Stimulated adverse drug reaction reporting in Pharmacovigilance: Indian Perspectives

Review Article

  • Anusha Thota NDDTC, Adverse reaction Monitoring Centre, Pharmacovigilance programme of India, Ghaziabad, UP 201002 https://orcid.org/0000-0002-3123-4251
  • Siddharth Sarkar NDDTC, All India institute of medical sciences, Ghaziabad, UP 201002
  • Snehil Guptha NDDTC, All India institute of medical sciences, Ghaziabad, UP 201002
  • Prasad Thota Indian Pharmacopoeia Commission, Ghaziabad, UP 201002
Keywords: HCPs, Safety reporting, the culture of reporting, awareness program

Abstract

The voluntary reporting of adverse drug reactions requires continuous stimulation and motivation. It is achieved by the development of a positive approach towards pharmacovigilance among healthcare professionals so that adverse reaction reporting becomes an accepted and understood routine. In summary, the various strategies developed and made available in India to stimulate reporting, promotion, educational interventions/ awareness program/academics, hospital-based ADRs reporting, establish a culture of reporting. These exclusive strategies progress the reporting rate in India by altering the mindset of healthcare professionals, undergraduates, and consumers towards safety reporting.

Author Biographies

Anusha Thota, NDDTC, Adverse reaction Monitoring Centre, Pharmacovigilance programme of India, Ghaziabad, UP 201002

Department of Pharmacovigilance

Siddharth Sarkar, NDDTC, All India institute of medical sciences, Ghaziabad, UP 201002

Department of Psychiatry

Snehil Guptha, NDDTC, All India institute of medical sciences, Ghaziabad, UP 201002

Department of Psychiatry

Prasad Thota, Indian Pharmacopoeia Commission, Ghaziabad, UP 201002

Department of Microbiology

References

Arici MA, Gelal A, Demiral Y, Tuncok Y. Short and long-term impact of pharmacovigilance training on the pharmacovigilance knowledge of medical students. Indian Journal of Pharmacology, 2015;47(4):436–9.

Cassels A, Hughes MA, Cole C, Mintzes B, Lexchin J, McCormack JP. Drugs in the news: an analysis of Canadian newspaper coverage of new prescription drugs. Canadian Medical Association Journal, 2003;168(9):1133-7.

Cassels AK. The media-medicine mix: quality concerns in medical reporting. Open Medicine. 2007;1(1):e52–e54.

Dorsey ER, Rabbani A, Gallagher SA, Conti RM, Alexander GC. Impact of FDA black box advisory on antipsychotic medication use. Archives of Internal Medicine 2010;170(1):96–103.

Edwards IR, Lindquist M. Social media and networks in pharmacovigilance: boon or bane? Drug Safety, 2011; 34(4): 267-271.

Gavaza P, Brown CM, Lawson KA, Rascati KL, Wilson JP, et al. Influence of attitudes on pharmacists intention to report serious adverse drug events to the Food and Drug Administration. British Journal of Clinical Pharmacology, 2011;72(1):143-152.

Gony M, Badie K, Sommet A, Jacquot J, Baudrin D, Gauthier P, Montastruc JL, Bagheri H. Improving adverse drug reaction reporting in hospitals: results of the French Pharmacovigilance in Midi-Pyrénées region (PharmacoMIP) network 2-year pilot study. Drug Safety, 2010;33(5):409-16.

Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Safety, 2006;29(5):385-96.

Herdeiro MT, Polonia J, Gestal-Otero JJ, Figueiras A. Factors that influence spontaneous reporting of adverse drug reactions: a model centralized in the medical professional. Journal of Evaluation in Clinical Practice, 2004; 10(4):483-9.

Iaboli L, Caselli L, Filice A, Russi G, Belletti E. The unbearable lightness of health science reporting: a week examining Italian print media. PLoS One, 2010;5(3):e9829.

Indian Pharmacopoeia Commission, https://ipc.gov.in/PvPI/adr.html, last accessed on 26/11/2019.

Jha N, Rathore D, Shankar P, Gyawali S, Hassali M, Alshakka M, and Alshammri T. Strengthening adverse drug reaction reporting in Nepal. Asian Journal of Medical Sciences, 2015;6(4): 9-13.

Johansson ML, Hagg S, Wallerstedt SM. Impact of information letters on the reporting rate of adverse drug reactions and the quality of the reports: a randomized controlled study. BMC Clinical Pharmacology, 2011;11(14);1-6.

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. Journal of Natural Science, Biology and Medicine, 2013;4(1):191–6.

Klopotowska JE, Wierenga PC, Smorenburg SM, Stuijt CC, Arisz L, Kuks PF, Dijkgraaf MG, Lie-A-Huen L, de Rooij SE; WINGS study group.Recognition of adverse drug events in older hospitalized medical patients. European Journal of Clinical Pharmacology, 2013;69(1):75–85.

Motola D, Vargiu A, Leone R, Conforti A, Moretti U, Vaccheri A, Montanaro N. Influence of Regulatory Measures on the Rate of Spontaneous Adverse Drug Reaction Reporting in Italy. Drug Safety,2008;31(7): 609–616.

Moynihan R, Bero L, Ross-Degnan D, Henry D, Lee K, Watkins J, Mah C, Soumerai SB. Coverage by the news media of the benefits and risks of medications. New England Journal of Medicine, 2000;342(22):1645–50.

IPC, NCC-Pharmacovigilance Programme of India. Recommendation letter to regulators. Sep 19, 2019.1-6

Pharmacovigilance Programme of India, ADR Reporting status. https://ipc.gov.in/PvPI/adr.html last accessed on 26/12/2019.

Pharmacovigilance Programme of India drug alerts. http://www.pvpi.in/das.html last accessed on 26/12/2019.

Pillars PI. Clinical perspective in drug safety and adverse drug reactions. Expert Review of Clinical Pharmacology, 2008; 1(5): 695–705.

Rehan HS. Vasudev K. Tripathi CD. Adverse drug reaction monitoring. Knowledge, attitude, and practices of medical students and prescribers. National Medical Journal of India, 2002;15(1), 24–6.

George C, Reporting adverse drug reactions, A guide for healthcare professionals.BMA Board of Science, 2006:1-36.

Sloane R, Osanlou O, Lewis D, Bollegala D, Maskell S, Pirmohamed M. Social media and pharmacovigilance: A review of the opportunities and challenges. British Journal of Clinical Pharmacology, 2015;80(4):910–920.

Williams D, Feely J. Underreporting of adverse drug reactions. Attitudes of Irish Doctors. Irish Journal of Medical Science, 1999;168 (4): 257– 261.

Wong CK, Marshall NS, Grunstein RR, et al. Spontaneous Adverse Event Reports Associated with Zolpidem in the United States 2003-2012. Journal of Clinical Sleep Medicine, 2017;13(2):223–234.

Yong PL, Bigman C, Flynn DN, Mittermaier D, Long JA. Messages about black-box warnings: a comparative analysis of reports from the FDA and lay media in the US. Drug Saf, 2009;32(12):1147–1157.

Published
2021-06-01
How to Cite
1.
Thota A, Sarkar S, Guptha S, Thota P. Stimulated adverse drug reaction reporting in Pharmacovigilance: Indian Perspectives. jpadr [Internet]. 2021Jun.1 [cited 2021Jun.13];2(2):11-5. Available from: https://jpadr.com/index.php/jpadr/article/view/30