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The extent to which postintensive care unit (ICU) clinics may improve patient safety for those discharged after receiving intensive care remains unclear. This observational cohort study conducted at an academic, tertiary care medical center used qualitative survey data analyzed via conventional content analysis to describe patient safety threats encountered in the post-ICU clinic. For 83 included patients, safety threats were identified for 60 patients resulting in 96 separate safety threats. These were categorized into 7 themes: medication errors (27%); inadequate medical follow-up (25%); inadequate patient support (16%); high-risk behaviors (5%); medical complications (5%); equipment/supplies failures (4%); and other (18%). Of the 96 safety threats, 41% were preventable, 27% ameliorable, and 32% were neither preventable nor ameliorable. Nearly 3 out of 4 patients within a post-ICU clinic had an identifiable safety threat. Medication errors and delayed medical follow-up were the most common safety threats identified; most were either preventable or ameliorable.

Background Post-intensive care syndrome (PICS) is defined as a new or worsening impairment in physical, cognitive, or mental health following critical illness. Intensive care unit recovery centers (ICU-RC) are one means to treat patients who have PICS. The purpose of this study is to describe the role of pharmacists in ICU-RCs. Research Question What is the number and type of medication interventions made by a pharmacist at an ICU-RC at 12 different centers? Study Design and Methods This prospective, observational study was conducted in 12 intensive care units (ICUs)/ICU-RCs between September 2019 and July 2021. A full medication review was conducted by a pharmacist on patients seen at the ICU-RC. Results 507 patients were referred to the ICU-RC. Of these patients, 474 attended the ICU-RC and 472 had a full medication review performed by a pharmacist. Baseline demographic and hospital course data were obtained from the electronic health record and at the ICU-RC appointment. Pharmacy interventions were made in 397 (84%) patients. The median number of pharmacy interventions per patient was 2 (interquartile range [IQR] = 1,3). Medications were stopped and started in 124 (26%) and 91 (19%) patients, respectively. The number of patients that had a dose decreased and a dose increased was 51 (11%) and 43 (9%), respectively. There was no difference in the median total number of medications that the patient was prescribed at the start and end of the patient visit (10, IQR = 5, 15). Adverse drug event (ADE) preventive measures were implemented in 115 (24%) patients. ADE events were identified in 69 (15%) patients. Medication interactions were identified in 30 (6%) patients. Interpretation A pharmacist plays an integral role in an ICU-RC resulting in the identification, prevention, and treatment of medication-related problems. This paper should serve as a call to action on the importance of the inclusion of a pharmacist in ICU-RC clinics.

Purpose To describe the prevalence of burnout and secondary traumatic stress (STS) in health-system pharmacists during the coronavirus disease 2019 (COVID-19) pandemic. Methods A cross-sectional, professional pharmacy organization listserver–based online survey of a target group of health-system pharmacists across the United States was conducted. The survey was sent out through professional organization listservers and was anonymous and voluntary. The survey questionnaire included items regarding demographics and employment characteristics, COVID-19–related questions, a survey of respondents’ perceptions of the prevalence and severity of burnout, and the Professional Quality of Life Scale (ProQOL). The ProQOL assessed respondents for compassion satisfaction (subcategorized as burnout and STS) and compassion fatigue. Descriptive statistics was used to assess the prevalence of burnout and STS. Results Four hundred eighty-four health-system pharmacists completed the survey. Based on respondents’ self-ratings of burnout, 47% were identified as having current burnout and 81% as having a history of burnout. Based on ProQOL scoring, 65.3% of respondents were identified as having a moderate or high likelihood of burnout, which was a prevalence higher than that indicated by respondents’ self-ratings. Additionally, 51.4% of respondents were identified as having a moderate or high probability of STS and 99.4% as having a moderate or high probability of compassion satisfaction. Conclusion The survey found that over half of health-system pharmacists were affected with burnout, half with STS, and all with compassion satisfaction during the COVID-19 pandemic. Unfortunately, the development of burnout and STS in these health-system pharmacists may lead to several work-related consequences (eg, increase risk of medical errors, depression); therefore, addressing burnout and STS is crucial. Further studies of the consequences of burnout and STS during the COVID-19 pandemic are needed.

The demands posed during the coronavirus disease 2019 (COVID-19) pandemic have led to greater stress and frustration, which in turn can fuel exhaustion, cynicism, secondary traumatic stress (STS), and burnout. More evidence is needed regarding the prevalence of burnout and STS throughout the pandemic.The aim of this study was to describe the changing pattern of the prevalence of burnout and STS in health-system pharmacists throughout the pandemic (early to 20 months into the pandemic).A cross-sectional, listserv-based online survey was conducted in health-system pharmacists. The survey was administered between April and May 2020 (early group) and again between October and December 2021 (20-month group). The survey questionnaire included demographics, employment characteristics, COVID-19-related questions, survey of respondent's perceptions of prevalence and severity of burnout, and Professional Quality of Life Scale (ProQOL) which assessed compassion satisfaction and fatigue (burnout and STS).A total of 1126 health-system pharmacists completed the survey (484 in the early group and 642 in the 20-month group). Based on respondents' self-rating of burnout, significantly more respondents reported feeling burned out in the 20-month group vs the early group (69% vs 47.7%;Twenty months into the COVID-19 pandemic, almost 83% of health-system pharmacist respondents were identified with burnout, 63% with STS, and 99% with compassion satisfaction. These rates are significantly higher compared with rates early in the pandemic. Unfortunately, the development of burnout and STS in these pharmacists may lead to several work-related consequences (eg, increase risk of medical errors); therefore, further studies are critical to develop and assess effective interventions to address the long-term effects of the pandemic and well-being of health-system pharmacists.

