Previous studies throughout North America have yielded strong evidence that inpatient and outpatient warfarin dosing services and clinics staffed by qualified personnel are associated with better patient outcomes and anticoagulation management. This study was performed to determine whether a pilot project at Providence Healthcare would support a hospital-wide inpatient warfarin dosing service.

The goals and objectives for the warfarin dosing service, listed above, were met during the 5-month period of the pilot project. Anticoagulation therapy provided during the pilot project was safe and effective, as indicated by maintenance of the INR within the therapeutic range for most INR tests, lower frequency of negative outcomes, and prevention of DVT and pulmonary embolism.

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An evaluation of the pilot project was conducted as an open case series. The aim was to enroll 30 patients in the pilot warfarin dosing service over a 5-month study period (October 16, 2003, to March 18, 2004).

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INTRODUCTION

Patients are routinely referred from acute care sites to rehabilitation hospitals for subacute care and transition into the community. Providence Healthcare is a Toronto health care facility specializing in rehabili­tation for patients who have experienced strokes, orthopedic surgery, and lower limb amputation. Services include complex continuing care, long-term care, and community outreach, with a particular emphasis on the clinical treatment and care of elderly patients. One of the Providence Healthcare sites, Providence Hospital (where the study reported here took place) is the third-largest rehabilitation and complex continuing care hospital in Ontario, with 338 beds.

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Data Obtained during Pilot Project for Rehabilitation Warfarin Dosing Service (2003-2004)

A total of 33 patients were followed through the pilot project for the rehabilitation warfarin dosing service during the 5-month study period. A group of 33 patients who underwent physician dosing on other units during this period served as the concurrent control group. Tables 5 to 8 compare results for the concurrent control group with those of the patients treated through the warfarin dosing service (pilot project group).

The concurrent control group had fewer women than the pilot project group, a similar mean age but a greater age range, and similar body weight (Table 5). In both groups, the primary reason for admission was rehabilitation after major orthopedic surgery. Slightly more patients in the pilot project group had cardiovas­cular disease, and more of these patients had a history of gastrointestinal problems. The mean duration of the hospital stay was 22.2 days for the concurrent control group and 26.9 for the pilot project group.

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Hospital Administrators’ Concerns

The rehabilitation program director (M.R.) and the facility’s vice-president were interviewed in February 2004, near the end of the pilot project. At that time, they reported the following reasons for establishing a warfarin dosing service: inconsistent warfarin dosing and monitoring at the institution; lack of familiarity with patients and inconsistent coverage by on-call physicians on weekends and statutory holidays; high volume of patients receiving warfarin therapy referred from acute care facilities; no standardized protocol for prevention of deep vein thrombosis (DVT) and no policy for discontinuing anticoagulation (including low-molecular- weight heparin [LMWH]); no on-site anticoagulation expertise; lack of laboratory services on weekends and statutory holidays; a desire to build and expand pharmacists’ scope of practice; a desire to delegate anticoagulation resources from physicians to pharmacists; greater physician support for pharmacy and patients; increased length of stay because of delayed anticoagulation; and desire for physician and staff education.

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Because only small changes in clozapine concentration could be detected under the storage conditions studied, assurance of the specificity of the analytical method is very important. In addition, the separation and detection of intact drug in the presence of degradation compounds must be assured before the method can be considered suitable for indicating stability. The specificity of the analytical method was demonstrated during the accelerated degradation studies (Figure 1). In these studies, the clozapine concentrations declined as the concentration of apparent degradation products increased.

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During the study period, the concentration of clozapine observed in all study samples remained within 5% of the initial concentration. Multiple linear regression detected a significant (p = 0.0379) trend for a change in concentration over the study period, but the change averaged only 2.56%. There were no significant differences in the rate of clozapine degradation among the suspension vehicles, and the lowest percentage of initial concentration remaining, estimated with 95% confidence on day 63, was 93.97%. Furthermore, degradation products observed during the accelerated degradation of clozapine were not observed during the stability study. Assuming no degradation and assuming that all concentration determinations represented estimates of an unchanging concentration, the inter-day reproducibility of sample concentrations was less than 1.7% (CV expressed as a percentage), which is similar to the error observed during the assay validation of quality control samples and standards (1.4%).

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