Evaluation and optimization of a clinical pharmacist driven transitions of care model for malignant hematology.

PURPOSE: To implement and optimize a pilot transitions of care model for scheduled chemotherapy admissions in patients with hematologic malignancies at our institution.Methodology: We utilized the plan-do-study-act (PDSA) quality improvement technique to prospectively measure success of interventions related to improving transitions of care processes that occurred in multiple stages including development of standardized operating procedures, electronic medical record documentation, and education to the malignant hematology multidisciplinary group. Chart review was performed retrospectively for at least nine patients per PDSA cycle. Areas of intervention addressed and measured regarding communication between the ambulatory care and acute care settings included: admission purpose, processes related to insurance benefits investigations for specialty medications required in the post-discharge setting, and plan for growth factors, prophylactic antimicrobials, and follow-up.Results and conclusions: We included 28 patients and performed a total of three PDSA cycles demonstrating specific improvements in: communication regarding status of benefits investigations performed for specialty medications prior to admission, resolution of these benefits investigations at various time points, improvement in efficient use of the electronic medical record for chemotherapy orders, and patient instructions for appropriate use of prophylactic antimicrobials. Although improvement was noted initially with prescribing of discharge antiemetics and antimicrobials, regression to baseline was noted with the third PDSA cycle.

A comparison of response in the presence or absence of a delay in induction therapy with bortezomib, lenalidomide, and dexamethasone.

PURPOSE: Lenalidomide, bortezomib, and dexamethasone (RVd) has emerged as a preferred induction therapy in multiple myeloma (MM) in the United States. Due to lenalidomide's teratogenic risk, patients and prescribers must comply with a risk evaluation and mitigation strategy (REMS) program. The REMS program limits dispensing to certain third-party specialty pharmacies, whose average prescription fill times are longer than in-house specialty pharmacies. In practice, a delay in procurement of lenalidomide may mean that patients start therapy with only bortezomib and dexamethasone, delaying the start of more effective triplet therapy. The primary objective of this study is to determine if a delay from start of bortezomib and dexamethasone to start of triplet therapy with lenalidomide impacts rate of achievement of very good partial response (VGPR) after four cycles of RVd. METHODS: This was a single-center retrospective review of adults with newly diagnosed MM who received RVd induction therapy at University of North Carolina Medical Center between April 2014 and June 2017. Patients who started lenalidomide ≥10 days after bortezomib comprised the "Delay" group, while those who started lenalidomide concurrently with bortezomib or within 1-9 days after bortezomib comprised the "No Delay" group. The primary outcome was VGPR or better response rate after four cycles of RVd. RESULTS: Thirty-eight patients met inclusion criteria. Nine patients (23.7%) experienced any delay in initiation of lenalidomide, with a mean delay of 7.8 days (range 1-18). Four patients (10.5%) experienced a delay ≥10 days. No patients in the Delay group were of reproductive potential, compared to 8.8% in the No Delay group (p = 0.54). VGPR or better response rate did not differ between the Delay and No Delay groups (66.7% vs. 58.8%, p = 0.79). The mean number of lenalidomide prescriptions generated per RVd cycle was 1.35 (range 1-5, SD 0.74). CONCLUSIONS: This study did not demonstrate an effect on clinical response after delays ≥10 days between bortezomib and lenalidomide initiation. No patients in the delay group were females of reproductive potential, which is the primary target for increased safety behind the REMS program.

Patient engagement in first cycle comprehensive chemotherapy consultation pharmacist services and impact on patient activation.

