Awareness among consumers on adverse drug reaction reporting system in India - A cross-sectional questionnaire-based study

Yamuna Devi M. S (1) , Saratha Muthukumar (2) , Kaavya S (3)
(1) Department of Pharmacology, Saveetha Medical College, Chennai – 602105, Tamil Nadu, India, India ,
(2) Saveetha Medical College, Chennai – 602105, Tamil Nadu, India, India ,
(3) Department of Pharmacology, Saveetha Medical College, Chennai – 602105, Tamil Nadu, India, India

Abstract

The adverse drug reaction (ADR) reporting system in India came into existence in 2010 through an initiative by the Government, the Pharmacovigilance Programme of India (PvPI), considering the social and economic consequences of drug effects. Though the system is functioning effectively for almost a decade, there has been a lacuna in reporting due to the lack of awareness among the patients who are the direct consumers. Medicine side-effects reporting is the newest initiative started in 2014 by PvPI, and the forms for consumer reporting is made available in over 10 different Indian languages like Tamil, Hindi, etc. It is imperative to determine the level of awareness among the public regarding drug side-effects and the existence of a National Programme to monitor the same, especially in a country like India with a population of nearly 1.38 billion. The aim of this study was to determine the awareness among the general population about the ADR reporting system in India. This cross-sectional study was done over a period of one year amongst the general public in South India. Data was collected from about 338 participants using a standardized questionnaire and analyzed descriptively using SPSS statistical software version 24. The overall response rate was 93.8%, and the mean age was 35.62 ± 10.43 years. Though the respondents had sufficient knowledge (66%) about ADRs, their awareness about the reporting system was very poor (19%). Reporting through phone (78%) was preferred over-reporting through specific forms (10%). To conclude, our study emphasizes that public participation and awareness are crucial in strengthening the existing system of Pharmacovigilance.

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References

Adisa, R., Adeniyi, O. R., Fakeye, T. O. 2019. Knowledge, awareness, perception and reporting of experienced adverse drug reactions among outpatients in Nigeria. International Journal of Clinical Pharmacy, 41(4):1062–1073.

Angamo, M. T., Chalmers, L., Curtain, C. M., Bereznicki, L. R. 2016. Adverse drug reaction related hospitalisations in developed and developing countries: a review of prevalence and contributing factors. Drug Safe, 39(9):847–857.

Backstrom, M., Mjorndal, T. 2006. A small economic inducement to stimulate increased reporting of adverse drug reactions-a way of dealing with an old problem. European journal of clinical pharmacology, 62(5):381–385.

Hakkarainen, K. M., Hedna, K., Petzold, M., Hägg, S. 2012. Percentage of Patients with Preventable Adverse Drug Reactions and Preventability of Adverse Drug Reactions–A Meta-Analysis. PLoS ONE, 7(3): e33236–e33236.

Kalaiselvan, V., Prasad, T., Bisht, A., Singh, S., Singh, G. N. 2014. Adverse drug reactions reporting culture in Pharmacovigilance Programme of India. The Indian journal of medical research, 140(4):563–564.

Mulchandani, R., Kakkar, A. K. 2018. Reporting of adverse drug reactions in India: A review of the current scenario, obstacles and possible solutions. International Journal of Risk & Safety in Medicine, 30(1):33–44.

Pahuja, R., Shrivastava, B., Sharma, P. K., Kishore, K., Mahajan, S., Sood, R. 2014. Awareness on adverse drug reaction reporting system in India: a consumer survey. American Journal of Phytomedicine and Clinical Therapeutics, 2(12):1361–1369.

Patel, J. J., Shah, M. K., Patel, P. P., Gandhi, A. M., Desai, M. K. 2019. Knowledge, attitude and practice among consumers about adverse drug reaction reporting. International Journal of Basic & Clinical Pharmacology, 8(8):1776–1776.

Patel, K. J., Kedia, M. S., Bajpai, D., Mehta, S. S., Kshirsagar, N. A., Gogtay, N. J. 2007. Evaluation of the prevalence and economic burden of adverse drug reactions presenting to the medical emergency department of a tertiary referral centre: a prospective study. BMC Clinical Pharmacology, 7(1):1–5.

Rishi, R. K., Patel, R. K. 2012. Under Reporting of ADRs by Medical Practitioners in India-Results of Pilot Study. Advances in Pharmacoepidemiology & Drug Safety, 1(3):1–3.

Shepherd, G., Mohorn, P., Yacoub, K., May, D. W. 2012. Adverse drug reaction deaths reported in the United States vital statistics, 1999-2006. Ann Pharmacother, 46(2):169–175.

WHO, World Health Organizations 2002. WHO-Safety of Medicines-A guide to detecting and reporting adverse drug reactions. pages 1–20.

Authors

Yamuna Devi M. S
dr.yamuna14@gmail.com (Primary Contact)
Saratha Muthukumar
Kaavya S
Yamuna Devi M. S, Saratha Muthukumar, & Kaavya S. (2021). Awareness among consumers on adverse drug reaction reporting system in India - A cross-sectional questionnaire-based study. International Journal of Research in Pharmaceutical Sciences, 12(2), 1276–1282. Retrieved from https://ijrps.com/home/article/view/163

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