Author(s):
Vikas P. Londhe, Rahul Chanshetti, S.N. Dhole
Email(s):
vikas.londhe2011@gmail.com
DOI:
10.52711/2231-5691.2024.00029
Address:
Vikas P. Londhe1, Rahul Chanshetti2, S.N. Dhole3
1Assistant Professor, Dept. of Pharmacy Practice, PES’S Modern College of Pharmacy for Ladies, Moshi, Pune.
2Co-ordinator, Dept. of Pharmacy Practice, PES’S Modern College of Pharmacy for Ladies, Moshi, Pune.
3Pricipal, Modern College of Pharmacy for Ladies, Moshi, Pune.
*Corresponding Author
Published In:
Volume - 14,
Issue - 2,
Year - 2024
ABSTRACT:
Pharmacovigilance is a field now everyone in healthcare industry is well aware of. Pharmacovigilance study ensure that the medicine consumed by patient is effective enough to be sell in market and having less harm as compared to its benefit. Historically the medicine safety was not the prime focus during approval of medicine but some unforeseen events happened in past emphasized the need of stringent rules and regulation on drug research and approval process. Though many events happened in past which harmed the mankind seriously but thalidomide was the biggest tragedy happened and turning to be the stepping stone of modern pharmacovigilance. Many countries like USA, Japan and UK realized the importance of pharmacovigilance to ensure patient safety and took serious steps to regularize the drug development process. At collaborative level also many countries come forward to strengthen pharmacovigilance. World health organization (WHO)-Uppsala Monitoring Centre, Council for International Organizations of Medical Science (CIOMS), International council on harmonization (ICH) and Good Pharmacovigilance Practice (GVP) are the bodies which lay down stringent rules and regulations on drug development process and primarily focused on drug safety. Now pharmacovigilance come long a way since its inception back in history, and modern pharmacovigilance is not remains limited to only check effectiveness and safety of medicine but its ensuring the patient safety. It uses many advance tools and trends for effective pharmacovigilance process and to dig more and more safety data related to medicine which finally uses to ensure patient safety.
Cite this article:
Vikas P. Londhe, Rahul Chanshetti, S.N. Dhole. Pharmacovigilance: Past, Present and Future. Asian Journal of Pharmaceutical Research. 2024; 14(2):175-2. doi: 10.52711/2231-5691.2024.00029
Cite(Electronic):
Vikas P. Londhe, Rahul Chanshetti, S.N. Dhole. Pharmacovigilance: Past, Present and Future. Asian Journal of Pharmaceutical Research. 2024; 14(2):175-2. doi: 10.52711/2231-5691.2024.00029 Available on: https://asianjpr.com/AbstractView.aspx?PID=2024-14-2-14
6. REFERENCES:
1. Jeetu G, Anusha J. Pharmacovigilance: A worldwide master key for drug safety monitoring. J Young Pharm. 2010; 2(3): 315-320.
2. Dave VS. Current Trends in Pharmacovigilance. J Pharmacovigilance. 2013; 1(2): 1000e104.
3. European Medicine Agency. Guidelines on good pharmacovigilance practices (GVP). Introductory Cover Note EMA/213497/2017.
4. WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems. World Health Organization, Geneva 2004.
5. Lichtenfeld I. The past, present and future of pharmacovigilance. dddmag.com/drug safety 2016 March 17. Available from https://www.dddmag.com/article/2016/03/past-present-and-future-pharmacovigilance
6. Young S. FDA warns about benzocaine baby pain gel. cnn.com 2012 June 1st. Available from http://thechart.blogs.cnn.com/2012/06/01/fda-warns-about-benzocaine-in-baby-pain-gels/?hpt=hp_bn12
7. Jones JK, Kingery E. History of Pharmacovigilance. Elizabeth B. Andrews and Moore N Editors. Mann’s Pharmacovigilance. 3rd ed. John Wiley and Sons, Ltd. 2014. p. 11-24.
8. Knight III PR, Bacon DR. An unexpected death Hannah greener and chloroform. Anesthesiology 2002; 96:1250–3.
9. DeHovitz RE. The 1901 St Louis incident: The first modern medical disaster. Pediatrics. 2014; 133 (6): 964-65.
10. McIntyre A. Upton Sinclair’s The Jungle: The legal and social impact of classic novel. Food Regulation in the United States. 2008 Feb 02. P-1-11.
11. Ballentine C. Taste of raspberries, taste of death the 1937 sulphanilamide incident. Sulphanilamide disaster, FDA Consumer Magazine. June 1981.
12. A History of the FDA and Drug Regulation in United States. FDA Centennial 1906-2006. Available from https://www.fda.gov/downloads/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandingover-the-countermedicines/ucm093550.pdf
13. Ridings JE. The thalidomide disaster, Lessons from the past. Barrow PC editor. Teratogenicity Testing: Methods and Protocols, Methods in Molecular Biology, Vol 947. Humana Press; 575-86.
