The name of the drug is warfarin, usually known by the brand name Coumadin. It can prevent strokes and blood clots, and the result can be healthier people and fewer hospitalizations.
But it's a tricky and potent medication. On one hand, it's only effective if the dose is strong enough. But too strong a dose can trigger internal bleeding.
"It can be lifesaving, but the complications can be life-threatening," said Lee Sacks, M.D., a family practice physician on the staff of Lutheran General Hospital, Park Ridge, Ill.
Dr. Sacks led a clinical team that succeeded in taming the drug through a procedure that relies on a pharmacist to monitor blood levels of warfarin and make dosage adjustments on the spot.
The monitoring process is just a part of a game plan worked out for warfarin therapy during a two-year initiative. The study also identified the best candidates for the treatment, established standardized reporting of test results and came up with physician guidelines on how to use the drug depending on a patient's problem.
But the monitoring center set up just for the warfarin program is what made the difference, Dr. Sacks said. It centralized the task of educating and tracking patients, and it reduced to as little as 10 minutes a monitoring and adjusting process that otherwise involved several days of hassle for physician and patient, he said.
The blood test used in the process is classified as too sophisticated to be done in most physician offices, so patients had to make an appointment at the outpatient lab. At Lutheran General, that meant parking a good distance away, taking a shuttle bus, going through a maze of halls to the lab, registering and then being shown to a station for drawing blood, Dr. Sacks said.
The results wouldn't be available until the next day when they'd be faxed to the patient's physician. The chart was pulled, the doctor would check results against the accepted range and decide whether the dosage required adjustment.
Then the patient would have to be located and instructed on the changes. If the initial test indicated a potentially serious problem, the delay in detecting it could adversely affect a patient's health.
In fact, a rash of hospitalizations for bleeding in the spring of 1992 is what touched off the study of warfarin therapy at Lutheran General, Dr. Sacks said.
An audit of charts from patients treated with warfarin in the Lutheran General Health Plan detected subpar monitoring of the oral anticoagulant and adverse outcomes that were potentially preventable.
Subsequent study showed that physicians were not certain about when to use the drug, how much to use and how to interpret the results of lab tests showing warfarin blood levels, Dr. Sacks said. But the study also determined that the drug was not being used by many physicians "because of the hassle involved or the potential risks," even though medical literature affirms improvement in outcomes among patients with disorders that can produce blood clots, he said.
"We believe many practitioners view the use of Coumadin not in terms of its proven clinical benefits, but in terms of the risks of anticoagulation and the difficulties associated with managing Coumadin therapy," said a multidisciplinary task force formed to establish guidelines for its use within the Lutheran General Health Plan. "The economic benefits are obvious but are either ignored or are outweighed by the perceived risks."
Reasonable concern.The concern
over warfarin's potential to cause bleeding was reasonable. Causing a hemorrhage, in fact, is warfarin's intended goal in its other principal use: as the biological attack ingredient in a form of rat poison.
In October 1992, the task force developed guidelines for warfarin use based largely on investigation of medical literature. Physicians in the health plan were presented with the list of medical indications and taken through the procedural instructions.
That's all the task force originally expected to do, but merely supplying the medical knowledge turned out to be insufficient, Dr. Sacks said.
In a three-month period, no patients were readmitted for complications, but the percentage of blood readings within acceptable ranges improved only to about 60%, compared with 50% without any special effort.
"Going around and reminding doctors about the guidelines was only going to get us so far," Dr. Sacks said. "We needed to be revolutionary."
In October 1993, Lutheran General HealthSystem opened a small "anticoagulation center" at a strip shopping center near the hospital. Physicians could refer their patients to the center instead of taking on the drug-administration program themselves.
Patients now park near the front door of the office, get a finger-stick blood sample that's immediately analyzed and receive their results in about 10 minutes, Dr. Sacks said. The pharmacist in charge of the office measures the results against a set of parameters established by the physician-led task force and is authorized to make adjustments in medication within those parameters.
If the results fall outside the norm, or if a patient complains of bleeding, the pharmacist immediately contacts a physician. A hematologist is on call, or a patient in serious enough straits can be sent to the emergency department.
Besides monitoring, the anticoagulation center takes responsibility for educating patients about warfarin side effects and the specific diet and drug-to-drug issues pertaining to their case.
Education of first-time patients extends the length of the initial visit to 45 to 60 minutes, still a fraction of the time it took for a routine blood test before the center was established.
Marked improvement.The program started with 41 referred patients in the first month of operation, and after a year it had a patient load of 172. Of those, only three experienced complications.
One had a blood clot even though warfarin levels were in the accepted range. Two others had minor bleeding, though other health problems were also present and may have contributed to the bleeding episodes, Dr. Sacks said. No hospitalizations were required.
The monitoring results were strikingly improved. Of the program's patients, 85% to 88% have blood-test results in the therapeutic range, he said.
Anecdotally, the patient dropout rate is very low. In fact, some non-program patients being treated for blood clots called the center after a local newspaper's account and asked for names of physicians who would refer them to the center, Dr. Sacks said.
Lutheran General HealthSystem is collecting data on outcomes of treatment and comparing the results with warfarin treatment outside the center and with patients who would benefit from warfarin but aren't receiving it.
The study, aided by a two-year, $145,000 grant from Coumadin maker DuPont Pharma, also will document healthcare costs and savings related to the regimen, Dr. Sacks said.
The tracking will include hospitalizations and length of stay for both warfarin users and those for whom warfarin therapy could be expected to prevent the need for resource use if administered appropriately.