Engagement in Prescription Opioid Tapering Research: the EMPOWER Study and a Coproduction Model of Success.

Patients with chronic pain experience stigma within the healthcare system. This stigma is compounded for those taking long-term prescription opioids. Often, public messaging and organizational policies have telegraphed that opioid treatment is a problem to be solved by focusing only on medication reduction efforts. Lack of data has contributed to misperceptions and poor opioid policies. In part, data collection remains poor because patients feel fractured from systems of care and are often not interested in engaging with opioid reduction mandates and research. Similarly, clinicians may fail to engage with opioid stewardship and research due to complexities that exceed their training or capacities. The EMPOWER study applies a coproduction model that engages researchers, patients, clinicians, managers, and other health system users. Key stakeholders shaped the design of the study to best ensure acceptability and engagement of the "end users"-patients who enroll in the study and the clinicians who implement the opioid tapers. Targeting the needs of any stakeholder group in isolation is suboptimal. Accordingly, we detail the EMPOWER patient-centered opioid tapering clinical research framework and specific strategies to address stakeholder concerns. We also discuss how this framework may be applied to enhance engagement in healthcare research broadly.

Descriptive Analysis of Patient Readmissions Within 60 Days Due to Medication-Related Events.

BACKGROUND: Hospital readmissions have become a marker for quality health care. Readmissions secondary to failures of the medication use process are poorly documented and underrecognized. OBJECTIVE: To identify the incidence of readmissions related to the medication use process and identify associated patient- and therapy-related risk factors. METHODS: A prospective observational cohort study including patients discharged from an acute care medicine unit and readmitted within 60 days. The primary outcome was percentage of readmissions related to drug-related problems (DRPs) as defined by Pharmaceutical Care Network Europe (PCNE). Secondary outcomes included classification of problems using PCNE criteria, type and extent of pharmacist involvement in patient care, and identification of variables associated with a readmission related to a DRP. RESULTS: One hundred patients provided informed consent and were included for analysis. A DRP associated with readmission was identified in 64 patients. Sixty-one percent were classified as a potential problem with effect or lack of effect of pharmacotherapy. Patients who had a pharmacy consult were less likely to have a DRP (27% vs 47%; P = .04), and patients who missed follow-up appointments were more than 3 times as likely to have a DRP (20% vs 4%; P = .03). Presence of a pharmacy consult (odds ratio [OR], 0.38; 95% CI, 0.15-0.99; P = .05) and missed follow-up appointments (OR, 5.63; 95% CI, 1.52-20.86; P = .01) remained significant in a multivariate regression model. CONCLUSION: DRPs were frequent in patients who were readmitted within 60 days. Clinical pharmacist involvement in care and support for appropriate patient follow-up may reduce unnecessary admissions.

Impact of Glucagon-Like Peptide 1 Receptor Agonists in Patients with Hemoglobin A1c of 9% or Greater.

Background: Glucagon-like peptide-1 receptor agonists (GLP-1 agonists) are effective hemoglobin A1c (HbA1c) and weight-lowering agents. The treatment effect is unknown in patients with HbA1c of 9% or greater. Objective: The purpose of this study was to evaluate glycemic control and weight loss after adding a GLP-1 agonist in patients with a baseline HbA1c of 9% (75 mmol/mol) or greater. Methods: A single-health system retrospective chart review screened adults with type 2 diabetes mellitus with a baseline hemoglobin A1c of 9% (75 mmol/mol) or greater and were prescribed a GLP-1 agonist for eligibility. The primary outcome assessed was the change in HbA1c from baseline to the first HbA1c check. Secondary outcomes included change in weight (kg) from baseline to the first HbA1c check. Results: Three hundred sixty-two patients were screened of which 151 (41.7%) were included in the final analysis. The mean change in HbA1c from baseline to first HbA1c check for all participants was -2.1% (95% CI: -2.3% to -1.8%; P < .001; -23 mmol/mol [95% CI: -25 to -20 mmol/mol]). The mean change in weight from baseline to first HbA1c check was -2.0 kg (95% CI: -2.6 kg to -1.4 kg; P < .001). Conclusion: In patients with type 2 diabetes mellitus with a baseline HbA1c ≥ 9%, GLP-1 agonist initiation resulted in a significant reduction of both HbA1c and weight compared to baseline. Large, prospective, multisite studies are needed to confirm findings of this retrospective study.

Publication of Pharmacy Residency Research: A 12-Year Cohort From an Academic Medical Center.

