Characterization of collaborative practice agreements held by hematopoietic stem cell transplant pharmacists.

BACKGROUND: Current workforce shortages within the hematopoietic stem cell transplant field necessitate capitalizing on the role of oncology-trained pharmacists. Working within an agreed-upon protocol, pharmacists are able to expand patient care delivery through optimal medication therapy management. METHODS: An electronic survey was developed by the Advocacy & Policy Working Committee of the American Society for Blood and Marrow Transplantation Pharmacy Special Interest Group and distributed to pharmacists involved in the care of hematopoietic stem cell transplant patients. The primary objective was to assess the current state of collaborative practice agreements in the hematopoietic stem cell transplant setting. RESULTS: Forty-eight responses representing 41 institutions were returned. Respondents were mostly female (67%) and practiced in the adult setting (83%). Reponses represented a range of practice experience in hematopoietic stem cell transplant with the majority of the hematopoietic stem cell transplant positions (83%) funded by the department of pharmacy at an academic medical center. Of the 48 responses, 22 (46%) respondents reported having collaborative practice agreements in place; 10 (21%) respondents did not currently have collaborative practice agreements, but were planning to implement them; and 16 (33%) respondents did not have collaborative practice agreements at their institution. Clinical activities performed under a collaborative practice agreement included medication selection and dosing modifications, therapeutic drug monitoring, supportive care management, and management of comorbid conditions and chronic diseases. The most commonly cited barrier to establishing collaborative practice agreements was the inability to secure reimbursement for services provided. No respondents reported a negative impact on job satisfaction. CONCLUSIONS: The results of this survey provide the pharmacy community with a robust understanding of the current landscape of hematopoietic stem cell transplant pharmacy collaborative practice agreements.

Choosing Wisely BMT: American Society for Blood and Marrow Transplantation and Canadian Blood and Marrow Transplant Group's List of 5 Tests and Treatments to Question in Blood and Marrow Transplantation.

Choosing Wisely encourages dialogue about reducing unnecessary procedures, tests, or treatments in healthcare. The American Society for Blood and Marrow Transplantation (ASBMT) and Canadian Blood and Marrow Transplant Group (CBMTG) established a Choosing Wisely BMT Task Force whose objective was to create a list of top 5 practices in blood and marrow transplantation to be questioned. The Task Force consisted of representatives from ASBMT's Quality Outcomes, Education, and Practice Guidelines committees; ASBMT's Pharmacy Special Interest Group; CBMTG Program Directors; and Center for International Blood and Marrow Transplant Research (CIBMTR). Suggestions for current transplantation practices to question were elicited from the CBMTG Program Directors; members of ASBMT's Quality Outcomes, Practice Guidelines, and Education committees; and chairs of the CIBMTR scientific working committees. We received 119 unique suggestions that were ranked based on their potential impact on harm reduction, cost reduction, necessity of the test or practice, and the strength of available evidence. Through a modified Delphi process, suggestions were narrowed down to 6, which were then subjected to systematic reviews. The final 5 recommendations focus on graft source for patients with aplastic anemia, corticosteroid dose for initial treatment of graft-versus-host-disease, optimal number of umbilical cord blood units for transplantation, graft source in matched unrelated donor transplantation, and use of prophylactic intravenous immunoglobulin in transplant recipients. These Choosing Wisely BMT recommendations are relevant to the current clinical practice of blood and marrow transplantation and focus on tests, treatments, or procedures that may be harmful, wasteful, or for which there is no apparent clinical benefit.

Findings of a Naloxone Database and its Utilization to Improve Safety and Education in a Tertiary Care Medical Center.

