Pathway to Compounding Standardization

December 2021 - Vol.18 No. 12 - Page #8
Category: Compounding Supplies

Medication compounding is an essential service which requires significant oversight to meet regulatory and patient safety standards. Crucial to meeting these standards and maintaining a safe compounding program are designated decision makers with clearly outlined responsibilities, along with standardization across the hospital system. The absence of these components can lead to confusion due to lack of a transparent chain of management or a clear understanding of protocols.

Riverside Health System (RHS) is a five-hospital system which includes a behavioral health hospital in the Greater Peninsula-Williamsburg and Middle Peninsula-Northern Neck regions of eastern Virginia (see the SIDEBAR). The health system offers integrated care through a network of hospitals, surgery centers, outpatient infusion centers, physician groups, and continuing care facilities, primarily in a community setting. Riverside Regional Medical Center (RRMC), the flagship hospital of RHS, is a 450-bed hospital and the only care that provides 24-hour onsite pharmacy services. RRMC provides after-hour pharmacy services to the other RHS facilities, including medication compounding services.

To ensure standardization of practice across this expansive system, the pharmacy department established a health system Compounding Committee, which in turn created an arsenal of tools dedicated to standardizing protocols quickly and efficiently. Through its commitment to standardizing and managing medication compounding services, the Compounding Committee toolkit meets several goals of RHS, including working toward USP compliance and addressing compounding challenges as they arise.

Background

Before creating the Compounding Committee, each pharmacy department and facility was responsible for establishing its compounding practices, including training, competency, and USP <797> compliance. Attempts at standardization occurred through a health system pharmacy leadership workgroup, with each facility’s individual decision-makers responsible for implementation. However, this standardization was difficult to implement, as each pharmacy leader instead developed unique processes to meet their own facility’s needs. Among other challenges this model posed, RHS had more than 230 unique sterile pharmacy recipes that lacked a standard format, with multiple versions of the same compounds existing to meet the needs of different facilities.

Purpose

The Compounding Committee was initially developed to help standardize and resolve discrepancies with compounding recipes in order to reach USP <797> compliance by developing a Master Formulation Record. Simultaneously, RHS began an intensive campaign of zero-harm and high reliability. The health system senior leadership challenged every team member and department to maintain a commitment to zero patient harm by focusing on providing evidence-based care. RHS departments were also tasked with following best practices and protocols of care that give all patients the best chance for positive outcomes. This campaign expanded the scope and purpose of the committee to ensure the compounding program aligned with RHS’s strategy of becoming a high reliability organization. Thus, building organizational knowledge through standardization meant being sensitive to the diverse practice settings across RHS, including the non-24 hour hospital pharmacies.

Challenges

A project of this scope may face challenges related to its membership, decision making, authority, and reporting relationships, which can be compounded by limited resources. In order to combat these challenges, we incorporated the following during the early stages of development:

  • A membership structure that allows for the fair representation of all stakeholders, facilities, and practice settings
  • Subject matter experts to ensure recommendations are evidence-based
  • Establish the committee’s authority through a reporting relationship that acts on behalf of the committee, or assign the committee regulatory responsibility for its scope and goal (eg, assign the committee as a subcommittee that reports to a parent committee established by hospital bylaw)

Membership

As noted above, all stakeholders must be fairly represented within the committee. We examined a variety of membership models and decision-making structures to help ensure this, and narrowed them down to the following options for voting members to satisfy the requirements above. Our committee would be composed of either:

  1. One representative from each facility, which would result in about six members

    or

  2. Two representatives from the acute care hospitals (one from a 24-hour facility and the other from a non-24 hour facility), a representative from the outpatient infusion, a pharmacy leader-member, a sterile compounding subject matter expert, and a nonsterile compounding subject matter expert.

We selected the second option because it allowed for equal representation across the health system. It also ensured that all perspectives needed to develop standardization across RHS were included, and that required subject matter experts were present to make evidence-based recommendations.

While pharmacists comprise most of the Compounding Committee, ad-hoc members from the IT department, nursing, and medication safety are invited to the committee as needed.

Committee Protocols

The committee meets every other week to discuss any compounding-related issues. Since the official creation of the committee in November 2020, it has focused heavily on USP compliance and standardization. Issues raised include standardizing compounding recipes, addressing operational challenges such as product overfill, providing drug information support to resolve IT tickets, adding administration routes to intravenous drugs, and standardizing education and competencies.

To address these issues, the committee developed an approval pathway for new/existing items and used the following algorithm to reach decisions:

  • A subject matter expert must review all requests
  • The decision must be supported by evidence from a peer-reviewed journal as appropriate
  • A simple majority must vote in favor of the decision, including the subject matter expert
  • In a case where the committee cannot resolve an issue, the Pharmacy Leadership Committee would be consulted to advise and resolve

In addition to the above, the committee gave the subject matter expert veto power over a simple majority where appropriate. The goal of this approach is to align with the concept of deference to expertise, a principle of a high-reliability organization.

