Disease-Modifying Medications in Patients with Rheumatoid Arthritis in the USA: Trends from 2016 to 2021.

BACKGROUND: Disease-modifying anti-rheumatic drugs (DMARDs), since their introduction in 1990, have revolutionized the management of rheumatoid arthritis. Newer DMARDs have recently been approved, influencing treatment patterns and clinical guidelines. OBJECTIVE: To update the current prescribing patterns of DMARDs in the pharmacotherapy of rheumatoid arthritis (RA) to include the pandemic era. METHODS: This was a retrospective cross-sectional multi-year study. Using Optum's Clinformatics® Data Mart Database, we summarized trends in the prevalence of DMARD use in the USA from 2016 to 2021 by year for adult patients ≥ 18 years old with at least one medical RA claim and one pharmacy/medical claim of a DMARD medication. Trends included type of DMARD, class of DMARD (conventional (csDMARDs), biologics [tumor necrosis factor (TNFi) and Non-TNFi), and Janus kinase inhibitors (JAKs)], and triple therapy [methotrexate (MTX), hydroxychloroquine (HCQ), sulfasalazine (SUL)] used. RESULTS: The total sample from 2016 to 2021 was 670,679 commercially insured patients. The average age was 63.7 years (SD 13.6), and 76.7% were female and 70% were White. csDMARDs remain the most prescribed (ranging from 77.2 to 79.2%). Although JAKs were the least prescribed DMARD class, their proportion more than doubled from 2016 (1.5%) to 2021 (4%). MTX utilization declined from 40% in 2016 to 34% in 2021. In contrast, HCQ use increased during the pandemic era from < 25% in 2018 to 30% in 2021. Although there is evidence of the therapeutic benefit of triple therapy, its use was very low (~ 1%) compared to biologics only (~ 17%) or biologics+MTX (~ 10%). CONCLUSION: About half of patients with RA were on DMARDs. As expected, csDMARDs were highly used consistently. The COVID-19 pandemic might have influenced the use of HCQ and infusion DMARDs. Triple therapy use remains low.

Interinstitutional simulation of patients with COVID-19 during a remote acute-care advanced pharmacy practice experience.

Introduction: Faculty and staff from Duquesne University and the University of Pittsburgh Schools of Pharmacy created a simulation activity focused on the care of critically ill patients with coronavirus disease 2019 (COVID-19). Students on remote, short-term-care advanced pharmacy practice experiences (APPE) rotations from both universities worked in comingled teams and completed two educational electronic health record reviews, complex simulation sessions, and debriefs. Individually, students completed two educational electronic health record reviews and verbal patient presentations before and after the simulation sessions. Objectives: Evaluate the effects of a simulation activity during a remote short-term-care APPE on student confidence and knowledge surrounding the care of a critically ill patient with COVID-19. Methods: Student knowledge surrounding COVID-19 short-term-care treatment principles was assessed through pre-/postcase-based multiple-choice examinations and an intermittent clinical examination (ICE). Student confidence and perceptions were gathered through anonymous pre-/postsurveys. The written examination and patient presentation recordings were compared from baseline to the final assessment using the Wilcoxon signed-rank test. Results: In total, 92 students participated in the activity. There was a statistically significant improvement from baseline to the final assessment (preassessment median [interquartile range (IQR)]: 55.3% [50%-60.5%]; postassessment median [IQR]: 68.4 [60.5%-73.7%]; P < .001) on the written examination. ICE total scores improved from baseline (preassessment median [range]: 33 [28-36] vs postassessment median [range]: 36.5 [29.5-43.52]; P = .004) as well as the objective (P < .001), plan (P < .001), and monitoring (P < .001) subdomain scores. Student confidence reported on surveys improved from baseline in all domains. Conclusion: Remote simulation sessions improve student knowledge and confidence and provide an opportunity for students to experience caring for patients with COVID-19 in a safe environment. Collaboration between schools of pharmacy can be successfully employed to leverage resources and expertise to expand opportunities for students.

