The adoption of standardized vasoactive medication concentrations is increasingly common in the treatment of adult patients, but health care providers are often hesitant to use standardized concentrations in treating pediatric patients due to the unique challenges of that population, particularly medication volume constraints, the accuracy of IV infusion pumps, and the need to dose continuous vasoactive medications in pediatric patients as mcg/kg/min. Vasoactive medications (dopamine, dobutamine, epinephrine, norepinephrine, nitroglycerin, and sodium nitroprusside) are considered high risk due to their potency and ability to cause significant harm to patients if used incorrectly. When standardized concentrations are not utilized, the pharmacy must prepare unique concentrations, further increasing the risk of error.
Children’s Mercy Hospitals and Clinics pediatric health system in Kansas City, Missouri, is one of the largest pediatric institutions in the Midwest, with two main hospitals, two urgent care centers, and two freestanding outpatient clinic locations serving the region. Our primary motivation for purchasing premade vasoactive medications was to standardize pediatric concentrations in order to decrease or eliminate compounding and reduce the risk of error in continuous vasoactive infusions.
Spreading the Word
To initiate our standardization project, we performed a prospective failure mode and effects analysis (FMEA) to provide all departments and staff involved in the process an opportunity to identify possible obstacles and risks with the change in their respective areas. The FMEA provided an effective knowledge-sharing opportunity to detail the workflow and nuances of processes that otherwise might not have been shared.
The project plan was presented separately to medical staff, pharmacy, and information services (IS) to address the implications of concentration change. Medical staff examined the initiative in regard to specific patient populations such as cardiac, surgery, and neonates, as well as the utility and safety benefits of purchasing premade medications for a pediatric population. By demonstrating the elimination of a dilution step in the preparation stage and comparing the change in volume that patients would receive, the medical staff was amenable to this change in practice. Pharmacy discussed changes in pharmacy workflow, including drug procurement, preparation, and bar coding. IS staff from multiple disciplines (PICU, ICN, pharmacy, OR, CV surgery, and anesthesia) met to discuss IS requirements to ensure that all electronic databases (and future updates) would reflect the correct concentrations.
Once all involved staff approved the initiative, we developed a process for changing medication concentrations in all electronic databases, including the pharmacy information system, IV preparation and verification software, smart pumps, order sets in our CPOE system, and the drug database in the anesthesia information system. In each area, members of the IS teams were assigned responsibility for the appropriate timing and sequence of the switch to standardized concentrations. When we added the new concentrations, we included language to help guide providers to the correct concentrations (eg, less than 2 kg, greater than 2 kg). The prescribers adapted well, because other than the added language, the process for ordering remained essentially unchanged. The concentrations that became standard were detailed as such in the ordering description and 50% of all vasoactive products (dopamine, dobutamine, nitroglycerin) are now purchased as RTU.
Rolling Out the Changes
We began the changeover with dopamine, as this is our most commonly used vasoactive medication and it has the largest dosing range (see Table 1.) Next, we targeted dobutamine, which has the lowest usage, then nitroglycerin and sodium nitroprusside, and finally norepinephrine and epinephrine, the most tightly titrated of these medications. The required products were obtained from our wholesaler two weeks prior to the change and sequestered from current medication stock to eliminate the risk of any premature use. To prevent any erroneous choice of medication concentration, the new products were added to all appropriate databases in a test location inaccessible to daily users, one week prior to the change.
All of the database updates were completed remotely, which greatly aided the synchronicity of the update. However, the smart pumps did not have wireless capability and had to be manually updated by the biomedical staff in coordination with the nursing units. A critical step was updating the smart pumps with the new medication orders without interrupting existing patient medication schedules using the previous concentrations. To manage the increase in workload for biomedical staff and to coordinate with the OR patient schedule, the initial update occurred over a weekend, with a go-live the following Monday. New pump identification numbers, along with color-coded stickers to assist nursing and anesthesia in identifying updated pumps, assisted in the transition.
Staff in the affected patient care areas reviewed the order sets to ensure that the providers were able to select the correct medication and that pharmacy staff was able to choose the new medication concentration. Additionally, during this test period, bar code verification and IV workflow software systems were tested to verify that the preparation, labeling, and dispensing of the product was valid and active.
Communication was a key component to effecting this change simultaneously throughout the hospital without interrupting patient medication schedules. Nursing educators received information regarding the dates, medications, and new concentrations one month in advance of the change. This information was then disseminated to nursing and physician staff by email, with flyers posted throughout the various units, and at department meetings. The pharmacy appointed individual team leads who served as communication liaisons between management and staff in the various locations. We were able to roll out the project utilizing only current staff; no additional FTEs were required. Additional staff was required by biomedical services during the weekend that the change occurred; however, this was a practice that had been in place for other changes prior to this project.
