Knowledge, Attitude, and Perception regarding Pharmacovigilance among the Current Pharmacy Students of R. P. Shaha University in Bangladesh: A Retrospective Study
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Assistant Professor
MuajIbneSahid1Phone+8801673910800Emailsahid_phr@rpsu.edu.bdEmailmuajsk@gmail.comMdFaiazul1
HaqueLamem1
1Department of PharmacyR. P. Shaha University1400NarayanganjBangladesh
Muaj Ibne Sahid1, Md Faiazul Haque Lamem1
1Department of Pharmacy, R. P. Shaha University, Narayanganj- 1400, Bangladesh
*Corresponding author: Muaj Ibne Sahid, Assistant Professor, Department of Pharmacy, R. P. Shaha University, Narayanganj- 1400, Bangladesh.
Contact No: +8801673910800
E mail: sahid_phr@rpsu.edu.bd or muajsk@gmail.com
Knowledge, Attitude, and Perception regarding Pharmacovigilance among the Current Pharmacy Students of R. P. Shaha University in Bangladesh: A Retrospective Study
Abstract
The goal of Pharmacovigilance is to establish secure and rational utilization of medications among the public after their release. Focusing on educating pharmacy students toward pharmacovigilance is crucial for encouraging them to report any adverse reactions to drugs they encounter in clinical practice. This research aims to assess the knowledge, attitude, and perception (KAP) regarding pharmacovigilance among students attending the Department of Pharmacy at R. P. Shaha University, located in Narayanganj-1400, Bangladesh. A questionnaire-based study was conducted to assess the KAP related to pharmacovigilance. This study involved only the participation of pharmacy students from their second year, pre-final year, and final year. Result is determined by appropriate statistical analysis. The current study was conducted in the university campus, which included a total of 70 current students of pharmacy department. Students show high awareness (94.3%) and positive attitude (72.9%) towards ADRs reporting but no one reports ADRs. understanding of specific aspects, such as how, whom, and where to report, is less prevalent. Study endorses emphasize training and incentives for improvement.
Keywords:
Drug safety monitoring
Pharmacovigilance
Adverse drug reactions (ADRs)
Drug safety education
Healthcare system improvement
ADR reporting system
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1. Introduction
According to the World Health Organization, pharmacovigilance encompasses the science and activities aimed at detecting, assessing, understanding, and preventing adverse effects or other drug-related issues (World Health Organization, 2002). An article published in the Research Journal of Pharmacy and Technology suggests that ADRs may be responsible for up to 8.5% of hospital admissions in Bangladesh, highlighting the substantial strain they place on the healthcare system (Amin et al., 2015). Numerous adverse effects, interactions with other drugs and foods, and various risk factors, including specific toxicities, often emerge years after a medication is introduced. Some rare adverse effects (occurring in 1 out of 100,000 cases) only become apparent after the drug has been widely used (Oberg, 1999). Effective pharmacovigilance is the only way to identify such uncommon side effects of the medication.
The pharmacovigilance program (PP) has been instrumental in identifying ADRs and in removing several drugs from the market. But, not reporting enough ADRs is a big problem with PP (Ponmari et al., 2015). Because of differences in drug response, prescribing habits, regulatory systems, and drug availability, it's recommended that each country establishes its own PP. (World Health Organization, 2002).
Limited knowledge and perception concerning ADRs reporting among pharmacy students have been documented in various studies, highlighting the importance of addressing this gap in order to improve overall pharmacovigilance efforts (Akhtaruzzaman et al., 2021). Underreporting of ADRs by pharmacy students can result from various factors, such as limited time, thinking a single case isn't significant, worrying about increased study load, and fears of facing legal consequences (Loke et al., 2011).
Another study revealed that despite high self-reported confidence, pharmacy students’ actual ability to recognize and manage ADRs was lacking (Khan et al., 2017). This shows we urgently need to teach pharmacovigilance better in Bangladesh's pharmacy schools. To address this gap, several initiatives have been taken in recent years, Administration (DGDA) launched a nationwide campaign aimed at educating healthcare professionals, including pharmacy students, about the importance of ADRs reporting (Directorate General of Drug Administration, 2021).
The purpose of this study was to examine and appraise the knowledge, attitude, and perception (KAP) regarding pharmacovigilance among the students of Current Pharmacy Students of R. P. Shaha University,
2. Methods and materials
Study Design
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This research was conducted at R. P. Shaha University in Narayanganj-1400, Bangladesh. The survey-based study was conducted on (September 17th, 2024) to explore Pharmacovigilance's knowledge, attitude, and perception (KAP). Data was collected from the target students using a structured questionnaire, including sections on demographic information, knowledge, attitude, and practice of pharmacovigilance. The target population was current undergraduate students of the Department of Pharmacy at R.P. Shah University. Only participants who provided their consent were included in the study.Sampling Technique
A stratified random sampling technique was employed to select participants from different academic years (3rd, 4th) who were already familiar with ADRs and pharmacovigilance. For categorization purposes, we assessed 3rd-year students as pre-final-year candidates and 4th-year students as final-year candidates.
