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 Table of Contents  
ORIGINAL ARTICLE
Year : 2021  |  Volume : 26  |  Issue : 1  |  Page : 46-51

A cross-sectional study on pharmacovigilance among rural doctors and private practitioners


1 Department of Pharmacology, Government Medical College, Surat, Gujarat, India
2 Post Intern Doctor, Government Medical College, Surat, Gujarat, India
3 Department of Community Medicine, Government Medical College, Surat, Gujarat, India

Date of Submission19-Jun-2020
Date of Acceptance08-Jan-2021
Date of Web Publication29-Jun-2021

Correspondence Address:
Dr. Mamtarani Verma
B-13 Assistant Professor Quarters, New Civil Hospital Campus, Majura Gate, Surat - 395 001, Gujarat
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jmgims.jmgims_75_20

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  Abstract 

Introduction: Rise in the introduction of newer drugs in the market has increased the need to monitor the adverse drug reactions (ADRs) to ensure patient safety. To overcome this need, a nation-wide Pharmacovigilance Programme was initiated by the Government of India with an objective to assure drug safety. Even after a decade of its initiation, the program is in the stage of infancy. Aims and Objectives: To document knowledge, attitude, and practice (KAP) regarding pharmacovigilance among Primary Health Center/Community Health Centers (PHC/CHC) and private doctors. To document the opinion of PHC/CHC and private doctors with regard to reporting of ADRs. Materials and Methods: Doctors working in private setup, PHC and CHC in rural district and doctors willing to give written informed consent were included. A cross-sectional study design was used. KAP questionnaire was designed to assess the demographic details of doctors, their knowledge of pharmacovigilance, attitudes toward pharmacovigilance and practice on ADR reporting. Data entry and analysis was done using SPSS software. Results: 109 doctors of PHC/CHC and private set-up responded in the study. Out of 109 doctors, 52 were private practitioners. The mean age of participants was 43.09 ± 14.15 years. 56 (51.4%) of PHC/CHC and private set-up doctors were aware regarding the existence of a National Pharmacovigilance Programme in India. 107 (98.2%) doctors of PHC/CHC and private set up have the opinion that there is the necessity of reporting ADRs. Conclusion: This study will definitely act as a sensitizer toward ADR reporting among rural and private doctors. It is the need of the hour that doctors must spare time out of their busy schedule to report ADRs. Strong policy formation should be done to motivate them for reporting ADRs.

Keywords: Attitude and practice, knowledge, pharmacovigilance, PHC/CHC doctors, private doctors


How to cite this article:
Divakar B, Patel R, Verma M. A cross-sectional study on pharmacovigilance among rural doctors and private practitioners. J Mahatma Gandhi Inst Med Sci 2021;26:46-51

How to cite this URL:
Divakar B, Patel R, Verma M. A cross-sectional study on pharmacovigilance among rural doctors and private practitioners. J Mahatma Gandhi Inst Med Sci [serial online] 2021 [cited 2021 Jul 24];26:46-51. Available from: https://www.jmgims.co.in/text.asp?2021/26/1/46/319839


  Introduction Top


Pharmacological interventions are an integral part of the patient care system. The safety of patients with regard to the cautious use of medicines is of highest priority in the modern-day therapy.[1] Adverse drug reactions (ADRs) are associated with significant morbidity and mortality in addition to imposing considerable economic burden on society.[2]

Rise in the introduction of newer drugs in the market has increased the need to monitor the ADRs to ensure patient safety. To overcome this need, a nation-wide Pharmacovigilance Programme was initiated by the Government of India with an objective to assure drug safety. Even after a decade of its initiation, the program is in the stage of infancy.[3] This is evident from the fact that there is a high level of under-reporting of ADRs.[4] A total of 3.7% of hospitalized patients experience an ADR, of which 1.3% was fatal.[5] ADRs increase the financial burden on the patients and hospitals apart from contributing to the mortality and morbidity of patients.[6]

Underreporting of adverse drug reactions

Currently, there is underreporting of ADRs to the ADR Monitoring Centre in our district as <50 ADRs, on an average per month are reported, most being from two Medical Colleges. With 13 Community Health Centers (CHCs), one Sub-District Hospital, 52 Primary Health Centers (PHCs) and numerous private health establishments in this district, the reporting is expected to be more considering the equal incidence of occurrence of ADRs within the whole country.