14. Fintel B, Samras AT, Caria E. The thalidomide tragedy: lessons for drug safety and regulation. Available from http://helix.northwestern.edu/article/thalidomide-tragedy-lessons-drug-safety-and-regulation
15. Sen A. Thalidomide tragedy revisited. Pharma Bio World 2013 September. Available from http://oviyamedsafe.com/wp-content/uploads/2015/01/Thalidomide-Tragedy-Revisited.pdf
16. Hamburg M. 50 years after thalidomide: Why regulation matters. FDA Voices 2012 February 02. Available from https://blogs.fda.gov/fdavoice/index.php/2012/02/50-years-after-thalidomide-why-regulation-matters/
17. Rice EL. Frances Kelsey. Turning the thalidomide tragedy into food and drug administration reform. Research Paper. 2007: p-1-25. Available from http://www.section216.com/history/Kelsey.pdf
18. World Health Organization. The importance of pharmacovigilance, safety monitoring of medicinal products. The Uppsala Monitoring Centre WHO collaborating centre for international drug monitoring; 2002.
19. The Medicines and Healthcare Products Regulatory Agency. Medicines and Medical Devices Regulation: What you need to know; April 2008. Available from http://www.mhra.gov.uk/home/groups/comm-sic/documents/websiteresources/con2031677.pdf
20. Post marketing surveillance of drugs. Chapter 4 Pharmaceutical regulation in Japan. Available from http://www.jpma.or.jp/english/parj/pdf/2017_ch04.pdf
21. CIOMS. Benefit risk balance for marketed drugs: evaluating safety signals. Report of CIOMS working group IV. Geneva; 1998.
22. CIOMS. Organization, Activities, Members. Geneva; 1994.
23. Cortez A. Introducing the International Conference on Harmonization Guidelines into the World Trade Organization: A Strategy to Remove Technical Trade Barriers for Pharmaceutical Products. MACD Project; spring 2002. Available from http://www.commercialdiplomacy.org/ma_projects/cortez.htm
24. ICH Harmonization for better health. Understanding MedDRA, medical dictionary for drug regulatory activities. International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use. ICH Secretariat; 2013.
25. World Health Organization. International Conference on Harmonization (ICH): pharmacovigilance activities. WHO Drug Information; 16(1): 2002: p-11-12.
26. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH Harmonised tripartite guideline. Pharmacovigilance Planning (E2E); 2004 November 18.
27. European Medicine Agency. Pharmacovigilance risk assessment committee. Rules of procedure. 2013 March 03.
28. Yes leading in regulatory solution. Recent development in pharmacovigilance from regulator perspective. Available from https://d2cax41o7ahm5l.cloudfront.net/cs/speaker-ppts/mohammad-wasif-khan-yes-regulatory-healthcare-services-india-pvt-ltd-india.pdf
29. Post marketing reporting of adverse drug experiences. 21 C.F.R. Sect. 314.80 (2017).
30. Suke SG, Kosta P, Negi H. Role of pharmacovigilance in India: An Overview. Online Journal of Health Informatics 2015; 7(2): 1-34.
31. Biswas P. Pharmacovigilance in Asia. J Pharmacol Pharmacother 2013; 4:7-19.
32. Ghewari PS, Salunkhe SS, Bhatia NM, Kileedar SG. Strategies and current scenario of Pharmacovigilance in India. Journal of Advanced Drug Delivery 2014; 1(3); 122-134.
33. Kalaiselvan V, Thota P, Singh GN. Pharmacovigilance Programme of India: Recent developments and future perspectives. Indian J Pharmacol 2016; 48: 624-8.
34. Gupta V, Kaur K, Sharma R, Kaushal IG, Kaushal S. Pharmacovigilance: Current schedule Y perspective. J Adv Res Pharm Sci Pharmacol Interv 2016; 1(1&2): 26-32.
35. 3 Trends in the Global Pharmacovigilance Market. Future market insight 2016 Jan 14. Available from http://www.mynewsdesk.com/us/future-market-insights/pressreleases/3-trends-in-the-global-pharmacovigilance-market-1292566
36. Sikdar S, Souttou A. The current challenges in dealing with adverse event reports from social media. 26th Annual Euro Meeting; 2014 March 25-27; Vienna, Austria. Available from http://www.ubc.com/sites/default/files/library/poster_challenges_ae_social_media.pdf
37. Brennan W. Industry trends shaping the future of pharmacovigilance. C3i solutions 2015 Nov 15. Available from https://www.c3isolutions.com/blog/future-of-pharmacovigilance/
38. Sciformix Corporation. The impact and use of social media in pharmacovigilance. Westborough MA. Available from https://www.sciformix.com/wp-content/uploads/Social_Media_in_PV_Whitepaper.pdf
39. Pierce CE, Bouri K, Pamer C, Proestel S, Rodriguez HW, Le HV et al. Evaluation of Facebook and Twitter Monitoring to Detect Safety Signals for Medical Products: An Analysis of Recent FDA Safety Alerts. Drug Saf 2017; 40:317–331.
