scholarly journals Real-world data-based adverse drug reactions detection from the Korea Adverse Event Reporting System databases with electronic health records-based detection algorithm

2021 ◽  
Vol 27 (3) ◽  
pp. 146045822110330
Author(s):  
Hyunah Shin ◽  
Jaehun Cha ◽  
Youngho Lee ◽  
Jong-Yeup Kim ◽  
Suehyun Lee
Keyword(s):  
Adverse Event ◽  
Adverse Drug Reactions ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
World Health ◽  
Drug Reactions ◽  
Event Reporting ◽  
Medical Databases ◽  
Electronic Health

Pharmacovigilance involves monitoring of drugs and their adverse drug reactions (ADRs) and is essential for their safety post-marketing. Because of the different types and structures of medical databases, several previous surveillance studies have analyzed only one database. In the present study, we extracted potential drug–ADR pairs from electronic health record (EHR) data using the MetaNurse algorithm and analyzed them using the Korean Adverse Event Reporting System (KAERS) database for systematic validation. The Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) Adverse Reactions Terminology (WHO-ART) were mapped for signal detection. We used the Side Effect Resource (SIDER) database to select 2663 drug-ADR pairs to investigate unknown drug-induced ADRs. The reporting odds ratio (ROR) value was calculated for the drug-exposed and non-exposed groups of drug–ADR pairs, and 19 potential pairs showed significant signals. Appropriate terminology systems and criteria are needed to handle diverse medical databases.

scholarly journals Completeness of adverse drug reactions reports of the Saudi adverse event reporting system

2015 ◽  
Vol 36 (7) ◽  
pp. 821-828 ◽  
Author(s):  
Thamir Alshammari, ◽  
Wa’ad Al-Kathiri ◽  
Hervé Le Louet ◽  
Hisham Aljadhey
Keyword(s):  
Adverse Event ◽  
Adverse Drug Reactions ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Drug Reactions ◽  
Event Reporting

Assessing Adverse Drug Reactions Reported for New Respiratory Medications in the FDA Adverse Event Reporting System Database

2021 ◽  
pp. respcare.08809
Author(s):  
Hyunwoo Kim ◽  
Colin M Pfeiffer ◽  
Matthew P Gray ◽  
Britney A Stottlemyer ◽  
Richard D Boyce ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Drug Reactions ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Drug Reactions ◽  
Event Reporting ◽  
System Database

Comparison of Adverse Drug Reactions for Patients Treated with Tyrosine Kinase Inhibitors: Data Mining of the Public Version of the FDA Adverse Event Reporting System (AERS)

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 1698-1698
Author(s):  
Tetsuya Tanimoto ◽  
Yasuo Oshima ◽  
Koichiro Yuji ◽  
Masahiro Kami
Keyword(s):  
Data Mining ◽  
Adverse Event ◽  
Odds Ratio ◽  
Kinase Inhibitors ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Drug Reactions ◽  
Suspected Drug ◽  
Event Reporting

