Specialty pharmacies dispensing erythropoiesis-stimulating agents can improve outcomes by effectively monitoring patients.
Two business models characterize most specialty pharmacies dispensing erythropoiesis-stimulating agents (ESAs): the integrated care model and the coordinated care model. Each of these business models appears in a variety of shapes and sizes, but one fundamental disparity separates the 2—ready access to patient clinical records.1
In the integrated care model of specialty pharmacy, pharmacists are included as part of a larger health care network. For these models, specialty pharmacies are usually integrated into a preexisting hospital or clinic network. A critical strength of the integrated system in treating patients is the capability of the specialty pharmacy to access patient electronic medical records (EMRs).1
The coordinated care model, on the other hand, is designed so pharmacies operate separately from other entities providing patient care. Pharmacists functioning in coordinated care specialty pharmacies do not have ready access to patient EMRs, and therefore must make clinical decisions based on information procured from patients and physicians’ offices.
In some situations, pharmacists treating patients within a coordinated care system may have access to enough patient information to provide improved clinical oversight compared with traditional pharmacy models; however, for complex specialty medications, such as ESAs, the coordinated care business model may fall short.1
Why is access to patient records so valuable when managing patients on complex specialty medications, such as ESAs?
ESAs are specialty medications widely used in the treatment of chemotherapy- and chronic kidney disease-related anemia. ESAs fall into the specialty class of drugs due to cost and the risks associated with treatment (thrombosis, cerebrovascular events, and possibly tumor proliferation in cancer patients).2,3,4
Access to patient medical records is invaluable when managing patients on ESAs because effective treatment with these medications requires close monitoring of more than a patient’s dosing regimen or refill schedule.
When a patient receives an ESA (eg epoetin alfa) for anemia, evidence indicates they should also be optimally treated with concomitant intravenous (IV) iron therapy, typically through IV infusion administered at an infusion clinic or dialysis center. The efficacy of ESA therapy is dependent on how much iron a patient is receiving and the dose of the ESA.
Monitoring the usage frequency of both medications and their dosage is vital to not only optimizing the benefit of the ESA therapy, but also in leading to a decrease in the amount of ESA medication needed, which reduces the risks associated with ESA therapy.5
The ability of IV iron to decrease the amount of ESA in patients was documented in a meta-analysis that noted a reduction in ESA dosing was possible when optimal IV iron was provided to patients. In contrast, suboptimal iron supplementation was found to potentially increase the need for higher ESA dosing.
Intervention groups in this analysis were separated according to the prescribed iron dose: optimal therapy (100 to 200 mg IV iron per week) or suboptimal therapy (less than 100 mg IV iron per week or oral iron dosage form use). Results of the analysis showed a mean difference of 1733 units/week of ESA (95% CI; -3073, -392) in patients who received optimal dosing versus suboptimal iron therapy.5
Specialty pharmacies can help optimize patient ESA therapy by adequately monitoring ESAs, IV iron utilization, and associated labs. This is illustrated by recent evidence that shows the utility of IV iron in the treatment of anemia is well-known by medical physicians and other practitioners, but it is apparently not well understood.
A study of 43,760 hemodialysis patients treated with ESAs from 2000 to 2011 found the use of IV iron increased from 46.9% in 2000 to 79.3% in 2010; however, the study also noted that, in spite of the increase in IV iron use, the quantity of ESAs prescribed per patient remained relatively constant.6
Additionally, it is not enough for pharmacists to merely educate providers on the importance of decreasing ESA dosing when IV iron administration increases. IV iron bolus injections typically range from 100 mg to 1000 mg, which far surpasses the body’s pool of free transferrin to ligand the free iron and transport it in plasma.
Too much IV iron can also cause issues related to the formation of hydroxyl radicals. Sustained production of hydroxyl radicals leads to cytotoxicity, inflammation, and tissue damage.7 Accordingly, there is an important balance between the amount of iron required to augment ESA therapy and levels that might be toxic.
In light of these myriad factors, for specialty pharmacies to improve patient outcomes and provide clinically meaningful services for patients on ESAs, active and consistent participation in both ESA and IV iron drug therapy and lab monitoring is key. Integrated care specialty pharmacies have an advantage in this area because they have access to patients’ complete medical records, including IV iron infusion records. Coordinated care pharmacies, on the other hand, must rely on an inefficient system that requires consistent contact with the patient or doctor to obtain the information necessary to modify therapy.
Where do we go from here?
To address the deficit of patient clinical information for coordinated care specialty pharmacies, the most important step to take is to provide coordinated care pharmacies with the same access to patient information as integrated care pharmacies. There is no reason patient care should suffer simply due to lack of access to EMR records.
Fortunately, EMR access and sharing barriers may be alleviated in the future. There has been a recent move by some legislators to correct this and similar problems. A bill to change federal requirements relating to the development and use of electronic health records (EHR) technology is under deliberation.
The bill, S2511 — Improving Health Information Technology Act, was placed on the Senate legislative calendar in April 2016. Its purpose is to mandate interoperability among medical technology vendors. If this type of legislation is passed and implemented, it would allow providers to share EHR information with ease.
Another effort being made by Congress to help improve care coordination among providers is HR 5942, the Dialysis Patient Access to Integrated-care, Empowerment, Nephrologists, Treatment, and Services Demonstration Act of 2016. This act is specific for care concerning patients with end-stage renal disease, and seeks to aid in integrating care among providers for these patients.
While neither bill alone, nor together, will solve communication issues among health care providers, at least this new legislation carries the potential to improve access to patient information and advance services for patients cared for by coordinated-care specialty pharmacies.
About the Author
Alice M. Knotts is a 2018 Doctor of Pharmacy candidate at Washington State University.