Develop a Strategy to Provide Pediatric Medications in Unit of Use
To deliver all medications to pediatric patients in bar coded unit dose, a combination of approaches may be necessary, including purchasing medications in unit of use, repackaging bulk medications in-house manually or with repackaging automation, and utilizing the services of a contracted repackaging service. Each organization should conduct a cost-benefit analysis of the various practices to identify a viable strategy. In this pursuit, it is prudent to keep several goals in mind:
- Reduce Waste by Maximizing Beyond-Use Dating. To prevent waste, it is crucial to maximize a medication’s beyond-use dating (BUD). Weigh the organization’s medication usage against the BUD that can be applied to a medication repackaged in-house. Federal or state regulations may require limiting the BUD to 1 year or less. For low-volume products, significant waste may result from shorter BUDs; thus, it may be prudent to purchase a commercially available unit dose product rather than repackage bulk product in-house. Although purchasing products in unit of use is typically more expensive, extended BUD may create cost efficiencies. For higher volume products, in-house repackaging with tabletop or high-volume repackaging machines may be a successful strategy.
- Maximize the Role of Repackaging Automation. In-house repackaging automation is available in a variety of styles and sizes. Depending on pharmacy size and repackaging volume, automation can be invaluable. When introducing automation, it is important to develop standard operating procedures and a thorough staff training program. Equipment must be regularly cleaned and maintained, and used in a manner that ensures staff and medication safety. It is important to implement practices that reduce the risk of cross-contamination. After each batch, any leftover medication should be removed from the area and the automation thoroughly inspected to ensure no medication remains in the repackaging machine.
- Implement Standard Operating Procedures (SOPs) for Manual Repackaging. Depending on the dosage form or handling requirements, some medications may not be suitable for repackaging automation. For example, tablets may be too large to fit into standard size automation packaging, or soft gel caps may melt when exposed to the heat used by automation to seal packaging. In these scenarios, manual unit dose packaging solutions are available in a variety of styles. SOPs must be developed and implemented to ensure cleanliness, reduce the risk of cross-contamination, and produce a high-quality, properly labeled finished product.
- Identify Opportunities for Outsourced Repackaging. Outsourced repackaging can be a beneficial strategy for high-volume products when a commercially packaged product is unavailable, and when there is insufficient staff to manually repackage medications in-house. Moreover, utilizing packaging services can reduce the potential for packaging errors, making this an appealing option for high-risk medications. When working with an outsourcing company, organizations should note that it may be challenging for these companies to immediately respond to large fluctuations in usage. In this scenario, organizations may need to supplement with additional repackaging strategies.
Employ Standardized Doses
One of the most significant safety concerns involved in repackaging pediatric medications is identifying the appropriate dose to meet the majority of patient needs. Because pediatric patient medications are typically dosed based on weight, and patients range from newborns to young adults, it can be challenging to find one strength or dosage form to meet most patient requirements. In some cases, pharmacy may split tablets and repackage them (eg, one-half of an 81-mg aspirin) to provide a targeted dose. Standardized dosing can help ensure medication availability. Pharmacists must work closely with providers to standardize doses to the greatest extent possible and then ensure availability of these products. Reviewing historical prescribing data from the EHR can help identify the most common doses utilized.
Segregate Pediatric Products
When repackaging several medications concurrently, segregating pediatric medications from other products is key to ensuring safety. Separate bins can be used, or consider assigning separate workstations for pediatric syringe and cup preparation.
Segregation is equally critical during the labeling process. Children’s Mercy Hospital in Kansas City, Missouri, used its EHR to create an in-house pediatric medication labeling program. A notification was added at the end of each label batch, which alerts the user that the end of the row of labels has been reached; this prevents the user from accidentally mislabeling repackaged products. Any unused labels are immediately discarded to prevent labeling errors with future batches.
Overall, labeling must be compliant with federal, state, and regulatory requirements, and include the medication name (generic and brand, if desired), dosage form, strength, quantity, BUD, special notes/warnings, a facility control or lot number, and a readable bar code. A variety of packaging materials are available to help avoid look-alike packaging issues. In addition, auxiliary labels can serve to highlight specific medication precautions. Likewise, warnings such as “cytotoxic” or “controlled substance” often can be incorporated into the labeling software program.
Ensure Product Integrity
Each hospital should develop a standard procedure for ensuring medication quality and integrity throughout the repackaging process. Drug information software resources are available to confirm a medication’s appearance and markings. Some organizations may retain a sample of each dosage form in the original container for comparison. Once the repackaging is complete, a qualified technician and/or pharmacist should visually inspect each finished product to confirm that all are intact, sealed, and labeled appropriately.
Consult Published Guidelines
There are excellent resources available to support the goal of dispensing pediatric medications in the most ready-to-administer form possible.
- USP provides guidance on repackaging practices (The United States Pharmacopeial Convention (USPC). 2018 USP Compounding Compendium. Chapter <1136>: Packaging and Repackaging – Single-unit containers. In: The United States Pharmacopeia, 41st ed, and the National Formulary, 36th ed. Rockville, MD: USPC; 2017.)
- Consult ASHP’s Technical Assistance Bulletin on Repackaging Oral Solids and Liquids in Single Unit and Unit Dose Packages (available at www.ashp.org/-/media/assets/policy-guidelines/docs/technical-assistance-bulletins/technical-assistance-bulletins-repackaging-oral-solids-liquids.ashx?la=en&hash=96C42BE98D90C781F8D0B25A637D000A5604FD2B)
Sarah Bledsoe, PharmD, CPHIMS, is the assistant director of pharmacy at Children’s Mercy Hospital in Kansas City, Missouri, a 367-bed comprehensive pediatric medical center. She attended the University of Missouri Kansas City School of Pharmacy.
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