Real-world, long-term evaluation of the tolerability and therapy retention of Epidiolex® (cannabidiol) in patients with refractory epilepsy.

OBJECTIVE: Epidiolex® (CBD) is FDA-approved for seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), and tuberous sclerosis complex (TSC). Phase III studies suggest that certain adverse effects (AEs), possibly linked to pharmacokinetic/pharmacodynamic (PK/PD) interactions may be therapy-limiting. We sought to identify these factors that contribute to treatment success and retention of therapy. METHODS: A single-center, retrospective review of patients with refractory epilepsy taking Epidiolex® was performed. Kaplan-Meier analysis was performed to describe Epidiolex® retention, as a measure of overall effectiveness. RESULTS: One hundred and twelve patients were screened; 4 were excluded due to loss to follow-up or never starting Epidiolex®. Of 108 patients, mean age was 20.3 years (13.1, range 2 to 63), and 52.8% were female. Mean initial and maintenance doses were 5.3 mg/kg/day (1.3) and 15.3 mg/kg/day (5.8), respectively. At the final evaluation, 75% of patients remained on Epidiolex®. The 25th percentile for discontinuation was 19 months. 46.3% of patients experienced at least one treatment-emergent adverse effect (TEAE) with 14.5% d/c Epidiolex® due to treatment emerging adverse effects (TEAE). The most common reasons for discontinuation were lack of efficacy (37%), increased seizure activity (22%), worsened behavior (22%), and sedation (22%). One out of 27 discontinuations was due to liver function test (LFT) elevations (3.7%). At initiation, 47.2% were concurrently taking clobazam, and 39.2% of those patients had an initial clobazam dose decrease. 53% of patients were able to either discontinue or lower the dose of at least one other antiseizure medication. SIGNIFICANCE: Epidiolex® is generally well-tolerated and the majority continued long-term treatment. Patterns of adverse effects were similar to clinical trials, however gastrointestinal complaints, and significant LFT elevations were less common. Our data suggest most patients discontinue within the first several months of treatment and suggest that further studies designed to evaluate early identification and potential mitigation of adverse effects and including drug interactions are warranted.

Nirmatrelvir-ritonavir treatment of COVID-19 in a high-risk patient population: A retrospective observational study.

Background: Coronavirus disease 2019 (COVID-19) is a highly contagious, airborne viral infection that can infect anyone. Those with certain underlying conditions may be at higher risk for infection to develop into a severe disease requiring hospitalization. This report summarizes use of nirmatrelvir-ritonavir for the treatment of COVID-19 in high-risk patients at a single academic medical center through a pharmacist delegation protocol and demonstrates real-world efficacy and safety of treatment. Methods: This retrospective, single-center, observational study analyzed all patients who received nirmatrelvir-ritonavir ordered by a clinical pharmacist for treatment of COVID-19 infection. The primary outcomes were safety and efficacy of nirmatrelvir-ritonavir. Safety was evaluated by analyzing drug interaction management and adverse events. Efficacy was evaluated through hospitalization and death within 28 days of nirmatrelvir-ritonavir use. Results: Sixty patients were eligible for inclusion. No patients were hospitalized or died within 28 days after initiation of nirmatrelvir-ritonavir. Pharmacists identified 101 drug interactions with 60% considered clinically significant, requiring modification of home medications. Adverse outcomes associated with the use of nirmatrelvir-ritonavir were reported in 13 patients (21.7%). Conclusions: A comprehensive program to mitigate drug interactions and prescribe nirmatrelvir-ritonavir ensured timely access to COVID-19 therapy, which may be associated with the prevention of hospitalization and death.

Implementation of telehealth for first-dose device teaching within a health-system specialty pharmacy.

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

Implementing Clinical Pharmacists in Primary Care: Care Team Satisfaction Survey Results.

BACKGROUND: The rising demand on primary care providers encourages innovative use of care extenders, such as primary care pharmacists. Our academic medical center includes 34 multidisciplinary primary care clinics that provide general pediatric and adolescent medicine, internal medicine, and family medicine services. Primary care pharmacy services (PCPS) have grown since 2016 across 13 clinics serving internal and family medicine services. This study evaluated care team member satisfaction and workflow implications with current PCPS and systematically identified priorities for future expanded services. METHODS: A 15-question survey was developed and administered through an online platform targeting multidisciplinary care team members. Likert and ranked scale responses were averaged by the electronic survey platform to calculate overall composite scores or weighted averages for each question. RESULTS: The survey response rate was 24.7%. There was a high level of agreement among care team members about the satisfaction with currently provided PCPS (range 3-5; mean 4.65 ± 0.66). Care team members disagreed with the perception of increased clinical burden from the PCPS (range 1-5; mean 1.82 ± 1.13). The most beneficial components of current PCPS included hypertension medication management and clinical consult activities (composite scores 3.8 and 3.19, respectively). The highest priority future PCPS identified was diabetes medication management (composite score 4.21). DISCUSSION: Care team members perceive the most value derived from PCPS when pharmacists are able to independently manage medications as care extenders under collaborative agreements with providers.

