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1.
J Korean Med Sci ; 30(11): 1567-76, 2015 Nov.
Article in English | MEDLINE | ID: mdl-26538999

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The relationship between the number of withdrawn/restricted drugs and socioeconomic, health, and welfare indicators were investigated in a comprehensive review of drug regulation information in the United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 A total of of 362 drugs were withdrawn and 248 were restricted during 1950-2010, corresponding to rates of 12.02 ± 13.07 and 5.77 ± 8.69 (mean ± SD), respectively, among 94 UN countries.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health, and welfare analysis was performed for 33 OECD countries for which data were available regarding withdrawn/restricted drugs.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hour worked, health expenditure per GDP, and elderly population rate were positively correlated with the numbers of withdrawn and restricted drugs (P 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 The lists of withdrawn/restricted drugs showed markedly poor international agreement between them (Fleiss's kappa = -0.114). Twenty-seven drugs that had been withdrawn internationally by manufacturers are still available in some countries.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


Subject(s)
Drug Utilization/economics , Gross Domestic Product/statistics & numerical data , Health Status Indicators , Life Expectancy , Product Surveillance, Postmarketing/economics , Safety-Based Drug Withdrawals/economics , Adolescent , Adult , Aged , Child , Child, Preschool , Drug Utilization/statistics & numerical data , Female , Humans , Infant , Infant, Newborn , Internationality , Male , Middle Aged , Product Surveillance, Postmarketing/statistics & numerical data , Safety-Based Drug Withdrawals/statistics & numerical data , Social Welfare/economics , Social Welfare/statistics & numerical data , Socioeconomic Factors , Statistics as Topic , Young Adult
2.
Article in English | WPRIM (Western Pacific) | ID: wpr-66180

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The relationship between the number of withdrawn/restricted drugs and socioeconomic, health, and welfare indicators were investigated in a comprehensive review of drug regulation information in the United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.


Subject(s)
Adolescent , Adult , Aged , Child , Child, Preschool , Female , Humans , Infant , Infant, Newborn , Male , Middle Aged , Young Adult , Drug Utilization/economics , Gross Domestic Product/statistics & numerical data , Health Status Indicators , Internationality , Life Expectancy , Product Surveillance, Postmarketing/economics , Safety-Based Drug Withdrawals/economics , Social Welfare/economics , Socioeconomic Factors , Statistics as Topic
3.
Crit Care ; 16(1): 107, 2012 Feb 06.
Article in English | MEDLINE | ID: mdl-22309988

ABSTRACT

Following the failure of PROWESS-SHOCK to demonstrate efficacy, Eli Lilly and Company withdrew drotrecogin alfa (activated) from the worldwide market. Drotrecogin was initially approved after the original trial, PROWESS, was stopped early for overwhelming efficacy. These events prompt consideration of both the initial approval decision and the later decision to withdraw. It is regrettable that the initial decision was made largely on a single trial that was stopped early. However, the decision to approve was within the bounds of normal regulatory practice and was made by many approval bodies around the world. Furthermore, the overall withdrawal rate of approved drugs remains very low. The decision to withdraw was a voluntary decision by Eli Lilly and Company and likely reflected key business considerations. Drotrecogin does have important biologic effects, and it is probable that we do not know how best to select patients who would benefit. Overall, there may still be a small advantage to drotrecogin alfa, even used non-selectively, but the costs of determining such an effect with adequate certainty are likely prohibitive, and the point is now moot. In the future, we should consider ways to make clinical trials easier and quicker so that more information can be available in a timely manner when considering regulatory approval. At the same time, more sophisticated selection of patients seems key if we are to most wisely test agents designed to manipulate the septic host response.


Subject(s)
Drug Industry/methods , Protein C/therapeutic use , Safety-Based Drug Withdrawals/methods , Animals , Anti-Infective Agents/adverse effects , Anti-Infective Agents/economics , Anti-Infective Agents/therapeutic use , Drug Approval/economics , Drug Approval/methods , Drug Industry/economics , Drug Industry/standards , Fibrinolytic Agents/adverse effects , Fibrinolytic Agents/economics , Fibrinolytic Agents/therapeutic use , Humans , Protein C/adverse effects , Protein C/economics , Randomized Controlled Trials as Topic/economics , Randomized Controlled Trials as Topic/standards , Randomized Controlled Trials as Topic/trends , Recombinant Proteins/adverse effects , Recombinant Proteins/economics , Recombinant Proteins/therapeutic use , Risk Assessment/economics , Risk Assessment/methods , Risk Assessment/standards , Safety-Based Drug Withdrawals/economics , Sepsis/drug therapy , Sepsis/economics
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