Hospitals changing in response to USP Chapter 797

A mail survey of 600 hospital pharmacy directors found that United States Pharmacopeia Chapter 797 has influenced hospital pharmacy compounding practices nationwide, including a drop in the compounding of high-risk preparations, an increase in budget allocations, and implementation of better quality assurance practices. Larger hospitals tended to implement more changes than did smaller hospitals. And the researchers found there still is room for improvement.

Taking effect Jan. 1, 2004, Chapter 797 became the nation's first enforceable standard for compounding sterile preparations. Ohio State University researchers say it was developed in response to a growing demand to hold pharmacies more accountable for preparations compounded outside a controlled environment. Thus, although FDA requires that drug companies adhere to current good manufacturing standards (cGMPs), pharmacies that prepare the same products themselves are not held to the same standards. Chapter 797 was intended to provide a more rigorous regulatory standard for pharmacy operations with regard to cGMPs and pharmacy compounding.

FDA considers Chapter 797 an enforceable standard, and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is referring to it when surveying hospitals. To assist hospitals in complying with the new standard, JCAHO developed a recommended timeline for implementing specific requirements in the chapter.

Master of Science candidate Timothy Candy, PharmD, who conducted the research along with two Ohio State University professors, says past national surveys have shown that hospital pharmacies don't routinely comply with published guidelines for compounding sterile preparations. In fact, the most recent survey evaluating compliance with American Society of Health-System Pharmacists (ASHP) Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products found that only 5.2% of pharmacies were fully compliant with garb attire requirements for compounding low-risk preparations. And only 4.7% of hospitals were fully compliant with documentation procedures for high-risk preparations.

Candy's study was intended to determine the response of the pharmacy profession to Chapter 797 and to report on the current state of hospital pharmacy practice as it relates to implementing the chapter.

Four categories of questions asked

Questions asked in the survey fall into four categories — current opinions, current compounding practices, impact of chapter requirements, and budget and resource allocation. Data collection occurred between February and May of 2005.

Of the 600 mailed surveys, 262 were returned, for a 43.7% response rate. Eleven surveys could not be used (including seven from pharmacy directors saying they had never heard of Chapter 797), reducing the number evaluated to 251, or a 41.8% response rate. Candy says respondents and nonrespondents did not significantly differ in MSA (metropolitan statistical area) status, ownership, or medical school affiliation. Hospitals with fewer than 50 staffed beds were underrepresented, as were hospitals in the West and South.

In larger hospitals with more than 200 staffed beds, the most common methods of learning about Chapter 797 were reading the chapter itself (80%) or reading the ASHP discussion guide on the chapter (80%). In smaller hospitals with fewer than 200 staffed beds, respondents referred to the ASHP guide (54.8%) and summaries from other sources (47.5%) more often than the actual chapter (45.8%). Respondents from larger hospitals were more likely to have attended a live presentation or read on-line postings than those from smaller hospitals, while respondents from smaller hospitals tended to use word-of-mouth as a means to learn about the chapter more often than respondents from larger hospitals. Larger hospitals were more likely to have a copy of the published standard than were smaller hospitals. Overall, 61.8% of those answering said they had learned more about Chapter 797 because JCAHO is using it when surveying hospitals.

Although those surveyed said Chapter 797 will have a positive impact on patient care, they also said it will have a negative impact on pharmacy technician workload, pharmacist workload, overall efficiency of operations, a pharmacy's ability to provide compounded sterile preparations in a timely manner, and a pharmacy's ability to provide excellent customer service. Respondents believe the standard goes further than necessary for hospital pharmacy practice. They also believe there will be more wasted sterile products because of the new beyond-use dating recommendations.

Larger hospitals more likely to do gap analysis

Overall, 79% of respondents' hospitals had analyzed the gap between their current practices and the Chapter 797 requirements. Larger hospitals were more likely to have completed the gap analysis. Only 35% of respondents' hospitals had a cleanroom in the central pharmacy that met Chapter 797 requirements. Of those, 72% met the more stringent International Organization for Standardization Class 7 standard (< 10,000 particles/ft3).

Overall, only 46% of hospitals used the chapter to evaluate nursing practices in preparing sterile doses in patient care areas. Larger hospitals were more likely to evaluate nursing and pharmacy practices than were smaller hospitals. They also were more likely to compound sterile preparations in satellite pharmacies and compound high-risk preparations than were smaller hospitals.

Most commonly, survey respondents said they have not been willing to comply with the following requirements: validating accuracy of automated compounding devices, sterilizing products and equipment before entering the cleanroom, rotating the type of disinfectants, and prohibiting staff cosmetic use.

