2022 ASHP Survey of Health-System Specialty Pharmacy Practice: Clinical Services.

PURPOSE: Results of the first ASHP national survey of clinical services provided by health-system specialty pharmacies (HSSPs) are presented. METHODS: A survey questionnaire was developed by 26 HSSP contacts after reviewing available literature on the role and services of HSSPs. After pilot and cognitive testing resulting in a final questionnaire of 119 questions, a convenience sample of 441 leaders in HSSPs was contacted using email and invited to participate in the survey. RESULTS: The survey response rate was 29%. Almost half of respondents (48%) had offered pharmacy services for 7 years or more, and most (60%) dispensed more than 15,000 prescriptions annually. Respondents most commonly (42%) reported a specialist model wherein staff are dedicated to specific specialty disease states. Over half of respondents reported providing several medication access, pretreatment assessment, and initial counseling services to patients referred to them, regardless of whether the HSSP was used for medication fulfillment. All HSSP activities were noted to be documented in the electronic health record and visible to providers frequently or always. Almost all respondents noted that HSSP pharmacists have a role in specialty medication selection. Disease-specific outcomes were tracked in 95% of responding HSSPs, with 67% reporting that outcomes were used to drive patient monitoring. HSSPs were often involved in continuity of care services such as transitions of care (reported by 89% of respondents), referral to other health-system services (53%), and addressing social determinants of health (60%). Most respondents (80%) reported providing clinical education to specialty clinic staff, including medicine learners (62%). Though only 12% of respondents had dedicated outcomes research staff, many reported annually publishing (47%) or presenting (61%) outcomes research. CONCLUSION: HSSPs are a clinical and educational resource for specialty clinics and have developed robust patient care services that encompass the patient journey from before specialty medication selection through treatment monitoring and optimization.

Health-system specialty pharmacy role and outcomes: A review of current literature.

PURPOSE: Specialty medications can have life-altering outcomes for patients with complex diseases. However, their benefit relies on appropriate treatment selection, patients' ability to afford and initiate treatment, and ongoing treatment optimization based on patient response to therapy. Mounting research demonstrates the benefits of the health-system specialty pharmacies (HSSPs) in improving specialty medication access, affordability, and outcomes. The purpose of this rapid review is to describe the currently reported role and function of HSSP pharmacists and outcomes reported with use of the HSSP model, and to identify gaps in the literature where more information is needed to better understand the HSSP model and outcomes. SUMMARY: Current literature describes the role of HSSP pharmacists in facilitating patient access, affordability, and initiation and maintenance of specialty medications. Though it is clear HSSP pharmacists are involved in treatment monitoring, often through utilizing the electronic health record, more information is needed to elucidate the frequency, method, and extent of monitoring. Despite several valuable continuity of care services reported to be provided by HSSPs, the breadth and degree of standardization of these services remains unclear. There is minimal literature describing HSSP education and research involvement. HSSPs have reported significant benefits of this patient care model, as demonstrated by higher adherence and persistence; better clinical outcomes; financial benefits to patients, payers, and the health system; better quality of care; higher patient and provider satisfaction with services, and highly efficient specialty pharmacy services. More literature comparing clinical and diagnosis-related outcomes in HSSP versus non-HSSP patients is needed. CONCLUSION: HSSPs provide comprehensive, patient-centered specialty medication management that result in improved care across the continuum of the specialty patient journey and act as a valuable resource for specialty clinics and patients beyond medication management. Future research should build on the current description of HSSP services, how services affect patient outcomes, and the impact HSSP network restrictions.

Effect of a Multifaceted Clinical Pharmacist Intervention on Medication Safety After Hospitalization in Persons Prescribed High-risk Medications: A Randomized Clinical Trial.

