Technical specifications for hospital-based intensive monitoring of post-marketing Chinese patent medicine / 中国中药杂志

In 2013,China pharmaceutical regulatory department issued guiduance on postmarketing drug safety monitoring for industry. It aimed to encourage industry to carry out postmarketing drug safety monitoring including hospital-based intensive monitoring of postmarketing Chinese patent medicine. Subsequently,more and more such kind of studies have been performed all over China. However,in view of the current situation in this field,the development of hospital-based intensive monitoring of postmarketing Chinese patent medicine lacks standardization,such as unreasonable design,omission of reports about adverse drug reactions,inadequate process of quality control,non-standardized interpretation of adverse reactions,etc. Therefore,it is necessary to formulate relevant technical specifications to guide this area. The developing of this technical specification refered to the international post-marketing safety monitoring model and advanced design concepts and methods. We developed it under the guidance of relevant laws,regulations and technical documents in China. Meanwhile the characteristics of Chinese patent medicines and the real situation in this area were considered. The aim of this technical specification is to obtain the incidence,type,degree and clinical manifestation of adverse drug reactions of Chinese patent medicines,to find new risk signals of adverse reactions,to identify risk factors,and to provide a basis for the formulation of risk management and control plans. This specification has been approved by China association of Chinese medicine which is numbered T/CACM011-2016.

Reacciones adversas por antipalúdicos en hospitales centrales y provinciales de Angola / Adverse reactions due to antimalarials in central and provincial hospitals in Angola

Introducción: El paludismo es la primera causa de morbilidad y mortalidad en Angola. Las particularidades de las reacciones adversas a antipalúdicos no están bien establecidas en pacientes hospitalizados. Objetivo: Caracterizar las reacciones adversas a medicamentos antipalúdicos. Método: Estudio de farmacovigilancia activa de serie de casos. El universo fueron 2 634 pacientes ingresados con paludismo confirmado en los hospitales centrales y provinciales de Angola durante el primer semestre de 2015. Médicos entrenados realizaron pesquisa diaria a través de interrogatorios farmacológicos, pases de visita y revisión de historias clínicas. Resultados: Hubo una tasa de 7,5 reacciones adversas por cada 100 pacientes internados. El 77,8 por ciento eran adultos y el 15,7 por ciento niños. Hubo predominio del sexo femenino en los niños y adultos (51,6 por ciento y 52,6 por ciento, respectivamente). Las reacciones más notificadas fueron las náuseas y vómitos (14,3 por ciento), el dolor abdominal (13,4 por ciento) y la erupción cutánea y los temblores, ambos con el 11,7 por ciento. La quinina endovenosa fue el antipalúdico de mayores reportes de reacciones adversas (29,0 por ciento). Además, las quininas (oral y endovenosa) provocaron el 41,1 por ciento del total de reacciones adversas encontradas. Predominaron las reacciones adversas leves (73,2 por ciento), las probables (47,6 por ciento) y las de aparición frecuentes (69,7 por ciento). Conclusiones: Existen reacciones adversas a los tratamientos antipalúdicos impuestos en los hospitales centrales y provinciales de Angola. Es importante la vigilancia activa en la identificación y el reporte de los efectos adversos por fármacos en los escenarios con sistema de farmacovigilancia que no alcanzan una implementación efectiva(AU)

Introduction: Malaria is the main cause of morbidity and mortality in Angola. Characteristics of adverse reactions due to antimalarials are not well established in hospitalized patients. Objective: Characterization of adverse reactions to antimalarial drugs. Method: An active pharmacovigilance study was carried out in a series of cases. There was a total of 2 634 patients admitted in central and provincial hospitals of Angola with confirmed malaria during the first semester of 2015. Trained doctors conducted daily screenings through pharmacological questionnaires, visits to the patients and reviews of medical records. Results: It was found that there was a rate of 7.5 adverse reactions per 100 hospitalized patients. 77.8 percent were adults and 15.7 percent were children. There was a predominance of females in children and adults (51.6 percent and 52.6 percent, respectively). The most commonly reported reactions were nausea and vomiting (14.3 percent), abdominal pain (13.4 percent) and rash and tremors both with 11.7 percent. Intravenous quinine was the antimalarial with the highest number of reports of adverse reactions (29.0 percent). In addition, oral and intravenous quinine caused 41.1 percent of the total number of ADRs found. Mild adverse reactions (73.2 percent), probable adverse reactions (47.6 percent) and frequent adverse reactions (69.7 percent) were predominant. Conclusions: Data provided by the study show the existence of adverse reactions to antimalarial treatments in central and provincial hospitals in Angola. It is highlighted the importance of an active surveillance in the identification and reporting of adverse effects due to drugs in scenarios with a pharmacovigilance system that does not reach an effective implementation(AU)

