|Year : 2015 | Volume
| Issue : 1 | Page : 23-29
Awareness related to reporting of adverse drug reactions among health caregivers: A cross-sectional questionnaire survey
Nilesh Arjun Torwane1, Sudhir Hongal2, Abhishek Gouraha3, Eshani Saxena4, Kalpesh Chavan5
1 Department of Public Health Dentistry, People's Dental Academy, People's University, Bhopal, Madhya Pradesh, India
2 Department of Public Health Dentistry, A.M.E. Dental College and Hospital Raichur, Raichur, Karnataka, India
3 Department of Oral Pathology, Mansarovar Dental College, Bhopal, Madhya Pradesh, India
4 Department of Public Health Dentistry, YRC Dental College, Ahemadnagar, Maharashtra, India
5 Department of Public Health Dentistry, K.M. Shah Dental College and Hospital, Vadodara, Gujrat, India
|Date of Web Publication||8-Jul-2015|
Dr. Nilesh Arjun Torwane
Department of Public Health Dentistry, People's Dental Academy, People's University, Bhopal, Madhya Pradesh
Source of Support: None, Conflict of Interest: None
Aim: The present cross-sectional questionnaire survey was conducted with an aim of assessing the knowledge, attitude, and practice (KAP) related to pharmacovigilance among the health-care professionals in a teaching hospital located in Central India region.
Materials and Methods: To assess the demographic details of the health-care professionals, their KAPs toward pharmacovigilance and adverse drug reaction (ADR) reporting; a predesigned, structured, close-ended 18 item questionnaire was used.
Results: A total of 392 questionnaires were distributed among the health-care professionals. It was found that only 38.01% health-care professionals comprising 54.43% medical, 38.01% nursing and 19.01% dental professionals were aware regarding the existence of pharmacovigilance program of India. While, only 40.56% health-care professionals felt that ADR monitoring center should be established in every hospital. Similarly, very few health-care professionals, that is, 6.12% have ever reported ADR to pharmacovigilance center.
Conclusion: The results of our study indicate that the majority of the health-care professionals had a poor knowledge and attitude about pharmacovigilance. There was a huge gap between the ADR experienced, and ADR reported by the health-care professionals especially among dentist and nursing staff. It has been advised that the health-care professionals; especially dental and nursing, should be trained properly on ADR reporting to improve the current scenario in the pharmacovigilance program of the country.
Keywords: Adverse drug reactions, adverse drug reactions reporting, health-care professionals, pharmacovigilance
|How to cite this article:|
Torwane NA, Hongal S, Gouraha A, Saxena E, Chavan K. Awareness related to reporting of adverse drug reactions among health caregivers: A cross-sectional questionnaire survey. J Nat Accred Board Hosp Healthcare Providers 2015;2:23-9
|How to cite this URL:|
Torwane NA, Hongal S, Gouraha A, Saxena E, Chavan K. Awareness related to reporting of adverse drug reactions among health caregivers: A cross-sectional questionnaire survey. J Nat Accred Board Hosp Healthcare Providers [serial online] 2015 [cited 2019 Jul 15];2:23-9. Available from: http://www.nabh.ind.in/text.asp?2015/2/1/23/160241
| Introduction|| |
Safety and efficacy are the two major concerns about a drug. The efficacy of a drug can be quantified with relative ease; the same cannot be said about safety. This is because, the adverse effect of a drug may be uncommon (but very serious), and many patients may be affected or subjected to a potential risk before the relationship with the drug is established. , According to Barker, there are three possible actions of drug: The one you want, the one you don't want, and the one you don't know about. 
Adverse drug reaction (ADR) is defined by the World Health Organization (WHO) as "a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function." 
Adverse drug reactions are an imperative public health crisis striking a substantial fiscal burden on the society and health-care systems. It is one of the significant bases of hospitalization varying between 5% and 20%. ,,, Furthermore, according to Uppsala Monitoring Centre (WHO), Sweden; which maintains the international database of the ADR reports, only 6-10% of all the ADRs are reported.  Hence, the detection, recording, and reporting of ADRs becomes vital and health experts should be encouraged to execute this appropriately to ensure safer usage of medicines. For this purpose, the concept of pharmacovigilance has been taken place.
World Health Organization defines pharmacovigilance as "the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problems."  In an effort to strengthen the pharmacovigilance in India, government has initiated pharmacovigilance programme of India (PvPI). Similarly, the Drug Controller General of India and Indian Council of Medical Research have established ADR monitoring centers in many hospitals in major cities of India.  Despite these efforts and the presence of a large number of tertiary care facilities, pharmacovigilance is still in its infancy. The major reason behind this is poor understanding of the health-care professionals toward the existing pharmacovigilance program. 
