Evaluation of a Pharmacist-Led Implementation of Standardized Medication Administration Times for Inpatients Receiving Hemodialysis.

BACKGROUND: Missed medication doses are a common and often preventable medication-related error that have been associated with an increased length of stay and mortality. Hemodialysis is a common, relatively predictable reason that patients are unavailable, resulting in missed doses. OBJECTIVE: To evaluate the implications of a pharmacist-led intervention to standardize the medication administration times for patients requiring hemodialysis who were prescribed antihypertensives, antiepileptics, apixaban, and/or antimicrobials. METHODS: A retrospective preanalysis and postanalysis of a pharmacist-led intervention were performed at a single-center, safety net hospital. Patients receiving dialysis and prescribed one of the targeted medications were included. The primary endpoint was the composite of missed and delayed doses. RESULTS: A total of 25 patients receiving 126 dialysis sessions in the preintervention group and 29 patients receiving 80 dialysis sessions in the postintervention group were included for analysis. For the primary endpoint, 118 (18%) versus 57 (9.3%) doses were missed or delayed in the preintervention versus postintervention group, respectively (P < 0.001). The primary endpoint was driven by fewer delayed doses in the postgroup. The number of antimicrobials given on a correct schedule increased in the postintervention group (98.3% vs 99.1%, P = 0.044). CONCLUSION AND RELEVANCE: A pharmacist-led intervention for standard medication administration times in patients requiring hemodialysis increased the number of prescribed medication doses given and given on time. The intervention also led to more antimicrobials administered at appropriate times relative to dialysis sessions.

Characterization of vitamin D deficiency and use of a standardized supplementation protocol in orthopaedic trauma patients.

PURPOSE: The objectives of this study were to assess the incidence of vitamin D deficiency in orthopaedic trauma patients, evaluate the safety and efficacy of a vitamin D supplementation protocol, and investigate the utility of vitamin D supplementation in reducing nonunions. METHODS: Three hundred seventy patients with operative tibia and/or fibula fractures were retrospectively reviewed. Both overall and matched cohorts were analysed. RESULTS: Ninety-eight per cent (n = 210) were found to have vitamin D insufficiency (serum 25(OH)D level < 30 ng/ml). There were no cases of vitamin D toxicity following vitamin D replacement. Median follow-up vitamin D level was 22.7 ng/mL. No statistical difference between union rates was found between either the two consecutive cohorts or matched cohorts. CONCLUSION: This vitamin D replacement protocol was a safe treatment for hypovitaminosis D, but post hoc analysis shows there would need to be over 1200 matched patients to achieve adequate power.

Implementation of a Pharmacist-Driven Contraception Service at a Safety-Net Health-System.

Background: Access to safe, effective, and appropriate contraception significantly reduces the rates of unintended pregnancies; however, this preventative care is not always easily accessible. There is a high patient demand for contraception visits that is often delayed or unmet due to lack of access to traditional providers. Pharmacists are highly accessible and can help manage this high demand, yet clinical pharmacists as providers of contraception services remains a gap in published literature. Objective: Develop and implement a pharmacist-led contraception service at a safety-net health-system. Methods: A comprehensive pharmacist-led clinical contraception service was created to improve patient access. To support this project, a collaborative practice agreement (CPA) was developed and enhancements were built into an electronic medical record. The CPA allowed the pharmacist to complete contraception-related interventions such as ordering urine pregnancy tests, prescribing hormonal and emergency contraceptives, and manage adverse effects. The piloting pharmacist was available at the Narcotics Treatment Program (NTP) clinic one half-day each week for scheduled and same-day visits. Results: Within the initial five half-day clinic sessions at NTP, the pharmacist had written seven prescriptions, including three for emergency contraceptives. Of all patients seen for this service at NTP, only one had been using a method of contraception consistently prior to their visit. Conclusion: The interventions that were able to be made by the pharmacist highlighted the need for improved access to contraceptives. Pharmacist-managed services in sexual and reproductive health can help fill this gap. Patients also self-reported ease of access as a benefit to this service.

Vitamin D Deficiency Is Associated With Increased Length of Stay After Acute Burn Injury: A Multicenter Analysis.

