Wolters Kluwer pharmacy compliance expert, Annie Lambert, PharmD, BCSCP, discusses the state of pharmacy compounding USP chapters in 2021. Learn more about four major areas of focus this year.
This time last year, the compounding community was focused on pharmacy remodels or construction projects and journeying ahead towards USP compliance with the new chapters. Then COVID-19 came along, and many priorities shifted. To some, it may feel like Groundhog’s Day as we turn the calendar to 2021 and find our attention still firmly on COVID-19 management. But it is important to recognize how many things have changed in the last year. There needs to be a renewed focus on pharmacy compliance within the ebbs and flows of the “new normal.” Consider these four priority areas for compliance in the year ahead.
1. USP and NIOSH in limbo
While 2020 brought some progress and clarity for both the revision of the USP compounding chapters and the long-awaited NIOSH list of hazardous drugs, the reality is that the official versions of these guiding documents are dated. Many organizations are or will soon be fully compliant with the 2019 USP revisions. Yet, the regulatory bodies will be surveying on the current versions, with a few exceptions at the state level or even by a section of the USP Chapters. Even the 2020 proposed NIOSH list of hazardous drugs included drugs approved only through 2015.
For better or worse, the pharmacy department’s responsibility is to understand which versions and standards to comply with. Understanding how the 2020 NIOSH update impacts your practice is a first step. It can be tempting to abide by the minimum standards, but this time of limbo allows pharmacy teams more time to make a concerted effort to move towards best practices, which will soon enough become contemporary standards. Focus on what you know is not changing— USP <800> for example— and build a plan from there. By bringing your entity’s hazardous drug list up to date to include evaluating new drugs approved since 2016, you will bridge the gap between the NIOSH list and current practice and ensure your employees are safe.
2. FDA Insanitary Conditions
In November 2020, the FDA released their Final Guidance Document on Insanitary Conditions at Compounding Facilities. This is an essential read for everyone in the compounding community. Many of the conditions described are often overlooked and within our control to eliminate or prevent. Examples include personnel garbing (exposed skin or hair), unsealed or loose-fitting ceiling tiles, and debris and residue within a Primary Engineering Control. In some cases, construction or new equipment is necessary to remedy issues like rust or leaks. Use these major projects as an opportunity to reset expectations with staff for cleaning and maintaining your new investment.
It is also important to note that insanitary conditions findings apply to both sterile and non-sterile compounded products. With the revisions of USP <795> on hold, many organizations may be pushing their non-sterile compounding areas lower on the priority list. Don't wait to assess USP <795> compliance. These areas often get little attention in my experience, especially if non-sterile compounding is not a routine part of your practice.
3. USP and FDA Interim Guidance
From the evolving context of drug and PPE shortages to new drugs approved under EUA to compounding hand sanitizer, the USP and FDA issued nearly 40 documents to provide interim or final guidance related to COVID-19, many directly relevant to the compounding community.
Regulatory bodies will be looking for how your pharmacy responded to the challenges and implemented interim practices applicable to your facility from a compliance perspective. Examples include assignment of Beyond-use Dates (BUDs), certification of PECs and SECs, cleaning and disinfecting the facility, and garbing standards.
Documentation to help you be more prepared for an inspection should include:
- Subject of the guidance, issuing agency, and date
- What assessment criteria were used and rationale for any changes made to practice
- Who was involved in the decision-making process and who was impacted by the changes
- When interim practices were in place and when they ended
- How changes were communicated to affected staff and relevant training or competency (if applicable)
Be sure to follow-up to assess if any of these changes resulted in positive improvements in workflow. What went well, and what can you continue, while balancing the impact to patient safety and compliance with official (not interim) standards.
4. Surveys Resuming and Inspection Readiness
While regulatory surveys paused early in the pandemic, many agencies implemented virtual surveys later in 2020. We anticipate a less-vigorous inspection cycle in 2021 compared to pre-pandemic due to COVID travel limitations and public health priorities, but it is still important to focus on a constant state of readiness for the sake of our patients and employees.
What can you do to be prepared for an inspection?
- Move toward as many compounding best practices as practical, such as facility design improvements and USP <800>, that will likely meet both current and future USP standards.
- Build on collaborative relationships you are forging during COVID-19 response - invite an “outsider” to view your pharmacy and compounding suite. A peer from another hospital or colleagues in Engineering, Infection Prevention, or Quality departments can offer a fresh perspective on areas you see every day.
- Get your documentation in order based on the tips above and be prepared to explain any gaps. During the pandemic, typical maintenance activities may have fallen by the wayside. Or, your usual documentation may have gaps due to interim practice changes. This includes personnel competency, certification, and cleaning. Make sure you acknowledge and rectify those gaps as you compile the necessary content to prepare for an inspection.
- Ensure you are comfortable interpreting your semi-annual certification reports. More importantly, ensure you have a plan of action when criteria are out of limits, and documentation to support your response. If you didn’t document it, it didn’t happen! This subject is a high priority for all inspectors and surveyors, as it has the greatest impact to patient safety.
As the COVID-19 vaccine rolls out, we approach the new year 2021 with hope and optimism. It is a key component in protecting our employees and patients, the same people we strive to keep safe by following the USP and FDA compounding standards. Let’s renew our efforts by refocusing on the compliance road ahead.
