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

Children have dynamic process of maturation and substantial changes in growth and development which eventually make the drug safety profiles different from adults. Medication errors (MEs) in pediatrics are reported to occur three times more likely than adults. The aims of this study were to identify the characteristics of pediatric MEs in Korea at national level and help raise awareness of risks from the MEs in pediatrics. We conducted a descriptive analysis with the pediatric ME reports in Korea Adverse Event Reporting System (KAERS) database from 1989 to 2012 and 208 ME reports in pediatrics were found. Based on KAERS database, the proportion of reported pediatric ME in adverse drug event (ADE) reports was 2.73 times (95% CI, 2.35-3.17) higher than that of adult ME. In 208 ME reports, we found a total of 236 ME-related terms within 19 types of MEs. The most common type of MEs was "accidental overdose" (n = 58, 24.6%), followed by "drug maladministration" (n = 50, 21.2%) and "medication error" (n = 41, 17.4%). After the narratives of ME reports were reviewed, we noticed that most of them did no harm to patients, but some cases were needed for medical treatment. Our data suggest that MEs in pediatrics are not negligible in Korea. We expect that this study would increase the awareness of the problem in pediatric MEs and induce the need for further development of an effective national ME preventing system in Korea.
Adult ; *Adverse Drug Reaction Reporting Systems ; Child ; *Databases, Factual ; Humans ; Medication Errors/*statistics & numerical data ; Republic of Korea/epidemiology ; Time Factors

Since the state food and drug administration (SFDA) issued the first edition of adverse drug reaction(ADR) information in November, 2001, it has 32 edition, reported the drug 66 species of adverse reactions, involving the variety of 12 traditional Chinese medicines, it was effectively reminds all social concern of adverse drug reaction. For statistical analysis in recent years reported adverse drug reaction of prepared Chinese medicine, collected 462 literatures from 2005-09 CNKI Chinese journal full-text database of medicine health directory. In all the collections, about 94 literatures are closely related to adverse drug reaction report of prepared Chinese medicine. But there are only 7 references could identify traditional Chinese medicine and western medicine correctly in 72 literatures with the value of statistical analysis. That means only 8.9% of literatures can correctly identify western medicine and Chinese traditional medicine. So it proved that TCM workers' knowledge of ADR remains to be greatly improved.
Adverse Drug Reaction Reporting Systems ; Drug Therapy ; statistics & numerical data ; Drug-Related Side Effects and Adverse Reactions ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Humans ; Medicine, Chinese Traditional ; adverse effects

AIM: Combine disproportionality analysis with dynamically interactive graphics to understand spontaneously-reported adverse events in pharmacovigilance. METHODS: Four statistical methods, including Reporting Odds Ratio, Proportional Reporting Ratio, Multi-Item Gamma Poisson Shrinker and Bayesian Confidence Propagation Neural Network that are used for computing disproportionality are described. Tree maps and other graphical techniques are used to display the disproportionality results. RESULTS: Spontaneously-reported adverse events in pharmacovigilance are collected from physicians, patients, or the medical literature by regulatory agencies, pharmaceutical companies and device manufacturers to monitor the safety of a product once it reaches the market. In order to identify potential safety-signals, disproportionality analysis methods compare the rate at which a particular event of interest co-occurs with a given drug with the rate this event occurs without the drug in the event database. Tree maps are employed to interactively display the adverse events for particular drugs and compare the adverse events among the drugs. CONCLUSION Interactive graphical displays of disproportionality allow the analyst to quickly identify safety signals and perform additional follow-up analyses. Combining statistical methods with dynamically interactive graphics affords insights into the data inaccessible by traditional analysis methods.
Adverse Drug Reaction Reporting Systems ; statistics & numerical data ; Bayes Theorem ; Data Interpretation, Statistical ; Databases, Factual ; Drug-Related Side Effects and Adverse Reactions ; Humans ; Odds Ratio ; Pharmacovigilance ; Product Surveillance, Postmarketing ; statistics & numerical data

OBJECTIVETo analyze the adverse events following immunization (AEFI) in Minhang District of Shanghai from 2007 to 2010 and evaluate the safety of vaccines.

METHODThe data of AEFI cases were collected and reported by the Vaccine Adverse Events Surveillance System (VAESS). The data were classified as non-serious or serious reaction according to the symptoms and medical records.

