Evaluation of prior authorizations in transplant recipients at an urban institution.

BACKGROUND: Increasing prior authorization (PA) requirements for immunosuppression remain a burden for solid organ transplant (SOT) recipients and transplant staff. The objective of this study was to evaluate the number of PAs required and the approval rates at an academic, urban transplant center. METHODS: This was a retrospective study of SOT recipients at the University of Illinois Hospital and Health Sciences System (UI Health) that required PAs between 11/1/2019 and 12/1/2020. Inclusion criteria were SOT recipients greater than 18 years of age and prescribed a medication by the transplant team that required PA. Duplicate PA requests were excluded from the analysis. RESULTS: A total of 879 PAs were included in the study. Of these PAs, 85% (747/879) were approved. Seventy-four percent of the denials were overturned by an appeal. Most PAs were in black (45.4%), kidney transplant (62%), Medicare (31.7%), and Medicaid recipients (33.2%). The median approval time was 1 day for PAs and 5 days for appeals. Tacrolimus extended release (XR) (35.4%), tacrolimus immediate release (IR) (9.7%),and mycophenolic acid (7%) required most PAs. Black recipients and immunosuppression were identified as predictors of eventual PA approval, whereas recipients with Medicaid were less likely to obtain approval. CONCLUSIONS: At our transplant center, there was a high approval rate of PAs for immunosuppression, which calls into question the utility of PAs in this patient population, where these medications are standard of care. More black recipients and patients with Medicare and Medicaid had increased PA requirements, highlighting further disparities within the current system.

Virtualization and standardization of a health-system specialty pharmacy call center.

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

Integrated clinical and specialty pharmacy practice model for management of patients with multiple sclerosis.

PURPOSE: An integrated clinical and specialty pharmacy practice model for the management of patients with multiple sclerosis (MS) is described. SUMMARY: Specialty medications, such as disease-modifying therapies (DMTs) used to treat MS, are costly and typically require special administration, handling, and storage. DMTs are associated with high rates of nonadherence and may have associated safety risks. The University of Illinois Hospital and Health Sciences System developed an MS pharmacy practice model that sought to address the many challenges of coordinating care with multiple entities outside the health system. Several key features of the integrated model include a dedicated clinical pharmacist on the MS specialty team, an integrated specialty pharmacy service, direct access to the electronic medical record, and face-to-face interaction with patients. Through the active involvement of the neurology clinical pharmacist and an onsite specialty pharmacy service, targeted assessments and medication and disease education are provided to the patient before DMT initiation and maintained throughout therapy. In addition, the regular point of contact and refill coordination encourages improved compliance, appropriate medication use, ongoing safety monitoring, and improved communication with the provider for quicker interventions. This fosters increased accessibility, convenience, and patient confidence. Improving patient outcomes--the priority goal of this service model--will be assessed in future planned studies. Through this new practice model, providers are empowered to incorporate specialty medication management into transitions in care, admission and discharge quality indicators, readmissions, and other core measures. CONCLUSION: An integrated pharmacy practice model that includes an interdisciplinary team of physicians, nurses, and pharmacists improved patient compliance with MS therapies.

Improvement in safety monitoring of biologic response modifiers after the implementation of clinical care guidelines by a specialty.

BACKGROUND: Tumor necrosis factor (TNF)-alpha inhibitors and other biologic response modifiers (BRMs) are frequently used to treat a variety of inflammatory diseases. Use of these agents may increase risk of serious infections, malignancies, and other complications such as worsening symptoms of heart failure or demyelinating disease. Because of these risks, a baseline assessment and routine monitoring have been recommended, but standardized guidelines for monitoring have yet to be established. OBJECTIVE: To measure the compliance with the recommended safety monitoring in the Clinical Care Guidelines for BRMs at the University of Illinois Hospitals and Health Sciences System (UI Health). METHODS: The Clinical Care Guidelines for BRMs was developed by a committee of pharmacists, nurses, and physicians based on an assessment of published literature and medication labeling. The guidelines included recommendations for safety monitoring prior to BRM therapy, such as the tuberculosis (TB) test, Hepatitis B surface Antigen (HBsAg) test, liver function test (LFT), complete blood count (CBC), up-to-date vaccinations, risk assessment for cancer, pregnancy testing, monitoring for contraindications with concomitant medications, concomitant disease state risk assessment, and patient education. The guidelines were introduced to UI Health in February 2012 by a systemwide email and by in-services given by the health system's Specialty Pharmacy Service. In-services were given in the clinics known to generate large numbers of BRM orders (e.g., gastroenterology and rheumatology) and at the outpatient center for infused therapies. The purpose of the in-services was to introduce providers to the guidelines and encourage their compliance. To ensure that guideline requirements were met when BRMs were ordered, a process was established to identify BRM orders, assess the orders for compliance with 4 of the safety monitoring tests from the guidelines (TB, HBsAg, LFT, and CBC), and make interventions. When necessary, Specialty Pharmacy Services coordinated with the pharmacists and other providers in the clinic to order lab tests and ensure they were completed prior to the start of therapy. Feedback was provided during the study to proactively improve compliance with the guidelines. After completion of the study, a report containing outpatient prescription orders for BRMs (abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab, and tocilizumab) from August 2011 through July 2012 was generated from the electronic medical record. Retrospective analyses of completion of safety monitoring were conducted for patients administered BRM treatment. Completion rates were compared before and after implementation of guidelines in February 2012. Completion was considered to have occurred when all 4 safety monitoring tests had been conducted -TB (unless known to be positive from a previous test), HBsAg, LFT, and CBC. Completion data from August 2011 through January 2012 were before the guidelines were implemented, and data from February 2012 through July 2012 were after the guidelines. Chi square analyses were performed on completion frequencies in the patients before and after the guidelines were implemented. RESULTS: Of the 320 unique patient BRM orders evaluated in this study, 195 (61%) were generated in the Rheumatology clinic, 99 (31%) in the Gastroenterology clinic, 21 (6.5%) in the Dermatology clinic, and 5 (1.5%) in the Transplant clinic. Before the guidelines were implemented, 54 ( 31%) of 173 patient orders complied with the safety monitoring by having all 4 clinical tests performed at the appropriate time points. After guideline implementation, 88 (60%) of 147 patient orders were compliant and had all 4 clinical tests conducted, which represents a statistically significant improvement in the rate of compliance (Pearson chi square = 26.43, degrees of freedom (df) = 1, P less than 0.0001). This significant improvement in compliance rates after guideline implementation was observed in both the new patient group and the patients with continuing prescription orders/treatment changes. There was also an improvement in patients whose prescriptions were dispensed by UI Health and to a lesser degree those whose prescriptions were dispensed by an outside pharmacy. When the new patient group was analyzed separately (n = 92), 50 patients were treated before the guidelines were implemented, and 42 patients were treated after the guidelines were implemented. Compliance rates with safety monitoring in these 2 groups were 52% pre-implementation and 83% post-implementation, which represented a statistically significant improvement in compliance (Pearson chi square = 10.03, df=1, P = 0.0015). Similar results were observed in the second patient subgroup with continuing prescription orders/treatment change (n = 228). A total of 123 patients were treated before the guidelines were implemented, and 105 were treated after the guidelines were implemented. Compliance rates were 23% pre-implementation compared with 50% post-implementation, which represented a statistically significant improvement in compliance (Pearson chi square = 18.99, df = 1, P less than 0.0001). CONCLUSION: Given the widespread and long-term use of BRMs, safety monitoring and management should be an important part of a comprehensive medication management program for their use. A coordinated effort may have a significant impact on compliance with safety monitoring guidelines.