Electronic healthcare databases for active drug safety surveillance: is there enough leverage?
OBJECTIVE
To provide estimates of the number and types of drugs that can be monitored for safety surveillance using electronic healthcare databases.


METHODS
Using data from eight European databases (administrative claims, medical records) and in the context of a cohort study, we determined the amount of drug exposure required for signal detection across varying magnitudes of relative risk (RR). We provide estimates of the number and types of drugs that can be monitored as a function of actual use, minimal detectable RR, and empirically derived incidence rates for the following adverse events: (i) acute myocardial infarction; (ii) acute renal failure; (iii) anaphylactic shock; (iv) bullous eruptions; (v) rhabdomyolysis; and (vi) upper gastrointestinal bleeding. We performed data simulation to see how expansion of database size would influence the capabilities of such system.


RESULTS
Data from 1,947,452 individuals (59,594,132 person-years follow-up) who used 2,289 drugs in the EU-ADR network show that for a frequent event such as acute myocardial infarction, there are 531 drugs (23% of total) for which an association with RR = 2, if present, can be investigated. For a rare event such as rhabdomyolysis, there are 19 drugs (1%) for which an association of same magnitude can be investigated.


CONCLUSIONS
Active surveillance using healthcare data-based networks for signal detection is feasible, although the leverage to do so may be low for infrequently used drugs and for rare outcomes. Extending database network size to include data from heterogeneous populations and increasing follow-up time are warranted to maximize leverage of these surveillance systems.
Department of Medical Informatics, Erasmus Medical Center, Rotterdam, The Netherlands. p.coloma@erasmusmc.nl
Preciosa M
PM
Coloma
Gianluca
G
Trifirò
Martijn J
MJ
Schuemie
Rosa
R
Gini
Ron
R
Herings
Julia
J
Hippisley-Cox
Giampiero
G
Mazzaglia
Gino
G
Picelli
Giovanni
G
Corrao
Lars
L
Pedersen
Johan
J
van der Lei
Miriam
M
Sturkenboom
D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards* / Q000706:statistics & numerical data; D016208:Databases, Factual / Q000592:standards* / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions; D057286:Electronic Health Records / Q000592:standards* / Q000706:statistics & numerical data; D006801:Humans; D015233:Models, Statistical; D060735:Pharmacovigilance