TY - JOUR
T1 - When More Is Less
T2 - An Exploratory Study of the Precautionary Reporting Bias and Its Impact on Safety Signal Detection
AU - Klein, Kevin
AU - Scholl, Joep H G
AU - De Bruin, Marie L
AU - van Puijenbroek, Eugène P
AU - Leufkens, Hubert G M
AU - Stolk, Pieter
N1 - © 2017 American Society for Clinical Pharmacology and Therapeutics.
PY - 2018/2
Y1 - 2018/2
N2 - Concerns have been expressed that large numbers of nonvalue-added reports have been accumulating in adverse drug reaction (ADR) databases, for example, via patient support programs. We performed an assessment of the impact of such reports, which we refer to as "precautionary reports," on safety signal detection in the Netherlands. The case narratives of ADR reports of three case products were screened with text-mining algorithms to identify those reports that lack a causal relationship with the suspected medicinal product. We demonstrate that precautionary reports impede the optimal use of the pharmacovigilance system by, on the one hand, masking safety signals and, on the other hand, creating spurious signals. The precautionary reporting bias and its suppressing effect on statistical signal detection results in an altered adverse event safety profile. The findings from this study highlight the need for a better alignment between regulatory authorities and marketing authorization holders regarding pharmacovigilance guidelines.
AB - Concerns have been expressed that large numbers of nonvalue-added reports have been accumulating in adverse drug reaction (ADR) databases, for example, via patient support programs. We performed an assessment of the impact of such reports, which we refer to as "precautionary reports," on safety signal detection in the Netherlands. The case narratives of ADR reports of three case products were screened with text-mining algorithms to identify those reports that lack a causal relationship with the suspected medicinal product. We demonstrate that precautionary reports impede the optimal use of the pharmacovigilance system by, on the one hand, masking safety signals and, on the other hand, creating spurious signals. The precautionary reporting bias and its suppressing effect on statistical signal detection results in an altered adverse event safety profile. The findings from this study highlight the need for a better alignment between regulatory authorities and marketing authorization holders regarding pharmacovigilance guidelines.
U2 - 10.1002/cpt.879
DO - 10.1002/cpt.879
M3 - Article
C2 - 28913827
SN - 0009-9236
VL - 103
SP - 296
EP - 303
JO - Clinical Pharmacology and Therapeutics
JF - Clinical Pharmacology and Therapeutics
IS - 2
ER -