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Purpose Upadacitinib has been found to improve symptoms as early as day 1 in patients with inflammatory bowel disease. As a result, early and timely initiation of upadacitinib is paramount to prevent hospital admission for an acute flare. The purpose of this study was to identify the time to initiation of upadacitinib, comparing external specialty pharmacies (ESPs) to a health-system specialty pharmacy (HSSP). Methods This was a single-center, retrospective study at the University of Chicago Medicine (UCM) Inflammatory Bowel Disease Center and included patients initiated on upadacitinib between March 1, 2022, and April 1, 2023. Data collected included demographics, prior authorization information, appeal information, insurance type, date the prescription was sent, and date the patient initiated therapy (patients were called to confirm the date). The primary outcome evaluated was the days from prescribing to patient initiation. Secondary outcomes included the total time to initiation and the time to notification from insurance regarding determination of a prior authorization or appeal. Patients were excluded if they were lost to follow-up, initiated therapy through alternative means, or had previously initiated upadacitinib. Results A total of 107 patients were initiated on upadacitinib during the study period (n = 18 through the UCM HSSP, n = 89 through an ESP). The median number of days to patient initiation was 3 days (interquartile range, 3-6 days) for the UCM specialty pharmacy vs 9 days (interquartile range, 4-13 days) for ESPs (P = 0.003). A total of 88.9% of patients filling through the UCM specialty pharmacy initiated upadacitinib within 7 days, compared to 47.2% of patients filling through an ESP (P = 0.001). Seven patients needed earlier initiation of therapy to prevent hospital admission. Conclusion This study validates the ability of HSSPs to initiate therapies earlier than ESPs with a particular focus on upadacitinib. [ABSTRACT FROM AUTHOR]

Purpose To assess the impact of a clinical pharmacy specialist (CPS) embedded within a rheumatology clinic at a large academic medical center on the prescription capture rate at the health-system specialty pharmacy. Methods Initially low prescription capture rates for the health-system specialty pharmacy led to the integration of a CPS in the main campus rheumatology clinic. Benchmarking was completed by assessing the prior prescription capture rate using electronic medical record analytics and Loopback Analytics (a database of prescription capture for the health-system specialty pharmacy). The existing workflows for both the rheumatology clinic and specialty pharmacy were observed with regard to biologic medication ordering and processing. Strategies for an updated workflow for biologic ordering with the incorporation of an embedded CPS in the rheumatology clinic were designed. This new workflow was established with key stakeholders, including the CPS, rheumatology providers, clinic staff, and pharmacy technicians. Once the workflow was established, all parties were educated and updated, including rheumatology providers, nursing staff, and specialty pharmacy staff. Prescription capture rate was monitored on a monthly basis. Results Prescription capture increased from 13.16% before pharmacist implementation (October to December 2021) to 35.42% after pharmacist implementation (October to December 2022) (P = 0.019). During the same periods, the revenue generated increased from $43,222.89 to $135,198.70 (P = 0.224) and the proportion of prescriptions initially sent to the health-system specialty pharmacy compared to other specialty pharmacies increased from 37% to 79% (P < 0.001) with CPS implementation. Conclusion Expansion and implementation of pharmacy services by integrating a CPS in a rheumatology ambulatory clinic increased prescription capture and pharmacy revenue while optimizing patient care. We hope to expand similar CPS services to other clinics within the health system. [ABSTRACT FROM AUTHOR]

Purpose Health-system specialty pharmacy (HSSP) pharmacists play an integral role in the care of patients with multiple sclerosis (PwMS) by facilitating medication access, providing counseling, improving adherence, and decreasing provider workload. However, current literature detailing pharmacist interventions and their acceptance rates in this population is limited. The purpose of this study was to identify the types and acceptance rate of clinical interventions completed by pharmacists for PwMS. Methods To evaluate the acceptance rate of HSSP pharmacist interventions, we conducted a retrospective, multicenter, observational, descriptive study for the period from October 2019 to August 2022. Intervention types were categorized into reasons for intervention, recommendations from the pharmacists, and their acceptance rates. Results For 225 patients enrolled in HSSP services, 449 interventions were completed, with an average of 2.0 interventions per patient. Most interventions identified were associated with medication adherence (28.7%), medication regimen (27.6%), adverse drug reaction (ADR) (20.7%), and laboratory values (15.1%). The average adherence, defined by the proportion of days covered, was 94%. The most common recommendations were to continue therapy (14.9%), schedule laboratory tests (12.7%), and follow up with providers (11.8%). Recommendations had an acceptance rate of 85.3%, with 3.8% of recommendations declined and 10.9% requiring follow-up with providers. Conclusion Pharmacists impact patient outcomes through the completion of clinical interventions that improve adherence, identify medication regimen problems, manage ADRs, and coordinate proper laboratory testing. Pharmacist recommendations were most often accepted for interventions related to medication regimen and ADRs. Proper identification and management of medication regimen concerns, as well as tolerability of medications, can positively impact adherence and improve overall patient outcomes. [ABSTRACT FROM AUTHOR]

Purpose Specialty medications often have high costs, pose difficulties with payor approval, and require additional monitoring. Earlier articles have defined various examples of clinical outcome measures (COMs); however, goals and benchmarks have not been well defined, and a gap in the literature exists. This study evaluated the effectiveness of our health-system specialty pharmacy (HSSP) patient management program (PMP) in achieving predefined COM goals. Methods Disease state protocols were developed within the HSSP, and clinical and adherence goals were created for each COM based on primary literature. This retrospective, single-center review examined outcomes and adherence data on patients enrolled in the PMP during 2022. The primary outcome was the number of predefined disease state COM goals met. Secondary outcomes included the number of predefined adherence goals met and annual financial impact. Results Of 1,431 patients whose records were reviewed, 1,053 met criteria for inclusion. The primary outcome analysis showed that 85% (33 of 39) of the predefined disease state goals were met. Predefined adherence goals were met, with an average proportion of days covered (PDC) for all specialty medications of >90%. The PMP yielded $5,167,043 in direct patient cost savings and $167,260 in cost avoidance. Conclusion The PMP yielded positive results in meeting goals set for the COMs in the disease states managed within the HSSP. COMs will remain a focus for HSSPs to help patients achieve desired clinical outcomes and HSSPs adhere to accreditation standards. More research in this field and standardization of COM goals may benefit the larger HSSP community. [ABSTRACT FROM AUTHOR]

Purpose The prevalence of specialty pharmacies has grown, especially within the hospital setting. These pharmacies have shown benefits in the areas of patient education and adherence, financial support, and patient and provider satisfaction. Currently, there are gaps in literature describing use of a hybrid clinical model in health-system specialty pharmacies. Summary The UofL Health – UofL Hospital Specialty Pharmacy (UofL Health SP) is attached to a retail pharmacy in a larger health system. Pharmacists in the UofL Health SP utilize a hybrid clinical model in which they split their time between working in a specialty clinic and staffing in the specialty pharmacy. The specialty pharmacy and its oncology satellite pharmacy each have a primary staffing pharmacist, and 5 other pharmacists participate in this hybrid clinical model. In addition to the specialty pharmacists, pharmacy technicians and patient care advocates support the operations of the specialty pharmacy and ensure financial access to medications for patients. Conclusion With the hybrid clinical model at UofL Health SP, there is increased workflow efficiency and better communication between specialty clinics and the specialty pharmacy, which results in a streamlined patient experience. Additionally, there has been an increase in specialty pharmacy prescriptions dispensed in the specialty pharmacy since the implementation of this hybrid clinical model. [ABSTRACT FROM AUTHOR]

