{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,31]],"date-time":"2025-12-31T14:58:53Z","timestamp":1767193133512,"version":"3.40.5"},"reference-count":28,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2020,12,8]],"date-time":"2020-12-08T00:00:00Z","timestamp":1607385600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>To evaluate the impact of including a medicine in the list of medicinal products subject to additional monitoring (AM) on the reporting of adverse drug reactions (ADRs) in the european economic area (EEA).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Interrupted time series using the monthly number of EEA ADR reports in EudraVigilance during 12\u2009months before and after the addition to AM list. The main outcome was the change (%) in reporting of ADRs with step change as the <jats:italic>a priori<\/jats:italic> impact model. Further time series analysis was performed using Joinpoint Regression.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The analysis included 11 active substances. No significant immediate (step change) increase of reporting was identified for any product at time of addition to AM list. We identified a significant gradual increase of ADR reporting after addition to AM list (slope change) for two out of five new products\u2014boceprevir (10% per month, 95% confidence interval (CI) 3%\u201318%) and denosumab\u2010Xgeva (13% per month, 95% CI 4%\u201322%). No change was identified for Prolia, another denosumab\u2010containing product not subject to AM. No significant increase was identified for any product included in the AM list due to the requirement to conduct a PASS. Conversely, a gradual decrease in reporting was identified for natalizumab (\u22125% per month; 95% CI \u221210% to \u22121%), rivaroxaban (\u22125%; \u22128 to \u22123%), and varenicline (\u221216%; \u221221 to \u221210%). The results were corroborated by the Joinpoint analyses, which yielded similar results.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>We identified limited evidence that reporting of ADRs increased modestly and gradually for some new products and not for products with PASS requirement.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.5174","type":"journal-article","created":{"date-parts":[[2020,11,16]],"date-time":"2020-11-16T13:37:46Z","timestamp":1605533866000},"page":"350-359","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Does additional monitoring status increase the reporting of adverse drug reaction<scp>s<\/scp>? An interrupted time series analysis of <scp>EudraVigilance<\/scp> data"],"prefix":"10.1002","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2881-0593","authenticated-orcid":false,"given":"Andrej","family":"Segec","sequence":"first","affiliation":[{"name":"Pharmacovigilance and Epidemiology Department European Medicines Agency  Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8352-9350","authenticated-orcid":false,"given":"Jim","family":"Slattery","sequence":"additional","affiliation":[{"name":"Pharmacovigilance and Epidemiology Department European Medicines Agency  Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0063-8069","authenticated-orcid":false,"given":"Daniel R.","family":"Morales","sequence":"additional","affiliation":[{"name":"Pharmacovigilance and Epidemiology Department European Medicines Agency  Amsterdam The Netherlands"},{"name":"Division of Population Health and Genomics University of Dundee  Dundee UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6758-650X","authenticated-orcid":false,"given":"Justina","family":"Januskiene","sequence":"additional","affiliation":[{"name":"Pharmacovigilance and Epidemiology Department European Medicines Agency  Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9838-7754","authenticated-orcid":false,"given":"Xavier","family":"Kurz","sequence":"additional","affiliation":[{"name":"Pharmacovigilance and Epidemiology Department European Medicines Agency  Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6640-0117","authenticated-orcid":false,"given":"Peter","family":"Arlett","sequence":"additional","affiliation":[{"name":"Pharmacovigilance and Epidemiology Department European Medicines Agency  Amsterdam The Netherlands"},{"name":"London School of Hygiene &amp; Tropical Medicine  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,12,8]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"crossref","unstructured":"JanuskieneJ SegecA SlatteryJM et al.What are the patients' and health care professionals' understanding and behaviors towards adverse drug reaction reporting and additional monitoring? Pharmacoepidemiol Drug Saf.2020 Oct 25.https:\/\/doi.org\/10.1002\/pds.5162.","DOI":"10.1002\/pds.5162"},{"key":"e_1_2_10_3_1","unstructured":"Regulation (EC) No 726\/2004 of the European Parliament and of the council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency Official Journal L \u2013 136 30\/04\/2004 p. 1\u201333.https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=celex:02004R0726-20190128. Accessed April 30 2019."