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USP 800 and Hazardous Medications
Trung H. Nguyen, PharmD and Alesha Davis, CPhT
Dayton VA Medical Center
Trung.Nguyen610@va.gov
Alesha.Davis@va.gov
The speaker has no actual or potential conflict of interest in relation to this presentation
VETERANS HEALTH ADMINISTRATION
Objectives
• Discuss the differences between USP 797 and 800
• Discuss safety measures and handling of the various
categories of hazardous medications
• Explain differences amongst hazardous medications
VETERANS HEALTH ADMINISTRATION
Background
VETERANS HEALTH ADMINISTRATION
New England Compounding Center
New England Compound Center, Strickler, 2012
VETERANS HEALTH ADMINISTRATION
United States Pharmacopeia (USP)
• USP is not an enforcement agency
• State board of pharmacy usually regulate the compounding practices within
their jurisdiction
• FDA has oversight over compounding and may legally enforce USP’s
compounding standards
• The Joint Commission on Accreditation Of Healthcare Organizations has
standards that are congruent with <797> principles
• Anticipate Joint Commission to take a similar approach to USP<800>.
VETERANS HEALTH ADMINISTRATION
What is USP 797 vs USP 800
• Responsibilities of compound personnel
• Personnel training and facilities
• Storage and testing of finished preparations
USP 797
• Safe handling of hazardous drugs
• Minimize risks of exposure
• Protect healthcare personnel and environment
USP 800
Compounding Standards, usp.org
VETERANS HEALTH ADMINISTRATION
Sterile Compounding Preparations
Aqueous bronchial and
nasal inhalations
Bath and soaks for live organs and
tissues
Injections
Irrigations for wounds and body cavities
Ophthalmic drops and ointments
Dialysis fluids
All have restrictions for sterility
USP 797, Chapter 35 Pharmaceutical Compounding, 2012
VETERANS HEALTH ADMINISTRATION
Standard Operating Procedures
Prior to entering the sterile compounding room:
– Personnel must comply with cleaning and garbing procedures
– All containers must be clean with 70% isopropyl alcohol
– Compounding supplies must be placed within the hold to minimize
air flow turbulence
– Discard all syringes and needles in proper sharps container
– Label all compounded products properly
USP 797, Chapter 35 Pharmaceutical Compounding, 2012
VETERANS HEALTH ADMINISTRATION
USP 797 versus USP 800
VETERANS HEALTH ADMINISTRATION
Highlights from USP 800
Internal lists
Facilities
Personal protective equipment
Environmental quality and
control
Responsibilities of personnel
VETERANS HEALTH ADMINISTRATION
Storage and Unpacking of Hazardous Drugs
New in USP 800:
– HDs MUST be unpacked in negative pressure with at least 12 air
changes per hour
– HDs MUST be stored separately
USP 797 SHOULD but USP 800 MUST
– Negative pressure
– Externally vented
Sahadeo et al, Journal of Hospital Pharm, 2015
VETERANS HEALTH ADMINISTRATION
Compounding of Hazardous Drugs
Nonsterile HDs:
– Containment primary engineering control (C-PEC or the hood) SHOULD be externally
vented
Sterile HDs:
– C-PEC MUST provide a Class 5 or superior air quality and MUST be externally
vented
– SHOULD not used laminar airflow workbench (LAFW) or compounding aseptic
isolator (CAI)
Requires C-PEC containment secondary engineering control ISO Class 7
Sahadeo et al, Journal of Hospital Pharm, 2015
VETERANS HEALTH ADMINISTRATION
Closed-System Transfer Device (CSTD)
USP 800:
– Protect health care workers from
occupational exposure to HDs
– Not require by pharmacy during
preparation
BUT
– Requires nurses when administering HDs
to patients
New England Compound Center, Strickler, 2012
VETERANS HEALTH ADMINISTRATION
Medical Surveillances
USP 800:
– Mandates tracking of personnel via assessments and documentation
• Symptom complaints
• Physical findings
• Laboratory values
– Health trends among exposed personnel vs unexposed personnel
– Program MUST include:
• Identifying potential exposed workers
• Confidentiality and maintenance of health records
• Follow-up plans
Sahadeo et al, Journal of Hospital Pharm, 2015
VETERANS HEALTH ADMINISTRATION
Hazardous Drugs
VETERANS HEALTH ADMINISTRATION
Hazardous Drug Exposure
“About 8 million U.S. healthcare workers are
potentially exposed to hazardous drugs.
Exposures to hazardous drugs can cause both
acute and chronic health effects.” – NIOSH.org
VETERANS HEALTH ADMINISTRATION
Who is at Risk of Exposure?
