Working to Improve Oral Chemotherapy Administration

FigureBOSTON—Despite the rapid increase in the use of oral chemotherapy agents, there are as yet no best practices for administering the drugs so that they achieve their maximum benefit. Several presentations here at the American Society of Clinical Oncology's Quality Care Symposium attempted to address that. In a podium presentation, Monika Krzyzanowska, MD, MPH, an oncologist at Princess Margaret Cancer Centre in Toronto, called on oncologists to recognize the current disparity between protocols for intravenous therapy and oral agents (Abstract 185). “How can we extend the quality and safety agenda from parenteral chemotherapy, where we've done a lot of good work, to oral chemotherapy?” she asked. “Oral chemotherapy does have its unique challenges.” She noted that a 2010 study found that approximately 16 percent of patients receiving chemotherapy received oral treatment, and that the percentage has been growing steadily. At least 25 percent of cancer treatments in the pipeline are for oral agents. While the advantages of oral therapies are obvious—for example, they are more convenient for patients and there is a reduced need for IV access, with the associated complications—Krzyzanowska identified several downsides: Range of prescribers and dispensers. “There's nothing stopping a primary care physician or another type of non-oncology trained physician to prescribe oral chemotherapy. We have patients filling their prescriptions at community pharmacies, and there are data that suggest that community pharmacies have little training and little experience to dispense these medications.” Patients and their caregivers are responsible for making sure that the right dose is consistently taken at the right time—a responsibility that is handled by highly trained clinicians in the case of IV therapy. An Oncology Nursing Society survey found that more than half of nurses surveyed believed that at least 25 percent of their patients had problems adhering to oral regimens. Lack of information about food/drug interactions that might affect the patient's experience with the drug. Lack of high-quality education materials regarding oral chemotherapy and training for community pharmacists and others who have traditionally not been involved in cancer care. No standardized processes for monitoring patients' adherence to their drug regimens and the side effects they may experience. The danger of poor adherence is that the drug may therefore not work as intended. Krzyzanowska noted that there is little data that examines the relationship between adherence and effectiveness, but pointed to one study that shows why understanding the connection is essential: In that 2010 study (Marin et al: JCO 2010:28:2381-2388), researchers analyzed the outcomes of 87 chronic myelogenous leukemia patients treated with imatinib packaged in pill bottles with “smart caps” that record every time the bottle is opened. The results showed that greater than 90 percent adherence was significantly associated with the probability of a complete molecular response. “Interestingly enough, in the literature a threshold of about 80 percent has often been quoted as the adequate threshold for adherence,” she said. “In the area of CML, which has been revolutionized by the discovery of imatinib, we see that poor adherence may be the predominant reason for inadequate molecular response.” What to Do Now She encouraged oncology practices to evaluate their current processes in four areas—prescribing, education, dispensing, and monitoring—and prioritize which area has the most urgent need for improvement. For many practices, improving the prescribing process will be job number one, she said. “If we don't have a safe prescription and a correct prescription, much that follows is going to be problematic. Areas for work to improve prescribing oral chemotherapy agents may include the following, she said: Setting prescription standards so all prescribers know the right regimen for each situation; Using computerized physician order entry or preprinted orders to facilitate standardization; Educating providers and dispensers about the importance of complying with standards; and Assessing compliance to the standards. She also pointed to dispensing as a high priority for improvement initiatives. “I think this is the area where we really need to do a lot of work. We need to set dispensing standards; we need to support the dispensers through education and communication; and we really need to make sure that safe handling practices are followed.” Possible solutions include allowing only cancer clinic pharmacies to dispense oral chemotherapy and using tele-pharmacy technology to support community pharmacists. Experience from the Field In 2013, ASCO and ONS updated their chemotherapy administration safety standards to, for the first time, include oral chemotherapy—with a caution, though, that implementation of the standards might prove difficult. Three poster studies presented at the symposium confirmed that they were right to have that concern. A quality improvement team of oncologists, nurse practitioners, and pharmacists at Abramson Cancer Center at the University of Pennsylvania analyzed the center's oral chemotherapy practice and identified two problems: (1) only about 20 percent of patients signed informed consent forms for oral chemotherapy; and (2) oncology pharmacists did not review prescriptions for oral chemotherapy. Nirav Niranjan Shah, MD, presented the study showing that Abramson established a policy requiring signed informed consent for all chemotherapy agents, regardless of administration route and set a goal that at least 75 percent of patients will provide informed consent before therapy begins. Additionally, the center's electronic medical record system was programmed to route all orders for oral chemotherapy to an oncology-certified pharmacist for verification of dose, route, and drug interactions. A three-month review of patients in the melanoma division after the changes were made found that only half of the patients had signed informed consent forms. However, all oral chemotherapy orders were reviewed by pharmacists—who intervened in 33 percent of the orders. The most common intervention was ordering tests to monitor patients taking an oral agent. Other interventions included adjusting the dose and modifying an interacting drug (Abstract 120). In another study, Sharon Lane, RN, MSN, Senior Director of Patient Safety at Dana-Farber Cancer Institute, reported on the creation of a new process to ensure that patients who are prescribed oral chemotherapy receive education and adherence monitoring (Abstract 146). The process starts when a physician, nurse practitioner, or physician assistant informs the patient about the dosing schedule and side effects, provides a standard education sheet, and notifies a pharmacist that the drug has been prescribed. Within 24 hours, a pharmacist contacts the patient to conduct a teaching session that covers the dosing schedule, management of side effects, drug handling, drug/food interactions, and how to contact the practice for follow-up questions. Within five days, a nurse calls the patient to reinforce education and monitor side effects and adherence to the regimen. Chart audits of about 250 patients treated in five disease centers found that 78 percent of patients starting oral chemotherapy received a teaching session and 73 percent had a follow-up call to monitor adherence. Compliance with the education and monitoring protocols varied considerably. In one disease center, nearly 90 percent of patients received both the education call and the adherence-monitoring call, while just 50 percent of patients in another disease center received either. The third study, reported by Carole Dalby, RN, MBA, OCN, CCRP, Quality Administrator of the Dana-Farber Network Practices, assessed the challenges of implementing the ASCO/ONS oral chemotherapy standards in a community practice network (Abstract 93), focusing on four elements: (1) consent; (2) completion of a chemotherapy treatment plan; (3) education provided by an RN; and (4) ongoing monitoring of adherence. As part of the initiative, pharmacists developed oral chemotherapy treatment algorithms for Dana-Farber's electronic health record (EHR) system. The system's parenteral chemotherapy treatment plan was adapted for use with oral chemotherapy, a nursing education program was created and implemented, and a process was developed to continuously monitor toxicity and adherence during clinic visits and through telephone calls. The new processes were incorporated into the workflow at all three campuses of the network, and a 12-month review showed a wide range of compliance with the new processes between campuses and over time. Challenges included staff turnover and resistance to change, patients not filling prescriptions and not participating in the processes, and limitations of the EHR system. “Oral chemotherapy administration is a work in progress that must be refined to achieve high reliability,” Dalby and her coauthors concluded.

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