Ensuring USP <797> Compliance in the OR

September 2020 - Vol.17 No. 9 - Page #20
Category: USP Training Programs

Pharmacy has a rich history of involvement in the perioperative setting. Beginning in the early 1980s, Duke University Hospital implemented one of the first operating room (OR) pharmacy satellites, with pharmacy playing a direct role in medication management in the OR, primarily focusing on medication distribution and regulatory compliance. A decade later, the American Society of Health-System Pharmacists (ASHP) published the first bulletin on this subject, ASHP Technical Bulletin on Surgery and Anesthesiology Pharmaceutical Services,1 to provide guidance on pharmacy services in the perioperative suite. This technical bulletin has since evolved into guidelines on both the clinical and operational management of pharmacy services that detail processes for medication distribution, controlled substance management, medication order review, quality oversight, pharmacy education, oversight of boarded patients, compounded sterile preparation (CSP) management, and other clinical and operational recommendations to ensure a robust pharmacy program in the perioperative setting.2

Over the years, much discussion has centered on the application of USP <797> standards in the perioperative setting. Given the OR’s dynamic environment and workflows that do not necessarily mimic the typical inpatient unit, some <797> standards, such as immediate-use requirements and beyond use dating (BUD), have been controversial and challenging for ORs to comply with. However, there is hope on the horizon with the new USP <797> standards currently under review (see the SIDEBAR3,4 for the history of USP <797>).

(For the remainder of this article, the use of OR and perioperative environment will be used interchangeably.)

Key Differences Between the Inpatient and OR Environment

Medication management in the perioperative setting can be quite challenging given the unique practices in this environment. In comparison to the typical inpatient unit, perioperative suites often require very different practices and workflows (see TABLE 1).

The Impact of USP <797> on the Perioperative Area

Analyzing compliance with <797> in the perioperative environment can be accomplished by reviewing the medication-use process and parsing out the specific activities (ie, dispensing and administration) directly related to the chapter (see FIGURE 1 describing the medication-use process).

Dispensing

For the purposes of this article, medication preparation will be included in the dispensing phase. Pharmacies have three primary options for providing medications to the perioperative staff:

  • Commercially packaged doses
  • In-house pharmacy prepared doses
  • Third-party vendor premixed/prepackaged doses

After pharmacy provides the medications to the perioperative team, additional manipulation of the dose may be required prior to patient administration in order to ensure safe administration practices—for example, diluting a concentrated vial of epinephrine. If additional manipulation is required, the <797> standards impacting compounding and admixture practices include the following4:

  • Ensure that proper aseptic technique is used and that personnel are educated on sterile compounding
  • Apply the appropriate BUD to the compounded product and to the remaining unused doses (ie, multiple-dose vials) when appropriate
  • Add compliant labeling to the product (organizations must ensure labels meet compliance with USP <797>, the hospital’s accrediting organization [eg, The Joint Commission or Det Norske Veritas Healthcare], and the state board of pharmacy)

Administration

During the administration phase in the medication-use process, the following USP <797> standards should be taken into account when monitoring for compliance4:

  • Ensure proper aseptic technique is used
  • Administration must occur within the assigned BUD

Top 3 USP <797> Compliance Challenges

For both the dispensing and administration phases in the medication-use process, ensuring compliance with the USP <797> standards can present a cadre of challenges in the OR environment. However, as the medication experts, pharmacy is well positioned to help establish and maintain compliance in the perioperative environment.

Challenge #1: Pharmacy Oversight

To ensure proper pharmacy oversight of the OR areas, some hospitals have established satellite pharmacies located in or near the OR suite, allowing for direct pharmacist involvement in medication management. Other hospitals may provide indirect services through the use of ADCs and designated, pre-stocked medication storage areas or carts. Whichever tactic is employed, it is important that pharmacy partners with the perioperative team and their leadership to manage the medication-use process in the OR areas. ASHP states that pharmacy “Should be knowledgeable in OR practices, the OR medication use processes, regulatory requirements, and medications that are administered perioperatively”.2 Building a collaborative relationship between pharmacy and the ORs and having a full understanding of the workflow will facilitate the insight needed to ensure appropriate oversight of compounding practices in the OR.

