Erasmus University Medical Center and IQVIA announce a collaboration with the EMA to study the exposure of ranitidine and alternatives of ranitidine
The European Medicines Agency (EMA) has signed a contract with IQVIA in partnership with Erasmus University Medical Center, together with partners from 6 European countries to investigate the treatment patterns on the use of ranitidine and alternatives of ranitidine. For this study, all clinical data are standardised to the Observational Medical Outcomes Partnership (OMOP) -Common Data Model, which is maintained by the Observational Health Data Sciences and Informatics (OHDSI) community (www.ohdsi.org). The use of the OMOP-CDM enables standardised analytics, tools, and methodologies.
Ranitidine reduces the amount of acid in the stomach and is available both on prescription and as over the counter drug in pharmacies and supermarkets in many European countries. It is indicated for heartburn, stomach ulcers and acid reflux, but also for rare indications such as reduction of gastric secretion in specific tumours. Novel findings in July 2019 indicated that ranitidine can generate N-Nitrosodimethylamine (NDMA) a substance that is potentially carcinogenic. In view of this, the European Commission triggered a referral procedure in September 2019 to evaluate the relevance of these findings, the potential root causes and their impact on the benefit-risk balance of medicinal products containing ranitidine. Based on this evaluation, in April 2020 EMA’s Human Medicines Committee recommended the suspension of all ranitidine-containing medicines in the EU until further notice which resulted in a recall of ranitidine in the different member states.
Due to the unavailability of ranitidine, many patients will switch treatment to alternative medicines. The extent of switches to alternative medicines remains unknown as well as the rate of patients permanently discontinuing ranitidine treatment. By means of an international drug utilisation study using electronic health care data from 6 EU countries, we will explore drug utilisation and prescription patterns of ranitidine and describe switching from ranitidine to alternative therapies both in the pre-referral and post-referral phase. This study is a follow-up study from a previous EMA initiated rapid study exploring cumulative exposure to ranitidine and other H2 receptor antagonists led by Erasmus University Medical Center (EMA/2018/21/PE).
This multinational project is led by IQVIA by Hanne van Ballegooijen, senior epidemiologist and Deborah Layton, Professor of Pharmacoepidemiology at University of Keele, UK and Director of Drug Safety in close in collaboration with Peter Rijnbeek, Associate Professor of Health Data Science and Katia Verhamme, Associate Professor of Use and Analysis of Observational Data, both from the Erasmus University Medical Center, Rotterdam. The study will provide an impact assessment of the EMA referral procedure and switching to alternative medicines for a widely prescribed medicine. We are delighted to conduct such an important project and provide insight into the drug utilisation patterns. The results are expected in 2 years – spring 2023.