Projects by Topic

Since our inception as an outcome committee in 2015, we have consistently and considerably expanded our ability to produce rigorous outcomes research. In 2018, we established a more formal program and leadership, including full time outcomes research staff. The result of these allocated resources has been a productive output across multiple specialty disease states. Below are highlighted outcomes from studies completed in recent years.

Specialty Pharmacy Practice

Provider Satisfaction with Specialty Pharmacy Services Comparing the Integrated Health-System to External Practice Models: A Multi-Site Survey

This multi-site, cross-sectional, online survey study of specialty clinic healthcare providers at ten academic health-systems with integrated specialty pharmacies was performed with the Vizient Specialty Pharmacy Outcomes and Benchmarking Workgroup. Prescribers of specialty medications within each institution were identified and invited to participate in the study by email, which included a link to the anonymous questionnaire. Respondents were asked to rate their agreement with 10 statements regarding quality of services for integrated and external specialty pharmacies, on a five-point scale (1=strongly disagree, 5=strongly agree). Mean overall satisfaction with integrated specialty pharmacies was significantly higher than satisfaction with external specialty pharmacies (integrated: M=4.72 ± 0.58; external: M=2.97 ± 1.20, CI 1.64-1.87, p<0.001) as well as for all 10 items evaluating the quality of services (all p-values <0.05). These study results confirm that the health-system integrated specialty pharmacy practice model, implemented at institutions across the US, demonstrates high rates of provider satisfaction with services and perceived benefits.

Download Publication Anguiano RH, Zuckerman AD, Hall E, Diamantides E, Kumor L, Duckworth DL, Peter M, Sorgen PJ, Nathanson A, Kandah HM, Dura J, Campbell U. Provider satisfaction with specialty pharmacy services comparing the integrated health-system to external practice models: A multi-site survey. Am J Health Syst Pharm. 2021 Mar 2:zxab079. doi: 10.1093/ajhp/zxab079.

From Natural Disaster to Pandemic: A Health-System Pharmacy Rises to the Challenge

This report describes a health-system pharmacy department’s response to recovering from a natural disaster and preparing for the coronavirus disease 2019 (COVID-19). By detailing our experience and efforts, we hope to help other institutions who are or will be in a similar crisis-response mode.

Download Publication Zuckerman AD, Patel PC, Sullivan M, Potts A, Knostman M, Humphreys E, O’Neal M, Bryant A, Torr D, Lobo B, Peek G, Kelley T, Manfred J, Tomichek J, Crothers G, Catlin R, Brumagin HE, Hughes L, Hayman J. From natural disaster to pandemic: A health-system pharmacy rises to the challenge. AJHP, zxaa180, https://doi.org/10.1093/ajhp/zxaa180

Development, Implementation and Evaluation of a Health Outcomes and Research Program at an Integrated Health-System Specialty Pharmacy

The purpose of this descriptive report is to describe the development and results of this program. 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. Department leadership invested resources to build a research program with dedicated personnel, engaged research experts to train pharmacists, and foster internal and external collaborations to facilitate research efforts. 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.

Download Publication Zuckerman AD, Shah NB, Peter ME, Jolly JA, Kelley TN. Development, implementation and evaluation of a health outcomes and research program at an integrated health-system specialty pharmacy. Am J Health Syst Pharm. 2021 Mar 9:zxab082. doi: 10.1093/ajhp/zxab082.

Transitions of Care: A Focus on Specialty Medication Challenges and Specialty Pharmacist Opportunities

Adherence and persistence to specialty medications can be challenging during transitions in sites of care, provider types, specialty medications, and financial coverage changes. In this report, we review obstacles encountered within these transitions and the role of the specialty pharmacist in overcoming obstacles. Case examples for each type of specialty transition provide insight into the unique complexities faced by patients and shed light on pharmacists’ vital role in patient care.

Download Manuscript Zuckerman A, Carver A, Cooper K, Markley B, Mitchell A, Reynolds VW, Saknini M, Wyatt H, Kelley T. Transitions of care: a focus on specialty medication challenges and specialty pharmacist opportunities. Pharmacy, 2019 Dec; 7, 163. doi:10.3390/pharmacy7040163

Converting Prescriptions to 90-day Supply Increases Specialty Pharmacy Technician Efficiency

Pharmacy technicians facilitate medication refills for patients following transplant by conducting phone calls and scheduling medication shipments. Standard prescribing of these medications required calls to be made every 30 days. However, technician’s ability to service an increasing number of patients was limited by high call volume workload. In this study, we found that converting medication supply from 30 to 90-days reduced daily call volume and allowed the technician to service more patients; results remained stable over the 12-month follow-up.

Download Poster Ward-Isbell A, Peter M. Converting prescriptions to 90-day supply increases specialty pharmacy technician efficiency.

Advancing Patient Care through Specialty Pharmacy Services in an Academic Health System

Pharmacists at health system-based specialty pharmacies have the opportunity to improve patient care by providing comprehensive medication management for patients prescribed specialty medication. This manuscript describes how Vanderbilt Specialty Pharmacy integrated pharmacy services into existing outpatient specialty disease clinics at Vanderbilt University Medical Center, which improved patient access to therapy and continuity of care.

Download Manuscript Bagwell A, Kelley T, Carver A, Lee JB, Newman B. Advancing patient care through specialty pharmacy services in an academic health system. J Manag Care Spec Pharm, 2017 Aug; 23(8):815-820. doi: 10.18553/jmcp.2017.23.8.815.

Adherence

Identifying Nonadherence to Specialty Medications: Comparing Pharmacy Claims Data and Individual Reasons for Nonadherence

This study addressed the rates and reasons for nonadherence to specialty medications and highlighted the inaccuracy of PDC when measuring adherence in a specialty population.

Download PosterAlhashemi B, Kibbons AM, Peter M, Zuckerman AD. Identifying misidentified nonadherence to specialty medications: comparing rates and reasons behind nonadherence. Poster presented at: American Society of Health Systems Pharmacists Midyear Clinical Meeting and Exhibition; December, 2020; Virtual Meeting.

Kibbons AM, Peter M, Bell J, Jolly J, Zuckerman AD. Identifying nonadherence to specialty medications: comparing pharmacy claims data and individual reasons for nonadherence. Poster presented to AMCP Nexus Annual Conference, Virtual Meeting. October, 2020

Specialty Medication Adherence Rates in Patients with Rheumatoid Arthritis Across Health-System Specialty Pharmacies

This study evaluated rates of adherence to biologic DMARDS, measured by PDC, across 20 health-system specialty pharmacies through the Health-System Specialty Pharmacy Outcomes Research Consortium. We included 3,528 patients with 4,065 medications and 29,900 fills. Most were female (75%) with commercial insurance (51.1%) and a median age of 55 (IQR 42-63). Adalimumab (34.2%) and etanercept (31.3%) prescriptions were most common. Median PDC for all sites was 94% (IQR 83, 99), with 80.1% of patients with a PDC >80%. High rates of adherence to biologic DMARDs were seen across 20 health-systems specialty pharmacies, demonstrating the benefits of health-system specialty pharmacies in helping patients with RA remain on effective therapies.

Download PosterZuckerman AD, DeClercq, J, Cowgill N, McCarthy K, Lounsbery B, Shah R, Kehasse A, Thomas K, Sokos L, Stutsky M, Young J, Carter J, Lach M, Wise K, Thomas TT, Ortega M, Jinkyu Lee, Lewis K, Dura J, Gazda N, Gerzenshtein L, Canfield S, Health-Systems Specialty Pharmacy Outcomes Research Consortium. Specialty Medication Adherence Rates in Patients with Rheumatoid Arthritis Across Health-System Specialty Pharmacies. Poster presented to AMCP, October 2020.

Pharmacist Interventions to Improve Specialty Medication Adherence

The effectiveness of high-cost specialty medications used to treat complicated clinical conditions depends on adherence to therapy. However, specialty medications pose unique barriers to adherence. This manuscript describes a study protocol designed to determine if pharmacist interventions can improve patient adherence to specialty medications.

Download ManuscriptKibbons AM, Peter M, DeClercq, Choi L, Bell J, Jolly J, Cherry E, Alhashemi B, Shah NB, Zuckerman AD. Pharmacist Interventions to Improve Specialty Medication Adherence: Study Protocol for a Randomized Controlled Trial. Drugs - Real World Outcomes (2020). https://doi.org/10.1007/s40801-020-00213-8

Rates and Reasons for Primary Medication Non-Adherence

Primary medication non-adherence (PMN), defined as the rate at which a prescription is written but never obtained by the patient within a specified time period, is commonly used as a quality metric. This two-part study aimed to identify the rates and reasons of PMN for specialty oral oncolytic agents.

In Part I, we used 24 methods to calculate PMN based on combinations of three parameters: lookback window, duplicate window, and fill window. We evaluated 4,482 specialty oral oncolytic prescriptions from 1422 patients. Across the 24 methods, rate of PMN ranged from 16% to 23%. A shorter fill window of 14 days had the largest impact on PMN rate. Using a combination of 90-day lookback window, 2-day duplicate prescription window, and 30-day fill window, 198 prescriptions were considered cases of primary medication adherence.

Download Poster Mitchell E, McDonald A, Reynolds V, Shah N, Peter M, DeClercq J, Choi L, Zuckerman A. Modeling rates of primary medication nonadherence with specialty oncolytic agents. Encore poster presented to National Association of Specialty Pharmacy (NASP) annual conference, Virtual Meeting. September 2020. *Awarded Top Poster for “Adherence” category

Mitchell E, McDonald A, Reynolds V, Shah N, Peter M, DeClercq J, Choi L, Zuckerman A. Modeling rates of primary medication nonadherence with specialty oncolytic agents. Encore poster presented to the 2020 Vanderbilt Health Systems Specialty Pharmacy Outcomes Research Summit, Virtual Meeting. August 2020.

Mitchell E, McDonald A, Reynolds V, Shah N, Peter M, DeClercq J, Choi L, Zuckerman A. Modeling rates of primary medication nonadherence with specialty oncolytic agents. Poster presented to the American Society of Health Systems Pharmacists Midyear Clinical Meeting and Exhibition, Last Vegas, NV. December, 2019.