Background: Compass Rose™, a case management tool developed by Epic®, was designed to track various patient coordination tasks, outreaches, and outcomes. This report describes the implementation of Compass Rose™ within an internal health-system specialty pharmacy (HSSP) and changes in care coordination metrics before and after implementation. To the best of our knowledge, this is the first study of its kind to discuss the implementation of Compass Rose™. Objectives: The goals of this study were to describe the implementation process of Compass Rose™ at an internal HSSP and compare staff satisfaction before and after Compass Rose™ as the primary outcome. Methods: This was an Institutional Review Board exempt, retrospective cohort study conducted between June 2022 to December 2022 that assessed staff satisfaction, refill documentation time, prescription turnaround time, and patient satisfaction pre- and post- Compass Rose™ implementation through survey administration, observed time studies, and internal data reports. The process of Compass Rose™ implementation was also described and discussed. Results: 24 specialty pharmacy staff members participated in the Compass Rose™ implementation survey. No statistically significant differences were observed in either staff satisfaction (3.96 ± 0.95 versus 3.70 ± 0.69, p = 0.29) or predicted versus actual challenge of implementation (3.67 ± 1.17 versus 3.09 ± 0.96, p = 0.064). There was no significant difference in refill documentation time pre- versus post- Compass Rose™ implementation (4.22 ± 3.15 minutes versus 4.10 ± 2.36 minutes, p = 0.82); however, there was a statistically significant increase in prescription turnaround time post implementation (2.59 ± 2.85 days versus 2.69 ± 2.35 days, p = 0.002). Conclusion: Compass Rose™ implementation had no significant impact on staff satisfaction, patient satisfaction, or overall refill documentation time. Prescription turnaround time increased, which could be due to significant workflow changes with Compass Rose™ or several other contributing factors such as increased prescription volume and training new staff during this period.Benefits of Compass Rose™ included standardization of workflow, ability to quantify staff performance and clinical impact, and increased transparency regarding care provided by the specialty pharmacy team.

The article presents a study which examined the finding from a proof-of-concept specialty pharmacy services program integrated into the patient experience for both occupational postexposure prophylaxis (oPEP) and nonoccupational PEP (nPEP) patients receiving HIV prevention medications at hospital-based emergency departments (EDs). Topics discussed include ED pharmacy operations, summary of specialty pharmacy services workflow, and study findings.

Background: Understanding risk factors for nonadherence can help specialty pharmacies optimize resources to prevent nonadherence and inform risk-stratification processes. Objective: To determine which individual and community-level characteristics are associated with nonadherence to specialty medications. Methods: We analyzed a cohort of patients enrolled in a prospective randomized controlled trial having filled a specialty medication at least 4 times in the previous 12 months with a proportion of days (PDC) covered < 0.90. We collected patient age, gender, race, medication administration type, therapy start date, home address, insurance type, and online patient portal status from the electronic health record. An ordinal logistic regression model was used to assess the association of nonadherence with individual and community-level patient characteristics. Results: Most patients were female (68%), white (82%), and held commercial insurance (58%) with a median age of 53 (interquartile range [IQR] 40, 64) years. Patients were mostly from the adult rheumatology (35%), multiple sclerosis (20%) and lipid (17%) clinics. Given a 10-year increase in age, patients had lower odds of having lower PDC (odds ratio [OR] = 0.82, 95% confidence interval [CI] = 0.71-0.94, P = 0.005). Patients on therapy greater than or equal to 1 year had half the odds of having lower PDC relative to patients on therapy less than 1 year (OR = 0.52, CI = 0.35 – 0.75, P < 0.001). No statistically significant associations were found between PDC and gender, race, insurance type, route of administration, clinic type, patient portal status, median income, percent receiving government assistance, or percent with no health insurance. Conclusion: Patients with younger age and shorter duration on treatment may be at-risk for lower adherence. Specialty pharmacies may benefit from targeting adherence interventions to these groups. [ABSTRACT FROM AUTHOR]

Purpose This descriptive report describes the process used to obtain access to providing ambrisentan from a health-system specialty pharmacy (HSSP) affiliated with a pulmonary hypertension Center of Comprehensive Care, develop a pulmonary arterial hypertension (PAH) care team at the HSSP, and characterize medication adherence and access metrics. Summary PAH is a rare disease treated with several specialty medications requiring intensive monitoring. Historically, specialty medications used to treat PAH have been provided by only select specialty pharmacies due to restricted drug distribution channels. It is recommended that patients with PAH receive their care at centers with expertise in the diagnosis and management of this disorder, but the HSSPs at these expert centers are unable to provide specialty PAH medications. The current care model for PAH leads to patients receiving their medical and pharmaceutical care from separate entities. This descriptive report describes a multidisciplinary team's approach to gaining access to providing ambrisentan and developing a disease state care team within an established HSSP. After implementing this service, specialty pharmacy metrics were assessed, including proportion of days covered (PDC), time to first fill, patient contact rate, Risk Evaluation and Mitigation Strategy (REMS) program compliance, time to prior authorization (PA) approval, rate of optimal adherence (PDC of >80%), and PA renewal rate, to demonstrate a proof-of-concept HSSP model for PAH. In this model, the HSSP was able to demonstrate high-quality specialty pharmacy metrics with regard to medication adherence, medication access, and REMS program compliance. Conclusion The development of a PAH care team to provide ambrisentan at an existing HSSP was associated with high adherence rates, efficient and reliable medication access, and REMS program compliance. [ABSTRACT FROM AUTHOR]

Purpose The results of the 2022 American Society of Health-System Pharmacists (ASHP) Survey of Health-System Specialty Pharmacy (HSSP) Practice: Practice Models, Operations, and Workforce are presented. Methods A total of 273 leaders in HSSPs were contacted by email to complete a survey hosted using Qualtrics. The survey sample was compiled from ASHP member lists, the presence of a specialty pharmacy indicated in previous ASHP surveys, and outreach to ASHP member organizational leaders. Results The survey response rate was 35.9%. Most HSSPs dispense 30,000 or fewer specialty prescriptions annually. Most respondents have an annual revenue of $100 million or less, are part of a 340B-covered entity, operate one location, have 1 to 2 specialty pharmacy accreditations, dispense both nonspecialty and specialty medications, and employ an average of 15.5 pharmacists and 17.6 technicians. The majority (66.7%) dispense 50% or less of prescriptions written by internal providers due to payor and manufacturer network restrictions. Over one-third employ nonpharmacist and nontechnician professionals. Specialty pharmacists are involved in treatment decisions and therapy selection before prescription generation (69.8%), and 47.7% of respondents report pharmacists operating under collaborative practice agreements. Most (82.6%) offer experiential or formal education in specialty pharmacy. The top point of pride remains patient satisfaction and level of service. Top challenges include access to payor networks, the ability to hire and retain qualified staff, and shrinking reimbursement from payors. Conclusion The HSSP is a continually maturing integrated advanced practice model focused on providing patient-centric care to all patients and employees of the health system regardless of network status. HSSPs are raising the standards for quality in specialty pharmacy care. [ABSTRACT FROM AUTHOR]

Purpose Medication nonadherence is a multifactorial healthcare problem that contributes to increased healthcare costs and morbidity. To improve medication adherence, specialty pharmacies offer services not typically provided by retail pharmacies such as benefits investigation, financial assistance, medication synchronization, and proactive refill reminders. This study assessed the impact of the specialty pharmacy care model on medication adherence for patients on nonspecialty medications. Methods This study was a quasi-experimental cohort comparison of patients who were transferred from a health-system retail pharmacy to a health-system specialty pharmacy between April 1, 2020, and June 30, 2021. The primary endpoint in this study was the difference in mean medication adherence proportion of days covered (PDC) between the post-transfer and pretransfer periods. Secondary outcomes included the proportion of patients with PDC of greater than 80%, medication adherence by drug group, shipment volumes, number of medications per shipment, and the mean copay per medication. Results In this study of 163 patients, use of a specialty pharmacy care model led to a significant increase of 7.0% in mean PDC, a significant increase in the percentage of patients with PDC of greater than 80%, a significant decrease in the number of shipments per 30 days per patient, a significant increase in the number of medications included per shipment, and a significant reduction in the mean copay per medication. Conclusion The findings in this study suggest that the application of the specialty pharmacy care model to nonspecialty pharmacy patients may improve medication adherence, decrease the number of shipments per patient sent from the pharmacy, and reduce patient copays. [ABSTRACT FROM AUTHOR]

