Volume : 13, Issue : 01, January – 2026

Title:

PHARMACOVIGILANCE AND DRUG SAFETY

Authors :

Dr.Padige Sri Varsha*, Padakanti Naga Harshitha, Banda Jashwanth, Vaddera Prashanthi

Abstract :

Through the identification, evaluation, comprehension, and prevention of adverse drug reactions (ADRs) throughout a medication’s lifecycle, pharmacovigilance plays a crucial role in guaranteeing drug safety. Strong pharmacovigilance systems are essential because, despite thorough pre-marketing clinical trials, uncommon, long-term, and population-specific side effects frequently only manifest during post-marketing use. The purpose of this study is to assess how pharmacovigilance can enhance drug safety outcomes, with a focus on risk minimization techniques, signal detection, and reporting adverse drug reactions. A thorough analysis of active surveillance databases, pharmaco-epidemiological studies, and spontaneous reporting systems was carried out. To evaluate patterns of ADR reporting, causality assessment, and regulatory actions taken in response to identified safety signals, data from national and international pharmacovigilance programs were analysed. The results show that early signal detection and prompt regulatory interventions, such as label modifications, risk communication, and, in certain situations, drug withdrawal, are greatly aided by efficient pharmacovigilance systems. ADR underreporting is still a significant issue, especially in low- and middle-income nations. Signal detection capabilities have been improved through the integration of real-world evidence, electronic health records, and sophisticated analytical techniques. In order to protect public health and maximize the benefit-risk profile of pharmaceuticals, pharmacovigilance is crucial. To advance drug safety surveillance worldwide, it is imperative
to adopt innovative technologies, improve data quality, and strengthen the culture of ADR reporting.
Keywords: Pharmacovigilance, Drug Safety, Adverse Drug Reactions, Signal Detection, Post-Marketing Surveillance.
Phytochemical studies; Herbal face serum.

Cite This Article:

Please cite this article in press Padige Sri Varsha et al., Pharmacovigilance And Drug Safety, Indo Am. J. P. Sci, 2026; 13(01).

REFERENCES:

