INTRODUCTION
Adverse drug reactions (ADRs), one of the significant causes of morbidity and mortality in all age groups of patients, are shown to increase the health-care cost globally.[ 1 ] ADR defined as per the World Health Organization is “A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease or for the modification of physiological functions.”[ 2 ] India is one of the largest producers of pharmaceuticals in the world with too many new drugs introduced in the country. However, the Pharmacovigilance Programme of India (PvPI) was started in July 2010 with the primary objective of safeguarding the people’s health in India.[ 3 ] So far, the PvPI has established nearly 534 ADR monitoring centers all over India, with the toll-free number and paper-based ADR forms available to encourage ADR reporting by health-care professionals as well as public. Despite having a population of 1.3 billion people in India, with having high number of hospitals, health care personnel, and wider use of Pharmaceuticals, a small number of ADR’s are being recorded.[ 4 , 5 ] Underreporting of ADRs is the biggest problem experienced globally.[ 6 ] One of the reasons for underreporting is the lack of knowledge, attitude, and practice (KAP) on the importance of reporting of ADRs. These problems need to be addressed by ADR monitoring centers through various strategies including imparting of continuous awareness on ADR reporting, highlighting on different aspects of reporting ADRs, and emphasis on the role of health-care providers in drug safety issues.[ 7 ] Resident doctors are the backbone of health-care system; hence, they play a significant role in detecting and reporting ADR, particularly for hospitalized patients, as they are in contact with a patient and available round the clock.
The aim of our study was:
To assess the knowledge, attitude, and practice (KAP) regarding pharmacovigilance among resident doctors
To improve reporting of ADR by training resident doctors for filling the ADR reporting form.
Our study regarding educational intervention on pharmacovigilance among resident doctors differs from other studies[ 8–10 ] in regard to the objective as follows:
Objectives
The objectives of our study were:
To assess the KAP about ADR reporting through distributing questionnaire before the commencement of the educational training
To assess the impact of educational training by comparing the scores of pre- and posttraining knowledge questions using paired “t ”- test. Evaluation was done on the basis of improvement of the knowledge postintervention by using the mean score.
Our study has not only evaluated the KAP of resident doctors, but we also aimed to improve reporting of ADR in our institute by training resident doctors for filling the ADR reporting form. On the other hand, the primary objective of previous studies[ 8 , 9 ] conducted was to evaluate the KAP of health-care workers.
Furthermore, an educational interventional KAP study conducted in Nepal[ 10 ] was done on pharmacists and nurses of the Oncology Department. Our study primarily focused on giving educational training to the residents of a tertiary care teaching hospital as they are the backbone of the health-care system. Residents are available around the clock and are usually the first ones to come in contact with the patient.
SUBJECTS AND METHODOLOGY
Study setting
This study was conducted at a tertiary care hospital. The approval for conducting this study was obtained from the Institutional Ethics Committee prior to the study.
Study design
This was a prospective cross-sectional, questionnaire-based study. The study participants consisted of all resident doctors of clinical as well as paraclinical departments who gave their informed consent and who were working at the hospital during the study period. KAP questionnaire was designed to assess residents’ knowledge of pharmacovigilance, attitudes toward pharmacovigilance, and their practice on ADR reporting.[ 8 ] The study instrument was self-administered, semi-structured, predesigned, pretested, and modified based on previous studies.[ 11 ] KAP questionnaire were designed and modified by the expert faculties of the Pharmacovigilance Committee of our institute, i.e., Coordinator and Deputy Coordinator, along with Head of the Department of Pharmacology, and Associate Professors of Pharmacology. KAP questionnaires consisted of 27 questions, out of which 15 questions assessed knowledge on ADR, 5 questions assessed attitude toward pharmacovigilance, and the remaining 7 questions assessed their practice on reporting ADR.
Study training
The study took place in four sessions in the stipulated time of 2 h.
Session I (total duration 30 min)
Introductory lecture was conducted by the Pharmacovigilance Coordinator, Deputy Coordinator, and Head of the Department of Pharmacology citing the importance ADR reporting and the purpose of conducting this training. This was followed by distribution and filling out pretraining questionnaires by the residents.
