Controlling Occupational Exposure to Hazardous Drugs and USP 797

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Controlling Occupational Exposure to Hazardous
Drugs and USP 797

• LT Mark Strauss
• Alaska Native Tribal Health Consortium
• December 8, 2005

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What are hazardous drugs?

• A group of drugs that are associated with or
  suspected of causing adverse health effects
  including
• genotoxic effects
• carcinogenic effects
• teratogenic effects or fertility impairment
• cause serious toxicity to specific organs
• Usually used for cancer treatment but also in the
  form of anti-viral agents, investigational drugs,
  or drugs used in non-malignant treatments

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Health Effects

• Acute
• skin rashes
• chromosomal aberrations
• soft tissue damage
• Chronic
• leukemia
• adverse reproductive effects

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Routes of Exposure - Inhalation

• No engineering control (BSC, isolator, glovebox)
• Improper engineering control (LAFW, Class II Type
  A1, A2 BSC, Isolator?)
• Use of auto-counters
• Room ventilation
• (aerosolized drugs)

Photos courtesy of Luci Power Pharmacy,
University of California Medical Center
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Routes of Exposure Dermal Absorption

• Unprotected contact with contaminated surfaces
• Contamination may be found far away from
  preparation and administration areas

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Pictures from Tom Connor, NIOSH and Luci Power,
USC Medical Center
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Routes of Exposure Dermal Absorption

• Unprotected contact with contaminated surfaces
• Contamination may be found far away from
  preparation and administration areas
• Glove permeability
• PPE issues improper PPE PPE not worn or
  donned/doffed incorrectly
• Priming at bedside
• Spills/ leaks

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Routes of Exposure Ingestion and Injection
Photo courtesy of Bob DeChristoforo NIH CRC
Pharmacy
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Components of the Circular

• Background
• Risk of Exposure
• Responsibilities
• Definitions
• Prevention of Employee Exposure
• General Requirements
• Detailed Requirements

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Prevention of Employee Exposure

• General Requirements
• Assess Hazards
• Hazardous Drug Inventory
• Handle Drugs Safely
• Use and Maintain Equipment Properly
• Detailed Requirements

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Personal Protective Equipment
Knit or elastic cuffs
Closed front
Double gloves
Photos courtesy of Luci Power Pharmacy,
University of California Medical Center
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Receiving, Storage, and Transportation

• Ship and store in labeled, leak-proof containers

Photo courtesy of Bob DeChristoforo NIH CRC
Pharmacy
Photo courtesy of Bob DeChristoforo NIH CRC
Pharmacy
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Preparation
Class II Biological Safety Cabinet Appropriate
for HDs (but must be right type).
Class III Glovebox Appropriate for HDs.
Class I Chemical Fume Hood Not appropriate for
HDs.
Photo credits Nuaire Corp www.nuaire.com
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Class II BSCs

• A1 Not appropriate
• A2 OK for limited amounts
• B1 Partially exhausted to outside ? Good
• B2 Total exhaust vented to outside ? Best

BSC exhausted to outside. Photo courtesy of Bob
DeChristoforo NIH CRC Pharmacy
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Isolator

• No design criteria, common def
• May vent to outside or recirculate
• May be pos. or neg. to ambient environment
• No field performance testing

Photo credit Containment Technologies Group, Inc.
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Preparation

• Dont crowd the work area
• Put only the items you need out

Photo courtesy of OSHA http//www.osha.gov/SLTC/e
tools/hospital/lab/lab.html

• Use a chemo mat
• Leave BSC on at all times

Photos courtesy of Luci Power Pharmacy,
University of California Medical Center
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NO NO NO!!!
Photo credit http//dfw-neuronetwork.com/Drug_The
rapy.htm
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Preparation

• Dont rest arms on the edge of the BSC
• Movements in and out should be perpendicular to
  face of BSC (no sweeping)

Photo credit Melissa McDiarmid Univ. of MD
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Preparation

• Count uncoated tablets in the BSC

Photos courtesy of Luci Power Pharmacy,
University of California Medical Center
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Preparation

• Seal products prior to removing from BSC

Photo courtesy of Bob DeChristoforo NIH CRC
Pharmacy

• Clean work surfaces with detergent followed by
  disinfectant

Photo credit SurfaceSafe by SuperGen Corp
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Preparation

• Remove outer gloves in the BSC

Photos courtesy of Luci Power Pharmacy,
University of California Medical Center
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Preparation

• PhaSeal (closed-system device) can reduce
  contamination in the BSC
• Never use in place of a BSC

Photo credit PhaSeal, Carmel Pharma
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Administration

