Poster Board #: - · Web viewThe 2014 NHIA Idea Exchange Poster Session Program ABSTRACTS Board Number Poster Title Poster Type Moderating Author: 1 Implementing antimicrobial stewardship

The 2014 NHIA Idea Exchange Poster Session Program ABSTRACTS

Board Number

Poster Title Poster Type Moderating Author:

1Implementing antimicrobial stewardship in the home infusion practice setting: Successes and challenges

Performance Improvement

Mala Crossley, PharmD

2Uridine triacetate: Investigational antidote for 5-FU overexposure

Original Research Michael Bamat, PhD

3Life of a prescription event analysis applies Lean principles in a home infusion safety management program


Jamie C Tharp, PharmD

4Types of cancer patients that receive home parenteral nutrition and their outcomes


Kristie Jesionek-Brewton, RD, LDN, CNSC

5How an immunoglobulin registry provides insight into immunoglobulin usage and provision of care for primary immune and neurological patients

Original Research Loretta Kristofek RN, BSN

6Positive outcomes demonstrated from parenteral nutrition weaning initiated by the dietitian of a home nutrition support team

Original ResearchNoreen Luszcz RD, MBA,

CNSC

7Successful 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

8Patient migration from hospitals to home: Understanding and validating product needs as home care / infusion services expand


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


Amy E. Clarke, RN

11Monitoring productivity and workload balancing: A novel pharmacy tool to measure and compare home infusion pharmacy technicians


Jonathan Grant, Pharm.D.

12Good catch program: Error avoidance within a home infusion operation


Kimberly Stone, RPh

13Optimization of new pharmacist training in home and specialty infusion


Brittany A. Singleton, BA, PharmD

14The use of teduglutide in patients with short bowel syndrome on long-term home parenteral nutrition: Impact on TPN and fluid requirements

Case StudyRichard Leong, Pharm.D.,

BCNSP

15Total parenteral nutrition (TPN) electrolyte pool overfill using an automated compounding device (ACD): An evaluation of waste


Tiara M. Patten, PharmD

16Assessment of estimated vial reduction associated with the use of 40 gram 10% liquid intravenous immune globulin (IVIG)


Dustin Elliott, MS

17Strategies to reduce late deliveries in home infusion: A performance improvement initiative


Crystin Gloude, PharmD

18Clinical and economic outcomes for head and neck cancer patients on home-based enteral nutrition therapy: Establishing a baseline


Crystal Jackson, MS, RD, CSO, LD/N, CNSC

19Optimizing a documentation tool for the clinical management of home parenteral nutrition patients


Maleeha F. Bader, PharmD

20Measuring the impact of home infusion verses infusion center on patient outcomes and quality of life


Carla Taylor, CRNI®

21Development of practice recommendations: Regional standardization of administration methods


David J. Thompson, BS, PharmD

22Pharmacist-driven patient interventions: Type and frequency for patients receiving intravenous immunoglobulin therapy in the home care setting

Original Research Debbie McNutt, RPh, MBA

23Development of a home infusion drug library for implementing smart pump technology


Joseph Gromelski, PharmD

24Using electronic connectivity to improve pump management efficiency


David J. Bonar

25A 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

26Shifting the patient satisfaction measurement and process improvement paradigm


Lisa Siefert RPh, ASQ-CMQ/OE, FASHP

27Impact of a decentralized consumer advocate program on patient satisfaction with subcutaneous and intravenous immune globulin therapy


Peg Gruenemeier, RN, CRNI®

28An innovative approach to providing customized home parenteral nutrition despite national drug shortages


David Benedict, Pharm D, BCPS

29Comparison of peripherally inserted central catheter flushing protocols

Original Research Elizabeth Roesch, RN, CRNI®

30Lessons learned from subcutaneous immunoglobulin administration challenges: Enhancing manufacturer responsiveness through stakeholder feedback

Case Study Brad Sealfon

31Evaluating the safety and feasibility of conducting an investigational drug study in the home infusion setting


Suzanne Kluge, RPh, BS

32Evaluation of the occurrence of hypermanganesemia in patients on long-term parenteral nutrition

Original ResearchCarol J. Rollins, MS, RD,

PharmD, BC

33Study outcomes of a novel sutureless securement system

Original ResearchLaura Rutledge, RN, MN,

CRNI, CCRA

34Specialty medication care pathways for an outpatient infusion pharmacy: Economic impact from the patient and health care system perspective


Michael Rigas, Pharm.D.

35Clinical 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.

CONCLUSION: The findings were consistent with other published reports in which ACPs receiving PN are most likely to be diagnosed with malignancies that grow locally in the abdomen, resulting in bowel obstruction with inability to receive oral or enteral feeding. While a significant number of ACPs received HPN for ≤60 days, it was encouraging to find 20% were able to transition off HPN, usually to oral intake. Further research is under way to examine impact of HPN on the ACPs quality of life, and to explore relationships that may exist between type of cancer, treatment with HPN and quality of life measures.

FINAL ABSTRACT # 5

TITLE: How an Immunoglobulin Registry Provides Insight into Immunoglobulin Usage and Provision of Care for Primary Immune and Neurological Patients

AUTHORS: Loretta Kristofek RN, BSN1; Sean Kearns, PhD1; Keith Crawford1; Robin Kirylo1; Luqman Seidu, MD2 1Coram Specialty Infusion Services, Denver, CO; 2Omni Allergy, Immunology and Asthma, Atlanta, GA

BACKGROUND: There is increasing recognition that the availability of clinical trial data, collected from highly specialized research settings, does not necessarily translate into improved patient outcomes in real-world clinical settings. This provider’s immunoglobulin (Ig) patient registry collects real-world longitudinal information on subjects receiving Ig therapy in an alternate care setting starting from July 1, 2010, including information related to a subject’s initial diagnosis and referral, health outcomes, Ig treatment experience, and quality of life.

PURPOSE: As Ig is a blood product associated with a long intravenous (IV) infusion time, self-infusion procedures, and potentially serious side effects, the challenge for the home infusion industry is to know the time/personnel commitment necessary to supply quality, long-term care, taking into account patients’ perception of care, compliance, and outcomes.

METHODS: Patients of any age, gender, or diagnosis requiring subcutaneous Ig (SCIg) or IVIg therapy referred by one of 139 registry investigators and able to be serviced by Coram were eligible to enroll via a written informed consent. Subject data was collected from home infusion forms completed by nurses and pharmacists, as well as from quality-of-life SF-36 questionnaires and LQIQ surveys completed by patients every six months by mail. For this report, Coram analyzed data from the IRB-approved IDEaL Patient Registry related to patients’ average dosing, switches from IV to SC administration and the number of training visits this required, the average duration of nursing visits, and treatment compliance and outcomes.

RESULTS/DISCUSSION: As of November 2013, 277 subjects were enrolled in the Registry. For PID patients, the average SCIg dose was 136 mg/kg/wk (544 mg/kg/mo), and the IVIg dose was 473 mg/kg/mo. For neurological disorders, the IVIg average was 616 mg/kg/mo. For PID patients receiving 30-40 grams of IVIg, visits averaged 4 hours 25 minutes; for SCIg, the visits averaged 1 hour 24 minutes. For patients receiving IVIg for neurological disorders, infusion visits for 50-100 grams averaged 4 hours 58 minutes. For self-infusing SCIg patients, it took an average of two training visits to become proficient. Twenty-four patients switched from IV to SC, and four patients switched back to IV. PID patients averaged three infections per year, with no significant difference between routes. Similar overall side-effect incidence rates between routes were noted (<12%), with skin reactions significantly more common in SCIg infusions, and headaches more common in IVIg. Quality-of-life surveys showed most subjects felt positive about their infusions, though subjects reported a slightly more negative perception regarding treatment cost. Patients averaged 27.9 months on service and the majority of patients (40%) were discharged due to insurance reasons.

CONCLUSIONS: There is a significant difference in personnel time required to care for IVIg and SCIg patients, and a significant difference between visit time of IV doses for PID and neurological disorders. Subjects reported low infection incidence, low side-effect rates, and generally positive quality of life. Similar studies that assess treatment efficacy and contribute to the optimal Ig delivery are increasingly important to maintaining effective and affordable Ig care for patients.

FINAL ABSTRACT # 6

TITLE: Positive Outcomes Demonstrated from PN Weaning Initiated by the Dietitian of a Home Nutrition Support Team

AUTHORS: Noreen Luszcz RD, MBA, CNSC; Amber Barron RD, LD, CNSC; Shamir Patel Pharm.D.; Walgreens Infusion Services, Deerfield, IL

BACKGROUND: Interdisciplinary nutrition support teams have demonstrated improved outcomes, safety and positive financial impact for payers and patients (1). Unnecessary or prolonged parenteral nutrition (PN) therapies have incurred greater costs when nutrition therapy is solely managed by the attending physician without the inclusion of a nutrition support team (2). The dietitian plays a unique role in transitioning home nutrition support patients between therapies, by identifying readiness, monitoring the transition, and providing guidance on oral intake. Studies have demonstrated the probability of weaning short bowel syndrome patients from home parenteral nutrition is < 6% if not successfully undertaken in the first 2 years,(3) further stressing the critical nature of this process.

PURPOSE: The purpose of this study was to collect and analyze PN weaning data to demonstrate the positive impact of dietitians who proactively transition PN patients from PN to enteral or oral nutrition.

METHODS: A large home infusion company prospectively collected PN weaning data from 8/1/2012-7/31/13. Dietitians determined patient eligibility for weaning based on stability of weight and labs, tolerance to an increase in oral/enteral intake, overall clinical status, and motivation to wean; and discussed the plan with the team and referring physician. Monthly data reports were submitted including patient demographics, diagnosis, payer source, number of days to wean and reasons why some patients did not wean completely off therapy.

RESULTS/DISCUSSION: Twenty five offices with a Home Nutrition Support Team (HNST) initiated PN weaning of 102 patients over a one year period of which 82 successfully weaned off PN, 14 were still weaning and 6 were unsuccessful in

weaning. Of the 82 patients that successfully weaned, the following data was reported: 60 female, 22 males; average age: 48 years; 77 patients transitioned from PN to oral, 5 transitioned from PN to enteral; average days to transition was 32 (median 17.5); average length of PN therapy was 107 days (median 60.5); payer mix: 70% private, 18% Medicare, 11% Medicaid, 1% no insurance; the top 5 diagnoses were also noted.

CONCLUSIONS: There is a lack of evidence based PN weaning data available. This study demonstrated a large range in days to wean. Many causes played a role in that variability including patient’s clinical status, response to oral/enteral intake and compliance. Published PN weaning guidelines suggest reduction of 1 day of PN per week (4). In this conservative approach it would take approximately 49 days to wean off daily PN; our study averaged 32 days. The difference of 17 days of extended therapy for these 82 patients would have incurred an additional $88,925 in PN costs (not including additional associated healthcare costs). Extrapolate this to a larger number of patients and the savings is substantial. The dietitian as part of the HNST is instrumental in supporting early weaning determination and providing close monitoring to achieve positive results. Additional research on this subject is needed to further support clinical success and financial savings.

REFERENCES: 1) Schneider, P. Nutrition Support Teams: An Evidence-Based Practice. Nutrition in Clinical practice. 2006; 21;62-67.2) O’Brien, D et al. Recommendations of Nutrition Support Team Promote Cost Containment. Journal of Parenteral and

Enteral Nutrition. 1986;10:300-302.3) Messing, B, et al. Long-Term Survival and Parenteral Nutrition Dependence in Adult Patients with the Short Bowel

Syndrome. Gastroenterology. 1999;117:1043-10504) DiBaise, J et al. Strategies for Parenteral Nutrition Weaning in Adult Patients with Short Bowel Syndrome. J Clin

Gastoenterology. 2006;vol40: 2;S94-S98

FINAL ABSTRACT # 7

TITLE: Successful Team Management of a Complex Case: An Infant with Short Bowel Syndrome on Home Enteral and Parenteral Nutrition

AUTHORS: Bill Nadeau, MS, RD, CNSC; Zoe Glaras, PharmD; Holly Kostuk, RN, OCN, CRNI. Walgreens Infusion Services, Stratford, CT

BACKGROUND: Short bowel syndrome (SBS) is a rare condition, affecting 24.5 infants per 100,000 live births1. It poses complex medical management challenges, including optimizing nutrient delivery from parenteral nutrition (PN) and/or enteral nutrition (EN). Providing PN and EN is especially difficult because these fragile infants have reduced bowel surface area and mucosal function, leading to chronic malabsorption and fluid and electrolyte abnormalities2. Failure to correct these shifts can rapidly change the patient’s condition. The goal is to transition infants from PN to EN to enhance intestinal adaptation to a shortened bowel, prevent intestinal failure associated liver disease, and decrease incidence of central venous line (CVL) infections3. Intensive monitoring can be challenging in the home, and necessitates close collaboration between the hospital-based medical team and a qualified home nutrition support team (HNST).The patient is an ex-26 week female twin with a birth weight of 710 grams. She was diagnosed with SBS secondary to stage III necrotizing enterocolitis, with 15cm of small bowel remaining.