Use of an immersive, simulated learning game to teach pharmacy students clinical concepts of toxicology.

BACKGROUND AND PURPOSE: Management of a poisoned patient is a critical part of any health care professional's education. A new, innovative teaching platform was developed allowing students to try to "break out" of various kits, locks, and scrambled codes to build collaboration, problem-solving, and critical thinking skills - similar to the recently popular "escape rooms." Our purpose was to illustrate how this learning game can be utilized in pharmacy education to teach and apply clinical knowledge and evaluate its effectiveness on student-perceived confidence and competency in management of toxicologic emergencies. EDUCATIONAL ACTIVITY AND SETTING: Students participated as part of an acute care elective. They worked in small groups and were given the same test pre- and post-quiz for two cases. Students were also administered a survey about their confidence in managing toxidromes after completion of the activity. FINDINGS: Drastic improvements in test scores were observed with both cases' pre- and post-test. Students also found the activity increased their knowledge of toxicology concepts and level of student-perceived confidence in managing similar cases. The majority of students were satisfied with the experience and thought it should be included elsewhere in the doctor of pharmacy curriculum. SUMMARY: The learning game was an effective and satisfying educational tool to understand and apply medical toxicology principles for pharmacy students. Additional implementation of this game would be preferred by most students and may aid in the education of other health care professionals on complex clinical management of toxicology cases.

Use of Disproportionality Analysis to Identify Previously Unknown Drug-Associated Causes of Cardiac Arrhythmias Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database.

INTRODUCTION: Drug-induced QTc-prolongation is a well-known adverse drug reaction (ADR), however there is limited knowledge of other drug-induced arrhythmias. PURPOSE: The objective of this study is to determine the drugs reported to be associated with arrhythmias other than QTc-prolongation using the FAERS database, possibly identifying potential drug causes that have not been reported previously. METHODS: FAERS reports from 2004 quarter 1 through 2019 quarter 1 were combined to create a dataset of approximately 11.6 million reports. Search terms for arrhythmias of interest were selected from the Standardized MedDRA Queries (SMQ) Version 12.0. Frequency of the cardiac arrhythmias were determined for atrial fibrillation, atrioventricular block, bradyarrhythmia, bundle branch block, supraventricular tachycardia, and ventricular fibrillation and linked to the reported causal medications. Reports were further categorized by prior evidence associations using package inserts and established drug databases. A reporting odds ratio (ROR) and confidence interval (CI) were calculated for the ADRs for each drug and each of the 6 cardiac arrhythmias. RESULTS: Of the 11.6 million reports in the FAERS database, 68,989 were specific to cardiac arrhythmias of interest. There were 61 identified medication-reported arrhythmia pairs for the 6 arrhythmia groups with 33 found to have an unknown reported association. Rosiglitazone was the most frequently medication reported across all arrhythmias [ROR 6.02 (CI: 5.82-6.22)]. Other medications with significant findings included: rofecoxib, digoxin, alendronate, lenalidomide, dronedarone, zoledronic acid, adalimumab, dabigatran, and interferon beta-1b. CONCLUSION: Upon retrospective analysis of the FAERS database, the majority of drug-associated arrhythmias reported were unknown suggesting new potential drug causes. Cardiac arrhythmias other than QTc prolongation are a new area of focus for pharmacovigilance and medication safety. Consideration of future studies should be given to using the FAERS database as a timely pharmacovigilance tool to identify unknown adverse events of medications.

Pharmacy Personnel's Involvement in Transitions of Care of Intensive Care Unit Patients: A Systematic Review.

