KNOWLEDGE, ATTITUDE AND PRACTICE OF ADVERSE DRUG REACTIONS REPORTING IN NURSES OF A TERTIARY CARE HOSPITAL

KNOWLEDGE, ATTITUDE AND PRACTICE OF ADVERSE DRUG REACTIONS REPORTING IN NURSES OF A TERTIARY CARE HOSPITAL

Pooja Patil *, Aparna Chincholkar and Ganesh Pentewar

Department of Pharmacology, MIMER Medical College, Talegaon, Dabhade, Maharashtra, India.

ABSTRACT: Introduction: ADRs significantly contribute to death and morbidity. The underreporting of adverse drug reactions is a widespread concern worldwide. Nurses are vital to healthcare and significantly contribute to adverse drug reaction reporting inside hospitals. This study was planned to assess nurses' knowledge, attitude and practice about ADR reporting, as well as to provide suggestions for improvement. Methods: This research was a cross-sectional questionnaire-based study involving 60 nurses, using a questionnaire with questions on knowledge (12), attitude (5) and practice (9) about ADR reporting. Responses were analysed both item-wise and domain-wise. Knowledge (12), attitude (5), and practice (9) responses were summarized using descriptive statistics and expressed as percentages for each item. In addition to item-wise descriptive percentages, responses were grouped into three domains: knowledge (12), attitude (5), and practice (9). Domain-wise responses were summarized using descriptive statistics to describe overall trends in nurses’ knowledge, attitude and practice related to ADR reporting. Results: A majority of the nurses (89.33%) were knew the term PV. 95% of nurses agreed that adverse drug reaction reporting is a professional obligation. 82% of nurses were aware about the existence of the ADR Monitoring Centre (AMC) located within the hospital. 72% of nurses were aware that the CDSCO is the regulatory body responsible for ADRs. 80% said that they had received training on reporting ADRs. 85% nurses noted ADRs in patients; however, only 48.33% reported to the pharmacovigilance centre. The primary cause of underreporting of ADRs was lack of time to submit reports. Conclusions: A notable disparity exists between adverse drug reactions noticed in patients and those reported by nurses. Participants agreed that adverse drug reactions reporting is essential and that regular awareness activities are required to enhance knowledge of adverse drug reactions, hence improving the existing state of adverse drug reactions reporting.

Keywords: Knowledge, Attitude, Practice, ADR reporting, Pharmacovigilance, Nurses

INTRODUCTION: According to the World Health Organization, pharmacovigilance is defined as the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems ¹.

An adverse drug reaction (ADR) is defined as any noxious and unintended response to a drug that occurs at doses normally used in humans for prophylaxis, diagnosis, or treatment of disease ¹.

Adverse drug reactions are linked to considerable death, morbidity, and increased treatment costs. Therefore, adequate surveillance of ADRs is essential ^{2, 3}. The aim of pharmacovigilance is to assurance the safe as well as judicious use of medications after their release for public usage. The primary goal of pharmacovigilance is to avert adverse effects of medication ². ADR monitoring facilitates the identification of novel, severe, unfamiliar, along with most prevalent responses. It further identifies risk variables ⁴. Healthcare workers, including doctors, chemists, and nurses, play a significant part in pharmacovigilance programs ⁵. The underreporting of ADRs is a prevalent issue in pharmacovigilance programs ⁶. It has been estimated that only a small proportion of adverse drug reactions are reported through pharmacovigilance systems worldwide, indicating substantial underreporting in spontaneous reporting programs ⁷. To address underreporting of adverse drug reactions, the Pharmacovigilance Programme of India (PvPI) was launched by the Ministry of Health and Family Welfare, Government of India, in July 2010. The programme is coordinated by the Indian Pharmacopoeia Commission (IPC) and functions through a network of Adverse Drug Reaction Monitoring Centres (AMCs) located in hospitals across the country. These centres collect and report ADR data to the national database for monitoring drug safety ⁸. The purpose of PvPI is to collect and evaluate ADR data and use its findings to elucidate the hazards associated with medications to Medical specialists as well as the common population ⁸.

The success of pharmacovigilance program relies on the engagement of healthcare specialists and the voluntary recording of ADRs ⁹. Healthcare professionals are responsible for recognising and reporting ADRs and enhancing pharmacovigilance program by submitting the Adverse Drug Reaction form to the Central Medicines Quality Controlling Commission ⁹.