In burn patients, vitamin D deficiency has been associated with increased incidence of sepsis and infectious complications. The objective of this study was to assess the impact of vitamin D deficiency in adult burn patients on hospital length of stay (LOS). This was a multicenter retrospective study of adult patients at 7 burn centers admitted over a 3.5-year period, who had a 25-hydroxyvitamin D concentration drawn within the first 7 days of injury. Of 1147 patients screened, 412 were included. Fifty-seven percent were vitamin D deficient. Patients with vitamin D deficiency had longer LOS (18.0 vs 12.0 days, P < .001), acute kidney injury (AKI) requiring renal replacement therapy (7.3 vs 1.7%, P = .009), more days requiring vasopressors (mean 1.24 vs 0.58 days, P = .008), and fewer ventilator-free days of the first 28 days (mean 22.9 vs 25.1, P < .001). Univariable analysis identified burn center, AKI, TBSA, inhalation injury, admission concentration, days until concentration drawn, days until initiating supplementation, and dose as significantly associated with LOS. After controlling for center, TBSA, age, and inhalation injury, vitamin D deficiency was associated with longer LOS. In conclusion, patients with thermal injuries and vitamin D deficiency on admission have increased LOS and worsened clinical outcomes when compared with patients with nondeficient vitamin D concentrations.

A Multicenter, Retrospective Outcome Analysis of Vancomycin Area Under the Curve versus Trough-Based Dosing Strategies in Patients with Burn OR Inhalational Injuries (MONITOR).

Vancomycin is a glycopeptide antibiotic that requires close therapeutic monitoring. Prolonged exposure to elevated concentrations increases risk for serious adverse effects such as nephrotoxicity. However, sub-therapeutic concentrations may lead to bacterial resistance and clinical failure or death. The most recent Infectious Diseases Society of America (IDSA) publication regarding therapeutic monitoring of vancomycin recommends utilizing area under the curve (AUC)-based monitoring to maximize clinical success. Despite the guideline recommendation for AUC-guided dosing, many institutions still use trough-only monitoring in their practices, including those caring for patients with acute burn injuries. Following burn injury, patients are at a higher risk for infections, multi-organ failure, and pharmacokinetic alterations. The primary objective of this multi-center retrospective study is to determine optimal therapeutic monitoring of vancomycin by comparing clinical success between AUC vs. trough-based monitoring in burn patients. MONITOR was a multicenter, retrospective study of patients with thermal or inhalation injury admitted to one of 13 burn centers from 1/1/17 to 8/31/22 who received vancomycin. Demographic and clinical course data, including acute kidney injury (AKI) incidence and clinical success were obtained. Patients were evaluated for clinical success and grouped according to method of monitoring and adjusting doses: AUC vs. trough-based monitoring. Clinical success was a composite definition and lack of meeting any 1 of 5 criteria: 1) persistent infection, 2) relapse, 3) antibiotic failure (clinical worsening), 4) AKI, 5) death. Five-hundred seventeen vancomycin courses were assessed from 485 patients. There was no difference in the rate of clinical success between AUC monitored and the trough-only monitored groups. Incidence of AKI was higher in the trough-only group; however, was not statistically significant after controlling for renal function on admission, past medical history of chronic kidney disease (CKD), and concomitant nephrotoxins.

An Appraisal of Pharmacotherapy-Pertinent Literature Published in 2021 and 2022 for Clinicians Caring for Patients With Thermal or Inhalation Injury.

Studies focusing on pharmacotherapy interventions to aid patients after thermal injury are a minor focus in burn injury-centered studies and published across a wide array of journals, which challenges those with limited resources to keep their knowledge current. This review is a renewal of previous years' work to facilitate extraction and review of the most recent pharmacotherapy-centric studies in patients with thermal and inhalation injury. Twenty-three geographically dispersed, board-certified pharmacists participated in the review. A Medical Subject Heading-based, filtered search returned 2336 manuscripts over the previous 2-year period. After manual review, 98 (4%) manuscripts were determined to have a potential impact on current pharmacotherapy practice. The top 10 scored manuscripts are discussed. Only 17% of those reviewed were assessed to likely have little effect on current practice. The overall impact of the current cohort was higher than previous editions of this review, which is encouraging. There remains a need for investment in well-designed, high-impact, pharmacotherapy-pertinent research for patients sustaining thermal or inhalation injuries.

