Utilization of Drugs With Pregnancy Exposure Registries During Pregnancy

Pharmacoepidemiol Drug Saf. 2018 Jun;27(6):604-611. doi: 10.1002/pds.4409. Epub 2018 Mar 8.


Purpose: To describe the utilization of drugs with pregnancy exposure registries by trimester during pregnancy, in comparison with matched nonpregnant episodes and a pre-pregnancy period.

Methods: We identified live-born deliveries from women aged 10 to 54 years and matched the pregnancies 1:1 with nonpregnant episodes from a comparator cohort not delivering live-born infants, using data from 2001 to 2013 in the Sentinel Distributed Database. We evaluated the utilization of 34 drugs with pregnancy exposure registries, comparing utilization during pregnancy to the matched nonpregnant episodes, and to the 90 days before pregnancy.

Results: We identified 1 895 597 pregnancies ending in live births in 1 598 697 women and 1 895 597 matched nonpregnant episodes in 1 582 581 women. We observed a lower prevalence of use for most drugs during pregnancy compared with the matched nonpregnant episodes, and the 90-day pre-pregnancy period. The median (interquartile range) prevalence ratio of use, at any time during pregnancy, for all products was 0.2 (0.1-0.3) comparing pregnant to nonpregnant episodes. Overall, there was a decrease in drug utilization by trimester; from 2.6% in the 90 days preceding pregnancy to 2.1% in the first trimester, 1.1% in the second trimester, and 0.9% in the third trimester.

Conclusions: Among drugs with pregnancy exposure registries, use was less during pregnancy compared with before pregnancy and to the matched nonpregnant episodes. The lower utilization during pregnancy suggests that women may be avoiding these drugs to minimize potentially harmful exposure during pregnancy. This lower utilization may increase the challenges of further studying the safety of these drugs using pregnancy exposure registries.

Keywords: drug safety; drug utilization; pharmacoepidemiology; pregnancy; pregnancy exposure registries.

Publication types

  • Comparative Study
  • Research Support, U.S. Gov't, Non-P.H.S.
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Child
  • Cohort Studies
  • Drug Utilization / statistics & numerical data*
  • Drug Utilization Review*
  • Female
  • Humans
  • Live Birth
  • Middle Aged
  • Postpartum Period
  • Pregnancy
  • Pregnancy Complications / drug therapy*
  • Pregnancy Trimesters*
  • Registries / statistics & numerical data*
  • Young Adult