Review; Pharmacovigilance and Drug Safety: A Global Perspective

Authors

  • T. Shivamurthi Department of Pharmacology, Dr. K. V. Subbareddy Institute of Pharmacy, Dupadu, Kurnool, 518218, Andhra Pradesh, India
  • D. Chaitanya Dixit Department of Pharmacology, Dr. K. V. Subbareddy Institute of Pharmacy, Dupadu, Kurnool, 518218, Andhra Pradesh, India
  • M. Sri Ramachandra Department of Pharmacology, Dr. K. V. Subbareddy Institute of Pharmacy, Dupadu, Kurnool, 518218, Andhra Pradesh, India

DOI:

https://doi.org/10.22270/ajprd.v13i1.1519

Abstract

A significant and essential component of clinical research is pharmacovigilance. Throughout the product lifecycle, post-marketing pharmacovigilance and clinical trial safety are both crucial. The pharmacological science that deals with the identification, evaluation, comprehension, and avoidance of negative consequences is known as pharmacovigilance. What is known about its advantages and disadvantages, difficulties, and prospects in Indian medicine? Here, the primary emphasis is on the objectives and function of pharmacovigilance in the regulation of medications and their partners. including the short- and long-term negative consequences of medications. In India, pharmacovigilance is still in its infancy, and very little is known about the field. Although the field of pharmacovigilance has made significant strides in western nations, nothing has been accomplished inIndia chose to join the Uppasla Centre for Adverse Event Monitoring at that time. With the help of the media and regulatory bodies, pharmacovigilance has become increasingly important as people have grown more knowledgeable about the risks and benefits of medications. Any unfavourable medical event that may arise when taking a medication but is not always connected to its use is referred to as an adverse event. "An adverse drug reaction is any unpleasant, unexpected, and undesirable side effect of a medication that happens at  dosage used in humans for diagnosis, treatment, prevention, or alteration of physiological function." In order to collect safety data for early detection, spontaneous reporting of adverse drug reactions and events is a crucial tool. A growing number of Indian businesses have emerged in recent years. In 2008, this is really recent data and has been used here since most recent and relevant data available are of this year. Available, it was estimated that (ADRS) accounted for 5% of the total amount of reports, thus minimizing the number of times that honest adverse reaction reports were being eliminated

 

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Author Biographies

T. Shivamurthi, Department of Pharmacology, Dr. K. V. Subbareddy Institute of Pharmacy, Dupadu, Kurnool, 518218, Andhra Pradesh, India

Department of Pharmacology, Dr. K. V. Subbareddy Institute of Pharmacy, Dupadu, Kurnool, 518218, Andhra Pradesh, India

D. Chaitanya Dixit , Department of Pharmacology, Dr. K. V. Subbareddy Institute of Pharmacy, Dupadu, Kurnool, 518218, Andhra Pradesh, India

Department of Pharmacology, Dr. K. V. Subbareddy Institute of Pharmacy, Dupadu, Kurnool, 518218, Andhra Pradesh, India

M. Sri Ramachandra, Department of Pharmacology, Dr. K. V. Subbareddy Institute of Pharmacy, Dupadu, Kurnool, 518218, Andhra Pradesh, India

Department of Pharmacology, Dr. K. V. Subbareddy Institute of Pharmacy, Dupadu, Kurnool, 518218, Andhra Pradesh, India

References

Pipasha, B., Arun , K.B.„Setting standards for proactive pharmacovigilance inIndia: The way forward‟, Indian J pharmacol , 2007; 39(3): 124-128.

Kumanan, R., Sudha, S., Vijayashre, P., Charumath, S., Gowridevi, K.C., Mahesh, M.Imperative Approach on pharmacovigilance in Indian systems of medicines‟, International journal of pharma sciences and Research (ijpsr), 2010; 1(9): 378-390.

Deepa, A. Pharmacovigilance obligations of the pharmaceutical companies in India‟, India J pharmacol, 2008; 40: S13-S16.

European Commission. MEMO/08/782, Brussels, 10 December November 2008. Strengthening pharmacovigilance to reduce adverse effects of medicines. http://europa.eu/rapid/press-release_ MEMO-08-782_en.htm?locale=en (2017). Accessed 3 Jul 2017.

Miller MT (1991). "Thalidomide Embryopathy: A Model for the Study of Congenital Incomitant Horizontal Strabismus". Transactions of the American Ophthalmological Society. 81: 623–674.