PURPOSE: Demonstrate positive outcomes for a patient with SBS measured by weight gain, achievement of growth targets by following percentile channels on growth curves, and a continual shift as tolerated from PN to EN.

METHODS: The infant was discharged from the hospital at corrected gestational age (CGA) 3-weeks. Nursing visits were made to instruct the family on PN infusion. A visual aide was created to outline the schedule of PN additives. EN was an elemental infant formula, advanced by the primary physician. Goal EN and PN calorie provision, 105kcals/kg/day, and weight and length, were tracked daily for 13 weeks post discharge. Data were gathered from all clinicians involved. A successful outcome was demonstrated by weight gain, achievement of growth targets, and a greater ratio of EN to PN.

RESULTS/DISCUSSION: The patient gained weight weekly. On the Fenton growth chart4, the patient advanced from the 3rd-10th percentile weight for age at 3 weeks CGA (3.38kg) to the 10th-50th percentile at 13 weeks CGA (5.87kg). Total kcals/kg remained relatively stable (95-117 kcals/kg) for 66 of 70 days. Trickle feeds were initiated for 4 days when the patient was vomiting, which resolved with medication adjustment. Percentage of goal kcals from EN increased from 21% to 50%. Despite electrolyte shortages, the patient was maintained on the prescribed PN formula, reviewed weekly by the pharmacists. The family was independent with PN administration and CVL dressing changes, and the patient had no hospitalizations or CVL infections.

CONCLUSIONS: An experienced HNST co-managed the care of an infant with SBS on home PN and EN. The team coordinated a myriad of challenges, including PN additive shortages, EN and PN order variations, nursing instruction and communication with the medical team. Despite these obstacles, a successful outcome was demonstrated by weight gain, achievement of targets on growth curves and increased kcal intake ratio of EN to PN. All EN and PN associated complications were managed at home and the patient remained free of hospitalizations and CVL infections. Comparison of outcome data to the patient’s twin will be of interest in future studies.

FINAL ABSTRACT # 8

TITLE: Patient Migration from Hospitals to Home: Understanding and Validating Products Needs as Home Care / Infusion Services Expand

AUTHORS: Robin Huneke Rosenberg, RN, MA, VA-BC; Joseph Hommes, RN, BSN, VA-BC; Kendra Gregerson, RN3M Health Care, St. Paul, MN

BACKGROUND: Providing patient care outside acute care facilities in the U.S. will continue to grow given historical legislation and the health care payment structure. The increase in patient volumes and patient acuity presents new opportunities and challenges for long-term care, home care and home infusion services. Some of these patients are discharged from the acute care setting, with orders to infuse prescribed intravenous antibiotics, parenteral nutrition, and other necessary medicinal and fluid therapy using devices such as Peripherally Inserted Central Catheters (PICCs). Unscheduled patient visits are a common challenge for the home care/infusion clinician’s workload causing interruptions to their scheduled visits contributing to delays in treatment. Vascular Access Device (VAD) dysfunction or migration, difficulty with dressing and securement device application, VAD insertion site re-assessments are a few reasons for these unscheduled patient visits. Therefore, device manufacturers need to provide trusted technology that the clinicians require to reduce unscheduled patient visits. The use of one such device was studied by home care infusion services.

PURPOSE: A survey study was implemented requiring clinicians, who insert, provide care and/or maintain PICCs and Short-Term Central Venous Catheters (CVCs), to compare the performance of a new catheter securement system to their current system. For this audience, the results presented will be limited to the securement system’s performance when used with PICCs.

METHODS: Clinicians used the 3M™ PICC/CVC Securement Device + Dressing for 2-3weeks to secure and cover their patients PICC sites rather than either Bard Stat lock® + dressing, or nylon sutures + dressing. After the evaluation period, clinicians used a tool to rate and communicate their experience using the new system compared to their current system.

RESULTS/DISCUSSION: A total of 19 facilities participated in the PICC segment of the study (2 infusion centers, 1 Long term acute care facility, 5 infusion/home care centers, 1 physician office and 10 hospitals). 97 clinicians completed evaluations that met the strict criteria of applying, removing, and observing at least 2 securement systems. 95% (n=90) rated the overall performance as the same, better or much better than their current system. 89.4% (n=84) rated “prevents migration or movement of the catheter” as the same, better, or much better than their current system. 94.7% (n=90) rated the “overall securement provided by the new system” as the same, better or much better than their current system. 93.3% (n=84) rated “migration/movement of catheter during dressing change” as the same, better or much better than their current system. 89.1% (n-82) rated “patient comfort for duration of wear time” as the same, better, or much better than their current system. 94.4% (n=85) rated “length of time system adheres to skin before replacement as the same, better or much better than their current system.

CONCLUSIONS: Based on the findings of the evaluation, 82.2% of the clinicians were willing to replace their current PICC securement system with the new securement system.

FINAL ABSTRACT # 9

TITLE: Retrospective Analysis of the Clinical Utility of Biweekly Dosing With High-Concentration Subcutaneous Immunoglobulin in 13 Patients With Primary Immunodeficiency

AUTHORS: Richard L. Wasserman, MD, PhD1; Shahnaz Fatteh, MD2; Javaid Khan, DO2; Elie Haddad, MD, PhD3; M. Elizabeth M. Younger, CRNP, PhD4 1Medical City Children’s Hospital; Dallas, TX, USA; 2Larkin Community Hospital; South Miami, FL, USA; 3CHU Sainte-Justine; Montreal, QC, Canada; 4Johns Hopkins University School of Medicine; Baltimore, MD, USA

BACKGROUND: Until recently, subcutaneous immunoglobulin (SCIG) treatment for patients with primary immunodeficiency disease (PIDD) was FDA approved only for weekly dosing. A pharmacometric model provided data allowing for FDA approval (in September 2013) of biweekly (every 14 days) SCIG administration which increases treatment flexibility. Because of patient preference, some physicians have already been using this dosing schedule for their patients with PIDD. However, limited data have been published thus far assessing the effectiveness of biweekly SCIG administration in preventing serious bacterial infections (SBIs).

PURPOSE: The purpose of the study was to determine the clinical effectiveness of biweekly administration of SCIG in patients with PIDD.

METHODS: A retrospective record review, conducted at 4 centers, of patients with PIDD administered 20% SCIG at biweekly intervals was conducted using a standard case report form that allowed investigators to collect information regarding patient characteristics, immunoglobulin (Ig) treatment history, SBI occurrence, general overall patient health, and serum Ig concentrations. Institutional review board approval was obtained in each center.

RESULTS: 13 patients (9 females, 4 males) aged 9–64 years with common variable immunodeficiency (n=9) or specific antibody deficiency (n=4) received biweekly 20% SCIG treatment. Monthly doses ranged from 231 to 744 mg/kg via 2 to 8 sites per infusion (10-35 mL/site), and infusion duration ranged from 30 to 180 min. The most recent serum Ig concentrations ranged from 711 to 1828 mg/dL. As of November 2013, total therapy duration has ranged from <1 to >35 months (median approximately 20 months). Only 1 patient was hospitalized for pneumonia during >28 months of biweekly treatment; 12 patients experienced no acute SBIs and did not require hospitalization. Most patients were subjectively evaluated as in “fair,” “good,” or “excellent” general health during biweekly SCIG therapy. All patients have continued the biweekly dosing regimen.

CONCLUSION: Biweekly administration of 20% SCIG maintained effective prevention of SBIs and allowed patients with PIDD to experience good general health. Increasing dosing flexibility and individualizing treatment with SCIG may lead to improved patient adherence and quality of life.

FINAL ABSTRACT # 10

TITLE: Reducing incidences of local infusion site reactions in subcutaneous immunoglobulin patients through enhanced patient education with a focus on “dry” versus “wet” priming technique

AUTHORS: Amy E. Clarke, RN; Hetty A. Lima, BSPharm., R.Ph., FASHP; Melissa Johnson, CPhT; Penny Erickson, CPhT; Benjamin Lima, B.S., Financial ManagementDiplomat Specialty Pharmacy; Buffalo Grove, IL

BACKGROUND: For the past two years our organization observed a correlation between patients who were experiencing painful, itching or warm local site reactions during subcutaneous immunoglobulin (SCIG) therapy and those who prime their needle sets completely, inserting a “wet” needle through their skin. Similar observations had been reported at the 2012 AAAAI Conference in the Clinical Management Workshop on IVIG vs. SCIG. Industry experts believe that the tracking of the IgG antibodies through the dermis triggers mast cell production leading to localized reactions. While only anecdotal reports have been published to date regarding this practice, an SCIG manufacturer includes instructions for dry needle placement in their clinician trouble-shooting resource materials.

PURPOSE: The purpose of this project was to determine if education regarding dry priming of infusion needle sets reduced the incidence of local site reactions during the administration of subcutaneous immunoglobulin infusions.

METHODS: 41 patients were initially included in this study on SCIG 20%. Following elimination criteria, the final patient population of 36 adults was retained in the study. Patients were eliminated in the event that any of the following needed immediate changing: needle length, brand of set or angle of needle insertion. All patients were previously exposed to SCIG 20% and assessed via an internally developed tool. Cohort evaluation occurred from 8/2012 – 8/2013. If the initial data collection revealed self-reported localized reactions and prior training including a wet needle technique, patients were placed on study. Nursing visits to retrain patients occurred as needed. Subsequent telephonic assessments were conducted by clinical staff trained on the assessment tool, every 28-30 days, to evaluate the current level of site reaction and infusion technique. The data collection tool was used with each interaction and included a rating of tissue reaction (using a color scale or numerical rating scale), technique for insertion of needles and patient satisfaction.

RESULTS/DISCUSSION: Of 36 patients utilizing wet needle placement during the setup of SCIG 20% concentration, 77% (n=28) reported either complete resolution or decrease in size or severity of local site reactions following a nursing visit or telephonic training on dry-priming technique. Patients were their own control and continued using same brand of needle sets

with no change in number of needles or length during this process. Results were self-reported as follows for wet-needle priming (before): no patients report “No redness”; four patients reported “Redness, Raised”; 21 patients reported “Redness, Raised, Itchy”; seven patients reported “Redness, Raised, Itchy, Warm”; and four patients reported “Redness, Raised, Itchy, Warm, Painful.” Results were self-reported as follows for dry-needle priming (after): 20 patients reported “No redness”; three patients reported “Redness”; five patients reported “Redness, Raised”; four patients reported “Redness, Raised, Itchy”; four patients reported “Redness, Raised, Itchy, Warm”; and no patients reported “Redness, Raised, Itchy, Warm, Painful.”

CONCLUSIONS: This organization found that patients with existing local site reactions had a decrease or elimination of reactions once retrained to insert a “dry” needle. These findings were similar to anecdotal reports discussed at AAAAI in 2012. Based on findings using this data tool, this organization has been able to assess tolerance and initiate retraining where needed. Future research will include assessing our entire SCIG patient population and collecting additional data on volume per needle/site to compare differences in local infusion reactions related to number of needle sites and concentration of SCIG.

