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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., (© American Society of Health-System Pharmacists 2023. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

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., (© American Society of Health-System Pharmacists 2022. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Integrated health-system specialty pharmacies (IHSSP) have shown high medication access, adherence, and provider satisfaction. The goal of this study was to explore healthcare providers' experiences with specialty medications distributed via Limited Distribution Networks (LDN) that do not include IHSSPs. We investigated healthcare providers' perceived impact of LDNs on clinic workflow, clinical practice, and patient outcomes. Interviews and focus groups were conducted with fourteen healthcare providers from four outpatient specialty clinics at an academic health system with an IHSSP. Qualitative analysis using an iterative inductive/deductive approach of coded transcripts was used to identify themes. Participants discussed requirements and barriers to communicating with insurance providers, drug manufacturers, and external pharmacies; time and effort required to navigate LDNs and impact on workload and clinic workflow; financial awareness of medication costs and methods for communication about financial information with patients; and advocating for patients to ensure access to necessary therapy and avoid missed doses or treatment lapse. Participants reported barriers to navigating LDNs that can interfere with clinic workflow and patient care. IHSSPs may reduce clinic burden by helping patients access, afford, and remain on therapy., Competing Interests: The authors have declared that no competing interests exist.

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., (© American Society of Health-System Pharmacists 2021. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Access to proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors that lower low-density lipoprotein cholesterol in patients at high risk of atherosclerotic cardiovascular disease events has proven challenging. Methods to overcome access barriers are needed to fully realize the benefits of these novel agents., Objective: This study evaluated medication access rates in patients prescribed a PCSK9 inhibitor at a health care system with integrated specialty pharmacy services., Methods: We performed a single-center, ambispective cohort study of patients prescribed a PCSK9 inhibitor between September 2015 and December 2016 at Vanderbilt University Medical Center outpatient clinics. The primary end point was the percentage of PCSK9 inhibitor prescriptions resulting in access of the total prescriptions triaged to Vanderbilt Specialty Pharmacy. Secondary end points assessed among patients approved for therapy included time between benefits investigation and insurance approval, financial assistance use, and treatment initiation rates., Results: Two hundred ninety-nine patients met inclusion criteria (average age = 63 years). Forty-six percent were female, 57% held commercial insurance, and 70% had an atherosclerotic cardiovascular disease indication. Overall, 96% of prescriptions resulted in access to a PCSK9 inhibitor. Most patients were approved with an initial prior authorization (58%) or after one appeal (29%). The median time to approval was 8 days. Among patients approved for therapy, 53% received financial assistance and 94% initiated therapy., Conclusion: An integrated specialty pharmacy service model in outpatient clinics produced high rates of PCSK9 inhibitor therapy access and initiation. This high level of access supports this model as a best practice for prescribing PCSK9 inhibitor therapy., (Copyright © 2019 National Lipid Association. Published by Elsevier Inc. All rights reserved.)

Background: The central face high-energy avulsive injury has been frequently encountered and predictably managed at the R Adams Cowley Shock Trauma Center. However, despite significant surgical advances and multiple surgical procedures, the ultimate outcome continues to reveal an inanimate, insensate, and suboptimal aesthetic result., Methods: To effectively address this challenging deformity, a comprehensive multidisciplinary approach was devised. The strategy involved the foundation of a basic science laboratory, the cultivation of a supportive institutional clinical environment, the innovative application of technologies, cadaveric simulations, a real-time clinical rehearsal, and an informed and willing recipient who had the characteristic deformity., Results: After institutional review board and organ procurement organization approval, a total face, double jaw, and tongue transplantation was performed on a 37-year-old man with a central face high-energy avulsive ballistic injury., Conclusions: This facial transplant represents the most comprehensive transplant performed to date. Through a systematic approach and clinical adherence to fundamental principles of aesthetic surgery, craniofacial surgery, and microsurgery and the innovative application of technologies, restoration of human appearance and function for individuals with a devastating composite disfigurement is now a reality., Clinical Question/level of Evidence: Therapeutic, V.

Background: With the transplantation of more extensive facial vascularized composite allografts, fundamental craniofacial and aesthetic principles become increasingly important. In addition, computer-assisted planning and intraoperative navigation may improve precision and efficiency in these complex procedures., Methods: Ten mock face transplants were performed in 20 cadavers. The vascularized composite allograft consisted of all facial skin, mimetic muscles, the tongue, the midface by means of a Le Fort III osteotomy, and the mandible by means of sagittal split osteotomies. Craniofacial computed tomographic scans were obtained before and after the mock transplants. Surgical planning software was used to virtually plan the osteotomies, and a surgical navigation system guided the osteotomies intraoperatively. Cephalometric analyses were compared between the virtually planned transplants and the actual postoperative results., Results: The combination of preoperative computerized planning and intraoperative guidance consistently produced a vascularized composite allograft that could be easily fixated to the prepared recipient, with only minimal burring of osteotomy sites necessary. Satisfactory occlusion was maintained, and postoperative computed tomography confirmed accurate skeletal fixation. Insignificant differences with regard to cephalometric analyses were noted when predicted and actual postoperative data were compared., Conclusions: The authors' experience treating severe craniofacial injury allowed consistent transfer of facial vascularized composite allografts, maintaining proper occlusion. Preoperative computer planning and intraoperative navigation ensured precise osteotomies and a good donor-recipient skeletal match, which greatly reduced the need for intraoperative adjustments and manipulation. This total facial vascularized composite allograft represents one of the most extensive described and is intended to represent a typical central facial demolition pattern.

Background: Transplantation of a facial vascularized composite allograft is a highly complex procedure that requires meticulous planning and affords little room for error. Although cadaveric dissections are an essential preparatory exercise, they cannot simulate the true clinical experience of facial vascularized composite allograft recovery., Methods: After obtaining institutional review board approval to perform a facial vascularized composite allograft research procurement, a 66-year-old, brain-dead donor was identified. The family graciously consented to donation of a total face, double jaw, and tongue allograft and multiple solid organs., Results: A craniofacial computed tomographic angiogram was obtained preoperatively to define the vascular anatomy and facilitate virtual computerized surgical planning. The allograft was procured in 10 hours, with an additional 2 hours required for an open tracheostomy and silicone facial impression. The donor was coagulopathic throughout the recovery, resulting in an estimated blood loss of 1500 ml. Fluorescence angiography confirmed adequate perfusion of the entire allograft based on lingual and facial arterial and external jugular and thyrolinguofacial venous pedicles. The solid organ transplant team initiated abdominal organ isolation while the facial allograft procurement was in progress. After completion of allograft recovery, the kidneys and liver were recovered without complication., Conclusions: Before conducting a clinical face transplant, adequate preparation is critical to maximize vascularized composite allotransplantation outcomes and preserve solid organ allograft function. As more centers begin to perform facial transplantation, research procurement of a facial vascularized composite allograft offers a unique educational opportunity for the surgical and anesthesia teams, the organ procurement organization, and the institution.