The number of studies published assessing knowledge, attitude, and practices (KAP) of doctors of PHCs/CHCs and private practitioner's regarding Pharmacovigilance and ADR reporting are quite less. Most studies have focused on tertiary care hospitals and few on private practitioners. Looking to the lack of availability of data on ADRs reporting from government and private set-up this study has focused on KAP of doctors regarding pharmacovigilance and their opinion about different ways to ADR reporting.

Aims and objectives

  1. To document KAP regarding pharmacovigilance among PHC/CHC and private doctors
  2. To document the opinion of PHC/CHC and private doctors with regard reporting of ADRs.



  Materials and Methods Top


A cross-sectional study was done among doctors of PHC/CHC of rural districts and among private practitioners. The study was done after obtaining Institutional Ethics Clearance and consent from doctors. Doctors working at PHC and CHC of the rural district and in private setup willing to give informed consent were included and those who denied participating in the study were excluded. KAP questionnaire was designed to assess the demographic details of doctors, their knowledge of pharmacovigilance, attitudes toward pharmacovigilance and practice on ADR reporting. Their opinions regarding reporting of pharmacovigilance was also inquired. The study was done for 2 months from June to July 2018.

For smooth conduction of the study permission of chief district health officer (CDHO) of the district was obtained. Private doctors were covered by snow-ball sampling. The informed consent form and the standard questionnaire, which is validated, published, and not copyrighted, was used. Doctors were sent the fillable Google form through CDHO e-mail to their respective e-mail IDs.

Data analysis was performed using SPSS software (version 19). Data were expressed as mean ± standard deviation. Proportions of response for KAP were calculated. The analysis was kept confidential and the anonymity of the participants was maintained.


  Results Top


109 (100.0%) doctors of PHC/CHC and private set-up responded in our study. The response rate among PHC/CHC doctors was approximately 57 (90%), as they were instructed by the CDHO of the district. Out of 109 doctors, 52 were private practitioners. The mean age of participants was 43.09 ± 14.15 years. The mean duration of practicing in their profession was 15.82 ± 12.82 years.

65 (59.6%) participants responded correctly about what is pharmacovigilance. The rest of the 44 (40.4%) participants defined pharmacovigilance incorrectly. 71 (65.1%) participants were aware that the most important purpose of pharmacovigilance is to identify the safety of the drug. 57 (52.3%) participants have knowledge that ADR reporting is professional obligation for them. 83 (76.1%) participants have knowledge that reporting ADRs in a hospital is the combined responsibility of doctors, nurses, and pharmacists. 56 (51.4%) participants were aware regarding the existence of the National Pharmacovigilance Programme in India. 74 (67.9%) participants were aware that the regulatory body responsible for monitoring ADRs in India is Central Drugs Standard Control Organization. 33 (30.3%) participants were aware that the international center for ADR monitoring is located in Sweden [Table 1].
Table 1: Knowledge about pharmacovigilance among PHC/CHC and Private set-up doctors

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107 (98.2%) participants have the opinion that there is the necessity of reporting ADRs. 102 (93.6%) participants have the opinion that pharmacovigilance should be taught to health care professionals. 67 (61.5%) participants have read any article on the prevention of ADRs. 65 (59.6%) participants have positive opinions regarding establishing ADR monitoring Centre in each hospital [Table 2].
Table 2: Attitude towards pharmacovigilance among PHC/CHC and private set-up doctors

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81 (74.3%) participants have experienced ADRs in patients. 13 (11.9%) participants have reported ADRs to the pharmacovigilance center. 45 (41.3%) participants have seen the ADR reporting form. 22 (20.2%) doctors of PHC/CHC and private set-up had ever been trained on reporting ADRs. 57 (52.3%) participants were aware that a serious adverse event should be reported to the regulatory authority within one day. 44 (40.4%) doctors of PHC/CHC and private set-up were aware that rare ADRs can be identified during phase 4 clinical trial. 40 (36.7%) doctors of PHC/CHC and private set-up were aware regarding the spontaneous reporting system as a tool to monitor ADRs of new drugs. 27 (24.8%) participants know regarding the pharmacovigilance committee in their district [Table 3].
Table 3: Practice toward pharmacovigilance among PHC/CHC and private set up doctors

