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Promoting Collaboration of Regulators and Patients in Improving Drug Safety and Regulatory Decision Making

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Abstract

Pharmacovigilance involves a continuous process of evaluating, monitoring and communicating the safety profile of a medicine throughout its life cycle. This process involves a range of stakeholders, including national regulatory authorities, industry, health organisations, healthcare providers and patients. Although patients are the end users of medicines and experts in their medical conditions, patient involvement is still nascent in the Asia-Pacific region. While there are positive examples and encouraging trends, several key challenges currently hinder systemic patient involvement in drug safety and regulatory decision making. Systemic issues such as a lack of formalised frameworks or platforms, underdeveloped communication and information exchange channels, and paternalistic health systems constrain greater patient involvement and collaborative regulator-patient activities. Addressing these challenges will greatly advance collaboration among regulators, patients, and patient advocates to enhance drug safety and regulatory decision making.

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Notes

  1. Council for International Organizations of Medical Sciences.

  2. The eight rungs of Arnstein’s ladder of citizen participation are manipulation, therapy, informing, consultation, placation, partnership, delegated power and citizen control.

  3. The IAP2 spectrum of public participation was developed to assist with selecting the appropriate level of participation that defines the public’s role in the public participation process.

  4. Patients Active in Research And Dialogues for an Improved Generation of Medicines.

  5. The Association of South-East Asian Nations comprises Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam. Timor Leste has observer status.

References

  1. World Health Organization. Regulations and laws promoting health and well-being goals (SDG3) in WHO South-East Asian countries. New Delhi, 2022. https://apps.who.int/iris/rest/bitstreams/1461864/retrieve. Accessed 2 Dec 2023.

  2. Trifirò G, Crisafulli S. A new era of pharmacovigilance: future challenges and opportunities. Front Drug Saf Regul. 2022;2: 866898. https://doi.org/10.3389/fdsfr.2022.866898.

    Article  Google Scholar 

  3. Sultana J, Cutroneo P, Trifirò G. Clinical and economic burden of adverse drug reactions”. J Pharmacol Pharmacother. 2013;4(1_Suppl):S73–7. https://doi.org/10.4103/0976-500X.120957.

    Article  PubMed  PubMed Central  Google Scholar 

  4. US Centers for Disease Control and Prevention. About the Vaccine Adverse Event Reporting System (VAERS). https://wonder.cdc.gov/controller/datarequest/D8. Accessed 9 Jun 2023.

  5. Medicine & Healthcare products Regulatory Agency (MHRA). The Yellow Card Scheme: MHRA. https://yellowcard.mhra.gov.uk/information. Accessed 8 Jun 2023.

  6. Ball R, Dal Pan G. Artificial intelligence’ for pharmacovigilance: ready for prime time? Drug Saf. 2022;45(5):429–38. https://doi.org/10.1007/s40264-022-01157-4.

    Article  PubMed  PubMed Central  Google Scholar 

  7. Rudolph A, Savage R. Vulval aphthous ulcers in adolescents following COVID-19 vaccination: analysis of an international case series. J Pediatr Adolesc Gynecol. 2023. https://doi.org/10.1016/j.jpag.2023.03.006.

    Article  PubMed  PubMed Central  Google Scholar 

  8. Krapf JM, Casey RK, Goldstein AT. Reactive non-sexually related acute genital ulcers associated with COVID-19”. BMJ Case Rep. 2021;14(5): e242653.

    Article  PubMed  PubMed Central  Google Scholar 

  9. Sultana J, Crisafulli S, Gabbay F, Lynn E, Shakir S, Trifirò G. Challenges for drug repurposing in the COVID-19 pandemic era. Front Pharmacol. 2020;11: 588654. https://doi.org/10.3389/fphar.2020.588654.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  10. Lumpkin MM, Lim JCW. Pandemic best regulatory practices: an urgent need in the COVID-19 pandemic. Clin Pharmacol Ther. 2020;108(4):703–5. https://doi.org/10.1002/cpt.1932.

