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Annual Meeting Abstracts 2004 FEATURE treated identically. Fifteen patients were evaluated before and after implementation of the protocol to assess preexisting ordering practices for laboratory tests, epoetin route of administration (subcutaneous versus intravenous) and iron supplements (yes or no). As per the protocol, subcutaneous injections were used in all patients unless the volume (>1 mL) required use of the intravenous route and/or the patient refused the subcutaneous injection. All 15 patients in the intervention group had laboratory monitoring done to assess iron deficiency anemia. Iron supplements were ordered (iron sulfate 300 mg three times daily) for patients with transferrin saturation less than 20% and/or serum ferritin less than 100 ng/mL. The primary end points of the project included: utilization of the subcutaneous route for epoetin, monitoring of baseline iron laboratory values, and increased use of iron when appropriate. Results: Epoetin therapy was not optimized in the host institution before the implementation of the protocol. Before pharmacist intervention, the subcutaneous route was not the primary route of administration, and the intravenous route was used routinely when it was not indicated. In addition, iron store studies were not done consistently to assess for irondeficiency anemia. Even when laboratory values were available and iron was indicated, supplementation was often not ordered with epoetin. In the postpharmacy intervention group, all epoetin orders were changed to subcutaneous where feasible. Iron stores were checked with every new order for epoetin, and iron supplements were consistently ordered if indicated. Conclusions: Pharmacist intervention and pharmacy-managed programs can help optimize drug use. A pharmacy-initiated protocol was shown to improve the use of the appropriate route for administration of epoetin (usually subcutaneous) in chronic renal failure patients. In addition, the protocol improved laboratory monitoring of iron stores and led to increased iron use in patients receiving epoetin. 109—EXPERIENCE WITH A SYMPTOM- TRIGGERED ALCOHOL WITHDRAWAL SYNDROME PRACTICE GUIDELINE IN HOSPITALIZED PATIENTS. Worrall C, Padgett S, Medical University of South Carolina, Stanley K, Medical University of South Carolina. E-mail: worrallc@musc.edu Objective: We developed a symptom-triggered alcohol withdrawal syndrome (AWS) Practice Guideline and piloted its use in general surgery and medicine patients. Our primary and secondary objectives were to improve outcomes in hospitalized patients at risk for AWS and to evaluate the safety and efficacy of the guideline to determine whether hospital-wide implementation would be appropriate. This report summarizes our experience using the guideline in 106 hospitalized patients. Methods: An evidence-based AWS Practice Guideline was developed by a multidisciplinary team of practitioners. After appropriate staff education, the guideline was piloted in a general surgery and a general medicine group. Control data were collected retrospectively, while guideline data were collected concurrently for each group. Primary outcome measures included milligrams of drug administered, presence of AWS seizures or QTc prolongation, transfer to an intensive-care unit (ICU), use of restraints or sitters, and length of stay (LOS). Continuous data were assessed using a two-tailed t test, and proportional data were assessed using chisquare and Fisher‘s exact test. Multivariate logistic regression was used to assess LOS. Results of each individual analysis and a combined analysis are described below. Results: Demographics of the surgery or combined analysis groups were similar, but the medicine analysis demonstrated significantly more women in guideline group (P = .02). Lorazepam use decreased significantly across all guideline-managed patients (surgery P = .01, medicine P < .01, combined P < .01). Clonidine use increased significantly in the guideline-managed surgery and combined groups (P < .01 in both groups). There was no difference in haloperidol use in any group. The medicine and combined analyses demonstrated a significant number of guideline-managed patients requiring no drug therapy (P = .01 and P < .01, respectively). Withdrawal seizures, QTc prolongation, transfers to an ICU, restraint hours, and LOS were similar between groups. Sitter hours decreased significantly in the guideline combined analysis (P = .01), but the surgery and medicine analyses did not reach significance. Conclusions: The AWS Practice Guideline significantly decreased benzodiazepine use in guideline-managed general surgery and medicine patients. Many patients required no drug therapy when managed using this symptom-triggered approach. We are currently working with our hospitalists to expand the use of this practice guideline hospitalwide. 