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dc.contributor.authorAndrade, Susan E.
dc.contributor.authorToh, Sengwee
dc.contributor.authorHoustoun, Monika
dc.contributor.authorMott, Katrina
dc.contributor.authorPitts, Marilyn
dc.contributor.authorKieswetter, Caren
dc.contributor.authorCeresa, Carrie
dc.contributor.authorHaffenreffer, Katherine
dc.contributor.authorReichman, Marsha
dc.date2022-08-11T08:08:20.000
dc.date.accessioned2022-08-23T15:51:30Z
dc.date.available2022-08-23T15:51:30Z
dc.date.issued2016-04-01
dc.date.submitted2017-02-17
dc.identifier.citationMatern Child Health J. 2016 Apr;20(4):895-903. doi: 10.1007/s10995-015-1878-8. <a href="https://doi.org/10.1007/s10995-015-1878-8">Link to article on publisher's site</a>
dc.identifier.issn1092-7875 (Linking)
dc.identifier.doi10.1007/s10995-015-1878-8
dc.identifier.pmid26645616
dc.identifier.urihttp://hdl.handle.net/20.500.14038/28913
dc.description.abstractOBJECTIVES: 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.
dc.language.isoen_US
dc.relation<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=26645616&dopt=Abstract">Link to Article in PubMed</a>
dc.relation.urlhttps://doi.org/10.1007/s10995-015-1878-8
dc.subjectPregnancy
dc.subjectPrescription medications
dc.subjectSurveillance
dc.subjectFemale Urogenital Diseases and Pregnancy Complications
dc.subjectMaternal and Child Health
dc.subjectWomen's Health
dc.titleSurveillance of Medication Use During Pregnancy in the Mini-Sentinel Program
dc.typeJournal Article
dc.source.journaltitleMaternal and child health journal
dc.source.volume20
dc.source.issue4
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/faculty_pubs/1143
dc.identifier.contextkey9706559
html.description.abstract<p>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.</p> <p>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.</p> <p>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.</p> <p>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.</p>
dc.identifier.submissionpathfaculty_pubs/1143
dc.contributor.departmentDepartment of Medicine
dc.contributor.departmentMeyers Primary Care Institute
dc.source.pages895-903


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