    Article  CAS  PubMed  Google Scholar 

  11. Bolislis WR, de Lucia ML, Dolz, et al. Regulatory agilities in the time of COVID-19: overview, trends, and opportunities. Clin Ther. 2021;43(1):124–39. https://doi.org/10.1016/j.clinthera.2020.11.015.

    Article  CAS  PubMed  Google Scholar 

  12. Zhao Y, Fitzpatrick T, Wan B, Day S, Mathews A, Tucker JD. Forming and implementing community advisory boards in low- and middle-income countries: a scoping review. BMC Med Ethics. 2019;20(1):73. https://doi.org/10.1186/s12910-019-0409-3.

    Article  PubMed  PubMed Central  Google Scholar 

  13. Yue Q-Y. The International Society of Pharmacovigilance (ISoP) Pharmacogenomic Special Interest Group: pharmacogenomics in pharmacovigilance. Drug Saf. 2021;44(6):615–7. https://doi.org/10.1007/s40264-021-01068-w.

    Article  PubMed  PubMed Central  Google Scholar 

  14. Cavaller-Bellaubi M, Faulkner SD, Teixeira B, et al. Sustaining meaningful patient engagement across the lifecycle of medicines: a roadmap for action. Ther Innov Regul Sci. 2021;55(5):936–53. https://doi.org/10.1007/s43441-021-00282-z.

    Article  PubMed  PubMed Central  Google Scholar 

  15. Patient involvement in the development, regulation and safe use of medicines. CIOMS Working Group report. Geneva, Switzerland: Council for International Organizations of Medical Sciences (CIOMS), 2022. https://doi.org/10.56759/iiew8982.

  16. World Health Organization. Global patient safety action plan 2021–2030: towards eliminating avoidable harm in health care. Geneva, 2021. https://www.who.int/teams/integrated-health-services/patient-safety/policy/global-patient-safety-action-plan. Accessed 2 Dec 2023.

  17. Adopo D, Daynes P, Benkebil M, et al. Patient involvement in pharmacovigilance: determinants and evolution of reporting from 2011 to 2020 in France. Eur J Clin Pharmacol. 2023;79(2):229–36. https://doi.org/10.1007/s00228-022-03422-y.

    Article  CAS  PubMed  Google Scholar 

  18. Berrewaerts J, Delbecque L, Orban P, Desseilles M. Patient participation and the use of Ehealth tools for pharmacoviligance. Front Pharmacol. 2016;7:90. https://doi.org/10.3389/fphar.2016.00090.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  19. Paola K, Claudio G. The value of direct patient reporting in pharmacovigilance. Ther Adv Drug Saf. 2020;11:2042098620940164. https://doi.org/10.1177/2042098620940164.

    Article  PubMed  PubMed Central  Google Scholar 

  20. Inácio P, Cavaco A, Airaksinen M. The value of patient reporting to the pharmacovigilance system: a systematic review: the value of patient reporting to the pharmacovigilance system. Br J Clin Pharmacol. 2017;83(2):227–46. https://doi.org/10.1111/bcp.13098.

    Article  PubMed  Google Scholar 

  21. Blenkinsopp A, Wilkie P, Wang M, Routledge PA. Patient reporting of suspected adverse drug reactions: a review of published literature and international experience. Br J Clin Pharmacol. 2007;63(2):148–56. https://doi.org/10.1111/j.1365-2125.2006.02746.x.

    Article  CAS  PubMed  Google Scholar 

  22. Suwankesawong W, Dhippayom T, Tan-Koi W-C, Kongkaew C. Pharmacovigilance activities in ASEAN countries. Pharmacoepidemiol Drug Saf. 2016;25(9):1061–9. https://doi.org/10.1002/pds.4023.

    Article  PubMed  Google Scholar 

  23. Hugman B. The Erice Declaration: the critical role of communication in drug safety. Drug Saf. 2006;29(1):91–3. https://doi.org/10.2165/00002018-200629010-00007.

    Article  PubMed  Google Scholar 

  24. Kim Y-S, Kim HA, Kim M-S, et al. How to improve patient safety literacy? Int J Environ Res Public Health. 2020;17(19):7308. https://doi.org/10.3390/ijerph17197308.

