On January 1, 2004, chapter 797

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1 Impact of United States Pharmacopeia chapter 797: Results of a national survey On January 1, 2004, chapter 797 of the United States Pharmacopeia (USP) became the nation s first enforceable standard for the compounding of sterile preparations. 1,2 This new standard was developed in response to a growing demand to hold pharmacies more accountable for preparations that are compounded outside of a controlled environment. For example, although the Food and Drug Administration (FDA) requires that drug manufacturers adhere to current good manufacturing practices (cgmps), a pharmacy that prepares the same product is not held to that same rigorous standard. 3,4 USP chapter 797 is intended to provide a more rigorous standard for pharmacy operations since cgmps cannot be applied to compounding in pharmacies. Not only does FDA consider USP chapter 797 an enforceable standard, but the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is using USP chapter 797 when surveying hospitals. 1 To assist pharmacies in complying with this new standard, JCAHO has developed a recommended timeline for implementation of specific requirements of chapter TIMOTHY A. CANDY, PHILIP J. SCHNEIDER, AND CRAIG A. PEDERSEN Purpose. The initial response of the pharmacy profession to United States Pharmacopeia (USP) chapter 797 and the current state of hospital pharmacy practice as it relates to implementing this chapter were studied. Methods. A stratified random sample of 600 hospital pharmacy directors across the nation were surveyed by mail. Results. A total of 251 surveys (41.8%) were returned. Larger hospitals ( 200 staffed beds) were more likely than smaller hospitals (<200 staffed beds) to have read USP chapter 797 (80.0% versus 45.8%, respectively) and have a copy of the chapter (94.6% versus 78.0%, respectively). Overall, respondents felt that chapter 797 would negatively affect workload and pharmacy s ability to provide sterile preparations in a timely manner. Conversely, respondents replied that the new standard would have a positive effect on the quality of care provided by the hospital. Overall, 45.3% of respondents reported plans to build a cleanroom, and 21.7% reported plans to obtain new equipment to comply with chapter 797. Furthermore, 42.3% of respondents had decreased the quantity of high-risk compounding. Respondents also reported that their pharmacy s budget had in- From the public s perspective, recent incidents of contaminated sterile products causing patient harm and death have given the profession creased in order to comply with chapter 797. The most common requirements with which respondents were not willing to comply were validating the accuracy of automated compounding devices, sterilizing products and equipment before entering the cleanroom, rotating the type of disinfectants, and prohibiting use of cosmetics by staff. Conclusion. USP chapter 797 standards have influenced the compounding practices of hospital pharmacies nationwide, including a decrease in the compounding of high-risk preparations, an increase in budgetary allocations, and implementation of better quality assurance practices. Larger hospitals tended to implement more changes than did smaller hospitals, and there remains room for improvement overall. Index terms: Aseptic areas; Automation; Budgets; Compliance; Compounding; Control, quality; Data collection; Disinfectants; Equipment; Pharmacists, hospital; Pharmacy, institutional, hospital; Quality assurance; Standards; Sterile products; United States Pharmacopeia; Workload Am J Health-Syst Pharm. 2006; 63: of pharmacy a negative reputation These incidents occurred because recommended published compounding guidelines were not fol- TIMOTHY A. CANDY, PHARM.D., M.S., was an M.S. degree candidate at The Ohio State University (OSU) and an administrative pharmacy resident at Grant Medical Center, Columbus. PHILIP J. SCHNEIDER, M.S., FASHP, is Clinical Professor and Director, Latiolais Leadership Program; and CRAIG A. PEDERSEN, PH.D., FAPHA, is Associate Professor and Director of Graduate Studies, Division of Pharmacy Practice and Administration, College of Pharmacy, OSU. Address correspondence to Mr. Schneider at the College of Pharmacy, The Ohio State University, 500 West 12th Avenue, Columbus, OH (schneider.5@osu.edu). The assistance and guidance of Sam Augustine and Firouzan Fred Massoomi are acknowledged. The assistance of ASHP is acknowledged for the use of the SMG database. This survey was funded by OSU s Latiolais Leadership Program. Copyright 2006, American Society of Health-System Pharmacists, Inc. All rights reserved /06/ $ DOI /ajhp Am J Health-Syst Pharm Vol 63 Jul 15, 2006