BACKGROUND: Pharmacy residency programs provide research training experiences to residents, and publication is considered an indicator of high-quality research experiences. OBJECTIVE: This study described attributes of pharmacy residents, residency programs, and residency major research projects and their associations with the outcome of publication in a peer-reviewed journal. METHODS: Pharmacy residents who graduated from one academic medical center between 2001 and 2012 were invited to participate via an electronic survey distributed in February 2014. The survey collected attributes of the resident, residency program, and research project. The outcome of publication was self-reported by residents in 2014 and updated in July 2019 using a validated search strategy. RESULTS: This study included 53 resident graduates representing 66 major pharmacy residency projects. Eighteen (27%) projects were published, occurring at an average of 13.8 months after residency graduation. The outcome of publication was more likely for residents with human subjects research experience prior to PGY1 training, residency programs that cultivated resident expertise in Institutional Review Board submission and statistical analysis, and projects with Institutional Review Board approval, a larger number of co-investigators, non-pharmacy co-investigators, and a larger sample size. CONCLUSION: This cohort of residents, programs, and projects at an academic medical center identified many modifiable attributes that were associated with successful publication of resident research projects. Unfortunately, residency projects rarely used study design features that attenuate bias. Residents and preceptors were perceived as having limited expertise with statistical analysis and database management, which underscores the need to develop research infrastructure to enhance research training for pharmacy students, residents, and preceptors.

Pandemic preparedness in Hawaii: a multicenter verification of real-time RT-PCR for the direct detection of influenza virus types A and B.

OBJECTIVE: We integrated multicenter, real-time (RTi) reverse transcription polymerase chain reaction (RT-PCR) screening into a statewide laboratory algorithm for influenza surveillance and response. METHODS: Each of three sites developed its own testing strategy and was challenged with one randomized and blinded panel of 50 specimens previously tested for respiratory viruses. Following testing, each participating laboratory reported its results to the Hawaii State Department of Health, State Laboratories Division for evaluation and possible discrepant analysis. RESULTS: Two of three laboratories reported a 100% sensitivity and specificity, resulting in a 100% positive predictive value and a 100% negative predictive value (NPV) for influenza type A. The third laboratory showed a 71% sensitivity for influenza type A (83% NPV) with 100% specificity. All three laboratories were 100% sensitive and specific for the detection of influenza type B. Discrepant analysis indicated that the lack of sensitivity experienced by the third laboratory may have been due to the analyte-specific reagent probe used by that laboratory. Use of a newer version of the product with a secondary panel of 20 specimens resulted in a sensitivity and specificity of 100%. CONCLUSIONS: All three laboratories successfully verified their ability to conduct clinical testing for influenza using diverse nucleic acid extraction and RTi RT-PCR platforms. Successful completion of the verification by all collaborating laboratories paved the way for the integration of those facilities into a statewide laboratory algorithm for influenza surveillance and response.

Validity and Reliability of a Systematic Database Search Strategy to Identify Publications Resulting From Pharmacy Residency Research Projects.

PURPOSE: This study aims to develop a systematic search strategy and test its validity and reliability in terms of identifying projects published in peer-reviewed journals as reported by residency graduates through an online survey. METHODS: This study was a prospective blind comparison to a reference standard. Pharmacy residency projects conducted at the study institution between 2001 and 2012 were included. A step-wise, systematic procedure containing up to 8 search strategies in PubMed and EMBASE for each project was created using the names of authors and abstract keywords. In order to further maximize sensitivity, complex phrases with multiple variations were truncated to the root word. Validity was assessed by obtaining information on publications from an online survey deployed to residency graduates. RESULTS: The search strategy identified 13 publications (93% sensitivity, 100% specificity, and 99% accuracy). Both methods identified a similar proportion achieving publication (19.7% search strategy vs 21.2% survey, P = 1.00). Reliability of the search strategy was affirmed by the perfect agreement between 2 investigators (k = 1.00). CONCLUSION: This systematic search strategy demonstrated a high sensitivity, specificity, and accuracy for identifying publications resulting from pharmacy residency projects using information available in residency conference abstracts.

Successful use of N-acetylcysteine to treat severe hepatic injury caused by a dietary fitness supplement.

