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Background: Accurately estimating glomerular filtration rate (GFR) is crucial for dosing medications in hospitalized patients. Due to limitations of serum creatinine for GFR estimation, serum cystatin C (CysC) has been explored as an alternative functional kidney biomarker. This study assessed discordance between eGFRCr and eGFRCysC in a large sample of hospitalized patients and examined the frequency of renally eliminated medications affected by eGFR discordance. Methods: This multisite historical study included adults hospitalized between 2011 and 2023 with CysC and serum creatinine reported within 24 h of each other. The first concurrent biomarker pair for each patient was analyzed. eGFR discordance and use of renally eliminated medications were described. Results: 17,718 hospitalized patients with concurrent creatinine and CysC assessments were included. The median eGFRCr was 65 mL/min, and the eGFRCysC was 46 mL/min. The median absolute difference of eGFRCr−eGFRCysC was 15 mL/min, and 7972 patients (45%) had a > 30% absolute difference. There was a significantly greater percentage of patients with an eGFR <30 mL/min based on eGFRCysC (26%) compared to eGFRCr (15%) (p < 0.001). Patients were prescribed an average of 20 medications in the 24 h surrounding the concurrent biomarker assessment. Renally eliminated medications accounted for 39% ± 13% of medication orders, and 80% of patients with eGFR discordance were prescribed five or more renally eliminated medications. Conclusion: Substantial eGFR discordance between eGFRCysC and eGFRCr was observed in hospitalized patients, which directly affects the dosing of renally eliminated medications. Further research is needed to optimize the pharmacotherapy of renally eliminated medications with discordant GFR assessments to improve medication safety and effectiveness. [ABSTRACT FROM AUTHOR]

Drug‐associated acute kidney injury (D‐AKI) constitutes approximately 19%–26% of all acute kidney injury (AKI) cases in hospitalized patients. Notably, there is often a deficiency in optimal drug management after D‐AKI diagnosis, with only about half of the patients experiencing discontinuation of nephrotoxins and one‐fifth avoiding further nephrotoxin administration. Nephrotoxin stewardship involves the application of coordinated care management strategies to ensure the safe utilization of nephrotoxins and renally eliminated medications. The purpose of this paper is to review nephrotoxin stewardship strategies and highlight contemporary considerations for estimating kidney function and the use of novel biomarkers as part of the stewardship program. The Chronic Kidney Disease Epidemiology Collaboration (CKDEPI) 2021 serum creatinine formula is now recommended for estimating kidney function for adults in most clinical situations in the United States. It is time to reevaluate how healthcare professionals think of estimating kidney function for drug dosing with the use of the non‐indexed, race‐free, CKDEPI 2021 equation. In addition, widespread use of serum cystatin C (CysC) is anticipated so estimated glomerular filtration rate equations that incorporate serum CysC will need to be further evaluated for drug dosing recommendations and how the use of serum CysC can complement serum creatinine‐based equations. Lastly, novel kidney stress/damage biomarkers should be viewed as a piece of a complex scenario of D‐AKI prediction, diagnosis, and prognosis and should be interpreted along with other diagnostic criteria in relation to the clinical condition of the patient. These contemporary considerations for drug dosing and D‐AKI management are important components of nephrotoxin stewardship. [ABSTRACT FROM AUTHOR]

The 2023 ACCP Research Affairs Committee was charged with developing a commentary to address best practices in pharmacy resident research and quality improvement projects and to consider methods to overcome the challenges encountered in conducting these projects. Literature regarding best practices was evaluated, and approaches were recommended that might help (1) advance the value of the projects to stakeholders; (2) overcome limited preparation for research by residents and mentors, including writing skills and dissemination experience; (3) overcome challenges related to resources (e.g., time and mentors); and (4) avoid burnout among residents and mentors. Although there are many challenges to completing projects and disseminating the results, studies have provided useful recommendations to help circumvent the barriers. [ABSTRACT FROM AUTHOR]

