Implementation and results of a standardized process for identifying ambulatory pharmacy clinical outcome measures.

PURPOSE: Given the variation in clinical practice, a clinician-centric, standardized process to implement and validate clinical pharmacy outcome measures was developed. SUMMARY: Four specialty clinics with embedded clinic-based pharmacists underwent an iterative process to define, refine, and implement the build of electronic health record functionality for outcome measure data collection and reporting. Starting with a list of identified measures, clinic workgroups met to discuss each measure and identify gaps in measure implementation. Information technology experts created electronic documentation forms with discrete data and reports based on criteria specified by the clinic workgroups. Of 32 outcome measures identified as priorities for demonstrating pharmacists' impact in previous research, 29 were implemented for routine monitoring through this project. Implementation strategies included identification through existing reporting, development of discrete documentation tools within the electronic health record, and development of new reporting tools from available discrete data fields. Time to implementation decreased from the first to the last pilot clinic implementation, as demonstrated through a 9-day reduction in electronic documentation form development and 31-day reduction in report development turnaround time. CONCLUSION: A standardized and reproducible process was developed for the implementation of clinical pharmacy outcomes measures for 4 specialty clinics. The process was successfully utilized to develop measurable outputs for a variety of oncology and nononcology specialty disease states based upon multidisciplinary stakeholder input.

Development and implementation of a standardized process for identifying ambulatory pharmacy clinical outcomes measures.

PURPOSE: There is minimal available guidance on the process for selection of clinical outcomes measures to demonstrate the impact of clinic-based pharmacists (CBPs) despite an increased need and desire for outcomes data. The overall aims of this project were to (1) develop a standardized process for identifying clinical outcomes measures impacted by CBPs and (2) identify and prioritize potential clinical outcomes measures to track for CBPs within 4 specialty clinic pilot sites. METHODS: To develop a standardized process for identification and prioritization of measures, 4 consecutive Plan-Do-Study-Act (PDSA) cycles were performed with 4 different specialty clinics serving as pilot sites. Following each pilot cycle, rapid cycle improvements were implemented. A modified Delphi methodology served as the framework for measure selection and included gathering expert stakeholder insights regarding importance, feasibility, and validity of potential measures. Measures were identified via environmental scan of existing validated quality metrics, clinical guidelines, and other relevant literature. RESULTS: The primary outcome for this project was the development and refinement of a standardized process for measure identification and prioritization. The secondary outcome was narrowed and ranked lists of stakeholder-prioritized measures for 4 CBP-embedded pilot specialty clinics. These lists included 12 cardiothoracic transplant, 6 breast oncology, 9 neurology, and 7 gynecologic oncology measures. CONCLUSION: The measure identification and prioritization process developed was successfully utilized to identify and prioritize outcomes measures to track for 4 CBP-embedded specialty clinics. Due to the successful use of the process in a variety of specialty clinics, the standardized process has significant potential for expansion.

Decision-making framework for an acute care clinical pharmacist productivity model: Part 1.

PURPOSE: Clinical pharmacist productivity assessment has long been challenging, as a standard definition does not exist. A multistep project was undertaken with the intent to develop, validate, and implement an acute care clinical pharmacist productivity model. The initial step of the project was designed to identify, define, prioritize, and weight a comprehensive list of daily pharmacist responsibilities stratified by relative time spent on each function via consensus. METHODS: Delphi methodology applied by a panel of experts was used to identify a comprehensive list of acute care pharmacist responsibilities ranked in order of time intensity. Twenty-three acute care clinical pharmacists participated in the process. The consensus list was validated by time observation studies. Each responsibility was assigned a weight and corresponding work outputs by a consensus panel. Weighting of each responsibility was assigned according to the relative time intensity and complexity of each task. RESULTS: The results of the Delphi consensus process included the top 20 time-intensive responsibilities identified by the acute care clinical pharmacists. Timed observations of acute care clinical pharmacists yielded results similar to those of the consensus process. Selection of corresponding work outputs and weights for each responsibility provided the final requirements for the productivity model. CONCLUSION: The development of an acute care clinical pharmacist productivity model first requires the selection of appropriate work outputs and weighting. The consensus process provided a newly identified comprehensive list of pharmacist responsibilities that will serve as the foundation of the clinical productivity model. Validated consensus methodology can be useful for engaging clinical pharmacists in decision-making and the development of a clinical productivity model.

