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Patient Safety and Oral Chemotherapy

(Part one of a series)

By Jennifer M. Hinkel, NCCN eBulletin Editor-in-Chief, and Ed Li, NCCN eBulletin Drugs and Biologics Editor

This is the first of a series of NCCN eBulletin articles on challenges in oncology patient safety.

In the context of treating patients with cancer, “patient safety” is amplified. At the same time, some of the patient safety goals set forth by national organizations, such as The Joint Commission, become seemingly complex when applied to oncology, and especially when applied to the provision of outpatient oncology services.

One challenging area for oncology patient safety is the use of oral anticancer agents. Management of oral agents that carry a high risk of adverse events or those that have complex dosing schedules is a relatively new hazard in the scope of patient safety. Moreover, some oral agents are prescribed as part of a treatment regimen that includes both parenteral and oral therapies, making issues of schedule and dose potentially more confusing for patients.

“At every step of the process, there are vulnerabilities,” said Dr. Saul Weingart, MD, PhD, vice president for Patient Safety and director of the Center for Patient Safety at Dana-Farber Cancer Institute. Dr. Weingart and his team have conducted research on the safety challenges specifically associated with oral chemotherapy (see Weingart SN et al. “Oral chemotherapy safety practices at US cancer centers: questionnaire survey.” BMJ  2007; 334: 407.)As one example of a vulnerability in the prescribing process, few cancer centers or practices have the capability to prescribe oral agents electronically in a system that would alert the prescriber with dose limits or potential drug interactions.

Another significant challenge with oral chemotherapy safety is that unlike parenteral therapies, where a patient is closely monitored by an infusion nurse or other clinician during and after treatment, oral agents are taken at home. For a vulnerable patient population, keeping track of the frequency, cycle, and dose of an oral agent may be especially difficult. Patients may underestimate the risks associated with oral chemotherapy. Anecdotal reports of patients taking “extra” doses in an effort to “get better faster” (i.e., “over-adherence”) are alarming, and most likely result in toxicity. On the other hand, patients may skip doses for reasons ranging from side effects of the medication to the co-payment cost of refilling a prescription, potentially leading to inferior outcomes. (Partridge AH, et al. Adherence to Therapy with Oral Antineoplastic Agents. J Natl Cancer Inst. 2002;94(21):652-661). Adherence to therapy is difficult to monitor, especially when a patient is on long-term oral therapy and may not be coming to the clinic or infusion room on a regular basis. 

Some risks with oral chemotherapy are less well documented. OSHA, Occupational Health and Safety Administration, and ASHP, the American Society of Health-System Pharmacists, have strict guidelines on how oral chemotherapy should be handled and administered by practitioners. However, in the case of oral chemotherapy taken at home, the patient or a caregiver fills this role of handling and administering the agent. For example, in pediatric oncology, parents of patients may be handling oral chemotherapy agents, but may be unaware of precautions to avoid any potentially harmful exposure.  As one precaution that can be partially managed by the prescriber and pharmacist, patients should be dispensed a formulation that requires minimal manipulation to prevent family contamination and exposure that might occur when, for example, a tablet must be broken in half to achieve the desired dose.

Cancer centers and oncology practices are employing new techniques to help reduce the patient safety risks associated with oral chemotherapy and to better monitor adherence. Some of these approaches “borrow” from other specialties, such as public health, where “Directly Observed Treatment” or DOT for tuberculosis has long been a mainstay of keeping patients adherent to a course of oral therapy. While directly observing patients on oral chemotherapy may not be realistic, centers and practices are incorporating telephone outreach into their methodologies for gauging adherence to oral therapy and monitoring for potential adverse events. This type of outreach, combined with greater patient education and the development of tools to help patients understand issues such as cycles and scheduling of oral therapies, have the potential both to increase adherence to oral therapies (and thereby improve health outcomes) and to reduce the risk that patients will experience harm associated with oral anticancer agents.