FINAL ABSTRACT # 11

TITLE: Monitoring Productivity and Workload Balancing: A Novel Pharmacy Tool to Measure and Compare Home Infusion Pharmacy Technicians

AUTHORS: Jonathan Grant, Pharm.D.; Fred Choy, MS, RPh; Hae Jin Cho, Pharm.D. Candidate; Rowell Medina, Pharm.D.; Mitra Gavgani, Pharm.D.; Justin DiPaula, BA, LSSBBJohns Hopkins Pharmaquip Infusion Services; Baltimore, MD

BACKGROUND: One common challenge to managing a home infusion pharmacy is ensuring that the workload amongst pharmacy technicians is evenly distributed. There are many possible consequences that may ensue when technicians believe that work is not evenly distributed among the staff. The morale of the staff may drop, tension may develop, and unfortunately, quality of work may be compromised as a result. Pharmacy manager’s often do not have an effective tool to accurately assess the productivity of individual technicians.

PURPOSE: The purpose of this project was to collect, analyze, and assess home infusion pharmacy technician productivity using a Microsoft Excel based data collection tool.

METHODS: In this single center retrospective study, we assessed the workload balance of five technicians. Pharmacy technician productivity data was analyzed using a Microsoft Excel based data collection tool. The data was collected for a period of three weeks and were classified into eight categories: 1) eclipse with powder, 2) eclipse with liquid, 3) bags with additives, 4) bags without additives, 5) syringes, vials, mini bags, 6) chemotherapy, and 7) intravenous immunoglobulin (IVIG). The collection tool records the quantity from each category that each technician completed in data charts and converts the data into both pie and bar graphs. Graphs for the total overall as well as each individual compound were generated. A null hypothesis was defined as the absence of significant difference in compounding productivity among the five technicians. Using the collected data, the one-way ANOVA test was applied on the null hypothesis, as well as on the individual categories to assess any difference per category among the technicians.

RESULTS: Of the five technicians in the study group, a total of 6292 doses were compounded over a time period of three weeks. After the one-way ANOVA test for overall productivity, the p-value of the compounded products was 0.115 (>0.05). Of the 7 individual compound categories, there was a statistically significant difference in two of the seven compound categories. In the Eclipse with powder compound category, the one way ANOVA test produced a p-value of 0.031 for one technician. In the syringes, vials, and mini bags category, the one-way ANOVA produced a p-value of 0.016 for one technician.

CONCLUSION: There was no statistically significant difference (p>0.05) in the total compounding productivity among the technicians. However, there was a statistically significant difference found between pharmacy technicians in two of seven individual compound categories. By using this tool, we are able to visually show technicians that overall, workload is being shared evenly. Correspondingly, by using our tool and analysis, we are able to identify opportunities for improvement in workload allocation. We will continue to collect data quarterly to watch for trends, ultimately striving for a workload where there are no statistically significant differences between technicians.

FINAL ABSTRACT # 12

TITLE: Good Catch Program: Error avoidance within a home infusion operation

AUTHORS: John W. Waldo, PharmD; Kimberly Stone, RPh; Jennifer Keyton, CPhT; Angela Weldon CPhT; Richard Sibert; University of Virginia Health System, Continuum Home Health Care, Charlottesville, VA

BACKGROUND: A multitude of clinical and operational work-flow steps are essential for preparing, dispensing and delivering therapy to home-based patients. All human or system process errors need to be promptly investigated and resolved to prevent potential patient harm. A non-punitive environment has been shown to be most effective at increasing staff participation in voicing and problem-solving issues, such as in a “good catch” program where staff is encouraged to report. A literature review identified examples of “good catch” healthcare programs in a hospital laboratory, trauma and intensive care, inpatient units and cancer centers, yet none for home infusion pharmacies. Agency leadership at this organization wanted to increase the identification of errors so work flow procedures could be addressed to prevent recurrence.

PURPOSE: A monitoring program was developed to capture both minor and major events related to workflow policies, procedures, and standards of practice. The program objectives were to identify work-flow errors, support staff awareness, provide education/retraining, redesign policies as needed, and create consistent and reliable systems for obtaining staff feedback. The overarching purpose of this program is to catch errors before they leave the infusion pharmacy and reach the patient.

METHODS: A framework was used to support the design and roll-out of the “good catch” program in January 2013, starting with identifying the types and degree (minor/major) of errors staff members should report. Minor errors were defined as not posing an immediate threat to patient safety. Examples included missing auxiliary labels, incomplete paperwork, extra supplies dispensed, and cooler temperature issues. Major errors were defined as potentially causing patient harm. Examples included calculation errors, medications dispensed to wrong patient, and incorrect compounding directions. Team meetings were held to explain the project goals and to obtain staff buy-in. Clipboards with blank “good catch” forms were placed strategically throughout the pharmacy. Staff members were rewarded with positive feedback and “good catch” points for reporting, that they submitted for reward items. Weekly reviews of reported errors were conducted, with monthly trending analysis performed for 6 months.

RESULTS: An immediate result was the correction of errors before they reached the patient. Events were then categorized as major or minor by the infusion pharmacy team. Trending analysis identified five patterns of errors. Action plans were developed to address database errors, correct delivery information in the database, and correct supply and work-card errors. An average of 34 errors/work-flow opportunities were reported per month during the first three months. Months four to six demonstrated a decrease to 12 or fewer opportunities per month after the team began meeting to devise work-flow and process solutions.

CONCLUSION: This program reduced the incidence of all errors. An improvement was noted in staff ability to identify workflow issues, which enhanced each team member’s trouble-shooting and resolution skills. Research has shown that eliminating small errors helps prevent more serious errors down the line. By decreasing our minor errors, we decreased the volume of both major and minor errors in 2013. Employee engagement increased with this program, although staff morale was not specifically measured. Impact of leadership support for the reporting of errors on staff morale is an opportunity for future study.

FINAL ABSTRACT # 13

TITLE: Optimization of New Pharmacist Training in Home and Specialty Infusion

AUTHORS: Brittany A. Singleton, BA, PharmD; Caryn Dellamorte Bing, RPh, MS, FASHP; Suzanne Kluge, B.S., RPh; Walgreens Infusion Services, Deerfield, IL

BACKGROUND: Effective new hire pharmacist orientation and training is essential in all practice settings. The practice of home and specialty infusion pharmacy requires a foundation of specialized clinical, operational, and vascular access knowledge which is typically not part of pharmacy academic training. Most experienced community pharmacists have limited current knowledge of infusion pharmacy care. Hospital pharmacists have clinical and infusion experience, but may not be experienced with the specialty medications and other long term infusion therapies. Whatever a pharmacist’s background or previous experience, a successful initial training program should bring all new home infusion pharmacists to a baseline competency to practice in this setting. The training and competency assessment should be thorough, efficient, accessible and user-friendly for the oriented, the management and staff leading the on boarding process. Major challenges to the completion

of orientation training include a lack of time or staff. New employee training may produce an additional workload for those who might be best at orienting the new hire; staff and management personnel. One result is more virtual and autonomous training activities. These educational activities should incorporate principles of adult learning, and demonstrate awareness of different individual learning styles. Inclusion of these components will encourage active participation in the process, facilitate total completion of the training objectives, and thus result in long term recall and application of the information. Optimal training of new pharmacists will result in high quality patient care as well as overall organizational success.

PURPOSE: The goal of this project is to review and enhance the available resources and methods for new hire pharmacist training at a national infusion provider, with the focus on development of a training tool for choosing an administration method for home infusion therapy orders.

METHODS: Methods included review of the resources currently in use by this national provider, comparison with methods and tools from other providers (primarily those used by acquired business units) and identification of best elements from each as well as noted gaps. All existing training resources and protocols were reviewed. From this resource compilation, a training module to guide the clinician’s choice of administration method when dispensing home infusion therapy orders was developed. This base for a virtual, self-directed learning module incorporates audio and visual components, as well as active participation, which are cornerstones of adult education and meet the needs of adults with different learning styles.

RESULTS: An optimal training tool was developed for orientation training, and competency assessment of new home infusion pharmacists, focused on guiding the clinician’s choice of administration method when dispensing home infusion therapy orders. The tool and decision tree will be shared as part of the poster presentation. The tool is adaptable for a self-directed multimedia presentation, which is currently under consideration for deployment. With the building of this module, the 1st phase of its development is complete. The 2nd phase will be an automation phase, and the 3rd will be an evaluation phase.

CONCLUSION: The final product will incorporate audio and visual components, as well as active participation, which are cornerstones of adult education and meet the needs of adults with different learning styles. The quality of this training tool when deployed will be measured by survey for its thoroughness, time efficiency, user friendliness, interactivity, mid & post-test measures, and its incorporation of techniques to fit varied learning styles. This method can serve as a template for future training needs.

FINAL ABSTRACT # 14

TITLE: The use of teduglutide in patients with short bowel syndrome on long-term home parenteral nutrition: Impact on TPN and fluid requirements

AUTHORS: Richard Leong, Pharm.D., BCNSP; Thomas Diamanditis, Pharm.D.; Rod Okamoto, RPh; Nutrishare, Inc., Elk Grove, CA

BACKGROUND: Patients with short bowel syndrome (SBS) have a reduced ability for adequate intestinal absorption of nutrients. Nutritional support with parenteral nutrition (PN) and intravenous fluids (IVF) are often required to compensate for this reduction. Teduglutide (TED), a human recombinant analogue of glucagon-like peptide 2 (GLP-2), was approved by the FDA on December 12, 2012 to treat adults with SBS who are dependent on PN. TED improves intestinal absorption and has been shown in preliminary clinical trials to reduce the need for parenteral support.

PURPOSE: The purpose of this case study review was to evaluate the effects of TED on PN and IVF support in patients with SBS.

METHODS: A retrospective chart review of patient demographics including age, sex, and primary gastrointestinal diagnosis was completed. TED data including dose, route, and duration of administration was collected. Gastrointestinal data including primary diagnosis, intestinal anatomy including intestinal length was collected. PN data including days/week, volume, amino acid/energy doses as well as IVF data were collected. A responder to TED was defined as a >20% reduction of PN or IVF support. Drug therapy including antidiarrheals or acid suppressive therapy was reviewed. Follow up data collected after >24 weeks of TED were collected. Treatment exclusions were defined as intolerance to TED.

RESULTS: Five patients were maintained on TED (4 for >24wks and 1 for 12 wks). There were four females and one male with a mean age (±SD) of 64±19.8 years. The mean small bowel length (±SD) was 60 cm±23.4 cm. Four of the five patients did not have an ileocecal valve (ICV). The mean colon length (±SD) was 2.89±2.26 ft. There were 4 patients who completed at least a 24 week course, and 1 patient completed at least a 12 week course of TED at 0.05 mg/kg/d administered subcutaneously. One patient was removed from the study after developing abdominal pain and cramping associated with intestinal obstruction. A macronutrient review in the pre and post TED periods revealed a mean reduction in amino acids of 37.8%, and

mean reduction in PN calories of 47.7%. A nutritional parameter review revealed an 8.2% mean reduction in albumin levels, and a 4.45% mean increase in weight. All patients on TED reduced their total fluid requirements by >20%.

CONCLUSION: There was a reduction in the PN requirement, however a longer study period is necessary to determine the nutritional implications of this therapy. It is of concern that there was a 8.2% reduction in the mean serum albumin. The effects of this therapy in patients with SBS receiving PN will require a greater number of patients studied for a longer period of time. This report represents a preliminary experience.

FINAL ABSTRACT # 15

TITLE: Total Parenteral Nutrition (TPN) Electrolyte Pool Overfill Using an Automated Compounding Device (ACD): an Evaluation of Waste

AUTHORS: Tiara M. Patten, PharmD; Caryn Bing, RPh, MS, FASHP; Robin Espiriti, RPh, BCNSP; Critical Care Systems, A Walgreens Company, Tempe AZ

BACKGROUND: Parenteral electrolytes and mineral products have been on national shortage in recent years. Shortages have led to changes in practice to optimize patient care using available resources. Additives are rationed and prioritized based on practitioner judgment of patients’ needs. Provider efforts to reduce product waste can help insure supplies are available to meet patient demand. Organizations such as ASPEN and others have developed tools to assist clinicians to navigate the complex situation. Automated compounding devices (ACDs) are utilized by institutions and home infusion pharmacies to prepare patient-specific total parenteral nutrition (TPN). Two preparation methods can be employed to add electrolytes and minerals to TPN bags: manually adding to each TPN bag, and the use of formulated patient-specific pool bags for use on an ACD. Pooling combines minerals and electrolytes into a single container which is then used to compound multiple TPN bags for a patient. The ACD delivers each base component to the final TPN bag along with an aliquot of the pooled micro-ingredient bag. When formulating the electrolyte pool bag for ACD filling, it is common practice to formulate a certain volume of overfill to account for priming the ACD tubing to avoid running dry during compounding. The percentage of pool overfill varies by organizational policy and ACD brand.

