12 minute read
POLICY
A Standardized Solution to Better Compounding
By recruiting a team of champions and incorporating new compounding software, AdventHealth in Florida was able to more easily standardize its compounding operations across eight locations in the Orlando area and meet all requirements of USP <797>.
The journey to standardization began in 2019, after Richard Montgomery, BSPharm, MBA, the health system’s corporate pharmacy contracts and operations manager, was looking across the enterprise trying to figure out the best way to do this, he explained during a recent webinar. Although the system includes 46 hospitals across nine states, the Orlando area had eight hospitals and some freestanding emergency rooms. With a radius of 25 miles between hospitals, it wasn’t uncommon for pharmacists or pharmacy technicians to travel among campuses, making this a perfect test site for a pilot, Montgomery said. In addition, the health system’s software vendor, Pharmacy Stars, mentioned its Compounding360 module could be used to help with training and formulas.
Some areas that Montgomery was concerned about included sterile preparation and personal protective equipment, engineering controls, training and competency, and documentation, as well as having standard formulas for IV preparations.
At the time, anticipated updates for USP Chapter <797> were looming, along with a requirement to define a designated person (DP) at each site to be accountable for compounding operations and personnel, said Amanda “Mandy” Wollitz, PharmD, the program director of pharmacy policy and quality at AdventHealth Orlando.
“We were really excited about that accountability piece, but we also had concerns about how it could have complications for a health system trying to function as one unit and be greater as a whole,” she said. The health system already had several policies in place detailing its compounding requirements and expectations, but there was potential for misalignment across the system. “We really had our work cut out for us.”
Reviewing the chapter in depth, Wollitz noted that some operational responsibilities of the DP, such as ensuring the quality of the environment, training oversight and following up on corrective actions, were already handled by each facility. But new requirements for overseeing changes to standard operating procedures (SOPs) and developing and reviewing quality assurance programs would need to be consistent.
So, Wollitz reached out to the operations manager at each campus, who in large part were the pharmacy consultants of record. They were excited to take on this new role, she said. They formed a committee to help with items that would need to be standardized across the organization; the committee was made up of the DP from each site and the director of policy and quality and Christine Hong, the quality manager for the pharmacy department, to help offer guidance. The committee met monthly to discuss SOPs or any necessary operational changes. They also reviewed any new formulas to standardize them and used the Compounding360 software to review scorecards on how each site was following policies. They used meeting time to discuss any barriers or issues seen at the campuses,
implementing changes across the board if necessary. Members also had access to an internal messaging channel.
Standardizing operations helped in several ways, Wollitz said. One is garbing. While the 360 platform posts instructions for sterile compounding, some pharmacy locations had unique layouts that needed individual instruction. The committee reworked instructions, ensuring each pharmacy’s layout, and updated the group document. The approach also helped with formulations. Typically, one person at each campus would create these, Wollitz said; now the work is distributed among multiple experts, with some designated second checks built into the process. It also helped ensure that facilities were using recommended or contracted supplies, and improved efficiency in creating a standard list for ordering.
“We also now have a unified voice and expectations. There is no longer variation at our campuses,” she said. “We have floaters who go between campuses. They might previously have found different recipes or cleaning tasks at each pharmacy. Now, through the 360 platform, everything is streamlined.”
One of the biggest improvements that Wollitz said she has seen is in staff attending to SOP and policy reviews. The organization does an annual review and has about 20 compounding policies. It’s difficult for one person to conduct a review and catch everything that may need to be tweaked, she said, “but with the committee, we now have many sets of eyes reviewing documents for accuracy. There have been a significant number of changes that we owe to the committee review.”
The committee also developed a standard compounding and investigation action plan to research the root cause of any adverse events, and created a folder for all investigations to be centralized and easily accessed through the 360 platform. The committee also created a centralized environmental monitoring team to provide feedback to the DP and panel on any trends they note, and to share corrective action plans.
Additionally, the compounding platform provided the team a just-in-time scorecard to review compliance on a daily basis, enabled central control of task and formula creations, and allowed for a library to share literature and standard education. Changes can be pushed out from a central account, Wollitz said.
“Our quality program increases the transparency of our practices; we meet monthly and make decisions together, which allows us to pool experience across the organization to weigh in on any significant decisions,” Wollitz said. “Engaging experts at each site and sharing compliance data across the system, I can say we have exponentially improved quality and safety across our compounding sites.”
The team is planning some additional upgrades to their system. They include filming the compounding areas and putting it into a virtual reality format so new employees can explore and interact with a virtual model of their own facility’s cleanroom environment before starting work. Furthermore, they are elevating the training component by adding additional scenarios specific to their work sites and including polls on learning styles.
A Boon for Multiple Sites
Although commercial software products to help with compounding and standardization aren’t free, they can be beneficial depending on the needs of a particular health system, commented Michael Ganio, PharmD, the senior director of pharmacy practice and quality at ASHP. “When you have multiple sites, being able to standardize so that staff can float back and forth makes the process much easier for individuals who might be in an unfamiliar cleanroom or unfamiliar pharmacy,” Ganio said. “At least they know the operations are the same.”
Going with an outside vendor may make sense for multiple-site health systems such as AdventHealth, he said, whereas smaller facilities may find it easier to internally manage the process through centrally stored spreadsheets, training materials or other documents to track their tasks. Factors to consider include the individual needs of the health system, how complex the compounding operations are, and how many sites and staff members are part of the process.
When selecting a vendor, Ganio advised, cost is always a primary concern, especially now during the pandemic, when hospital budgets are squeezed. In addition, he said: “I always recommend getting in touch with an institution that’s already using the software, to ask questions and find out how it is used in the real world.
