How to classify women exposed to drug prescriptions during pregnancy in pharmaco-epidemiology studies? Method using treatment intensity and individual trajectories of exposure over time

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Not applicable
• If ‘Not applicable’, further details on the study type:
  Development of new methods in Pharmacoepidemiology

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N05) PSYCHOLEPTICS

  PSYCHOLEPTICS

  (N06) PSYCHOANALEPTICS

  PSYCHOANALEPTICS

Population studied

• Short description of the study population:
  Women exposed to psychotropic drugs during pregnancy in EFEMERIS database.
• Age groups:
  • Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  3700

Study design details

• Main study objective:
  The objective of the present study is to propose a new method to classify women according to drug exposure during pregnancy taking into account treatment intensity, duration and evolution.We will apply this method to psychotropic drugs during pregnancy in EFEMERIS.
• Data analysis plan:
  With the proposed method, pregnant women are classified according to drug exposure taking into account treatment intensity and prescription evolution during pregnancy. Three steps are required to set up the new method : 1.Convertion of filled prescriptions into exposure variables (using ATC-DDD) 2.Construction of individual trajectories of exposure 3.Classification of individual trajectories of exposure in homogeneous groups.