Technology and error-prevention strategies: Why are we still overlooking the IV room?
Harmful or fatal errors that have occurred when compounding sterile intravenous (IV) preparations in the pharmacy—including simple IV admixtures—have been fodder for headline news during the past decade.1 The 2012 meningitis outbreak that led to the death of 64 people from contaminated epidural solutions prepared by the New England Compounding Center (NECC) will long be remembered. There has been no shortage of sterile compounding errors in hospital pharmacies, either—from the accidental chemotherapy compounding error 9 years ago that claimed the life of 2-year-old Emily Jerry and eventually sent pharmacist Eric Cropp to jail, to the recent December 2014 compounding error in which a rocuronium infusion was prepared and dispensed instead of a fosphenytoin infusion, leading to the death of a 65-year-old woman.
Sterile compounding errors in hospital pharmacies have devastated the patients, family members, and healthcare practitioners involved in the events. Unfortunately, the lessons learned from these and other events have not been widely acknowledged, understood, and/or acted upon by pharmacies that were not involved in the tragic events.
The causes of sterile compounding errors are diverse, involving both sterility and other drug safety issues. ISMP visits dozens of hospitals and health systems each year for various reasons and has observed unsafe practices associated with sterile compounding in hospital pharmacies. Through our ISMP National Medication Errors Reporting Program and other reliable sources, we have compiled and analyzed many sterile compounding errors to determine the causes, and published our findings when possible in this newsletter. And late last month, an important report was released that mentioned the slow rate of adoption of pharmacy IV workflow technology with barcode scanning—only 6-7% of hospital pharmacies employ this technology despite its reasonable cost.2
To gain a wider perspective regarding the causes of sterile compounding errors and the slow adoption of technology and other error-reduction strategies, we recently held a discussion with our close colleague, sterile compounding expert Eric Kastango, president and CEO of Clinical IQ, LLC. Five entangled systems and behavioral causes surfaced as we discussed the issues: 1) depreciating importance of the compounding and dispensing processes in pharmacy practice, 2) lack of knowledge and standardization around best practices, 3) training based on traditions handed down from one pharmacist to another, 4) learned workplace tolerance of risk and routine practice deviations that persist, and 5) a reluctance to learn from the mistakes of others. These five causes are further described.
Depreciating importance of the compounding and dispensing processes in pharmacy
During the last few decades, pharmacy practice has undergone a significant transformation into a more clinical realm. While we applaud the augmented clinical roles that pharmacists now play and their positive impact on patient safety, some of the core elements of pharmacy practice seem to have been lost or relegated to low priority status. Core practices such as sterile compounding and distribution do not receive the attention devoted to clinical pharmacy roles such as antibiotic stewardship, anticoagulation management, and disease state management. Many tasks associated with sterile compounding are carried out by pharmacy technicians, with minimal oversight by a pharmacist who may often rely on a woefully inadequate “syringe pull-back” method to verify the technician’s work.3 Stated simply, sterile compounding is not very “sexy.”
Lack of knowledge and standardization around best practices
When it comes to sterile compounding, there is little confidence that pharmacists and technicians know what best practices look like. While the US Pharmacopeial Convention (USP) <797> provides proscriptive guidance on the sterility and quality components of the process, deficits abound amid unwarranted confidence that practices are on par with the standards. For other aspects of IV sterile compounding safety, there have been scarce resources for staff to consult. To help fill that void, in 2013 ISMP published a set of guidelines for safe preparation of sterile compounds. The guidelines, which were developed following a national summit, offer pharmacists and technicians a credible, peer reviewed resource on IV sterile compounding safety. While the guidelines provide consensus statements for many process steps involved in sterile compounding, the national summit did not delve into the details of some specific tasks, including the required components of an effective sterile compounding checking process.
Without standardization of best practices, there is clearly wide variability, even among staff in the same pharmacy, in completing the tasks associated with the compounding process—how the products are assembled for preparation, the size of syringes used during compounding, how the checking process is carried out and in what order, what constitutes a thorough check, when and where signatures are placed on labels, when and where labels are placed on the preparations, and so on. Further, despite USP <797> guidance on sterility, it appears that pharmacy staff are still getting it wrong. Suffice it to say that many do not understand all the necessary safety steps required during sterile compounding, why they are necessary, and what best practices look like.
Training based on traditions
New pharmacy graduates have often been shortchanged when it comes to learning the robust principles associated with IV sterile compounding. Schools of pharmacy typically do not adequately teach students sterile compounding, and new graduates are often immediately responsible for verifying compounded sterile preparations and overseeing processes they have never carried out themselves. Thus, it is not surprising that sterile compounding procedures are typically handed down from one pharmacist to another, often with little scientific merit. New pharmacists learn via tribal knowledge taught by a practicing pharmacist employing a well known mantra from medical school—see one, do one, teach one. Most training is prefaced with, “Here’s how I do it.” We have even heard of hospitals that maintain bound manuals of compounding procedure “legacies” or “legends” to pass on to new staff.
When training does occur, it is often hurried and without an explanation regarding why subtasks need to be carried out. Often, staff do not understand the rationale for certain steps that help ensure sterility and safety. Why must the checking process be carried out in a distinct order and manner? Why is it important to check the contents of some preparations before they are mixed? Why is a technology-aided checking system far superior to a manual checking system? Without explanatory information, practice change and long-term compliance is unlikely. There is virtually no support for more in-depth, unhurried training, perhaps because sterile compounding is increasingly overlooked and rarely featured as a prestigious aspect of pharmacy practice.