• Use safer devices
• Dont prime at the bedside
• Wear appropriate PPE

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Aerosolized Administration

• 6 ACH (min)
• Neg. pressure room
• N-95 or better respirator

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Housekeeping and Waste Handling

• Specially labeled bags and sharps containers
• Trace incinerate or landfill, RMW?
• Bulk becomes RCRA hazardous waste if listed

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U-Listed Wastes

• chlorambucil
• cyclophosphamide
• daunomycin
• melphalan
• mitomycin
• streptozotocin
• uracil mustard

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Spill Control

• Pharmacists or nurses who prepare/ administer HDs
  should clean up spills

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Maintenance

• NSF-49 certification semi-annually

• Bag-in/bag-out filters recommended

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Medical Surveillance

• Frequency pre-employment, post-employment,
  post-exposure, periodically (lt 2 years)
• Elements
• Detailed work history
• Physical examination
• Laboratory testing
• Special biological testing

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Training

• Risks of handling drugs
• PPE
• Work practices
• Transporting drugs
• Waste disposal

• Management of acute exposures
• Spill Management
• Recordkeeping
• Medical Surveillance

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Circular Exhibits

• A List of Hazardous Drugs
• B Assessment of Hazardous Drug Handling in the
  Workplace
• C Personal Protective Equipment Recommendations
• D Community Health Representative Information
  Sheet
• E Hazardous Drugs and Times for Protective
  Handling of Patient Excreta
• F Medical Surveillance Form Sample

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Assessment of Hazardous Drug Handling in the
Workplace
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http//www.anthc.org/cs/dehe/envhlth/ieh/index.cfm
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• USP 797

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USP General Chapter 797 Pharmaceutical
Compounding Sterile Preparations

• Effective January 2004
• Applies where compounded sterile preparations
  (CSPs) are prepared, stored, or dispensed
• Enforceable by FDA
• Reviewed by JCAHO

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Classifications USP 797

• Classifies operations as
• Low risk
• Medium risk
• High risk
• Most facilities are low or medium risk

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Overview of Requirements

• Clean rooms
• Environmental controls
• CSP environment
• Cleaning/ sanitizing
• Personnel
• Environmental monitoring
• Particulate monitoring
• Microbial monitoring

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CSP EnvironmentLow/ Medium Risk
Buffer Area
Ante Area
Preparation Area
LAFW or BSC
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CSP EnvironmentHigh Risk
Buffer Area
Ante Area
Preparation Area
LAFW or BSC
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Ante Area

• Clean area for donning PPE
• Storage area for syringes, ampuls, bags, fluids,
  transfer tubing
• Hands-free sink for handwashing
• No air quality requirements

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Buffer Area

• Clean area prior to preparation
• Only nonpermeable and nonshedding equipment/
  supplies immediately needed (no cardboard)
• Specific construction rec.
• No sinks, floor drains
• ISO Class 8 (3,520,000 particles/ m3)

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Critical Work Area

• Drugs are exposed to air in the physical
  environment active manipulation
• Inside of BSC or LAFW
• ISO Class 5 (3,520 particles/ m3)

BSC/ LAFW
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CSP and HD Preparation
LAFW
BSC
Buffer Area
Buffer Area
Ante Area
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Cleaning/ Disinfection

• Critical Work Area beginning of each shift
  before compounding
• Buffer Area shelving, carts, surfaces cleaned
  weekly floor mopped daily
• Ante Area shelving, carts, surfaces cleaned
  weekly floor mopped daily (mop from buffer to
  ante area) sanitize supplies with sterile 70
  IPA
• Cleaning tools must be nonshedding and dedicated
  to area

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Personnel

• Prior to entering Buffer Area
• Remove jewelry and all makeup
• Don PPE (hair covers, shoe covers, gowns, gloves,
  mask)

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Environmental Monitoring - Particulates

• Viable and nonviable micro.
• Every 6 mos
• Different from NSF-49
• Buffer (ISO 8) and critical work env. (ISO 5)

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Environmental Monitoring - Microorganisms

• Viable micro
• Monthly
• Determine baseline, track for change
• Expose sterile agar for 3-8 hours ? count CFUs

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Proposed changes to USP 797

• New revisions may come out in April 2006 followed
  by 4 month comment period
• ISO Class ISO 8 ? ISO 7 at 0.5 micrometer
• HEPA Buffer air must be HEPA filtered
  (potentially Class C)
• Measurements must assess as in use
• Airflow ACH specs still undecided

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Proposed changes to USP 797

• Cosmetics Remove if flaking is possible
• Jewelry Remove if it interferes with gloves or
  cuffs
• Sequence of donning
• Shoe covers
• Head/ facial covers
• Face mask (if needed)
• Gown
• Gloves

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Questions?