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College medical center develops DTI management service
Program wins Best Practices award
Pharmacists are uniquely qualified to monitor direct thrombin-inhibitor (DTI) drug therapy and should consider working with physicians and hospital leaders to improve patient outcomes by developing such a program.
The 2008 Joint Commission National Patient Safety Goals include a goal of reducing the risk of patient harm from anticoagulation use. So a DTI drug therapy management program could meet this goal by reducing medication errors related to adjusting DTI dosages.
One model for involving pharmacists in DTI drug therapy management is through the implementation of a collaborative drug therapy management agreement that enables trained pharmacists to make changes to medication doses without first contacting a physician.
Pharmacists at the Medical University of South Carolina (MUSC) have created such an agreement over a two-year period, and it has resulted in better patient outcomes.1,2
For example, a study of DTI patients post-implementation showed that they had achieved therapeutic activated partial thromboplastin time (aPTT) more rapidly and maintained therapeutic aPTT more consistently. The pre-implementation rate was 7.7 hours vs. the post-implementation rate of 3.4 hours.1
Also, the program resulted in reduced medication errors. Data show that pre-implementation, medication errors occurred in 40% of patients, while post-implementation, medication errors occurred in 12% of patients. And prescribing errors, which occurred in 24% of patients pre-implementation, were eliminated post-implementation.1
The MUSC pharmacist team received a 2009 Best Practices Award in Health-System Pharmacy from the American Society of Healthcare Pharmacists (ASHP) for their DTI process.
The first step was to create a DTI treatment protocol as part of the collaborative drug therapy management agreement.
"The protocol was approved by physicians and pharmacists," says Heather Kokko, PharmD, clinical assistant professor, director of pharmacy services, and director of graduate pharmacy education at MUSC.
"We have a process to make sure pharmacists are well-trained by going through a credentialing process," Kokko says. "Only those pharmacists could participate in the program."
Joseph Mazur, PharmD, a clinical pharmacy manager at MUSC, helped develop the credentialing program and competencies.
"I've always been involved in anticoagulation," Mazur notes.
Mazur, along with Kokko and the other MUSC pharmacists who received the ASHP award for the DTI program, researched available literature on DTI programs and pharmacists and found little to no available guidelines and protocols.
Yet it made sense to make DTI management a pharmacist-driven process, Mazur notes.
"We think we can do as well as physicians in terms of dosing patients," he says. "They're diagnosticians, and we can manage the protocols."
So a team of MUSC pharmacists worked for more than six months to develop a preprinted order form and protocol. These outlined how pharmacists would manage DTI patients, and it included these main features:1
After the protocol was developed, it had to be approved by MUSC's pharmacy and therapeutics (P&T) committee, which consists of pharmacists, physicians, nurses, and dietitians.
"Once the P&T committee had all of its questions answered, and the committee approved the protocol, then it was sent to the medical executive committee for approval," Kokko says. "That committee mostly consists of physicians, but also includes the hospital's leadership."
Kokko sits on the medical executive committee as a nonvoting member.
The protocol is 3-4 pages long and is available to MUSC clinicians via an Intranet.
"The protocol is in an electronic format, but they can print it out, fill it in, and we still have a paper chart," Kokko notes.
The order form for prescribing DTIs includes a definition of heparin induced thrombocytopenia, along with a boxed decision diagram that juxtaposes "Clinical suspicion" with "Platelet Factor 4 Antibody" and lists high and low instructions for both positive and negative results.2
For example, an HIT-confirmed positive result that is high would require the actions of stopping heparin and LMWH products and starting DTI. A low positive HIT result would result in the actions of stopping heparin and LMWH products, considering other causes of thrombocytopenia, and using DTI specific to patient risk versus benefit.
The order form also includes checkboxes for indicating anticoagulation use for prophylaxis, use of argatroban, use of bivalirudin, and pharmacy dosing.
A second page of the order form features monitoring instructions, clinical practice points, and a flow chart of the process from initiation of warfarin.
And the last page provides a table for a scoring system for the pretest probability for the presence of HIT.
The next part of the process is to train pharmacists who are part of the collaborative care agreement.
"We held interactive educational sessions on DTIs, pharmacokinetics," Mazur says. "We had two-hour training sessions with PowerPoint slides, and then we gave participants competency exams with a minimum passing score of 85%."
The in-depth exams included one oral exam and one written assessment involving two patient cases, he adds.
Physicians can look up on-line the names of pharmacists who are credentialed for the DTI drug therapy management program. This way they'll know who to call when they have a case.
It took a while for the program to expand, and this created a little difficulty at first for the handful of pharmacists who were trained, Mazur notes.
"For about a year, we only had three of us who took calls from physicians, and it was a lot of work," he says. "Now we have expanded to about a dozen people trained."
Pharmacy residents can assist the trained pharmacists with patient care, but they are not credentialed and are not part of the DTI drug therapy management program.
"We require pharmacy residents to be backed up by a preceptor, and all of their recommendations are co-signed by faculty back-up," Kokko says.
Hospital pharmacists should be able to convince health system leaders that a DTI drug therapy management program and collaborative agreement are good investments both from the patient safety perspective and from the indirect cost savings.
"Many people will say that a medication error could cost a hospital an average of $5,000 because this increases the patient's length of stay and requires additional treatments," Kokko says. "So having the kind of reduction in medication errors that we had is really valuable for a hospital from a cost standpoint, as well as from a patient safety standpoint."
MUSC has 100 full-time equivalency pharmacist positions, and the medical college did not need to hire additional staff to implement the DTI drug therapy management program, Kokko says.
Pharmacists who receive the special training do so voluntarily.
And it wasn't difficult to obtain physician buy-in.
"We have medication management agreements in other areas, so this was not a new concept to our physicians," Kokko says. "They've been very supportive of our pharmacy services, and we're only limited by how much of our resources we can offer to our physician friends."
Before starting the program, pharmacists provided informal input on DTI cases, Mazur says.
"In this state, nurses cannot take verbal [medication] orders from pharmacists," he explains. "So per our institutional protocol, we are allowed that opportunity to assist in medication monitoring and prescribing."
Everything is based on the protocol and collaborative agreement, and pharmacists are responsible for ensuring that pharmacists using the DTI protocol are deemed competent and have received credentials for their expertise and training.
"Often when we are involved with monitoring programs, we have to get a verbal order from the physician," Kokko says. "What makes this different is we are able to dose the medications without going to the physician each time we want to make a change."