OBJECTIVE: Do pharmacy personnel- (ie, pharmacist or pharmacy technician) driven interventions at transitions of care into or out of the intensive care unit (ICU) improve medication safety measures compared to interventions made by other health-care team members or no intervention? DATA SOURCES: A literature search of MEDLINE and Embase limited to English language and humans was performed (from 1969 until January 2019). Bibliographies of included investigations were reviewed for additional citations. METHODS: Investigations were selected if they described a pharmacy-driven intervention at any point of transfer into or out of an ICU setting. Ten investigations were included. Five described interventions relevant to the entire ICU population, and 5 described interventions targeted to specific medications or disease. RESULTS: A variety of interventions were utilized in the 10 included investigations. A significant improvement was demonstrated with pharmacy-driven intervention in all 4 studies that evaluated the entire ICU patient population. Interventions specific to certain medication and disease improved medication safety measures but were not always statistically significant. Medication error rates are high in patients transferred into and out of the ICU, and limited data exist to address this concern. This review compares and evaluates the current literature to guide future interventions and research in this area. CONCLUSIONS: Although pharmacy-driven interventions demonstrated some benefit in various medication safety measures in the majority of studies, additional randomized and prospective trials with patient-centered outcomes that assess morbidity and mortality are needed.

Pharmacologic Management of Delirium in the ICU: A Review of the Literature.

PURPOSE: Conflicting data exists on the pharmacologic management of intensive care unit (ICU) delirium. This review appraises the current evidence of pharmacologic management of ICU delirium. MATERIALS AND METHODS: A systematic literature search of MEDLINE and Embase was conducted to answer the population, intervention, comparison, and outcome (PICO) question of: "Does the use of a pharmacologic agent compared to standard of care or placebo improve ICU delirium in a critically ill patient population?" RESULTS: After application of the PICO question and the inclusion and exclusion criteria, 13 articles were included. Of these articles, 7 were prospective randomized controlled trials, 1 was a prospective nonrandomized controlled trial, and 5 were retrospective investigations. The included articles differed in the agents evaluated, primary outcome, and method of identifying delirium. CONCLUSION: The variability of outcomes illustrates the need for a large-scale investigation to further evaluate the role of pharmacologic management of ICU delirium.

A community pharmacy-led intervention for opioid medication misuse: A small-scale randomized clinical trial.

BACKGROUND: Stemming the opioid epidemic requires testing novel interventions. Toward this goal, feasibility and acceptability of a Brief Motivational Intervention-Medication Therapy Management (BMI-MTM) intervention was examined along with its impact on medication misuse and concomitant health conditions. METHODS: We conducted a two-group randomized trial in 2 community pharmacies. We screened patients for prescription opioid misuse at point-of-service using the Prescription Opioid Misuse Index. Participants were assigned to standard medication counseling (SMC) or SMC + BMI-MTM (referred to as BMI-MTM herein). BMI-MTM consists of a pharmacist-led medication counseling/brief motivational session and 8-weekly patient navigation sessions. Assessments were at baseline, 2-, and 3-months. Primary outcomes included feasibility, acceptability, and mitigation of opioid medication misuse. Secondary outcomes included pain and depression. Outcomes were analyzed with descriptive and multivariable statistics (intent-to-treat [ITT] and adjusted for number of sessions completed [NUMSESS]). RESULTS: Thirty-two participants provided informed consent (74.4% consent rate; SMC n = 17, BMI-MTM n = 15; 3-month assessment retention ≥93%). Feasibility was demonstrated by all BMI-MTM recipients completing the pharmacist session and an average of 7 navigation sessions. BMI-MTM recipients indicated ≥4.2 (5 maximum) level of satisfaction with the pharmacist-led session, and 92.4% were satisfied with navigation sessions. Compared to SMC at 3-months, BMI-MTM recipients reported greater improvements in misuse (ITT: Adjusted Odds Ratio [AOR] = 0.13; 95% CI = 0.05, 0.35, p < 0.001. NUMSESS: AOR = 0.05; 95% CI = 0.01, 0.25; p < 0.001), pain (ITT: В = 8.8, 95% CI=-0.95, 18.5, p = 0.08; NUMSESS: В = 14.0, 95% CI = 3.28, 24.8, p = 0.01), and depression (ITT: B= -0.44; 95% CI=-0.65, -0.22; p < 0.001. NUMSESS: B= -0.64; 95% CI=-0.82, -0.46; p < 0.001). CONCLUSIONS: BMI-MTM is a feasible misuse intervention associated with superior satisfaction and outcomes than SMC. Future research should test BMI-MTM in a large-scale, fully-powered trial.

