Advancements in IV robotics are mitigating the risks of human error in the compounding process. The misconceptions of IV robotics are many, but there are also many real world examples of how hospitals and health systems are improving processes by implementing technology to support in-house sterile compounding.
BarickmanThe evidence underscoring the inherent dangers and potential for error with common sterile IV compounding processes cannot be denied. Industry statistics point to wrong drug or diluent selection and subsequent mislabeling errors in one out of every 100 IVs and compounding error rates of up to 9% in prepared solutions.
Ensuring clinically sound, cost-effective medication therapy is a critical function of formulary managers and pharmacists alike, yet IV sterile compounding processes-one of the most complex and risky pharmacy operations-are still evolving in most facilities. Technology-enabled workflows are recognized nationally-by both the American Society of Health System Pharmacists and Institute for Safe Medication Practices-as a critical and credible solution to achieve pharmacy patient safety initiatives. Yet, IV rooms remain one of the last areas where basic safety technology such as bar code scanning or gravimetric measurement, are being employed.
Advancements in IV robotics are mitigating the risks of human error in the compounding process. In fact, a recent study points to significant improvements in accuracy, yet the industry still has doubts about the benefits and opportunity with this technology. The misconceptions of IV robotics are many, but there are also many real world examples of how hospitals and health systems are improving processes by implementing technology to support in-house sterile compounding.
Myth #1: Hospitals with smart pumps and Bar Code Medication Administration (BCMA) have a reliable medication system that insures patient safety, so IV compounding automation isn’t needed.
Reality: According to the just released 10th Annual State of Pharmacy Automation survey, only 15% of hospitals use bar code medication verification in the initial and critical compounding stage, where there is most potential for error. While the final product is ultimately labeled with a barcode for administration, industry research suggests that there is at least a 1% chance that what is stated on the IV label is incorrect because the BCMA process occurs after IV compounding is complete and does not take into account upstream errors.
Hospital administrators and clinical leaders are often not fully educated about the window of error that exists in patient safety related to IV compounded medications. Once the IV solution is distributed to the nursing unit with a label, clinical staff have no other means by which to verify the contents and thus must assume that the clear solution in front of them is the correct one. The label essentially presents a false sense security since there is no way to truly confirm that the solution in the IV bag is accurate.
A recent study by American Drug & Health Benefits showed that preventable adverse drug events associated with injectable medications impact 1.2 million hospitalizations annually, adding up to $300 million to $600 million in medical professional liability costs and resulting in an average of $600,000 in extra costs for hospitals. When bar code medication verification is applied while sterile compounding activity is underway, the potential for error and mislabeling is minimized.
Myth #2: Robotics and automation cannot match the performance of highly trained professionals.
Reality: Humans make mistakes. Numerous well-conducted industry studies attest to this fact revealing IV error rates in the range of 1% to 9%. In fact, drug selection error and subsequent mislabeling of compounded preparations is a recurring finding across multiple studies. These statistics are alarming, since even a fraction of a percent error can result in an immediate and irreversible adverse event with IV medications.
A recent study on the accuracy of IV compounding found that only 71.7% of doses prepared manually met the five percent threshold and only 87.4% met a 10% threshold. Industry research also reveals a significant improvement in the accuracy of IV medication doses when robotics are leveraged. IV robots can measure accuracy for every preparation and reject a preparation if the dose falls outside of a predetermined threshold, which is normally set at 5% for robotically prepared doses.
Sterility of IV preparations-a crucial component to patient safety-is also enhanced through robotics by removing human risk factors involving direct bodily contact or particulate contamination of sterile solutions. USP <1116> Microbiologic Evaluation of Clean Rooms and Other Controlled Environments clearly points out that microbial contamination is inevitable in any environment where humans are present. Advanced robotic technologies offer a direct compounding chamber, within a completely isolated ISO class 5 environment, eliminating the potential for human contamination and error and improving IV compounding performance.
Myth #3: IV Robots aren’t ready for my organization. They are too big, too expensive and can be complicated and unreliable.
Reality: Robotic technology has matured to provide scalable, cost-efficient solutions that are designed to address the nuances of pharmacy workflows, becoming an efficient addition to the pharmacy. Hundreds of hospitals across the globe are now taking advantage of advanced second-generation IV robot offerings to produce millions of preparations each year. These solutions streamline and automate IV compounding workflows assuring standardization of industry best practices including gravimetric dose control for the gold standard in IV dose accuracy. Many hospitals are realizing a return on investment within 2 years, with some health systems even achieving this goal in a matter of months.
Through ongoing vendor-hospital partnerships designed to address organization-specific needs, robotic technologies have also evolved to address spatial issues. While many hospitals may hold the perception that IV robotic machines are too large to integrate into their compounding rooms, advanced solutions today can accommodate spaces as small as 3 feet by 3 feet, making them scalable to the available resources within a given facility.
Myth # 4: IV Robots and IV workflow don’t integrate or interface with other systems.
Reality: While system interfaces have been an issue in the past and remain a focal point of national initiatives for interoperability, some vendors are hitting the challenge of pharmacy system integration head-on. Solutions exist that are addressing the need for HL7 interfaces with major electronic medical record (EMR) vendors within IV robotics and workflow software. Specifically, these interfaces ensure that data can be shared accurately across EMRs and pharmacy systems to elevate patient safety and streamline workflows.
It’s a critical part of robotics functionality that must be considered to fully leverage the potential of IT investments. When all systems function interoperably, staff can more readily anticipate and account for all patient doses and procedures. In fact, system integration should be a priority consideration when an organization is beginning to devise a sustainable strategy for IV automation.
First steps toward an IV technology strategy
The first step a hospital pharmacy should take when developing an IV compounding strategy is to conduct a risk assessment of current compounding operations. The Guidelines for SAFE Preparation of Sterile Compounds by the Institute of Safe Medication Practices or the Guidelines for Compounding Sterile Preparations by the American Society of Health-System Pharmacists provide a strong foundation when beginning to design and implement a strategy.
As industry trends point toward increased sterile compounding activity within hospitals and health systems, patient and staff safety considerations must be placed at the forefront and the benefits of advanced IV robotics embraced. By exploring the modern-day technologies available within this space, facilities of all sizes can fulfill the hallmark goal of streamlined workflows that deliver safer, more accurate and efficient means by which to provide IV solutions that support improved outcomes from both an organizational and patient standpoint.
John Barickman, RPh, MBA, FACHE, is senior executive IV pharmacist consultant, Aesynt, and clinical advisor, Sterile Compounding Process Improvement.