Best practices of pain, agitation, and delirium (PAD) management require coordinated, bundled care among an interprofessional intensive care unit (ICU) team. Clinical pharmacists are essential health care team members in optimizing sedation and analgesia management in critically ill patients. The purpose of this systematic review is to summarize the clinical impact of pharmacist‐led interventions targeting PAD in mechanically ventilated adult ICU patients. A literature search was conducted using MEDLINE, EMBASE, CINAHL, SCOPUS, and the Cochrane Central Register of Controlled Trials between January 1, 2000 and September 1, 2022. Randomized controlled trials, quasi‐experimental, or observational studies comparing pharmacist‐led interventions aimed at PAD management best practices and usual care in adult (≥18 years) ICU patients were included. Clinical (mechanical ventilation duration, hospital length of stay, and mortality) and economic outcomes as well as sedation and analgesia utilization were evaluated. A total of 1418 citations were identified with 9 studies (n = 3769 patients) meeting eligibility. The types of pharmacist‐led intervention strategies were inconsistent among included studies. Four of the 9 studies showed that pharmacist‐led interventions were associated with a significant reduction in mechanical ventilation duration ranging from 4.0 to 8.5 days compared with approximately 5.6 to 14.0 days in the control groups. Three (50%) of 6 studies evaluating length of stay showed significant reductions with the intervention group compared with controls. No impact on mortality and ICU‐acquired delirium/coma rates was shown. The pharmacist‐led intervention group was also associated with significant reductions in opioid analgesia and sedative utilization. Only two studies evaluated the financial impact of the intervention group with one study finding a positive benefit attributed to decreased drug utilization, while the other report failed to find an impact on total hospital stay costs. Pharmacist‐led interventions promote PAD best practices in the ICU, although the impact on patient‐centered outcomes remains controversial. [ABSTRACT FROM AUTHOR]

Kratom is a widely used Asian botanical that has gained popularity in the United States due to a perception that it can treat pain, anxiety, and opioid withdrawal symptoms. The American Kratom Association estimates 10–16 million people use kratom. Kratom‐associated adverse drug reactions (ADRs) continue to be reported and raise concerns about the safety profile of kratom. However, studies are lacking that describe the overall pattern of kratom‐associated adverse events and quantify the association between kratom and adverse events. ADRs reported to the US Food and Drug Administration Adverse Event Reporting System from January 2004 through September 2021 were used to address these knowledge gaps. Descriptive analysis was conducted to analyze kratom‐related adverse reactions. Conservative pharmacovigilance signals based on observed‐to‐expected ratios with shrinkage were estimated by comparing kratom to all other natural products and drugs. Based on 489 deduplicated kratom‐related ADR reports, users were young (mean age 35.5 years), and more often male (67.5%) than female patients (23.5%). Cases were predominantly reported since 2018 (94.2%). Fifty‐two disproportionate reporting signals in 17 system‐organ‐class categories were generated. The observed/reported number of kratom‐related accidental death reports was 63‐fold greater than expected. There were eight strong signals related to addiction or drug withdrawal. An excess proportion of ADR reports were about kratom‐related drug complaints, toxicity to various agents, and seizures. Although further research is needed to assess the safety of kratom, clinicians and consumers should be aware that real‐world evidence points to potential safety threats. [ABSTRACT FROM AUTHOR]

As health care transitions to value‐based care, it is more critical than ever to emphasize and quantify the impact on patient outcomes made by inpatient/acute care pharmacists and pharmacist extenders as members of the interprofessional care team. Thus, the American College of Clinical Pharmacy (ACCP) took to task the development of quality measures that were broadly applicable to the diverse inpatient/acute care landscape and important for standardizing practice, measuring impact, contextualizing benefit within the health care landscape, and allowing benchmarking within and between institutions. A framework was established by the writing committee of this paper in order to develop quality measures in a methodical manner. The resulting process led the writing committee to devise 31 foundational quality measures to be used in efforts to champion the pharmacist's role in achieving the quadruple aims in health care. Application and evaluation of quality measure performance as well as limitations and future implications of the measures are addressed to further highlight the evolving role of the inpatient/acute care pharmacist and pharmacist extender. [ABSTRACT FROM AUTHOR]

Telehealth has emerged as an essential health care delivery modality to improve patient access to health care and allow providers to meet their patients' health care needs. It is imperative that pharmacy learners and clinical pharmacists have the requisite knowledge and skills to comfortably deliver patient‐centered care via telehealth with devices, software, digital therapeutics, wearables, and other technological applications. This manuscript supplements the existing ACCP resources on this subject, educates clinical pharmacists on the rapidly advancing field of telehealth and its available technologies, and summarizes methods for training current and prospective clinical practitioners. [ABSTRACT FROM AUTHOR]

