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Identifying pregnancies in insurance claims data: Methods and application to retinoid teratogenic surveillance.
- Source :
-
Pharmacoepidemiology and drug safety [Pharmacoepidemiol Drug Saf] 2019 Sep; Vol. 28 (9), pp. 1211-1221. Date of Electronic Publication: 2019 Jul 22. - Publication Year :
- 2019
-
Abstract
- Purpose: 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.<br />Methods: 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.<br />Results: 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.<br />Conclusions: 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.<br /> (© 2019 John Wiley & Sons, Ltd.)
- Subjects :
- Abnormalities, Drug-Induced etiology
Administrative Claims, Healthcare statistics & numerical data
Adolescent
Adult
Databases, Factual statistics & numerical data
Drug Prescriptions statistics & numerical data
Female
Humans
Infant, Newborn
Maternal Exposure adverse effects
Maternal Exposure statistics & numerical data
Middle Aged
Pregnancy
Pregnancy Rate
Prevalence
Product Surveillance, Postmarketing statistics & numerical data
United States epidemiology
Young Adult
Abnormalities, Drug-Induced epidemiology
Isotretinoin adverse effects
Pregnancy Outcome epidemiology
Product Surveillance, Postmarketing methods
Tretinoin adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1099-1557
- Volume :
- 28
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- Pharmacoepidemiology and drug safety
- Publication Type :
- Academic Journal
- Accession number :
- 31328328
- Full Text :
- https://doi.org/10.1002/pds.4794