110—GABAPENTIN: A POOLED ANALY- SIS OF ADVERSE EVENTS FROM THREE POSTHERPETIC NEURALGIA CLINICAL TRIALS. Parsons B, Pfizer, Tive L, Huang S, Pfizer, Inc. E-mail: stephens@fallonmedica.com Objective: Gabapentin has been shown to effectively and safely manage the pain of postherpetic neuralgia (PHN). Adverse events are often doserelated, with frequency and severity increasing with increasing dosage. Here, we assessed the relationship between gabapentin dose and adverse events using data from studies of patients with PHN. Methods: Data were pooled from three randomized, double-blind, placebo-controlled, parallelgroup studies (N = 599 PHN patients). Three treatment category groups were included in the analysis: patients receiving placebo (N = 243); patients receiving less than 1,800 mg/day (N = 356) and patients receiving 1,800 mg/day gabapentin or more (N = 321). Gabapentin was initiated at 300 mg and titrated to maintenance doses of 1,800–3,600 mg/day by days 12–24. Patients receiving higher doses had received lower doses. An adverse event was scored at dose of first onset, and scored again at a higher dose if it worsened in severity. Results: The three most common adverse events were dizziness, somnolence, and peripheral edema. Patients had a higher incidence of peripheral edema with gabapentin in doses of 1,800 mg/day or more (7.5%) compared with lower gabapentin doses (1.4%). The incidence at the higher (P = .0014) but not the lower (P > .05) doses was significantly different from the placebo rate of 1.6%. By contrast, patients did not have a higher incidence of dizziness and somnolence with higher gabapentin doses. Patients receiving less than 1,800 mg/day of gabapentin reported dizziness (20.2%) and somnolence (14.9%) at a significantly greater frequency than the respective placebo rates of 7.4% and 5.8% (P = .005). However, at less than 1,800 mg/day, the 9.7% and 6.9% rates of dizziness and somnolence were both comparable to placebo (P > .05). Discontinuation rates were comparable between patients receiving placebo and gabapentin. Conclusions: These data demonstrate that although a mild increase in the incidence of peripheral edema is observed when patients receive greater than or equal to 1,800 mg/day of gabapentin, dizziness and somnolence are transient and do not occur more frequently or worsen when patients are titrated to doses of 1,800 mg/day or more by days 12–24. Therefore, safety concerns should not limit titration to achieve optimal efficacy. 111—RAPID ONSET OF ABSORPTION WITH OLANZAPINE ORALLY DISINTE- GRATING TABLETS. Houston J, Bergstrom R, Mitchell M, Hill A, Taylor C, Liu-Seifert H, Yadav Marya R, Jones B, Witcher J, Eli Lilly and Company. E-mail: rich.bergstrom@lilly.com Objective: A clinical perception exists suggesting more rapid onset of action with olanzapine orally disintegrating tablet (ODT) versus olanzapine standard oral tablet (SOT). Olanzapine bioavailability data were evaluated to assess early plasma concentration time profiles for olanzapine ODT versus SOT. Methods: In three crossover bioequivalence studies of olanzapine ODT (5, 10, or 20 mg) versus SOT (1 × 5 mg, 2 × 5 mg, 4 × 5 mg), approximately 20 healthy subjects received single-dose ODT and the corresponding dose of SOT (13 or more days between treatments). Olanzapine plasma concentrations, area under the serum concentration– time curve (AUC) and peak concentrations (C max ) values were evaluated to assess bioequivalence. Early onset of absorption was assessed using comparative absorption profiles. Results: Olanzapine ODT and SOT are bioequivalent based on AUC and C max . Overall plasma concentration-time profiles and absorption rate constants were nearly identical between formulations. Nonetheless, with 5 mg olanzapine, 79% of ODT versus 0% of SOT patients had measurable olanzapine concentrations at 15 minutes. Significantly more subjects receiving ODT had higher plasma concentrations over the first hour versus SOT (e.g., 63% versus 10% with 1 ng/mL or more at 45 min- 2004 Abstracts of Contributed Papers Vol. 44, No. 2 March/April 2004 www.japha.org Journal of the American Pharmacists Association 253 Downloaded From: http://japha.org/ on 01/25/2014
