Risk management plans as a tool for proactive pharmacovigilance: a cohort study of newly approved drugs in Europe

TY - JOUR

T1 - Risk management plans as a tool for proactive pharmacovigilance

T2 - a cohort study of newly approved drugs in Europe

AU - Vermeer, N S

AU - Duijnhoven, R G

AU - Straus, S M J M

AU - Mantel-Teeuwisse, A K

AU - Arlett, P R

AU - Egberts, A C G

AU - Leufkens, H G M

AU - De Bruin, M L

PY - 2014/9/15

Y1 - 2014/9/15

N2 - Risk Management Plans (RMPs) have become a cornerstone in the pharmacovigilance of new drugs in Europe. The RMP was introduced in 2005 to support a proactive approach in gaining knowledge on safety concerns through early planning of pharmacovigilance activities. However, the rate at which uncertainties in the safety profile are resolved through this proactive approach is unknown. We therefore examined the evolution of safety concerns in the RMP after initial approval for a selected cohort of 48 drugs, to provide insight into the knowledge gain over time. We found that 20.7% of the uncertainties existing at approval had been resolved 5 years after approval. Because new uncertainties were included in the RMP at a similar rate, the overall number of uncertainties remained approximately equal. The relatively modest accrual of knowledge, as demonstrated in this study through resolution of uncertainties, suggests that opportunities for optimization exist while ensuring feasible and risk-proportionate pharmacovigilance planning.

AB - Risk Management Plans (RMPs) have become a cornerstone in the pharmacovigilance of new drugs in Europe. The RMP was introduced in 2005 to support a proactive approach in gaining knowledge on safety concerns through early planning of pharmacovigilance activities. However, the rate at which uncertainties in the safety profile are resolved through this proactive approach is unknown. We therefore examined the evolution of safety concerns in the RMP after initial approval for a selected cohort of 48 drugs, to provide insight into the knowledge gain over time. We found that 20.7% of the uncertainties existing at approval had been resolved 5 years after approval. Because new uncertainties were included in the RMP at a similar rate, the overall number of uncertainties remained approximately equal. The relatively modest accrual of knowledge, as demonstrated in this study through resolution of uncertainties, suggests that opportunities for optimization exist while ensuring feasible and risk-proportionate pharmacovigilance planning.

KW - Cohort Studies

KW - Drug Approval

KW - Europe

KW - Humans

KW - Pharmacovigilance

KW - Risk Management

KW - Journal Article

KW - Research Support, Non-U.S. Gov't

U2 - 10.1038/clpt.2014.184

DO - 10.1038/clpt.2014.184

M3 - Journal article

C2 - 25222619

SN - 0009-9236

VL - 96

SP - 723

EP - 731

JO - Clinical Pharmacology and Therapeutics

JF - Clinical Pharmacology and Therapeutics

IS - 6

ER -