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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.

In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.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.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.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.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.

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.

In 2009 the University of North Carolina (UNC) Medical Center opened the North Carolina Cancer Hospital to serve as the premier location for oncology patients in the state. For the Department of Ph...

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.

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.

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.

Purpose: To address the growing use of oral anticancer therapy, an integrated, closed-loop, pharmacist-led oral chemotherapy management program was created within an academic medical center. Methods: An integrated, closed-loop, pharmacy-led oral chemotherapy management program was established. From September 2014 until June 2015, demographic information, rates of adherence, patient understanding of treatment, pharmacist interventions, patient and provider satisfaction, and molecular response rates in patients with chronic myeloid leukemia (CML) were collected. Results: After full implementation, 107 patients were enrolled in our oral chemotherapy management program from September 2014 until June 2015. All patients were educated before starting oral chemotherapy, and using pre- and postassessment tests, comprehension of oral chemotherapy treatment increased from 43% to 95%. Patient-reported adherence was 86% and 94.7% for the GI/breast and malignant hematology patient populations, respectively, and these were validated with medication possession ratio, revealing adherence rates of 85% and 93.9% for the GI/breast and malignant hematology patient populations, respectively. A total of 350 encounters with a clinical pharmacist and 318 adverse effects were reported, which led to 235 interventions. This program led to a higher major molecular response rate (83%) in our CML population compared with published clinical trials (average major molecular response rates, 40% and 60% with 1- and 2-year follow-up, respectively). Conclusion: An innovative model was developed and resulted in improved patient knowledge regarding oral chemotherapy, improved adherence rates that exceeded nationally established thresholds, and superior major molecular response outcomes for patients with CML compared with published literature. As a result, this model has produced the gold standard in managing patients receiving oral chemotherapy.

Purpose One academic medical center’s efforts to move toward compliance with requirements of United States Pharmacopeia ( USP ) chapter 800 through a multidepartmental collaborative initiative are described. Summary Requirements of USP general chapter 800 (enforceable as of December 2019) address the handling of hazardous drugs (HDs) throughout the entire operational and clinical cycle, from receiving to compounding, administration, and waste disposal. Due to the variety of pharmacy operational areas in which HDs are encountered at University of North Carolina Medical Center (UNCMC), multiple pharmacy managers oversee the safe handling of HDs. To determine baseline compliance with USP chapter 800 requirements, a common assessment tool was developed to ensure a standardized approach to compliance assessment in all areas. An interdepartmental workgroup was created to ensure institutionwide support for a collaborative compliance initiative, a uniform understanding of compliance risks, and robust action planning. UNCMC has taken a number of steps toward USP chapter compliance in areas such as engineering controls, environmental quality and controls, use of personal protective equipment, hazard communication programs, personnel training, spill control, and medical surveillance. Conclusion Achieving USP chapter 800 compliance presented several operational, clinical, and financial challenges for the medical center, requiring months of preparation and diligence by the hospital leadership. The pharmacy department–led compliance collaborative allowed departments to proactively align while implementing practice and quality standards to foster safety for patients, workers, and the environment.

Objective: Oncolytic immunotherapy involves the use of viruses to target and destroy cancer cells and to induce immune responses for an enhanced antitumor effect. Talimogene laherparepvec, a genetically modified herpes simplex virus type 1 (HSV-1) that selectively replicates in tumors to induce lytic cell death, tumor antigen release, and the local production of granulocyte–macrophage colony-stimulating factor (GM-CSF), has been approved for the treatment of a defined population of patients with metastatic melanoma. Talimogene laherparepvec is administered as a series of intralesional injections, and specific procedures are implemented to minimize the risk of viral exposure. Because talimogene laherparepvec represents a novel therapeutic modality, its preparation, administration, and handling requirements differ from current therapies; pharmacists have an important role in developing new procedures to incorporate it into clinical practice. Methods: In this review, pharmacists with experience dispensing talimogene laherparepvec, in the clinical trial setting and/or as a commercially available product at US academic institutions, synthesized their personal experiences through group discussions to provide insights on the ordering, receipt, storage, preparation, administration, and handling of talimogene laherparepvec. Results: Suggestions for patient education and practical guidance to assist hospital pharmacists and decision makers with implementing talimogene laherparepvec at their institutions are provided. Conclusion: These insights may further inform the development of policies or procedures to incorporate talimogene laherparepvec into clinical settings and improve patient outcomes.

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.

