Combining multiple healthcare databases for postmarketing drug and vaccine safety surveillance: why and how?

• Published in: Journal of internal medicine Vol. 275; no. 6; pp. 551 - 561
• Main Authors: Trifirò, G., Coloma, P. M., Rijnbeek, P. R., Romio, S., Mosseveld, B., Weibel, D., Bonhoeffer, J., Schuemie, M., Lei, J., Sturkenboom, M.
• Format: Journal Article
• Language: English
• Published: England 01.06.2014
• Subjects: Adverse Drug Reaction Reporting Systems - organization & administration; claims database; Databases, Factual; drug monitoring; Drug Monitoring - methods; electronic health records; Electronic Health Records - organization & administration; Humans; Needs Assessment; Pharmaceutical Preparations - standards; Population Surveillance - methods; postmarketing; product surveillance; Product Surveillance, Postmarketing - methods; vaccine; Vaccines - standards; postmarketing; vaccine; product surveillance; electronic health records; claims database; drug monitoring

A growing number of international initiatives (e.g. EU‐ADR, Sentinel, OMOP, PROTECT and VAESCO) are based on the combined use of multiple healthcare databases for the conduct of active surveillance studies in the area of drug and vaccine safety. The motivation behind combining multiple healthcare da...