In Part II, we reviewed electronic medical records of 198 prescriptions considered PMN by our previous calculation, and found that 81% of prescriptions were not actually PMN (e.g., the patient filled the prescription, prescription was sent to external pharmacy). Thirty-seven prescriptions (19%) met criteria for true PMN. The most frequent reason for true PMN was patient’s decision to not start therapy (32%). Findings indicate that the algorithm by which PMN is traditionally defined grossly overestimates the true rate of primary medication non-adherence.

Download Poster McDonald A, Mitchell E, Reynolds V, Shah N, Peter M, DeClercq J, Choi L, Zuckerman A. Assessing reasons for primary medication non-adherence in oncology specialty medications. Encore poster presented to the 2020 Vanderbilt Health Systems Specialty Pharmacy Outcomes Research Summit, Virtual Meeting. August 2020.

McDonald A, Mitchell E, Reynolds V, Shah N, Peter M, DeClercq J, Choi L, Zuckerman A. Assessing reasons for primary medication non-adherence in oncology specialty medications. Poster presented to the American Society of Health Systems Pharmacists Midyear Clinical Meeting and Exhibition, Last Vegas, NV. December, 2019.

Navigating the Wild West of Medication Adherence Reporting in Specialty Pharmacy

This article highlights the challenges in standardizing adherence methodologies as well as the key elements to consider when interpreting adherence results. Specialty pharmacies should consider using adherence measures to identify and intervene on non-adherence patients. In addition, integrated specialty pharmacies should work to link adherence to clinical outcomes and healthcare cost savings.

Download Manuscript Canfield SL, Zuckerman A, Anguiano RH, Jolly JA, DeClercq J, Wascher M, Choi L, Knox S, Mitchell DF. Navigating the wild west of medication adherence reporting in specialty pharmacy. J Manag Care Spec Pharm, 2019 Oct; 25(10):1073-1077. doi:10.18553/jmcp.2019.25.10.1073.

Adherence to Specialty Medications: Assessing rates and correlates of nonadherence at an integrated specialty pharmacy

This study analyzed rates and correlates of medication nonadherence in 7,297 unique prescription/generic product identifiers prescribed specialty medication at an integrated specialty pharmacy in an academic health center. Median PDC of the sample was 99%; 14% of the sample (n=1027) was classified as nonadherent. Nonadherence was more common in women and nonadherent patients were significantly younger than adherent patients.

Download Poster Cherry E, Jolly J, Zuckerman A, Peter M. Adherence to specialty medications: assessing rates and correlates of nonadherence at an integrated specialty pharmacy. Poster presented to the Academy of Managed Care and Specialty Pharmacy Annual Meeting, San Diego, CA. March, 2019.

Closing the Gap: Identifying Rates and Reasons for Nonadherence in a Specialty Population

Common adherence calculations using pharmacy claims are ineffective in identifying reasons, intentional or unintentional, for gaps in therapy. Methods to accurately assess the incidence and cause of specialty medication nonadherence are needed to design effective interventions for nonadherence. This study evaluated reasons for nonadherence in a random 10% sample of the patients identified as nonadherent (PDC <80%) from the study below. We found that 40% of patients classified as nonadherent were misclassified, with 31% of those due to external fills, and 60% due to provider-recommended gaps in therapy. Most cases of true nonadherence were due to an inability to reach the patient.

Download Manuscript Paolella D, Cherry E, Jolly J, DeClercq J, Choi L, Zuckerman A. Closing the gap: identifying rates and reasons for nonadherence in a specialty population. J Manag Care Spec Pharm, 2019 Nov; 25(11): 1282-1288. doi: 10.18553/jmcp.2019.25.11.1282

Download Poster Paolella D, Zuckerman A, Cherry E, Jolly J. Closing the gap: identifying rates and reasons for nonadherence in a specialty population. Poster presented to the Academy of Managed Care Pharmacy Nexus Annual Meeting, Orlando, FL. October, 2018. *Silver Ribbon Abstract Winner*

Using Rates of Non-Adherence to Identify Opportunities for Intervention in Outpatient Specialty Clinics

This study was the first in a multi-phase project to identify rates and reasons for non-adherence and implement programs within VSP to reduce non-adherence. Here, we found an average adherence rate (using proportion of days covered (PDC)) of 93% across 2,307 prescriptions filled within one year time period. Those clinics with the lowest rates of adherence were likely to have clinically appropriate reasons for disruptions in therapy that may lead to a less than optimal PDC rate based on current calculations. This study led to a deeper dive into reasons for non-adherence referenced above.

Download Poster Cherry E, Jolly JA, Zuckerman A. Using rates of non-adherence to identify opportunities for intervention in outpatient specialty clinics. Poster presented to the National Association of Specialty Pharmacy Annual Meeting, Washington, DC. September, 2018.

Cystic Fibrosis

Testicular Pain Following Initiation of Elexacaftor / Tezacaftor / Ivacaftor in Males with Cystic Fibrosis

Elexacaftor/tezacaftor/ivacaftor (Trikafta) was approved by the Food and Drug Administration in October 2019 for treatment of cystic fibrosis (CF) in patients 12 years and older with at least one F508del mutation in the CFTR protein. There were no documented reports of testicular pain during clinical trials. In this case series, we discuss 7 males between 17 and 39 years of age who reported testicular pain or discomfort within the first two weeks of starting therapy. The precise mechanism of this side effect is unknown, but it may be related to restoration of CFTR function in the male reproductive tract. All patients experienced resolution of this side effect within a week after onset, regardless of the management, exception for one patient. Further research is needed to determine short- and long-term impact of this drug on male fertility.

Download Publication Rotolo SM, Duehlmeyer S, Slack SM, Jacobs HR, Heckman B. Testicular pain following initiation of elexacaftor / tezacaftor / ivacaftor in males with cystic fibrosis. J Cyst Fibros, 2020 Sep;19(5):e39-e41. doi: 10.1016/j.jcf.2020.04.017. Epub 2020 May 27.

Implementing a Medication Reconciliation Protocol for Adult Cystic Fibrosis Patients in an Integrated Outpatient Clinic

Disease management in cystic fibrosis (CF) is complex and time consuming, resulting in high rates of medication non-adherence. Effective interventions are needed to increase adherence with CF therapies. In this study, we conducted a quality improvement initiative to increase the number of patients taking standard of care maintenance therapies, including cystic fibrosis transmembrane receptor (CFTR) modulators. With implementation of a specialty pharmacist directed protocol, rate of standard of care medication use increased for all therapies. The highest rate of increase was in CFTR modulator use.

Download Poster Tolle J, Slack S, Miller A, Eastman S, Hinton K, Jones S, Glenn S, Patel B. Implementing a medication reconciliation protocol for adult cystic fibrosis patients in an integrated outpatient clinic. Poster presented to the North American Cystic Fibrosis Conference, Nashville, TN. October, 2019.

Dermatology

Evaluating Prescription Outcomes for Specialty Agents used to Treat Dermatologic Conditions: A Quality Improvement Initiative

In this initiative, we evaluated outcomes following prescription of specialty dermatology medications in biologic-naïve patients. Of the 28 prescriptions evaluated, median time to approval was 9 days, with delays resulting from the need for a pharmacist to ascertain clinical data such as disease severity and treatment history.

Download PosterLanham HT, Bowles M, Schneider M, Shah N, DeClercq J, Zuckerman A. Evaluating prescription outcomes for specialty agents used to treat dermatologic conditions: a quality improvement initiative. Encore poster presented to National Association of Specialty Pharmacy (NASP) annual conference, Virtual Meeting. September 2020.

Lanham HT, Bowles M, Schneider M, Shah N, DeClercq J, Zuckerman A. Evaluating prescription outcomes for specialty agents used to treat dermatologic conditions: a quality improvement initiative. Encore poster presented to the 2020 Vanderbilt Health Systems Specialty Pharmacy Outcomes Research Summit, Virtual Meeting. August 2020.

Lanham HT, Bowles M, Schneider M, Shah N, DeClercq J, Zuckerman A. Evaluating prescription outcomes for specialty agents used to treat dermatologic conditions: a quality improvement initiative. Poster presented to the American Society of Health Systems Pharmacists Midyear Clinical Meeting and Exhibition, Last Vegas, NV. December, 2019.

Hematology

Primary Prevention of Venous Thromboembolism with Apixaban for Multiple Myeloma Patients Receiving Immunomodulatory Agents

Immunomodulatory therapies for multiple myeloma can increase patient risk for venous thromboembolism (VTE). This phase IV single-arm study assessed the rate of symptomatic VTE over 6 months in 50 patients with multiple myeloma receiving immunomodulatory therapy and apixaban for primary prevention. The primary efficacy endpoint was symptomatic VTE and safety outcomes were major hemorrhage and clinically relevant non-major hemorrhage. No patients experienced symptomatic VTE or a major hemorrhage and 3 patients experienced clinically relevant non-major hemorrhage but were able to resume apixaban after medical management.

Download Manuscript Cornell RF, Goldhaber SZ, Engelhardt BG, Moslehi J, Jagasia M, Harrell S, Rubinstein SM, Hall R, Wyatt H, Piazza G. Primary prevention of venous thromboembolism with apixaban for multiple myeloma patients receiving immunomodulatory agents. Br J Haematol, 2020 Apr; doi: 10.1111/bjh.16653

Venetoclax-Based Salvage Therapy for Post-Hematopoietic Cell Transplantation Relapse in Acute Myeloid Leukemia

This study looked at 21 acute myeloid leukemia patients who had received a hematopoietic cell transplant and experienced relapsed disease. Each patient underwent salvage therapy with a venetoclax- based treatment regimen. Nineteen patients were assessed for treatment response and 12 of the 19 patients responded to venetoclax-based salvage therapy, leading to a 63.2% response rate.

Download Poster Byrne MT, Danielson N, Rasche A, Hammers R, Culos KA, Katwood KS, Wyatt H, Fogo K, Dholaria B, Engelhardt BG, Ferrell PB, Jagasia M, Kassim AA, Mohan SR, Savani BN, Strickland SA, Sengsayadeth SM. Venetoclax-based salvage therapy for post-hematopoietic cell transplantation relapse in acute myeloidleukemia. Poster presented to the American Society of Hematology, Orlando, FL. December, 2019.

Ivosidenib: IDH1 Inhibitor for the Treatment of Acute Myeloid Leukemia

Ivosidenib is the first approved oral, targeted, small molecule inhibitor of the isocitrate dehydrogenase 1 (IDH1) mutation seen in acute myeloid leukemia. This review article discusses the clinical trials and dose escalation studies conducted to secure the U.S. Food and Drug Administration approval.

