The Experts below are selected from a list of 21 Experts worldwide ranked by ideXlab platform

Figueirinha Moital, Maria Inês - One of the best experts on this subject based on the ideXlab platform.

  • Intoxicación por dietilenglicol en productos de uso medicinal: Análisis de episodios en el período 1990-2015
    'Universitat Autonoma de Barcelona', 2017
    Co-Authors: Figueirinha Moital, Maria Inês
    Abstract:

    La falsificación y la contaminación de productos de uso medicinal es un grave problema actual con un impacto sanitario, social y económico. La primera tragedia asociada al empleo de medicamentos con sustancias tóxicas se debió a la comercialización de un preparado de sulfanilamida en el que empleó como solvente el dietilenglicol (DEG) que llevó a la promulgación de la Federal Food, Drug and Cosmetic Act, 1938, el cambio legislativo más destacado de la historia de la reglamentación farmacéutica. A pesar del impacto de este caso y del reconocimiento de su toxicidad en humanos se han detectado 16 episodios más de intoxicación por DEG desde 1937, a pesar los cambios legislativos y la publicación de normas de control de la calidad de medicamentos. En este trabajo se analizaron los diversos episodios de intoxicación por DEG utilizado en la preparación de medicamentos durante el período 1990-2015 con los siguientes objetivos: 1) Determinar las características epidemiológicas y sociológicas de las principales intoxicaciones masivas por DEG en productos de uso medicinal; 2) Analizar su repercusión en la prensa general escrita, tanto a nivel global como por país de aparición; y 3) Revisar las medidas legislativas que se tomaron tras las intoxicaciones masivas y su impacto en la prevención de nuevos episodios. La búsqueda sistemática en bases de datos científicas (Medline y EMBASE) y en Google Scholar, permitió identificar de 12 episodios en 9 países a través del análisis de 84 publicaciones. La mayoría de los episodios ocurrieron en países en vías de desarrollo (11/12) e implicaron jarabes de paracetamol (7/12). Con excepción del episodio ocurrido en un país desarrollado (Francia), la fabricación del producto final se realizó en laboratorios locales. El conocimiento y la alerta de los profesionales sanitarios, la sensibilización de las autoridades para iniciar las investigaciones y la recogida de la medicación tras la identificación del agente tóxico fueron los factores críticos en la minimización del impacto de los episodios. La investigación periodística publicada en el New York Times sobre los episodios de Haití y Panamá fue crucial para la identificación del origen del producto tóxico. La prensa general escrita tuvo su mayor impacto en el episodio de Panamá contribuyendo a la alerta del episodio pero especialmente en el proceso de defensa de los derechos de afectados. Panamá fue identificado también como el episodio con mayores repercusiones en los cambios reglamentarios y en la implementación de la legislación, con efectos internos pero también en otros países. Globalmente, se identificaron 21 medidas legislativas asociadas a los episodios de intoxicación de las cuales destaca la creación de agencias reglamentarias en Nigeria y Argentina. Sin embargo, y a pesar del incremento del control de calidad de medicamentos resultante de las medidas implementadas a lo largo de los últimos 25 años, estas no parecen ser suficientes para la prevención de episodios futuros. Esta deberá incluir medidas que procuren una adaptación a las características y aspectos