Assessing Pharmacovigilance Awareness Among Healthcare Professionals: An Observational and Randomized Survey

Vanshree Rathod, Sakshi Pathrikar, Vaishnavi Mukhmale, Nandakishor Deshmukh, Swati Deshmukh,

doi:10.5281/zenodo.15387500

Case Study | Open Access
Volume 03 | Issue 05 | Article Id IJPS/250305312

Assessing Pharmacovigilance Awareness Among Healthcare Professionals: An Observational and Randomized Survey
Vanshree Rathod* Sakshi Pathrikar Vaishnavi Mukhmale Nandakishor Deshmukh Swati Deshmukh
Shraddha Institute of Pharmacy, Kondala Zambre, Washim 444-505

Abstract

Pharmacovigilance (PV), the science concerned with the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs), is vital for patient safety and the effective use of medicines. This study aimed to assess the knowledge, attitudes, and practices (KAP) of healthcare professionals (HCPs) regarding PV in urban and rural areas of Washim, India. Using a mixed-methods approach, the survey revealed that while a significant proportion of HCPs demonstrated sound theoretical knowledge but practical application remained insufficient. Only 39.6% had ever reported an ADR, and over half had never received formal training in ADR reporting. Attitudes toward PV were overwhelmingly positive. Pharmacists exhibited higher knowledge and participation levels compared to doctors and nurses, and those with formal training or working in government institutions were more actively engaged. The findings underscore a crucial gap between awareness and practice, highlighting the need for targeted educational programs, simplified reporting mechanisms, and institutional support to improve PV engagement. Enhancing PV practices is essential for strengthening patient care and ensuring the safe use of medications in clinical settings.

Keywords

Pharmacovigilance, Adverse Drug Reactions, Healthcare Professionals, Post-Marketing Surveillance, Survey and Knowledge, Attitudes, and Practices.

Introduction

Pharmacovigilance (PV) is the science and set of activities dedicated to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. [1] It is crucial for ensuring the safe use of medicines throughout their lifecycle. Healthcare professionals (HCPs) play a pivotal role in pharmacovigilance, as their knowledge, attitudes, and practices (KAP) directly influence the detection and reporting of adverse drug reactions (ADRs), thereby impacting overall patient safety.[2]

Although PV is not new to India—with formal efforts beginning in 1998 when India joined the Uppsala Monitoring Centre—its implementation remains limited.[3] Many HCPs lack adequate training and awareness, leading to underreporting of ADRs and delayed identification of drug safety issues. In recent years, the growing pharmaceutical sector and increased research and development activity in India have further underscored the need for a strong, systematic PV framework, especially given that a significant proportion (35%–50%) of ADRs are preventable.[4] This study aims to assess the current state of KAP regarding PV among healthcare professionals in both urban and rural areas of Washim district, Maharashtra. Using a mixed-methods approach including observational and randomized survey designs the research will gather and analyze data to identify knowledge gaps and behavioral patterns.[5] A structured survey questionnaire developed and refined through literature review, will be used for data collection. The demographic. data will be analyzed using frequency distribution methods, while KAP responses will be statistically assessed using SPSS software.[6] The findings will provide insights to inform policies, educational initiatives, and interventions aimed at strengthening pharmacovigilance practices among HCPs, ultimately promoting safer medication use and improving patient outcomes.[7]

Fig no.1: - Pharmacovigilance: The science in public welfare

MATERIALS AND METHODS:

Study Design

This study employed a cross-sectional, mixed-methods approach, integrating both observational and randomized survey designs to assess the knowledge, attitudes, and practices (KAP) related to pharmacovigilance among healthcare professionals (HCPs) in the urban and rural areas of Washim district, Maharashtra, India.