Formation and validation of an acute care clinical pharmacist productivity model: Part 2.

PURPOSE: The purpose of the project described here was to use the work outputs identified in part 1 of a 2-part research initiative to build and validate an acute care clinical pharmacist productivity model. METHODS: Following the identification of work outputs in part 1 of the project, relative weighting was assigned to all outputs based on the time intensity and complexity of each task. The number of pharmacists verifying an inpatient medication order each day was selected to represent the labor input. A multivariable linear regression was performed to determine the final work outputs for inclusion in the model. Productivity and productivity index values were calculated for each day from July 1, 2018, through June 30, 2019. RESULTS: Of the 27 work outputs identified via consensus by the clinical pharmacist working team, 17 work outputs were ultimately included in the productivity model. The average productivity during the period July 2018 through June 2019 was derived from the model and will serve as the baseline productivity for acute care clinical pharmacists. CONCLUSION: Validated consensus methodology can be useful for engaging clinical pharmacist in decision-making and developing a clinical productivity model. When thoughtfully designed, the model can replace obsolete measures of productivity that do not account for the responsibilities of clinical pharmacists.

Evaluation of telepharmacy and the use of a gravimetric technology-assisted workflow system for remote sterile product pharmacist checks.

PURPOSE: To evaluate the impact of remote sterile product pharmacist checks when used with a gravimetric-based technology-assisted workflow (TAWF) system on product checking accuracy, pharmacist review time, workload sharing, cost savings, and staff perceptions. METHODS: A double-arm, prospective study was conducted at 4 pharmacy locations for a 90-day period. Each compounded sterile product (CSP) checked by a remote pharmacist was also checked by a local pharmacist at the site of CSP preparation. An anonymous, online survey was emailed to staff before and after implementation to evaluate perceptions of the accuracy, timeliness, safety, potential impact, and value of the remote process. RESULTS: There was no statistically significant difference in the numbers of errors detected through the remote process and through the current, nonremote process (P = 0.177). The median pharmacist review time in the local process was significantly lower (P < 0.001). Remote pharmacists in the study workflow verified 30.4% of the total number of CSPs verified in the 90-day period. Annualized cost savings were calculated to be $23,770.08. Percent agreement increased from the preimplementation to the postimplementation period for survey questions about the safety of the remote process, opportunity for workload sharing, and optimization of current workflow. Percent agreement decreased for questions about the accuracy, timeliness, and value of the remote process and its impact on job security. CONCLUSION: The study demonstrated that with use of a gravimetric-based TAWF system, there was no difference in the accuracy and safety of sterile product pharmacist checks performed remotely and those performed at the product preparation site. In addition, the remote process allows for opportunities for workload sharing and cost savings.

Infusion reactions following administration of intravenous rolapitant at an academic medical center.

In 2017, due to a fluid shortage secondary to Hurricane Maria's devastation of Puerto Rico, hospitals and health-systems began to substitute rolapitant for fosaprepitant as part of chemotherapy-induced nausea and vomiting prevention and treatment strategies. However, despite advantageous pharmacologic and formulation (e.g. long half-life, quicker time to onset, and lack of first-pass hepatic metabolism) profiles, there seems to be significant risk of infusion-related hypersensitivity reactions associated with the administration of intravenous rolapitant. In January 2018, the U.S. FDA issued a Health Care Provider Letter stating that anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions have been reported in the postmarketing setting. Importantly, these reactions were observed at a higher rate than initially reported in the phase 1 bioequivalence study that led to FDA approval of intravenous rolapitant (2.8%), with many resulting in hospitalizations. At our institution, rolapitant-induced infusion-related reactions also occurred in more patients than expected (8.7%). Described herein are six cases of infusion-related hypersensitivity reactions with intravenous rolapitant at the North Carolina Cancer Hospital. Due to the quick onset of the infusion-related hypersensitivity reactions with intravenous rolapitant, interpatient differences in pharmacokinetics or pharmacodynamics are unlikely to be the cause. An objective assessment utilizing the Naranjo Causality Scale rates these infusion-related hypersensitivity reactions as definite adverse drug reactions.