Importance: The National Action Plan for Adverse Drug Event (ADE) Prevention identified 3 high-priority, high-risk drug classes as targets for reducing the risk of drug-related injuries: anticoagulants, diabetes agents, and opioids. Objective: To determine whether a multifaceted clinical pharmacist intervention improves medication safety for patients who are discharged from the hospital and prescribed medications within 1 or more of these high-risk drug classes. Design, Setting, and Participants: This randomized clinical trial was conducted at a large multidisciplinary group practice in Massachusetts and included patients 50 years or older who were discharged from the hospital and prescribed at least 1 high-risk medication. Participants were enrolled into the trial from June 2016 through September 2018. Interventions: The pharmacist-directed intervention included an in-home assessment by a clinical pharmacist, evidence-based educational resources, communication with the primary care team, and telephone follow-up. Participants in the control group were provided educational materials via mail. Main Outcomes and Measures: The study assessed 2 outcomes over a 45-day posthospital discharge period: (1) adverse drug-related incidents and (2) a subset defined as clinically important medication errors, which included preventable or ameliorable ADEs and potential ADEs (ie, medication-related errors that may not yet have caused injury to a patient, but have the potential to cause future harm if not addressed). Clinically important medication errors were the primary study outcome. Results: There were 361 participants (mean [SD] age, 68.7 [9.3] years; 177 women [49.0%]; 319 White [88.4%] and 8 Black individuals [2.2%]). Of these, 180 (49.9%) were randomly assigned to the intervention group and 181 (50.1%) to the control group. Among all participants, 100 (27.7%) experienced 1 or more adverse drug-related incidents, and 65 (18%) experienced 1 or more clinically important medication errors. There were 81 adverse drug-related incidents identified in the intervention group and 72 in the control group. There were 44 clinically important medication errors in the intervention group and 45 in the control group. The intervention did not significantly alter the per-patient rate of adverse drug-related incidents (unadjusted incidence rate ratio, 1.13; 95% CI, 0.83-1.56) or clinically important medication errors (unadjusted incidence rate ratio, 0.99; 95% CI, 0.65-1.49). Conclusions and Relevance: In this randomized clinical trial, there was not an observed lower rate of adverse drug-related incidents or clinically important medication errors during the posthospitalization period that was associated with a clinical pharmacist intervention. However, there were study recruitment challenges and lower than expected numbers of events among the study population. Trial Registration: ClinicalTrials.gov Identifier: NCT02781662.

Pharmacotherapy of Autism Spectrum Disorder: Results from the Randomized BAART Clinical Trial.

The objective of this trial, Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART), was to provide support and guidance for an evidence-based approach for the selection and monitoring of initial pharmacotherapy in patients with autism by assessing predictors of efficacy, tolerability, and safety. This randomized double-blind parallel-group study was conducted in three academic medical centers and a single private pediatric practice. Eighty children or adolescents (aged 6-17 yrs) with autistic disorder were enrolled, and 61 patients were randomized to the study drug. Of those patients, 51 completed the 10-week trial, and 31 completed an optional 12-week blinded extension phase. All patients were treated with 2 weeks of placebo before random assignment to receive aripiprazole (31 patients) or risperidone (30 patients) for 10 weeks. Sixteen placebo responders (20%) were excluded from further analysis. Drug dosing followed U.S. Food and Drug Administration (FDA) labeling, and weekly dosage adjustments were allowed until week 4; patients were then maintained on a fixed dose for 6 additional weeks. Safety, physical, and psychological assessments were recorded weekly or every 2 weeks. No significant differences in severity of illness between the aripiprazole and risperidone groups were noted at baseline. All patients significantly improved on the Aberrant Behavior Checklist-Irritability subscale after 1 week and continued for the remaining 9 weeks and the extension phase. Improvement was greatest in the risperidone group at every assessment period and was statistically significantly better than that in the aripiprazole group at weeks 3 and 6 (p<0.05). No dose-limiting adverse events occurred during the dose-titration period. Mean weight gain in the aripiprazole group was significantly less than that in the risperidone group at week 4 (0.62 vs 1.38 kg, p=0.033) and week 10 (1.61 vs 3.31 kg, p<0.001), but the difference became nonsignificant for the 31 patients completing the 3-month extension phase (4.36 vs 5.55 kg, p=0.26). Pharmacotherapy of patients with autism spectrum disorder resulted in behavioral improvement within 1 week and lasted at least 22 weeks. Weight gain occurred to a greater degree with risperidone than aripiprazole initially, but the differences became nonsignificant by the end of the trial. Our trial supports previous results of drug efficacy and safety in patients with autism spectrum disorder from other trials and extends the evidence-based support for choosing an FDA-approved drug for initial pharmacotherapy for autism spectrum disorder.

Venous thromboembolism prophylaxis in medically ill patients: a mixed treatment comparison meta-analysis.

