Introduction
“The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem” is called Pharmacovigilance(PV) as per the World Health Organization(WHO).1 The main objective of PV is to enhance patient safety through tracking and reporting the adverse drug reactions(ADR). ADR surveillance during drug discovery and development; Encouraging health care professionals(HCP) on rationale prescription; Enlightening knowledge about PV and ADR reporting to Health care students, professionals and public's are the vital elements necessary to effectuate the public health care system through PV.2 In brief, PV significantly concerns on ADRs, which is an “noxious and unintended response to the drug occurring at doses normally used in human for the prophylaxis, diagnosis or treatment of disease or for the modification of physiological functions”. It also extended its target to include the blood products; vaccines; biological; medical devices; herbal drug products; traditional and complementary medicines.3
Though, India underwent series of formidable challenges earlier on PV programs. Later, the Indian government recognized the significance and need for the refinement of ADR monitoring and launched an new framework called “The Pharmacovigilance Programme for India (PvPI)”.4 It is then coordinated by the Indian Pharmacopoeia Commission(IPC) as the National Coordination Centre(NCC) during 2011 with a goal to prompt ADR reporting nurture instead looking for the quality of reports and it was proposed to familiarize the HCP to report the ADRs despite of limited data available.4, 5 After which, PVPI was functioning efficiently with 567 ADR monitoring centres(AMC), initiating with 22 centres in 2010 and a recent report asserts that India has contributed more than 2,80,000 individual case safety reports(ICSRs) to vigibase.5, 6
Although, under reporting being the massive hindrance of PV globally. For which, India has adopted an reporting methodology called spontaneous ADR reporting system, as it is worthwhile in discovering rare, unexpected ADRs as quick as possible.7 On that ground, Knowledge and Attitude being the critical elements directly influencing the spontaneous ADR reporting status.8, 9 Hence, it is very essential for every health care worker to be aware of what to, where to, how to report ADRs. As dental professionals also embraced in prescribing diverse forms of medications, their ADR reporting culture is also tremendously required.10, 11 Thus aim of the current study is to evaluate the knowledge and attitude towards Pharmacovigilance and ADR reporting among dental undergraduates.
Materials and Methods
After receiving the approval from IEC (MAPIMS/IEC/52/2021 - 180(12)2021) this cross sectional questionnaire based study was conducted in the department of Pharmacology, Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research in collaboration with Adhiparasakthi Dental College and Hospital, Melmaruvathur Tamil Nadu. Total 101 second year dental students were included in the study with prior acquirement of written informed consent from them. A Pre-validated questionnaire were distributed to all participants, those questions are derived from extensive search of literatures and were validated by the experts of Pharmacovigilance committee – AMC, MAIMSR. It is comprised of two division, first division to analyse knowledge domain (Q:1-10) whereas second to analyse attitude domain (Q:11-20). Each participants were given maximum time limit of 30 minutes to fill questionnaire. For any clarification needed in understanding the questions additional time were provided. All the collected data are tabulated & analyzed statistically using SPSS 20.0 version and expressed in terms of frequency, mean, or percentages.
Results
Out of total 101 participants, predominant were females with 69% and males were 31% (Figure 1 ). Mean age of study population were 20.35 ± 0.67. All the 101 participants agreed that the important purpose of PV is to identify the safety of drug and drug related problems. 99% of participants were familiar with the term PV and its WHO definition. Awareness regarding ADR definition and WHO online database were 97% and 96% respectively, whereas regarding ADR causality assessment scale only 36.6% were aware. 61.4% responded that ADRs can also be identified during phase 4 clinical trial and 57.4% participants know that IPC, located at Ghaziabad functioning as NCC for PvPI since 2011. But only 39.6% were aware of international ADR monitoring centre location.
On assessing attitude towards ADR reporting only 1% agreed to report other ADRs apart from serious and unexpected ADRs, 99% consent that PV is essential in the curriculum of heath care students. 98% admit that ADR might result in prolonged hospitalization or even death and in extreme cases, NCC can ban particular drug. 98% accepted that ADRs can be reported by health professionals other than doctor. 75.2% are agreed to the availability of consumers ADR reporting form, whereas only 59.4% sensed on android application ADR-PvPI And 70.3% knows that Haemovigilance, Materiovigilance, Biovigilance comes under PvPI. 51.5% stated that ADR form can be submitted to NCC-PvPI directly and 73.3% accepted that NCC-PvPI involved in final analysis before forwarding to global database. Thus, on average 78.6% has responded correct for knowledge domain assessment and 72.4% has showed better and appropriate attitude towards PV and ADR reporting.
Discussion
The genuine attempt of this present questionnaire based study has explored a satisfactory result, showing an average of 78.6% participants had adequate knowledge and 72.4% had better attitude towards PV and ADR reporting. On assessing knowledge domain 100% of the participants precisely aware of the purpose of PV, which is considered the most superior result of our study. Similarly > 95% exhibited higher level of knowledge upon ADR definition and WHO online database. Hence these results are highly satisfying compared to other similar KAP studies.12, 13
But, while assessing the attitude domain, one of the result were unanticipated that 99% of the participants disagreed to report ADRs other than serious and unexpected ADR which is highly contrasting the result of an Malaysian KAP study.13 This provides an implicit result that student still unclear on “what to report”. Even though indirectly delivers an positive approach that 99% were agreed to report serious and unexpected ADR, which is the most appropriate attitude that is required for further enhancement of the spontaneous ADR reporting culture. Similarly 98% dental students attitude towards the essentiality of PV in curriculum is comparatively elevated from other similar studies.13, 14, 15
This results imply that basic understanding about Pharmacovigilance among the dental students is enhancing and they also show relative interest towards ADR reporting. Henceforth, this improving status conferring an assurance that our future professionals can minimize the under-reporting of ADR effectively, ultimately it will influence the furtherance of PV and ADR reporting system. To sustain the progress, we emphasize the concerned authoritative to adhere constantly on organization of awareness and training programs regarding what to, who to, where to report for the upcoming pillars of practice, to improve the patient safety. This will also benefit the aspiring future doctors by slendering the distance between academic knowledge and clinical practice. Hence, we conclude our dental undergraduates possess appreciable knowledge and attitude towards PV and ADR reporting and affirms students positive tendency about PV.
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