James A. Jorgenson

Workplace Contamination with Antineoplastic Agents in a New Cancer Hospital Using a Closed-System Drug Transfer Device

Objective To determine levels of environmental chemotherapy contamination in a new cancer hospital that has exclusively used a closed-system drug transfer device (PhaSeal) for preparing and administering all compatible antineoplastics. Methods After 6 months of operation, surface samples were collected from pharmacy and nursing areas to determine levels of contamination with cyclophosphamide and ifosfamide. In addition, urine samples were collected from pharmacists, pharmacy technicians, and nurses to determine employee exposure to these agents. All samples were analyzed using liquid chromatography/tandem mass spectrometry. Results Twenty-one percent (7/34) of surface samples collected tested positive for cyclophosphamide contamination. Twelve percent (4/34) of surface samples tested positive for ifosfamide. To place this into perspective, historical data collected at our outpatient oncology infusion clinic 6 months after converting to PhaSeal from conventional methods of antineoplastic preparation showed 33% (7/21) and 71% (15/21) of samples tested positive for cyclophosphamide and ifosfamide, respectively. The level of ifosfamide contamination found in samples that tested positive at our new hospital also appeared to be lower than in positive samples at the outpatient infusion clinic. In the current study, the urine of one participant (1/11), a pharmacy technician, tested positive for low levels of cyclophosphamide and ifosfamide. To compare, 71% and 0% of participants tested at the outpatient infusion clinic had positive urine samples prior to and 6 months after implementation of PhaSeal, respectively. Conclusions: Compared with historical levels of contamination in our outpatient oncology infusion clinic, levels of chemotherapy contamination appeared lower. However, some contamination was still present in our new cancer hospital where PhaSeal had been used exclusively.

Contamination Comparison of Transfer Devices Intended for Handling Hazardous Drugs

Purpose Heightened awareness of hazardous drug contamination in the workplace has increased the number of marketed, closed-system drug transfer devices (CSTDs). Currently, no official specifications for a closed-system device are available. Therefore, it is important to validate each system against the recommendations given by International Society of Oncology Pharmacy Practitioners and the National Institute for Occupational Safety and Health to make the best decision for an institution. Summary Titanium tetrachloride was selected to simulate the escape of vapor from each product. The second evaluation concentrated on the “dry connections” between the vial and syringe during drug preparation and between the syringe and access port during administration. Fluorescein sodium was selected to simulate contamination with the dry connections between the vial and syringe and between the syringe and access port. Conclusion The 2 studies found that only 1 of the 5 devices tested met the criteria or definition of a CSTD.

Continued Challenges with the Use of Erythropoiesis‐Stimulating Agents in Patients with Cancer: Perspectives and Issues on Policy‐Guided Health Care

Erythropoiesis‐stimulating agents (ESAs) are approved as an alternative to blood transfusions for treating anemia secondary to chemotherapy in patients with cancer. Recently, ESAs have been a source of controversy and confusion in the oncology community. This began when two European trials—the Breast Cancer Erythropoietin Survival Trial (BEST) and the Advanced Head‐and‐Neck Cancer Treated with Radiotherapy (ENHANCE) Study—raised safety concerns about decreased overall survival and increased venous thromboembolic events. In 2004, the United States Food and Drug Administration (FDA) convened its Oncologic Drugs Advisory Committee (ODAC) to review the data and reassess the risks and benefits of ESAs in patients with cancer. On May 10, 2007, ODAC reconvened when five trials (BEST, ENHANCE, AMG‐20010103, AMG‐20000161, and EPO‐CAN‐20) showed decreased overall survival. The briefing document noted that studies demonstrating detrimental effects on survival and/or tumor outcomes used an unapproved treatment regimen designed to maintain hemoglobin levels above 12 g/dl. On May 14, 2007, just days after the ODAC reconvened, the Centers for Medicare and Medicaid Services (CMS) released a proposed decision memo for a national coverage determination (NCD) imposing restrictions on ESAs. For health care providers, aspects of the proposed NCD were markedly inconsistent with FDA‐approved ESA use and generally were considered ambiguous and unclear. Over objections of several professional associations and members of Congress, on July 30, 2007, CMS posted the final NCD and declared it effective immediately. When compared with FDA‐approved labeling and professional society guidelines, the NCD revealed differences in ESA initiation, dosage escalation, dosage reduction, and definition of response. These discrepancies have generated confusion among health care providers, who are struggling over whether they can feasibly provide a dual system of care—one for Medicare patients and another for non‐Medicare patients—that is evidence based. With this supplement, we hope to educate health care providers on the issues and challenges associated with policy‐guided health care when discrepancies exist between the policy and evidence‐based practice; offer guidance on implementing the NCD; and highlight the important role of pharmacists in the process.

