Assessment of Knowledge, Attitude, and Practice of Pharmacovigilance and Materiovigilance among Oral Health Practitioners in India

ABSTRACT

Aim:

This electronic survey was carried out to assess the knowledge, attitude, and practices among the oral health practitioners.

Methods:

A questionnaire survey was conducted among undergraduates, graduated practitioners, and specialist practitioners. A Google Form that included a specified instruction format, informed consent with a clear description of the purpose of the study, and questions in different categories were sent through Whatsapp and email. Descriptive statistics were used to analyze responses. The association of knowledge and attitude with respect to oral health professionals was analyzed with the Chi-square test.

Results:

The questionnaire was completed by 570 participants. Thirty percent of participants encountered ADR related to the drugs available in the market and 33.2% of participants encountered adverse reaction related to materials used in practice. ADR should be reported as soon as it is detected, according to this study about 12.1% of participants reported the ADRs, and this reporting is primarily for patient safety. Almost 66.8% of participants perceived that dental products can cause ADR owing to a lack of information about ADR and reporting procedures, or due to fear of legal concerns. Only about 9.5% of the participants had previously attended an ADR workshop.

Conclusion:

Oral health practitioners have a general understanding of ADR; however, there is substantial evidence of underreporting and a lack of reporting system information. Organizing an orientation program and raising awareness about ADR reporting could help improve spontaneous reporting and better patient care.

INTRODUCTION

The drug discovery and development process necessitate meticulous safety monitoring at all stages of any clinical study. It is even more critical to monitor the safety of medicines after they have been approved and are being used in the real world. The phrase “vigilance” refers to the close monitoring of any negative effects.[1,2,3] It is mostly dependent on spontaneous reporting by healthcare professionals and patients to health authorities and marketing authorization holders in the post-marketing situation. However, the study of adverse occurrences connected with the use of medical devices is known as materiovigilance. It is concerned with the close monitoring of medical devices following the post-marketing phase.[1,4] The purpose of this study is to assess oral health practitioners’ knowledge, attitude, and practice of pharmacovigilance and materiovigilance program of Government of India.

MATERIAL AND METHOD

This study was carried out using a questionnaire survey among the undergraduates, graduated practitioner, and specialist practitioner. The questionnaire was evaluated by the experts from Lady Hardinge Medical College and Hospital, who has sound knowledge on the topic, and their suggestions regarding the relevance, clarity, and appropriate of the items were considered for inclusion in the questionnaire.

A pilot study was conducted among 20 oral health practitioners before performing the study and necessary modifications were done as required.

An electronic survey was undertaken among undergraduates, graduated practitioner, and specialist practitioner between the periods of August 2022 and December 2022. There were twenty-four multiple choice questions out of which seven questions were to collect demographic data and seventeen multiple choice questions were meticulously crafted to assess the ADR (adverse drug reaction) KAP (knowledge, attitude, and practice) among oral health practitioners. A Google link questionnaire was sent to the participants via Whatsapp group or email, briefing them on the study’s necessity and nature, as well as their role in the study. Ten replies were rejected because they were incomplete and thus not included in the study. As a result, the 570 responses from participants who completed the questionnaire were included in the study.

Statistical analysis

All data collected were input into a personal computer on a Microsoft Excel spreadsheet and analyzed using the statistical software for social science (SPSS, IBM, Chicago, USA) version 20. In our study, descriptive and inferential statistical analyses were performed. Continuous measurement results were presented on average SD, and categorical measurement result were presented in number (%). The degree of significant was set at P = 0.05, and any value below or equal to 0.05 was regarded statistically significant. The Chi-square analysis was used to determine the significance on categorical scale of study parameters.

RESULTS

A total of 570 complete responses were received from the oral healthcare professionals, which composed of a highest 330 (57.9%) of specialist practitioner followed by 135 (23.7%) graduated practitioner, 105 (18.4%) undergraduates. The most of the oral healthcare professionals were female, that is, 54.7% compared to 45.3% males. Furthermore, the mean age of the study participants was 30.85 years [Table 1].

Table 1.

Demographic details of the study subjects

Demographic details	Frequency (%)
Gender
Males	258 (45.3%)
Females	312 (54.7%)
Mean age (in years)	30.85±10.0
Age Distribution (in years)
<25	117 (20.5%)
25-35 years	225 (39.5%)
35-45 years	123 (21.6%)
>45	105 (18.4%)
Distribution of oral healthcare professionals
Undergraduates	105 (18.4%)
Graduated practitioner	135 (23.7%)
Specialist practitioner	330 (57.9%)

Assessment of knowledge regarding ADRs

In the section related to knowledge of ADRs, 546 of the 570 participants were aware of the word pharmacovigilance, whereas the only remaining 24 were aware of the term materiovigilance [Table 2]. Among 570 participants, 546 (96%) responded correctly as the pharmacovigilance program was for monitoring adverse events linked with medical drugs in India [Figure 1].

Table 2.

Responses of the participants regarding adverse drug reaction

Question	Responses
	Yes, n (%)	No, n (%)
Are you aware about pharmacovigilance term	546 (95.8%)	24 (4.2%)
Are you aware about materiovigilance term	24 (4.2%)	546 (95.8%)
Whether experienced ADR in a dental set up	171 (30.0%)	399 (70.0%)
Whether experienced ADR due to material among patients	189 (33.2%)	381 (66.8%)

ADR=Adverse Drug Reaction

Figure 1.

Showing response of the oral healthcare professionals in relation to ongoing program for monitoring the ADR associated with medical

However, only 78 (13.7%) participants were able to correctly identify Indian Pharmacopoeia Commission (IPC) as regulatory authority that governs the regulation of medical devices in India [Figure 2].

