|Year : 2017 | Volume
| Issue : 2 | Page : 75-79
Impact of educational intervention on knowledge, attitude and practice of pharmacovigilance among interns
Divya Goel, Majid Farooq
Department of Pharmacology, Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana, Haryana, India
|Date of Web Publication||28-Apr-2017|
Department of Pharmacology, Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana, Haryana
Source of Support: None, Conflict of Interest: None
Introduction: Pharmacovigilance (PV) plays an important role in generating adverse drug reaction (ADR) data. However, the practice of PV is still very low among health-care professionals due to lack of knowledge and awareness. Internship is the phase when medical graduates work for the first time under supervision of the seniors. At present, we have little knowledge about awareness of PV among interns in India. Hence, this study was planned to assess the level of knowledge awareness and practice of PV among interns and subsequent change in these after PV training session.
Materials and Methods: A cross-sectional descriptive questionnaire-based study was conducted among interns of a tertiary health care and teaching institute. Participants were given descriptive questionnaire; they completed the questionnaire before and after undergoing training program in PV. The impact of the effectiveness of educational intervention among interns was evaluated by Chi-square test.
Results: Out of 150 participants, 120 interns completely filled the questionnaires before and after the educational intervention. Educational program on PV was found to increase knowledge and positive attitudes towards various aspects of PV.
Conclusion: Training program on PV may help increase the knowledge as well as awareness about principles and techniques of PV, which will increase the credibility of health care in the country.
Keywords: Awareness, educational intervention, interns, knowledge, pharmacovigilance, practice
|How to cite this article:|
Goel D, Farooq M. Impact of educational intervention on knowledge, attitude and practice of pharmacovigilance among interns. Adv Hum Biol 2017;7:75-9
|How to cite this URL:|
Goel D, Farooq M. Impact of educational intervention on knowledge, attitude and practice of pharmacovigilance among interns. Adv Hum Biol [serial online] 2017 [cited 2020 Jun 2];7:75-9. Available from: http://www.aihbonline.com/text.asp?2017/7/2/75/205397
| Introduction|| |
Since the advent of drugs, the utilisation of medicines has been connected with adverse events. There are only three activities of a medication: 'The one you want, the one you don't want and the one you don't know about'. Adverse drug reactions (ADRs) are described as 'a response to a medicament which is noxious and unforeseen and which happens at dosages ordinarily utilised for the diagnosis, prophylaxis or treatment of a disease or for the alteration of physiological function'. ADRs inflict a considerable economic burden on the healthcare system and society, thereby posing a major impact on public health. The World Health Organization (WHO) defined the term pharmacovigilance (PV) as 'The pharmacological science and activities relating to the detection, assessment, understanding and prevention of the adverse effects or any other drug related problems'. In the recent past, its worries have been broadened to incorporate herbal, traditional and complementary medicines, blood products, medical devices and vaccines. Studies conducted worldwide showed that ADRs produce a significant reduction in the quality of life, increase hospitalisation, lengthen hospital stay and increase mortality. The switching from prescription-only medicines to over the counter drugs has increased the risk of general public to ADRs, which are reported sporadically. The cost of drug-related morbidity and mortality exceeded 177.4 million dollars as on 2000, of which about 70% were expenses for hospital admissions. This is due to superfluous prescription, imprecise diagnosis, cursory application of evidence-based medicines, outstanding development of new drugs and their unjustified promotion. The international database of ADRs, maintained by the Uppsala monitoring centre, Sweden, reported about 4.7 million cases from several national centres of 96 member countries. However, only 6%–10% of all ADRs are likely reported.
Such under-reported volume of ADR reporting from countries including India is essentially due to the absence of vibrant ADR monitoring system and also inadequacies in reporting culture among health-care professionals. The reporting rate of ADRs could be improved with proper and extensive training about PV during the undergraduate and internship periods.
Aims and objectives
The aim behind conducting this study was to explore the knowledge, attitude and practice (KAP) of the interns towards PV and subsequent change in these after training session on PV.
| Materials and Methods|| |
Study design and study site
A cross-sectional descriptive (KAP) questionnaire-based study was conducted among interns of Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana, Ambala, during the year 2015.
After obtaining verbal consent from the participants, the study was commenced. The participants were ensured that their participation is voluntary and confidentiality will be maintained. Initially, all the participants were briefed about the purpose of the study; later, a self-administrated pre-validated questionnaire adapted from previous studies was framed in English to consist of three parts. The first part (Question No. 1–10) contained the set of questions seeking the knowledge in depth of interns about PV. Part two (Question No. 11–14) contained questions to know their attitude towards PV as interns. The third part (Question No. 15–19) contained set of questions to assess their practical aspects of PV. The questionnaire (pre-KAP) was administered and participants were asked to submit the completed questionnaire. Every participant was given 30 min to fill up the questionnaire. An interactive educational intervention was designed in the form of PowerPoint presentation by trained faculty to all interns to facilitate the transfer of knowledge of PV and ADR's reporting. The educational intervention consisted of a hands-on training and theoretical presentation on what is PV, its main objectives, ADRs reporting, Vigiflow database, classification of ADRs, incidence of ADRs, role of health-care professionals, reporting of suspected ADR followed by economic and epidemiological importance of reporting the ADRs and its effect on patient safety and causality assessment of ADRs. After the interactive educational intervention program on PV, all participants in the study were again administered with (post-KAP) questionnaire.