Effects of Cross-Training on Medical Teams' Teamwork and Collaboration: Use of Simulation.

Previous research in the US Navy demonstrated that cross-training enhances teamwork and interpersonal collaboration. Limited data exists on cross-training effectiveness in medical education. This research aimed to assess whether cross-training would have similar effects on medical teams. A multidisciplinary pair of resident participants-consisting of one physician and one pharmacist-was randomly assigned to cross-training or current training condition. The training experience involved one video-based content module (training a pharmacist's task of pharmacokinetic dosing and a physician's task of intubation) and one simulation-based practice scenario (collaborative treatment of an unstable critically ill simulated patient). Interprofessional pairs randomized to cross-training condition participated in both the content module and practice scenario in the alternative professional role whereas pairs randomized to current training condition participated in their own professional role. Pairs also participated in pre- and post- training assessment scenarios in their own professional role. Teamwork and interprofessionalism were measured immediately following assessment scenarios. Knowledge assessments were conducted at the start and end of the scenario sequence. Multidisciplinary pairs experiencing cross-training showed a significant improvement in teamwork (increased by 6.11% vs. 3.24%, p < 0.05). All participants demonstrated significant improvement in knowledge scores (increase of 14% cross-training, p < 0.05, and increase of 13.9% control, p < 0.05). Our project suggests that cross-training can improve teamwork in interprofessional medical teams.

Assessing Adverse Drug Reactions from Psychotropic Medications Reported to the U.S. Food and Drug Administration in Older Adults.

OBJECTIVE: Identify trends in adverse drug reactions (ADRs) reported to the U.S. Food and Drug Administration's Adverse Event Reporting System in three subpopulations of older adults (ages 55-64, 65-74, 75+) receiving psychotropic medications. METHODS: Almost 12 years of ADR reports were compiled for adults over 55 years of age receiving psychotropic medications with known side effect profiles. A comparison of the frequency of ADRs reported, odds ratios (ORs), and 95% confidence intervals (CIs) between subpopulations to the whole population of patients aged 55+ was conducted. RESULTS: ADRs reported in three subpopulations of older adults differed significantly when receiving the same psychotropic medications. For example, reports of increased blood glucose (OR, 1.8, CI, 1.4-2.2) were all significantly increased in the youngest population (55-64). CONCLUSION: Current classification of age greater than 65 years when evaluating likely ADRs in older adults using psychotropic medications may be inadequate and require further assessment by subpopulations of older adults.

Evaluation of pharmacist satisfaction with simulation-based learning in Singapore.

BACKGROUND AND PURPOSE: High fidelity human patient simulation (HPS) has been incorporated in various United States doctor of pharmacy programs with favorable learning experiences, knowledge retention, and problem-solving skills reported. In Singapore, HPS is a novel learning technique as it has not been utilized in the Bachelor of Science (Pharmacy) curriculum or for continuing professional education (CPE). It is necessary to evaluate acceptance of HPS compared to asynchronous online learning (AOL). EDUCATIONAL ACTIVITY AND SETTING: Nineteen participants from two institutions completed the study in Singapore. This was an experimental study design with participants randomized into groups A and B. Group A completed AOL followed by HPS, whereas group B completed them in reverse order. Acceptance of teaching modalities was evaluated with a Likert scale survey and analyzed with Fisher's exact test. Educational content was congestive heart failure and was evaluated externally for equivalency. FINDINGS: All participants enjoyed the HPS activity compared to 13 (68.4%; p = 0.02) for AOL. Eighteen (94.7%) and 15 (78.9%; p = 0.34) participants felt that HPS activity and AOL improved their critical and decision-making skills respectively. Sixteen (84.2%) and 17 (89.5%) agreed that AOL and HPS activity improved their confidence (p = 1.00). DISCUSSION: Participants enjoyed HPS activity significantly more than AOL. HPS activity could be used to achieve improved critical and decision-making skills of learners as there was a trend of more learners perceiving improvement compare to AOL. SUMMARY: High fidelity HPS learning was well received by participants in Singapore and can be implemented in CPE.

