منابع مشابه
Black Box Warnings in Prescription Drug Labeling:
Prescription drugs are unavoidably associated with adverse effects, but the benefits of using such drugs outweigh the accompanying risks so long as the expert judgment of a licensed practitioner is first applied in the decision to use a drug for a particular patient. Most risks for prescription drugs appear in descending order of importance in the drug’s labeling, i.e., the package insert. The ...
متن کاملImplementing Black Box Warnings (BBWs) in Health Information Systems
Objective: To develop a practical approach for implementing clinical decision support (CDS) for medication black box warnings (BBWs) into health information systems (HIS). Methods: We reviewed all existing medication BBWs and organized them into a taxonomy that identifies opportunities and challenges for implementing CDS for BBWs into HIS. Results: Of the over 400 BBWs that currently exist, the...
متن کاملContent, Consistency, and Quality of Black Box Warnings: Time for a Change.
A black box warning (BBW) is the highest level of warning issued by the U.S. Food and Drug Administration (FDA). It aims to inform the patient and the prescriber of the potential major risks or lifethreatening adverse reactions associated with the use of a medication. The warning is usually placed on top of the drug information label and is highlighted with a black box that distinguishes it fro...
متن کاملTiming of new black box warnings and withdrawals for prescription medications.
CONTEXT Recently approved drugs may be more likely to have unrecognized adverse drug reactions (ADRs) than established drugs, but no recent studies have examined how frequently postmarketing surveillance identifies important ADRs. OBJECTIVE To determine the frequency and timing of discovery of new ADRs described in black box warnings or necessitating withdrawal of the drug from the market. ...
متن کاملManaging Behavioral and Psychological Symptoms of Dementia in the Era of Black Box Warnings
Jost and Grossberg3 found that behavioral symptoms were observed in 72% of individuals more than 2 years before the actual diagnosis of dementia. The prevalence of BPSD increased to 81% 10 months after the formal diagnosis of dementia. Unlike cognition, which declines over time in individuals with dementia, BPSD tends to fluctuate; agitation is the most persistent symptom.4 Apathy is the most c...
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ژورنال
عنوان ژورنال: The Lancet Psychiatry
سال: 2015
ISSN: 2215-0366
DOI: 10.1016/s2215-0366(15)00428-9