The American College of Chest Physicians guidelines recommend unfractionated heparin (UFH), low molecular weight heparins (LMWHs) or fondaparinux for prevention of venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), in medically-ill patients. Direct oral anticoagulants (DOACs) have been evaluated relative to enoxaparin for VTE prophylaxis though head-to-head comparisons of these agents are lacking. Therefore, we conducted a mixed treatment comparisons meta-analysis to evaluate the safety and efficacy of established treatments and DOACs for VTE prophylaxis in medically-ill patients. A comprehensive literature search was conducted to identify randomized trials evaluating UFH, LMWHs or DOACS for the prevention of VTE in medically ill patients. Articles were retrieved and cross-referenced for additional trials, evaluated and entered into ADDIS (version 1.16.6) to generate direct and indirect treatment comparisons for VTE, DVT, PE, death from any cause, and bleeding. Ten articles were included and eight anticoagulants were evaluated in a treatment network representing data on 28,382 patients. We found each treatment had similar efficacy in preventing VTE, DVT, PE, death from any cause and each had similar risk of minor and major bleeding. Overall, placebo was associated with more VTE and DVT events compared to LMWHs and DOACs. We found that UFH, LMWHs and DOACs are comparable in preventing VTE, DVT, PE, and death from any cause and in association with minor and major bleeding. Anticoagulant selection for VTE prophylaxis in medically-ill patients should be individualized by patient characteristics, risks and preferences along with specific pharmacokinetic and pharmacodynamic considerations.

Incorporating the American Pharmacists Association's Delivering Medication Therapy Management services certificate program into an accelerated pharmacy curriculum.

BACKGROUND AND PURPOSE: To describe the incorporation of the American Pharmacists Association (APhA) Delivering Medication Therapy Management (MTM) Services program into a PharmD curriculum and to describe student perceptions of the program. EDUCATIONAL ACTIVITY AND SETTING: The program was delivered over 12 months to students on two campuses via two didactic courses in the second professional year and during the first two advanced pharmacy practice experiences in the third professional year of an accelerated school of pharmacy program. FINDINGS: Student perceptions were assessed by review of responses to the APhA MTM program evaluation survey. DISCUSSION AND SUMMARY: Incorporation of the APhA MTM program into an accelerated PharmD program required careful planning and coordination amongst faculty and course coordinators. Students perceived that the program was valuable, met their educational needs, and incorporated effective learning experiences and cases. These perceptions were reinforced by the high percentage of students who completed the program.

Implications of an inpatient warfarin dosing nomogram on safety outcomes post-discharge.

Many hospitals have implemented warfarin dosing nomograms to improve patient safety. To our knowledge, no study has assessed the impact inpatient warfarin initiation has in both medical and surgical patients, on safety outcomes post discharge. To evaluate the impact of a suggested institutional nomogram for the initiation of warfarin, the primary endpoint was the incidence of bleeding throughout follow up. Secondary endpoints included the composite of INR changes ≥0.5/day and INR >4. Patients were followed for a period of 2 weeks post-discharge. The composite endpoint was evaluated for an effect on reaching therapeutic INR, time to reach therapeutic INR, and bleeding events throughout follow up. A single center retrospective study comparing the safety of adherence vs. non-adherence to a warfarin nomogram. A total of 206 patients were included, 73 patients in the nomogram adherence vs. 133 in the nonadherence arm. There was no difference in the proportion of patients who bled throughout the follow up period, adherence 9.6% vs. nonadherence to the nomogram 13.5%, p = 0.407. There was however a statistical difference in the mean total number of bleeding events, 0.096 (7/73) in the adherence vs. 0.158 (21/133) in the non-adherence arm, p = 0.022. There was also no difference in the composite endpoint, 19.2% in the adherence vs. 28.6% in the non-adherence arm p = 0.180. A positive correlation between the inpatient composite and risk of bleeding throughout follow up was noted. The findings of this study support adherence to the nomogram as opposed to non-adherence.

Meta-analysis of Ivabradine in Patients With Stable Coronary Artery Disease With and Without Left Ventricular Dysfunction.