Changes in clinical markers observed from pharmacist-managed cardiovascular risk reduction clinics in federally qualified health centers: A retrospective cohort study.

BACKGROUND: Reductions in hemoglobin A1c (HbA1C) have been associated with improved cardiovascular outcomes and savings in medical expenditures. One public health approach has involved pharmacists within primary care settings. The objective was to assess change in HbA1C from baseline after 3-5 months of follow up in pharmacist-managed cardiovascular risk reduction (CVRR) clinics. METHODS: This retrospective cohort chart review occurred in eight pharmacist-managed CVRR federally qualified health clinics (FQHC) in Indiana, United States. Data were collected from patients seen by a CVRR pharmacist within the timeframe of January 1, 2015 through February 28, 2020. Data collected include: demographic characteristics and clinical markers between baseline and follow-up. HbA1C from baseline after 3 to 5 months was assessed with pared t-tests analysis. Other clinical variables were assessed and additional analysis were performed at 6-8 months. Additional results are reported between 9 months and 36 months of follow up. RESULTS: The primary outcome evaluation included 445 patients. Over 36 months of evaluation, 3,803 encounters were described. Compared to baseline, HbA1C was reduced by 1.6% (95%CI -1.8, -1.4, p<0.01) after 3-5 months of CVRR care. Reductions in HbA1C persisted at 6-8 months with a reduction of 1.8% ([95%CI -2.0, -1.5] p<0.01). The follow-up losses were 29.5% at 3-5 months and 93.2% at 33-36 months. CONCLUSIONS: Our study augments the existing literature by demonstrating the health improvement of pharmacist-managed CVRR clinics. The great proportion of loss to follow-up is a limitation of this study to be considered. Additional studies exploring the expansion of similar models may amplify the public health impact of pharmacist-managed CVRR services in primary care sites.

Evaluation of the Role of a Clinical Pharmacist on Medication Management in an Adult Burn Clinic via a Collaborative Drug Therapy Management Protocol.

Historically, pharmacists have not been formally involved in managing burn clinic patients. Collaborative Drug Therapy Management (CDTM) protocols allow pharmacists working within a defined context to independently assume responsibility for direct patient care activities. The objective of this study was to evaluate the number and type of medication-related interventions made by a clinical pharmacist, in an adult burn clinic, via a CDTM protocol. The protocol allows pharmacists to independently manage the following disease states: pain, agitation, delirium, insomnia, venous thromboembolism, skin/soft tissue infections, and hypermetabolic complications. All pharmacist visits between 1/1/22 and 9/22/22 were included. A total of 16 patients were seen at 28 visits with a clinical pharmacist for a total of 148 interventions. Patients were mostly males (81%) with a mean ± SD age of 41 ± 15 years. The majority of patients were in-state (94%), with 9 (56%) being from an outlying county. Patients were seen for a median (IQR) of 2 (1,2) visits. Interventions were made at all visits (100%) with a median of 5 (4,6) per visit. Interventions (per visit) included medication reconciliation [28 (100%)], a median of 1 (0,2) medication ordered or adjusted, labs ordered at 7 (25%) visits, with adherence and patient education both reviewed at over 90% of visits. To the best of our knowledge, ours is the first burn center to implement a Clinical Pharmacist CDTM Protocol, with a pharmacist directly impacting transitions of care. This may serve as a framework for other sites. Future directions include continuing to track data for medication adherence and access, billing/reimbursement, and clinical outcomes.

Implementation of a unique mass casualty and emergency preparedness longitudinal learning experience for postgraduate year 2 pharmacy residents.

