Identification of potential drug name confusion errors in the Sentinel System

Autor: Qoua L. Her, Michael Nguyen, Elizabeth C. Dee, Chi-Ming Tu, Nancy D. Lin, Kevin Haynes, Austin Cosgrove, Noelle M. Cocoros, Yulan Ding, Sengwee Toh
Rok vydání: 2019
Předmět:
Drug
Acute coronary syndrome
medicine.medical_specialty
Ticagrelor
Epidemiology
media_common.quotation_subject
030226 pharmacology & pharmacy
Drug Prescriptions
Proof of Concept Study
03 medical and health sciences
0302 clinical medicine
Health care
medicine
Product Surveillance
Postmarketing
Electronic Health Records
Humans
Medication Errors
Pharmacology (medical)
030212 general & internal medicine
Acute Coronary Syndrome
Intensive care medicine
Stroke
media_common
Drug Labeling
Vortioxetine
Depressive Disorder
Major
business.industry
United States Food and Drug Administration
Off-Label Use
medicine.disease
Antidepressive Agents
United States
Identification (information)
Major depressive disorder
Feasibility Studies
business
Administrative Claims
Healthcare
Algorithms
Platelet Aggregation Inhibitors
medicine.drug
Zdroj: Pharmacoepidemiology and drug safetyREFERENCES. 28(10)
ISSN: 1099-1557
Popis: Purpose In July 2015, the US Food and Drug Administration (FDA) published a drug safety communication regarding errors in prescribing and dispensing of the antidepressant Brintellix (vortioxetine) and the antiplatelet Brilinta (ticagrelor) that arose due to proprietary drug name confusion. Brintellix is indicated for major depressive disorder; Brilinta is indicated to reduce cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or history of myocardial infarction. Brintellix was renamed to Trintellix in May 2016. Using Brilinta and Brintellix as a proof-of-concept feasibility use case, we assessed whether drug name confusion errors between the pair could be identified in electronic health care data via the combination of a claims-based algorithm and limited manual claims data review. Methods Using data from the Sentinel System, we defined potential errors as Brintellix users without an on- or off-label indication for Brintellix, without a dispensing for a drug with the same indications as Brintellix, and with an on- or off-label indication for Brilinta between -365 and +30 days after index Brintellix dispensing; the reverse was done for Brilinta. We manually reviewed claims profiles of potential cases. Results We identified 27 (0.1%) potential errors among 21 208 Brintellix users; 16 appeared to be likely errors based on claims profile review. Fifty-one (0.3%) of the 16 779 Brilinta users were identified as potential errors, and four appeared to be likely errors. Conclusions A claims-based algorithm combined with manual review of claims profiles could identify potential drug name confusion errors, and narrow down likely errors that warrant further investigation.
Databáze: OpenAIRE
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