Expansion and Evaluation of Pharmacist Services in Primary Care.

Challenges with primary care access and overextended providers present opportunities for pharmacists as patient care extenders for chronic disease management. The primary objective was to align primary care pharmacist services with organizational priorities and improve patient clinical outcomes. The secondary objective was to develop a technological strategy for service evaluation. An interdisciplinary workgroup developed primary care pharmacist services focused on improving performance measures and supporting the care team in alignment with ongoing population health initiatives. Pharmacist collaborative practice agreements (CPAs) were developed and implemented. An electronic dashboard was developed to capture service outcome measures. Blood pressure control to <140/90 mmHg was achieved in 74.15% of patients who engaged with primary care pharmacists versus 41.53% of eligible patients electing to follow usual care pathways. Appropriate statin use was higher in patients engaged with primary care pharmacists than in eligible patients electing to follow usual care pathways both for diabetes and ischemic vascular disease (12.4% and 2.2% higher, respectively). Seventeen of 54 possible process and outcome measures were identified and incorporated into an electronic dashboard. Primary care pharmacist services improve hypertension control and statin use. Service outcomes can be measured with discrete data from the electronic health record (EHR), and should align with organizational priorities.

Primary care pharmacy technicians: Effect on pharmacist workload and patient access to clinical pharmacy services.

PURPOSE: Improve patient access to clinical pharmacy services and decrease pharmacist technical task workload in primary care (PC) clinics. SUMMARY: Due to concerns with the amount of technical tasks performed by University of Wisconsin Health PC clinical pharmacists negatively impacting their capacity to care for patients and perform clinical tasks, the pharmacy department piloted a new PC pharmacy technician role that involved completion of technical tasks previously performed by PC pharmacists. PC pharmacist daily technical and clinical activities were identified through shadowing and quantified by a 4-week period of work sampling. A PC pharmacist workgroup determined the technical tasks that would be appropriate for a pharmacy technician to complete and developed the technician workflows. A PC pharmacy technician was implemented during a 3-week pilot, when pharmacist daily technical and clinical activities were quantified through work sampling. Following implementation, a 52.7% (P < 0.001) relative reduction and a 10.2% (P < 0.001) relative increase in pharmacist technical and clinical activities, respectively, were identified. Additionally, a 10% relative increase from the previous 3-month average was observed in the PC pharmacist rolling patient panel size during the pilot period, correlating with an increase of patient access to pharmacist clinical services. CONCLUSION: Up to 17% of PC pharmacist daily activities are technical tasks. Leveraging pharmacy technicians to support pharmacists with completion of these tasks increases patient access to clinical pharmacy services but requires additional staff resources.

Inpatient pharmacists' patient referrals to a transitions-of-care pharmacist: Evaluation of an automated referral process.

OBJECTIVES: To evaluate the impact of a pharmacist screening and automated referral process that identifies patients at risk for readmission due to medication-related problems (MRPs). SETTING: University of Wisconsin (UW) Hospital is 505-bed flagship hospital that is part of UW Health, an academic health system. PRACTICE DESCRIPTION: The integrated pharmacy practice model at UW Health has inpatient pharmacists who perform discharge medication reconciliation. Before enhancing the screening and referral process, a transitions-of-care (TOC) pharmacist identified patients with the use of a low yield report and performed a second postdischarge medication reconciliation on selected patients. PRACTICE INNOVATION: A screening process was developed to identify patients at risk for readmission due to MRPs and allow for direct referral from inpatient pharmacists to a TOC pharmacist for postdischarge follow-up. EVALUATION: Patient characteristics, readmission risk, and readmission rate were compared between inpatient only (before referral) and inpatient plus second medication reconciliation (after referral). MRPs identified during medication reconciliation were quantified and categorized as provider or patient-associated. RESULTS: Before process improvement, 9 patients (5%) received a second medication reconciliation out of 175 patients who received standard-of-care inpatient medication reconcilation. After implementation, 45 patients (24%) received a second medication reconcilation out of 188 referrals. Patients referred for postdischarge follow-up with the TOC pharmacist had an average of 3.2 more medications and 2.7 more chronic conditions than before process implementation (P < 0.01). Both inpatient and TOC pharmacists identified at least 1 MRP in about two-thirds of patients (P = 0.60). Provider-associated MRPs were more commonly identified in both inpatient and postdischarge settings. CONCLUSION: Inpatient pharmacist screening is an effective method for identifying patients for referral to a TOC pharmacist to receive postdischarge follow-up. Despite the robustness of the inpatient medication reconciliation process in identifying provider-associated MRPs, patient-associated MRPs still emerged after discharge that warranted additional pharmacist intervention.