RESULTFrom 2007 to 2010, 5088 AEFI cases were reported to the surveillance system after 4.85 million doses of 24 kinds of vaccines (viral vaccines, bacterial vaccine and non-vaccine product) use. A total of 5013 non-serious AEFI were reported with a rate of 103.24/100 000 doses. Among the non-serious AEFIs, the majority were fever (3314 cases, 68.25/100 000 doses), followed by local reactions (1686 cases, 34.72/100 000 doses). A total of 75 serious AEFIs were reported, with a rate of 1.54/100 000 doses. The anaphylaxis (26 cases, 0.54/100 000 doses) accounted for the most among the serious AEFIs, followed by allergic rash (24 cases, 0.49/100 000 doses) and abscess at injection site (14 cases, 0.29/100 000 doses). The susceptibility of data on AEFI rose year by year from 2007 to 2010, and the reported rate rose from 40.48/100 000 in 2007 to 134.17/100 000 in 2010.

CONCLUSIONTo maintain the sensitivity of AEFI surveillance is key to detect rare serious adverse events. The sensitivity should be enhanced, at the same time, pediatricians should treat the AEFI with standard methods, so as to minimize the negative impacts of vaccination and to maintain the confidence among the public.

Adverse Drug Reaction Reporting Systems ; statistics & numerical data ; Anaphylaxis ; epidemiology ; Child ; Child, Preschool ; China ; epidemiology ; Dermatitis, Allergic Contact ; epidemiology ; Fever ; epidemiology ; Humans ; Immunization ; adverse effects ; Population Surveillance ; Retrospective Studies ; Vaccines ; adverse effects ; classification

Hepatic adverse drug reactions (ADRs) to certain drugs may differ within each country, reflecting different patterns of prescription, socioeconomic status, and culture. The purpose of this study was to assess the suspected cause of hepatic ADRs using the spontaneously reported pharmacovigilance data from Korea. A total of 9,360 spontaneously reported adverse drug events (ADEs) from nine Pharmacovigilance Centers were analyzed. Risk of hepatic ADEs was assessed by calculating the reporting odds ratio (ROR). Of the 9,360 cases, 567 hepatic ADEs were reported. The most frequently prescribed drug classes inducing hepatic ADEs were anti-tuberculotics, cephalosporins, valproic acids, penicillins, quinolones, non-steroidal anti-inflammatory drugs (NSAIDs), anti-viral agents, and statins. ROR values were especially high in anti-tuberculosis drugs, systemic antifungal drugs for systemic use, anti-epileptics, propylthiouracil, and herbal medicines. Underlying diseases such as tuberculosis (6.9% vs 0.9%), pneumonia (4.9% vs 1.7%), intracranial injury including skull fracture (4.5% vs 0.9%), HIV (3.4% vs 0.4%), subarachnoid hemorrhage (2.8% vs 0.5%), and osteoporosis (2.4% vs 1.4%) were significantly more common in hepatic ADE group. In conclusion, anti-infective drugs, anti-epileptics, NSAIDs and statins are the most common suspects of the spontaneously reported hepatic ADEs, in Korea. Careful monitoring for such reactions is needed for the prescription of these drugs.
Adult ; *Adverse Drug Reaction Reporting Systems/statistics & numerical data ; Aged ; Anti-Infective Agents/adverse effects ; Anti-Inflammatory Agents, Non-Steroidal/adverse effects ; Anticonvulsants/adverse effects ; Drug Monitoring ; Drug-Induced Liver Injury/*epidemiology/*etiology ; Female ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects ; Male ; Middle Aged ; Odds Ratio ; Pharmacovigilance ; Republic of Korea/epidemiology ; Risk Factors

Spontaneous reporting system (SRS) datais currently an important source of monitoring and finding ADRs signals throughout the world. This method can promptly and effectively discover ADR signals, thus preventing and avoiding ADRs effectively. Parenterally administered Shenmai has the functions of benefiting vital energy, nourishing Yin and generating body fluids, and activating the pulse. Clinically it is used in various diseases including shock, coronary heart disease, viral myocarditis, chronic pulmonary heart disease, and granulocytopenia. The large, national SRS database of ADRs needs effective evaluation methods. We report on the use of Bayesian confidence propagation neural network method (BCPNN) and proportional reporting ration (PRR) with propensity score to control for confounding variables. Early warning signs of an ADR are, a feeling of suffocation (difficulty exhaling), anaphylactoid reactions and flushing. Furthermore, relevant relationships between the different factors is analysed by association rules (AR). It is found that there is a close relationship between past history of ADRs, a family history of ADRs and itching.
Adolescent ; Adult ; Adverse Drug Reaction Reporting Systems ; statistics & numerical data ; Aged ; Aged, 80 and over ; Child ; Child, Preschool ; China ; epidemiology ; Databases, Factual ; Drug Combinations ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; etiology ; Drugs, Chinese Herbal ; adverse effects ; Female ; Humans ; Infant ; Infusions, Parenteral ; Male ; Middle Aged ; Pharmacovigilance ; Propensity Score ; Young Adult