Virtual Electronic Health Record Technology with Simulation-Based Learning in an Acute Care Pharmacotherapy Course.

Electronic health record (EHR) technology use in the educational setting to advance pharmacy practice skills with patient simulation has not been described previously in the literature. Therefore, the purpose of this study was to evaluate the impact of a virtual EHR on learning efficiency, perceptions of clinical skills, communication, and satisfaction. This was a prospective study conducted in a cardiovascular therapeutics course in the Doctor of Pharmacy curriculum. Students were randomized to use of a virtual EHR with patient simulation or to patient simulation alone (control). The efficiency of learning was assessed by the time to optimal recommendation for each scenario. Surveys (n = 12 questions) were administered electronically to evaluate perceptions of clinical skills, communication, and learning satisfaction. Data were analyzed with the Mann⁻Whitney U or Wilcoxon signed-rank test as appropriate. Use of the virtual EHR decreased the amount of time needed to provide the optimal treatment recommendations by 25% compared to control. The virtual EHR also significantly improved students' perceptions of their clinical skills, communication, and satisfaction compared to control. The virtual EHR demonstrated value in learning efficiency while providing students with an engaging means of practicing essential pharmacist functions in a simulated setting.

A community pharmacy intervention for opioid medication misuse: A pilot randomized clinical trial.

OBJECTIVES: Community pharmacy continues to play a crucial role in the national response to the opioid epidemic. The purpose of this article is to describe the protocol for a pilot study that is examining the feasibility and acceptability of the Motivational Intervention-Medication Therapy Management (MI-MTM) model. This study also examines the preliminary clinical effect of MI-MTM for improving opioid medication misuse and patient activation in self-management of health conditions that increase risk for misuse. DESIGN: MI-MTM is a pharmacy-based integrated care model made up of 4 evidence-based practices: medication therapy management; brief motivational intervention; patient navigation; and naloxone training and referral. To test MI-MTM compared with Standard Medication Counseling (SMC), we are conducting a 2-group randomized single-blinded controlled trial with assessments at 3 time points. SETTING AND PARTICIPANTS: The study is being conducted within a western Pennsylvania university-based community pharmacy with 46 patients with opioid misuse (MI-MTM = 23; SMC = 23). MAIN OUTCOME MEASURES: Feasibility will be measured by capturing patient completion rate of MI-MTM sessions. Acceptability will be measured by administering satisfaction surveys regarding pharmacist and patient navigator services. Acceptability will also be captured by conducting intensive qualitative interviews. Preliminary effect of the intervention on misuse will be measured with the use of the Prescription Opioid Misuse Index and the Opioid Compliance Checklist. Activation in self-management will be measured with the use of the Patient Activation Measure. RESULTS: This project is currently recruiting, and results are to come. CONCLUSION: This study is the first in the United States to implement an evidence-based integrated behavioral intervention into the community pharmacy setting to address opioid medication misuse among pharmacy patients. The results of this study will provide necessary foundational data that allow further testing of this intervention model in a larger trial.

Intensive care unit drug costs in the context of total hospital drug expenditures with suggestions for targeted cost containment efforts.