culturales de los países en vías de desarrollo, pero también acciones que permitan la capacitación de los profesionales de salud y la población en la identificación de episodios de intoxicación por productos falsificados, así como la sensibilización de las autoridades de cada país.Counterfeiting and contamination of medicines is a serious problem today with public health, social and economic impact. The first tragedy associated with the use of medicines contaminated with toxic substances was due to the commercialization of an Elixir Sulfanilamide preparation tainted with diethylene Glycol (DEG), used as a solvent, that lead to the enactment of the Federal Food, Drug and Cosmetic Act, 1938, the most relevant regulatory change in the history of pharmaceutical regulation. Despite several legislation changes, guidelines implementation to improve medicine quality control and the recognition of the impact of this case in humans, 16 additional episodes of DEG intoxication were detected since 1937. In this thesis DEG-associated intoxication episodes that happened between 1990-2015 were analyzed with the following objectives: 1) To determine the epidemiological and sociological characteristics of main mass intoxications by DEG in medicines; 2) To analyze its impact on local general written press and global publications; and 3) To review the legislative initiatives implemented after DEG-relative massive intoxications and their impact on the prevention of new episodes. The systematic search in scientific databases (Medline and EMBASE) and in google Scholar resulted in the identification of 12 episodes from 9 countries, based on the analysis of 84 publications. Most episodes occurred in developing countries (11/12) and were associated with paracetamol liquid formulations (7/12). With the exception of one episode in a developed country (France), the manufacture of the final product was carried out in local laboratories. The critical factors for minimizing episodes’ impact were healthcare professionals’ knowledge and alertness, healthcare authorities’ awareness to early initiation of investigations and quick recall of medication after identification of the toxic substance. The New York Times journalistic research on the Haitian and Panamanian episodes was crucial for the identification of the origin of the toxic product. The written general press had its greatest impact on the episode of Panama contributing to the alert of the episode but especially in the process of defending the rights of those affected. Panama was also identified as the episode with the greatest impact on regulatory changes and implementation of legislation, with internal effects but also abroad, in other countries. Globally, this analysis identified 21 legislative measures associated with poisoning DEG episodes, including the establishment of regulatory agencies in two countries, Nigeria and Argentina. However, and despite the increase in quality control of medicines, resulting from legislation and regulations implemented over the last 25 years, these do not seem to be sufficient for the prevention of new episodes. The implementation of new measures should seek to adapt to each country specific characteristics and cultural aspects of developing countries. It should also be considered actions that allow training of healthcare professionals and population in the identification of episodes of poisoning by counterfeit medicines, as well as actions that increase awareness of the authorities of each country

