Meldau, Eva-Lisa http://orcid.org/0000-0003-0268-7769
Bista, Shachi http://orcid.org/0000-0001-8319-4936
Rofors, Emma
Gattepaille, Lucie M. http://orcid.org/0000-0002-6046-2181
Article History
Accepted: 9 February 2022
First Online: 17 May 2022
Declarations
:
: There was no specific funding for this study.
: The UMC is a non-profit organisation and the WHO Collaborating Centre for International Drug Monitoring. UMC sells WHODrug Koda as part of its product offerings to pharmaceutical companies. Eva-Lisa Meldau, Shachi Bista, Emma Rofors and Lucie Gattepaille declare being employed by UMCÂ at the time of writing but have no other conflicts of interest that are directly relevant to the contents of this article.
: The datasets generated and analysed during the current study are not publicly available due to agreements between contributors of data to the database used (VigiBase) and the custodian of this database. National centres (mainly national drug regulatory authorities) constituting the WHO PIDM contribute data to VigiBase and the UMC is the custodian in its capacity as WHO Collaborating Centre for International Drug Monitoring. Some subsets of the data may be available from the corresponding author on reasonable request.
: WHODrug Koda is proprietary software provided by the UMC (an independent, non-profit foundation) and neither the software nor the code for this evaluation are available for public release.
: All authors designed and conceptualised the manuscript, interpreted the data, drafted the manuscript, and revised the manuscript. Additionally, EM and SB generated and analysed the data, LG supervised the study, and ER provided support to the manual evaluation teams. All authors read and approved the final version.
: Not applicable.
: Not applicable.
: Not applicable.