Background/Objectives: Federally‐mandated consultant pharmacist‐conducted retrospective medication regimen reviews (MRRs) are designed to improve medication safety in nursing homes (NH). However, MRRs are potentially ineffective. A new model of care that improves access to and efficiency of consultant pharmacists is needed. The objective of this study was to determine the impact of pharmacist‐led telemedicine services on reducing high‐risk medication adverse drug events (ADEs) for NH residents using medication reconciliation and prospective MRR on admission plus ongoing clinical decision support alerts throughout the residents' stay. Design: Quality improvement study using a stepped‐wedge design comparing the novel service to usual care in a one‐year evaluation from November 2016 to October 2017. Setting: Four NHs (two urban, two suburban) in Southwestern Pennsylvania. Participants: All residents in the four NHs were screened. There were 2,127 residents admitted having 652 alerts in the active period. Intervention: Upon admission, pharmacists conducted medication reconciliation and prospective MRR for residents and also used telemedicine for communication with cognitively‐intact residents. Post‐admission, pharmacists received clinical decision support alerts to conduct targeted concurrent MRRs and telemedicine. Measurement: Main outcome was incidence of high‐risk medication, alert‐specific ADEs. Secondary outcomes included all‐cause hospitalization, 30‐day readmission rates, and consultant pharmacists' recommendations. Results: Consultant pharmacists provided 769 recommendations. The intervention group had a 92% lower incidence of alert‐specific ADEs than usual care (9 vs 31; 0.14 vs 0.61/1,000‐resident‐days; adjusted incident rate ratio (AIRR) = 0.08 (95% confidence interval (CI) = 0.01–0.40]; P =.002). All‐cause hospitalization was similar between groups (149 vs 138; 2.33 vs 2.70/1,000‐resident‐days; AIRR = 1.06 (95% CI = 0.72–1.58); P =.75), as were 30‐day readmissions (110 vs 102; 1.72 vs 2.00/1,000‐resident‐days; AIRR = 1.21 (95% CI = 0.76–1.93); P =.42). Conclusions: This is the first evaluation of the impact of pharmacist‐led patient‐centered telemedicine services to manage high‐risk medications during transitional care and throughout the resident's NH stay, supporting a new model of patient care. [ABSTRACT FROM AUTHOR]

To perform an in‐depth analysis of opioid‐related ADRs reported by consumers, manufacturers and healthcare professionals. Delving into the depth and breadth of reported opioid‐related adverse drug reactions (ADRs) provides an opportunity to strategize better clinical management and alleviate safety concerns. Retrospective pharmacovigilance disproportionality analysis for opioid‐related ADRs in the FDA Adverse Event Reporting System (FAERS) database was performed. Detailed analysis of patient (sex, age) and report (year of report; reporter: healthcare worker vs consumer) characteristics were conducted using reports from 2004 quarter 1 to 2018 quarter 4. Reporting odds ratios and confidence intervals (RORs,CI) were calculated. Of the 1 916 674 ADR reports, 300 985 indicated opioids as the primary medication. There was a surge in opioid‐related ADRs reported in 2018 with six times more reports compared to 2004 and twice the number of reports compared to 2017. The largest ROR among the 20 common ADRs was depression and suicide‐self‐injury (ROR 3.12, 95% CI 3.01‐3.22) for reports in age group ≥65 compared to age group 18 to 64, and lack of efficacy (ROR 6.80, 95% CI 6.61‐7.00) for males compared to females. ADRs with the largest RORs for consumers included lack of efficacy/effect (ROR 3.37, 95% CI 3.28‐3.46), administration site reactions (ROR 3.21, 95% CI 3.11‐3.32), depression and suicide self‐injury (ROR 2.26, 95% CI 2.14‐2.38) compared to healthcare professionals. Important aspects of opioid ADR voluntary reporting included suicidal ideation in elderly patients and lack of efficacy, especially in male patients. This examination provides insight to better manage safety concerns of opioids. [ABSTRACT FROM AUTHOR]

Innovations in clinical pharmacy education have advanced patient‐centered care knowledge in skills of pharmacy graduates through the use of simulation, virtual reality, and gaming. Pharmacy schools and colleges, as well as health care institutions, have adopted simulation education in various clinical education formats for all levels of learners and practitioners. Over the past 15 years, the University of Pittsburgh School of Pharmacy has embraced innovative approaches to learning and documented advancement of clinical pharmacy education. This brief report will discuss advances in national and international pharmacy education, as well as the PittPharmacy experience with simulation education. A particular emphasis is on human patient simulation, computer‐based simulation, virtual patient, and gaming in the settings of direct patient care‐related education and assessment. The available literature and the experience at PittPharmacy shows improvement in learner satisfaction, knowledge enhancement, critical thinking skills, and problem solving in patient care topics. The evidence included provides support for the use of simulation to advance clinical pharmacy education and can serve to encourage further scholarship in this area. [ABSTRACT FROM AUTHOR]