PURPOSE: Ivabradine is a novel If-channel antagonist that controls heart rate and may be helpful in treating patients with left ventricular dysfunction (LVD) who are unable to tolerate ß-blockers or achieve a heart rate of 70 beats/min with standard therapy. Three landmark trials were used for the approval of ivabradine in the United States. These trials tested ivabradine in addition to a standard of care (including ß-blockers) in patients with stable coronary artery disease (CAD) and found modest benefit in those with established LVD unable to tolerate ß-blockers. The goal of this review was to pool data from ivabradine studies in all patients with stable CAD to compare cardiovascular and safety-related outcomes. METHODS: Three randomized, double-blind, placebo-controlled trials of ivabradine added to standard treatment (including ß-blockers) in patients with stable CAD with and without LVD were reviewed for effects on mortality, cardiovascular outcomes, and adverse events. Data were independently abstracted by 2 reviewers; the Oxford quality scoring system was used to evaluate randomization, blinding, withdrawals, and dropouts; and a Mantel-Haenszel random effects pairwise meta-analysis was used to combine data into odds ratios. FINDINGS: The initial search identified 116 trials; 3 of these trials, representing 36,524 patients with stable CAD, met inclusion criteria. According to the pooled results, ivabradine did not consistently reduce all-cause mortality (odds ratio [OR], 1.00 [95% CI, 0.91-1.11]; P = 0.98], cardiovascular death (OR, 1.02 [95% CI, 0.91-1.15]; P = 0.74), or hospitalization for worsening or new onset heart-failure in patients with stable CAD (OR, 0.94 [95% CI, 0.71-1.25]; P = 0.69). Ivabradine did not increase serious adverse drug reactions (OR, 0.99 [95% CI, 0.88-1.13]; P = 0.93) or cardiac disorders (OR, 1.03 [95% CI, 0.87-1.22]; P = 0.74). However, it was associated with drug-specific effects, including new-onset atrial fibrillation (OR, 1.35 [95% CI, 1.19-1.53]; P < 0.001], bradycardia (OR, 6.54 [95% CI, 3.30-12.9]; P < 0.001), phosphenes (OR, 7.77 [95% CI, 4.12-14.63]; P < 0.001), and blurry vision (OR, 3.07 [95% CI, 2.18-4.32]; P < 0.001). IMPLICATIONS: Unselective use of ivabradine in patients with stable CAD is not supported by evidence and can be associated with new-onset atrial fibrillation, bradycardia, and drug-related nuisance adverse events.

A Pilot Health Information Technology-Based Effort to Increase the Quality of Transitions From Skilled Nursing Facility to Home: Compelling Evidence of High Rate of Adverse Outcomes.

OBJECTIVES: Older adults are often transferred from hospitals to skilled nursing facilities (SNFs) for post-acute care. Patients may be at risk for adverse outcomes after SNF discharges, but little research has focused on this period. DESIGN: Assessment of the feasibility of a transitional care intervention based on a combination of manual information transmission and health information technology to provide automated alert messages to primary care physicians and staff; pre-post analysis to assess potential impact. SETTING: A multispecialty group practice. PARTICIPANTS: Adults aged 65 and older, discharged from SNFs to home; comparison group drawn from SNF discharges during the previous 1.5 years, matched on facility, patient age, and sex. MEASUREMENTS: For the pre-post analysis, we tracked rehospitalization within 30 days after discharge and adverse drug events within 45 days. RESULTS: The intervention was developed and implemented with manual transmission of information between 8 SNFs and the group practice followed by entry into the electronic health record. The process required a 5-day delay during which a large portion of the adverse events occurred. Over a 1-year period, automated alert messages were delivered to physicians and staff for the 313 eligible patients discharged from the 8 SNFs to home. We compared outcomes to those of individually matched discharges from the previous 1.5 years and found similar percentages with 30-day rehospitalizations (31% vs 30%, adjusted HR 1.06, 95% CI 0.80-1.4). Within the adverse drug event (ADE) study, 30% of the discharges during the intervention period and 30% of matched discharges had ADEs within 45 days. CONCLUSION: Older adults discharged from SNFs are at high risk of adverse outcomes immediately following discharge. Simply providing alerts to outpatient physicians, especially if delivered multiple days after discharge, is unlikely to have any impact on reducing these rates.

Approaches to Gradual Dose Reduction of Chronic Off-Label Antipsychotics Used for Behavioral and Psychological Symptoms of Dementia.

OBJECTIVE: Little is known about how to best taper antipsychotics used in patients with dementia. To address this gap, we reviewed published antipsychotic discontinuation trials to summarize what is known about tapering strategies for antipsychotics used with older adults with dementia. We further developed pharmacokinetic-based gradual dose reduction (GDR) protocols based on antipsychotic half-lives. DATA SOURCES: MEDLINE, EMBASE, and International Pharmaceutical Abstracts were searched up to October 2014 to identify intervention studies reporting the behavioral and psychological symptoms of dementia outcomes resulting from discontinued off-label use of antipsychotics in nursing facility populations. Recently published pharmacokinetic reviews and standard pharmacology texts were used to determine antipsychotic drug half-lives for the pharmacokinetic-based GDR protocols. STUDY SELECTION: For the review, studies with an intervention resulting in antipsychotic medication discontinuation or tapering were eligible, including randomized controlled trials and pre- and post-intervention studies. DATA EXTRACTION: When available, we extracted the protocols used for antipsychotic GDR from each study included in the review. DATA SYNTHESIS: We found that clinical trials used different approaches to antipsychotic discontinuation, including abrupt discontinuation, slow tapers (more than two weeks), and mixed strategies based on drug dosage. None of the published trials described an approach based on pharmacokinetic principles. We developed a two-stage GDR protocol for tapering antipsychotic medications based on the log dose-response relationship; each stage was designed to result in a 50% dose reduction prior to discontinuation. This pharmacologically based strategy for patients chronically prescribed antipsychotics resulted in recommendations for slow tapers. CONCLUSION: Our theoretically derived GDR recommendations suggest a different approach than previously published in clinical trials. Further study is needed to evaluate the effect of this approach on patients.