2 lowed, particularly guidelines addressing quality assurance and personnel training. Chapter 797 was developed to eliminate the risk of patient harm due to improperly compounded sterile preparations, but it is unknown how an enforceable standard will influence the changes that FDA, JCAHO, and the public demand. Past national surveys have shown that hospital pharmacies do not routinely comply with published guidelines for compounding sterile preparations In the most recent national survey evaluating compliance with the American Society of Health-System Pharmacists (ASHP) Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products, only 5.2% of pharmacies were fully compliant with garb attire requirements for compounding lowrisk preparations. 12 Furthermore, only 4.7% of hospital pharmacies were fully compliant with documentation procedures for high-risk preparations. The national surveys have also found that larger hospitals are more compliant with guidelines than are smaller hospitals Since there are more smaller hospitals in the country than larger hospitals, implementing chapter 797 will be a significant challenge for the profession of pharmacy. This study was designed to determine the response of the pharmacy profession to USP chapter 797 and to report on the current state of hospital pharmacy practice as it relates to implementing chapter 797. Methods Survey design. A survey instrument was created to measure the impact of chapter 797 on budgetary concerns, the building of cleanrooms, the acquisition of new equipment, and the operation of satellite pharmacies. The questions were grouped into four categories: (1) current opinions, (2) current compounding practices, (3) impact of chapter requirements, and (4) budget and resource allocation. A fourpage, 20-question survey instrument in a multiple-choice format was developed. The survey instrument was field tested with three different pharmacy managers from various sizes of hospitals and modified according to reviewers comments. The study design, including the final survey instrument, was approved by The Ohio State University s investigational review board. Study sample. Using the SMG database (Verispan, Yardley, PA), demographic characteristics were obtained, including the number of beds, U.S. Census Bureau region, ownership, U.S. Census Bureau metropolitan statistical area (MSA) status, and medical school affiliation status. Of the 6837 hospitals in the United States, 4963 general and children s medical surgical hospitals were included in the sampling frame. Specialty, federal, and Veterans Affairs hospitals were excluded. Based on the number of staffed beds, hospitals were stratified into the following six categories: <50, 50 99, 199, , , and 400 staffed beds. One hundred pharmacy directors were randomly sampled from each strata, yielding a total of 600 mailed surveys. Data collection. Data collection followed a slightly modified Dillman 16 method. The surveys were mailed to the randomly selected pharmacy directors with a letter describing the intent of the survey and a selfaddressed, stamped return envelope. Participants were assured that their responses would be kept confidential and that only aggregate data would be reported. Reminder postcards were sent approximately one week later. Approximately four weeks after sending the first survey, a duplicate survey with a self-addressed, stamped return envelope was sent to all of the pharmacy directors who did not initially respond. Data collection occurred between February and May of Data analysis. Each participant was assigned a unique identification number that allowed the survey response to be matched with hospital characteristics in the SMG database. Because of the stratified random sampling procedure, it was necessary to employ a design-based analysis. 17 This technique produces population estimates that are much more accurate by accounting for the complex sampling design and improves the reliability of the estimates for each subdomain (e.g., hospital size). Data were entered using SPSS, version 12.0 (SPSS Inc., Chicago, IL), and converted to an Intercooled Stata, version 7 (StataCorp LP, College Station, TX), readable format using DBMS Copy version 7 (Statistical Solutions, Saugus, MA). All nondesign-based analyses were conducted using SPSS, version All designbased analyses were conducted using Stata, version 7, with the set of survey commands. To account for oversampling the largest hospitals, weights were assigned to participants to adjust their contribution to the population estimate. The calculated weights assigned were as follows: for hospitals with fewer than 50 beds, for bed hospitals, for 199-bed hospitals, for bed hospitals, for bed hospitals, and for hospitals with 400 or more staffed beds. Descriptive statistics were used extensively. Chi-square analysis and analysis of variance or regression were used to examine how responses differed as a function of hospital characteristics. The a priori level of significance was set at Results Of the 600 mailed surveys, 262 surveys were returned, yielding a response rate of 43.7%. Eleven surveys were not usable, which adjusted the returned sample to 251 surveys, with Am J Health-Syst Pharm Vol 63 Jul 15,