FEATURE Annual Meeting Abstracts 2004 utes). Small early concentration differences at become indistinguishable before reaching C max . Conclusions: Olanzapine ODT yields a more rapid onset of absorption than SOT as significantly more subjects given ODT achieved slightly higher olanzapine concentrations immediately after administration. The small differences are likely attributable to more rapid onset of ODT gastrointestinal absorption. These differences do not change the conclusion of bioequivalence. The relevance of earlier onset of absorption to clinical treatment has not been tested. Original Citation: U.S. Psychiatric Congress, November 6–9, 2003, Orlando, Fla. 112—STANDARDIZED CHEMOTHERAPY ORDER FORMS. Sano H, Waddell J, Doulaveris P, Myhand R, Walter Reed Army Medical Center. E-mail: harold.sano@na.amedd.army.mil Objective: To develop standardized chemotherapy order forms (SCOFs) for our institution’s most commonly prescribed cancer chemotherapy regimens and determine if the use of these SCOFs is associated with a decrease in prescribing error rate and a decrease in antiemetic costs. Methods: Of the most commonly used chemotherapy regimens from medical and gynecologic oncology, 60 were identified from textbooks, handbooks, primary literature, and consultation with experts. The medication doses, schedules, routes and durations of administration, cycles, required laboratory tests, and recommended supportive measures were extracted from primary literature. Antiemetic needs were drawn from standard nomograms. For each regimen, all of the above data were incorporated into a one-page SCOF in standard word-processing software. Final approval of each SCOF was obtained from the Chief, Oncology Pharmacy Service, the Director, Oncology Pharmacy Residency Program, and the Chief, Hematology-Oncology Service. The 60 SCOFs were developed over a 4-month control period, during which antiemetic cost and prescribing error data were monitored. After the control period, all 60 SCOFs were fielded during a 4-month intervention period, which is ongoing. Antiemetic cost and prescribing error data are being monitored. Differences in prescribing error rate and antiemetic cost between the control and intervention periods will be calculated. Prescribing error rate in the intervention period will also be compared with a historical prescribing error rate for this service. Results: NA. Conclusions: NA. APhA–APPM Nuclear Pharmacy Practice 113—ENHANCED LIVER UPTAKE OF TC- 99M–LABELED RED BLOOD CELLS DUR- ING GASTROINTESTINAL BLEED SCINTIGRAPHY USING TRANSFUSED RBC COMPARED TO AUTOLOGOUS RBC. Melchior W, Wong K, Beauvais M, Snyder S, William Beaumont Hospital. E-mail: wmelchior@ beaumonthospitals.com Objective: To report two cases of altered distribution of Tc-99m–labeled red blood cells (RBC) to the liver during GI studies. Methods: GI bleed studies were performed on two occasions for a 91-year-old woman and one occasion for a 96-year-old man. The in vitro method of RBC labeling with Tc-99m was used (Ultratag, Mallinckrodt Medical, following the package insert directions). For the woman, the first study used autologous blood, while her second study was performed using cells from donor packed cells infused the day of the study. The study for the man was performed using cells from donor packed cells infused the day of the study. Quality control was performed following the package insert directions for all lots of labeled RBC. Binding of Tc-99m to the RBC was 98.0% to 99.4%. Results: All studies were negative for a GI bleed. Using the heart as the reference organ, the relative degree of liver uptake for the woman was 45% using autologous blood and 97% using transfused blood, and 91% for the man using transfused blood. Conclusions: Increased liver uptake of Tc- 99m–labeled RBC obtained from a unit of transfused packed RBC was demonstrated compared with Tc-99m–labeled autologous RBC. Liver uptake of Tc-99m–labeled RBC is normally 50% or less using the heart as the reference organ. Although survival of transfused RBC is normal in cells surviving beyond 24 hours, a small but unknown percentage of transfused RBC is not expected to survive the transfusion process. The basis of the increased liver uptake of Tc-99m–labeled RBC obtained from a unit of transfused packed RBC seen in these cases is unknown. When using Tc- 99m–labeled transfused RBC for the evaluation of gastrointestinal bleeding increased uptake in the liver may be anticipated. 