Data mining of adverse drug reaction of iodine contrast media based on spontaneous reporting system / 中国药房

OBJECTIVE To mine the risk sig nals o f iodine contrast media from spontaneous reporting system. METHODS Reporting odds ratio ，proportional reporting ratio ，Medicines and Healthcare Products Regulatory Agency and Bayesian confidence propagation neural network were used to mine risk signals of 5 iodine contrast media （iopamidol，iohexol，iopromide，ioversol， iodixanol）. RESULTS 1 164（2 446 case times ）adverse drug reaction of iodine contrast media were included ，a total of 14 risk signals involving systems/organs such as respiratory system （3，2，4，3，2 for the above 5 iodine contrast media ）and immune system and 32 specific adverse drug reaction signals including anaphylactic shock ，rash and flushing （11，7，7，3，4 for the above 5 iodine contrast media ）were found in 5 iodine contrast media. CONCLUSIONS The risk signals of 5 iodine contrast media verify that there is a certain correlation between these drugs and above adverse drug reactions. It is suggested that before using iodine contrast media in clinic ，it is necessary to pay attention to whether the patient has a history of tumor and combined medication ，evaluate the patient’s renal function ，and give preventive measures such as hydration in advance. When using iodine contrast media ，it is necessary to pay attention to the temperature ，dose and injection rate. And medical staff need to follow up the patient ’s situation in time after using iodine contrast media to avoiding the impact of delayed adverse reactions.

2．A Checklist of Important Points in Research Using JADER / 薬剤疫学

Spontaneous reporting is an important source of information in pharmacovigilance. In Japan, the Japanese Adverse Drug Event Report database (JADER) was released in 2012, and this has led to numerous conference presentations and academic research papers that have reported the detection of signals based on the use of data mining methods. However, spontaneous reporting generally has certain limitations, including under-reporting, a lack of denominator information, and the effects of reporting bias, and these problems apply equally to JADER. The system of collecting spontaneous reports also influences the results obtained based on JADER analysis, as JADER in principle comprises serious adverse drug event reports and includes solicited reports. The detection of signals showing statistical significance does not necessarily imply a causal relationship between a particular drug and adverse events, and consequently, the cause of the signals detected requires careful interpretation. However, it has been pointed out that findings are sometimes accepted without considering the limitations.For pharmaceutical companies, the Guidance on good pharmacovigilance practices Module Ⅸ and Guidance for Industry - Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment are available in the European Union and United States, respectively, for the purpose of signal management in pharmacovigilance activities. In contrast, there are limited resources to which researchers can refer when they publish scientific findings obtained using spontaneous reporting databases. To rectify this deficiency, we created a “checklist of important points to be noted during research that uses the data mining method in JADER (mainly signal detection by disproportionality analysis)” for the benefit of researchers using JADER. That study was supported by a Grant for Research Projects of the Japanese Society of Drug Informatics in 2017. In this article, we provide an overview of the checklist, with reference to the “Report of CIOMS Working Group Ⅷ： practical aspects of signal detection in pharmacovigilance,” which was used as a source when creating the checklist.

Basic Dos and Don’ts in Applying Signal Detection Methods to Spontaneous Reporting Systems Databases / 医薬品情報学

“Signals are useless until they are read and possibly subjected to intensive study by appropriate investigators in WHO or in national centres”, cited from Finney’s 1974 first article on the theory of signal detection. Recently, freely available large-scale spontaneous reporting systems databases and improved computational power of personal computers have made it easier to perform signal detection in personal researches. However, adequate knowledge for the limitations of source spontaneous reports and understanding the differences with conventional clinical and epidemiological studies are imperatives for valid interpretation of signal indexes. This review describes the basic theory, aims and limitations of the signal detection method using spontaneous reporting systems databases and practical considerations.

Analysis of adverse reactions risk signal of Xinyuan Capsules based on national ADR monitoring spontaneous reporting system / 中国中药杂志