The most common requirements addressed with a long-term action plan requiring more than 12 months to implement included sterilizing products and equipment before entering the cleanroom, performing end-product bacterial endotoxin testing on all high-risk preparations, and prohibiting nurses and other health care providers from making non-emergent sterile preparations outside of the central pharmacy.

The most common requirements addressed with a short-term action plan needing fewer than 12 months to implement were initially and annually validating aseptic technique skills of personnel who compound sterile preparations by using media-fill tests, regularly using settle plates to monitor cleanroom environmental conditions over time, sanitizing the I.V. cleanroom floors daily, and addressing garb attire requirements for pharmacy staff working in the I.V. cleanroom.

Chapter 797 is impetus for changes

Some 45.3% of respondents said their hospital obtained approval to build a cleanroom because of Chapter 797. Of those, 60.8% said the chapter was the sole reason for obtaining approval, and 22.2% said the standard had a very large influence on obtaining approval. Only 8.8% of respondents said the chapter had no influence on obtaining approval for a new cleanroom. Of those who received approval to build a new cleanroom, 57.3% said their cleanroom will meet ISO Class 7 standards.

Only 21.7% of respondents had obtained new equipment for compounding sterile preparations such as laminar-airflow hoods, barrier isolators, or automated compounding devices. Of those who did, 58.9% indicated that Chapter 797 was the sole reason for obtaining the new equipment, and 33.4% stated that the chapter largely influenced the decision to obtain new equipment for compounding sterile preparations. No respondents stated that the new standard had little or no influence on obtaining the new equipment.

Larger hospitals more commonly had satellite pharmacies preparing sterile products, compared with smaller hospitals (50% vs. 9.6%, respectively). In response to the chapter requirements, 19.9% of respondents shifted all compounding to the central pharmacy, 45.7% shifted some compounding to the central pharmacy, and 34.4% did not shift any compounding to the central pharmacy.

When asked about high-risk preparations, 42.3% of respondents were decreasing the quantity of these preparations being compounded because of Chapter 797. Of the hospital size most commonly associated with compounding high-risk products (at least 400 staffed beds), 65.2% of hospitals were decreasing the quantity of high-risk preparations being compounded because of Chapter 797.

Overall, 22.6% of respondents said that their staffing had changed because of Chapter 797, either by shifting existing full-time-equivalent (FTE) employees or adding new FTEs to perform functions related to compounding sterile preparations. Only 16.3% of hospitals with fewer than 200 staffed beds stated that their staffing changed, compared with 38.5% of hospitals with 200 or more staffed beds. This was not associated with a compensatory decrease in other budgetary items, as three-quarters of the respondents reported that the overall pharmacy budget increased due to Chapter 797.

Higher pharmacy budgets to comply

Overall, 75.1% of hospitals had total pharmacy budget increases for the next fiscal year as a result of changes necessary to comply with USP chapter 797. I.V. room supplies and equipment were the most common increase in resource allocation. Furthermore, 51% and 44.8% of hospitals were increasing the budget to purchase point-of-care activated I.V. medication devices and manufacturer pre-made or frozen sterile products, respectively.

State boards of pharmacy are using Chapter 797 to guide development of regulations for compounding sterile preparations, and JCAHO is using it during accreditation surveys. The consequences of not meeting regulatory and accreditation standards are likely to prompt administrators to support full compliance with Chapter 797. But Candy says the results of this survey indicate that many institutions are not planning to change processes despite the enforceable nature of Chapter 797.

One factor related to compliance is hospital size. Small hospitals may not have the volume of sterile preparations to justify the cost of building a cleanroom, he says. While there is evidence that hospitals of all sizes are trying to implement changes to meet Chapter 797 requirements, Candy says, results suggest that smaller hospitals are more reluctant to change practices compared with larger hospitals. This is an important finding because 71% of all general and children's medical-surgical hospitals in the United States are smaller hospitals with fewer than 200 staffed beds.

More than one-third of respondents stated that they were not going to change their noncompliant practice of validating the accuracy of automated compounding devices daily. Candy says this result "is alarming considering the critical condition of patients receiving total parenteral nutrition (TPN) and the effect that an improperly calibrated TPN machine could have on patients. Undetected errors when compounding highly potent medications using such a device could lead to adverse drug events for many patients."

Another factor limiting change is a lack of information about Chapter 797 among smaller hospitals. Of hospitals with fewer than 200 staffed beds, 45.8% of respondents had read Chapter 797, compared with 80% of respondents in larger hospitals. All seven surveys returned by respondents stating that they were not aware of Chapter 797 came from facilities with fewer than 50 staffed beds.

