Q&A with Joseph I. Boullata, PharmD, RPh, CNS-S, FASPEN, FACN
Clinical Nutrition Support Services
The Hospital of the University of Pennsylvania
PP&P: What risks are associated with parenteral nutrition?
Joseph I. Boullata, PharmD, RPh, CNS-S, FASPEN, FACN: Although parenteral nutrition (PN) is commonly considered simply a nutritional product, it is important to understand that PN is actually a high-alert medication that requires robust management and the development of safety-focused policies and procedures (P&Ps). There are two fundamental risks to PN safety: clinical and process-related errors.
Clinical complications involve the IV access device (eg, thrombus, line infection) and metabolic sequelae (eg, glycemic control, fluid and electrolyte status); these are closely monitored and managed by the clinical team. Process-related errors often receive less attention than clinical complications, which is unfortunate, as process errors are not rare occurrences. Nearly 20% of all injectable drug-related errors have been attributed to PN, with PN often ranking in the top 10 medications associated with errors in organizations that track them.1 Oftentimes, these errors occur because proper systems to manage PN have not been put in place.
Multiple steps and numerous health care workers, including the physician, dietitian, pharmacist, pharmacy technician, and nurse, are involved throughout the process from recommending and prescribing, to reviewing, preparing, and administering PN. The PN process requires myriad components—so many that in fact it is possible for multiple errors to occur in a single PN prescription. In addition, production of PN may be outsourced offsite. The risk of error increases exponentially when multiple steps, clinicians, and locations are utilized.
Active communication is critical to managing the clinical and process-related risks associated with PN ordering, production, and administration. For example, dietitians who recommend PN must communicate with the pharmacists who are reviewing the PN orders. When organizations treat PN as a simple nutritional product, rather than a high-alert medication, it is easy for errors to make their way into the PN medication-use process. Organizations with lackadaisical PN management practices typically have high PN error rates, but these are often underreported or not captured at all. Reviewing PN errors retrospectively throughout the medication-use process is crucial to avoiding such errors in the future.
PP&P: What specific PN safety concerns are associated with the pharmacist’s review of PN orders?
Boullata: Regardless of whether PN is produced in-house or outsourced, safety should be the pharmacist’s top priority. For example, orders must be reviewed by a pharmacist to verify the clinical appropriateness, dosing, volume, and stability, as well as to ensure the compatibility of all the ingredients. A national survey conducted by the American Society for Parenteral and Enteral Nutrition (ASPEN) showed that about 23% of pharmacies that prepare PN do not dedicate any FTEs to PN order review.2 Outsourcing PN still requires that the hospital pharmacist review the PN orders first, with an additional review step at the PN outsourced vendor. The vendor should be selected for their reliable practices that ensure pharmacist review and other safety concerns are a priority. One benefit of outsourcing PN is that an outsourcer is able to focus specifically on the safe production of PN, compared with a hospital pharmacy that must address multiple, competing priorities.
PP&P: What safeguards should be put in place to prevent patient harm from errors in the PN process?
Boullata: According to the Institute for Safe Medication Practices (ISMP), only about half (58%) of organizations have implemented safety precautions for PN use.1 Considering that these are high-alert medications, this fact is extremely concerning.
Three safeguards are integral to a safe PN process and must be considered in any comprehensive PN safety program:
PP&P: How do drug shortages impact safe PN use?
Boullata: Drug shortages have a profound impact on safe PN use. PN requires an array of ingredients—so many components are required when preparing PN, in fact, that one or more are almost always on shortage. In the past 5 years, I do not remember a time when there was not a shortage that affected PN.
PN shortages are different from shortages of most other medications. For example, if one antibiotic is on shortage, there are usually therapeutic alternatives to consider. With PN components, there are no alternatives. Therefore, comprehensive contingency plans are essential.
Interdepartmental collaboration is especially critical when managing PN component shortages. The Hospital of the University of Pennsylvania has implemented an interdepartmental drug shortages committee to address shortages of all kinds, including PN component shortages. The committee is proactive, focusing on shortages that might be forthcoming, so plans can be made in advance. These contingency plans are not always implemented, but it is important that they are available and can be put into action quickly. For example, if we are aware that a selenium shortage is imminent, we can be more selective as to which patients receive selenium, in order to provide it to our most critical patients first. We can also reduce the dose that these critical patients receive in order to stretch scarce resources.
Communication among all stakeholders is imperative during PN shortages. Be sure to include the IT group in shortages discussions, so any necessary changes in technology systems can be implemented smoothly.
