Antimicrobial activity of LB10827, a new orally administered cephalosporin, tested against Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae.

A new orally administered cephalosporin, LB10827, was compared to 16 other antimicrobial agents tested against Streptococcus pneumoniae (520 strains), Haemophilus influenzae (302 strains) and Moraxella catarrhalis (188 strains) by reference broth microdilution methods. LB10827 (MIC90, 0.12 mg/L; highest MIC, 0.5 mg/L) was 8-16-fold more potent than cefdinir, cefpodoxime or cefuroxime when tested against S. pneumoniae. All Gram-negative strains were inhibited at

Emerging antimicrobial resistances among Proteus mirabilis in Europe: report from the MYSTIC Program (1997-2001). Meropenem Yearly Susceptibility Test Information Collection.

Resistance patterns that are currently problematic in Europe can vary greatly within the same species over time, among various patient populations and among geographic regions on the same continent. The results from the Meropenem Yearly Susceptibility Test Information Collection (MYSTIC) Program, which monitors carbapenem resistance rates in institutions using meropenem, were used to determine resistance differences among Proteus mirabilis. MIC results from 688 P. mirabilis strains were classified into 4 patient care groups: ICU (n=426), neutropenia patients (NP; n=145), general wards (n=97) and cystic fibrosis patients (CF; n=20). A total of 40 centers from 12 European countries have participated since 1997, divided into 3 geographic regions (East, North, South). All testing was performed by NCCLS reference methods and interpretive criteria, including screening of extended-spectrum beta-lactamase (ESBL) phenotypes. Over the monitored interval the resistance rates varied for each agent without a clear trend toward a greater rate. Rank order of susceptibility was: meropenem (99%) > piperacillin/tazobactam (TAZ; 96%) > cefepime (95%) > ceftazidime (CAZ; 94%) > imipenem (IPM; 92%). Ciprofloxacin (CIP) was the least active agent tested (MIC90 4 microg/ml; 86% susceptible). Unexpectedly, 3.6% of P. mirabilis were imipenem-resistant (MIC, > or = 16 microg/ml). Greater rates of resistance were found for strains from NP and CF patients, and from eastern or southern European sites, usually associated with epidemic clusters. Generally susceptible species such as P. mirabilis have recently emerged as therapeutic problems in European medical centers following mutations that compromise CIP, CAZ and aminoglycoside use. Imipenem also showed decreased susceptibility of greater than 7% compared to less than 1% for meropenem. Continued surveillance by the MYSTIC Program appears to be a prudent practice to focus effective empiric treatment regimens.

A cost-benefit analysis of RSV prophylaxis in high-risk infants.

OBJECTIVE: To determine the cost and benefit of using RSV-IG and palivizumab as prophylactic therapy against respiratory syncytial virus (RSV)-associated illness in high-risk infants. METHODS: A nonrandomized, retrospective, cohort control study was conducted comparing the outcomes of patients who received either RSV-IG or palivizumab therapy against RSV during the 1998-1999 RSV season with patients identified from the 1994-1995 RSV season who would have been eligible to receive prophylaxis had either agent been available at that time. Medical record reviews were conducted to gather data regarding the costs associated with both the administration of the prophylactic drugs and the treatment of RSV-associated hospitalizations in both groups. Decision analysis was used to determine the average cost per patient for both groups. A cost-benefit analysis was then conducted to determine the return on investment, if any, for the use of these drugs. A sensitivity analysis was also conducted to determine the robustness of the data. RESULTS: Patients who received RSV-IG or palivizumab had a hospitalization rate of 1.6% compared with 25% for the group who did not receive prophylactic drugs. The average costs for the RSV prophylaxis group were less per patient $3,733 compared with $4,258 in the group who did not receive prophylaxis. The benefit is a 23.4% lower chance of hospitalization for each infant or, in dollar figures, $3,985 ($17,031 x 0.234). The benefit-cost ratio is 1.15:1 ($3,985:3,461). The benefits, therefore, exceed the costs associated with the prophylaxis program. The prophylaxis program saved healthcare dollars by preventing RSV-related hospital-izations. CONCLUSIONS: Results demonstrate that when used according to our institution's criteria, RSV prophylaxis is of benefit to our institution.

