Abstract
Background
Establishing effective pharmacovigilance systems globally is challenging due to the need for comprehensive epidemiological data on pharmacovigilance-related events, particularly in countries at different stages of development.
Aim
This study aimed to determine magnitude and drivers of change in the global and regional burden of pharmacovigilance-related events from 1990 to 2019, analyzing variations between age groups and sex, providing data support for policymakers to adjust their pharmacovigilance policies.
Method
Pharmacovigilance-related events were defined as Adverse Effects of Medical Treatment (AEMT) and Drug Use Disorders (DUD) in the Global Burden of Diseases, Injuries, and Risk Factors Study 2019. Time trend analysis utilized joinpoint regression, age-period-cohort model, and decomposition method. Disease burden was measured in incidence, deaths, and disability-adjusted life years (DALYs).
Results
The global burden of pharmacovigilance-related events remained high, driven predominantly by population growth. Children and older adults were identified as particularly susceptible groups. Across various regions and periods of the socio-demographic index (SDI), the risk of death from AEMT showed a decreasing trend. In contrast, the incidence of AEMT and both the incidence and death rates from DUD showed a stable or worsening trend. Significant regional disparities in the burden of these diseases were noted between different SDI levels.
Conclusion
The study underscores the critical need for robust pharmacovigilance systems worldwide. The observed trends in the burden of pharmacovigilance-related events offer a clear direction for countries to refine and strengthen their pharmacovigilance policies and practices.
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References
Garashi HY, Steinke DT, Schafheutle EI. A systematic review of pharmacovigilance systems in developing countries using the WHO pharmacovigilance indicators. Ther Innov Regul Sci. 2022;56(5):717–43. https://doi.org/10.1007/s43441-022-00415-y.
Elshafie S, Roberti AM, Zaghloul I. Pharmacovigilance in developing countries (part II): a path forward. Int J Clin Pharm. 2018;40(4):764–8. https://doi.org/10.1007/s11096-017-0588-2.
Marcus KA, Sorbello A, Truffa M, et al. Current advances in pharmacovigilance in the USA and Europe: meeting the challenges of safety monitoring in HIV. Curr Opin HIV AIDS. 2012;7(4):292–8. https://doi.org/10.1097/COH.0b013e328354dcac.
Donaldson LJ, Kelley ET, Dhingra-Kumar N, et al. Medication without harm: WHO’s third global patient safety challenge. The Lancet. 2017;389(10080):1680–1. https://doi.org/10.1016/S0140-6736(17)31047-4.
Radecka A, Loughlin L, Foy M, et al. Enhancing pharmacovigilance capabilities in the EU regulatory network: the SCOPE joint action. Drug Saf. 2018;41(12):1285–302. https://doi.org/10.1007/s40264-018-0708-5.
Fossouo Tagne J, Yakob RA, Dang TH, et al. Reporting, monitoring, and handling of adverse drug reactions in Australia: scoping review. JMIR Public Health Surveill. 2023;9:e40080. https://doi.org/10.2196/40080.
Drug Overdose Death Rates. National Institute on Drug Abuse. https://nida.nih.gov/research-topics/trends-statistics/overdose-death-rates. Accessed 8 March 2024.
Vos T, Lim SS, Abbafati C, et al. Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. The Lancet. 2020;396(10258):1204–22. https://doi.org/10.1016/S0140-6736(20)30925-9.
Paulson KR, Kamath AM, Alam T, et al. Global, regional, and national progress towards Sustainable Development Goal 3.2 for neonatal and child health: all-cause and cause-specific mortality findings from the Global Burden of Disease Study 2019. Lancet. 2021;398(10303):870–905. https://doi.org/10.1016/S0140-6736(21)01207-1.
Stevens GA, Alkema L, Black RE, et al. Guidelines for accurate and transparent health estimates reporting: the GATHER statement. Lancet. 2016;388(10062):e19–23. https://doi.org/10.1016/S0140-6736(16)30388-9.
GBD Results. Institute for Health Metrics and Evaluation (IHME). https://vizhub.healthdata.org/gbd-results/. Accessed 8 March 2024.
Kim HJ, Fay MP, Feuer EJ, et al. Permutation tests for joinpoint regression with applications to cancer rates. Stat Med. 2000;19(3):335–51. https://doi.org/10.1002/(SICI)1097-0258(20000215)19:3%3c335::AID-SIM336%3e3.0.CO;2-Z.
Clegg LX, Hankey BF, Tiwari R, et al. Estimating average annual per cent change in trend analysis. Stat Med. 2009;28(29):3670–82. https://doi.org/10.1002/sim.3733.
Bell A. Age period cohort analysis: a review of what we should and shouldn’t do. Ann Hum Biol. 2020;47(2):208–17. https://doi.org/10.1080/03014460.2019.1707872.
Age Period Cohort Web Tool. National Cancer Institute Division of Cancer Epidemiology and Genetics. https://analysistools.cancer.gov/apc/. Accessed 8 March 2024.
Rosenberg PS, Check DP, Anderson WF. A web tool for age–period–cohort analysis of cancer incidence and mortality rates. Cancer Epidemiol Biomark Prev. 2014;23(11):2296–302. https://doi.org/10.1158/1055-9965.EPI-14-0300.
Cheng X, Yang Y, Schwebel DC, et al. Population ageing and mortality during 1990–2017: A global decomposition analysis. Basu S, ed. PLoS Med. 2020;17(6):e1003138. https://doi.org/10.1371/journal.pmed.1003138.
