Identification of potential drug name confusion errors in the Sentinel System.
Acute Coronary Syndrome
/ drug therapy
Administrative Claims, Healthcare
/ statistics & numerical data
Algorithms
Antidepressive Agents
/ adverse effects
Depressive Disorder, Major
/ drug therapy
Drug Labeling
/ standards
Drug Prescriptions
/ statistics & numerical data
Electronic Health Records
/ statistics & numerical data
Feasibility Studies
Humans
Medication Errors
/ prevention & control
Off-Label Use
/ statistics & numerical data
Platelet Aggregation Inhibitors
/ adverse effects
Product Surveillance, Postmarketing
/ methods
Proof of Concept Study
Ticagrelor
/ adverse effects
United States
United States Food and Drug Administration
/ standards
Vortioxetine
/ adverse effects
Sentinel System
claims data
medication errors
pharmacoepidemiology
Journal
Pharmacoepidemiology and drug safety
ISSN: 1099-1557
Titre abrégé: Pharmacoepidemiol Drug Saf
Pays: England
ID NLM: 9208369
Informations de publication
Date de publication:
10 2019
10 2019
Historique:
received:
15
04
2019
revised:
07
08
2019
accepted:
18
08
2019
pubmed:
5
9
2019
medline:
1
7
2020
entrez:
5
9
2019
Statut:
ppublish
Résumé
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. 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. 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. 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.
Substances chimiques
Antidepressive Agents
0
Platelet Aggregation Inhibitors
0
Vortioxetine
3O2K1S3WQV
Ticagrelor
GLH0314RVC
Types de publication
Journal Article
Research Support, U.S. Gov't, P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
1405-1410Subventions
Organisme : FDA HHS
ID : HHSF223200910006I
Pays : United States
Informations de copyright
© 2019 John Wiley & Sons, Ltd.
Références
US FDA. FDA Drug Safety Communication: FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor) 2015 [Available from: https://www.fda.gov/Drugs/DrugSafety/ucm456341.htm.
US FDA. FDA Drug Safety Communication: FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brilinta (ticagrelor) 2016 [Available from: https://www.fda.gov/Drugs/DrugSafety/ucm499576.htm.
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