In recent years, the safety problems and events of traditional Chinese medicine represented by liver injury have occurred frequently. In particular, Polygonum multiflorum has been widely used and considered as a "non-toxic" tonic traditional Chinese medicine for thousands of years. However, in recent years, frequent reports of liver injury events have attracted widespread attention at home and abroad, which has made unfavorable impacts on traditional Chinese medicine and its international development. Some scho-lars have found that susceptible genes of P. multiflorum on liver injury lay a scientific foundation for formulating rational comprehensive prevention and control measures for liver injury risk of P. multiflorum and its relevant preparations. But what are the risk signals of adverse reactions of P. multiflorum in clinical application? Spontaneous reporting system is an important way to monitor and find adverse drug reaction(ADR) signals after the drug is launched in the market. It can find the ADR signals in time and effectively, and then effectively prevent and avoid the occurrence of adverse drug events. At present, the data mining technique has gradually become the main method of ADR/adverse event(AE) report analysis and evaluation at home and abroad. Specifically, Bayesian confidence propagation neural network in Bayesian method is a commonly used risk signal early warning analysis method. In this paper, BCPNN method was used to excavate the risk signals of adverse reactions of Xinyuan Capsules, a traditional Chinese medicine preparation containing P. multiflorum, such as nausea, diarrhea, rash, dizziness, vomiting, abdominal pain, headache, liver cell damage, so as to provide evidence-based evidence for clinical safe and rational use of drugs.

Analysis of adverse reactions of Xianling Gubao preparation based on real world SRS data / 中国中药杂志

From January 1, 2004 to July 21, 2016 a total of 2 796 cases of adverse drug reaction/adverse event(ADR/AE) after the use of Xianling Gubao Capsules/Tablets were reported by National Adverse Drug Reaction Monitoring Center. The following results were obtained by analyzing the reports of 2 796 cases of adverse drug reactions/adverse drug events after the use of Xianling Gubao Capsules/Tablets. A total of 75 patients, accounting for 2.68% of the total ADR/AE time, had severe ADR/AE events. Among them, 30 patients were aged 65 and above, accounting for 40.00% of the total number of severe ADR/AE patients. All the patients with ADR/AE were aged 45-64 years, which totaled 1 346 cases and took up 48.14% of the total patients with ADR/AE. All of ADR/AE cases and severe ADR/AE cases were orally given Xianling Gubao Capsules/Tablets. Females accounted for 52.50% and 76.00%, respectively, and the proportion of females was significantly higher than that of males. Among patients with a medical history of ADR/AE, severe ADR/AE was higher than the average, accounting for about 1.33%. The proportion of cases orally given 1-3 tablets of Xianling Gubao Capsules/Tablets in all ADR/AE cases and severe ADR/AE cases was 95.32% and 96.00%, which conformed to the usage in the package insert. All ADR/AE cases and severe ADR/AE cases orally given Xianling Gubao Capsules/Tablets twice daily occupied the highest proportions, or 77.00% and 61.00%, respectively. The proportion of severe ADR/AE cases orally given Xianling Gubao Capsules/Tablets was slightly higher than that of all ADR/AE cases in the medication frequency, which didn't conform to the usage in the package insert. All the symptoms of ADR/AE orally given Xianling Gubao Capsules showed many manifestations, and the top 10 symptoms were nausea, rash, itching, stomach dysfunction, vomiting, abdominal pain, dizziness, diarrhea, anaphylaxis, and reflux heartburn. The symptoms of severe ADR/AE after oral administration of Xianling Gubao Capsules were varied, and the top 10 symptoms were abnormal liver function, rash, suffocation, itching, dizziness, vomiting, anaphylaxis, abdominal pain, weakness, and convulsions. Abnormal liver function accounted for 44.12%. All of ADR/AE cases occurred within 2 days after oral administration of Xianling Gubao Capsules/Tablets, accounting for 54.26%. Severe ADR/AE occurred within 2 days after the use of Xianling Gubao Capsules/Tablets, accounting for 25.34%. The proportion of ADR/AE cases occurring within 15 days after oral administration of Xianling Gubao Capsules/Tablets increased again(57.33%). The overall trend contained two peaks.

Analysis of adverse drug reaction/adverse event and early warning signal mining of Ginkgo biloba Dropping Pills based on SRS data / 中国中药杂志

