Search

Drug contamination appears to be responsible for a series of deaths from kidney failure among Haitian children. Between Oct, 1995 and Oct, 1996, 109 children developed kidney failure. Detailed records were kept on 87 children who remained in Haiti for treatment and 98% of these children died. Over one-quarter of the children transported to the US for treatment died. A locally manufactured acetaminophen syrup was strongly linked to these cases, and analysis of 36 different bottles revealed contamination with diethylene glycol in concentrations as high as 20%., Context. -- Contaminated pharmaceutical products can result in substantial morbidity and mortality and should be included in the differential diagnosis of deaths of unknown origin. Objective. -- To investigate an outbreak of deaths among children from acute renal failure in Haiti to determine the etiology and institute control measures. Design. -- Case-control study, cohort study, and laboratory toxicologic evaluation. Setting. -- Pediatric population of Haiti. Participants. -- Cases were defined as Haitian residents younger than 18 years with idiopathic anuria or severe oliguria for 24 hours or longer. Febrile hospitalized children without renal failure were enrolled as control subjects. Main Outcome Measure. -- The odds of exposure to suspected etiologic agents among cases and controls. Results. -- We identified 109 cases of acute renal failure among children. The clinical syndrome included renal failure, hepatitis, pancreatitis, central nervous system impairment, coma, and death. Of 87 patients with follow-up information who remained in Haiti for treatment, 85 (98%) died; 3 (27%) of 11 patients transported to the United States for intensive care unit management died before hospital discharge. A locally manufactured acetaminophen syrup was highly associated with disease (odds ratio, 52.7; 95% confidence interval, 15.2-197.2). Diethylene glycol (DEG) was found in patients' bottles in a median concentration of 14.4%. The median estimated toxic dose of DEG was 1.34 mL/kg (range, 0.22-4.42 mL/kg). Glycerin, a raw material imported to Haiti and used in the acetaminophen formulation, was contaminated with 24% DEG. Conclusions. -- An epidemic of severe systemic toxicity and deaths from DEG-contaminated acetaminophen syrup occurred in Haiti. Good manufacturing practice regulations should be used by all pharmaceutical manufacturers to prevent such tragedies.

Improving basic capacities for regulation of medicines and health technologies through regulatory systems strengthening is particularly challenging in resource-constrained settings. "Regionalization"--an approach in which countries with common histories, cultural values, languages, and economic conditions work together to establish more efficient systems--may be one answer. This report describes the Caribbean Regulatory System (CRS), a regionalization initiative being implemented in the mostly small countries of the Caribbean Community and Common Market (CARICOM). This initiative is an innovative effort to strengthen regulatory systems in the Caribbean, where capacity is limited compared to other subregions of the Americas. The initiative's concept and design includes a number of features and steps intended to enhance sustainability in resource-constrained contexts. The latter include 1) leveraging existing platforms for centralized cooperation, governance, and infrastructure; 2) strengthening regulatory capacities with the largest potential public health impact; 3) incorporating policies that promote reliance on reference authorities; 4) changing the system to encourage industry to market their products in CARICOM (e.g., using a centralized portal of entry to reduce regulatory burdens); and 5) building human resource capacity. If implemented properly, the CRS will be self-sustaining through user fees. The experience and lessons learned thus far in implementing this initiative, described in this report, can serve as a case study for the development of similar regulatory strengthening initiatives in resource-constrained environments. [ABSTRACT FROM AUTHOR]

Two cooperative public health initiatives involving representatives of civil society, academia, and the public and private sectors of the Americas are described and analyzed. One of them--the Multipartite Dialogue--promotes an intersectoral approach in its broadest sense, and the other--the Partners Forum--while it represents an institutional initiative, pays particular attention to chronic noncommunicable diseases. Both are a call to action for governments and offer alternatives to tackle regional health problems more effectively. [ABSTRACT FROM AUTHOR]

Competing Interests: Competing interests: CS and JH declare no competing interests.

Improving basic capacities for regulation of medicines and health technologies through regulatory systems strengthening is particularly challenging in resource-constrained settings. "Regionalization"-an approach in which countries with common histories, cultural values, languages, and economic conditions work together to establish more efficient systems-may be one answer. This report describes the Caribbean Regulatory System (CRS), a regionalization initiative being implemented in the mostly small countries of the Caribbean Community and Common Market (CARICOM). This initiative is an innovative effort to strengthen regulatory systems in the Caribbean, where capacity is limited compared to other subregions of the Americas. The initiative's concept and design includes a number of features and steps intended to enhance sustainability in resource-constrained contexts. The latter include 1) leveraging existing platforms for centralized cooperation, governance, and infrastructure; 2) strengthening regulatory capacities with the largest potential public health impact; 3) incorporating policies that promote reliance on reference authorities; 4) changing the system to encourage industry to market their products in CARICOM (e.g., using a centralized portal of entry to reduce regulatory burdens); and 5) building human resource capacity. If implemented properly, the CRS will be self-sustaining through user fees. The experience and lessons learned thus far in implementing this initiative, described in this report, can serve as a case study for the development of similar regulatory strengthening initiatives in resource-constrained environments.

Two cooperative public health initiatives involving representatives of civil society, academia, and the public and private sectors of the Americas are described and analyzed. One of them-the Multipartite Dialogue-promotes an intersectoral approach in its broadest sense, and the other-the Partners Forum-while it represents an institutional initiative, pays particular attention to chronic noncommunicable diseases. Both are a call to action for governments and offer alternatives to tackle regional health problems more effectively.

The recommendations from the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) were compared with those of a recent article by Aram V. Chobanian, Chairman of the JNC 7. The purpose was to identify the changes that this author proposed and determine how they might affect clinical work, as well as the health services and public health implications. The JNC 7 and the article in question coincide on all essential points, except that the article is more flexible when it comes to the use of diuretics at the start of treatment for high blood pressure. Chronic disease management should take place in health systems with primary care approach, where the epidemiology of such diseases and scientific advances in prevention offer an excellent opportunity for redesigning the health services and making them more effective. High blood pressure, as a public health problem, demands health interventions aimed not only at reducing harm but modifying its etiologic determinants. The challenge is to recognize that an integrated approach to clinical medicine, health services, and public health would offer an attractive opportunity to interrupt and prevent the continuous and costly vicious circle that managing high blood pressure and its complications implies.