INTRODUCTION: Analyzing hospital naloxone use may assist in identification of areas for quality and safety improvement. Our primary objective is to quantitate the incidence of hospital naloxone use and to assess certain patient populations at risk. METHODS: During the years 2008 to 2011, each clinical scenario where naloxone was administered on an in-patient care ward was reviewed. The events were assessed to separate situations where naloxone rescue was effective in reversing opioid-induced intoxication vs. others. Further analysis was conducted to stratify patient populations at greatest risk. RESULTS: Naloxone was administered for well-defined opioid-induced respiratory depression and oversedation 61% of the time, the remainder used for patient deterioration of other etiology. Surgical populations are at risk with an incidence of 3.8/1,000 hospitalized patients, and this is the greatest within 24 hours of surgery. General surgical patients represent the highest surgical patient risk at 5.5/1,000. Medical patients represent lower risk at 2.0/1,000. Patients with patient-controlled analgesia and epidural opioid infusion are high risk at 12.1 and 13.1/1,000 patients, respectively. Many quality and safety interventions were gradually implemented in response to this data and are summarized. These include nursing and provider education, electronic medical record modification, and more stringent patient monitoring practices. CONCLUSION: Examination of naloxone use can assist in the identification and stratification of patients at risk for opioid-induced respiratory depression and oversedation and can serve as a driver for improvements in hospital patient safety. This information can also guide other institutions interested in similar improvements.

Decreasing drug waste, reducing drug costs, and improving workflow efficiency through the implementation of automated chemotherapy dose rounding rules in the electronic health record system.

PURPOSE: To decrease drug waste and cost by implementing automated chemotherapy dose rounding rules in the electronic health record (EHR). Dose rounding of chemotherapy is a recognized method for reducing drug waste, and professional organizations have published guidelines recommending dose rounding when possible. SUMMARY: On the basis of current literature and guideline recommendations, Mayo Clinic developed system-wide consensus to allow dose rounding for biologic and chemotherapy agents to the nearest vial size if rounding resulted in the dose being within 10% of the originally calculated dose or to a convenient measurable volume, based on concentration of the drug, if rounding to the nearest vial size resulted in the dose being outside the 10% range. Oncology pharmacists reviewed and analyzed all drugs listed in the EHR used in injectable form for the treatment of cancer and developed dose rounding rules. The rules were implemented and applied at the dose calculation stage before provider signature. From January to June 2019, approximately 40,000 cancer treatment doses were administered. The rounding rules saved a total of 9,814 vials of drug, of which 5,329 were for biologic agents and 4,485 were for oncolytic drugs. This resulted in a total 6-month cost savings of $7,284,796 (in 2019 dollars; biologics, $5,727,402; oncolytics, $1,557,394). CONCLUSION: Systematic implementation of dose rounding rules utilizing the EHR can result in significant reduction of drug waste and realization of savings.

Efficacy of mitoxantrone-based salvage therapies in relapsed or refractory acute myeloid leukemia in the Mayo Clinic Cancer Center: Analysis of survival after 'CLAG-M' vs. 'MEC'.

Salvage therapy regimens for refractory and relapsed AML include mitoxantrone, etoposide, and cytarabine (MEC) and cladribine, cytarabine, filgrastim, and mitoxantrone (CLAG-M). We analyzed patients receiving either CLAG-M or MEC as salvage therapy for RR-AML between 09/01/2009-12/31/2017. Of 150 patients with RR-AML, 34 patients received CLAG-M and 116 MEC. CR/CRi rates for CLAG-M and MEC were 61.3 % (19/31) and 55.6 % (60/108). Median OS was 9.5 months for CLAG-M and 10.0 months for MEC (HR = 0.88,95 %CI = 0.54-1.41,p = 0.59). 76 patients proceeded to ASCT following salvage therapy. Median OS after ASCT was 13.0 months for CLAG-M and 31.0 months for MEC (HR = 1.76,95 %CI = 0.87-3.56,p = 0.12). Among those with late relapse and ASCT, median OS was 9.0 and 48.0 months for CLAG-M and MEC, respectively (HR = 17.6,95 %CI = 1.57-198,p < 0.001). There were no significant differences in outcome between CLAG-M vs. MEC regardless of transplant status. There was a significant improvement in survival in patients with late relapse treated with MEC who proceeded to ASCT.

Plasmapheresis therapy for rare but potentially fatal reaction to rituximab.

