Evaluating Compounding Compliance Coming Out of the COVID-19 Fog

The COVID-19 pandemic has fundamentally transformed every area of health care—from patient interactions to how drugs are prepared—and the pharmacy has been a central part of this evolution. While pharmacists rolled up their sleeves to help care for COVID-19 patients and administer vaccines to others, routine pharmacy operations including medication compounding still needed tending.

As pharmacists were pulled into patient-facing roles, many hospitals were forced to scale back or make adjustments in medication compounding practices. Annual “State of Pharmacy Compounding” survey results published this summer found that the impact of COVID has been far reaching. As COVID-19 spread last year, many hospitals shut down elective surgeries and in-person visits, leading to revenue shortfall.

Important construction and remodel projects intended to support compounding operations improvements were delayed as many hospitals needed to redirect those funds to more pressing issues, such as preserving staff.

As unvaccinated people are getting infected and new variants threaten those already vaccinated, COVID-19 will continue to heavily influence budgeting, operational, and workforce decisions. Pharmacy improvements and compounding decisions can’t continue to be delayed.

Interim guidance is in effect right now, but eventually will come to an end. As pharmacies prepare for this, their teams need to be doing everything they can to stay on track with compliance now to make this a seamless transition.

Current State of Compounding Amid COVID-19

While most pharmacies claim full compliance with United States Pharmacopeia (USP) <797> guidelines, the pandemic forced adjustments to compliance standards.¹ Recognizing the immense burden that providers and pharmacists are under amid COVID-19, federal regulators introduced interim guidance for medication compounding in less than ideal situations.

This guidance includes allowing for the reuse of personal protective equipment (PPE) when materials are in short supply and allowed for various workflow modifications to extend what limited resources are available.

The recent State of Pharmacy Compounding survey found that at least half of compounding pharmacies are operating in facilities that are not fully compliant and renovations to achieve the new standards have been put on pause.¹ At some point, the public health emergency is going to be over and pharmacy teams need to quickly get back to their compliance baseline, following the standards of USP <797> at minimum.

Next Steps for Pharmacy Compliance

Even when operating under interim guidance, there are a few distinct things pharmacies can do today to prepare for increased regulatory scrutiny that will inevitably follow the pandemic.

1. Consider where automation can support workflows. Interim changes to compounding have had impacts on pharmacy workflows, including the need to prepare medications more often because of reduced beyond use dates.

Simple, low cost, low training intensity systems can offer great benefits as pharmacists are asked to do more with their team. Only 36% of hospitals have IV workflow systems in place.³

While this is a 10% increase in adoption over the past year, more pharmacies should consider implementing these solutions to further extend their staff and supplies, such as PPE.

2. Reread the compliance chapters USP <795>, <797>, and <800> to remind pharmacy teams of what the standards should be. Interim guidance has been imperative to get through COVID-19, but facilities should start thinking about how to get back to baseline compliance. To begin, pharmacy directors should evaluate whether their pharmacy is compliant with the currently official USP compounding chapters and identify shortcomings as urgent priorities for your organization.

Allowances may have been made around beyond use dates, reuse of PPE, and staffing assignment changes. Resetting training for the pharmacy staff can be an essential step to getting compliance back on track, allowing teams to go back to the basics on how to adhere to the standards above and beyond interim guidance.

Compliance software that is up to date with USP guidance and closed-loop training offers a streamlined way to make sure pharmacy teams are meeting compliance baselines.

3. Once the pharmacy department has ensured it is compliant, reintroduce best practices. For example, this could include increasing the frequency of personnel competency assessments and environmental monitoring activities.

Hospital pharmacies may have been focused on the minimum or alternate practices, but don’t lose sight of best practices that are expected to become standards in the future. One area to prepare for compliance is semi-annual staff competency via media fill and gloved fingertip sampling.

This will require additional supplies, equipment, and staff resources to implement. Consider the budget implications as well as training resources that will be needed in 2022.

For environmental monitoring, some pharmacies may have even deferred certification or sampling procedures to minimize people coming into the space and conserve PPE. It is important to not only get caught up on certifications, but to also develop a plan for monthly surface sampling.

Pharmacies may also want to partner with an external group to conduct an audit of their practices, which could include another pharmacy leader within the health system, another department with fresh eyes, or working with compliance vendors who may offer support.

Prioritizing the Pharmacy

When evaluating compliance, pharmacy leaders need to consider where the pharmacy team excelled, where the team got stuck, and what the organization can do better next time to enhance efforts in the future. And as, unfortunately, COVID continues to surge across the country, this presents opportunities to continuously improve.

Increasingly, hospital leadership is recognizing the many contributions of pharmacy team members in supporting the mission of the health system and is looking to them for more strategic input.

Pharmacy departments have proven to be invaluable over the past 18 months, supporting vital medication and treatment decisions when guidance was limited as well as vaccination roll-out across the country. It is now time to leverage this goodwill to advocate for changes needed within the pharmacy or organization. There will be circumstances in which budgets are tight, but compliance and patient safety should never be compromised.

About the Author

Dr. Annie Lambert serves as Clinical Program Manager for Compliance Solutions for Clinical Surveillance & Compliance, Wolters Kluwer, Health and is Board Certified in Sterile Compounding Pharmacy. Her career has been focused on health systems pharmacy clinical services and general operations, primarily in oncology and infusion services. These responsibilities included developing and implementing policies, procedures and education, as well as coordinating the remodel of multiple facilities to meet USP compliance standards across both acute and ambulatory care areas, as well as retail pharmacies and clinics. Dr. Lambert received her PharmD from Washington State University and completed a PGY1 residency in pharmacy practice at MultiCare Health System.

References:

1. State of Pharmacy Compounding 2021 – USP <797> Compliance. https://www.pppmag.com/article/2727. Published April 2021. Accessed August 20, 2021.
2. State of Pharmacy Compounding 2021 – Budgeting & Renovation. https://www.pppmag.com/article/2726. Published April 2021. Accessed August 18, 2021.
3. State of Pharmacy Compounding 2021 – IV Workflow Management. https://www.pppmag.com/article/2736. Published April 2021. Accessed August 18, 2021.