The Medication Possession Ratio as a Predictor of Longitudinal HIV-1 Viral Suppression.

BACKGROUND: Antiretroviral adherence is essential to achieve viral suppression and limit HIV-related morbidity and mortality; however, antiretroviral adherence thresholds to achieve viral suppression in clinical practice have not been fully characterized using administrative claims data. OBJECTIVE: The purpose of this study was to assess the relationship between medication adherence and viral suppression among adult persons with HIV/AIDS (PWH) receiving antiretroviral therapy (ART) for ≥6 months. METHODS: This historical cohort, real-world investigation assessed maintenance of viral load suppression and viral load area-under-the-curve (vAUC) in PWH ≥18 years of age based on ART adherence. A marginal effects model was used to determine the predicted probabilities of final plasma HIV-1 RNA <50 copies/mL or vAUC <1,000 copy-days/mL according to the medication possession ratio (MPR), estimated using a Jackknife model variance estimator and a delta-method for marginal effects standard error. Tests for statistical significance used a Sidák method to correct for multiple comparisons. RESULTS: The mean MPR for ART was 86.7% (95% CI: 85.0%-88.4%) for the 372 PWH included in the study. The marginal effects analysis indicated that an MPR ≥82% was associated with a predicted probability of viral suppression <50 copies/mL (P < 0.05). Significant predicted probabilities for vAUC <1,000 copy-days/mL were observed with an MPR ≥90% (P < 0.05). CONCLUSION AND RELEVANCE: Medication possession ratio as a proxy for drug exposure was significantly and consistently associated with viral suppression using a longitudinal measure of HIV viremia. These findings can aid clinicians in the clinical management of PWH and inform future studies of adherence-viral suppression relationships with contemporary antiretroviral regimens.

Adherence, Persistence, Readmissions, and Costs in Medicaid Members with Schizophrenia or Schizoaffective Disorder Initiating Paliperidone Palmitate Versus Switching Oral Antipsychotics: A Real-World Retrospective Investigation.

INTRODUCTION: Long-acting injectable antipsychotic agents have been suggested to improve adherence and patient outcomes in schizophrenia or schizoaffective disorder. The purpose of this study was to assess medication use patterns (i.e., medication adherence, persistence), hospital and emergency department readmissions, and total direct medical costs of Oklahoma Medicaid members with schizophrenia or schizoaffective disorder switching from an oral antipsychotic (OAP) to once-monthly paliperidone palmitate (PP1M) or to another OAP (OAP-switch). METHODS: A historical cohort analysis was conducted from 1 January 2016 to 31 December 2020 among adults aged ≥ 18 and ≤ 64 years with schizophrenia or schizoaffective disorder who were previously treated with an OAP. The first claim for PP1M or a new OAP defined the study index date. Members who transitioned from PP1M to 3-month formulation (PP3M) were included (i.e., PP1M/PP3M). Proportion of days covered (PDC), 45-day treatment gaps, 30-day readmissions to hospitals or emergency department, and total direct medical costs were assessed using multivariable, machine-learning least absolute shrinkage, and selection operator (Lasso) regressions controlling for numerous demographic, clinical, mental health, and provider characteristics. RESULTS: Among 295 Medicaid members meeting full inclusion criteria, 183 involved PP1M/PP3Ms (44 PP1M cases transitioned to PP3M) and 112 involved an OAP-switch. The multivariable-adjusted odds of readmission were significantly associated with a 45-day treatment gap (p < 0.05) and non-adherence (i.e., PDC < 80%) (p < 0.05). Relative to PP1M/PP3Ms, the multivariable analyses also indicated that OAP-switch was associated with an 18.5% lower PDC, 92.3% higher number of 45-day treatment gaps, and an approximately 90% higher odds of all-cause 30-day readmission (p < 0.05). The adjusted pre- to post-index change in cost was approximately 49% lower for OAP-switches versus PP1M/PP3Ms (p < 0.001), although unadjusted post-index costs did not differ between groups (p = 0.440). CONCLUSION: This real-world investigation of adult Medicaid members with schizophrenia or schizoaffective disorder observed improved adherence and persistence with fewer readmissions with PP1M/PP3Ms versus OAP-switches.

Readmissions, costs, and duration to subsequent outpatient visit after hospital discharge among Medicaid beneficiaries utilizing oral versus long-acting injectable antipsychotics in bipolar disorder or schizophrenia.