Session II (total duration 60 min)
Educational training was given through slide presentations. Our institute is an ADR monitoring center; hence “continuous medical education (CME) on pharmacovigilance-sensitization and reporting of ADR for drug safety” presentation was shared by the national coordinating center of PvPI, Ghaziabad, to be taught for the training.
Topics covered in these presentations were:
When to report ADR: Delivered by Head of the Department of Pharmacology
Where to report ADR: Delivered by Coordinator of Pharmacovigilance and Associate Professor of the Department of Pharmacology
Who can report ADR: Delivered by Coordinator of Pharmacovigilance and Associate Professor of the Department of Pharmacology
What to report: Delivered by Coordinator of Pharmacovigilance and Associate Professor of the Department of Pharmacology
How to report: Delivered by Coordinator of Pharmacovigilance and Associate Professor of the Department of Pharmacology.
Session III (total duration 20 min)
Practical demonstration was given on ADR form filling along with group task for the residents for form filling: by tutor/demonstrator of the Department of Pharmacology.
Session IV (total time 10 min)
Finally, posttraining questionnaires were distributed and collected back from the residents.
Hence a 2 h session was conducted as an educational intervention.
Study data collection
A total of 156 resident doctors participated in this cross-sectional questionnaire-based study. At the commencement of the study, residents were briefed about the purpose of the study and distributed the questions. This was followed by an educational training for a period of 2 h. At the end of this training session, post-KAP questionnaire was distributed to all the participants. Pre- and postquestionnaires of each participant were then checked for its completeness and later compared for analysis.
Statistical analysis
The result was analyzed question wise. Each correct answer and positive response was given a score of 1, whereas wrong answer was given a score of 0. Question numbers 1–15 were knowledge based, questions 16–20 were pertaining to attitude, and question numbers 21–27 were practice based. Only questions related to knowledge were assessed using scoring system, maximum score being 15, and minimum being 0. More than one answer was acceptable in some of the questions related to attitude and practice. Questions related to knowledge were analyzed McNemar’s test and paired t- test, while questions related to attitude were analyzed descriptively.
Significance of our study
Our study regarding educational intervention on pharmacovigilance among resident doctors differs from other studies[ 8 , 9 ] in regard to Methodology as follows:
Methodology
To implement the purpose of our study, we had one-on-one interaction with the residents to solve their queries regarding reporting of ADR creating legal issues and other apprehensions. Furthermore, during the 2-h training sessions, resident doctors were given practical demonstration and taught how to fill the ADR reporting forms along with group tasks.
RESULTS
Of the 156 KAP questionnaires circulated, 5 responses were excluded from the study due to its incompleteness. A total of 151 resident doctors gave consent to participate in this study and responded to the questionnaire.
Resident doctors’ knowledge regarding adverse drug reaction reporting
Residents’ knowledge was determined based on important parameters. Among the residents, 97% of the respondents gave correct response regarding who can report ADR after the educational training; however, before training, 81% were able to do so. After training, 93% of the residents gained knowledge regarding the program under the blood component-related ADR be reported. After training, 90% of the residents were aware of the minimum criteria of ADR reporting, whereas before training, 77% were aware about it. Before training, 62% were aware about the purpose of pharmacovigilance which was increased to 74% after training. After applying the paired t -test and McNemar’s test, significance level is P < 0.05.
Resident doctors’ knowledge regarding Pharmacovigilance Programme of India
Among the respondents, 21% were aware about the scale used to establish the causality of ADR before the training which significantly improved to 81% after training. Only 47% were aware of the web-based ICSR system used for reporting of ADR, which was increased to 92% after training. Before training, 66% of the respondents gave correct response regarding the definition of pharmacovigilance, whereas after training, 89% were able to give correct response. Before training, 45% of the respondents felt that mild ADR should be reported, whereas after training, 91% agreed that mild ADR should also be reported.
Therefore, while comparing the mean score of knowledge, there was a significant improvement by a difference of 3.99 ± 0.07 after an educational training was given to the resident doctors [Table 1 ].
