1. Cohen, Michael R. RPh, MS, ScD (Hon), DPS (Hon), FASHP

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It has been a privilege to be able to communicate with members of INS for more than 25 years through my medication safety column in INS' bimonthly newsletter, Newsline. You and your nursing colleagues have shared many accounts of medication error-related problems. Some were profoundly tragic.

Michael R. Cohen, RP... - Click to enlarge in new windowMichael R. Cohen, RPh, MS, ScD (Hon), DPS (Hon), FASHP, President,

Discussions like those featured in Newsline, the Journal of Infusion Nursing, and other publications have had a significant impact on overall patient safety. In many cases, and sometimes with prodding, regulatory authorities such as the US Food and Drug Administration, standards organizations such as United States Pharmacopeia (USP) and The Joint Commission (TJC), and medical product manufacturers have recognized the serious nature of these discussions and reacted. Improvements have resulted. The good news is that many serious medication errors we talked about over the past 25 years are predominantly problems of the past, and our patients are safer for it.


Let me provide an example. In the 1980s and 1990s, we discussed tragic errors involving potassium chloride (KCl) concentrate vials, which were commonly stored on hospital nursing units for preparation of intravenous (IV) admixtures. Mental slips were occurring: Nurses somehow were converting an order for furosemide (Lasix) injection, which causes potassium loss, and instead were administering KCl concentrate injection. More than once, an IV potassium bolus was administered instead of Lasix. Patients would scream in pain, lunge backward in bed, and go into cardiac arrest. Resuscitation failures and fatalities resulted.


KCl mix-ups with Lasix weren't the only problem. At one time, KCl vials looked disconcertingly like vials of sodium chloride 0.9% injection used for flushing IV catheters or diluting medication powders for injection (same size, same color). In more than 1 case, 1 of these KCl vials wound up in a storage bin full of sodium chloride vials. At the Institute for Safe Medication Practices (ISMP), we heard about a recently graduated nurse who retrieved a vial from a bin marked "NaCl 0.9%," and used it to prepare a dose of ampicillin for an infant. Soon after the injection, the infant was dead. She had mixed the antibiotic with KCl instead of sodium chloride. A family was devastated. The nurse was so distraught she left nursing.


ISMP's focus in describing potassium errors and making recommendations for change has never been about blaming health professionals for making errors. For potassium, at first it was about needing to make the vials look different and employing new warning statements on the containers. USP set new standards for KCl, requiring a black cap and vial closure (ferrule) with the following printed in white: "Must be diluted." More important, we all worked together to get behind removing concentrated potassium vials from nursing units altogether, replacing them with available premixed potassium chloride large-volume containers. TJC addressed the issue by no longer allowing potassium vial storage on nursing units as one of its National Patient Safety Goals.


With these changes, I'm gratified to say that in the past 20 years or so, I've learned of only 1 potassium vial-related death in the United States, and that was in a non-TJC-accredited hospital. Yet, KCl-related deaths still occur outside the United States, where all too often, vials or ampules continue to be stored on nursing units, and nurses are responsible for preparing IV medications and solutions in the drug room. They are the ones who reconstitute antibiotics and other drugs. Nurses and their patients are still at risk. As I write this, it was only yesterday afternoon that I received a report from a colleague in England where a patient experienced cardiac arrest after someone reconstituted the antibiotic meropenem with an ampule of KCl concentrate instead of sodium chloride (Figure 1). No such packaging exists in the United States. During the past year, ISMP became aware of 3 other deaths from KCl (Table 1).

Figure 1 - Click to enlarge in new windowFigure 1. Ampule of European potassium chloride (KCl) product, right, was mistaken as sodium chloride 0.9% injection, left. The KCl may have been turned so that only the barcode label was displayed.
Table 1 - Click to enlarge in new windowTABLE 1 Deaths From Potassium Chloride Concentrate Outside the United States 2016-2017

Hundreds of serious medication errors have been successfully addressed since ISMP's column first appeared in Newsline in 1990. These include protection from infusion pump-related free flow; elimination of dangerous, large-volume containers of IV solutions as reservoirs for the preparation of sodium chloride syringes for flushing IV catheters; and removal of prefilled 1 g and 2 g lidocaine syringes for infusion preparation from the market. Those prefilled syringes were given accidentally by IV bolus injection instead of as an infusion, resulting in the deaths of more than 50 patients. More recently, ratio expressions on labels of EPINEPHrine and several other medications were removed (1:1000; 1:10 000, etc.) as a result of dosage miscalculation of the amount of drug needed for a dose. These 1-mL containers are now labeled only in quantity per mL; for example, 1 mg/mL.


Since becoming a charitable organization more than 2 decades ago, ISMP has pursued a singular mission to advance patient safety worldwide by empowering the health care community, including consumers, to prevent medication errors. At ISMP, we work in an expert advisory capacity only, with neither the power to set minimum standards of care nor the authority to certify, regulate, or accredit individuals or organizations based on any standards of care, including those associated with medication safety. While we often support the minimum standards of care required by regulatory, standards-setting (including INS), accrediting, and certifying agencies, ISMP also attempts to raise the bar by recommending alternative but practical high-leverage strategies to improve medication safety. We have published guidelines, but not standards, that reflect consensus among key stakeholders associated with medication use. ISMP has also published numerous tools and self-assessments, research findings, targeted medication safety best practices, and various lists-for example, confused drug names, drug pairs with tall-man letters, high-alert medications, and error-prone abbreviations-that best support safe medication practices. We hope you will take advantage of this information by visiting ISMP's website,


Although ISMP is a relatively small organization with roughly 30 full-time employees, its influence is deep, and our reach is far when it comes to medication error prevention. We review every error report received and use the information to help others prevent errors. While ISMP and clinicians or consumers who report specific hazards are rarely recognized as predecessors to medication safety-related changes stemming from ISMP reports, there is a good chance that together, our persistence has been an impetus for change. Your reports of hazards and errors sent to ISMP are powerful drivers of change, in both the United States and abroad, and they will continue to be a major force in the patient safety movement.


I sincerely appreciate the support you have given my colleagues and me at ISMP by following up and backing many of the safe practices we've recommended over the years. You've truly made a difference.