The 2014 NHIA Idea Exchange Poster Session Program ABSTRACTSBoard Number / Poster Title / Poster Type / Moderating Author:
1 / Implementing antimicrobial stewardship in the home infusion practice setting: Successes and challenges / Performance Improvement / Mala Crossley, PharmD
2 / Uridine triacetate: Investigational antidote for 5-FU overexposure / Original Research / Michael Bamat, PhD
3 / Life of a prescription event analysis applies Lean principles in a home infusion safety management program / Performance Improvement / Jamie C Tharp, PharmD
4 / Types of cancer patients that receive home parenteral nutrition and their outcomes / Performance Improvement / Kristie Jesionek-Brewton, RD, LDN, CNSC
5 / How an immunoglobulin registry provides insight into immunoglobulin usage and provision of care for primary immune and neurological patients / Original Research / Loretta Kristofek RN, BSN
6 / Positive outcomes demonstrated from parenteral nutrition weaning initiated by the dietitian of a home nutrition support team / Original Research / Noreen Luszcz RD, MBA, CNSC
7 / Successful team management of a complex case: An infant with short bowel syndrome on home enteral and parenteral nutrition / Case Study / Bill Nadeau, MS, RD, CNSC
8 / Patient migration from hospitals to home: Understanding and validating product needs as home care / infusion services expand / Performance Improvement / Robin Huneke Rosenberg, RN, MA, VA-BC
9 / Retrospective analysis of the clinical utility of biweekly dosing with high-concentration subcutaneous immunoglobulin in 13 patients with primary immunodeficiency / Original Research / Shahnaz Fatteh, MD
10 / Reducing incidences of local infusion site reactions in subcutaneous immunoglobulin patients through enhanced patient education with a focus on “dry” versus “wet” priming technique / Performance Improvement / Amy E. Clarke, RN
11 / Monitoring productivity and workload balancing: A novel pharmacy tool to measure and compare home infusion pharmacy technicians / Performance Improvement / Jonathan Grant, Pharm.D.
12 / Good catch program: Error avoidance within a home infusion operation / Performance Improvement / Kimberly Stone, RPh
13 / Optimization of new pharmacist training in home and specialty infusion / Performance Improvement / Brittany A. Singleton, BA, PharmD
14 / The use of teduglutide in patients with short bowel syndrome on long-term home parenteral nutrition: Impact on TPN and fluid requirements / Case Study / Richard Leong, Pharm.D., BCNSP
15 / Total parenteral nutrition (TPN) electrolyte pool overfill using an automated compounding device (ACD): An evaluation of waste / Performance Improvement / Tiara M. Patten, PharmD
16 / Assessment of estimated vial reduction associated with the use of 40 gram 10% liquid intravenous immune globulin (IVIG) / Performance Improvement / Dustin Elliott, MS
17 / Strategies to reduce late deliveries in home infusion: A performance improvement initiative / Performance Improvement / Crystin Gloude, PharmD
18 / Clinical and economic outcomes for head and neck cancer patients on home-based enteral nutrition therapy: Establishing a baseline / Performance Improvement / Crystal Jackson, MS, RD, CSO, LD/N, CNSC
19 / Optimizing a documentation tool for the clinical management of home parenteral nutrition patients / Performance Improvement / Maleeha F. Bader, PharmD
20 / Measuring the impact of home infusion verses infusion center on patient outcomes and quality of life / Performance Improvement / Carla Taylor, CRNI®
21 / Development of practice recommendations: Regional standardization of administration methods / Performance Improvement / David J. Thompson, BS, PharmD
22 / Pharmacist-driven patient interventions: Type and frequency for patients receiving intravenous immunoglobulin therapy in the home care setting / Original Research / Debbie McNutt, RPh, MBA
23 / Development of a home infusion drug library for implementing smart pump technology / Performance Improvement / Joseph Gromelski, PharmD
24 / Using electronic connectivity to improve pump management efficiency / Performance Improvement / David J. Bonar
25 / A case study examining treatment of five myasthenia gravis patients with high-dose immune globulin therapy administered via the subcutaneous route / Case Study / Randy Broyles, RPh
26 / Shifting the patient satisfaction measurement and process improvement paradigm / Performance Improvement / Lisa Siefert RPh, ASQ-CMQ/OE, FASHP
27 / Impact of a decentralized consumer advocate program on patient satisfaction with subcutaneous and intravenous immune globulin therapy / Performance Improvement / Peg Gruenemeier, RN, CRNI®
28 / An innovative approach to providing customized home parenteral nutrition despite national drug shortages / Performance Improvement / David Benedict, Pharm D, BCPS
29 / Comparison of peripherally inserted central catheter flushing protocols / Original Research / Elizabeth Roesch, RN, CRNI®
30 / Lessons learned from subcutaneous immunoglobulin administration challenges: Enhancing manufacturer responsiveness through stakeholder feedback / Case Study / Brad Sealfon
31 / Evaluating the safety and feasibility of conducting an investigational drug study in the home infusion setting / Performance Improvement / Suzanne Kluge, RPh, BS
32 / Evaluation of the occurrence of hypermanganesemia in patients on long-term parenteral nutrition / Original Research / Carol J. Rollins, MS, RD, PharmD, BC
33 / Study outcomes of a novel sutureless securement system / Original Research / Laura Rutledge, RN, MN, CRNI, CCRA
34 / Specialty medication care pathways for an outpatient infusion pharmacy: Economic impact from the patient and healthcare system perspective / Performance Improvement / Michael Rigas, Pharm.D.