In India, the gross under-reporting of ADRs is a cause of concern, the reasons for which may be due to lack of trained staff and lack of awareness regarding detection, communication, and spontaneous monitoring of ADRs among the health-care professionals (physicians, nurses, pharmacist, and dentists). ,
There is a requirement for constant training and enactment of regulations for ADR reporting among health-care professionals. Previously reported study has found that underreporting of ADR is related with shortcomings in the knowledge and attitude among health-care professionals. ,
It is important for health-care professionals to know how to report and where to report an ADR. The active participation of health-care professionals in the pharmacovigilance program can improve the ADR reporting. 
Therefore, the present study was contemplated and done to assess the knowledge, attitude, and practices (KAPs) of the health-care professionals working in a teaching hospital (institution) located in Central India region regarding ADRs reporting, to get an insight into the reasons for nonreporting and to suggest possible ways of improving spontaneous reporting based on our findings.
| Materials and Methods|| |
Study design and settings
A cross-sectional questionnaire survey was conducted in a teaching hospital located in Central India.
Source of data
The required information for the study was obtained from all the available health-care professionals (medical, dental, and nursing professionals) of the institution.
The study was conducted for a period of 2 months from October 2014 to December 2014.
The ethical approval was obtained from the Ethical Committee before the commencement of the study.
All the available health-care professionals that is, medical, dental, and nursing professionals who gave their informed consent and who were working at the hospital during the study period were included in the study. The health-care professionals who did not respond were excluded from the study.
A total of 392 subjects including 169 medical, 142 dental, and 81 nursing professionals participated in the study.
Assessment and structure of a questionnaire
To assess the demographic details of the health-care professionals, their knowledge of pharmacovigilance, attitudes toward pharmacovigilance, and their practice on ADR reporting; a predesigned, structured, close-ended 18 item questionnaire, which had been designed based on the primary objective of the study was used. The interview was conducted in English. To design a questionnaire; earlier studies for assessing KAP of ADR reporting were also reviewed. ,,,
The details of the questionnaire are as follows:
- Knowledge-related questions: The assessment of participant's knowledge of pharmacovigilance included five questions (items) on definition and purpose of pharmacovigilance, responsibility of reporting ADRs, knowledge of National Pharmacovigilance Programme, and regulatory body responsible for monitoring ADRs.
- Attitude-related questions: The assessment of participant's attitudes toward pharmacovigilance included four questions (items) on the necessity of reporting ADRs, teaching of pharmacovigilance, prevention of ADR, and opinion about ADR monitoring center.
- Practice-related questions: The assessment of participant's practice on ADR reporting included eight questions (items) on experience of ADRs, report to pharmacovigilance centre, ADR reporting form, training to report ADRs, reporting of serious adverse event, identification of rare ADRs, methods to monitor ADRs of new drug, presence of Pharmacovigilance Committee in Institute.
- One question was asked to determine the reasons for underreporting. That is, factors discouraging from reporting ADRs.
A preliminary pilot pretesting of the questionnaire was done on 20 randomly selected health-care professionals of the institute. The purpose behind this was to know the practical and communication difficulties while surveying. Furthermore, the pilot testing allowed us to modify the ambiguous and unsuitable questions. The reliability and internal consistency of the questionnaire-based on Cronbach alpha coefficient were between 0.7 and 0.8.
Furthermore, the questionnaire after its final drafting was reviewed by subject experts in the field of clinical pharmacology as regards the face validity, content validity, and the relevance and comprehensiveness.
Method of collection of data
All the subjects (medical, dental and nursing professionals) who were available at the time of the survey were approached personally by the principal investigator. The subjects were asked to respond to each item according to the response format provided in the questionnaire. Response format included multiple choice questions in which the subjects were asked to choose an appropriate response from provided list of options. The investigator recorded the responses of the subjects in the printed format. The completed response format was carefully checked by the investigator.
All the obtained data were entered into a personal computer on Microsoft Excel Sheet and analyzed using Statistical Package for Social Science (SPSS, IBM, Chicago, USA) version 20. The variables were characterized by their frequencies, and differences between groups were assessed using Chi-square tests. The statistically significant level was set at <0.05 with a confidence interval of 95%.
| Results|| |
A total of 392 questionnaires were distributed among the health-care professionals who comprised of a highest of 169 (43.11%) medical professionals followed by 142 (36.22%) dental and 81 (20.66%) nursing professionals. The most of the health-care professionals were males, that is, 64.54% compared to 35.45% females. Furthermore, the mean age of the study participants was 33.67 years [Table 1].
