Stringent planning needed for DVT outpatients
Stringent planning needed for DVT outpatients
Is the effort worth the potential savings?
Santoro A. Outpatient treatment of uncomplicated deep vein thrombosis: an overview of program development. J Managed Care Pharmacy 1997; 3:170-174.
As clinical trials for the outpatient treatment of acute uncomplicated deep vein thrombosis (DVT) via single-dose low molecular weight heparin (LMWH) treatment continue to show positive results, the goal for managed care facilities is to weigh their ability to develop and implement the protocols for the procedure against the financial bottom line.
Historical initial treatment for DVT entails a five- to seven-day inpatient regimen of intravenous heparin. But trials using one or two daily subcutaneous doses of low molecular-weight heparin on an outpatient basis report low levels of recurrent thromboembolism or significant bleeding, leading researchers to pursue what they are calling a safe and effective procedure.
But before your hospital system starts lining up patients, several factors must be considered, cautions Amy Santoro, PharmD, a resident at Harvard Pilgrim Health Care in Boston. She details those issues in the March/April issue of the Journal of Managed Care Pharmacy. (Specific outcomes of two recent clinical trials can be found in the March 14, 1996, issue of the New England Journal of Medicine.)
Consider these requirements
Without a U.S. Food and Drug Administration-approved dosage vial for subcutaneous treatment, hospitals must be able to determine their ability to repackage higher LMWH doses necessary for treatment into compatible syringes. Current single-dose vials are approved for DVT prevention after surgery. "Manufacturers are in the process of seeking FDA approval for DVT treatment, and a multidose vial would be best," Santoro says. She also advises that hospitals seek related literature or unpublished data compiled by manufacturers.1
Patient candidates and criteria also are key factors, simply to determine how many could be treated on an outpatient basis. Specific patient demographics, including the inclusion of other diseases, any history of DVT, or the range of symptoms appropriate for outpatient care should be determined. Also, in-house statistics on the incidence rate of DVT in the hospital population and the average length of stay for those already coming in for DVT treatment must be calculated, as well as which type of treatment is best for each patient.
"Some patients can be trained to do it themselves, others can come into a physician’s office, and a third option would be a home care nurse," with the managed care facility weighing the costs of coordinating different approaches, Santoro says.
Related factors include estimating the cost of establishing and then increasing ambulatory care resources, including necessary clinic visits, drug dispensing, and patient follow-up. Outpatient subcutaneous injections would eliminate the need for aPTT (activated partial thromboplastin time) monitoring necessary to adjust clotting time and dosage, which could be deemed a financial gain in the process.
How and who would be best to determine the above clinical factors as well as the financial impact is the beginning of protocol development. Can your facility take on a new variation of paperwork and patient monitoring? Can the research be undertaken? Have the trials and equipment needs been met? And finally, will it save enough money?
Get involved early
To tackle these issues, Santoro recommends that a multidisciplinary team of clinicians and administrators come together to present the program to a pharmacy and therapeutics or related committee.
Pharmacists should evaluate the best way and the capabilities for preparing, storing, and dispensing LMWHs, either in-house or through outsourcing, and have a substantial involvement in early research, she says. Pharmacists also should be active in patient education and counseling, everything from explaining the options to dispensing take-home literature to ensure patient compliance.
Other patient-specific protocols include the referral process from the emergency department to an outpatient treatment program; who will coordinate patient monitoring; how to determine the number of follow-up visits; and who patients should contact for simple questions or emergencies. Also, don’t forget a protocol for oral warfarin treatment to accompany the injections.
Give it a trial
And finally, facilities that are ready to implement an outpatient program should consider a trial period with a defined time to assess the program clinically and financially, factoring in patient success rates vs. recurrence or bleeding, as well as avoidance of hospitalization vs. costs incurred.
The point of Santoro’s program development overview is simple and well taken: As the allure of technological and clinical advances increases the potential for savings, it’s best to get a head start on determining whether the advances are right for your facility.
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