    Article  PubMed  PubMed Central  Google Scholar 

  25. Edwards IR. A new Erice Report considering the safety of medicines in the 21st century. Drug Saf. 2017;40(10):845–9. https://doi.org/10.1007/s40264-017-0571-9.

    Article  PubMed  PubMed Central  Google Scholar 

  26. Härmark L, Weits G, Meijer R, Santoro F, Norén GN, van Hunsel F. Communicating adverse drug reaction insights through patient organizations: experiences from a pilot Study in the Netherlands. Drug Saf. 2020;43(8):745–9. https://doi.org/10.1007/s40264-020-00932-5.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  27. van Hoof M, Chinchilla K, Härmark L, Matos C, Inácio P, van Hunsel F. Factors contributing to best practices for patient involvement in pharmacovigilance in Europe: a stakeholder analysis. Drug Saf. 2022;45(10):1083–98. https://doi.org/10.1007/s40264-022-01222-y.

    Article  PubMed  PubMed Central  Google Scholar 

  28. European Patients’ Academy on Therapeutic Innovation. Patient involvement in EMA regulatory committees. https://toolbox.eupati.eu/resources/patient-involvement-in-ema-regulatory-committees/. Accessed 4 Jun 2023.

  29. The Centre of Regulatory Excellence. Integrating patient engagement into healthcare and access to medicines in the Asia Pacific Region. Duke-NUS Medical School, Oct. 2019. https://www.duke-nus.edu.sg/core/think-tank/news/integrating-patient-engagement-into-healthcare-and-access-to-medicines-in-the-asia-pacific-region. Accessed 8 Jun 2023.

  30. Pitts PJ, Le Louet H. Advancing drug safety through prospective pharmacovigilance. Ther Innov Regul Sci. 2018;52(4):400–2. https://doi.org/10.1177/2168479018766887.

    Article  PubMed  Google Scholar 

  31. The Centre of Regulatory Excellence. Accelerating patient engagement for more resilient health systems. Duke-NUS Medical School, Nov. 2020. https://www.duke-nus.edu.sg/core/think-tank/news/regional-multi-stakeholder-roundtable-report-accelerating-patient-engagement-for-more-resilient-health-systems. Accessed 8 Jun 2023.

  32. Bahri P, Morales DR, Inoubli A, Dogné J-M, Straus SMJM. Proposals for engaging patients and healthcare professionals in risk minimisation from an analysis of stakeholder input to the EU valproate assessment using the novel Analysing Stakeholder Safety Engagement Tool (ASSET). Drug Saf. 2021;44(2):193–209. https://doi.org/10.1007/s40264-020-01005-3.

    Article  PubMed  Google Scholar 

  33. Bahri P, Pariente A. Systematising pharmacovigilance engagement of patients, healthcare professionals and regulators: a practical decision guide derived from the International Risk Governance Framework for Engagement Events and Discourse. Drug Saf. 2021;44(11):1193–208. https://doi.org/10.1007/s40264-021-01111-w.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  34. Worakunphanich W, Youngkong S, Suwankesawong W, Anderson C, Thavorncharoensap M. Comparison of patient adverse drug reaction reporting systems in nine selected countries. Int J Environ Res Public Health. 2022;19(8):4447. https://doi.org/10.3390/ijerph19084447.

    Article  PubMed  PubMed Central  Google Scholar 

  35. Kitabayashi A, Inoue Y. Factors that lead to stagnation in direct patient reporting of adverse drug reactions: an opinion survey of the general public and physicians in Japan. Ther Innov Regul Sci. 2022;56(4):616–24. https://doi.org/10.1007/s43441-022-00397-x.

    Article  PubMed  PubMed Central  Google Scholar 

  36. Kiguba R, Mwebaza N, Ssenyonga Ronald, et al. Effectiveness of the Med Safety mobile application in improving adverse drug reaction reporting by healthcare professionals in Uganda: a protocol for a pragmatic cluster-randomised controlled trial. BMJ Open. 2022;12(7):e061725. https://doi.org/10.1136/bmjopen-2022-061725.