Jump up to:a b c d Loue S, Sajatovic M (2004). Encyclopedia of Women's Health. Springer Science & Business Media. pp. 643–644. ISBN 9780306480737.

Sneader W (2005). Drug discovery: a history (Rev. and updated ed.). Chichester: Wiley. p. 367. ISBN 978-0-471-89979-2.

Jump up to:a b c Cuthbert A (2003). The Oxford Companion to the Body. Oxford University Press. p. 682. Doi:10.1093/acref/9780198524038.001.0001. ISBN 9780198524038.

Thomas, Katie (2020-03-23). "The Unseen Survivors of Thalidomide Want to Be Heard". The New York Times. ISSN 0362-4331. Retrieved 2020-03-23.

Williams, Roger (September 10, 2012). "The Nazis and Thalidomide: The Worst Drug Scandal of All Time". Newsweek. Retrieved 25 August 2021.

Thalidomide Monograph for Professionals". Drugs.com. Retrieved 14 November 2019.

Montgomery W. From the New Books (a review of 'Historic South Edinburgh' Vol 2 by CJ Smith), Scots Magazine, 1980; 112: 514. Forrester SD. Scots Magazine, 1980; 113: 122 (L).

Smith CJ. Scots Magazine, 1980; 113: 439-40 (L). Smith CJ. Scots Magazine, 1981; 114: 458-9 (L). Broomfield CEo No Women Allowed. Scots Magazine, 1985; 122: 611-4.

Ballentine, Carol (June 1981). "Sulphanilamide Disaster" (PDF). FDA Consumer Magazine.^ "Medicine: Post-Mortem". Time. December 20, 1937. Retrieved 2009-07-19.

The New York Times. November 26, 1937. Retrieved 2009-07-20.^ Shaw, Leslie M. (2001). The clinical toxicology laboratory: contemporary practice of poisoning evaluation. Washington, DC: AACC Press. ISBN 1-890883-53-0.

WHO. Global programme for vaccines and immunization: Expanded Programme on Immunization. Surveillance of adverse events following immunization: Field guide formanagers of immunization programmes. Geneva 1997.

Haramburu F, Bégaud B, Moride Y. Temporal trends in spontaneous reporting of unlabelled adverse drug reactions. Br J Clin Pharmacol. 1997;44:299–301. doi: 10.1046/j.1365-2125.1997.t01-1-00573.x.

Rawlins MD. Pharmacovigilance: paradise lost, regained or postponed? The William Withering Lecture 1994. J R Coll Physicians Lond. 1995;29:41–49. [published erratum appears in J R Coll Physicians Lond 1995; 29: 118]

S.K Gupta Textbook of pharmacovigilance 2nd edition .Jaypee brothers medicals publishers.2019.

Elizabeth B ,Andrews Nicholas moore mann’s pharmacovigilance 3rd edition wily Blackwell 2024.

Borton cobert ncobert,s manual pg drug safety and pharmacovigilance 2nd edition jones and b arlett learning 2022.

Wood L, Martinez C. The general practice research database: role in pharmacovigilance. Drug Saf 2004;27:871–81.

Norén GN, Bate A, Hopstadius J, Star K, Edwards IR. Temporal pattern discovery for trends and transient effects: its application to patient records. In: Proceeding of the 14th ACM SIGKDD International Conference on Knowledge Discovery and Data Mining, 24–27 August 2008, Las Vegas, Nevada, USA.

Hocine MN, Musonda P, Andrews NJ, Farrington C. Sequential case series analysis for pharmacovigilance. J R Stat Soc Ser A (Statistics in Society) 2009; 172:213–36. 10.1111/j.1467-985X.2008.00555.x

Baim DS, Mehran R, Kereiakes DJ, et al. Postmarket surveillance for drug-eluting coronary stents: a comprehensive approach. Circulation. 2006 Feb 14; 113(6):891–7.

U.S. Food and Drug Administration. Medical Device Reporting. [August 15, 2012].

Gross TP, Witten CM, Uldriks C, et al. A view from the US Food and Drug Administration. In: Frank E, Johnson KSV, editors. The Bionic Human: Health Promotion for People with Implanted Prosthetic Devices. Vol. 5. Totowa, New Jersey: Humana Press, Inc.; 2006. pp. 61–87.

