Identifying pregnancies in insurance claims data: Methods and application to retinoid teratogenic surveillance.

Détails

ID Serval
serval:BIB_0767DAE9297F
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Identifying pregnancies in insurance claims data: Methods and application to retinoid teratogenic surveillance.
Périodique
Pharmacoepidemiology and drug safety
Auteur⸱e⸱s
MacDonald S.C., Cohen J.M., Panchaud A., McElrath T.F., Huybrechts K.F., Hernández-Díaz S.
ISSN
1099-1557 (Electronic)
ISSN-L
1053-8569
Statut éditorial
Publié
Date de publication
09/2019
Peer-reviewed
Oui
Volume
28
Numéro
9
Pages
1211-1221
Langue
anglais
Notes
Publication types: Journal Article
Publication Status: ppublish
Résumé
The purpose of the study is to develop an algorithm to identify pregnancies in administrative databases and apply it to assess pregnancy rates and outcomes in women prescribed isotretinoin or tretinoin.
Using the 2011 to 2015 Truven Health MarketScan Database, we identified pregnancies, including losses and terminations. In a cohort design, nonpregnant women filling a prescription for isotretinoin or tretinoin were matched to five women without either prescription. Women were followed for 365 days or until conception, medication discontinuation, or enrollment discontinuation ("prescription episode"). Rates of pregnancy, risks of pregnancy losses, and prevalence of infant malformations at birth were assessed by exposure.
We identified 2 179 192 livebirths, 8434 stillbirths, 2521 mixed births, 415 110 spontaneous abortions, 124 556 elective terminations, and 8974 unspecified abortions. There were 86 834 isotretinoin and 973 587 tretinoin episodes, matched to 5 302 105 unexposed women. Pregnancy rates were 3 (isotretinoin), 19 (tretinoin), and 34 (unexposed) per 1000 person-years. Risk of spontaneous pregnancy losses were similar; however, terminations were more common in the isotretinoin-exposed (28% [95% CI: 21%-36%]) than the tretinoin-exposed (10% [95% CI: 9%-11%]) or unexposed pregnancies (6%). Malformations occurred in 4.5% (95% CI: 3.5%-5.6%) of the tretinoin-exposed pregnancies and 4.2% of the unexposed pregnancies (adjusted odds ratio: 1.16 [95% CI: 0.85-1.58]); isotretinoin-exposed births were too few to assess malformations.
Administrative databases can complement risk evaluation and mitigation strategies (REMS) for known teratogens and contribute to safety surveillance for other medications. Here, isotretinoin-exposed pregnancy rates were low, but existent, and many pregnancies were terminated. Tretinoin exposure was not associated with a meaningfully elevated risk of losses or malformations as compared with unexposed pregnancies.
Mots-clé
administrative data, healthcare claims, isotretinoin, pharmacoepidemiology, pregnancy, tretinoin
Pubmed
Web of science
Création de la notice
11/10/2019 7:44
Dernière modification de la notice
17/01/2020 7:26
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