Total parenteral nutrition (TPN) provides life-saving medical care when patients with intestinal failure cannot maintain adequate enteral caloric intake. These life-saving preparations are also among the most complex medications that pharmacy prepares, and they require a significant amount of time to compound. The high level of complexity involved in TPN compounding introduces an increased risk for error and microbial contamination. To reduce these risks, free up compounding staff for other pursuits, and ensure a smooth workflow, some organizations choose to outsource TPN compounding.
Covenant HealthCare is a 643-bed, acute-care hospital in Saginaw, Michigan, providing a variety of acute care, rehabilitation, inpatient, and outpatient surgical services. Covenant has a Level II trauma center, as well as a 55-bed neonatal intensive care unit (NICU), the only in the region. The pharmacy department utilizes a centralized distribution model to deliver pharmaceutical services. A 520-square-foot, USP <797>- and USP <800>-compliant cleanroom is equipped with positive and negative pressure buffer rooms, three laminar flow hoods, one biological safety cabinet, an automated PN compounder, and three repeater pumps. In August 2017, a decision was made to outsource the production of neonatal and adult TPNs. Our primary concerns when moving away from in-house compounding were ensuring medication safety, freeing up staff for other tasks, and mitigating the effects of medication shortages. The automated PN compounder is now reserved for emergency use.
Choosing a Vendor
When evaluating potential partners for outsourcing any pharmaceutical compounding services, it is essential to conduct due diligence. Selecting a vendor that meets all the regulatory requirements to compound and distribute compounded medications is critical. Using a tool, such as ASHP’s Outsourcing Sterile Products Preparation: Contractor Assessment Tool (www.ashpfoundation.org/sterileproductstool), is an excellent way to ensure that a thorough appraisal of each potential vendor’s compounding practices occurs.
In addition to regulatory compliance, several other factors about each vendor should be taken into consideration, including the following:
Perform scheduled reviews of your facilities’ TPN prescribing habits; providing feedback on how to improve prescribing practices will help identify which vendor will be able to best meet your specific needs.
The TPN Ordering Process
The process of ordering TPNs from an outsourcing facility is similar to entering an order into the facility’s EHR. After a provider writes the order, a pharmacist verifies that it is appropriate, and then a medication label for the TPN is generated internally. The TPN order is entered into the outsourcing facility’s ordering system, either manually or via an interface that integrates the EHR with the ordering system. Covenant HealthCare enters orders manually, although we are considering interfacing TPN ordering with the EHR. Before the order is sent to the facility, a pharmacist, preferably not the one who originated it, reviews the order for accuracy and then submits it. All TPN orders must be completed before the order submission cutoff time (in our case, 1:00pm).
The outsourcing facility reviews, prepares, and ships the TPN orders to the facility by a pre-established time each day, which at Covenant is 4:30pm. A pharmacist checks that each TPN has arrived and cross-checks the label the outsourcing facility placed on each TPN with the label that was generated internally. Once the internal labels have been verified and placed on the TPNs and signed by a pharmacist, they are ready for delivery and administration to patients.
Benefits of Outsourcing TPNs
Quality and Safety
Pharmacy’s top concern is ensuring that the medications provided to our patients have been prepared safely and accurately. We rely on outsourcing facilities that have the appropriate technology and properly trained staff to safely and accurately prepare TPNs. Upon receipt, pharmacists at the outsourcing facility who specialize in TPNs review the orders; this offers another set of eyes to catch any potential errors. Furthermore, each TPN arrives at the hospital with a report that details the steps taken for preparation and review.
Availability of Standardized TPNs
Standardized neonatal starter bags can be purchased from an FDA-registered 503B facility, which our organization utilizes and finds quite convenient. At Covenant, every premature baby receives standardized TPNs until we are able to provide custom TPNs. Standardized TPNs have extended expiration dates and can be securely stored in the NICU, making them readily available to nursing, a process which reduces delays without increasing waste.
Managing Medication Shortages
The ability to navigate shortages is critical to preventing disruptions in patient care, and currently several essential components of TPNs are on the ASHP and FDA national drug shortage lists.1,2 Consider that outsourcing facilities that prepare TPNs are often better positioned to address shortages than health care facilities, given their practice of purchasing components in bulk from several suppliers; health care facilities rarely have such broad access. Furthermore, outsourcers have the capacity to compound TPN components that are on shortage from raw, active pharmaceutical ingredients.
Reallocation of Staff Time
In-house preparation of TPNs requires a significant time commitment from technicians and pharmacists alike, even when automation is employed. Outsourcing TPNs frees up valuable time for staff to focus on patient care and improving quality in other areas of the pharmacy operation.
Addressing Outsourcing Challenges
Our organization’s decision to outsource TPN production has incurred some challenges. For example, certain providers were skeptical about purchasing TPNs from an outsourced vendor, and expressed concerns about potential delivery delays and errors. Some providers also felt that the order cutoff time would be difficult to meet given their existing schedules. Moreover, nurses might find any changes to the TPN hang time challenging to fit into their workflow.
Active communication and staff education are critical to overcome these challenges. Meet with providers, nurses, and other internal stakeholders to discuss and address their concerns. Frame the goals of the outsourcing project on common ground; for example, emphasize that all team members want what is best for the patients and the organization. Create a plan to address the concerns of each staff member. If order cutoff and delivery times are an issue, work with providers and nursing partners to develop solutions. Can labs be drawn at a different time, or can standard TPNs be used for orders written after the order cutoff time? In addition, communicate to key stakeholders the pharmacy department’s plan for handling challenges. If a provider needs a STAT TPN before delivery time, or if inclement weather impacts delivery times, how does pharmacy plan to overcome these obstacles? Sharing contingency plans and working with internal stakeholders to develop solutions to problems builds trust, and helps put any concerns to rest.
In addition, work directly with your outsourcing facility to address staff concerns. Communicate any problems you are facing and collaborate to develop unique solutions. Any vendor you work with should be a trusted business partner in addition to being proficient in TPN production. Ask your vendor if the order cutoff time and delivery times can be adjusted to fit your facility’s operations. Determine if a compromise can be put in place; perhaps if your facility commits to submitting TPN orders throughout the day instead of in a batch, the outsourcing vendor can guarantee an earlier delivery time.
While essential for patient care, compounding TPNs can be a complicated and time-consuming process. Partnering with an outsourcing facility can ensure that TPNs are prepared properly and safely. In addition, outsourcing allows for the reallocation of pharmacist and pharmacy technician time while reducing the impact of medication shortages.
When considering outsourcing options, it is essential to perform a thorough assessment of a potential vendor’s compliance with compounding standards and regulations. In addition, active communication with your outsourcing vendor and all internal stakeholders is critical to success.
Blake Bonkowski, PharmD, MBA, BCPS, is the pharmacy manager at Covenant HealthCare in Saginaw, Michigan. He received his Doctor of Pharmacy degree from Ferris State University and an MBA from Northwood University, and pursued a pharmacy practice residency at Spectrum Health. Blake’s professional interests include pharmacy automation, data analytics, and sterile and non-sterile compounding.