Current Challenges in Pharmacovigilance: Pragmatic Approaches (Report of CIOMS Working V), Geneva 2001

Rules Governing Medicinal Products in the European Union, Volume 9, Pharmacovigilance: Medicinal Products for Human Use, 2001 http://pharmacos.eudra.org/F2/eudralex/vol-9/home.htm

Safety Reporting Requirements for Human Drug and Biological Products, Proposed Rule, Food and Drug Administration, March 2003 5. Notification No 421 on Enforcement of the Law Revising Partially the Pharmaceutical Affairs Law, the Director General, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, March 1997

Current Challenges in Pharmacovigilance: Pragmatic Approaches (Report of CIOMS Working V) Rules Governing Medicinal Products in the European Union, Volume 9, PHARMACOVIGILANCE: Medicinal Products for Human Use,

Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines, Food and Drug Administration, (draft) Safety Reporting equirements for Human Drug and Biological Products, Proposed Rule, and Drug Food Administration,

Notification No 421 on Enforcement of the Law Revising Partially the Pharmaceutical Affairs Law, the Director General, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare,

Vlahović-Palčevski V, Mentzer D. Postmarketing surveillance. In: Seyberth H, Rane A, Schwab M. (eds) Pediatric clinical pharmacology. Berlin: Springer-Verlag, 2011, pp.339–351.

Hartzema AG, Porta MS, Tilson HH, et al. Adverse drug events: identification and attribution. Drug Intell Clin Pharm 1987; 21: 915–920.

Zhang X, Zhang Y, Ye X, et al. Overview of phase IV clinical trials for postmarket drug safety surveillance: a status report from the ClinicalTrials.gov registry. BMJ Open 2016; 6: e010643.

Faillie JL, Montastruc F, Montastruc JL, et al. Pharmacoepidemiology and its input to pharmacovigilance. Therapie 2016; 71: 211–216.

Lafond J. Pharmacovigilance implemented by patients: a necessity in the 21st century. Therapie 2016; 71: 245–247.

39. Sharrar RG, Dieck GS. Monitoring product safety in the postmarketing environment. Ther Adv Drug Saf 2013; 4: 211–219.

Varallo FR, Planeta CS, Mastroianni PD. Effectiveness of pharmacovigilance: multifaceted educational intervention related to the knowledge, skills and attitudes of multidisciplinary hospital staff. Clinics 2017; 72: 51–57.

Pain J, Levacher J, Quinqunel A, et al. Analysis of Twitter data for postmarketing surveillance in pharmacovigilance. In: Proceedings of the 2nd workshop on noisy user-generated text, Osaka, Japan, 2016, pp.94–101.

Bahri P, Tsintis P. Pharmacovigilance-related topics at the level of the international conference on harmonisation. In: Mann RD, Andrews EB. (eds) Pharmacovigilance 2nd ed. Chichester: John Wiley & Sons, 2007:51–62.

Uppsala Monitoring Centre. Annual report: July 2018–June 2019,.

Goldman SA. Limitations and strengths of spontaneous reports data. Clin Ther 1998; 20(Suppl. C): C40–C44.

AlShammari TM, Almoslem MJ. Knowledge, attitudes & practices of healthcare professionals in hospitals towards the reporting of adverse drug reactions in Saudi Arabia: a multi-centre cross sectional study. Saudi Pharm J 2018; 26: 925–931.

Pham D, Le BK, Ho TB, et al. System pharmacology: application of network theory in predicting potential adverse drug reaction based on gene expression data. In: 2016 IEEE RIVF international conference on computing & communication technologies, research, innovation, and vision for the future (RIVF), 7 November 2016, pp.241–246. Hanoi, Vietnam: IEEE. [Goo

Krebs K, Milani L. Translating pharmacogenomics into clinical decisions: do not let the perfect be the enemy of the good. Hum Genomics 2019; 13: 39.

Alanazi H, Abdullah A, Qureshi K. A critical review for developing accurate and dynamic predictive models using machine learning methods in medicine and health care. J Med Syst 2017; 41: 69.

Published

2025-02-15

How to Cite

Shivamurthi, T., Dixit , D. C., & Ramachandra, M. S. (2025). Review; Pharmacovigilance and Drug Safety: A Global Perspective. Asian Journal of Pharmaceutical Research and Development, 13(1), 152–160. https://doi.org/10.22270/ajprd.v13i1.1519