally used in humans. ADRs are a major public health concern and contribute significantly to hospital admissions, prolonged hospital stays, and increased healthcare expenditure. With the growing complexity of drug therapy and polypharmacy, the incidence of ADRs continues to rise.

Pharmacovigilance is the science concerned with the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Spontaneous reporting of ADRs forms the backbone of pharmacovigilance systems. In India, the Pharmacovigilance Programme of India (PvPI), coordinated by the Indian Pharmacopoeia Commission, monitors ADRs through a nationwide network of ADR Monitoring Centres.

Healthcare students are future prescribers and dispensers of medicines. Their awareness, attitude, and practice regarding ADR reporting will significantly influence the effectiveness of pharmacovigilance activities in the future. However, under-reporting of ADRs remains a major challenge due to lack of awareness, inadequate training, and fear of legal consequences. Hence, this study was undertaken to assess ADR reporting-related awareness, attitude, and practice among healthcare students.

II. OBJECTIVE OF THE STUDY  

Primary Objective:

To assess the awareness, attitude, and practice of ADR reporting among healthcare students.

Secondary Objectives:

To evaluate awareness regarding pharmacovigilance and ADR reporting systems.

To assess students’ attitude toward ADR reporting.

To analyse current practices related to ADR identification and reporting.

To identify barriers to ADR reporting.

To suggest measures for improving ADR reporting practices.   

III. METHODOLOGY

Study Design: A cross-sectional, questionnaire-based observational study.

Study Population: Healthcare students

Study Tool: A structured and pre-validated questionnaire developed using an online survey platform. The questionnaire included sections on demographic details, awareness, attitude, and practice regarding ADR reporting.

Data Collection: The survey link was distributed electronically. Participation was voluntary, and informed consent was obtained prior to data collection.

Data Analysis: Data were analysed using descriptive statistics and expressed as frequencies and percentages. Results were presented in tables and graphical formats.

Ethical Considerations:

Confidentiality of participants was maintained, and no personal identifiers were collected.

IV.RESULT  

The study results indicated that most participants were aware of the concept of ADRs and pharmacovigilance. A positive attitude toward ADR reporting was observed, with students acknowledging its importance in patient safety. However, only a small proportion of students had ever reported an ADR or were familiar with ADR reporting forms. The findings revealed a clear gap between knowledge and actual practice.

IV.DISCUSSION

The present study demonstrates that healthcare students possess satisfactory awareness and a positive attitude toward ADR reporting. Despite this, poor reporting practices were observed. Similar findings have been reported in earlier studies, suggesting that theoretical knowledge alone is insufficient to promote active participation in pharmacovigilance activities. Limited clinical exposure and lack of hands-on training were identified as major contributing factors. Strengthening pharmacovigilance education through practical training and active student involvement in ADR monitoring may help bridge this gap.

CONCLUSION  

The study concludes that while healthcare students show adequate awareness and a positive attitude toward ADR reporting, their reporting practices remain inadequate. Incorporation of structured pharmacovigilance training and practical exposure during undergraduate education is essential to improve ADR reporting and ensure patient safety.

 REFERENCES

  1. World Health Organization. The Importance of Pharmacovigilance: Safety Monitoring of Medicinal Products*. WHO, Geneva.
  2. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356:1255–1259.
  3. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients. *JAMA*. 1998;279:1200–1205.
  4. Pharmacovigilance Programme of India (PvPI). Indian Pharmacopoeia Commission, Ghaziabad.
  5. Hazell L, Shakir SAW. Under-reporting of adverse drug reactions. Drug Safety. 2006;29385–396.

Reference

  1. World Health Organization. The Importance of Pharmacovigilance: Safety Monitoring of Medicinal Products*. WHO, Geneva.
  2. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356:1255–1259.
  3. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients. *JAMA*. 1998;279:1200–1205.
  4. Pharmacovigilance Programme of India (PvPI). Indian Pharmacopoeia Commission, Ghaziabad.
  5. Hazell L, Shakir SAW. Under-reporting of adverse drug reactions. Drug Safety. 2006;29385–396.

Photo
Anshika Singh
Corresponding author

Bundelkhand University Jhansi

Photo
Dr. Nirmala Devi
Co-author

Assistant Professor, Bundelkhand University Jhansi

Anshika Singh, Dr. Nirmala Devi, Adverse Drug Reaction (Adr): Awareness, Attitude & Practice Of Adr Reporting Among Healthcare Students, Int. J. of Pharm. Sci., 2026, Vol 4, Issue 4, 2086-2088, https://doi.org/10.5281/zenodo.19563649

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