1.Guideline for postmarketing Chinese medicine pharmacoeconomic evaluation.
Xin WANG ; Zhi-Fei WANG ; Yan-Ming XIE ; Wen ZHANG ; Xing LIAO ; Yan-Peng CHANG ; null
Chinese journal of integrative medicine 2015;21(6):473-480
Pharmacoeconomics is an important part of the postmarketing Chinese medicine (CM) evaluation, and postmarketing pharmacoeconomic evaluation can reveal the clinical and market value of CM. The purpose of establishing the guideline for pharmacoeconomic evaluation is to make the evaluation process and results regarding Chinese patent medicines both scientific and fair. Every country's guidelines for pharmacoeconomic evaluation act as reference guidelines, we have already drawn up the guideline that takes into account the special characteristics of CM; and these are in preparation for the postmarketing CM pharmacoeconomic evaluation.
Clinical Trials as Topic
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Cost-Benefit Analysis
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Economics, Pharmaceutical
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Guidelines as Topic
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Humans
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Pharmaceutical Preparations
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economics
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Product Surveillance, Postmarketing
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economics
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Statistics as Topic
3.Correlation between Drug Market Withdrawals and Socioeconomic, Health, and Welfare Indicators Worldwide.
Kye Hwa LEE ; Grace Juyun KIM ; Ju Han KIM
Journal of Korean Medical Science 2015;30(11):1567-1576
The relationship between the number of withdrawn/restricted drugs and socioeconomic, health, and welfare indicators were investigated in a comprehensive review of drug regulation information in the United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 A total of of 362 drugs were withdrawn and 248 were restricted during 1950-2010, corresponding to rates of 12.02+/-13.07 and 5.77+/-8.69 (mean+/-SD), respectively, among 94 UN countries.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socioeconomic, health, and welfare analysis was performed for 33 OECD countries for which data were available regarding withdrawn/restricted drugs.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per hour worked, health expenditure per GDP, and elderly population rate were positively correlated with the numbers of withdrawn and restricted drugs (P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.
Adolescent
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Adult
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Aged
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Child
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Child, Preschool
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Drug Utilization/*economics/statistics & numerical data
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Female
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Gross Domestic Product/*statistics & numerical data
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*Health Status Indicators
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Humans
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Infant
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Infant, Newborn
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Internationality
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*Life Expectancy
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Male
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Middle Aged
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Product Surveillance, Postmarketing/*economics/statistics & numerical data
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Safety-Based Drug Withdrawals/*economics/statistics & numerical data
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Social Welfare/economics/statistics & numerical data
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Socioeconomic Factors
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Statistics as Topic
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Young Adult