Persistence to human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) is integral to preventing new HIV infections. Previous studies have shown real-world PrEP persistence is low and insight is needed into PrEP delivery strategies that improve persistence. This single-center, retrospective, cohort study measured persistence in patients filling PrEP through an integrated health-system specialty pharmacy (HSSP) compared to those filling at external pharmacies. The Kaplan–Meier estimates for persistence probability at 6, 12, and 18 months were 0.87 (95% CI 0.79–0.95), 0.75 (95% CI 0.66–0.86), and 0.64 (95% CI 0.53–0.76) for the HSSP cohort compared to 0.65 (95% CI 0.51–0.83), 0.41 (95% CI 0.28–0.62), and 0.32 (95% CI 0.2–0.53), respectively, for the non-HSSP cohort (log-rank p < 0.001, χ 1 2 = 11.2). Cox PH modeling showed that patients using a non-HSSP were 2.7 times more likely to be non-persistent than HSSP patients (HR 2.7, 95% CI 1.6–4.7, p < 0.001, χ 1 2 = 12.61), demonstrating patients were better maintained on PrEP therapy when their prescriptions were filled with the HSSP. [ABSTRACT FROM AUTHOR]

The article describes the development of a framework to support data-driven decision-making in a health-system specialty pharmacy. It discusses the significance of a specialty pharmacy program to the health system in areas measured in terms of pharmacy patient management, staffing ratios, patient access to care and quality of services provided. It highlights improvements to health-system specialty pharmacies (HSSP) and explains the significance of the program to pharmacy practice management.

Purpose The impact of the market entry of adalimumab biosimilars on clinical practices and specialty pharmacies is explained. A roadmap is also provided for how pharmacists can successfully navigate this landscape. Summary Biosimilars have previously been introduced as a mechanism to help curb biologic expenditures, with biosimilars undergoing an abbreviated regulatory approval process that focuses on biosimilarity and generating product competition. Adalimumab is currently the leading product in the biologics market, generating approximately $20 to $30 billion in sales worldwide consecutively from 2019 to 2021. Many adalimumab biosimilars are slated to enter the market in 2023 and become available for patient use. However, compared to other biosimilars, adalimumab biosimilars have several unique considerations, such as interchangeability and concentration, that will impact pharmacy practices and workflows. Because pharmacists embedded in clinical practices and specialty pharmacies will be significantly involved in the processes relating to adalimumab biosimilar implementation, adoption, and use, a primer on understanding the various adalimumab biosimilar products available and considerations surrounding these products with regard to workflow and patient use is critical. Several resources are also provided to help pharmacists successfully navigate the adalimumab biosimilar landscape. Conclusion The biosimilar landscape continues to evolve, and 2023 will see the launch of several adalimumab biosimilar products, which vary with regard to formulation, concentration, and interchangeability status. Pharmacists are well positioned to educate providers and patients about this landscape and help implement an efficient workflow to support adalimumab biosimilar adoption and use. [ABSTRACT FROM AUTHOR]

Objective: To describe and review the published evidence on use of multiple biologics within specialty pharmacy practice. Data Sources: A search of PubMed and Embase was conducted from October 2021 through September 2022. Keywords included biologics for immune-mediated conditions along with the terms "dual," "add-on," and "combination." Study Selection and Data Extraction: All human studies in the English language were considered. Published abstracts, case reports, case series, randomized controlled trials, systematic reviews, and meta-analyses were included. Data Synthesis: Although evidence is limited, there are published meta-analyses of combined biologic use within gastroenterology and rheumatology. There are also numerous case reports within dermatology. Clinical trials of dual biologics for severe rheumatologic conditions and inflammatory bowel disease are in progress. Existing evidence for use in pulmonology and allergy suggest dual biologic therapy can be safe and effective, but data are limited. Literature describing use of monoclonal antibodies for other overlapping conditions is lacking. Relevance to Patient Care and Clinical Practice: This article reviews the evidence describing combination biologic use and outlines remaining knowledge gaps. It also describes the essential role that specialty pharmacists play in managing therapeutic mAbs. Conclusions: High-quality evidence describing combination biologic use is limited and long-term safety data are lacking. Pharmacists should utilize their specialized training to assess appropriateness of therapy, provide patient counseling and monitor for safety and efficacy. [ABSTRACT FROM AUTHOR]

(1) Background: The rising prices of medical infusions have resulted in the increased utilization of policies for payors to manage costs. These policies can be disruptive to the continuity of care, and health systems should develop a systematic strategy to address market changes and prevent patient leakage. (2) Methods: A quality improvement study was conducted by an interdisciplinary workstream to assess the current state of infusion services in an academic medical center in the Midwest and to provide recommendations for immediate access improvement and long-term system planning. An organizational assessment of the value stream was completed, which analyzed the available infusion capacity, billing strategy, patient mix/volumes, payor mix, staffing levels, and current policies. The interventions implemented after developing the infusion system strategy were triaging patients to the appropriate site of care to increase infusion capacity and eliminating paper orders in one of the health system's Infusion Centers. (3) Results: Patients receiving medical infusions for oncologic conditions warrant unique considerations in evaluating the Infusion Center's efficiency due to the infusion regimen's length, complexity, and tolerability. The management of the payor site of care also poses a challenge for health systems to triage patients effectively without fragmenting care. (4) Conclusions: An organizational strategy around infusion services must include broad stakeholder representation to address the clinical, operational, and financial challenges to provide timely care to patients. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Purpose Ambulatory care and specialty pharmacy practices are rapidly growing in tandem with the accelerated development of advanced therapies for complex disease states. A coordinated and standardized interprofessional team–based approach is critical to providing high-quality care to specialty patients on complex, expensive, and high-risk therapies. Yale New Haven Health System dedicated resources to the creation of a medication management clinic under a unique care model that integrates ambulatory care pharmacists within specialty clinics who coordinate with centralized specialty pharmacists. The new care model workflow encompasses ambulatory care pharmacists, specialty pharmacists, ambulatory care pharmacy technicians, specialty pharmacy liaisons, clinicians, and clinic support staff. The strategies employed to design, implement, and optimize this workflow to meet the increasing demand for pharmacy support in specialty care is discussed. Summary The workflow incorporated key activities from highly diverse existing specialty pharmacy, ambulatory care pharmacy, and specialty clinic practices. Standard processes were developed for patient identification, referral placement, visit scheduling, encounter documentation, medication fulfillment, and clinical follow-up. Resources were created or optimized to support successful implementation, including an electronic pharmacy referral, specialty collaborative practice agreements to facilitate pharmacist-led comprehensive medication management, and a standardized note template. Communication strategies were developed to facilitate feedback and process updates. Enhancements focused on eliminating documentation redundancies and delegating nonclinical tasks to a dedicated ambulatory care pharmacy technician. The workflow was implemented in 5 ambulatory rheumatology, digestive health, and infectious diseases clinics. Pharmacists utilized this workflow to complete 1,237 patient visits, serving 550 individual patients over 11 months. Conclusion This initiative created a standard workflow to support an interdisciplinary standard of specialty patient care that is robust to accommodate planned expansion. This workflow implementation approach can serve as a road map for other healthcare systems with integrated specialty and ambulatory pharmacy departments undertaking similar models for specialty patient management. [ABSTRACT FROM AUTHOR]

Purpose Given the variation in clinical practice, a clinician-centric, standardized process to implement and validate clinical pharmacy outcome measures was developed. Summary Four specialty clinics with embedded clinic-based pharmacists underwent an iterative process to define, refine, and implement the build of electronic health record functionality for outcome measure data collection and reporting. Starting with a list of identified measures, clinic workgroups met to discuss each measure and identify gaps in measure implementation. Information technology experts created electronic documentation forms with discrete data and reports based on criteria specified by the clinic workgroups. Of 32 outcome measures identified as priorities for demonstrating pharmacists' impact in previous research, 29 were implemented for routine monitoring through this project. Implementation strategies included identification through existing reporting, development of discrete documentation tools within the electronic health record, and development of new reporting tools from available discrete data fields. Time to implementation decreased from the first to the last pilot clinic implementation, as demonstrated through a 9-day reduction in electronic documentation form development and 31-day reduction in report development turnaround time. Conclusion A standardized and reproducible process was developed for the implementation of clinical pharmacy outcomes measures for 4 specialty clinics. The process was successfully utilized to develop measurable outputs for a variety of oncology and nononcology specialty disease states based upon multidisciplinary stakeholder input. [ABSTRACT FROM AUTHOR]