Shock syndromes are associated with unacceptably high rates of mortality in critically ill patients despite advances in therapeutic options. Vasodilatory shock is the most common type encountered in the intensive care unit. It is manifested by cardiovascular failure, peripheral vasodilatation, and arterial hypotension leading to tissue hypoperfusion and organ failure. Hemodynamic support is typically initiated with fluid resuscitation strategies and administration of adrenergic vasopressor agents in nonresponsive patients to restore arterial pressure with subsequent adequate organ reperfusion. Unfortunately, high catecholamine dosing requirements may be necessary to achieve targeted hemodynamic goals that may increase the risk of vasopressor‐induced adverse events. The purpose of this article is to review the clinical efficacy and safety data and potential role in therapy for catecholamine‐sparing agents in vasodilatory shock. Adjunctive therapeutic options to reduce vasoactive support requirements without compromising arterial pressure include arginine vasopressin and analogs, corticosteroids, midodrine, methylene blue, and angiotensin II. Although concomitant vasopressin and corticosteroids have a more defined role in evidence‐based guidelines for managing shock, clinicians may consider other potential catecholamine‐sparing agents. [ABSTRACT FROM AUTHOR]

Over the last decade, the discovery of novel renal biomarkers and research on their use to improve medication effectiveness and safety has expanded considerably. Pharmacists are uniquely positioned to leverage this new technology for renal assessment to improve medication dosing and monitoring. Serum cystatin C is a relatively new, inexpensive, functional renal biomarker that responds more quickly to changing renal function than creatinine and is not meaningfully affected by age, sex, skeletal muscle mass, dietary intake, or deconditioning. Cystatin C has been proposed as an adjunct or alternative to creatinine for glomerular filtration rate assessment and estimation of drug clearance. Tissue inhibitor of metalloproteinase‐2·insulin‐like growth factor‐binding protein 7 ([TIMP‐2]·[IGFBP7]) is a composite of two damage biomarkers released into the urine at a checkpoint in mitosis when renal cells undergo stress or sense a future risk of damage. Concentrations of [TIMP‐2]·[IGFBP7] increase before a rise in serum creatinine is evident, thus providing insightful information for evaluation in the context of other patient data to predict the risk for impending kidney injury. This article provides a brief overview of novel renal biomarkers being used as a mechanism to improve medication safety including a discussion of cystatin C, as part of drug‐dosing algorithms and specifically for vancomycin dosing, and the use of [TIMP‐2]·[IGFBP7] for risk prediction in acute kidney injury and drug‐induced kidney disease. Select cases of clinical experience with novel renal biomarkers are outlined, and lessons learned and future applications are described. [ABSTRACT FROM AUTHOR]

Study Objective: Acute kidney injury (AKI) is a common condition associated with both short‐term and long‐term consequences including dialysis, chronic kidney disease, and mortality. Although the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database is a powerful tool to examine drug‐associated events, to our knowledge, no study has analyzed this database to identify the most common drugs reported with AKI. The objective of this study was to analyze AKI reports and associated medications in the FAERS database. Design: Retrospective pharmacovigilance disproportionality analysis. Data Source: Food and Drug Administration Adverse Event Reporting System database. Measurements and Main Results: We queried the FAERS database for reports of AKI from 2004 quarter 1 through 2015 quarter 3. Extracted drugs were assessed using published references and categorized as known, possible, or new potential nephrotoxins. The reporting odds ratio (ROR), a measure of reporting disproportionality, was calculated for the 20 most frequently reported drugs in each category. We retrieved 7,241,385 adverse event reports, of which 193,996 (2.7%) included a report of AKI. Of the AKI reports, 16.5% were known nephrotoxins, 18.6% were possible nephrotoxins, and 64.8% were new potential nephrotoxins. Among the most commonly reported drugs, those with the highest AKI ROR were aprotinin (7614 reports; ROR 115.70, 95% confidence interval [CI] 110.63–121.01), sodium phosphate (1687 reports; ROR 55.81, 95% CI 51.78–60.17), furosemide (1743 reports; ROR 12.61, 95% CI 11.94–13.32), vancomycin (1270 reports, ROR 12.19, 95% CI 11.45–12.99), and metformin (4701 reports; ROR 10.65, 95% CI 10.31–11.00). The combined RORs for the 20 most frequently reported drugs with each nephrotoxin classification were 3.71 (95% CI 3.66–3.76) for known nephrotoxins, 2.09 (95% CI 2.06–2.12) for possible nephrotoxins, and 1.55 (95% CI 1.53–1.57) for new potential nephrotoxins. Conclusion: Acute kidney injury was a common reason for adverse event reporting in the FAERS. Most AKI reports were generated for medications not recognized as nephrotoxic according to our classification system. This report provides data on medications needing further research to determine the risk of AKI with these new potential nephrotoxins. [ABSTRACT FROM AUTHOR]