Learned workplace tolerance of risk and routine practice deviations that persist
Production pressure to get a compounded sterile preparation out the door has often adversely affected safety. The pressure leads to shortcuts that eventually become unsafe practice habits. Because these shortcuts have yet to result in a readily apparent adverse outcome, they become routine. These “successful” violations are often practiced and accepted by an entire pharmacy staff. Thus, what begins as small deviations from a safe sterile compounding preparation process becomes, with enough repetitions, normalized staff practice patterns (normalization of deviance).
Routine practice deviations are learned workplace behaviors that often persist regardless of knowledge or experience. Knowing an action could be harmful rarely controls behavioral choices; rather, it’s the immediate reward (e.g., getting the product out the door) from the behavior that controls the choices made (a bias known as hyperbolic discounting). Uncertain or delayed consequences, even potential patient harm, do not motivate behavioral choices. It is human nature to drift into at-risk behaviors—checking a sterile compounded solution on the fly, removing the mask when it becomes uncomfortable—while losing sight of the risk or mistakenly believing the risk is insignificant or justified. Thus, staff who engage in routine practice deviations are often singly focused on production, not safety, and possess little situational awareness regarding how their behavioral choices could lead to patient harm.
Even those overseeing sterile compounding preparations have become blind to unsafe practices, easily overlooking violations—a pharmacist who, using a camera, carefully verifies the additives but never notices that the technician’s face mask is below her chin and her bangs are hanging out of the cap, for example. The workplace has long tolerated the risks associated with sterile compounding, in part because there is little understanding regarding best practices and why certain steps are critical to safety. Instead of noticing the risks associated with behavioral drift and then “stopping the line” to resolve the risk, as staff would in highly reliable industries like aviation, these at-risk behaviors have continued unchecked, leading to perfect storms with adverse patient outcomes.
Reluctance to learn from the mistakes of others
Healthcare practitioners are often disinclined to learn from the mistakes of others, believing that if the adverse event hasn’t happened to them, the lessons do not apply. This belief stems from a variety of cognitive biases from which we all suffer, including: conservatism (tendency to insufficiently revise one’s belief when presented with new evidence); normalcy bias (refusal to plan for or react to a disaster which has never happened to you); not invented here bias (aversion to use standards and knowledge developed outside of a group); ostrich effect (ignoring an obvious problem); Semmelweis reflex (tendency to reject new evidence that contradicts what is known); status quo bias (tendency to like things to stay the same); and others. Thus, even the high-profile sterile compounding events in the past decade have not prompted all pharmacists and technicians to impartially reassess their own sterile compounding processes to see if similar vulnerabilities exist.
It has also been hard to change longstanding behaviors in the face of new evidence. For example, if a technician has been washing his hands for 15 seconds for the past 30 years without a known sterility issue, even when faced with USP <797> standards that call for 30 seconds of handwashing, the technician is unlikely to make a long-term change without understanding, and appreciating the significance of, the risks associated with his longstanding practice. Keep in mind, changing to the new behavior—30 seconds of handwashing, for example—requires acknowledging that one was doing it wrong for 30 years. As a profession, pharmacy practitioners must first acknowledge that the way they have been compounding sterile preparations may not be the best way, before they can learn from the mistakes of others, identify vulnerabilities in their own processes, and improve.
Conclusions and next steps
Sterile compounding is a significant but perilous core pharmacy process in dire need of improvement. Variability in practices, a failure to identify and teach best practices, and a host of cultural issues associated with routine practice deviations and tolerance of risks have led to harmful and fatal errors that should serve as a call to action. It’s time for pharmacy to “sweat the small stuff,” contrary to the well known axiom, and examine every detail of every subtask involved in sterile compounding.
The details regarding how to perform each subtask associated with sterile compounding and why it is necessary are crucial and should be established and taught to all who are involved in sterile compounding, including pharmacy students. To date, USP <797> offers best practices associated with ensuring the quality of compounded preparations. However, these standards do not address processes for selecting and preparing the correct drug. We plan to update the ISMP sterile compounding guidelines to include additional details to better describe what needs to be done every time, why it is necessary, the best practices to achieve it, and how to teach it to those involved in sterile compounding. Our goal is to assist healthcare providers in: assessing their current sterile compounding processes; understanding the value of technology-assisted workflow; assessing pharmacy staffing requirements; establishing and implementing standard operating procedures and key technologies based on best practices; transferring knowledge to involved staff; evaluating staff knowledge, skills, and abilities; and monitoring ongoing performance.
To that end, ISMP is planning several initiatives in 2015 in which we hope newsletter readers will participate. Our first priority is to describe the sterile product checking process in detail, so we are asking newsletter readers to send us any checklists (or other materials) you use to guide the steps in this process. Please send the information via email to [email protected] or by fax to 215-914-1492. We also plan to conduct several surveys on this topic and ask newsletter readers to participate to the fullest extent possible. Look for the first survey later this quarter. We look forward to working closely with interested healthcare professionals during 2015 on this important endeavor.
ISMP thanks Eric Kastango for sharing his observations and contributing to this article.
- Pew Charitable Trusts. U.S. illnesses and deaths associated with compounded medications (2001-present). April 15, 2013.
- Neuenschwander M, Fahmi J. In the clean room. A review of technology-assisted sterile compounding systems in the US. Bellevue, WA: The Neuenschwander Company. 2014.
- ISMP. Syringe pull-back method of verifying IV admixtures unreliable. ISMP Medication Safety Alert! 2013;18(14):3.