Global Pharmacovigilance, challenges, and future considerations: West globe and East globe
Pharmacovigilance (PV) plays a consequential role in the drug regulatory system and is a constantly evolving multifaceted field. In the process of carrying out its effective management, the PV system does undergo a lot of challenges on a global pitch. PV system is well developed in the western globe (United States, United Kingdom, Germany) while the east globe (e.g.: India) is still in the evolving stage. Major discrepancies include different regulatory authorities for each nation with different forms for ADR reporting and also different timelines. To mention a few; there is a regulatory gap because of the continuously evolving regulations and business processes, it is difficult to comply with the diverse regulations effectively; gross underreporting in the east as compared to the west; increased concern about the safety and potential toxicity of traditional Chinese herbs in the east; self-medication; linguistic barrier, etc. Steps like harmonization of regulation by drafting guidelines that are uniform globally; leveraging digital technologies to optimize ADR reporting; meticulous and timely reporting; inclusion of PV in the curriculum etc. can be employed. While PV has witnessed substantial development over the years, areas of discrepancies need to be identified to build a seamless PV system. Need for an effective revolutionary roadmap to tackle all the hindrances to fortify its harmonious functioning.
Andrews E, Gilsenan A, Cook S. Therapeutic risk management interventions: feasibility and effectiveness. Journal of the American Pharmacists Association, 2004; 44(4):491-500
Beninger P. Pharmacovigilance: Challenges in getting from here to there. Clinical Therapeutics, 2018;40(12):1964-1966
Dal Pan GJ. Ongoing challenges in pharmacovigilance. Drug Safety, 2014;37(1):1-8.
Fernandes S, Narayanan AV, Castelino LJ, Rompicherla NC. A national approach to pharmacovigilance: The case of India as a growing hub of global clinical trials. Research in Social and Administrative Pharmacy, 2018;15(1):109-113.
Geneva World Health Organization. Looking at the Pharmacovigilance: ensuring the safe use of medicines. WHO Policy Perspectives on Medicines. Geneva: WHO, 2004. Cited on 2019 June 12
Hans M, Gupta SK. Comparative evaluation of pharmacovigilance regulation of the United States, United Kingdom, Canada, India and the need for global harmonized practices. Perspectives of Clinical Research, 2018;9(1):170-174.
Hori A, Pharmacovigilance activities in Japan. PMDA, 2011; Accessed on 2020 June 21
Sarinic VM. Pharmacovigilance new challenges for WHO. WHO TBS- Essential medicines and health products, Oct. 05, 2018.
Jose J, Rafeek NR. Pharmacovigilance in India in Comparison With the USA and European Union: Challenges and Perspectives. Therapeutic Innovation & Regulatory Science, 2019;53(6):781-786.
Kalaiselvan V, Srivastava S, Singh A, Gupta SK.. Pharmacovigilance in India: Present Scenario and Future Challenges. Drug Safety, 2018;42(3):339-346.
Mittal N, Mittal R, Gupta MC. An overview of the pharmacovigilance system in India. Clinical Research and Regulatory Affairs, 2016;33(1):4-8
Pipasha Biswas. Pharmacovigilance in Asia. Journal of Pharmacology and Pharmacotherapeutics, 2013;4(1): S7-S19
Singh A, Bhatt P. Comparative evaluation of adverse drug reaction reporting forms for introduction of a spontaneous generic ADR form. Journal of Pharmacology and Pharmacotherapeutics, 2012;3(3):228-232.
Sloane R, Osanlou O, Lewis D, Bollegala D, Maskell S, Pirmohamed M. Social media and pharmacovigilance: A review of the opportunities and challenges. British Journal of Clinical Pharmacology, 2015;80(4):910-920.
Zhang L, Wong LYL, He Y, Wong ICK. Pharmacovigilance in China: Current Situation, successes and Challenges. Drug Safety, 2014;37:765-770
Zhao Y, Wang T, Li G, Sun S. Pharmacovigilance in China: development and challenges. International Journal of Clinical Pharmacy, 2018;40(6):1-9.
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