BACKGROUND: Long-acting injectable antipsychotics (LAIs) may reduce hospitalizations versus oral formulations (OAP) in bipolar disorder (BP) and schizophrenia/schizoaffective disorder (SCZ), but the impact on time to outpatient follow-up is less understood. OBJECTIVES: To assess hospital readmissions and medical costs among Medicaid beneficiaries with BP or SCZ utilizing OAP or LAI SGAs. METHODS: Cross-sectional and longitudinal analyses utilized comprehensive administrative claims of Oklahoma Medicaid beneficiaries (≥18 years) with BP or SCZ between 1 January 2013 and 31 December 2017. Readmissions, total direct medical costs, and psychiatry-related outpatient visits were assessed via generalized linear models and generalized estimating equations, controlling for demographic and clinical covariates. RESULTS: Among 2523 included members, LAI utilization was associated with 1.50 and 1.73 times higher odds of any hospitalization and any readmission, respectively (p < .05). Cases involving both BP and SCZ were associated with a 2.40 times higher odds of any readmission, 2.26 times higher number of readmissions, and 24.5% higher costs (p < .001). Of the 468 members with a subsequent psychiatry-related outpatient visit, LAIs were associated with a 23.9% shorter duration to outpatient visit and 16.4% lower costs (p < .05). CONCLUSION: In contrast to prior studies, this real-world investigation noted higher hospitalizations and readmissions among LAIs relative to OAP medications, but among members with a hospitalization or ED visit, LAIs were associated with shorter durations to outpatient visits and lower costs. Those with diagnoses of both BP with SCZ had higher odds of any readmission, number of readmissions, and costs relative to those with bipolar disorder alone and may be a key target for interventions.

This study compared long-acting antipsychotics that were administered by injection (LAIs) to antipsychotic agents taken orally (OAPs) among Medicaid members with bipolar disorder and/or schizophrenia. Readmission to the emergency department (ED) or hospital (within 30 days of a previous visit) and costs were observed to be similar with LAIs relative to OAPs. Among members who went to the hospital, a shorter time to psychiatric follow-up outpatient visit and lower costs were observed among those taking LAIs relative to OAPs.

A National Assessment of Alzheimer Disease and Antipsychotic Medication Prescribing Among Older Adults in Ambulatory Care Settings.

OBJECTIVE: The objective of this study was to assess antipsychotic prescribing within ambulatory settings in the United States among older adults with Alzheimer disease after adjusting for demographic, provider, and clinical factors. METHODS: This cross-sectional cohort study utilized Centers for Disease Control's (CDC) National Ambulatory Medical Care Survey (NAMCS) ambulatory care data from 2014 to 2016 among visits 65 years old or older with any listed diagnosis of Alzheimer. Multivariable logistic regression analyses assessed the association between the outcome of antipsychotic prescribing after controlling for numerous demographic, provider, and clinical covariates. An extension of the Oacaxa-Blinder decomposition was used to assess observed differentials. RESULTS: An estimated 15,471,125 ambulatory visits involving Alzheimer disease among those 65 years old or older occurred from 2014 to 2016. Antipsychotics were prescribed in 9.3% of these visits, equating to 6.81 times higher multivariable-adjusted odds relative to non-Alzheimer visits (95% confidence interval: 2.86-16.20, P <0.001). The decomposition analysis indicated that the study's predictor variables explained 15.6% of the outcome gap between Alzheimer versus non-Alzheimer visits. CONCLUSIONS: Despite potential mortality risks with antipsychotics in adults 65 years old or older with Alzheimer disease and recommendations discouraging their use, this nationally representative study observed significantly higher odds of prescribing independent of demographic, provider, and clinical characteristics. Polypharmacy may be a risk factor that warrants continued assessment regarding the appropriateness of antipsychotic prescribing in this vulnerable population.

Clinical and economic outcomes associated with hospitalizations for acute idiopathic pericarditis in the United States.

BACKGROUND: Outcomes-based data regarding the management of hospitalized U.S. patients with acute idiopathic pericarditis (AIP) are lacking. OBJECTIVES: This study sought to elucidate the clinical and economic outcomes associated with the inpatient care of AIP. METHODS: Cohort study of adults with AIP; multivariable analyses of clinical and economic outcomes (inpatient mortality, surgical or medical complications, length of stay, and medical charges). RESULTS: Surgical or medical complications, pericardiocentesis, and pericardiotomy were each independently associated with a significantly higher odds of inpatient mortality (p<0.05). Pericardiocentesis, pericardiotomy, and pericardiectomy were also independently associated with significantly higher odds for complications (p<0.001) and, overall, surgical or medical complications were associated with longer lengths of stay and higher charges (p < 0.001). A higher odds of inpatient mortality was associated with micropolitan or rural patient residence, Medicaid payor, and African American race (p<0.05). CONCLUSIONS: U.S. inpatient cases of AIP are associated with significant use of healthcare resources, disparities, morbidity, and mortality.

