Gaining efficiencies: resources and demand for dialysis around the globe.

OBJECTIVES: End-stage renal disease (ESRD) is a debilitating condition resulting in death unless treated. Treatment options are transplantation and dialysis. Alternative dialysis modalities are peritoneal dialysis (PD) and hemodialysis (HD), each of which has been shown to produce similar outcomes and survival. Nevertheless, the financial implications of each modality are different and these differences vary by country, especially in the developing world. Changes in clinically appropriate dialysis delivery leading to more efficient use of resources would increase the resources available to treat ESRD or other disabling conditions. This article outlines the relative advantages of HD and PD and uses budget impact analysis to estimate the country-specific, 5-year financial implications on total dialysis costs assuming utilization shifts from HD to PD in two high-income (UK, Singapore), three upper-middle-income (Mexico, Chile, Romania), and three lower-middle-income (Thailand, China, Colombia) countries. RESULTS: Peritoneal dialysis is a clinically effective dialysis option that can be significantly cost-saving compared to HD, even in developing countries. CONCLUSIONS: The magnitude of costs associated with treating ESRD patients globally is large and growing. PD is a clinically effective dialysis option that can be used by a majority of ESRD patients and can also be significantly cost-saving compared to HD therapy. Increasing clinically appropriate PD use would substantially reduce health-care costs and help health-care systems meet ever-tightening budget constraints.

Survey of medication therapy management programs under Medicare part D.

OBJECTIVE: To describe and summarize the enrollment criteria and benefit designs for medication therapy management (MTM) programs offered throughout the United States during the first year of the Medicare Part D benefit. DESIGN: Cross-sectional survey. SETTING: United States between November 1, 2005, and June 30, 2006. PARTICIPANTS: MTM benefit plan managers of major health insurance companies nationwide selected nonrandomly by the investigators from lists provided by the Centers for Medicare & Medicaid Services. INTERVENTION: Telephone interview and/or e-mail 12-item survey with mostly open-ended questions. MAIN OUTCOME MEASURES: Characteristics required for a patient to be enrolled in MTM programs and types of services provided along with modes of delivery. RESULTS: Interviews were completed or surveys returned from 21 distinct MTM programs representing 70 health insurance plans covering 12.1 million Medicare enrollees. Of the MTM programs offered, 90.5% restricted their enrollment based on number of diseases, with a median of 3 (range, 2-5) diseases required; 57.1% restricted enrollment based on the type of chronic condition; and 95.2% had requirements for the number of medications (median, 6; range, 2-24) necessary for enrollment in the program. The most frequently provided MTM services were patient education (75.0% of programs),patient adherence (70.0%), and medication review (60.0%). The median number of different service types provided by MTM programs was 3 (range, 2-7). MTM program services included the use of mailed interventions (76.1%) and inhouse call centers (90.4%). While only 4 of the 21 MTM programscontracted with pharmacies to provide some or all of their MTM services, these plans covered a large number of beneficiaries (7.5 million lives). CONCLUSION: MTM programs offered by prescription drug plans and Medicare Advantage plans were highly variable during the first year of the Medicare Part D benefit. Definitive evidence supporting the effectiveness of many of the most common interventions is lacking.

Outcomes of oral anticoagulant therapy managed by telephone vs in-office visits in an anticoagulation clinic setting.

BACKGROUND: Anticoagulation management by a dedicated anticoagulation clinic improves patient outcomes compared to routine medical care. Telephone-based anticoagulation management has been described but has not been compared to management with traditional office-based visits. The objective of this study was to compare warfarin-related monitoring outcomes, clinical end points, and the use of health-care resources as a result of warfarin-related complications in anticoagulation clinic patients whose management was conducted by telephone or in-office-based visits. SETTING: Two university-affiliated anticoagulation clinics in Seattle, WA, and Chicago, IL. METHODS: A retrospective, observational cohort design was used to investigate anticoagulation clinic patients who were managed by telephone encounters compared to those managed during face-to-face in-office encounters. RESULTS: A total of 234 patients were evaluated; 117 patients managed by telephone were compared to 117 patients managed in office-based clinic visits. Monitoring outcomes (ie, time in therapeutic range and clinic visits per patient-year) were similar between groups. Differences in major bleeding (5.67% vs 5.62% per patient-year, respectively) and thromboembolic events (1.42% vs 2.81% per patient-year, respectively) between telephone-managed and face-to-face-managed patients did not reach statistical significance. The same was true for differences in the frequency of emergency department visits and hospital admissions to manage complications of warfarin therapy. CONCLUSIONS: Telephone-based management of oral anticoagulation through a pharmacist-staffed anticoagulation clinic yielded clinical outcomes that were at least as favorable as those associated with traditional office-based visits. Telephone follow-up can be successfully used to manage warfarin therapy in patients who are unable to present in person to an anticoagulation clinic.

