The National Coordinating Council for Medication Error Reporting and Prevention opposes the criminalization of errors in healthcare.
The Council acknowledges that human error is inadvertent and unintentional.1 Criminalizing human error is a deterrent to error reporting, learning from errors, and error prevention. As a result, unsafe systems may be perpetuated rather than improved. Criminal acts and patient harm related to competency and/or licensure issues are not addressed in this statement as they are beyond the Council's purview.
The Council believes that events that cause or may cause patient harm should be reported promptly and investigated thoroughly using established techniques to identify all possible causes and contributory factors. Medication safety, risk management, patient safety and other organizational leaders are accountable for determining the appropriate actions to help prevent further human error and ensure safe patient care.
In addition to medications, the Council recommends a focus on overall error reporting and analysis that identifies both inadequate or unsafe systems design and at-risk behavior.2 The Council also encourages a patient safety environment that rewards reporting, places high value on open communication and shared learning, and encourages caregivers to proactively report potential hazards, process opportunities and errors without fear of reprisal for human error. The Council urges healthcare organizations to analyze these data points to improve performance of systems and individuals. Further, the Council recommends proactive use of information from internal and external sources of information about risk and error to improve patient safety before patient harm occurs.
The Council also recommends a culture of shared accountability for safety among leaders (for good systems design within the scope of their ability and control) and healthcare workers (for making safe behavioral choices and immediately reporting unsafe conditions.)
Human error involves unintentional behavior that causes or could have caused an undesirable outcome. Criminalization does not prevent human error, nor do safety procedures prevent intentionally harmful or reckless behavior. A transparent, fair, and consistently applied process should be used to investigate health care errors and respond accordingly to the results.
The Council defines a "medication error" as follows:
"A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Such events may be related to professional practice, healthcare products, procedures, and systems, including prescribing, order communication; product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use."
An error is defined as the failure of a planned action to be completed as intended (i.e., error of execution) or the use of a wrong plan to achieve an aim (i.e., error of planning).4
1 Kohn, LT, Corrigan, JM, Donaldson, MS, eds. IOM Report: to Err is Human; Building a Safer Health System. Washington, DC: National Academy Press; 2001: 49.
2 The National Coordinating Council for Medication Error Reporting and Prevention. (2014) Reducing Medication Errors Associated with At-risk Behaviors by Healthcare Professionals. Available at: Reducing Medication Errors Associated with At-risk Behaviors by Healthcare Professionals. Accessed 2022 April 4.
3 NCC MERP. About Medication Errors, the Council defines a "medication error." Accessed on 2022 April 4 at About Medication Errors
4 Kohn, LT, Corrigan, JM, Donaldson, MS, eds. IOM Report: to Err is Human; Building a Safer Health System. Washington, DC: National Academy Press 2001.
5 Marx, D. (2001) Patient Safety and the "Just Culture": A Primer for Health Care Executives. Transfusion Medicine (Medical Event Reporting System for Transfusion Medicine [MERS-TM]). Supported by a grant provided by the National Heart, Lung, and Blood Institute. Accessed on 2022 April 4 at: https://psnet.ahrq.gov/issue/patient-safety-and-just-culture-primer-health-care-executives
Leape, L., Berwick,D., Clancy,C., et al. Transforming healthcare: A safety imperative. Qual Saf Health Care. 2009, Dec: 18(6): 424-8.
National Quality Forum (NQF). Safe Practices for Better Healthcare-2010 Update: A Consensus Report. Washington, DC: NQF: 2010.
Reason, J. Human error: models and management BMJ 2000, Mar 18; 320(7237):768-70.
Actions/Decisions are those of the Council as a whole and may not reflect the views/positions of individual member organizations.