Dissemination of Evidence-Based Antipsychotic Prescribing Guidelines to Nursing Homes: A Cluster Randomized Trial.

OBJECTIVES: To evaluate the effectiveness of efforts to translate and disseminate evidence-based guidelines about atypical antipsychotic use to nursing homes (NHs). DESIGN: Three-arm, cluster randomized trial. SETTING: NHs. PARTICIPANTS: NHs in the state of Connecticut. MEASUREMENTS: Evidence-based guidelines for atypical antipsychotic prescribing were translated into a toolkit targeting NH stakeholders, and 42 NHs were recruited and randomized to one of three toolkit dissemination strategies: mailed toolkit delivery (minimal intensity); mailed toolkit delivery with quarterly audit and feedback reports about facility-level antipsychotic prescribing (moderate intensity); and in-person toolkit delivery with academic detailing, on-site behavioral management training, and quarterly audit and feedback reports (high intensity). Outcomes were evaluated using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. RESULTS: Toolkit awareness of 30% (7/23) of leadership of low-intensity NHs, 54% (19/35) of moderate-intensity NHs, and 82% (18/22) of high-intensity NHs reflected adoption and implementation of the intervention. Highest levels of use and knowledge among direct care staff were reported in high-intensity NHs. Antipsychotic prescribing levels declined during the study period, but there were no statistically significant differences between study arms or from secular trends. CONCLUSION: RE-AIM indicators suggest some success in disseminating the toolkit and differences in reach, adoption, and implementation according to dissemination strategy but no measurable effect on antipsychotic prescribing trends. Further dissemination to external stakeholders such as psychiatry consultants and hospitals may be needed to influence antipsychotic prescribing for NH residents.

Exploring the effect of complex patients on care delivery tasks.

PURPOSE: The needs of complex patients with chronic conditions can be unpredictable and can strain resources. Exploring how tasks vary for different patients, particularly those with complex needs, can yield insights about designing better processes in healthcare. The purpose of this paper is to explore the tasks required to manage complex patients in an anticoagulation therapy context. DESIGN/METHODOLOGY/APPROACH: The authors analyzed interviews with 55 staff in six anticoagulation clinics using the Systems Engineering Initiative for Patient Safety (SEIPS) work system framework. The authors qualitatively described complex patients and their effects on care delivery. FINDINGS: Data analysis highlighted how identifying complex patients and their effect on tasks and organization, and the interactions between them was important. Managing complex patients required similar tasks as non-complex patients, but with greater frequency or more intensity and several additional tasks. After complex patients and associated patient interaction and care tasks were identified, a work system perspective was applied to explore how such tasks are integrated within clinics and the resulting implications for resource allocation. PRACTICAL IMPLICATIONS: The authors present a complex patient management framework to guide workflow design in specialty clinics, to better support high quality, effective, efficient and safe healthcare. ORIGINALITY/VALUE: The complex patient framework presented here, based on the SEIPS framework, suggests a more formal and integrated analysis be completed to provide better support for appropriate resource allocation and care coordination.

Use of atypical antipsychotics in nursing homes and pharmaceutical marketing.

OBJECTIVES: To describe the current extent and type of pharmaceutical marketing in nursing homes (NHs) in one state and to provide preliminary evidence for the potential influence of pharmaceutical marketing on the use of atypical antipsychotics in NHs. DESIGN: Nested mixed-methods, cross-sectional study of NHs in a cluster randomized trial. SETTING: Forty-one NHs in Connecticut. PARTICIPANTS: NH administrators, directors of nursing, and medical directors (n = 93, response rate 75.6%). MEASUREMENTS: Quantitative data, including prescription drug dispensing data (September 2009-August 2010) linked with Nursing Home Compare data (April 2011), were used to determine facility-level prevalence of atypical antipsychotic use, facility-level characteristics, NH staffing, and NH quality. Qualitative data, including semistructured interviews and surveys of NH leaders conducted in the first quarter of 2011, were used to determine encounters with pharmaceutical marketing. RESULTS: Leadership at 46.3% of NHs (n = 19) reported pharmaceutical marketing encounters, consisting of educational training, written and Internet-based materials, and sponsored training. No association was detected between level of atypical antipsychotic prescribing and reports of any pharmaceutical marketing by at least one NH leader. CONCLUSION: NH leaders frequently encounter pharmaceutical marketing through a variety of ways, although the impact on atypical antipsychotic prescribing is unclear.

