CREJ

Page 14 — Health Care Properties Quarterly — April 2018 www.crej.com Children’s Hospital of Colorado - Colorado Springs | Colorado Springs, CO The power of ingenuity ... ...the rewards of trusting relationships . ENRICHING People Community Ideas I n 2017, the United States Pharmacopeial Convention announced the release of a new general chapter regarding the protection of patients and health care workers in the handling of haz- ardous drugs. USP General Chapters 800, Hazardous Drugs – Handling in Healthcare Settings, and 797, Pharma- ceutical Compounding Sterile Prepara- tions, have significant impacts on the procedures, environment and space requirements of a pharmacy – for both inpatient and outpatient spaces.These chapters were developed to provide health care workers with a set of stan- dards to adhere to in the safe handling and compounding of hazardous drugs. There is no acceptable level of person- nel exposure to hazardous drugs – there is no real desire to be in the room with some of these HDs. Exposure to HDs can be through skin contact, inha- lation, ingestion or injection. USP 800 will now become effective Dec. 1, 2019, (original enforcement date was July 2018) to coincide with the update of USP 797, anticipated for release in September/October 2018. These updates are a requirement for all pharmacies involved in the compound- ing of hazardous drugs of any kind. Health care facilities and systems have already begun to look at the impacts and what they need to do to make sure their pharmacy is current and up to date. USP does not participate in the enforcement of this new regulation; however, the state of Colorado and the Federal Drug Administration are sup- portive of this general chapter. The significant issues and concerns raised by the USP 800 include: • Air change requirements – positive pressure vs. negative pressure spaces and the number of air changes per hour; • Separation of sterile and nonster- ile hazardous drugs; • Space available for staff to don and doff appropriate pro- tective equipment; and • Separation of clean and dirty areas. Many hospital pharmacies have dis- covered the need to not only meet the requirements of USP 800 but also to go back and meet the needs fromUSP 797, which became enforceable in Septem- ber 2004. USP 797 focused more on the cleanroom design, while USP 800 focus- es on the handling of drugs within that cleanroom.These two general chap- ters are not the only governing bodies when it comes to pharmacy operations and space needs – facilities also must meet the requirements of the state of Colorado and the Facilities Guidelines Institute. There are some major differences between the two general chapters. USP 800 appears to be more stringent and has a wider impact. USP 797 applied only to sterile compounding, while USP 800 applies to both sterile and non- sterile compounding. USP 800 applies from receipt of the hazardous drugs through administration to the patient; USP 797 only dealt with the receipt and compounding of the drug (not through administration). USP 800 clarifies that final HDs, not requiring assembly do not have the same stringent separation guidelines, as long as they are clearly labeled. USP 800 eliminates the low- volume exemption accommodated for in USP 797 and requires environmental and medical surveillance. So, what does this all mean to the pharmacy space within a hospital, medical office building or specialty center? In the last year, our firm has been involved in redesign efforts for four facilities in the state of Colorado that are working to meet the requirements of USP 800 and, in some cases, USP 797.The biggest challenge has proven to be having a separate or temporary space to move the exist- ing pharmacy while modifications are being made.This temporary location is still required to meet USP 797, which includes some of the following: • An area for gowning within the ante room on the dirty side of the “red line;” • Hands-free sink and soap dispens- ing; • Smooth and impervious finishes in the buffer area, including ceilings, walls, floors, fixtures, shelving, counters and cabinets; • Coved junctures at ceilings and walls; • Damage-resistant surfaces; poten- tially a prefab pharmacy box or stain- less-steel countertops; and • Separation of nonsterile and sterile containment primary engineering con- trols. Due to these concerns, some health care facilities may need to determine a space to design and build a new phar- macy to meet USP General Chapter 800 rather than renovate its existing space. Another option would be to consider a temporary trailer immediately adjacent to the hospital or health care facility. The reality is that the most critical piece to meeting the needs of a facility is to understand the process and proce- dures followed by the pharmacists and staff.The overall design of the phar- macy space needs to meet both the state and federal regulations and the functional operations and needs. Not every pharmacy is the same; and there are different solutions for each facility based on the current func- tional operations and space available to the facility. Many pharmacies have one open area for all functions.This solution is no longer acceptable, and separations are required. A wall may need to be built, at a minimum a line of demarcation, aka “red line,” needs Designing for the handling of hazardous drugs Design Mike Hagan, AIA Project architect, TreanorHL Please see Hagan, Page 24 The regulations for hazardous drug compounding areas within a pharmacy are more stringent than those required for sterilization in an operating room.