Institution of Just Culture Physician Peer Review in an Academic Medical Center.

OBJECTIVES: For academic medical centers to improve quality outcomes, identification and optimization of opportunities for improvement are necessary. Effective clinical peer review frequently has limitations on timeliness, transparency, and consideration of system processes related to untoward clinical outcomes. We developed a process to overcome these barriers and capture opportunities for process improvement identified within the clinical peer review system. METHODS: A multidisciplinary committee was formed to evaluate the current process of physician peer review at Magee Womens Hospital of the University of Pittsburgh Medical Center. Evaluation of current peer review triggers, processes, communication, transparency, and actionable outcomes was performed. A new approach was established that incorporated a protected electronic portal to improve communication and provider engagement, as well as initiation of a Just Culture peer review algorithm to realize opportunities for system improvements. RESULTS: The new process has been operative for 2 years. After initiation, the average time necessary for full case review decreased by 66% (6-2 months). Provider engagement and input have increased to 71%, from less than 10% before implementation. Most cases (51%) were identified as having more than one causative factor, with systems issues being the most frequent contributor to untoward outcomes. CONCLUSIONS: Given the recognized benefits, this approach is being considered for implementation on a broader scale within service-line quality initiatives across the University of Pittsburgh Medical Center health system. Although first implemented among faculty, consideration of incorporation into graduate medical education programs is ongoing.

The Pregnancy Recovery Center: A women-centered treatment program for pregnant and postpartum women with opioid use disorder.

OBJECTIVE: To evaluate the impact of women-centered substance abuse treatment programming on outcomes among pregnant women with opioid use disorder (OUD). METHODS: We compared two retrospective cohorts of pregnant women with OUD on buprenorphine maintenance therapy who delivered an infant at the University of Pittsburgh from 2014 to 2016. Cohort 1 was composed of pregnant women who received women-centered OUD treatment services through the Pregnancy Recovery Program (PRC) and Cohort 2 was composed of pregnant women who received buprenorphine at OUD programs without women-centered services (non-PRC). Women-centered outcomes were defined as a) pregnancy-specific buprenorphine dosing, b) prenatal and postpartum care attendance, c) breastfeeding and d) highly effective contraception utilization. Chi-square and t-tests were used to compare outcomes between PRC and non-PRC patients. RESULTS: Among 248 pregnant women with OUD, 71 (28.6%) were PRC and 177 (71.4%) were non-PRC patients. PRC patients were significantly more likely to initiate buprenorphine during vs. prior to their pregnancy (81.4% vs. 44.2%; p < .01) and have a higher buprenorphine dose at the time of delivery (16.0 mg vs. 14.1 mg; p = .02) compared to non-PRC patients. Likewise, PRC patients were significantly more likely to attend their postpartum visit (67.9% vs. 52.6%; p = .05) and receive a long-acting reversible contraceptive (LARC) method (23.9% vs. 13.0%, p = .03) after delivery compared to non-PRC patients. Finally, PRC patients had a smaller percent decrease in the rate of breastfeeding during their delivery hospitalization (-14.7% vs. -37.1%). CONCLUSIONS: Incorporating women-centered services into OUD treatment programming may improve gender-specific outcomes among women with OUD.

An evidence-based recommendation to increase the dosing frequency of buprenorphine during pregnancy.

BACKGROUND: Dose-adjusted plasma concentrations of buprenorphine are significantly decreased during pregnancy compared with the nonpregnant state. This observation suggests that pregnant women may need a higher dose of buprenorphine than nonpregnant individuals to maintain similar drug exposure (plasma concentrations over time after a dose). The current dosing recommendations for buprenorphine during pregnancy address the total daily dose of buprenorphine to be administered, but the frequency of dosing is not clearly addressed. Based on buprenorphine's long terminal half-life, once-daily or twice-daily dosing has generally been suggested. OBJECTIVE: The objective of the study was to assess the impact of dosing frequency on buprenorphine plasma concentration time course during pregnancy. STUDY DESIGN: We utilized 3 data sources to determine an optimal frequency for dosing of buprenorphine during pregnancy: data from a pharmacokinetic study of 14 pregnant and postpartum women on maintenance buprenorphine in a supervised clinical setting; data from pregnant women attending a buprenorphine clinic; and data from a physiologically based pharmacokinetic modeling of buprenorphine pharmacokinetics in nonpregnant subjects. RESULTS: Among the 14 women participating in the pharmacokinetic study during and after pregnancy, plasma concentrations of buprenorphine were <1 ng/mL (the theoretical concentration required to prevent withdrawal symptoms) for 50-80% of the 12 hour dosing interval while at steady state. Among 62 women followed up in a opioid agonist treatment program, in which dosing frequency is determined in part by patient preference, 10 (16%) were on once-daily dosing, 10 (16%) were on twice-daily dosing, 28 (45%) were on thrice-daily dosing, and 14 (23%) were on four-times-daily dosing. A physiologically based pharmacokinetic model in nonpregnant subjects demonstrated that dosing frequency has an impact on the duration over which the plasma concentrations are below a specified plasma concentration threshold. CONCLUSION: A more frequent dosing interval (ie, three-times-daily or four-times-daily dosing) may be required in pregnant women to sustain plasma concentrations above the threshold of 1 ng/mL to prevent withdrawal symptoms and to improve adherence.

Dose-adjusted plasma concentrations of sublingual buprenorphine are lower during than after pregnancy.

