An Overview about Safety Surveillance of Adverse Drug Reactions and Pharmacovigilance in India

Jump To References Section

Authors

  • Mehrukh Zehravi
     Department of Clinical Pharmacy Girls Section, Prince Sattam Bin Abdul Aziz University, Alkharj ,SA
  • Mudasir Maqbool
     Department of Pharmaceutical Sciences, University of Kashmir, Srinagar, Jammu and Kashmir - 190 006 ,IN
  • Irfat Ara
     Regional Research Institute of Unani Medicine, Srinagar, Jammu and Kashmir - 190 006 ,IN

DOI:

https://doi.org/10.21048/IJND.2021.58.3.27285

Keywords:

Medicines, unwanted effects, safety, injury, pharmacovigilance, animal models

Abstract

One pathway for more actively monitoring Adverse Drug Reactions (ADRs) and, as a result, improving patient care safety is a structured Adverse Drug Reaction Surveillance network. Multiple methods for testing and recording the efficacy of drugs in clinical use are important for avoiding or reducing patient injury and strengthening public health. This entails establishing a well-structured Pharmacovigilance programme in clinical practise. Once a prescription has been published into the "true world," pharmacovigilance is an important method of monitoring medication-related issues. Pharmacovigilance and other drug-related problems should be familiar to those whose life is impacted by prescription procedures in some way. In modern times, pharmacovigilance has gained prominence as a technology critical to sound clinical practise and public health science. Since ADRs have such a detrimental influence on patients' wellbeing and inflict too much financial strain, it's critical to carefully monitor each medication for any potential adverse effects in animal models (preclinical studies) and clinical trials until releasing it. Pharmacovigilance aims to serve a significant part in combating the dangers faced by an ever-growing number of drugs, each of which is vulnerable to unpredictably negative side effects. When adverse effects and toxicity occur, they must be recorded, analysed and the importance of the results correctly communicated to those who may understand the evidence. By ensuring that prescription drugs of high consistency, purity and effectiveness are used rationally, the risk of injury will be minimised. In this study it will briefly explore adverse drug reaction safety control and pharmacovigilance in India.

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...

Downloads

Published

2021-09-07

How to Cite

Zehravi, M., Maqbool, M., & Ara, I. (2021). An Overview about Safety Surveillance of Adverse Drug Reactions and Pharmacovigilance in India. The Indian Journal of Nutrition and Dietetics, 58(3), 408–418. https://doi.org/10.21048/IJND.2021.58.3.27285

Issue

Volume 58, Issue 3, July-September 2021

Section

Review Articles

License

All the articles published in IJND are distributed under a creative commons license. The journal allows the author(s) to hold the copyright of their work (all usages allowed except for commercial purpose).

Please contact us at editor@informaticsglobal.com for permissions related to commercial use of the article(s).

Crossref
Scopus
Google Scholar
Europe PMC
Received 2021-03-10
Accepted 2021-06-21
Published 2021-09-07

 

References

Organization, W.H. International drug monitoring: the role of national centres, report of a WHO meeting (held in Geneva from 20 to 25 September 1971), World Health Organization, 1972.

Classen, D.C., Pestotnik, S.L., Evans, R.S., Lloyd, J.F. and Burke, J.P. Adverse drug events in hospitalized patients: Excess length of stay, extra costs and attributable mortality. JAMA., 1997, 277, 301-306. DOI: https://doi.org/10.1001/jama.277.4.301

Ruiz, B., Garcí­a, M., Aguirre, U. and Aguirre, C. Factors predicting hospital readmissions related to adverse drug reactions. Eur J. Clin. Pharmacol., 2008, 64, 715-722. DOI: https://doi.org/10.1007/s00228-008-0473-y

Lazarou, J., Pomeranz, B.H. and Corey, P.N. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA., 1998, 279, 1200-1205. DOI: https://doi.org/10.1001/jama.279.15.1200

Kennedy, D.L. Spontaneous reporting in the United States. Pharmacoepidemiol., 2000, 149-174. DOI: https://doi.org/10.1002/0470842555.ch10

Organization, W.H. The importance of pharmacovigilance, 2002.

Zdrowia, Åš.O. The importance of pharmacovigilance: Safety monitoring of medicinal products, World Health Organization, 2002.

