Right-Size Compounded Medications for Your Pediatric Patients

Many medications are not manufactured in forms and doses suitable for pediatric patients, requiring pharmacists to use compounding to safely meet children's unique needs. Providing the best care means weighing available options and making complex calculations.

A Dec. 8 session at the ASHP 2024 Midyear Clinical Meeting & Exhibition, Pediatric Compounding Conundrums: Just Keep Swimming, will offer practical insights into some of the challenges for compounding pediatric patient formulations and how pharmacists might standardize their compounding strategies.

Speaker Cindy Brasher, manager of compounding at St. Jude Children’s Research Hospital in Memphis, Tennessee, spoke with ASHP’s News Center in advance of her session. “We call these conundrums for a reason — and in the pediatric setting, they’re happening pretty frequently,” she explained.

Compounding conundrums

It is ideal to use medications as created by manufacturers — but many formulations come in doses too large for pediatric patients or in formats they can’t easily take. Some patients even fall outside the norm of pediatrics, Brasher points out, such as the tiniest babies in the neonatal intensive care unit or patients experiencing fluid overload.

Compounding is often the answer, but the process can require multiple complex medication preparations and take pharmacists into uncharted territory. Common challenges in pediatric compounding include:

• Managing 12-hour in-use time limits for stock solutions, a new standard for sterile compounding required by USP <797>
• Addressing the limitations of IV automation workflows, which may not be calibrated for the smallest pediatric doses
• Preparing dilutions of standard product concentrations, which have limited stability information
• Pivoting when the beyond-use date recommendations in a product’s package insert don’t meet a patient’s needs. Brasher will present the example of blinatumomab, a cancer drug whose package insert information was recently updated.

Troubleshooting strategies

When faced with these gaps, pharmacists must evaluate the available options and use compounding to adapt treatment for their young patients, often in the absence of formal recommendations or much literature to draw from. In practice, this means customizing concentrations and making IV automation workflows and other technology work for you — but Brasher’s overarching goal is to equip fellow pharmacists with critical thinking skills and tips that will serve them in any situation.

The session will offer several real-world patient scenarios to illustrate how pharmacists must weigh the pros and cons in this gray area of pharmacy.

• “I want to walk people through the process of making a decision when it’s a hard decision to make, when there's not a clear-cut process for handling these challenges,” Brasher said, adding that knowledge-sharing among session attendees will be equally valuable.
• She advocated for a consistent decision-making framework. “Pharmacists need to have a standard way of addressing non-standard concentrations — so when this question comes up, you’re thinking it through the same way every time” Brasher said.
• To support their decision-making, pharmacists need to know where to find the literature to substantiate alternate concentrations and stability dating.
• Some pharmacy managers may choose to develop standard operating procedures for common compounding challenges, tailored to their practice.
• Brasher hopes pharmacists will become more comfortable and confident in making complex compounding decisions. “I can't give black-and-white answers for everything, but I can give [Midyear attendees] a process to support what they need for their patient care,” she said.

Above all, a standardized approach can help pharmacists make sense of any compounding conundrum they encounter in pediatric care. “Having a standardized approach to evaluating and addressing these challenges will help add that layer of safety, even though you're going outside of the norm,” Brasher said.