title: Correlation between Drug Market Withdrawals and Socioeconomic, Health, and Welfare Indicators Worldwide.
abstract: The relationship between the number of withdrawn/restricted drugs and socioeconomic, health, and welfare indicators were investigated in a comprehensive review of drug regulation information in the United Nations (UN) countries. A total of of 362 drugs were withdrawn and 248 were restricted during 1950-2010, corresponding to rates of 12.02 ± 13.07 and 5.77 ± 8.69 (mean ± SD), respectively, among 94 UN countries. A socioeconomic, health, and welfare analysis was performed for 33 OECD countries for which data were available regarding withdrawn/restricted drugs. The gross domestic product (GDP) per capita, GDP per hour worked, health expenditure per GDP, and elderly population rate were positively correlated with the numbers of withdrawn and restricted drugs (P < 0.05), while the out-of-pocket health expenditure payment rate was negatively correlated. The number of restricted drugs was also correlated with the rate of drug-related deaths (P < 0.05). The World Bank data cross-validated the findings of 33 OECD countries. The lists of withdrawn/restricted drugs showed markedly poor international agreement between them (Fleiss's kappa = -0.114). Twenty-seven drugs that had been withdrawn internationally by manufacturers are still available in some countries. The wide variation in the numbers of drug withdrawals and restrictions among countries indicates the need to improve drug surveillance systems and regulatory communication networks.
authors.affiliation: Seoul National University Biomedical Informatics (SNUBI) and Systems Biomedical Informatics Research Center, Division of Biomedical Informatics, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Kye Hwa
authors.initials: KH
authors.lastname: Lee
authors.affiliation: Seoul National University Biomedical Informatics (SNUBI) and Systems Biomedical Informatics Research Center, Division of Biomedical Informatics, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Grace Juyun
authors.initials: GJ
authors.lastname: Kim
authors.affiliation: Seoul National University Biomedical Informatics (SNUBI) and Systems Biomedical Informatics Research Center, Division of Biomedical Informatics, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Ju Han
authors.initials: JH
authors.lastname: Kim
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D004363:Drug Utilization / Q000191:economics* / Q000706:statistics & numerical data; D005260:Female; D059066:Gross Domestic Product / Q000706:statistics & numerical data*; D006305:Health Status Indicators; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D038622:Internationality; D008017:Life Expectancy; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing / Q000191:economics* / Q000706:statistics & numerical data; D056737:Safety-Based Drug Withdrawals / Q000191:economics* / Q000706:statistics & numerical data; D012946:Social Welfare / Q000191:economics / Q000706:statistics & numerical data; D012959:Socioeconomic Factors; D013223:Statistics as Topic; D055815:Young Adult
keywords: Health Expenditures; Organization for Economic Cooperation and Development; Postmarketing; Product Recalls and Withdrawals; Product Surveillance; Socioeconomic Factors