PP&P: What training and competency standards should be utilized to ensure safe PN use?
Boullata: Organizations should follow published training and competency standards, such as the ASPEN standards, which include a useful competency checklist (the ASPEN standards are available at: https://onlinelibrary.wiley.com/doi/full/10.1177/0884533616653833). These essential standards describe the basic knowledge necessary for pharmacists and technicians regarding dosing, stability, compatibility, and potential complications, to ensure safe PN use.
While it would be ideal if every hospital and home infusion service had a board-certified, nutrition support pharmacist on staff, in the real world, this is not always possible. However, any licensed pharmacist and certified technician can be trained to meet a threshold of competency to ensure that they are managing PN properly.
PP&P: What is the value of providing patient-specific, or customized, PN?
Boullata: The Hospital of the University of Pennsylvania is licensed for 720 beds and is typically at capacity most days. With one-quarter of our beds reserved for ICU patients, many of our patients are high acuity, and many of them receive PN. Our clinical service completes approximately 900 consults a month; on any given day, we have about 130 to 150 patients on nutrition support, with about 35-40 patients receiving PN. With so many high-acuity patients, a significant number of patient-specific PNs are required. Therefore, we provide all patients (adult and neonate) with patient-specific PNs that are prepared by an outsourced vendor.
Our reasons for outsourcing PN stem from the need to remain compliant with USP <797> requirements, as well as to manage space concerns for the PN inventory, were we to compound PN in-house. Our evaluation showed that outsourcing made sense from a financial perspective versus taking the necessary steps to produce PN in-house.
While we did informally evaluate the use of commercially manufactured, multichambered PN bags, we found they were not specific enough for our high-acuity patient population. For example, our patients typically require high amounts of amino acids; to meet the amino acid requirements with commercially prepared bags would mean exposure to significantly large volumes of the products with excessive calories, which our patients cannot tolerate.
Ultimately, it is the pharmacy’s responsibility to ensure that all medications used in the hospital are safe and appropriately managed. Therefore, it is important to note that even when outsourcing PN, pharmacy should still exert control over the process and review all PN orders before they are sent to the outsourced vendor.
PP&P: What is the process for ordering PN at the Hospital of the University of Pennsylvania?
Boullata: The PN ordering process involves the physician building a specific, complex order of amino acids, glucose, lipids, electrolytes, vitamins, and trace elements into the EMR. Alerts are in place so that if the physician orders an incorrect or excessive amount of a component, a notification is triggered and the correct dose is suggested. When reviewing the physician order, the pharmacist similarly has alerts in place to ensure safety of the formulation and assure consistency with the dietitian’s care plan.
Another benefit of using the EMR to order PN is that no transcription steps are required—the reviewed order is sent directly from the pharmacist to the outsourced PN supplier. By omitting transcription, there are fewer chances for errors to occur and safety is improved (see FIGURE 1). PN admixtures are compounded by the outsourcer and sent to our hospital ready to be administered to the patient.
For adult PN, order cutoff time is 3pm; all orders are reviewed by a pharmacist and then forwarded to our outsourced compounder. The orders are delivered to us by 6pm and hang time is 8pm, plus or minus 1 hour. We do maintain some flexibility in the hang time schedule in order to accommodate nursing’s busy schedule. For neonate PN, we follow a similar order and delivery schedule, but hang time can occur at any point in the day.
PP&P: What are your future goals for ensuring safe PN use?
Boullata: We are continually aiming to improve our PN processes to ensure safe use. Looking to the future, we hope to hone our pharmacist competency process to best evaluate pharmacists’ PN knowledge and competency. Moreover, we plan to develop a more efficient process of data mining the EMR to identify medication errors that will help us further refine our processes.
Joseph I. Boullata, PharmD, RPh, CNS-S, FASPEN, FACN, is a pharmacy specialist with Clinical Nutrition Support Services at the Hospital of the University of Pennsylvania in Philadelphia. He received his doctorate from the University of Maryland after completing undergraduate degrees in Nutrition Science at Penn State University and in Pharmacy at the Philadelphia College of Pharmacy. Joe completed a residency at the Johns Hopkins Hospital and a nutrition support fellowship at the University of Maryland Medical System prior to being Board Certified in Nutrition Support Pharmacy for over 20 years. As a specialist in nutritional pharmacotherapy (including nutrition support and pharmaceutical nutrition), his interests include drug-nutrition interactions as well as patient safety with nutrition support
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