Data Collection and Analysis
A planned set of questions was created using approved measurements and existing research through a comprehensive literature review. To ensure authenticity and integrity the questionnaire was distributed in a paper-based format to collect data from the respondents. Completed forms are collected from the students and analyzed for the results. Statistical analysis was performed using SPSS to obtain the results. The final data were presented as frequencies and percentages.
3. Results
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In this study, the KAP concerning pharmacovigilance were assessed among 70 students. Among these participants, 27 (38.57%) were in their second year, 19 (27.14%) were pre-final year students, and 24 (34.29%) were in their final year. Figure 1 illustrates the distribution of student involvement across these academic levels.Figure 1: Stratification of student involvement in the study
3.1 Analysis of Knowledge
The outcomes of the knowledge-focused questions are outlined in Table 1. Among the 70 individuals enrolled in the study, across academic years, approximately 94% correctly identified PV, and 86% recognized ADRs. Concerning PV's importance for patient safety, 89% of students acknowledged its significance. Notably, 93% believed pharmacists should be pivotal in ADRs reporting. However, perception varied regarding ADRs reporting's contribution to the PV system, with approximately 29% of second-year students and 53% of final-year students recognizing its importance. Nonetheless, 97% of students recognized ADRs reporting's significance in assessing side effects of marketed drugs. Among the three academic years, final-year students demonstrate the highest level of knowledge, pre-final year students demonstrate lower comprehension of the knowledge level of pharmacovigilance compared to second-year and final-year students.
Table 1: Students feedback to knowledge-oriented inquiries. (n = 70) | |||||
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Question | Correct responses n (%) | ||||
Second year | Pre-final year | Final year | Total n% | ||
1. PV is the science and practice of monitoring adverse drug reactions. | 27 (100) | 17 (89.5) | 22 (91.7) | 66 (94.3%) | |
2. ADRs are any harmful or unwanted effects of a medicine. | 22 (81.5) | 16 (84.2) | 22 (91.7) | 60 (85.7%) | |
3. PV is important for ensuring patients' safety when taking medicines. | 26 (96.3) | 12 (63.2) | 24 (100) | 62 (88.6%) | |
4. Pharmacists should be one of the most important healthcare professionals to report ADRs? | 23 (85.2) | 18 (94.7) | 24 (100) | 65 (92.9%) | |
5. Does the reporting of ADRs make a significant contribution to the PV system? | 6 (22.2) | 10 (52.6) | 4 (16.7) | 20 (28.6%) | |
6. ADR reporting is important to determine the side effects of marketed drugs | 25 (92.6) | 19 (100) | 24 (100) | 68 (97.1%) | |
| PV: Pharmacovigilance, ADRs: Adverse drug reactions | |||||
3.2 Analysis of Attitude
The analysis of attitude-oriented inquiries among students across different academic years showing in Table 2 reveals notable trends. Final-year students exhibit the highest familiarity with pharmacovigilance and ADRs (95.8%), followed by pre-final year students (42.1%) and second-year students (14.8%). They also show the highest agreement that reporting ADRs is a professional obligation (91.7%), compared to second-year students (74.1%) and pre-final year students (47.4%). Additionally, final-year students display the strongest belief in PV's contribution to patient safety (100%), followed by pre-final year students (92.9%) and second-year students (85.2%). While second-year students perceive knowing where to report ADRs as most crucial (92.6%), pre-final year students also find it important (78.9%), whereas final-year students perceive it as less essential (50%). Pre-final year students engage the most with articles on preventing ADRs (47.4%), followed by final-year students (29.2%) and second-year students (22.2%). Exposure to ADRs reporting forms is highest among second-year students (96.3%), followed by pre-final year students (89.5%) and final-year students (66.7%).
