Prescriptive Authority for Direct Entry Midwives in Washington State: Increasing Client Access to Contraception.

Improving health and achieving health equity includes access to sexual and reproductive health care for all populations, especially those most in need. However, access to life-saving and life-affirming contraception with an individual's chosen perinatal provider can be impeded by restrictive regulations that limit scope and practice authority. This is especially true for the majority of community and direct entry midwives in the United States who have historically been unable to legally provide effective contraceptive methods. Recently, licensed midwives in Washington state were the first in the nation to achieve prescriptive authority, enabling their clients to directly obtain contraception and access to medications for common prenatal and postpartum conditions. Sustained advocacy efforts in the state's capitol enabled the Midwives' Association of Washington State to build relationships over time with legislators and government agencies to achieve this long-term goal. We present a successful midwifery-led innovation that achieved scope expansion for licensed midwives whose practice authority was limited by restrictive laws. Lessons learned are described and strategies offered to aid midwives and their advocates in other locales who want to improve health equity and access to contraception. Midwives are well positioned to provide this essential care to individuals living in underserved rural and urban areas and those from historically marginalized communities, but their ability to do so is limited by restrictive legislation.

Tacrolimus placental transfer at delivery and neonatal exposure through breast milk.

AIM(S): The current investigation aims to provide new insights into fetal exposure to tacrolimus in utero by evaluating maternal and umbilical cord blood (venous and arterial), plasma and unbound concentrations at delivery. This study also presents a case report of tacrolimus excretion via breast milk. METHODS: Maternal and umbilical cord (venous and arterial) samples were obtained at delivery from eight solid organ allograft recipients to measure tacrolimus and metabolite bound and unbound concentrations in blood and plasma. Tacrolimus pharmacokinetics in breast milk were assessed in one subject. RESULTS: Mean (±SD) tacrolimus concentrations at the time of delivery in umbilical cord venous blood (6.6 ± 1.8 ng ml(-1)) were 71 ± 18% (range 45-99%) of maternal concentrations (9.0 ± 3.4 ng ml(-1)). The mean umbilical cord venous plasma (0.09 ± 0.04 ng ml(-1)) and unbound drug concentrations (0.003 ± 0.001 ng ml(-1)) were approximately one fifth of the respective maternal concentrations. Arterial umbilical cord blood concentrations of tacrolimus were 100 ± 12% of umbilical venous concentrations. In addition, infant exposure to tacrolimus through the breast milk was less than 0.3% of the mother's weight-adjusted dose. CONCLUSIONS: Differences between maternal and umbilical cord tacrolimus concentrations may be explained in part by placental P-gp function, greater red blood cell partitioning and higher haematocrit levels in venous cord blood. The neonatal drug exposure to tacrolimus via breast milk is very low and likely does not represent a health risk to the breastfeeding infant.

Smooth Transitions: Enhancing Interprofessional Collaboration when Planned Community Births Transfer to Hospital Care.

In Washington state, planned community births are attended by direct entry licensed midwives (LMs) and certified nurse-midwives (CNMs). The most recently published vital statistics data from 2018 reported that 3.6% of the 84,648 births in Washington occurred at home or in freestanding birthing centers. Approximately 16.2% of planned home birth and birth center clients experience intrapartum or early postpartum transfer to the hospital, while 1.8% of their newborns do. The safety of and satisfaction with these types of referrals depends on multisystem processes performed by a variety of health care professionals. Smooth Transitions is a quality improvement (QI) initiative in Washington state that was developed to enhance interprofessional collaboration between community-based midwives, emergency medical services (EMS), and hospital personnel to improve the quality of hospital transfers from planned community settings. Key interventions to date have included (1) information sharing to dispel misconceptions and provide context regarding community births and midwives; (2) co-creation of transfer guidelines; (3) regularly held interprofessional meetings to review transfers and build relationships; and (4) ongoing review of qualitative feedback that captures the perspectives of all involved. Responses on questionnaires and audits indicate that Smooth Transitions has had a positive impact on provider, staff, and patient experiences with hospital transfers. Future endeavors will include strengthening quantitative data collection processes to measure safety indicators, expanding relationships with EMS, and building a case review process that is legally protected. By engaging representatives of all stakeholder groups and addressing community-to-hospital transfers as a multisystems issue, replication of the Smooth Transitions QI Program nationally could promote increased community midwifery integration by enhancing the referral experience for both patients and caregivers.