BACKGROUND: Healthcare systems and policy makers worldwide are demonstrating interest in shared decision making, which requires patient activation. Patient activation can be measured using a validated tool called the patient activation measure-10. First cycle comprehensive chemotherapy consultation services (3CS) is provided by an oncology pharmacy team member during a patient encounter at the beginning of the patient's treatment for cancer. METHODS: This was a single center, prospective, non-randomized, observational clinical study in patients with cancer who required a new chemotherapy plan. A baseline patient activation measure-10 survey was administered and a pharmacy team member met with the patient to complete the first cycle 3CS encounter. Within two business days of that encounter, a second patient activation measure-10 survey was administered, and thus, patients served as their own control. RESULTS: Forty-nine patients who met the inclusion criteria were enrolled, of which 36 completed the study. Mean patient activation measure-10 scores measured at baseline and two business days after the 3CS encounter were significantly different (68.5 ± SD 14.7 vs. 75.0 ± SD 14.3, p = 0.001). This difference persisted when evaluated by gender (female: 70.0 ± SD 14.8 vs. 81.6 ± SD 10.5, p = 0.001; male: 66.1 ± SD 14.8 vs. 70.8 ± SD 14.7, p = 0.022). CONCLUSION: This study demonstrates that cancer patients had significantly increased patient activation scores after engagement in a 3CS encounter provided by an oncology pharmacy team. Further studies are needed to verify these data in a larger population, different healthcare settings, and to evaluate for patients who have solid tumor malignancies.

Continuous Care Provided Through Comprehensive Medication Management in an Acute Care Practice Model.

BACKGROUND: Pharmacy practice models that foster pharmacists' accountability for medication-related outcomes are imperative for the profession. Comprehensive medication management (CMM) is an opportunity to advance patient care. OBJECTIVE: The objective of this study was to evaluate the impact of a CMM practice model in the acute care setting on organizational, patient, and financial outcomes. METHODS: Three adult service lines focused on at-risk patients identified using internal risk stratification methodology were implemented. Core CMM elements included medication reconciliation, differentiated clinical pharmacy services, inpatient MTM consultations, discharge services, and documentation. Mixed methods compared the effect of the CMM model before and after implementation. Historical patients served as comparative controls in an observational design. Pharmacists completed a 60-minute interview regarding their experiences. Qualitative data were analyzed using thematic coding to characterize perception of the model. RESULTS: Three pharmacists implemented the model on cardiology, hematology/oncology, and surgery transplant services and provided services to 75 patients during the study. A total of 145 medication-related problems were identified and resolved. CMM was associated with a nonsignificant reduction of 8.8% in 30-day hospital readmission rates ( P = 0.64) and a 24.9% reduction in 30-day hospital utilization ( P = 0.41) as well as a significant reduction of 86.5% in emergency department visits ( P = 0.02). Patients receiving discharge prescriptions from our outpatient pharmacies increased by 21.4%, resulting in an 11.3% increase in discharge prescription capture and additional revenue of $5780. Themes identified from qualitative interviews included CMM structure, challenges, value, and resources. CONCLUSION: This study demonstrated successful implementation of a CMM model that positively affected organizational, patient, and financial outcomes.

Start using a checklist, PRONTO: Recommendation for a standard review process for chemotherapy orders.

Chemotherapy order review by pharmacists requires careful attention to many details, and serious consequences can occur if errors are made. Other high-risk industries have long used checklists to improve accuracy and reduce the risk of errors. Despite the recent expansion of checklist use in other areas of medicine, there is currently no published evidence that checklists are being widely used by pharmacists in the evaluation of chemotherapy orders. This article explains a flexible checklist called PRONTO (Patient, Regimen, Organ Function, Numbers, Toxicity, Order Verification) that has been successfully used by pharmacists in variety of practice settings in two academic centers in North Carolina. Proposed benefits of using a checklist in order review include standardization of review for better communication between collaborating pharmacists, a training tool for new or cross-training pharmacists, and an educational tool for students.

The role of screening and monitoring for bleomycin pulmonary toxicity.

Bleomycin-induced pulmonary toxicity can have a significant impact on patient outcomes. However, no guidelines for ideal screening and monitoring are available. This paper reviews the literature to identify the best way to monitor and reduce patient risk for bleomycin pulmonary toxicity. We have created evidence-based guidelines to help healthcare professionals identify patient risk factors and provide appropriate assessment and monitoring for patients receiving bleomycin therapy.

Workforce readiness for pharmacogenomics and key elements for sustainment within the Veterans Health Administration.

