Perspectives

As seen in Patient Safety and Quality Healthcare.

In April, Patient Safety and Quality Healthcare published an article summarizing a recent webinar presented through our Center for Safety and Clinical Excellence. The article is titled “Smart Pump Workarounds – What’s the Legal Risk?”, and it focuses on personal accountability on the part of caregivers in safely operating Smart IV pumps.  

Caregiver accountability has been a hot topic in recent months. As it relates to IV medication safety, it’s a critical issue and worth paying attention to. It’s been shown that clinicians often implement process workarounds, including not utilizing the drug library, overriding soft dose and concentration alerts, reprogramming infusions as rate in ml/hr following hard limits, and occasionally removing IV tubing from pumps and delivering medication boluses by gravity to avoid a high dose alert.  Although no formal study to date has explored the reasons for non-compliance, there are many potential contributing factors, including time, the belief among some caregivers that they do not make mistakes, alert settings that may not be consistent with current medication practices, and administration practices that are outside established hospital policies. 

Regardless of the reasons why, it’s become clear that compliant use of medication safety technologies varies within and between hospitals. But, when you combine high-risk IV medications and the frequency of programming errors, anything less than full compliance is a patient safety risk.  Lately, there’s been an increased focus on the “second victim” of medical errors—the clinician. In an earlier webinar and a recent Perspectives blog, we discussed the case of Eric Cropp, a pharmacist who served jail time after missing a medication error that ultimately took the life of two-year-old Emily Jerry. Eric did not have access to a technology solution that could have helped identify and prevent the compounding error. But, in cases where caregivers have a choice and choose to work around best practice and compliance guidelines, the concept of the second victim takes on a whole new meaning.

This topic brought me back to a familiar line from Hill Street Blues—one of my all-time favorite TV series. Based on a New York police department, each show began with Michael Conrad reminding his police force, “Let’s be careful out there!” Great advice for all of us.

As seen in Pharmacy Times, Healthcare Purchasing News and Surgical Products Magazine.

This month, we recognized the 10-year anniversary of “smart” infusion pumps – infusion devices with Dose Error Reduction Software, or DERS for short.  Infusion pumps have been in use since the late 1960s, and for the first 30 years they could infuse fluids and drugs at any programmed setting within the range of the pump, with no warning to caregivers if the infusion was programmed in error. With a rate range from a few drops to a whole liter of fluid per hour, nurses were in need of a safety net to help prevent inadvertent and potentially serious IV medication errors.

I have often been asked why it took so long for infusion pump manufactures to add “guardrails” into infusion pumps.  The short answer is that until it was possible for individual hospitals to create in their pumps custom drug libraries and best practice drug limits, the idea of adding safety alerts was only a dream.  Each time we heard about a death or serious injury due to an incorrectly programmed pump, we could only hope that caregivers would be more careful in the future.  Of course, this was of little comfort knowing how easy it was to make a mistake and how vulnerable nurses were without a safety net.   Imagine driving on a winding mountain road with no guardrails, no center line, no caution signs or stop lights – that example mirrors the reality of infusion pump therapy as we entered the 21^st century.

The technological breakthrough was the flash EPROM – basically, a chip that could be programmed with a hospital-specific drug library.  Because drugs may be used off-label and IV practices are often not standardized, infusion pump manufacturers began to market “dumb” pumps that hospitals could make “smart.”   As I reflect back on the first Alaris® smart pumps, I find it amazing that even the very limited capabilities at the initial release had such a game-changing impact on our industry.  Suddenly, we were in the software business and working feverishly to expand pump safety features to meet the demands of early adopters. We helped hospitals interpret data collected from the near misses and good catches, and we worked with customers and thought leaders to reduce practice and library variation, fine tune drug limits and interpret what Dr. David Bates called the new “treasure trove” of infusion data that was stored in each pump.

My friend and colleague, Phil Schneider, has tracked the adoption of medication safety technology over the years, and I have heard him lecture on the typical adoption cycle for new technology in hospitals.  Phil will tell you it is often a 20-year adoption period, and could be even longer in some cases.  Perhaps because infusion pumps have been in use for so long, and most other technologies that he has tracked are new and not replacements, the adoption has been much faster than bar code medication administration  (BCMA) and computerized prescriber order entry ( CPOE).  In his latest survey, the adoption rate of smart IV pumps is almost 70% after only 10 years.  One fact that has accelerated smart pump adoption is analogous to air bags in automobiles –these safety features now come standard.  And based on the “good catches” that the pump logs document, it is very evident that the pumps with DERS have prevented many potentially serious and possibly fatal medication errors. In a future update, I will discuss what we’ve learned from the use of smart pumps over the years, especially the information that we have gleaned from tracking millions of alerts from hundreds of hospitals across the U.S.  As I look back on the past 10 years, we have made tremendous progress in creating and adopting a safety net that is focused on drug administration and therapeutic application.  As I look ahead, the focus will be on making infusion pumps part of a much larger medication ecosystem, and in place of low and high dose limits, the pumps will inherently know what the right dose should be.  The concept of guardrails and airbags will still be relevant, but they will be patient—not drug—specific.  In the February 2002 Institute for Safe Medication Practices Newsletter, the following quote appeared:  “With CPOE and BCMA, and now “smart” infusion pumps, we may finally have a solid defense against the most serious medication errors.”  If I were to rewrite this today, I would say, “With the integration of CPOE, BCMA and smart infusion pumps, we now have a solid defense against serious medication errors”.

