Effectiveness and economic impact associated with a program for outpatient management of acute deep vein thrombosis in a group model health maintenance organization.

BACKGROUND: Controlled clinical trials have demonstrated that outpatient administration of low-molecular-weight heparin to patients with acute deep vein thrombosis (DVT) provides safety and efficacy equivalent to that of traditional inpatient therapy with unfractionated heparin. Whether favorable results reported in controlled clinical trials are achievable in clinical practice is an important consideration. METHODS: Appropriate patients with objectively diagnosed DVT were treated as outpatients with low-molecular-weight heparin and warfarin sodium according to an approved guideline. The primary end point for analysis consisted of objectively diagnosed symptomatic recurrent thromboembolism or major bleeding within a 90-day evaluation period. The incremental cost incurred by the organization while using the outpatient DVT treatment guideline was determined. Incremental cost savings of the outpatient DVT treatment program were determined based on the cost that would have accrued had the patient been admitted to the hospital for treatment with unfractionated heparin. RESULTS: We enrolled 391 patients (91.4%) in the outpatient DVT treatment program. Of these, 373 (95.4%) completed 90 days of therapy without reaching the primary end point. The percentage of patients reaching the primary outcome measure (4.6%) fell within the range of patients enrolled in controlled clinical trials (3.5%-9.4%). During the 2-year program evaluation, total cost savings of $1,108,587 were realized. CONCLUSIONS: Outpatient treatment of acute DVT can be managed safely and effectively in clinical practice. The potential savings associated with outpatient DVT treatment are substantial. Arch Intern Med. 2000;160:2926-2932

Randomized, placebo-controlled trial of oral phytonadione for excessive anticoagulation.

STUDY OBJECTIVE: To compare the efficacy of managing excessive anticoagulation in the absence of bleeding by either omitting warfarin therapy alone or administering oral phytonadione in addition to omitting warfarin therapy. DESIGN: Randomized, double-blind, placebo-controlled study. SETTING: Clinical pharmacy anticoagulation service in a group model health maintenance organization. SUBJECTS: Thirty nonbleeding patients with international normalized ratios (INRs) ranging from 6.0-10.0. INTERVENTIONS: Patients were randomized to receive either a single oral dose of phytonadione 2.5 mg or placebo. Both groups omitted warfarin doses until the INR became less than or equal to 4.0. MEASUREMENTS AND RESULTS: The mean calculated time to reach an INR of 4.0 was significantly greater in the placebo than the phytonadione group (2.6 vs 1.4 days, p=0.006). Overcorrection of anticoagulation was significantly more common in patients receiving phytonadione. Overt warfarin resistance was not observed in either group after reinitiating warfarin therapy. No major bleeding or thromboembolic complications occurred, and minor bleeding episodes were similar in both groups. CONCLUSION: The addition of oral phytonadione 2.5 mg reduced the time to achieve an INR of 4.0 by approximately 1 day compared with omitting warfarin therapy alone. Adverse events did not differ between the two groups. Both strategies were effective in managing asymptomatic patients with INRs of 6.0-10.0. Oral phytonadione may be most appropriate for patients at high risk for bleeding in whom the benefit of prompt INR reduction would outweigh the thromboembolic risk associated with INR overcorrection.

Clinical pharmacy anticoagulation services in a group model health maintenance organization.

The clinical pharmacy anticoagulation service (CPAS) at a large group model health maintenance organization is described. The service has expanded dramatically from a local service providing anticoagulation monitoring for the patients of a single physician to a regional service staffed by seven full-time employees who monitor over 3,000 patients. The structure and operations of the CPAS are described as well as the processes used to manage anticoagulation therapy complications. A program for treating patients with deep vein thrombosis in the outpatient setting using enoxaparin is also described.

Radiopacity study of extended-release formulations using digitalized radiography.

The purpose of this study was to evaluate the role of radiography in the assessment/treatment of toxic ingestions and to compare the radiopacity of extended-release formulations to their basic preparations using standard and digitized radiography in vitro. Medications were placed in an in vitro model of the human abdomen. Images were exposed at 80 kV, 20 MAS, with a tube to table distance of 101.6 cm. Images were enhanced by optical scanning and digitized. Radiopacity was compared with ferrous sulfate. A 100% increase in detection was appreciated when the standard radiograph was digitally enhanced. No trend toward one formulation being more radiopaque than the other. Only capsules were more radiolucent than surrounding in vitro model. Digital enhancement of a standard radiograph was shown to improve the detectability of the tested oral dosage forms in vitro. Sensitivity of digital radiography in vivo has not yet been established. Based on the data presented, however, further studies using digital radiography to document and to monitor acute toxic ingestions in-vivo are warranted.