3 an adjusted response rate of 41.8%. Of the 11 unusable surveys, 7 were returned by pharmacy directors stating they were not familiar with USP chapter 797. The remaining 4 surveys were not usable because one hospital was closing down, two hospitals did not compound sterile preparations, and one hospital had a policy that disallowed participation in national surveys. Table 1 shows the size, location, ownership, and affiliation status of the respondents hospitals, the nonrespondents hospitals, the surveyed hospitals, and the 4963 general and children s medical surgical hospitals with pharmacies in the SMG hospital database. The characteristics of the surveyed hospitals are presented to highlight the complex sampling design used in this survey. Respondents and nonrespondents did not significantly differ in MSA status, ownership, or medical school affiliation. Hospitals with fewer than 50 staffed beds were underrepresented, as were hospitals in the West and South. As a design-based analysis was employed, these slight differences were adjusted for in the population estimates. The sampling design ensured approximately equal distribution of hospitals by number of staffed beds. Mirroring the population, nearly two thirds of the respondents hospitals were in the South or the Midwest. Most respondents worked for nonprofit organizations (88%), were not affiliated with a medical school (67%), and were located within an MSA (66%). Information gathering. In larger hospitals ( 200 staffed beds), the most common methods of learning about USP chapter 797 were reading the actual chapter (80.0%) and reading the ASHP Discussion Guide on chapter 797 (80.0%). In smaller hospitals (<200 staffed beds), respondents referred to the ASHP Discussion Guide (54.8%) and other summaries from secondary sources (47.5%) more often than the actual chapter (45.8%). Respondents from larger hospitals were more likely to attend a live presentation (64.7%) or read postings on Internet bulletin boards, listservers, or s (40.4%) than respondents from smaller hospitals (37.3% and 27.4%, respectively) (p < and p = , respectively). Respondents from smaller hospitals tended to use word-of-mouth as a means to learn about USP chapter 797 more often than respondents from larger hospitals (45.8% versus 37.0%, respectively) (p = 0.187). Larger hospitals were more likely to have a copy of the published standard than were smaller hospitals (94.6% versus 78.0%, respectively) (p = ). Overall, 61.8% of survey respondents reported learning more about chapter 797 because JCAHO is using the standard when surveying hospitals. Table 1. Size, Location, Ownership, and Affiliation of Hospitals a Characteristic All hospitals Staffed beds e < Region f West Midwest South Northeast MSA status Within an MSA Outside an MSA Ownership For profit Nonprofit Medical school affiliation Yes No Respondents Nonrespondents Surveyed Population n % b n % b n % c n % d a From the SMG hospital database; MSA = metropolitan statistical area. b Calculated as a percentage of all hospitals surveyed in the category. c Calculated as a percentage of all hospitals surveyed. d Calculated as a percentage of all hospitals. e χ 2 = 14.09, df = 5, p = f χ 2 = 12.08, df = 3, p = Am J Health-Syst Pharm Vol 63 Jul 15, 2006

4 Current opinions. Respondents reported that chapter 797 will negatively affect the (1) workload of pharmacy technicians, (2) workload of pharmacists, (3) overall efficiency of operations, (4) pharmacy s ability to provide compounded sterile preparations in a timely manner, and (5) pharmacy s ability to provide excellent customer service (Table 2). Respondents agreed that the new standard exceeds what they think is necessary for hospital pharmacy practice. Conversely, respondents believed that chapter 797 will positively affect the quality of care provided to patients. Overall, 77.6% of respondents believed that wastage of sterile products would increase because of the new beyond-use dating recommendations. Current compounding practices. Overall, 79% of respondents hospitals had performed a gap analysis (Table 3). Larger hospitals are more likely to have completed the gap analysis. Only 35% of respondents hospitals had a cleanroom in the central pharmacy that met chapter 797 standards. Of those, 72% met the more stringent International Organization for Standardization (ISO) class 7 standard (<10,000 particles per cubic foot). Overall, only 46% of hospitals used USP chapter 797 to evaluate Rate the effect that USP chapter 797 will have on the b Workload of pharmacy technicians (n = 251) Workload of pharmacists (n = 251) Overall efficiency of operations (n = 249) Pharmacy s ability to provide compounded sterile preparations in a timely manner (n = 251) Pharmacy s ability to provide excellent customer service (i.e., nursing satisfaction) (n = 251) Quality of care provided to your hospital s patients (n = 251) Rate your agreement with the following statement c : The rigor of USP chapter 797 exceeds what is necessary for hospital pharmacy practice (n = 250) 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. Larger hospitals were also more likely to compound sterile preparations in satellite pharmacies and compound high-risk level preparations