Aim: Understanding barriers and facilitators to pharmacogenomics (PGx) implementation and how to structure a clinical program with the Veterans Health Administration (VA). Materials & methods: Healthcare provider (HCP) survey at 20 VA facilities assessing PGx knowledge/acceptance and qualitative interviews to understand how best to design and sustain a national program. Results: 186 (12% response rate) surveyed believed PGx informs drug efficacy (74.7%) and adverse events (71.0%). Low confidence in knowledge (43.0%) and ability to implement (35.4-43.5%). 23 (60.5% response rate) interviewees supported a nationally program to oversee VA education, consultation and IT resources. Prescribing HCPs should be directing local activities. Conclusion: HCPs recognize PGx value but are not prepared to implement. Healthcare systems should build system-wide programs for implementation education and support.

An Evaluation of the Effect of Pharmacist-Led Comprehensive Chemotherapy Consultation Services on Outpatient Appointment Adherence.

BACKGROUND: The North Carolina Cancer Hospital at the University of North Carolina Medical Center serves patients with a variety of malignant conditions and discharges more than 130 patients each month. Processes to improve transitions of care prompted implementation of a first-cycle, pharmacist-led chemotherapy consultation service on the inpatient oncology units. This process provides education to improve patient engagement and activation. High patient activation has been associated with better patient outcomes; poor patient activation has been associated with increased health care costs. OBJECTIVE: To determine the effect of pharmacist-led comprehensive chemotherapy consultation services on adherence to outpatient follow-up appointments within 30 days of discharge. METHODS: This was a single-center, retrospective chart review. This study consisted of 2 groups: adult patients who received comprehensive consultation services between April 2017 and September 2017 and a 2:1 historical group of adult control patients randomly selected from a list of patients who received their first cycle of chemotherapy during a hospital admission between April 2014 and April 2017. The primary endpoint was the effect of comprehensive consultation services on adherence to outpatient follow-up appointments within 1 month after discharge. RESULTS: Ninety-six patients were included in this study. The percentage of appointments attended was 98.0% for the intervention group and 92.3% for the control group (P = 0.0018). CONCLUSIONS: This study demonstrates that pharmacy consultation in the inpatient oncology setting is associated with improved adherence to outpatient appointments within 30 days of discharge. This represents the first published data on pharmacist interventions resulting in improved outpatient appointment adherence. DISCLOSURES: Funding for this study was contributed by the Hematology/Oncology Pharmacy Association (HOPA). This publication was also supported by Grant Number UL1TR002489 from the National Center for Advancing Translational Sciences at the National Institutes of Health. Auten reports fees from PTCE and ASHP/ACCP, unrelated to this study. Clark reports consulting fees from Ellion Benson Research, unrelated to this study. The other authors do not have any conflicts of interest to report. This study was presented as a trainee poster on April 5, 2019, at the HOPA Ahead 15th Annual Conference in Fort Worth, TX.

Clinical utility of rituximab in chronic graft-versus-host disease.

OBJECTIVE: To evaluate the use of rituximab in the clinical management of steroid-refractory chronic graft-versus-host disease (GVHD). DATA SOURCES: Literature was accessed through MEDLINE and International Pharmaceutical Abstracts (1990-September 2008), both indexed and nonindexed citations, using the terms rituximab, graft-versus-host disease, monoclonal antibodies, and CD20. In addition, reference citations from the publications identified were reviewed. STUDY SELECTION AND DATA EXTRACTION: All articles discussing rituximab as a therapeutic option in the treatment of GVHD that were published in English and enrolled human study participants were evaluated. DATA SYNTHESIS: Rituximab is a genetically engineered chimeric murine monoclonal antibody that binds to the CD20 differentiation antigen found on B-lymphocytes. GVHD is the leading cause of procedural-related morbidity and mortality following allogeneic hematopoietic stem cell transplantation (HSCT). Chronic GVHD (cGVHD) occurs in up to 70% of individuals undergoing HSCT, and approximately 40% of those patients are refractory to conventional T-lymphocyte-directed therapies. Limited treatments are available for individuals with steroid-refractory cGVHD. Rituximab therapy in individuals with extensive cGVHD has demonstrated clinical efficacy with manageable toxicities in retrospective and prospective studies. CONCLUSIONS: Available data suggest that rituximab is a treatment option for patients with extensive steroid-refractory cGVHD. Rituximab may be particularly effective for individuals with steroid-refractory cGVHD manifesting as thrombocytopenia or with sclerodermatous, cutaneous, and rheumatologic involvement.

