Pharmacist's guide to pregnancy registry studies.
OBJECTIVE
To introduce the concept and design characteristics of pregnancy registries and to discuss opportunities for pharmacist involvement.


METHODS
Previous and ongoing pregnancy registry studies that assess the safety of pharmaceutical agents in pregnant women were identified from the medical literature, Internet, abstracts from professional meetings, and personal communications.


METHODS
The development and use of the pregnancy registry study for evaluating drug safety is described. Then, to illustrate the application of scientific principles to this unique study design, examples are given from previous and ongoing pregnancy registry studies.


RESULTS
Pregnancy registry studies are increasingly used to assess the safety of drugs and other therapeutic agents during pregnancy. In a pregnancy registry, women who took the study drug while pregnant are identified soon after that exposure and followed until their pregnancy ends and its outcome is determined. Information is compiled from hundreds or thousands of pregnancies and used to make a safety assessment.


CONCLUSIONS
Pharmacists can explain pregnancy registries to pregnant women and encourage enrollment. Also, pharmacists can use information derived from these studies to help patients and health care providers manage inadvertent drug exposures and optimize pharmaceutical therapy during pregnancy.
Weiss
S R
SR
Department of Pharmacy Practice and Science, School of Pharmacy, University of Maryland, Baltimore 21201, USA. sweiss@rx.umaryland.edu
Cooke
C E
CE
Bradley
L R
LR
Manson
J M
JM
D003625:Data Collection / Q000379:methods; D005260:Female; D006801:Humans; D018579:Patient Selection; D010593:Pharmaceutical Services / Q000458:organization & administration*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D011256:Pregnancy Outcome; D012017:Referral and Consultation; D012042:Registries