Download Manuscript Merchant SL, Culos K, Wyatt H. Ivosidenib: idh1 inhibitor for the treatment of acute myeloid leukemia. J Adv Pract Oncol, 2019 Jul; 10(5):494-500. doi: 10.6004/jadpro.2019.10.5.7.

Apixaban for Primary Prevention of Venous Thromboembolism in Patients with Multiple Myeloma Receiving Immunomodulatory Therapy

This is a phase IV single-arm study prospectively evaluating the safety and efficacy of apixaban for primary prevention of VTE in patients with MM. This manuscript describes the methodology of this multidisciplinary collaborative study.

Download Manuscript Cornell RF, Goldhaber SZ, Engelhardt BG, Moslehi J, Jagasia M, Patton D, Patton D, Harrell S, Hall R, Wyatt H. Apixaban for primary prevention of venous thromboembolism in patients with multiple myeloma receiving immunomodulatory therapy. Front Oncol, 2019 Feb; 9(45). doi: 10.3389/fonc.2019.00045.

Prospective Study of Apixaban for Primary Prevention of Venous Thromboembolism in Patients with Multiple Myeloma Receiving Immunomodulatory Therapy, a 3-month Interim Analysis.

Interim results of the Phase IV single-arm study assessing the rate of symptomatic VTE over 6 months in patients with MM receiving immunomodulatory therapy and apixaban for primary prevention. No patients experienced a VTE, stroke, hemorrhage, or MI at this three month interim analysis.

Download Poster Cornell RF, Goldhaber S, Engelhardt BG, Moslehi J, Jagasia M, Patton D, Harrell S, Hall R, Wyatt H, Piazza G. Prospective Study of Apixaban for Primary Prevention of Venous Thromboembolism in Patients with Multiple Myeloma Receiving Immunomodulatory Therapy, a 3-month Interim Analysis. Presented at Annual Meeting & Exposition of the American Society of Hematology, San Diego, CA. December 2018

Predicting Time to Medication Access for Hematologic Malignancies: The Impact of an Integrated Specialty Pharmacy and Limited Distribution Drug Networks

Oral anti-neoplastic therapy can be difficult to access due to insurance authorization, out of pocket costs, and limited distribution of certain agents (LDDs). This study found that integrating a pharmacist into clinic significantly shortened time from treatment decision to shipment for LDD drugs, partially overcoming access barriers. Additionally, access to LDDs was still slower than non-LDDs as they cannot be fully integrated into clinic workflow. The integrated specialty pharmacy program adds value to patient access and outperforms LDDs, challenging the value of LDD networks beyond medical economics.

Download Publication Wyatt H, Peter M, Zuckerman A, Starks S, Maulis M, Declercq J, Choi L, Jagasia M. Assessing the impact of limited distribution drug networks on time to access oral oncolytic agents at an integrated specialty pharmacy. JHOP, Aug2020, 10 (4), 198-205.

Download PosterWyatt H, Zuckerman A, Peter M, Starks S, Maulis M, Declercq J, Choi L, Jagasia M. Predicting time to medication access for hematologic malignancies: the impact of an integrated specialty pharmacy and limited distribution drug networks. Encore poster presented to the National Association of Specialty Pharmacy (NASP) Annual Meeting & Expo, Washington, DC. September, 2019.

Wyatt H, Zuckerman A, Peter M, Starks S, Maulis M, Declercq J, Choi L, Jagasia M. Predicting time to medication access for hematologic malignancies: the impact of an integrated specialty pharmacy and limited distribution drug networks. Poster presented to the Academy of Managed Care Pharmacy Nexus Annual Meeting, Orlando, FL. October, 2018.

Hepatitis C

Crushing and Splitting DAAs for HCV Treatment: A Case Series

This poster described safety and effectiveness outcomes of patients requiring HCV DAA tablet manipulation.

Download Poster Whelchel K, Zuckerman AD, Koren D, Derrick C, Bouchard J, Chastain C. Crushing and splitting DAAs for HCV treatment: a case series. Poster presented at: The Liver Meeting; November, 2020; Virtual Meeting.

Incidence and Impact of Persistent Viremia on SVR Rates in Patients Receiving Direct-Acting Antiviral Therapy

Rates of persistent viremia (PV), defined as a detectable hepatitis c (HCV) viral load after 4 weeks of direct-acting antiviral (DAA) therapy, were low (5.7%) in a real-world cohort of 983 patients. High sustained virologic response (SVR) rates were achieved both in patients with PV (92.9%) and those with rapid virologic response (RVR) (96.5%), without significant differences.

Download Publication Carver AB, Zuckerman A, DeClercq J, Choi L, Chastain CA. Incidence and impact of persistent viremia on SVR rates in patients receiving direct acting antiviral therapy. OFID, ofaa569, https://doi.org/10.1093/ofid/ofaa569

Access to Direct Acting Antiviral Therapy for Recipients of Solid Organs from Hepatitis C Viremic Donors

Download Poster Edmonds C, Carver A, DeClercq J, Choi L, Peter M, Forbes R, Concepcion B, Schlendorf K, Perri R. Access to direct acting antiviral therapy for recipients of solid organs from hepatitis-c-viremic donors. Encore poster presented to National Association of Specialty Pharmacy (NASP) annual conference, Virtual Meeting. September 2020. *Awarded Top Poster for “Specialty Pharmacy Services” category

Edmonds C, Carver A, DeClercq J, Choi L, Peter M, Forbes R, Concepcion B, Schlendorf K, Perri R. Access to direct acting antiviral therapy for recipients of solid organs from hepatitis-c-viremic donors. Encore poster presented to the 2020 Vanderbilt Health Systems Specialty Pharmacy Outcomes Research Summit, Virtual Meeting. August 2020.

Edmonds C, Carver A, DeClercq J, Choi L, Peter M, Forbes R, Concepcion B, Schlendorf K, Perri R. Access to direct acting antiviral therapy for recipients of solid organs from hepatitis C viremic donors. Poster presented to American Transplant Congress, Virtual Meeting. June, 2020.

Predicting Treatment Failure for Initiators of Hepatitis C Virus Treatment in the Era of Direct-Acting Antiviral Therapy

This study highlighted baseline factors associated with HCV treatment failure in 1,253 patients. Treatment failure prediction may facilitate development of data-driven clinical tools to identify patients who would benefit from interventions to improve SVR rates.

Download Publication Nabulsi NA, Martin MT, Sharp LK, Koren DE, Teply R, Zuckerman A, Lee TA. Predicting treatment failure for initiators of hepatitis C virus treatment in the era of direct-acting antiviral therapy. Front. Pharmacol, 2020 Nov 13; 11 (1732). doi: 10.3389/fphar.2020.551500

Expanding Heart Transplant in the Era of Direct-Acting Antiviral Therapy for Hepatitis C

The objective of this study was to better define the association of hepatitis C-positive donors with heart transplant volumes, wait-list duration, and mortality at 1 year. In this observational study of 80 adult patients who underwent heart transplant using hearts from hepatitis C-positive donors between September 2016 and April 2019, median time from consent to heart transplant was 4 days (IQR= 1-18). Sixty-seven patients developed donor-derived hepatitis C. All were treated and achieved sustained virologic response with direct-acting antivirals. One-year survival did not differ between the infected cohort, uninfected cohort, or hepatitis C-negative donor recipients. Findings suggest that infection is well-tolerated and curable in heart transplant recipients with donor-derived hepatitis C, and 1-year survival is equivalent to that in recipients of hepatitis C-negative donors.

Download Publication Schlendorf KH, Zalawadiya S, Shah AS, et al. Expanding Heart Transplant in the Era of Direct-Acting Antiviral Therapy for Hepatitis C. JAMA Cardiol. Published online December 18, 2019. doi:https://doi.org/10.1001/jamacardio.2019.4748

Pharmacologic Management of HCV Treatment in Patients with HCV Monoinfection vs. HIV/HCV Coinfection: Does Coinfection Really Matter?

In this ambispective cohort study of patients referred to an outpatient Infectious Diseases Clinic for chronic HCV, we found significant differences in patient demographics, drug interactions, and time to treat between HCV monoinfected and HIV/HCV coinfected patients. This study provides a broad, yet concise overview of the differences in caring for patients with and without HIV/HCV coinfection.

Download Publication Zuckerman AD, Douglas A, Whelchel K, Choi L, DeClercq J, Chastain CA. Pharmacologic management of HCV treatment in patients with HCV monoinfection vs. HIV/HCV coinfection: Does coinfection really matter? PLoS ONE, 2019 Nov; 14(11): e0225434 doi: 10.1371/journal.pone.0225434

Hepatitis C virus sustained virologic response rates in African Americans

African Americans comprise 11% of the United States (US) population but approximately 25% of US hepatitis C virus (HCV) infections. Historic HCV treatment with interferon and ribavirin was associated with lower sustained virologic response (SVR) rates in African American patients partly due to increased prevalence of non CC IL28B genotypes. Specific HCV recommendations for African Americans exist in both the AASLD/IDSA HCV guidance and package labeling for one regimen. The objective of this study was to compare SVR rates for African American (AA) and non-African American (non-AA) patients in a multi-center cohort. We found no statistically significant difference in SVR rates between AA and non-AA patients treated with HCV DAAs. Non-AA patients reported a statistically significant higher rate of ADRs than the AA patient population

Download Poster Koren D, Zuckerman A, Teply R, Nabulsi N, Lee T, Martin M. Hepatitis C virus sustained virologic response rates in African Americans. Poster presented to the American Association of the Study of Liver Diseases (AASLD) The Liver Meeting, Boston, MA. November, 2019.

Expanding Hepatitis C Virus Care and Cure: National Experience Using a Clinical Pharmacist-Driven Model

The United States National Viral Hepatitis Action Plan calls for additional health care providers to expand hepatitis C virus (HCV) treatment capacity. This multi-site study evaluated the effectiveness of a clinical pharmacist-driven HCV delivery model in an open system. With an overall sustained virologic response (SVR) rate of 95% (per protocol), the clinical pharmacist-driven HCV treatment model was found to be effective and comparable to other real-world studies with specialist, non-specialist, and non-hepatology providers.