Liu, M., Matheny, M.E., Hu, Y. and Xu, H. Data mining methodologies for pharmacovigilance. ACM SIGKDD Explorations Newsletter., 2012, 14, 35-42. DOI: https://doi.org/10.1145/2408736.2408742

Walker, S. and Lumley, C. The attitudes of general practitioners to monitoring and reporting adverse drug reactions. Pharm. Med., 1986, 1, 195-203.

Egberts, T.C., Smulders, M., de Koning, F.H., Meyboom, R.H. and Leufkens, H.G. Can adverse drug reactions be detected earlier? A comparison of reports by patients and professionals. BMJ., 1996, 313, 530-531. DOI: https://doi.org/10.1136/bmj.313.7056.530

Martin, R.M., Kapoor, K.V. Wilton, L.V. and Mann, R.D. Underreporting of suspected adverse drug reactions to newly marketed ("black triangle”) drugs in general practice: Observational study. BMJ., 1998, 317, 119-120. DOI: https://doi.org/10.1136/bmj.317.7151.119

Lumley, C., Walker, S.R. and Hall, G.C. The under-reporting of adverse drug reactions seen in general practice. Pharm. Med., 1986, 1, 205-212.

Smith, C., Bennett, P.M., Pearce, H.M., Harrison, P.I., Reynolds, D.J., Aronson, J.K. and Grahame-Smith, D.G. Adverse drug reactions in a hospital general medical unit meriting notification to the committee on safety of medicines. Br. J. Clin. Pharmacol., 1996, 42, 423-429. DOI: https://doi.org/10.1046/j.1365-2125.1996.04376.x

Moride, Y., Haramburu, F., Requejo, A. A. and Bégaud, B. Under-reporting of adverse drug reactions in general practice. Bri. J. Clin. Pharmacol., 1997, 43, 177-181. DOI: https://doi.org/10.1046/j.1365-2125.1997.05417.x

Fornasier, G., Francescon, S., Leone R. and Baldo, P. An historical overview over Pharmacovigilance. Int. J. Clin. pharm., 2018, 40, 744-747. DOI: https://doi.org/10.1007/s11096-018-0657-1

Rawlins, M.D. Pharmacovigilance: Paradise lost, regained or postponed?: The William Withering Lecture 1994. J. Royal Colle. Physi. London., 1995, 29, 41.

Geiling, E. and P.R. Cannon. Pathologic effects of elixir of sulfanilamide (diethylene glycol) poisoning: A clinical and experimental correlation. J. Am. Med. Assoc., 1938, 111, 919-926. DOI: https://doi.org/10.1001/jama.1938.72790360005007

McBride, W.G. Thalidomide and congenital abnormalities. Lancet, 1961, 2, 90927-90928. DOI: https://doi.org/10.1007/978-94-011-6621-8_27

Routledge, P. 150 years of pharmacovigilance. Lancet., 1998, 351, 1200-1201. DOI: https://doi.org/10.1016/S0140-6736(98)03148-1

Venulet, J. and Ten Ham, M. Methods for monitoring and documenting adverse drug reactions. Int. J. Clin. Pharm. Therap., 1996, 34, 112-129.

Organization, W.H. WHO Programme for International Drug Monitoring, 2001.

Star, K., Sandberg, L., Bergvall,T., Choonara, L., Janosa, P.C. and Edwards, I.R. Paediatric safety signals identified in VigiBase: Methods and results from Uppsala Monitoring Centre. Pharmacoepidemiol. Drug Safet., 2019, 28, 680-689. DOI: https://doi.org/10.1002/pds.4734

Gross, F. The scientific basis of drug safety regulations. Drug Safety: Progress and Contro., 1982. DOI: https://doi.org/10.1016/B978-0-08-027074-6.50008-5

Belton, K. Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. Eur. J. Clin. Pharmacol., 1997, 52, 423-427. DOI: https://doi.org/10.1007/s002280050314

Goettler, M., Schneeweiss, S. and Hasford, J. Adverse drug reaction monitoring-cost and benefit considerations. Part II: Cost and preventability of adverse drug reactions leading to hospital admission. Pharmacoepidemiol. Drug safet., 1997, 6, S79-S90. DOI: https://doi.org/10.1002/(SICI)1099-1557(199710)6:3+<S79::AID-PDS294>3.3.CO;2-F

Muehlberger, N., Schneeweiss, S. and Hasford, J. Adverse drug reaction monitoring-cost and benefit considerations. Part I: Frequency of adverse drug reactions causing hospital admissions. Pharmacoepidemiol. Drug Safet., 1997, 6, S71-S77. DOI: https://doi.org/10.1002/(SICI)1099-1557(199710)6:3+<S71::AID-PDS282>3.3.CO;2-9

Maqbool, M., Gani, I., Geer, M. and Khan, M. Hemovigilance and blood safety: A review. Int. J. Pharm. Biol. Arch., 2018, 9, 122-127.