Table 1: Comparing mean score of knowledge before and after training
Resident doctors’ attitude toward adverse drug reaction reporting
Factors deterring adverse drug reaction reporting
Some of the factors discouraging residents from ADR were lack of time to report ADR (82%), a single unreported case may not affect ADR database (50%), and nonremuneration for reporting and concern that reporting may create unnecessary problem (42%) [Table 2 ].
Table 2: Attitude: Factors that may discourage reporting of adverse drug reactions
Factors encouraging adverse drug reaction reporting
Some of the factors encouraging residents in reporting ADR were serious reactions (92%), unusual reactions (90%), and if reaction to new drug (83%) [Table 3 ].
Table 3: Attitude: Factors that may encourage reporting of adverse drug reactions
Resident doctors’ practice toward adverse drug reaction reporting
Among the respondents, 68% have come across with an ADR in their day-to-day clinical practice, and out of 68% who have come across with an ADR, only 36% of the residents had reported an ADR. One of the reasons could be because only 30% have trained how to report an ADR.
Significance of our study
Our study regarding educational intervention on pharmacovigilance among resident doctors differs from other studies[ 8 , 9 ] in regard to the results as follows:
RESULTS
By applying the McNemar’s test, we individually assessed the pre- as well as posttraining questionnaires of each resident which showed us the improvement of knowledge at an individual level and as well as overall level of the residents.
Our study depicted that while 68% of the residents have come across with an ADR during their residency ship, however, only 36% have ever reported the ADR, and this could mainly be because only 30% have previously been trained on how to fill the ADR reporting form.
On the other hand, other studies[ 8 , 9 ] did not conduct an educational training; it was a onetime questionnaire-based study followed by the assessment.
DISCUSSION
The present study was a questionnaire-based study which assessed KAP of resident doctors toward ADR. After educational intervention, it shows that there was improvement of KAP toward pharmacovigilance. Most of the residents were not aware about PvPI (66%) and its coordinating center. Most of them (59%) were not aware about the purpose of pharmacovigilance program. Similar result was seen in a study conducted by Desai et al .[ 12 ] which shows that 70% of the respondents did not know where to report ADR.
In our study, we included educational training which shows significant improvement in KAP of resident doctors. A similar study was conducted by Nazli Sencan which concluded that to create reporting culture, CMEs are necessary for health-care professionals.[ 12–14 ]
Spontaneous reporting of ADRs by patients and health-care personnel, other than doctors, is practiced in many parts of the world.[ 7 ] An important finding from our study which was similar to Hindoliya & Chitapure[ 9 ] is that Pharmacovigilance should be taught in detail to postgraduate to postgraduate students. Majority of the resident doctors agreed that reporting of ADR is necessary.[ 8 ]
In this study, there was also a wide gap between the ADR experienced in practice (68%) and ADR reported (36%) by resident doctors showing the need of bringing pharmacovigilance in practice. A study conducted in South India[ 8 ] by Gupta et al . shows similar results 64.4% experienced ADR but only 22.8% reported ADR. Similar results were seen in Hindoliya and Chitapure.[ 9 ]
In our study, ADR reporting rate is low (36%) which is similar to previously reported studies.[ 8 , 12 ] Results of our study show that less percentage of residents (30%) were trained how to report ADR which is similar to other studies.[ 8 ]
In our study, most of the residents (86%) said that they would mainly report serious ADR or ADR to a new drug (80%). This was similar to response obtained in a study done in Nigeria.[ 14 ]
In our study, the reason for underreporting was lack of time (82%) and their belief that a single unreported ADR would not affect the database, and a comparable result was seen in studies done by Lakshman Das[ 15 ] and Gupta et al .[ 8 ] Results of our study show that 32% of the resident doctors had never come across an ADR which is similar to a study done by Khan et al .[ 16 ]
In the present scenario, there is a need to identify barriers to ADR reporting so that one can define interventions addressing such barriers. Educational interventions about the pharmacovigilance program and need of ADR reporting are not only needed for nursing staff, teaching faculty, resident doctors, and interns of our medical colleges but also to include private physicians. Furthermore, including general practitioners in such studies can contribute in a big way to the successful implementation of pharmacovigilance.
Among the various measures to improve pharmacovigilance, CME and training was the most common measure suggested. We had completed training of nursing staff and resident doctors and are planning to train interns also to increase ADR reporting.