I recently attended a conference hosted by the Association for the Advancement of Medical Instrumentation (AAMI).  It was a follow-up to the October 2011 Infusion Device Summit hosted by the FDA and AAMI which led to the formation of 10 working groups, each focused on  a different aspect of infusion safety.  The primary purpose of this meeting was to provide a forum for each working group to report on progress and to develop agendas for the next 12-18 months.

The working group I am involved with is focused on alarms management.  In an earlier blog entry, I discussed the growing national focus on medical device alarms and alerts. For this meeting, I was asked to share my perspective on alarms and alerts for IV infusion pumps.   For hospitals with the Alaris® System and wireless connectivity, CareFusion is able to capture alarm and alert data from a large number of hospitals who have implemented wireless connectivity capabilities.  In preparation for this meeting, I reviewed data on 7.6 million alarms and 5 million alerts from 131 hospitals, covering 7.5 million infusions and 2.5 million infusion pump days.

Prior to the meeting, I received an email from the chairman of the alarms management working group describing his experience with IV infusions during a series of ten recent hospitalizations. Before I go on, there are three things you should know about him:

1)  He is an engineer.

2)  His career has been focused on monitoring devices.

 3) Prior to his involvement in this working group, he had limited knowledge about infusion pumps and pump alarms and alerts.

Because of his interest in device alarms, and knowing he would be on an infusion pump for each treatment, he asked the hospital to also attach him to a multi-parameter monitor.  This monitoring was not required for his treatment, but he wanted to gain firsthand experience with the pump and the monitor in simultaneous use.

As a refresher, we define “alarms” as events that were not anticipated, compared to “alerts” which are programmed to occur at specific points, such as the end of a programmed infusion. During his treatment, he witnessed a series of four occlusion alarms (one after the other during the same hospitalization), one alarm for an air bubble detected below the pump, and ten alerts that signaled the infusions were complete. The series of four pump occlusions also detected the clotting off of his peripheral IV catheter, ultimately resulting in replacement of the IV access. There were also two visual alerts that provided safety “guardrails” to reprogram dosage.   In stark contrast, the multi-parameter monitoring device alarmed repeatedly, nearly 25 times more than the pump, often interrupting his sleep.  The multi-parameter monitor tracked oxygen saturation, heart rate, and blood pressure measurements.  Again, it is important to restate that his infusion therapy did not require this level of monitoring and was not expected to cause changes in the monitored parameters.  For our chairman, who had spent much of his career focusing on monitoring devices, this experience served as an epiphany of sorts as it relates to understanding the significance of infusion pump alarms.

So, how does this data from ten infusions compare to the 7.6 million alarms and 5,000,000 alerts (audible only) captured from 131 hospitals over several months. The results were surprisingly consistent.  Some highlights:   

• We reviewed 7,596,345 infusions with total of 13,169,210 alerts and alarms from July 1 to Dec. 31, 2011. 
• Each infusion averaged 1.73 alerts and alarms.
• 30 percent of alarms occurred while the caregiver was at the bedside.
• For each infusion pump, there was an average of 5.21 alarms and alerts per day.
• 71 percent of infusions had no alarms, and 38 percent of infusions had no alerts.
• 30 percent of the alarms occurred while the caregiver was at the bedside (some related to potentially unsafe actions such as a free flow condition, door open, etc.).
• More than 40 percent of alerts did not require a trip to the bedside.
• Infusions that had alarms typically had more than one.
• The most common alarm was occlusion below the pump, and the second most common was detection of air.
• The most common alert was to signal the end of an infusion.

So, one patient experienced four alarms in one hospitalization that were true occlusion alarms, one true  air alarm in a second hospitalization, and ten alerts – one per infusion – signaling that the infusion was completed.  This data is pretty consistent with the millions of other infusions we reviewed.

Now that comprehensive infusion data can be collected wirelessly, we are beginning to paint a picture of the true incidence of pump alarms and alerts.  Looking to the future, it may be possible to use this retrospective alarm data to begin to reduce pump alarms and some of the alerts through better matching of pump performance settings to clinical care workflow, rethinking certain long-standing practices and copying some of the monitoring innovation with self-cancelling alarms.  Infusion pump dose error reduction systems (DERS) include data capture on alerts and subsequent actions by the caregiver.  This treasure trove of new information has led to many new discoveries and safety enhancements.  I believe that what the DERS alert logs did for making infusion pumps smarter and safer will be repeated for alarms and alerts.