Tools and Results

Since the creation of the committee, significant progress has been made toward USP compliance and standardization, including:

  • An approval pathway and process for resolving compounding related issues
  • Management of IV container overfill (see FIGURE 1)
  • Standardized beyond-use-dating (BUD) assignment
  • Standardized compound nomenclature for safety
  • Completion/update of 58 sterile compounding records in seven months (22% of all RHS compounding records)
  • Hazardous waste classification
  • Adult IV product concentration standardization according to best practice (ie, ASHP’s Standardize 4 Safety IV concentrations)
  • Steps toward BCG dispensing standardization
  • Creation of a standard master formulation record template (see FIGURE 2)
 

Click here to download the full Overfill Handling Procedure.

Click here to view a larger version of FIGURE 2.

Click here to download full instructions for this template.

Today, the committee’s purpose is to ensure that RHS maintains a pharmaceutical compounding program that conforms to USP and best practice standards. To accomplish this goal, committee decisions are made by a simple majority vote among the voting members, including a subject matter expert.

The committee was also delegated the authority to manage all pharmaceutical compounds for RHS via reporting relationships to the Pharmacy Leadership and Pharmacy and Therapeutics Committees. This authority and reporting structure also satisfies the regulatory requirements for Pharmacy and Therapeutics to have oversight over all pharmaceuticals, including compounded drug products.

Looking Forward

While the compounding committee has made tremendous progress, especially within the acute care hospital, challenges remain for operationalizing USP requirements outside of the hospital pharmacy. For example, due to time constraints, the 1-hour BUD requirement for immediate use compounded sterile products poses a workflow challenge for outpatient facilities such as the ambulatory surgery centers and physician offices. Some potential solutions used by RHS to remain USP <797> compliant include dispensing ready-to-administer compounds by outsourcing to 503B pharmacies and optimizing other areas of the workflow to allow the time for immediate use compounding, as well as eliminating the need for advance prepping.

Another area of opportunity outside the pharmacy is the standardization of the compounding formulary and recipes to ensure that they include stability data and are evidence-based. To overcome this challenge, collaboration with the IT team is essential to ensure that new compound requests are routed to the appropriate committee or person for adequate review and approval.

Conclusion

One of the biggest threats to USP compliance is the lack of a responsible person or persons for decision-making and program oversight, especially when working toward standardization across a multi hospital health system. Thus, implementing a cohesive compounding program with a clear chain of command is essential. At RHS, we opted for a committee approach in order to meet the needs of all stakeholders. This team-based approach encourages the input of multiple perspectives in developing a robust and evidenced-based compounding program and toolkit that meets USP compliance and best practice standards, while also addressing challenges as they arise.


Akeem Bale, PharmD, MS, MBA, BCPS is the inpatient pharmacy operations manager at Riverside Regional Medical Center in Newport News, Virginia. He received his doctorate of pharmacy from the University of Toledo. Dr. Bale completed his post-graduate training in health-system pharmacy administration at Houston Methodist Hospital and the University of Houston, where he obtained his master’s degree in pharmacy leadership and administration. He later completed an MBA with a concentration in healthcare administration from Texas A&M University-Corpus Christi. Akeem is a member of the American Society of Health-System Pharmacists.

Acknowledgments
Soyon Lee, PharmD, BCPS, was, at the time of the committee’s creation, the sterile compounding subject master expert and a significant contributor to the compounding committee’s work, including developing the overfill handling procedure and completing the majority of the compounding recipes.

Olukemi Olatunji, PharmD, MBA, Senior Director of Pharmacy, RHS Acute Care; Lindsay Perkinson, PharmD, Director of Pharmacy, RDHW; and Shawn Hegner, PharmD, BCSCP, Senior Director of Pharmacy, RHS Infusion Services, provide leadership and executive support to the committee. Shawn also led the standardization of IV room equipment and the selection of an USP compliance software.

Amel Abdulaziz, PharmD, BCPS, Senior Pharmacy Operations Lead, RRMC, is the nonsterile compounding subject matter expert. Eileen Varnson, RHS Vice President of Marketing and Communications, contributed the sidebar information.

Riverside Health System is an integrated health network impacting two million lives annually. Serving Eastern Virginia since 1915, Riverside is guided by a mission to “care for others as we would care for those we love.” The health system offers various services and programs in prevention, primary care, diagnostics, neurosciences, oncology, orthopedics, aging-related services, rehabilitation, medical education, home care, and hospice.

Riverside operates four acute care hospitals, as well as a behavioral health hospital, a physical rehabilitation hospital, and a Critical Illness Recovery Hospital in partnership with Select Medical. Riverside Medical Group has more than 700 physicians and advanced practice providers across a broad spectrum of specialties in over 75 locations throughout the region. Riverside Lifelong Health comprises six nursing home facilities, three vibrant continuing care retirement communities, and Home Health and Hospice services. In addition to these health care services, Riverside operates the College of Health Careers and four medical residency programs. The company employs more than 9,000 team members throughout Eastern Virginia.

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