PURPOSE: To evaluate current TPN mineral and electrolyte pool overfill percentage practices and associated waste at three home infusion pharmacy locations of a national provider, all of which use the same brand of ACD.

METHODS: Data collection was conducted over one week in three locations which each use different pool overfill calculation methods. One uses a constant 7% overfill, the second uses 10%, and the third varies overfill percent to create an approximate 20 mL overfill. The compounding technician at each site documented the prescription number, number of bags, pool overfill percentage, total pool volume, and the measured volume of discarded remaining pool (waste). ACD tubing volume is constant and required for proper functioning and therefore is not considered waste. The ingredients of each pool bag were transcribed into an Excel spreadsheet for analysis. The cost of pooled components was based on average wholesale price (AWP) per milliliter as a standard to quantify waste.

RESULTS: The sample size included a total of 65 pools used for 387 TPN bags. The participating sites used different pool overfills: 7%, 10% and variable from 2-10% (13, 27, and 25 pool bags respectively). The average volume waste per bag per location was 9.16 mL, 12.73 mL, and 1.03 mL respectively. The average cost of waste per TPN bag per location was $2.65, $3.16 and $0.17 respectively. Cost of waste extrapolated over 52 weeks per location is $10,591, $27,240, and $1,258 respectively, based on the average workload of the sampled week.

CONCLUSION: The ACD set residual volume is a constant, therefore overfill should also be constant and independent of the pool bag volume. Through minimization of pool overfill, pharmacies can benefit financially while also minimizing waste of limited and clinically important additives.

FINAL ABSTRACT # 16

TITLE: Assessment of Estimated Vial Reduction Associated with the Use of 40 Gram 10% Liquid IVIG

AUTHORS: Ann Bullinger, PharmD; Dustin Elliott, MS1; David Schaefer, MBA2

1CSL Behring LLC, King of Prussia, PA; 2AxelaCare Health Solutions, LLC, Lenexa, KS

BACKGROUND: Intravenous immunoglobulin (IVIG) products used as immune replacement and immunomodulatory therapy have been commonly available in vial sizes ranging from 5g to 30g. A recently approved (February 2013) 40g vial of 10%

Liquid IVIG may reduce the number of individual vials required for some infusions or reduce the need to pool multiple vials for infusion of larger doses. Fewer vials to prepare and access for parenteral infusions may lead to improvements in overall efficiency by reducing the time spent by pharmacists on preparation and pooling. When vials are shipped for home preparation, fewer vials to access reduce the risk of introducing microbial pathogens and may reduce shipping costs due to smaller package sizes.

PURPOSE: The purpose of this study was to assess the potential impact the availability of the 40g 10% Liquid IVIG vial could have on the overall number of vials of IVIG used to treat specialty pharmacy patients.

METHODS: Historical IVIG shipment data between January 2011 and November 2013 was examined to determine the number of vials of IVIG shipped prior to and after the availability of the 40g 10% Liquid IVIG vial. The number of IVIG vials used was calculated using the number of grams per shipment to a patient. The assumption was made that all product was purchased from a manufacturer with a 20g vial maximum size until the approval of the 40g vial.

RESULTS/DISCUSSION: A total of 21,384 IVIG shipments occurred during the timeframe examined. Following availability of the 40g 10% Liquid IVIG vial, 56.7% of shipments to patients were reduced by 2–4 vials, 20.4% were reduced by 1 vial, and 5.5% were reduced by >4 vials. There was no change in the number of vials shipped in 17.5% of shipments. Following availability of the 40g 10% Liquid IVIG vial, the average number of vials used decreased by 42.2% (4.81 vials before and 2.78 vials after availability). The mean (SD) size of a shipment for all diagnoses was 90.4g (54.8g). Mean (SD) shipment sizes were 35.0g (18.5g) for patients with PIDD and 97.4g (48.9g) for patients with chronic inflammatory demyelinating polyneuropathy.

CONCLUSIONS: IVIG shipment data indicate that the introduction of the 40g 10% Liquid IVIG vial is associated with a reduction in the number of total vials used. This reduction has potential benefits for nurses such as fewer vials to prepare and access for parenteral infusions. Handling fewer vials may lead to improvements in overall efficiency and reduction in the risk of introducing microbial pathogens. Shipping fewer vials may also reduce the number of broken vials. Reductions in package size are likely to decrease packaging costs. Data complexity limited our ability to differentiate between loading and maintenance dose shipments. Parsing the data in this manner may have resulted in a less dramatic overall average reduction in vials per shipment as this metric is based solely on average grams per shipment.

FINAL ABSTRACT # 17

TITLE: Strategies to Reduce Late Deliveries in Home Infusion: A performance improvement initiative

AUTHORS: Crystin Gloude, PharmD; Cindy Kunzendorf, RPh, MBA; Julie Selfridge, RPh; Suzanne Kluge, RPh; Caryn Bing, RPh, MS, FASHP; Walgreens Infusion Services, Deerfield, IL

BACKGROUND: Late deliveries of medications, equipment, and supplies can lead to increased cost, extra workload, a negative impact on patient satisfaction and potential missed or late medication doses. An analysis of delivery data from the software tracking program in use at the branch showed that delivery descriptions used lacked standardization. More than 40% of medication deliveries were issued to the courier between 4-8 pm on weekdays, stressing the capacity of later in the day deliveries; this highlights an opportunity for workload redistribution. These non-standardized delivery times and related client concerns have brought this issue into focus as a performance improvement initiative, which included a process examination and modification focused on reduction of late deliveries.

PURPOSE: The goal of this performance improvement project was to decrease the frequency of late medication and related supplies/equipment deliveries to patients serviced by a busy metropolitan area branch of a national home infusion company by identifying controllable factors and implementing best practice methods.

METHODS: Established performance improvement techniques were used in one branch of a national home infusion pharmacy system in order to identify causal factors for late deliveries. Techniques included workflow mapping and analysis (WFMA), cause and effect Fishbone diagrams, and staff interviews and brainstorming that evaluated the workflow from the time a prescription started through delivery to a patient. In order to better measure if delivery time requirements were met, a standard method for inputting required delivery times was implemented. Two weeks after implementation of standardized delivery requirement entry methods, additional reports were run to validate implementation (phase 1). A second two week sample period (phase 2) was used to apply additional improvement methods after review of data from the initial implementation period.

RESULTS: Through the use of established performance improvement methods, including WFMA, improvement actions were identified, implemented, and evaluated with the goal of reduction in frequency of late deliveries. Measures of success and sustained progress included more evenly distributed actual delivery times and implementation of standardized delivery time

requirements. During phase 1 there was a 4% increase in morning deliveries. Phase 2 increased morning deliveries from phase 1 by nearly 5%. During the initial improvement, actions will be identified and shared with other branches as potential company best practices.

CONCLUSION: The branch experienced a decrease in the number of late deliveries as a result of the implementation of identified performance improvement actions, including an improved distribution of times packages left the building (sent time), which served as a surrogate marker for decreased late deliveries. Additionally, staff education on standardization of delivery time entry, and increased branch-wide communication and awareness of these requirements served to realign performance expectations.

FINAL ABSTRACT # 18

TITLE: Clinical and economic outcomes for head and neck cancer patients on home-based enteral nutrition therapy: Establishing a baseline

AUTHORS: Crystal Jackson, MS, RD, CSO, LD/N, CNSC1; Lisa Renzi, PhD2,3; Abby C. Sauer, MPH, RD2 1Barnes Healthcare Services; 2 Abbott Nutrition; Columbus, OH; 3The University of Georgia; Athens, GA

BACKGROUND: Head and neck cancer patients commonly experience malnutrition that varies in severity depending on tumor locus, stage- and grade-related metabolic effects, and treatment side effects. Malnutrition leads to significant negative consequences including decreased quality of life, increased complications, decreased treatment tolerance, increased hospital readmissions, and increased health care costs. In order to meet nutritional needs and prevent malnutrition in this population, enteral tube feeding is often a necessity and may positively impact the patient’s quality of life and reduce risk of infections, complications, and hospital readmissions. However, the lack of consistency in care and post-acute health care delivery for these patients may compromise nutritional status and outcomes, especially when patients and caregivers are not educated on the purpose of home-based enteral nutrition therapy and are not trained in best practices at administering that therapy. There is some recognition in the literature that home-based nutrition therapy that also provides coordinated education for caregivers may be efficacious at improving outcomes for enteral patients and may be considered the standard from which future quality improvement stems, but there is a lack of baseline data in a number of common conditions that call for home-based enteral therapy, such as head and neck cancer, a set of conditions that are increasing in incidence.

PURPOSE: As part of a larger project aimed at understanding the economic and clinical outcomes from coordinated, comprehensive nutrition therapy for this population, the goal of this phase of the project is to establish an outcome baseline from dietitian-led care that combines patient/caregiver education, staff education, and close patient assessment and monitoring.

METHODS: A retrospective chart review was conducted on 204 patients with head and neck cancer (average age 61.4 ± 9.86 years). The majority (71.6%) of patients evaluated were male. Patient outcomes were collected using electronic medical records over a period of 11 months of care. As a first step in establishing baseline clinical and economic outcomes, patient records were analyzed for the following: unplanned hospital readmission, body weight changes, enteral formula tolerance, enteral tube feeding tolerance, and tube-related infections.

RESULTS/DISCUSSION: Within the sample of evaluable patients, diagnoses included: tongue, esophagus, tonsil, pharyngeal, and oral cavity cancers. During the 11-month period, 4.4% of patients experienced weight gain, with an average gain of 8 pounds. Only three subjects lost weight, one of whom was obese, with an average weight loss of 12.3 pounds. With regard to tolerance, 8.3% of patients experienced enteral formula intolerance, 3.4% of patients experienced enteral tube feeding intolerance, 1.5% of patients experienced infection, and 6.9% of patients had one documented unplanned hospital readmission.

CONCLUSIONS: Head and neck cancer patients often require enteral tube feeding to meet basic nutritional needs. As a first step in identifying healthcare consumption in this vulnerable population, a baseline understanding of clinical and economic outcomes needed to be established. This project demonstrated that dietitian-led coordinated home-based enteral nutrition therapy can help head and neck cancer patients avoid weight loss, tolerate enteral tube feeding, and avoid infections and hospital readmissions, which can result in overall cost savings and improvements in quality of care. A future phase of this quality improvement project will examine the impact of dietitian-led home-based enteral nutrition therapy through coordinated care on clinical and economic outcomes via prospective data collection.

FINAL ABSTRACT # 19

TITLE: Optimizing a documentation tool for the clinical management of home parenteral nutrition patients

AUTHORS: Maleeha F. Bader, PharmD; Caryn Dellamorte Bing, RPh, MS, FASHP. Walgreens Infusion Services, Deerfield, IL

BACKGROUND: This national infusion provider currently has three separate home parenteral nutrition (HPN) assessment and clinical management forms (tools) used by the pharmacy and nutrition departments. In the pharmacy document, a Pharmaceutical Care Pathway is prepared at the start of care by the pharmacist, scanned into the online medical record, and then updated periodically and re-scanned throughout the course of care. A patient service representative (PSR) prepares a similar form that captures delivery and supply needs. The registered dietitian, as a member of the home nutrition support team, completes a separate assessment form that is then scanned into the online medical record. There is a significant overlap of information between the three forms utilized by the pharmacist, PSR and dietitian, which presents an opportunity to optimize the tool and documentation methods for HPN patient management. The assessments performed by nursing, while important to interdisciplinary care, are not targeted for consolidation into this tool.

PURPOSE: The overall objective of this project is the optimization of documentation tools used for initial and ongoing assessments of HPN patients. The primary goal is the development and trial of one form (tool) that will meet the interdisciplinary needs of home infusion pharmacists, PSRs, and dietitians. A uniform tool shared by pharmacy and nutrition departments should reduce redundant assessment questions directed at patients, as well as enhance the efficiency of clinical management of HPN patients through information access.