Warfarin-related outcomes in patients with antiphospholipid antibody syndrome managed in an anticoagulation clinic.

Patients with antiphospholipid antibody syndrome (APA) are at elevated risk of venous and arterial thromboembolic complications. Oral anticoagulation with warfarin is recommended for secondary prevention of thromboembolism, but warfarin-related outcomes have not been systematically investigated when warfarin therapy is managed by a dedicated anticoagulation clinic. The objectives of the study were to evaluate warfarin-related monitoring outcomes, clinical endpoints and the use of healthcare resources as a result of warfarin-related complications in patients with APA compared to a group of patients without APA, all of whom were managed in an anticoagulation clinic setting. A retrospective observational cohort design was used to investigate patients with and without APA, all of whom had a history of venous or arterial thromboembolism, and were matched for age, gender and indication for oral anticoagulation. Thirty-six APA patients taking warfarin were compared to a matched cohort of 36 patients without APA. Monitoring outcomes (time in therapeutic range, clinic visits per year, frequency of warfarin dosing adjustments, reasons for out-of-range INRs) were similar between groups, as was the frequency of major bleeding complications (3.2%/pt-yr vs. 3.1%/pt-yr). However, recurrent thromboembolic events (9.6%/pt-yr vs 0) occurred more frequently in APA patients. APA patients required more emergency room visits (6.4%/pt-yr vs. 1.6%/pt-yr) and hospital admissions (14.4%/pt-yr vs.3.0%/pt-yr) to manage complications of warfarin therapy. In conclusion, despite similar monitoring outcomes obtained in a dedicated anticoagulation clinic setting, adverse clinical outcomes are significantly more frequent in patients with APA syndrome than in those without APA, and require more frequent use of healthcare resources.

Factors that influence prescribing within a therapeutic drug class.

RATIONALE, AIMS AND OBJECTIVES: The decision to prescribe one drug instead of another within the same therapeutic class may be influenced by a variety of drug-related, direct, or indirect factors; but little is known about which considerations are most important in such choices. The low-molecular-weight heparins (LMWHs) represent a class of drugs that are commonly used and for which therapeutic equivalence has been debated in the literature. The purpose of this study was to identify and compare factors perceived by doctors and clinical pharmacists to be influential in prescribing decisions among LMWHs. METHODS: Doctors and clinical pharmacists were interviewed to elicit information and to rank factors that influence the prescribing and use of LMWHs in community hospitals in the United States. For each factor, the mean and median of the rating were determined along with the frequency distribution across ratings. The non-parametric Mann-Whitney U-test was used to examine differences between doctors and clinical pharmacists. RESULTS: Both groups considered efficacy, formulary status, and policies restricting drug use to be highly influential in the decision to use one LMWH instead of another. Compared to clinical pharmacists, doctors rated personal experience as more influential, whereas they rated drug cost and prescribing guidelines lower. CONCLUSIONS: These findings suggest that doctors and clinical pharmacists differentiate between LMWHs based on differences between products and because of hospital administrative programs (such as drug formularies). This information may be of value in designing programs to alter medication use.

Impact of oral direct thrombin inhibitors on anticoagulation clinics.