Background Currently, there is limited literature on the impact of the COVID-19 infection on medications and medical conditions in COVID-19 intensive care unit (ICU) survivors. Our study is, to our knowledge, the first multicenter study to describe the prevalence of new medical conditions and medication changes at hospital discharge in COVID-19 ICU survivors. Objective To determine the number of medical conditions and medications at hospital admission compared to at hospital discharge in COVID-19 ICU survivors. Methods Retrospective multicenter observational study (7 ICUs) evaluated new medical conditions and medication changes at hospital discharge in patients with COVID-19 infection admitted to an ICU between March 1, 2020, to March 1, 2021. Patient and hospital characteristics, baseline and hospital discharge medication and medical conditions, ICU and hospital length of stay, and Charlson comorbidity index were collected. Descriptive statistics were used to describe patient characteristics and number and type of medical conditions and medications. Paired t-test was used to compare number of medical conditions and medications from hospital discharge to admission. Results Of the 973 COVID-19 ICU survivors, 67.4% had at least one new medical condition and 88.2% had at least one medication change. Median number of medical conditions (increased from 3 to 4, P < .0001) and medications (increased from 5 to 8, P < .0001) increased from admission to discharge. Most common new medical conditions at discharge were pulmonary disorders, venous thromboembolism, psychiatric disorders, infection, and diabetes. Most common therapeutic categories associated with medication change were cardiology, gastroenterology, pain, hematology, and endocrinology. Conclusion and Relevance Our study found that the number of medical conditions and medications increased from hospital admission to discharge. Our results provide additional data to help guide providers on using targeted approaches to manage medications and diseases in COVID-19 ICU survivors after hospital discharge.

Background: Complex medication regimen changes burden intensive care unit (ICU) survivors and their caregivers during the transition to home. Intensive care unit recovery clinics are a prime setting for pharmacists to address patients’ and their caregivers’ medication-related needs. The purpose of this study was to describe ICU recovery clinic pharmacists’ activities, roles, and perceived barriers and facilitators to practicing in ICU recovery clinics across different institutions. Methods: An expert panel of ICU recovery clinic pharmacists completed a 15-item survey. Survey items addressed the pharmacists’ years in practice, education and training, activities performed, their perceptions of facilitators and barriers to practicing in an ICU recovery clinic setting, and general ICU recovery clinic characteristics. Descriptive statistics were used. Results: Nine ICU recovery clinic pharmacists participated. The average number of years in practice was 16.5 years (SD = 13.5, range = 2-38). All pharmacists practiced in an interprofessional ICU recovery clinic affiliated with an academic medical center. Seven (78%) pharmacists always performed medication reconciliation and a comprehensive medication review in each patient visit. Need for medication education was the most prevalent item found in patient comprehensive medication reviews. The main facilitators for pharmacists’ successful participation in an ICU recovery clinic were incorporation into clinic workflow, support from other health care providers, and adequate space to see patients. The ICU recovery clinic pharmacists perceived the top barriers to be lack of dedicated time and inadequate billing for services. Conclusions: The ICU recovery clinic pharmacists address ICU survivors’ medication needs by providing direct patient care in the clinic. Strategies to mitigate pharmacists’ barriers to practicing in ICU recovery clinics, such as lack of dedicated time and adequate billing for pharmacist services, warrant a multifaceted solution, potentially including advocacy and policy work by national pharmacy professional organizations.

Purpose Direct-acting antivirals (DAAs) used to treat hepatitis C virus (HCV) infection are associated with significant drug-drug interactions (DDIs). Pharmacists are well positioned to identify and mitigate these DDIs. Data to guide assessment of the impact of HCV specialty pharmacy services on identifying and addressing DDIs with DAAs are lacking. The overall purpose of the study described here was to determine the incidence and severity of DDIs identified by specialty pharmacists among patients treated with DAAs prior to and 1 month into therapy. Methods An observational, retrospective study was conducted to evaluate the impact of specialty pharmacy services in mitigating DDIs associated with use of DAAs. Adult patients with HCV infection (n = 200) who received DAAs and were enrolled with a specialty pharmacy service over a 1-year period were included. Endpoints included number, severity, and type of DDIs and DDIs per patient at baseline and 1 month into therapy, pharmacists’ interventions, and safety and clinical outcomes. Results Fifty-nine percent of patients had at least 1 DDI. A total of 170 DDIs were identified (137 at baseline and 33 at 1-month follow-up), and the mean number of DDIs per patient significantly decreased from baseline to 1-month follow-up (from 1.38 to 0.16, P < 0.0001). The rate of “potentially clinically significant” or “critical” interactions was significantly lower at 1-month follow-up vs baseline assessment (69.6% vs 81.7%, P < 0.0001). The most commonly identified DDIs involved acid suppressive medications (49.6% and 66.6% of DDIs at baseline and follow-up assessment, respectively) and cardiovascular medications (26.2% and 21.2%, respectively). Total number of DDI interventions was 131, with an acceptance rate of 85%. Most common intervention was patient education and monitoring. Conclusion Approximately 60% of patients had DDIs with DAAs. Implementing HCV specialty pharmacy services significantly decreased DDIs while maintaining SVR12.

