USP 800: Handling Hazardous Drugs in Healthcare Settings

54 Pages·2016·2.18 MB·English

Welcome!
2016 Annual Meeting and Trade Show
“Advancing as Providers | Reimaging the Present”
Wichita Marriott Hotel
Wichita, Kansas
USP 800: Handling Hazardous
Drugs in Healthcare Settings
September 24, 2016
Alison Smith, PharmD
Pharmacy Operations Manager
The University of Kansas Cancer Center
Disclosures
• I have no disclosures
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Program Summary
• The U.S. Pharmacopeial Convention (USP) Chapter 800 “Hazardous
Drugs – Handling in Healthcare Settings” was published in February
2016 and will become effective July 1, 2018
• USP Chapter 800 describes practice and quality standards for handling
hazardous drugs in healthcare settings and is intended to promote
patient safety, worker safety and environmental protection
• The chapter applies to all healthcare personnel and locations that
handle Hazardous drug preparations
• This presentation will focus on identifying Hazardous Drugs in your
practice setting and reviewing the facilities, systems, and policies and
procedures necessary for the safe handling of Hazardous Drugs
according to USP 800
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Learning Objectives
1. Review the history of hazardous drug guidelines,
recommendations and best practices
2. Define “Hazardous Drug”
3. Describe a process for creating a Hazardous Drugs list for your
Pharmacy
4. Review the facility requirements of USP 800
5. Review the workflow, procedural and personnel requirements of
USP 800
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Pre-Test
1. USP 800 applies to
A. Sterile compounders
B. Non-sterile compounders
C. Pharmacies
D. Doctors offices that handle hazardous drugs
E. All of the above
2. My pharmacy compounds hormone cream using estrogen and progesterone powders.
According to USP 800 I should compound these creams
1. On my countertop
2. In a separate area
3. Within a containment device, in a separate room with negative pressure and 12
air exchanges per hour
4. Within a containment device, in an ISO Class 7 negative pressure clean room
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Pre-Test
3. My specialty pharmacy dispenses a lot of oral chemotherapy agents on the NIOSH list.
However, our policy is that we only dispense full vials of oral chemotherapy agents
and we do not repackage them. I am compliant with USP 800
A. Yes
B. Yes if I do a risk assessment on each oral chemotherapy agent
C. No
4. Select all true statements about unpacking hazardous drug orders according to USP
800
A. PPE must be worn when unpacking hazardous drugs only if the HDs are not
packaged in plastic by the wholesaler
B. Hazardous drugs can be unpacked in the general pharmacy area
C. My entity should write an SOP about what PPE to wear when unpacking
hazardous drugs
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Pre-Test
5. My pharmacy purchases several HD active pharmaceutical ingredients and also does
compounding of intravenous chemotherapy. We should store these items
A. With the rest of our inventory
B. Separate from the rest of our inventory
C. Separate from the rest of our inventory, in an externally vented negative pressure
room that contains a designated refrigerator for hazardous drugs if necessary
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History of Hazardous Drug
Guidelines / Recommendations
National Institutes of AmericanSociety of Occupational National Institute of United States
Health (NIH) Health System Safety and Health Occupational Safety and Pharmacopeia
Pharmacists (ASHP) Administration Health (NIOSH) (USP)
(OSHA)
1980s Recommendationsfor the Technical assistance Guidelinesfor
safe handling of injectable bulletin(TAB) published Cytotoxic
antineoplastic drug on handling cytotoxic (Antineoplastic)
products (1981) drugs in hospitals (1985) Drugs (1986)
Recommendationsfor the
Safe Handling of
Parenteral Antineoplastic
Drugs (1983)
1990s Recommendationsfor the Defined “Hazardous Controlling
Safe Handling of Drug” for the first time Occupational
Parenteral Antineoplastic (1990) Exposure to
Drugs Updated (1999) Hazardous Drugs
Requirements
(1995)
2000s ASHP guidelineson Alert: Preventing USP797
handlinghazardous drugs Occupational Exposures published (2004)
(2006) to Antineoplastic and USP 797 updated
Other Hazardous Drugs (2008)
in Health Care Settings
Recommendations & Guidelines
(2004)
2010s NIOSH listupdates 2010, USP 800
2012, 2014, 2016 published (2016)
pending USP 800 effective
(2018)
1981
Zimmerman, P.F., et al. Am. J. Hosp. Pharm. 1981. 38:1693-5.
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