Increasing Access to Medications and Devices for the Care of Low-Risk Childbearing Families: An Analysis of Existing Law and Strategies for Advocacy.

Limited access to medications and devices relevant to the care of low-risk childbearing families acts as a barrier to the successful integration of high-quality midwifery care into health care systems. Families who live in clinically underserved areas, whether urban or rural, are particularly in need of perinatal professionals who can provide comprehensive care. This article reviews existing US laws that impact whether families who choose community-based care with direct entry midwives have access, through their chosen provider, to the medications and devices relevant to their normal perinatal and postpartum care. Scope of practice and practice authority are considered as they relate to access to medications and devices primarily for certified professional midwives and state-licensed midwives. These professionals are the primary health care providers offering community-based care and birth at home and in freestanding birth centers. Washington state laws are compared and contrasted with laws from other states and jurisdictions, with the aim of identifying ways to improve service delivery for families who choose community-based midwifery care. Recent and historical efforts to expand Washington state's midwifery drugs and devices formulary are described. This discussion outlines the Washington context for direct entry community midwifery practice, highlights relevant legal examples, and describes current and future efforts around quality improvement. Information from a midwifery clinic serving some of Washington's most vulnerable pregnant and postpartum families allows for an exploration of the role that access to essential medications and devices might play in supporting midwives to address health inequities. Ideal statutory and regulatory language, lessons learned from an analysis of Washington's experience, and strategies to overcome barriers are described to aid and inspire midwifery advocates in other jurisdictions who want to increase access and enhance their ability to offer current evidence-based care. Policy makers can improve health, health equity, consumer choice, and access to evidence-based care by using ideal legal language for midwifery practice authority.

Incorporating an Equity Agenda into Health Professions Education and Training to Build a More Representative Workforce.

Efforts to achieve health equity goals in the United States require the recruitment, retention, and graduation of an increasingly diverse student body of aspiring health professionals. Improving access to health care providers who are culturally congruent with the populations served is a related ethical priority that has the potential to improve the health inequities faced by communities of color and others in the United States. Midwifery education program administrators and faculty have responded to this need by acknowledging that creation of a more representative midwifery workforce starts with midwifery education. The Equity Agenda Guideline, related conceptual model, and website resources were developed for the purpose of supporting health professions educators and institutions who recognize a need for change and are seeking answers about how to train and graduate more health care providers from communities that are currently underrepresented. Using a systems approach to outline the transformative multilevel changes required, these resources offer a roadmap for how to address the underlying problems of racism and other differentisms that have limited the growth and diversification of the health and helping professions. This article addresses how health education programs interested in making an impact on this complex and persistent problem can adopt or adapt the Equity Agenda Guideline, originally developed for midwifery education programs in the United States.

A web-based resource for promoting equity in midwifery education and training: Towards meaningful diversity and inclusion.

Increasing the midwifery workforce requires that aspiring midwives complete education and training, but structural racism and microaggressions impact the lives of underrepresented midwifery students and apprentices, adding stressors and disparities to the usual demanding educational challenges. In order to be resilient, students rely on preceptors, faculty, administrators and institutions to promote equity. Equity-focused learning environments improve student experiences and success rates, and better prepare all students to provide culturally humble and sensitive care to diverse childbearing persons and other essential competencies outlined by the International Confederation of Midwives. The comprehensive web-based resource, www.equitymidwifery.org, is designed to support midwifery educators in promoting equity and social justice in midwifery education and training. The website highlights examples and provides tools including original webinar content and encourages visitors to attend virtual strategy and collaboration calls. It offers a model of continuous professional development that is easily accessible.

Pharmacokinetics of dacarbazine (DTIC) in pregnancy.