OBJECTIVES: To characterize the services and activities performed by anticoagulation clinics (ACCs) across the United States, examine the anticipated impact that oral direct thrombin inhibitors (DTIs) will have on the clinical services of ACCs, and elicit possible management strategies to realign services provided by ACCs and opportunities for restructuring clinical services. METHODS: A survey was developed in consultation with content experts in the field, pretested by several ACC providers, and subsequently refined. Surveys were mailed to 400 randomly selected ACC-based providers. RESULTS: The final usable response rate was 34.5% (115 of 333 surveys). Respondents anticipated that the number of patient visits/month would decrease from a median of 336 (interquartile range [IQR] 151-775) to 150 (IQR 71-350, p<0.001) after the introduction of oral DTIs. In addition, time spent on many direct and indirect patient care activities currently performed by ACCs was expected to decline. Respondents indicated that ACCs may find new roles by providing guidance on individual suitability for therapy, managing the transition to oral DTIs, providing education for patients and health care providers on thrombotic disease state management, monitoring patients for recurrent thrombosis and risk of bleeding complications, monitoring patient compliance, and providing counseling and safety surveillance for patients receiving treatment with oral DTIs. CONCLUSION: The advent of oral DTIs is likely to have a significant impact on the structure and delivery of antithrombotic services. Clinics that are proactive and redesign their patient care services to consider emerging anticoagulant agents will be more likely to remain relevant and viable.

Impact of prescribing guidelines for inpatient anticoagulation.

BACKGROUND: Anticoagulants are widely used and represent a class of drugs that are problem-prone and have a high potential for adverse patient outcomes. As such, these drugs may be amenable to the use of prescribing guidelines. However, relatively little has been published on the effect of such guidelines on clinical outcomes or costs of care. OBJECTIVE: To assess whether guidelines improve the appropriateness of prescribing, clinical outcomes, and costs associated with use of anticoagulants in a sample of community hospitals in the US. METHODS: A retrospective analysis was performed of data voluntarily collected by 15 hospitals before (July-September 2001) and after (March-May 2002) implementation of anticoagulant prescribing guidelines. Statistical analyses of both patient- and hospital-level variables were conducted. RESULTS: Implementation of the guidelines resulted in a significant increase in the proportion of anticoagulants that were prescribed appropriately (59.8% vs 86.9%; p < 0.001). The guidelines also resulted in a shift in the type of anticoagulants prescribed (decreased use of unfractionated heparin and increased use of low-molecular-weight heparins). There was suggestive evidence, although not statistically significant, that the guidelines resulted in fewer anticoagulant-associated adverse events (total bleeding RR 0.71) and lower costs (savings of $56.15 per patient per day). CONCLUSIONS: While limitations existed with the study design, sufficient benefits were identified to warrant hospitals to consider use of these or similar guidelines on a routine basis. Clearly, additional study in this area would be useful.

Factors that influence prescribing decisions.

BACKGROUND: Strategies to control the quality and cost of medication use are largely dependent on the ability to alter selection of medications. Previous models of prescribing behavior have focused on physicians. In the hospital setting, clinical pharmacists and formulary committee members are also key players in drug therapy decision-making. Differences between physicians, formulary committee members, and clinical pharmacists have not been compared. Knowledge of these differences could have importance in predicting the effectiveness of strategies designed to influence drug use in this setting. OBJECTIVE: To describe and compare the opinions of physicians, clinical pharmacists, and formulary committee members with respect to key factors that influence medication prescribing in community hospitals. METHODS: Physicians, clinical pharmacists, and formulary committee members were solicited to participate. A trained interviewer administered a standardized questionnaire designed to elicit opinions of participants regarding the importance of factors thought to influence drug prescribing. Responses were described using descriptive statistics, and differences between the groups were determined by post hoc analysis. RESULTS: A total of 150 individuals participated in the study. Safety, effectiveness, formulary status, and restrictions on prescribing were considered highly influential by all participants. Physicians rated the availability of drug samples and personal experience higher (more influential on prescribing) than clinical pharmacists and formulary committee members. Clinical pharmacists and formulary committee members rated the influence of recommendations by clinical pharmacists, prescribing guidelines, and cost or cost comparisons higher than physicians. Factors that were drug-related or that involved policy-related programs tended to be more influential than indirect factors. CONCLUSIONS: Those who seek to implement programs to alter medication use should recognize and employ factors that are most influential in the decision-making process. Further, it may be important to consider differences that exist between key participants in the medication use process.