In order to understand the characteristics of adverse drug reaction/adverse event(ADR/AE) of Ginkgo biloba Dropping Pills and evaluate the safety of clinical use after marketing, 407 ADR/AE case report data of Ginkgo biloba Dropping Pills collected by National Center for ADR Monitoring System during 2009-2018 was systematically analyzed, and its general characteristics were analyzed using descriptive statistical methods. The results showed that among the 407 cases of spontaneous reporting system(SRS) data, 401 cases were general ADR/AE, accounting for 98.5%, and 6 cases were severe ADR/AE, accounting for 1.5%; there were more females than males(171/150) in ADR/AE, and they were mainly middle-aged and elderly people aged 45-64 years(152 cases, accounting for 37.35%); gastrointestinal system(23.89%) was mostly involved in ADR/AE. The top ten clinical symptoms were nausea(15.49%), dizziness(9.88%), vomiting(8.11%), rash(5.60%), chest tightness(5.46%), palpitations(5.31%), pruritus(4.72%), headache(4.57%), abdominal distension(3.83%), gastric dysfunction(3.54%); proportional reporting ratio(PRR) and Bayesian confidence progressive neural network method(BCPNN) were adopted to mine ADR/AE warning signals. Due to the small sample size, there were only 0-2 ADR/AE cases with various symptoms in many quarters, with no warning signal by PRR and BCPNN methods. The findings suggest that ADR/AE of Ginkgo biloba Dropping Pills based on SRS system was not recorded in the package insert, and further active monitoring studies shall be conducted to improve relevant ADR/AE information and pay attention to its clinical drug safety issues.

Creating a Checklist and a Survey on Research That Used the Japanese Adverse Drug Event Report Database / 医薬品情報学

Objective: The purpose of this study was to create a checklist that summarizes checkpoints that should be noted when using the Japanese Adverse Drug Event Report database (JADER). After we created the checklist, we then used it to survey published academic papers that used JADER.Method: First, we created a draft checklist for research that uses JADER by citing the report of CIOMS working group VIII “Practical Aspects of Signal Detection in Pharmacovigilance”. Then, we conducted a pilot test and revised the draft checklist. Finally, the checklist was completed after the review by a pharmacoepidemiology expert. The checklist was applied to published academic papers that used JADER, and the fulfill rate of each checkpoints was calculated.Results: A “checklist of important points to be noted during research that uses the data mining method in JADER (mainly signal detection by disproportionality analysis)” was created. We also revealed problems with published academic papers that used JADER. For example, some researchers were thought to be inappropriately using JADER as a source of their research while others used an inappropriate version of MedDRA.Conclusion: The checklist created in this study summarizes key points that could be noted in research that uses JADER and is thought to contribute to an improvement in quality of research that uses JADER. Additionally, in our investigation of published academic papers that used JADER, we found the possibility that both the role of signal detection and the impact on analysis of JADER using the updated MedDRA version are not well understood.

Analysis on 1 500 adverse reactions of Guizhi Fuling Capsules based on spontaneous response system / 中国中药杂志

To understand the characteristics of adverse reactions and find early warning signs after intake of Guizhi Fuling Capsules. The 1 500 adverse reaction(ADR) cases of Guizhi Fuling Capsules obtained by spontaneous reporting system(SRS) from 2008 to 2017 were analyzed by proportional reporting ratios method(PRR), Bayesian confidence propagation neural network method(BCPNN) and propensity score method. The number of ADR reports increased year by year, and reached the peak in the fourth quarter of 2014. A total of 1 500 ADR cases were monitored, including 10 severe ADR cases. There were a total of 934 cases aged between 18-44 years old, accounting for 62.27%. All patients were orally administered. Among them, 1 398 patients received a single dose according to the package insert, and 57.4% had ADR within 24 h. The top five clinical manifestations of ADR were gastric dysfunction, abdominal pain, nausea, vomiting and rash, which mainly damaged the digestive system. The ADR signals were analyzed. PRR suggested that "gastric dysfunction" and "abdominal pain" were the early warning signals of Guizhi Fuling Capsules. BCPNN suggested that "nausea" and "abdominal pain" were the early warning signals of Guizhi Fuling Capsules. After the propensity score weighting method was used to control the confounding factors, the warning signals remained unchanged. The results show that Guizhi Fuling Capsules has fewer adverse reactions and is relatively safe. This study provides a basis for studying ADR of Guizhi Fuling Capsules, and guidance for drug vigilance and risk management of Guizhi Fuling Capsules.

Analysis of spontaneously reported adverse drug reactions to pharmacovigilance cell of a tertiary care hospital

Background: The objective of the study was to study the clinical patterns, causality and severity of adverse drug reactions in a tertiary care hospital.Methods: Total 131 ADR forms were collected from January 2012 to December 2012 and evaluated. Patient抯 characteristics, ADR and drug characteristics, causality, severity and preventability of collected ADR were analyzed.Results: Total 131 ADR forms were evaluated. Male patient experiencing ADR were more (73, 55.7%) than female (58, 44.2%). Adult patients (12-60 years) experienced 110 (84%) ADR followed by pediatric patients (< 12 years) 11 (8.4%) and geriatric patients (>60 years) 10 (7.63%). Antimicrobial were the most common group of drugs responsible for ADR followed by NSAIDs and antipsychotic group.Conclusions: Present study shows lack of awareness among health care professionals for reporting of an ADR. Training and collaboration of health care professionals are needed for improvement in ADR reporting. Appropriate feedback from ADR reporting will help in selection of drug and promotes safer use of drugs.