PURPOSE: The purpose of this report is to describe, for the first time, the pharmacokinetics of dacarbazine (DTIC) and its metabolites [5-[3-methyl-triazen-1-yl]-imidazole-4-carboxamide (MTIC), 5-[3-hydroxymethyl-3-methyl-triazen-1-yl]-imidazole-4-carboxamide (HMMTIC) and 5-aminoimidazole-4-carboxamide (AIC)] during pregnancy (n = 2) and postpartum (n = 1). METHODS: Non-compartmental DTIC, MTIC, HMMTIC, and AIC pharmacokinetics (PK) were estimated in one case at 29 week gestation and 18 day postpartum and a second case at 32 week gestation, in women receiving DTIC in combination with doxorubicin, bleomycin, and vinblastine for treatment of Hodgkin's lymphoma. Drug concentrations were measured by HPLC. RESULTS: In the subject who completed both pregnancy and postpartum study days, DTIC area under the concentration-time curve (AUC) was 27% higher and metabolite AUCs were lower by 27% for HMMTIC, 38% for MTIC, and 83% of AIC during pregnancy compared to postpartum. At 7 and 9 year follow-up, both subjects were in remission of their Hodgkin's lymphoma. CONCLUSIONS: Based on these two case reports, pregnancy appears to decrease the metabolism of the pro-drug dacarbazine, likely through inhibition of CYP1A2 activity. Lower concentrations of active metabolites and decreased efficacy may result, although both these subjects experienced long-term remission of their Hodgkin's lymphoma.

Prednisone Pharmacokinetics During Pregnancy and Lactation.

To evaluate the steady-state pharmacokinetics of prednisone and its metabolite prednisolone in pregnant and lactating female subjects, 19 subjects received prednisone (4-40 mg/day orally) in early (n = 3), mid (n = 9), and late (n = 13) pregnancy as well as postpartum with (n = 2) and without (n = 5) lactation. Serial blood and urine samples were collected over 1 dosing interval. Prednisone and its metabolite, prednisolone, steady-state noncompartmental pharmacokinetic parameters were estimated. During pregnancy, prednisone apparent oral clearance increased with dose (35.1 ± 11.4 L/h with 5 mg, 52.6 ± 5.2 L/h with 10 mg, and 64.3 ± 6.9 L/h with 20 mg, P = .001). Similarly, unbound prednisone apparent oral clearance increased with dose. In addition, prednisolone renal clearance increased with dose (0.3 ± 0.3 L/h with 5 mg, 0.5 ± 0.4 L/h with 10 mg, and 1.3 ± 1.1 L/h with 20 mg, P = .002). Higher prednisone (r = 0.57, P ≤ .05) and prednisolone (r = 0.75, P ≤ .05) concentrations led to a higher percentage of unbound drug. Breast-milk/plasma area under the concentration-time curve ratios were 0.5-0.6 for prednisone and 0.02-0.03 for prednisolone. Relative infant doses were 0.35% to 0.53% and 0.09% to 0.18%, for prednisone and prednisolone, respectively. Prednisone and prednisolone exhibit dose- and concentration-dependent pharmacokinetics during pregnancy, and infant exposure to these agents via breast milk is minimal.

The Professionalization of International Disaster Response: It Is Time for Midwives to Get Ready.

Disasters and humanitarian emergencies due to natural or human origins result in severe and often prolonged suffering of the affected population. Midwives have a role to play in providing assistance because women and their infants experiencing such crises have unique vulnerabilities and needs. This article introduces midwives and other women's health care practitioners to international humanitarian emergency response efforts and describes preparation and training activities they can undertake to get ready to volunteer with an international health aid agency. Various clinical realities and challenges are discussed, including recommended priorities for providing reproductive health care in disaster zones. Common ethical dilemmas in crisis health care settings are also reviewed. By arriving in the field well prepared to participate and collaborate, midwives can make substantial contributions to the safety, health, and comfort of women and their families who have experienced a natural disaster, armed conflict, or disease epidemic.

Gestational diabetes mellitus management with oral hypoglycemic agents.

