Surveillance of Medication Use During Pregnancy in the Mini-Sentinel Program.
Objectives Mini-Sentinel is a pilot project sponsored by the U.S. Food and Drug Administration to create an active surveillance system to monitor the safety of FDA-regulated medical products. We assessed the capability of the Mini-Sentinel pilot to provide prevalence rates of medication use among pr...
| Publicado en: | Maternal & Child Health Journal Vol. 20; no. 4; pp. 895 - 904 |
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| Autores principales: | , , , , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Springer Nature
Apr2016
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=113778723&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 113778723 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 10927875 N9J jtl: Maternal & Child Health Journal issn: 10927875 maglogo: N pubinfo: dt: Apr2016 vid: 20 iid: 4 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 113778723 113778723 113778723 10.1007/s10995-015-1878-8 113778723 ppf: 895 ppct: 9 formats: fmt: @attributes: type: P tig: atl: Surveillance of Medication Use During Pregnancy in the Mini-Sentinel Program. aug: au: Andrade, Susan Toh, Sengwee Houstoun, Monika Mott, Katrina Pitts, Marilyn Kieswetter, Caren Ceresa, Carrie Haffenreffer, Katherine Reichman, Marsha affil: Meyers Primary Care Institute (Fallon Community Health Plan, Reliant Medical Group, and University of Massachusetts Medical School), 630 Plantation St. Worcester 01605 USA sug: subj: Drug Monitoring In Pregnancy Drug Therapy In Pregnancy Human Pregnancy Female Algorithms Child Adolescence Adult Middle Age Descriptive Statistics Childbirth Multiple Sclerosis Lupus Erythematosus, Systemic Data Analysis Software Childbirth, Premature Pregnancy, Prolonged Databases Funding Source Child: 6-12 years Adolescent: 13-18 years Adult: 19-44 years Middle Aged: 45-64 years Female ab: Objectives Mini-Sentinel is a pilot project sponsored by the U.S. Food and Drug Administration to create an active surveillance system to monitor the safety of FDA-regulated medical products. We assessed the capability of the Mini-Sentinel pilot to provide prevalence rates of medication use among pregnant women delivering a liveborn infant. Methods An algorithm was developed to identify pregnancies for a reusable analytic tool to be executed against the Mini-Sentinel Distributed Database. Diagnosis and procedure codes were used to identify women ages 10-54 years delivering a liveborn infant between April 2001 and December 2012. A comparison group of age- and date-matched nonpregnant women was identified. The analytic code was distributed to all 18 Mini-Sentinel data partners. The use of specific medications, selected because of concerns about their safe use during pregnancy, was identified from outpatient dispensing data. We determined the frequency of pregnancy episodes and nonpregnant episodes exposed to medications of interest, any time during the pregnant/matched nonpregnant period, and during each trimester. Results The analytic tool successfully identified 1,678,410 live birth deliveries meeting the eligibility criteria. The prevalence of use at any time during pregnancy was 0.38 % for angiotensin-converting enzyme inhibitors and 0.22 % for statins. For ≤0.05 % of pregnancy episodes, the woman was dispensed warfarin, methotrexate, ribavirin, or mycophenolate. Conclusions The analytic tool developed for this study can be used to assess the use of medications during pregnancy as safety issues arise, and is adaptable to include different medications, observation periods, pre-existing conditions, and enrollment criteria. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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