8 I AnesthesiologyNews.com
JUNE 2013
PRN
A Dangerous Interplay: Rx Shortages and Med Errors
D
uring two months starting in November 2010, more than 200 patients at seven hospitals in the MedStar Health system in the Maryland and Washington, D.C., region received double their prescribed concentration of potassium acetate. In response to a shortage of the usual stock dose of the drug (2 mEq/mL), MedStar acted to fill the gap by procuring vials containing a 4-mEq/mL solution. The wrong concentration was entered into the IV compounder software, which then identified the new vials as containing the lower dose, and the drug was administered to patients receiving total parenteral nutrition. No patients experienced injuries or medical abnormalities, which is one reason the mistake went undetected for so long. That the error occurred is disturbing, but unfortunately no longer surprising in a time when medication errors are rampant. Yet something sets this event apart beyond its scope and duration: MedStar chose to allow non-MedStar colleagues to observe its failings, its investigation and the changes it implemented to increase medication safety. “We knew this error could happen anywhere because the compounding device we used is common and the problems with drug shortages are everywhere,” said Bonnie Levin, PharmD, MBA, corporate assistant vice president of pharmacy services at MedStar Health. “We didn’t want this happening at another hospital; we want others to learn about the approach we took to identify and fix the problem and prevent it from happening again.” The incident was central to a session at a meeting in December of the American Society of Health-System Pharmacists (ASHP) that explored the link between drug shortages and medication errors and how hospitals can mitigate their negative impact. In addition to Dr. Levin, the speakers at the session included Michael R. Cohen, RPh, MS, ScD, president of the Institute for Safe Medication Practices (ISMP), and Terry Fairbanks, MD, associate professor of emergency medicine at Georgetown University, in Washington, D.C., and director of the National Center for Human Factors Engineering in Healthcare (NCHFEH), a division of MedStar Health. Rapid Response Team “This is a rare situation where an entire health system allowed its staff to step forward and teach others what
they went through,” Dr. Cohen said. “I’m sure it was embarrassing to go public with this event and I hope they get credit for stepping up like this.” ISMP representatives, Dr. Fairbanks and other consultants from the NCHFEH were part of a response team summoned by MedStar within a day or two after the error was discovered. They worked closely with hospital clinicians and administrators to determine the cause of the error, examine IV compounding policies and procedures, and offer recommendations to decrease the risk for future errors. The ISMP reviewed every step of the
a prominent role. For instance, Dr. Cohen and his ISMP colleagues found that staff members were not always aware of the reasons for changing processes within the IV admixture service, and that a systematic approach to communication about shortages and product changes with staff was lacking. “Communication always turns out to be a major issue when the ISMP conducts consultations,” Dr. Cohen said. “Everything from the way orders are communicated by computers, the way drugs are listed on a screen, lookk alike drug names, handwriting problems, abbreviations, verbal orders, telephone
IV admixture process, from drug procurement, labeling and packaging, to communication issues, staffing competency and education. Among their findings: • Pharmacy staff focused on the ingredient name and the volume of the container, but not the concentration. Moreover, a high level of trust among the staff led to expectations that mistakes would occur at an unrealistically low level, which can lead to cursory checks of drug and patient information. • Buyers did not routinely inform the pharmacy supervisor when alternate products were purchased. • The purchased strength was not contained on log sheets and an assumption was made that 2 mEq/mL was received. • Most items stored in the drug room are high-alert medications; therefore, labeling them as such does not provide any additional safety benefit. • There was no standardized process that incorporated a printed checklist to validate that whatever changes are made to the databases are correct. Communication lapses played
orders, the way we speak with one another—all that falls under communication. In this case, the health system’s purchasing department knew it was buying the higher concentration because that’s all they could obtain, but that information never reached the people who make the adjustments in the automated compounder system.” Dr. Cohen urged health systems to use the ISMP’s “Ten Key Elements” of the medication-use system when evaluating pharmacy processes. “The Ten Key Elements offers a template for designing an interlocking system of safety checks and balances that is very helpful when alternative drugs are brought in,” Dr. Cohen said. “Hospitals will want to know what it has to teach the medical and nursing staffs about a drug in order to monitor it because it’s different.” ‘Inattentional Blindness’ To Blame Dr. Cohen also discussed the role of “inattentional blindness” in medication errors. The phenomenon occurs when someone performing a task fails to see what should have been plainly visible.
Later, the individual cannot explain the lapse. Inattentional blindness certainly played a part in the MedStar incident, because clinicians repeatedly looked at the stock drug vial but did not register the new drug concentration on the label, Dr. Cohen said. Inattentional blindness has been the culprit in many errors documented by the ISMP, such as when a nurse pulled a vial of heparin from an automated dispensing cabinet, read the label, prepared the medication and administered it intravenously to an infant, despite the heparin concentration being 1,000 times greater than prescribed. The child died. In another event, a pharmacist entered a prescription for methotrexate into the pharmacy computer daily. A dose warning appeared on the screen, which the pharmacist read and bypassed, leading to a fatal overdose. According to a 2009 ISMP Medication Safety Alert, “In many cases, people involved in the errors have been labeled as careless and negligent. But these types of accidents are common—even with intelligent, vigilant and attentive people. The cause is usually rooted in inattentional blindness, a condition all people periodically exhibit.” Dr. Fairbanks identified root causes of the MedStar incident from the vantage point of safety engineering. He found, for example, that the staff exhibited decreased sensitivity to changes after long-term drug shortages; to facilitate bar-code scanning, vials at the compounding station were hung upside down with labels turned away from the operator; and nonformulary drug concentrations were stored on formulary drug shelves. He also noted that a change in a drug’s concentration is a rare and, therefore, unexpected event— one that individuals are unlikely to detect unless forewarned. Among his group’s recommended corrective actions were measures to restrict access to the IV compounder database; define a formulary list in the drug purchasing system (purchasing outside of which required the buyer to involve the pharmacist); procedural review and revision; staff retraining and re-education; and promoting a culture of continual feedback among staff. More broadly, he emphasized that the success of medication safety hinges on designing systems that compensate for inevitable human error—a tenet that is central to human factors engineering. “The key to designing