Parenteral Nutrition Safety for Pediatric Patients

August 2021 : Parenteral Nutrition - Vol.18 No. 8 - Page #1
Category: Enteral Feeding Products

Parenteral nutrition (PN) has revolutionized and is now essential to the practice of neonatology. While life-sustaining, it is also associated with a host of complications including PN-associated liver disease (PNALD) and central line-associated bloodstream infections (CLASBIs), which carry high morbidity and mortality rates and pose a burden to the health care system. Because of this, providers, pharmacists, and dieticians must be proficient with various dosing parameters and suggested ingredients dependent on patient-specific factors.

Children’s Medical Center (CMC) Dallas, the flagship hospital of Children’s Health, has been at the forefront of improving care for children (see SIDEBAR). To best serve its population, Children’s Health provides PN to patients of all ages including neonates, infants, children, adolescents, and adults. CMC and Children’s Health follow the 2017 American Society for Parenteral and Enteral Nutrition (ASPEN) consensus recommendations on the appropriate use of PN, as well as other various ASPEN resources to ensure safe PN use. These protocols, along with CMC’s own experience and guidelines, can be used as a basis for a safe and efficient pediatric PN program in any facility.

Insourcing vs. Outsourcing PN

One of the first decisions to be made is whether to insource or outsource PN products. At Children’s Health, all PN product is outsourced through a third-party company. Outsourcing PN can allow for more efficient use of pharmacy staff, better mitigation of drug shortages, and avoidance of costs associated with purchasing and maintaining the equipment necessary for compounding PN product.

While outsourcing eradicates the burden on internal personnel to compound, there remain complications associated with this practice. These risks include, but are not limited to, the potential inability to do the following:

  • Track source of drug
  • Ensure BUD is supported by scientific evidence
  • Inspect outsourcing facility for compliance
  • Accept responsibility for all compounding processes without onsite oversight or management

Alternatively, insourcing risks include, but are not limited to, the potential inability to do the following:

  • Obtain drug due to shortages
  • Procure best pricing for drug
  • Recruit, train, and test necessary personnel
  • Establish BUD validation
  • Maintain compliance and personnel certification within the facility
  • Provide management expertise to oversee PN compounding

Each option presents its own risks and benefits. It is important to consider which approach is the best fit for the patient population and facility in terms of time, cost, and safety.

Reducing Errors

Whether insourcing or outsourcing, errors can still occur at any step in the PN-use process including during prescribing, ordering, verifying, compounding, dispensing, administering, monitoring, and documenting. One of the key differences between pediatric and adult PN is the use of dosing per kilogram (eg, sodium 3 mEq/kg) as opposed to per day. This can cause confusion at multiple points in the PN-use process.

At Children’s Health, recognizing the sheer number of potential errors associated with the transcription of PN orders was the first step in improving the process for standardization. Moreover, highlighting to providers the error-prone burden that befalls pharmacists was hugely helpful in gaining provider buy-in for improving the process. Currently, we are working to remove both transcription points from the ordering process entirely. Due to the enormity of this project, it was broken into two phases:

  1. Creation of an interface between the EHR and outsourcing program
  2. Removal of third-party ordering system and transition to providers entering orders directly into the EHR

We are also considering the creation and implementation of an inpatient nutrition consult service including providers, pharmacists, and dieticians to further advise on the PN-use process.

Double-checks by both pharmacy and nursing personnel throughout the PN-use process act as safeguards (see the TABLE). However, most pharmacy-related errors at Children’s Health surround pharmacists’ transcription of orders. The inherently manual work of transcribing is wrought with the risk of human error. Because of this, it is not uncommon for transcription errors to occur when entering PN orders into both the EHR and the outsourcing facility program. Therefore, our priority at this time is a change management initiative to improve standardization of ordering PN to prevent such errors and associated patient harm.

Drug Shortages

Drug shortages can present another challenge when managing PN use in pediatric patients, leaving them without readily available access to required key nutrients. Unfortunately, shortages are here to stay, as they can be related to several factors including, but not limited to, API release delay, increased demand, or manufacturing delay. As pharmacy administration works through purchasing options and strategic distribution arrangements, pharmacists should consult the ASPEN guidelines for mitigation recommendations when possible.

For example, both multivitamins (MVIs) and amino acids (AAs) have been on shortage over the past fiscal year. When MVIs went on backorder without a potential recovery date, our third-party PN supplier placed the product on allocation. Therefore, Children’s Health mandated a reduction in dosing to three times weekly or a 50% reduction in daily dosing, a recommendation directly adapted from the ASPEN guidelines. Additionally, if patients were able to take an oral vitamin, such formulation was recommended instead of adding IV MVI to their PN.

Moreover, when AAs were placed on national shortage, Children’s Health advised strict adherence to ASPEN recommendations including the following:

  • Consider minimizing the amount of overfill included in your PN orders (ie, if the standard is 100 mL overfill to accommodate administrator-set priming, consider lowering to 50 mL).
  • Assess and regularly reassess each patient as to the indication for PN and provide nutrition via the oral or enteral route when possible.
  • Only use neonatal/pediatric-specific amino acids or disease-specific amino acids for indicated patient populations.
  • Reserve high concentration amino acids products (ie, greater than 10%) for fluid-restricted patients requiring PN.

Conclusion

At Children’s Health, we are consistently working to improve our PN processes to ensure safe use. As mentioned previously, our institution is currently prioritizing a change management initiative to improve standardization of ordering PN to prevent errors and associated patient harm. A robust yet dynamic PN program is key to significantly impacting patient care by improving both quality and safety.


Lauren Stanz, PharmD, MS, BCPS, is the clinical pharmacy manager of acute care and specialty services at Children’s Health located in Dallas, TX. She received her bachelor of science and doctorate of pharmacy from The University of Texas at Austin as well as her master of science from The Ohio State University. Her post-graduate training also included a 2 year residency focused in Health-System Pharmacy Administration at The Ohio State University Wexner Medical Center. Lauren is actively involved in the American Society of Health-System Pharmacists and Texas Hospital Association Leadership Development Council.

 

Counting all campuses, Children’s Health is licensed for 601 beds, including 496 beds at the main campus in the Southwestern Medical District near the heart of downtown Dallas, 72 beds at Children’s Medical Center Plano, and 39 beds at the Our Children’s House facility in Dallas. Across all facilities, more than 800,000 patient visits are received annually from all 50 states and around the world. CMC Dallas offers tertiary and quaternary expertise in more than 50 pediatric specialties and is a designated level one trauma center.

Given the multitude of patients Children’s Health sees on any given day, a strict schedule for PN ordering, delivery, and administration is necessary to ensure that there is adequate time for smooth transitions between steps. Each facility functions on the following timeline:

To ensure adherence to and comprehension of this schedule and the PN protocols and procedures, Children’s Health requires pharmacists to complete both written and hands-on training during their new employee orientation. The following objectives are included in the written material:

  1. Identify the ingredients in PN
  2. Learn the components of PN and needs of pediatric patients
  3. Define ASPEN guidelines for initiation of PN
  4. Identify the risk factors and complications associated with PN
  5. Understand aluminum’s role in PN
  6. Learn the pharmacist’s role in reducing aluminum concentration
 

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