Background The coronavirus disease 2019 (COVID-19) pandemic has drastically disrupted primary health care and pharmacy services, posing a challenge in people with chronic diseases who receive routine care. Currently, there exists limited literature on the indirect impact of the pandemic on chronic disease management, particularly related to accessibility to medications and health care resources. Objectives To determine the prevalence of medical- and medication-related problems reported by people with chronic diseases during the pandemic. The secondary objective was to identify the barriers and contributing factors related to these medical- and medication-related problems. Methods The anonymous and voluntary, Web-based survey was filled out by interested adult respondents with chronic disease(s) across Michigan between September 1, 2020, and January 1, 2021. The primary outcome included self-reported medical- and medication-related problems during the pandemic. Secondary outcomes included potential risk factors for medical- and medication-related problems. Descriptive statistics was used to describe respondents’ demographics, chronic disease characteristics, medication adherence, medical- and medication-related problems, and COVID-19–related factors. The multivariable Firth logistic regression was used to analyze correlations between potential risk factors associated with medical- and medication-related problems. Results A total of 1103 respondents completed the survey and were included in the analysis. Approximately, 51% of respondents reported a medication-related problem with 19.6% reported problems obtaining medication(s) and 31.7% reported forgetting or not taking their medication(s). The top reason for problems obtaining medication(s) was doctor’s office being closed for in-person visit(s). In addition, of all responses, more than half reported worsening symptoms of their chronic disease(s) during the pandemic especially with psychiatric disorders (79.5%) and inflammatory bowel disease (60%). Respondents with a significantly higher risk of medication-related problems included those who were younger, were female, and had psychiatric disorder(s), diabetes, arthritis, or lupus, and respondents with a significantly higher risk of medical-related problems included those with multiple chronic diseases, psychiatric disorder(s), and heart failure. Conclusion Understanding the consequences of the pandemic, such as medical- and medication-related problems, in this population is critical to improving health care accessibility and resources through potential outpatient pharmacy services during this and future pandemics.

Background: Numerous equations are used for estimation of renal function, and many electronic medical records report multiple clearance estimates to assist with drug dosing. It is unknown whether the presence of multiple clearance estimates affects clinical decision-making. Objective: To determine whether the presence of multiple renal clearance estimates affects pharmacist drug dosing decisions. Methods: A randomized trial in the form of an electronic survey including 4 clinical vignettes was delivered to hospital pharmacists. Vignettes consisted of a patient presenting with an acute pulmonary embolism requiring enoxaparin therapy. Pharmacists were randomized to receive a single estimate of renal function or multiple estimates for all vignettes. The primary outcome was deviation from approved recommendations on at least 1 vignette. The χ2 test was used to detect differences in deviation rates between groups. Logistic regression was performed to adjust for the effects of potentially confounding variables. Results: A total of 154 studies were completed (73 in the multiple-estimate group and 81 in the single-estimate group). Pharmacists presented with multiple renal estimates were significantly more likely to deviate from recommended dosing regimens than pharmacists presented with a single estimate (54.7% vs 38.2%; P = 0.04). The results were driven primarily by the 2 vignettes that included discordance among Cockcroft-Gault equation creatinine clearance estimates. Logistic regression identified multiple estimates as the only independent predictor of deviation ( P = 0.04). Conclusion and Relevance: Pharmacists provided with a single renal clearance estimate were more likely to adhere to approved dosing recommendations than pharmacists provided with multiple estimates.

Introduction Developing pharmacy residents into effective preceptors is essential to meet the demands of pharmacy education. A survey was created to assess the availability of resident precepting educational opportunities, identify common barriers associated with developing preceptors’ skills, and discover strategies to optimize programming. Methods An online survey focused on the development of residents as preceptors was e-mailed to all residency program directors (RPD) for American Society of Health-System Pharmacists accredited residencies in the United States. Information was collected on program demographics, level of support and precepting activities offered and resident employment outcomes. Results Five hundred thirty-eight responses were received. The majority were postgraduate year one RPDs and had less than six residents. Sixty-one percent of programs were affiliated with a college of pharmacy. Seventy-eight percent devoted 10 hours or less per month in developing residents as preceptors with 33% providing less than five hours. Seventy-one percent of the residency programs did not offer a formal precepting rotation. However, 59% of respondents indicated that their residency graduates frequently accepted positions, which required teaching/precepting. The most common barriers to developing residents as preceptors included: lack of time for residents to precept within the residency structure (41%), availability of preceptors to mentor residents throughout experience (33%) and lack of preceptors’ availability to mentor residents’ precepting abilities over time (30%). Discussion and conclusions RPDs should prioritize training of residents as preceptors. Requiring residents to serve as primary preceptors in rotations dedicated to teaching is important to prepare for future job responsibilities.

Treatment of chronic hepatitis C virus (HCV) therapy has rapidly changed since the approval of IFN in the 1990s. Early treatment brought about significant and therapy limiting adverse drug events (ADEs) such as anemia. Since the direct-acting antivirals were first approved in 2011 and then advanced in 2013, treatment-related ADEs and therapy discontinuations have rapidly decreased, while sustained virologic response rates have significantly increased. As the market for treating chronic HCV therapy has changed, so too has the ADE profile clinicians may need to manage.

