|Ahead of print publication
Impact of educational interventions on pharmacovigilance and adverse drug reaction reporting by resident doctors and faculty members: A prospective comparative study
Mahesh N Belhekar, Shakeeb S Dhorajiwala, B Krishnamurthy
Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Parel, Mumbai, Maharashtra, India
|Date of Submission||01-Sep-2021|
|Date of Decision||22-Oct-2021|
|Date of Acceptance||28-Oct-2021|
|Date of Web Publication||27-May-2022|
Mahesh N Belhekar,
Department of Clinical Pharmacology, 1st Floor, New Multi-Storey Building, Seth GS Medical College and KEM Hospital, Parel, Mumbai - 400 012, Maharashtra
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Purpose/Aim: Adverse drug reactions (ADRs) are significantly under-reported worldwide. The aim of this study was to assess the impact of educational interventions (EIs) on knowledge, attitude, and practice (KAP) of hospital resident doctors and faculty members and compare ADR reporting in EI (medical specialties) vs. non-EI (surgical specialties) in these two cadres of doctors.
Materials and Methods: This study was a prospective comparative study conducted in two groups (EI and non-EI) in resident doctors and faculty members working at a tertiary care hospital. EI group (medical specialties) were provided with EI to increase awareness about ADR reporting, whereas in non-EI group (surgical specialties), no EI was provided and they served as control. Respondents were asked to fill a pretest questionnaire followed by interactive EI in EI group and posttest questionnaire in both groups. The impact of EI among respondents was evaluated by their response to questionnaire and number of ADRs reported after intervention.
Results: Total (n = 202) respondents were enrolled in the study. The number of resident doctors and faculty members in each group were (n = 101 [50%]). Overall, (n = 100 [49.5%]) were from the medical and (n = 102 [50.5%]) from surgical specialty. Post-EI period, there was statistically significant improvement in KAP domains.
Conclusion: Our study serves as credible evidence that through EI; statistically significant improvement in KAP of resident doctors and faculty members in both medical and surgical specialties toward ADR reporting and existing pharmacovigilance system can be achieved.
Keywords: Adverse drug reaction, educational intervention, medical specialties, Pharmacovigilance Program of India, surgical specialties
|How to cite this URL:|
Belhekar MN, Dhorajiwala SS, Krishnamurthy B. Impact of educational interventions on pharmacovigilance and adverse drug reaction reporting by resident doctors and faculty members: A prospective comparative study. Perspect Clin Res [Epub ahead of print] [cited 2022 Aug 14]. Available from: http://www.picronline.org/preprintarticle.asp?id=346209
| Introduction|| |
One reason for underreporting of adverse drug reactions (ADRs) is the lack of knowledge, attitude, and practice (KAP) toward ADR reporting. These problems can be addressed by ADR monitoring centers (AMCs) through strategies including imparting continuous awareness on ADR reporting, highlighting the different aspects of reporting ADRs and emphasis on the role of health-care professionals (HCPs) in drug safety issues.
Reporting of ADRs in hospitals is very important because severe ADRs are most likely to be seen in hospitals. ADRs can be detected early on and spontaneous reports can be more accurate. The integral part of postmarket safety surveillance is the role of HCPs and their duty to ensure patient safety. It is ultimately responsibility of HCPs to prescribe medicinal products and hence have a duty to monitor and report serious ADRs. The use of WhatsApp for social learning had a positive impact on learners' attitudes and achievement levels.
The aim of this study was to assess the impact of educational interventions (EIs) on KAP of hospital resident doctors and faculty members and compare ADR reporting in EI (medical specialties) vs. non-EI (surgical specialties) in these two cadres of doctors. Our aim and objective differed from previous studies as in this study we attempted to update the doctors KAP about pharmacovigilance (PhV) and ADR reporting in two groups as EI and non-EI.
| Materials and Methods|| |
This was a prospective comparative study conducted from July 2019 to January 2021 in various departments (medical and surgical specialties) of a tertiary care teaching hospital in Mumbai, Western India. Before beginning study, the Institutional Ethics Committee approval was obtained (EC/OA-09/2019) and study was conducted according to the Declaration of Helsinki guidelines.
A predesigned validated questionnaire adopted from a previously conducted similar study by Datta and Sengupta was used. The questionnaire covered demographic characteristics and KAP assessment of respondents.
After explaining the purpose of the study, written informed consent was obtained from all respondents (n = 202) and questionnaire was distributed to the participants during first and last meeting. Questions asked were multiple choice and respondents were asked to choose correct answer from among four options. Questionnaire comprised of 21 questions, of which seven were knowledge based, eight were attitude based, and six were practice based. Respondents were allowed 30 minutes to answer questions.
Initial contact with respondents was achieved through contact numbers given in the annual report of our hospital. Respondents were contacted telephonically, through E-mail or in person in their departments with prior appointment. After the completion of pretest questionnaire, interactive EIs were provided with help of clinical pharmacologists and PhV Program of India (PvPI) technical associate in EI group. Various EIs such as short lectures, regular ward rounds, newsletters, “dear doctor” letters, posters, and use of social media such as creation of WhatsApp group were undertaken to increase awareness about PhV and ADR reporting. The novelty in the interactive EI is that it differed from regular awareness programs of PhV in ways that presentations were delivered explaining functioning of AMC, role of technical associates in ADR collection, importance of ADR reporting, hands-on training of ADR form filling, and various methods of ADR reporting.