METHODS: The development and trial of an optimized HPN assessment tool in one large branch of a national home infusion provider involved several steps. The source, need, availability, and timing of information collected on the current tools was gathered through staff interviews, process reviews, and discussions with key stakeholders, including pharmacy, nutrition, and operations team members. Analysis of this information was conducted to identify opportunities for centralizing the collection of information from patients, thus limiting the redundancy and repeat phone calls to patients by different disciplines. In phase one, a consolidated documentation tool was developed that meets standards of practice, company policy, and, pharmacy and nutrition department user needs, and which can capture relevant clinical outcome measures. Phase two involves a trial period by the team that manages new and ongoing HPN patients, after which feedback will be solicited during its use through a standardized survey of the users. Based on the feedback, the tool and work flow may be modified after the trial to optimize interdisciplinary access and utility for all team members participating in HPN patient care.

RESULTS: The phase one tool will be presented with this poster. At the conclusion of this project, the unified pharmacy and nutrition tool that meets HPN patient care documentation requirements, limits the need for multiple patient calls, and eliminates redundant assessment activities by the pharmacy and nutrition departments will be ready for implementation across other company sites. Any process changes required to fully implement the optimized tool (e.g. sequence, responsibility, access to records), these will be identified as part of the training document that will accompany the new tool.

CONCLUSION: At the conclusion of this project, the unified pharmacy and nutrition tool that meets HPN patient care documentation requirements, limits the need for multiple patient calls, and eliminates redundant assessment activities by the pharmacy and nutrition departments will be ready for implementation across other company sites. User feedback from Phase II will drive process change before implementation across other company sites. Any process changes required to fully implement the optimized tool (e.g. sequence, responsibility, access to records), these will be identified as part of the training document that will accompany the new tool.

FINAL ABSTRACT # 20

TITLE: Measuring the Impact of Home Infusion verses Infusion Center on Patient Outcomes and Quality of Life

AUTHORS: Jeff Prosch, RPh; Carla Taylor, CRNI®. Fairview Home Infusion, Minneapolis, MN

BACKGROUND: Health care institutions are placing renewed and even greater focus on quality of life (QOL) as a way to prevent hospital readmissions, reduce costs and improve patient satisfaction to receive reimbursement under Affordable Care Act changes. These initiatives known as The Triple Aim are key goals of health care reform.International experience shows enzyme replacement therapy (ERT) for the treatment of lysosomal disorders at home restores independence and control of disease management to the patient, reduces use of hospital resources and is associated with improved QOL. Prior studies have found in-home infusion therapy improves compliance with treatment schedule, reduces missed infusions due to non-clinical reasons and eases the financial impact of ERT on the family budget. Furthermore, patients receiving ERT at home were better able to participate in desired activities, which is important for good QOL and normalcy

PURPOSE: While research shows in-home ERT is associated with improved QOL, the purpose of this study is to determine whether such improvements are significantly higher (as hypothesized) than those seen in patients receiving ERT in an infusion center.

METHODS: Patients were selected to participate in this descriptive study from the Advanced Therapy Clinic at University of Minnesota Medical Center. Inclusion criteria included patients age 12 and older and receiving ERT within the past 12 months. The telephone survey consisted of up to 11 questions, depending on whether the participant received ERT at home or in an infusion center. The questionnaire contained a scale (Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree) assessing QOL indicators commonly reported by patients receiving ERT for lysosomal disorders. Additional questions included current work/student status and number of times they missed an infusion due to their condition. Participants receiving in-home ERT were asked about duration of therapy and if any hospitalizations or visits to the emergency room have increased, decreased or stayed the same.

RESULTS: Of the possible 57 identified ERT patients, 29 completed the telephone survey. Significantly more home infusion patients agreed or strongly agreed with the following measures as compared to infusion center patients: better able to manage day to day responsibilities (home: 100%, infusion center: 47%); confident I can manage my condition (home: 100 %, infusion center: 60%); my quality of life has improved (home: 100%, infusion center: 47%). In addition, home infusion patients were significantly less likely to miss therapy doses compared to infusion center patients. A cost comparison that had been conducted in the past within the same health system revealed that payers saved up to 90% when using home infusion for ERT patient care than the hospital outpatient department.

CONCLUSION: Patients receiving ERT at home showed better clinical outcomes and improved QOL compared to those receiving ERT in an infusion center. All (100%) of the home infusion patients reported that location had a positive impact on their quality of life compared to 50% of infusion center patients. We believe The Triple Aim of the Affordable Care Act can be obtained with home infusion, but also recognize that having a choice in ERT location is an important part of patients’ QOL.

FINAL ABSTRACT # 21

TITLE: Development of Practice Recommendations: Regional Standardization of Administration Methods

AUTHORS: David J. Thompson, BS, PharmD; Caryn Dellamorte Bing, RPh, MS, FASHP. Walgreens Infusion Services, Southborough, MA

BACKGROUND: Patients who require home-infused antibiotics are usually trained to self-administer these medications. The standardization of criteria for establishing consistent administration methods can increase patient safety; reduce costs; provide streamlined and directed training for patients, caregivers and providers; and increase referral source satisfaction with consistency of services. Medication stability is typically a primary determinant for administration device selection, since home antibiotics are typically dispensed as compounded sterile preparations (CSP) as a week or longer supply at a time. Additionally, multiple parties are invested in how a medication is dispensed and administered: the home infusion nurse who teaches and follows the patient; the ordering physician and referral source who may have protocol preferences; third party payers who may pay differently for the same therapy when dispensed in different devices; patient and caregivers; and pharmacy staff who must prepare and insure the integrity of the CSP. Patient specific and clinical considerations are also part of the decision criteria, including patient age, vascular access device and placement, length of therapy, and patient/caregiver abilities.

PURPOSE: This project will establish standardized criteria for determining the administration method of selected home-infused antibiotics, including identification of typical administration device/methods, determination of criteria or factors influencing selection decisions, and proposal of standardized criteria to be implemented in a geographic region serviced by multiple branches of the same national home infusion provider.

METHODS: The project focused on four medications with multiple administration options and dosing schedules: ceftazidime, ceftriaxone, cefepime, and daptomycin as gravity infusion, flow regulated gravity infusion, IV push, electronic infusion pumps, and elastomeric infusion devices. Five geographically proximate branches of a national infusion company with shared regional referral sources participated in this project. The pharmacy resident developed a standardized questionnaire which focuses on the criteria and expectations for establishing the administration method for these medications. At least two clinical pharmacists from each location, including the pharmacy manager if available, were independently interviewed at each location. Interviews were conducted in person to clarify questions and to record additional comments.

RESULTS: A region-specific guidance document that is consistent with company policies and best practices was created reflecting results and feedback from the survey. The guidance document includes a decision tree which serves as a guide to clinicians when determining administration methods for the selected antibiotics. A chart was created to display pertinent information obtained from survey results.

CONCLUSION: The survey was designed and conducted in a medication-specific manner, however results show that interviewees had little variance in answers for different medications. Pre-established dispensing tendencies in different clinical locations are generally followed although they may not be optimal. A standardization process directed at pharmacists should encourage dispensing uniformity across the region, since pharmacists were identified by survey responses to be the primary decision maker. Standardized dispensing among different clinical locations in the same region may provide benefits in educational opportunities for clinicians, providing more consistent services to patients, and opportunities to decrease costs associated with dispensing.

FINAL ABSTRACT # 22

TITLE: Pharmacist-Driven Patient Interventions: Type and Frequency for Patients Receiving Intravenous Immunoglobulin Therapy in the Home Care Setting

AUTHORS: Debbie McNutt, RPh, MBA; Tiffany Fancher, PharmD; Beth Miesen, PharmD; Tianyi Chen, PharmD; Annie Manacheril, PharmD; Katherine Chin, PharmD; Amah Hamilton, PharmD; Wanda Rogers, MS, RPh. Coram Specialty Infusion Services, Denver, CO

BACKGROUND: A fundamental aspect of a home infusion pharmacist’s duties is patient assessment and monitoring. When issues are identified, a pharmacist should provide therapy recommendations as part of the clinical care team with the goal of maximizing therapy goals or decreasing therapy risks. This is particularly crucial for patients on drugs with the potential for severe adverse drug reactions, such as immunoglobulin (Ig), and for patients receiving care in the home setting. To date, several studies have been published regarding pharmacist intervention in community and hospital pharmacy settings, but there is a lack of studies involving home infusion pharmacy.

PURPOSE: The purpose of this project was to measure the frequency and type of pharmacist-driven interventions for immunodeficient patients on home intravenous Ig (IVIg) therapy. We hypothesized that using this organization’s existing tools (Ongoing Assessment Form, Initial Assessment Form, and Risk Level Assessment Calculator), pharmacists could identify issues with patient therapy, and that once these were identified, the pharmacists would work with prescribers to improve patient outcomes.

METHODS: A retrospective analysis was completed of adult patients (ages 18-75) receiving home IVIg, with a start-of-care date between January 1and June 30, 2013, and an admitting diagnosis of immunodeficiency. The number of times a pharmacist identified that a clinical intervention was necessary was measured. Secondarily, the point in the patient’s therapy when the pharmacist identified and acted upon an issue was categorized. These categories included: following initial prescription review; after completion of the Initial Clinical Assessment form; after completion (repeated every 60 days) of the Ongoing Ig Assessment Form; and based on the patient’s Risk Level Assessment score. Lastly, the outcomes of the pharmacist interventions were categorized. The categories included: a change of drug; a change in rate of infusion; a change in infusion frequency; and the prescribing of additional orders for symptom management, all done in consultation with the prescriber.

RESULTS: Thirteen patients met criteria for inclusion in the study. Seven of the patients had at least one intervention during their course of treatment, with twelve interventions total. Five patients had one intervention each during the initial prescription review. One patient had an intervention following the initial clinical assessment. Four patients had a total of six interventions (two patients had two interventions each) during ongoing assessments. Interventions were, as a percentage of total interventions: change of Ig drug (23%); change in rate of infusion (23%); obtaining of additional orders (15%); and change in dose frequency (7%). This study was not sufficiently powered for statistical significance.

CONCLUSION: Although the specificity of the inclusion criteria limited our pool of subjects, our study shows that home infusion pharmacists intervened for 58% of the study patients. Further research is needed with a larger sample size to confirm the findings of this retrospective chart review. Additional research can help confirm the active role of this organization’s (or any home infusion organization’s) pharmacists, particularly when working with the entire care team on behalf of immunodeficient patients who are prescribed home IVIg therapy or other therapies with potential for severe adverse reactions.

FINAL ABSTRACT # 23

TITLE: Development of a home infusion drug library for implementing smart pump technology

AUTHORS: Joseph Gromelski, PharmD1; Christina Knepley, PharmD; Hazel M. Atienza, PharmD Candidate 20142

1Jefferson Home Infusion; Philadelphia, PA; 2Jefferson School of Pharmacy; Philadelphia, PA

BACKGROUND: The majority of ambulatory infusion pumps currently used in the home setting are considered ‘dumb’ pumps because they require manual input of all infusion therapy parameters with no additional technology to reduce the potential for programming errors. With the recent introduction of ‘smart’ pump technology in ambulatory devices, providers now have the opportunity to streamline processes and reduce errors by developing a drug library to standardize common drug therapy protocols and promote adherence to recognized drug therapy standards.

PURPOSE: The purpose of this study was to describe one home infusion provider’s method for creating and utilizing a smart pump drug library, identifying the resources needed, and the effects on current and future process.

METHODS: The home infusion pump implementation team (consisiting of two clinical pharmacists and one nurse manager),received manufacturer training on drug library creation software and pump programming. The team was tasked with creating a standardized drug library using five delivery modes and configuring protocols in a Therapy, Qualifier, Drug format. For each protocol, soft and hard safety limits were established utilizing lexi-comp, package inserts and established organization practices. All pump programming characteristics were considered. All efforts required to create the library were recorded.