PURPOSE: To assess costs of intensive care unit (ICU) related pharmacotherapy relative to hospital drug expenditures, and to identify potential targets for cost-effectiveness investigations. We offer the unique advantage of comparing ICU drug costs with previously published data a decade earlier to describe changes over time. MATERIALS AND METHODS: Financial transactions for all ICU patients during fiscal years (FY) 2009-2012 were retrieved from the hospital's data repository. ICU drug costs were evaluated for each FY. ICU departments' charges were also retrieved and calculated as percentages of total ICU charges. RESULTS: Albumin, prismasate (dialysate), voriconazole, factor VII and alteplase denoted the highest percentages of ICU drug costs. ICU drug costs contributed to an average of 31% (SD 1.0%) of the hospital's total drug costs. ICU drug costs per patient day increased by 5.8% yearly versus 7.8% yearly for non-ICU drugs. This rate was higher for ICU drugs costs at 12% a decade previous. Pharmacy charges contributed to 17.7% of the total ICU charges. CONCLUSIONS: Growth rates of costs per year have declined but still drug expenditures in the ICU are consistently a significant driver in this resource intensive environment with a high impact on hospital drug expenditures.

Prospective Assessment of Inpatient Boxed Warning Prescriber Adherence.

OBJECTIVE: To evaluate medication boxed warning nonadherence in the inpatient setting. METHODS: This was a prospective cohort quality improvement project approved by our institution's Total Quality Council. General medicine and ICU patients 18 years and older were included if they were cared for by a prescriber-led multidisciplinary team that included a pharmacist. Patients were evaluated for medication orders with an actionable boxed warning; if boxed warning nonadherence occurred, the physician's reason was determined. Patients with boxed warning nonadherence were monitored for adverse drug reactions until discharge. RESULTS: A total of 393 patients (224 general medicine and 169 ICU) were evaluated for nonadherence to 149 actionable boxed warnings. There were 293 drugs (175 general medicine and 118 ICU) with boxed warnings prescribed, and more than 50% of these were medications restarted from home. A total of 23 boxed warning nonadherences occurred in general medicine patients, and NSAIDs accounted for 81% of these events. ICU patients experienced 11 boxed warning nonadherences, with nearly 54% from anti-infectives and immunosuppressants. Antipsychotics were the most commonly ordered boxed warning medication class in ICU patients. Reasons for nonadherence included knowledge deficit and an acceptable risk-to-benefit ratio. Two adverse drug reactions occurred from boxed warning nonadherences, both because of a drug-drug interaction. CONCLUSIONS: Boxed warning nonadherence is a concern in the inpatient setting, specifically with NSAID use in general medicine patients and antipsychotic use in ICU patients. More than half of boxed warning nonadherence occurred in medications restarted from home, which emphasizes the need for medication evaluation during transitions of care.

Use of Text Searching for Trigger Words in Medical Records to Identify Adverse Drug Reactions within an Intensive Care Unit Discharge Summary.

PURPOSE: To evaluate the performance of using trigger words (e.g. clues to an adverse drug reaction) in unstructured, narrative text to detect adverse drug reactions (ADRs) and compare the use of these trigger words to a targeted chart review for ADR detection within the intensive care unit (ICU) discharge summary note. MATERIALS: A retrospective medical record review was conducted. Evaluation of ADRs occurred in two phases - targeted chart review of the ICU discharge summary notes in Phase 1 and targeted chart review using specific words and phrases as triggers for ADRs in Phase 2. RESULTS: Four hundred ADRs were documented in 223 patients for Phase 1. For Phase 2, there were 219 ADRs identified in 120 patients. 138 real or accurate ADRs were identified from Phase 1 and 47 duplicate events. 34 ADRs from Phase 2 were not identified in Phase 1. Fifteen of the ADRs were inaccurately presumed in Phase 2. Fifty-eight of 127 text triggers identified at least one ADR. Low and moderate frequency trigger words were more likely to have PPVs > 5%. CONCLUSIONS: Targeted chart review using specific words and phrases as triggers for ADRs is a reasonable approach to identify ADRs and may save time compared to other methods after further refinement leads to a more accurately performing trigger word list.

