An International, Multicenter Evaluation of Comprehensive Medication Management by Pharmacists in ICU Recovery Centers.

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.

Identification of Patient Safety Threats in a Post-Intensive Care Clinic.

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.

Changing patterns of the prevalence of burnout and secondary traumatic stress in health-system pharmacists throughout the COVID-19 pandemic.

Introduction: 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. Objectives: 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). Methods: 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). Results: 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%; P < .001). Based on ProQOL, significantly more respondents were identified with moderate-high likelihood of burnout (83.8% vs 65.3%; P < .001) and moderate-high probability of STS (63.2% vs 51.4%; P < .001) in the 20-month group vs the early group. Approximately 99% of respondents in both groups were identified with moderate-high probability of compassion satisfaction. Conclusion: 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.

An Electronic Decision Support Intervention Reduces Readmissions for Patients With Cirrhosis.

INTRODUCTION: Rifaximin use in combination with lactulose is associated with a decreased risk of overt hepatic encephalopathy (HE). METHODS: We prospectively evaluated the impact of an interruptive electronic medical record alert to indicate rifaximin for patients with cirrhosis and HE on lactulose. RESULTS: The intervention was associated increased rifaximin utilization, particularly for nongastroenterology and hospitalist services odds ratio 1.20 95% confidence interval (1.09-1.31). For patients with HE, the intervention was associated with a lower readmission risk-adjusted subdistribution hazard ratio 0.63 95% confidence interval (0.48-0.82). DISCUSSION: An interruptive alert in the electronic ordering system was associated with a lower risk of readmissions.

Medication Changes and Diagnosis of New Chronic Illnesses in COVID-19 Intensive Care Unit Survivors.

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.

The impact of the COVID-19 pandemic on medical conditions and medication adherence in people with chronic diseases.

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.

Evaluation of a specialty hepatitis C virus telephone pharmacy service.

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.

Burnout and secondary traumatic stress in health-system pharmacists during the COVID-19 pandemic.

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 Impact of Multiple Renal Estimates on Pharmacist Dosing Recommendations: A Randomized Trial.

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.

Pharmacists' Perceptions on Their Role, Activities, Facilitators, and Barriers to Practicing in a Post-Intensive Care Recovery Clinic.

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.

Residents as preceptors and educators: What we can learn from a national survey to improve our residency programs.

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 10hours 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.

Therapeutic Advances in HCV Genotype 1 Infection: Insights from the Society of Infectious Diseases Pharmacists.

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-naïve 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.

Daclatasvir: A NS5A Replication Complex Inhibitor for Hepatitis C Infection.

OBJECTIVES: To review the pharmacology, efficacy, and safety of daclatasvir in the treatment of patients with chronic hepatitis C virus (HCV) infection. DATA SOURCES: A literature search through EMBASE and PubMed was conducted (January 1966 to August 2015) using the terms BMS-790052, daclatasvir, and hepatitis C. References from retrieved articles were reviewed for any additional material. Additionally, the new drug application and prescribing information were retrieved. STUDY SELECTION/DATA EXTRACTION: The literature search was limited to human studies published in English. Phase 1, 2, and 3 studies describing the pharmacology, pharmacokinetics, efficacy, and safety of daclatasvir for HCV were identified. DATA SYNTHESIS: Daclatasvir, a nonstructural 5A protein inhibitor, combined with sofosbuvir, is indicated for adult patients with chronic HCV genotype 3 regardless of treatment or cirrhosis status. The phase III ALLY-3 trial (n = 152) demonstrated that daclatasvir taken once daily with sofosbuvir for 12 weeks was effective at achieving sustained virological response (SVR) rates in treatment-naïve (97%) and treatment-experienced (94%) patients without cirrhosis. Patients with cirrhosis had significantly lower SVR rates (58 and 69%, respectively). The most common adverse drug events associated with daclatasvir and sofosbuvir in ALLY-3 were headache (20%), fatigue (19%), and nausea (12%). CONCLUSIONS: Daclatasvir, when combined with sofosbuvir, is an effective agent to treat HCV genotype 3, with SVR rates above 90% for patients without cirrhosis who are treatment naïve or experienced. SVR rates for treatment-naïve or -experienced patients with cirrhosis are not as robust (58%-69%).

The changing landscape of adverse drug events associated with chronic hepatitis C virus therapy.

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.

Ledipasvir-sofosbuvir: interferon-/ribavirin-free regimen for chronic hepatitis C virus infection.

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.

Use of an iPad to Provide Warfarin Video Education to Hospitalized Patients.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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 (P < 0.001). 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). CONCLUSION: 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.

Provision of clinical pharmacist services for individuals with chronic hepatitis C viral infection: Joint Opinion of the GI/Liver/Nutrition and Infectious Diseases Practice and Research Networks of the American College of Clinical Pharmacy.

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.

Vedolizumab: an α4ß7 integrin inhibitor for inflammatory bowel diseases.

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 α4ß7 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.