A Cross-Sectional Study of Knowledge, Attitude, And Practice of ADR And Pharmacovigilance Among Diploma in Pharmacy Students in Manipur, India

Abstract

All drugs come with some harmful side effects. Most of them are minor effects however, some drugs can cause serious harmful effects which can leads to negative health impact. Hence all drugs that are in the market are need to monitor their effects. It can be done through reporting of adverse drug reaction (ADR) to any of the pharmacovigilance centre. For this, the knowledge, attitude and practice of health care professionals toward ADR and pharmacovigilance is a must. The present study was performed to assess the knowledge, attitude and practice toward ADR reporting by diploma pharmacy students. A questionnaire was distributed and the response was analysed using descriptive statistical method. The participants had good knowledge on ADR are pharmacovigilance. 92% of the participants were aware with the term pharmacovigilance and 72.6% of them knows that ADR can be reported directly. The attitude of the participants was found to be good. 91.9% participants thinks that ADR reporting is necessary and 98.6% participants think it will ensure patient safety. 50% of the participants had received training on ADR reporting and 77.5% are willing to report ADR in the future. It was concluded that the pharmacy students displayed relatively good knowledge and positive attitude but insufficient practice regarding ADRs and pharmacovigilance. There is a need for continuous awareness and learning strategy for the pharmacists and to emphasise the importance for active participation in the pharmacovigilance process for a safety and improve quality of life for the patient.

Keywords

Introduction

Assessment of Knowledge about ADR and Pharmacovigilance

Knowledge about ADR reporting and pharmacovigilance among the participants was assessed by eight (8) knowledge questioners and the responses are shown in the Table 1. Out of 62 participants, 48 participants i.e. 77.5% gave the correct definition of an adverse events and 74.2% participant knows the definition of pharmacovigilance whereas majority of the participants i.e. 92% are aware about pharmacovigilance. In a study conducted by K. Bharathi Priya, 80% of the participants gave correct response regarding the definition of ADR.¹¹ Similarly, in a study conducted by Jeevan Gowda B. T.  et.al. 75.3% participant answered correctly but, in a study, conducted by Debasis Ray et. al. 92.9% of its participants knows the definition of pharmacovigilance.^12,13 72.6% of the participants knows that ADRs can be reported directly and 46.8% are aware regarding under reporting of ADR. In the study conducted by Priya K.B. et al, 70% of the student participants were aware of who can report ADR.¹¹ Only 45.16% of the participants gave correct response regarding the official year when Pharmacovigilance programme of India was launched. 64.52% of the participants thinks that ADRs can be reported by health care professionals only, 12.9% and 16.13% thinks it can be reported through hospital only and individually respectively.  However, only 3.23% knows that ADR can be reported through all the sections i.e. health care professionals, hospital and individually which is much less than 70% students stated that non-medical person can report ADR to a nearby healthcare professional in the study conducted by Priya K.B.¹¹ 20.96% of the participants knows that a serious adverse reaction should be reported to the regulatory body within 2 weeks of the event occurred whereas in the study conducted by Priya K.B.,76% students were aware that a serious adverse reaction should be reported to the regulatory body within 15 calendar days which is much more than our study.¹¹