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The opinion of doctors with regard to methods for reporting of ADRs were; E-mail 34.75%, reporting to higher authority 15.25%, online submission 14.41%, awareness generation/training among the community, doctors, staff nurses, patients (regarding history taking, through mass media), instructions to follow guidelines 11.86%, form filling following standard reporting format 7.63%, telephonically and text messaging 5.93%. Few suggestions were; setting deadlines for reporting, creating helpline number, experience sharing regarding ADRs, through proper channels and audits of medical and clinical cases [Table 4].
Table 4: Describing opinion of doctors with regard to methods for reporting of adverse drug reactions

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  Discussion Top


In our study, 65 (59.6%) doctors responded correctly about what is pharmacovigilance. While 56 (51.4%) doctors were aware regarding the existence of a National Pharmacovigilance Programme in India. In a study done by Komaram and Dhar among health care professionals in a tertiary care set-up, 61.76% of the study participants gave the correct response to the definition of pharmacovigilance and 58.82% responded correctly regarding knowledge on the existing pharmacovigilance program in India.[1]

The fact that the majority of respondents 107 (98.2%) agreed that reporting of ADR is necessary and pharmacovigilance 102 (93.6%) should be taught in detail to healthcare professionals is a major finding from our study. In a study done by Gupta et al. among the health-care professionals in a teaching hospital in South India, 97% of respondents agreed that reporting of ADR is necessary and pharmacovigilance (92.1%) should be taught in detail to healthcare professionals.[7]

In our study, 22 (20.2%) doctors had been trained on reporting ADRs which is similar to the low percentage of training imparted to healthcare professionals in previously reported studies from Indore[8] and Trivandrum.[9]

81 (74.3%) doctors had experienced ADRs in patients while only 13 (11.9%) doctors had reported ADRs to pharmacovigilance centres. This gap between the ADR experienced (64.4%) and ADR reported (22.8%) by healthcare professionals is in parallel with the study done by Gupta et al.[7] In a study done by Desai, even as ADR reporting was considered to be important by a large majority of the respondents, the actual reporting was very low. Just 15% of the respondents stated that they had reported an ADR previously.[10]

27 (24.8%) doctors were aware about the pharmacovigilance committee in their district. In a study by Desai, few respondents could identify B. J. Medical College as an ADR reporting center in Gujarat (under the older National Pharmacovigilance Program of India) and only 3% could identify any reporting system in the world.[10] However, it was different at Mumbai and Mysore where nearly 50% and 89% of the respondents, respectively, knew about the reporting center at their college.[11],[12] The adverse event reporting rate from our study is low which is similar to previously reported different Indian studies from Trivandrum,[9] Nagpur,[13] Bangalore,[14] Jalandhar,[15] Ahmedabad,[10] and Indore.[8]

40 (36.7%) doctors of our study were aware regarding spontaneous reporting the system as a tool to monitor ADRs of new drugs. 83 (76.1%) doctors of PHC/CHC and private set-up have knowledge that reporting ADRs in a hospital is the combined responsibility of doctors, nurses, and pharmacists. In another study by Sushma et al. less than half identified nurses, pharmacists, and dentists to be capable of reporting ADRs.[14] These findings were also observed in the Mumbai study where respondents did not identify nurses and pharmacists as qualified reporters.[15] In our study, 57 (52.3%) doctors from both government and private set-up were aware that a serious adverse event should be reported to the regulatory authority within one day. This indicates a lack of awareness of the principles and practice of pharmacovigilance among the respondents.

Opinion of doctors with regard to methods for reporting of ADRs were: email 34.75%, system of reporting to higher authority 15.25%, online submission 14.41%, awareness generation/training among community, doctors, staff nurse and patients, to follow guidelines 11.86%, form filling using standard reporting format 7.63%, telephonically and text messaging 5.93%. Few responses were: setting the deadline for reporting, creating helpline number, experience sharing regarding ADRs, through proper channel and carrying out the audit of medical and clinical cases.