Management of Acute Idiopathic (Viral) Pericarditis in the Emergency Department: A Review for the Nursing Professional.

Acute pericarditis is an inflammatory disorder that contributes to chest pain admissions in the emergency department (ED). Nursing professionals can play a vital role in the differential, triage and management of acute pericarditis in the ED. First-line pharmacotherapy to specifically treat acute pericarditis of viral or idiopathic origin is paramount in improving patients' quality of life and reducing the risk of further recurrences of pericarditis and consists of combination therapy with aspirin (acetylsalicylic acid [ASA]) or a nonsteroidal anti-inflammatory drug (NSAID), in combination with colchicine. Corticosteroids should not be initiated as first-line therapy in idiopathic (viral) pericarditis, as they increase the risk of recurrences. Nursing professionals are also pivotal in monitoring pharmacotherapy with respect to safety and efficacy. Overall, the nursing professional can facilitate timely administration and monitoring of medications, provide patient education, promote adherence, and assist in transitions of care for patients diagnosed with acute idiopathic (viral) pericarditis in the ED.

Prediction and Comparison of Fentanyl Infusion Pharmacokinetics in Obese and Nonobese Children.

OBJECTIVES: To compare fentanyl infusion pharmacokinetic variables in obese children and nonobese children. DESIGN: A pharmacokinetic simulation study. SETTING: We used a semi-physiologically based pharmacokinetic model to generate fentanyl pharmacokinetic variables. SUBJECTS: Simulations of pharmacokinetic variables were based on historical inpatient demographic data in less than 18-year-olds. INTERVENTIONS: Obese children were defined as children less than 2 years with weight-for-length greater than or equal to 97.7th percentile or body mass index-for-age greater than or equal to 95th percentile for greater than or equal to 2-17-year-olds. MEASUREMENTS AND MAIN RESULTS: Overall, 4,376 patients were included, with 807 (18.4%) classified as obese children. The majority (52.9%) were male, with a median age of 8.1 years (interquartile range, 4.3-13.0 yr). The differences in total clearance (CLS), volume of distribution at steady-state values, weight-normalized CLS, and weight-normalized volume of distribution at steady state were assessed in obese children and nonobese children. Multivariable analyses indicated that obesity was significantly associated with a higher CLS in obese children greater than 6-year-olds (p < 0.0375). However, there was an 11-30% decrease in weight-normalized CLS in obese children versus nonobese children in all age groups (p < 0.05). Both volume of distribution at steady state and weight-normalized volume of distribution at steady state increased significantly in obese children compared with nonobese children (p < 0.05). Fentanyl plasma concentration-time profiles of obese children and nonobese children pairs (ages 4, 9, and 15) receiving 1 µg/kg/hr using total body weight were also compared. Steady-state concentrations of the obese children using similar weight-based dosing increased by 25%, 77%, and 44% in comparison to nonobese children 4-, 9-, and 15-year-olds, respectively. Time to steady state and elimination half-lives were two- to four-fold longer in obese children. An additional simulation was conducted for 15-year-old obese children and nonobese children using a fixed dose of 50 µg/hr and it provided similar pharmacokinetic profiles. CONCLUSIONS: CLS may increase less than proportional to weight in obese children greater than 6-year-olds, while volume of distribution at steady state increases more than proportional to weight in all obese children compared with nonobese children. Weight-based dosing in obese children may cause an increase in steady-state concentration while prolonging the time to steady state. Exploring alternative dosing strategies for obese children is warranted.

Hepatitis C Direct-Acting Antiviral Treatment Selection, Treatment Failure, and Use of Drug-Drug Interactions in a State Medicaid Program.