35 / Clinical outcomes of home inotropic therapy: A 4-year retrospective review / Original Research / Kami Jenkins, PharmD
FINAL ABSTRACT # 1
TITLE: Implementing Antimicrobial Stewardship in the Home Infusion Practice Setting: Successes and Challenges
AUTHORS: Mala Crossley, PharmD; Cathy Johnson, RPh. BioScrip, Inc.; King of Prussia, PA
BACKGROUND: The need for an antimicrobial stewardship program in our organization was identified in 2012, when multiple payers and prescribers started requesting proof of a clinical benefit from utilizing the company's services. The goals of this project were to develop a documentation method for the clinical care provided by our pharmacists and show how their clinical interventions prevented potential adverse outcomes and/or therapy failures. Unlike hospital pharmacy where antimicrobial stewardship has been clearly defined and the value of clinical interventions has been published, this has not been the case in the home infusion setting.
PURPOSE: The purpose of this project was to implement an antimicrobial stewardship program in the home infusion setting, using data collection tools built into the electronic clinical chart.
METHODS: The pharmacy staff was educated on the new documentation tools. Data from these tools was pulled into a data warehouse and presented in a user-friendly format. Available data included diagnosis, prescribed anti-infective, clinical improvement, re-hospitalizations, medication side effects, and pharmacists’ therapy-related clinical interventions. Data was aggregated company-wide for antimicrobial patients in the first three quarters of 2013, covering over 8,000 dispenses and approximately 7,000 patients. 350 clinical interventions were documented. A compliance monitoring process was used to assess implementation of the program.
RESULTS/DISCUSSION: The project had some success. A 40% company-wide documentation rate was achieved overall. 90% of the documented clinical interventions were accepted by the prescriber with no changes, showing their clinical value. Some data was incomplete, making data analysis difficult. Migrating to the new documentation process was a major challenge for most of the pharmacists. In order to overcome this barrier, multiple education sessions on the new process were held with the staff. Cases were also presented on specific interventions that helped a patient avoid a negative outcome. In addition, positive feedback from prescribers and referral sources was used to help the clinicians realize the positive value perceived by other health care professionals in the clinical care our staff was providing. Implementing this project took significant time, including 1-2 hours of education per pharmacy team and 10-12 hours for corporate setup and testing of the data. Once the staff became familiar with the new documentation tools, it took about 5 minutes per patient to complete a pharmacist intervention, and 5-10 minutes for patient care planning and patient interviews to identify potential problems.
CONCLUSIONS: The role of the home infusion pharmacist in contributing to antimicrobial stewardship is related to monitoring the resolution of the infection, maintaining appropriate drug levels, verifying appropriate drug utilization based on disease process, preventing re-hospitalization, preventing IV catheter related infections, and ensuring therapy compliance. The value of this clinical monitoring was shown by the documented interventions. This project showed that it is possible to have a meaningful antimicrobial stewardship program in a home infusion practice setting. Where implemented, the process worked to achieve the goals of the program. Ongoing challenges include incomplete documentation that affects the quality of the reported data, and the need to extend the process to locations within the company that have not yet been able to implement it.