1)World Health Organization. The importance of pharmacovigilance – safety monitoring of medicinal products. World Health Organization, Geneva, 2002.
2)WHO, Pharmacovigilance: ensuring the safe use of medicines, Geneva: WHO, 2004.
3)Commission on Anaesthetics. Lancet, 1893; i: 629–38
4)Shuka SS, Gidwani B, Pandey R, Rao SP, Singh V, Vyas A, Importance pharmacovigilance in Indian Pharmaceutical Industry, Asian Journal of Research in
Pharmaceutical Science, 2012; (2): 04-08.
5)Stephens K. Pharmacovigilance future prospective. Journal of Pharmacovigilance, 2000;
2: 23-29.
6)Edwards IR, Aronson JK, Adverse drug reactions: definitions, diagnosis, and management.
Lancet. 2000;356(9237):1255–1259.
7)van Grootheest K, Olsson S, Couper M, de Jong-van den Berg L-,Pharmacists’ role in reporting adverse drug reactions in an international perspective. Pharmaco- epidemol Drug Safe, 2004;13(7):457–464.
8)Osemene KP, Ayeni MI, Afolabi MO. The role of community pharmacists in monitoring adverse drug reactions in Nigeria. J Pharm Health, Serv Res. 2012;3(4):197–204.
9)Olsson S. National Pharmacovigilance Systems-Country profiles and Overview. 2nd ed. Uppsala: Uppsala Monitoring Centre; 1999.
10)Roberts PI, Wolfson DJ, Booth TG. The role of pharmacists in adverse drug reaction reporting. Drug Safe. 1994:11:7–11.
11)Hadi MA, Ming LC. Impact of pharmacist recruitment on ADR reporting: Malaysian experience. South Med Rev. 2011;4(2):102–103.
12)Glassman P. Clinical pharmacist’s role in preventing adverse drug events:brief update review. In: Making Health Care Safer II: An Updated Critical Analysis of the Evidence for Patient Safety Practices. Rockville, MD, agency for Healthcare Research and Quality (US); 2013 Mar. Evidence Reports/Technology Assessments, No. 211.) Chapter 4.
13) Calvert RT. Clinical pharmacy—a hospital perspective. Br J Clin Pharmacol,. 1999;47(3):231–238.
14) Schlienger RG, Lüscher TF, Haefeli WE, Schoenenberger RA. Academic detailing improves identification and reporting of ad-verse drug events,Pharm World Sci. 1999;21(3):110–5
15)Parsons RL, David JA. Gastrointestinal disease and drug absorption. In Amsterdam: EMA; 2023, Prescott LF, Nimmo WS, eds. Drug absorption. Sydney: Adis Press,1979:262-77.
16)Smith SE, Rawlins MD. Variability in human drug response, London.
17)Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions, Am J Hosp Pharm 1992; 49: 2222–31.
18)Black D. The limitations of evidence. J R Coll Physicians Lond 1998;32:23-6.
19)Lindley CM, Tully MP, Paramsothy V, Tallis RC. Inappropriate medication is a major cause of adverse drug reactions in elderly patients. Age Ageing 1992;21:294-300
20)Atkin PA, Veitch PC, Veitch EM, Ogle SJ. The epidemiology of serious adverse drug reactions among the elderly. Drugs Aging 1999;14:141-52.
21)Kalisch LM, Caughey GE, Roughead RE, Gilbert AL. The prescribing cascade, Aust Prescr 2011;34:162-6.
22)European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) EMA/813938/2011 Rev 1. 2012.
23)The importance of pharmacovigilance: safety monitoring of medicinal products, Geneva: World Health Organization; 2002.
24)The WHO Programme for International Drug Monitoring: celebrating 40 years, Uppsala: UMC; 2018.
25)VigiBase: WHO Global Database of Individual Case Safety Reports, Uppsala: UMC; 2022.
26)FDA Adverse Event Reporting System (FAERS),Silver Spring (MD): FDA; 2023.
27)MedWatch: The FDA Safety Information and Adverse Event Reporting Program,Silver Spring (MD): FDA; 2023.
28)EudraVigilance – European database of suspected adverse drug reaction reports.
29)Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India: overview and operational guidelines, Ghaziabad: IPC; 2022.
30)The importance of pharmacovigilance: safety monitoring of medicinal products, Geneva: World Health Organization; 2002.
31)WHO pharmacovigilance indicators: a practical manual for the assessment of pharmacovigilance systems, Geneva: World Health Organization; 2015.
32)Edwards IR, Aronson JK, Adverse drug reactions: definitions, diagnosis, and management, Lancet. 2000;356(9237):1255–1259.
33)International Council for Harmonisation (ICH),ICH Harmonised Guideline E2A: Clinical safety data management – definitions and standards for expedited reporting, Geneva: ICH; 1994.
34)International Council for Harmonisation (ICH), ICH Harmonised Guideline E2B(R3): Electronic transmission of individual case safety reports (ICSRs), Geneva: ICH; 2013.
35)Bate A, Evans SJW, Quantitative signal detection using spontaneous adverse event reporting systems, Pharmaco-epidemiol Drug Safe. 2009;18(6):427–436.
36)Lindquist M, VigiBase, the WHO Global ICSR database system: basic facts, Drug Inf J. 2008;42(5):409–419.
37)Waller PC, Evans SJ,A model for the future conduct of pharmacovigilance, Pharmaco-epidemiol Drug Safe. 2003;12(1):17–29.
38)Mann RD, Andrews EB, editors, Pharmacovigilance. 2nd ed,Chichester: John Wiley & Sons; 2007.
39)Strom BL, Kimmel SE, Hennessy S, Pharmacoepidemiology. 5th ed,Oxford: Wiley-Blackwell; 2012.
40)Kalaiselvan V, Thota P, Singh GN,Pharmacovigilance Programme of India: recent developments and future perspectives, Indian J Pharmacol. 2016;48(6):624–628.
41)Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India: overview and operational guidelines, Ghaziabad: IPC; 2022.
42)The importance of pharmacovigilance: safety monitoring of medicinal products.
Geneva: World Health Organization; 2002.