Drug Utilization Studies in Pregnant Women for Newly Licensed Medicinal Products: A Contribution from IMI ConcePTION
Table 2
Items for the introduction.
Items of information
Number of reports ()
The new medicine(s)
Approved indication(s) with approval and launch dates
9
Date medicine first appears in the country/region/reimbursement database(s)
6
Other treatment(s) for same indication(s)
7
Regulatory requirements for the approval of medicine, e.g., postauthorization requirements
11
Risk minimization measures, e.g., advice to “avoid” or “use only if benefits outweigh risk,” as recommended by the manufacturers or regulators
4
Pharmacokinetic parameters particularly placental transfer, the elimination half-life, and volume of distribution for each trimester
3
Safety information related to pregnancy from preapproval animal or clinical studies
4
Data on adverse drug reactions (ADRs), particularly those related to pregnancy or breastfeeding from spontaneous reporting systems, such as the EudraVigilance database, and pregnancy registries for the medicine in question, medicines of the same class or for the same indication
2
Summary of existing phase 3 trial data, both benefits and risks (ADRs) for women of childbearing age. If not available, for the whole population
2
Prevalence of the condition for which the medicine is approved or used for
In women of childbearing age and in pregnant women (before, during, and after pregnancy)
2
Specify the denominator used, as applicable: general population, women in the general population, women in reproductive age, or women prescribed the medicine of interest
4
In the country where the DUS is conducted (women of childbearing age and/or pregnant women)
6
International variation
4
Prevalence of drug use
In women of childbearing age
2
All women
1
In pregnant women (before, during, and after pregnancy)
