OBJECTIVETo discuss the modes for smooth progress of ADR monitoring under the new Measures for the Administration of Adverse Drug Reaction Report and Monitoring.

METHODWork modes for ADR monitoring in drug manufacturers were explored by explaining the new Measures and analyzing current state and constrains.

RESULT AND CONCLUSIONAs there is a larger gap between the requirements of new Measures and current status, it is difficult for drug manufacturers to meet all the requirements in short-term. Therefore, drug manufacturers are suggested to gradually complete ADR monitoring under the mode of one platform and four expansions, and thereby finally meeting the requirements of new Measures and fulfilling their duties and missions.

Adverse Drug Reaction Reporting Systems ; Drug Industry ; Drug-Related Side Effects and Adverse Reactions ; diagnosis ; Humans

Evidence body is defined as an evidence complex incorporating the evidence obtained from various research methods and various resources. As one of common parenterally administered Chinese medicines, Shuxuetong's safety drew high concern from doctors. However, we only have grasped several but less systematic evidence on the safety of Shuxuetong. To build a safety evidence body of Shuxuetong injection. Review and evaluate the evidence related to the safety of Shuxuetong injection after accumulating, searching and classfying related literature. Accoeding to levels of evidence from high to low, the evidence related to the safety of Shuxuetong injection was classified as following: the evidence from a long-term, prospective, large-sample-size and intensive hospital monitoring study was the strongest; the evidence of hospital information system (HIS) data analysis; the evidence of spontaneous reporting system (SRS) data analysis; the evidence of adverse drugreactions (ADRs)/adverse drug events (ADEs) reported in systematic evaluation, ADRs case report, toxicological tests, pharmacological tests were weakest. Based on the evidence body, Shuxuetong Injection was proved to be safe, and its ADRs were mainly allergic reactions, and more often happened among the old patients.
Adverse Drug Reaction Reporting Systems ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Female ; Humans ; Prospective Studies

OBJECTIVEThis paper is aimed to explore the adverse reaction condition of Shuanghuangli an injection with three common used signal detecting methods based on SRS database of Jiangsu province, and to evaluate the performance of three methods.

METHODThree methods would be used to detect the signals based on the SRS database of Jiangsu province. Consistency of the results of these three methods with that proved in descriptions was evaluated by Kappa test. The trend graph of the confidence intervals of several time points was used to demonstrate the trend of the signal.

RESULTThe PRR method was consistent with ROR method in high degree in any situation. The results of BCPNN method was close to PRR and ROR method only when the related report count was larger. PRR and ROR methods had higher false positive rate than BCPNN method.

CONCLUSIONPRR or ROR method is proposed for signal detecting when the report count is large. BCPNN method is proposed for trend demonstration of signal with graph.

Adverse Drug Reaction Reporting Systems ; Data Mining ; methods ; Drugs, Chinese Herbal ; adverse effects ; Humans

Along with the general improving of public consciousness on drugs' safety and the increasing of new Chinese drugs' manufacture and application, the safety of Chinese drugs has become a more prominent concern and a focus of attention. The scientific identification, analysis and evaluation of this affairs greatly impacts the scientific decision-making for ensuring the public use of drugs in security, also influences the healthy development of Chinese medicine industry. In this paper, the different meanings of "adverse reaction" and "adverse events" of Chinese drugs were introduced from pharmacovigilance idealistic view, and the influencing factors on safety of Chinese drugs were analyzed from the perspective of pharmacovigilance. The authors proposed that "Chinese medicine safety monitoring and evaluation" is a much more practical concept in consistency with the current situation. They pointed out that introducing sufficiently the concept of pharmaco vigilance idea into the safety monitoring and evaluation process is the basis for overall evaluation and effective risk controlling of Chinese drugs.
Adverse Drug Reaction Reporting Systems ; Drug Evaluation ; standards ; Drug-Related Side Effects and Adverse Reactions ; Drugs, Chinese Herbal ; adverse effects

Safety assessment in clinical trials is dependent on an in-depth analysis of the adverse events to a great extent. However, there are difficulties in summary classification, data management and statistical analysis of the adverse events because of the different expressions on the same adverse events caused by regional, linguistic, ethnic, cultural and other differences. In order to ensure the normative expressions, it's necessary to standardize the terms in recording the adverse events. MedDRA (medical dictionary for regulatory activities) has been widely recommended and applied in the world as a powerful support for the adverse events reporting in clinical trials. In this paper, the development history, applicable scope, hierarchy structure, encoding term selection and standardized query strategies of the MedDRA is introduced. Furthermore, the practical process of adverse events encoding with MedDRA is proposed. Finally, the framework of statistical analysis about adverse events is discussed.
Adverse Drug Reaction Reporting Systems ; standards ; statistics & numerical data ; Databases, Pharmaceutical ; standards ; Humans

