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Contributions to this column are prepared by the Institute for Safe Medication Practices Canada (ISMP Canada), a key partner in the Canadian Medication Incident and Prevention System. From time to time, ISMP Canada invites others to share learning based on local initiatives. The article presented here is reprinted, with permission, from the ISMP Canada Safety Bulletin 2008; 8(7):1–2.
Reports of near-miss incidents offer valuable learning opportunities.1 This bulletin highlights a near miss with cyclophosphamide for intravenous administration, with the goal of sharing learning and recommendations related to the use of cytotoxic medications for non-oncology indications.
A 55-kg adult patient was receiving care in an intensive care unit. During the patient’s stay, Wegener’s granulomatosis was diagnosed, and a physician ordered cyclophosphamide 2.2 grams daily, by intravenous administration, for 3 days. The pharmacist who reviewed the order checked the patient’s medication profile in the pharmacy but could not identify the indication for cyclophosphamide. Furthermore, given the dose of cyclophosphamide that had been ordered, the pharmacist expected an accompanying order for the bladder-protective drug mesna, but there was no order for this drug. The pharmacist contacted the intensive care unit and was advised of the patient’s new diagnosis by one of the nurses. The pharmacist initiated a literature search, because she believed that usual cyclophosphamide dosing for an autoimmune disorder such as Wegener’s granulomatosis would be much lower than the dose that had been prescribed. The literature review confirmed the pharmacist’s suspicions, and she contacted the physician. The physician initially affirmed the order as prescribed, but after discussing the matter further with the pharmacist and reviewing the information presented by the pharmacist, the physician realized that he had intended to order a dose of 220 mg. The physician changed the order and expressed gratitude for the pharmacist’s follow-up.
The following factors were identified as potentially contributing to this near-miss incident:
Procedures that govern the use of cytotoxic medications for oncology indications are also applicable when medications such as cyclophosphamide are used for non-oncology purposes. This near-miss incident exemplifies the value of ensuring that all orders for cytotoxic medications are reviewed by a pharmacist with the skills for performing such reviews. The following recommendations were developed in collaboration with the reporting facility:
Cytotoxic medications are high-alert medications.3 Furthermore, cytotoxic drugs have a narrow therapeutic window (the difference between an effective dose and a toxic dose), regardless of the indication for which they are used. When cytotoxic agents are ordered for the treatment of cancer, the protocols are typically readily available, and the drugs are ordered, dispensed, and administered by specially trained health care professionals. In addition, the high-alert nature of these medications is well recognized in oncology practice, and stringent processes, including ensuring availability of the information required to process an order and performing the necessary multiple checks, are routine. Similar system-based safeguards are required for cytotoxic medications used for non-oncology indications.
Medication incidents (including near misses) can be reported to ISMP Canada in 1 of 2 ways:
ISMP Canada gratefully acknowledges the input provided by Larry Broad-field, BScPhm, MHSc, FCSHP, Manager Systemic Therapy Program, Cancer Care Nova Scotia, and the expert review by (in alphabetical order): Patti Cornish, RPh, BScPhm, Patient Safety Service, Sunnybrook Health Sciences Centre; Roxanne Dobish, BSc(Pharm), Assistant Director, Provincial Pharmacy, Cross Cancer Institute; Robin J Ensom, PharmD, FCSHP, Regional Director, Pharmacy, Vancouver Coastal Health and Providence Health Care; Edward Etchells, MD, FRCPC, Director, Patient Safety Service, and Staff Physician, Division of General Internal Medicine, Sunnybrook Health Sciences Centre; Sophie Kim, BScPhm, Department of Pharmacy, Princess Margaret Hospital; Sharon F Lane, RN, MSN, AOCN, Associate Director Center for Patient Safety, Dana-Farber Cancer Institute; Dan Perri, BScPhm, MD, FRCPC, Clinical Pharmacologist and Intensivist, St. Joseph’s Health-care Hamilton, Assistant Professor, Department of Medicine, McMaster University; John W Senders, PhD, Professor Emeritus, University of Toronto.