Objectives: To review the pharmacology, efficacy, and safety of ledipasvir-sofosbuvir for the treatment of chronic hepatitis C virus (HCV). Data Sources: A literature search through clinicaltrials.gov, EMBASE, and PubMed was conducted (January 1966 to October 2014) using the terms ledipasvir, sofosbuvir, GS-5885, and GS-7977. References from retrieved articles and abstracts presented at recent meetings were reviewed for any additional material. The prescribing information was also reviewed. Study Selection/Data Extraction: Phase 1, 2, and 3 human and animal studies describing the pharmacology, pharmacokinetics, efficacy, and safety of ledipasvir and sofosbuvir for HCV were identified. Data Synthesis: Ledipasvir-sofosbuvir, a fixed-dose combination (FDC) tablet inhibiting nonstructural (NS) 5A and 5B proteins, without peginterferon and ribavirin is indicated for adult patients with genotype 1 HCV infection who are treatment naïve or experienced, with or without cirrhosis. Pivotal trials (n = 1952) have demonstrated that once-daily administration of ledipasvir-sofosbuvir for 12 or 24 weeks is effective at achieving sustained virological response (SVR) rates (94%-99%) in treatment-naïve patients (12 weeks), treatment-experienced patients without cirrhosis (12 weeks), and treatment-experienced patients with cirrhosis (24 weeks). Treatment-naïve patients without cirrhosis and baseline viral levels of less than 6 million IU/mL may be considered for 8 weeks of treatment. The most common adverse drug events (ADEs) associated with ledipasvir-sofosbuvir include headache, fatigue, insomnia, nausea, and diarrhea. Conclusions: Ledipasvir-sofosbuvir is the first interferon- and ribavirin-free FDC agent that has SVR rates much greater than 94%, with minimal ADEs, for the treatment of chronic HCV genotype 1 in naïve and treatment-experienced patients.

The objective of this opinion paper was to identify and describe potential clinical pharmacists' services for the prevention and management of patients infected with the hepatitis C virus (HCV). The goals of this paper are to guide the establishment and development of pharmacy services for patients infected with HCV and to highlight HCV research and educational opportunities. Recommendations were based on the following: a review of published data on clinical pharmacist involvement in the treatment and management of HCV-infected patients; a consensus of clinical pharmacists who provide direct patient care to HCV-infected patients and practice in different pharmacy models, including community-based and academic settings; and a review of published guidelines and literature focusing on the treatment and management of HCV infections. The recommendations provided in this opinion paper define the areas of clinical pharmacist involvement and clinical pharmacy practice in the treatment and management of patients with HCV. Clinical pharmacists can promote preventive measures and education about reducing HCV transmission, improve medication adherence, assist in monitoring clinical and adverse effects, recommend treatment strategies to minimize adverse effects and drug interactions, and facilitate medication acquisition and logistics that positively improve patient outcomes and reduce the health care system costs.

Objectives: To review the pharmacology, efficacy, and safety of vedolizumab in the treatment of patients with ulcerative colitis (UC) and Crohn’s disease (CD). Data Sources: A literature search through clinicialtrials.gov, EMBASE and MEDLINE was conducted (January 1966-June 2014) using the terms vedolizumab and MLN0002. References from retrieved articles were reviewed for any additional material. Additionally, the prescribing information was retrieved. Study Selection/Data Extraction: Phase 1, 2, and 3 human and animal studies describing the pharmacology, pharmacokinetics, efficacy, and safety of vedolizumab were identified. Data Synthesis: Vedolizumab, an α4β7 integrin inhibitor, was recently approved for adult patients with moderate to severe active UC or CD who are refractory or intolerant to standard therapies or who are dependent on corticosteroids. Trial data have demonstrated that vedolizumab 300 mg at weeks 0, 2, and 6 followed by every 8 weeks is effective at inducing and maintaining clinical response and remission, improving mucosal appearance, and achieving corticosteroid-free remission in patients with UC. This regimen is also effective at achieving clinical response, remission, and corticosteroid-free remission in patients with CD. Patients treated with vedolizumab, unadjusted for exposure, reported experiencing nasopharyngitis, headache, nausea, arthralgias, pyrexia, upper-respiratory-tract infections, fatigue, and cough. Conclusions: Vedolizumab is an effective agent at inducing and maintaining remission in patients with UC or CD. Vedolizumab is generally well tolerated and has not been associated with progressive multifocal leukoencephalopathy.