Shen J, Hua G, Li C, et al. Prevalence, incidence, deaths, and disability-adjusted life-years of drug use disorders for 204 countries and territories during the past 30 years. Asian J Psychiatr. 2023;86:103677. https://doi.org/10.1016/j.ajp.2023.103677.
Murray CJL, Aravkin AY, Zheng P, et al. Global burden of 87 risk factors in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020;396(10258):1223–49. https://doi.org/10.1016/S0140-6736(20)30752-2.
Pelkonen O. Metabolism and pharmacokinetics in children and the elderly. Expert Opin Drug Metab Toxicol. 2007;3(2):147–8. https://doi.org/10.1517/17425255.3.2.147.
Han BH, Funk-White M, Ko R, et al. Decreasing perceived risk associated with regular cannabis use among older adults in the United States from 2015 to 2019. J American Geriatrics Society. 2021;69(9):2591–7. https://doi.org/10.1111/jgs.17213.
Fletcher CV, Acosta EP, Strykowski JM. Gender differences in human pharmacokinetics and pharmacodynamics. J Adolesc Health. 1994;15(8):619–29. https://doi.org/10.1016/s1054-139x(94)90628-9.
Pirmohamed M, Atuah KN, Dodoo ANO, et al. Pharmacovigilance in developing countries. BMJ. 2007;335(7618):462–462. https://doi.org/10.1136/bmj.39323.586123.BE.
Dally A. Thalidomide: Was the tragedy preventable? Lancet. 1998;351(9110):1197–9. https://doi.org/10.1016/S0140-6736(97)09038-7.
Basile AO, Yahi A, Tatonetti NP. Artificial intelligence for drug toxicity and safety. Trends Pharmacol Sci. 2019;40(9):624–35. https://doi.org/10.1016/j.tips.2019.07.005.
Garashi HY, Steinke DT, Schafheutle EI. A qualitative exploration of pharmacovigilance policy implementation in Jordan, Oman, and Kuwait using Matland’s ambiguity-conflict model. Global Health. 2021;17(1):97. https://doi.org/10.1186/s12992-021-00751-y.
Olsson S, Pal SN, Stergachis A, et al. Pharmacovigilance activities in 55 low- and middle-income countries: a questionnaire-based analysis. Drug Saf. 2010;33(8):689–703. https://doi.org/10.2165/11536390-000000000-00000.
Alshammari TM, Mendi N, Alenzi KA, et al. Pharmacovigilance systems in Arab countries: overview of 22 Arab countries. Drug Saf. 2019;42(7):849–68. https://doi.org/10.1007/s40264-019-00807-4.
Preston C, Freitas Dias M, Peña J, et al. Addressing the challenges of regulatory systems strengthening in small states. BMJ Glob Health. 2020;5(2):e001912. https://doi.org/10.1136/bmjgh-2019-001912.
Agustí A, Cereza G, De Abajo FJ, et al. Clinical pharmacology facing the real-world setting: pharmacovigilance, pharmacoepidemiology and the economic evaluation of drugs. Pharmacol Res. 2023;197:106967. https://doi.org/10.1016/j.phrs.2023.106967.
Acknowledgements
The authors thank Chongqing Runchi Translation Company for English language editing and review services.
Funding
This study was supported by the Project of the National Social Science Foundation of China Grant Number (No. 18XGL019) and the Fundamental Research Funds for the Central Universities (Xi’an Jiaotong University: xzy022024030).
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11096_2024_1738_MOESM1_ESM.tif
Supplementary Figure 1. Trends and joinpoints in the burden of DUD disease from 1990 to 2019 in Global region and SDI quintiles. A Incidence; B Deaths (TIF 25519 KB)
11096_2024_1738_MOESM2_ESM.tif
Supplementary Figure 2. Age-period-cohort analysis of AEMT deaths in the global region and SDI quintiles. Sex = both, male, female. A Age effects. B Periods effects. C Cohort effects. (TIF 25519 KB)
11096_2024_1738_MOESM3_ESM.tif
Supplementary Figure 3. Age-period-cohort analysis of DUD incidence in the global region and SDI quintiles. Sex = both, male, female. A Age effects. B Periods effects. C Cohort effects. (TIF 25519 KB)
11096_2024_1738_MOESM4_ESM.tif
Supplementary Figure 4. Age-period-cohort analysis of DUD deaths in the global region and SDI quintiles. Sex = both, male, female. A Age effects in global, high SDI, high-middle SDI regions. B Age effects in the middle, low-middle, and low SDI regions. C Periods effects. D Cohort effects. (TIF 25519 KB)
11096_2024_1738_MOESM5_ESM.tif
Supplementary Figure 5. From 1990 to 2019, the change in incidence/deaths/DALYs of DUD due to Aging, Population, and Epidemiological change. Location: in the global region and SDI quintiles. The black dots imply the overall difference in numbers from 2019 to 1990. A Incidence; B Deaths; C DALYs. (TIF 17135 KB)
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Lin, S., Lei, S., Liu, W. et al. Global trends in pharmacovigilance-related events: a 30-year analysis from the 2019 global burden of disease study. Int J Clin Pharm (2024). https://doi.org/10.1007/s11096-024-01738-6
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DOI: https://doi.org/10.1007/s11096-024-01738-6