than were smaller hospitals. Impact of chapter requirements. Table 4 summarizes the action plans of pharmacy directors for 14 requirements specifically stated in chapter 797. The most common requirements that respondents were not willing to comply with were validating the accuracy of automated compounding devices (ACDs), sterilizing products and equipment before entering the cleanroom, rotating the type of disinfectants, and prohibiting cosmetic use by staff. The most common requirements that were addressed with a long-term action plan (>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 nonemergent sterile preparations outside of the central pharmacy. The most common requirements that were addressed with a Table 2. Respondents Opinions About United States Pharmacopeia (USP) Chapter 797 a Survey Questions Mean (95% CI) 2.10 ( ) 2.14 ( ) 2.08 ( ) 2.11 ( ) 2.41 ( ) 3.57 ( ) 3.86 ( ) a USP = United States Pharmacopeia, CI = confidence interval. b 1 = very negative or restrictive effect, 2 = somewhat negative effect, 3 = neutral or no effect, 4 = somewhat positive effect, 5 = very positive or helpful effect. c 1 = strongly disagree, 2 = somewhat disagree, 3 = neutral, 4 = somewhat agree, 5 = strongly agree. short-term action plan ( 12 months to implement) included initially and annually validating aseptic technique skills of personnel who compound sterile preparations by using mediafill tests, regularly using settle plates to monitor environmental conditions of the cleanroom over time, sanitizing the i.v. cleanroom floors daily, and addressing garb attire requirements for pharmacy staff working in the i.v. cleanroom. Overall, 45.3% of respondents stated that their hospital obtained approval to build a cleanroom because of USP chapter 797. Of those, 60.8% stated that chapter 797 was the sole reason for obtaining approval, and 22.2% stated that the new standard had a very large influence on obtaining approval. Only 8.8% of respondents indicated that the chapter had no influence on obtaining approval for a new cleanroom. Of the respondents who did receive approval to build a new cleanroom, 57.3% stated that the new cleanroom would meet ISO class 7 standards. Only 21.7% of respondents had obtained new equipment for compounding sterile preparations (e.g., laminar-airflow hood, barrier isolator, ACD). Of those who did, 58.9% indicated that USP 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% versus 9.6%, respectively) (p < 0.001). In response to USP chapter 797 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. Am J Health-Syst Pharm Vol 63 Jul 15,

5 Table 3. Current Compounding Practices Current Practice Compound sterile preparations in satellite pharmacies Hospital pharmacy has a cleanroom b in the central pharmacy area that meets chapter 797 standards Of those with a central pharmacy cleanroom, the hospital pharmacy s cleanroom meets ISO class 7 standards The hospital pharmacy compounds highrisk preparations c The hospital has performed a gap analysis to identify any deficiencies in complying with chapter 797 The hospital uses chapter 797 to evaluate nursing practice in preparing sterile doses in patient care areas <50 (n = 28) (n = 54) % Hospitals, by Staffed Bed Size 199 (n = 43) (n = 41) (n = 43) 400 (n = 42) Overall a d e a Uncorrected χ 2 = 65.81, design-based F(3.43, ) = 12.36, p < b A cleanroom is described as a specific room designated solely for the compounding of sterile preparations, separated from the outside environment by a door. The cleanroom maintains at least an International Organization for Standardization (ISO) class 8 (,000 particles per cubic foot) environment and has a line of demarcation designating one section of the room as the anteroom area and the other section of the room as the buffer zone, whereby the laminar-airflow workbench is located. c Sterile products made from nonsterile ingredients (e.g., bulk powders) or preparations using sterile ingredients in nonsterile devices before sterilization. d Uncorrected χ 2 = 29.78, design-based F(3.53, ) = 5.70, p = e Uncorrected χ 2 = 24.13, design-based F(3.67, ) = 5.13, p = 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 ( 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 changed because of USP 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 (p = ). Budget and resource allocation. 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, 51.0% and 44.8% of hospitals were increasing the budget to purchase point-of-care activated i.v. medication devices and manufacturerpremade or frozen sterile products, respectively (Table 5). Discussion Past studies have shown a general lack of compliance with guidelines for compounding sterile preparations in hospitals This may be related to a lack of enforceable standards similar to cgmps that the pharmaceutical industry must follow. Before 2004, most pharmacy directors used ASHP guidelines to learn how to develop and maintain a high-quality sterile compounding program. 