Does additional monitoring status increase the reporting of adverse drug reaction s ? An interrupted time series analysis of EudraVigilance data-Reference-Cited by-同舟云学术

Does additional monitoring status increase the reporting of adverse drug reaction s ? An interrupted time series analysis of EudraVigilance data

Published:2020-12-08 Issue:3 Volume:30 Page:350-359
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Segec Andrej¹^ORCID,Slattery Jim¹^ORCID,Morales Daniel R.¹²^ORCID,Januskiene Justina¹^ORCID,Kurz Xavier¹^ORCID,Arlett Peter¹³^ORCID

Affiliation:

1. Pharmacovigilance and Epidemiology Department European Medicines Agency Amsterdam The Netherlands

2. Division of Population Health and Genomics University of Dundee Dundee UK

3. London School of Hygiene & Tropical Medicine London UK

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.5174

Reference28 articles.

1. 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.

2. 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 – 136 30/04/2004 p. 1–33.https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:02004R0726-20190128. Accessed April 30 2019.

3. 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.

4. European Medicines Agency.Guideline on good pharmacovigilance practices Module X – additional monitoring.http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/04/WC500142282.pdf. Accessed April 30 2019.

5. Measuring the impact of medicines regulatory interventions - Systematic review and methodological considerations

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