  • Intoxicación por dietilenglicol en productos de uso medicina : análisisi de episodios en el período 1990-2015 /
    2017
    Co-Authors: Figueirinha Moital, Maria Inês, Universitat Autònoma De Barcelona. Departament De Farmacologia, De Tera
    Abstract:

    La falsificación y la contaminación de productos de uso medicinal es un grave problema actual con un impacto sanitario, social y económico. La primera tragedia asociada al empleo de medicamentos con sustancias tóxicas se debió a la comercialización de un preparado de sulfanilamida en el que empleó como solvente el dietilenglicol (DEG) que llevó a la promulgación de la Federal Food, Drug and Cosmetic Act, 1938, el cambio legislativo más destacado de la historia de la reglamentación farmacéutica. A pesar del impacto de este caso y del reconocimiento de su toxicidad en humanos se han detectado 16 episodios más de intoxicación por DEG desde 1937, a pesar los cambios legislativos y la publicación de normas de control de la calidad de medicamentos. En este trabajo se analizaron los diversos episodios de intoxicación por DEG utilizado en la preparación de medicamentos durante el período 1990-2015 con los siguientes objetivos: 1) Determinar las características epidemiológicas y sociológicas de las principales intoxicaciones masivas por DEG en productos de uso medicinal; 2) Analizar su repercusión en la prensa general escrita, tanto a nivel global como por país de aparición; y 3) Revisar las medidas legislativas que se tomaron tras las intoxicaciones masivas y su impacto en la prevención de nuevos episodios. La búsqueda sistemática en bases de datos científicas (Medline y EMBASE) y en Google Scholar, permitió identificar de 12 episodios en 9 países a través del análisis de 84 publicaciones. La mayoría de los episodios ocurrieron en países en vías de desarrollo (11/12) e implicaron jarabes de paracetamol (7/12). Con excepción del episodio ocurrido en un país desarrollado (Francia), la fabricación del producto final se realizó en laboratorios locales. El conocimiento y la alerta de los profesionales sanitarios, la sensibilización de las autoridades para iniciar las investigaciones y la recogida de la medicación tras la identificación del agente tóxico fueron los factores críticos en la minimización del impacto de los episodios. La investigación periodística publicada en el New York Times sobre los episodios de Haití y Panamá fue crucial para la identificación del origen del producto tóxico. La prensa general escrita tuvo su mayor impacto en el episodio de Panamá contribuyendo a la alerta del episodio pero especialmente en el proceso de defensa de los derechos de afectados. Panamá fue identificado también como el episodio con mayores repercusiones en los cambios reglamentarios y en la implementación de la legislación, con efectos internos pero también en otros países. Globalmente, se identificaron 21 medidas legislativas asociadas a los episodios de intoxicación de las cuales destaca la creación de agencias reglamentarias en Nigeria y Argentina. Sin embargo, y a pesar del incremento del control de calidad de medicamentos resultante de las medidas implementadas a lo largo de los últimos 25 años, estas no parecen ser suficientes para la prevención de episodios futuros. Esta deberá incluir medidas que procuren una adaptación a las características y aspectos culturales de los países en vías de desarrollo, pero también acciones que permitan la capacitación de los profesionales de salud y la población en la identificación de episodios de intoxicación por productos falsificados, así como la sensibilización de las autoridades de cada país.Counterfeiting and contamination of medicines is a serious problem today with public health, social and economic impact. The first tragedy associated with the use of medicines contaminated with toxic substances was due to the commercialization of an Elixir Sulfanilamide preparation tainted with diethylene Glycol (DEG), used as a solvent, that lead to the enactment of the Federal Food, Drug and Cosmetic Act, 1938, the most relevant regulatory change in the history of pharmaceutical regulation. Despite several legislation changes, guidelines implementation to improve medicine quality control and the recognition of the impact of this case in humans, 16 additional episodes of DEG intoxication were detected since 1937. In this thesis DEG-associated intoxication episodes that happened between 1990-2015 were analyzed with the following objectives: 1) To determine the epidemiological and sociological characteristics of main mass intoxications by DEG in medicines; 2) To analyze its impact on local general written press and global publications; and 3) To review the legislative initiatives implemented after DEG-relative massive intoxications and their impact on the prevention of new episodes. The systematic search in scientific databases (Medline and EMBASE) and in google Scholar resulted in the identification of 12 episodes from 9 countries, based on the analysis of 84 publications. Most episodes occurred in developing countries (11/12) and were associated with paracetamol liquid formulations (7/12). With the exception of one episode in a developed country (France), the manufacture of the final product was carried out in local laboratories. The critical factors for minimizing episodes' impact were healthcare professionals' knowledge and alertness, healthcare authorities' awareness to early initiation of investigations and quick recall of medication after identification of the toxic substance. The New York Times journalistic research on the Haitian and Panamanian episodes was crucial for the identification of the origin of the toxic product. The written general press had its greatest impact on the episode of Panama contributing to the alert of the episode but especially in the process of defending the rights of those affected. Panama was also identified as the episode with the greatest impact on regulatory changes and implementation of legislation, with internal effects but also abroad, in other countries. Globally, this analysis identified 21 legislative measures associated with poisoning DEG episodes, including the establishment of regulatory agencies in two countries, Nigeria and Argentina. However, and despite the increase in quality control of medicines, resulting from legislation and regulations implemented over the last 25 years, these do not seem to be sufficient for the prevention of new episodes. The implementation of new measures should seek to adapt to each country specific characteristics and cultural aspects of developing countries. It should also be considered actions that allow training of healthcare professionals and population in the identification of episodes of poisoning by counterfeit medicines, as well as actions that increase awareness of the authorities of each country

Paul M Wax - One of the best experts on this subject based on the ideXlab platform.