Assessment of pharmacovigilance related knowledge
While assessing the knowledge of the health-care professionals on pharmacovigilance, it was found that a highest of 70.14% medical and 69.13% nursing professionals gave correct response regarding the definition of pharmacovigilance compared to 42.95% dental professionals. The difference among health-care professionals was statistically significant (P = 0.001).
According to 59.43% health-care professionals who included 66.27% medical, 59.25% nursing and 51.40% dental professionals; the most important purpose of pharmacovigilance is to identify a safety of the drug. The difference among health-care professionals was statistically significant (P = 0.002).
Only 48.72% health-care professionals who comprised of 68.63% medical, 35.91% dental, and 29.62% nursing professionals believed that ADR reporting is a professional obligation for them. The difference among the health-care professionals was statistically significant (P = 0.001).
Similarly, only 38.01% health-care professionals comprising 54.43% medical, 38.01% nursing, and 19.01% dental professionals were aware regarding the existence of PvPI. Furthermore, only few, that is, 28.57% health-care professionals including 51.47% medical, 12.67% dental, and 8.64% nursing professionals were aware that the regulatory body responsible for monitoring ADRs in India is Central Drugs Standard Control Organization (CDSCO). The differences among the health-care professionals were statistically significant (P = 0.001) [Table 2].
|Table 2: Showing pharmacovigilance related knowledge of the healthcare professionals|
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Assessment of pharmacovigilance-related attitude
While assessing the pharmacovigilance related attitude of the health-care professionals, it was found that a total of 75.51% health-care professionals comprised of 81.06% medical, 72.53% dental and 69.13% nursing professionals; agreed that reporting of ADR is necessary. Overall, 82.39% health-care professionals, that is, 89.34% medical, 78.87% dental and 74.07% nursing professionals were of the view that pharmacovigilance should be taught in detail to health-care professionals. The differences among the health-care professionals were statistically significant (P = 0.004).
In continuation with this, only few, that is, 23.97% health-care professionals including 47.33% medical, 7.04% dental and 4.93% nursing professionals have read articles on prevention of ADRs. Furthermore, only 40.56% health-care professionals felt that ADR monitoring center should be established in every hospital. These differences among health-care professionals were statistically significant (P = 0.001) [Table 3].
|Table 3: Showing pharmacovigilance related attitude of the healthcare professionals|
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Assessment of pharmacovigilance-related practices
On assessing the pharmacovigilance-related practices, it was found that only 52.29% health-care professionals who included 61.53% medical, 64.19% nursing, and 34.50% dental professionals have experienced ADRs in patient during their practice. Similarly, very few health-care professionals, that is, 6.12% have ever reported ADR to pharmacovigilance center. Highest among them were the medical professionals (14.20%). While, none of the dentist and nursing professionals have never reported the ADRs. The differences between health-care professionals were statistically significant (P = 0.001).
Furthermore, it was observed that only 40.82% medical, 4.93% nursing, and 3.52% dental professionals have ever seen the ADR reporting form. In accordance with this, it was found that only 37.86% medical, 16.04% nursing and none of the dental professionals have been trained on reporting on ADR. The differences among the health-care professionals were statistically significant (P = 0.001) [Table 4].
|Table 4: Showing pharmacovigilance related practices among the healthcare professionals|
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In addition, a highest of 95.66% health-care professionals agreed that there is no Pharmacovigilance Committee in their Institution. While exploring the factors discouraging from reporting ADRs, it was found that 70.42% dental and 66.27% medical professionals felt it difficult to decide whether the ADR has occurred or not. On the other hand, 83.95% nursing professional had a lack of time to report the ADR [Figure 1] and [Figure 2].
|Figure 1: Response of the health-care professionals in relation to the presence of Pharmacovigilance Committee in the Institute|
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|Figure 2: Showing response of the healthcare professionals in relation to the factors discouraging from reporting ADRs|
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| Discussion|| |
During the developmental phase of a drug, a good deal is known about its therapeutic activity but rather less about its safety because the clinical trials are conducted in a controlled environment in a lesser number of patients and subjects. Once a drug gains entry into the market, it will be prescribed by hundreds of doctors to thousands of patients belonging to different age groups. The scenario is complicated when there are ethnic variations, presence of co-morbid conditions and concomitant medications. During this phase, only unusual and rare ADRs are encountered. Hence, if we have a system which can help us determine any new information available in relation to their safety profile can be critically useful. And since there are considerable social and economic consequences of ADRs, there is a need to engage health-care professionals, in a well-structured program to build synergies for monitoring ADRs. ADR reporting is of prime importance in the success of any pharmacovigilance program. 