BACKGROUND: Newer hepatitis C virus (HCV) treatments often provide high success rates with fewer adverse events, although the extent of all potential drug interactions is not fully known. OBJECTIVE: To assess outcomes of receiving HCV treatment and subsequent sustained virologic response (SVR) based on patient and clinical characteristics, including direct-acting antiviral (DAA) drug-drug interactions (DDIs), in Medicaid members with chronic HCV. METHODS: Comprehensive medical and pharmacy claims and prior authorization data were collected for HCV patients requesting treatment between January 2014 and June 2015. Outcomes of receiving treatment with DAAs and treatment failure based on SVR were analyzed according to demographics, prior/current HCV treatment, severity of DDIs, advancing liver disease, and comorbidities. Multivariable generalized linear models were employed, including a Bayesian sensitivity analysis. RESULTS: Among 3,412 Medicaid members with HCV, 13.6% received DAAs (n = 464), averaging 53.6 ± 10.0 years, with 52.8% female. Multivariable analyses indicated that higher odds of DAA treatment initiation were associated with older age, prior HCV treatment, and advancing liver disease. Some 4.8% of treatment failures occurred among 168 patients with reported SVRs, wherein a 3.218 times higher adjusted odds of treatment failure was associated with concomitant use of medications with DDIs classified as significant or potentially clinically significant by the University of Liverpool HEP Drug Interactions resource (P = 0.001). CONCLUSIONS: In a cohort of state Medicaid members with chronic HCV, a markedly higher adjusted odds of treatment failure was independently associated with DDIs classified as significant or potentially clinically significant, warranting continued inquiry and potential alternate treatments concerning conditions that require their use. DISCLOSURES: This research was funded by an unrestricted research grant by Gilead Sciences. During the course of this study, all authors were either employed by the Oklahoma HealthCare Authority or engaged in contractual work for this employer. Keast, Holderread, and Skrepnek report unrelated research grants from AbbVie, Otsuka, and Amgen. Keast and Skrepnek acknowledge funding from Purdue Pharma for an unrelated research fellowship grant. Posters based on this work were presented at HepDart 2015 on December 6-10, 2015, in Grand Wailea, HI, and at Academy of Managed Care Nexus 2015 on October 26-29, 2015, in Orlando, FL.

Low-dose versus high-dose methadone for the management of neonatal abstinence syndrome.

OBJECTIVES: The primary objective was to compare median time to symptom relief (time from methadone initiation until two consecutive modified Finnegan [neonatal abstinence syndrome, NAS] scores < 8) between neonates receiving low-dose (≤0.275 mg/kg/day) versus high-dose (>0.275 mg/kg/day) methadone. Secondary objectives included assessment of factors associated with symptom relief. DESIGN: Retrospective cross-sectional study. SETTING: Ninety-nine bed neonatal intensive care unit within a tertiary-care academic hospital. PARTICIPANTS: Seventy-two neonates who received methadone for NAS over a 7.5-year period. MAIN OUTCOME MEASURES(S): Kaplan-Meier curves with a log-rank test and a stepwise Cox proportional-hazard model were used to analyze outcomes. RESULTS: The median dose for the low-dose (n = 40) and high-dose (n = 32) groups were 0.19 mg/kg/day (interquartile range [IQR], 0.12-0.24) divided every 6-12 hours and 0.4 mg/kg/day (0.3-0.44) divided every 6-8 hours, respectively. The median time to symptom relief was higher in the low-dose versus high-dose groups, 9.3 (5.8-24.6) versus 6.0 (5.4-12.5) hours, respectively (p = 0.014). Low-dose males had a longer time to symptom resolution than other groups (p = 0.008). Female premature neonates (<37 weeks gestation) had a shorter time to symptom relief than term neonates [adjusted hazard ratio = 2.96 (1.02-8.62)]. The median total duration of methadone was shorter but not statistically significant between high- versus low-dose groups, 17.5 (IQR: 11.0-25.0) versus 21.0 days (IQR: 10.0-28.0), respectively (p = 0.483). CONCLUSIONS: Neonates receiving high-dose methadone had a significantly shorter time to symptom relief. Differences in sex were noted in response to therapy with low-dose males having a longer time to symptom relief and premature neonates a shorter time to symptom relief.

Clostridium difficile treatment in neutropenic patients: Clinical outcomes of metronidazole, vancomycin, combinations, and switch therapy.