Medication use evaluation: a work in progress.

The medication use evaluation (MUE) Program at the University of Iowa Hospitals and Clinics (UIHC) is a dynamic program that is constantly changing to meet the needs of this tertiary care institution. This article will provide an overview of the MUE process at UIHC as well as provide an example of a long-standing initiative that has evolved significantly since its inception in 1993. Examples of four other initiatives also will be provided to demonstrate the scope of this program. The examples to be covered in this article include: 5-HT3 receptor antagonists, alteplase, automatic substitution of cefotaxime, proton pump inhibitors, and COX-2 selective agents.

University of Iowa Hospital and Clinics: outcomes management.

Delivery of quality patient care and management of patient outcomes is critical to the success of academic medical centers in the ever-changing health care market. The University of Iowa Hospitals and Clinics (UIHC) promotes quality care through the provision of organizational structures and processes that are described in this article. In addition, quality of care and outcomes management are described by members in various roles within the UIHC health care system. It is the authors' belief that understanding quality from these various perspectives helps UIHC work across departments to achieve excellence in patient care.

The integration of quality assessment and a patient-specific intervention/outcomes program.

The clinical intervention program in place at the University of Iowa Hospitals and Clinics is based on the pharmacist's evaluation of the patient, the disease state, and the appropriateness of the selected therapy. The system was developed so that all pharmacists within our institution: staff pharmacists, clinical pharmacy specialists, clinical pharmacists, and pharmacy residents can easily and efficiently document all interactions with other health care providers. The recent introduction of the Medication Use Indicators process by the Joint Commission has provided many pharmacy departments with a series of outcome measurements which may prove useful in their attempts to maximize contributions to the medication use process. In this article, we describe how our department has begun to utilize the Joint Commission indicator data by integrating information from them into the daily practices of our staff, and how our department has utilized a formal interventions and outcomes program to evaluate such efforts.

Cost savings and avoidance from clinical interventions.

A method that lets a pharmacy department collect data on cost savings and avoidance achieved through pharmacist interventions is described. The pharmacist intervention program at an 849-bed institution is based on the pharmacist's evaluation of the patient, the disease or condition, and the appropriateness of the drug therapy selected. The pharmacist records the recommendation, the rationale, and the intervention outcome, and the data are entered into the medication order-entry system. An assigned code indicates the potential severity of consequences had the intervention not been made. The information is forwarded to the clinical interventions and financial assessment committee (CLIFAC) for analysis of cost savings and potential cost avoidance. To calculate savings, CLIFAC determines the drug acquisition and relevant laboratory costs that would have been charged, as well as the cost of a change in therapy. A method was developed that allows CLIFAC to use hospital-specific diagnosis-related-group data to determine potential cost avoidance as a function of hospital days prevented. From July 1994 through April 1995, 4648 interventions were documented by the 50-member inpatient and ambulatory care pharmacist staff and evaluated and quantified. Of these interventions, 87% were accepted by the medical staff. The accepted interventions represent a net therapy cost saving of $487,833, as well as a cost avoidance of $158,563 achieved by prevention of a potential net 371.9 additional hospital days. A pharmacy department's financial assessment committee evaluated pharmacist interventions by determining changes in the cost of therapy and estimating potential changes in the length of stay.

The implementation of a pharmaceutical care practice system.

The growing emphasis on a well-rounded clinical pharmacy practitioner, combined with the implementation of the six-year Doctor of Pharmacy degree requires innovative training strategies. A method to integrate clinical practice and training missions is described in Development of a Patient Care Unit(PCU). Pharmacist practice is described.

Drug allergy assessment at a university hospital and clinic.

