Recent studies have highlighted the inherent susceptibility for medication errors by anesthesia providers in the perioperative environment. In a prospective survey at Massachusetts General Hospital, investigators identified a concerning potential error rate of 1 in 20 medication administrations, many of which resulted in patient harm.
To those of us who toil daily in the trenches of the operating room, this come as no surprise, for we are the only type of healthcare provider that prescribes, dispenses, premixes, repackages, relabels and administers the medications, independently and without secondary verification or use of technologic support. In one sense this may seem to be an advantage, for if there are fewer intermediaries, such as pharmacists or registered nurses, there are fewer humans to make a mistake. On the other hand, more intermediaries or additional verification might identify previously unrecognized errors.
Patients (and healthcare workers) would be surprised to learn that there are almost no laws or regulations pertaining to medication administration safety. I believe it is time for that to change. Although public health law has traditionally focused on the legal methods to prevent transmissible disease, over the past century this focus broadened to include prevention of chronic diseases, environmental hazards, and injuries. In fact, as early as 1958, Vickers characterized public health as “successive re-definings of the unacceptable.”
In an upcoming issue of the Journal of Patient Safety and Risk Management, I argue the case that harm from medication errors can be considered within the ambit of “public health”, and can be decreased using the public health law framework of increasingly stringent levels of paternalism, as described by Friedman. The least stringent (libertarian or apaternalistic) level, where the government allows a free market and relies on consumers to process relevant information, is the current level that exists in the U.S. (and throughout the world) today: patients need to figure out for themselves which hospitals have the safest medication administration procedures. This is essentially an impossible task, since hospitals generally do not keep close track of medication errors, and certainly do not make the results available to public if they do.
There are two main kinds of medication errors made by anesthesia providers. The first occurs when a medication syringe is accidentally prepared from the wrong drug vial. This can occur when drug vials look similar or are situated near each other in the anesthesia drug tray. The other main type of error occurs when the anesthesia provider administers a correctly filled syringe, but it was not the one that was intended, a process referred to as “syringe swap.” Without systematic mechanisms to prevent either of these two types of errors, patients have to rely on the anesthesia provider’s vigilance and mental focus to remain safe. Since human errors are inevitable and arguably normal, reliance only on vigilance will ultimately be unsuccessful; thus, more systematic safety methods are required to prevent these types of errors.
In the paper, I argue that there should exist regulations aimed at the prevention of vial and syringe swap errors, by mandating the availability of methods that circumvent the possibility of human error. This was accomplished by OSHA in 2000 with the Needlestick Safety and Prevention Act, created to confront the preventable problem of healthcare workers who contract serious viral illnesses by accidental needlesticks.
That Act requires healthcare employers to provide their employees with technologically advanced needles that are engineered to prevent accidental sticks during patient care. The Act forced healthcare employers to supply the needles to the employees at risk, without mandating their use; a clever solution to the infringement on the practice of medicine obstacle. Infection rates decreased because the needles were readily available, easy to use, and had no demonstrable disadvantages.
A similar regulation to decrease the incidence of medication errors would mandate the availability of pre-filled syringes, thus eliminating the possibility of vial swap. After all, what provider would go to the trouble of preparing their own syringe when one was immediately available? The prevention of syringe swap is admittedly more difficult, and will require the availability of technological equipment, such as barcoding, to confirm that the drug one intends to give is truly the correct one. Both of these medication safety advances are currently available but very few hospitals use them, primarily because of the increased cost, and the lack of knowledge of their availability. However, this is beginning to change, as hospitals that invest in these safety methods are beginning to publish their success.
Although gaps in legal and regulatory structure of medication administration by clinicians may indirectly allow patient harm, this gap can be filled by solutions based on the public health law framework that reveals the vulnerabilities of the current apaternalistic situation that exists in the U.S. today.
Ron Litman, D.O., M.L. is an anesthesiologist at the Children’s Hospital of Philadelphia and Professor of Anesthesiology and Pediatrics at the Perelman School of Medicine at the University of Pennsylvania. He is the medical director of the Institute for Safe Medication Practices, and a current member of the FDA’s AADPAC.
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