Use and prescribing patterns for erythropoiesis-stimulating agents in inpatient and outpatient hospital settings.

PURPOSE Erythropoiesis-stimulating agent (ESA) use in the outpatient and inpatient settings through pharmacist-conducted, hospital-based chart audits is examined and discussed. METHODS Data from four hospital chart audits conducted in 250 hospitals between October 2005 and July 2006 were pooled for analyses. Eligible hospitals were categorized by ESA sales volume, with approximately equal numbers randomly selected from each decile. The last five inpatients and outpatients within each specified month receiving either darbepoetin alfa or epoetin alfa were evaluated. Study variables by setting included ESA use, prescriber specialty, and dosage regimen. RESULTS The most common hospital locations of ESA administration were a cancer center in the outpatient setting (49%) and general medicine (57%) in the inpatient setting. ESA prescribers were most commonly hematologists and oncologists in the outpatient setting, and nephrologists were the most common prescribers in the inpatient setting. In the outpatient analysis, 2155 patients were prescribed darbepoetin alfa and 3106 were prescribed epoetin alfa. The predominant administration frequencies were every two weeks and once weekly for darbepoetin alfa, and once weekly for epoetin alfa. In the inpatient analysis, 1633 patients were prescribed darbepoetin alfa and 3231 were prescribed epoetin alfa. The predominant administration frequencies were once weekly for darbepoetin alfa and once weekly and three times weekly for epoetin alfa. Common uses for both ESAs were chemotherapy-induced anemia (outpatient setting) and anemia of end-stage renal disease with chronic dialysis (inpatient setting). There was considerable variability in ESA dosages and administration frequencies in both settings within all patient groups when analyzed by specified use. CONCLUSION ESA use differed between outpatient and inpatient settings in indication, frequency of administration, and specialty of the prescriber.

Benefit of ribose in a patient with fibromyalgia.

Ribose was added to the existing treatment regimen of a woman with fibromyalgia, resulting in a decrease in symptoms. It has been postulated that patients with fibromyalgia may have an alteration in muscle adenine nucleotide metabolism, leading to depleted energy reserves and an imbalance in cellular adenosine 5′‐triphosphate:adenosine 5′‐diphosphate:adenosine 5′‐monophosphate (ATP:ADP:AMP) ratios with an abnormal energy charge. As a key component in adenine nucleotide synthesis, ribose supplementation may be useful in such patients.

Budget impact analysis of insulin therapies and associated delivery systems.

PURPOSE A budget impact analysis of insulin therapies and associated delivery systems is presented. METHODS Based on inputted procurement totals, per-item costs (based on 2011 average wholesale price), insulin distribution system (floor stock or individual patient supply), waste, and treatment protocols for a specified time frame, the budget impact model approximated the number of patients treated with subcutaneous insulin, costs, utilization, waste, and injection mechanism (pen safety needle or syringe) costs. To calculate net changes, results of one-year 3-mL vial use were subtracted from one-year 10-mL vial or 3-mL pen use. RESULTS Switching from a 10-mL vial to a 3-mL vial was associated with reductions in both costs and waste. The net reductions in costs and waste ranged from

Tools of the trade: Creativity, innovation, influence, and advocacy

15,482 and 120,000 IU, respectively, for floor-stock 10-mL vial to floor-stock 3-mL vial conversion to

Development and implementation of a pharmacy directed community health education and screening program

871,548 and 6,750,000 IU, respectively, for individual patient supply 10-mL vial to floor-stock 3-mL vial conversion. Switching from floor-stock 10-mL vials to individual patient supply 3-mL vials increased costs and waste by

Combined medication-and-supply automated delivery system in an ambulatory setting

164,659 and 1,275,000 IU, respectively. Converting from individual patient supply 3-mL pens to individual patient supply 3-mL vials reduced costs by

Using a closed-system protective device to reduce personnel exposure to antineoplastic agents

117,236 but did not decrease waste. CONCLUSION A budget impact analysis of the conversion of either 10-mL insulin vials or 3-mL insulin pens to 3-mL insulin vials found reductions in both cost and waste, except when converting from floor-stock 10-mL vials to individual patient supply 3-mL vials.