Hence, the cross-sectional questionnaire survey was conducted with the intention of assessing the outlook of prescribers toward ADRs and pharmacovigilance. The current study was conducted in a working hospital of Central India; which included a total of 392 health-care professionals, that is, 169 (43.11%) medical, 142 (36.22%) dental, and 81 (20.66%) nursing professionals. The response rate reported in our study was highest (100%) than that reported in other studies. ,
It was observed that the awareness about ADR among all the health-care professionals was very low. In fact, one of the major findings of our study is that the percentage of awareness among the dental and nursing staff was surprisingly negligible. This indicates a serious issue of concern and immediate measures should be taken regarding this as both these professionals are an integral part of our health-care system.
Most of the health-care professionals (75.51%) accepted that reporting ADR is necessary, and pharmacovigilance should be taught in detail to health-care professionals. These findings are in correlation with findings of a study conducted by Gupta et al. 
Only 38.01% health-care professionals knew the existence of PvPI. Whereas only few, that is, 28.57% health-care professionals knew that in India the CDSCO is a regulatory body responsible for monitoring ADRs. These findings are lower compared to other studies conducted among the health-care professionals. 
According to the outcomes of our research, health-care professionals' practice toward ADR reporting was far below expectation. We observed that there was a huge gap between the ADR experienced (52.29%), and ADR reported (6.12%) by the health-care professionals. These findings are similar to those reported by WHO  and with other studies conducted by Aziz et al.,  Herdeiro et al.  and Okezie and Olufunmilayo.  More alarming, however, is the fact that the dentists and nursing staff have never reported a single case of ADR while working in the institution.
It was noticed that the participants in our study could not utilize their knowledge to conduct proper ADR reporting since they had a lack of training in this regard. We found that only 19.64% health-care professionals were trained on how to report ADR. Similarly, a survey conducted in United Arab Emirates revealed that only 5.5% of doctors received training on ADR reporting.  This shows that there is an urgent need for all stakeholders to come together to ensure proper implementation of pharmacovigilance program.
The hallmark finding of our study was to know that dentists were never been trained on ADR reporting. This finding was very discouraging for us as the role of dentist becomes critical to ensure safe and effective oral care.
Nwokike  in his study suggested that attention should shift from spontaneous reporting by health-care workers to self-report or patient initiated reporting of ADRs; encouraging health-care professionals to self-report incidences of personal experiences of ADR may motivate them into engaging in pharmacovigilance activities after graduation.
Furthermore, in relation to ADR reporting, we also identified the various possible factors responsible for underreporting. These determinants of underreporting include no remuneration, difficulty in deciding whether ADR has occurred or not, lack of time, belief that a single unreported case may not affect ADR database, lack of training, and unawareness regarding the ADR reporting form etc. Similar factors were identified by studies conducted by Gupta et al.,  and Showande and Oyelola. 
Many Indian studies have indicated that there is a gradual increase in the knowledge and attitude of the health-care professionals toward pharmacovigilance, ,,, but unfortunately, it seems that the actual practice of ADR reporting is still deficient.
It has been reemphasized that there is a positive correlation between training of Pharmacovigilance and reporting ADR by health-care professionals.  Factors like the unawareness about the method to decide the causal relationship between the ADR can only be removed by regular training.  The significance of adverse event monitoring and reporting can be increased through academic interference. This will ultimately help in improving the efficiency of pharmacovigilance program in India.
We recommend that hospital managements, pharmaceutical companies, drug regulatory agencies should pay a significant contribution toward educating doctors on ADR monitoring and reporting. Along with this; few more suggestions were advised by previous researches. These include: Inclusion of pharmacovigilance in the undergraduate curriculum for health-care professionals,  Perseverance of pharmacovigilance center,  establishing a network of doctors for ADR reporting,  easy accessibility to ADR reporting forms,  Promotion of patient self-reporting,  and regular E-mail update on the safety of drugs. 
Limitations of the study include; results are of only a single hospital (institution) and those inherent to questionnaire-based studies such as subjective response and recall bias. It would be logical to extend this study to other teaching hospitals, private practitioners, members of allied fields, students of medical and associated streams to enable us generalize our findings.
| Conclusion|| |
The results of our study indicate that the majority of the health-care professionals had a poor knowledge and attitude about pharmacovigilance. There was a huge gap between the ADR experienced, and ADR reported by the health-care professionals especially among dentist and nursing staff. Similarly, a clear-cut correlation between training of pharmacovigilance and reporting ADR was found. Furthermore, the majority of the respondents agreed that reporting of ADR is necessary and awareness that pharmacovigilance should be taught in detail to the health-care professionals. It has been advised that the health-care professionals; especially dental and nursing should be trained properly on ADR reporting to improve the current scenario in the pharmacovigilance program of the country.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4]