Released September 2024

In hospital settings, particularly within critical care units, the role of the pharmacist is crucial in ensuring the timely administration of life–saving medications. The preparation and delivery of compounded sterile preparations (CSPs) often determines the outcome of patients whose conditions are rapidly deteriorating. However, the traditional process of compounding, especially when handled through the standard IV room workflow, can introduce delays that are costly in emergency situations. Recognizing this, recent updates to USP <797> have clarified the provisions for immediate–use compounding. In this month’s article, we will discuss the pharmacist‘s essential role in patient care in the context of the recent USP <797> update, and considerations for developing Standard Operating Procedures (SOPs) for immediate–use compounding to enhance patient safety and outcomes.

Pharmacy’s Role in Patient Safety and Well-Being

Pharmacists are integral to the healthcare team, especially in critical care, where they ensure that patients receive the correct medications safely and efficiently. In emergency situations, the role of the pharmacy becomes even more vital. Delays in medication delivery can lead to severe consequences, including organ damage, prolonged recovery, or even death. Therefore, having a plan that enables the pharmacy and authorized personnel to rapidly deliver essential drugs to address a patient’s deteriorating condition is crucial.

Emergent drug compounding refers to the preparation of medications in direct response to urgent, life-threatening situations. In these scenarios, the speed of drug preparation and administration is paramount. For instance, in a Code Blue situation, where a patient experiences cardiac arrest, the immediate availability of medications can mean the difference between life and death. Similarly, during intubation, the rapid administration of sedatives and paralytics is essential to prevent hypoxia and stabilize the patient. Seizure management offers another clear example of the critical need for immediate drug administration. In the case of prolonged seizures, particularly in pediatric patients, the brain is at risk of permanent damage if anticonvulsants are not administered swiftly. Here, every second counts, and responders must be equipped with the appropriate preparations to provide rapid support.

USP <797> and Immediate-Use CSPs: Key Updates

USP <797> sets the standard for compounding sterile preparations, ensuring these preparations meet high safety and quality standards. The guidelines are designed to minimize the risk of contamination and errors, which is particularly important given the vulnerable condition of many patients who require sterile medications. However, some requirements of USP <797> can create challenges in emergency situations, where the “need for speed” overrules the normal avenue of compounding these medications in cleanroom environments. To address these challenges, the recent update to USP <797> amended the guidelines for immediate-use CSPs.

The revised USP <797> guidelines for immediate-use compounding, effective November 1, 2023, introduce several key changes to enhance patient safety and CSP quality in emergency situations. These changes include extending the beyond-use date (BUD) for immediate-use CSPs from 1 hour to 4 hours based on evidence of a microbial lag phase, requiring comprehensive aseptic techniques with written SOPs, and mandating training and competency evaluations for personnel involved in compounding. These updates emphasize a holistic, organization-wide approach to implementing safe compounding practices, balancing the need for rapid medication access with stringent safety standards.

Considerations for Developing SOPs for Immediate-Use Compounding

To implement the immediate-use provision of USP <797> effectively, hospitals must develop comprehensive SOPs that integrate this practice into their emergency response protocols. These SOPs should reflect the latest USP <797> recommendations and consider the unique demands and workflows of the institution. Below are key considerations when developing these SOPs:

1. Define Clear Criteria for Emergencies 

Although the emergency situation requirement has been removed, the revised USP <797> provides more updated guidance on safe practices for immediate-use compounding. SOPs should clearly define what justifies the use of immediate-use CSPs, such as cardiac arrest, severe respiratory distress requiring intubation, or prolonged seizures. This helps ensure that immediate compounding is limited to situations where timely medication administration is critical to prevent significant patient harm. SOPs should also consider the new allowance for up to a 4-hour Beyond-Use Date (BUD) for immediate-use CSPs, based on recent microbiological studies indicating a 4 to 6-hour lag phase of microbial growth. This change reflects a balance between medication access and quality. 

2. Designation of Safe Compounding Areas

Although immediate-use CSPs do not require an ISO Class 5 environment, the revised guidelines emphasize the need for aseptic technique and environmental controls. SOPs should designate specific areas for immediate-use compounding that are strategically located for rapid access and equipped with necessary supplies while minimizing contamination risks. Mobile compounding carts or designated areas within the pharmacy can be effective solutions. SOPs should detail protocols for maintaining these areas, including regular cleaning, use of antiseptics, and proper handling techniques to reduce the risk of both microbial and non-microbial contamination.

3. Enhanced Training and Competency Requirements

The updated USP <797> mandates that personnel involved in immediate-use compounding must be trained and demonstrate competency in aseptic processes. SOPs should outline comprehensive training programs that cover both didactic education and practical simulations, focusing on aseptic techniques and the specific procedures related to immediate-use compounding. Competency assessments should be conducted regularly, at least annually, to ensure ongoing compliance with best practices. Training should also address potential non-microbial contamination risks, such as vial coring and glass particle contamination, and the appropriate techniques to mitigate these risks.

4. Labeling and Administration 

SOPs developed in accordance with the updated USP 797 guidelines section 1.3 Immediate Use CSPs, should outline step-by-step instructions for preparing CSPs intended for direct and immediate administration, ensuring they are exempt from the requirements of Category 1 and Category 2 CSPs. These procedures must specify that each CSP must be labeled accurately with the names and amounts of all active ingredients, along with the preparer’s name or initials, or individual preparing the CSP is either the one administering it or witnessing its administration. The SOP should also enforce the labeling of the exact 4-hour window within which administration must begin, ensuring that any deviations are immediately addressed to prevent errors or compromise in sterility and efficacy. Regular training and audits can help ensure adherence to these procedures, minimizing risks associated with immediate-use compounding.

Conclusion

The pharmacy’s participation in patient care, especially during emergencies, is crucial to ensuring positive outcomes. The recent updates to USP <797> regarding immediate-use CSPs provide pharmacists with the flexibility needed to respond quickly when every second counts. By developing and implementing comprehensive SOPs that incorporate the latest USP <797> recommendations, hospitals can ensure immediate-use compounding is performed safely, efficiently, and in a way that supports the highest standards of patient safety. Ultimately, having a well-structured plan that empowers pharmacists to act swiftly will shorten turnaround times for emergency CSPs and save lives. 

About the Author

Luis Hernandez, RPh, BCSCP, is a certified sterile compounding pharmacist and the founder of Seven97 Training Solutions. Dedicated to advancing USP 797 pharmaceutical training, validation, and certification, Luis aims to promote and inspire excellence in aseptic processing, medication and patient safety, and regulatory compliance.

References

1.  Pharmacy Purchasing & Products. USP <797> Immediate-Use CSPs: Small Changes, Big Impact. https://www.pppmag.com/article/3041. Accessed September 19, 2024.

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