Prescription opioid use: Patient characteristics and misuse in community pharmacy.

OBJECTIVES: Opioid pain medication misuse is a major concern for US public health. The purpose of this article is to: 1) describe the demographic and physical, behavioral, and mental health characteristics of patients who fill opioid medications in community pharmacy settings; and 2) describe the extent of opioid medication misuse behaviors among these patients. DESIGN: We recruited and screened a convenience sample of patients with the use of a tablet computer-based assessment protocol that examined behavioral, mental, and physical health. Descriptive and inferential statistics were calculated to describe respondents and their opioid medication misuse and health characteristics. SETTING: Patients were screened in 2 urban and 2 rural community pharmacies in southwestern Pennsylvania. PARTICIPANTS: Survey participants were adult patients filling opioid pain medications who were not currently receiving treatment for a cancer diagnosis. INTERVENTION: None. MAIN OUTCOME MEASURES: Validated screening measures included the Prescription Opioid Misuse Index, Alcohol Use Disorders Identification Test C, Short Form 12, Drug Abuse Screening Test 10, Primary Care Post-traumatic Stress Disorder (PTSD) screen, and the Patient Health Questionnaire 2. RESULTS: A total of 333 patients were screened (71.2% response rate). Nearly the entire population reported pain above and general health below national norms. Hydrocodone (19.2%) and morphine (20.8%) were found to be the medications with the highest rates of misuse-with hydrocodone having more than 4 times higher odds of misuse compared with other medications (adjusted odds ratio [AOR] 4.48, 95% confidence interval [CI] 1.1-17.4). Patients with positive screens for illicit drug use (AOR 8.07, 95% CI 2.7-24.0), PTSD (AOR 5.88, 95% CI 2.3-14.7), and depression (AOR 2.44, 95% CI 1.0-5.9) also had significantly higher odds for misuse compared with those with negative screening results. CONCLUSION: These findings provide important foundational data that suggest implementation of regular opioid misuse screening protocols within community pharmacies. Such screening activities could foster a culture of prevention and overall reduction for misuse among patients filling opioid medications in community pharmacies.

A Review of the Perceptions of Healthcare Providers and Family Members Toward Family Involvement in Active Adult Patient Care in the ICU.

OBJECTIVE: The objective of this article is to provide a summary of the perceptions of healthcare providers and family members toward their role in active patient care in the ICU and compare the views of healthcare providers with those of relatives of critically ill patients. DATA SOURCES: The search was conducted using PubMed as the primary search engine and EMBASE as a secondary search engine. STUDY SELECTION: Studies were included if they were conducted in the ICU, had an adult patient population, and contained a discussion of active patient care, including perspective or actions of family members or healthcare providers about the active participation. DATA EXTRACTION: Titles and abstracts of articles identified through PubMed and EMBASE were assessed for relevancy of family involvement. The full article was reviewed of titles and abstracts involving family involvement of care in the ICU to assess if the topic was active care and if the article involved perceptions of healthcare providers or family members. The references of all selected articles were then evaluated for the inclusion of additional studies. DATA SYNTHESIS: Articles including perceptions of healthcare providers were grouped separately from articles including attitudes of family members. Articles that contained the perceptions of both healthcare providers and family members were considered in both groups but were evaluated with each perspective separately. Examples of specific patient care tasks that were mentioned in each article were identified. CONCLUSIONS: A positive attitude exists among both family members and providers toward the involvement of family members in active care tasks. Providers and family members share the attitude that a partnership is necessary and that encouragement for family members to participate is essential. The findings in this review support the need for more objective research regarding how families are caring for their loved ones and how family involvement in care is affecting patient and family outcomes.