40. Pharmacovigilance programme of India. Newsletter 2015; 5(12).
41. WEB RADR. Theme 2: Using mobile technology for real-time pharmacovigilance. WEB RADR stakeholder Event. 2017 Sept 7. Available from https://webradr.files.wordpress.com/2017/09/web-radr-stakeholder-event_theme2.pdf
42. Houyez F. Web-RADR: Use of mobile applications for ADRs reporting and social media data mining. Eurordis PCWP-HCPWP meeting EMA. 2015 March 4. Available from http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2015/04/WC500185781.pdf
43. Outsourcing Trends in Pharmacovigilance. Available from http://www.cliniminds.com/presentation/pdffiles/Outsourcing_Trends_in_Pharmacovigilance_full.pdf
44. Williams A. Hot trends in pharmacovigilance. QuintilesIMS blog 2017 January 19. Available from http://www.quintiles.com/blog/hot-trends-in-pharmacovigilance
45. Stepping in to the future of pharmacovigilance The what why and how of knowledge process outsourcing. Parexel white paper. Available from https://www.parexel.com/files/8113/8869/0490/Stepping_Into_the_Future_of_Pharmacovigilance.pdf
46. Global market insight. Pharmacovigilance Market will grow at lucrative CAGR to cross $8 billion by 2024. Industry Today 2017 September 20. Available from https://industrytoday.co.uk/health_and_safety/pharmacovigilance-market-will-grow-at-lucrative-cagr-to-cross--8-billion-by-2024/64154/64154
47. Pitts P. 21st Century Pharmacovigilance and the Role of Artificial Intelligence. Morning Consult 2016 October 6. Available from https://morningconsult.com/opinions/21st-century-pharmacovigilance-role-artificial-intelligence/
48. Bataller C. Case Study: Pharmacovigilance Monitoring Adverse Drug Reactions. Coming of age of artificial intelligence Disruption, transformation ahead. Accenture. P-8-10. Available from http://irpaai.com/AI2015-recap-London/resources/AI-Coming-of-Age-Bataller-for-distribution.pdf
49. Automation in Pharmacovigilance Data Processing – Do You Trust Artificial Intelligence? ArisGlobal 2017 May 16. Available from http://www.arisglobal.com/automation-pharmacovigilance-data-processing-trust-artificial-intelligence/
50. Sherlock A, Adolf C. Artificial Intelligence as an Aid to Pharmacovigilance. PharmaExec.com 2017 March 12. Available from http://www.pharmexec.com/artificial-intelligence-aid-pharmacovigilance
51. Alsayed I. An integrated pharmacovigilance model to meet the new regulatory trends. Parexel white paper. Available from https://www.parexel.com/files/3814/5494/7588/Access_Pharmacovigilance_IntegratedModel_WhitePaper_ONLINE_DEC15.pdf
52. Kumar V. Challenges and Future Consideration for Pharmacovigilance. J Pharmacovigilance. 2013; 1 (1): 1-3.
53. Issued by Strategic priority group of the global vaccine safety initiative (GVSI): Global Vaccine Safety Initiative 2013-2014 Annual Report. World Health Organization; 2015. Report No.: WHO/EMP/RHT/SAV/2015.2.
54. Maure CG, Dodoo AN, Bonhoeffer J, Zuber PLF. The Global Vaccine Safety Initiative: enhancing vaccine pharmacovigilance capacity at country level. Bull World Health Organ. 2014; 92:695–696.
55. Global Vaccine Safety Global Advisory Committee on Vaccine Safety. World Health Organization. 2017 June 7-8. Available from http://www.who.int/vaccine_safety/committee/en/
56. US Food and Drug Administration. The Sentinel Initiative. US department of health and human services. Centre for drug evaluation and research. Office of medical policy. Available from https://www.fda.gov/downloads/safety/fdassentinelinitiative/ucm233360.pdf
57. European Medicines Agency. Guideline on key aspects for the use of Pharmacogenomics in the Pharmacovigilance of Medicinal Products. 2015 September 24.
58. Ehmann F. Personalised Medicine 2020 –Regulatory Aspects and Early Dialogue. EHFG‐Forum 4 “Personalised Medicine 2020” – 2014 October 2, Bad Hofgastein, Austria.
59. Wertheimer A. The Impact of Personalized Medicine on Pharmacovigilance. J Pharmacovigilance 2015; 3 (1).
60. McCully S. Conducting non-interventional studies in Europe attempts at clarity lead to increased complexity. Inventive Health Clinical 2015 January. Available from http://www.inventivhealthclinical.com/Collateral/Documents/English-US/landing/Non-Interventional%20Research_Jan_Feb%202015.pdf
61. Companies encouraged to seek scientific ad-vice for PASS. What’s new in pharmacovigilance QPPV update 2016 (1). Available from http://www.ema.europa.eu/docs/en_GB/document_library/Newsletter/2016/04/WC500205595.pdf