ArticlePharmacy (Basel, Switzerland)2020
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.
Article in Pharmacy (Basel, Switzerland), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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Who cites it
4 citing papers in PubMed, 4 citations in OpenAlex.
- Contributions of Pharmacovigilance to the Understanding of Risks Associated with Ibuprofen: Descriptive and Disproportionality Analysis Using FAERS Data.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Navigating Global Regulatory Divergence in Over-the-counter Drugs: Addressing Emerging Risks and Harmonization Challenges.Current drug research reviews · 2026Review
- Beyond Pain Relief: A Cross-Sectional Study on NSAID Prescribing, Polypharmacy, and Drug Interaction Risks in Community Pharmacies.Healthcare (Basel, Switzerland) · 2025Article
- Digital monitoring of medication safety in children: an investigation of ADR signalling techniques in Malaysia.BMC medical informatics and decision making · 2024Article
Corrections and comments
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Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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.
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