Another reason for reluctance to implement changes to meet Chapter 797 requirements is related to how pharmacy directors feel about the chapter. If a pharmacy director is under pressure to improve the department's productivity, efficiency, and timeliness, there may be a reluctance to implement changes that would detract from those goals. More than three-fourths of the respondents felt that the beyond-use dating standards would increase wastage, which would decrease efficiency and deter a pharmacy from implementing the new requirements. The survey results also demonstrated that respondents felt that Chapter 797 requirements exceed what is necessary for hospital pharmacy practice.

A positive impact not felt before

Despite the reasons that pharmacy directors may have for not implementing Chapter 797, the survey showed that the chapter is having a positive impact not realized with previously published guidelines, Candy says. The biggest impact of the chapter has been on the sterile preparation compounding environment. Chapter 797 emphasizes the importance of a controlled environment wherever compounded sterile preparations are prepared. One of the best ways to ensure a safe, controlled environment is a cleanroom. Almost half of the respondents reported that they had built or were building a cleanroom, and almost two-thirds of those respondents stated that Chapter 797 was the sole reason for this construction.

Candy says Chapter 797 also has had a significant effect on high-risk compounding procedures. The standards for compounding high-risk preparations are much more stringent than those for low- and medium-risk preparations. These more stringent standards seem to be forcing hospital pharmacy directors to either decrease the amount of high-risk preparations that are compounded or increase compliance with quality assurance measures and facility requirements.

Chapter 797 strongly emphasizes the importance of training and validating aseptic technique, Candy says. One component of validating aseptic technique is media-fill testing, which requires a trainee to pass a rigorous series of sterile transfers without contaminating the media before compounding sterile preparations. More than 70% of respondents indicated that they were planning to implement annual media-fill testing, and 22.5% were already compliant with this standard.

The chapter also emphasizes the importance of continuous monitoring of environmental quality, and reintroduces the practice of using settle plates, which contain a growth medium that is exposed to the air at critical points in a cleanroom. Almost three-fourths of the survey respondents stated that there were plans to use settle plates. Particle counts are necessary to ensure compliance to the requirements for an ISO Class 7 cleanroom. More than two-thirds of respondents stated that their particle counts met ISO Class 7 cleanroom requirements. The impact of Chapter 797 on practices for monitoring environmental quality is seen by comparing the current survey results with those from the 2002 quality assurance compliance survey, in which only 35.5% of hospitals measured particle counts in the cleanroom and only 6.3% of hospital pharmacies met ISO Class 7 requirements.

Satellite pharmacies affected

According to Candy, one area of pharmacy practice not specifically addressed in Chapter 797 is satellite pharmacies. Even though sterile preparations can still be compounded in a satellite pharmacy and meet Chapter 797 requirements, the chapter seems to have resulted in pharmacies compounding more preparations in the central pharmacy. Two-thirds of respondents stated that they have shifted some or all of the compounding in satellite pharmacies to the central pharmacy.

Hospital problems show need for compliance

Meanwhile, Pharmacy OneSource, a pharmacy documentation and formulary software provider, says the need for action to improve the safety of compounded medicines is seen in media accounts of incidents such as one at Virginia's Mary Washington Hospital in which at least 11 cardiac surgery patients developed serious bacteria infections last year after their hearts were injected with a contaminated solution mixed at a pharmacy that contracted with the hospital. Three of the patients died and eight of them have filed a lawsuit against the hospital and Central Admixture Pharmacy Services, which compounded the product.

"The importance of following USP 797 guidelines cannot be overstated," said Pharmacy OneSource executive vice president Keith Streckenbach. "Well-documented processes carried out by trained personnel with ongoing quality monitoring and improvement have been proven to reduce the likelihood of defective product, or in pharmacy's case, contaminated medication reaching the patient."

Pharmacy OneSource's Simplifi 797 is a web-based application that automates, integrates, and streamlines the quality activities and documentation required to meet Chapter 797, Streckenbach says. It uses expert rules developed by Eric Kastango, MBA, RPh, FASHP, manages task scheduling and monitoring, and automates the reporting of exceptions and compliance. Also, practice-based policies and procedures are integrated into the application to simplify compliance and include important aspects such as staff competencies, environmental monitoring, and media qualification.

[Editor's note: Information on the Ohio State University study is available from Philip Schneider at (614) 292-1514 or e-mail More information on Pharmacy OneSource is available on-line at Contact Keith Streckenbach at]