12,18,19 Lack of funds to comply with ASHP guidelines may be related to capital cost justification: investment in compounding sterile preparations will not generate increased revenue for the hospital. State boards of pharmacy are using USP chapter 797 to guide the development of regulations for compounding sterile preparations, and JCAHO is using chapter 797 during accreditation surveys. The consequences of not meeting regulatory and accreditation standards are likely to prompt administrators to support full compliance with chapter 797. The results of this survey, however, indicate that many institutions are not planning to change processes despite the enforceable nature of chapter 797. One factor related to compliance with USP chapter 797 is hospital size. Small hospitals may not have the volume of sterile preparations to justify the cost of building a cleanroom. While there is evidence that hospitals of all sizes are trying to implement changes to meet chapter 797 requirements, results from this survey suggest that smaller hospitals are more reluctant to changing 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 (Table 1) Am J Health-Syst Pharm Vol 63 Jul 15, 2006

6 Table 4. Compliance with United States Pharmacopeia Chapter 797 Requirements and Future Plans Specific Standard The pharmacy validates the accuracy of automated compounding devices on a daily basis The pharmacy sterilizes products and equipment (e.g., carts) prior to entering the cleanroom The pharmacy regularly rotates the type of disinfectants used in the i.v. cleanroom The pharmacy has a policy in place prohibiting makeup for staff working in the i.v. cleanroom The i.v. cleanroom floors are sanitized on a daily basis The pharmacy uses settle plates on a regular basis (i.e., at least monthly) to monitor environmental conditions of the cleanroom The pharmacy uses a cleanroom to compound sterile preparations Hospital policy prohibits nurses and other health care providers from making nonemergent sterile preparations outside of the central pharmacy The pharmacy utilizes specific garb attire requirements for the pharmacy staff who work in the i.v. cleanroom The pharmacy performs end-product bacterial endotoxin testing on all high-risk preparations The pharmacy uses the recommended beyond-use dating for products that do not undergo end-product sterility testing The pharmacy performs end-product sterility testing on all high-risk preparations Initially, the pharmacy uses media-fill testing methods to validate the aseptic technique skills of personnel who compound sterile preparations Annually, the pharmacy uses media-fill testing methods to validate the aseptic technique skills of personnel who compound sterile preparations Does Not Meet Standard; No Plans To Change (n = 251) a Plans for change after 12 months were considered long term. b Plans for change before or in exactly 12 months were considered short term. Does Not Meet Standard; Long- Term Plans To Change (n = 251) a % Hospitals Does Not Meet Standard; Short- Term Plans To Change (n = 251) b No Changes Needed; Currently Meets Standard (n = 251) More than one third of respondents stated that they were not going to change their noncompliant practice of validating the accuracy of ACD daily. This 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 an ACD 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 USP chapter 797, compared with 80% of respondents in larger hospitals (p < ). 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 Am J Health-Syst Pharm Vol 63 Jul 15,

7 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. Despite the reasons that pharmacy directors may have for not implementing chapter 797, the survey did show that the chapter is having a positive impact not realized with previously published guidelines. The biggest impact of this 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. 2 Almost half of the respondents reported that they had built or were building a cleanroom, and almost two thirds of these respondents stated that chapter 797 was the sole reason for this construction. USP chapter 797 has also 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. USP chapter 797 strongly emphasizes the importance of training and validating aseptic technique. 2 One component of validating aseptic technique is media-fill testing, which requires a trainee to pass a rigorous series of sterile transfers without Table 5. Effect of United States Pharmacopeia Chapter 797 on Resource Allocation Budgeted Resource I.V. room supplies or equipment I.V. cleanroom floors sanitized on a daily basis (similar to how operating room suites are sanitized) Manufacturer-premade or frozen compounded sterile products Point-of-care activated devices (e.g., Add-Vantage, Mini-Bag Plus) Pharmacy technician FTEs a Pharmacist FTEs a FTEs = full-time equivalents. % Hospitals That Have Increased Allocation contaminating the media before compounding sterile preparations. More than 70% of respondents indicated that there were plans to implement annual media-fill testing; 22.5% of respondents were already compliant with this standard. USP chapter 797 also emphasizes the importance of continuous monitoring of environmental quality. This chapter reintroduces the practice of using settle plates, which contain a growth medium that is exposed to the air at critical points in a cleanroom. 