Drug Utilization Studies in Pregnant Women for Newly Licensed Medicinal Products: A Contribution from IMI ConcePTION

Table 3

Possible objectives of a drug utilization study in pregnancy.

To assess if pregnant women are being prescribed or dispensed a specific new medicine	8
To assess the feasibility of conducting a pregnancy safety study for a newly approved medicine (are pregnant women and/or women of childbearing age using the medicine) by generating data for a sample size calculation	2
To estimate the prevalence of use amongst pregnant women or all women or those of childbearing age	8
To describe patterns of drug use in childbearing/pregnant women (dose, formulation, routes of administration, repeat prescriptions, trimester of use, and switching to other medicines or discontinuing any or all medicines)	4
To estimate the prevalence of the condition amongst women of childbearing age, and the proportion using the medicine, those of a similar class, and other medicines for the condition	3
To estimate the prevalence of drug use (or drug class) in women before, during (first, second, and third trimester), and/or after pregnancy and during breastfeeding	5
To estimate the prevalence of drug (or drug class) use in women of childbearing age or pregnant women by subgroups, e.g., socioeconomic status, ethnicity, clinical conditions, indications, concomitant prescribing, smoking or substance misuse, demographics including age, country/region, rurality, calendar years	2
To assess potential comparator groups for safety studies in pregnancy when it is not clear which group of patients would be the best comparators (e.g., patients with the disease not taking a medicine, or using other medicines)	3
To describe and/or compare drug utilization in populations, over time and/or according to other characteristics such as socioeconomic status	4
To compare the patient profiles of pregnant women using the medicine of interest with those prescribed other medicines for the same indications/disease	3