Potential for Detection of Safety Signals for Over-the-Counter Medicines Using National ADR Spontaneous Reporting Data: The Example of OTC NSAID-Associated Gastrointestinal Bleeding

Potential for Detection of Safety Signals for Over-the-Counter Medicines Using National ADR Spontaneous Reporting Data: The Example of OTC NSAID-Associated Gastrointestinal Bleeding

One post-marketing surveillance challenge for many regulatory authorities is access to information regarding the safety of over-the-counter (OTC) medicines. National spontaneous adverse drug reaction (ADR) report data represent a rich potential data source for the detection of safety signals associa...

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Bibliographic Details
Main Authors: Elina Amatya, Romano Fois, Kylie A. Williams, Lisa G. Pont
Format: Article
Language:English
Published: MDPI AG 2020-09-01
Series:Pharmacy
Subjects:
pharmacovigilance
OTC medicines
signal detection
NSAIDs
gastrointestinal bleeding
Online Access:https://www.mdpi.com/2226-4787/8/3/174

Internet

https://www.mdpi.com/2226-4787/8/3/174

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