},{"key":"e_1_2_10_4_1","unstructured":"European Medicines Agency.List of medicines subject to additional monitoring EMA\/245297\/2013 Rev.60.https:\/\/www.ema.europa.eu\/en\/human-regulatory\/post-authorisation\/pharmacovigilance\/medicines-under-additional-monitoring\/list-medicines-under-additional-monitoring. Accessed January 17 2020."},{"key":"e_1_2_10_5_1","unstructured":"European Medicines Agency.Guideline on good pharmacovigilance practices Module X \u2013 additional monitoring.http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2013\/04\/WC500142282.pdf. Accessed April 30 2019."},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13469"},{"key":"e_1_2_10_7_1","unstructured":"European Medicines Agency.PRAC strategy on measuring the impact of pharmacovigilance activities (Rev 1) EMA\/165407\/2017.http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Other\/2016\/01\/WC500199756.pdf. Accessed April 30 2019."},{"key":"e_1_2_10_8_1","unstructured":"European Commission.European Medicines Agency and Member States joint report to the European Commission on the experience with the list of products subject to additional monitoring.https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/pharmacovigilance\/docs\/2019_ema-ms_additional-monitoring_en.pdf. Accessed November 19 2019."},{"key":"e_1_2_10_9_1","unstructured":"European Medicines Agency.2018Annual Report on EudraVigilance for the European Parliament the Council and the Commission.https:\/\/www.ema.europa.eu\/en\/documents\/report\/2018\u2010annual\u2010report\u2010eudravigilance\u2010european\u2010parliament\u2010council\u2010commission\u2010reporting\u2010period\u20101\u2010january_en.pdf. Accessed July 18 2019."},{"key":"e_1_2_10_10_1","unstructured":"European Medines Agency.EudraVigilance.https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/pharmacovigilance\/eudravigilance. 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Accessed April 30 2019."},{"key":"e_1_2_10_13_1","unstructured":"Register of Medicinal Product Statistics.www.medstat.dk."},{"key":"e_1_2_10_14_1","unstructured":"Health Insurance system.http:\/\/www.ameli.fr\/l-assurance-maladie\/statistiques-et-publications\/donnees-statistiques\/medicament\/medic-am\/medic-am-mensuel-2016.php."},{"key":"e_1_2_10_15_1","unstructured":"The Drug Information System of National Health Care Institute (GIP Databank).www.gipdatabank.nl."},{"key":"e_1_2_10_16_1","unstructured":"Norwegian Prescription Database (NorPD).http:\/\/www.norpd.no."},{"key":"e_1_2_10_17_1","unstructured":"Statistikdatabas f\u00f6r l\u00e4kemedel.http:\/\/www.socialstyrelsen.se\/statistik\/statistikdatabas\/lakemedel."},{"key":"e_1_2_10_18_1","unstructured":"National Health Service\/Information Services Division Scotland.http:\/\/www.isdscotland.org\/Health\u2010Topics\/Prescribing\u2010and\u2010medicines\/Community\u2010Dispensing\/Prescription\u2010Cost\u2010Analysis\/. 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Accessed July 24 2019."},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0258(20000215)19:3<335::AID-SIM336>3.0.CO;2-Z"},{"key":"e_1_2_10_23_1","unstructured":"European Medicines Agency.Xgeva European Public Assessment Report.https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/xgeva. Accessed July 18 2019."},{"key":"e_1_2_10_24_1","unstructured":"European Medicines Agency.Prolia European Public Assessment Report.https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/prolia. Accessed July 18 2019."},{"issue":"1","key":"e_1_2_10_25_1","first-page":"54","article-title":"Under\u2010reporting of adverse drug reactions, a problem that also involves medicines subject to additional monitoring. Preliminary data from a single\u2010center experience on novel oral anticoagulants","volume":"19","author":"Patrignani A","year":"2018","journal-title":"G Ital Cardiol"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200629050-00003"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1590\/S0080-623420140000400023"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13159"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40259-018-0281-6"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.5174","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/pds.5174","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.5174","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,1]],"date-time":"2023-09-01T08:33:42Z","timestamp":1693557222000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.5174"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,12,8]]},"references-count":28,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2021,3]]}},"alternative-id":["10.1002\/pds.5174"],"URL":"https:\/\/doi.org\/10.1002\/pds.5174","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"type":"print","value":"1053-8569"},{"type":"electronic","value":"1099-1557"}],"subject":[],"published":{"date-parts":[[2020,12,8]]},"assertion":[{"value":"2020-04-20","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-11-11","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-12-08","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}