Aims: To summarize and extend the main conclusions and recommendations relevant to drug management during acute kidney disease (AKD) as agreed at the 16th Acute Disease Quality Initiative (ADQI) consensus conference. Methods: Using a modified Delphi method to achieve consensus, experts attending the 16th ADQI consensus conference reviewed and appraised the existing literature on drug management during AKD and identified recommendations for clinical practice and future research. The group focussed on drugs with one of the following characteristics: (i) predominant renal excretion; (ii) nephrotoxicity; (iii) potential to alter glomerular function; and (iv) presence of metabolites that are modified in AKD and may affect other organs. Results: We recommend that medication reconciliation should occur at admission and discharge, at AKD diagnosis and change in AKD phase, and when the patient's condition changes. Strategies to avoid adverse drug reactions in AKD should seek to minimize adverse events from overdosing and nephrotoxicity and therapeutic failure from under‐dosing or incorrect drug selection. Medication regimen assessment or introduction of medications during the AKD period should consider the nephrotoxic potential, altered renal and nonrenal elimination, the effects of toxic metabolites and drug interactions and altered pharmacodynamics in AKD. A dynamic monitoring plan including repeated serial assessment of clinical features, utilization of renal diagnostic tests and therapeutic drug monitoring should be used to guide medication regimen assessment. Conclusions: Drug management during different phases of AKD requires an individualized approach and frequent re‐assessment. More research is needed to avoid drug associated harm and therapeutic failure. [ABSTRACT FROM AUTHOR]

Regardless of practice setting, it is imperative that pharmacists be able to either participate in generating new knowledge or use the ever-expanding body of literature to guide patient care. However, competing priorities in Pharm.D. curricula and residency training programs have resulted in limited emphasis on acquiring research and scholarly skills. Factors likely contributing to this reduced focus include the lack of curricular and postgraduate training standards emphasizing the development of research skills, time to commit to scholarly activity, and accessibility to experienced mentors. Strategies for increasing scholarly activity for pharmacy students and residents should therefore continue to be a focus of professional degree and residency training programs. Several resources are available for academic planners, program directors, and institutions to augment scholarly experience for pharmacy trainees and clinicians. This commentary highlights the importance of providing research opportunities for students and residents, describes the potential barriers to these activities, and provides recommendations on how to increase the instruction and mentoring of trainees to generate and use research. [ABSTRACT FROM AUTHOR]

The article focuses on innovations in medication safety. Topics discussed include use of services and technologies for enhancing the understanding and prevention of adverse drug reactions. Topics include role of health care professionals in improving patients quality of life; capitalization of existing data for postmarketing surveillance approaches; and use of computerized prescriber order entry, and clinical decision support for preventing the same.

Objectives To determine whether a clinical surveillance system could be used to detect drug-associated hypoglycemia events and determine their incidence in nursing home ( NH) residents. Design Retrospective cohort. Setting Four NHs in western Pennsylvania. Participants Any resident of the four NHs who had a computer-generated alert detecting potential drug-associated hypoglycemia over a 6-month period were included. Measurements Descriptive statistics were used to summarize all variables, including the frequency and distribution of alert type according to glucose threshold. Analyses were conducted according to numbers of alerts and residents. The medications associated with the drug-associated hypoglycemia alerts were identified, and frequency of their inclusion in alerts was calculated. Additional calculations included time to drug-associated hypoglycemic event alert from date of admission and frequency of events associated with postacute, short-stay (≤35 days) admissions. Results Seven hundred seventy-two alerts involving 141 residents were detected. Ninety (63.8%) residents had a glucose level of 55 mg/dL or less, and 42 (29.8%) had a glucose level of 40 mg/dL or less. Insulin orders were associated with 762 (98.7%) alerts. Overall incidence of drug-associated hypoglycemia events was 9.5 per 1,000 resident-days. Conclusion Hypoglycemia can be detected using a clinical surveillance system. This evaluation found a high incidence of drug-associated hypoglycemia in a general NH population. Future studies are needed to determine the potential benefits of use of a surveillance system in real-time detection and management of hypoglycemia in NHs. [ABSTRACT FROM AUTHOR]

Postgraduate year one ( PGY1) and postgraduate year two ( PGY2) residencies serve to develop pharmacists into skillful clinicians who provide advanced patient-centered care in various general and specialized areas of pharmacy practice. Pharmacy residencies are a minimum requirement for many clinical pharmacy positions, as well as for positions in academia. The role of clinical pharmacists typically includes teaching, regardless of whether they pursue an academic appointment. Common teaching duties of pharmacist-clinicians include giving continuing education or other invited presentations, providing education to colleagues regarding clinical initiatives, precepting pharmacy students (early and advanced experiences) and residents, and educating other health care professionals. Although ASHP provides accreditation standards for PGY1 and PGY2 residencies, the standards pertaining to teaching or education training are vague. Through the years, teaching certificate programs that develop residents' teaching skills and better prepare residents for a diverse pharmacy job market have increased in popularity; moreover, teaching certificate programs serve as an attractive recruitment tool. However, the consistency of requirements for teaching certificate programs is lacking, and standardization is needed. The Task Force on Residencies developed two sets of guidelines to define teaching experiences within residencies. The first guideline defines the minimum standards for teaching experiences in any residency-training program. The second guideline is for programs offering a teaching certificate program to provide standardization, ensuring similar outcomes and quality on program completion. One of the main differences between the guidelines is the recommendation that residency programs offering a teaching certificate program be affiliated with an academic institution to provide the pedagogy and variety of teaching experiences for the resident. Residency program directors should consider adopting these guidelines to offer consistent teaching experiences. In addition, residents should inquire about the elements of teaching in a program as an aid to selecting the training best suited to their needs. [ABSTRACT FROM AUTHOR]