Published cases of adverse drug reactions: has the quality of reporting improved over time?

PURPOSE: A previous study of cases published approximately 10-30 years ago reveals that substantial improvement in the quality of adverse drug reaction (ADR) case reports is needed. Since that evaluation, recommendations are available concerning the content and formatting of case reports. OBJECTIVE: To compare the quality of recently published ADR case reports to a previously published study of the quality of ADR case reports from 10-30 years ago. A secondary objective is to determine the quality of reporting by specialty journal. METHODS: This was a two-phase study. Phase 1 included an assessment of the 23 patient, drug and ADR variables evaluated in the previous study to allow comparison with recently published case reports in specialty journals. Phase 2 mimicked the methods of Phase 1 with a random selection of available case reports in a 1-year period from a variety of journals. RESULTS: For Phase 1, 19 of the 23 variables had significant differences in reporting compared with the previous study. Reporting of active diseases, social history, weight, race, other drugs and dose had frequencies ranging from 25 to 80%, which was an improvement, but affording an opportunity for greater improvement. For Phase 2, 21 of the 23 variables had significant differences compared with the previous evaluation; however illicit drug use, mechanism for ADR and route of administration had significant reductions in reporting. CONCLUSION: Progress has been made in ADR case reporting quality for a variety of journals, but more improvement is required to ensure data are understandable and relatable to patient care.

Pharmacokinetic evaluation of prasugrel for the treatment of myocardial infarction.

INTRODUCTION: Prasugrel is a novel P2Y12 inhibitor approved for treatment of patients with acute coronary syndrome (ACS) who undergo percutaneous coronary intervention (PCI). AREAS COVERED: This article focuses on the pharmacokinetics of prasugrel and recently published pharmacodynamic and clinical studies. The authors searched PubMed and Ovid databases for English language pharmacokinetic, pharmacodynamic and clinical studies which described the use of prasugrel in human subjects and patients, published through October 2013. The keyword 'prasugrel' was used. EXPERT OPINION: Prasugrel exhibits favorable pharmacokinetic and pharmacodynamic properties compared to clopidogrel. These effects have translated to significant clinical benefits, despite the increased bleeding risk, in the context of ACS with primary PCI. Recent clinical trial evidence does not support the use of prasugrel in other ACS settings at this time, including medical management of non-ST segment elevation myocardial infarction and routine pretreatment prior to angiography. Careful patient selection for prasugrel is also imperative, taking into account the need for maintenance dose reductions in certain patient subgroups. Antiplatelet decision making for high-risk patients in the future may be facilitated with the use of both genotypic and phenotypic characteristics, including platelet function, and should be an imperative for future research efforts.

A real-world, multicenter assessment of drugs requiring weight-based calculations in overweight, adult critically ill patients.

Prescribing appropriate doses of drugs requiring weight-based dosing is challenging in overweight patients due to a lack of data. With 68% of the US population considered overweight and these patients being at an increased risk for hospitalization, clinicians need guidance on dosing weight-based drugs. The purpose of this study was to identify "real-world" dose ranges of high-risk medications administered via continuous infusion requiring weight-based dosing and determine the reasons for dosing changes (ineffectiveness or adverse drug reactions). A prospective, multicenter, observational study was conducted in four intensive care units at three institutions. A total of 857 medication orders representing 11 different high-risk medications in 173 patients were reviewed. It was noted that dosing did not increase in proportion to weight classification. Overall, 14 adverse drug reactions occurred in nine patients with more in overweight patients (9 of 14). A total of 75% of orders were discontinued due to ineffectiveness in groups with higher body mass indexes. Ineffectiveness leads to dosing adjustments resulting in the opportunity for medication errors. Also, the frequent dosing changes further demonstrate our lack of knowledge of appropriate dosing for this population. Given the medications' increased propensity to cause harm, institutions should aggressively monitor these medications in overweight patients.