Survey Development

Questionnaire Design: A structured questionnaire was developed based on an extensive review of existing literature, including previous KAP studies and pharmacovigilance guidelines issued by organizations such as the World Health Organization (WHO) and the Indian Pharmacopoeia Commission (IPC). The questionnaire comprised both closed-ended and Likert-scale-based questions, divided into four sections:
- Demographic Information (age, gender, profession, practice setting)
- Knowledge related to pharmacovigilance definitions, objectives, and processes
- Attitudes toward reporting ADRs and the perceived importance of PV
- Practices involving ADR identification, documentation, and reporting behavior

Data Collection

Sampling and Recruitment: A stratified sampling technique was used to ensure representation from both urban and rural healthcare settings within Washim district. Healthcare professionals including physicians, nurses, pharmacists, and allied health staff from public and private institutions were invited to participate.
Survey Administration: The finalized questionnaire was administered in online formats, depending on participant accessibility. For online responses, Google Forms was used.
Data Handling and Storage: The digital responses were compiled into a master database using Microsoft Excel for cleaning and preparation before analysis.

Data Analysis and Interpretation

Descriptive Analysis: The demographic data of participants were analyzed using frequency distribution and percentages to describe the sample characteristics.
Statistical Analysis: The responses from the KAP sections of the questionnaire were analyzed using percentages. Descriptive statistics (mean, standard deviation) and inferential statistics (e.g., Chi-square test, ANOVA, or t-test where applicable) were used to assess the relationships between demographic variables and KAP levels.
Interpretation of Results: The analysis aimed to identify significant patterns and factors influencing the knowledge, attitudes, and practices of healthcare professionals towards pharmacovigilance. The results were interpreted in light of the current national and international PV framework to propose targeted interventions for improving ADR reporting and pharmacovigilance awareness.

RESULT AND DISCUSSION:

Questionnaire was circulated in online formats in 105 KAP, out of those 96 healthcare professionals (Pharmacist 51, Doctors 28 and Nurses 17) gave consent to participate in this study and responded to the questionnaire. The demographic details of the healthcare professionals with baseline characteristics are summarized in (Table 1)

Table 1: Demographic Details of the Healthcare Professionals

Characteristics	Frequency (Number)
Gender
Male	49
Female	46
Age (in Year)
20-30		52
30-40		38
Above 40		6
Profession
Doctors			28
Pharmacists			51
Nurses			17

Knowledge among Healthcare Professionals regarding Pharmacovigilance:

In terms of knowledge, a majority of the participants showed familiarity with key pharmacovigilance concepts. Specifically, 85.4% of respondents correctly defined pharmacovigilance, while 93.8% were aware of the adverse drug reaction (ADR) reporting procedures. Furthermore, 89.5% correctly identified the Central Drugs Standard Control Organization (CDSCO) as India’s regulatory body responsible for ADR monitoring, and 74% recognized the international centre for ADR monitoring in Sweden. Additionally, 68.8% of healthcare professionals were aware of drugs recently banned due to ADRs, and 74% were familiar with the ADR reporting system in India. However, knowledge levels varied significantly across professions and experience levels. Pharmacists, likely due to their training, demonstrated better understanding of pharmacovigilance concepts compared to doctors and nurses.

Table 2: Interpretation of Knowledge-Based Responses regarding Pharmacovigilance

Knowledge Parameter	Percentage (%)	Interpretation
Correct definition of pharmacovigilance	85.4%	High conceptual awareness; most HCPs understand the basic purpose and scope of PV.
Awareness of ADR reporting procedures	93.8%	Very high procedural knowledge, indicating successful dissemination of reporting guidelines.
Identification of CDSCO as India's regulatory body	89.5%	Strong national regulatory knowledge among respondents.
Recognition of Uppsala Monitoring Centre (Sweden) as international ADR body	74%	Good global awareness, though scope for improvement exists.
Awareness of recently banned drugs due to ADRs	68.8%	Moderate knowledge; suggests need for more updates/training on recent regulatory actions.
Familiarity with ADR reporting system in India	74%	Fair level of operational knowledge; reflects engagement with national PV systems.