Statistical analysis was done using descriptive statistics. To measure changes in the knowledge and attitude towards pharmacovilance among interns between pre- and post-intervention and to evaluate the impact of effectiveness of educational intervention among interns, the Chi-square test was used to compare the difference in correctness for each question. To see the practice of interns in PV, correctness was analysed in percentage. All statistical calculations were performed using Epi Info, Atlanta, Georgia (USA), a web-based epidemiological and statistical calculator. The significance was assessed at a 5% level of significance (P < 0.05) with 95% confidence interval.
| Results|| |
In this hospital-based cross-sectional study, a total of 150 interns participated, but only 120 interns completely filled the questionnaires before and after the educational intervention. The questions answered by the participants about the knowledge of PV are depicted in the following [Table 1].
|Table 1: Knowledge of pharmacovigilance and adverse drug reactions reporting before and after educational intervention|
Click here to view
Among the 150 participants (interns) participated in our study, 120 questionnaires were returned with the response rate of 80%. Knowledge about the PV among the participants was assessed by Part-I (Question No. 1–10) of the questionnaire [Table 1]. Forty-eight participants (40%) were aware of the term PV. Among the participants who were aware of the term PV, only 34 (28.33%) had knowledge about the function of PV and 45 (37.5%) participants had knowledge about the regulatory body of Pharmacovigilance Programme of India (PVPI). With respect to the awareness about centres for PV and ADR reporting, only 18 (15%) gave correct response referring to international centre for ADR monitoring, 15 (14.17%) participants provided appropriate response about most commonly used scale to establish causality of an ADR, 53 (44.16%) furnished precise response about ADR reporting system in India. Only 15 (12.5%) responded correctly with reference to the 'WHO online database' for reporting ADRs. With reference to the question 'who can report ADR?' 45 (37.5%) participants gave correct response. Twenty-two (18.33%) participants gave correct response with respect to the time period within which an ADR should be reported, while 36 (30%) gave correct response as to which kind of ADRs should be reported. In our study, a statistically significant (P = 0.0001) increase in the correct response to all the questions in knowledge part of the questionnaire as compared to pre-KAP was seen in the post-educational intervention (post-KAP).
Assessment of attitude regarding PV among the participants was assessed by part-II (Question No. 11–14) of the questionnaire [Table 2]. For the question on the necessity of ADR reporting, 52 (43.2%) participants agreed that ADR reporting should be necessary. In response to the question, whether ADR reporting should be mandatory, 35 (29.16%) participants were in favour of making it mandatory. With reference to the question, The healthcare professional/s responsible for reporting ADRs in hospitals is/are?“ 45 (37.5%) participants correctly expressed both health-care and non-health-care professionals can report. About 75 (62.5%) of participants had positive perception that PV should be taught in detail to all health-care professionals during their curriculum. However, as depicted in [Table 2], there was a statistically significant (P = 0.0001) increase in the correct response by the participants after the educational intervention (post-KAP).
|Table 2: Attitude of pharmacovigilance and adverse drug reactions reporting before and after educational intervention|
Click here to view
The practice of PV and reporting ADRs was assessed by the part-III (Question No. 15–19) of the questionnaire [Table 3]. This study reveals the fact that none of the participants had ever reported an ADR. Only 40 (33.3%) of participants had ever come across a case of an ADR, but did not report it, the main reasons of not reporting an ADR by the participants were not knowing how to report. Ninety-five (79.16%) participants had never undergone any kind of training on reporting ADRs or PV.
|Table 3: Practice of pharmacovigilance and adverse drug reaction reporting before educational intervention|
Click here to view
| Discussion|| |
Spontaneous ADR reporting plays a vital role in PV program. This study was conducted on inters with aim to assess their KAP about PV as internship is that phase of their training where they are involved for the first time in patient care. This study shows that interns lack the knowledge regarding PV and ADR reporting system; this may be due to limited exposure to the pharmacology and related activities. The medical students get exposed to pharmacology in the 2nd year of their curriculum and by the time these students complete their course, the knowledge and awareness regarding PV are washed out. The practice of the medical students largely needs to be upgraded to prepare them for future challenges.