Spectrum of adverse drug reactions and implicated drugs in a tertiary care centre: a prospective study

Background: Adverse Drug Reaction(ADR) is the major limitation in providing health care to patients at a global level. It affects patient’s recovery and is an important cause of mortality and morbidity in both hospitalized and ambulatory patients. ADR can occur with any class of drugs. Early detection and evaluation of ADR is essential to reduce harm to the patients. Thus, the present study was aimed to estimate the number of ADR’s reported, analyze its spectrum and the drugs attributed to it.Methods: This was a prospective study conducted in a tertiary care teaching hospital for a period of 3 months from March 2016 to May 2016 in SRM Medical College and Hospital, Potheri. Adverse drug reactions were collected by spontaneous reporting by active and passive methods. The causality assessment of the reported ADR’s was done using Naranjo causality assessment scale.Results: A total of 38 ADR’s were reported during the study period with male predominance (58%). Most of the ADR’s (42%) were common in patients in the age group 19-39 years. More number of ADR’s were from Medicine (29%) followed by Surgery (16%) and OG (16%) departments. Most commonly affected organ systems were skin (45%) followed by GIT (24%). The drugs mostly accounted were antibiotics (55%) especially Cephalosporins (33%). Most of the reactions were type A (68%) rather than type B (32%) and thus predictable. According to Naranjo’s causality assessment, 63% of reactions were probable, 26% were possible and 11% were definite. No reactions were unlikely. Severity assessment by Modified Hartwig and Seigel scale revealed 45% ADRs to be moderate, 42% were mild and 13% were severe and life threatening.Conclusions: The study concluded that Adverse Drug Reactions are common and some of them resulted in increased healthcare cost due to need of some interventions and increased length of hospital stay. As majority of ADR is predictable (Type A), so preventable. The health system should promote the spontaneous reporting of Adverse Drug Reactions (May be done mandatory). The proper documentation and periodic reporting to regional pharmacovigilance centres to ensure drug safety.

Analysis of adverse drug reactions encountered in a tertiary care hospital: a cross sectional study

Background: Adverse drug reactions are due to hazards of drug therapy and can occur with any class of drugs. The aim of this study was to evaluate and record adverse drug reactions reported from various departments of a tertiary care hospital.Methods: A Cross Sectional study conducted in a tertiary care hospital for a period of 4 months from March to June 2017 after Institutional Ethics Committee approval. ADRs reports collected and analyzed for causality, severity and preventability by international standardized scales.Results: A total of 38 ADR’s were reported during the study period with male predominance (58%). Most of the ADR’s (42%) were common in patients in the age group 19-39 years. More number of ADR’s were from Medicine (29%). Most commonly affected organ systems were skin (45%). The drugs mostly accounted were antibiotics (55%) especially Cephalosporins (33%). According to Naranjo’s causality assessment scale 74% of reactions were probable, 26% were possible, Modified Hartwig and Seigel severity assessment scale revealed 45% ADRs to be moderate, 42% were mild and 13% were severe, Modified Schumock and Thorton Preventability assessment scale which revealed 61% ADRs were not preventable, 32% were probably preventable,7% were definitively preventable.Conclusions: Adverse Drug Reactions are common and some of them resulted in increased healthcare cost due to need of some interventions and increased length of hospital stay. The health system should promote the spontaneous reporting of ADR’s. The proper documentation and periodic reporting to Pharmacovigilance Centres is required to ensure drug safety.

A retrospective study to evaluate the pattern of spontaneously reported antiretroviral induced adverse drug reactions in a tertiary care hospital