Assessment of Attitude about ADR and Pharmacovigilance

Attitude about ADR reporting and pharmacovigilance among the participants was assessed by fifteen (15) attitude questioners and the responses are shown in the Table 2. Out of 62 participants, 53 (85.5%) participants thinks that ADR monitoring center should be established in every hospital, whereas, 3 (4.8%) thinks that it’s not required in every hospital. Similar study was conducted by Adheed Khalid Sharrad, where only 69.9% agree that ADR monitoring centre should be established in every hospital.¹⁶ 91.9% thinks reporting of ADR is necessary whereas in the study conducted by Sivadasan et al. only 42.9% think adverse drug reaction reporting is necessary. ¹⁴ 88.7% of the participants think Pharmacovigilance should be taught in detail to health care professionals. 58.1% participants have time to read article on prevention of ADRs and 82.2% of the respondent thinks non-medical person can report ADR to a nearby healthcare professional whereas 9.7% thinks non- medical person cannot report ADR.  In a study conducted by Adheed Khalid Sharrad, 26.5 % thinks pharmacovigilance should be taught to all health care students during their curriculum and 28.9% strongly agrees that ADRs reporting are duty of all health care professionals whereas only 21.7% have time to read article on prevention of ADRs.¹⁵ 96.8% participants think ADR reporting will ensure patient safety. 48.4% think reporting of an ADR is time consuming and cumbersome activity and 37.1% participant thinks it’s not. In the study conducted by Sam, et al, 79.54% of the pharmacy students thinks its time consuming, which is much higher from our study.¹⁶ 71%of the total participant think ADR reporting by one person can make a significant difference to the community and 96.8% think ADR reporting will increase patient safety. Similarly, in the study by Priya KB,71% students agreed the same and 95% students agreed that reporting ADR will increase patient safety.¹¹  90.3% respondent thinks reporting of ADRs a part of pharmacist duty. 91.9% of the participant believe pharmacy students could help with adverse drug reaction reporting. 37.1% believe ADR forms are difficult to complete and only 5% feels it’s not difficult to fill up the ADR form. 72.6% believe that disclosing ADRs is beneficial to both patients and doctors whereas 19.3% thinks it is not beneficial to disclose ADR. Similarly, in the study conducted by Umashankar N et al, 95.3% agreed that ADR reporting is necessary and reporting ADR should be made mandatory.¹⁷ 96.8% participants believe that new drugs should be closely monitored and 88.7% participants believe pharmacy students will be able to report ADRs whereas in a study conducted by Venkatasubbaiah et al, 78.4% accepted the need for close monitoring of the new drugs.⁵ And in the study by Alam K et al.  only 50% agreed that reporting of ADRs is a part of pharmacist duty and it is important to report ADRs leading to hospitalization.⁷

Assessment of Practice about ADR and Pharmacovigilance

Practice about ADR reporting and pharmacovigilance among the participants was assessed by six (6) practice questioners and the responses are shown in the Table 3. 24.2% of the participants, out of 62, have come across ADR. 61.3% have seen an ADR reporting form and 24.2% have filled an ADR reporting form. In a study conducted by Umashankar N et al, 94% have seen an ADR reporting form.¹⁷ 50% of the participants in our study have received training on how to fill an ADR reporting form. Similarly, 48.1% participants in the study conducted by Anu Manuel et al have received the same.¹⁸ In the study, 20.9% participants have experienced/ encountered ADR in the past. Similarly, in the study conducted by Umashankar N et al 29.3% responders had witnessed an ADR. 77.5% are willing to report ADR in future.¹⁷

Limitations:

The drawback of the research is that the number of participants who were involved in this study was comparatively small.

CONCLUSION:

When toxicity and negative consequences manifest, particularly when they were previously unidentified, it is critical that they be properly documented, examined, and report to the pharmacovigilance centres. Attitudes and knowledge have a big impact on ADR reporting. Pharmacovigilance and ADR reporting would be underreported due to lack of knowledge and unfavourable opinions. To reduce ADR underreporting, seminars and conferences should be held to raise awareness and encourage a reporting culture. Pharmacists, an indispensable part of an integrated healthcare system, should play a fundamental role in reporting ADRs. This, in turn, can contribute to controlling avoidable morbidity and mortality to a great extent. Current study findings give an overall idea of the ADR reporting understanding among pharmacy students and displays their readiness to be included in the workforce as potential healthcare professional. We conclude that pharmacy students have favourable knowledge, attitude and practice on ADRs. Therefore, providing special training and educational awareness may increase the KAP of the students towards ADRs.

ACKNOWLEDGEMENT:

The authors thank to the institution where the study was conducted and all the students who participated in the study.

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