  • Elixirs diluents and the passage of the 1938 federal food drug and cosmetic act
    Annals of Internal Medicine, 1995
    Co-Authors: Paul M Wax
    Abstract:

    The Elixir Sulfanilamide disaster of 1937 was one of the most consequential mass poisonings of the 20th century. This tragedy occurred shortly after the introduction of Sulfanilamide, the first sulfa antimicrobial drug, when diethylene glycol was used as the diluent in the formulation of a liquid preparation of Sulfanilamide known as Elixir Sulfanilamide. One hundred five patients died from its therapeutic use. Under the existing drug regulations, premarketing toxicity testing was not required. In reaction to this calamity, the U.S. Congress passed the 1938 Federal Food, Drug and Cosmetic Act, which required proof of safety before the release of a new drug. The 1938 law changed the drug focus of the Food and Drug Administration from that of a policing agency primarily concerned with the confiscation of adulterated drugs to a regulatory agency increasingly involved with overseeing the evaluation of new drugs. The Elixir Sulfanilamide tragedy, its effect on drug regulations, and the history of other diethylene glycol and diluent mass poisonings are discussed.

  • Elixirs, diluents, and the passage of the 1938 Federal Food, Drug and Cosmetic Act
    1995
    Co-Authors: Paul M Wax
    Abstract:

    the most consequential mass poisonings of the 20th century. This tragedy occurred shortly after the intro-duction of Sulfanilamide, the first sulfa antimicrobial drug, when diethylene glycol was used as the diluent in the formulation of a liquid preparation of Sulfanilamide known as Elixir Sulfanilamide. One hundred five pa-tients died from its therapeutic use. Under the existing drug regulations, premarketing toxicity testing was not required. In reaction to this calamity, the U.S. Congress passed the 1938 Federal Food, Drug and Cosmetic Act, which required proof of safety before the release of a new drug. The 1938 law changed the drug focus of the Food and Drug Administration from that of a policing agency primarily concerned with the confiscation of adulterated drugs to a regulatory agency increasingly involved with overseeing the evaluation of new drugs. The Elixir Sulfanilamide tragedy, its effect on drug regulations, and the history of other diethylene glycol and diluent mass poisonings are discussed

Universitat Autònoma De Barcelona. Departament De Farmacologia, De Tera - One of the best experts on this subject based on the ideXlab platform.

  • Intoxicación por dietilenglicol en productos de uso medicina : análisisi de episodios en el período 1990-2015 /
    2017
    Co-Authors: Figueirinha Moital, Maria Inês, Universitat Autònoma De Barcelona. Departament De Farmacologia, De Tera
    Abstract:

