TY - JOUR
T1 - The role of electronic healthcare record databases in paediatric drug safety surveillance
T2 - A retrospective cohort study
AU - De Bie, Sandra
AU - Coloma, Preciosa M.
AU - Ferrajolo, Carmen
AU - Verhamme, Katia M.C.
AU - Trifirò, Gianluca
AU - Schuemie, Martijn J.
AU - Straus, Sabine M.J.M.
AU - Gini, Rosa
AU - Herings, Ron
AU - Mazzaglia, Giampiero
AU - Picelli, Gino
AU - Ghirardi, Arianna
AU - Pedersen, Lars
AU - Stricker, Bruno H.C.
AU - Van Der Lei, Johan
AU - Sturkenboom, Miriam C.J.M.
PY - 2015/8/1
Y1 - 2015/8/1
N2 - Aim Electronic healthcare record (EHR)-based surveillance systems are increasingly being developed to support early detection of safety signals. It is unknown what the power of such a system is for surveillance among children and adolescents. In this paper we provide estimates of the number and classes of drugs, and incidence rates (IRs) of events, that can be monitored in children and adolescents (0-18 years). Methods Data were obtained from seven population-based EHR databases in Denmark, Italy, and the Netherlands during the period 1996-2010. We estimated the number of drugs for which specific adverse events can be monitored as a function of actual drug use, minimally detectable relative risk (RR) and IRs for 10 events. Results The population comprised 4 838 146 individuals (25 575 132 person years (PYs)), who were prescribed 2170 drugs (1 610 631 PYs drug-exposure). Half of the total drug-exposure in PYs was covered by only 18 drugs (0.8%). For a relatively frequent event like upper gastrointestinal bleeding there were 39 drugs for which an association with a RR ≥4, if present, could be investigated. The corresponding number of drugs was eight for a rare event like anaphylactic shock. Conclusion Drug use in children is rare and shows little variation. The number of drugs with enough exposure to detect rare adverse events in children and adolescents within an EHR-based surveillance system such as EU-ADR is limited. Use of additional sources of paediatric drug exposure information and global collaboration are imperative in order to optimize EHR data for paediatric safety surveillance.
AB - Aim Electronic healthcare record (EHR)-based surveillance systems are increasingly being developed to support early detection of safety signals. It is unknown what the power of such a system is for surveillance among children and adolescents. In this paper we provide estimates of the number and classes of drugs, and incidence rates (IRs) of events, that can be monitored in children and adolescents (0-18 years). Methods Data were obtained from seven population-based EHR databases in Denmark, Italy, and the Netherlands during the period 1996-2010. We estimated the number of drugs for which specific adverse events can be monitored as a function of actual drug use, minimally detectable relative risk (RR) and IRs for 10 events. Results The population comprised 4 838 146 individuals (25 575 132 person years (PYs)), who were prescribed 2170 drugs (1 610 631 PYs drug-exposure). Half of the total drug-exposure in PYs was covered by only 18 drugs (0.8%). For a relatively frequent event like upper gastrointestinal bleeding there were 39 drugs for which an association with a RR ≥4, if present, could be investigated. The corresponding number of drugs was eight for a rare event like anaphylactic shock. Conclusion Drug use in children is rare and shows little variation. The number of drugs with enough exposure to detect rare adverse events in children and adolescents within an EHR-based surveillance system such as EU-ADR is limited. Use of additional sources of paediatric drug exposure information and global collaboration are imperative in order to optimize EHR data for paediatric safety surveillance.
KW - active drug safety surveillance
KW - electronic healthcare records
KW - EU-ADR
KW - paediatric drug safety
KW - pharmacovigilance
KW - safety monitoring
UR - http://www.scopus.com/inward/record.url?scp=84937517878&partnerID=8YFLogxK
U2 - 10.1111/bcp.12610
DO - 10.1111/bcp.12610
M3 - Article
C2 - 25683723
AN - SCOPUS:84937517878
SN - 0306-5251
VL - 80
SP - 304
EP - 314
JO - British Journal of Clinical Pharmacology
JF - British Journal of Clinical Pharmacology
IS - 2
ER -