    Article  PubMed  PubMed Central  Google Scholar 

  37. Munshi R, Maurya M, Pawaskar P. Public awareness and perception about drug safety in the population residing in Western India: a questionnaire based cross sectional survey. Biomed Pharmacol J. 2022;15(4):1937–45. https://doi.org/10.13005/bpj/2532.

    Article  Google Scholar 

  38. Arnstein SR. A ladder of citizen participation. J Am Inst Plann. 1969;35(4):216–24. https://doi.org/10.1080/01944366908977225.

    Article  Google Scholar 

  39. Bammer G. Stakeholder engagement: learning from Arnstein’s ladder and the IAP2 spectrum. https://i2insights.org/2022/08/30/learning-from-arnsteins-ladder-and-iap2-spectrum/. Accessed 10 Jun 2023.

  40. Sim-Devadas A-L, Mathiyan Lakshmanan E, Foo Z, Sook MC. Building a Patient advocacy network in an Asian healthcare system to enhance patient experience and patient safety. J Patient Saf Healthc Qual. 2022;1(2):141–54. https://doi.org/10.59439/V01N02A06.

    Article  Google Scholar 

  41. European Patients’ Academy on Therapeutic Innovation. History of the European Patients’ Academy on Therapeutic Innovation (EUPATI). https://eupati.eu/about-us/history/. Accessed 4 Jun 2023.

  42. Osei-Anto HA, Puerini R. The current landscape of the science of patient input: Milken Institute, Nov. 2022. https://milkeninstitute.org/sites/default/files/2022-11/Current_Landscape_Patient_Input_Milken_Institute_0.pdf. Accessed 14 Jun 2023.

  43. Younus MM, Alkhakany M, Bahri P, et al. The ISoP PatEG-SIG for promoting patient engagement in pharmacovigilance: a change of paradigm is needed. Drug Saf. 2023. https://doi.org/10.1007/s40264-023-01313-4.

    Article  PubMed  PubMed Central  Google Scholar 

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Author notes

  1. Yoong Khean Khoo and John C. W. Lim are equal contributors to this work and designated as co-first authors.

Authors and Affiliations

  1. Centre of Regulatory Excellence, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore

    Yoong Khean Khoo, John C. W. Lim, Wei Chuen Tan-Koi & Nokuthula Sikhethiwe Kitikiti

  2. SingHealth Duke-NUS Global Health Institute, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore

    Yoong Khean Khoo & John C. W. Lim

  3. Consortium for Clinical Research and Innovation, 23 Rochester Park, Singapore, 139234, Singapore

    John C. W. Lim

  4. Takeda Pharmaceuticals International, 8 Marina Boulevard, Singapore, 018981, Singapore

    Nokuthula Sikhethiwe Kitikiti

  5. Lee Kong Chian School of Medicine, Nanyang Technological University, 11 Mandalay Road, Singapore, 308232, Singapore

    Ai Ling Sim-Devadas

  6. SingHealth Patient Advocacy Network, Singapore Health Services, 31 Third Hospital Avenue, Singapore, 168753, Singapore

    Ai Ling Sim-Devadas

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  1. Yoong Khean Khoo
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Correspondence to Yoong Khean Khoo.

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Yoong Khean Khoo, John C.W. Lim, Wei Chuen Tan-Koi, Nokuthula Sikhethiwe Kitikiti and Ai Ling Sim-Devadas have no conflicts of interest that are directly relevant to the content of this article.

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The manuscript was prepared equally by YKK and JCWL with substantial contributions from WCT-K, NSK and ALS-D. All authors read and approved the final manuscript.

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Khoo, Y.K., Lim, J.C.W., Tan-Koi, W.C. et al. Promoting Collaboration of Regulators and Patients in Improving Drug Safety and Regulatory Decision Making. Drug Saf 47, 217–225 (2024). https://doi.org/10.1007/s40264-023-01385-2

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