Abstract Abstract 1698 Backgrounds: The consecutive approvals of tyrosine kinase inhibitors (TKIs) have been changing the landscape of treatment strategy for patients with chronic myeloid leukemia (CML). Currently, three TKIs are available worldwide, including imatinib (Glivec/Gleevec; Novartis Pharmaceuticals, East hanover, NJ), nilotinib (Tasigna; Novartis Pharmaceuticals) and dasatinib (Sprycel; Bristol-Myers Squibb, Princeton, NJ). Although second generation TKIs (nilotinib and dasatinib) have shown their efficacy and safety in recent clinical trials, additional data are needed for better understanding and differences in their safety profiles may be helpful when choosing a TKI. We compared the adverse drug reactions (ADRs) for patients treated with three TKIs using spontaneous adverse event reporting after approval to investigate the characteristics of safety profiles. Method: To compare adverse events characteristics among three TKIs, the case/noncase adverse events reports associated with TKIs use were retrieved from the U.S. Food and Drug Administration Adverse Event Reporting System (AERS) between 2004 and 2010. We calculated the reporting odds ratio (ROR), which is known as one of data mining algorithms for signal detection techniques of ADRs, characterized by providing a fast and cost-efficient way of detecting possible ADR signals. All events in the AERS have been coded for data entry in accordance with the standardized terminology, known as Preferred Terms, in the Medical Dictionary for Regulatory Activities. The ROR is similar to the idea of odds ratio, calculating the odds of exposure of the suspected drug in patients who had events divided by the odds of exposure of the suspected drug in those without events. The ROR -1.96 standard error greater than 1 with at least 4 ADR reports was used as a signal criterion in this study. Results: We identified 18,979 ADRs for imatinib, 5,388 ADRs for nilotinib, and 2,482 ADRs for dasatinib. The number of ADRs flagged by our signal criterion was 91 for imatinib, 82 for nilotinib, and 109 for dasatinib. Top 10 lists of ADRs with higher ROR are shown in Table for each TKI. The safety profiles were almost different among TKIs. ADRs related to skin and hepatic function were noted for imatinib, whereas ADRs related to cardiac events were prominent for nilotinib, and ADRs related to lymphocytosis, edema and effusion were noticeable for dasatinib. The different dosing requirements of dasatinib and nilotinib may be an additional factor of ADRs. Conclusions: ADRs reported in the AERS for each TKI were relatively consistent with known characteristics of ADRs reported in previous clinical trials. Our information would be supportive data for choosing a TKI for CML patients based on comorbidities and drug safety profiles. The choice of therapy in a given patient with CML may depend on age, past history and comorbidities as well as disease risk score and mutational analysis. Disclosures: Oshima: Sanofi Aventis: Employment.

scholarly journals Cefaclor-induced hypersensitivity: Differences in the incidence of anaphylaxis relative to other 2nd and 3rd generation cephalosporins

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0254898
Author(s):  
Hyo-In Rhyou ◽  
Young-Hee Nam ◽  
Su-Chin Kim ◽  
Go-Eun Doo ◽  
Chae-Yeon Ha ◽  
...  
Keyword(s):  
Adverse Event ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Incidence Rates ◽  
Drug Reactions ◽  
Oral Cephalosporin ◽  
Event Reporting ◽  
Patient Demographics ◽  
Number Of Individuals

Cefaclor, a second-generation oral cephalosporin, is the most frequently prescribed cephalosporin in Korea. Studies, however, have yet to analyze the incidence of cefaclor-associated adverse drug reactions (ADRs), including hypersensitivity (HS), according to total national usage rates. This study aimed to investigate the incidence rates and clinical features of cefaclor ADRs reported to the Korean Adverse Event Reporting System (KAERS) and Health Insurance Review and Assessment Service (HIRA) database for the most recent 5 years. Reviewing the HIRA database, which contains information on all insurance claims, including prescribed medications and patient demographics, we identified the total number of individuals who had been prescribed cefaclor and other cephalosporins including 2nd generation without cefaclor and 3rd generation antibiotics from January 2014 to December 2018. Additionally, we retrospectively analyzed all ADRs reported to the KAERS for these drugs over the same study period. Incidence rates for ADRs, HS, and anaphylaxis to cefaclor were 1.92/10,000 persons, 1.17/10,000 persons, and 0.38/10,000 persons, respectively, lower than those to other 2nd and 3rd cephalosporins. Among all ADRs, HS (60.9% vs. 43.6% vs. 44.8%, P <0.001) and anaphylaxis (19.8% vs. 4.6% vs. 4.7%, P <0.001) were more common for cefaclor than for other 2nd and 3rd cephalosporins. Females, individuals under 65 years of age, concomitant use of drugs, and serious ADRs were more strongly associated with HS to cefaclor than with HS to other 2nd and 3rd cephalosporins. In a nationwide database for the Korean population, the incidence of cefaclor-induced ADRs, particularly HS and anaphylaxis, was high. Female sex, age younger than 65 years, and concomitant use of drugs may be associated with HS to cefaclor.

Sign in / Sign up

Export Citation Format

Share Document