Improving Safety and Quality with Oral Chemotherapy

Howard Cohen RPh, MS, FASHP

Stephanie Buia Amport, MBA, CPHQ

Howard Cohen RPh, MS, FASHP, is Interim Associate Director, Oncology Pharmacy at the Smilow Cancer Hospital at Yale-New Haven.

The Smilow Cancer Hospital at Yale-New Haven is an NCCN- and NCI-designated cancer center. Over the past several years, process improvements in the care of our oncology patients have been implemented that focus on the provision of safe and high quality clinical care and employee safety. These process improvements included implementation of Epic EMR, development of standardized oncology treatment protocols, and a standardized multidisciplinary approach to patient care.

While tremendous work has been accomplished within our clinics, care centers and inpatient units, little has been done with regard to the oral chemotherapy drugs that are prescribed for home administration by our ambulatory patients. It is widely recognized that these oral drugs are considered hazardous medications that carry with them potential safety and quality of care issues. Patients prescribed oral chemotherapy and targeted therapies should be supported, educated, and monitored with the same vigilance as those receiving chemotherapy in our clinics and inpatient units.

We need to ensure patients have access to the oral chemotherapy drugs and adhere to the oral chemotherapy regimens. We need to educate our patients about potential toxicities and serious side effects. We need to understand that when we prescribe an oral chemotherapy agent, we shift much of the responsibilities of managing the treatment regimen including the monitoring and potential toxicities from the oncology care team to the patient. In 2013, our ASCO QOPI (Quality Oncology Practice Initiative) certification visit identified oral chemotherapy as an area that needed attention. A standardized program for oral chemotherapy was needed to effectively monitor and improve patient outcomes.

In an effort to address the management of oral chemotherapy medications, we first conducted a survey of all clinical staff to determine satisfaction with the current processes, and to identify gaps within our system. Many issues were identified and included the following:

• Lack of feedback from specialty pharmacies
• Variable documentation and inconsistent oral chemotherapy tracking
• Delays with prior authorization
• Delays with patients obtaining their medications
• An overall lack of a coordinated patient communication and education plan

A chartered multidisciplinary task force met over the course of 4 months to reach the goal of developing a specific program for patients prescribed oral chemotherapy that would: (1) help to identify all patients prescribed oral chemotherapy; (2) standardize the process of the oral chemotherapy prescription, including patient consent; (3) ensure patient access to oral chemotherapy drugs; (4) ensure clinical support, including patient education and counseling and ongoing monitoring.

Oral Chemotherapy Process Map

The Epic oral chemotherapy treatment plan development included a clinical review by oncology trained pharmacists and nurses.

• All patients prescribed oral chemotherapy receive pretreatment evaluation and patient consent.
• A plan for staff and patient caregiver education
• A work plan that would decrease delays in patient access to oral chemotherapy medications, including the development of a specialty pharmacy that would serve as a hub for all discharged oral chemotherapy prescriptions
• Only one cycle of treatment would be dispensed at first cycle of treatment, and all prescriptions would be dispensed in blister packaging to avoid contact with the hazardous medications.
• All prior authorizations will be completed, and patients would be given a choice to have their prescriptions filled by our specialty pharmacy or at a specialty pharmacy of their choice. Additionally, we included our Medication Assistance Program (MAP) to assist indigent patients with access and reimbursement issues regarding oral chemotherapy.
• A plan to provide ongoing patient education and counseling
• An ongoing process for the monitoring of the patient for regimen specific adherence and compliance with flow sheet documentation and follow up
• A process to ensure ongoing toxicity assessment and early identification of side effects
• An ongoing evaluation process, including quality assurance, and patient and staff satisfaction

We also wanted to ensure patient safety and compliance by establishing an ongoing and regimen-specific adherence and toxicity assessment program that would include early identification of side effects.

Recognizing high patient copayments, limited access to medications, and several other patient barriers, we decided to include the development and implementation of a specialty pharmacy in our improvement plan. The specialty pharmacy would serve as the hub to identify all patients prescribed oral chemotherapy and triage all prescriptions.

Given the oral chemotherapy team acknowledged that oral chemotherapy medications are classified as hazardous medications that bring about concern for patient safety, we first created a current state process map, identified potential risk points through a gap analysis process using a cause-and-effect diagram, and then mapped our ideal approach to ensure both safety and quality.

A final oral chemotherapy process map was developed that detailed our care model to support patients receiving oral chemotherapy (Box).

Implementation of the new oral chemotherapy care model will include a pilot in several adult ambulatory Cancer Care Centers and one oncology disease team. The success of the pilot would allow for hospital-wide expansion.We believe that the care model that has been developed will improve care for our patients who are prescribed oral chemotherapy. We recommend the ongoing review and adjustment of our workflow and the development of programs that address approaches for safe administration of oral chemotherapy.