BACKGROUND AND PURPOSE: The American Society of Health-System Pharmacists (ASHP) postgraduate year 2 (PGY2) critical care pharmacy residency program offers an elective competency area, E3: Mass Casualty. Similar elective competencies are also available for PGY2 emergency medicine and postgraduate year 1/2 pharmacotherapy programs. Because of the COVID-19 pandemic, pharmacist proficiency in the management of disasters is even more urgent. However, few residency programs require or include a specific learning experience to achieve this competency. This article provides examples of opportunities that residency programs can implement to offer an Emergency Preparedness/Mass Casualty (EP/MC) learning experience. EDUCATIONAL ACTIVITY AND SETTING: A longitudinal EP/MC learning experience was integrated into a PGY2 critical care program. FINDINGS: A longitudinal EP/MC learning experience within the PGY2 critical care, emergency medicine, and pharmacotherapy residency program curricula is achievable and promotes resident development. Learning experience components included topic discussions, participation on local and state-level emergency preparedness (EP) committees, completion of certification programs, projects, and participation on statewide emergency response teams. SUMMARY: Implementation of a longitudinal EP/MC learning experience formalizes topics and activities that support achievement of the ASHP elective competency area of Mass Casualty for PGY2 residency programs. EP/MC goals and objectives should be a requirement for critical care, emergency medicine, pharmacotherapy, and health-system pharmacy administration and leadership PGY2 programs. By formalizing training, pharmacists can be better prepared for EP and more integrated into multidisciplinary disaster response teams.

Interrater reliability and ease of use of the High-Alert Medication Stratification Tool‒Revised Prospective (HAMST-R PRO): A prospective, multisite study.

OBJECTIVE: The High-Alert Medication Stratification Tool‒Revised (HAMST-R) was originally designed to standardize the identification of high-alert medications (HAMs) according to safety risk. The primary objective of this multisite study was to assess interrater reliability of the HAMST-R PRO, a version of the tool designed to prospectively evaluate safety risk of medications during evaluation for formulary addition. METHODS: HAMST-R was designed as an objective tool to evaluate HAMs at a single site during the HAMST-R phase I study. Phase II of the study demonstrated the validity of the tool in a multisite, national study. In this third study, 11 medication safety experts from 8 health systems across the United States and 1 in Canada facilitated evaluation of medications prospectively with the HAMST-R PRO during the formulary review process for 27 medications. At each site, at least 5 individuals were asked to review each medication. Interrater reliability was evaluated using Kendall's coefficient of concordance. Ease of use was determined by participant interviews. RESULTS: Overall interrater reliability for HAMST-R PRO was found to be 0.76 (P < 0.001) across all sites, indicating substantial agreement between users. Interrater reliability among individual sites ranged from 0.52 to 0.82 (P < 0.05 for all sites). CONCLUSION: Interrater reliability of HAMST-R PRO is substantial, indicating consistency and agreement among pharmacists utilizing this tool to evaluate safety risk of medications before their addition to a health-system formulary. This information can be used to identify potential interventions for each step of the medication-use process that institutions may implement to decrease a medication's potential safety risk.

Development of a pharmacist-managed protocol for the transition from intravenous to subcutaneous insulin in critically ill adults.

PURPOSE: To evaluate the efficacy and safety of a pharmacist-managed protocol for transitioning critically ill patients from intravenous (IV) to subcutaneous insulin. METHODS: This single-center, retrospective, observational study included patients admitted to the medical or surgical/trauma intensive care unit who received a continuous infusion of IV insulin from January 2019 to April 2021. Patients were excluded if they were less than 18 years old, pregnant, or incarcerated or received IV insulin for the diagnosis of diabetic ketoacidosis, hyperglycemic hyperosmolar state, calcium channel blocker or ß-blocker overdose, or hypertriglyceridemia. The primary outcome was to evaluate the percentage of blood glucose (BG) concentrations within the target range of 70 to 150 mg/dL within 48 hours of the transition to subcutaneous insulin. Secondary outcomes included the percentage of BG concentrations within the goal range following transition at 0 to 12 hours and 12 to 24 hours, the incidence of hypo- and hyperglycemia, and the percentage of patients requiring dose adjustments after the initial transition. RESULTS: Pharmacists were able to achieve BG concentrations in the target range for 53% of transitions at 12 hours, 40% of transitions at 24 hours, and 47% of transitions at 48 hours. With respect to safety endpoints, the pharmacist-managed group had a low rate of hypoglycemia (1.0%) and no severe hypoglycemia. Hyperglycemia was reported for 28% of BG concentrations while severe hyperglycemia was reported for 27%. Pharmacists transitioned patients to an average of 63% of the 24-hour total daily dose of insulin as basal insulin. CONCLUSION: Pharmacists can effectively and safely transition critically ill patients from IV to subcutaneous insulin utilizing a standardized protocol.