Background: Telaprevir-induced rash is a common, therapy-limiting adverse drug event (ADE) for patients with hepatitis c virus (HCV) infection. Given the similarity between telaprevir and simeprevir, real-world management of rash during treatment with an NS3/4A protease inhibitor and its implications are important. Objective: The objectives of this study were to determine the incidence of rash in telaprevir-treated patients, its management, and the impact on sustained virological response and to identify any risk factors for rash development. Method: This was a retrospective study of adult patients who were treated with telaprevir in a hepatology clinic from July 1, 2011, to August 31, 2012. Pertinent information on demographics, past medical history, medications, laboratory data, outcomes of rash, other ADEs related to treatment, and physician grading of rash were collected. Result: Of 159 patients included, 44% (70/159) developed rash, and 4% (7/159) discontinued therapy because of rash. Median number of days until rash did not differ between patients who continued and discontinued therapy (25 vs 45, respectively; P = 0.88). Patients who developed rash were more likely to have lower actual body weight (ABW) or body mass index (BMI; P ≤ 0.01). No significant difference in rash development when drug-allergy history was considered was found. Most patients who continued telaprevir were prescribed topical corticosteroids (93.7%) and cetirizine (41.3%). Patients who discontinued therapy were more likely to be evaluated by dermatology ( P = 0.002), prescribed oral corticosteroids ( P = 0.02), hydroxyzine ( P = 0.001), and topical triamcinolone ( P = 0.01). Conclusion: ABW and BMI appear to be related to rash development. This finding may have implications in the treatment of HCV with simeprevir, given its similarity to telaprevir.

Hepatitis C virus (HCV) is the most common blood-borne infection in the United States. The high morbidity and mortality due to untreated infection have prompted updated screening recommendations that now include one-time HCV screening for all patients born between 1945 and 1965, in addition to risk factor-based screening. Current guidelines recommend treatment for all patients with chronic HCV. Treatment for HCV genotype 1 has evolved dramatically since the approval of the direct-acting antivirals. The approval of ledipasvir-sofosbuvir, ombitasvir-paritaprevir-ritonavir and dasabuvir, and simeprevir with sofosbuvir has dramatically altered the treatment landscape. High sustained virologic response (SVR) rates favor treatment, yet access to care poses a challenge for patients and providers. Current and emerging data with new therapies indicate high SVR rates in treatment-naive and treatment-experienced patients, including patients with cirrhosis and in other special populations. Additional data suggest the addition of ribavirin can decrease treatment duration without compromising SVR rates. Resistance is an increasing area of interest in HCV, with baseline mutations identified and the potential for the development of resistance-associate variants in patients undergoing treatment. Due to the rapid evolution of HCV treatment, pharmacists should address challenges and play an integral role in agent selection, dosing, drug interaction screening, adverse effect monitoring, and the coordination of treatment. Clinical application of the latest information will reduce patient risk and improve outcomes.

OBJECTIVE: To evaluate the efficacy and safety of combination therapy for the treatment and prevention of hepatic encephalopathy (HE). DATA SOURCES: A PubMed MEDLINE search was conducted (1947-June 2012) using the key terms lactulose, lactitol, nonabsorbable disaccharide, metronidazole, rifaximin, neomycin, probiotics, and hepatic encephalopathy. Searches were limited to include articles published in English. STUDY SELECTION AND DATA EXTRACTION: Study selection included published trials, case reports, and case series of humans with HE who were treated with combination therapy of rifaximin, lactulose, lactitol, metronidazole, neomycin, and/or probiotics. DATA SYNTHESIS: Only 6 studies that evaluated the benefits of combination drug therapy in the treatment or prevention of HE were available for review. Four studies addressed the treatment of HE, 2 found no significant difference between lactulose/neomycin versus placebo or rifaximin/lactulose, 1 assessed the use of rifaximin/lactulose without a control group, and the fourth found no significant difference between lactulose/probiotics versus either drug alone, although each group showed improvement from baseline. In the 2 prevention trials, both of which stemmed from the same data, the combination of rifaximin/lactulose was superior to lactulose alone, showing significant improvement in mental status, blood ammonia levels, and health-related quality of life and reductions in HE recurrence and hospitalization. Currently, there are no available clinical studies evaluating dual antibiotic therapy, metronidazole with nonabsorbable disaccharides, or antibiotics with probiotics. CONCLUSIONS: The evidence evaluating the use of combination therapy for the treatment of HE does not support its widespread use. The combination of rifaximin and lactulose may be considered in the treatment of HE and in patients refractory to monotherapy. The combination of rifaximin and lactulose should be considered for the prevention of HE, especially after the second episode of HE recurrence.

The American College of Clinical Pharmacy charged the Public and Professional Relations Committee to develop a short white paper describing quality measures of clinical pharmacists' patient care services in transitional care settings. Transitional care describes patient movement from one health care setting or service to another. Care transitions are associated with an increased risk of adverse events for patients. Pharmacists play an important role in ensuring that medication errors and adverse events are minimized during these transitions, largely through the reconciliation of medications and assurance of continuity of care. Quality measures are often divided into three domains: structure, process, and outcome. Given the typical nature of the pharmacist's role, process indicators are best suited to evaluate quality clinical pharmacist services. However, process indicators relevant to pharmacists' activities are not yet fully described in the literature. The committee searched available literature describing quality measures that are directly influenced by the pharmacist during care transitions. This white paper describes these process indicators as quality measures of clinical pharmacists' services, identifies the transitional settings and activities to which they are most applicable, and provides the published sources from which indicators were derived. For process indicators that could not be found in published sources, we propose relevant measures that can be adapted for use in a given setting. As pharmacists become more involved in diverse and emerging patient care areas such as transitional care, it will be critical that they use these types of measures to document the quality of new services and reinforce the need for pharmacist participation during transitions of care.