In a study carried out in Nigeria, imparting continuous medical education, training, encouraging feedback from patients, prescribers and dispensers, publicity of a reporting scheme in local journals, and appointing an ADR specialist in every hospital, were some of the suggestions put forward by the prescribers for improving reporting. It was also opined that reporting of serious ADRs should be prioritized considering the workload of the prescribers and reporting should be made easy and convenient (by post or E-mail/websites, etc). These measures could improve the quantum and quality of the reports.[16]

Under-reporting of ADRs can be due to various reasons. A KAP study has certain limitations also.[16] This study does provide an insight into the possible interventions that could be planned in future.

ADR reporting system should be established and practitioners, pharmacists, and nurses should be made aware of this system. They should be trained properly. Moreover, proper feedback after data generation of ADR reporting should be given to respective reporters. Reporter must be acknowledged for their work. The deficits in the practice of ADR reporting can be resolved only if the prescribers are aware of the importance of reporting, the reporting system, and their obligation to report ADRs.

We conclude that this study will definitely act as sensitizer toward ADR reporting among rural and private doctors. It is the need of hour that doctors must spare time out of their busy schedule to report ADRs. Strong policy formation should be done to motivate them for reporting ADRs.

Acknowledgment

Study was approved by the Indian Council of Medical Research under the STS project, New Delhi. We are thankful to the CDHO of Surat District for giving the necessary permission and support. Our thanks go to Institutional Ethical Committee for approving the study. Last but not the least we are thankful to all the study participants.

Financial support and sponsorship

Study was approved and supported by ICMR, New Delhi under STS project.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

1.
Komaram RB, Dhar M. A study on assessment of knowledge, attitude and practice regarding pharmacovigilance among healthcare professionals in a tertiary care hospital, Andhra Pradesh. Int J Pharm Sci Res 2016;7:5082-7.  Back to cited text no. 1
    
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Meher BR, Joshua N, Asha B, Mukherji D. A questionnaire based study to assess knowledge, attitude and practice of pharmacovigilance among undergraduate medical students in a Tertiary Care Teaching Hospital of South India. Perspect Clin Res 2015;6:217-21.  Back to cited text no. 2
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Swain TR, Nityadarshini N, Pattnaik S, Swain KP. Knowledge, attitude and practice study regarding pharmacovigilance programme of India among private practitioners in urban Odisha, India. Int J Basic Clin Pharmacol Res 2016;5:1315-20.  Back to cited text no. 3
    
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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.  Back to cited text no. 7
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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.  Back to cited text no. 8
    
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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.  Back to cited text no. 10
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Gupta P, Udupa A. Adverse drug reaction reporting and pharmacovigilance: Knowledge, attitudes and perceptions amongst resident doctors. J Pharm Sci Res 2011;3:1064-9.  Back to cited text no. 11
    
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Ramesh M, Parthasarathi G. Adverse drug reactions reporting: Attitudes and perceptions of medical practitioners. Asian J Pharm Clin Res 2009;2:10-4.  Back to cited text no. 12
    
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Pimpalkhute SA, Jaiswal KM, Sontakke SD, Bajait CS, Gaikwad A. Evaluation of awareness about pharmacovigilance and adverse drug reaction monitoring in resident doctors of a tertiary care teaching hospital. Indian J Med Sci 2012;66:55-61.  Back to cited text no. 13
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Muraraiah S, Rajarathna K, Sreedhar D, Basavalingu D, Jayanthi CR. A questionnaire study to assess the knowledge, attitude and practice of Pharmacovigilance in a paediatric tertiary care centre. J Chem Pharm Res 2011;3:416-22.  Back to cited text no. 14
    
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Hardeep, Bajaj JK, Rakesh K. 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.  Back to cited text no. 15
    
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Oshikoya KA, Awobusuyi JO. Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria. BMC Clin Pharmacol 2009;9:1-8.  Back to cited text no. 16
    



 
 
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  [Table 1], [Table 2], [Table 3], [Table 4]



 

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