114—EXPECTED QUALITY OF LIFE AND COST IMPLICATIONS OF R-CHOP AND RADIOIMMUNOTHERAPY REGIMENS FOR INDOLENT NON-HODGKIN´S LYMPHOMA. Chumney E, Kit S, Cheng K, Chris B, Hall P, Medical University of South Carolina. E-mail: chumneye@musc.edu Objective: The recent introduction of radiolabeled antibodies (radioimmunotherapy) has offered a promising new therapy for indolent non- Hodgkin’s lymphoma (NHL), though with varying efficacy estimates. The major objective of this study is to examine the effect of these varying estimates on patient outcomes, costs, and quality of life. Methods: A Markov model was used to simulate the experience of newly diagnosed indolent NHL patients treated with the conventional course of rituximab and cyclophosphamide/doxorubicin/vincristine/prednisone (R-CHOP) followed by radioimmunotherapy and then palliative care. The model comprises 10 health states including complete, partial, and no response to each treatment course, and then death. Patients transition through at 1-month intervals with transition probabilities based on published estimates; the literature searches included Medline, ScienceDirect, general Internet searches, and company information. Quality of life estimates were based on expert pharmacist opinion using visual analog scales, and cost estimates were based on the average wholesale price (AWP). Results: Our base model with a 26% complete response rate to radioimmunotherapy has total treatment costs of $212,233 per patient. Median survival time after diagnosis is 7.8 years, with 41% of patients still alive at the end of the ten-year period. Mean quality-adjusted life-years (QALYs) are 2.89. We next programmed the model with a 76% complete response rate and found total treatment costs of $211,639 per patient with mean QALYs of 3.54. We will also report on potential benefits if the order of treatment is reversed so that patients have radioimmunotherapy as their front-line therapy. Conclusions: Although the efficacy estimates of radioimmunotherapy vary widely in the literature, we found they produced only a slight difference in the resulting 10-year cost estimates. This is primarily attributed to the treatment sequence of the base model. The different assumptions of efficacy had a large effect on the patients’ overall quality of life. 115—ORGANIZATION OF LYM- PHOSCINTIGRAPHY PROTOCOLS. Beauvais M, William Beaumont Hospital, Dobish D, William Beaumont Hospital, Melchior W, William Beaumont Hospital. E-mail: mbeauvais@ beaumonthospitals.com Objective: Various lymphoscintigraphy protocols are ordered by the surgical physicians in a large teaching hospital. To clarify the instructions of the physicians, a nuclear medicine department unfiltered Tc-99m sulfur colloid breast lymphatic mapping request form was developed. The purpose of this project was to create a simplified method for drawing up and dispensing the requested doses. This led to the creation of a nuclear pharmacy preparation guideline form. Methods: Physician requests were reviewed and a Tc-99m sulfur colloid breast lymphatic mapping request form was devised. The form describes the Tc-99m sulfur colloid activity required for each protocol, the size and number of syringes the dose should be dispensed in, the gauge of needle to attach to the syringes, the radiopharmaceutical concentration and volume as well as injection instructions for the physician. Tc-99m sulfur colloid syringes for the subareolar and peritumoral protocols were measured before and after injection to determine the residual activity in the syringes. The postinjection activity was decay corrected to the time of the preinjection measurement. The appropriate concentrations for each protocol were determined and a nuclear pharmacy preparation guideline form was developed. Results: A nuclear pharmacy preparation guideline form was devised based on preinjection and postinjection Tc-99m sulfur colloid syringe measurements to aid radiopharmacy personnel to prepare the necessary concentration for each lymphoscintigraphy protocol. 254 Journal of the American Pharmacists Association www.japha.org March/April 2004 Vol. 44, No. 2 Downloaded From: http://japha.org/ on 01/25/2014
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