Stacey McCullough, PharmD

The number of oral medications to treat hematologic and oncologic diseases continues to rapidly increase. These targeted therapies represent tremendous advances and offer additional treatment options across many different disease states, throughout lines of therapies, and in combination with infused chemotherapy, monoclonal antibodies, and, most recently, immunotherapy.

As more patients are exposed to oral medications, awareness grows of the need to coordinate care. This coordination is necessary for medically integrated, independent, and pharmacy benefit manager—owned outside specialty pharmacies. Such coordination is also needed for oral therapies and when an oral therapy is used in combination with infused drugs. We pharmacists are well positioned to expand our roles throughout the health care team within the scope of patient navigation, both through opera-tional oversight and clinical management.

At Tennessee Oncology, a large community-based practice with 30 sites of care throughout the mid-state region, a centrally located pharmacy provides oral medications to patients under the care of our physicians across all locations. As members of a team of a medically integrated pharmacy, the pharmacists have access to patients’ complete profiles within electronic medical records (EMRs). It is the insight and knowledge of each patient’s specific journey that distinguishes our pharmacists’ ability to converge the roles of traditional dispensing and clinical pharmacy.

Pharmacists lead a team well versed in submitting prior authorizations and obtaining foundation and financial assistance, as well as in engaging and educating patients and promoting optimal medication adherence. Oversight and understanding of the patient journey throughout the fulfillment process can provide valuable insights and context when transitioning the conversation to education and adherence.

Our access to EMRs identified an opportunity to redesign and improve how our practice and systems approached oral therapies. Prescriptions were often the only documentation of an oral therapy. This meant that patients receiving oral therapies did not have any information displayed within the treatment section of the EMR. Determining therapy initiation or duration of therapy required combing through an often long and convoluted list of all prescribed medications. In addition to this process being time-consuming and error-prone, the assumption that the prescribed date was indicative of fulfillment and therapy initiation actually lacked any means for validation.

To correct this situation, treatment plans were developed for all oral medications. The framework mirrored that of an intravenous treatment plan, thereby allowing physician workflows to remain consistent, agnostic to the route of administration. Monitoring parameters specific to the drug label at baseline and at subsequent intervals were prebuilt activities, as were physician follow-up visits at predetermined time intervals that were correlated to anticipated adverse effects and/or tolerability issues.

The implementation of treatment plans offered a viable solution to improve the accuracy of information in EMRs, including oral therapy use, initiation, and the duration of therapy. And just as medication administration records are available for intravenous drugs, so were activities within the treatment plan; they were designated and reserved for standardized locations. These activities include pharmacy input on the status of authorization or appeals, submission for financial assistance, patient education information shared with the patient, and routine adherence assessments.

As patient information accumulated within the oral treatment plans, it was found that the day 1—cycle 1 (D1-C1) data for the medication did not align with the pharmacy dispense date in the EMR. The D1-C1 most often reflected the day on which the medication was prescribed. Since treatment plans include follow-up visits and lab monitoring at intervals predicated on D1-C1, the schedules were not appropriately correlated to therapy initiation. This resulted in increased cost of care due to unnecessary use of health care resources, created a poor patient experience, and potentially contributed to worse outcomes due to less-than-optimal follow-up and management.

The disconnect was not unexpected because at this point, the physician and patient have agreed upon the treatment plan for intravenous therapy. D1-C1 is determined based on the convenience, availability, and coordination of all parties: patient, physician, and infusion suite. A time buffer is included for obtaining drug authorization and financial assistance.

So, how are oral therapies different from other cancer treatments, and what amount of time should be allotted for script fulfillment?

Specialty pharmacy accreditation standards require pharmacies to monitor and report average time to fill—or the time required to get a medication to a patient&mdash;upon receiving a prescription for a new treatment regimen. But using an average of any interval totaling less than 7 days posed the issue of weekend appointments or could extend the time to treat for combination oral and infused products. Pharmacists can play an integral role in providing transparency throughout the prescription fulfillment process by ensuring that the date of therapy initiation is established with the patient when doing the initial counseling, and by establishing a means of communicating this D1-C1 to the physician and the extended health care team.

Medically integrated pharmacies with access to the EMR incorporate this information directly into the treatment plan. Pharmacists at outside specialty pharmacies should be mindful of resource coordination, asking patients about follow-up physician or infusion suite visits if the oral drug is a part of a combination therapy. For instances in which both the oral and infused drugs are covered under the pharmacy benefit, the pharmacist should ensure coordination of fulfillment as well as counsel the patient on the importance of coordinating the initiation of the oral medication with the infused product.

Recent approvals of oral targeted agents for renal and endometrial diseases add to the cancer types—including multiple myeloma, chronic lymphocytic leukemia, and breast and colon cancers&mdash;for which combination mixed routes of administration are the standard of care. As these options continue to expand, so to do opportunities for pharmacists to bring value to patients through coordination of care, educational efforts, assistance with navigating complex regimen schedules, adherence support, and discussions about mixed routes of administration and drug utilization management. Regardless of your practice site, look for these opportunities and develop a plan for how your team can engage with other providers along the health care continuum, with pharmacy initiatives that support the overall goal of improved patient outcomes.

Find ways to integrate opera-tional or educational pharmacy information at a broader level. Patient counseling is an area in which pharmacists typically shine, so evaluate how you’re counseling patients: Are you giving them quality information or just a large quantity of information? Are you empowering them to understand the drugs and their administration schedule, to know which adverse effects to anticipate and what to do or who to call when they occur?

Drugs are the epicenter of oncology care and as pharmacists, we should strive to be assets to physicians, patients, and the extended health care team as the most knowledgeable source of new drugs and new combination therapies.

, is senior vice president of pharmacy at Tennessee Oncology.

Articles

Medically integrated pharmacies with access to the EMR incorporate this information into the treatment plan.