BACKGROUND: Clostridium difficile infection treatment guidelines exist for immunocompetent patients; however, there is a paucity of data evaluating clinical outcomes and time to C. difficile-associated diarrhea resolution in neutropenic patients. OBJECTIVE: To assess clinical outcomes in neutropenic patients treated with metronidazole, oral vancomycin, the combination of metronidazole plus oral vancomycin, and switch of metronidazole to oral vancomycin. METHODS: This retrospective, observational cohort study assessed adult neutropenic inpatients with C. difficile-associated diarrhea treated with metronidazole, oral vancomycin, combination (metronidazole and oral vancomycin), or switch therapy (metronidazole to oral vancomycin). The primary outcome was time to diarrhea resolution based on treatment regimen. Secondary outcomes included C. difficile-associated diarrhea resolution of diarrhea by day 14, recurrence, and occurrence of major complications. RESULTS: Overall, 44 patients met full inclusion criteria (52.2% metronidazole monotherapy, 22.7% combination, and 25.0% switch therapy). Two patients on oral vancomycin monotherapy were excluded due to insufficient sample size. Overall time to C. difficile-associated diarrhea resolution was 9.1 ± 10.7 days. The Cox regression results suggested both switch and combination therapy were associated with 65.5% (p = 0.002) and 65.9% (p = 0.046) longer time to C. difficile-associated diarrhea resolution compared to metronidazole monotherapy, respectively. An increasing absolute neutrophil count was associated with an increase in C. difficile-associated diarrhea resolution (p = 0.007). CONCLUSION: Switch or combination therapy was associated with a prolonged time to C. difficile-associated diarrhea resolution. The decision to use switch or combination therapy may represent a surrogate marker for more severe disease and need for therapy escalation. It is unknown if initial therapy with oral vancomycin would provide better outcomes as this could not be assessed.

Optimal Medical Therapy Prescribing Patterns and Disparities Identified in Patients with Acute Coronary Syndromes at an Academic Medical Center in an Area with High Coronary Heart Disease-Related Mortality.

BACKGROUND: Coronary heart disease (CHD)-related mortality is high in the southern United States. A five-drug pharmacotherapy regimen for acute coronary syndromes (ACS), defined as optimal medical therapy (OMT), can decrease CHD-related mortality. Studies have indicated that OMT is prescribed 50-60% of the time. Assessment of prescribing could provide insight into the potential etiology of disparate mortality. OBJECTIVE: The aim was to evaluate prescribing of OMT at discharge in patients presenting with an ACS event at an academic medical center and identify patients at risk of not receiving OMT. METHODS: A single-center, retrospective cohort of patients with ACS diagnosis between July 2013 and July 2015 was investigated, and a multivariable regression analysis conducted to identify populations at risk of not receiving OMT. RESULTS: A total of 864 patients were identified by International Classification of Diseases, Ninth Revision (ICD-9) codes, with 533 excluded and 331 analyzed. OMT was prescribed in 69.79%. Patients ≥ 75 years of age [p = 0.003; odds ratio (OR) 0.30; 95% confidence interval (CI) 0.136-0.673], unstable angina presentation (p = 0.042; OR 0.55; 95% CI 0.307-0.977), and surgical management (p = 0.001; OR 0.22; 95% CI 0.095-0.519) were less likely to receive OMT. CONCLUSIONS: The percentage of patients prescribed OMT exceeded the reported global percentage of prescribed OMT. However, disparities exist among specific populations.

Clinical outcomes of fidaxomicin vs oral vancomycin in recurrent Clostridium difficile infection.

WHAT IS KNOWN AND OBJECTIVE: Recurrent Clostridium difficile infection (CDI) occurs after initial treatment in approximately 20%-30% of patients, regardless of therapy chosen. The objective of this study was to assess clinical outcomes of recurrent CDI treated with fidaxomicin or oral vancomycin. METHODS: This study was a retrospective, propensity score-matched nationwide analysis of adult patients with first or second CDI recurrence prescribed fidaxomicin or oral vancomycin from any Veterans Affairs Medical Center between June 2011 and December 2015. The primary outcome was evidence of clinical failure or 90-day recurrence. RESULTS AND DISCUSSION: Univariate variables associated with failure or recurrence were identified among 65 fidaxomicin-treated episodes and 1065 vancomycin-treated episodes and placed into a multivariable logistic regression model. Propensity scores were calculated from this model; 195 vancomycin-treated episodes were matched by the next-nearest propensity score to 65 fidaxomicin-treated episodes. CDI failure or recurrence was similar between the two groups (18 of 65 [27.7%] fidaxomicin-treated episodes vs 42 of 195 [21.5%] vancomycin-treated episodes [P = 0.31]). Multivariate analysis demonstrated only baseline second recurrence episode, not choice of drug, as independently associated with failure or recurrence. WHAT IS NEW AND CONCLUSION: There was no difference in the combined outcome of clinical failure or 90-day recurrence between fidaxomicin and oral vancomycin in the treatment of first or second recurrent CDI.