Download Manuscript Koren D, Zuckerman A, Teply R, Nabulsi N, Lee T, Martin M. Expanding hepatitis c virus care and cure: national experience using a clinical pharmacist-driven model. Open Forum Infect Dis, 2019 Jul; 6(17):ofz316. doi:10.1093/ofid/ofz316.

Download Poster Koren D, Zuckerman A, Teply R, Nabulsi N, Lee T, Martin M. Hepatitis C virus sustained virologic response rates in African Americans. Poster presented to the American Association of the Study of Liver Diseases (AASLD) The Liver Meeting, Boston, MA. November, 2019.

Download PosterKoren D, Zuckerman A, Teply R, Nabulsi N, Lee T, Martin MT. Expanding hepatitis c virus care and cure: national experience using a clinical pharmacist-driven model. Poster presented to the American Association of the Study of Liver Diseases (AASLD) The Liver Meeting, San Francisco CA, November 2018

Prediction Model of Treatment Failure Among Chronic Hepatitis C Patients at Four United States Institutions

Hepatitis C virus (HCV), the leading cause of advanced liver disease, has enormous economic burden. Effective treatments exist, yet identifying patients at risk of treatment failure could lead to interventions that improve cure rates. Our goal was to develop and evaluate a prediction model of HCV treatment failure. Most likely predictors of treatment failure in our dataset were older age, presence of hepatocellular carcinoma, and private versus public insurance, which appeared in 89%, 84%, and 80% of bootstrap models, respectively.

Download Poster Nabulsi NA, Martin MT, Sharp LK, Koren DE, Teply R, Zuckerman A, Lee TA. Prediction model of treatment failure among chronic HCV. Poster presented to the International Society for Pharmacoeconomics and Outcomes (ISPOR) Annual Meeting, New Orleans, LA. May, 2019.

Appropriate Management of Drug Interactions Results in Safe Use of Hepatitis C Therapies in Heart Transplant Recipients

A growing number of institutions are usingHCV-positive donor hearts for transplant inHCV-negative recipients. While results of this practice have proven to be successful, management of drug-drug interactions between transplant medications and direct acting antivirals (DAAs) is necessary to ensure safety and efficacy. This study reviews the frequency and type of drug-drug interactions and appropriate management strategies.

Download Presentation Boyle K, Edmonds C, Schlendorf K, Gray J, Lindenfeld J, Pollack A, Fowler R. Appropriate management of drug interactions results in safe use of hepatitis c therapies in heart transplant recipients. Podium presentation presented to The International Society for Heart & Lung Transplantation Annual Meeting, Orlando, FL. April, 2019.

Building a Hepatitis C Clinical Program: Strategies to Optimize Outcomes

An increasing number of specialists and non-specialists are developing clinical programs to treat and cure hepatitis C virus (HCV). The goal of this paper is to evaluate and describe optimal strategies to improve outcomes related to HCV care delivery.

Download Publication Zuckerman A, Carver A, Chastain CA. Building a hepatitis c clinical program: strategies to optimize outcomes. Curr Treat Options Infect Dis, 2018 Oct; 10(4):431-446. doi: 10.1007/s40506-018-0177-5.

Multispecialty Collaboration Benefits Efforts at Expanding Donor Pools: Transplanting HCV Positive Grafts into HCV Negative Heart Transplant Recipients

This oral presentation reviewed early results of the HCV-positive donor heart transplant program.

Download Oral Presentation Slide Deck O’Dell HW, Darragh CR, Smith SS, Schlendorf K, Perri RE, Awad J, Shah AS, Edmonds C, Carver A, Chung CY. Multispecialty collaboration benefits efforts at expanding donor pools: transplanting HCV positive grafts into HCV negative heart transplant recipients. Podium presentation presented to the American Association of the Study of Liver Diseases (AASLD) The Liver Meeting, San Francisco, CA. November, 2018.

Universal Hepatitis C Screening in a Tennessee Tertiary Care Emergency Department

This oral presentation reviewed results of a universal screening in tertiary care center emergency department. Of 11,637 tests performed, 8.7% resulted in positive HCV antibodies and 4.2% in positive HCV RNA.

Download Oral Presentation Slide Deck Chastain C, Johnson J, Miller K, Moore K, Lako A, Zuckerman A, Han J, Self W. Universal hepatitis c screening in a Tennessee tertiary care emergency department. Podium presentation presented to ID Week, San Francisco, CA. October, 2018.

Early Outcomes Using Hepatitis C–Positive Donors for Cardiac Transplantation in the Era of Effective Direct-Acting Anti-Viral Therapies

Given the shortage of suitable donor hearts for cardiac transplantation, and the favorable safety and efficacy of current agents used to treat hepatitis C virus(HCV), our institution recently piloted transplantation of select patients using HCV-positive donors. In the era of highly effective DAAs, the use of HCV-positive donors represents a potential approach to safely expand the donor pool.

Download Publication Schlendorf KH, Zalawadiya S, Shah AS, Wigger M, Chung CY, Smith S, Sacks SB. Early outcomes using hepatitis c–positive donors for cardiac transplantation in the era of effective direct-acting anti-viral therapies. J Heart Lung Transplant, 2018 Jun; 37(6):763-769. doi: 10.1016/j.healun.2018.01.1293.

Increasing Success and Evolving Barriers in the Hepatitis C Cascade of Care During the Direct Acting Antiviral Era

This study examines movement between the stages of the HCV cascade of care and identifies reasons why patients and specific patient populations fail to advance through care in a real world population.

Download Publication Zuckerman A, Douglas A, Nwosu S, Choi L, Chastain C. Increasing success and evolving barriers in the hepatitis c cascade of care during the direct acting antiviral era. PloS One, 2018 Jun; 13(6):e0199174. doi: 10.1371/journal.pone.0199174.

The Hepatitis C Cascade of Care for Traditional versus Emergency Department Referrals

Universal HCV screening was recently suggested to have the biggest impact on cascade of care improvement. The objective of this study was to compare cascade of care completion rates among patients referred for HCV treatment from traditional referral sources to those referred from the emergency department. We found that patient demographics vary between the two referral sources and patients referred from the emergency department had significantly lower linkage and engagement in HCV care.

Download Poster Zuckerman A, Peter M, Johnson J, Miller K, Chastain C. Referral source matters: the hepatitis c cascade of care for traditional versus emergency department referrals. Poster presented to the American Society of Health Systems Pharmacists Midyear Clinical Meeting and Exhibition, Anaheim, CA. December, 2018.

Persistent Viremia on DAA Therapy: Real-World Experience, Interventions, and Outcomes

Current treatment for hepatitis C virus (HCV) infection includes a variety of oral direct-acting antiviral (DAA) medications, which typically result in rapid viral response. However, the clinical impact of persistent viremia (PV) after day 21 of therapy has not been consistently demonstrated in clinical trials. Persistent viremia occurred in 3.8% of the 1,572 patients included in this analysis. Of those with PV, 86.7% achieved a sustained virologic response. Rates and impact of interventions resulting from PV are also presented.

Download Poster Lines TH, Carver AB, Zuckerman A, Chastain CA. Persistent viremia on DAA therapy: real-world experience, interventions, and outcomes. Poster presented to the American College of Clinical Pharmacy Updates in Therapeutics, Jacksonville, FL. February, 2018.

Retreatment Options Following HCV Direct Acting Antiviral Failure

Based on recent clinical trial data, most patients who fail HCV treatment with direct acting antiviral agents now have excellent retreatment options. In this article, we review the current state of the evidence for HCV retreatment after DAA failure.

Download Publication Zuckerman A, Chastain CA, Naggie S. Retreatment options following HCV direct-acting antiviral failure. Curr Treat Options Infect Dis, 2017 Dec; 9(4):389-402. doi: 10.1007/s40506-017-0136-6.

Adjustments to Antiretroviral Therapy Regimens in Co-Infected Human Immunodeficiency Virus and Hepatitis C Virus Patients

This study describes a real world cohort of HIV/HCV co-infected patients in an outpatient infectious diseases clinic with a focus on the frequency and impact of HIV antiretroviral adjustments required prior to HCV direct acting antiviral initiation.

Download Poster Douglas A, Chastain C, Zuckerman A. Adjustments to antiretroviral therapy regimens in co-infected human immunodeficiency virus and hepatitis c virus patients. Poster presented to the American Society of Health Systems Pharmacists Midyear Clinical Meeting and Exhibition, Orlando, FL. December, 2017.

Optimizing the Hepatitis C Cascade of Care in the Direct-Acting Antiviral Era

Despite improved treatments for Hepatitis C Virus (HCV) infection, barriers remain in the HCV cascade of care (CoC), limiting the overall impact of direct acting antivirals. The Vanderbilt Infectious Diseases (ID) clinic provides multidisciplinary care involving a physician, clinical pharmacist, and nurse for patients with HCV infection. The objective of this study was to identify factors associated with movement through the HCV CoC after referral to a multidisciplinary ID clinic to sustained virologic response (SVR), including both general and historically difficult to treat populations. These findings were published in the 2018 PLoS One article referenced above.

Download Poster Bagwell A, Douglas A, Farris K, Chastain C. Evaluation of the hepatitis c cascade of care in a multidisciplinary infectious diseases clinic. Poster presented to ID Week, San Diego, CA. October, 2017.

Download Poster Zuckerman A, Douglas A, Farris K, Chastain C. Merit project: optimizing the hepatitis c cascade of care in the direct-acting antiviral era. Poster presented to the American College of Clinical Pharmacy Annual Meeting, Phoenix, AZ. October, 2017.

Download Poster Bagwell A, Farris K, Chastain C. MeRit project: optimizing the hepatitis c cascade of care in the direct-acting antiviral era. Poster presented to the American College of Clinical Pharmacy Annual Meeting, Hollywood, FL. October, 2016.

Retreatment of Genotype 1 Hepatitis C Virus with Sofosbuvir, Simeprevir, and Ribavirin Following Treatment Failure with an NS5A-Containing Direct-Acting Antiviral Regimen

Prior to the release of sofosbuvir/velpatasvir/voxilaprevir, few options for retreating patients failing HCV direct acting antiviral (DAA) therapy. This study evaluated the effectiveness of sofosbuvir + simeprevir + ribavirin for 24 weeks in retreating patients who previously failed HCV treatment containing an NS5A inhibitor.