Dual antiplatelet therapy with a thienopyridine (ticlopidine or clopidogrel) and aspirin is used to reduce the risk of late stent thrombosis and complications (myocardial infarction [MI] and death) after placement of a drug-eluting stent (DES).This article reviews available clinical efficacy and safety data on antiplatelet therapies for the prevention of stent thrombosis and cardiac events after DES placement.MEDLINE, EMBASE, and International Pharmaceutical Abstracts (1966-June 2010) were searched for studies relating to the clinical efficacy and safety of antiplatelet therapy after DES placement using the terms antiplatelet therapy, thienopyridine, aspirin, clopidogrel, cilostazol, prasugrel, ticlopidine, paclitaxel-eluting stent, sirolimus-eluting stent, and drug-eluting stent. The reference lists of the identified articles were reviewed for additional relevant publications.Ten studies were identified that evaluated the efficacy of antiplatelet therapies after DES placement; of these, 5 also assessed safety. In a prospective, observational cohort study, early discontinuation of clopidogrel (within the first 6 months after DES placement) was a major predictor of stent thrombosis (hazard ratio [HR] = 13.74; 95% CI, 4.04-46.68; P0.001). In an observational cohort study, early discontinuation of clopidogrel was associated with significantly higher rates of long-term clinical events (death and death or MI) (discontinuation at 6 months: P = 0.004; discontinuation at 12 months: P0.001). A multicenter, randomized, double-blind, prospective study found a reduction in the composite end point of death, MI, and target-vessel revascularization within 30 days after DES placement in patients who received a high loading dose of clopidogrel (600 mg) compared with the conventional loading dose (300 mg) (4% vs 12%, respectively; P = 0.041). In a multicenter, randomized, prospective study in patients with long coronary lesions undergoing DES placement, triple antiplatelet therapy (clopidogrel, cilostazol, and aspirin) was associated with significant reductions at 6 months compared with dual antiplatelet therapy (clopidogrel and aspirin) in in-stent late loss (mean [SD], 0.22 [0.48] vs 0.32 [0.51] mm, respectively; P = 0.03) and in-segment late loss (0.34 [0.49] vs 0.51 [0.49] mm; P = 0.001). In a similar study in patients with diabetes mellitus, triple therapy was associated with significant reductions at 6 months in rates of in-segment restenosis (8.0% vs 15.6%; RR = 0.51; 95% CI, 0.27-0.96; P = 0.033), target-lesion revascularization (2.5% vs 7.0%; RR = 0.36; 95% CI, 0.13-0.97; P = 0.034), and major adverse cardiac events (2.8% vs 7.6%; P = 0.016). In a multicenter, retrospective study comparing triple and dual antiplatelet therapy in patients with ST-segment elevation MI undergoing DES placement, triple therapy was associated with significant reductions at 8 months compared with dual therapy in rates of cardiac deaths (2.0% vs 3.2%; P = 0.019), total deaths (3.1% vs 4.9%; P = 0.006), and total major adverse cardiac events (7.6% vs 9.3%; P = 0.049). Overall, use of triple therapy was not associated with an increased risk of major or minor bleeding events compared with dual therapy. In a multicenter, randomized, double-blind, prospective study in patients with acute coronary syndrome (ACS) who underwent DES placement and received the combination of prasugrel or clopidogrel and aspirin, the prasugrel regimen was associated with significant reductions in rates of the composite end point of cardiovascular death, nonfatal MI, and nonfatal stroke (HR = 0.82; 95% CI, 0.69-0.97; P = 0.019) and late stent thrombosis (0.42% vs 0.91%, respectively; P = 0.04). However, the combination of prasugrel and aspirin was associated with significant increases compared with clopidogrel and aspirin in rates of total bleeding events (5.0% vs 3.8%; P = 0.002), major bleeding events (2.4% vs 1.8%; P = 0.03), and life-threatening bleeding events (1.4% vs 0.9%; P = 0.01).The combination of clopidogrel (loading dose, 300-600 mg; maintenance dose, 75 mg/d) and low-dose aspirin (75-162 mg/d) for 12 months is the preferred regimen for the prevention of stent thrombosis and cardiac complications after DES placement. The combination of prasugrel and aspirin may be appropriate in patients with ACS, although it was associated with a significantly increased risk for bleeding. Triple antiplatelet therapy may be beneficial in certain high-risk patients.

Study Objective. To assess the effect of a prolonged continuous infusion of pantoprazole on patient outcomes when the drug was combined with standard octreotide therapy in patients with variceal hemorrhage. Design. Retrospective cohort study Setting. Large academic hospital. Patients. One hundred thirty adults who received treatment for a documented variceal hemorrhage; 53 patients received standard octreotide therapy plus a prolonged continuous infusion of pantoprazole (continuous-infusion group) and 77 patients received either octreotide alone, octreotide with a short-term (< 24 hrs) infusion of pantoprazole, or octreotide with intermittent acid suppression (control group). Measurements and Main Results. The primary outcome measure was the number of units of packed red blood cells transfused during hospitalization. Baseline characteristics between the treatment groups were similar. The duration of therapy for variceal hemorrhage was significantly longer in the continuous-infusion group than in the control group. Transfusion requirements for packed red blood cells (mean ± SD 6.4 ± 6.5 vs 5.8 ± 6.6 units, p=0.66) and platelets (8.8 ± 15.1 vs 5.1 ± 11.9 units, p=0.13) were similar for the continuous-infusion group versus the control group. The continuous-infusion group, however, received significantly more units of fresh-frozen plasma than the control group (6.1 ± 10.6 vs 2.9 ± 6.2 units, p=0.05). There was no significant difference in mortality rate between groups. Conclusion. Prolonged continuous infusions of pantoprazole with octreotide seemed to offer no additional benefit compared with octreotide plus short-term infusions of pantoprazole or intermittent acid suppression in the management of acute variceal hemorrhage. Prospective studies should be conducted to evaluate the role of continuously infused proton pump inhibitors in this setting before their use can be advocated.