Creation of a certification requirement for pharmacists in direct patient care roles.

PURPOSE: Steps taken by a large health system to require certification for all pharmacists in direct patient care roles are detailed. SUMMARY: Major supply chain changes and rising payer expectations are reshaping pharmacy practice, resulting in expanded responsibilities for pharmacists and a heightened need for certification in specialized practice areas. In response, the pharmacy leadership team at UW Health, the integrated health system of the University of Wisconsin-Madison, used an iterative process and a "rolling" FAQ format to develop and implement a certification requirement. Key decisions during the process included decisions to accept only rigorous certifications (mainly those offered by the Board of Pharmacy Specialties), to provide institutional support for continuing education-based recertification, and to use an accepted definition of direct patient care in determining which pharmacists need to be certified. The team obtained the support of the UW Health human relations department by drafting a policy and rewriting all pharmacist position descriptions to incorporate the certification requirement. An all-pharmacist forum was held to build staff commitment. As a result of the requirement, 73 pharmacists were required to obtain certification by 2018 at a total cost to UW Health of $44,000; ongoing support of certification maintenance will cost an estimated $40,000 per year. CONCLUSION: Health systems can be successful in establishing uniform certification expectations for pharmacists in direct patient care roles, even across diverse practice settings, by aligning expectations with organizational goals.

Development and implementation of a pharmacist-run comprehensive medication review program in Wisconsin.

PURPOSE: The development and implementation of a centralized, pharmacist-run population health program were pursued within a health system to increase patient exposure to comprehensive medication reviews (CMRs) and improve visit processes. SUMMARY: Program implementation included choosing appropriate pilot pharmacy locations, developing a feasible staffing model, standardizing the workflow, and creating a patient referral process. The impact on patient exposure, specific interventions, and the sustainability of the program were evaluated over a seven-month period. A total of 96 CMRs were scheduled during the data collection period. Attendance at scheduled CMRs was 54% (52 visits); there were 25 cancellations (26%) and 19 no-shows (20%). Since program implementation, there has been more than a twofold increase (2.08) in the number of CMRs completed within the health system. On average, all aspects of each patient visit took 1.78 hours to complete. Pharmacists spent 28% of scheduled time on CMR tasks and 72% of time on telephone calls and technical tasks to maintain appointments. CONCLUSION: A pharmacist-run CMR program helped to elevate the role of the community pharmacist in a health system and to improve patient exposure to CMRs. Sustaining a centralized CMR program requires support from other members of the health-system team so that pharmacists can spend more time providing patient care and less time on the technical tasks involved.

Impact and application of material learned in a pharmacy residency teaching certificate program.

OBJECTIVE: To describe the impact and application of material learned in a pharmacy resident teaching certificate program on the career experiences of alumni 1 to 11 years after completion of the program. DESIGN: A teaching certificate program was established in 2001 that brought together residents from various training programs throughout Wisconsin to discuss essential educational skills in a dynamic learning environment. The purpose of the program was to teach participants the fundamental skills to continue to develop as a pharmacy educator throughout their career. ASSESSMENT: An electronic survey instrument was sent to alumni of the program. Greater than 70% of respondents agreed that the teaching certificate program reinforced their desire to teach in practice and that the program helped qualify them for their current or previous practice position. Alumni in academic positions more strongly agreed that the program changed their career interest to include academia and qualified them for their position in academia. CONCLUSIONS: A teaching certificate program can reinforce or stimulate interest among pharmacy residents in pursuing an academic career and prepare them for this role. Completion of the program led to a high level of confidence among the majority of alumni in their ability to precept students and residents and influenced some alumni involved in the hiring of pharmacists.