    La falsificación y la contaminación de productos de uso medicinal es un grave problema actual con un impacto sanitario, social y económico. La primera tragedia asociada al empleo de medicamentos con sustancias tóxicas se debió a la comercialización de un preparado de sulfanilamida en el que empleó como solvente el dietilenglicol (DEG) que llevó a la promulgación de la Federal Food, Drug and Cosmetic Act, 1938, el cambio legislativo más destacado de la historia de la reglamentación farmacéutica. A pesar del impacto de este caso y del reconocimiento de su toxicidad en humanos se han detectado 16 episodios más de intoxicación por DEG desde 1937, a pesar los cambios legislativos y la publicación de normas de control de la calidad de medicamentos. En este trabajo se analizaron los diversos episodios de intoxicación por DEG utilizado en la preparación de medicamentos durante el período 1990-2015 con los siguientes objetivos: 1) Determinar las características epidemiológicas y sociológicas de las principales intoxicaciones masivas por DEG en productos de uso medicinal; 2) Analizar su repercusión en la prensa general escrita, tanto a nivel global como por país de aparición; y 3) Revisar las medidas legislativas que se tomaron tras las intoxicaciones masivas y su impacto en la prevención de nuevos episodios. La búsqueda sistemática en bases de datos científicas (Medline y EMBASE) y en Google Scholar, permitió identificar de 12 episodios en 9 países a través del análisis de 84 publicaciones. La mayoría de los episodios ocurrieron en países en vías de desarrollo (11/12) e implicaron jarabes de paracetamol (7/12). Con excepción del episodio ocurrido en un país desarrollado (Francia), la fabricación del producto final se realizó en laboratorios locales. El conocimiento y la alerta de los profesionales sanitarios, la sensibilización de las autoridades para iniciar las investigaciones y la recogida de la medicación tras la identificación del agente tóxico fueron los factores críticos en la minimización del impacto de los episodios. La investigación periodística publicada en el New York Times sobre los episodios de Haití y Panamá fue crucial para la identificación del origen del producto tóxico. La prensa general escrita tuvo su mayor impacto en el episodio de Panamá contribuyendo a la alerta del episodio pero especialmente en el proceso de defensa de los derechos de afectados. Panamá fue identificado también como el episodio con mayores repercusiones en los cambios reglamentarios y en la implementación de la legislación, con efectos internos pero también en otros países. Globalmente, se identificaron 21 medidas legislativas asociadas a los episodios de intoxicación de las cuales destaca la creación de agencias reglamentarias en Nigeria y Argentina. Sin embargo, y a pesar del incremento del control de calidad de medicamentos resultante de las medidas implementadas a lo largo de los últimos 25 años, estas no parecen ser suficientes para la prevención de episodios futuros. Esta deberá incluir medidas que procuren una adaptación a las características y aspectos culturales de los países en vías de desarrollo, pero también acciones que permitan la capacitación de los profesionales de salud y la población en la identificación de episodios de intoxicación por productos falsificados, así como la sensibilización de las autoridades de cada país.Counterfeiting and contamination of medicines is a serious problem today with public health, social and economic impact. The first tragedy associated with the use of medicines contaminated with toxic substances was due to the commercialization of an Elixir Sulfanilamide preparation tainted with diethylene Glycol (DEG), used as a solvent, that lead to the enactment of the Federal Food, Drug and Cosmetic Act, 1938, the most relevant regulatory change in the history of pharmaceutical regulation. Despite several legislation changes, guidelines implementation to improve medicine quality control and the recognition of the impact of this case in humans, 16 additional episodes of DEG intoxication were detected since 1937. In this thesis DEG-associated intoxication episodes that happened between 1990-2015 were analyzed with the following objectives: 1) To determine the epidemiological and sociological characteristics of main mass intoxications by DEG in medicines; 2) To analyze its impact on local general written press and global publications; and 3) To review the legislative initiatives implemented after DEG-relative massive intoxications and their impact on the prevention of new episodes. The systematic search in scientific databases (Medline and EMBASE) and in google Scholar resulted in the identification of 12 episodes from 9 countries, based on the analysis of 84 publications. Most episodes occurred in developing countries (11/12) and were associated with paracetamol liquid formulations (7/12). With the exception of one episode in a developed country (France), the manufacture of the final product was carried out in local laboratories. The critical factors for minimizing episodes' impact were healthcare professionals' knowledge and alertness, healthcare authorities' awareness to early initiation of investigations and quick recall of medication after identification of the toxic substance. The New York Times journalistic research on the Haitian and Panamanian episodes was crucial for the identification of the origin of the toxic product. The written general press had its greatest impact on the episode of Panama contributing to the alert of the episode but especially in the process of defending the rights of those affected. Panama was also identified as the episode with the greatest impact on regulatory changes and implementation of legislation, with internal effects but also abroad, in other countries. Globally, this analysis identified 21 legislative measures associated with poisoning DEG episodes, including the establishment of regulatory agencies in two countries, Nigeria and Argentina. However, and despite the increase in quality control of medicines, resulting from legislation and regulations implemented over the last 25 years, these do not seem to be sufficient for the prevention of new episodes. The implementation of new measures should seek to adapt to each country specific characteristics and cultural aspects of developing countries. It should also be considered actions that allow training of healthcare professionals and population in the identification of episodes of poisoning by counterfeit medicines, as well as actions that increase awareness of the authorities of each country

Gisela Sin - One of the best experts on this subject based on the ideXlab platform.