CONCLUSION
The educational training given in different sessions has improved the KAP among resident doctors. Queries regarding reporting of ADR creating legal issues and apprehensions regarding other issues have been solved. The present requirement in India is to motivate the residents through CMEs and trainings in order to enhance the importance of Pharmacovigilance practice.
Limitations
Our study included only residents of the second and final years as the result of NEET PG is awaited. Further training sessions are needed for interns and faculties to strengthen the effectiveness of pharmacovigilance program. There is a great need to create awareness among private doctors to improve the reporting of ADR.
Ethical approval
The study was approved by the Institutional Ethics Committee.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
Acknowledgments
We would like to express our gratitude to Dr. Anupama Desai Madam (Professor and Head) of the Department of Pharmacology, SMIMER, for her valuable intellectual support and constant motivation in carrying out this work. We would also like to thank the ADR Monitoring Centre, as well as Coordinator, and Deputy Coordinator of Pharmacovigilance Centre, SMIMER, Surat. We would like to extend our gratitude to residents of SMIMER Medical College and Hospital, Surat, who took time out from their busy work schedule and participated in the educational training.
REFERENCES
1. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients:A meta-analysis of prospective studies. JAMA 1998;279:1200-5
2. World Health Organization. International Drug Monitoring:The Role of National Centers Report No:498. Geneva: World Health Organization; 1972
3. PvPI Tool Kit. Pharmacovigilance Programme of India (PvPI). Available from:
http://www.ipc.gov.in/PvPI/pv_toolkit1.html . [Last accessed on 2016 May 25]
4. Pharmacovigilance Programme of India (PvPI): Newsletter. 2014. Available from:
http://www.ipc.gov.in/PvPI/Newsletter_April_issue.pdf . [Last accessed on 2016 May 25]
5. Lihite RJ, Lahkar M. An update on the Pharmacovigilance Programme of India. Front Pharmacol 2015;6:194
6. Vallano A, Cereza G, Pedròs C, Agustí A, Danés I, Aguilera C, et al. Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital. Br J Clin Pharmacol 2005;60:653-8
7. Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions:A systematic review. Drug Saf 2009;32:19-31
8. Gupta SK, Nayak RP, Shivaranjani R, Vidyarthi SK. A questionnaire study on the knowledge, attitude, and the practice of pharmacovigilance among the healthcare professionals in a teaching hospital in South India. Perspect Clin Res 2015;6:45-52
9. Hindoliya M, Chitapure F. A study on the knowledge, attitude and practice on adverse drug reactions and pharmacovigilance among post graduate residents in Gandhi Medical College, Bhopal. Int J Basic Clin Pharmacol 2019;8:2108-12
10. Shrestha S, Sharma S, Bhasima R, Kunwor P, Adhikari B, Sapkota B. Impact of an educational intervention on pharmacovigilance knowledge and attitudes among health professionals in a Nepal cancer hospital. BMC Med Educ 2020;20:179
11. Srinivasan V, Sheela D, Mridula D. Knowledge, attitude, and practice of pharmacovigilance among the healthcare professionals in a Tertiary Care Hospital –A questionnaire study. Biomed Pharmacol J 2017;10:1441-7
12. Desai CK, Iyer G, Panchal J, Shah S, Dikshit RK. An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting among prescribers at a tertiary care hospital. Perspect Clin Res 2011;2:129-36
13. Şencan N, Altınkaynak M. The knowledge and attitudes of physicians and nurses towards adverse event reporting and the effect of pharmacovigilance training:A hospital experience. Hacet Univ J Fac Pharm 2010;30:25-40
14. Oshikoya KA, Awobusuyi JO. Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria. BMC Clin Pharmacol 2009;9:14
15. Das L, Bhattacharjee P, Ghosh R. Knowledge, attitude, and practice of pharmacovigilance among doctors in a tertiary care teaching hospital of Tripura. Natl J Physiol Pharm Pharmacol 2017;7:218-23
16. Khan SA, Goyal C, Chandel N, Rafi M. Knowledge, attitudes, and practice of doctors to adverse drug reaction reporting in a teaching hospital in India:An observational study. J Nat Sci Biol Med 2013;4:191-6