Career Skills Assessment in a Doctor of Pharmacy Curriculum.

Objective. To assess students' knowledge of, perceived importance of, and confidence in six career skills areas (curriculum vitae/resume writing, interviewing skills/business attire, phone interviews, thank you notes, business/dining etiquette, and networking) before, immediately after, and six months after participating in a career skills workshop. Methods. All students in a senior-level seminar course participated in the same simulation/performance-based workshop that was coupled with verbal or rubric-based feedback for each of the areas. Results. Ninety-one students participated in the study and all students' knowledge significantly increased over the study as determined by study baseline, conclusion, and six-month follow-up assessments. At study follow-up, knowledge increased an average of +7.1 percentage points from baseline. Multivariate analysis indicated significant increases in confidence from baseline to follow-up ranging from +0.15 to +0.29 across the six workshop areas, with resume/CV preparation having the highest increase. From study onset to follow-up, students perceived that the six career skills areas were above the average importance midpoint (3.0). Conclusion. The workshop was effective in increasing students' knowledge and confidence of essential career skills vital to pursuing post-graduate employment. These career skills are important for helping students distinguish themselves in a competitive job market.

Assessment of the effect of an enhanced prior authorization and management program in a United States Medicaid program on chronic hepatitis C treatment adherence and cost.

OBJECTIVES: The market for chronic hepatitis C (HCV) treatment has changed rapidly. New treatments offer high cure rates, fewer adverse effects, and shorter treatments-but also increased costs per therapy. The objective of this study was to compare adherence and cost between HCV patients included in an enhanced prior authorization and management program (PAMP) versus no intervention in Medicaid members undergoing treatment. DESIGN: A retrospective study using longitudinal panel data assessed differences in adherence and costs associated with implementation of the PAMP from the payer perspective. The PAMP included case management, patient education, pharmacy counseling, and medication adherence. Multivariable generalized estimating equations were used to assess associations between program and outcomes. SETTING AND PARTICIPANTS: Patients with HCV enrolled in a state Medicaid program receiving or requesting HCV treatment from January 2014 to November 2015. OUTCOME MEASURES: Outcomes included medication adherence, treatment gaps, and pharmacy and total direct costs after controlling for demographic and clinical factors between those in the PAMP and those in the preintervention period. RESULTS: There were 384 Medicaid members included (156 pre-PAMP, 228 post-PAMP). Overall adherence was high regardless of PAMP intervention, although an adjusted 1.086-fold increase in medication possession ratio (MPR) was observed with the program and a 2.732-fold higher odds of adherence above 80% (P < 0.05). Members in the program had 0.358 times lower adjusted odds of a greater than 3-day treatment gap, and pharmacy-related costs were 0.940 times lower (P < 0.05); no difference was observed in total medical costs (P = 0.333). CONCLUSION: This enhanced Medicaid program was associated with increased adherence to HCV therapy, decreased treatment gaps, and decreased pharmacy-related costs compared with the preintervention period. Because challenges exist if patients fail HCV treatment or if viral resistance emerges, ensuring high adherence and persistence remains key. Continued work is needed to develop and assess enhanced management programs for this population.

Overview of Prescription Opioid Deaths in the Oklahoma State Medicaid Population, 2012-2016.

BACKGROUND: Medicaid members are predisposed to unintentional prescription opioid overdose. However, little is known about their individual risk factors. OBJECTIVES: To describe demographic and clinical characteristics, medical utilization, opioid use, concurrent use of benzodiazepines, risk factors, and substances involved in death for Oklahoma's Medicaid members who died of unintentional prescription opioid poisoning. SUBJECTS: Decedents who were Medicaid eligible in Oklahoma during the year of death, had an opioid recorded in cause of death, and had ≥1 opioid prescription claim between January 1, 2011 and June 30, 2016 were cases. Controls were living Medicaid members and were matched 3:1 to cases through propensity score matching. MEASURES: Demographics, clinical characteristics, and medical/pharmacy utilization were examined in the 12 months before the index date. RESULTS: Of 639 members with fatal unintentional prescription opioid overdoses, 321 had ≥1 opioid prescription claim in the year before death; these were matched to 963 controls. Compared with controls, decedents had significantly greater proportions of nonopioid substance use disorders, opioid abuse/dependence, hepatitis, gastrointestinal bleeding, trauma not involving motor vehicle accidents, nonopioid poisonings, and mental illness disorders. Decedents had significantly higher daily morphine milligram equivalent doses (67.2±74.4 vs. 47.2±50.9 mg) and greater opioid/benzodiazepine overlap (70.4% vs. 35.9%). Benzodiazepines were involved in 29.3% of deaths. CONCLUSIONS: Several comorbidities indicative of opioid use disorder and greater exposure to opioids and concomitant benzodiazepines were associated with unintentional prescription opioid overdose fatalities. Prescribers and state agencies should be aware of these addressable patient-level factors among the Medicaid population. Targeting these factors with appropriate policy interventions and education may prevent future deaths.