Rituximab (Rituxan), a genetically engineered chimeric murine and human IgG1 monoclonal antibody directed against CD20 antigen, is an emerging drug used for a wide spectrum of disease processes and found to be relatively safe. We report a near-fatal reaction to rituximab, which started 30 min after infusion and worsened over 24 to 48 h, resulting in hemodynamic and respiratory compromise that necessitated both intubation and high-dose vasopressors. Subsequent treatment with plasmapheresis helped stabilize and improve the patient's clinical condition, and the patient was discharged home on hospital day 5. There is no specific treatment for these severe and sometimes fatal reactions except supportive care with plasmapheresis. With the increased use of rituximab therapy in the medical management of numerous diseases, those in the medical community need to be cognizant of the rare fatal or near-fatal infusion reaction and the benefit that may accrue from plasmapheresis therapy.

Preoperative oral methadone for postoperative pain in patients undergoing cardiac surgery: A randomized double-blind placebo-controlled pilot.

Background: Inadequately controlled sternotomy pain after cardiac surgery can lead to delayed recovery and patient suffering. Preoperative intravenous methadone is effective for reducing both postoperative pain and opioid consumption. Despite ease of administration, the effects of preoperative oral methadone are not well described in the literature. Aims: This pilot study investigated the effect of preoperative oral methadone on pain scores, analgesia requirements, and opioid-induced side effects. Methods: A randomized double-blind placebo-controlled model was used with sampling of patients undergoing sternotomy for isolated coronary artery bypass graft (CABG) surgery (ClinicalTrials.gov registration no. NCT02774499). Participants were randomized to receive oral methadone (0.3 mg/kg) or oral placebo prior to entering the operating room. The primary outcome was pain scores on a 0-10 Verbal Rating Scale. Secondary outcomes included morphine requirements using patient-controlled analgesia (PCA), time to extubation, level of sedation, and side effects such as nausea, vomiting, pruritus, hypoventilation, and hypoxia over a 72-h monitoring time. Results: Twenty-one patients completed the study. Oral methadone did not reduce pain scores in the methadone group (P = 0.08). However, postoperative morphine requirement during the first 24 h was reduced by a mean of 23 mg in the methadone group (mean difference, -23; 99% confidence interval [CI], 37-13 mg; P < 0.005). No reduction in pain scores or PCA morphine was observed beyond 24 h postoperatively. There was no difference in incidence of opioid-related side effects between groups throughout the postoperative period. Conclusions: Though preoperative oral methadone did not reduce pain scores, morphine requirements were reduced in the first 24 h post-CABG.

Single dose versus multiple doses of rituximab for preemptive therapy of Epstein-Barr virus reactivation after hematopoietic cell transplantation.

Epstein-Barr virus (EBV) reactivation is an unresolved medical issue after allogeneic hematopoietic stem cell transplantation (HSCT). Rituximab treatment is recommended for EBV reactivation after HSCT but the number of doses of rituximab to use is unclear. In this study, risk factors and outcomes of patients who needed 1 dose vs >1 doses of preemptive rituximab to clear EBV viremia were compared. A higher viral load was more likely to be associated with higher doses of rituximab. Patients whose EBV viremia cleared with 1 dose of rituximab were more likely to have a preceding reduction of immunosuppression. Overall survival (OS) in these 2 cohorts was not different (18.7 vs 26.6 months, respectively, p = .96). Since rituximab can have side effects and is fairly costly, a predictive model to determine the number of rituximab doses using viral load would be a useful and cost-effective manner to utilize rituximab for this indication.

Early fluctuations in busulfan levels with therapeutic dose monitoring during allogeneic stem cell transplantation: do they matter?

Therapeutic dose monitoring is widely adopted for determination of busulfan (Bu) dose for use as a conditioning regimen. However, while dose adjustments are being incorporated, transient fluctuations of Bu levels may occur. We aim to understand if these fluctuations affect clinical outcomes of these patients. We compared outcomes in patients in whom the absolute dose changes and fluctuation of AUC were ≥ median% versus < median%. Rates of sinusoidal obstructive syndrome, grades 2-4/grades 3-4 acute and chronic graft versus host disease were not different between the two cohorts. The Kaplan-Meier curves for overall survival showed no significant differences. Six patients required >50% dose adjustment and four had a fluctuation in AUC of >50%. One of these patients died of sinusoidal obstruction syndrome and two died of infections. In our study, the transient fluctuations in Bu levels did not affect clinical outcomes; hence obviating the need for test dose strategy.