In addition to building this relationship, compliance monitoring is key to help validate practice. Working with and conducting audits with key champions/leaders in the area will facilitate more complete oversight of operations and provide the data needed to support compliance.

Challenge #2: Education

It is important for pharmacy to spend time in the perioperative environment to witness the actual medication preparation process for multiple types of cases (eg, cataract surgery vs catheterization lab procedure vs cardiac surgery) in order to gain a full understanding of the processes prior to developing or modifying educational materials. Although there are many differences in how medications are managed in the OR compared with the inpatient unit, education of certain general concepts can be combined and standardized. For example, proper hand hygiene and aseptic technique during medication preparation, medication administration, and proper labeling of compounded products may be standardized for both environments.

However, understanding the differences in medication preparation practices between each provider (ie, the OR nurse vs the inpatient unit nurse vs the anesthesia provider) is key to ensuring that education is complementary and relevant to every provider. A significant amount of literature exists on infection prevention in the OR for nursing and anesthesia—for example, the Society for Healthcare Epidemiology of America’s SHEA Expert Guidance: Infection Prevention in the Operating Room Anesthesia Work Area.5 Review the available literature to help design your educational materials to ensure they align with peer-reviewed journal articles and regulatory guidelines.

Challenge #3: Adoption of USP Standards

Arguably, the most controversial standard in USP <797>, and the one that the perioperative environment has the most challenges adopting, is the immediate-use BUD of 1 hour. The American Society of Anesthesiology (ASA) has submitted multiple statements and voiced their concerns disagreeing with this standard,6 which requires that providers waste medications compounded outside of an ISO 5 environment if not used within 1 hour of compounding. This standard is in place due to the increased risk of product contamination that exists over time, since medications are not prepared in an environment that limits the amount of particle exposure to the general medication preparation area. The ASA argues that complying with this standard has the potential to endanger patient safety and care, and states it is an inefficient use of medication resources, particularly in light of increasing medication costs and drug shortages.6

Although compliance with this specific standard can be challenging, a strategy to help gain buy-in to adopt the practice in the OR setting is to utilize premixed, unit-of-use products. These products may be compounded in the pharmacy or purchased directly from a third-party vendor or wholesaler. With this approach, some or all of the commonly used perioperative medications are then readily available without requiring additional admixture at the point of care. Consider the cost and storage of the products to ensure the strategy meets the financial needs of the hospital as well as the operational/workflow needs of care providers.

On the Horizon

On June 1, 2019, revision to USP <795> nonsterile preparations, USP <797> sterile preparations, and new chapter <825> radiopharmaceutical preparation, compounding, dispensing, and repackaging, were published.7 Appeals were received related to BUD in <795> and <797> and to the framework and BUD in <825>. USP issued a notice of intent to revise content (NITR) and is currently undergoing a series of stakeholder engagement discussions to review the appeals. Both invite-only and open forum sessions are being held to gather feedback to determine the final recommendations for the chapter. The current, official version of USP <797> was last revised in 2008. The newly revised chapter <797>, however, is only “Informational and not compendially applicable”.7 Regardless of the outcome of the appeal hearing, a 6-month implementation period will be granted once a decision has been made. (This timeframe has yet to be announced at the time of publication of this article.)

An important change in the newly revised <797> chapter is a change to the immediate-use BUD standard. As currently written, hospitals may apply a 4-hour BUD to an immediate-use compounded product. This 4-hour window provides a better opportunity for compliance. The ASA has published a statement supporting this change.6

Last of all, not discussed in this article is the management of hazardous medications and compliance with the current <797> chapter and recently published USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, which is also considered “Informational and not compendially applicable”.7 However, in the interest of public health, USP recommends adopting USP <800>.3 USP <800> is intended to decrease risk to health care workers associated with handling hazardous drugs in health care settings. This chapter provides information on hazardous drugs and hazardous drug handling, as defined by the National Institute for Occupational Safety and Health (NIOSH), and applies to hospitals, community pharmacies, physician practices, and clinics.3

