Risk Management in Oncology: Health-System Pharmacist Perspectives
Walter L. Fitzgerald, Jr, MS, JD, DPh*
Although it has been widely reported by the Institute of Medicine that at least 1.5 million preventable adverse drug effects from medication errors occur in the United States each year, little is known about the prevalence of medication errors associated with antineoplastic agents. Various case reports have examined the issue and one study that evaluated approximately 10 000 medication orders from 3 ambulatory oncology clinics indicated an error rate of 3%.1 Although this rate is relatively low and many of the errors studied did not reach the patient, it may be reasonable to assume that, because of the toxic nature of these drugs, any incorrect use may potentially lead to serious adverse effects, including death. After all, these narrow therapeutic index agents are known to frequently cause toxicity at US Food and Drug Administration-approved dosages and administration schedules. Thus, even slight deviations from these guidelines are associated with unacceptable risk and, therefore, risk management strategies that focus on medication error prevention are a central component of oncology services.
Because pharmacists are so intertwined in the medication-use process, they have an inherent occupational risk of various types of errors (eg, order entry, calculations, and preparation), but they also can and do play a critical role in intercepting errors before they reach the patient. As a result, it is vital for pharmacists to be knowledgeable about the various risk management strategies that are used to correct system failures and consequences of medication errors.
This issue of University of Tennessee Advanced Studies in Pharmacy consists of 4 case studies that include various scenarios of potential risks, followed by a discussion of ways to effectively manage these risks. Provided examples of the types of errors are meant to be used for educational purposes only and are not actual historical events. Nelly G. Adel, PharmD, BCOP, presents a case study illustrating chemotherapy errors that may occur during several phases of the medication-use process (eg, prescribing, dispensing, and administering) and involve multiple healthcare providers. In her discussion, Dr Adel, a manager of clinical pharmacy services and Oncology Residency Program Director at Memorial Sloan-Kettering Cancer Center, focused on specific and general measures that can be taken in correcting these types of errors and preventing future similar incidents from occurring. Dr Adel also contributed a case study involving the prescribing and dispensing of a chemotherapy order with an off-label dosing schedule. She stresses that, although quite common and essential in oncology, off-label drug use should still be supported by some evidence-based literature and diligent dispensing by the pharmacist.
Walter L. Fitzgerald, Jr, MS, JD, DPh, presents a case study that exemplifies unintentional overdilution of chemotherapy leading to underdosing. In discussing the consequences of this type of error, Dr Fitzgerald, Dean of Pharmacy Education Program Development at South College, focuses on financial and legal implications related to submission of false claims and reimbursement for care resulting from subtherapeutic dosing of chemotherapy. In another case study illustrating a calculation error that led to a significant overdose and subsequent toxicity, Dr Fitzgerald discloses specific risk management strategies that can be used to minimize the financial and legal tolls of medication errors involving chemotherapy. In acknowledging that mistakes may happen despite meticulous quality control within pharmacy systems, Dr Fitzgerald emphasizes that using risk management to correct system failures that led to these errors makes all the difference.
1. Gandhi TK, Bartel SB, Shulman LN, et al. Medication safety in the ambulatory chemotherapy setting. Cancer. 2005;104:2477-2483.
*Dean, Pharmacy Education Program Development, South College, Knoxville, Tennessee.
Address correspondence to: Walter L. Fitzgerald, Jr, MS, JD, DPh, Dean, Pharmacy Education Program Development, South College, 3904 Lonas Drive, Knoxville, TN 37909. E-mail: email@example.com.
The content in this monograph was developed with the assistance of a staff medical writer. Each author had final approval of his/her article and all its contents.