Acute kidney injury in critically ill patients is often a complication of an underlying condition such as organ failure, sepsis, or drug therapy. In these patients, stress-induced hypercatabolism results in loss of body cell mass. Unless nutrition support is provided, malnutrition and negative nitrogen balance may ensue. Because of metabolic, fluid, and electrolyte abnormalities, optimization of nutrition to patients with acute kidney injury presents a challenge to the clinician. In patients treated with conventional intermittent hemodialysis, achieving adequate amino acid intake can be limited by azotemia and fluid restriction. With the use of continuous renal replacement therapy (CRRT), however, better control of azotemia and liberalization of fluid intake allow amino acid intake to be maximized to support the patient's metabolic needs. High amino acid doses up to 2.5 g/kg/day in patients treated with CRRT improved nitrogen balance. However, to our knowledge, no studies have correlated increased amino acid intake with improved outcomes in critically ill patients with acute kidney injury. Data from large, prospective, randomized, controlled trials are needed to optimize the dosing of amino acids in critically ill patients with acute kidney injury who are treated with CRRT and to study the safety of high doses and their effects on patient morbidity and survival.

Background The substantial cost of erythropoietic growth factors (EGFs), darbepoetin alfa and epoetin alfa, has led many institutions to evaluate EGF usage and costs in the hospital setting. The primary objectives of this study were to determine the clinical impact on hemoglobin (Hb) concentration, postdischarge epoetin alfa dose requirements, and the economic impact of a darbepoetin alfa for epoetin alfa therapeutic interchange program in hospitalized hemodialysis patients. Methods A retrospective review was conducted in 79 patients (43 during a control period and 36 during the interchange period). The control group consisted of chronic hemodialysis patients admitted to the hospital before the therapeutic interchange program was implemented (September 2002 through September 2003); the interchange group included patients admitted after implementation of the interchange program (October 2003 through October 2004). Clinical parameters including Hb concentration, concomitant iron therapy, packed red blood cell (PRBC) transfusions, EGF dose and cost were collected beginning 2 months prior to hospitalization, during hospitalization, through 2 months post hospital discharge. Results No differences were observed between groups in baseline demographics. There was a greater decrease in Hb concentration in the control group compared to the interchange group, but this did not achieve statistical significance (0.5 g/dL vs 0.3 g/dL, respectively; P = 0.67). EGF dose requirements did not differ between the two groups, nor did the total EGF cost per patient admission before and after hospitalization. Total cost per patient during hospitalization was $164 ± 144 in the control group and $165 ± 156 in the interchange EGF group ( P= 0.97). Conclusion: In the treatment of anemia in hospitalized chronic hemodialysis patients, there were no differences seen in Hb concentration, EGF dose requirements, or overall EGF cost per patient admission. Implementation of the interchange program allowed for market share gains to permit an overall economic benefit across all patients in the amount of $300,000 annually.

To evaluate the effectiveness of a warfarin educational video in the hospital setting and to determine patients' satisfaction with using an iPad to view a warfarin educational video.This prospective quality improvement project included adult (≥18 years of age) patients on warfarin in the hospital. All patients completed pre-video and post-video knowledge tests on the iPad before and after viewing the educational video on warfarin therapy. Patients also completed a patient satisfaction survey.Forty hospitalized patients were educated using the warfarin video and included for analysis. The majority of patients were new to warfarin therapy (65%). Forty-three percent of patients passed the pre-video knowledge test, and 90% passed the post-video knowledge test (P0.001). No significant differences were observed among knowledge test scores when compared by age, sex, level of education, and use of central nervous system depressant medications. Most patients (82.5%) reported they liked using the iPad and found it easy to use. Patients who were younger (65 years) and female subjects reported they liked using the iPad more than older patients (P = 0.01) and male subjects (P = 0.02), respectively. Also, younger patients found the iPad easier to use compared with patients who were older (P = 0.01).Educating hospitalized patients about warfarin by using a video on an iPad was effective. Video education on an iPad may be an alternative to traditional education in the hospital setting.

Purpose The pharmacology, pharmacokinetics, pharmacodynamics, clinical efficacy, safety, drug interactions, viral drug resistance, dosage and administration, and place in therapy of telaprevir are reviewed. Summary Telaprevir is an oral NS3/4A protease inhibitor that was recently approved by the Food and Drug Administration for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection in adult patients with compensated liver disease, including cirrhosis. In Phase II clinical trials, triple therapy (telaprevir with peginterferon alfa and ribavirin) demonstrated 20–39% higher rates of sustained virological response (SVR) versus standard therapy (peginterferon alfa and ribavirin) in patients with chronic HCV genotype 1. Higher SVR rates were observed in treatment-naive patients or patients who did not respond to prior therapy (did not achieve SVR). Phase III studies also found improved SVR rates in patients treated with triple therapy. Telaprevir is recommended in combination with peginterferon alfa-2a and ribavirin for treatment-naive patients and patients who did not previously respond to peginterferon alfa-2a and ribavirin therapy. Telaprevir is a substrate and inhibitor of cytochrome P-450 (CYP) isoenzyme 3A4 and P-glycoprotein. Drugs that induce or inhibit CYP3A4 may affect concentrations of telaprevir, resulting in reduced efficacy or increased concentrations of telaprevir (and an increased risk for adverse reactions). The most common adverse events reported with telaprevir monotherapy versus placebo were diarrhea, nausea, fatigue, and dry skin. Conclusion Telaprevir, an HCV NS3/4A protease inhibitor, has been shown to be effective in increasing SVR rates when used with peginterferon alfa and ribavirin in patients with chronic HCV genotype 1 infection, regardless of treatment history.

