Predicting the submission frequency of periodic safety update reports: development and application of the EURD tool
IntroductionPeriodic Safety Update Reports (PSURs) are a key pharmacovigilance tool for the continuous evaluation of the benefit–risk balance of a medicinal product in the post-authorisation phase. The PSUR submission frequency for authorised active substances and combinations of active substances a...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2024-02-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2024.1299190/full |
| _version_ | 1797320533467987968 |
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| author | María Gordillo-Marañón María Gordillo-Marañón Gianmario Candore Marta López-Fauqued Katerina-Christina Deli Loris Piccolo Paolo Alcini Tom Paternoster-Howe Irene Rager Robin Ruepp Menno van der Elst |
| author_facet | María Gordillo-Marañón María Gordillo-Marañón Gianmario Candore Marta López-Fauqued Katerina-Christina Deli Loris Piccolo Paolo Alcini Tom Paternoster-Howe Irene Rager Robin Ruepp Menno van der Elst |
| author_sort | María Gordillo-Marañón |
| collection | DOAJ |
| description | IntroductionPeriodic Safety Update Reports (PSURs) are a key pharmacovigilance tool for the continuous evaluation of the benefit–risk balance of a medicinal product in the post-authorisation phase. The PSUR submission frequency for authorised active substances and combinations of active substances across the EU is individually determined. The objective of this research was the development and application of the EURD tool, a statistical method based on readily available safety data to predict PSUR frequencies and to ensure a consistent risk-based approach.MethodsFirst, variables considered relevant in determining the PSUR frequency were identified from data sources available at the European Medicines Agency. A subsequent first survey with National Competent Authorities in Europe lead to a prioritisation of identified variables, while a second survey was carried out to propose the PSUR frequencies for a set of substances. Finally, a regression model was built on the information collected, applied to a larger list of substances and its results tested via a third survey with the same experts.ResultsThe developed EURD tool was applied to the 1,032 EURD list entries with a PSUR assessment deferred to 2025 at the time of the creation of the list in 2012. As the number of procedures would have had a significant impact on the workload for the European Medicines Regulatory Network (EMRN), in a second step the workload impact was estimated after allocating the entries according to their proposed frequency. The analysis suggests that all entries could be reviewed by 2038 by increasing the median workload by 15% (from 868 to 1,000 substances/year).ConclusionThe EURD tool is the first data-driven application for supporting decision making of PSUR frequencies based on relevant active substance safety data. While we illustrated its potential for improving the assignment of PSUR submission frequencies for active substances authorised in the EU, other institutions requiring periodic assessment of safety data and balancing of the resulting workload could benefit from it. |
| first_indexed | 2024-03-08T04:44:25Z |
| format | Article |
| id | doaj.art-0a377b317bc14f79a773c8fe17459be0 |
| institution | Directory Open Access Journal |
| issn | 2296-858X |
| language | English |
| last_indexed | 2024-03-08T04:44:25Z |
| publishDate | 2024-02-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medicine |
| spelling | doaj.art-0a377b317bc14f79a773c8fe17459be02024-02-08T11:14:55ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2024-02-011110.3389/fmed.2024.12991901299190Predicting the submission frequency of periodic safety update reports: development and application of the EURD toolMaría Gordillo-Marañón0María Gordillo-Marañón1Gianmario Candore2Marta López-Fauqued3Katerina-Christina Deli4Loris Piccolo5Paolo Alcini6Tom Paternoster-Howe7Irene Rager8Robin Ruepp9Menno van der Elst10Healthcare Data Workstream, Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, NetherlandsInstitute of Cardiovascular Science, Faculty of Population Health, University College London, London, United KingdomHealthcare Data Workstream, Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, NetherlandsVaccines and Therapies for Infectious Diseases Office, Human Medicines Division, European Medicines Agency, Amsterdam, NetherlandsHealthcare Data Workstream, Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, NetherlandsHealthcare Data Workstream, Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, NetherlandsHealthcare Data Workstream, Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, NetherlandsHealthcare Data Workstream, Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, NetherlandsVaccines and Therapies for Infectious Diseases Office, Human Medicines Division, European Medicines Agency, Amsterdam, NetherlandsReferrals Office, Human Medicines Division, European Medicines Agency, Amsterdam, NetherlandsDutch Medicines Evaluation Board, Utrecht, NetherlandsIntroductionPeriodic Safety Update Reports (PSURs) are a key pharmacovigilance tool for the continuous evaluation of the benefit–risk balance of a medicinal product in the post-authorisation phase. The PSUR submission frequency for authorised active substances and combinations of active substances across the EU is individually determined. The objective of this research was the development and application of the EURD tool, a statistical method based on readily available safety data to predict PSUR frequencies and to ensure a consistent risk-based approach.MethodsFirst, variables considered relevant in determining the PSUR frequency were identified from data sources available at the European Medicines Agency. A subsequent first survey with National Competent Authorities in Europe lead to a prioritisation of identified variables, while a second survey was carried out to propose the PSUR frequencies for a set of substances. Finally, a regression model was built on the information collected, applied to a larger list of substances and its results tested via a third survey with the same experts.ResultsThe developed EURD tool was applied to the 1,032 EURD list entries with a PSUR assessment deferred to 2025 at the time of the creation of the list in 2012. As the number of procedures would have had a significant impact on the workload for the European Medicines Regulatory Network (EMRN), in a second step the workload impact was estimated after allocating the entries according to their proposed frequency. The analysis suggests that all entries could be reviewed by 2038 by increasing the median workload by 15% (from 868 to 1,000 substances/year).ConclusionThe EURD tool is the first data-driven application for supporting decision making of PSUR frequencies based on relevant active substance safety data. While we illustrated its potential for improving the assignment of PSUR submission frequencies for active substances authorised in the EU, other institutions requiring periodic assessment of safety data and balancing of the resulting workload could benefit from it.https://www.frontiersin.org/articles/10.3389/fmed.2024.1299190/fullpharmacovigilancedrug safetyperiodic safety update reportEURD listdata drivenprediction |
| spellingShingle | María Gordillo-Marañón María Gordillo-Marañón Gianmario Candore Marta López-Fauqued Katerina-Christina Deli Loris Piccolo Paolo Alcini Tom Paternoster-Howe Irene Rager Robin Ruepp Menno van der Elst Predicting the submission frequency of periodic safety update reports: development and application of the EURD tool Frontiers in Medicine pharmacovigilance drug safety periodic safety update report EURD list data driven prediction |
| title | Predicting the submission frequency of periodic safety update reports: development and application of the EURD tool |
| title_full | Predicting the submission frequency of periodic safety update reports: development and application of the EURD tool |
| title_fullStr | Predicting the submission frequency of periodic safety update reports: development and application of the EURD tool |
| title_full_unstemmed | Predicting the submission frequency of periodic safety update reports: development and application of the EURD tool |
| title_short | Predicting the submission frequency of periodic safety update reports: development and application of the EURD tool |
| title_sort | predicting the submission frequency of periodic safety update reports development and application of the eurd tool |
| topic | pharmacovigilance drug safety periodic safety update report EURD list data driven prediction |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2024.1299190/full |
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