Medicines have contributed substantially to treating diseases in the modern era. The use of medicine not only results in beneficial effects but can also cause some unexpected or noxious effects known as adverse drug reactions (ADR). There is a worldwide concern about increasing number of adverse effects caused by drugs.¹World Health Organization (WHO) defines Pharmacovigilance as “science and activities relating to detection, assessment, understanding and prevention of adverse effects or any other drug related problems.”²

Central Drugs Standard Control Organization (CDSCO), New Delhi, Ministry of Health and Family Welfare Government of India, had initiated the National Pharmacovigilance (PV) Program in July 2010. The main reason behind initiating this program was to provide information regarding the safety of medicines to health-care professionals, to recommend the regulatory authorities for intervention and to create signals^. Although Pharmacovigilance Programme of India (PvPI) contributes to Uppsala Monitoring Centre database due to the lack of vibrant ADR monitoring and reporting system among the health-care workers, the reports contributed by India are very little only.³The major reason behind under reporting of ADRs is due to lack of trained and dedicated staffs and lack of awareness regarding detection, communication and spontaneous monitoring of ADRs among the physicians, dentists, nurses, pharmacists^4,5

The success of any pharmacovigilance system relies on the active participation of all healthcare professionals, including dentists. Dentists play a crucial role in pharmacovigilance activities and ADR reporting during their practice. Several countries have initiated pharmacovigilance programs, and national centre’s consolidate reports from hospitals and pharmaceutical companies.⁶ Few studies have been conducted on undergraduate medical and dental students about KAP regarding Pharmacovigilance.⁷So this study was aimed to assess the knowledge, attitude and practice of Pharmacovigilance among 2nd year BDS students at Government Medical College and Hospital, Nagpur, Maharashtra India, regarding pharmacovigilance and ADR monitoring.

material and methods

Study design and setting:

This study was a cross-sectional, survey-based study conducted to assess the knowledge, attitude, and practice of pharmacovigilance  among IInd year dental students at a tertiary care teaching hospital in India. A self-validated questionnaire consisting of open and close-ended questions were used. The study was conducted after obtaining approval from the Institutional Ethics Committee (IEC), with Reference number: 3642 EC/Pharmac/GMC/NGP/. Electronic informed consent was taken from all study participants.

Study duration:

The study was conducted for a duration of two months, starting from 21^st February 2025.The inclusion criteria for participants in this study were IInd year dental students willing to participate in the study. The exclusion criteria were IInd year dental students who provided incompletely filled responses.

Data Collection Methods and Tools:

The data for this study were collected through a self- designed, semi-structured, pre-validated questionnaire circulated through Google forms to IInd year BDS students. The questionnaire consisted of questions related to knowledge, attitude, and practice of Pharmacovigilance. The questionnaire was validated by circulating it to a panel of 10 experts in the subject who were asked to review and evaluate the design, content, and relevance of the questionnaire as well as assess its comprehensibility and readability which was consequently modified slightly based on their feedback. The responses were then collected anonymously.

Study procedure: The questionnaire was structured to obtain the demographics of the participants and total 23 questions–12 about knowledge, 7 about attitude and 4 about practice designed specifically to answer the awareness about pharmacovigilance. Before commencement of the questionnaire, the objectives of the study were mentioned in the google forms. It was assured that the data which was collected would be used only for research purposes and the findings will not be revealed to anybody.

Statistical analysis:

The collected data and the results were presented using descriptive statistics such as percentages.

RESULTS

A total of 75 IInd year BDS students were involved in questionnaires of pharmacovigilance Among the participants, 57 (76%) were women while 18 (24 %) were men. [Table 1]                                 

About 81.3% participants were aware about pharmacovigilance. About 38.7% participants had the knowledge of the existence of ADR reporting and monitoring systems in India. Participants' awareness regarding location of the National Pharmacovigilance Centre of India was only 11%. According to participants ADR reporting is a professional obligation (61.3%). About 21.3% participants said that they have seen an ADR form by CDSCO. [Table 4]

Table 1: Demographic characteristics of Participants (n=75)

Table 2: Knowledge about Pharmacovigilance among Participants (n=75)

Figures in parentheses indicate percentages, ADR=Adverse drug reactions, PV=Pharmacovigilance

11. Which of the following Health Professionals are qualified to report adverse reactions of a drug?

Figure:1 Health care professionals qualified to Report Adverse Drug Reactions

12. What can be done to increase awareness about Pharmacovigilance?

When asked about how to increase awareness about pharmacovigilance, 80% of the participants answered awareness by educational campaign, while 20% answered awareness by Mass media and social media

Table 3 : Attitudes about Pharmacovigilance among Participants (n=75)

Figures in parentheses indicate percentages, ADR=Adverse drug reactions, PV=Pharmacovigilance

7. ADRs with which of the following should be reported?

Figure 2: ADRs which should be reported

Table 4 : Practice questions  about Pharmacovigilance among Participants (n=75)

Figures in parentheses indicate percentages, ADR=Adverse drug reactions, PV=Pharmacovigilance, CDSCO = Central Drug Standard Control Organization

4. What can be done to facilitate reporting of ADRs?

When asked about what can be done to facilitate reporting of ADRs, 90% of the participants responded to increase awareness about ADRs reporting and 10% didn’t have any idea.

