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Research & Reviews: A Journal of Drug Formulation, Development and Production Review Article

Pharmacovigilance and drug safety current trends and challenges

  1. Mohd. Wasiullah Dept. of Pharmacy, Prasad Institute Technology, Jaunpur
  2. Piyush Yadav Dept. of Pharmaceutical Chemistry, Prasad Institute of Technology, Jaunpur
  3. Shivendra Dubey Dept. of Pharmacy, Prasad Polytechnic, Jaunpur
  4. Ritu Yadav Dept. of Pharmacy, Prasad Polytechnic, Jaunpur

Abstract

Pharmacovigilance and drug safety are critical areas of focus in healthcare, aimed at monitoring the safety and efficacy of pharmaceutical products throughout their lifecycle. This review explores current trends, emerging technologies, and challenges in pharmacovigilance, emphasizing their impact on public health and regulatory practices. With the increasing complexity of global pharmaceutical markets, pharmacovigilance systems are evolving to integrate real-time data analytics, artificial intelligence (AI), and machine learning (ML) to detect adverse drug reactions (ADRs) more efficiently. Despite significant advancements, challenges persist in data standardization, reporting inconsistencies, underreporting of ADRs, and the growing volume of data that needs to be processed. This article highlights key innovations, discusses the barriers hindering optimal drug safety practices, and provides recommendations for enhancing pharmacovigilance frameworks to improve patient safety and regulatory oversight.

Keywords

References (20)

  1. Pharmacovigilance (PVG. Pharmacovigilance: ensuring the safe use of medicines [Internet]. Who.int. World Health Organization; 2004 [cited 2024 Dec 27]. Available from: https://www.who.int/publications/i/item/WHOEDM2004.8
  2. Härmark L, van Grootheest AC. Pharmacovigilance: methods, recent developments and future perspectives. European Journal of Clinical Pharmacology. 2008;64(8):743-752. doi:10.1007/s00228-008-0475-9
  3. Biswas P, Biswas A. Setting standards for proactive pharmacovigilance in India: The way forward. Indian Journal of Pharmacology. 2007;39(3):124. doi:10.4103/0253-7613.33431
  4. World Health Organization. The Importance of Pharmacovigilance [Internet]. 2002 [cited 2024 Dec 27]. Available from: https://www.who.int/publications/i/item/10665-42493
  5. World Health Organization. (‎1973)‎. Handbook of resolutions and decisions of the World Health Assembly and the Executive Board, v. 1: cumulative definitive ed.; v. 2: cumulative definitive ed.; v. 3: 3rd ed.. World Health Organization. https://iris.who.int/handle/10665/79012
  6. van Grootheest K, Olsson S, Couper M, de Jong‐van den Berg L. Pharmacists' role in reporting adverse drug reactions in an international perspective. Pharmacoepidemiology and Drug Safety. 2003;13(7):457-464. doi:10.1002/pds.897
  7. World Health Organization. (‎2000)‎. WHO medicines strategy : framework for action in Essential Drugs and Medicines Policy 2000-2003. World Health Organization. https://iris.who.int/handle/10665/66503
  8. Olsson S. The Role of the WHO Programme on International Drug Monitoring in Coordinating Worldwide Drug Safety Efforts. Drug Safety. 1998;19(1):1-10. doi:10.2165/00002018-199819010-00001
  9. Coulter DM. The New Zealand Intensive Medicines Monitoring Programme. Pharmacoepidemiol Drug Saf. 1998 Mar;7(2):79-90. doi:10.1002/(SICI)1099-1557(199803/04)7:23.0.CO;2-1
  10. Mackay FJ. Post-Marketing Studies. Drug Safety. 1998;19(5):343-353. doi:10.2165/00002018-199819050-00002
  11. Folb PI, ten Ham M. Drug monitoring in developing countries: A drug regulator’s perspective. Drug Inf J. 1995;29:303–5.
  12. Talbot JCC, Nilsson BS. Pharmacovigilance in the pharmaceutical industry. British Journal of Clinical Pharmacology. 1998;45(5):427-431. doi:10.1046/j.1365-2125.1998.00713.x
  13. Moore N. The Role of the Clinical Pharmacologist in the Management of Adverse Drug Reactions. Drug Safety. 2001;24(1):1-7. doi:10.2165/00002018-200124010-00001
  14. Hall M, McCormack P, Arthurs N, Feely J. The spontaneous reporting of adverse drug reactions by nurses. British Journal of Clinical Pharmacology. 1995;40(2):173-175. doi:10.1111/j.1365-2125.1995.tb05774.x
  15. Inman WHW, Evans DAP. Evaluation of Spontaneous Reports of Adverse Reactions to Drugs. BMJ. 1972;3(5829):746-749. doi:10.1136/bmj.3.5829.746
  16. Benefit-Risk Balance for Marketed Drugs: Evaluating Safety Signals [Internet]. COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES. ; 2022 [cited 2024 Dec 27]. Available from: https://cioms.ch/publications/product/benefit-risk-balance-for-marketed-drugs-evaluating-safety-signals/
  17. Lazarou J, Pomeranz BH, Corey PN. Incidence of Adverse Drug Reactions in Hospitalized Patients. JAMA. 1998;279(15):1200. doi:10.1001/jama.279.15.1200
  18. White TJ, Arakelian A, Rho JP. Counting the Costs of Drug-Related Adverse Events. PharmacoEconomics. 1999;15(5):445-458. doi:10.2165/00019053-199915050-00003
  19. Avorn J, Solomon DH. Cultural and Economic Factors That (Mis)Shape Antibiotic Use: The Nonpharmacologic Basis of Therapeutics. Annals of Internal Medicine. 2000;133(2):128-135. doi:10.7326/0003-4819-133-2-200007180-00012
  20. Ball LK, Evans G, Bostrom A. Risky Business: Challenges in Vaccine Risk Communication. Pediatrics. 1998;101(3):453-458. doi:10.1542/peds.101.3.453
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