RESULTS: After training, approximately 10 hours were spent discovering all potential alarms, security parameters, display functions and settings of the pump. Template settings for these parameters were chosen in consideration of patient populations served and organization preferences. Example protocols were created to explore the best way to describe and develop the qualifier and drug name descriptions in the library. Drug libraries were then developed for the therapies most commonly administered in each mode of operation (Continuous, Intermittent, Taper, Step and PCA). With PCA mode, broad programming was utilized given the balance needed between meeting patient request for a wide range of dose titrations and the safety of utilizing finite maximum doses. A total of 248 protocols were created in 9 business days, requiring 27 hours to create the protocols and an additional 17 hours to enter the protocols into the software. As the library creation progressed, improvement opportunities were identified: current prescription labels for the same therapies were found to vary tremendously, and a standardization project was initiated; standardized concentrations were developed to promote protocol consistency; and the pump double-check process needed to be overhauled to streamline distribution and decrease chance for error.

CONCLUSION: The smart pump software and streamlined pump distribution process has increased staff confidence that there will be less chance of pump programming errors, however additional study is needed regarding actual impact of these measures on drug error rate. The ease of creating and adding drug protocols to the pump was encouraging, however too many pump protocols could create inefficiencies and potential errors in selection. The process for maintaining the drug library is currently under development, as is a study of the impact of smart pump technology on medication error rates.

FINAL ABSTRACT # 24

TITLE: Using Electronic Connectivity to Improve Pump Management Efficiency and Accuracy

AUTHORS: Tom Ruiz, David J. Bonar, Kevin Vanhoozier; InfuSystem, Inc., Madison Heights, MI

BACKGROUND: Home infusion providers are often challenged with managing dozens or hundreds of infusion pumps, completing their preventative maintenance on time, scheduling repair when needed, storing and referencing pump service records, and ordering additional pumps—all of which can make for a time consuming set of manual tasks. Electronic tools exist that can simplify, automate, and improve the accuracy of these tasks. Transcription errors anywhere in the supply chain can be costly and lead to redeliveries and delivery delays. Manual processes increase the possibility of transcription errors, while direct, electronic connections have been found to reduce them by eliminating manual intervention. Ordering via telephone is a resource-intensive operation that necessitates manual tracking or back-end data entry, all of which could be incorporated into an electronic system.

PURPOSE: The purpose of this exercise was to implement electronic pump asset management technology to bring the home infusion provider closer to their fleet of infusion pumps, and the fleet's corresponding details such as order tracking,

scheduled maintenance, repair orders, pump rentals and leasing, and service history logs. Goals included demonstrating the efficiency and cost savings that can be realized with implementation of an electronic ordering and tracking system.

METHODS: A home infusion provider was granted secure, direct (username/password) access to the equipment vendor’s ordering system. Training was provided, allowing infusion provider staff to manage their pump fleet 24 hours/day, seven days/week as the need arose. Training included use of an electronic order screen that offered verification of order to enhance accuracy, minimize transcription errors, and improve order visibility to the customer. Manual interventions in the pump ordering process by the vendor were noted to prove or disprove the efficiencies proposed by the use of an electronic system.

RESULTS: Staff reported that 24/7 access to the electronic ordering system, in addition to more simplified electronic ordering processes as compared to phone orders that could only occur during normal business hours, resulted in the re-deployment of an entire FTE to other duties. In addition, 330 manual interventions to equipment orders reported in the 1 month prior to implementation of the electronic system, dropped to 26 manual interventions to equipment orders in the 1 month following implementation.

CONCLUSION: Electronic processing of pump orders offered a more efficient and accurate method of order processing for both the home infusion provider and for the equipment vendor, as demonstrated by the redeployment of an FTE and the reduction in equipment ordering interventions. Phase two of the implementation will include real-time access to pump service records, and allow the user to schedule service and track their pumps throughout service, repair, and shipping process.

FINAL ABSTRACT # 25

TITLE: A Case Study Examining Treatment of Five Myasthenia Gravis Patients with High-Dose Immune Globulin Therapy Administered Via the Subcutaneous Route

AUTHORS: Randy Broyles, RPh; Peg Gruenemeier, RN, CRNI®, CHC; BioRx, Cincinnati, OH

BACKGROUND: Intravenous Immunoglobulin (IVIG) has demonstrated efficacy in the treatment of acute exacerbations of Myasthenia Gravis (MG), although the use for this indication is off-label. MG is a disease characterized by progressive weakness and exhaustibility of voluntary muscles without atrophy or sensory disturbance and caused by an autoimmune attack on acetylcholine receptors at the neuromuscular junction. Treatment for MG may include anticholinesterase agents, immunosuppressive drugs, thymectomy, plasmapheresis, and high-dose IVIG. Subcutaneous immunoglobulin (SCIG) therapy is not routinely administered for neurologic disorders due to the large volumes associated with their dose requirements, which would necessitate frequent administration at multiple sites.

PURPOSE: The purpose of this case study was to determine if high-dose Ig therapy could be safely administered and tolerated via the subcutaneous route for five MG patients who were unable to receive Ig intravenously.

METHODS: Five patients diagnosed with an acute exacerbation of MG and initially treated by this organization with high-dose IVIG (1-2 grams/ kg in two to five divided daily doses) were identified as unable to tolerate IVIG during the evaluation period from 2009 to 2013. Intolerable side effects included nausea, vomiting, change in blood pressure, headache, fatigue and generalized body aches, to name a few. Reduction in flow rates did not reduce or impact reports of symptoms. One patient also experienced a lack of peripheral access sites. The care team consisting of the home nurse, pharmacist and prescribing physician met to consider alternatives. SCIG administration was chosen, and patients were monitored weekly for 30 days, then monthly, for acute exacerbations of MG symptoms, side effects of SCIG therapy, and hospitalizations reported during the evaluation period.

RESULTS: Case study patients ranged in age from 38 to71 years old, and included four females, and one male. SCIG doses ranged from 0.4 grams/ kg to 2.0 grams/kg administered via syringe pump into 4 to 8 subcutaneous sites and divided over one to three times per week dosing. Length of therapy was four to 48 months, with an average of 31 months. No acute exacerbations of MG symptoms were reported during the evaluation period. All patients continued to receive SCIG therapy as maintenance therapy at the conclusion of the evaluation except one who received four months of treatment for an acute exacerbation then discontinued therapy when the exacerbation had resolved. No hospitalizations related to MG symptoms or therapy side effects occurred during the evaluation period. Mild to moderate local injection site reactions were reported by all of the patients and were managed without interruption in therapy.

CONCLUSION: The five patients in this case study tolerated high-dose SCIG for the treatment of MG with minimal side effects or complications such as unplanned hospitalizations or exacerbations of the disease state. Further research is needed to validate the long-term efficacy, tolerance, and cost-effectiveness of high-dose SCIG in the routine management of MG.

REFERENCE: Misbah S, Sturzenegg M.H., Borte M., Shapiro R.S., Wasserman R.L., Berger M., Ochs H.D. Subcutaneous Immunoglobulin: Opportunities And Outlook, Clin Exp Immunol. 2009 December; 158(Suppl 1):51–59.

FINAL ABSTRACT # 26

TITLE: Shifting the Patient Satisfaction Measurement and Process Improvement Paradigm

AUTHORS: Lisa Siefert RPh, ASQ-CMQ/OE, FASHP1; Beverly Terranova2 1Walgreens Infusion Services; Deerfield, IL; 2Walgreen Co; Deerfield, IL

BACKGROUND: Patient satisfaction in home infusion is historically comprised of components of process improvement (PI), marketing, and sales. The data is collected, tabulated and summarized internally by each provider. The industry lacks standard patient satisfaction questionnaires allowing customers to compare providers. Additionally, failing to use third party vendors to collect or analyze data may lend question to its accuracy, validity, and use for benchmarking. Standardized questions administered by vendors have been utilized in other health care settings, for example, the Centers for Medicare & Medicaid Services’ Consumer Assessment of Healthcare Providers and Systems program, which allows consumers to compare health care providers.

PURPOSE: Describe the experiences of a national infusion provider implementing a standardized and objective patient satisfaction program and incorporating the results into the organization’s PI processes.

METHODS: A year-long journey shifting the paradigm of patient satisfaction data collection began in 2009. The following were steps taken to establish a national program. Compare consumer loyalty third party vendors and determine budgets. Establish survey methodology and develop question sets. Integrate and implement the new program into operations and develop reports. Integrate collected data into organization’s PI. Lastly, create materials to share results with referral sources. In early 2010, the vendor recommended an outbound live call patient satisfaction program, reaching 1,600 patients per year. The survey questions covered the patient’s entire infusion experience, and utilized the AHRQ-CAHPS® satisfaction survey templates and National Home Infusion Association (NHIA) provider survey questionnaire. Patients were randomly chosen from previous week’s active dispensing report allowing randomization of new and existing patients from all locations. The determination of program success was the elimination of local level tasks collecting patient satisfaction data and detailed customer experience insight data.

RESULTS: The vendor analyzed satisfaction results from delivery, nursing visit, etc., and offered areas of service that drove high and low satisfaction. Reports were reviewed by corporate managers and discussed during quality committee meetings and senior leadership who provided input for improvement. The recommended action items were then shared with field offices to improve satisfaction. A successful example utilizing low satisfaction level data related to delivery, led to an initiative to communicate delivery delays to patients. Ratings improved from 77% in 4th quarter of fiscal year 2011 to an organization high of 84% in quarter 2 of fiscal year 2013. The organization’s overall satisfaction in the most recent year was 96.5%.

CONCLUSION: The survey program produces generally consistent, unbiased, and valid data. Management views the results to identify areas of excellence and improvement. Patient satisfaction has since become one of the four components to our organization’s quality and PI program. Local resources spent collecting satisfaction was eliminated. As the program evolved, facilities wanted results unique to their branch, which is unavailable through the national program. In response, an adjunct program to collect location specific satisfaction via web-based surveys was launched in 2013. Though industry-wide benchmarks for patient satisfaction are unavailable, infusion providers can benefit from the objective and standardized collection of patient satisfaction, to set internal benchmarks, and future comparison among infusion providers.

FINAL ABSTRACT # 27

TITLE: Impact of a Decentralized Consumer Advocate Program on Patient Satisfaction with Subcutaneous and Intravenous Immune Globulin Therapy

AUTHORS: Nicole Bouchard; Carol Ernst, RN; Peg Gruenemeier, RN, CRNI®, CHC; John Louis; BioRx, Cincinnati, OH

BACKGROUND: In a traditional home infusion delivery model, immune globulin (Ig) therapy is provided to patients by a local team that includes nursing, pharmacy, reimbursement and customer service staff. Some providers work within a cost-effective decentralized model in which care is coordinated and telephonically monitored remotely on a monthly basis by an experienced clinician (titled a “consumer advocate” at this provider organization). As health care providers are increasingly being held accountable for reducing unnecessary expenditures in the delivery of services while producing positive patient

outcomes, patient satisfaction with care provided has evolved as an important measure of health care delivery reform success. Published data is lacking regarding patient satisfaction with home infusion of Ig therapy in general, although individual providers have anecdotally reported overall satisfaction rates of 96 to 97% for the average patient.

PURPOSE: The purpose of this project was to document satisfaction with care received via a decentralized model, for patients diagnosed with primary immune deficiency disease (PIDD) receiving either intravenous (IVIG) or subcutaneous immune globulin (SCIG) in the home.

METHODS: A written survey was mailed to 1595 patients diagnosed with PIDD who were previously, or actively, treated with IVIG or SCIG by this organization. Treatment periods ranged from new patient to more than five years on service. The survey consisted of two parts: a demographics section gathering data about the treatment, and a satisfaction section using a scale of “strongly disagree” to “strongly agree.” Questions included type and frequency of infusion, length of time receiving Ig therapy, whether administration method had changed during course of treatment (e.g., from SCIG to IVIG or vice versa), and comfort with self-infusion (if receiving SCIG). Satisfaction with education provided by the pharmacy, service provided by the decentralized consumer advocate, and overall pharmacy services was assessed.

