Existing Knowledge of Medication Error Must Be Better Translated Into Improved Patient Safety

Abstract

The use of medicines in healthcare is safer and more effective than it has ever been, with pharmacovigilance having been active in some form for over 150 years (1). Yet, in 2000, marking what is often thought of as the beginning of the modern patient safety era, two landmark reports appeared, one by the Institute of Medicine in the United States, and the other by the Department of Health in the United Kingdom, demonstrating that avoidable patient harm during healthcare remains extraordinarily expensive and unacceptably common (2, 3). Both reports identified that medication errors are a leading cause of patient harm, and called for a “systems” approach to error prevention. A systems approach promotes the redesign of faulty or error-prone aspects of work systems, environments and procedures, based on an understanding of human factors and ergonomics, rather than exhorting individuals to be more careful or blaming them when patient harm occurs. Employing such a systems approach, some high-profile successes have been achieved in the last 20 years (4, 5). However, medication errors remain a persistent and concerning source of patient harm throughout the world, prompting the World Health Organization (WHO) in 2017 to launch its third Global Patient Safety Challenge, namely Medication Without Harm (6). The WHO Challenge report makes it clear that medication errors typically do not occur because of negligence or carelessness, but because of poor quality or unsafe medication systems, and estimates the global cost of medication errors at $42 billion annually. The report calls for a global reduction in the level of avoidable harm related to medications by 50% over 5 years (6). The field of human factors has demonstrated that human beings have measurable physical and psychological limits within which individuals operate at their best (7). Once outside of these limits, sheer effort or exhortation to try harder will have little or no lasting effect, and performance will inevitably decline. In a study in the United States based on 5,888 h of direct observation, hospital interns working traditional shifts involving multiple work periods longer than 24 h each month, had a 21% greater chance of making serious medication errors than when working without extended-duration shifts (8). Fatigue levels, such as these, have been equated to blood-alcohol levels in terms of their detrimental effects on performance, suggesting that work shifts of 17 h or more are equivalent to being intoxicated over the legal limit to drive a car (9). No one would accept a clinician practicing while drunk, yet the expectation is often that equivalent fatigue levels should be worked through simply by sheer effort. A prominent recent reminder that blame is often the first course of action when patient harm occurs can be seen in the response to the tragic death of 6-year old Jack Adcock in 2011 while under the care of Dr. Bawa-Garba (10). Dr. Bawa-Garba did make mistakes during Jack's care, including with medications, but she was operating in a system where any doctor would be have been dangerously overstretched—she was a junior doctor with no senior assistance, in sole charge of six hospital wards, in which the computer system for laboratory results was not functioning at the time (11). Dr. Bawa-Garba was prosecuted for manslaughter, and she and a senior nurse involved in Jack's death, were removed from their professional registers. Such a blame reaction does little or nothing to improve patient safety, as it fails to address the obvious systemic problems underlying the fatal healthcare failure, hence leaving these conditions unaddressed to precipitate further failures in the future. To make matters worse, the legal proceedings against Dr. Bawa-Garba led to widespread concern in the United Kingdom that doctors should no longer record personal reflections on their practice for fear of these records being used against them in a court of law at a later date (12). Given that reflective practice is considered an important part of quality improvement for individual practitioners, it can only be concluded that patient safety in the United Kingdom is now substantially poorer than it was before the Bawa-Garba case. After a long and expensive legal process Dr. Bawa-Garba was reinstated as a medical practitioner in 2018, yet little attention has been given to the system problems that precipitated the tragedy (13). Unfortunately, criminal prosecutions of clinicians for simple human errors are not uncommon, and continue to occur, as demonstrated by the current high-profile case in the United States in which nurse, RaDonda Vaught, has been found guilty of criminally negligent homicide resulting from a medication error (14, 15). Despite policy level directives that the systems approach should be prioritized over exhortation and blame when aiming to reduce medication errors and patient harm, evidence would suggest that this is often not the case during everyday clinical work (16). For example, in 2020, a 10-year multisite study reported 4223 local corrective measures taken in response to 7072 patient safety incident reports made during perioperative and critical care (17). The study lists the five leading corrective measures as: (1) communication through mortality and morbidity meetings; (2) email alerts; (3) new or revised clinical protocols; (4) a change in material or supplier; and (5) more training. Note that four out of five of these corrective measures are exhortative in nature, and are consistent with the belief that patient safety is best achieved through greater effort on the part of clinicians (e.g., be more aware, follow the new protocol, get better trained). Only one corrective measure (a change in material or supplier), involves a minor change to the work system in which clinicians are expected to perform safely. The perioperative period is one of the most intensive phases of medication administration in...