BACKGROUND: Buprenorphine is a Food and Drug Administration-approved maintenance therapy for opioid use disorders and is increasingly being used in pregnant women with opioid use disorders as an alternative to methadone. Dosing of buprenorphine in pregnant women is based on the regimen recommended for nonpregnant females and males. Limited data are available defining the pharmacokinetic properties of sublingual buprenorphine administered during pregnancy. OBJECTIVE: This study evaluated the impact of physiological changes associated with pregnancy on the pharmacokinetics of sublingual buprenorphine during and after pregnancy. STUDY DESIGN: Pregnant women (n = 13), between 180/7 and 376/7 weeks' singleton gestation, receiving sublingual buprenorphine twice daily for opioid use disorders were studied. Pharmacokinetic-2 studies were performed between 18 and 25 weeks (n = 7), pharmacokinetic-3 studies were performed between 31 and 37 weeks (n = 11), and pharmacokinetic-P was performed 4-18 weeks postpartum (n = 10). On the day of the study, blood was withdrawn prior to the daily morning dose of buprenorphine and at 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, and 12 hours after the dose. Buprenorphine plasma concentrations were analyzed by liquid chromatography tandem mass spectrometric detection. All pharmacokinetic parameters were observed or estimated using Microsoft Excel. Statistical analyses were performed to identify significant changes in study participants' buprenorphine pharmacokinetic parameter estimates over the duration of the study. Univariate linear and generalized linear mixed models were used to investigate changes in these measures over time, some of which were log transformed for normality. RESULTS: Dose-normalized (plasma concentration per dose) buprenorphine plasma concentrations were significantly lower during pregnancy (pharmacokinetic-2 plus pharmacokinetic-3) than during the postpartum period (pharmacokinetic-P). Specific pharmacokinetic parameters (and level of significance) were as follows: the area under the buprenorphine plasma concentration-time curves (P < .003), maximum buprenorphine concentrations (P < .018), buprenorphine concentrations at 0 hour (P < .002), and buprenorphine concentrations at 12 hours (P < .001). None of these parameters differed significantly during pregnancy (ie, pharmacokinetic-2 vs pharmacokinetic-3). The time to maximum buprenorphine concentrations did not differ significantly between groups. CONCLUSION: The dose-normalized plasma concentrations during a dosing interval and the overall exposure of buprenorphine (area under the buprenorphine plasma concentration-time curves) are lower throughout pregnancy compared with the postpartum period. This indicates an increase in apparent clearance of buprenorphine during pregnancy. These data suggest that pregnant women may need a higher dose of sublingual buprenorphine compared with postpartum individuals. The dose of buprenorphine should be assessed after delivery to maintain similar buprenorphine exposure during the postpartum period.

Clinical review: Considerations for the triage of maternity care during an influenza pandemic--one institution's approach.

The ongoing pandemic of 2009 H1N1 swine-origin influenza A has heightened the world's attention to the reality of influenza pandemics and their unpredictable nature. Currently, the 2009 H1N1 influenza strain appears to cause mild clinical disease for the majority of those infected. However, the risk of severe disease from this strain or other future strains remains an ongoing concern and is noted in specific patient populations. Pregnant women represent a unique patient population that historically has been disproportionately affected by both seasonal and pandemic influenza outbreaks. Data thus far suggest that the current 2009 H1N1 outbreak is following this same epidemiologic tendency among pregnant women. The increased predilection to worse clinical outcomes among pregnant women has potential to produce an acute demand for critical care resources that may overwhelm supply in facilities providing maternity care. The ability of healthcare systems to optimize maternal-child health outcomes during an influenza pandemic or other biologic disaster may therefore depend on the equitable allocation of these limited resources. Triage algorithms for resource allocation have been delineated in the general medical population. However, no current guidance considers the unique aspects of pregnant women and their unborn fetuses. An approach is suggested that may help guide facilities faced with these challenges.

Labor induction process improvement: a patient quality-of-care initiative.

OBJECTIVE: To examine the effects that medical staff education and a new process for scheduling inductions had on decreasing inappropriate inductions. METHODS: At our institution in 2004, guidelines were developed and shared with the medical staff and reinforced in 2005. The guidelines for elective induction required patients to have completed 39 weeks of gestation and to have a Bishop score of at least 8 for nulliparas and 6 for multiparas. In 2006, the induction scheduling process was changed and the guidelines were strictly enforced. All scheduled inductions during the same 3-month time period (June through August) in 2004 (n=533) and 2005 (n=454) and during a 13-month period from November 2006 to December 2007 (n=1,806) were compared. Outcomes included elective inductions less than 39 weeks, cesarean birth rate for elective inductions among nulliparas, and the overall induction rate. RESULTS: From 2004-2007, the overall induction rate dropped from 24.9% to 16.6%, a 33% reduction(P<.001); the elective induction rate dropped from 9.1% to 6.4%, a 30% reduction (P<.001); the percentage of elective inductions before 39 weeks of gestation dropped from 11.8% to 4.3%, a decrease of 64% (P<.001); and the frequency of cesarean delivery among nulliparas undergoing elective induction dropped from 34.5% to 13.8%, a decrease of 60%. (P=.01). CONCLUSION: Medical staff education and the development and enforcement of induction guidelines contributed to a decrease in inappropriate inductions, a lower cesarean birth rate for electively induced nulliparas, and a lower elective and overall induction rate. LEVEL OF EVIDENCE: III.