In our study, more than half of the study participants were unaware of the correct meaning and function of PV, regulatory authority of PVPI. The student's knowledge on the location of the international centre for ADR monitoring was very poor and only few students were aware about the 'WHO online database' for reporting ADR and the most commonly used scales to establish the causality of an ADR, timeframe for reporting of serious adverse events, who can report the ADRs and what type of ADRs to report. The knowledge of PV assessed through this study in medical interns was similar to the various previous studies reported in literature.,, A study conducted by Ramesh and Parthasarathi stated that doctors were less aware and there is lack of knowledge of national and international PV program among doctors. Hema et al. concluded that lack of proper knowledge and awareness about PV among the health-care professional as the main reason for under-reporting of ADRs. A study by Praveen et al. concluded that the lack of knowledge and awareness was found to be the most common cause of failure in successful implementation of the PV programme of India.
In our study, 43.3% participants agreed that reporting ADRs is necessary and 29.16% participants agreed that ADR reporting should be made mandatory. An another study found that ADR reporting was considered to be important by 97.3% of the respondents. In our study, the overall attitude towards ADR reporting and PV was acceptable; however, the actual practice of ADR reporting was lacking.
A study done in Mumbai showed that high knowledge but poor practices for ADRs reporting in doctors. Another two studies conducted in Mysore  and Muzzafarnagar  have shown high knowledge, but poor practice for ADR, among prescribers. In contrast, our study has found not only poor practice but also inadequate knowledge regarding ADR reporting. The overall attitude towards ADR reporting and PV was acceptable, but on assessing the practice, it was found that none of the participants had ever reported an ADR even though 40 (33.33%) participants had come across a case of ADR and the main reasons for not reporting were pointed out as lack of knowledge about how to report. The above observations point out to the lack of knowledge about reporting system as one of the causes of under-reporting; similar observations were also reported in other studies., 16, ,,,
In our study, the focus of educational intervention was to increase the medical students awareness to PV, regulatory bodies responsible for monitoring of ADR's, types of ADR's. This was demonstrated by an increase in the correct responses in pre- and post-KAP questions (1–19) about PV and ADR's reporting with statistical significance (P = 0.0001).
A study involving medical students in which both pre-KAP and post-KAP was conducted on PV, it was evident that all the participants had very less information about ADRs reporting during pre-KAP studies. However, there was a significant improvement in their knowledge and attitude after post-KAP studies. The study involved educational session using lectures and PowerPoint presentations as teaching aids after pre-KAP session (Bagewadi et al., 2015). The outcomes of the study showed that lectures, PowerPoint presentations and diagrams increased, the concept of ADRs reporting among the medical students. As a result, it was suggested that knowledge of medical students can be increased by including PV topics in the undergraduate curriculum and again during internship and residency (Bagewadi et al., 2015).
Another Malaysian study finding suggested inadequate KAP and the need for educational interventions with respect to the PV program in both undergraduate studies and during internship. Medical schools, regulatory authorities claimed that a lot of improvement was made in the undergraduate training, but yet there are an abundance of irrational prescribing worldwide (Ismail et al., 2015). It is important to note that without proper ADRs reporting, a lot of ADR will occur in future. Necessary measures should be taken to improve the medical student curriculum with respect to PV program (Ismail et al., 2015).
A study from Northern India reported that the KAP regarding ADR monitoring was low and the knowledge scores needed an improvement and update KAPs about ADR and PV. A survey among medical residents in France showed that the majority of them had a lower knowledge regarding PV. A study from Italy reported that doctors had little information concerning ADRs and ADR reporting systems. A recent study from India also identified that the awareness about PV program and the knowledge of ADR reporting were very low among the doctors. In our study, similar results were found. These findings suggest the need for interventions to improve the KAP of the health-care professionals. A better training about PV in undergraduate curriculum might help solve this emergent problem of under-reporting of ADR's. A regular simulated environment and workshop on PV should be conducted for the students and periodic evaluation of their responses should be done. An educational visit to the PV centre to observe the academism will help improvise the need for ADR reporting.
| Conclusion|| |
Our study suggested that though the attitude towards PV and the eager to learn about ADR reporting were appreciable among the medical interns, there lies an insufficient knowledge and awareness about PV. The main reason for under-reporting of ADRs was found to be gaps in knowledge. Widening the teaching programmes for medical professionals during their undergraduate period might provide a solution to strengthen ADR reporting in India. The reporting of ADRs using the relevant forms should be demonstrated and assigned to students such as prescription writing and other practical procedures. The results of the present study demonstrate that an educational intervention can increase awareness of PV, ADR's reporting among the medical interns and the gained knowledge would thereby help the students during their everyday clinical practice in future. Educational campaigns in form of workshop/continued medical education, symposia, lectures for health personnel and implementing ADR reporting as part of the undergraduate training, internship and postgraduate training will not only make them aware of their responsibility to report ADRs but will also curb under-reporting. Other initiatives in form of financial incentives and simplifying the reporting process might change the attitudes. Further, making ADR reporting mandatory can make health professionals aware of the importance of PV in India.