Download Poster Carver A, Porayko M. Retreatment of genotype 1 hepatitis c virus with sofosbuvir, simeprevir, and ribavirin following treatment failure with an ns5a-containing direct-acting antiviral regimen. Poster presented to the National Association of Specialty Pharmacy Annual Meeting, Washington, DC. September, 2017.

Improvements Following Clinical Pharmacist Integration in the Management of Hepatitis C

This study quantified patient and provider benefits of implementing a multidisciplinary team approach to HCV management involving a clinical pharmacist in an existing infectious diseases (ID) clinic. We found decreased provider burden, decreased time to medication approval and initiation, and increased prescription generation.

Download Poster Bagwell A, Chastain C. Improvements following clinical pharmacist integration in the management of hepatitis c. Poster presented to the National Association of Specialty Pharmacy Annual Meeting, Washington, DC. September, 2017.

An Interdisciplinary Team Approach to Hepatitis C Evaluation and Treatment: Assessing the Impact of Clinical Pharmacist Involvement on HCV Clinical Practice and Treatment

This study demonstrated the benefits of pharmacist integration into an interdisciplinary to treatment patients with chronic HCV. Pharmacist integration resulted in improved patient engagement, reduced provider burden, and increased rate of HCV treatment.

Download Poster Bagwell A, Chastain C. An interdisciplinary team approach to hepatitis c evaluation and treatment: assessing the impact of clinical pharmacist involvement on HCV clinical practice and treatment. Poster presented to the American College of Clinical Pharmacy Annual Meeting, Hollywood, FL. October, 2016.

Real World Assessment of All-Oral, Sofosbuvir-Based, Hepatitis C Therapy at an Academic Medical Center with Integrated Specialty Pharmacy Services

This study was among the first to evaluate patient outcomes to all-oral, sofosbuvir (SOF)-based, HCV therapies in a real world setting and assess the impact of a clinic-integrated specialty pharmacy on therapy completion. We found higher completion rates in patients filling through VSP (97%) compared to outside pharmacies (93%), and a 100% medication access rate.

Download Poster Nelsen C, Carver A. Real world assessment of all-oral, sofosbuvir-based, hepatitis c therapy at an academic medical center with integrated specialty pharmacy services. Poster presented to the National Association of Specialty Pharmacy Annual Meeting, Washington, DC. September, 2016.

Real World Assessment of Interferon Free Oral Sofosbuvir Based Therapy in Hepatitis C Patients

This study evaluated the efficacy, safety and discontinuation rates of sofosbuvir-based, all oral direct acting antiviral HCV Therapy in a real-world population compared to results reported in clinical trials.

Download Poster Beavers J, Nelsen C, Carver A, Bagwell A. Real world assessment of interferon free oral sofosbuvir based therapy in hepatitis c patients. Poster presented to the Southeastern Resident Conference (SERC), Athens, GA. May, 2016.

Hepatitis C Treatment in HIV Coinfection: Approaches, Challenges, and Future Opportunities

Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) coinfection is a significant cause of morbidity and mortality in people living with HIV/AIDS. While historical treatments combining interferon and ribavirin were less efficacious in HIV/HCV coinfection, modern direct-acting antiviral (DAA) therapies have shown similar clinical efficacy in HIV/HCV coinfection as in HCV monoinfection. In light of these findings, HIV/HCVcoinfected patients may benefit even more from new HCV treatment approaches. This article reviews the many therapeutic options for HIV/HCV coinfected patients with emphasis on avoiding drug-drug interactions.

Download Publication Bagwell A, Chastain CA. Hepatitis c treatment in HIV coinfection: approaches, challenges, and future opportunities. Curr Treat Options Infect Dis, 2016 Oct; 8(4):379-399. https://doi.org/10.1007/s40506-016-0097-1.

HIV

Overcoming Prescriber Concerns Through Successful Access and Affordability of PrEP

This poster focused on HIV PrEP access and affordability

Download PosterWhelchel K, Zuckerman AD, DeClercq J, Choi L, Rashid S, Kelly S. Overcoming prescriber concerns through successful access and affordability of PrEP. Poster presented to ID Week, Virtual Meeting. October, 2020

Extended Adherence and Persistence to HIV PrEP in a Multidisciplinary PrEP Clinic

This poster focused on extended adherence and persistence to HIV PrEP in a multidiciplinary PrEP clinic

Download PosterWhelchel K, Zuckerman AD, DeClercq J, Choi L, Rashid S, Kelly S. Extended adherence and persistence to HIV PrEP in a multidisciplinary PrEP clinic. Poster presented to ID Week, Virtual Meeting. October, 2020

Evaluation of Human Immunodeficiency Virus Curricular Content in Schools of Pharmacy in the United States

The purpose of this study was to explore student education about HIV and related topics using a cross-sectional, population-based survey of U.S. pharmacy schools with a 15-item questionnaire. We found diversity in the amount of time devoted to HIV didactic education among the 37 U.S. pharmacy schools who completed the survey, with some schools providing minimal didactic teaching on the topic of HIV along with low rates of exposure to PLWH in experiential training. Few schools have dedicated faculty spending a substantial amount of time in direct care of PLWH. Minimum standards for HIV education in schools of pharmacy should be established to prepare student pharmacists to care for PLWH.

Download PublicationRathbun RC, Durham SH, Farmer KC, Zuckerman AD, Badowski M. Evaluation of human immunodeficiency virus curricular content in schools of pharmacy in the United States. Curr Pharm Teach Learn, 2020 Aug; 12(8): 910-917. Available online 16 April 2020. DOI: 10.1016/j.cptl.2020.04.007

Healthcare Provider Attitudes and Knowledge Around Pre-Exposure Prophylaxis (PrEP) for the Prevention of HIV-Infection in Tennessee

In the Southern US, HIV prevalence is disproportionately high and PrEP use is disproportionately low. This cross-sectional survey study assessed Tennessee primary care providers’ current PrEP knowledge, attitudes, and prescribing practices with the aim to determine barriers to PrEP provision specific to TN providers.

Download Poster Moore E, Kelly S, Alexander L, Luther P, Cooper R, Rebeiro P, Zuckerman A, Hargreaves M, Bourgi K, Schlundt D, Bonnet K, Pettit A. Healthcare provider attitudes and knowledge around pre-exposure prophylaxis (PrEP) for the prevention of HIV-infection in Tennessee. Poster presented at ID Week 2019. Washington, DC. October, 2019.

Inflammatory Bowel Disease

Clinical Characteristics and Three-month Outcomes of Patients Prescribed Alternate-dose Self-injectable Biologic Therapy for the Management of Inflammatory Bowel Disease

This poster evaluates patient characteristics and 3-month outcomes in patients prescribed alternate-dose biologic therapy. Of 220 patients, one-third were previous/current smokers, and 40% had a psychiatric comorbidity. Median disease duration was 11 years (IQR 6-18), 46% previously underwent surgery.

Download PosterCherry L, Vimathalas P, Shah NB, DeClercq J, Zuckerman A, Choi L, Horst S. Persistence, discontinuation and specialty pharmacist interventions in patients receiving droxidopa for the management of orthostatic hypotension. Poster presented at: American Society of Health Systems Pharmacists Midyear Clinical Meeting and Exhibition; December, 2020; Virtual Meeting.

Tofacitinib Adherence and Outcomes in Patients with Refractory Crohn’s Disease

This study evaluates medication adherence and outcomes for tofacitinib in patients with refractory Crohn's disease. Mean Proportion of Days Covered (PDC) was 93.1% (n=7), with only one PDC less than 80%. Most common cause of discontinuation was lack of response, with only one discontinuation due to adverse event.

Download PosterWiles CA, Shah NB, Bell J, Pabla BS, Scoville E, Dalal R, Beaulieu D, Schwartz D, Horst SN. Tofacitinib adherence and outcomes in patients with refractory Crohn's disease. Poster presented to American College of Gastroenterology Annual Meeting, Virtual Meeting. October, 2020

Tofacitinib Adherence and Outcomes in Patients with Refractory Ulcerative Colitis

This study evaluates medication adherence and outcomes for tofacitinib in patients with refractory ulcerative colitis. Mean proportion of days covered (PDC) was 95.7% (n =20), with only one PDC less than 80%. Tofacitinib demonstrated improvement in c-reactive protein and patient-reported outcomes, however many patients required use of prednisone.

Download PosterWiles CA, Shah NB, Bell J, Pabla BS, Scoville E, Dalal R, Beaulieu D, Schwartz D, Horst SN. Tofacitinib adherence and outcomes in patients with refractory ulcerative colitis. Poster presented to American College of Gastroenterology Annual Meeting, Virtual Meeting. October, 2020

Alternative Subcutaneous Biologic Dosing in Inflammatory Bowel Disease is Delayed Depending on Insurance Approval Requirements

This study evaluated the prior authorization (PA) process for alternative biologic dosing in IBD. Of 221 patients, 46.6% of patients required a PA, of which 33% were initially denied. Majority of PA denials were approved on appeal; ultimately, only one patient did not receive approval. Mediantime from decision to treat to approval was 7 days. Time to approval was longer is the initial PA was denied. Longer time to approval was observed for ustekinumab.

Download PosterCoe C, Cherry L, Shah NB, Zuckerman A, DeClercq J, Choi L, Pabla B, Scoville E, Dalal R, Beaulieu B, Schwartz D. Alternative subcutaneous biologic dosing in inflammatory bowel disease is delayed depending on insurance approval requirements. Poster presented to American College of Gastroenterology Annual Meeting, Virtual Meeting. October, 2020. Awarded ACG Outstanding poster presenter" award

Risk Factors for Non-Adherence to Self-Injectable Biologic Therapy in Inflammatory Bowel Disease: A Validation Cohort Study

The purpose of this study was to validate prior findings of risk factors for non-adherence to biologic therapy for adult inflammatory bowel disease: narcotic use, psychiatric diagnosis history, prior biologic use, and smoking. This study found that previously identified cumulative risk factors remain significant. Adherence (medication possession ratio greater than or equal to 0.86) was 74% and 73% in patients with 0 to 1 risk factors, decreasing to 61%, 67% and 48% respectively in those with 2,3, or 4 risk factors (p<0.05).

Download PosterCausey EE, George L, Rossmann L, Shah NB, Zuckerman A, Slaughter J, Duley C, Annis K, Wagnon J, Dalal R, Scoville E, Beaulieu DB, Schwartz D, Cross RK, Horst SN. Risk factors for non-adherence to self-injectable biologic therapy in inflammatory bowel disease: a validation cohort study. Virtual poster presented to Digestive Disease Week. May, 2020.