As seen on SurgicalProducts.com

Anesthesia professionals in the operating room have a unique role and responsibility in that they are the only medical personnel who prescribe, secure, prepare, administer, and document medications—a process that can require more than 40 steps—usually within a very short time interval. While advances in safer medication therapy, such as bar code medication administration (BCMA), have been shown to help nurses administer IV medications, many of these systems do not fit the workflow for anesthesiologists.  The checks and balances that function well outside the OR may not  exist in anesthesia practice.  Although published evidence of medication errors in the OR is limited, there have been some studies that demonstrate error occurrence and risk. Consider the following:

• In 1984, medication errors were reported as a leading cause of adverse events during anesthesia.¹
• In 2001, one drug administration error was reported for every 133 anesthetics administered.²
• More recently, the United States Pharmacopeia’s MEDMARX database identified nearly 3,300 medication errors in U.S. operating rooms from 1998 to 2005.At a recent Anesthesiology Patient Safety Foundation (ASPF) board of directors workshop, a high percentage of anesthesiologists indicated they or a colleague had been involved in a serious adverse drug event. Sixty percent of respondents acknowledged that among a list of safety initiatives, safer medication practices was the most likely to increase safety in the OR.  In addition, there was close to unanimous support for drug standardization and premix/prefilled medications. 

Since its founding over 25 years ago, the Anesthesia Patient Safety Foundation (APSF) has focused on implementing safe anesthesia practices. In response to growing awareness of medication errors in the OR, the APSF has advocated a new campaign, “Medication Safety in the Operating Room – Time for a New Paradigm.”  In much the same way that improvements in aviation safety practices have advanced safe air travel, the APSF is advocating for a team approach that includes four pillars – standardization, technology, pharmacy, and culture. 

As an APSF board member and a pharmacist involved in medication safety, I am excited to announce the release of a new video that focuses on improving medication safety in the OR.  This video discusses the medication safety issue, discuses the four pillars and provides examples of model practices initiated by anesthesia departments.  Distribution of this video is made possible through an unrestricted grant from CareFusion. You can also download a similar video by APSF and the ECRI Institute focusing on preventing OR fires. 

1. Cooper JB, Newbower RS, Kitz RJ. An analysis of major errors and equipment failures in anesthesia management: considerations for prevention and detection. Anesthesiology. 1984;60:34-42.

2. Webster CS, Merry AF, Larson L, McGrath KA, Weller J. The frequency and nature of drug administration errors during anesthesia. Anaesth Intensive Care. 2001;29:494-500.

As a kid, I spent much of my time playing outside in a forest near my home. I recall my parents warning me that the stream running through the woods was off limits. Void of any living creatures, the stream was clearly contaminated – the result of untreated water and pollutants discharged by a number of nearby factories. Many of us have heard stories of rivers and lakes that were so polluted they caught fire. Over the years, as factories and corporations adopted safer and more responsible environmental practices – enforced by strict state and federal regulations – I came to believe that we could once more trust our water sources. That bubble burst last month when I attended a lecture by Dr. Fred Massoomi at the ASHP MidYear Annual Meeting.  Dr Massoomi is the Pharmacy Operations Coordinator at Nebraska Methodist Hospital and an expert on a different type of waste now polluting our waterways – pharmaceutical waste. His presentation included statistics that were sobering to say the least:

• Health facilities flush more than 250 million pounds of drugs each year.
• A 2002 U.S. geological survey found pharmaceutical waste, including antibiotics, mood stabilizers and reproductive hormones in 80 percent of sampled water streams.

As he spoke about the problems, I started thinking back to my days as a pharmacy resident and later as a satellite pharmacy supervisor, and I realized that pharmacists could be as guilty as the factory managers who polluted the stream in my home town. Every drug that we wasted went into the sink or into the trash. I’ve since read a 2008 Associated Press investigation that found a vast array of pharmaceutical trace compounds in drinking water for 41 million Americans in 24 major metropolitan areas.

This is not a new problem, and while waste management regulations have existed for hospitals for some time, only recently has the Environmental Protection Agency (EPA) and state health departments started to enforce the regulations. Still, it is estimated that as many as 60 percent of U.S. hospitals have not implemented comprehensive pharmaceutical waste disposal programs, putting them at risk of compliance infractions that carry significant financial penalties. 

Later this month, the CareFusion Center for Safety and Clinical Excellence will host a continuing education webcast to help educate pharmacists and pharmacy technicians on how to implement pharmaceutical waste management solutions.  In addition to Dr. Massoomi, the session faculty will include Lisa Lauer from the EPA who will provide background on medical waste management regulations. 

Please join us January 20 at Noon Eastern Time (9 a.m. PST).  You can RSVP online to participate or look for a replay here following the session.