Purpose Patients receiving biologic therapy for inflammatory bowel disease (IBD) require routine laboratory monitoring to ensure the safety and efficacy of therapy. The purpose of this quality improvement project was to evaluate the implementation of a dashboard to prevent treatment gaps by prospectively identifying patients with IBD and outdated laboratory results receiving biologics. Methods We performed a pre/post analysis of dashboard implementation to assess the number of patients with overdue laboratory work resulting in treatment gaps. The dashboard combined data from the electronic health record (EHR) and pharmacy claims database to identify patients on a biologic with laboratory tests (white blood cell count, liver transaminases, C-reactive protein, and erythrocyte sedimentation rate) completed 5 or more months ago and/or a tuberculosis screen completed 11 or more months ago. After implementation, specialty pharmacists reviewed the dashboard and communicated via EHR if a new prescription and laboratory tests were needed. Messages were sent 4 weeks in advance of the next refill-eligible date. Mixed methods were used for analysis of qualitative data, including surveys, and quantitative data, assessing treatment gap length. Results A total of 40 patients who had outdated laboratory values and required a new prescription (15 before dashboard implementation and 25 after implementation) were included in the analysis. The frequency of a treatment gap decreased from 80% (n = 12) in the preimplementation phase to 32% (n = 8) in the postimplementation phase. The median gap length was shorter after dashboard implementation, decreasing from 21 days (range, 3-97 days) to 11 days (range, 2-23 days). Conclusion Utilization of a quality measures dashboard decreased treatment gaps in patients with IBD receiving biologic therapy. Integrated specialty pharmacists are uniquely positioned to monitor adherence to laboratory monitoring parameters for patients on biologics. [ABSTRACT FROM AUTHOR]

As pharmacy services expand, it is critical for schools/colleges of pharmacy to prepare learners to provide patient care in a variety of settings and to subsequently assess skills that are necessary for clinical practice. The objectives of this study were to (1) develop and implement a simulation that required students to integrate knowledge from multiple courses and disciplines, (2) assess students' performance and perceptions of the activity, and (3) measure student confidence related to managed care, specialty pharmacy, and clinical and foundational concepts prior to and after the simulation. Faculty developed an integrated simulation that required students to provide information for prior authorization of a new medication, counsel a patient on rheumatoid arthritis and the medication, and address patient questions about insurance formularies, cost, and prior authorization processes. Students completed pre- and post-surveys to determine changes in knowledge and perceptions of the simulation. Exam questions that corresponded to simulation concepts were also analyzed. Analysis of pre-post surveys indicated that students' self-perceived knowledge and confidence significantly improved in all areas (P <.001 and P <.05, respectively). Student perceptions of the simulation were positive, with comments referencing the activity's realism. Correct answers on knowledge-based questions related to simulation concepts were selected by at least 90% of students on course examinations. This integrated simulation was effective at increasing self-perceived student knowledge and confidence on concepts from all disciplines, and it can easily be replicated and adapted at other pharmacy institutions. [ABSTRACT FROM AUTHOR]

In rheumatoid arthritis, the use of Routine Assessment of Patient Index Data 3 (RAPID3) assessments to meet treat-to-target goals is endorsed by the 2021 American College of Rheumatology guidelines. In November 2020, the Baylor Scott & White specialty pharmacy implemented a new service that included more frequent collection of RAPID3 scores and standardized provider communication for patients co-managed by a Baylor Scott & White rheumatology clinic. The objective was to evaluate the impact of this new service on rheumatoid arthritis disease activity. Before the new service started, patients followed a protocol of RAPID3 assessments that occurred every 6 months; once the service began, patients were followed using an algorithm in which patients with higher disease activity were contacted more frequently. Eighty-six percent of patients in the pre-intervention group (n = 7) compared with 100% of patients in the post-intervention group (n = 10) had high to moderate disease activity at baseline. Within a 6-month follow-up period in both groups, the percentage of high to moderate disease activity patients decreased by 30% in the post-intervention group and remained the same in the pre-intervention group. These results support the positive impact increased specialty pharmacy services may have on clinical outcomes; therefore, the continued expansion of these services should be considered. [ABSTRACT FROM AUTHOR]

Purpose There is minimal available guidance on the process for selection of clinical outcomes measures to demonstrate the impact of clinic-based pharmacists (CBPs) despite an increased need and desire for outcomes data. The overall aims of this project were to (1) develop a standardized process for identifying clinical outcomes measures impacted by CBPs and (2) identify and prioritize potential clinical outcomes measures to track for CBPs within 4 specialty clinic pilot sites. Methods To develop a standardized process for identification and prioritization of measures, 4 consecutive Plan-Do-Study-Act (PDSA) cycles were performed with 4 different specialty clinics serving as pilot sites. Following each pilot cycle, rapid cycle improvements were implemented. A modified Delphi methodology served as the framework for measure selection and included gathering expert stakeholder insights regarding importance, feasibility, and validity of potential measures. Measures were identified via environmental scan of existing validated quality metrics, clinical guidelines, and other relevant literature. Results The primary outcome for this project was the development and refinement of a standardized process for measure identification and prioritization. The secondary outcome was narrowed and ranked lists of stakeholder-prioritized measures for 4 CBP-embedded pilot specialty clinics. These lists included 12 cardiothoracic transplant, 6 breast oncology, 9 neurology, and 7 gynecologic oncology measures. Conclusion The measure identification and prioritization process developed was successfully utilized to identify and prioritize outcomes measures to track for 4 CBP-embedded specialty clinics. Due to the successful use of the process in a variety of specialty clinics, the standardized process has significant potential for expansion. [ABSTRACT FROM AUTHOR]

The purpose of this study was to implement and evaluate a specialty pharmacy workshop across pharmacy management and skills lab courses. A specialty pharmacy workshop was developed and implemented. The lecture cohort (fall 2019) consisted of a 90-min lecture in pharmacy management. The lecture/lab cohort (fall 2020) consisted of the lecture plus a 30-min pre-lab video assignment and a two-hour laboratory activity. At the completion of lab, students presented findings virtually to specialty pharmacists. Pre-surveys and post-surveys assessed knowledge (10 items), self-confidence (9 items), and attitudes (11 items). Of the 123 students enrolled in the course, 88 students (71.5%) completed pre- and post-surveys. On a 10-point scale, knowledge improved from 5.6 (SD = 1.5) to 6.5 (SD = 2.0) points in the lecture cohort and from 6.0 (SD = 1.6) to 7.3 (SD = 2.0) points in the lecture/lab cohort with a significance difference favoring the lecture/lab cohort. Perceived confidence improved for five out of nine items in the lecture cohort but improved significantly for all nine items in the lecture/lab cohort. Attitudes toward learning about specialty pharmacy were generally positive for both cohorts. The specialty pharmacy workshop exposed students to workflow management and medication access processes. Students perceived the workshop to be a relevant and meaningful, allowing them to feel confident in developing knowledge and understanding of specialty pharmacy topics. The workshop can be replicated at a larger scale with schools of pharmacy utilizing the integration between didactic and laboratory courses. [ABSTRACT FROM AUTHOR]

Purpose To demonstrate how the integration of a pharmacist-led, telehealth-based first-dose device teaching (FDDT) workflow helped to improve the efficiency of the work system, expand access, and maintain the high quality of care. Summary The telehealth program was designed utilizing existing specialty pharmacy infrastructure and a partnership with a dermatology clinic. The program includes patients receiving a self-injectable specialty medication (SISM) who require an FDDT and fill with our health system's specialty pharmacy. Patients complete a virtual FDDT with a specialty pharmacist following an initial pharmacist consult and medication shipment. Patient experience and program feedback were captured via a standardized 5-point Likert telephone survey. A total of 30 patients completed the FDDT program. Surveys following the FDDT visit completed by 19 patients showed that patients had high satisfaction with the quality and convenience of the telehealth visit (4.53 and 4.79, respectively). Overall care and education received from the pharmacist was also rated highly (5.00). Notable feedback captured in free responses emphasized the helpfulness of the pharmacist and the convenience of the visit. Areas to improve focused on technology difficulties. Conclusion As SISMs continue to grow in utilization, telehealth services should be considered as part of the clinic workflow. Specialty pharmacists delivered high-quality and convenient care to patients through this patient education program. Expansion of this program into additional clinics may help improve specialty care access and increase the availability of nursing staff for additional clinical needs. [ABSTRACT FROM AUTHOR]