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.
Adverse Drug Reaction Reporting Systems ; China ; Hospitals ; Medicine, Chinese Traditional ; Nonprescription Drugs ; Product Surveillance, Postmarketing

This research based on the analysis of spontaneous reporting system (SRS) data which the 9 601 case reports of Shuxuening injection adverse drug reactions (ADR) in national adverse drug reaction monitoring center during 2005-2012. Apply to the association rules to analysis of the relationship between Shuxuening injection's ADR and the characteristics of ADR reports were. We found that ADR commonly combination were "nausea + breath + chills + vomiting", "nausea + chills + vomiting + palpitations", and their confidence level were 100%. The ADR and the case reports information commonly combination were "itching, and glucose and sodium chloride Injection, and generally ADR report, and normal dosage", "palpitation, and glucose and sodium chloride injection, and normal dosage, and new report", "chills, and generally ADR report, and normal dosage, and 0.9% sodium chloride injection", and their confidence level were 100% too. The results showed that patients using Shuxuening injection occurred most of ADRs were systemic damage, skin and its accessories damage, digestive system damage, etc. And most of cases were generally and new reports, and patients with normal dosage. The ADR's occurred had little related with solvent. It is showed that the Shuxuening injection occurred of ADR mainly related to drug composition. So Shuxuening injection used in clinical need to closely observation, and focus on the ADR reaction, and to do a good job of drug risk management.
Adverse Drug Reaction Reporting Systems ; Drug-Related Side Effects and Adverse Reactions ; diagnosis ; Drugs, Chinese Herbal ; adverse effects ; Female ; Humans ; Male

Adverse drug reaction (ADR) causality judgement is a routine procedure in pharmacovigilance, no unified judgement standard and categories standard are established. Temporal relations, consistency, specificity, intensity of reaction are the basic principle of ADR causality jugement we should abide by. There are many ADR causality assessment methods, which classifies standard algorithms, expert judgement, bayesian approches. The implicit definitions of some categories standard, incomplete information from case reports coupled with vast differences in the application of clinical judgements are the major problems facing ADR evaluation. Almost every kind of method shares certain common feature, that is, causal relationship of ADR is classified about five categories. However, causality assessment methods differ in basic principle, evaluation standard, specificity and sensitivity. There are some advantages and disadvantages among methods, but no causality assessment method can be applied to all ADR evaluation to date.
Adverse Drug Reaction Reporting Systems ; standards ; China ; Drug Therapy ; Drug-Related Side Effects and Adverse Reactions ; Humans ; Pharmaceutical Preparations ; administration & dosage

There are no drugs without the risk of potential adverse reactions. All pharmacologically active substances can cause adverse drug reactions (ADRs). This paper aims at introducing recent trends in pharmacosurveillance systems for ADRs, which can be broadly classified into type A and B reactions. Since type A reactions are associated with drug pharmacology, they are usually dose-dependent and predictable. Whereas, type B reactions occur in some susceptible individuals, regardless of the pharmacological action of drug. Drug hypersensitivity reactions are typical examples of type B reactions and are subclassified according to the underlying pathomechanism. Recent advancements in pharmacogenomics have enlightened the understanding of individual differences in drug efficacy and susceptibility to ADRs. Therefore, expectations for safe personalized medicines are higher than ever before. However, premarketing clinical trials are too small and too short to uncover rare but serious ADRs and detect long-standing ADRs. In the past, post-marketing surveillance systems mainly focused on passive ADR monitoring systems, based on spontaneous reports. Recently, the importance of active pharmacovigilance systems, which use big data, is growing with recent advancements in medical informatics. Thus, regarding ADRs, suspecting and detecting the causative drug using causality assessment based on data science may contribute to decrease suffering induced by ADRs.
Adverse Drug Reaction Reporting Systems ; Drug Hypersensitivity ; Drug-Related Side Effects and Adverse Reactions ; Humans ; Individuality ; Medical Informatics ; Pharmacogenetics ; Pharmacology ; Pharmacovigilance

OBJECTIVETo provide analytical data and automatic method for more quickly and accurately discovering warning signals of adverse reactions of traditional Chinese medicine (TCM) injections from a large number of adverse reaction data.

METHODConstructed the TCM injection adverse reaction monitoring system, integrated of multiple mining algorithms of warning signals of adverse reactions and automatically generate early warning analysis, and extended the algorithm to achieve better effect of warning and analysis.

RESULTBy data validation, the system can provide consistent warning results with the actual situation.

CONCLUSIONThe established system has good scalability, it can provide warning analysis of adverse reaction data from multiple sources, and provide a basis for decision making to experts in the field.

Adverse Drug Reaction Reporting Systems ; instrumentation ; standards ; Algorithms ; Drug Hypersensitivity ; epidemiology ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Humans