RESULTS: 411 surveys were returned for a survey response rate of 26%. Of the 275 active patient surveys reviewed, 69 patients received IVIG therapy (25%), and 206 received SCIG (75%). 92% agreed or strongly agreed that they were satisfied with the level of education provided by the pharmacy. 92% agreed or strongly agreed that the Consumer Advocate position provided them with good service. 95% reported overall satisfaction with pharmacy services. 17 (25%) of the 69 IVIG patients had tried SCIG therapy and returned to IVIG therapy. 75% of the IVIG patients were naive to SCIG. 183 (88%) of the 206 SCIG patients were comfortable with self-infusion and therapy type.

CONCLUSION: Remote coordination of Ig therapy care by an experienced clinician, including frequent telephonic monitoring assessments, contributed to a high rate of patient satisfaction. Further research is needed to compare satisfaction in traditional Ig therapy delivery models to this decentralized model. A comparison of costs associated with each service model would also be of value in determining cost-effectiveness.

FINAL ABSTRACT # 28

TITLE: An Innovative Approach to Providing Customized Home Parenteral Nutrition Despite National Drug Shortages

AUTHORS: David Benedict, Pharm D, BCPS; Brianne Lucas, Pharm D; Jenifer Ashner, RN, BSN. Chartwell Pennsylvania, Pittsburgh, PA

BACKGROUND: Providing customized home parenteral nutrition (HPN) has become increasingly difficult due to national shortages of macronutrients, vitamins, minerals, and electrolytes. In February, 2013, the University of Utah Drug Information Service reported 228 sterile injectable medications were in short supply (70% of all shortages at that time). All HPN products except dextrose and water have been in short supply at some point since spring of 2010. Electrolytes such as calcium, magnesium, and phosphate have become increasingly difficult to obtain due to interrupted supply chain availability from too few manufacturers. Historically, compounding pharmacies were an alternative source for these products, however regulatory changes following highly publicized contamination issues have made this source a less reliable alternative. As a result, providers are increasingly challenged with safely meeting patient needs for customized HPN in the midst of these severe and prolonged component shortages.

PURPOSE: The purpose of this project was to develop a strategy for obtaining the components necessary for customized compounding in order to meet our patients’ HPN needs in the midst of ongoing component shortages. The overall goal was to avoid medication errors while contributing to the homeostasis of our HPN patients’ health.

METHODS: In February 2013, an interdisciplinary team gathered to assess product alternatives to meet our patient’s electrolyte needs. Pre-mixed nutrition products and components that contained electrolytes were identified as the most viable alternatives to individual electrolytes, however using such products greatly increased the complexity of total electrolyte calculations. The team devised an Excel spreadsheet in which electrolyte concentrations within each product were established to assist in formula customization and accuracy for our adult PN patients (greater than 18 years of age). Accuracy of the software tool was validated with manual calculation double-checks. As pre-mixed products were selected by the clinician, additional substrates were added to achieve the final prescription calculations as indicated by the Excel spreadsheet tool. All compatibility guidelines were enforced to provide stabile formulations and compounding was performed in accordance with USP <797> standards. Serum electrolyte levels were assessed and trended for each patient in accordance with physician’s orders. Medication error data collection was completed in accordance with the organization’s existing incident-based quality improvement program.

RESULTS: A total of 93 HPN patients were evaluated from March through November, 2013, with durations of therapy ranging from 2 weeks to greater than 10 months. Laboratory data was trended and mean electrolyte serum levels were found to be within normal limits of reference lab ranges for all patients during this evaluation period. No dose calculation or formula errors associated with electrolyte levels were reported for these patients during the evaluation period.

CONCLUSION: Utilization of pre-mixed products aided in providing appropriate macronutrients and electrolytes to our adult PN patient population. Serum electrolyte levels could be safely maintained within normal limits, and calculation and dose accuracy were achieved using the new software tool. The concept of using these pre-mixed products as source containers allowed us to increase our HPN census (24%) during this evaluation, and provided a safe option for our patients during a time of severe drug shortage.

FINAL ABSTRACT # 29

TITLE: Comparison of Peripherally Inserted Central Catheter Flushing Protocols

AUTHORS: Elizabeth Roesch, RN, CRNI®1; Martha Michael, RN, CRNI®1, Peggy Lyons, DNP, RN, CRNI®1; Ann Phalen, PhD, CRNP, NNP-BC2

1Walnut Home Therapeutics, Philadelphia, PA; 2Thomas Jefferson University School of Nursing, Philadelphia, PA

BACKGROUND: Infusion therapies in the home have become more complex and, often, necessitate the use of Peripherally Inserted Central Catheters (PICC). In the inpatient setting, clinicians provide around the clock care of PICC Lines. In the home, however, PICC lines may not be accessed by the same level of personnel. The intermittent nature of home infusion therapy may contribute to patency issues in PICC’s. In response to a nationwide heparin shortage, this agency changed its policy from saline followed by heparin lock to saline only. Since adopting this policy, reports of PICC patency issues have increased. Whether the issue is sluggishness or occlusion, missed doses can occur. This results in an increased use of a catheter clearing agent to restore patency.

PURPOSE: The purpose of this project was to compare three flushing protocols and determine which method was most effective at maintaining PICC patency in the home with the fewest missed doses and least amount of alteplase.

METHODS: A single-blinded controlled study was undertaken following IRB approval, with the flushing protocol as the independent variable. Data was collected from Feb 1, 2012 – April 28, 2013. Group I was the control, with saline only PICC flushing. Group II used a flushing method called SASH-High (saline flush, drug administration, saline flush, heparinized saline solution 100U/ml [3ml or 300 units] as final lock). Group III used the SASH-Low method, in which the concentration of heparinized saline was 10 U/ml (5ml or 50 units). Patients over age 18 with a PICC and therapy duration greater than one week were recruited from a medical center and outpatient sources and seen in the home setting. Time in study was calculated in catheter days, and subject participation was for the duration of their treatment or until the study ended. Exclusion criteria included: younger than age 18; history of heparin allergy, cancer and active pregnancy; and patient with multiple providers. A power analysis determined an appropriate sample size of 30 subjects in each group. Documentation was completed weekly and at the time of incident by the principal investigator to record incidents of catheter sluggishness or occlusion.

RESULTS: Statistical significance was not achieved. The sample size did not reach the expected counts. Preliminary results showed some groups trending toward significance. The following results were analyzed by the Clinical Standards Committee: Patients using saline only flush had the highest percentage of additional nursing visits to assess sluggish/occluded PICC lines and administer alteplase. These patients also had the highest percentage of missed therapy doses. Patient using SASH-High had the lowest percentage of alteplase administration. Patients using SASH-Low had the lowest number of sluggish PICC lines and the lowest percentage of missed doses.

CONCLUSION: Based on the preliminary results showing efficacy with low-dose heparin flush, our Clinical Standards Committee decided to trial a low dose heparin flush for all PICC patients. We will trial heparinized saline 10 units/ml in a 5ml flush, measuring our occlusion rate before and after. After 6 months, we will analyze the data to determine if a long term practice change is warranted.

FINAL ABSTRACT # 30

TITLE: Lessons Learned from Subcutaneous Immunoglobulin Administration Challenges: Enhancing Manufacturer Responsiveness through Stakeholder Feedback

AUTHORS: Brad Sealfon1; Nancy Kramer, RN, BSN, CRNI®2; Kathy Puglise, MSN/ED, BSN, RN, CRNI®3; Melissa Leone, RN, BSN4; Kelly Bertolazzi MSN RN5

1RMS Medical Products, Chester, NY; 2National Home Infusion Association (NHIA), Alexandria, VA; 3BioScrip, Norfolk, VA; 4Coram Specialty Infusion Services, Denver, CO; 5Walgreens Infusion Services, Deerfield, IL

BACKGROUND: As therapies administered in the alternate site of care increase in complexity, great demands are placed on medical device manufacturers to respond accordingly. When new therapies and administration methods enter the marketplace, new ancillary supplies (devices, products) are often required to meet customer and patient’s needs. Consumers and providers alike have reported challenges related to higher concentrations of SCIG administration and selection of ancillary supplies that will deliver the therapy safely with optimal outcomes. Tools and/or product innovations that effectively address these current marketplace challenges would benefit all stakeholders. Actionable clinical feedback is a cornerstone to both the development of new tools and products, and to their successful adoption in the marketplace, as evidenced by the inclusion of such end-user feedback requirements in Food and Drug Administration (FDA) Guidance documents for the clearance of medical devices.

PURPOSE: The purpose of gathering an expert clinical advisory panel was to address key challenges experienced in the administration of SCIG, and to prioritize potential solutions that could be implemented by this manufacturer and/or the panel.

METHODS: A diverse panel of nursing leaders was identified to provide insight into a wide range of patient populations and SCIG administration experiences via in-person meetings and regular conference calls. Invited members represented prescribers, home infusion providers, the industry trade association, a pharmaceutical manufacturer, and the medical device manufacturer who initiated the panel. A meeting was held in October 2013 to discuss SCIG challenges, identify those challenges related to ancillary supplies and equipment, and define/prioritize actionable next steps.

RESULTS: Challenges identified by the group included: general lack of knowledge regarding best practices in SCIG administration contributing to ineffective supply/device selection and use; inadequate patient education contributing to issues with self-administration; inadequate reimbursement of equipment and supplies; and lack of options for cost-effective delivery of small-volume pediatric infusions. The group identified, then prioritized, potential solutions to the challenges with the first priority being development of a cost-effective syringe infuser that could accommodate smaller volume administrations (20ml size) for pediatric patients. The second priority was development of an expert consensus-driven SCIG treatment algorithm that would incorporate best-practices to enhance clinician decision-making when initiating care, selecting supplies and troubleshooting issues.

CONCLUSION: The panel meeting produced vital feedback and actionable solutions for SCIg-related challenges. A 20ml syringe infusion system is under development in response to panel demands for cost-effective dosing flexibility and pediatric administration. Also in development is an SCIG Treatment Decision Algorithm in which a wide range of patient, product, equipment and supply-related factors are being incorporated to reflect a best-practice approach to effective initiation and management of SCIG therapy. Additional projects are planned to address remaining, as well as future, priorities. The panel also identified the need to broaden its interdisciplinary representation to include immunologists and pharmacists as key members of the patient’s clinical support team with unique perspectives to contribute.

FINAL ABSTRACT # 31

TITLE: Evaluating the Safety and Feasibility of Conducting an Investigational Clinical Trial in the Home Infusion or Ambulatory Treatment Setting

AUTHORS: Suzanne Kluge, RPh, BS; Donna Ford, RN, BSN. Walgreens Infusion Services, Deerfield, IL

BACKGROUND: A national home infusion provider is frequently approached to help facilitate and conduct investigational clinical studies in the home infusion /ambulatory treatment (HI/AT) setting. In cases where patients are unable to or choose not to travel to a hospital or physician office, it would offer an opportunity for patients to participate in an investigational clinical study. Patients being treated in the hospital are in a controlled setting with physicians readily available as well as crash carts and emergency rescue services. Conversely, treating patients in the HI/AT setting can be more challenging due to the lack of direct physician oversight and distance to emergency services. In addition, the safety of administration of investigational medications is not well documented in the literature because they lack history of adverse drug reactions or side effects.

PURPOSE: The purpose of this project was to develop a process that could be used to consistently evaluate the safety and feasibility of investigational medication administration in the HI/AT setting.

METHODS: A multi-disciplinary team consisting of a corporate nurse, a corporate pharmacist, and representatives from purchasing, legal and risk management departments met to determine how each clinical trial or study will be evaluated. Specific items to be addressed in each evaluation include: potential impact on patient safety; stability and storage of investigational medications; method of administration and suitability for the HI/AT setting; pharmacy and nursing implications and responsibilities; laboratory monitoring; documentation requirements; estimating the direct and indirect costs of treatment; and evaluating reimbursement options.

RESULTS: A request form was developed for the individual location to complete for corporate to evaluate participation in a clinical trial. The evaluation process was established and all the aspects of a clinical trial incorporated into an assessment tool. Spreadsheet templates were created to address all possible administration scenarios, incorporating costs associated with any needed supplies, infusion pumps, personnel time, documentation time, inventory, recordkeeping, and training time (staff and patient). After identifying the processes, costs and scenarios, a policy and procedure was developed to support this feasibility evaluation. A corporate review board analyzes the feasibility evaluations and study documents, and oversees the implementation of any clinical study.