Pharmacoeconomic, Medication Access, and Patient-Satisfaction Analysis of a Pharmacist-Managed VTE Clinic Compared to Primary Care Physician Outpatient Therapy.

Venous thromboembolism (VTE) is a common medical condition often treated with direct oral anticoagulants (DOACs). Current literature supports outpatient treatment of select, low-risk VTE patients by a pharmacist with DOACs; however, no studies exist to demonstrate if a pharmacist-managed VTE clinic provides financial benefit compared to physician-managed outpatient care. To compare the financial implications and patient satisfaction of pharmacist-managed VTE care versus outpatient VTE care by a primary care physician. A single-center retrospective chart review was conducted on all patients seen at a pharmacist-managed VTE clinic for safety and reimbursement outcomes between August 1, 2018 and July 31, 2019. These data points were used to assess the primary endpoint of net gain per patient visit and secondary outcomes, including patient satisfaction score. The primary outcome median (IQR) for net gain per visit was $16.57 (16.57, 16.57) for the pharmacist-managed group and $64.37 (47.04, 64.37) in the physician-managed group with a 95% CI of 39.13-47.80. The median cost to the organization per visit was $4.96 (4.96, 4.96) for the pharmacist-managed group and $39.41 (23.65, 39.41) for the physician managed group with a 95% CI of 26.57-34.45. Statistical difference was also found for a secondary outcome of percentage of days covered for the pharmacist-managed group compared to the physician managed group, median (IQR) 100% (76,100) vs 92.2% (67.2, 98.9) respectfully, with a p-value of 0.043. The pharmacist-managed VTE clinic, although financially sustainable, provides significantly less net revenue per patient than physician managed clinics, demonstrating the need for increased payer recognition for pharmacists.

A Review of the Most Impactful Published Pharmacotherapy-Pertinent Literature of 2019 and 2020 for Clinicians Caring for Patients With Thermal or Inhalation Injury.

Keeping abreast with current literature can be challenging, especially for practitioners caring for patients sustaining thermal or inhalation injury. Practitioners caring for patients with thermal injuries publish in a wide variety of journals, which further increases the complexity for those with resource limitations. Pharmacotherapy research continues to be a minority focus in primary literature. This review is a renewal of previous years' work to facilitate extraction and review of the most recent pharmacotherapy-centric studies in patients with thermal and inhalation injury. Sixteen geographically dispersed, board-certified pharmacists participated in the review. A MeSH-based, filtered search returned 1536 manuscripts over the previous 2-year period. After manual review and exclusions, only 98 (6.4%) manuscripts were determined to have a potential impact on current pharmacotherapy practices and included in the review. A summary of the 10 articles that scored highest are included in the review. Nearly half of the reviewed manuscripts were assessed to lack a significant impact on current practice. Despite an increase in published literature over the previous 2-year review, the focus and quality remain unchanged. There remains a need for investment in well-designed, high impact, pharmacotherapy-pertinent research for patients sustaining thermal or inhalation injuries.

High-Alert Medication Stratification Tool-Revised: An Exploratory Study of an Objective, Standardized Medication Safety Tool.

OBJECTIVE: To develop an objective tool designed to standardize the identification of high-alert medications (HAMs) according to patient safety risk. METHODS: Medications were evaluated using the High-Alert Medication Stratification Tool (HAMST). Tool revision occurred through assessing medications on an organization-approved HAM list and comparing scores with control medications not included on the list. Because of variations in HAMST interpretation by end users in interdisciplinary committees, a revision of the scoring tool was completed to create the High-Alert Medication Stratification Tool-Revised (HAMST-R), and the assessment was repeated. Both tools range from 0 to 10, with 10 describing agents with highest risk. RESULTS: The median (interquartile range [IQR]) initial HAM (n = 44) score using HAMST was 6 (5-7). The median (IQR) control (n = 45) score was 1 (0-2). Using the modified tool, HAMST-R, the median (IQR) HAM score was 4 (4-6) versus 1 (0-1) for controls. Scores for HAMs were significantly higher than controls using both tools (P < 0.001). A HAMST-R score of 4 or higher defines medications as high alert, as this score includes 75% of HAMs and no controls. CONCLUSIONS: Through this exploratory study, clarification of the tool was required to increase its concurrent validity, interrater reliability, and implementation among other health systems. The revised tool, HAMST-R, is a newly developed, objective tool for standardized identification of HAMs. The tool may also be used for prospective identification of medications as high risk to patient safety during formulary review.