The rollout of all six medications occurred over the course of a year, with updates for each of the medications occurring in succession during quarterly smart pump upgrades. After each update, the program manager contacted the nursing, physician, and IS leadership teams to review the process, identifying any issues that resulted from each change. Despite meticulous planning, each upgrade identified unanticipated obstacles or revealed existing processes that did not synchronize with the change. Some of these challenges were small and easily correctable (eg, difficulty finding product from the prescriber view, product not stored in an easily identifiable area, anesthesia technician not informed of medication change), while others were serious and high risk, such as inadequate nurse education for the first concentration change, and an incorrect concentration programmed into the dopamine pump library.
A key step in ensuring that standard concentrations are properly prepared and administered is to consistently update all paper forms and reference guides for times when the EMR system is unavailable due to system upgrades or malfunctions. In emergent situations, critical care nurses or EMS staff may have to prepare vasoactive medications without assistance from pharmacy, increasing the risk of error, so having the proper instructions available is vital. These forms were not identified as a need in the original FMEA but are now included in every new product addition, modification, or deletion.
It is important to remember with multiple electronic drug libraries that not all software is compatible with existing databases. Recently, the anesthesia department added a new component to its charting record that includes a stand-alone drug library, which required its own separate upgrade. IS staff had to accurately time when and how drug library updates would be available for providers, and ensure that the updates were applied to the correct patient population. This identified another critical step in any new process: verifying with all affected areas whether any new technology or processes have been implemented since the previous modification.
Error Reductions and Improved Workflow
Standardizing concentrations has had a positive impact on workflow for the pharmacy and nursing staff, as it has reduced the time required for preparation and dispensing. The premade bags are stored in our ADCs in RTU form; previously, the nurse or anesthesiologist was required to dilute concentrated medications prior to administration. While quantifying the overall impact on patient safety from these practices is difficult, as there is no single metric to apply, data from the Institute for Safe Medication Practices and other safety organizations have shown that standardizing products increases patient safety. Nonetheless, it remains critically important for the prescriber to verify that the patient’s medication concentration is accurate for the patient’s weight, particularly in the case of pediatric patients.
Because we use an automated IV workflow system in the cleanroom, we can track any errors made during drug preparation and analyze our practice against historical data. Following the first two standardization implementations (dopamine and dobutamine), our records showed that past compounding errors, such as adding too great a concentration of dobutamine or dopamine to diluent, were eliminated. Given its high usage, dopamine had the greatest error reduction, from 32 errors in the 12 months prior to standardization to zero errors after the change. Dobutamine, with its low usage, went from two errors to zero after implementation.
Shortages Create Unforeseen Challenges
The move toward standardization was complicated by shortages of certain vasoactive medications. Shortly after the change, we experienced shortages of nitroglycerin bottles, dobutamine bags, and dopamine bags, forcing us to revert to our prior method of diluting concentrated product into the final concentration. The nitroglycerin shortage in particular seriously impacted our standardized dosing efforts. Even though the number of errors resulting from nitroglycerin compounding fell dramatically just after standardization, approximately one month later, nitroglycerin went on shortage and the pharmacy had to revert to the traditional method of compounding, which in turn drove the number of compounding errors back up to previous levels until the shortage was resolved. However, this undulating effect revealed an unexpected benefit; the rapid increase in errors with the return to nonstandardization demonstrated the success of standardization in reducing medication errors. The true impact of standardizing epinephrine and norepinephrine will not be seen until later in 2013 when pre- and post-intervention numbers can be evaluated.
Additional Safety Improvements
After one year, six vasoactive medication concentrations are successfully standardized in all of our departments. The next step is to dispense all vasoactive medications in bags, effectively removing any need for pharmacy to manipulate the medication prior to patient administration. This also will reduce the need for nursing to change syringes of continuous vasoactive medications, necessitating fewer entries into the patient’s IV lines, and thereby lowering the risk for bloodstream infections. Less manipulation of the IV pump and tubing also lowers the risk of a pump programming error or an interruption in the patient’s medication therapy. Combined with the switch to standardized concentrations, these planned changes will help us provide our pediatric patients with safer and more effective care.
Richard K. Ogden, PharmD, BCPS, is a pharmacy manager at Children’s Mercy Hospitals and Clinics in Kansas City, Missouri. He manages pharmacy operations for the pediatric intensive care unit, intensive care nursery, emergency department, and operating room. Ricky graduated from the University of Missouri-Kansas City School of Pharmacy and is a member of the American College of Clinical Pharmacy and American Society of Health-System Pharmacists.
Enter our Sweepstakes now for your chance to win the following prizes:
Just answer the following quick question for your chance to win:
Entries are limited to one entry per person in any active sweepstakes.
Thank you for your entry.