Background: To evaluate the adverse effect profile of spontaneously reported cases of adverse drug reactions due to antiretroviral (ART) drugs in a tertiary care teaching hospital.Methods: A descriptive retrospective study of pattern of ART induced adverse drug reactions (ADRs) spontaneously reported to the Pharmacology department at a tertiary care hospital from January 2011 to December 2016. The details of suspected ADRs including drugs involved, treatment given for ADRs, and the outcome were also documented. These ADRs were analyzed for causality (WHO scale), severity (Hartwig et al. scale), seriousness (ICH E 2A guidelines), preventability (Schumock and Thornton scale) and type based on Edwards and Aronson classification system.Results: Of the 75 cases of ART induced ADRs, reactions were slightly more common in males (52%) and had median age and duration of ART as 36 years and 109 days respectively. Drug induced anemia was the most common presentation followed by cutaneous ADR and zidovudine being the commonest offender. Severity was moderate in 85.3% and causality was probable in 16% and possible in 84% cases. The type reaction was augmented type in 41.3% and not preventable in 76%.Conclusions: Zidovudine is the commonest drug implicated in causing anemia amongst the antiretrovirals. Spontaneous reporting method for antiretroviral pharmacovigilance is insufficient. Targeted spontaneous reporting or cohort event monitoring need to be studied for antiretroviral pharmacovigilance.

Study on Signal Detection of Xiyanping Injection-induced Urticaria Based on BCPNN Warning Technology / 中国药房

OBJECTIVE:To explore and analyze signals of Xiyanping injection-induced urticaria from spontaneous reporting system database of Jiangxi province. METHODS:The continuous ADR report monitoring data were collected from spontaneous re-porting system of Jiangxi province,and established database. Bayesian confidence propagation neural network(BCPNN) method was used to calculate information component,IC value of Xiyanping injection-induced urticaria. The year-to-year changes of IC val-ue and its interval were analyzed. RESULTS:A total of 328324 ADR reports were collected in Jiangxi province during 2004-2016. The IC value of Xiyanping injection-induced urticaria detected by BCPNN method was 1.10(the lower limit of IC value was 0.65, and upper limit was 1.54),i.e. there was signal and the IC value ranged from-0.87 to 1.65. CONCLUSIONS:The results of BCPNN method suggest that urticaria is a warning signal of Xiyanping injection. The risk is increasing gradually,and prediction precision increase with the addition of report quantity.

Knowledge, attitude and practice of pharmacovigilance among private healthcare professionals of Rajkot city.

Background: Spontaneous reporting is an important tool in pharmacovigilance. However, its success depends on cooperative and motivated prescribers. In order to improve the reporting rate, it is essential to improve the Knowledge, Attitude and the Practices (KAP) of the healthcare professionals with regards to the ADR reporting and the pharmacovigilance. The present study was undertaken to evaluate the knowledge, attitude, and practices (KAP) of pharmacovigilance among private prescribers of Rajkot city. Methods: It was a prospective questionnaire based survey type of study which was carried out among the private practitioners of Rajkot city. A questionnaire which was suitable for assessing the basic Knowledge, Attitude and the Practice (KAP) of pharmacovigilance was designed and distributed among the private doctors and filled up forms collected back and analyzed by microsoft excel 2007. Results: Out of 600 distributed forms 332 forms were received back, reflecting a response rate of 55.33%. 13.86% doctors didn’t know about the term pharmacovigilance. 76.80% doctors experienced ADR during their clinical practices. 17.77% doctors maintain the record for patient safety and medico legal aspect.13.25% doctors reported ADR at different places. Lack of knowledge and awareness and medico legal problems were common reasons for under reporting of ADR.78.30% doctors agreed to keep ADR monitoring mandatory. Preferred methods for reporting ADR were electronic media and personal communication. Conclusions: There was a great need to create awareness among the private doctors to improve the reporting of ADRs. Even though ADR reporting make compulsory by doctors unless there is no strict government rules and regulation success of pharmacovigilance programme is questionable.

Research on Application Model of Clinical Practice Guideline in Traditional Chinese Medicine based on Spontaneous Reporting Network / 世界科学技术-中医药现代化

The development, application and revision of the clinical practice guideline (CPG) in traditional Chinese medicine (TCM) are a whole thing. However, the development and revision of TCM CPGs have been influenced due to lack of TCM CPGs reporting and feedback channel. Therefore, during the TCM standardization network establish-ment, we studied the application model of TCM CPGs with spontaneous reporting network, in order to provide the ba-sis for further TCM CPGs development and revision.