To improve the reporting rate of ADR, it is crucial to improve the knowledge, attitude, and practice about ADR reporting and pharmacovigilance amongst healthcare professionals. Before commencing any intervention, it is crucial to evaluate the initial knowledge, attitude, as well as practices regarding adverse drug reaction reporting including pharmacovigilance amongst healthcare professionals ².

Nurses are essential to healthcare as well as play a significant role in adverse drug reaction reporting in hospitals ⁴. Nurses are primarily engaged in direct patient care and spend majority of their time with patients. Nurses prepare and dispense medications and are therefore in a unique position to detect, recognise, and report adverse drug reactions ¹⁰. Their understanding of adverse drug reactions, perspectives and attitudes towards ADR reporting, and challenges in reporting ADRs will influence the ADR reporting rate ⁴. This research was conducted to evaluate the knowledge, attitudes, and practices of ADR reporting among nurses at a tertiary care teaching hospital. The objective of this study was to assess the knowledge, attitude, and practice (KAP) of nurses regarding adverse drug reaction reporting in a tertiary care hospital. The study also aimed to identify factors contributing to underreporting of ADRs and to suggest measures for improving ADR reporting practices.

MATERIAL AND METHODS:

Study Setting: Nurses at the Dr. Bhausaheb Sardesai Talegaon Rural Hospital in Talegaon Dabhade, Pune, Maharashtra, India, participated in this research. Since 2014, the institution has an ADR monitoring centre. The college's IEC granted approval for this research. The research was conducted from August 2024 to November of 2024.

Study Design: This investigation was observational, cross-sectional, and questionnaire-based. Participants were recruited using convenience sampling, and all nurses available during the study period who met the eligibility criteria and consented to participate were included. A total of 60 nurses participated in the study. No eligible participants declined participation.

Participants:

Inclusion Criteria: Registered nurses working in wards or OPD of the hospital. Nurses willing to participate and provide informed consent.

Exclusion Criteria: Nursing staff on leave during the study period. Nurses unwilling to participate.

Questionnaire: A structured questionnaire previously used in similar KAP studies on pharmacovigilance was adopted for the present study. The questionnaire consisted of 26 questions- knowledge (12 questions), attitude (5 questions), and practice (9 questions). The questionnaire was reviewed by pharmacology faculty members for content relevance and clarity and minor modifications were made to suit the local hospital setting ⁶.

Data Collection: The principle investigator contacted all study participants at each ward and departmental OPD personally. Nursing staff were provided with a research information sheet. The participants received one-on-one instruction on how to complete the survey. Where appropriate, they were permitted to mark more than one choice. Informed permission was obtained and appropriately signed. Nurses were asked to fill out a questionnaire and return it within 25 minutes in order to increase the response rate. Participants completed the questionnaire independently without discussion to ensure unbiased responses. Their names were kept anonymous. Participation in the study was voluntary and anonymous. The questionnaire did not collect personal identifiers such as name or employee identification number. Completed questionnaires were stored securely by the principal investigator, and access to the data was restricted to the research team.

Statistical Analysis: Using a Excel sheet in the MS Office 2021 program, KAP survey was analysed question by question, as well as its percentage was determined. Knowledge, attitude and practice responses were analysed primarily as descriptive percentages for each item; domain-wise trends were also summarized to describe overall patterns in ADR reporting awareness and practice.

RESULTS: This research had 60 participants. It took an average of 20 to 22 minutes to complete the questionnaire. The response rate among the participating nurses was 100%.

Demographic Details: Table 1 provides a summary of the nurses' demographic data.

TABLE 1: DEMOGRAPHIC DETAILS OF THE PARTICIPANTS (N=60)

ANM: Auxiliary Nerve Midwife, GNM: General Nursery and Midwifery, BSc: Bachelor of Science, MSc: Master of Science.

Age, gender, education level, and job experience were the demographic data gathered for this study. The study included 60 nurses. Most participants were female (91.7%). The largest age group was 31–35 years (25%).

The majority of participants held a General Nursing and Midwifery (GNM) qualification (58.3%), followed by B.Sc. Nursing (21.7%). The largest proportion of nurses had 10–12 years of work experience (20%).