Evaluation of oral anticoagulants for the extended treatment of venous thromboembolism using a mixed-treatment comparison, meta-analytic approach.

PURPOSE: Target-specific oral anticoagulants (apixaban, rivaroxaban, and dabigatran) are widely available for the treatment of venous thromboembolism (VTE). Although analyses comparing these agents to placebo or warfarin exist, direct comparisons of these agents for extended VTE treatment have not been conducted. Therefore, this network meta-analysis aimed to evaluate the efficacy and tolerability of VKA and target-specific oral anticoagulants for extended VTE treatment using a mixed-treatment comparison, meta-analytic approach. METHODS: A comprehensive literature search of EMBASE and MEDLINE was conducted to identify relevant randomized, controlled trials published in English between 1960 and November 2013. Eligible studies investigated the extended use (≥6 months) of oral anticoagulants (apixaban, dabigatran, rivaroxaban, and/or warfarin [conventional or low dose]) and placebo in patients with confirmed VTE. Search terms included extension or extended treatment or therapy, venous thromboembolism (or VTE), deep vein thrombosis (or DVT), pulmonary embolism (or PE), and anticoagulant or anticoagulant agent. Key articles were cross-referenced for additional studies. The efficacy end points evaluated were recurrent VTE or death from any cause, DVT, and nonfatal pulmonary embolism PE. Tolerability end points included major bleeding and nonmajor or clinically relevant bleeding. The data were screened, evaluated, and entered into statistical software to generate direct and indirect comparisons of the various anticoagulants across each study. The data are reported as rate ratios and 95% credible intervals. FINDINGS: Ten trials were analyzed and aggregated, representing data from >14,000 patients. With respect to efficacy end points, no statistically significant between-treatment differences in the composite end point of VTE or death, nonfatal PE, or DVT were found. Major bleeding was significantly greater with warfarin versus apixaban (rate ratio, 4.24; credible interval, 1.28-25.0), and the risk for major bleeding varied somewhat with warfarin and greatly with rivaroxaban. The assessment of nonmajor or clinically relevant bleeding did not identify any meaningful differences between these agents. IMPLICATIONS: The majority of the data represented in this study were derived from noninferiority trials. In the present meta-analysis, efficacy end points in the extended treatment of VTE with apixaban, dabigatran, rivaroxaban, warfarin (conventional and low dose), and placebo were not significantly different. Elevated bleeding risks were identified with rivaroxaban and warfarin; however, the wide credible intervals with rivaroxaban prevent the interpretation of these increased risks.

An electronic health record-based intervention to increase follow-up office visits and decrease rehospitalization in older adults.

OBJECTIVES: To assess the effect of an electronic health record-based transitional care intervention involving automated alerts to primary care providers and staff when older adults were discharged from the hospital. DESIGN: Randomized controlled trial. SETTING: Large multispecialty group practice. PARTICIPANTS: Individuals aged 65 and older discharged from hospital to home. INTERVENTION: In addition to notifying primary care providers about the individual's recent discharge, the system provided information about new drugs added during the inpatient stay, warnings about drug-drug interactions, recommendations for dose changes and laboratory monitoring of high-risk medications, and alerts to the primary care provider's support staff to schedule a posthospitalization office visit. MEASUREMENTS: An outpatient office visit with a primary care provider after discharge and rehospitalization within 30 days after discharge. RESULTS: Of the 1,870 discharges in the intervention group, 27.7% had an office visit with a primary care provider within 7 days of discharge. Of the 1,791 discharges in the control group, 28.3% had an office visit with a primary care provider within 7 days of discharge. In the intervention group, 18.8% experienced a rehospitalization within the 30-day period after discharge, compared with 19.9% in the control group. The hazard ratio for an office visit with a primary care physician did not significantly differ between the intervention and control groups. The hazard ratio for rehospitalization in the 30-day period after hospital discharge in the intervention versus the control group was 0.94 (95% confidence interval = 0.81-1.1). CONCLUSION: This electronic health record-based intervention did not have a significant effect on the timeliness of office visits to primary care providers after hospitalization or risk of rehospitalization.

The need for PGY2-trained clinical pharmacy specialists.