FINAL ABSTRACT # 2
TITLE:Uridine Triacetate: Investigational Antidote for 5-fluorouracil (5-FU) Overexposure
AUTHORS: Michael Bamat, Robert Tremmel, Joan Helton, Reid von Borstel. Wellstat Therapeutics Corporation, Gaithersburg, MD
BACKGROUND: 5-fluorouracil (5-FU) is widely used to treat solid tumors. It is commonly administered by IV infusion in homes or in hospitals and clinics, at or near its maximum tolerated dose, over several days via an electronic infusion pump or elastometric device. Life-threatening and lethal toxicity has been reported related to programming errors, infusion reservoir errors and dosage miscalculations. Partial or total dihydropyrimidine dehydrogenase (DPD) deficiency (~3% of the population) leading to impaired 5-FU elimination can also result in serious or lethal toxicity. The National Cancer Institute estimates 1300 lethal exposures and over 8,250 serious or life-threatening exposures annually in the 275,000 U.S. patients receiving 5-FU.
PURPOSE: Uridine triacetate, an orally bioavailable direct biochemical antagonist of 5-FU toxicity, has been used as an antidote to treat patients overexposed to 5-FU. The purpose of this presentation is to provide efficacy, safety and tolerability data in all patients treated thus far.
METHODS: Uridine triacetate was provided under emergency use provisions or an expanded access protocol (EAP) when requested by qualified clinical sites following 5-FU overexposures, most due to infusion pump errors. A common treatment regimen and protocol was used to treat all patients. Key EAP inclusion criteria include excess risk of 5-FU toxicity due overdosage or known/suspected impaired elimination or early onset of severe toxicities; able to take oral medications; 18 years old; and able to provide written informed consent. Key exclusion criteria include probable noncompliance; >96 hours past cessation of 5-FU dosing; or inability to provide written informed consent. Patients received oral uridine triacetate (10g q6h for 20 doses) granules mixed in easily swallowed food (e.g., applesauce) as soon as possible after recognition of 5-FU overexposure. Clinical outcomes, including safety, survival, and resumption of chemotherapy, were monitored and compared to historical control cases (5-FU overdose with best supportive care). The clinical outcomes of all 131 patients treated to date are compared to approximately 40 historical controls not treated with uridine triacetate. One-hundred fourteen were treated after mid-2009; 55 were treated under the EAP following initiation in September 2011. This ongoing study is registered on clinicaltrials.gov (NCT01432301).
RESULTS: To date131 patients overexposed to 5-FU have been treated with uridine triacetate. Treatment was initiated 7-96 hours after 5-FU administration ceased. Of the 131 patients, 127 (97%) recovered fully. Approximately 50% of patients resumed chemotherapy within 21 days of the 5-FU overexposure. In contrast, 36 of 40 (90%) historical controls with similar overdose severity receiving best supportive care, but not uridine triacetate, died. Reductions in or absence of GI, hematologic, and other toxicities associated with 5-FU poisoning were observed in patients treated with uridine triacetate. Only occasional mild or moderate adverse events (nausea, vomiting, diarrhea, headache) have been attributed to uridine triacetate. Four deaths unrelated to uridine triacetate were reported: 1 due to aggressive disease progression/MRSA; 1 tumor lysis syndrome; and 2 due to acute respiratory failure with sepsis, septicemia, and neutropenic fever, including a DPD-deficient patient who did not begin antidote treatment until 8 days after 5-FU ceased.
CONCLUSION: As evidenced by comparison to historical controls, uridine triacetate appears to be a safe and effective life-saving antidote for 5-FU overexposure in emergency situations.
FINAL ABSTRACT # 3
TITLE: Life of a Prescription Event Analysis Applies Lean Principles in a Home Infusion Safety Management Program
AUTHORS: Jamie C Tharp, PharmD; Deven M Millay, BSE, PharmD Candidate. University of Michigan Health System, HomeMed; Ann Arbor, MI
BACKGROUND: Many Health Systems have adopted Lean Management principles from the automotive industry to improve safety and efficiency through process analysis and workplace transformation from a focus on continuous improvement and staff engagement. This organization changed its approach to safety event analysis using a framework of Lean workflow mapping techniques. This organization developed, the Life of a Prescription, a system to categorize patient safety events by process origin and type. The new approach converted qualitative information into quantitative, measurable data that facilitates tracking and trending of process failures within the operational workflow.
PURPOSE: The purpose of this project was to apply Lean philosophies and devise a medication safety tracking system that would facilitate identification and quantification of medication errors and near misses where they occurred within the Life of a Prescription, as well as the implementation of process improvement activities to prevent their recurrence.