Economic Impact of Oral Therapies for Chronic Lymphocytic Leukemia-the Burden of Novelty.

PURPOSE OF REVIEW: Small molecule tyrosine kinase inhibitors (TKIs) and BCL2 inhibitors are oral targeted therapies that have changed the treatment approach to patients with chronic lymphocytic leukemia (CLL). The aim of this review is to summarize the relevant literature on the economic impact of oral novel therapies for the treatment of CLL and discuss the underlying factors and suggested solutions for high drug prices. RECENT FINDINGS: The cost of therapy for CLL has increased substantially since the introduction of oral therapies. This increase in cost is caused by multiple factors including cost of drug development, alternate reimbursement patterns, lack of transparency, and lack of free market competition. Oral therapies for CLL have dramatically increased costs for both patients and payers. Some solutions to overcome this include value-based pricing, transparency, and legal action that allow Medicare to negotiate drug prices with manufacturers.

Oral Chemotherapy in Patients with Hematological Malignancies-Care Process, Pharmacoeconomic and Policy Implications.

Patients with hematologic malignancies are increasing being prescribed oral anticancer medications (OAMs) and/or biologics. These newer targeted OAMs are associated with a host of practical and pharmacoeconomic implications for patients and healthcare providers. Issues such as safety, procurement challenges, and the need for proactive involvement of all stakeholders to optimize adherence for successful use of these agents are increasingly being recognized. The current reactive model is negatively impacting the patient experience through delays in care, financial toxicity, and decreased safety. It also impacts the healthcare providers in the form of lost revenue and staff burnout due to labor-intensive procurement and patient financial assistance burdens. In this review, we describe some of the issues identified and discuss potential strategies to improve patient access, minimize healthcare burden, and review current policy initiatives and patient advocacy efforts to reduce financial toxicity.

Chronic Anemia and the Role of the Infusion Therapy Nurse.

Chronic anemia develops over a course of weeks to months and is usually mild to moderate in nature. It is important to understand the etiology of the reduced number of circulating red blood cells to treat the anemia appropriately. Diagnosis is dependent on patient history and laboratory findings, such as complete blood counts, iron studies, a peripheral smear, and occasionally, a bone marrow biopsy. Treatment modalities frequently administered by infusion therapy nurses include treatment of the underlying chronic disease, replacement of deficiencies (iron, vitamin B12, folate, or erythropoietin), or transfusion of red blood cells. Infusion therapy nurses play a vital role in the assessment and delivery of medication therapy to patients with chronic anemia.

Allogeneic stem cell transplantation for myeloproliferative neoplasm in blast phase.

The prognosis for patients with Philadelphia-negative myeloproliferative neoplasms (MPN) who evolve into acute myeloid leukemia (AML) or blast phase (MPN-BP) is extremely poor. Although allogeneic stem cell transplantation (allo-SCT) is considered potentially curative, very few patients have been reported who have undergone allo-SCT for MPN-BP; therefore the success rate remains unknown. In a retrospective review, we identified 13 patients with an MPN transformation to blast phase after a median 9 years (range 5 months to 30 years); 8 (median age 55) continued to allo-SCT within 6 months. Induction chemotherapy cleared blood/marrow blasts in 60% (6/10) (2 declined therapy, 1 had early death). At the time of allo-SCT, 5/8 patients were in complete remission (CR) of their leukemia or had returned to MPN chronic phase (CP), 2 had residual blood blasts and 1 was refractory with >5% marrow blasts. At follow-up (median 20.3 months), 6 patients are alive in CR of both their leukemia/MPN. All 5 patients in CR/CP at pre-allo-SCT remain alive in remission, while 2/3 with persistent blood/marrow blasts relapsed and expired. We conclude that MPN-BP can be cured by allo-SCT in a significant percentage of patients, but that adequate leukemic clearance prior to allo-SCT offers an optimal outcome.