chapters and to allow institutions more time to make the necessary facility and administrative changes. The risk of working with hazardous drugs was first addressed over 35 years ago in ASHP’s 1983 publication Recommendations for handling cytotoxic drugs in hospitals.11 In 2004, the National Institute of Occupational Safety and Health (NIOSH) published an alert with examples of FDA-approved drugs that are deemed hazardous to workers and also contained general policies on handling hazardous drugs.12 The risks of occupational exposure to hazardous drugs have been well documented and include reproductive toxicity and DNA damage.13-16 Despite the evidence of potential harm caused by exposure to hazardous drugs, there have been no enforceable standards on handling hazardous drugs until Chapter <800>. Implementation The facility requirements, engineering controls, and administrative controls required in Chapters <797> and <800> can represent substantial direct and indirect costs to hospital pharmacy budgets. While the standards are intended to improve the quality and safety of compounded products, the direct cost of compliance will likely include facility construction, capital equipment, and disposables (e.g. garb/ personal protective equipment, closedsystem transfer devices). The required external exhaust capabilities may pose additional challenges to Chapter <800> compliance. Successful approaches to compliance with Chapters <797> and <800> have included performing a gap analysis, forming an interprofessional collaborative of stakeholders, establishing timelines and milestones, and building in contingency plans. Because the scope of USP <800> extends well beyond pharmacy, the interprofessional team should include leadership representatives from nursing, environmental services, epidemiology, and quality. When construction is necessary, pharmacy leadership should also be involved with the selection of an architect and contractor to ensure they have the proper expertise to design and build to correct specifications.17,18 While Chapters <797> and <800> set www.pswi.org a high minimum standard to meet, the cost of noncompliance may be greater.19 The Pew Charitable Trusts tracked 1,416 compounding-related adverse events, including 115 deaths, between 2001 and 2017. The most common cause of compounding errors was contamination, highlighting the need for the quality controls established in regulations and standards.20 Future Advancements Changes to Federal law, FDA rules, and the evolution of USP compounding chapters have made sterile compounding a complex field requiring expertise in both practical and regulatory knowledge. In February of 2018, the Board of Pharmacy Specialties recognized sterile-product compounding as a specialty and will begin offering certification in the fall of 2019.21 Pharmacists will have the opportunity to develop and demonstrate expertise in the standards and best practices associated with sterile compounding to ensure the field continues to advance in the future. Michael Gaino is the Director of Pharmacy Practice and Quality at ASHP. References 1. United States Pharmacopeia and National Formulary (USP 27-NF22). Chapter <797> “Pharmaceutical Compounding–Sterile Preparations.” Rockville, MD: United States Pharmacopeial Convention; 2004. 2. U.S. Food and Drug Administration. Milestones in U.S. food and drug law history. https:// www.fda.gov/AboutFDA/History/FOrgsHistory/ EvolvingPowers/ucm2007256.htm. Published February 1 2018. Accessed March 31, 2019. 3. Newton DW, Trissel LA. A primer on USP Chapter <797> pharmaceutical compounding— sterile preparations and usp process for drug practice standards. National Home Infusion Association. http://www.nhia.org/members/documents/ usp_797_primer.pdf. Accessed March 31, 2019. 4. U.S. Food and Drug Administration. compounding laws and policies. https://www.fda.gov/ Drugs/GuidanceComplianceRegulatoryInformation/ PharmacyCompounding/ucm606881.htm. Published July 23, 2018. Accessed March 31, 2019. 5. Pedersen CA, Schneider PJ, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: dispensing and administration—2002. Am J Health Syst Pharm. 2003;60(1):52-68. 6. Pedersen CA, Schneider PJ, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: dispensing and administration—2017. Am J Health Syst Pharm. 2018;75(16):1203-1226. 7. Reece KM, Lozano MA, Roux R, Spivey SM. Implementation and evaluation of a gravimetric i.v. workflow software system in an oncology ambulatory care pharmacy. Am J Health Syst Pharm. 2016;73(3):165-173. 8. Roberts PA, Willoughby IR, Barnes N, et al. Evaluation of a gravimetric-based technology-assisted workflow system on hazardous sterile product preparation. Am J Health Syst Pharm. 2018;75(17):1286-1292. 9. Moniz TT, Chu S, Tom C, et al. Sterile product compounding using an i.v. compounding workflow management system in a pediatric hospital. Am J Health Syst Pharm. 2014;71(15):1311-1317. 10. United States Pharmacopeia. General Chapter <797> pharmaceutical compounding—sterile preparations. http://www.usp.org/compounding/ general-chapter-797. Accessed March 31, 2019. 11. Stolar MH, Power LA, Viele CS. Recommendations for handling cytotoxic drugs in hospitals. Am J Health Syst Pharm. 1983;40(7):1163–71. 12. Centers for Disease Control and Prevention. NIOSH alert: preventing occupational exposures to antineoplastic and other hazardous drugs in health care settings. DHHS (NIOSH) 2004-165. 13. McDiarmid M, Egan T. Acute occupational exposure to antineoplastic agents. J Occup Med. 1988;30(12):984-987. 14. Valanis B, Vollmer WM, Steele P. Occupational exposure to antineoplastic agents: self-reported miscarriages and stillbirths among nurses and pharmacists. J Occup Environ Med. 1999;41(8):632-638. 15. Dranitsaris G, Johnston M, Poirier S, et al. Are health care providers who work with cancer drugs at an increased risk for toxic events? A systematic review and meta-analysis of the literature. J Oncol Pharm Pract. 2005;11(2):69-78. 16. Suspiro A, Prista J. Biomarkers of occupational exposure to anticancer agents: a minireview. Toxicol Lett. 2011;207(1):42-52. 17. Mekoba BC, Turingan EM, Roberts PA, et al. A pharmacy-led United States Pharmacopeia (USP) chapter 800 compliance collaborative at an academic medical center. Am J Health Sys Pharm. 2018;75(15):627–632. 18. Gilbreath J. Lessons learned in complying with <797> and <800>. Pharmacy Purchasing & Products. 2019;16(2):8. 19. Kastango E. The bottom line on USP compliance: what is your risk? Beckers Hospital Review. https://www.beckershospitalreview.com/ human-capital-and-risk/the-bottom-line-on-uspcompliance-what-is-your-risk.html. Published August 31, 2017. Accessed April 1, 2019. 20. The Pew Charitable Trusts. U.S. illnesses and deaths associated with compounded or repackaged medications, 2001-2017. http://www.pewtrusts.org/-/ media/assets/2018/03/dsp_us_illnesses_and_deaths_ associated_with_compounded_medications_or_ repackaged_medications. .pdf?la=fr&hash=BBD2D35 01C774B10034493F83C40E8C27CE859E3. Published March 2018. Accessed April 1, 2019. 21. Board of Pharmacy Specialties. Compounded sterile preparations in pharmacy. https://www. bpsweb.org/bps-specialties/compounded-sterilepreparations-pharmacy/. Accessed April 1, 2019. July/August 2019 The Journal 29

The Journal July/August 2019