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

Abstract

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 associated with OTC medicines, yet little is known regarding the possibility of detecting safety signals for OTC medicines within these datasets. The aim of this study was to evaluate the potential for detecting safety signals for OTC medicines in National ADR spontaneous reporting data, using OTC non-steroidal anti-inflammatory drugs (NSAIDs) and gastrointestinal bleeding as an example. Data from the Australian Adverse Drug Reactions System (ADRS) dataset (1971–2008) and the Canadian Vigilance Adverse Reaction Online Database (VAROD) (1965–2013) were used to explore the feasibility of using spontaneous reporting data, exploring the association between gastrointestinal bleeding and the use of OTC NSAIDs. Safety signals were examined using disproportionality analyses and reporting odds ratios calculated. After adjusting for age, gender, medications known to increase the risk of bleeding, and medications used for the management of conditions associated with an increased risk of bleeding, a two-fold increase in the risk of gastrointestinal (GI) bleeding with OTC NSAID was observed within each dataset. This study demonstrates that spontaneous ADR reporting data can be used in pharmacovigilance to monitor the safety of OTC medicines.

Keywords

• pharmacovigilance
• OTC medicines
• signal detection
• NSAIDs
• gastrointestinal bleeding