Severe esophagitis induced by antituberculosis drugs: a case report

ABSTRACT Tuberculosis stands as one of humanity's oldest afflictions, intrinsically intertwined with social disparities. This formidable disease spares no age group and remains the prevailing cause of infection-induced mortality worldwide, particularly in developing nations. We present a case of a 56-year-old woman with diabetes who was diagnosed with Pulmonary Tuberculosis. After receiving antituberculosis drugs as part of her treatment, she experienced a range of systemic manifestations and suffered from severe ulcerative esophagitis. This adverse reaction led to uncontrollable gastrointestinal intolerance, tragically resulting in her untimely demise. The incident underscores the potential seriousness of adverse reactions that can arise from tuberculosis treatment medications.

Discussion on the management of Suspected Unexpected Serious Adverse Reaction reports during clinical trials / 中华医学科研管理杂志

Objective:According to the new GCP regulations issued by national medical products administration, this paper discusses the management mode of Suspected Unexpected Serious Adverse Reaction (SUSAR) reports during clinical trials.Methods:Combined with GCP regulations and working practice, this paper comprehensively analyzes the issues identified and related reasons for the management of SUSAR reports during clinical trials, and propose possible countermeasures.Results:There are some problems in the management of SUSAR reports among different stakeholders during clinical trials, such as defects in the performance of obligations and responsibilities. It is suggested that investigators should be more carefully to fulfill GCP responsibilities; sponsors should be more accurately implement the reporting procedures; institutional and ethical supervision should also be strengthened to assure better conduct of clinical trials.Conclusions:Multi-party collaboration and management mode play crucial roles in conducting high-quality clinical trials.

Costo del tratamiento farmacológico de las reacciones adversas graves por medicamentos en Cuba (2003-2013) / Cost of Pharmacological Treatment for Serious Adverse Drug Reactions in Cuba (2003-2013)

Introducción: Los problemas de seguridad y costo de las reacciones adversas medicamentosas (RAM) graves tienen un peso considerable en los sistemas de salud, pero la evidencia demostrada en los estudios publicados en Cuba, es aún escasa. Objetivo: Determinar costos asociados al tratamiento farmacológico de las reacciones adversas graves en el país. Método: Se realizó una evaluación parcial de tipo descripción de costos desde la perspectiva del Sistema Nacional de Salud en el periodo 2003-2013. Se utilizó una técnica de microcosteo, se calcularon los costos unitarios y totales para un horizonte temporal de 24 horas de ocurrida la reacción adversa grave y estos se expresaron en pesos cubanos. Resultados: Del total de RAM graves, en 13 293 hubo descripción del tratamiento farmacológico inmediato (17,9 por ciento). Este representó un costo total de $ 62 228,05. El costo medio fue de $ 4,69. Los mayores porcentajes de RAM graves se ubicaron en los rangos entre $ 1,00 y 3,00 (24,3 por ciento). Se observó que las RAM de hipersensibilidad representaron el 34,2 por ciento del costo total con $ 21 283,41 CUP. Aquellas de intensidad moderada representaron el 81,7 por ciento de los costos. Prácticamente en todos los casos costó más tratar las RAM graves que el costo del tratamiento farmacológico que la originó. Conclusiones: Los resultados muestran que las RAM graves verifican un problema y generan un costo para el sistema nacional de salud, por lo que se requieren medidas encaminadas a su detección y prevención para mejorar la seguridad del paciente y reducir los costos(AU)

Introduction: The safety and cost problems of serious adverse drug reactions (ADRs) have a considerable weight in health systems, but the evidence shown in the studies published in Cuba is still scarce. Objective: To determine costs associated with the pharmacological treatment of serious adverse reactions in the country. Method: A partial evaluation of cost description was carried out from the perspective of the National Health System in the 2003-2013 period. A micro-costing method was used. Unit and total costs were calculated for a time horizon of 24 hours after the serious adverse reaction occurred and these were expressed in Cuban pesos. Results: 13 293 of the total of serious AMR had a description of the immediate pharmacological treatment (17.9 percent). This represented a total cost of $ 62,228.05. The average cost was $ 4.69. The highest percentages of serious RAM were in the ranges between $ 1.00 and $ 3.00 CUP (24.3 percent). Hypersensitivity ADRs represented 34.2 percent of the total cost with $ 21,283.41 CUP. Those of moderate intensity represented 81.7 percent. In practically all cases, it cost more to treat serious ADRs than the cost of the pharmacological treatment that originated it. Conclusions: The results showed that serious ADRs prove to be a problem and generate costs for the national health system, which is why measures aimed at its detection and prevention are required to improve patient safety hence reduce costs(AU)

A Study on Management and Report of Adverse Event in Clinical Trials

BACKGROUND: This research is to identify the difficulties occuring in the course of managing the adverse events and the adverse event related standard operating procedure in the regulation of each institutional review board. METHODS: In order to identify the issues of the management of adverse events of each institution, this research surveyed the IRB administrators in fifty two university hospitals nation-wide. This survey is conducted among one chairman and one IRB member from the IRB members per each IRB who have experience in reviewing adverse events. The survey also includes investigators and sponsors who engage in reporting adverse events. RESULTS: The result of this survey demonstrates that the objects and the terms of adverse event reports provided by the Standard Operating Procedure and the KGCP of each institution are not very different from each other. However, according to the survey, any cases reported to the IRBs, although they are not specified as the object of reports in the institution, have been reviewed by the IRB members. To sum up the results of the survey, the major issues include ambiguous regulations on adverse event reports and reviews, the use of different report formats for each institution, and the difficulty with evaluating the causal relationship with Investigational Product. CONCLUSION: It is necessary to develop concrete and specified guidelines on the objects and the terms of reports, the standard for the causal relationship and the adequate measures for adverse events after review and to standardize the format of adverse event reporting.