Study on the Application Effects of ADR Rapid Reporting System in the Hospital / 中国药房

OBJECTIVE:To improve the quality of ADR reports. METHODS:By using intensive hospital monitoring mode, ADR reports before and after the application of the system would be collected and factors as report quantity,type,time and quality of reports were analyzed statistically. RESULTS:It provided rapid reporting function after the implementotion of the system. Total quantity of reported ADR cases increased from 589 to 748,and the proportion of all the serious ADR reports increased from 62.8%to 11.76%. The score of repert quality increased from 93.64 to 98.36,the proportion of time-out reports increased from 94.05% to 97.33%,with statistical significance (P<0.05). CONCLUSIONS:Rapid reporting system of ADR in the hospital is beneficial to improve the efficiency and guarantee the quality of the reports. It also can expand the coverage of the monitoring network,and can lay the foundation for drug safety scientific evaluation and monitoring.

Post-marketing safety surveillance of Diemailing Kudiezi injection: real world study in 30 233 cases / 中国中药杂志

This study was aimed to obtain the incidence of adverse drug reaction (ADR) of Diemailing Kudiezi injection, explore its characteristics, related risk factors and application in real world. A prospective single cohort study was conducted from 25 hospitals (including Chinese medicine hospitals and Western medicine hospitals) for 4 years. 30 233 consecutive inpatients using Diemailing Kudiezi injection were observed. Their general information was analyzed by using statistic frequency description. Association rules were used to analyze the correlation between comorbidities or drug combinations; the influential factors for ADRs were initially screened by using cross contingency method and Chi-square test, and then Group LASSAO method was used for further analysis. 54 patients with adverse drug events and 30 patients with ADRs were reported among 30 233 patients, with a total ADR incidence of 0.099%[95%CI (0.06%, 0.13%)]. There were 27 patients identified as the "general" ADR, one patients with "severe" ADR (anaphylactic shock) and two patients with new ADRs. ADR occurred most in 30 min after using Diemailing Kudiezi injection, in a total of 16 patients. The most ADRs were palpitation, vomiting, chills, pruritus and rash, 6 times for each symptom. Diemailing Kudiezi injection was well tolerated in the general population. The overall incidence of adverse reactions was rare, with high safety. However, the real incidence of ADRs may be underestimated in this study, and the blood samples were not obtained for the patients, so further mechanism studies shall be conducted.

Analysis of Diemailing Kudiezi injection use in real world in 7 189 patients with cerebral infarction / 中国中药杂志

This is a study based on hospital intensive monitoring to explore medication use of Diemailing Kudiezi injection(one Chinese herbal medicine injection) in real word in the patients with cerebral infarction. The active monitoring model was adopted and hospital intensive monitoring on safety of 7 189 cases of patients with cerebral infarction was conducted to obtain the drug use information of Diemailing injection. The results were analyzed by using statistical description and association rule method. The statistical description and association rule analysis were conducted based on patients' basic demographic characteristics, use of Diemailing injection and combined use of drugs. Sixty-two percent(4 437/7 189) of the patients were from traditional Chinese medicine hospitals as compared with 39%(2 752/7 189) from western medicine hospitals; 84%(6 003/7 189) of the patients were from tertiary hospitals as compared with 16%(1 186/7 189) from second-class hospitals. The hospitals were mostly located in north China. Drug related indicators such as a single dripping speed, stash time after allocating transfusion, duration of injection, and injecting room temperature were not noted in instruction manual. It was also found that there were off label use in the practice, for instance, non-intravenous infusion, >14 d treatment course, use of non-designated solvent, and a single dose>40 mL or<10 mL. Analysis of association rules showed that only Edaravone among the most frequent combined drugs was listed in the current guideline in China, and the other three most frequent combined drugs deproteinized calf blood extractive injection, Cinepazide Maleate injection and Alprostadil injection were used with little evidence. Diemailing＋Aspirin＋Alprostadil was the most common combined use in our study, but the recommended clopidogrel＋Aspirin was not found in this study. The drug use situation of Diemailing injection in the real world was obtained by data analysis on large size samples, providing basic reference information for clinicians and researchers. However, efficacy was not concerned in this study, so efficacy-related information could not be explained.