Development of a Quality Measures Tool for the Use of Self-Injectable Biologic Therapy in Inflammatory Bowel Disease: An Integrated Specialty Pharmacy Initiative

This article discusses development of a quality measures tool to track outcomes for self-injectable biologic therapy used in the management of inflammatory bowel disease. Through a collaborative initiative, a set of clinical and specialty pharmacy quality measures was developed to assess outcomes such as patient safety, disease status, treatment efficacy, and healthcare resource utilization.

Download Publication Shah NB, Jolly JA, Horst SN, Peter M, Limper H, Zuckerman AD. Development of a quality measures tool for the use of self-injectable biologic therapy in inflammatory bowel disease: an integrated specialty pharmacy initiative. Am J Health Syst Pharm, 2019 Sep; 76(17): 1296-1304.doi: 10.1093/ajhp/zxz142.

Risk Factors for Non-Adherence to Biologic Therapy in Adult Patients with Inflammatory Bowel Disease (IBD): A Retrospective Analysis

This study assessed medication non-adherence (defined as medication possession ratio (MPR) < 0.86) for injectable biologic medication at a tertiary care IBD center. The average MPR for 460 included patients was 89% +/-13%. We identified the following risk factors for non-adherence: psychiatric history, smoking, narcotic use, and prior biologic use.

Download Publication Shah NB, Haydek J, Slaughter J, Ashton JR, Zuckerman AD, Wong R, Raffa F, Garrett A, Duley C, Annis K, Wagnon J, Gaines L, Dalal R, Scoville E, Beaulieu D, Schwartz D, Horst SN. Risk factors for medication nonadherence to self-injectable biologic therapy in adult patients with inflammatory bowel disease. Inflamm Bowel Dis, 2019 Oct; pii: izz253. doi: 10.1093/ibd/izz253.

Download Oral Presentation Haydek J, Shah N, Slaughter JC, Ashton J, Zuckerman A, Wong R, Raffe F, Garrett A, Duley C, Annis K, Wagnon J, Gaines L, Dalal R, Scoville E, Beaulieu D, Schwartz D, Horst S. Risk factors for non-adherence to biologic therapy in adult patients with inflammatory bowel disease (IBD): a retrospective analysis. Podium presentation presented to the American College of Gastroenterology Annual Scientific Meeting, Philadelphia, PA. October, 2018. *Recognized as Best of ACG 2018 IBD & Liver*

Non-adherence to Self-injectable Biologic Medication in Patients with moderate to Severe Inflammatory Bowel Disease is Associated with Increased Healthcare Resource Utilization

This study evaluated the impact of non-adherence on healthcare utilization (hospitalizations, emergency department visits and prednisone use).

Download Poster Shah N, Zuckerman A, Wong R, Garret A, Duley C, Annis K, Wagnon J, Dalal R, Scovile E, Beaulieu D, Schwartz D, Slaughter C, Horst S. Non-adherence to self-injectable biologic medication in patients with moderate to severe inflammatory bowel disease is associated with increased healthcare resource utilization. Poster presented to the Digestive Disease Week Annual Meeting, San Diego, CA. May, 2019.

Lipidology: PCSK9 Inhibitors

Exploring Rates of PCSK9 Inhibitor Persistence and Reasons for Treatment Non-Persistence in an Integrated Specialty Pharmacy Model

This study evaluates PCSK9i persistence at 2, 12 and 24 months after initiation of therapy, reasons for non-persistence and percent change in LDL.

Download PosterHall N, Rizvi F, DeClercq J, Choi L, Donald D, Reynolds V. Exploring rates of PCSK9 inhibitor persistence and reasons for treatment non-persistence in an integrated specialty pharmacy model. Poster presented at: American Society of Health Systems Pharmacists Midyear Clinical Meeting and Exhibition; December, 2020; Virtual Meeting.

Real-World Use of PCSK9 Inhibitors and Adherence to Guideline-Directed Therapy in an Integrated Specialty Pharmacy

This study evaluates adherence to guideline-directed lipid management and PCSK9 inhibitor use, as well as clinical outcomes during 24 months of therapy.

Download PosterRizvi F, Hall N, DeClercq J, Choi L, Donald D, Reynolds V. Real-world use of PCSK9 inhibitors and adherence to guideline-directed therapy in an integrated specialty pharmacy. Poster presented at: American Society of Health Systems Pharmacists Midyear Clinical Meeting and Exhibition; December, 2020; Virtual Meeting.

Integrated Specialty Pharmacy Yields High PCSK9 Inhibitor Access and Initiation Rates

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 (ASCVD) events has proven challenging. This study evaluated medication access rates in patients prescribed a PCSK9 inhibitor at a healthcare system with integrated specialty pharmacy services. Overall, 96% of prescriptions resulted in access to a PCSK9 inhibitor, with a median time to approval of 8 days. This high level of access supports this model as a best practice for prescribing PCSK9 inhibitor therapy.

Download PublicationReynolds VW, Chinn ME, Jolly JA, Kelley TN, Peter ME, Choi L, Nwosu S, Leon BC, Zuckerman AD. Integrated specialty pharmacy yields high pcsk9 inhibitor access and initiation rates. J Clin Lipidol, 2019 Jan; 13(2):254-264. doi: 10.1016/j.jacl.2019.01.003.

Download PosterReynolds V, Peter M, Jolly J, Chinn M, Nwosu S, Choi L, Zuckerman A. Impact of an integrated clinical and specialty pharmacy service model on access to PCSK9 inhibitor therapy. Encore poster presented to the National Association of Specialty Pharmacy Annual Meeting, Washington, DC. September, 2018.

Download PosterChinn M, Reynolds V, Jolly J, Zuckerman A, Kelley T. Impact of an integrated clinical and specialty pharmacy service model on access to PCSK9 inhibitor therapy. Poster presented to the American Society of Health Systems Pharmacists Midyear Clinical Meeting and Exhibition, Orlando, FL. December, 2017.

Multiple Sclerosis

Impact of an Integrated Specialty Pharmacy Model on Patient Access to Dalfampridine

Dalfampridine, an oral specialty medication, increases walking speed and duration in patients with multiple sclerosis (MS). However, patients often struggle to access specialty medication due to high cost, insurance barriers, or limited distribution drug networks (which require patients to fill medication from one or few select pharmacies). This study compared patient access to dalfampridine before versus after Vanderbilt Specialty Pharmacy obtained access to dispense the drug. We found that insurance approval rate increased from 97% to 100%, the percent of patients who initiated prescribed therapy increased from 93% to 100%, and median time to access therapy decreased to 1 day. Findings highlight how integrated specialty pharmacists can provide effective medication monitoring, counseling, and access when limited distribution networks are removed.

Download Publication Peter ME, Markley B, DeClercq J, Choi L, Givens G, Zuckerman AD, Banks A. Inclusion in limited distribution drug network reduces time to dalfampridine access in patients with multiple sclerosis at a health system specialty pharmacy. J Manag Care Spec Pharm, 2021 Feb;27(2):256-262. doi: 10.18553/jmcp.2021.27.2.256

Download PosterGivens G, Banks A, DeClercq J, Choi L, Zuckerman A, Peter M. Impact of an integrated specialty pharmacy model on patient access to dalfampridine. Encore poster presented to National Association of Specialty Pharmacy (NASP) annual conference, Virtual Meeting. September 2020.

Givens G, Banks A, DeClercq J, Choi L, Zuckerman A, Peter M. Impact of an integrated specialty pharmacy model on patient access to dalfampridine. Encore poster presented to the 2020 Vanderbilt Health Systems Specialty Pharmacy Outcomes Research Summit, Virtual Meeting. August 2020.

Givens G, Banks A, DeClercq J, Choi L, Zuckerman A, Peter M. Impact of an integrated specialty pharmacy model on patient access to dalfampridine. Poster presented to the American Society of Health Systems Pharmacists Midyear Clinical Meeting and Exhibition, Last Vegas, NV. December, 2019.

Adherence to Disease Modifying Therapies at a Multiple Sclerosis Clinic: The Role of the Specialty Pharmacist

Disease modifying therapy (DMT) delays disease progression and improves quality of life for patients with Multiple Sclerosis (MS), but adherence to DMT is often sub-optimal. Vanderbilt Specialty Pharmacy (VSP) embeds pharmacists within an outpatient MS clinic to provide medication management and address barriers to adherence. We found an average adherence rate of 94% as measured by proportion of days covered (PDC), with 89% of all VSP patients achieving the industry standard of 80% PDC. Additionally, results indicate that ensuring financial assistance and low out-of-pocket costs are associated with high adherence to DMT within an integrated specialty clinic.

Download PublicationBanks AM, Peter ME, Holder GM, Jolly JA, Markley BM, Zuckerman SL, Choi L, Nwosu S, Zuckerman AD. Adherence to disease-modifying therapies at a multiple sclerosis clinic: the role of the specialty pharmacist. J Pharm Pract, 2019 Jan; :897190018824821. doi: 10.1177/0897190018824821.

Improving Adherence to Multiple Sclerosis Disease Modifying Therapies through an Integrated Specialty Pharmacy Model

This presentation detailed the specialty pharmacy practice model within the multiple sclerosis clinic at Vanderbilt University Medical Center with corresponding adherence results. This study is now published in the Journal of Pharmacy Practice (referenced above).

Download PosterJolly JA, Markley B, Holder G, Banks A, Zuckerman S, Zuckerman A. Improving adherence to multiple sclerosis disease modifying therapies through an integrated specialty pharmacy model. Poster presented to the National Association of Specialty Pharmacy Annual Meeting, Washington, DC. September, 2017.

Neurology / Movement Disorders

Persistence on Droxidopa for the Management of Orthostatic Hypotension at an Integrated Care Center

This was a single-center, retrospective analysis of persistence on droxidopa for the management of orthostatic hypotension in adults patients. This study also evaluated adherence, patient-reported adverse events and falls as well as healthcare resource utilization. A total of 89 patients were included. Restricted mean survival time for persistence was 1.5 years out of the 2-year study duration. Median proportion of days covered was 0.97. Twenty-eight patients reported an adverse event, half of patients reported a fall, 11 patients had at least one emergency room visit and 9 patients had at least one hospitalization.