Purpose The coronavirus disease 2019 (COVID-19) pandemic provided an opportunity to change how health-system specialty pharmacy (HSSP) call center operations are organized. This article describes the steps taken to virtualize the current operations of a specialty pharmacy services call center and evaluate the impact. Summary The onset of the COVID-19 pandemic and its impact on the normal provision of healthcare necessitated that HSSPs drastically modify existing procedures to both accommodate the expectations of staff and overcome the many barriers to care being experienced by patients. To fully understand and improve upon the workflow processes of an HSSP call center, a combination of qualitative feedback from patients, quantitative claims data, and quality metrics was evaluated. This project was divided into 3 phases: phase 1 (baseline) from July 2020 through August 2020, phase 2 (implementation) from September 2020 through December 2020, and phase 3 (analysis) from January 2021 through March 2021. Phase 1 included baseline review of workflow. Phase 2 encompassed development of new standard operating procedures (SOPs), making critical decisions to promote virtual capabilities of staff, and collaboration with team members to increase efficiency of current workflow. During phase 3, an evaluation of operational and service-related metrics was conducted to determine the impact of phase 2 workflow changes. Optimization of the specialty pharmacy call center allowed for staff members to transition to remote work to minimize exposure risk and prioritize the safety of patients and team members. Conclusion The call center team was able to transition to fully remote operations, implement new SOPs, and undergo significant workflow changes to optimize performance while still maintaining all call center metric goals and without increased complaints from patients or errors. This approach allowed for added staff value and safety and improved organization during the COVID-19 pandemic. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Purpose This article identifies, prioritizes, and summarizes published literature on the ambulatory care medication-use process (ACMUP) from calendar year 2020 that can impact ambulatory pharmacy practice. Summary The medication-use process is the foundational system that provides the framework for safe medication utilization within the healthcare environment and was reimagined to focus on new innovations and advancements in ambulatory pharmacy practice. The ACMUP is defined in this article as having the following components: transitions of care, prescribing and collaborative practice, accessing care, adherence, and monitoring and quality. Articles evaluating at least one step of the ACMUP were assessed for their usefulness toward practice improvement. A PubMed search covering calendar year 2020 was conducted in January 2021 using targeted Medical Subject Headings (MeSH) keywords and the table of contents of selected pharmacy journals, providing a total of 9,433 articles. A thorough review identified 65 potentially practice-enhancing articles: 14 for transitions of care, 19 for prescribing and collaborative practice, 10 for adherence, 6 for accessing care, and 16 for monitoring and quality. Ranking of the articles for importance by peers led to the selection of key articles from each category. The highest-ranked articles are briefly summarized, with a mention of why each article is important. The other articles are listed for further review and evaluation. Conclusion It is important to routinely review the published literature and to incorporate significant findings into daily practice. This article is the first to define and evaluate the currently published literature pertinent to the ACMUP. As healthcare continues to advance and care shifts to ambulatory settings, the ACMUP will continue to be a crucial process to evaluate. [ABSTRACT FROM AUTHOR]

Purpose To describe the presence, type, and management of drug-drug interactions (DDIs) at prescription cannabidiol (CBD) therapy initiation. Methods We conducted a single-center, retrospective study of patients prescribed CBD from a medical center's neurology clinic for seizure management from January 2019 through April 2020. Patients were excluded if they were enrolled in a CBD clinical trial or the insurance approval or medication fulfillment process was not completed by the center's specialty pharmacy. The primary outcomes were the numbers, types, and management of DDIs identified at the time of CBD prescribing. Results Of the 136 patients included, 109 (80%) had a DDI identified at baseline. Of the 260 DDIs, 71% (n = 184) were pharmacodynamic and 29% (n = 76) were pharmacokinetic in nature. Management of the 260 DDIs detected included counseling only (89% [n = 232 interactions]), discontinuation of the interacting agent [9% (n = 22 interactions]), and dosage change for the interacting agent [2% (n = 6 interactions]). Clobazam was the most commonly identified interacting medication (n = 63, 24%), while valproic acid accounted for 10% (n = 26) of the DDIs. The population was predominantly white (n = 115, 85%), 18 years of age or younger (n = 92, 68%), and had an indication for prescription CBD treatment of Lennox-Gastaut syndrome (n = 117, 86%). Conclusion This study provides new information on the role that integrated specialty pharmacists can play in identifying and managing initial DDIs in patients starting prescription CBD. [ABSTRACT FROM AUTHOR]

Background: Prior authorizations (PAs) for biologic medications, used to treat Inflammatory Bowel Disease (IBD), are often denied by Pharmacy Benefits Managers and can require a complex appeal process for patients to gain access to medication., Objective: This quality improvement project evaluated the impact of implementing a standardized appeal letter template and customizable clinical rationale letter content on specialty pharmacist workflow and workload in an integrated Hospital Health System Specialty Pharmacy (HSSP) IBD clinic., Practice Description: This initiative was conducted in an IBD outpatient clinic at a tertiary academic medical center with an integrated HSSP whose specialty pharmacists work collaboratively with providers to manage specialty medications., Practice Innovation: A letter template was created in the electronic health record (EHR) for pharmacists to use when submitting appeal letters. The template automatically populates patient results from recent labs, imaging, and clinic visit notes as part of the appeal documentation. Clinical rationale letter content was developed for the most common appeal reasons using EHR functionality that allows the creation of standardized notes that can be shared among team members and customized at time of use., Evaluation Method: An analysis of 2 months of data pre/post implementation was conducted using descriptive statistics to report the number of appeals submitted, time from PA denial to appeal submission, and appeal approval rate. A pharmacist post implementation satisfaction score was also collected., Results: The number of appeals submitted pre- (n=73) and post-implementation (n=73) was the same. Post-implementation, 89% of appeals were submitted within 3 days of PA denial compared to 29% pre-implementation. PA approval rate was high (93%) pre- and post-implementation. Overall pharmacist satisfaction was 9.7 out of 10., Conclusion: Implementation of an appeal letter template and standardized clinical rationale letter content in the EHR led to decreased time to appeal submission and high specialty pharmacist satisfaction., (Copyright © 2024. Published by Elsevier Inc.)

Disclaimer: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time., Purpose: There is a growing number of specialty medications with accompanying requirements that exceed standard characteristics, which may be referred to as "ultra complex." This article details examples of ultra-complex specialty medications, including the characteristics that make them ultra complex, and strategies implemented by an integrated health-system specialty pharmacy (IHSSP) to maintain an optimal patient journey., Summary: Before therapy initiation, ultra-complex specialty medications often require additional steps that go beyond what is required of traditional specialty treatments, such as ensuring patients have appointments scheduled and attended and coordinating medical procedures. At the time of initiation, ultra-complex therapy might require additional immunizations or dosing based on specific tests. Finally, specialty pharmacists managing ultra-complex medications often have to dedicate more time and effort to medication monitoring to ensure patients are able to stay on appropriate doses without treatment interruption. Manufacturers of ultra-complex medications must consider the resources and requirements that will be needed to ensure the success of these medications in the real world. Health systems must be aware of resource and staffing requirements necessary to ensure the success of ultra-complex medications. One consideration is the addition of a dedicated risk evaluation and mitigation strategy (REMS) pharmacist whose primary role is to ensure compliance with REMS requirements., Conclusion: Ultra-complex specialty medications provide unprecedented therapeutic advancements but demand multidisciplinary resources and workflows to enable safe medication initiation, appropriate dosing and monitoring, and achievement of desired therapeutic goals. IHSSPs are integrated into the care team and provide advanced monitoring capabilities, making them an ideal setting for managing ultra-complex specialty medications. External IHSSP partnerships working together before and after the launch of ultra-complex specialty medications allow for an optimal patient and provider journey from medication initiation through ongoing care coordination and monitoring., (© American Society of Health-System Pharmacists 2024. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