Pharmacists
Pharmacy Technicians
Nurses
Physicians
Environmental Services
Patient Family Members
Laboratory Staffs
Other Hospital Staffs
Center for Disease Control and Prevention, Hazardous Drug Exposures in Health Care 2018, www.cd.gov
VETERANS HEALTH ADMINISTRATION
Definition of Hazardous Drugs (HDs)
American Society of Health System
Pharmacists (ASHP) – 1990
National Institute of Occupational
Safety and Health (NIOSH) - 2016
Genotoxicity Genotoxicity
Carcinogenicity Carcinogenicity
Teratogenicity or fertility impairmentTeratogenicity/Developmental
toxicity
Serious organ toxicity at low dose Reproductive toxicity
Organ toxicity at low dose
Structure/toxicity profiles of new
drugs that mimic existing HDs
US Department of Labor, 2016
VETERANS HEALTH ADMINISTRATION
Potential Routes of Exposures
– Inhalation
– Dermal absorption
– Ingestion
– Injection
VETERANS HEALTH ADMINISTRATION
Wick et al
Objective• Assess surface contamination
• Personnel exposure to antineoplastic agents (i.e. Cyclophosphamide and Ifosfamide)
Participants
• Pharmacists
• Pharmacy technicians
• Nurses
Method• 24-hour urine collection
• Wipe samples collected from four areas of the infusion center and pharmacy
Results
• Cyclophosphamide (+):
• 18/48 urine sample
• 17/17 wipe sample
• Ifosfamide (+):
• 10/48 urine sample
• 11/17 wipe sample
VETERANS HEALTH ADMINISTRATION
Differences Amongst Hazardous
Drug Groups
VETERANS HEALTH ADMINISTRATION
Hazardous Drugs Group 1:
Antineoplastics
Group 1 meets one or more of the NIOSH criteria for a hazardous drug:
– Majorities are hazardous to males or females who are:
• Actively trying to conceive
• Women who are pregnant or may become pregnant
• Women who are breastfeeding
Represent an occupational hazard
Should always be handled with care
– Recommended engineering controls
– Personal protective equipment (PPE) regards of dosage form:
• IV (intravenous)
• SC (subcutaneous)
• Topical
• Tablet or capsule
VETERANS HEALTH ADMINISTRATION
Hazardous Drugs Group 1:
Antineoplastics
Common Group 1 Drugs:
– Hydroxyurea
– Tamoxifen
– Carboplatin
– Flutamide
VETERANS HEALTH ADMINISTRATION
Hazardous Drugs Group 2:
Non-Antineoplastic
Drugs in Table 2 meet one or more of the NIOSH criteria for a hazardous drug:
– May represent an occupational hazard:
• Males or females who are actively trying to conceive
• Women who are pregnant or may become pregnant
• Women who are breastfeeding, because they may be present in breast milk.
– Unopened, intact tablets and capsules may not pose the same degree of
occupational exposure risk as injectable drugs, which usually require extensive
preparation.
– Cutting, crushing, or otherwise manipulating tablets and capsules will increase the
risk of exposure to workers.
VETERANS HEALTH ADMINISTRATION
Hazardous Drugs Group 2
Common Group 2 Drugs:
– Risperidone
– Phenytoin
– Divalproex
– Abacavir
VETERANS HEALTH ADMINISTRATION
Hazardous Drugs Group 3:
Non-Antineoplastic
Drugs in Table 3 primarily meet the NIOSH criteria for reproductive hazards:
• Represent a potential occupational hazard:
– Males or females who are actively trying to conceive
– Women who are pregnant or may become pregnant
– Women who are breastfeeding, as they may be present in breast milk
• Unopened, intact tablets and capsules may not pose the same degree of
occupational risk as injectable drugs that usually require extensive preparation
• Cutting, crushing, or otherwise manipulating tablets and capsules will increase
the risk of exposure to workers.
VETERANS HEALTH ADMINISTRATION
References
• Strickler, L. (2012, October 16). Inside the New England Compounding Center. Retrieved March 30, 2018, from
https://www.cbsnews.com/news/inside-the-new-england-compounding-center
• “General Chapter Pharmaceutical Compounding – Sterile Preparations.” USP,
www.usp.org/compounding/general-chapter-797.
• “United States Department of Labor.” Occupational Safety and Health Administration,
www.osha.gov/SLTC/hazardousdrugs/controlling_occex_hazardousdrugs.html.
• United States Pharmacopeia <797> Pharmaceutical Compounding Sterile. (2012). Physical Tests. Retrieved from
www.forums.pharmacyonesource.com
• Sahadeo, P., & Weber, R. J. (2015). USP <800>: Key Considerations and Changes for Health Systems. Hospital
Pharmacy, 50(10), 941–949. http://doi.org/10.1310/hpj5010-941
• Wick,C., Slawson, M.H., Jorgenson, J.A., Tyler, L.S., Using a closed-system protective device to reduce
personnel exposure to antineoplastic agents, Am. J. Health Syst. Pharm. 60/22 (2003) 2314–2320.
• The National Institute for Occupational Safety and Health (NIOSH). (2018, February 15). Retrieved April 01, 2018,
from https://www.cdc.gov/niosh/topics/hazdrug/default.html
USP 800 and Hazardous Medications
Trung H. Nguyen, PharmD and Alesha Davis, CPhT
Dayton VA Medical Center
Trung.Nguyen610@va.gov
Alesha.Davis@va.gov
The speaker has no actual or potential conflict of interest in relation to this presentation
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