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.

Hepatitis C

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.

To be presented: The International Society for Heart & Lung Transplantation, April 2019
Download Poster (link coming soon): 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.

Lipidology: PCSK9 Inhibitors

Multiple Sclerosis

Inflammatory Bowel Disease

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 nonadherence on healthcare utilization (hospitalizations, emergency department visits and prednisone use).

To be presented: Digestive Disease Week, San Diego CA, May 2019
Download (Link coming soon):: Jennifer Haydek, Nisha Shah, James C. Slaughter, Jonathan R. Ashton, Rochelle Wong, Autumn Zuckerman, Caroline Duley, Ailish Garrett, Kim Annis, Julianne Wagnon, Robin L. Dalal, Elizabeth A. Scoville, Dawn Beaulieu, David A. Schwartz, Sara N. Horst. Non-adherence to Self-injectable Biologic Medication in Patients with moderate to Severe Inflammatory Bowel Disease is Associated with Increased Healthcare Resource Utilization.

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

The purpose of this initiative was to develop a tool to measure quality in the use of self-injectable biologic therapy for the management of inflammatory bowel disease at a health-system specialty pharmacy. With a focus on improving patient health outcomes, the objective of this project was to set measurable standards to track variables assessing baseline and longitudinal medication safety and efficacy. We developed a set of three clinical quality measures and four specialty pharmacy-specific quality measures. Clinical measures assess quality at three points in the treatment cascade: pre-treatment, on-treatment, and longitudinally. These measures monitor outcomes including patient safety, disease status, treatment efficacy and healthcare resource utilization. Specialty pharmacy measures set standards related to medication adherence, medication persistence, specialty pharmacy accreditation, and patient satisfaction.

Accepted for Publication: 2019
Manuscript (link coming soon): : Shah N, Jolly J, Horst S, 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, American Journal of Health-System Pharmacy.

Specialty Medication Adherence

Hematology

Osteoporosis

Lapses and discontinuations in denosumab therapy: Associations with fracture incidence

The purpose of the study was to assess rates of treatment lapses and discontinuations and associations with fracture incidence in adult patients treated with denosumab (a clinic-administered osteoporosis treatment given every six months). We conducted retrospective chart review of 534 patients who received 2+ treatment doses at VUMC between 2010-2018. Of these, 13% of patients incurred a total of 120 fractures after initiating denosumab; most fractures occurred during continuous therapy or after discontinuing therapy. Fracture incidence was associated with higher age and was more common in patients who discontinued treatment, but was not associated treatment lapses, race, gender, or body mass index. We are currently collecting follow-up longitudinal data for these patients to explore long-term incidence and risk factors for fracture incidence.

Presented: International Society for Clinical Densitometry Annual Meeting, Kuala Lumpur, Malaysia, March 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.

Accepted for Publication: 2019
Manuscript (link coming soon): Shah, N., Mitchell, R., Proctor, S.T., Choi, L., DeClercq, J., Jolly, J… & Zuckerman, A.D. (2019). High Rates of Medication Adherence in Patients with Pulmonary Arterial Hypertension: An Integrated Specialty Pharmacy Approach. PLoS One.

Oncology

Transplant

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.

To be presented: 2019 American Transplant Congress, Boston, MA, June 2019
Download poster (Link coming soon): R. Chelewski, K. Johnson, A. Zuckerman, Declerq J, Choi L, Peter M, A. Langone. Development of a Pharmacy Collaborative Practice Agreement to Improve Efficiency and Management of Prescribing in a Renal Transplant Clinic.