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Purpose Research pharmacy effort required to safely and compliantly manage investigational products (IP) varies between studies. No validated tool exists in the United States to evaluate these differences in effort. The Vizient Pharmacy Research Committee Investigational Drug Services (IDS) Subcommittee previously developed a systematic complexity scoring tool (CST) through expert consensus to assign a complexity score for pharmacy effort. This project seeks to develop and validate complexity categories based on CST scores. Methods Vizient member institutions in IDS assigned a CST complexity score and a perceived complexity category (low, medium, or high) for study initiation and maintenance. Receiver operating characteristic (ROC) curve analysis defined the best CST score cutoff points for each complexity category. Comparing the CST-assigned to the user-perceived complexity category determined whether the CST-assigned complexity category aligned with practitioner assignment. Results A total of 322 responses were used to determine complexity score categories. The AUC values for study initiation and maintenance were 0.79 (P < 0.001) for the low/medium boundary and 0.80 (P < 0.001) for the medium/high boundary, suggesting the performance of the CST is good. The agreement between CST-assigned and user-perceived complexity categories was 60% for study initiation and 58% for maintenance. The Kendall rank correlation coefficient between the raters and ROC categories was strong, with a value of 0.48 for study initiation and 0.47 for maintenance. Conclusion Development of the CST allows IDS pharmacies to objectively measure the complexity of clinical trials, which is a significant step towards assessing workload and guiding resource allocation. [ABSTRACT FROM AUTHOR]

Background: Given the relatively high rates of suicidal ideation and attempt among people with chronic pain, there is a need to understand the underlying factors to target suicide prevention efforts. To date, no study has examined the association between pain phenotypes and suicide related behaviors among those with mild traumatic brain injuries. Objective: To determine if pain phenotypes were independently associated with suicidal ideation / attempt or if comorbidities within the pain phenotypes account for the association between pain phenotypes and suicide related behaviors. Methods: This is a longitudinal retrospective cohort study of suicide ideation/attempts among pain phenotypes previously derived using general mixture latent variable models of the joint distribution of repeated measures of pain scores and pain medications/treatment. We used national VA inpatient, outpatient, and pharmacy data files for Post-9/11 Veterans with mild traumatic injury who entered VA care between fiscal years (FY) 2007 and 2009. We considered a counterfactual causal modeling framework to assess the extent that the pain phenotypes during years 1–5 of VA care were predictive of suicide ideation/attempt during years 6–8 of VA care conditioned on covariates being balanced between pain phenotypes. Results: Without adjustment, pain phenotypes were significant predictors of suicide related behaviors. When we used propensity scores to balance the comorbidities present in the pain phenotypes, the pain phenotypes were no longer significantly associated with suicide related behaviors. Conclusion: These findings suggest that suicide ideation/attempt is associated with pain trajectories primarily through latent multimorbidity. Therefore, it is critical to identify and manage comorbidities (e.g., depression, post-traumatic stress disorder) to prevent tragic outcomes associated with suicide related behaviors throughout the course of chronic pain and mild traumatic brain injury management. [ABSTRACT FROM AUTHOR]

Background: Although concern exists regarding the adverse effects and rate of zolpidem use, especially long-term use, limited information is available concerning patterns of zolpidem use. Objective: To examine the prevalence and correlates of zolpidem exposure in Iraq and Afghanistan Veterans (IAVs). Methods: A retrospective cohort study of zolpidem prescriptions was performed with National Veterans Health Administration (VHA) data. We gathered national VA inpatient, outpatient, and pharmacy data files for IAV’s who received VA care between fiscal years (FY) 2013 and 2014. The VA pharmacy database was used to identify the prevalence of long term (>30 days), high-dose zolpidem exposure (>10mg immediate-release; >12.5mg extended-release) and other medications received in FY14. Baseline characteristics (demographics, diagnoses) were identified in FY13. Bivariate and multivariable analyses were used to examine the demographic, clinical, and medication correlates of zolpidem use. Results: Of 493,683 IAVs who received VHA care in FY 2013 and 2014, 7.6% (n = 37,422) were prescribed zolpidem in FY 2014. Women had lower odds of high-dose zolpidem exposure than men. The majority (77.3%) of IAVs who received zolpidem prescriptions had long-term use with an average days’ supply of 189.3 days and a minority (0.9%) had high-dose exposure. In multivariable analyses, factors associated with long-term zolpidem exposure included age greater than 29 years old, PTSD, insomnia, Selim Index, physical 2–3 conditions, opioids, antidepressants, benzodiazepines, atypical antipsychotics, and stimulants. High dose exposure was associated with PTSD, depression, substance use disorder, insomnia, benzodiazepines, atypical antipsychotics, and stimulant prescriptions. Conclusion: The current practices of insomnia pharmacotherapy in IAVs fall short of the clinical guidelines and may reflect high-risk zolpidem prescribing practices that put Iraq and Afghanistan Veterans at risk for adverse effects of zolpidem and poor health outcomes. [ABSTRACT FROM AUTHOR]

Study Objective To evaluate the effect of therapeutic doses of intravenous acetaminophen (IV APAP) on postoperative opioid use following bariatric surgery. Design Retrospective review of medical records. Setting A 654-bed academic hospital. Patients Records for 104 patients who underwent laparoscopic sleeve gastrectomy ( LSG; 44 patients) or laparoscopic Roux-en-Y gastric bypass ( LRYGB; 60 patients) were reviewed. Patients received IV APAP 1 g every 6 hours postoperatively (22 LSG patients and 30 LRYGB patients) or no IV APAP (22 LSG patients and 30 LRYGB patients). Measurements and Main Results Baseline demographic features were similar for both groups. Patients receiving IV APAP required fewer intravenous morphine equivalents than patients treated with opioids alone. Reductions in morphine equivalents with IV APAP were 21 mg ( LSG), 33 mg ( LRYGB), and 28 mg (all patients) (p<0.001 for all comparisons). IV APAP was associated with a shorter hospital length of stay (LOS) for the LRYGB (mean difference 1.47 days; p =0.039) and combined groups (mean difference 0.95 days; p =0.025). Patients who received IV APAP had earlier return of bowel sounds and flatus. IV APAP did not reduce mean pain scores in any group. Conclusion Patients undergoing bariatric surgery who received IV APAP during the 24-hour postoperative period consumed fewer intravenous morphine equivalents and had similar pain scores as patients who were treated with opioids alone. Use of IV APAP reduced the hospital LOS and resulted in earlier return of bowel sounds and passage of flatus. [ABSTRACT FROM AUTHOR]