The American College of Clinical Pharmacy and other stakeholder organizations seek to advance clinical pharmacist practitioners, educators, and researchers. Unfortunately, there remains an inadequate supply of residency-trained clinical specialists to meet the needs of our health care system, and nonspecialists often are called on to fill open specialist positions. The impact of clinical pharmacy specialists on pharmacotherapy outcomes in both acute care and primary care settings demonstrates the value of these specialists. This commentary articulates the need for postgraduate year two (PGY2)-trained clinical specialists within the health care system by discussing various clinical and policy rationales, interprofessional support, economic justifications, and their impact on quality of care and drug safety. The integrated practice model that has grown out of the American Society of Health-System Pharmacists Pharmacy Practice Model Initiative (PPMI) could threaten the growth and development of future clinical specialists. Therefore, the ways in which PGY2-trained clinical pharmacist specialists are deployed in the PPMI require further consideration. PGY2 residencies provide education and training opportunities that cannot be achieved in traditional professional degree programs or postgraduate year one residencies. These specialists are needed to provide direct patient care to complex patient populations and to educate and train pharmacy students and postgraduate residents. Limitations to training and hiring PGY2-trained clinical pharmacy specialists include site capacity limitations and lack of funding. A gap analysis is needed to define the extent of the mismatch between the demand for specialists by health care systems and educational institutions versus the capacity to train clinical pharmacists at the specialty level.

Adverse drug events after hospital discharge in older adults: types, severity, and involvement of Beers Criteria Medications.

OBJECTIVES: To characterize adverse drug events (ADEs) occurring within the high-risk 45-day period after hospitalization in older adults. DESIGN: Clinical pharmacists reviewed the ambulatory records of 1,000 consecutive discharges. SETTING: A large multispecialty group practice closely aligned with a Massachusetts-based health plan. PARTICIPANTS: Hospitalized individuals aged 65 and older discharged home. MEASUREMENTS: Possible drug-related incidents occurring during the 45-day period after hospitalization were identified and presented to a pair of physician-reviewers who classified incidents as to whether an ADE was present, whether the event was preventable, and the severity of the event. Medications implicated in ADEs were further characterized according to their inclusion in the 2012 Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. RESULTS: At least one ADE was identified during the 45-day period in 18.7% (n = 187) of the 1,000 discharges. Of the 242 ADEs identified, 35% (n = 84) were deemed preventable, of which 32% (n = 27) were characterized as serious, and 5% (n = 4) as life threatening. More than half of all ADEs occurred within the first 14 days after hospitalization. The percentage of ADEs in which Beers Criteria medications were implicated was 16.5% (n = 40). Beers criteria medications with both a high quality of evidence and strong strength of recommendation were implicated in 6.6% (n = 16) of the ADEs. CONCLUSION: ADEs are common and often preventable in older adults after hospital discharge, underscoring the need to address medication safety during this high-risk period in this vulnerable population. Beers criteria medications played a small role in these events, suggesting that efforts to improve the quality and safety of medication use during this critical transition period must extend beyond a singular focus on Beers criteria medications.

Evaluation of antiplatelet agents for secondary prevention of stroke using mixed treatment comparison meta-analysis.

BACKGROUND: The current guidelines recommend various antiplatelet agents used alone or in combination for secondary prevention of noncardioembolic stroke. OBJECTIVE: The purpose of this study was to conduct a mixed treatment comparison meta-analysis to determine which antiplatelet or combination of antiplatelet agents is most efficacious and tolerable in patients with prior stroke. METHODS: A comprehensive literature search was conducted in MEDLINE (1945 through March 2012), EMBASE (1974 through March 2012), and the Cochrane Controlled Trials Registry (1975 through April 2012) to identify randomized trials evaluating the role of various antiplatelet agents and combinations for the secondary prevention of stroke. Key articles were cross-referenced for additional studies. Data were screened and evaluated to generate direct and indirect comparisons for recurrent stroke and overall hemorrhagic events. Data were reported as rate ratios (RRs) and 95% CIs. RESULTS: A total of 24 articles were included in the analysis. Eleven antiplatelet regimens were compared in >88,000 patients. The combination of acetylsalicylic acid (ASA) plus dipyridamole (DP) was more protective against recurrent stroke than ASA alone (RR = 0.78; 95% CI, 0.64-0.93), and no differences were found in all other direct and indirect comparisons with active treatment. ASA plus DP was associated with more overall hemorrhagic events than DP (RR = 1.83; 95% CI, 1.17-2.81), cilostazol (RR = 2.12; 95% CI, 1.21-3.48), and triflusal (RR = 1.67; 95% CI, 1.05-2.78) but fewer events than the combination of ASA plus clopidogrel (RR = 0.38; 95% CI, 0.25-0.56). The combination of ASA plus clopidogrel was associated with an excess of overall hemorrhagic events compared with clopidogrel (RR = 2.81; 95% CI, 1.96-4.10), cilostazol (RR = 5.56; 95% CI, 3.03-9.66), DP (RR = 4.78; 95% CI, 2.80-8.21), sarpogrelate (RR = 3.59; 95% CI, 1.96-6.45), terutroban (RR = 2.13; 95% CI, 1.21-3.61), ticlopidine (RR = 2.80; 95% CI, 1.69-5.00), and triflusal (RR = 4.36; 95% CI, 2.62-7.81). CONCLUSION: We found that ASA plus DP was more protective than ASA alone for preventing recurrent stroke; however, no difference was found between most direct and indirect comparisons of antiplatelet agents and combinations. More overall hemorrhagic events seemed to occur with the combination of ASA and clopidogrel than with other treatments. Selection of antiplatelet therapy for the secondary prevention of stroke must be individualized according to patient comorbidities, including risk of stroke recurrence and bleeding.