(1) Background: The rising prices of medical infusions have resulted in the increased utilization of policies for payors to manage costs. These policies can be disruptive to the continuity of care, and health systems should develop a systematic strategy to address market changes and prevent patient leakage. (2) Methods: A quality improvement study was conducted by an interdisciplinary workstream to assess the current state of infusion services in an academic medical center in the Midwest and to provide recommendations for immediate access improvement and long-term system planning. An organizational assessment of the value stream was completed, which analyzed the available infusion capacity, billing strategy, patient mix/volumes, payor mix, staffing levels, and current policies. The interventions implemented after developing the infusion system strategy were triaging patients to the appropriate site of care to increase infusion capacity and eliminating paper orders in one of the health system’s Infusion Centers. (3) Results: Patients receiving medical infusions for oncologic conditions warrant unique considerations in evaluating the Infusion Center’s efficiency due to the infusion regimen’s length, complexity, and tolerability. The management of the payor site of care also poses a challenge for health systems to triage patients effectively without fragmenting care. (4) Conclusions: An organizational strategy around infusion services must include broad stakeholder representation to address the clinical, operational, and financial challenges to provide timely care to patients.

Purpose To describe and quantify patient care activities performed by ambulatory clinical pharmacists supporting medical specialty clinics in a pediatric health system utilizing a hybrid staffing model during the coronavirus disease 2019 (COVID-19) pandemic. Methods Five ambulatory clinical pharmacists, integrated within a health-system specialty pharmacy (HSSP), utilized a web-based data collection tool to record time spent performing patient care activities over a 2-week period. Work location (onsite or offsite) of the pharmacist was reported for each activity. Activities were classified as direct or indirect patient care. Direct patient care activities were subcategorized as telemedicine appointments, in-person clinic appointments, HSSP call center work, medication access support, electronic medical record consults, and previsit planning/postvisit documentation. Administrative tasks and precepting were considered indirect patient care activities. Results A total of 1,190 activities were completed, with 77% of all activities performed offsite. Direct and indirect patient care activities accounted for 871 (73.2%) and 319 (26.8%) of total activities, respectively. No activity took longer for the pharmacists to complete offsite versus onsite. Conclusion Using a hybrid staffing model employed by a pediatric health system, ambulatory clinical pharmacists were able to efficiently provide a high volume of direct patient care activities even when working offsite. Rapid adaptation and implementation of telemedicine services was critical for pharmacists to continue to provide essential services within pediatric medical specialty clinics. [ABSTRACT FROM AUTHOR]

• Persistence to PCSK9i increased within an integrated specialty pharmacy care model. • Medication access was not a main contributor to PCSK9 inhibitor non-persistence. • LDL-C values of persistent patients were similar to other real-world studies. • Specialty pharmacists are positioned to help increase persistence to PCSK9i therapy. Nearly 40% of patients do not continue proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) therapy after 6 months, despite their ability to lower low-density lipoprotein cholesterol (LDL-C) and risk of cardiovascular events. Limited work has assessed persistence to PCSK9i therapy in an integrated specialty pharmacy model. To assess rates of persistence to PCSK9i therapy and report reasons for non-persistence in patients serviced within an integrated specialty pharmacy. We conducted a single-center, retrospective review of patients prescribed a PCSK9i at an academic health system between September 2015 and August 2018. Persistence was calculated as a binary measure (yes/no) of whether the patient was still receiving PCSK9i therapy at 3-, 12-, and 24-months; frequency distributions described reasons for non-persistence and descriptive statistics described the change in LDL-C from baseline to 24 months. 477 patients met inclusion criteria, 53% were male with median age of 63 years [IQR 56-70]. Median LDL-C at baseline was 157mg/dL and 86% had an atherosclerotic cardiovascular disease indication. Persistence at 3-, 12-, and 24-months was 94%, 80%, and 68%, respectively. Of the 262 patients persistent on PCSK9i therapy at 24 months with LDL-C values available, median LDL-C was 65 mg/dL. The most common reasons for non-persistence at 24 months included medication adverse effects (54%) and loss to follow-up (17%). High rates of persistence to PCSK9i were seen in patients receiving care within an integrated specialty pharmacy model compared with rates in previous studies, suggesting specialty pharmacists may play a role in mitigating many common reasons for PCSK9i non-persistence. [ABSTRACT FROM AUTHOR]

Introduction: Access to pimavanserin, the only Parkinson disease–related psychosis treatment approved by the FDA, is restricted by insurance requirements, a limited distribution network, and high costs. Following initiation, patients require monitoring for safety and effectiveness. The primary objective of this study was to evaluate impact of specialty pharmacist (SP) integration on time to insurance approval. Additionally, we describe a pharmacist-led monitoring program. Methods: This was a single-center, retrospective study of adults prescribed pimavanserin by the neurology clinic from June 2016 to June 2018. Patients receiving pimavanserin externally or through clinical trials were excluded. Pre- (June 2016 to December 2016) and post-SP integration (January 2017 to June 2018) periods were assessed. Proportional odds logistic regression was performed to test association of approval time with patient characteristics (age, gender, insurance type) postintegration. Interventions were categorized as clinical care, care coordination, management of adverse event, or adherence. Results: We included 94 patients (32 preintegration, 62 postintegration), 80% male (n=75) and 96% white (n=90) with a mean age of 73 years. Median time to approval was 22 days preintegration and 3 days postintegration. Higher rates of approval (81% vs 95%) and initiation (78% vs 94%) were observed postintegration. Proportional odds logistic regression suggested patients with commercial insurance were likely to have longer time to approval compared with patients with Medicare/Medicaid (odds ratio 7.1; 95% confidence interval: 1.9, 26.7; P=.004). Most interventions were clinical (51%, n=47) or care coordination (42%, n=39). Conclusion: Median time to approval decreased postintegration. The SP performed valuable monitoring and interventions.

Background: The number of Food and Drug Administration (FDA) approvals for anticancer therapies has significantly increased in recent years, but these novel therapies are costly and present challenges to patients and providers. Many institutions have implemented health systems specialty pharmacies (HSSPs) to help patients and providers navigate financial and logistical barriers to treatment with oral anticancer therapies. Patients on oral anticancer therapy are often treated across multiple sites of care which can complicate the inpatient specialty medication initiation process. Health systems often limit inclusion of oral anticancer therapies for inpatient administration due to costs, however several new therapies necessitate admission for treatment initiation. Health systems are then faced with the challenge of starting costly oral anticancer therapy inpatient and ensuring continued access to therapy upon discharge. We describe the integrated HSSP multidisciplinary approach to this MUP including providers, inpatient and outpatient pharmacists, specialty and inpatient pharmacies, institutional procurement team, and the institutional pharmacy and therapeutics (P&T) committee to streamline this process. The HSSP multidisciplinary processes addresses a growing need for cancer patients to receive timely and affordable treatments across different sites of care. The healthcare team and P&T committee ensure the patient receives the most appropriate therapy while being conscious of health-system costs. The HSSP and procurement team ensure the patient can obtain and afford the medication. The implemented processes allows for direct communication and collaboration between different sites of care and this collaborative approach leads to optimal patient care. [ABSTRACT FROM AUTHOR]

The article recommends a preferred adherence metric and minimum calculation specifications for specialty pharmacies. Topics discussed include appropriate variability in calculation methodologies and the continued need for outcomes-driven thresholds, standardized calculation methods, and potential reasons for misidentified nonadherence.