Respondents were followed up for 19 months by study investigators during regular ward rounds, face-to-face interactions, short message services, and WhatsApp group messages. The novelty here is that, we effectively used social-media namely WhatsApp group for communication/reminders/follow-ups. Effect of EI was evaluated after 19 months by posttest, with same questionnaire being distributed to all respondents. Those not willing to participate/submitted incompletely filled questionnaires were excluded.
All relevant data of each respondent were recorded in a specially designed case record form. Data entry was done in Microsoft Excel (Publisher: Microsoft Corporation, Redmond, Washington, USA, 2016) and analysis was performed with IBM Statistical Package for the Social Sciences Statistics for Windows, Version 25.0 (Publisher: IBM Corp., USA, 2017).
Demographic characteristics and responses to individual KAP questions were summarized using median+ interquartile range for continuous data namely age and absolute number with percentages for categorical data namely proportion of respondents. Normality was assessed using Shapiro − Wilk's test. Difference in pre-and postintervention responses in respective cadres was evaluated using McNemar's test. We used McNemar's test for inferential statistics, whereas in previous studies, the analysis of data was done using the descriptive statistics and at the most Chi-square test was used for the comparison.
| Results|| |
A total of 450 HCPs (faculty members and residents) of various departments (medical specialties [Pulmonology, Endocrinology, Gastroenterology, Hematology, Internal Medicine, Neonatology, Nephrology, Neurology, Pediatrics, Psychiatry, Sexually Transmitted Diseases, and Skin] and surgical specialties [ENT, General Surgery, Ophthalmology, Pediatric Surgery, Neurosurgery, Plastic and Reconstructive Surgery, and Urology]) of our tertiary care hospital were approached for participation in the study; from which 220 did not fill the questionnaire completely and were excluded. Twenty-eight of them were lost to follow-up, and hence, their post-EI readings were not available. As shown in [Figure 1] as flow chart. The remaining 202 HCPs comprised of equal number of resident doctors and faculty (n = 101 (50%) in each group) as shown in consort flowchart-Figure 1. Very few Indian studies to the best of our knowledge managed to assess KAP of over 200 doctors including residents and senior faculty members toward PvPI and ADR reporting over such broad range of specialties and super-specialties. Majority of them were in their fourth decade of life with youngest resident being 24 years old (median age − 32 + 3 years) and eldest faculty member being 62 years old (median age − 35 + 12 years).
We imparted EI to 100 HCPs from the medical specialties while 102 HCPs from surgical specialties did not receive any intervention and hence served as control. After EI, there was a statistically significant improvement in all three K, A, and P domain questions [Table 1],[Table 2],[Table 3].
|Table 1: Assessment of knowledge of resident doctors and faculty members towards pharmacovigilance (pre- and post-educational interventions)|
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|Table 2: Assessment of attitude of resident doctors and faculty members toward pharmacovigilance (pre- and post-educational interventions)|
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|Table 3: Assessment of practice of resident doctors and faculty members toward pharmacovigilance (pre- and post- educational interventions)|
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[Table 1] shows that post-EI, 100% of respondents correctly defined PhV and ADR. All of them were well educated about the purpose of ADR and presence of ADR reporting system in India. Improvements in knowledge about “which ADRs are to be reported” and “location of National Coordinating Center (NCC)” were statistically significant (P < 0.001 for both) in respondents but resident doctors outperformed faculty.
The findings of [Table 2] show that post-EI 100% of respondents appreciated the necessity of ADR reporting and that PhV should be taught to all HCPs. All of them were supportive of using social media to improve ADR reporting. We observed statistically significant increase in percentage of faculty members (from 64.4% to 86.1%) who were of the opinion that ADR reporting should be mandatory (P < 0.001). We also observed statistically significant decrease in the percentage of residents (from 92.1% to 54.5%) who considered ADR form filling to be a complex process (P < 0.001).
[Table 3] shows that post-EI there was statistically significant increase in percentage of respondents who were adequately trained to report an ADR (P < 0.001). There was also a statistically significant increase in the percentage of respondents who now report not only severe/life-threatening ADRs but other ADRs too. Statistically significant increase in the percentage of faculty members who have themselves filled ADR reporting forms and now reported at least one ADR in the last 1 year (P < 0.001 for each comparison) was also observed.
| Discussion|| |
The World Health Organization defines ADR as “any response to a drug which is noxious and unintended, and which occurs at doses normally used in male for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function and PhV is defined as science and activities relating to detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. PvPI was launched with a broad objective to safeguard health of 1.39 billion people of India. Since its initiation in 2010, PvPI has been enriching quality of performance and expanding its field activity. NCC-PvPI monitors ADRs among the Indian population and helps the regulatory authority of India, Central Drug Standard Control Organization in taking decision for the safe use of medicines.
