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Schwarz E.B.,University of Pittsburgh | Parisi S.M.,University of Pittsburgh | Handler S.M.,University of Pittsburgh | Koren G.,Motherisk Laboratory | And 3 more authors.
Journal of General Internal Medicine | Year: 2012

Background: Potentially teratogenic medications are frequently prescribed without provision of contraceptive counseling. Objective: To evaluate whether computerized clinical decision support (CDS) can increase primary care providers' (PCPs') provision of family planning services when prescribing potentially teratogenic medications. Design: Cluster-randomized trial conducted in one academic and one community-based practice between October of 2008 and April of 2010. PARTICIPANTS/INTERVENTIONS: Forty-one PCPs were randomized to receive one of two types of CDS which alerted them to risks of medication-induced birth defects when ordering potentially teratogenic medications for women who may become pregnant. The 'simple' CDS provided a cautionary alert; the 'multifaceted' CDS provided tailored information and links to a structured order set Designed to facilitate safe prescribing. Both CDS systems alerted PCPs about medication risk only once per encounter. Main Measures: We assessed change in documented provision of family planning services using data from 35,110 encounters and mixed-effects models. PCPs completed surveys before and after the CDS systems were implemented, allowing assessment of change in PCP-reported counseling about the risks of medication-induced birth defects and contraception. Key Results: Both CDS systems were associated with slight increases in provision of family planning services when potential teratogens were prescribed, without a significant difference in improvement by CDS complexity (p∈=∈0.87). Because CDS was not repeated, 13% of the times that PCPs received CDS they substituted another potential teratogen. PCPs reported significant improvements in several counseling and prescribing practices. The multifaceted group reported a greater increase in the number of times per month they discussed the risks of medication use during pregnancy (multifaceted: +4.9∈±∈7.0 vs. simple: +0. 8∈±∈3.2, p∈=∈0.03). The simple CDS system was associated with greater clinician satisfaction. Conclusions: CDS systems hold promise for increasing provision of family planning services when fertile women are prescribed potentially teratogenic medications, but further refinement of these systems is needed. © 2011 Society of General Internal Medicine.

Schwarz E.B.,University of Pittsburgh | Parisi S.M.,University of Pittsburgh | Handler S.M.,University of Pittsburgh | Koren G.,Motherisk Laboratory | And 2 more authors.
Journal of Women's Health | Year: 2013

Background: We evaluated how computerized clinical decision support (CDS) affects the counseling women receive when primary care physicians (PCPs) prescribe potential teratogens and how this counseling affects women's behavior. Methods: Between October 2008 and April 2010, all women aged 18-50 years visiting one of three community-based family practice clinics or an academic general internal medicine clinic were invited to complete a survey 5-30 days after their clinic visit. Women who received prescriptions were asked if they were counseled about teratogenic risks or contraception and if they used contraception at last intercourse. Results: Eight hundred one women completed surveys; 27% received a prescription for a potential teratogen. With or without CDS, women prescribed potential teratogens were more likely than women prescribed safer medications to report counseling about teratogenic risks. However, even with CDS 43% of women prescribed potential teratogens reported no counseling. In multivariable models, women were more likely to report counseling if they saw a female PCP (odds ratio: 1.97; 95% confidence interval: 1.26-3.09). Women were least likely to report counseling if they received angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. Women who were pregnant or trying to conceive were not more likely to report counseling. Nonetheless, women who received counseling about contraception or teratogenic risks were more likely to use contraception after being prescribed potential teratogens than women who received no counseling. Conclusions: Physician counseling can reduce risk of medication-induced birth defects. However, efforts are needed to ensure that PCPs consistently inform women of teratogenic risks and provide access to highly effective contraception. © Mary Ann Liebert, Inc. 2013.

Hutson J.R.,Motherisk Laboratory | Hutson J.R.,University of Toronto | Rao C.,Motherisk Laboratory | Fulga N.,Motherisk Laboratory | And 3 more authors.
Alcohol | Year: 2011

Fatty acid ethyl esters (FAEEs) are nonoxidative metabolites of ethanol, and elevated levels of FAEE in meconium are a useful biomarker for heavy prenatal alcohol exposure. FAEE in meconium has been recommended as useful and cost-effective for universal screening for prenatal alcohol exposure. To support an efficient universal screening program, an analytical method to detect and quantify FAEE in meconium needs to be accurate, inexpensive, and rapid. The purpose of this study was to develop an analytical method that would satisfy these criteria and to validate this method using established laboratory guidelines. A method was developed and validated to detect and quantify four FAEEs (ethyl palmitate, ethyl linoleate, ethyl oleate, and ethyl stearate) from 0.5. g of meconium using d5-ethyl esters as internal standards. The sample undergoes liquid-liquid extraction with heptane:acetone, the heptane layer is isolated and evaporated, and then, the resulting residue undergoes headspace solid-phase microextraction coupled with gas chromatography-mass spectrometry. The detection limits of the four FAEEs ranged from 0.020 to 0.042. nmol/g and are 6- to 25-fold lower than the individual FAEE threshold concentrations (0.5. nmol/g). This method also has good precision with the coefficient of variation ranging from 2.6 to 19.4% for concentrations of individual FAEE between 0.5 and 2.62. nmol/g meconium (n=4). Calculated concentrations of FAEE that underwent extraction from meconium were 100-101% of the expected concentration, demonstrating the accuracy of the method. The peak shape and retention time of each FAEE were unaffected by the presence of the matrix, and there is no carryover at clinically relevant concentrations. This method was also able to produce clean chromatograms from meconium samples that could not be quantified using a previous method because of high chromatographic background. This method provides an optimal approach to detecting and quantifying FAEE in meconium that could be used in a universal screening program for prenatal alcohol exposure. © 2011 Elsevier Inc.

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