TABLE 2: KNOWLEDGE OF NURSES ABOUT ADR REPORTING (N=60)

The above table details nurses' knowledge of ADR reporting as well as proportion of "Yes" or "No" answers they gave Table 2.

Approximately 88% of nurses understood that PV deals with ADRs, and 89.33% of nurses knew the term ‘Pharmacovigilance’. 81% of nurses knew that ADR reporting can done by patients, healthcare professionals, nurses, chemists. 82% of nurses were aware that the institution had a AMC. 80% said they needed training on ADR reporting Table 2. About 72% of nurses were aware that the regulatory body responsible for ADR monitoring is CDSCO. 43% were aware that VIGIFLOW is a connected database for reporting ADR. In order to enhance ADR reporting, about 98.33% of nurses believed that regular awareness programs were necessary. 92% of participants have reported skin rash as the most common ADR.

TABLE 3: ATTITUDE OF NURSES TOWARDS ADR REPORTING (N=60)

The above table details nurses' attitude towards ADR reporting as well as proportion of "Yes" or "No" answers they gave Table 3. 95% of nurses agreed that adverse drug reaction reporting is a professional obligation. All nurses agreed that ADR reporting will improve patient’s safety. 93.33% agreed that PV should be taught in detail to healthcare professionals. The primary cause of underreporting of ADRs was lack of time to submit reports.

TABLE 4: PRACTICE OF NURSES ABOUT ADR REPORTING (N=60)

Nurses' ADR reporting practices are shown in Table 4, along with the proportion of "Yes" or "No" answers. Only 48.33% of nurses reported ADRs to the pharmacovigilance centre, although 85% of nurses experienced ADRs in patients. 51.67% of nurses have not reported any adverse drug reactions, instead of reporting they had informed physician. 80% of nurses were aware that the pharmacology department get the ADR forms. While 18.33% of nurses believed that only major and life-threatening ADRs must be reported, 81.67% of nurses were alert that all ADRs must be reported.

DISCUSSION: The present study evaluated the knowledge, attitude, and practice of ADR reporting among nurses in a tertiary care hospital. The findings indicated that nurses had relatively good awareness of pharmacovigilance concepts and a positive attitude toward ADR reporting. However, the actual reporting practice was suboptimal, as only 48.33% of nurses who observed ADRs reported them to the ADR Monitoring Centre. 60 nurses from a tertiary care hospital participated in current research, which was questionnaire-based. The completed survey was analysed.

The response rate of the completed questionnaires had a 100% response rate which was more in comparison to studies conducted among nursing staff in Bhopal by Tiwari et al. (71%) and among nurses of two medical schools by Scandashree et al. (63%) ^{11, 12}. This might be because there were fewer research participants and the primary investigator personally met each participant at their particular ward and departmental OPD. The majority of nursing staff (91.7%) were female, in contrast to another study among nursing staff in Deoghar by Bankar et al. (74%) ¹⁰. In difference to a study done in nurses by Bankar et al., which found that 87% of nurses had a B.Sc. nursing degree, the majority of nurses (58.3%) had a GNM nursing degree in present study ¹⁰. Compared to studies conducted on health care workers by Gupta et al. (62.4%) and hospital nurses in Iran by Hanafi et al. (32.1%), 89.33%nurses knew the word PV as well as the majority (88%) understood that it deals with ADRs ^{3, 6}.

Similar to a study done in South India among healthcare workers by Gupta et al. (78.2%), the majority of nurses (72%) were aware that the CDSCO is the regulatory body responsible for ADR reporting ³. In difference to study done in nursing staff by Tiwari et al. (32%), 82% nurses were aware that the institution had a PV committee, as well as the study conducted by Khan et al. (80.9%), physicians were aware of the institute's AMC ^{7, 11}. Compared to the research conducted on healthcare professionals by Gupta et al., only half of the nurses (55%) were aware that a staff member from the pharmacology department visited the hospital once a week to remind them to report adverse drug reactions ³. Most nurses (95%) knew that adverse drug reactions (ADRs) from blood transfusions and vaccinations should be recorded. This was higher than the percentage of prescribers in a study by Desai et al. (20.6%) and comparable to the percentage of PG students in a research by Chincholkar et al. (89.77%) ^{9, 13}.