CONCLUSION: While it is a unique opportunity to be able to conduct a clinical drug study for an investigational medication, challenges inherent in the home infusion or ambulatory treatment setting must be addressed to ensure patient safety. Having clear processes, policies and procedures available increases the likelihood that future prospective studies will be evaluated consistently and effectively.

FINAL ABSTRACT # 32

TITLE: Evaluation of the occurrence of hypermanganesemia in patients on long term parenteral nutrition

AUTHORS: Carol J. Rollins, MS, RD, PharmD, BCNSP; Olga Lowrey, PharmD; Laura Thaler, PharmD; Kathryn R. Matthias, PharmD; The University of Arizona Medical Center, Tucson, AZ

BACKGROUND: Patients receiving parenteral nutrition (PN) for more than a few weeks are at risk of trace element (TE) depletion due to inadequate gastrointestinal absorption, excessive losses, and abnormalities in storage or metabolism. To prevent deficiencies a multiple trace element (MTE) product providing zinc, chromium, copper, and manganese is typically added daily in PN. Unfortunately, MTE products may not provide correct doses for each individual TE and the patient may be at risk of TE imbalances. Potential for hypermanganesemia is particularly concerning given American Society for Parenteral and Enteral Nutrition (ASPEN) recommendations for 60-100 mcg/day intravenous manganese supplementation in PN compared to the 500 mcg (0.5 mg) manganese per dose in common MTE products.

PURPOSE: The purpose of this study is to evaluate whole-blood manganese concentrations obtained in patients prescribed PN for more than 30 days and establish the extent to which hypermanganesemia occurs in patients receiving PN. Manganese concentrations were analyzed relative to the duration of manganese supplementation to determine if there is an association between hypermanganesemia and time of exposure to manganese as a PN additive.

METHODS: This retrospective study was approved by the institutional review board. Patients with at least one whole-blood manganese concentration result in the clinical laboratory database of an academic medical center between January 2007 and December 2011 were screened for PN use. Data from adults (18 years of age or older) prescribed PN for at least 30 consecutive days as a hospitalized patient or through the outpatient healthcare system were included in the analysis. Subjects were grouped by duration of PN and inclusion of TE supplementation in PN. Data collection included: demographic information, reason for initiation and discontinuation of PN, duration of PN, duration and timing of other nutrient sources, amount of PN prescribed, duration and dose of TE supplementation, TE blood concentrations, and documentation of potential manganese toxicity in medical records. Abnormal versus normal range manganese concentrations were compared relative to the duration of PN with MTE using fisher’s exact test in STATA 11.2.

RESULTS: 21 females (64%) and 12 males (36%) met inclusion criteria and 42 whole-blood manganese concentrations were included in the analysis. Malabsorption, enteric fistula, or short bowel syndrome was the diagnoses leading to long-term PN use in 75% of the patients. Duration of PN was over 90 days for 21 patients, over one year for 7 patients, and at least 90 days but unknown total duration for 14 patients. The percentage of patients with manganese concentrations above the normal range that were obtained between 0-30, 31-90, 91-365, and >365 days after initiation of PN with MTE was 0%, 63%, 83%, and 100%, respectively. The percentage of patients with elevated concentrations between 0 to 90 days post initiation of PN with MTE was lower at 54% compared to 87% of patients with concentrations obtained after 90 days (p=0.096). Overall, 64% of patients had hypermanganesemia by laboratory report. One patient had changes associated with hypermanganesemia on magnetic resonance imaging (MRI).

CONCLUSION: The results of this study support the need for a prospective study to evaluate whole-blood manganese concentrations and appropriate adjustment of trace element supplementation in patients receiving long-term PN with MTE supplementation.

FINAL ABSTRACT # 33

TITLE: Study Outcomes of a Novel Sutureless Securement System

AUTHORS: Laura Rutledge, RN, MN, CRNI, CCRA; Shelley Ann Walters, MS. 3M Health Care, St. Paul, MN

BACKGROUND: Increasing numbers of patients are receiving infusion therapy in their home or alternate-site care settings, partially due to the advancements in infusion therapy and technology, including the use of devices such as Peripherally Inserted Central Catheters (PICCs). As the PICC dwells over time, the risk for displacement increases. To prevent catheter displacement, adhesive anchor devices, suture or modified dressings are commonly used. If a novel technology is available with similar or better catheter securement than current devices and has additional skin friendly benefits, this technology could prove beneficial for home infusion patients.

PURPOSE: The purpose of this case study is to summarize results of two prospective studies conducted on a new securement system to examine its catheter securement and gentle to skin outcomes.

METHODS: A drop test method was used to measure catheter securement that simulated a forceful tug on the catheter. Thirty-six (36) volunteers received two of three systems applied to each of their forearms. Twelve (12) volunteers were assigned to each unique pair of systems: either (1) 3M securement system and StatLock®, or (2) 3M securement system and SorbaView®, or (3) StatLock® and Sorbaview®. A 2.5 pound weight was attached to the catheter and allowed to drop at a zero degree angle 10 minutes after sample application. A system failed if the device lifted from the skin, the plastic doors opened, the plastic piece separated from the base or when the catheter completely removed from under the dressing. McNemar’s test was used to compare failure rates. “Gentle to skin” was characterized by measuring skin cells (protein) on the devices’ adhesive when removed at 48 hours using the Bicinchoninic acid (BCA) assay test method. 20 healthy volunteers wore one 3M and four StatLock® devices with and without a skin protectant on their back. At removal, subjects rated the amount of pain experienced using a 0 to10 scale and the skin condition was visually assessed for erythema/edema and skin stripping using two different 0-4 rating scales. Devices were placed in Petri dishes for BCA testing. Mixed linear model on the rank or log transformed data was used to test for sample differences.

RESULTS: The drop test revealed no failures (0/24) observed for the new system and 100% failures (24/24) observed for the other systems. The novel securement device had: (1) significantly lower mean BCA values than the other samples; (2) significantly lower erythema/edema on average than the other samples; (3) the lowest frequency of skin stripping than the other samples; and (4) significantly lower pain scores on average than the other samples after 48 hours of wear.

CONCLUSION: The data suggest that the novel catheter securement system offers an improvement in catheter securement and gentle to skin performance characteristics compared to current methods of securement. However, the test results could vary using different time points and patients rather than healthy volunteers. Therefore we encourage providers to collect patient use data to compare their results to the “healthy volunteer” results reported here.

FINAL ABSTRACT # 34

TITLE: Specialty Medication Care Pathways For An Outpatient Infusion Pharmacy: Economic Impact From The Patient And Healthcare System Perspective

AUTHORS: Michael Rigas, Pharm.D.1; Kristie Luu, BA2; Jan D. Hirsch, R.Ph., Ph.D.2

1Kabafusion; Cerritos, CA 2Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California; San Diego, La Jolla, CA

BACKGROUND: Specialty medications are known as expensive injectable, infusible, oral or inhaled drugs that require complex clinical management to treat patients with life-threatening diseases. The high cost, insurance barriers and complicated process of administration can deter patients from receiving timely treatment. Currently there is no standard method to manage the distribution and administration of infused and injected acute (e.g. IV antibiotics) and chronic specialty (e.g. high cost biologics) therapies in the outpatient setting. Creating care pathways is a method of clearly delineating and illustrating the key four elements - efficacy, cost, delivery process (how and where), and structures - needed to ensure quality delivery for optimized patient outcomes.

PURPOSE: The purpose of this study was to establish care pathways for three common infusion therapies encountered at a home infusion pharmacy, estimating the cost of each pathway from the patient and healthcare system perspective to determine economic impact.

METHODS: A literature review was conducted in US peer reviewed journals but due to little information related to the specific aims of the study, information from an Infusion Therapy Pharmacy was used as the primary data source. The Chief Clinical Officer of an Infusion Therapy Pharmacy served as co-preceptor and provided access to relevant clinical, dispensing, distribution and reimbursement data for care-path creation. This study used de-identified data that were routinely tracked by the pharmacy for their treatment and operational needs. Care pathway scenarios were created for intravenous immune globulin (IVIG), natalizumab (Tysabri, Biogen Idec), and daptomycin (Cubicin, Cubist Pharmaceuticals, Inc.) therapy.

RESULTS: The cost estimate of a course of therapy for each varied for the patient as well as the health care system. The third party reimbursement for the drug per dose varied widely. IVIG averaged $6,300 per dose, natalizumab averaged $4,696 per dose, and daptomycin averaged $318 per dose from the healthcare system perspective. Patient true out of pocket costs per year were substantial for IVIG ($17,190/year) and natalizumab ($10,222/year) and less so for daptomycin ($6582/course) (assuming a 30% co-payment rate for insured patients). There were also other non-economic factors such as more frequent dosing, transportation issues, inability to receive care in preferred setting (e.g. home or home infusion center) that often impacted the patients’ experience.

CONCLUSION: Care pathways for specialty infusion medications are currently complex and driven by clinical, regulatory and insurance requirements. The true out of pocket cost for the patient are substantial and can significantly impact the patient’s ability to receive timely therapy. Further research is needed to determine if care pathways experienced by home infusion pharmacy patients could be optimized to reduce healthcare system or patient costs, or improve the patient’s overall treatment experience and outcomes achieved.

FINAL ABSTRACT # 35

TITLE: Clinical Outcomes of Home Inotropic Therapy: A 4-year retrospective review

AUTHORS: Kami Jenkins, PharmD, Amerita Specialty Infusion Services, Amarillo, TX

BACKGROUND: Congestive heart failure (CHF) patients face many obstacles, including repeat hospitalizations, compromised quality of life, and limited options for control of symptoms. Current research is inconclusive regarding the use of continuous home inotropic therapy (CHIT). Historically, intravenous inotropic therapy (IIT), outside of intensive care cardiac units, was administered in outpatient CHF clinics as intermittent infusions. As a result, a majority of the data reporting outcomes for patients receiving IIT was collected from these two settings. Transplant teams began to prescribe CHIT for patients awaiting heart transplant. Observations of this patient population prompted CHIT as an option for end-stage CHF patients. The home infusion industry has provided CHIT for many years with positive outcomes. Providers would benefit from a review of outcomes to support development of best practices. This provider developed a CHIT program focused on education for patients, physicians, home health agencies and inpatient healthcare providers.

PURPOSE: The purpose of this review is to report clinical outcomes that may influence providers’ decisions to prescribe CHIT and that impact CHF goals of therapy.

METHODS: A retrospective review of electronic medical records (EMR) for patients receiving CHIT from one location of this provider was performed to report clinical outcomes. Study inclusion criteria included patients started on CHIT between July 1, 2009 and November 30, 2013. Outcome parameters include the endpoints of therapy, 30-day and aggregate hospital admissions, and vascular access device (VAD) complications. Exclusion criteria included active patients on therapy less than 150 days as of November 30, 2013. A subgroup (sample size: 52) which excluded patients on service less than 30 days was also reviewed to predict long-term outcomes.

RESULTS: 65 CHIT patients met inclusion criteria. Endpoints of therapy included 15% of patients still active on service; 25% were deceased; 15% had transitioned to hospice; 12% received a left ventricular assist device (LVAD, 2 later received transplant); 15% were discontinued for various reasons; 6% elected to stop therapy; 5% received a heart transplant; and 6% were weaned. Total therapy days were 17,784. Average days on therapy were 274 (338 days for the subgroup). The occurrence of VAD complications (occlusion, infection, inadvertent removal) was 2.2 per 1,000 catheter days. Patients readmitted for all causes within 30 days following initiation of therapy (excluded hospitalizations during which the patient died) was 0.12 as compared to the national average in 2006-2009 of 0.251. Aggregate hospital admissions were 1.01 per patient (one admit every 269 patient days).

CONCLUSION: While the sample size lacked statistical significance, the results suggest CHIT may be an effective treatment option for select advanced heart failure patients based on reduced rates of hospitalization observed in this small sample. Further research is needed before results can be extrapolated to a larger population. A reduction in the 30-day readmission rate may result in decreased healthcare costs, in addition to reduced risk of nosocomial/iatrogenic complications that contribute to adverse outcomes and anticipated increased mortality. Active patients were included in these results, which falsely lowers the average days on therapy. The potential variation of documentation in electronic medical record (EMR) may be considered a limitation of this study.

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