2 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 8 cleanroom. 2 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 the environmental quality is evidenced 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. 12 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. USP chapter 797 seems to have slightly affected staffing. Almost 40% of hospitals with more than 200 staffed beds indicated that the pharmacy changed its staffing model to better comply with chapter 797 requirements. This change can be attributed to shifting more FTEs to compounding functions and adding more responsibilities to technicians and pharmacists to meet new requirements. Chapter 797 has resulted in more human resources being assigned to compound sterile preparations, whether through shifting existing FTEs or by adding new FTEs. 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 USP chapter 797. The results of this survey are limited in that the data collected were self-reported. It is possible that the directors responses do not reflect actual practices. However, many responses were opinion based, and this report captures respondent opinions. In addition, nonresponse can be a concern in survey research. In this survey, hospitals with fewer than 50 beds had a decreased response rate compared 1342 Am J Health-Syst Pharm Vol 63 Jul 15, 2006

8 with larger hospitals. However, because a design-based analysis was used to account for the stratified random sampling procedure, our population estimates should not be affected by this underreporting. Conclusion USP chapter 797 standards have influenced the compounding practices of hospital pharmacies nationwide, including a decrease in highrisk compounding, an increase in budgetary allocations, and implementation of better quality assurance practices. Larger hospitals tended to implement more changes than did smaller hospitals, and there remains room for improvement overall. References 1. Thompson CA. USP publishes enforceable chapter on sterile compounding. Am J Health-Syst Pharm. 2003; 60: News. 2. Pharmaceutical compounding sterile preparations (general information chapter 797). In: The United States pharmacopeia, 27th rev., and The national formulary, 22nd ed. Rockville, MD: United States Pharmacopeial Convention; 2004: Vivian J. Pharmacy compounding and the FDA. US Pharm. 2003; 28: Food and Drug Administration. Guidance for industry: sterile drug products produced by aseptic processing current good manufacturing practice. gov/cber/gdlns/steraseptic.pdf (accessed 2006 Apr 18). 5. Joint Commission on Accreditation of Healthcare Organizations. Time frames for completing the various sections of USP chapter 797. Jt Comm Perspect. 2004; 24(10): Selenic D, Dodson DR, Jensen B et al. Enterobacter cloacae bloodstream infections in pediatric patients traced to a hospital pharmacy. Am J Health-Syst Pharm. 2003; 60: Centers for Disease Control and Prevention. Exophiala infection from contaminated injectable steroids prepared by a compounding pharmacy United States, July November MMWR. 2002; 51: Tresoldi AT, Padoveze MC, Trabasso P et al. Enterobacter cloacae sepsis outbreak in a newborn unit caused by contaminated total parenteral nutrition solution. Am J Infect Control. 2000; 28: Centers for Disease Control and Prevention. Enterobacter cloacae bloodstream infections associated with contaminated prefilled saline syringes California, November MMWR. 1998; 47: Thompson CA. Pharmacy error likely caused hepatitis C outbreak, report says. cfm?id=10618 (accessed 2005 May 25). 11. Thompson CA. Compounded i.v. solution linked to sepsis cases. news/showarticle.cfm?id=10275 (accessed 2005 May 25). 12. Morris AM, Schneider PJ, Pedersen CA et al. National survey of quality assurance activities for pharmacy-compounded sterile preparations. Am J Health-Syst Pharm. 2003; 60: Crawford SY, Narducci WA, Augustine SC. National survey of quality assurance activities for pharmacy-prepared sterile products in hospital. Am J Hosp Pharm. 1991; 48: Santell JP, Kamalich RF. National survey of quality assurance activities for pharmacy-prepared sterile products in hospitals and home infusion facilities Am J Health-Syst Pharm. 1996; 53: Pedersen CA, Schneider PJ, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: dispensing and administration Am J Health- Syst Pharm. 2003; 60: Dillman DA. Mail and internet surveys: the tailored design method. 2nd ed. New York: Wiley; Levy PS, Lemeshow S. Sampling of populations: methods and applications. 3rd ed. New York: Wiley; 1999: American Society of Hospital Pharmacists. ASHP technical assistance bulletin on quality assurance for pharmacyprepared sterile products. Am J Hosp Pharm. 1993; 50: American Society of Health-System Pharmacists. ASHP guidelines on quality assurance for pharmacy-prepared sterile products. Am J Health-Syst Pharm. 2000; 57: Am J Health-Syst Pharm Vol 63 Jul 15,