Implementing a Longitudinal Sterile Compounding Rotation for Pharmacy Residents

PRÉCIS

A longitudinal sterile compounding rotation implemented at an academic medical center for acute care pharmacy practice residents facilitates development of practical knowledge around safe, efficient compounded sterile preparations in accordance with the law.

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INTRODUCTION

It has been 20 years since United States Pharmacopeia Chapter <797> “Pharmaceutical Compounding—Sterile Preparations” (USP <797>) became a federally enforceable standard, yet formal training options for new pharmacy graduates in this discipline are limited.¹ This manuscript will describe the creation and development of a longitudinal sterile compounding rotation at an academic medical center for postgraduate year 1 (PGY-1) acute care pharmacy residents.

USP <797> outlines the standards for compounding sterile preparations in all health care settings and includes specific training and credentialing for any personnel involved with sterile compounding.² USP <797> describes “the minimum requirements that apply to all persons who prepare [compounded sterile preparations (CSPs)] and all places where CSPs are prepared.” Revisions to USP <797> that became official in November 2023 require significant changes around training and evaluations.² Although USP has no role in enforcement, its standards are often adopted and enforced by state boards of pharmacy.

In terms of pharmacy residents, hands-on sterile compounding experience needed for mastering aseptic technique and key concepts of sterile compounding is also variable.³ Even though some pharmacy schools offer sterile compounding instruction in a laboratory, only 13% of surveyed deans at US schools of pharmacy reported feeling that their students had received adequate training on compounding sterile preparations before graduation.³ In this author’s opinion, a simulated environment is not the same as compounding an actual medication order that will be injected into an actual patient. In addition, these simulated labs also typically take place early on in pharmacy school curriculum.⁴ The fact that so much time has passed since the simulations can be a challenge when a new pharmacy resident has to acclimate to and become competent in pharmacy clean room operations and the medication use process involving sterile compounds.⁵

The skill set required to provide oversight also needs to be developed over time. An area of practical interest during the development of this sterile compounding rotation involved oversight because it can present a challenge when a newly licensed pharmacy resident must both oversee sterile compounding technicians and understand the fundamentals of sterile compounding. USP <797> defines oversight as “the review, monitoring, and supervision of actions taken by personnel, bearing responsibility for those actions, and being available for consultation if and when needed.”² The ability to provide oversight is also mentioned by the joint American Society of Health-System Pharmacists–Accreditation Council for Pharmacy Education Task Force publication of entry-level competencies needed for working in a health system or hospital environment.⁵

OBJECTIVES

The implementation of a longitudinal sterile compounding rotation included developing specific goals that the resident could achieve within a 6-month period. Although PGY-1 residency programs typically include staffing requirements that involve operational shifts, the number of hours covering sterile compounding operations is not standardized among programs, and the amount of time spent physically working in a clean room also varies based on practice site. Moreover, despite many state-level pharmacy laws and regulations requiring compliance with USP <797> in all pharmacy settings,⁶ The Pew Charitable Trusts drug safety project identified “73 reported compounding errors or potential errors associated with more than 1562 adverse events, including at least 116 deaths” from 2001 to 2019.⁷ Standardizing the training experience through this rotation will give PGY-1 acute care pharmacy residents a deeper knowledge of sterile compounding and help ensure quality preparations for patients.

The objectives for implementing this rotation were as follows:

• provide foundational and structured training for pharmacy residents in sterile compounding principles;
• provide practical learning activities to develop oversight skills;
• design a consistent schedule for the rotation;
• decrease variable hours of training components; and
• solicit qualitative feedback from preceptors, technicians, and residents to improve the rotation experience.

METHODS

All elements of the rotation were initially built into the PharmAcademic system, including a general description of the practice area, the role of the pharmacist, expectations for the residents, and the progression of residents over time. A weekly schedule of learning activities and a list of topic discussions were developed, and technician colleagues were asked whether they would be interested in having the resident shadow them while they performed sterile compounding. The rationale for inquiring about technician involvement was 3-fold: (1) Pharmacy technicians are experts at aseptic technique and physically compounding CSPs, (2) the resident can gain a better understanding of the technician workflow and workflow dynamics, and (3) technicians training pharmacists in their expertise can encourage the technicians to be involved in teaching activities, which can lead to their professional development.

The sterile compounding rotation is defined as a half-day, once-a-week rotation for 6 months. Expectations for the resident prior to starting the rotation are in line with USP <797> standards that are necessary for staff to complete before they are involved with any workflow involving CSPs.² The PGY-1 resident assumes the role of a clinical pharmacist, providing sterile compounding services for the hospital and supervising the preparation of sterile products while working in collaboration with their preceptor. The precepting pharmacist is always present in the clean room to ensure all policies, procedures, and standards are followed and to ensure a constant element of support for the resident.

The rotation includes goals and learning objectives defined by the American Society of Health-System Pharmacists, which are used to assess the resident’s progress throughout the rotation.8 Weekly activities for the resident are described in Box 1, and weekly topic discussions are planned methodically to increase the resident’s skill-building progress (Box 2). For example, to address compounding outbreak awareness, residents are assigned to review FDA Form 483 issued to the New England Compounding Center.⁹ The New England Compounding Center outbreak of 2012 resulted in at least 100 patient deaths due to contaminated epidural steroid injections (Table) and was the “largest public health crisis ever caused by a contaminated pharmaceutical drug,” according to a 2021 news release issued by the US Attorney’s Office for the District of Massachusetts.¹⁰

In addition to having pharmacist preceptors for the rotation, 3 technicians are involved with training the resident. These colleagues include 2 pharmacy technicians who are highly skilled in sterile compounding and a pharmacy technician who has extensive experience with parenteral narcotic distribution. Pertinent topics are strategically discussed to allow for technician involvement, and the schedule for the resident is paired with the technician’s schedule in advance. This rotation allows the resident to build rapport with pharmacy technicians over time while simultaneously learning oversight skills. The hope is that more technician colleagues will be interested in lending their expertise as the rotation advances.