“The important take-home [message] is that health systems standardize in some way,” Ganio added. “It’s critical to have all of this information documented and accessible to the staff.” —Karen Blum
Sterile preparation and personal protective equipment, engineering controls, and formulas for IV preparations all can benefit from standardized operations.
TJC Standards Gap
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Jeannell Mansur, PharmD, a principal consultant in medication management and safety at Joint Commission Resources and Joint Commission International, said during a presentation at the ASHP 2020 Midyear Clinical Meeting and Exposition.
Topping the list of noncompliance in 2019 was the medication administration standard (MM.06.01.01), which 49% of hospitals failed to adhere to, Mansur noted. “Surveyors have been finding medications being administered for an indication when another medication was specified, or an ordered medication given for a different indication, and often this is done without a documented explanation,” she said. “Surveyors will also often see that administration of medication, particularly titration medication, is performed differently than is directed by the order.”
Mansur cited one common reason why orders are not carried out as written: Some nurses tend to administer medications based on patient preference. The Joint Commission has clarified that patient preference can indeed guide drug administration, provided that the patient-requested agent is less potent than the ordered medication, or is the same drug at a smaller dose or delivered via a less invasive route of administration. “For example, a patient prescribed a narcotic for severe pain and a nonnarcotic for moderate pain can choose to receive the nonnarcotic for severe pain, but institutions need a policy guiding this practice. and it needs to be documented in the medical record,” Mansur said.
What’s in a Medication Order?
The Joint Commission also has revised standard MM.04.01.01, element of performance (EP) 2, which now specifies that a complete medication order should, at a minimum, include the medication name, dose, route of administration and frequency.
“The Joint Commission has for years required hospitals to have a policy stating what the required elements are for your basic garden-variety medication order, but they now felt that they needed to be more proscriptive to direct minimal requirements,” Mansur said.
John Hertig, PharmD, an associate professor at Butler University College of Pharmacy and Health Sciences, in Indianapolis, who was not involved with the presentation, welcomed this revision. “Health systems now have clear guidance as to what should be minimally included on a medication order.” He added: “These elements form the foundation of a supporting policy regarding this medication management standard.”
Titration Tweaks
The Joint Commission also has issued clarifications to its titration order requirements, which Mansur said have been a “major challenge for hospitals to comply with. These are complex orders, and the Joint Commission requires [they contain] specific elements, which institutions sometimes omit,” she said. “We often find that medications are not administered in accordance with these complex orders.”
The Joint Commission now allows titration orders to specify adjustments of several drugs meant to achieve the same physiologic end point, Mansur said. “This [allowance] gives nurses the option of using their clinical judgment to decide whether to adjust one or another drug, both prescribed for the same end point, as long as they stay within the defined parameters of the order itself.”
However, Mansur noted that to take advantage of this allowance, hospitals need an organizational policy specifying which medications can be titrated in this way, as well as any other hospital requirements for the management of orders in this manner. The practice
PHARMACY WORKFLOW MANAGER
DRIVING INCREASED DRUG PREPARATION SAFETY
30% of hospitals have experienced a patient event involving a compounding error in the past 5 years1 , yet only 33% of hospital facilities use IV workflow technology to help prevent dose preparation errors.2 A recent study found that hospitals using IV workflow technology detected14 timesmore medication preparation errors than hospitals performing manual IV workflow.3
4.2%
OF ALL DOSES COMPOUNDED in 2019 by facilities using the DoseEdge System experienced an error intercepted by the system4
~2,800
COMPOUNDING ERRORS were intercepted by the the average hospital facility in 2019 using the DoseEdge System4
~42%
INCORRECT DRUG ERROR was the most common compounding error intercepted by the DoseEdge System in 20194
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For the safe and proper use of the device, refer to the appropriate user’s guide.
The Joint Commission has clarified that a medication may be paused and then restarted without requiring a new order, as long as the restarting dose for the given drug is specified in the order or in an institutional policy.
Photo credit: Registerednursing.org.
also must be allowable by state law, and the nurse must demonstrate competency, Mansur said. “Competency requirements will be up to the hospital, but I’d encourage hospitals to develop competencies that confirm that nurses know how to make decisions for managing two titrated medications for the same indication.”
Clarifying Order Restarts
The Joint Commission also has clarified that a medication may be paused and then restarted without requiring a new order, as long as the restarting dose for the given drug is specified in the order or in an institutional policy, Mansur added.
The organization now permits that, in specific urgent or emergent situations where rapid and minute infusion rate changes might be necessary, block charting can be done in up to four-hour chunks. Again, hospitals need to have a policy in place defining these allowable urgent or emergent situations and specifying what documentation is required, which the Joint Commission also has described, Mansur noted.
The Joint Commission specifies these orders should include the time of initiation and completion of the charting block; the name of the medications administered during the block; the starting, ending and maximum rates of medications given during the block; and the physiologic parameters evaluated to determine the administration of titratable medications during the block.
“This allowance should help nurses manage very unstable patients, where it can be impractical to document every change in dosing as it is done,” Mansur said.
The Joint Commission’s requirements for block charting, pausing of a medication and administration of more than one titration medication to the same end point were published in the June 2020 edition of The Joint Commission Perspectives (bit.ly/3q8qkIB).
For health systems and hospitals struggling to meet all Joint Commission requirements, Hertig offered some words of advice: “Ambiguity is the enemy of safety, and these clarifications will help not only ensure compliance but hopefully safer care as well.”
With these revisions, he added, institutions can optimize adherence to Joint Commission requirements by “writing a good policy and set of procedures, and making sure you actually follow them. Then, commit to reviewing policies and procedures at least yearly to ensure they are accurate, being followed and are up to date with contemporary best practices.”
—John Hertig, PharmD
—David Wild
The sources reported no relevant fi nancial disclosures.
