BOX 1-1

The Betsy Lehman Case

Betsy Lehman, a 39-year-old wife and mother of two and health reporter for the Boston Globe, was diagnosed with breast cancer in September 1993. She was admitted to the Dana-Farber Cancer Institute in Boston on November 14, 1994, for her third round of cyclophosphamide, a toxic chemotherapy agent. Betsy was participating in a dose-escalating phase 1 clinical trial in which higher-than-normal doses of the drug were being administered to wipe out cancer cells. She was undergoing a bone marrow transplant to restore immune and blood-forming cells.

Betsy received the wrong dose of cyclophosphamide. The correct dose was 1,000 milligrams (mg) per square meter (m2) of body surface area, given each day for a total of 4 days (or, for her height and weight, a total of 4,000 mg/m2 or 6,520 mg infused over the 4-day course of therapy). But after reading the trial protocol, a physician fellow wrote the order as “4,000 mg/m2 × 4 days.” The erroneous dosing went unrecognized, and Betsy died as a result of the overdose on December 3, 1993. The error was not discovered until 10 weeks later, when her treatment data were entered into the computer for the clinical trial (Bohmer, 2003; Bohmer and Winslow, 1999).

Experts at the hospital, as well as outside consultants, recognized that many factors contributed to this tragedy (Conway and Weingart, 2005). System issues included minimal double-checks, orders written by fellows without attending MD signoff, and unclear protocols that were not current and not easily available to RNs and pharmacists. Some dosages were written in total dose and some in daily dose formats, often in the same protocol. Maximum dose checking was not a feature of the pharmacy computer system. Both the patient and her family had felt that Betsy was not being listened to and mechanisms for reporting issues were not clear. When reporting did occur, it did not move up the organization in a timely fashion.

Today, the hospital has a strong culture of safety and engages interdisciplinary groups of front-line clinicians in the design and implementation of chemotherapy protocols. There is an understanding that safe cancer care requires an extraordinarily high level of communication, coordination, and vigilance, with a strong focus on being aware of and acting on the incidence of errors (Gandhi et al., 2005). Authority to prescribe cancer chemotherapy is reserved for attending staff, and dosages must be expressed only in terms of daily dose. Computer system warnings prevent physicians from placing drug orders that exceed the safe maximum, and the computerized provider order entry system is extensively supported by online protocols and templates. Alerts such as a red “WARNING: HIGH CHEMOTHERAPY DOSE” appear on the screen. To override the computer and exceed current guidelines, doctors must show the pharmacist new scientific results that prove a higher dose may be safe and effective. Much has been done to encourage independent checks of prescribed doses by nurses and pharmacists, and staff have been explicitly authorized to question openly any presumed dosing error. The organization describes the key lessons learned in the 10 years since Betsy’s overdose as the importance of the engagement of governance and leadership, vigilance by all every day, support for victims of errors, system support for safe practice, interdisciplinary practice, and patient- and family-centered care (Conway and Weingart, 2005; Conway et al., 2006).



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