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

Elina Amatya,Romano Fois,Kylie A Williams,Lisa G Pont

doi:10.3390/pharmacy8030174

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.

Highlights

Data from spontaneous reports of suspected adverse drug reactions (ADRs) play a critical role in pharmacovigilance and ensuring the safety of medicines
While there are a number of methods used internationally to monitor adverse drug reactions, including prescription event monitoring and active surveillance, spontaneous reporting of ADRs is considered the best practice for safety signal detection [2] and it is the most widely used pharmacovigilance method for monitoring the safety of marketed medicines internationally [3]
Given that the 2014 Therapeutics Goods Administration (TGA) review regarding the safety of non-steroidal anti-inflammatory drugs (NSAIDs) may have increased awareness and reporting of ADRs associated with OTC NSAIDs in Australia, in this study, we focused on the detection of safety signals prior to the publication of the 2014 TGA report

Summary

Introduction

Data from spontaneous reports of suspected adverse drug reactions (ADRs) play a critical role in pharmacovigilance and ensuring the safety of medicines. While there are a number of methods used internationally to monitor adverse drug reactions, including prescription event monitoring and active surveillance, spontaneous reporting of ADRs is considered the best practice for safety signal detection [2] and it is the most widely used pharmacovigilance method for monitoring the safety of marketed medicines internationally [3]. One challenge for many regulatory authorities in the post-marketing surveillance of medicines is access to information regarding the safety of over-the-counter (OTC) medicines. OTC medicines are available from a wide range of sources including pharmacies, supermarkets, health food stores, and the internet [4], and as such information regarding their use and safety can be problematic to access. While many countries have pharmacovigilance programs which require manufacturers to report ADRs, these tend to focus on the surveillance of prescription medicines and do not always include OTC and non-prescription medicines

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