Death or Debt? National Estimates of Financial Toxicity in Persons with Newly-Diagnosed Cancer.

PURPOSE: The purpose of this study was to evaluate the impact of cancer upon a patient's net worth and debt in the US. METHODS: This longitudinal study used the Health and Retirement Study from 1998-2014. Persons ≥50years with newly-diagnosed malignancies were included, excluding minor skin cancers. Multivariable generalized linear models assessed changes in net worth and debt (consumer, mortgage, home equity) at 2 and 4 years after diagnosis (year+2, year+4), controlling for demographic and clinically-related variables, cancer-specific attributes, economic factors, and mortality. A 2-year period before cancer diagnosis served as a historical control. RESULTS: Across 9.5 million estimated new diagnoses of cancer from 2000-2012, individuals averaged 68.6±9.4 years with slight majorities being married (54.7%), not retired (51.1%), and Medicare beneficiaries (56.6%). At year+2, 42.4% depleted their entire life's assets, with higher adjusted odds associated with worsening cancer, requirement of continued treatment, demographic and socioeconomic factors (ie, female, Medicaid, uninsured, retired, increasing age, income, and household size), and clinical characteristics (ie, current smoker, worse self-reported health, hypertension, diabetes, lung disease) (P<.05); average losses were $92,098. At year+4, financial insolvency extended to 38.2%, with several consistent socioeconomic, cancer-related, and clinical characteristics remaining significant predictors of complete asset depletion. CONCLUSIONS: This nationally-representative investigation of an initially-estimated 9.5 million newly-diagnosed persons with cancer who were ≥50 years of age found a substantial proportion incurring financial toxicity. As large financial burdens have been found to adversely affect access to care and outcomes among cancer patients, the active development of approaches to mitigate these effects among already vulnerable groups remains of key importance.

Sustained Virologic Response and Costs Associated with Direct-Acting Antivirals for Chronic Hepatitis C Infection in Oklahoma Medicaid.

BACKGROUND: Outcomes involving newer direct-acting antiviral (DAA) hepatitis C virus (HCV) regimens have not been studied extensively among the Medicaid population. OBJECTIVE: To assess clinical (treatment failure) and economic outcomes for chronic HCV-infected Oklahoma Medicaid members following treatment with DAAs and to measure associations with patient, treatment, and clinical characteristics. METHODS: This cross-sectional study used Oklahoma Medicaid pharmacy and medical claims data for adult members who used a newer DAA agent and had reported a successful or failed sustained virological response rate 12 weeks after therapy completion (SVR12) from January 1, 2014, to June 30, 2016. Multivariable logistic and gamma regressions assessed predictors of SVR12 failure and costs controlling for member demographics (i.e., age, sex, race, rural residence); type of DAA and adherence; clinical characteristics (e.g., comorbid conditions, advanced liver disease); and the implementation of changes to a prior authorization program. RESULTS: Of 934 Medicaid members eligible for treatment with DAAs between January 1, 2014, and June 30, 2016, 906 received DAA treatment, 40.6% (368/906) had reported SVR12 outcomes, and 59.4% (n = 538) did not have a reported SVR recorded. Of those with reported SVR12 outcomes, patients were 53.1 ± 9.7 years of age, 51.1% were male, 8.4% had SVR12 failure, and each member had mean costs of $140,283 ± $52,779. Multivariable analyses indicated higher odds of SVR12 failure was independently associated with cirrhosis (OR [decompensated] = 6.69 and OR [compensated] = 3.52, P < 0.001), while males had higher odds of failure than females (OR = 3.34, P < 0.010). No significant difference in SVR12 failure was noted, according to DAA type or a medication adherence threshold of > 95%. Ledipasvir/sofosbuvir was independently associated with lower costs (exp[b] = 0.81; P < 0.001) compared with sofosbuvir, while higher costs were associated with decompensated cirrhosis (exp[b] = 1.22; P < 0.001) and treatment failure (exp[b] = 1.18, P < 0.010). In an analysis including members without reported SVR12 outcomes, decompensated and compensated cirrhosis had lower odds (P < 0.001) of no reported SVR12 from ambulatory clinic settings. CONCLUSIONS: Almost 60% of Medicaid members receiving DAA treatment did not have a final reported SVR12 outcome. Among those with viral load measurements, treatment success was high and both decompensated and compensated cirrhosis were independently associated with significantly higher odds of treatment failure. Addressing a loss to follow-up among HCV patients and curtailing the development of cirrhosis to improve treatment success may warrant interventions that improve access to care and remove barriers that impede treatment initiation and completion. DISCLOSURES: No outside funding supported this study. Pham, Keast, Holderread, Nesser, and Skrepnek disclose either employment by the Oklahoma Health Care Authority or contractual work for this employer. Pham discloses fellowship funding from Purdue Pharma unrelated to this study. Keast and Skrepnek disclose research grant funding from Gilead Sciences and Abbvie. Holderread also reports grant funding from Gilead Sciences and fees from PRIME Education. Thompson, Farmer, and Rathbun have nothing to disclose.

