Compounding pharmacies have long practiced within standards established by authoritative agencies that include United States Pharmacopeia (USP), the Food and Drug Administration (FDA) and state regulators. Perhaps the most widely known are USP <795> and <797>, which lay out important guardrails for patient safety, and USP <800>, which establishes worker safety standards for handling hazardous drugs. Professional organizations and industry leaders often disseminate best practices that strive to exceed those minimum standards.
Even before the COVID-19 pandemic, remodeled IV rooms, supply shortages and USP chapter revisions had created numerous gray areas for compounding pharmacies to navigate. COVID-19 exacerbated these challenges. USP and the FDA responded by issuing interim guidance documents to help the industry navigate the pandemic’s impact on drug shortages, the use of new medications, PPE, and increased demand for compounding.
Many compounding pharmacies have struggled to adapt. An Institute for Safe Medication Practices (ISMP) survey of compounding best practices conducted in July 2020 found that only 56% of respondents said they could always find standard operating procedures or always follow them. Industry leaders have adopted some best practices to address these ongoing concerns.
Managing drug shortages
Drug shortages, of course, are not a new problem. Many health systems and pharmacies already had strong emergency preparedness plans to help manage drug shortages. Many also took advantage of opportunities to learn from each other to proactively manage shortages caused by the pandemic. Some of the best practices that emerged include the following:
- Make a list of critical drugs and supplies.
- Take inventory regularly.
- Consider the operational impact of availability changes on your entire team.
- Identify drug and dosage alternatives – and remember that an FDA-approved product is typically the best choice for patient safety.
- Assess dosage formulations and be mindful of medication safety impacts.
- Pay attention to how your wholesale manufacturer and outsourcing partners may be changing contract terms or product availability. Then assess and adjust your workflow for the impact on compounding capacity.
- Consider changes in concentration or vial size, which may cause patient harm if not well communicated or trigger revisions to Master Formulation Records or Smart Pump libraries. Reference interim guidance to maintain compliance within the flexibility offered by FDA and USP.
- If an FDA-approved product is unavailable, the preferred route is to obtain products from a 503b outsourcing facility.
- If supply chain barriers contributed to increased in-house compounding, consult FDA criteria for allowing the compounding, especially the list of approved drugs on the drug shortage list.
- Be sure to document that assessment and any evidence you have to support your choices.
Managing PPE shortages
During the pandemic, masks, gloves, head and foot covers, and chemotherapy and standard gowns could be hard to come by due to greater demand. Guidance from USP and the FDA provided some strategies for PPE conservation or prioritization.
- Prioritize sterile gloves and facemasks for sterile compounding activities.
- Prioritize HD gowns for Table 1 antineoplastic compounding.
- Maintain garb for reuse inside classified areas or perimeter lines.
- Limit staff performing sterile compounding.
Any of these alternate practices, however, can impact compounding operations, including increasing the risk for microbial contamination. This led to recommendations for more frequent cleaning and/or reduced beyond use dates (BUDs) of your compounded sterile preparations (CSPs). The table below summarizes the various USP standards and interim BUD allowances with changes from the current standards bolded and in red, but you should review the full documents . When in doubt, shorter BUDs, more cleaning and more monitoring are better.
Four concepts to maintain focus in compounding pharmacies
Though vaccinations may ease the pandemic over the next few months, some of the chaos and uncertainty will remain. Compounding pharmacies must keep their focus on how best to maintain both patient and worker safety. Four concepts will be particularly important.
Focus on what you can control.
- Revisions to USP <795> and <797> are delayed, so ensure you're compliant with the current standards, with an eye toward proposed revisions.
- USP <800> has not changed and NIOSH has proposed updates. Remember to annually update your hazardous drug list and utilize this opportunity to adjust your standard operating procedures (SOPs) based on employee feedback and the impact of COVID-19. While the NIOSH 2016 List is the List of reference, assess your Hazardous Drug list for impacts to your Assessment of Risk approach with proposed NIOSH changes. Surveyors will also look for how you address drugs beyond the NIOSH list.
- Make inspection readiness a priority.
- Consider building on collaborative relationships forged during your COVID‐19 response and inviting an "outsider" to view your pharmacy and compounding suite.
- Ensure you are comfortable interpreting your semi‐annual certification reports, have a plan of action for when criteria are out of limits and have documentation to support your response. Collaborative review can be useful here, so consider including infection prevention or engineering in your response team.
Document practice changes.
- Regulatory bodies, such as the Joint Commission, are resuming on site inspections and will be looking for evidence of how you’ve adopted interim guidelines, your assessment criteria for returning to SOPs, and your staff communications.
- Keep a record when compounding is performed without standard PPE.
- Keep a record when there are changes in the sterilization approach.
- Document mitigation strategies in a new or updated SOP.
- When documenting, consider including: (see sample document template below)
- Subject of the guidance
- Issuing agency
- Date of issuance
- When your organization conducted its assessment
- Criteria used to help determine roles
- Who was involved in the review
- Departments impacted
- Recommendations for adoption at your own organization that then might transition into an implementation plan that could help you capture any SOP updates
- How communication or training was issued to staff
- Start and reassessment dates
- Start and stop dates
Use data to showcase your compounding operation and how you maintain compliance.
- Review your USP documentation for core tasks, such as hood and room cleaning, as well as aseptic techniques and gloved fingertip and media fill competencies.
- Identify any gaps in your data and be prepared to explain the cause, especially if it was related to interim practice changes, such as gloved fingertip testing due to waivers for on time certifications.
Implement tools that can automate and streamline your workflow within safety guidelines.
- Arm the pharmacy with tools that help you develop SOPs, build pharmacy staff competency and expertise, and implement workflows that help ensure accuracy in CSP compounding.
- A comprehensive compliance management system can establish the training, documentation and quality assurance practices necessary for a safe, efficient and sterile compounding environment.
- A quality compliance management system will also compile data for inspections and help you identify trends that guide you in your shift from interim standards to SOPs.
The past year has posed some unprecedented challenges for many industries and individuals; compounding pharmacies have certainly not been spared. With multiple and sustained shortages and frequent guidance updates, it has been difficult to keep your balance. Throughout it all, pharmacy teams have been well positioned to step in with solutions based on their extensive experience managing the supply chain and collaborating with interdisciplinary teams. By understanding the interim guardrails, focusing on what you can control, and never wavering on patient and worker safety, you can maintain some sense of stability during these trying times.
