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PURPOSE The Precision Medicine Initiative (PMI) goal of ushering in a new and more effective era of health care that benefits all Americans requires two critical and interdependent components: a cohort assembly of 1 million or more Americans who reflect the diversity of the United States of America and an interdisciplinary workforce that includes nursing. The purpose of this article is to provide an example of nursing involvement in PM, specifically as related to gathering biospecimens (saliva) from vulnerable, understudied adolescents with disruptive behavior disorders and their family members. SOURCE(S) First, we provide a brief description of important concepts related to PM as well as current roles of nurses in PM. Then, we share lessons learned from our feasibility study aimed at increasing the diversity of our statewide cohort assembly that has provided biospecimens for the Indiana Biobank. CONCLUSION Nurses can definitely contribute to biobanks in support of the PMI. This article is a call to action for nurses to take their rightful place in PM. [ABSTRACT FROM AUTHOR]

Objective To characterize the pharmacokinetics and pharmacogenetics of nifedipine in pregnancy. Study Design Pregnant women receiving oral nifedipine underwent steady-state pharmacokinetic testing over one dosing interval. DNA was obtained and genotyped for cytochrome P450 (CYP) 3A5 and CYP3A4*1B. Nifedipine and oxidized nifedipine concentrations were measured in plasma, and pharmacokinetic parameters were compared between those women who expressed a CYP3A5*1 allele and those who expressed only variant CYP3A5 alleles (*3,*6, or *7). Results Fourteen women had complete data to analyze. Four women (29%) expressed variant CYP3A5; three of these women were also CYP3A4*1B allele carriers. The mean halflife of nifedipine was 1.68 ± 1.56 hours. The area under the curve from0 to 6 hours for the women receiving nifedipine every 6 hours was 207± 138 μgEh /L. Oral clearance was different between high expressers and low expressers (232.0 ± 37.8 μg/mL versus 85.6 ± 45.0 μg/mL, respectively; p = 0.007). Conclusion CYP3A5 genotype influences the oral clearance of nifedipine in pregnant women. [ABSTRACT FROM AUTHOR]

Objective. To characterize the pharmacokinetics of nifedipine when used for tocolysis in preterm labor and to determine the impact of genetics on these parameters. Study design. Pharmacokinetic study performed on women given tocolytic nifedipine. Over one dosing interval, drug concentrations, clinical data, and genotype for Cytochrome P450 (CYP)3A5 polymorphisms were obtained. Non-compartmental pharmacokinetic analysis was used to estimate nifedipine exposure at steady state. Results. The mean nifedipine area under the curve in 20 pregnant women was 86.1±61.1 ng/ml/h. The mean nifedipine exposure differed by expression of CYP3A5 (expressers [[exp]]: 139.5±97.3 ng/ml/h vs. nonexpressers[[non]]: 68.3 ± 31.8 ng/ml/h, p == 0.02). Four women consumed CYP3A inhibitors and this affected the nifedipine concentrations ( p < 0.001). CYP3A5 expressers had less improvement in contraction frequency after the loading dose ( p == 0.04), at steady state ( p == 0.006), and at 0-1 h after the study dose ( p < 0.001). Conclusions. CYP3A5 genotype plays a role in nifedipine concentration when used as a tocolytic. [ABSTRACT FROM AUTHOR]

To address provider struggles to provide evidence-based, rational drug therapy to pregnant women, this third Conference was convened to highlight the current progress and research in the field. Speakers from academic centers, industry, and governmental institutions spoke about: the Food and Drug Administration's role in pregnancy pharmacology and the new labeling initiative; drug registries in pregnancy; the pharmacist's role in medication use in pregnancy; therapeutic areas such as preterm labor, gestational diabetes, nausea and vomiting in pregnancy, and hypertension; breast-feeding and medications; ethical challenges for consent in pregnancy drug studies; the potential for cord blood banks; and concerns about the fetus when studying drugs in pregnancy. The Conference highlighted several areas of collaboration within the current Obstetrics Pharmacology Research Units Network and hoped to educate providers, researchers, and agencies with the common goal to improve the ability to safely and effectively use individualized pharmacotherapy in pregnancy. Clin Trans Sci 2011; Volume 4: 204-209 [ABSTRACT FROM AUTHOR]

The article emphasizes the efficacy of pharmacotherapy in assuring the safety among pregnant women as they take optimum drug doses while minimizing its side effects to them and their unborn babies. The U.S. Food and Drug Administration (FDA)emphasizes the individualization of pharmacotherapy in pregnancy to take individual women under specific surveillance and assistance in taking drugs while minimizing the side effects. The process stresses the involvement of medical practitioners to provide optimal health care to women needing medications in pregnancy.

Background: Vincristine-induced peripheral neuropathy (VIPN) is difficult to quantify in children., Objective: The study objective was to examine the reliability, validity, and clinical feasibility of several VIPN measures for use in children with acute lymphoblastic leukemia., Interventions/methods: Children (n = 65) aged 1 to 18 years receiving vincristine at 4 academic centers participated in the study. Baseline and pre-vincristine administration VIPN assessments were obtained using the Total Neuropathy Score-Pediatric Vincristine (TNS©-PV), the National Cancer Institute Common Terminology Criteria for Adverse Events, the Balis grading scale, and the FACES Pain Scale. The TNS-PV scores (n = 806) were obtained over 15 weeks. Blood was obtained at several time points to quantify pharmacokinetic parameters., Results: Cronbach's α for a reduced TNS-PV scale was .84. The TNS-PV scores correlated with cumulative vincristine dosage (r = 0.53, P = 0.01), pharmacokinetic parameters (r = 0.41, P = 0.05), and grading scale scores (r range = 0.46-0.52, P = .01). FACES scores correlated with the TNS-PV neuropathic pain item (r = 0.48; P = .01) and were attainable in all ages. A 2-item V-Rex score (vibration and reflex items) was the most responsive to change (effect size = 0.65, P < 0.001). The TNS-PV scores were attainable in 95% of children 6 years or older., Conclusions: The TNS-PV is reliable and valid for measuring VIPN. It is sensitive to change over time (15 weeks) and feasible for use in children 6 years or older., Implications for Practice: The TNS-PV may be a useful tool for assessing vincristine toxicity in children with acute lymphoblastic leukemia.