Download Poster Daniell J, Shah NB, DeClercq J, Choi L, Zuckerman A, Livezey S. Clinical characteristics and three-month outcomes of patients prescribed alternate-dose self-injectable biologic therapy for the management of inflammatory bowel disease. Poster presented at: American Society of Health Systems Pharmacists Midyear Clinical Meeting and Exhibition; December, 2020; Virtual Meeting.

Download PosterLivezey S, Daniell J, DeClercq J, Choi L, Zuckerman A, Shah N. Persistence on droxidopa for the management of orthostatic hypotension at an integrated care center. Encore poster presented to National Association of Specialty Pharmacy (NASP) annual conference, Virtual Meeting. September 2020.

Livezey S, Daniell J, DeClercq J, Choi L, Zuckerman A, Shah N. Persistence on droxidopa for the management of orthostatic hypotension at an integrated care center. Encore poster presented to the 2020 Vanderbilt Health Systems Specialty Pharmacy Outcomes Research Summit, Virtual Meeting. August 2020.

Livezey SN, Daniell J, DeClercq J, Choi L, Zuckerman A, Shah NB. Persistence on droxidopa for the management of orthostatic hypotension at an integrated care center. Virtual poster presented to the College of Psychiatric and Neurologic Pharmacists. April, 2020.

Impact of Specialty Pharmacist Integration on Time to Medication Access for Pimavanserin

Patient access to pimavanserin treatment, an antipsychotic agent used to treat Parkinson’s disease-related psychosis, is limited by insurance approval and navigating a limited distribution network. Once initiated, safety and efficacy monitoring is needed to ensure adherence and clinical benefit. In this study, we found the time to access pimavanserin reduced by 21 days on average after pharmacist integration. Similarly, the rate of third party approval increased by 16% and treatment initiation increased by 18%.

Livezey S, Shah NB, McCormick R, Choi L, DeClercq J, Zuckerman A. Specialty pharmacist integration into an outpatient neurology clinic improves pimavanserin access. MHC, Forthcoming.

Download PosterLivezey S, McCormick R, Shah N, Choi L, DeClercq J, Zuckerman A. Impact of specialty pharmacist integration on time to medication access for pimavanserin. Encore poster to be presented to the National Association of Specialty Pharmacy (NASP) Annual Meeting & Expo, Washington, DC. September, 2019.

Download PosterLivezey S, McCormick R, Shah N, Choi L, DeClercq J, Zuckerman A. Impact of specialty pharmacist integration on time to medication access for pimavanserin. Poster presented to the College of Psychiatric and Neurologic Pharmacists Annual Meeting, Salt Lake City, UT. April, 2019.

Oncology

PARP Inhibitor Therapy Initiation: Patient Characteristics and Treatment Access Considerations

This poster evaluates patient characteristics and treatment access considerations for patients prescribed PARPi therapy. Median age at start of therapy was 61 years, mean disease duration was 4 years, and baseline ECOG performance status was either 0 (n=3) or 1 (n=12). Most common cancer indication was ovarian (n=10). Prior authorization was required for 88% of patients, with 100% approved through a pharmacist-led insurance approval process. After financial assistance, most patients (n=11) had $0 OOP cost.

Download PosterTruong V, Looney B, Moore R, Zuckerman A, Shah NB. PARP Inhibitor Therapy Initiation: Patient Characteristics and Treatment Access Considerations. Poster presented at: American Society of Health Systems Pharmacists Midyear Clinical Meeting and Exhibition; December, 2020; Virtual Meeting.

A Targeted Approach to Reducing Rates of Discontinuation and Dose Reduction in Patients Receiving Sorafenib or Regorafenib

Sorafenib and regorafenib are oral multikinase inhibitors used to treat some cancers, but adverse events for both drugs are common and often cause patients to discontinue therapy or reduce their dose within several months of initiating therapy. This study found that a pharmacist-initiated tailored intervention reduced sorafenib and regorafenib discontinuations (29% to 13%) and dose reductions due to adverse reactions (18% to 13%).

Download PosterNix R, Looney B, Lamb C, Peter M, Zuckerman A. A targeted approach to reducing rates of discontinuation and dose reduction in patients receiving sorafenib or regoranfenib. Poster presented to the Academy of Managed Care and Specialty Pharmacy Annual Meeting, San Diego, CA. March, 2019. *Gold abstract award winner*

Development of a Quality Measures Tool for the Utilization of Tyrosine Kinase Inhibitors in Non-small Cell Lung Cancer: An Integrated Specialty Pharmacy Initiative

Tyrosine kinase inhibitors (TKIs) require close monitoring to ensure safety, efficacy, and appropriate utilization. Developing quality measures for the use of TKIs is needed to appropriately monitor, evaluate, and report patient outcomes. The purpose of this initiative was to develop a tool to assess quality in the use of TKIs to manage NSCLC and ultimately track variables such as proper medication use, patient safety and healthcare resource utilization.

Download PublicationCrothers G, Shah NB, Kim M, Zuckerman AD. Development of a quality measures tool for the utilization of tyrosine kinase inhibitors in non-small cell lung cancer: An integrated specialty pharmacy initiative. J Oncol Pharm Pract, DOI: 10.1177/1078155220937754

Download PosterCrothers G, Shah N, Kim M, Zuckerman A. Development of a quality measures tool for the utilization of tyrosine kinase inhibitors in non-small cell lung cancer: an integrated specialty pharmacy initiative. Poster presented to the Pharmacy Quality Alliance Annual Meeting, Baltimore, MD. May, 2019.

Osteoporosis

Exploring Denosumab Therapy For Osteoporosis: Treatment lapses, discontinuations, and fracture incidence

In this study, we examined patients with osteoporosis prescribed denosumab. We explored the association between treatment lapses and discontinuations with fracture incidence. We also assessed reasons patients incurred a lapse in therapy or discontinued treatment, and discussed the role of the specialty pharmacist in supporting patient adherence and persistence.

Download Poster Gipson HM, Gregory WT, Chakrabarti A, DeClercq J, Choi L, Peter M. Assessing rates and reasons for treatment lapses in patients treated with denosumab. Encore poster presented to National Association of Specialty Pharmacy (NASP) annual conference, Virtual Meeting. September 2020

Download Poster Gregory WT, Gipson HM, Chakrabarti A, Peter M. Rates, reasons, and timing for treatment discontinuation in patients prescribed denosumab. Encore poster presented to National Association of Specialty Pharmacy (NASP) annual conference, Virtual Meeting. September 2020.

Download Poster Gipson HM, Gregory WT, Chakrabarti A, DeClercq J, Choi L, Peter M. Assessing rates and reasons for treatment lapses in patients treated with denosumab. Encore poster presented to the 2020 Vanderbilt Health Systems Specialty Pharmacy Outcomes Research Summit, Virtual Meeting. August 2020.

Download Poster Gregory WT, Gipson HM, Chakrabarti A, Peter M. Rates, reasons, and timing for treatment discontinuation in patients prescribed denosumab. Encore poster presented to the 2020 Vanderbilt Health Systems Specialty Pharmacy Outcomes Research Summit, Virtual Meeting. August 2020.

Download Poster Gipson HM, Gregory WT, Chakrabarti A, DeClercq J, Choi L, Peter M. Assessing rates and reasons for treatment lapses in patients treated with denosumab. Poster presented to the American Society of Health Systems Pharmacists Midyear Clinical Meeting and Exhibition, Last Vegas, NV. December, 2019.

Download Poster Gregory WT, Gipson HM, Chakrabarti A, Peter M. Rates, reasons, and timing for treatment discontinuation in patients prescribed denosumab. Poster presented to the American Society of Health Systems Pharmacists Midyear Clinical Meeting and Exhibition, Last Vegas, NV. December, 2019.

Peter M, Chakrabarti A, Gipson H, Gregory WT, DeClercq J, Choi L, Gibbs K, Tanner SB. Lapses and discontinuations in denosumab therapy: associations with fracture incidence. Abstract presented to the International Society for Clinical Densitometry Annual Meeting, Kuala Lumpur, Malaysia. March, 2019.

Factors That Impact Treatment Completion of Teriparatide

Many patients do not complete the two year course of teriparatide. In this study, we explored factors related to teriparatide completion. We found that smoking status significantly impacted teriparatide completion. Additionally, most patients required some form of financial assistance for teriparatide use.

Download Poster Singleton E, Boils B, Litten K, Burkes S, Zuckerman A. Factors that impact treatment completion of teriparatide. Poster presented to the American Society of Health Systems Pharmacists Midyear Clinical Meeting and Exhibition, Orlando, FL. December, 2017.

Assessing the Impact of High Touch Specialty Pharmacy Services in Patients Receiving Teriparatide

In 2013, the Vanderbilt Specialty Pharmacy (VSP) integrated a full-time clinical pharmacist into the Vanderbilt University Medical Center (VUMC) Endocrinology clinic to assist with continuity of care. This study found that patients utilizing VSP services were 62% more likely to complete teriparatide treatment and 49% less likely to drop out of treatment after completing 12 months of teriparatide compared to non-VSP patients. Additionally, the majority of patients (64%) required the use of the Vanderbilt Medication Assistance Program (MAP) to complete teriparatide treatment, a program only available to VSP patients.

Download Poster Singleton E, Boils B, Litten K, Burkes S, Zuckerman A. Assessing the impact of high touch specialty pharmacy services in patients receiving teriparatide. Poster presented to the National Association of Specialty Pharmacy Annual Meeting, Washington, DC. September, 2017. *Third place abstract winner*

Pediatrics

Evaluation of Response to Adalimumab Dose Intensification in Pediatric Patients with Inflammatory Bowel Disease

This study evaluated the response to adalimumab dose intensification (defined as a change in adalimumab therapy with reinduction or an increase in dosing frequency) in pediatric patients with inflammatory bowel disease. Of the 109 patient included in the study, 27% (29) changed from biweekly to weekly dosing or from 20mg biweekly to 40mg biweekly. Ten out of the 29 patients requiring a change achieved an improvement in the Physicians Global Assessment Score. The median adalimumab level prior to the dosing change in these patients was 6.1 mcg/mL and 11.2 mcg/mL after the change.

Download Poster Reynolds VW, Moulton D, Yarwais M, Hawkins S, Mitchell A, DeClercq J, Choi L. Evaluation of response to adalimumab dose intensification in pediatric patients with inflammatory bowel disease. Poster presented at: North American Society for Pediatric Gastroenterology, Hepatology & Nutrition; November, 2020; Virtual Meeting.