Our EI study about PhV included resident doctors and faculty members of medical and surgical specialties. KAP evaluation was a part of EI in this study as it is the key to consider when it comes to ADR reporting. Several previously published studies have reported that HCPs have inadequate knowledge about PhV before EIs., Our study contributes to new information since it was a practical demonstration of effectiveness of use of social media for instance using instant messaging application such as WhatsApp in creating better awareness among HCPs. Through online telecommunication services, we could reach out to hundreds of medicos despite their busy schedule and COVID crises which limited human interactions.
In our study, majority of respondents were in their 4th decade of life with young residents and elderly faculty members both included, similar to a study conducted by Güner and Ekmekci Response rate in our study was 44.89% as we distributed questionnaire forms to 450 respondents but received only 202 completed forms. Response rate in similar studies conducted by Pimpalkhute et al. and Gupta and Udupa were 93.33% and 77.2%, respectively, and was comparatively higher. The reason for lower response rate in our study could be the ongoing SARS-COV-2 pandemic.
We found that post-EI, all respondents correctly answered questions like “definition of PhV and ADR,” “purpose of pharmacovigilance” and “presence of ADR reporting system in India,” indicating an improvement in their knowledge. There was statistically significant increase in the percentage of residents and faculty who were then willing to report all ADRs after EI. A previously published similar study reported only 15.48% of respondents who were in favor of reporting all ADRs.
We also observed statistically significant increase in percentage of faculty members who now opined that ADR reporting should be made mandatory. The need for ADR reporting process to be made mandatory was also felt by respondents in a study wherein they suggested this as one of the measures to promote nationwide ADR reporting; however, they did not find it to be practically feasible. Resident doctors were benefited more than faculty members after EI, as 45.5% of resident doctors post-EI found it easier to report ADR as opposed to only 8% pre-EI.
EI also significantly changed the practice of respondents as 73.3% of residents and 70.3% of faculty now felt that they have been adequately trained to report ADRs than pre-EI (1% and 8.9%, respectively). Another significant change observed in their practice was that 80.2% of resident doctors and 68.3% of faculty in post-EI period now not only reported severe life-threatening ADRs but also mild and moderate ADRs. In pre-EI period, only 6.9% of residents and 20.8% of faculty used to report ADRs (P < 0.001 for both comparisons).
The impact of EI can also be seen in the statistically significant increase in percentage of faculty reporting ADR at least once a year from 28.7% to 71.3% post-EI (P < 0.001). Furthermore, faculty were adequately familiarized with ADR form filling and 40.6% of them have now filled ADR forms (P < 0.001). However, it has to be emphasized that overall, resident doctors' contribution was more in ADR reporting who were already reporting ADRs even before EI. This finding of ours was in concordance with a study conducted by Milstein et al. who too reported high percentage of doctors reporting ADRs post-EI. In contrast, in another study only 25% of doctors had ever reported an ADR and similar low percentages were also reported by another study.
After every EI, significant increase in the number of ADRs was noted which is evident from [Figure 2]. However; this study was hurdled by SARS-COV-2 pandemic and ADR reporting slumped steeply by four folds. Our study was stalled for months reflected well by flat line in [Figure 2]. Despite this, we continued our endeavors which led to an equally steep rise in the number of ADRs reported later toward the end of year and of the study. Another study conducted by Tabali also reported similar findings.
In another Indian study, doctors performed well in the knowledge aspect but it did not translate into improvement in attitude or practice, whereas in our study, greater improvements in practice and attitude were also observed reflected by increase in ADRs reported [Figure 2] post-EI corroborating that effective EI can translate into better outcomes.
We suggest that CMEs, workshops, symposia should be conducted at all AMCs, with assistance of funding agencies if necessary to provide such interventions. PhV can also be integrated in the UG and PG medical curricula to sensitize them at an early age as fresh minds are more receptive. Process of ADR reporting should be made seamless, hassle free, convenient, and less time-consuming through online reporting of ADRs and ADR PvPI mobile app. Our ultimate goal is to make doctors sufficiently aware that for any clinical presentation, suspected ADR should be one of their differential diagnoses.
Many similar studies have been conducted in India and abroad but what sets our study apart is that we continued our endeavors even amidst SARS-COV-2 pandemic and succeeded in completing assessment of over 200 doctors. Only two Indian studies to the best of our knowledge managed to assess KAP of residents and senior faculty members toward PvPI and ADR reporting over such broad range of specialties and super-specialties. Our efforts paid off as through our EI we could achieve improvements in all the three domains of our assessment. Awareness which we created even translated into better ADR reporting practice.
| Conclusion|| |
Our study was limited to being a single-centric study, and hence, findings cannot be generalized. The most historic hurdle which prolonged our study was the ongoing SARS-COV-2 pandemic.
| Conclusion|| |
Our study serves as credible evidence that through EI; statistically significant improvement in KAP of resident doctors and faculty of both medical and surgical specialties toward ADR reporting and PhV system can be achieved. Therefore, we recommend that such similar studies be periodically conducted.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3]