Evaluation of a gravimetric-based technology-assisted workflow system on hazardous sterile product preparation.

PURPOSE: The impact of a gravimetric-based technology-assisted workflow (TAWF) system on hazardous compounded sterile product (CSP) production time, staff perception of safety, and job satisfaction was evaluated. METHODS: For 2 weeks before implementation of a gravimetric-based TAWF, staff utilized an automated punch clock to document the time to prepare and check CSPs compounded volumetrically. Simultaneously, an anonymous, online survey was e-mailed to staff to evaluate their perceptions regarding the safety of volumetric preparation and satisfaction with their role preparing CSPs. At 30 and 90 days postimplementation of the TAWF, staff completed identical follow-up surveys to evaluate safety and satisfaction using the gravimetric-based TAWF. The TAWF software captured product preparation and check times postimplementation. Data regarding the accuracy of compounding were collected postimplementation and compared to accuracy data available in the published literature. RESULTS: The median time to prepare CSPs preimplementation (n = 643) was 445 seconds versus 359 seconds (n = 728) 90 days after implementation of the gravimetric-based TAWF (p < 0.001). The median time to review and check CSPs was 45 seconds before implementation and 19 seconds 90 days after implementation (p < 0.01). Survey respondents preferred to use the TAWF to compound CSPs over volumetric preparation. There was no difference in respondents' perception of safety and accuracy of the TAWF preimplementation versus postimplementation. CONCLUSION: The gravimetric-based TAWF preparation of hazardous CSPs was faster and more accurate than manual volumetric preparation and improved staff perception regarding the accuracy of the CSP preparation process.

Implementation of a longitudinal early immersion student pharmacist health system internship program.

PURPOSE: The initiation, implementation, and benefits of a longitudinal early immersion student pharmacist health system internship are described. EDUCATIONAL ACTIVITY: A two-year longitudinal internship experience was implemented to provide exposure into distributional operations, direct patient care activities, and health-system pharmacy administration. The intent of the program was to create an opportunity for student pharmacists to enhance the quality of their education with practical experience by immersing them early in their careers within the healthcare system. Early in their academic training the student interns were exposed to a broad range of services and programs while contributing longitudinally to the service line through quality improvement projects and distributional operations. The first year primarily focuses on distributional operations with direct patient care shadowing, while the second year targets intern involvement in hematology/oncology direct patient care activities. In this role, they are able to serve as pharmacist extenders. SUMMARY: Our comprehensive, longitudinal two-year health-system pharmacy internship program offers student pharmacists a unique early immersion experience that builds upon itself throughout their didactic training but is outside of the academic requirements. Students are exposed to distributional operations, direct patient care activities, and health system pharmacy administration prior to APPE rotations.

Implementation of an integrated pharmacy supply management strategy.

PURPOSE: Implementation of an integrated pharmacy supply management strategy is described. SUMMARY: In 2011, the formulary approval process and supply management for oncology medications were independent of each other at an oncology infusion center. Numerous nonformulary medications were kept on hand and reordered based on inventory levels that were established with inadequate usage information, while some formulary agents did not have on-hand inventory levels and had to be reordered on a patient-specific basis, which required paperwork and then a review by drug information staff per institutional policy. Because there was no true distinction in the ordering of formulary versus nonformulary oncology agents, the medical staff prescribed both in the same manner, leaving the pharmacy staff responsible for ensuring that enough quantities were on hand for many drugs, regardless of formulary status. Using supply chain management principles, a formal analysis of the on-hand inventory was performed. In addition, the formulary process for oncology drugs was restructured to align with how oncology drugs are managed for on-hand inventory levels. The alignment of these processes allowed the operation to have 1 supply strategy for the ambulatory oncology infusion center. As a result, inventory exhaustion rates were reduced by 70% and inventory turn rates improved by 78%. There was also significant time savings in the operational process streamlining, eliminating the rework and inefficiencies caused by an unclear process that was not fully captured in this assessment. CONCLUSION: Alignment of the formulary review process with inventory analyses that support supply management principles reduced inventory exhaustion while improving inventory turn rates.

