J Korean Med Sci.  2015 Nov;30(11):1567-1576. 10.3346/jkms.2015.30.11.1567.

Correlation between Drug Market Withdrawals and Socioeconomic, Health, and Welfare Indicators Worldwide

• Lee KH
• Kim GJ
• Kim JH

• KMID: 2351105
• DOI: http://doi.org/10.3346/jkms.2015.30.11.1567

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The relationship between the number of withdrawn/restricted drugs and socioeconomic, health, and welfare indicators were investigated in a comprehensive review of drug regulation information in the United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 A total of of 362 drugs were withdrawn and 248 were restricted during 1950-2010, corresponding to rates of 12.02+/-13.07 and 5.77+/-8.69 (mean+/-SD), respectively, among 94 UN countries.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socioeconomic, health, and welfare analysis was performed for 33 OECD countries for which data were available regarding withdrawn/restricted drugs.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per hour worked, health expenditure per GDP, and elderly population rate were positively correlated with the numbers of withdrawn and restricted drugs (P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 The lists of withdrawn/restricted drugs showed markedly poor international agreement between them (Fleiss's kappa=-0.114). Twenty-seven drugs that had been withdrawn internationally by manufacturers are still available in some countries.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.

Keyword

Product Recalls and Withdrawals; Product Surveillance; Postmarketing; Organization for Economic Cooperation and Development; Health Expenditures; Socioeconomic Factors

MeSH Terms

Adolescent
Adult
Aged
Child
Child, Preschool
Drug Utilization/*economics/statistics & numerical data
Female
Gross Domestic Product/*statistics & numerical data
*Health Status Indicators
Humans
Infant
Infant, Newborn
Internationality
*Life Expectancy
Male
Middle Aged
Product Surveillance, Postmarketing/*economics/statistics & numerical data
Safety-Based Drug Withdrawals/*economics/statistics & numerical data
Social Welfare/economics/statistics & numerical data
Socioeconomic Factors
Statistics as Topic
Young Adult

Figure

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  Fig. 1 Withdrawn and restricted drugs worldwide. (A) Distribution on a per-country basis (mean and SD data) and (B) correlation across 94 countries.

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  Fig. 2 Distributions of the numbers of withdrawn and restricted drugs in 33 OECD members and partners.

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  Fig. 3 Correlations between health/economic indicators and the number of drug withdrawals from the market in 33 OECD countries. (A) GDP per capita, (B) GDP per hour worked, (C) out-of-pocket payment rate, (D) health expenditure per GDP, and (E) elderly population rate all exhibit significant correlations with the number of drug withdrawals (P < 0.05).

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  Fig. 4 Correlations between health and economic indicators and the number of drug market restrictions in the market in 33 OECD countries. (A) GDP per capita, (B) GDP per hour worked, (C) out-of-pocket payment rate, (D) health expenditure per GDP, (E) elderly population rate, and (F) drug-use deaths per 100,000 persons all exhibit significant correlations with the number of drugs restricted (P < 0.05).

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  Fig. 5 Agreement of the list of withdrawn drugs in the five countries with the largest numbers of (A) withdrawn and (B) restricted drugs.

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