ABSTRACT Purpose This study aimed to determine the frequency and type of adverse drug events (ADEs) identified in intensive care unit (ICU) transfer summaries and in the hospital discharge summaries to demonstrate the effectiveness of ICU transfer summary surveillance in the identification of ADEs. Methods A retrospective electronic medical record review was conducted for medical ICU patients admitted between January 2009 and April 2009 to a large, academic medical center. The Harvard Practice Scale and the modified Leonard Assessment Scale were used to evaluate the presence of an ADE from the ICU transfer and hospital discharge summaries. Results Two hundred and fifty-four patients were identified for inclusion with a median medical ICU length of stay of 4.5 days and hospital length of stay of 13 days. The ICU transfer summary review revealed 173 ADEs among 124 unique patients with a rate of 33.9 ADEs per 1000 hospital patient days. Sixty-nine ADEs among 63 unique patients were identified through the hospital discharge summary with a rate of 13.5 ADEs per 1000 hospital patient days. Only 23.1% of ADEs discussed in the ICU transfer summary were also discussed in the hospital discharge summary. Conclusions The use of ICU transfer summaries is an effective tool to increase ADE detection. The use of an ICU transfer summary should be considered as an adjunct method to an existing ADE surveillance system for heightened pharmacovigilance. Copyright © 2013 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Purpose Signals are used to alert clinicians of potential ADRs. Positive predictive values (PPVs) of antidote signals in ICUs are unknown. The primary purpose was to determine PPVs of six signals. The secondary objective was to determine the sensitivity of various ADR detection strategies including manual chart review, administrative data review, and voluntary reporting at identifying the same ADRs discovered using antidotes as a signal. Methods Adult patients admitted to a medical ICU from July 1, 2005 to June 30, 2006 who were prescribed select signals were eligible. Evaluated antidote signals included injectable diphenhydramine, protamine, phytonadione, dextrose 50%, injectable methylprednisolone, and sodium polystyrene. For each signal, a random sample of 50 patients was evaluated for the presence of an ADR. ADR occurrences were determined using two objective causality instruments through retrospective chart review. Agreement between the instruments was required for ADR consideration. PPVs were determined for each signal. Results Two hundred and twenty three patients (52% male) were evaluated, with a mean ± SD age of 60 ± 17 years, and a median simplified acute physiology score (SAPSII) of 48. PPVs were 0.64, 0.50, 0.38, 0.26, 0.24, and 0.02 for protamine, sodium polystyrene, dextrose 50%, diphenhydramine, phytonadione, and methylprednisolone, respectively. Sensitivity of other detection strategies from highest to lowest was chart review for explicit documentation, administrative database review, and voluntary reporting. Conclusions Protamine and sodium polystyrene performed the best by detecting ADRs in at least one out of two evaluations. Detection strategies other than signals were not as sensitive at identifying the same ADRs as antidote signals. Copyright © 2009 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Objective. To compare clinical outcomes and glycoprotein IIb-IIIa inhibitor use in patients undergoing percutaneous coronary intervention (PCI) who received bivalirudin or unfractionated heparin (UFH) in a real-world setting. Design. Retrospective cohort analysis. Setting. University-affiliated medical center. Patients. One thousand seventy-five adult patients who underwent PCI and received either bivalirudin (539 patients) or UFH (536 patients) from April 1, 2003-April 1, 2004. Measurement and Main Results. Patient data on demographics, comorbidities, laboratory values, and reports of radiologic examinations, cardiac catheterizations, and discharge summaries were obtained. Outcomes evaluated included rates of in-hospital mortality, myocardial infarction, revascularization, and length of stay (LOS), as well as Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events (REPLACE-2) and Thrombosis in Myocardial Infarction (TIMI) bleeding categorization. Bivalirudin use was associated with a significant reduction in TIMI major (5.0% vs 9.7%, p=0.003), REPLACE-2 major (5.4% vs 12.9%, p<0.001), and TIMI minor (1.7% vs 6%, p<0.001) bleeding complications compared with UFH use. Significantly fewer patients in the bivalirudin group received glycoprotein IIb-IIIa inhibitors (27.3% vs 62.7%, p<0.001). Patients receiving bivalirudin had significantly fewer myocardial infarctions after catheterization (10.7% [40/375] vs 18.0% [51/284], p=0.007). No differences were noted in mortality and revascularization rates between groups. A shortened LOS was observed in the bivalirudin group. Conclusions. This real-world analysis that included high-risk patients provides further evidence that bivalirudin is an attractive alternative to UFH because of a decrease in bleeding events without compromising efficacy. [ABSTRACT FROM AUTHOR]