Expanding care through a layered learning practice model.

PURPOSE: The outcomes of a patient-centered layered learning practice model (LLPM) in which the clinical specialist acted as the attending pharmacist and managed a pharmacy team to provide direct patient care were evaluated. METHODS: Two 30-day evaluations were conducted on the acute care malignant hematology and medical oncology services of the University of North Carolina Medical Center in 2011. The primary objective of this study was to design an LLPM that used a team to expand the pharmacist care services offered. The primary outcome was the frequency of pharmacy team encounters at discharge (medication reconciliation and counseling), termed the discharge capture rate. RESULTS: During the study months, 42 and 78 malignant hematology and medical oncology patients were eligible for study inclusion, respectively. The overall discharge capture rate was 51%. Sixty-one patients received discharge medication reconciliation services during patient counseling. Patients included in the malignant hematology group received a mean of 11 prescriptions at discharge, compared with 9.83 in the medical oncology group. Means of 1.26 and 2.1 medication-related problems per patient were identified in the malignant hematology and medical oncology studies, respectively, during discharge medication reconciliation. The overall mean face time spent per patient was 21.3 minutes. CONCLUSION: Patients in malignant hematology and medical oncology services were counseled and provided discharge medication reconciliation by a pharmacy student or resident whose activities were managed and reviewed by an attending pharmacist using an LLPM, resulting in an improvement in all clinical outcomes and measures.

Converting to transdermal fentanyl: avoidance of underdosing.

BACKGROUND: Converting between the various opioid agents continues to be challenge for many practitioners. Specifically, variable recommendations for converting to the transdermal fentanyl patch may lead to confusion among clinicians and errors in dosing. OBJECTIVE: Our aim was to describe the inconsistencies among available opioid conversions with regard to transdermal fentanyl and to provide recommendations for safe and effective utilization of this product in patients with chronic pain. RESULTS: Available reports support the use of the morphine intravenous to oral ratio of 1:3 during the conversion to transdermal fentanyl product. CONCLUSIONS: Underdosing is an often overlooked complication of switching to transdermal fentanyl. Current recommendations for converting to transdermal fentanyl do not reflect contemporary clinical practice and should be reevaluated.

Integration of a clinical pharmacist into the hematology-oncology clinics at an academic medical center.

PURPOSE: The development, implementation, and early experience with a program providing clinical pharmacist services at the hematology-oncology clinics of a university teaching hospital are described. SUMMARY: With funding from a university research grant and other sources, a pharmacist was hired to launch a new program addressing four goals identified in a needs assessment: (1) improved management of supportive care, (2) enhanced education of patients receiving complicated chemotherapy regimens, (3) improved efficiency in the chemotherapy infusion unit, and (4) development of an experiential learning opportunity for pharmacy students and residents. The pharmacist hired to lead the ongoing program was a state-approved clinical pharmacist practitioner (CPP) who had authority to prescribe with physician oversight under established protocols. EXPERIENCE: An oncology supportive care consultation service implemented by the CPP in collaboration with a nurse and a physician served 89 new patients in its first 18 months of operation; during that period the CPP made 186 interventions and wrote 136 prescriptions. The CPP also established a chemotherapy counseling service that provided more than 900 bill-able patient education sessions over 18 months. In addition, the CPP launched an effort to increase use of a rituximab rapid-infusion protocol among eligible patients. The creation of the new oncology pharmacist position has given dozens of pharmacy students and residents a new opportunity for interaction with oncology clinic patients and other health care team members. CONCLUSION: Integration of the services of a CPP into the hematology-oncology clinics has helped achieve goals set by physician, nursing, and pharmacy leaders.