A Study of Layered Learning in Oncology.

Objective. To explore use of pharmacy learners as a means to expand pharmacy services in a layered learning practice model (LLPM), to examine whether an LLPM environment precludes achievement of knowledge-based learning objectives, and to explore learner perception of the experience. Design. An acute care oncology pharmacy practice experience was redesigned to support the LLPM. Specifically, the redesign focused on micro discussion, standardized feedback (eg, rubrics), and cooperative learning to enhance educational gain through performing clinical activities. Assessment. Posttest scores evaluating knowledge-based learning objectives increased in mean percentage compared to pretest values. Learners viewed the newly designed practice experience positively with respect to perceived knowledge attainment, improved clinical time management skills, contributions to patient care, and development of clinical and self-management skills. A fifth theme among students, comfort with learning, was also noted. Conclusion. Layered learning in an oncology practice experience was well-received by pharmacy learners. Data suggest a practice experience in the LLPM environment does not preclude achieving knowledge-based learning objectives and supports further studies of the LLPM.

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.

Management of menorrhagia associated with chemotherapy-induced thrombocytopenia in women with hematologic malignancy.

Abnormal uterine bleeding in women with a blood dyscrasia, such as leukemia, or who experience thrombocytopenia secondary to myelosuppressive chemotherapy is a clinical condition associated with significant morbidity. Consequently, effective management is necessary to prevent adverse outcomes. Prevention of menorrhagia, defined as heavy regular menstrual cycles with more than 80 ml of blood loss/cycle or a cycle duration longer than 7 days, in this patient population is the goal of therapy. Gonadotropin-releasing hormone analogs (e.g., leuprolide) are promising therapies that have been shown to decrease vaginal bleeding during periods of thrombocytopenia and to have minimal adverse effects other than those associated with gonadal inhibition. In patients who experience menorrhagia despite preventive therapies, or in patients who have thrombocytopenia and menorrhagia at diagnosis, treatment is indicated. For these women, treatment options may include platelet transfusions, antifibrinolytic therapy (e.g., tranexamic acid), continuous high-dose oral contraceptives, cyclic progestins, or other therapies for more refractory patients such as danazol, desmopressin, and recombinant factor VIIa. Hormonal therapies are often the mainstay of therapy in women with menorrhagia secondary to thrombocytopenia, but data for these agents are sparse. The most robust data for the treatment of menorrhagia are for tranexamic acid. Most women receiving tranexamic acid in randomized trials experienced meaningful reductions in menstrual bleeding, and this translated into improved quality of life; however, these trials were not performed in patients with cancer. Further clinical trials are warranted to evaluate both preventive and therapeutic agents for menorrhagia in premenopausal women with cancer who are receiving myelosuppressive chemotherapy.

Antizyme induction by polyamine analogues as a factor of cell growth inhibition.

The polyamines spermidine and spermine and their diamine precursor putrescine are essential for mammalian cell growth and viability, and strategies are sought for reducing polyamine levels in order to inhibit cancer growth. Several structural analogues of the polyamines have been found to decrease natural polyamine levels and inhibit cell growth, probably by stimulating normal feedback mechanisms. In the present study, a large selection of spermine analogues has been tested for their effectiveness in inducing the production of antizyme, a key protein in feedback inhibition of putrescine synthesis and cellular polyamine uptake. Bisethylnorspermine, bisethylhomospermine, 1,19-bis-(ethylamino)-5,10,15-triazanonadecane, longer oligoamine constructs and many conformationally constrained analogues of these compounds were found to stimulate antizyme synthesis to different levels in rat liver HTC cells, with some producing far more antizyme than the natural polyamine spermine. Uptake of the tested compounds was found to be dependent on, and limited by, the polyamine transport system, for which all these have approximately equal affinity. These analogues differed in their ability to inhibit HTC cell growth during 3 days of exposure, and this ability correlated with their antizyme-inducing potential. This is the first direct evidence that antizyme is induced by several polyamine analogues. Selection of analogues with this potential may be an effective strategy for maximizing polyamine deprivation and growth inhibition.