Some 148,000 patients in the VA system receive anticoagulation therapy to prevent and treat cardiac disease, stroke and deep vein thrombosis (DVT), but the primary anticoagulation drug, Warfarin, which has been in use since the 1950s, is complex to manage, and improper usage can harm patients.
To address issues such as the drug’s narrow therapeutic range and the role of patient compliance on outcomes, VHA has a come up with a novel system of pharmacist-run anticoagulation units which have increased both the safety and effectiveness of the drug.
“This medication needs intense monitoring,” said Jeanne Tuttle, R.Ph., pharmacist program manager for the VA’s Pharmacy Benefits Management Services in Washington.
“It’s not easy. But we’re diligent with these patients,” added Petra Flanagan, Pharm.D, director of anticoagulation at the VA Ann Arbor Healthcare System in Michigan. “We’re one clinic for one drug.”
The VA provides that intense monitoring through its system of anticoagulation units. The units are clinics within regional VA hospitals or community-based outpatient clinics (CBOCs). The majority are led by pharmacists who oversee an interdisciplinary team.
“Pharmacists, as the drug-therapy experts, are a good fit in providing anticoagulant care, given their background and extensive training in drug pharmacology, therapy and interactions,” Tuttle explained.
Clinicians work to keep a Warfarin patient’s International Normalized Ratio (INR) between 2 and 3. If the INR is below the therapeutic range, clotting might occur. If it is above, the possibility of internal bleeding arises.
A VA study found that 70.6 percent of patients seen in high-volume anticoagulation units had their INR tested. Of these patients, 58 percent were in the therapeutic range.
The percentage is 70 to 75 percent at the Ann Arbor VA, which is monitoring more than 700 patients, Flanagan said. Her team includes a scheduling clerk, a medical technician, a registered nurse and a rotation of clinical pharmacists. Pharmacy students and pharmacy residents also train in the clinic with direct supervision by a clinical pharmacist.
Role of Clinics Likely to Change
Despite that success, several factors are likely to alter the role of the anticoagulation units in the near future. Flanagan and others are cautiously optimistic about a new class of anti-clotting drugs becoming available, direct thrombin inhibitors, which don’t require regular laboratory monitoring and, because of shorter half-lives, make it easier to alter dosage more quickly in an emergency. The downsides are expense and the lack of a reversing agent, Flanagan said.
Lisa Longo, Pharm D, BCPS, a clinical pharmacy specialist for the VA’s Pharmacy Benefits Management Services in Hines, IL, added that she expected use of the new class of anticoagulants “to be significant over time” after careful review and testing.
“It is too early to tell how the current model will change,” Tuttle and Longo noted in an e-mail response to U.S. Medicine questions. “This class of medications is new to the market, and, currently, only one product has been approved by the FDA and, for that product, FDA currently has only approved one indication.
“While the trials look promising, we do not know the long-term safety and efficacy profile of this drug or if and what concerns may emerge during post-marketing surveillance. VA/PBM has been closely following the approval process and clinical trials for this drug and drug class. We will continue to monitor our patients as transition in therapy occurs.”
They added that “VA is prepared to adjust current models of care as new information emerges and through information we gather by monitoring patient safety during the transition.”
The anticoagulation clinics could also be affected by a VA study released in October that found home and clinic testing produce similar outcomes for Warfarin patients.
“Patients can then call in the results to their provider and get advice on dose adjustments without coming to the clinic,” a VA press release said of self-testing at home. “In some cases, they can even set the proper dose of Warfarin on their own.”
“VA already recognizes a role for patient self- testing,” Tuttle and Long said, referring to VHA Directive 2010-020, “Anticoagulation Therapy Management,” issued last May.
“We remain committed to using safe processes in the selection of our patients that would be appropriate for self-testing,” Tuttle and Longo said, explaining that patients and/or their caregivers would have to have a certain level of dexterity, language and cognitive skills to perform the testing and processes that provide patient/provider education to ensure patients have appropriate follow-up.
“We do not see the use of patient self-testing as affecting the role of anticoagulation clinics,” they added. “With patient self-testing, therapy still needs to be managed [e.g., dose adjustments] by a knowledgeable clinician and comprehensive patient education and follow-up still needs to occur.”
Patients Are Seen Weekly At Beginning
Under the current system, anticoagulation units initially see patients weekly. Once a patient begins to stabilize, visits are scheduled biweekly and then monthly.
“At each visit, the patient is asked to fill out a questionnaire,” Flanagan explained. “The answers provide valuable information that is used during the interview to determine the appropriate dose of Warfarin. The questionsrevolve around missed doses, medication changes, alcohol and cigarette use or changes, over-the-counter products, unusual bruising or bleeding.”
That monthly schedule is straightforward enough for patients who live in cities and suburbs. Those in rural areas may have a long drive to reach a unit, a ride that foul weather may make even more difficult.
The monitoring schedule takes that into consideration, according to Longo, Long-term therapy has a greater chance of success if the patient doesn’t become unnecessarily dispirited.
“We want everyone to come in every four weeks, but we can see them every six weeks,” Longo said. “We don’t want people to think they failed their test because there was two feet of snow on the ground.”
The Goal Is Standardized Care
Care throughout the system was standardized by the May 2010 directive. The directive called for, among other things, each unit to put in place a Veterans Integrated Service Network (VISN) policy, minimal competencies for the interdisciplinary team, and therapy education for clinical staff.
Another requirement was patient education, including Warfarin tablet identification, indication for therapy, interactions, daily dosage, monitoring requirements, the importance of medication adherence, the dangers of using Warfarin from different sources, management of missed doses, symptoms of bleeding and thromboembolic events, and risks associated with falling.
The directive was the culmination of several years of initiatives by the VA, Joint Commission and the National Center for Patient Safety.
In 2006, the Institute for Healthcare Improvement (IHI) think-tank launched “Protecting 5 Million Lives from Harm,” and included among its safety interventions, “prevent harm from High-Alert Medications … starting with a focus on anticoagulation…”
The next year, the Joint Commission called for “Reduc[ing] the likelihood of patient harm associated with the use of anticoagulation therapy” and sought implementation of its goals by accredited institutions by the end of 2008.
The VA followed by establishing a multidisciplinary anticoagulation work group to analyze safety issues, to determine “the best of the best,” as Tuttle puts it, and to issue recommendations. It did so in 2008, leading to the 2010 directive.
An interdisciplinary approach
When interviewed, Tuttle had just returned from a winter site visit to a rural community-based clinic, more than four hours by car from the main VA facility. The clinic’s isolation required that its staff take extra measures to serve some of its patients.
“They had to set up a fee-based service for one patient for a home health care nurse to go into the patient’s home to perform the INR test, as the patient’s driveway is 4.5 miles long and he could not get out in the vehicle he had,” Tuttle said. “In another case, they have a nurse that takes a boat to make a home visit to do the INR test.
“They had an excellent process to make sure that patients are seen and don’t fall through the cracks,” she continued. “That’s the danger, when they fall through the cracks.”
While many facilities have dedicated clinics where patients are seen face-to-face, some have other means to provide individualized patient care, she said. “For example, a rurally located facility’s policy may be to provide telephone-based care when patients live too far or are unable to come into a clinic. Some community-based clinics may not have anticoagulation clinics on-site, but patients are still followed in a defined process. For instance, the CBOC may be drawing the blood, and then the pharmacist at the main facility follows up on the result and contacts the patient by telephone.”