Institutional profile. UNC Institute for Pharmacogenomics and Individualized Therapy: interdisciplinary research for individual care.

The Institute for Pharmacogenomics and Individualized Therapy (IPIT) at the University of North Carolina at Chapel Hill (NC, USA) is a collaborative, multidisciplinary unit that brings together faculty from different disciplines and crosses the traditional departmental/school structure to perform pharmacogenomics research. IPIT investigators work together towards the goal of developing therapies to enable the delivery of individualized medical care. The NIH-supported Comprehensive Research on Expressed Alleles in Therapeutic Evaluation (CREATE) group leads the field in the evaluation of pathways regulating drug activity, and also provides a foundation for future IPIT research. IPIT members perform bench research, clinical cohort analysis and prospective clinical intervention studies, research on the integration of pharmacogenomic therapy into practice and research to foster global health pharmacogenomics application through the Pharmacogenetics for Every Nation Initiative. IPIT Investigators are actively incorporating a pharmacogenomics curriculum into existing teaching programs at all levels.

Fondaparinux and the management of heparin-induced thrombocytopenia: the journey continues.

OBJECTIVE: To review the available literature addressing the role of fondaparinux in the management of heparin-induced thrombocytopenia (HIT). DATA SOURCES: Primary articles were identified by a MEDLINE search (2004-June 2009) of English-language literature using the MeSH headings fondaparinux, heparin, low-molecular-weight heparin, and thrombocytopenia. Relevant consensus guidelines (2006-June 2009) were also identified. STUDY SELECTION AND DATA EXTRACTION: All published studies and case reports, as well as relevant consensus guidelines, evaluating the use of fondaparinux for the management of HIT were included. DATA SYNTHESIS: The role of fondaparinux in the management of HIT is a therapeutic controversy challenging clinicians today. An open-label, prospective pilot study of 7 patients with acute HIT supports fondaparinux as an alternative anticoagulant. Additionally, a total of 12 patients with HIT from a larger case study and retrospective cohort were successfully treated with fondaparinux. Much of the supporting data exists in the form of case reports, each demonstrating normalization of platelet counts without any evidence of new thrombosis. The differences in clinical scenarios as well as the role and dose of fondaparinux make interpretation of these reports difficult. Three case reports have been published raising concerns regarding fondaparinux causing or failing to manage HIT appropriately. However, common weaknesses such as small sample sizes and nonuniform definitions of HIT limit the usefulness of these findings. The updated American College of Chest Physicians consensus guidelines now recognize fondaparinux as an option in the management of HIT; however, the level of evidence supporting this is of low quality. The use of fondaparinux as a bridging agent between direct thrombin inhibitor and warfarin therapy has been proposed. A recently published case report gives support to this approach. CONCLUSIONS: Controlled clinical trials evaluating the use of fondaparinux in the management of HIT need to be completed before this therapy can be routinely recommended.

Pharmacogenomics: implications and considerations for pharmacists.

The Renaissance period of world history is analogous to the renewal of healthcare that will arise from pharmacogenomic discoveries. Just as geography, science, art and communication were reawakened by the works of Columbus, da Vinci, Michelangelo and Gutenberg; genetic science will revitalize the clinical role of pharmacists and generate new interest in pharmacy research and education.

What's New in Antifungals?

The incidence of fungal infections is steadily rising. Until recently, clinicians have been limited in the number of effective antifungal agents at their disposal. Our traditional antifungal agents have either been hampered by troublesome side effects or a limited spectrum of activity. Due to the rising demand for better antifungal agents there are more agents in development than ever. Voriconazole and caspofungin are the most recent agents approved for use, offer a broad spectrum of activity, and are generally well tolerated. Several other novel agents are moving into clinical trials. A better understanding of these novel agents is critical for clinicians to effectively treat emerging fungal pathogens.