The following example demonstrates why it’s advantageous to have technicians training the resident: The first pharmacy resident taking the rotation successfully compounded multiple hazardous CSPs, including doxorubicin hydrochloride, vincristine, ganciclovir, cyclosporine, and fosphenytoin. The resident had previous experience compounding nonhazardous CSPs but did not have any previous hazardous drug compounding experience. Also, the precepting pharmacist was always available during the technician-led training sessions to provide support to both the resident and the technician colleague.

Qualitative feedback was solicited by colleagues involved with precepting and training the resident to provide electronic or verbal comments before the resident’s midpoint and final evaluations. Initial comments from pharmacy technicians included how a training matrix could be helpful to use while the resident is shadowing the technicians during sterile compounding activities. A training matrix of teaching topics was then created for pharmacy technicians to utilize as a guide so that they had a variety of potential topics to discuss while training the resident. Topics in the matrix include types of tubing, attachments, dispensing pins, calculations, triaging of workload, hazardous drug compounding, and more.

The residents’ evaluations and progress were documented in the PharmAcademic system and then the residents provided additional insights that helped improve practical aspects of the rotation, resulting in deliverables that could be used for future residents. The need to improve triaging the clean room workload and to have more training on triaging skills were mentioned during midpoint evaluations. This feedback resulted in a triage guide that reviews clean room workflow in terms of pharmacy technician duties at pertinent times throughout the day. Additional insights on how the resident should have more shadowing opportunities on cart-fill orders, including hazardous drug cart fills and prostacyclin cart fills, led to the immediate incorporation of having residents shadow this workflow.

RESULTS

A staffing rotation for pharmacy residents is the norm in an acute care residency program. However, training elements can be inconsistent in terms of experience with sterile compounding. A scheduled longitudinal rotation provides a set schedule of time dedicated to sterile compounding operations. At the time of this publication, 2 residents have completed the rotation—with all rotation goals achieved.

Rotation outcomes are documented in the PharmAcademic system to align with achievable goals for the rotation. Outcomes include whether the resident can do the following:

• understand clean room workflow;
• compound sterile preparations for patients;
• proactively determine how CSPs are compounded;
• assist technician colleagues with clarification questions and calculations on CSPs; and
• perform the final quality check on CSPs.

Additional outcomes include whether the resident can prepare and dispense CSPs and is proficient in clean room operations. As the rotation progresses, each outcome is documented as needs improvement, satisfactory progress, or achieved.

Qualitative feedback from preceptors, technicians, and residents resulted in program changes to enhance resident competence and engagement with the rotation. Based on comments from the residents, for example, more pharmacy technician shadowing earlier in the rotation has been incorporated to help residents understand technician workflow, workload, and responsibilities.

DISCUSSION

The information included in this manuscript provides a framework to help other institutions successfully implement a longitudinal sterile compounding rotation, and more sterile compounding rotations may lead to a standardized process throughout the residency program continuum. Handling compounded sterile preparation orders firsthand vs discussing hypothetical orders or mock orders leads to a more solidified understanding of sterile compounding work practices. This practical, hands-on learning can be a more effective modality of teaching new pharmacists the various facets of sterile compounding,⁴ including thoroughly assessing medication orders, triaging, and working proficiently in a pharmacy clean room.

PGY-1 pharmacy residents have many opportunities to collaborate on multidisciplinary patient care activities at our acute care academic medical center. Residents are required to staff 20 weekends out of the residency year, which gives them experience in patient care and operations under the supervision and support of preceptors. Having a foundational knowledge of sterile compounding can assist with questions from providers and nurses regarding patients’ parenteral orders about things such as medication concentrations, compatibility, beyond-use dates, infusion rates, and tubing selection. Effectively addressing these questions from colleagues can help develop the resident’s skill set and build rapport with interdisciplinary team members.

As noted earlier, incorporating pharmacy technicians into resident rotations supports the development of the resident as well as the professional development of the pharmacy technician. A sterile compounding rotation such as this may be applied not only to PGY-1 residents but also to PGY-2 residents in health-system pharmacy administration and leadership who want to pursue management roles. Future adoption of a sterile compounding rotation may also lead to a standardized foundational skill set for other residents.

CONCLUSION

The purpose of developing a sterile compounding longitudinal rotation, in addition to providing more formalized training options, is to help pharmacy residents gain experience over a longer period and be incorporated as a member of the pharmacy sterile compounding team. This rotation helps residents become more confident when providing oversight and enforcing sterile compounding standards and provides opportunities for residents to build rapport with pharmacy technicians. This experience may provide additional utility for the residents when they graduate from their PGY-1 program and pursue either employment or a second-year residency.

Upon completion of the sterile compounding rotation, residents will have gained familiarity with the responsibilities and workflow of a sterile compounding pharmacist. This rotation helps residents develop practical, foundational skill sets on how to prepare CSPs safely, efficiently, and in accordance with the law. Significant impacts of the rotation are having residents establish and maintain autonomy in the pharmacy clean room, actively contribute to sterile compounding team operations, and achieve competence in sterile compounding principles.

Successful implementation of the rotation required establishing clear goals for the resident, actively listening to resident insights to improve rotation activities, ensuring that teaching methods employed were practical and encouraged resident engagement, and performing continuous evaluations with qualitative feedback. Future considerations for program development include expanding the rotation to a second hospital site, creating an additional 5-week block rotation, implementing the rotation as a mandatory facet of the residency program, and incorporating pharmacy technicians as nonpharmacist preceptors.

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