Efficacy and Safety of Abatacept, Adalimumab, and Etanercept in Pediatric Patients with Juvenile Idiopathic Arthritis

The objective of this study was to assess the efficacy of abatacept, adalimumab, and etanercept in pediatric JIA patients through changes in the Physician’s Global Assessment (PGA). We found that the majority of patients saw an improvement in their PGA score. Adverse events were similar across all three biologics, and the most common reason for biologic discontinuation was lack of response to therapy.

Download Publication Goettel A, DeClercq J, Choi L, Graham TB, Mitchell A. Efficacy and safety of abatacept, adalimumab, and etanercept in pediatric patients with juvenile idiopathic arthritis. JPPT, 2021; 26(2): 157–162.

Podium Presentation Goettel A. Efficacy and safety of abatacept, adalimumab, and etanercept in pediatric patients with juvenile idiopathic arthritis. Podium presentation presented to the Pediatric Pharmacy Advocacy Group Annual Meeting, Oklahoma City, OK. April, 2019.

Psychiatry

Pharmacist Managed Lithium in an Inpatient Academic Medical Center

This evaluation assessed the impact of a pharmacist-managed lithium consult service. Implementation of this service resulted in an increase in obtaining a serum lithium level within 24 hours of hospitalization as well as time savings to providers.

Download Poster Johnson K, Haffler Z, Miller L. Pharmacist managed lithium in an inpatient academic medical center. Poster presented to the College of Psychiatric and Neurologic Pharmacists Annual Meeting, Salt Lake City, UT. April, 2019.

Pulmonary Arterial Hypertension

High Rates of Medication Adherence in Patients with Pulmonary Arterial Hypertension: An Integrated Specialty Pharmacy Approach

We performed a retrospective cohort analysis of adult patients with PAH who were prescribed PDE-5I therapy by the center’s outpatient pulmonary clinic and who received medication management through the center’s specialty pharmacy. Of the 131 patients meeting inclusion criteria, 94% achieved optimal adherence of ≥ 80% PDC. Within this cohort, 47% of patients experienced an adverse event and 27% had at least one hospitalization. Hospitalization, OOP cost, and frequency of dosing were not associated with adherence in this cohort. Patients receiving PDE-5I therapy through an integrated model achieved high adherence rates and low OOP costs.

Download Manuscript Shah NB, Mitchell RE, Proctor ST, Choi L, DeClercq J, Jolly JA, Hemnes AR, Zuckerman AD. High rates of medication adherence in patients with pulmonary arterial hypertension: an integrated specialty pharmacy approach. PloS One, 2019 Jun; 14(6):e0217798. doi: 10.1371/journal.pone.0217798.

Improving Medication Adherence in Pulmonary Arterial Hypertension: An Integrated Specialty Pharmacy Approach

Phosphodiesterase-5 inhibitors (PDE-5I) have demonstrated improvement in disease 2 symptoms and quality of life for patients with pulmonary arterial hypertension (PAH). Despite these benefits, reported adherence to PDE-5I therapy is sub-optimal. Clinical pharmacists at VSP are in a unique position to mitigate barriers related to PAH therapy including medication adherence and costs. We analyzed 131 patients with PAH and found 94% achieved optimal adherence of ≥ 80% proportion of days covered (PDC) despite 47% of patients experiencing adverse effects and 27% having at least one hospitalization. Financial outcomes are also presented.

Download Poster Mitchell R, Shah N, Terry S, Slack S, Zuckerman A, Jolly J. Improving medication adherence in pulmonary arterial hypertension: an integrated specialty pharmacy approach. Poster presented to the National Association of Specialty Pharmacy Annual Meeting, Washington, DC. September, 2017.

Rheumatoid Arthritis

Rates and Reasons for Medication Switching and Cycling in Patients with Rheumatoid Arthritis at an Integrated Health System Specialty Pharmacy

This study evaluates rates and reasons for switching and cycling in patients with RA. The most common reasons for switching and cycling were loss of efficacy, no efficacy and intolerable adverse effects.

Download Poster Morton S, Reynolds V, Wyatt K, DeClercq J, Choi L, Peter M. Rates and reasons for medication switching and cycling in patients with rheumatoid arthritis at an integrated health system specialty pharmacy. Poster presented at: American Society of Health Systems Pharmacists Midyear Clinical Meeting and Exhibition; December, 2020; Virtual Meeting.

Switching and Cycling Among Patients with Rheumatoid Arthritis at an Integrated Health System Specialty Pharmacy

Patients with rheumatoid arthritis must change therapy when a medication is ineffective or causes adverse effects. In these cases, patients either “switch” to a medication with a different mechanism of action, or “cycle” to another medication with the same mechanism of action. In patients prescribed biologic disease modifying anti-rheumatic drugs, in the first year of therapy, most patients (86%) did not switch or cycle therapy. Medication adherence and persistence remained high during the first year of therapy. Integrated specialty pharmacists provide high-touch care that ensures patients remain adherent to therapy despite necessary changes in medication.

Download Poster Zuckerman A, James C, Choi J, Peter M, Nadler MA, Nola KM, Jones A, Cooper K, DeClercq J, Choi L, Tanner SB. Switching and cycling among patients with rheumatoid arthritis at an integrated health system specialty pharmacy. Poster presented to the Academy of Managed Care Pharmacy Nexus Annual Meeting, National Harbor, MD. October, 2019.

Learn more about the project Specialty Pharmacy Continuum

Adherence to Disease-Modifying Anti-Rheumatic Drugs in Patients in an Integrated Clinic and Specialty Pharmacy

In patients treated with specialty medication for rheumatoid arthritis, optimal treatment outcomes require adherence and persistence to therapy. This study demonstrated high medication adherence rates and low patient out-of-pocket costs for patients in an integrated clinic and specialty pharmacy. Adherence measured using mean proportion of days covered was 0.89 and 80% of patients were adherent (PDC≥0.80). Rates of financial assistance were high and low out-of-pocket costs were associated with higher adherence.

Download Publication Berger N, Peter M, DeClercq J, Choi L, Zuckerman AD. Rheumatoid arthritis medication adherence in a health-system specialty pharmacy. Am J Manag Care, 2020 Dec 1;26(12):e380-e387. doi: 10.37765/ajmc.2020.88544.

Adherence to disease-modifying anti-rheumatic drugs (DMARDs) is associated with reduced rheumatoid arthritis (RA) disease activity and better radiological outcomes. Adherence to DMARDs is low, ranging 30-85% in previous reports. In this study, high rates of adherence to DMARDs were seen in a health-system integrated specialty pharmacy model, with a median proportion of days covered (PDC) of 94% (IQR= 82-99%). Most patients received financial assistance to reduce out-of-pocket costs, which might contribute to high adherence. Female patients and treatment non-naïve patients may be at higher risk for non-adherence.

Download Poster Berger N, Peter M, DeClercq J, Choi L, Zuckerman A. Adherence to disease-modifying anti-rheumatic drugs in patients in an integrated clinic and specialty pharmacy. Poster presented to the American Society of Health Systems Pharmacists Midyear Clinical Meeting and Exhibition, Anaheim, CA. December, 2018.

Transplant

Assessing Interventions to Improve Patient Care Conducted by Pharmacists at an Outpatient Renal Transplant Clinic within a Collaborative Pharmacy Practice Agreement

Download Poster Chelewski RJ, Johnson KE, Zuckerman AD, Peter M, Langone A. Assessing interventions to improve patient care conducted by pharmacists at an outpatient renal transplant clinic within a collaborative pharmacy practice agreement. Encore poster presented to the AMCP Nexus Annual Conference, Virtual Meeting. October, 2020

Chelewski R, Johnson K, Zuckerman A, Peter M, Langone A. Assessing interventions to improve patient care conducted by pharmacists at an outpatient renal transplant clinic within a collaborative pharmacy practice agreement. Encore poster presented to National Association of Specialty Pharmacy (NASP) annual conference, Virtual Meeting. September 2020.

Chelewski R, Johnson K, Zuckerman A, Peter M, Langone A. Assessing interventions to improve patient care conducted by pharmacists at an outpatient renal transplant clinic within a collaborative pharmacy practice agreement. Encore poster presented to the 2020 Vanderbilt Health Systems Specialty Pharmacy Outcomes Research Summit, Virtual Meeting. August 2020.

Chelewski R, Johnson K, Zuckerman A, Peter M, Langone A. Assessing interventions to improve patient care conducted by pharmacists at an outpatient renal transplant clinic within a collaborative pharmacy practice agreement. Poster presented to Academy of Managed Care and Specialty Pharmacy Annual Meeting, Virtual Meeting. April, 2020.

Development of a Pharmacy Collaborative Practice Agreement to Improve Efficiency and Management of Prescribing in a Renal Transplant Clinic

Post-transplant patients require complex medication regimens to ensure the survival of the transplanted organ and patient overall well-being. These regimens are frequently adjusted, initiated, or discontinued within soon after transplant. Pharmacist expertise can be utilized to optimize post-transplant medication use. This study describes the creation and corresponding outcomes of a Collaborative Pharmacy Practice Agreements (CPPA) between pharmacists and physicians within a renal transplant clinic.

Download Poster Chelewski R, Johnson K, Zuckerman A, DeClercq J, Choi L, Peter M, Langone A. Development of a collaborative pharmacy practice agreement to improve efficiency and management of prescribing in a renal transplant clinic. Encore poster presented to the National Association of Specialty Pharmacy (NASP) Annual Meeting & Expo, Washington, DC. September, 2019. *Top poster award winner*

Podium Presentation Chelewski R, Johnson K, Zuckerman A, DeClercq J, Choi L, Peter M, Langone A. Development of a pharmacy collaborative practice agreement to improve efficiency and management of prescribing in a renal transplant clinic. Podium presentation presented to the American Transplant Congress Annual Meeting, Boston, MA. June, 2019.

Download Poster Chelewski R, Johnson K, Zuckerman A, Peter M, DeClercq J, Choi L, Langone A. Development of a pharmacy collaborative practice agreement to improve efficiency and management of prescribing in a renal transplant clinic. Poster presented to the Academy of Managed Care and Specialty Pharmacy Annual Meeting, San Diego, CA. March, 2019. *Gold ribbon abstract winner*