Accuracy of a single-lead mobile smartphone electrocardiogram for QT interval measurement in patients undergoing maintenance methadone therapy.

STUDY OBJECTIVE: Methadone is associated with QT interval prolongation and torsades de pointes. Expert panel recommendations advocate a pre-methadone electrocardiogram (ECG) and another ECG at 30 days of therapy in patients with risk factors. Some guidelines recommend a pre-methadone ECG and routine ECG monitoring in all methadone patients, but this is controversial due to the resources required. Availability of a convenient, less resource-intensive method of ECG monitoring for patients taking methadone is desirable. The objective of this study was to assess the accuracy of a handheld smartphone ECG (iECG) for QT measurement in patients on maintenance methadone therapy in an urban opioid treatment program. DESIGN: Prospective study. SETTING: Urban opioid treatment program. PATIENTS: n = 115 patients in normal sinus rhythm who were on steady-state maintenance methadone therapy INTERVENTION: Patients (n = 115) underwent a simultaneous 12-lead ECG and a single-lead iECG. MEASUREMENTS AND MAIN RESULTS: The first three QT and RR intervals from lead II of the 12-lead ECG and simulated lead I from the iECG were compared using the Bland-Altman analysis of measurement agreement. Mean [± standard deviation) age was 34 ± 11 years; 71% were female, 75% were white. Compared to the 12-lead ECG, the iECG was associated with a QTc bias of - 0.14 ms (SD = 12 ms, 95% CI = -2.4 to 2.1 ms). The absolute mean difference in QTc between the two methods was 9.5 ± 7.1 ms. For identification of patients with methadone-associated QTc prolongation, the iECG performed moderately well [c-statistic 0.97 (95% CI 0.91-0.99); sensitivity and specificity 75% (95% CI 43-95%) and 99% (95% CI 94-99%), respectively]. The positive and negative likelihood ratios of the iECG for identifying patients with methadone-associated QTc prolongation were 77.25 (95% CI 10.69 to 558.18) and 0.25 (95% CI 0.09 to 0.67), respectively, while the positive and negative predictive values were 90% (95% CI 56-99%) and 97% (95% CI 92-99%), respectively. The accuracy of the iECG for identifying patients with QTc prolongation was 97% (95% CI 91-99%). CONCLUSION: A handheld smartphone ECG is accurate for QT interval measurement in patients taking maintenance methadone therapy, and its performance is moderately good for identifying patients with methadone-associated QTc prolongation.

Methadone-associated QT interval prolongation in patients undergoing maintenance therapy in an urban opioid treatment program.