Although limited, certain perioperative procedures commonly use hazardous medications, such as intravesicular mitomycin instillation and hyperthermic intraperitoneal chemotherapy, and so consideration of USP chapter <797> and the recently published <800> should be taken into account as perioperative practices and policies are developed or modified. Hazardous medications must be prepared in the pharmacy under safe, sterile conditions, as well as transported and administered using safe practices (eg, closed system drug-transfer devices) as outlined in USP <800>, rather than requiring the providers to prepare these medications or manipulate the medication packaging at the point of care in a manner that places themselves at an increased risk of exposure.

Conclusion

Adhering to USP <797> standards in the perioperative environment can be challenging. However, by adopting a collaborative culture between pharmacy and the OR team, a system can be implemented to help ensure compliance. It is critical, however, that pharmacy have a robust understanding of operations in the OR environment.

References

  1. American Society of Health-System Pharmacists. ASHP technical assistance bulletin on surgery and anesthesiology pharmaceutical services. Am J Health-Syst Pharm. 1991;48:319-325.
  2. ASHP Website. ASHP Guidelines on Perioperative Pharmacy Services. Medication Therapy and Patient Care: Specific Practice Areas—Guidelines. 410-425.
  3. USP Website. https://www.usp.org/. Accessed August 5, 2020.
  4. Pharmaceutical compounding—sterile preparations (general information chapter 797). In: The United States Pharmacopeia, 36th rev, and the National Formulary, 31 ed. Rockville, MD: The United States Pharmacopeial Convention; 2013: 361–398.
  5. SHEA Expert Guidance: Infection Prevention in the Operating Room Anesthesia Work Area https://www.shea-online.org/index.php/practice-resources/41-current-guidelines/635-shea-expert-guidance-infection-prevention-in-the-operating-room-anesthesia-work-area. Accessed July 27, 2020.
  6. American Society of Anesthesiologists. ASA Submits Comments on USP <797> Proposed Language on Compounded Sterile Preparations. https://www.asahq.org/advocacy-and-asapac/fda-and-washington-alerts/washington-alerts/2018/11/asa-submits-comments-on-usp-797-proposed-language-on-compounding-sterile-preparations. Accessed July 27, 2020.
  7. USP Website. Important Compounding Chapter Updates. https://www.usp.org/compounding/compounding-appeals. Accessed July 29, 2020.

Christopher Murray, PharmD, MS, is the system director of pharmacy at CHI St. Luke’s Health Memorial in East Texas. Christopher received his PharmD from Hampton University in 2008, where he also received a minor in Leadership Studies. He then went on to complete his health system pharmacy administration residency at Duke University Hospital while obtaining in parallel an MS in health system pharmacy from the University of North Carolina. Christopher’s professional interests include pharmacy leadership, mentorship, and medication safety.

Venita Papillion, PharmD, MBA, is the divisional vice president of pharmacy at CommonSpirit Health in Houston, Texas, where she has responsibility for 15 sites. She received her PharmD from Xavier in New Orleans, Louisiana and completed a PGY1 residency in Seattle, Washington at the VA Puget Sound. Venita also received a Master’s in Business Administration and is currently in process on a Master’s in Education.


SIDEBAR

The History of USP <797>3,4

The United States Pharmacopeia (USP), a compendium published annually by the similarly named non-profit organization and combined with the National Formulary, is known as USP-NF. USP creates written standards that are adopted by regulatory agencies to ensure that the identity, strength, quality, purity, and consistency of medications are accurate and correct. USP does not enforce any regulations; enforcement is the responsibility of the Food and Drug Administration (FDA) and other governmental bodies. The compounding compendium features over 40 general chapters and 170 compounding monographs. New USP-NF editions and supplements are delivered electronically.

USP <797> provides recommendations on sterile product compounding. The chapter looks primarily at five components to make assessments: microbial contamination, bacterial endotoxins, variability in strength of ingredients, chemical or physical contaminants, and other ingredients that affect the quality of the sterile compound. The standards are intended to provide guidance for compounding high-quality CSPs.

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