The accuracy of drug allergies reported in patients' medical records and the cost-effectiveness of pharmacist interviews to clarify these reports were studied. Fourteen pharmacists interviewed hospital and clinical patients about reported allergies and noted their assessments in the patients' charts. The patient's physician was notified of discrepancies between previous allergy documentation and the pharmacist's assessment. The pharmacy resident re-interviewed a convenience sample of the patients to determine consistency among the pharmacists. The reported reactions were classified as true allergies, severe adverse effects, or vague reactions (drug should be avoided); drug intolerance and mild or moderate adverse effects; excessive pharmacologic effects; or no reaction experienced. The medication profile for each patient was reviewed after discharge to identify the pharmacists' prevention of adverse effects or allergic reactions; cost avoidance was then estimated. The pharmacists assessed 347 reports of allergies in 195 patients. Anti-infective agents accounted for 53% of the stated allergies, followed by narcotics (18%), psychotropic medications (7%), nonsteroidal anti-inflammatory drugs (6%), cardiovascular medications (5%), and others (11%). For more than 80% of the reports of allergies to beta-lactam antibiotics and sulfonamides, pharmacists either found or could not rule out true allergies; this was the case for only 31% of reported allergies to narcotics. Nine percent of patients who reported allergy to a beta-lactam or sulfonamide had never experienced a reaction to the drug. Pharmacists intervened in four cases to prevent adverse reactions and a total of 4.4 additional hospital days, and in five instances the use of a less suitable or more expensive drug was avoided. Pharmacists found a large discrepancy between reported allergies and true allergies and helped prevent uses of drugs that could have prolonged patients' hospital stay.

Locally derived clinical practice guidelines using a decision analysis model.

As health-care providers continually are faced with the need to identify the most cost-effective modalities when initiating therapy among many therapeutic options, standardized clinical guidelines become the foundation for decision making. This article discusses how decision analysis can be useful in the formulation of locally derived clinical practice guidelines. The following is an example of using decision analysis to evaluate data gathered within the institution, supplemented by peer-reviewed literature, to choose the most cost-effective agent in the treatment of chemotherapy-induced nausea and vomiting at the authors' institution.

A cost analysis comparing erythropoietin and red cell transfusions in the treatment of anemia of prematurity.

BACKGROUND: Anemia of prematurity is invariably observed in very low birth weight infants and may become symptomatic enough to be treated with packed red cell transfusions. Recently, treatment of this condition with recombinant human erythropoietin has been advocated. STUDY DESIGN AND METHODS: To compare the costs of training symptomatic anemia in hospitalized premature infants with transfusions alone or with erythropoietin plus red cell transfusions as needed, cost estimates were derived from local hospital and published cost data. Decision analysis and sensitivity analysis were applied to a "base case." The base case was derived from results of a multicenter erythropoietin trial in the United States in which premature infants received 500 U of erythropoietin per kg of body weight each week. Because erythropoietin treatment began on average at 3 weeks of life, when infants were clinically stable, they had already received 3.5 red cell transfusions. During the 6-week treatment period, erythropoietin-treated infants received significantly fewer additional transfusions: a mean of 1.6 versus 1.1. RESULTS: The base-case cost in 1993 dollars for treating anemia in hospitalized premature infants with erythropoietin and transfusions was $1,326. This was nearly twice the cost of conventional treatment with transfusions alone ($721). If the 6-week treatment period alone is considered, erythropoietin is 3.6 times more costly: $840 versus $235. CONCLUSION: The largest available US study using erythropoietin to treat anemia in premature infants has demonstrated a small, but significant, reduction in transfusion needs. However, this study's cost data alone do not justify the widespread use of erythropoietin in premature infants. When this issue is probed in great depth, sensitivity analyses demonstrate that major reductions in erythropoietin's cost and/or improvements in its effectiveness quite possibly will make its use economically more attractive.

Use of decision analysis to evaluate the costs and benefits of filgrastim (G-CSF) therapy.

The FDA's approval of filgrastim (granulocyte colony-stimulating factor [G-CSF]) for accelerated recovery of neutrophil counts following chemotherapy has prompted discussions regarding the cost and benefits associated with such expensive new therapies. One method to evaluate the cost effectiveness of a therapy is decision analysis, which provides a quantitative method of cost analysis. Using the principles of decision analysis, we created a decision-analysis tree for evaluating the cost effectiveness of G-CSF therapy. Based on data gathered from a retrospective review of ambulatory oncology patients, we found that routine administration of G-CSF to all outpatients receiving chemotherapy is not cost effective, although it would be justifiable for some patients.