Oral hypoglycemic agents such as glyburide (second-generation sulfonylurea) and metformin (biguanide) are attractive alternatives to insulin due to lower cost, ease of administration, and better patient adherence. The majority of evidence from retrospective and prospective studies suggests comparable efficacy and safety of oral hypoglycemic agents such as glyburide and metformin as compared to insulin when used in the treatment of women with gestational diabetes mellitus (GDM). Glyburide and metformin have altered pharmacokinetics during pregnancy and both agents cross the placenta. In this article, we review the efficacy, safety, and dosage of oral hypoglycemic agents for the treatment of gestational diabetes mellitus. Additional research is needed to evaluate optimal dosage for glyburide and metformin during pregnancy. Comparative studies evaluating the effects of glyburide and metformin on long-term maternal and fetal outcomes are also needed.

Pharmacokinetics of doxorubicin in pregnant women.

PURPOSE: Our objective was to evaluate the pharmacokinetics (PK) of doxorubicin during pregnancy compared to previously published data from non-pregnant subjects. METHODS: During mid- to late-pregnancy, serial blood and urine samples were collected over 72 h from seven women treated with doxorubicin for malignancies. PK parameters were estimated using non-compartmental techniques. Pregnancy parameters were compared to those previously reported non-pregnant subjects. RESULTS: During pregnancy, mean (±SD) doxorubicin PK parameters utilizing 72 h sampling were: clearance (CL), 412 ± 80 mL/min/m(2); steady-state volume of distribution (Vss), 1,132 ± 476 L/m(2); and terminal half-life (T1/2), 40.3 ± 8.9 h. The BSA-adjusted CL was significantly decreased (p < 0.01) and T1/2 was not different compared to non-pregnant women. Truncating our data to 48 h, PK parameters were: CL, 499 ± 116 ml/min/m(2); Vss, 843 ± 391 L/m(2); and T1/2, 24.8 ± 5.9 h. The BSA-adjusted CL in pregnancy compared to non-pregnant data was significantly decreased in 2 of 3 non-pregnant studies (p < 0.05, < 0.05, NS). Vss and T1/2 were not significantly different. CONCLUSIONS: In pregnant subjects, we observed significantly lower doxorubicin CL in our 72 h and most of our 48 h sampling comparisons with previously reported non-pregnant subjects. However, the parameters were within the range previously reported in smaller studies. At this time, we cannot recommend alternate dosage strategies for pregnant women. Further research is needed to understand the mechanism of doxorubicin pharmacokinetic changes during pregnancy and optimize care for pregnant women.

Duration of cisplatin excretion in breast milk.

Cisplatin, a platinum-based chemotherapy agent, is commonly used in treating cancers that may affect women of childbearing age, including cervical cancer, triple-negative breast cancer, and pediatric tumors in adolescents. The authors found that platinum was undetectable in breast milk at 66 hours and beyond following a 70-mg dose of intravenous cisplatin. Relative infant dose of platinum was calculated to be between 0.29% and 0.40% of the maternal dose corrected for body weight. This case demonstrates minimal exposure to platinum via breast milk, following a single 70-mg intravenous dose of cisplatin.

Interpreting tacrolimus concentrations during pregnancy and postpartum.

Pregnancy after solid organ transplantation, although considered high risk for maternal, fetal, and neonatal complications, has been quite successful. Tacrolimus pharmacokinetic changes during pregnancy make interpretation of whole blood trough concentrations particularly challenging. There are multiple factors that can increase the fraction of unbound tacrolimus, including but not limited to low albumin concentration and low red blood cell count. The clinical titration of dosage to maintain whole blood tacrolimus trough concentrations in the usual therapeutic range can lead to elevated unbound concentrations and possibly toxicity in pregnant women with anemia and hypoalbuminemia. Measurement of plasma or unbound tacrolimus concentrations for pregnant women might better reflect the active form of the drug, although these are technically challenging and often unavailable in usual clinical practice. Tacrolimus crosses the placenta with in utero exposure being approximately 71% of maternal blood concentrations. The lower fetal blood concentrations are likely due to active efflux transport of tacrolimus from the fetus toward the mother by placental P-glycoprotein. To date, tacrolimus has not been linked to congenital malformations but can cause reversible nephrotoxicity and hyperkalemia in the newborn. In contrast, very small amounts of tacrolimus are excreted in the breast milk and are unlikely to elicit adverse effects in the nursing infant.