Discussion

The current study aimed to assess the knowledge, attitude, and practice of 2^nd year BDS students regarding pharmacovigilance and ADR monitoring. A total of 75, 2^nd year BDS students were involved in questionnaires of pharmacovigilance. Among the participants, 57 (76%) were women while 18 (24 %) were men in our study. similar findings were seen in study conducted by (Chhabra KG et al, 2016).⁸

In our study, the awareness about the term pharmacovigilance in BDS students was good (81%), however only half of them knew the standard definition of Pharmacovigilance. Similar findings were seen in study carried out by (Gupta et al, 2017).⁹

One of the positive findings of our study was more than half of the participants knew the meaning of adverse drug reaction and majority of the participants were aware that adverse drug reactions and adverse drug events are not the same. These findings are similar to the study conducted by (M Alwhaibi et al, 2020).¹⁰

Around 40 %  of the participants were aware of the existence of ADR reporting and monitoring systems in India. These findings were in contrast to the study conducted by (SA khan et al, 2015) where only very few participants were aware of the existence of ADR reporting and monitoring systems in India. ¹¹One third of the participants of our study knew how to report an ADR whereas only very few participants knew how to report an ADR in a study carried out by (ZE Ozgen et al, 2021).¹²

In our study, 30 % of the participants reported that it is compulsory to report ADR. These findings were in contrast to the study conducted by (Sidhu GS et al, 2023).¹³ Interestingly our study found that majority of the participants agreed that dentists are qualified health professionals to report ADR. These findings are similar to the study conducted by (Kalaikar et al, 2020).¹⁴

More than half of the participants from our study knew that CDSCO is the regulatory body responsible for monitoring ADRs. These findings were consistent with a study carried out by (Kumar s et al, 2020).¹⁵ Only very few participants were aware that National Coordination Centre (NCC) for Pharmacovigilance is located at Ghaziabad. In contrast to this finding more than half of the participants were aware about that the NCC for Pharmacovigilance is located at Ghaziabad in a study conducted by (Gayathri V et al, 2022).¹⁶

In our study, Around 61% participants regard ADR reporting as a professional obligation in contrast to in a study conducted by (Era N et al, 2020).¹⁷ Majority of the participants in our study think that ADRs due to Allopathic medicine and for newly marketed drugs should be reported  and it benefits both doctors and patients which was similar to the findings in a study conducted by (Kalaikar et al, 2020).¹⁴ Majority of the participants in our study think that it is necessary to report an ADR which was similar to a study conducted by (Kharadi D et al, 2021).¹⁸

In our study 60% of the participants think that all ADRs should be reported not just serious or unexpected ones. These findings were in contrast to a study carried out by (Khan SA et al, 2015).¹¹

In the present study, practice-oriented questions revealed important insights into the engagement of dental students with pharmacovigilance. Only a few of them (29%) had actually observed an adverse drug reaction (ADR) in a patient, in contrast to findings of the study by (Prasad et al, 2021) where 36.4% had observed ADR.¹⁹

When asked about awareness of the Central Drugs Standard Control Organization (CDSCO) reporting form, only few of them had ever seen the official ADR reporting form. Similar findings have been documented in study done by (Reddy L et al, 2017).²⁰

The question on discouraging factors for ADR reporting further highlighted the practical challenges. Half of the participants cited that there was uncertainty in deciding whether ADR has occurred or not lack of time for the reporting ADR (28%), and a single unreported case may not affected ADR database (36%). Contrast results have been seen in study done by (Srinivasan et al, 2017).²¹ Although Attitude of the participants were good but knowledge and practice was unsatisfactory.

LIMITATIONS

The study only includes participants from a specific hospital, limiting generalizability of results to other settings or populations. The knowledge and attitudes of healthcare professionals can vary widely based on location and experience. Self-reported data is subject to recall bias and respondent’s answer does not justify the actual practice as actual practice was not assessed in the present study.

Conclusion

IInd year BDS  students showed a positive attitude toward pharmacovigilance, but their knowledge and practice of pharmacovigilance were limited. This findings suggests to incorporate structured training of the pharmacovigilance] to promote patient safety.

Acknowledgement : We would like to express our gratitude to the dental students who took an active part in our research. We would especially like to thank the Dean, the Head of Department of Pharmacology, the members of the pharmacovigilance committee, Mr. Piyush Nama, for their professional insights, and the other faculty members of the Department of Pharmacology at GMC, Nagpur for their assistance.

Financial support and sponsorship :  Not funded and not sponsored.

Competing interests – No conflict of Interest.

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