Limitations of the study
- The study could not verify the change in the practice of the study population due to time restrictions
- The outcome of this study cannot be generalised to all medical students; more studies need to be carried out with larger and broader study group.
Financial Support and Sponsorship
Conflicts of Interest
There are no conflicts of interest.
| References|| |
Barker CI, Talbot JC, Aronson JK. Selected national pharmacovigilance websites: An analysis of contents. Drug Saf 2012;35:141-8.
Nebeker JR, Barach P, Samore MH. Clarifying adverse drug events: A clinician's guide to terminology, documentation, and reporting. Ann Intern Med 2004;140:795-801.
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.
Alhat BR. Pharmacovigilance: An overview. Int J Res Pharm Chem 2011;1:968-74.
Shukla SS, Gidwani B, Pandey R, Rao SP, Singh V, Vyas A. Importance of pharmacovigilance in Indian Pharmaceutical Industry. Asian J Res Pharm Sci 2012;2:4-8.
Gosh AK, De A, Bala NN. Current problems and future aspects of pharmacovigilance. Int J Pharm Bio Sci 2011;2:15-28.
Johnson JA, Bootman JL. Drug-related morbidity and mortality. A cost-of-illness model. Arch Intern Med 1995;155:1949-56.
McGavock H. Prescription-related illness – A scandalous pandemic. J Eval Clin Pract 2004;10:491-7.
World Health Organization. Safety of Medicines: A Guide to Detecting and Reporting Adverse Drug Reactions. WHO/EDM/QSM/2002. Geneva, Switzerland: World Health Organization; 2002.
Praveen S, Prakash RJ, Manjunath GN, Gautham MS, Kumar N. Adverse drug reaction reporting among medical and dental practitioners: A KAP study. Indian J Med Specialities 2013;4:10-5.
Vora MB, Paliwal NP, Doshi VG, Barvaliya MJ, Tripathi CB. Knowledge of adverse drug reactions and Pharmcovigilance activity among the undergraduates medical students of Gujarat. Int J Pharm Sci Res 2012;3:1511-5.
Palaian S, Ibrahim MI, Mishra P. Health professionals' knowledge, attitude and practices towards pharmacovigilance in Nepal. Pharm Pract (Granada) 2011;9:228-35.
Ramesh M, Parthasarathi G. Adverse drug reactions reporting: Attitudes and perceptions of medical practitioners. Asian J Pharm Clin Res 2009;2:10-4.
Hema NG, Bhuvana KB, Sangeetha. Pharmacovigilance: The extend of awareness among the final year students, interns and postgraduates in a government teaching hospital. J Clin Diagn Res 2012;6:1248-53.
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. [Full text]
Gupta P, Udupa A. Adverse drug reaction reporting and pharmacovigilance: Knowledge, attitudes and perceptions among resident doctors. J Pharm Sci Res 2011;3:1064-9.
Ghosh S, Ali S, Chhabra L, Prasad C, Gupta A. Investigation of attitudes and perception of medical practitioners on adverse drug reaction reporting – A pilot study. Pharm Res 2010;3:1-9.
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.
Hanafi S, Torkamandi H, Hayatshahi A, Gholami K, Javadi M. Knowledge, attitudes and practice of nurse regarding adverse drug reaction reporting. Iran J Nurs Midwifery Res 2012;17:21-5.
Hardeep, Bajaj JK, Kumar R. A survey on the knowledge, attitude and the practice of pharmacovigilance among the health care professionals in a teaching hospital in Northern India. J Clin Diagn Res 2013;7:97-9.
Karelia BN, Piparava KG. Knowledge, attitude and practice of pharmacovigilance among private healthcare professionals of Rajkot city. Int J Basic Clin Pharmacol 2014;3:50-3.
Bagewadi HG, Rekha MS, Anand SJ. A comparative evaluation of different teaching aids among fourth term medical students to improve the knowledge, attitude and perceptions about pharmacovigilance: An experimental study. Int J Pharm Res 2015;5:91-7.
Ismail S, Rahman NI, Haque M. Comparative study of professionalism of future medical doctors between Malaysia and Bangladesh. J App Pharm Sci 2014a; 4:66-71.
Graille V, Lapeyre-Mestre M, Montastruc JL. Drug vigilance: Opinion survey among residents of a university hospital. Therapie 1994;49:451-4.
Cosentino M, Leoni O, Banfi F, Lecchini S, Frigo G. Attitudes to adverse drug reaction reporting by medical practitioners in a Northern Italian district. Pharmacol Res 1997;35:85-8.
[Table 1], [Table 2], [Table 3]