A Comparison of Active Surveillance Programs Including a Spontaneous Reporting Model for Phamacovigilance of Adverse Drug Events in a Hospital

BACKGROUND/AIMS: Spontaneous reporting systems have several weak points, such as low reporting rates and insufficient clinical information. Active surveillance programs, such as ward rounds and a clinical data repository (CDR), may supplement the weak points of such systems. We developed active surveillance programs and compared them with existing spontaneous reporting. METHODS: We collected adverse drug event (ADE) cases, which comprised 1,055 cases of spontaneous reporting, 309 reported by ward rounds, and 229 found using a CDR. The clinical features and causative drugs were evaluated. RESULTS: Active surveillance programs detected additional serious ADEs compared to those of spontaneous reporting programs. The ADEs identified by CDR (22.9%) were more likely to be classified as "serious" than those reported spontaneously (5.2%) or identified during ward rounds (10.3%). Causative drugs also differed. Opioids, antibiotics, and contrast media were the most common drugs causing ADEs in the spontaneous reporting system, whereas the active surveillance programs identified antibiotics as the most common causative drug. Clinical features also differed. ADEs with gastrointestinal manifestations were reported most frequently by spontaneous reporting programs. ADEs reported from active surveillance more reliably identified events associated with changes in laboratory values, such as hepatobiliary toxicity, hematologic manifestations, and nephrologic manifestations, compared with spontaneous reporting programs. CONCLUSIONS: Our findings suggest that active surveillance programs can supplement spontaneous reporting systems in hospitals. ADEs related to laboratory abnormalities were monitored more closely by active surveillance programs and may be useful for identification of serious ADEs.

Spontaneous Reporting of Adverse Drug Reactions through Electronic Submission from Regional Society Healthcare Professionals in Korea

PURPOSE: Pharmacovigilance Research Network built a spontaneous reporting system and collected adverse drug reactions (ADRs) by electronic submission (e-sub) in Korea. We analyzed ADRs spontaneously reported through e-sub from regional health professionals. MATERIALS AND METHODS: Nine hundred and thirty three ADR cases were collected and analyzed from January to December in 2008. "A matter" was defined as one symptom matched to one culprit drug included in an ADR case. We collected and analyzed e-sub ADR cases and matters to determine common culprits and organ specified ADR matters. RESULTS: There were 3,049 matters in 933 ADR cases for 1 year, and 3.3 matters per case were reported. In organ specific ADR classification, skin reactions which took the first place in 866 matters (28%) included urticaria and rash. The next cases were neurologic symptom (624 matters, 21%) and gastrointestinal symptom (581 matters, 19%). Doctor (53%) and pharmacist (31%) were the most important participants in e-sub spontaneous reporting system, and 3% of ADR cases were reported by patients or their guardians. WHO-Uppsala Monitoring Center causality assessment results showed certain 10.6%, probable 37.7%, possible 41.7% and below unlikely 10.0%. Culprit drugs were antibiotics (23.4%), neurologic agents (14.7%) and non-steroidal anti-inflammatory drugs (9.4%). CONCLUSION: In our study, antibiotic was most common culprit drug, and skin manifestation was most common symptom in e-sub ADRs collected from regional healthcare practitioners in Korea.

New Strategy for Pharmacovigilance Using Data-Mining Methods in Pharmaceuticals and Medical Devices Agency / 薬剤疫学

During FY 2004 through 2008, as one of the projects in the first medium term plan, the Pharmaceuticals and Medical Devices Agency(PMDA)had been engaged in the research and establishment of data mining method as an operational support tool to assist staff in charge of post-marketing safety measures, with the goal to implement this tool in April 2009.<br>This article was written with objective to demonstrate the current operation process of data mining in PMDA.

Signal Detection of Adverse Drug Reactions / 薬剤疫学

During the post-approval period, hypotheses about potentially new adverse drug reactions (ADR) have traditionally emerged from passive surveillance systems that collect large volumes of spontaneous case reports of suspected adverse drug reactions. With signal detection by traditional (or conventional, or manual) methods, quantitative (or statistical, or automated) methods for spontaneous reporting system (SRS) databases were introduced in the late 1990’s in order to detect serious ADR as early as possible. Most quantitative methods rely on comparisons of relative reporting frequencies, also known as disproportionality analyses. In FY 2009, the Pharmaceuticals and Medical Device Agency (PMDA) plans to introduce the quantitative methods (data mining method) used on Japanese SRS database. This paper introduces the recent situation on signal detection and signal management of adverse drug reactions.

Analysis on Spontaneous Reporting System of ADR Monitoring / 中国药房

OBJECTIVE:To investigate the form, advantage, limitation, influence factor and effect of spontaneous reporting system of ADR monitoring. METHODS: Based on domestic and foreign literatures and information, the importance of spontaneous reporting system of ADR monitoring was evaluated with the method of literature analysis according to the condition of China. RESULTS&CONCLUSION: Spontaneous reporting system of ADR monitoring is the foundation of drug risk management and is the most rapid, powerful and economic administration method of early warning for drug safety monitoring.