  • Crisis and the Emergence of Economic Regulation: The Food, Drug and Cosmetic Act of 1938
    2011
    Co-Authors: Daniel Carpenter, Gisela Sin
    Abstract:

    Preliminary, with tentative conclusions. (I wouldn’t cite this if I were you.) Scholars commonly remark that new safety or environmental regulations follow a “crisis ” or “tragedy ” (for example, thalidomide, Bhopal, Three Mile Island). Yet these arguments are often vague and poorly established. Historians of the Food Drug and Cosmetic Act of 1938 point in particular to the Elixir Sulfanilamide disaster of 1937 as having generated a “public outcry ” for a new law. Others invoke industry capture explanations, namely that established drug firms supported new regulation as a way of winnowing competition from patent medicine firms. In this paper we explain the 1938 Act as a combination of bureaucratic agenda-setting and the geographically conditional nature of consumer crises. We use new evidence from (1) the evolution of the dominant bills, (2) the distribution of organized pharmaceutical and patent medicine firms, and (3) the distribution of shipments and deaths from Elixir Sulfanilamide in 1937 to support this argument. While our conclusions are tentative, our analyses give plausible support to the argument that the concentration of Sulfanilamide shipments and deaths in key Southern states induced previously reluctant but pivotal Southern Democrats to support an unprecedented expansion of bureaucratic power over a burgeoning industry. Had Sulfanilamide deaths occurred outside the South, we conclude, the Act would probably not have passed. Yet had the Sulfanilamide tragedy occurred at another time, when FDA regulation as the dominant alternative to the status quo was not advanced by bureaucratic leaders, the Act would either not have passed or would have taken a much different form. In addition, we find strong evidence against capture and rent-seeking explanations of the 1938 Act

Daniel Carpenter - One of the best experts on this subject based on the ideXlab platform.

  • Crisis and the Emergence of Economic Regulation: The Food, Drug and Cosmetic Act of 1938
    2011
    Co-Authors: Daniel Carpenter, Gisela Sin
    Abstract:

    Preliminary, with tentative conclusions. (I wouldn’t cite this if I were you.) Scholars commonly remark that new safety or environmental regulations follow a “crisis ” or “tragedy ” (for example, thalidomide, Bhopal, Three Mile Island). Yet these arguments are often vague and poorly established. Historians of the Food Drug and Cosmetic Act of 1938 point in particular to the Elixir Sulfanilamide disaster of 1937 as having generated a “public outcry ” for a new law. Others invoke industry capture explanations, namely that established drug firms supported new regulation as a way of winnowing competition from patent medicine firms. In this paper we explain the 1938 Act as a combination of bureaucratic agenda-setting and the geographically conditional nature of consumer crises. We use new evidence from (1) the evolution of the dominant bills, (2) the distribution of organized pharmaceutical and patent medicine firms, and (3) the distribution of shipments and deaths from Elixir Sulfanilamide in 1937 to support this argument. While our conclusions are tentative, our analyses give plausible support to the argument that the concentration of Sulfanilamide shipments and deaths in key Southern states induced previously reluctant but pivotal Southern Democrats to support an unprecedented expansion of bureaucratic power over a burgeoning industry. Had Sulfanilamide deaths occurred outside the South, we conclude, the Act would probably not have passed. Yet had the Sulfanilamide tragedy occurred at another time, when FDA regulation as the dominant alternative to the status quo was not advanced by bureaucratic leaders, the Act would either not have passed or would have taken a much different form. In addition, we find strong evidence against capture and rent-seeking explanations of the 1938 Act