Lihite, R. J., Lahkar, M., Das, S., Hazarika, D., Kotni, M. and Maqbool, M. A study on adverse drug reactions in a tertiary care hospital of Northeast India. Alexand. J. Med., 2017, 53, 151-156. DOI: https://doi.org/10.1016/j.ajme.2016.05.007

Lezotre, P.L. International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations: A Global Perspective, Academic Press, 2013.

Ahmad, A., Patel, I., Balkrishnan, R., Mohanta, G.P. and Manna, P.K. An evaluation of knowledge, attitude and practice of Indian pharmacists towards adverse drug reaction reporting: A pilot study. Persp. Clin. Res., 2013, 4, 204. DOI: https://doi.org/10.4103/2229-3485.120168

Figueiras, A., Tato, F., Fontaiñas, J. and Gestal-Otero, J.J. Influence of physicians' attitudes on reporting adverse drug events: A case-control study. Med. care., 1999, 809-814. DOI: https://doi.org/10.1097/00005650-199908000-00010

Williams, D. and Feely, J. Underreporting of adverse drug reactions: Attitudes of Irish doctors. Irish J. Med. Sci., 1999, 168, 257-261. DOI: https://doi.org/10.1007/BF02944353

Hasford, J., Goettler, M., Munter, K.H. and Müller-Oerlinghausen, B. Physicians' knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. J. Clin. Epidemiol., 2002, 55, 945-950. DOI: https://doi.org/10.1016/S0895-4356(02)00450-X

Perlik, F., Slanar, O., Smí­d, M. and Petrácek, J. Attitude of Czech physicians to adverse drug reaction reporting. Eur. J. Clin. Pharmacol., 2002, 58, 367-369. DOI: https://doi.org/10.1007/s00228-002-0476-z

Rehan, H., et al. Adverse drug reaction monitoring: knowledge, attitude and practices of medical students and prescribers. Nat. Med. J. India., 2002, 15, 24-26.

Dhikav, V. Adverse drug reaction monitoring in India. J. Ind. Acad. Clin. Med., 2004, 5, 27-33.

Upadhyaya, H.B., Vora, M.B., Nagar, J.G., Patel, P.B. Knowledge, attitude and practices toward pharmacovigilance and adverse drug reactions in postgraduate students of Tertiary Care Hospital in Gujarat. J. Adv. Pharm. Technol. Res., 2015, 6, 29. DOI: https://doi.org/10.4103/2231-4040.150369

Blenkinsopp, A., Wilkie, P., Wang, M., Routledge, P.A. Patient reporting of suspected adverse drug reactions: A review of published literature and international experience. Br. J. Clin. Pharmacol., 2007, 63, 148-156. DOI: https://doi.org/10.1111/j.1365-2125.2006.02746.x

Margraff, F. and Bertram, D. Adverse drug reaction reporting by patients: an overview of fifty countries. Drug safet., 2014, 37, 409-419. DOI: https://doi.org/10.1007/s40264-014-0162-y

Biswas, P. Pharmacovigilance: Safety matter. Ind. J. pharmacol., 2008, 40, S1.

Kulkarni, R. Reporting systems for rare side effects of non-narcotic analgesics in India. Problems and opportunities. Med. Toxicol., 1986, 1, 110-113.

Kalaiselvan, V., Srivastava, S., Singh, A. and Gupta, S.K. Pharmacovigilance in India: Present scenario and future challenges. Drug safet., 2019, 42, 339-346. DOI: https://doi.org/10.1007/s40264-018-0730-7

Ara, I., Bukhari, B., Ara, N. and Maqbool, M. Present status, standardization and safety issues with herbal drugs. Int. J. Res. Pharm. Sci. Technol., 2020, 1, 95-101. DOI: https://doi.org/10.33974/ijrpst.v1i3.169

Maqbool, M., et al. Drug safety and Pharmacovigilance: An overview. J. Drug Deliv. Therap., 2019, 9, 543-548.