METHODS: This organization's safety program identified the following fundamental pieces of information to capture for each safety event: the workflow process step, the work area where the event occurred, and the outcome. The program goals were to track and trend data, to identify system failures, to increase communication among employees, and improve intervention turnaround time. Key program steps included: formation of a multidisciplinary Safety Committee with representatives from all operational areas (April 2011), mapping The Life of a Prescription from prescribing to administration and applying the methodology to event analysis (June 2012), reviewing significant events at monthly safety meetings where staff members recommend changes to prevent event recurrence, and quarterly and annual checkpoints to identify observed trends and processes improvement opportunities.
RESULTS/DISCUSSION: Since implementing a formal safety program, this organization has an increasing trend (240%) in reporting of near miss events (Categories A and B, did not reach patient) demonstrating an increase in staff engagement and transformation in the culture of safety. Overall, rates of events reaching patients (Categories C-I) remain unchanged at 0.01% of prescriptions filled. Key error types in fiscal year 2013 were highest during Translation/Transcribing (20%), Order Preparation (33%), and Fill Processing (25%). These trends influenced interventions made throughout the year including work process review and standardization, staff education and coaching, and modification of operational software templates.
CONCLUSIONS: Lean Management tools have been used in numerous complex work models including the automotive industry, materials management, and more recently, healthcare. Since implementing The Life of a Prescription for safety event analysis, longitudinal results show that event analysis has become process focused resulting in sustained staff engagement in a culture of continuous improvement. Currently, work is being done to redesign the organization’s event capture system so that the Life of a Prescription methodology can be incorporated into initial event-reporting. Ideally, individuals reporting events would select from a list of categories when electronically documenting the event, thereby eliminating the current manual categorization of events and improving selective staff notification of events.
FINAL ABSTRACT # 4
TITLE:Types of cancer patients that receive home parenteral nutrition and their outcomes
AUTHORS: Kristie Jesionek-Brewton, RD, LDN, CNSC1; Snorri Olafsson, MD, PhD, MPH1,2
1Heartland IV Care, Nashville, TN 2 Loma Linda University Medical Center, Loma Linda, CA
BACKGROUND: Advanced cancer patients (ACPs) are those in whom cure is considered unlikely, but who are not necessarily without treatment options. Active treatment options may include home parenteral nutrition (HPN) for ACPs who cannot tolerate an oral or enteral diet, however this treatment option is not without risk and complication. While a number of studies have been conducted to assess impact of HPN on survival in advanced cancer, and on quality of life, a 2009 Cochrane review found there are insufficient good quality studies to make any recommendations for practice with regards to the use of PN in palliative care patients. This organization undertook a review of characteristics of ACPs receiving HPN as a first step in evaluating impact on quality of life and determining if a patient “type” was more likely to benefit from PN therapy.
PURPOSE:The purpose of this review is to describe the characteristics of ACPs receiving HPN.
METHODS: A retrospective chart review of 409 HPN patients from January 2010 to July 2013 was conducted. Approximately half (n=206) had a cancer indication. The characteristics reviewed included age, gender, length of therapy and if HPN was started at home. Outcomes included successful transition to oral or enteral nutrition, HPN discontinued per patient preference, transition to nursing home, change of provider, extended hospitalization, hospice status and death.
RESULTS:In the patient population (n=209) males represented 48% (mean age 62.8 yrs., range 23-97) and females 52% (62.4, 22-90). Cancers were divided into 3 main groups: gastrointestinal (GI) at 67%, reproductive 20% and others 14%. The reproductive group was all female except one prostate cancer. The “big four” ACPs were colorectal (19%), stomach (15%), ovarian (14%) and pancreatic (13%). Other cancers with ≥5 patients were esophagus (8%), small intestine (5%), breast (3%), lung (3%), lymphoma (3%), “other abdominal” (3%) and liver (2.4%). Sixteen percent of ACPs started HPN at home. Forty-six percent received HPN for ≥ 30 days, and 24% for ≥ 60 days. Sixteen percent successfully transitioned to an oral diet and 4% to enteral nutrition. Nineteen percent elected to stop HPN, despite their inability to tolerate an adequate oral diet. Three percent required a higher level of care and transitioned to a nursing home and 3% continued HPN with another provider. Three percent required an extended hospitalization with their final outcome unknown. Fifty-seven percent were on hospice service from admission and an additional 21% transitioned to hospice during therapy. Fifty-two percent expired while on HPN.