Influencing prescribing practices and associated outcomes utilizing the drug use evaluation process.

Influencing prescribing practices and the implementation of pharmaceutical care utilizing the drug use evaluation (DUE) process at a 891-bed teaching hospital are described. The DUE program has been structured to provide for significant pharmacy involvement while maintaining medical staff responsibility as outlined by the Joint Commission on Accreditation of Healthcare Organizations. A multidisciplinary approach is used to identify problems and develop prescribing criteria and educational initiatives. Pharmacists provide drug therapy monitoring and engage in clinical interventions and documentation of outcomes on a daily basis. DUE program pharmacists help target possible interventions, assure monitoring and outcome documentation, and compile results of all initiatives for reporting purposes to the medical staff and quality assessment program. Specific performance compliance and problems are identified and incorporated into the credentialing process. Corrective measures are determined by the Pharmacy and Therapeutics (P&T) Subcommittee with subsequent actions carried out by peer physicians. The net result is a positive influence on prescribing practices that improves the appropriate and effective use of drugs and improves patient outcomes.

Recombinant human erythropoietin vs transfusions in the treatment of anemia of prematurity. A cost-benefit analysis.

OBJECTIVE: To evaluate the costs relative to the benefits of using recombinant human erythropoietin (rHuEPO) therapy as an alternative to red blood cell (RBC) transfusions in infants with anemia of prematurity. DESIGN: A cost-benefit analysis of rHuEPO therapy was performed based on its use in very-low-birth-weight premature infants. SETTING AND PATIENTS: Data were drawn from published studies or were provided by the University of Iowa Hospitals and Clinics, Iowa City. MAIN OUTCOME MEASURES: Costs and benefits were analyzed as a comparison of incurred costs to averted costs. Incurred and averted costs of rHuEPO therapy and RBC transfusions included direct product costs and estimates of costs of adverse events. The analysis was viewed in terms of net savings. Sensitivity analysis was performed. RESULTS: The base case analysis yielded a net loss of $299.48 per infant. A 54% reduction in the direct product costs of rHuEPO therapy yielded a break-even point. No other variations in the sensitivity analysis resulted in a net savings. CONCLUSION: Using assumptions based on the current state of clinical research, it appears that routine use of rHuEPO with supplemental RBC transfusions would not generate any cost savings as an alternative to RBC transfusions alone. As further evidence is compiled on the efficacy of rHuEPO therapy in very-low-birth-weight premature infants, the true costs may be better established.

Application of decision analysis in antibiotic formulary choices.

OBJECTIVE: To introduce the reader to the fundamentals involved in using decision analysis as a tool in evaluating the associated costs and effectiveness of comparable therapeutic agents. DATA SOURCES: Currently available literature citations were used to provide the reader with basic references whose purpose is to provide a step-by-step approach for using Decision Analysis in conducting a cost-effective comparison of three commonly used antibiotics. Data were gathered from a previously conducted retrospective chart review where the three antibiotics were used for either prophylactic, empiric, or documented infections. Although this study was limited by its retrospective nature, the reader can use the data to appreciate the fundamentals of decision analysis. CONCLUSIONS: The continually changing climate in healthcare and the added visibility of pharmacologic agents in the treatment and prevention of disease has increased pressure on pharmacy departments to provide therapeutic agents that are cost-effective. Decision analysis can be used to compare therapeutic agents, in terms of financial as well as clinical outcomes, in a structured fashion that all members of the health care team can understand. The application of Decision analysis is appropriate for many therapeutic agents, not just antibiotics.

Clinical strategies in drug therapy selection: an application of "counter-detailing".

These projects have realized significant control of drug costs while also serving as a basis for future project implementation. In general, communication through the P&T, medical department heads, and senior hospital administrators has positively impacted on the ability to achieve these cost savings. The forms of communication have incorporated written and posted information along with oral presentations for the purposes of enhancing positive and progressive service in the cost-efficient delivery of pharmacotherapy.