In the absence of adequate premarketing efficacy and safety evaluations, adverse events from over-the-counter supplements are emerging as a public health concern. Specifically, bodybuilding products are being identified as a frequent cause of drug-induced liver injury. We present a case of a 20-year-old Hispanic male who presented with acute nausea and vomiting accompanied by severe right upper quadrant abdominal pain, shivering, and shortness of breath. Laboratory data pointed to mixed cholestatic and hepatocellular damage, and after exclusion of known alternate etiologies, the patient was diagnosed with acute drug-induced liver injury secondary to the use of "Friction," a bodybuilding supplement. Treatment with N-acetylcysteine (NAC) 20% oral solution was initiated empirically at a dose of 4000 mg [DOSAGE ERROR CORRECTED] (70 mg/kg) every 4 hours and was continued once the diagnosis was made. Within 48 hours of admission to our hospital, the patient began to show clinical resolution of right abdominal pain and tolerance to oral diet associated with a significant decline toward normal in his liver function tests and coagulopathy. The WHO-UMC causality assessment system suggested a "certain causality" between exposure to the supplement and the acute liver injury. In the event of suspected drug-induced liver injury, treatment with NAC should be considered given its favorable risk-benefit profile.

Evaluation and Pharmacokinetics of Treatment Dose Enoxaparin in Hospitalized Patients With Morbid Obesity.

BACKGROUND: The pharmacokinetic properties of enoxaparin may lead to supratherapeutic antifactor Xa (anti-Xa) levels and increased bleeding when standard treatment doses are used in patients with morbid obesity. OBJECTIVE: To evaluate the dose of enoxaparin needed to achieve therapeutic anti-Xa levels in a prospective, masked observational cohort of heterogeneous inpatients with morbid obesity and to determine whether patients with morbid obesity treated with 1 mg/kg of enoxaparin are at increased risk of supratherapeutic levels and bleeding events compared to patients receiving lower doses. METHODS: Hospitalized patients with a body mass index ≥40 kg/m(2) or actual body weight ≥140 kg and prescribed treatment doses of enoxaparin >60 mg per day were enrolled and consented to phlebotomy for determination of anti-Xa levels. RESULTS: Forty-one patients were included for data analysis. The dose of enoxaparin that resulted in therapeutic and supratherapeutic anti-Xa levels at steady state was 0.83 mg/kg and 0.98 mg/kg (-0.11; 95% confidence interval [CI] -0.20 to -0.01, P = .02), respectively. Enoxaparin dose as mg/kg of actual body weight was an independent predictor of having a supratherapeutic anti-Xa level. Patients with doses <0.95 mg/kg versus ≥0.95 mg/kg were less likely to have supratherapeutic levels (odds ratio 0.21 [95% CI 0.05-0.84], P = .02) and had similar rates of subtherapeutic levels. Doses <0.95 mg/kg and ≥0.95 mg/kg resulted in similar bleeding rates of 17.9% and 22.2% (P = .71), respectively. CONCLUSION: Patients with morbid obesity required less than the recommended 1 mg/kg enoxaparin dose to achieve therapeutic peak anti-Xa levels; therefore, initiation with lower dosages is prudent and anti-Xa monitoring should guide dosage adjustments.

Incidence of cholinesterase inhibitor therapy initiation among hospitalized patients.

BACKGROUND: Initiation of cholinesterase inhibitor (ChEI) therapy for delirium during hospitalization is ineffective and may be associated with increased morbidity and mortality. OBJECTIVE: To describe the incidence of initiating ChEI therapy during hospitalization. DESIGN: A retrospective cross-sectional study. SETTING: A tertiary-care academic medical center. PATIENTS: Inpatient admissions from September 2010 through March 2011 with ChEI administration. INTERVENTION: None. MEASUREMENTS: Incidence of ChEI exposure, initiation of ChEI therapy, initiation of antipsychotics and benzodiazepines, infection, in-hospital mortality, and hospital length of stay. RESULTS: The incidence of adult admissions with ChEI exposure and ChEI initiation was 23.2 (95% confidence interval: 21.2-25.4) and 2 (95% confidence interval 1.5-2.8) per 1000 admissions, respectively. Of 476 admissions receiving ChEI, 9% (n = 42) initiated therapy during the hospital stay and 91% (n = 434) continued on previously started therapy. Patients initiated on ChEI therapy frequently had infection (20 of 42) and were commonly initiated on antipsychotics (14 of 42) and benzodiazepines (13 of 42). Patients were hospitalized for a median of 2 days (interquartile range, 1-4) before initiation of ChEI and were exposed to therapy for a median of 3 days (interquartile range, 2-6). Of the 41 patients discharged from the hospital, 90% (n = 37) had orders to continue the ChEI postdischarge. CONCLUSIONS: Despite a lack of evidence to support the practice, 9% of patients who received ChEI therapy were initiated during the inpatient setting. These patients were not routinely screened for delirium and frequently received treatments associated with delirium.