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

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
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