Background Pharmacist-led medication reconciliation (PMR) ensures adequate recording and use of medications by patients. PMR may be important for cancer patients initiating new therapies, as they have a high burden of medication use and are more susceptible to inadvertent medication discrepancies. To describe medication changes (additions, discontinuations, and modifications) made to the electronic health record during a PMR among cancer patients initiating chemotherapy. Methods From October 2011 to March 2012, 397 cancer patients initiating chemotherapy underwent a PMR at the University of North Carolina Cancer Hospital. Self-reported medications and those in the patients’ electronic health record were reviewed. Log-binomial regression models were used to estimate adjusted prevalence ratios and 95% confidence intervals for the associations between patient characteristics and medication changes made to the electronic health record. Results Mean age at time of the PMR was 58. Median number of medications taken prior to the PMR was 10 and median time to PMR completion was 11 min. Vitamins and herbal supplements accounted for the largest proportion of medication additions (38%) and modifications (20%). Antimicrobials accounted for the largest share of discontinuations (15%). After adjustment for all other covariates, patients aged 60–69 years were more likely to have additions than those aged 50 and under (aPR = 1.47, 95%CI: 1.10–1.97). Patients 70 years and over were more likely to have modifications (aPR = 1.74, 95%CI: 1.07–2.82). Conclusion Our results show that most cancer patients had a medication change in the electronic health record. A brief oncology PMR can accurately capture and improve medication safety by preventing prescribing and administration errors.

Purpose Appropriate use of oral chemotherapy is a challenge for patients and clinicians. The purpose of this study was to analyze cancer patients’ use of oral chemotherapies and identify opportunities to improve adherence. Methods We developed a 30-question survey to address frequency and reasons for reducing/skipping doses; sources of information for oral chemotherapy use; perceived importance of food–drug effects; and ease of understanding labeling directions. Results Ninety-three patients taking oral chemotherapies with chronic myeloid leukemia, renal cell carcinoma, breast cancer, and colorectal cancer completed the survey. This was a well-educated population with 69% (n = 62) having completed some college; 51% (n = 47) female and 59% (n = 54) older than 50 years of age. Thirty percent of patients reported forgetting to take their oral chemotherapy at least “sometimes”. Younger patients (Conclusion There are three main barriers associated with appropriate use of oral chemotherapies: misunderstanding about the timing of drug with food; stopping drug without informing physicians; and difficulty understanding labeling directions. A multipronged approach is needed to optimize communication of directions for optimal oral chemotherapy use.

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.

Background: Despite widespread recognition of the need for innovative pharmacy practice approaches, the development and implementation of value-based outcomes remains difficult to achieve. Furthermore, gaps in the literature persist because the majority of available literature is retrospective in nature and describes only the clinical impact of pharmacists’ interventions. Objective: Length of stay (LOS) is a clinical outcome metric used to represent efficiency in health care. The objective of this study was to evaluate the impact of pharmacist-driven interventions on LOS in the acute care setting. Methods: A separate samples pretest-posttest design was utilized to compare the effect of pharmacist interventions across 3 practice areas (medicine, hematology/oncology, and pediatrics). Two time periods were evaluated: preimplementation (PRE) and a pilot period, postimplementation of interventions (POST). Interventions included targeted discharge services, such as discharge prescription writing (with provider cosignature). Participating pharmacists completed semistructured interviews following the pilot. Results: A total of 924 patients (466 PRE and 458 POST) were included in the analysis. The median LOS decreased from 4.95 (interquartile range = 3.24-8.5) to 4.12 (2.21-7.96) days from the PRE versus POST groups, respectively ( P < 0.011). There was no difference in readmission rates between groups (21% vs 19.1%, P = 0.7). Interviews revealed several themes, including positive impact on professional development. Conclusion and Relevance: This pilot study demonstrated the ability of pharmacist interventions to reduce LOS. Pharmacists identified time as the primary barrier and acknowledged the importance of leaders prioritizing pharmacists’ responsibilities. This study is novel in targeting LOS, providing a value-based outcome for clinical pharmacy services.

Cancer patients have a high rate of emergency department (ED) visits and inpatient hospitalizations (IHs) that may be reduced by use of outpatient palliative care services.To determine whether the outpatient adult palliative care service at the University of North Carolina (UNC) Hospital, begun in 2008, reduced the frequency of ED visits and IH during a two-year period.The charts of patients with lung cancer or head and neck cancer seen by the supportive care service from 2010 to 2011, and of a contemporaneous set of potential consults that were not seen, were retrospectively reviewed to determine the impact of this care delivery model.The number of individuals with lung cancer and head cancer seen during this two-year period was 24 and 23, respectively, permitting a statistical analysis from which meaningful conclusions could be drawn.The frequency of ED visits and IHs for each patient was reviewed. Descriptive statistics were used. Fisher's exact test was used for data categorized into two by two contingency tables. The nonparametric Jonckheere-Terpstra method was used to test for ordered differences across categories.Consultation with supportive care did not decrease overall use of ED visits. Patients with head and neck cancer showed an increase in ED visits (p = 0.08) but a reduction in inpatient admissions (p = 0.0004). In patients with lung cancer, the opposite effect was seen-an increase in inpatient visits (p = 0.02) but a decrease in ED visits. The frequency of ED visits was correlated with distance to the ED (p = 0.02), a finding that has not been noted before.Further work is needed to define the best model for outpatient palliative care.

The delivery of an accurate dose of a compounded sterile product (CSP) is paramount to ensuring effective treatment and preventing patient harm. Cases of patient harm due to errors in the production of CSPs have been widely documented.[1][1] An observational study at 5 U.S. hospitals that prepare

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.