Figure 2.

Response of the oral healthcare professionals in relation to regulatory authority that governs the regulation of medical devices in India

Attitude regarding ADR

The first question was designed to assess participants’ attitudes toward adverse drug reactions (ADRs), specifically whether they reported ADRs to the appropriate authorities when they encountered them in their practice. It was observed that 12.1% (undergraduates 1%, graduated practitioners 3.7%, and specialist practitioners 7.36%) reported to concerned authority, 48 (8.4%) did not report, and 453 (79.5%) did not report because they did not know how and where to report [Figure 3]. Only 54 (9.5%) participants out of 570 had attended training/education program about pharmacovigilance and materiovigilance in the last one year [Table 3]. In the responses in relation to what people thought about reporting drug and medical device adverse events by healthcare professionals, 492 (86.3%) said it should be mandatory, 5 (8.9%) said it should be voluntary, 6 (1.1%) said it should not be required, and 21 (3.7%) stated they did not know or were unsure.

Figure 3.

Response of the oral healthcare professionals in relation to reporting of ADR to concerned authority

Table 3.

Awareness regarding adverse drug reaction among the participants

Responses of participants regarding ADR-related awareness
Question	Responses
	Yes, n (%)	No, n (%)
Attended any workshops on pharmacovigilance and materiovigilance	54 (9.5%)	516 (90.5%)
Institution/department/practice maintain an ADR register	201 (35.3)	150 (26.3%) 219 (38.4%) maybe
Pharmacovigilance and materiovigilance to be taught in accordance with DCI to oral health practitioner	510 (89.5%)	60 (10.5%)

ADR=Adverse Drug Reaction

Practice regarding ADR

In the assessment of practice, ADRs were encountered in the practice of 171 (30.0%) of the 570 participants in relation to the drugs used. A total of 189 (33.2%) participants out of 570 had an adverse reaction to the materials used in dental practice [Table 2]; totally, 300 (52.6%) of the 570 participants suggested that it should be mandatory to monitor the patients after adverse events in oral health practice after the recovery period and 270 (47.4%) advised not to follow up after adverse events. 201 (35.3%) participants claimed they keep an ADR registration in their institution/department/practice, 150 (26.3%) said they do not keep an ADR register, and 219 (38.4%) said they are unsure [Table 3].

Awareness regarding ADR

510 (89.5%) respondents believe that pharmacovigilance and materiovigilance should be taught to oral health practitioners in academic courses in accordance with the DCI (Dental Council of India), whereas 60 (10.5%) disagree [Table 3]. Only 9.5% attended the ADR workshop in last one year.

DISCUSSION

ADR monitoring is a branch of pharmaceutical care concerned with the identification, management, and reporting of adverse events.[5] This requires health practitioners all around the world to report ADRs when they encounter them. The current questionnaire-based survey was done among undergraduates, graduated specialists, and practitioner specialists.

The study included 570 participants, 312 (54.7%) of them were female candidates, and the remaining 258 (45.3%) were male participants. This study included 105 undergraduates, 135 graduate practitioners, and 330 specialist practitioners.

The WHO International Drug Monitoring System, of which India has been a member since 1998, has around 150 members. Pharmacovigilance program was implemented in 2003 in India, and the Materiovigilance System of India was launched in 2015 to track and report ADRs. Allergies to dental products like latex, impression materials, local anesthetic agents, composites, endodontic materials, and metals can occur in both practitioners and patients.

Among total prescribed oral antibiotics, oral health practitioners account for around 10%. Clindamycin had the highest fatal ADR rates. This was more than twice that of any other commonly used dental antibiotic and >15 times higher than amoxicillin, the most widely used antibiotic, which had the lowest overall ADR rates.[6]

However, overall reported incidence of ADRs related to use of local anesthesia in oral health care varies from 4.5-26.2%, with signs and symptoms like toxicity, syncope, nausea, agitation, tremor, sweating, or clutching.[7,8,9]

Similarly, two recent meta-analyses for the adverse effects of opioids in pain management showed that about one-third of patients abandoned treatment because of adverse events.[10] Dry mouth (affecting 25% of patients), nausea (21%), and constipation (15%) were most common.[11] The frequency of adverse events with opioids is more common than with non-steroidal anti-inflammatory drugs and acetaminophen, making them a poor choice for dental pain.[10,11]

However, putting the knowledge into reality can be challenging due to a lack of understanding of the reported allergies to known components. Usually, dental patients have symptoms primarily on the oral mucosa, whereas dental staffs typically have hand dermatitis. In this study, approximately 30.0% participants encountered adverse reaction due to drugs and 33.2% participants encountered adverse reaction due to materials in their practice. Only 35.3% respondents maintain ADR register in any form (digital or offline records).

In our study, 12.1% (undergraduates 1%, graduated practitioners 3.7%, and specialist practitioners 7.36%) of participants accepted that they reported the ADRs to concerned authority and 79.5% participants did not report, where approximately 8.4% participants were not aware about the reporting the ADRs.

It is important to monitor the patients for any adverse events beyond the recovery period for patient safety, and in our study, we noted only 52.6% participants monitor patients beyond recovery period. Only 9.5% attended the ADR workshop in last one year, which is insignificant. This could be one of the primary causes of underreporting. To bridge the gap of adverse drug reactions (ADRs) encounter and underreporting, 89.5% of participants perceived that pharmacovigilance and materiovigilance should be taught to oral health practitioners in accordance with the DCI curriculum.

CONCLUSION

• Participants have a general understanding of ADRs; however, there is substantial evidence of underreporting and a lack of reporting system-related information and training. Organizing an orientation program and raising awareness about ADR reporting could help improve spontaneous reporting with patient and caregivers’ safety.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.