The purpose of this study was to quantify the total hospital resource use for decompensated heart failure according to disease progression categories. Clinical and cost information was obtained from an electronic data repository and chart review. During the 1-year period from June 2002 to June 2003, qualified patients were categorized based on disease progression as (1) new onset, (2) known heart failure, or (3) readmission. The primary outcome variables were total hospital resource use and resource use by services. Analysis of variance, Scheffé analysis for pairwise comparisons, and chi-square analysis were performed to determine differences among groups. Total hospitalization costs are similar whether it is a new diagnosis of heart failure, known diagnosis, or readmission. Among the 3 categories, 5 services contained statistically significant differences in costs (P<.05): echocardiography, electrophysiology, neurodiagnostic, nuclear cardiology, and pharmacy. Careful analysis of hospital resource use by services for heart failure patients provides opportunities for institutional cost containment. [ABSTRACT FROM AUTHOR]

Aim To develop an appropriate dosing strategy for continuous intravenous infusions (CII) of enoxaparin by minimizing the percentage of steady-state anti-Xa concentration ( Css) outside the therapeutic range of 0.5–1.2 IU ml−1. Methods A nonlinear mixed effects model was developed with NONMEM® for 48 adult patients who received CII of enoxaparin with infusion durations that ranged from 8 to 894 h at rates between 100 and 1600 IU h−1. Three hundred and sixty-three anti-Xa concentration measurements were available from patients who received CII. These were combined with 309 anti-Xa concentrations from 35 patients who received subcutaneous enoxaparin. The effects of age, body size, height, sex, creatinine clearance (CrCL) and patient location [intensive care unit (ICU) or general medical unit] on pharmacokinetic (PK) parameters were evaluated. Monte Carlo simulations were used to (i) evaluate covariate effects on Css and (ii) compare the impact of different infusion rates on predicted Css. The best dose was selected based on the highest probability that the Css achieved would lie within the therapeutic range. Results A two-compartment linear model with additive and proportional residual error for general medical unit patients and only a proportional error for patients in ICU provided the best description of the data. Both CrCL and weight were found to affect significantly clearance and volume of distribution of the central compartment, respectively. Simulations suggested that the best doses for patients in the ICU setting were 50 IU kg−1 per 12 h (4.2 IU kg−1 h−1) if CrCL < 30 ml min−1; 60 IU kg−1 per 12 h (5.0 IU kg−1 h−1) if CrCL was 30–50 ml min−1; and 70 IU kg−1 per 12 h (5.8 IU kg−1 h−1) if CrCL > 50 ml min−1. The best doses for patients in the general medical unit were 60 IU kg−1 per 12 h (5.0 IU kg−1 h−1) if CrCL < 30 ml min−1; 70 IU kg−1 per 12 h (5.8 IU kg−1 h−1) if CrCL was 30–50 ml min−1; and 100 IU kg−1 per 12 h (8.3 IU kg−1 h−1) if CrCL > 50 ml min−1. These best doses were selected based on providing the lowest equal probability of either being above or below the therapeutic range and the highest probability that the Css achieved would lie within the therapeutic range. Conclusions The dose of enoxaparin should be individualized to the patients’ renal function and weight. There is some evidence to support slightly lower doses of CII enoxaparin in patients in the ICU setting. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the paper "Relationship Between Potential Opioid-Related Adverse Effects and Hospital Length of Stay in Patients Receiving Opioids After Orthopedic Surgery" published in "Pharmacotherapy" journal.