STUDY OBJECTIVE: Methadone is associated with QT interval prolongation and torsades de pointes. The objective of this study was to (a) determine the incidence of QT interval prolongation among patients on maintenance methadone therapy in an urban opioid treatment program (OTP), (b) compare characteristics of patients who developed methadone-associated QT prolongation with those who did not develop QT prolongation, and (c) investigate the relationship between QT interval prolongation and stereospecific serum methadone and metabolite [2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)] concentrations. DESIGN: Prospective study. SETTING: Urban opioid treatment program (OTP). PATIENTS: n = 93 patients on maintenance methadone therapy in an urban OTP. INTERVENTION: Patients underwent a 12-lead electrocardiogram (ECG) prior to initiating methadone and again during steady-state maintenance methadone therapy. In a subset (n = 43), blood was obtained to determine serum (S)- and (R)-methadone and (S)- and (R)-EDDP concentrations, which were compared in patients who developed Bazett's-corrected QT (QTc) prolongation [≥470 ms (men) or ≥480 ms (women) and/or ≥60 ms lengthening from pretreatment value] with those who did not have QTc prolongation. MEASUREMENTS AND MAIN RESULTS: Mean [± standard deviation (SD)] age was 36 ± 12 years; 73% were female, and 74% were white. QTc prolongation occurred in 14 (15.1%) patients. Patients who developed QTc prolongation were older (41 ± 13 vs. 35 ± 9 years, p = 0.03) and had a longer pre-methadone QTc compared with those who did not have QTc prolongation (429 ± 11 vs. 420 ± 20 ms, respectively, p = 0.02). Serum (S)-methadone concentrations were higher in patients with QTc prolongation compared to patients without prolongation (199 ± 81 vs. 128 ± 68 ng/ml, respectively, p = 0.01), whereas the difference in serum (R)-methadone concentrations between the groups did not reach significance (189 ± 68 vs. 125 ± 60 ng/ml, respectively, p = 0.08). Serum (R)-methadone concentrations correlated with QTc intervals [R2  = 0.15 (95% confidence interval (CI) 0.11-0.62, p = 0.0009)]. The correlation between serum (S)-methadone concentrations and QTc did not reach significance [R2  = 0.08 (95% CI -0.01 to 0.54, p = 0.06)]. Serum (S)-and (R)-EDDP concentrations were not significantly different between the groups and did not significantly correlate with QTc intervals. CONCLUSIONS: Approximately 15% of patients taking maintenance methadone therapy developed QT interval prolongation. Both serum (S)- and (R)-methadone concentrations, but not (S)- or (R)-EDDP, contribute to methadone-associated QT prolongation.

High-Alert Medication Stratification Tool-Revised Phase II: A Multisite Study Examining the Validity, Interrater Reliability, and Ease of Use of the High-Alert Medication Stratification Tool-Revised.

OBJECTIVES: The primary objective of this multisite study, High-Alert Medication Stratification Tool-Revised (HAMST-R) phase II, was to assess the content validity of HAMST-R. Secondary outcomes included interrater reliability and ease of use. METHODS: HAMST-R was designed as an objective tool to evaluate high-alert medications (HAMs) at a single site during HAMST-R Phase I. Medication safety experts from 7 health systems across the United States volunteered to participate in this phase II study. Participants completed a demographic survey, oversaw evaluation of 47 HAMs and 35 non-HAMs using HAMST-R, and submitted scores for each medication evaluated. In addition, participants rated each question of HAMST-R on its relevance to assess a medication's safety risk, measured as scale-content validity index. Positive and negative predictive values were evaluated in a post hoc analysis. Interrater reliability was evaluated using the Kendall coefficient of concordance (K), and ease of use was assessed using a mixed-methods approach. RESULTS: Scale-content validity index was 0.80, indicating that the tool was valid. Positive predictive value was 90.5% (95% confidence interval, 87.2%-93.0%), and negative predictive value was 98.2% (95% confidence interval, 95.4%-99.3%). A score of 4 or more differentiated between HAMs and non-HAMs, confirming phase I findings. K was 0.56, indicating moderate agreement. Participants confirmed that the tool was easy to use and plan to incorporate the tool into HAM policies and procedures, formulary review, and safety strategy implementation. CONCLUSIONS: HAMST-R is a valid, objective, and easy to use method that institutions may implement to evaluate a medication's potential safety risk.

The MALAdy of metformin poisoning: Is CVVH the cure?