Mixed treatment comparison meta-analysis of aspirin, warfarin, and new anticoagulants for stroke prevention in patients with nonvalvular atrial fibrillation.

BACKGROUND: Warfarin and aspirin are used to prevent stroke in patients with atrial fibrillation (AF). There are inherent challenges with both treatments, including variable and inconsistent benefit and increased bleeding risks. The availability of new anticoagulants offers some alternatives. OBJECTIVE: A mixed treatment comparison meta-analysis to evaluate direct and indirect treatment data including aspirin, warfarin apixaban, dabigatran, edoxaban, and rivaroxaban for the prevention of primary or secondary stroke in patients with AF. METHODS: A comprehensive, systematic literature search was conducted to identify randomized trials comparing aspirin, warfarin, apixaban, dabigatran, edoxaban, and rivaroxaban in patients with AF requiring treatment for stroke prevention. Open-label and blinded designs were included if they evaluated any stroke or any bleeding event. Data on stroke and bleeding events were abstracted, verified, evaluated, scored, and entered into Aggregate Data Drug Information System version 1.16 to generate a mixed treatment comparison meta-analysis. Direct and indirect comparisons were evaluated, and we looked for inconsistency in closed loop structures. Data are reported as rate ratios with 95% credible intervals. In addition, we reviewed variance statistics and explored variance with node-splitting models. RESULTS: Our literature search yielded 30 articles, 21 of which were included. All treatments except aspirin reduced the risk of any stroke compared with placebo. Warfarin (0.43 [0.33-0.57]), apixaban (0.37 [0.27-0.54]), dabigatran (0.34 [0.21-0.57]), rivaroxaban (0.36 [0.22-0.60]), and aspirin with clopidogrel (0.73 [0.53-0.99]) were more protective than aspirin alone. Warfarin and the new anticoagulants were similar in the reduction of stroke, vascular death, and mortality. There was no difference in major bleeding between any treatment group. There were more nonmajor bleeding events when comparing warfarin and apixaban (1.83 [1.05-4.03]); no other differences between warfarin and the other new anticoagulants were found. CONCLUSIONS: This mixed treatment comparison meta-analysis found similarity between warfarin and the new anticoagulants with the exception of one comparison, in which warfarin was associated with more non-major bleeding than apixaban. Thus, the new anticoagulants are therapeutically comparable when warfarin is inappropriate.

Heparin-induced thrombocytopenia in the pediatric population: a review of current literature.

Heparin-induced thrombocytopenia is a rare and serious reaction to unfractionated heparin and low-molecular-weight heparins in children. Quick recognition, discontinuation of heparin, and subsequent treatment with an alternative anticoagulant are essential steps to prevent serious complications such as thrombus and limb amputation. The purpose of this review is to describe the clinical features of heparin-induced thrombocytopenia in children and to summarize the data available for its management. This paper summarizes data and relates the use of direct thrombin inhibitors with clinical outcomes. A literature search was conducted with Ovid, using the key terms argatroban, bivalirudin, hirulog, danaparoid, lepirudin, direct thrombin inhibitor, heparin-induced thrombocytopenia, thrombosis, warfarin, and fondaparinux. Articles were excluded if they were classified as editorials, review articles, or conference abstracts or if they involved patients 18 years of age or older or described disease states not related to thrombosis. Nineteen articles containing 33 case reports were identified and evaluated for this review. Of the 33 cases, 14, 10, 4, and 2 cases described the use of lepirudin, danaparoid, argatroban, and bivalirudin, respectively. Two cases did not report the type of anticoagulant used, and 1 case used aspirin. The most commonly reported complication was bleeding.