Background: Previous literature has illustrated a wide range of primary medication nonadherence (PMN) rates due to inconsistent calculation methods and parameters, but the impact of parameter specifications on PMN rates has not been assessed.Objectives: The objective of this study was to evaluate the impact of lookback window (LBW), duplicate window (DW), and fill window (FW) specifications on PMN rates in patients prescribed specialty self-administered oncology medications.Methods: This was a single-center, retrospective cohort analysis. Patients receiving a new electronic specialty oncology prescription January-December 2018 were included; excluded if re-routed to an external pharmacy within 2 days, fell within a DW, or cancelled within a FW. Twenty-four methods were used to calculate PMN based on combinations of the following parameters: (i) absence of prior specialty self-administered oncology medication fill within LBW (90, 180 days); (ii) absence of a duplicate prescription within DW (2, 7, 30 days); and (iii) sold status within FW (14, 30, 60, 90 days). For each method, PMN was calculated as the number of unsold prescriptions within the FW divided by all eligible prescriptions.Results: We evaluated 4,482 prescriptions, resulting in PMN ranging from 16% to 23%. Patients were commonly male (53%) and white (83%), with a median age of 64 years (interquartile range, IQR, 54, 72). Increasing the LBW from 90 to 180 days resulted in exclusion of 72 (2%) prescriptions and minimally impacted PMN rates. Most duplicate prescriptions (87%) occurred within two days of original prescription and PMN rates were minimally affected by DW. Most fulfilled prescriptions were filled within FW 30 days, 98% with a method of LBW 180, DW 2, and FW 30. Adjusting the FW consistently impacted PMN rates.Conclusions: Because various PMN definitions can significantly impact results, a thorough explanation of all parameter specifications should be reported in research using PMN. [ABSTRACT FROM AUTHOR]

There have been significant advances in Cystic Fibrosis (CF) treatment, with the introduction of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulators. Adherence is an important goal for CF management, as nonadherence is linked to poor health outcomes. To calculate the medication adherence in patients taking CFTR modulators using a national specialty pharmacy database. This retrospective observational cohort study utilized de-identified specialty pharmacy data from September 2017 to August 2018 to assess medication adherence for three CFTR modulators: ivacaftor, lumacaftor/ivacaftor, and tezacaftor/ivacaftor & ivacaftor. The primary outcome was proportion of days covered (PDC) for each medication, with mean PDC values compared across age groups and insurance characteristics. All analyses were performed using the SAS 9.4 University Edition (SAS Institute, Cary, NC). A total of 2,548 patients were analyzed, including 1,289 (50.59%) patients on lumacaftor/ivacaftor, 784 (30.77%) on ivacaftor, and 475 (18.64%) on tezacaftor/ivacaftor & ivacaftor. The mean PDC value for all CFTR modulators was above 0.80. Tezacaftor/ivacaftor & ivacaftor had the highest overall PDC of 0.92, while PDC values for both lumacaftor/ivacaftor and ivacaftor were 0.84. Children/adolescents on lumacaftor/ivacaftor (p = 0.0001) and tezacaftor/ivacaftor & ivacaftor (p = 0.001) had significantly higher mean PDC values compared to adults but not for ivacaftor (p = 0.3744). No statistical differences were seen in PDC across insurance characteristics. To the best of our knowledge, this is the first study to assess the adherence of three CFTR modulators using a large nationwide specialty database. With high acquisition costs of CFTR modulator therapies, there is a need to improve rates of adherence in patients with CF. [ABSTRACT FROM AUTHOR]

Disclaimer: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time., Purpose: Compared to estimated population prevalence rates, relatively few patients at risk are diagnosed with and treated for transthyretin cardiac amyloidosis (ATTR-CA). Where along the clinical pathway patient drop-off occurs, as well as the association of drop-off with patient sociodemographic characteristics, remains unknown., Methods: Using data from a healthcare system-wide cardiovascular imaging repository and specialty pharmacy, we characterized the clinical pathway from diagnosis with pyrophosphate scintigraphy (PYP) to tafamidis prescription, initiation, and adherence. Standardized differences (d values of ≥0.20, indicating at least a small effect size) were used to compare sociodemographics (age, sex, race, Area Deprivation Index) among patients with PYP-identified ATTR-CA by tafamidis prescription status and among patients prescribed tafamidis by initiation status. Tafamidis adherence was measured with the proportion of days covered (PDC)., Results: Of 97 patients with ATTR-CA, 58.8% were prescribed tafamidis, with 80.7% of those initiating therapy. Patients with ATTR-CA prescribed tafamidis were younger than those not prescribed tafamidis (d = -0.30). Utilization of a specialty pharmacy resulted in enrichment of treatment in subgroups traditionally undertreated in cardiovascular medicine, with higher rates of tafamidis initiation among women (100% initiation), patients of Black/African American race (d = 0.40), and those living in more economically disadvantaged areas (d ≥ 0.30). Adherence was high (PDC of >80%) in 88.4% of those initiating tafamidis., Conclusion: These findings highlight the tremendous opportunity for more robust ATTR-CA clinical programs, identifying potential patient subgroups that should be targeted to reduce disparities. For patients diagnosed with ATTR-CA, utilization of a specialty pharmacy process appears to ensure equitable provision of tafamidis therapy., (© American Society of Health-System Pharmacists 2024. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Compass Rose™, a case management tool developed by Epic®, was designed to track various patient coordination tasks, outreaches, and outcomes. This report describes the implementation of Compass Rose™ within an internal health-system specialty pharmacy (HSSP) and changes in care coordination metrics before and after implementation. To the best of our knowledge, this is the first study of its kind to discuss the implementation of Compass Rose™., Objectives: The goals of this study were to describe the implementation process of Compass Rose™ at an internal HSSP and compare staff satisfaction before and after Compass Rose™ as the primary outcome., Methods: This was an Institutional Review Board exempt, retrospective cohort study conducted between June 2022 to December 2022 that assessed staff satisfaction, refill documentation time, prescription turnaround time, and patient satisfaction pre- and post- Compass Rose™ implementation through survey administration, observed time studies, and internal data reports. The process of Compass Rose™ implementation was also described and discussed., Results: 24 specialty pharmacy staff members participated in the Compass Rose™ implementation survey. No statistically significant differences were observed in either staff satisfaction (3.96 ± 0.95 versus 3.70 ± 0.69, p  = 0.29) or predicted versus actual challenge of implementation (3.67 ± 1.17 versus 3.09 ± 0.96, p  = 0.064). There was no significant difference in refill documentation time pre- versus post- Compass Rose™ implementation (4.22 ± 3.15 minutes versus 4.10 ± 2.36 minutes, p  = 0.82); however, there was a statistically significant increase in prescription turnaround time post implementation (2.59 ± 2.85 days versus 2.69 ± 2.35 days, p  = 0.002)., Conclusion: Compass Rose™ implementation had no significant impact on staff satisfaction, patient satisfaction, or overall refill documentation time. Prescription turnaround time increased, which could be due to significant workflow changes with Compass Rose™ or several other contributing factors such as increased prescription volume and training new staff during this period.Benefits of Compass Rose™ included standardization of workflow, ability to quantify staff performance and clinical impact, and increased transparency regarding care provided by the specialty pharmacy team., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors. Published by Elsevier Inc.)

Purpose Results of the first ASHP National Survey of Health-System Specialty Pharmacy Practice are presented. Methods A sample of 230 leaders in health-system specialty pharmacies were contacted by email and invited to participate in a survey hosted using an online survey application. The survey sample was compiled from ASHP member lists, through review of data from other ASHP surveys indicating the presence of specialty pharmacies, and by outreach to ASHP member organizational leaders. Results The response rate was 53.0%. Most health-system specialty pharmacies dispense 30,000 or fewer specialty prescriptions per year, have an annual revenue of $100 million or less, are part of an entity eligible to participate in the 340B Drug Pricing Program, operate 1 specialty pharmacy location, have at least 1 specialty pharmacy accreditation, dispense nonspecialty medications in addition to specialty medications, and employ an average of 13 pharmacists and 15 technicians. More than two-thirds of health-system specialty pharmacies (68.8%) dispense no more than half of the prescriptions written by their providers due to payer network restrictions or limited distribution drugs. The health-system specialty pharmacy practice model includes access to the electronic health record (100% of respondents), pharmacists and technicians dedicated to specific clinics (64.9% and 57.7%, respectively), specialty pharmacist involvement in treatment decisions and drug therapy selection prior to the prescription being written (64.9%), and documenting recommendations and progress notes in patients' electronic health record (93.4%). Most health-system specialty pharmacies (83.3%) offer experiential or formal education in specialty pharmacy. Top challenges that survey respondents expected to face in the next year included restricted access to payer networks and limited distribution drugs, 340B Drug Pricing Program changes, and shrinking reimbursement from payers. Conclusion The health-system specialty pharmacy represents an integrated advanced practice model that incorporates specialty medication-use management across the continuum of care. [ABSTRACT FROM AUTHOR]

The article offers an overview of the innovative, nontraditional, and nonclinical roles in specialty pharmacy that are necessary to operate a high-performance specialty pharmacy. Topics covered include the role played by advanced pharmacy technicians, business managers, compliance and regulatory affairs personnel, leaders, and data analysts in supporting a health specialty pharmacy, and the key considerations for the purpose and function of each role.

