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

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. 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. 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. 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.

Polypharmacy and comorbidities during pregnancy in a cohort of women with migraine

“…Estimated LMP was determined by subtracting the gestational length from the end date of the pregnancy. Additional cohort details, including classifications of pregnancy type and estimation of gestational length, have been previously described (16).…”

<p>Impact of the Transition from ICD–9–CM to ICD–10–CM on the Identification of Pregnancy Episodes in US Health Insurance Claims Data</p>

“…3 Several algorithms have been proposed to identify unique pregnancy episodes using the clinical encounter information coded using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) system. [4][5][6][7][8] The validity of such algorithms has been demonstrated against birth certificate and electronic health records in different settings, including pregnancies that followed in vitro fertilization where the accurate conception date is known. [9][10][11][12] However, the transition from ICD-9 to ICD-10 codes in the US healthcare system in 2015 has imposed a new challenge to the identification of pregnancy episodes in claims databases.…”

A Pharmacoepidemiologic Approach to Evaluate Real-world Effectiveness of Hormonal Contraceptives in the Presence of Drug–drug Interactions

“… 1 , 2 To ensure accurate timing of drug exposure, pregnancy episodes are usually determined via a specific pregnancy endpoint, estimation of gestational age at the time of the endpoint, and imputation of the pregnancy start date. 3 – 5 Although the International Classification of Disease (ICD) coding offers detail on gestational age at delivery, the codes are not consistently applied to medical encounter claims, thus leaving some uncertainty about the exact date of conception. Such inaccuracies are more pronounced for preterm deliveries and other adverse pregnancy endpoints such as stillbirths and abortions.…”