A Propensity-Matched Analysis Between Standard Versus Tapered Oral Vancomycin Courses for the Management of Recurrent Clostridium difficile Infection.

BACKGROUND: This study was conducted to compare clinical outcomes of oral vancomycin courses without taper versus oral vancomycin courses with taper for treatment of recurrent Clostridium difficile infection (CDI). METHODS: This investigation was a multicenter, retrospective, propensity score-matched analysis study using a Veterans Health Administration national clinical administrative database. Adult patients who were treated for recurrent CDI from any Veterans Affairs Medical Center between June 1, 2011 and October 31, 2016 were included if they were treated with oral vancomycin with or without a tapering regimen. The 2 groups were matched by next-nearest approach from a propensity score formula derived from independent variables associated with the selection of a taper regimen. RESULTS: Propensity score matching resulted in 2 well-matched groups consisting of 226 episodes of patients treated with a vancomycin taper regimen and 678 episodes treated by vancomycin regimen without taper. No difference was found for the primary outcome of 180-day recurrence (59 of 226 [26.1%] for taper regimens versus 161 of 678 [23.8%], P = .48). A secondary outcome of 90-day all-cause mortality met statistical significance, favoring a taper regimen (5.31% vs 9.29%, P = .049); however, secondary outcomes of 90-day recurrence and 180-day all-cause mortality were not different. CONCLUSIONS: Vancomycin taper regimens did not provide benefit over vancomycin regimens without taper in preventing additional CDI recurrence in patients with first or second recurrent episodes in this propensity score-matched analysis.

Detectable Concentrations of Inhaled Tobramycin in Critically Ill Children Without Cystic Fibrosis: Should Routine Monitoring Be Recommended?

OBJECTIVES: To determine the percentage of detectable tobramycin troughs and acute kidney injury in critically ill children without cystic fibrosis on inhaled therapy. DESIGN: Historic cohort. SETTING: Academic hospital. PATIENTS: Forty children less than 18 years receiving inhaled tobramycin across 6.5 years. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The primary objective was to determine the percentage of detectable tobramycin troughs greater than or equal to 0.5 µg/mL. Secondary objectives included a comparison of acute kidney injury in children with and without detectable troughs. Twenty-two (55%) had trough concentrations obtained. Ten of these (45.5%) had detectable concentrations, with a median of 0.85 µg/mL (interquartile range, 0.5-2.0). There was no statistical significance between the detectable and nondetectable groups in age, gender, and method of administration. However, patients in the detectable group tended to be younger than nondetectable group and more likely to have a tracheotomy. There was a clinically significant decrease in estimated glomerular filtration rate in the detectable trough group. CONCLUSIONS: Detectable troughs were noted in almost half of patients with concentrations obtained. A clinically significant decrease in estimated glomerular filtration rate was noted in patients with detectable concentrations. Continued work should be directed to better understand outcomes and monitoring in children requiring inhaled tobramycin.