Failed check system for chemotherapy leads to pharmacist's no contest plea for involuntary manslaughter
From the April 23, 2009 issue
The April 19, 2009, Cleveland Plain Dealer covered another disconcerting report about a healthcare professional who is facing criminal charges for his role in a fatal medication error.(1) According to the news report, a former Ohio pharmacist will plead no contest next month to involuntary manslaughter of a 2-year-old child who died in 2006 as a result of a chemotherapy compounding error. We first wrote about this tragic error in our March 8, 2007 newsletter, when criminal investigation of the event was being considered.(2) Since then, the pharmacy board revoked the pharmacist’s license, and a grand jury indicted him on charges of reckless homicide and involuntary manslaughter. The pharmacist faces up to 5 years in prison.
Prosecutors hold the pharmacist responsible for the toddler’s death because he oversaw the preparation of her chemotherapy. The child had undergone surgeries and four rounds of chemotherapy to treat a curable malignant tumor at the base of her spine. She was supposed to receive her last dose of chemotherapy on the day of the error. A pharmacy technician mistakenly prepared the infusion using too much 23.4% sodium chloride. According to a news report,(3) the technician mentioned to the pharmacist that the final preparation didn’t seem right, but the error went unnoticed. The infusion was administered to the child, who died 3 days later.
Though we cannot shed more light on the root causes of the error, our experiences with analyzing other errors strongly suggest that underlying system vulnerabilities played a role. For example, some pharmacies remove fluid from a bag when they have to add a large volume of medication to infuse, and then add additional fluid to the bag and titrate with 23.4% sodium chloride injection to bring the final concentration of the infusion to whatever was prescribed. Or they start with an empty bag and follow a similar process. Compounding the solution from scratch is error-prone. Such exactness of base solutions is most often unnecessary from a clinical standpoint. Communication failures between technicians and pharmacists, IV compounder-related failures, inadequate documentation of the exact products and amounts of additives, and other system issues have contributed to numerous fatal errors. We have also seen compounding errors and subsequent failed double-checks due to adverse performance shaping factors such as poor lighting, clutter, noise, and interruptions. In fact, in this particular case, news reports suggest that the pharmacist felt rushed, causing him to miss any flags that may have signaled an error.(3)
Without minimizing the loss of life in this case, we continue to be deeply concerned about the criminalization of human errors in healthcare. Ever since the advent of powerful machines like automobiles, the law allows for the criminal indictment of people who make errors that harm others, despite no intent to cause harm. To cite one instance, drivers who have been involved in an accident that caused the death of another person might be prosecuted in most states for vehicular homicide, even if the accident resulted from human error. The reality is, mere human errors that randomly occur in well-meaning people are considered “criminal” in a number of circumstances where public safety is at issue.
Safety experts including ISMP advocate for a fair and just path for individuals involved in adverse events, arguing that punishment simply because the patient was harmed does not serve the public interest. Its potential impact on patient safety is enormous, sending the wrong message to healthcare professionals about the importance of reporting and analyzing errors. It could also have a chilling effect on the recruitment and retention of an already depleted healthcare workforce. All professionals are fallible human beings destined to make mistakes along the way and drift away from safe behaviors as perceptions of risk fade when trying to do more in resource-strapped professions. Who would knowingly put themselves at risk for criminal indictments by entering the medical profession? If warranted, licensing boards can protect patients from reckless or incompetent actions of healthcare practitioners by limiting or revoking licenses.
While the law clearly allows for the criminal indictment of healthcare professionals who make harmful errors, despite no intent to cause harm, it will long be debated whether this course of action is fair, required, or even beneficial. The fact remains that the greater good is served by focusing on system issues that allow tragedies like this to happen. By focusing instead on those involved—the easy targets—one can easily avoid addressing the systems issues. Focus on the easy target in this case makes us wonder whether any regulatory or accreditation agency is assuring that all hospitals learn from this event and adjust their systems to prevent the same type of error. If not, the death of this little girl is a heartbreaking commentary on healthcare’s inability to truly learn from mistakes so they are not destined to repeat.
Some good has come from this tragic error. In Ohio, Senate Bill 203, called Emily’s Law after the child that died, requires pharmacy technicians to be 18 years or older, possess a high-school diploma, pass a criminal background check, and pass a competency exam approved by the Ohio State Board of Pharmacy. A similar House bill did not pass in the federal legislature.
References: 1) McCarty J. Eric Cropp, ex-pharmacist in case in which Emily Jerry died, is ready to plead no contest. Cleveland Plain Dealer. April 19, 2009. Available at: www.cleveland.com/news/plaindealer/index.ssf?/base/cuyahoga/1240129922221300.xml&coll=2. 2) ISMP Medication Safety Alert! Criminal prosecution of human error will likely have dangerous long-term consequences. 2007;12(5):1-2. 3) McCoy K, Brady E. Drug error killed their little girl. USA Today. February 25, 2008. Available at: www.usatoday.com/money/industries/health/2008-02-24-emily_N.htm.