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. [ABSTRACT FROM AUTHOR]

Purpose There is a growing need for specialty pharmacy leaders within integrated delivery networks (IDNs). Traditional training for students and residents has not met the demand for pharmacy leaders in this space. This article describes the partnership between UW Health (UWH) and the University of Wisconsin School of Pharmacy (UWSOP) in developing a specialty pharmacy elective course at UWSOP and in creating a postgraduate residency training program at UWH. Future directions for the partnership are discussed. Summary Members of the leaderships of UWH and UWSOP met to discuss expanding coursework related to specialty pharmacy business fundamentals at UWSOP. This meeting led to the development of a 2-credit elective course beginning in spring 2017. The course focused on marketplace economics, channel strategies, and specialty pharmacy practice development. Additionally, UWH identified the need to provide postgraduate training to meet the increasing demand across IDNs for specialty pharmacy leaders. The residency program was initiated in 2013 and received accreditation in 2016. The residency provides experience in specialty pharmacy leadership, managed care, finance, the revenue cycle, accreditation, and the supply chain. Future partnership opportunities include creation of a longitudinal student pharmacist track and joint project coordination between UWSOP students and UWH residents. Conclusion This partnership has provided a pathway for students to gain expertise in specialty pharmacy business fundamentals as well as postgraduate training opportunities for future specialty pharmacy leaders. IDN and school of pharmacy partnerships can expand educational opportunities for future specialty pharmacy leaders and help fulfill the market gap in specialty pharmacy leaders. [ABSTRACT FROM AUTHOR]

The article discusses the health-system specialty pharmacy (HSSP) model that can help specialty pharmacies align to an outcomes-focused mission. Topics covered include a nimble and thought-leadership approach required by the model, the challenges facing HSSP that are entering a highly fragmented and competitive environment, ways of translating differentiated HSSP capabilities into value, and best practices and outcomes measures of HSSP program implementations.

Purpose Direct and indirect costs related to the growth of specialty pharmacy services and the insurance navigation process for specialty clinic patients are discussed, and development and implementation of a pharmacy-driven and system-wide prior authorization (PA) processing center within a health system are described. Summary Expensive specialty drugs require PA. Due to the concentration of specialists, health systems with multiple specialties experience higher PA burden and resulting care delays. Although clinic staff typically handle PA requests, health-system specialty pharmacies are well positioned to support patients, clinic staff, and physicians by assuming responsibility for the PA process entirely. University of Utah Health established its Pharmacy Ambulatory Clinical Care Center (PAC3) to centralize PA processing for selected specialty and primary care clinics within the health system. In fiscal year 2019, the PAC3 team (10 pharmacy technician and 1.5 pharmacist full-time equivalents) completed over 13,000 PAs. The pharmacy labor cost increase was significant; however, the benefits gained from increased services, quality, and financial strength surpassed all costs associated with the implementation and maintenance of the pharmacy operation. Other tangible benefits included decreased delays in therapy initiation, increased patient satisfaction, increased clinic visits, and increased staff and provider satisfaction and engagement. Conclusion Increased PA requests associated with specialty drugs have placed considerable stress and staff burden on specialty clinics within health systems. However, development and implementation of an efficient PA processing infrastructure within a health-system specialty pharmacy may reduce the burden, increase financial strength, and improve the patient experience. [ABSTRACT FROM AUTHOR]

Purpose The purpose of this study is to obtain insight into providers' satisfaction with services offered by health-system integrated specialty pharmacies and to determine whether providers' perceptions of services offered under an integrated model differ from perceptions of external specialty pharmacy services. Methods A multi-site, cross-sectional, online survey of specialty clinic healthcare providers at 10 academic health systems with integrated specialty pharmacies was conducted. The questionnaire was developed by members of the Vizient Specialty Pharmacy Outcomes and Benchmarking Workgroup and was pretested at 3 pilot sites prior to dissemination. Prescribers of specialty medications within each institution were identified and sent an email invitation to participate in the study that included a link to the anonymous questionnaire. Respondents were asked to rate their agreement with 10 statements regarding quality of services of integrated and external specialty pharmacies on a 5-point scale (1 = strongly disagree, 5 = strongly agree). An analysis to determine differences in providers' overall satisfaction with the integrated and external specialty pharmacy practice models, as well as differences in satisfaction scores for each of the 10 statements, was performed using paired-samples t tests. Results The mean (SD) score for overall satisfaction with integrated specialty pharmacies was significantly higher than the score for satisfaction with external specialty pharmacies: 4.72 (0.58) vs 2.97 (1.20); 95% confidence interval, 1.64-1.87; P < 0.001. Provider ratings of the integrated specialty pharmacy model were also higher for all 10 items evaluating the quality of services (P < 0.05 for all comparisons). Conclusion The study results confirm that the health-system integrated specialty pharmacy practice model promotes high rates of provider satisfaction with services and perceived benefits. [ABSTRACT FROM AUTHOR]

Purpose Health-system specialty pharmacies (HSSPs) provide high-quality, efficient, and collaborative care to patients receiving specialty therapy. Despite proven benefits of the integrated model, manufacturer and payer restrictions challenge the viability and utility of HSSPs. Vanderbilt Specialty Pharmacy developed a health outcomes and research program to measure and communicate the value of this model, drive improvement in patient care delivery, and advocate for recognition of HSSP pharmacists' role in patient care. The purpose of this descriptive report is to describe the development and results of this program. Summary The health outcomes and research program began as an initiative for pharmacists to evaluate and convey the benefits they provide to patients, providers, and the health system. Early outcomes data proved useful in communicating the value of an integrated model to key stakeholders and highlighted the need to further develop research efforts. The department leadership invested resources to build a research program with dedicated personnel, engaged research experts to train pharmacists, and fostered internal and external collaborations to facilitate research efforts. As of March 2021, the health outcomes and research program team has published 33 peer-reviewed manuscripts, presented 88 posters and 7 podium presentations at national conferences, and received 4 monetary research awards. Further, the program team engages other HSSP teams to initiate and expand their own health outcomes research in an effort to empower all HSSPs in demonstrating their value. Conclusions The health outcomes and research program described has pioneered outcomes research among HSSPs nationwide and has proven valuable to specialty pharmacists, the health system, and key specialty pharmacy stakeholders. [ABSTRACT FROM AUTHOR]

Purpose To provide health systems with baseline knowledge on existing and pipeline gene therapy treatments, including considerations that health-system pharmacies and specialty pharmacy programs may reference when evaluating and implementing services around gene therapies. Summary Advancements in research and biotechnology have recently led to the development and launch of the first commercially available gene therapy treatments in the United States. These treatments have the ability to significantly alter and even effectively cure diseases. Alongside these significant advances and clinical benefits, these therapies present unique challenges due to their cost and complexity. Given the large number of additional gene therapy treatments that are currently in late-stage clinical development, stakeholders across the healthcare industry must increasingly adapt and ready themselves to meet these challenges. The diagnosis and treatment of patients with diseases being targeted by gene therapies largely occurs within health systems, and judging by the gene therapy pipeline, this trend is likely to continue. To prepare for these novel treatments, health systems must understand and consider the methods in which gene therapies are developed, procured, reimbursed, administered, and monitored. Conclusion The future of health-system pharmacy practice must include comprehensive gene therapy services and stakeholder engagement strategies to ensure patients have access to these life-changing treatments. [ABSTRACT FROM AUTHOR]