Fifty-five thousand patients are cared for in the intensive care unit (ICU) daily with sedation utilized to reduce anxiety and agitation while optimizing comfort. The Society of Critical Care Medicine (SCCM) released updated guidelines for management of pain, agitation, and delirium in the ICU and recommended nonbenzodiazepines, such as dexmedetomidine and propofol, as first line sedation agents. Dexmedetomidine, an alpha-2 agonist, offers many benefits yet its use is mired by the inability to consistently achieve sedation goals. Three hypotheses including patient traits/characteristics, pharmacokinetics in critically ill patients, and clinically relevant genetic polymorphisms that could affect dexmedetomidine response are presented. Studies in patient traits have yielded conflicting results regarding the role of race yet suggest that dexmedetomidine may produce more consistent results in less critically ill patients and with home antidepressant use. Pharmacokinetics of critically ill patients are reported as similar to healthy individuals yet wide, unexplained interpatient variability in dexmedetomidine serum levels exist. Genetic polymorphisms in both metabolism and receptor response have been evaluated in few studies, and the results remain inconclusive. To fully understand the role of dexmedetomidine, it is vital to further evaluate what prompts such marked interpatient variability in critically ill patients. [ABSTRACT FROM AUTHOR]

The article focuses on the updated white paper "Rewards and Advancements for Clinical Pharmacy Practitioners," published by the American College of Clinical Pharmacy (ACCP). The white paper discusses existing systems of providing rewards and allowing career advancements for clinical pharmacists. According to clinical pharmacists surveyed, the significant factors for success in their career include work-life balance and professional advancement opportunities. Two thirds of the clinical pharmacists were found to have no professional development plan.

The American College of Clinical Pharmacy charged the Clinical Practice Affairs Committee to review and update the College's 1995 White Paper, "Rewards and Advancements for Clinical Pharmacy Practitioners." Because of the limited data on the present state of rewards and advancements for clinical pharmacists, an online survey of "front-line" clinical pharmacists and pharmacy managers was conducted (1126 total respondents, 14% response rate). The resulting White Paper discusses motivators and existing systems of rewards and advancements for clinical pharmacists, as well as perceived barriers to implementation of these systems. Clinical pharmacists reported work-life balance, a challenging position, and opportunities for professional advancement as the most important factors for career success. At the time of the survey, financial rewards appeared not to be a major motivator for clinical pharmacists. Managers underestimated the importance that clinical pharmacists place on work-life balance and favorable work schedules. Although almost two thirds of the clinical pharmacists surveyed had not developed a professional development plan, 84% indicated an interest in career planning. Both clinical pharmacists and managers rated the lack of a clear reward and advancement structure as the most important barrier to effective systems of rewards and advancements. Pharmacy managers and administrators are encouraged to develop effective systems of rewards and advancements for clinical pharmacists that positively impact patient care and the institution's mission; these systems will benefit the clinical pharmacist, the health care institution, and the patient.

Aim: To develop an appropriate dosing strategy for continuous intravenous infusions (CII) of enoxaparin by minimizing the percentage of steady-state anti-Xa concentration (C(ss)) outside the therapeutic range of 0.5-1.2 IU ml(-1)., Methods: A nonlinear mixed effects model was developed with NONMEM for 48 adult patients who received CII of enoxaparin with infusion durations that ranged from 8 to 894 h at rates between 100 and 1600 IU h(-1). Three hundred and sixty-three anti-Xa concentration measurements were available from patients who received CII. These were combined with 309 anti-Xa concentrations from 35 patients who received subcutaneous enoxaparin. The effects of age, body size, height, sex, creatinine clearance (CrCL) and patient location [intensive care unit (ICU) or general medical unit] on pharmacokinetic (PK) parameters were evaluated. Monte Carlo simulations were used to (i) evaluate covariate effects on C(ss) and (ii) compare the impact of different infusion rates on predicted C(ss). The best dose was selected based on the highest probability that the C(ss) achieved would lie within the therapeutic range., Results: A two-compartment linear model with additive and proportional residual error for general medical unit patients and only a proportional error for patients in ICU provided the best description of the data. Both CrCL and weight were found to affect significantly clearance and volume of distribution of the central compartment, respectively. Simulations suggested that the best doses for patients in the ICU setting were 50 IU kg(-1) per 12 h (4.2 IU kg(-1) h(-1)) if CrCL < 30 ml min(-1); 60 IU kg(-1) per 12 h (5.0 IU kg(-1) h(-1)) if CrCL was 30-50 ml min(-1); and 70 IU kg(-1) per 12 h (5.8 IU kg(-1) h(-1)) if CrCL > 50 ml min(-1). The best doses for patients in the general medical unit were 60 IU kg(-1) per 12 h (5.0 IU kg(-1) h(-1)) if CrCL < 30 ml min(-1); 70 IU kg(-1) per 12 h (5.8 IU kg(-1) h(-1)) if CrCL was 30-50 ml min(-1); and 100 IU kg(-1) per 12 h (8.3 IU kg(-1) h(-1)) if CrCL > 50 ml min(-1). These best doses were selected based on providing the lowest equal probability of either being above or below the therapeutic range and the highest probability that the C(ss) achieved would lie within the therapeutic range., Conclusions: The dose of enoxaparin should be individualized to the patients' renal function and weight. There is some evidence to support slightly lower doses of CII enoxaparin in patients in the ICU setting.