Table 2: Students feedback to Attitude-oriented inquiries. (n = 70) | |||||
|---|---|---|---|---|---|
Question | Response | Second year | Pre-final year | Final year | Total n% |
Are you familiar with the concept of pharmacovigilance and its role in monitoring ADRs? | NO | 23 (85.2) | 11 (57.9) | 1 (4.2) | 35 (50) |
YES | 4 (14.8) | 8 (42.1) | 23 (95.8) | 35 (50) | |
Do you think reporting on ADRs is a professional obligation for pharmacists? | NO | 7 (25.9) | 10 (52.6) | 2 (8.3) | 19 (27.1) |
YES | 20 (74.1) | 9 (47.4) | 22 (91.7) | 51 (72.9) | |
Does pharmacovigilance significantly contribute to patient safety? | NO | 4 (14.8) | 0 (0.0) | 1 (4.2) | 5 (7.1) |
YES | 23 (85.2) | 19 (100) | 23 (95.8) | 65 (92.9) | |
Do you think it's important to know where to report ADRs? | NO | 25 (92.6) | 15 (78.9) | 12 (50.0) | 52 (74.3) |
YES | 2 (7.4) | 4 (21.1) | 12 (50.0) | 18 (25.7) | |
Have you read any article on prevention of ADRs? | NO | 21 (77.8) | 10 (52.6) | 17 (70.8) | 48 (68.6) |
YES | 6 (22.2) | 9 (47.4) | 7 (29.2) | 22 (31.4) | |
Have you ever seen ADRs reporting form? | NO | 26 (96.3) | 17 (89.5) | 16 (66.7) | 59 (84.3) |
YES | 1 (3.7) | 2 (10.5) | 8 (33.3) | 11 (15.7) | |
| PV: Pharmacovigilance, ADRs: Adverse drug reactions | |||||
3.3 Analysis of Perception
Analysis of Perception among Students Data The analysis of student perceptions regarding ADRs reporting reveals strong awareness but low reporting practices. Among second-year students, 96.3% believe improving ADRs reporting can enhance the health system, with 100% of pre-final and final-year students agreeing. Similarly, 96.3% of second-year, 94.7% of pre-final year, and 95.8% of final-year students think pharmacists should be more aware of the ADR reporting system in Bangladesh. Despite this, only 7.4% of second-year, 21.1% of pre-final year, and 8.3% of final-year students report ADRs. To address this gap, it is recommended to enhance training programs, provide incentives, establish mentorship programs, integrate ADRs reporting into the curriculum, and conduct continuous awareness campaigns. These steps aim to convert high awareness into active reporting, improving health outcomes and strengthening the ADRs reporting system in Bangladesh.
A Table 3: Students feedback to Perception-oriented inquiries (n = 70) | |||||
|---|---|---|---|---|---|
Question | Response | Second year | Pre-final year | Final year | Total n% |
Improving ADRs reporting can improve the overall health system by educating about unknown adverse effects of medicines? | NO | 1 (3.7) | 0 (0.0) | 0 (0.0) | 1 (1.4) |
YES | 26 (96.3) | 19 (100) | 24 (100) | 69 (98.6) | |
As a pharmacist, we should be more aware about the ADRs reporting system in Bangladesh? | NO | 1 (3.7) | 1 (5.3) | 1 (4.2) | 3 (4.3) |
YES | 26 (96.3) | 18 (94.7) | 23 (95.8) | 67 (95.7) | |
Do you report ADRs? | NO | 25 (92.6) | 15 (78.9) | 22 (91.7) | 62 (88.6) |
YES | 2 (7.4) | 4 (21.1) | 2 (8.3) | 8 (11.4) | |
| ADRs: Adverse drug reactions | |||||
4. Discussion
The analysis of student’s feedback on pharmacovigilance shows strong theoretical knowledge but low practical engagement. While 94.3% of students understand PV as monitoring adverse drug reactions and 85.7% recognize ADRs as harmful effects of medicine, only 28.6% believe reporting ADRs significantly contributes to the PV system.
Attitudes are mixed; 50% are familiar with PV's role in ADR monitoring, 72.9% see ADRs reporting as a professional obligation, and 92.9% agree it enhances patient safety. However, only 25.7% know where to report ADRs, and 84.3% have never seen an ADR reporting form.
Perceptions are positive, with 98.6% believing ADR reporting improves the health system and 95.7% thinking pharmacists should be more aware of ADR reporting in Bangladesh. Despite this, only 11.4% of students report ADRs.
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According to a study assessing the knowledge and attitudes of medical students towards ADRs reporting in Bangladesh found that less than half (45.8%) of their sample had ever heard of ADRs, while only 42.5% knew about pharmacovigilance (Rahman et al. 2019). Despite pre-final year students show the best engagement, with 100% recognizing the importance of ADR reporting and 21.1% actively reporting ADRs.5. Conclusion
In conclusion, while students exhibit strong knowledge and positive attitudes towards pharmacovigilance, there's a gap in practical application and awareness of reporting procedures. Pre-final year students demonstrate the highest engagement. To bridge this gap, enhancing practical training, increasing awareness, and fostering mentorship programs can empower students to actively contribute to ADRs reporting and improve patient safety.
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Conflict of InterestThe writers don't have any competing interests.
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