To review the pharmacology and pharmacokinetics and evaluate the safety and efficacy of eltrombopag for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP) and thrombocytopenia associated with hepatitis C virus (HCV) cirrhosis.A Cochrane Controlled Trial Register, clinicaltrials.gov, EMBASE, and MEDLINE search was performed (January 1966-March 2010) using the key terms eltrombopag and SB-497115-GR. Searches were limited to published English-language studies in humans and a reference review of the pertinent literature was conducted.Published pharmacokinetic data and safety and efficacy trials, case reports, and case series on the use of eltrombopag were selected for inclusion.Eltrombopag is a novel second-generation thrombopoietin receptor agonist that was approved by the Food and Drug Administration for the treatment of chronic ITP in patients who had an insufficient response to corticosteroids, intravenous immune globulin, or splenectomy. Eltrombopag has been shown to be superior to placebo in increasing platelet counts, with more patients achieving counts50 x 10(3)/microL. One study has also shown eltrombopag to be effective in the treatment of thrombocytopenia associated with HCV cirrhosis. Eltrombopag has a boxed warning related to risk of hepatotoxicity, with criteria for discontinuation in patients with elevated liver enzyme levels or clinical signs of liver damage. As such, close monitoring of laboratory parameters is required, and patients must be registered with the PROMACTA CARES program.Eltrombopag is effective in increasing platelet counts in patients with chronic ITP and in patients with HCV cirrhosis. In the treatment of ITP, eltrombopag has been studied only for short durations and is more expensive than first-line oral corticosteroids; therefore, it should be considered a second-line agent. More studies are needed to identify a place in therapy for eltrombopag in the treatment of thrombocytopenia associated with HCV cirrhosis.

Objective: To evaluate the available literature describing the use of inhaled amphotericin B for prophylaxis of invasive Aspergillus spp. infections. Data Sources: A MEDLINE search was conducted (1966–July 2006) using the key terms amphotericin B, inhaled amphotericin B, Aspergillus spp., invasive aspergillosis, solid-organ transplant, neutropenia, and inhalation. Review of the reference lists of the identified articles was also performed. Study Selection And Data Extraction: Study selection included published trials, case reports, and case series of humans with hematologic disease and solid-organ transplant who used inhaled amphotericin B in the prevention of invasive Aspergillus infections. Data Synthesis: Inhaled amphotericin B has been evaluated for the prevention of invasive aspergillosis (IA) infections in neutropenic patients and certain solid-organ transplant recipients. Use of inhaled amphotericin B seems to reduce the incidence of IA in these patients; however, some of the clinical evidence was limited by factors such as small sample sizes, lack of statistical analyses, and lack of power to detect a difference between prophylaxis and control groups. Although the clinical evidence supporting the use of inhaled amphotericin B has some limitations, its use still may be beneficial for the prophylaxis of invasive Aspergillus infections, especially in solid-organ transplant recipients where the evidence is strongest. Conclusions: Invasive Aspergillus infections are becoming more prevalent in high-risk populations (eg, patients with malignancies, following bone marrow transplantation, or following solid-organ transplantation). The mortality rates associated with IA are great in these populations, making prophylaxis an important consideration. Inhaled amphotericin B has recently come into vogue as an option for prophylaxis against IA. Some of the data available supports the use of inhaled amphotericin B for the prevention of IA while providing evidence of fewer drug interactions and toxicities associated with other antifungal agents.

To assess student satisfaction and learning of course objectives following the integration of virtual patient cases designed to promote active, patient-centered learning in an advanced therapeutics pharmacy course.A dynamic virtual patient platform that incorporated a branched-narrative, decision-making teaching model was used in an advanced therapeutics course to supplement lecture content.Presimulation and postsimulation tests were used to assess student learning. The use of virtual patients significantly enhanced student learning for both higher- and lower-level test questions (p0.001 and p=0.01, respectively). Students agreed or strongly agreed that the virtual patient cases provided an effective way to learn (72%), were enjoyable (69%), and were appropriate in content (80%), and that more should be incorporated (59%).The use of virtual patients in an advanced therapeutics practicum effectively promoted active, patient-centered learning; engaged students in an interactive and dynamic educational technology; encouraged teamwork; enhanced higher-level student learning; and improved student satisfaction in the course.

Consistent with the American College of Clinical Pharmacy's vision that future clinical pharmacy practitioners who provide direct patient care should be board-certified specialists, a new framework for pharmacist specialty board certification is proposed. This White Paper describes the current and projected needs of the pharmacy profession regarding board certification, provides a rationale for the new framework, and discusses the potential ramifications of changes in the current board-certification process.