Austin, TX—A successful pharmacist-driven drug-monitoring protocol can be achieved in a medical practice when necessary elements are considered, according to Felicia Zook, PharmD, BCOP, Clinical Oncology Pharmacist, Froedtert & the Medical College of Wisconsin, Milwaukee, who spoke at the 11th annual Hematology/Oncology Pharmacy Association conference.
“Our pharmacists were involved in the management side, and gave input regarding dose recommendations, but we didn’t have a standard expectation for any of our pharmacists as to what they should be doing with patients receiving tacrolimus,” Dr Zook explained. This unmet need was the basis for the collaborative practice agreement (CPA).
Establishing Goals, Developing a CPA
A CPA is a legal agreement granting pharmacists the authority to manage medication therapy under the supervision of individual physicians. The CPA should detail workflow for all the healthcare professionals involved, provide recommendations and guidelines for managing medications, and document how the CPA itself is maintained.
“Goals have to be one of the first things noted in a CPA,” Dr Zook explained. The 3 main goals of the tacrolimus-monitoring CPA at Froedtert included: (1) increasing the safe and efficacious use of tacrolimus in ambulatory patients with llogeneic hematopoietic stem cell transplantations (HSCTs) by incorporating the pharmacist more regularly into the daily workflow; (2) decreasing the workload of physicians and advanced practice providers; and (3) decreasing the amount of time patients spend waiting for treatment.
Elements of the Tacrolimus-Monitoring CPA
The CPA workflow begins with the emergency medical records, when a provider enters in the order for the CPA consult. A provider should specify the goal trough concentration of the tacrolimus, and the patient’s length of therapy in their consult order. Once the pharmacist is alerted about the consult, they evaluate the specified trough level and perform any necessary follow-ups with the patient; the pharmacist is required to meet with the patient at least once every 30 days, and maintain a detailed medication history. Any modifications to the tacrolimus dose are based on the pharmacist’s clinical judgment.
During follow-up, clinical factors besides the tacrolimus trough concentration should be considered, including the timing of the tacrolimus level in relation to when the patient last took their dose; any missed doses the patient skipped (or taken doses the patient should have skipped); previous tacrolimus level trends and whether they were stable; drug interactions of new or discontinued medications; and any changes in renal function.
The pharmacist is required to contact the provider if they observe serum creatinine and/or hepatic function tests increasing twofold or more from baseline, or if the patient reports any adverse events that might be caused by the tacrolimus (eg, headache or tremor). Furthermore, if the oncology team has not ordered or scheduled any follow-ups, the pharmacists are able to do that, Dr Zook noted.
Dr Zook and colleagues measure tacrolimus trough levels at least once per week for the first 100 days after transplantation. Longer intervals are considered for patients whose levels have been stable, and who show no signs or symptoms of graft-versus-host disease (GVHD). Shorter intervals are considered in select patient cases based on time elapsed since their transplantation, signs of hepatic or renal dysfunction, and/or introduction or discontinuation of interacting drugs.
Benefits, Barriers, and Future Directions
Both patient and provider satisfaction have improved since the introduction of the tacrolimus-monitoring CPA. “Patients have told us and their providers that they really appreciate the more thorough follow-up, and they also appreciate knowing who their pharmacist is on the care team,” she stated. “Providers have come to us directly and said having the pharmacists more involved saves them time, and they trust our judgment and our dose recommendations.”
According to Dr Zook, barriers to establishing a CPA include the amount of time needed for development, and the potential for negative reception once implemented. “Like any new process, when we first tried to implement the CPA in the clinic, some of the providers were unsure about it,” Dr Zook explained. “However, after some time and reassurance, and once they saw how useful it was for them, we now manage roughly 30% to 40% of the patients who are on tacrolimus for acute GVHD prevention, and we hope to keep increasing that number.”
Moving forward, Dr Zook and colleagues hope to expand the protocol to include inpatient pharmacists and other immunosuppressive agents besides tacrolimus. They also plan to perform data collection to validate and optimize their CPA and workflow, and to continue proving that pharmacists are valued members of the interdisciplinary HSCT team.
Through development and implementation of a CPA, Dr Zook and colleagues concluded that pharmacists offer a unique perspective on medications, and that they can be trusted to manage tacrolimus therapy in the ambulatory setting.