Inadvertent or intentional metformin overdose can result in death from refractory lactic acidosis. We report a death from metformin-induced refractory lactic acidosis despite aggressive care. A 49-year-old hypertensive diabetic female presented 1 hour after ingesting 60 tablets of 500 mg metformin and 20 combination tablets of 12.5 mg hydrochlorothiazide/20 mg lisinopril. She was awake and alert, with a blood glucose of 579 mg/dL. Chemistry panel revealed lactic acidosis and acute renal failure (arterial blood gas pH, 7.18; pCO(2), 15 mm Hg; pO(2), 127 mm Hg; HCO(3), 6 mmol/L; lactate, 9.6 mmol/L; and creatinine, 1.2 mg/dL [0.8 mg/dL previously]). She received normal saline, sodium bicarbonate, and insulin. On arrival to the intensive care unit she was obtunded, with a blood pressure of 40/25 mm Hg and had worsening acidosis and poor oxygenation (arterial blood gas pH, 6.79; pCO(2), 55; pO(2), 57; HCO(3), 8.4; and base excess of -25 on 100% fractional inspired oxygen). She was intubated and received additional fluid boluses, bicarbonate, and norepinephrine. Continuous veno-venous hemofiltration (CVVH) was started 6 hours after her ingestion. Metformin was 380 microg/mL on CVVH initiation. The patient developed pulseless electrical activity 30 hours after her ingestion, which recurred 20 minutes later. The family requested no further resuscitation. She died 31.5 hours after her ingestion. Metformin concentrations decreased to 97 microg/mL 28 hours after the ingestion on CVVH, with a first-order elimination half-life of 11.3 hours (r(2) = 0.99) and a clearance of 56.2 mL/min. Further investigations on the place of CVVH in the management of the poisoned patient with MALA unable to hemodynamically tolerate conventional hemodialysis may be needed.

The Impact of Changes to an Electronic Admission Order Set on Prescribing and Clinical Outcomes in the Intensive Care Unit.

BACKGROUND: Implementation of disease-specific order sets has improved compliance with standards of care for a variety of diseases. Evidence of the impact admission order sets can have on care is limited. OBJECTIVE: The main purpose of this article is to evaluate the impact of changes made to an electronic critical care admission order set on provider prescribing patterns and clinical outcomes. METHODS: A retrospective, observational before-and-after exploratory study was performed on adult patients admitted to the medical intensive care unit using the Inpatient Critical Care Admission Order Set. The primary outcome measure was the percentage change in the number of orders for scheduled acetaminophen, a histamine-2 receptor antagonist (H2RA), and lactated ringers at admission before implementation of the revised order set compared with after implementation. Secondary outcomes assessed clinical impact of changes made to the order set. RESULTS: The addition of a different dosing strategy for a medication already available on the order set (scheduled acetaminophen vs. as needed acetaminophen) had no impact on physician prescribing (0 vs. 0%, p = 1.000). The addition of a new medication class (an H2RA) to the order set significantly increased the number of patients prescribed an H2RA for stress ulcer prophylaxis (0 vs. 20%, p < 0.001). Rearranging the list of maintenance intravenous fluids to make lactated ringers the first fluid option in place of normal saline significantly decreased the number of orders for lactated ringers (17 vs. 4%, p = 0.005). The order set changes had no significant impact on clinical outcomes such as incidence of transaminitis, gastrointestinal bleed, and acute kidney injury. CONCLUSION: Making changes to an admission order set can impact provider prescribing patterns. The type of change made to the order set, in addition to the specific medication changed, may have an effect on how influential the changes are on prescribing patterns.

Risk Factors and Prevalence of QTc Prolongation in Adult Burn Patients Receiving Methadone.

Methadone is an opioid commonly used for acute pain management in burn patients. One adverse effect of methadone is QTc interval prolongation, which may be associated with adverse cardiac outcomes. There is currently a paucity of data regarding risk of QTc prolongation in burn patients taking methadone and a lack of evidence-based recommendations for monitoring strategies in this population. The study objective was to determine the prevalence, risk factors, and cardiac outcomes related to methadone-associated QTc prolongation in adult burn patients. A total of 91 patients were included and were divided into groups according to maximum QTc. QTc prolongation was defined as greater than or equal to 470 ms (males) or 480 ms (females). There were no differences between groups regarding patient-specific risk factors, baseline QTc, or time to longest QTc. Patients in the prolonged QTc group had a higher rate of cardiac events (44% vs 9%; P < .001), higher median (IQR) change from baseline to longest QTc (61 ms [18,88] vs 23 ms [13,38]; P < .001), higher median (IQR) total daily dose of methadone (90 mg [53,98] vs 53 mg [30,75]; P = .004), and longer median (IQR) length of stay (53 [33,82] vs 35 [26,52] days; P = .008). QTc prolongation in burn patients was associated with increased methadone dose and resulted in a higher rate of cardiac events. This study was the first of its kind to look at risk factors and cardiac outcomes associated with methadone use in burn patients.