Healthcare Professionals Attitude Towards ADR Reporting

The attitude-related findings revealed an overwhelmingly positive outlook toward pharmacovigilance. A significant majority (96.9%) agreed that pharmacovigilance should be included in the undergraduate curriculum to build early awareness. Additionally, 95.8% supported the establishment of ADR monitoring centers in every hospital, and 99% believed that reporting ADRs is necessary. A large portion (92.7%) also felt that pharmacovigilance should be taught in detail to healthcare professionals. These responses reflect a strong recognition of the importance of pharmacovigilance among the healthcare community. However, while the theoretical attitude toward PV was optimistic, practical engagement still remained suboptimal.

Table 3: Interpretation of Attitude-Based Responses on Pharmacovigilance

Attitude Statement	Percentage (%)	Interpretation
Pharmacovigilance should be included in undergraduate curriculum	96.9%	Indicates strong consensus on the need for early education and awareness-building among future healthcare professionals.
ADR monitoring centers should be established in every hospital	95.8%	Reflects widespread support for institutional infrastructure to support systematic ADR reporting.
Reporting ADRs is necessary	99%	Near-universal agreement highlights strong ethical and professional commitment to patient safety.
Pharmacovigilance should be taught in detail to HCPs	92.7%	Majority believe in the importance of in-depth PV education for clinical practice and safety outcomes.
General attitude toward PV	Very Positive	Demonstrates high theoretical support and acknowledgment of the importance of pharmacovigilance in healthcare.

Health care professionals response towards practice-related questions

When it came to practice-related behavior, the results highlighted a considerable gap between awareness and action. Only 47.9% of healthcare professionals had encountered ADRs in their practice, and more than half (53.1%) had never received formal training on how to report ADRs. Only 50% had seen an ADR reporting form, and just 39.6% had ever reported an ADR to a pharmacovigilance center. Moreover, only 47.9% maintained records of ADRs, though a Shraddha Institute of Pharmacy, Washim 2024-25 Page 29 Assessing Pharmacovigilance Awareness among Healthcare Professionals: An Observational and Randomized Survey promising 81.3% expressed willingness to report ADRs in the future.

Table 4: Interpretation of Practice-Based Responses on Pharmacovigilance

Practice Indicator	Percentage (%)	Interpretation
Healthcare professionals who have encountered ADRs in practice	47.9%	Less than half have identified ADRs, suggesting possible under recognition or underreporting in clinical settings.
Healthcare Professionals who received formal training on ADR reporting	46.9%	Majority have not received formal training, highlighting a key barrier to effective ADR reporting.
Healthcare Professionals who have seen an ADR reporting form	50%	Indicates a lack of exposure to reporting tools, which may deter or delay ADR documentation.
Healthcare Professionals who have reported an ADR to a PV center	39.6%	Low actual reporting rate despite high awareness, pointing to a disconnect between knowledge and implementation.
Healthcare Professionals who maintain ADR records	47.9%	Suggests inconsistent documentation practices, affecting data continuity and follow-up.
Healthcare Professionals who willingness to report ADRs in the future	81.3%	Encouraging outlook; reflects potential to improve practice with the right support and training.

CONCLUSION

This study highlights a strong and encouraging attitude toward pharmacovigilance among healthcare professionals in Washim district, reflecting widespread recognition of its importance in clinical practice. However, the findings also reveal critical gaps in knowledge and real-world application. Limited formal training, unfamiliarity with ADR reporting procedures, perceived complexity of the reporting process, and lack of institutional support have emerged as major barriers to effective pharmacovigilance practices. Despite the high willingness to engage in ADR reporting, the actual participation remains suboptimal, pointing to a disconnect between awareness and action. Bridging this gap requires targeted interventions such as integrating pharmacovigilance into academic curricula, offering regular training programs, simplifying reporting systems, and fostering a supportive institutional culture. Strengthening pharmacovigilance is essential not only for enhancing patient safety but also for reinforcing the overall healthcare system. By empowering healthcare professionals with the right knowledge, tools, and support, we can significantly improve pharmacovigilance practices and contribute to safer, more effective healthcare delivery.

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