Parenterally administered Shuxuening is a commonly used Chinese medicine. There is a need to understand the characteristics of adverse drug reactions (ADRs) to it. 9 601 ADR cases reports were collected from the national adverse drug reaction monitoring center reported between January, 2005 and December, 2012. These included 326 serious ADR cases, accounting for 3.93% of the total. It was found that ADR reports increased annually from 2005, reaching a peak in the third quarter of 2009. The number of ADR cases reports were greatest in the third quarter of each year. ADRs in patients aged 60-74, accounted for 3 348 (34.87%) of all cases. 9 391(97.81%) cases were administered by intravenous infusion. In 8 431 cases, the dosage was in accordance with instructions. 61.61% ADR cases occurred on first administration. The ten most frequent symptoms were, rashes, itching, dizziness, palpitations, chills, allergic reactions, shortness of breath, nausea, phlebitis and vomiting. Systemic damage mainly affected the skin and its accessories damage, or the nervous system damage. Through the use of proportional reporting ratio (PRR) and Bayesian confidence propagation neural network (BCPNN) and propensity score applying generalized boosted models (GBM) to control for 17 confounding factors, analysis of the 10 kinds of ADRs found that for the ADR signals of dizziness, palpitations, phlebitis, and vomiting, BCPNN found that dizziness and phlebitis were early warning signals. This research found that in the 60-89 age group, higher dosages of parenterally administered Shuxuening gave rise to more phlebitis. This study provides important information for parenterally administered Shuxuening research, and guidance for its risk management.
Adolescent ; Adult ; Adverse Drug Reaction Reporting Systems ; statistics & numerical data ; Aged ; Aged, 80 and over ; Child ; Child, Preschool ; China ; epidemiology ; Databases, Factual ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; etiology ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Female ; Humans ; Infant ; Infusions, Parenteral ; Male ; Middle Aged ; Pharmacovigilance ; Young Adult

This article focused on early warning signals regarding the safety of parenterally administered Xiyanping. The study data was obtained from reports made between 2005-2012 from the national spontaneous reporting system (SRS). Proportion reporting ratio (PRR) and Bayesian confidence propagation neural network (BCPNN) algorithms were used to analyse: erythra, pruritus, anaphylactoid reactions and shiver with cold, these 4 adverse drug reactions had a total count of more than 500 events. The article found that Xiyanping's incidence rate of erythra was higher than for background-drugs in every year and in every season. Pruritus was an early warning signal in the second season of 2009, and anaphylactoid reaction was an early warning signal in the fourth season of 2011 and in the second season of 2012. There was however no early warning signal indicated by shiver with cold. This data indicates that erythra maybe an adverse drug reactions to parenterally administered Xiyanping, and if the incidence rate of pruritus and anaphylactoid reaction rises attention should be paid to its safety.
Adolescent ; Adult ; Adverse Drug Reaction Reporting Systems ; statistics & numerical data ; Aged ; Aged, 80 and over ; Child ; Child, Preschool ; China ; epidemiology ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; etiology ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Female ; Humans ; Infant ; Infusions, Parenteral ; Male ; Middle Aged ; Pharmacovigilance ; Propensity Score ; Young Adult

Spontaneous reporting system (SRS) is currently a basic method to monitor and find adverse drug reactions (ADR) signals used worldwide. This method can promptly and effectively discover ADR signals and is of great significance to effectively prevent and avoid ADRs. Parenterally administered salvianolate has the functions of activating blood circulation and removing stasis. It is mainly used in the treatment of stable angina pectoris. As the drug is widely used clinically and ADRs are increasingly reported promptly, ADR information in the national ADR monitoring center's SRS database has also increased. How to quickly and effectively identify suspicious ADRs is a major concern. This study uses BCPNN and PRR to detect early warning signals. S739 ADR case reports were identified. There were 106 types, 1 310 events, and 24 serious ADR cases ( 3.25% of 739 case reports) There wre no deaths. The ten most frequent ADRs were: rash, dizziness, itch, headache, chills and breath, nausea, palpitation, anaphylactic reaction and hot. The drugs early warning signs were dizziness, headache, nausea, itchiness and rash estimated using PRR. Early warning signs based on BCPNN were dizziness and headache. The ADRs of dizziness and headache are early warning signals associated with the nervous system.
Adolescent ; Adult ; Adverse Drug Reaction Reporting Systems ; statistics & numerical data ; Aged ; Aged, 80 and over ; Child ; Child, Preschool ; China ; epidemiology ; Databases, Factual ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; etiology ; Female ; Humans ; Infant ; Infusions, Parenteral ; Male ; Middle Aged ; Pharmacovigilance ; Plant Extracts ; administration & dosage ; adverse effects ; Young Adult