Analogous to research performed on healthcare practitioners by Gupta et al. (80.2%) and nursing staff by Tiwari et al. (73%), the majority of nurses (81%) believed that medicinal doctors, chemists, patients, nurses and health workers are all can report ADRs ^{3, 11}. ADR reporting was seen favourably by nurses, as 95% of them believed it was a professional duty, which is consistent with research conducted among physicians by Scandashree et al. (93.25%) and among nursing staff by Tiwari et al. (90%) ^{11, 12}. Similar results were also found by Gupta et al. in a research conducted among medical staff at a South Indian teaching hospital ³. The most frequent adverse drug reaction (ADR) they reported was skin rash (92%) which was comparable to the Chincholkar et al. research (79.59%) ⁹. Approximately 98% of nurses thought the institute's ADR reporting system was useful, indicating that they had a favourable attitude toward ADR reporting. Underreporting of ADRs was seen in the present study. Lack of time (49%), lack of knowledge (25%), difficulty to decide ADR has occurred or not (16.66%), fear of legal liability (7%), and a single unreported case may not affect ADR database (2.34%) are the challenges and reasons for underreporting of ADRs.

The following actions must be made in order to get over these problems: 1. Display the AMC emergency phone number in conspicuous places around the hospital. 2. The ADR forms should be made readily available online and via mobile devices by implementing a scanner. 3. Recurring instruction on how to file an ADR.

The research conducted on healthcare workers by Gupta et al. (22.6%) as well as Dudhe et al. (60%), also found that although the majority of nurses (85%) had observed ADRs in patients, barely half of them (48.33%) reported them ^{3, 14}. Similar to results from research performed among nurses in Gujarat and South India, the nurses in this study exhibited a positive approach about ADR reporting. In an investigation showed in Iran by Hanafi et al., the majority of nurses (91.1%) had never reported an adverse drug reactions ⁶. Approximately 81% of nurses knew that the reporting of all types of ADRs is necessary. It indicates a favourable attitude towards need of reporting. This conclusion was greater in comparison to another research conducted among doctors by Dudhe et al (62%) and among nurses by Bahekar et al (53%) ^{14, 15}. The study's main conclusions were that healthcare workers should get thorough training in pharmacovigilance and almost all of them had the belief that ADR reporting is essential.

Limitations of the Study: The study has several limitations. First, it was conducted in a single tertiary care hospital with a relatively small sample size, limiting generalizability of the findings. Second, the study relied on self-reported responses, which may be subject to recall bias and social desirability bias. Third, inferential statistical analyses were limited, and therefore associations between demographic variables and KAP outcomes could not be fully explored.

Implications: Based on the study findings, several practical measures may improve ADR reporting within hospitals:

• Simplification of ADR reporting procedures.
• Availability of ADR forms in all wards.
• Mobile or online reporting systems.
• Periodic pharmacovigilance training programs.
• Feedback to healthcare professionals after ADR submission.
• Allocation of protected time for reporting ADRs.

CONCLUSION: This study found that nurses have relatively good knowledge and positive attitudes towards adverse drug reaction reporting. However, the actual reporting practice remained suboptimal, with a substantial gap between ADRs observed and those reported. Lack of time and insufficient awareness were identified as key barriers to reporting. Strengthening pharmacovigilance training, improving accessibility of reporting systems, and providing institutional support may help improve ADR reporting among nurses.

ACKNOWLEDGEMENTS: The authors express gratitude to all nursing staff for their involvement in the research.

Recommendation: Regular awareness programs are essential to improve knowledge of nursing staff about adverse drug reactions and pharmacovigilance.

Ethical Approval: The Institutional Review Board of MAEER’S MIT Pune’s MIMER Medical College and B.S.T.R Hospital approved this study. Ethical Approval No. IEC/MIMER/2024/INST/1012, Date: 02/08/2024.

Funding: Nil

CONFLICT OF INTEREST: Nil

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    How to cite this article:

    Patil P, Chincholkar A and Pentewar G: Knowledge, attitude and practice of adverse drug reactions reporting in nurses of a tertiary care hospital. Int J Pharm Sci & Res 2026; 17(7): 2216-23. doi: 10.13040/IJPSR.0975-8232.17(7).2216-23.

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