1. Hazardous Drug Handling
Environmental Management Services
<USP 800>
Malarie Clark, RN
VA Maine Healthcare System

2. What, Who and Why? WHAT: USP 800 WHO: NIOSH WHY: FOR YOU USP 800:
“United States Pharmacopeia General Chapter 800”
Describes requirements and responsibilities of personnel handling hazardous drugs (HDs)
Standards are enforceable by federal and state regulation and apply to all healthcare personnel who receive, prepare, administer, transport or otherwise come in contact with HDs
NIOSH:
“National Institute for Occupational Safety and Health”
The governing organization that determines if a drug is hazardous
FOR YOU:
These regulations and standards are to protect YOU, the healthcare worker

3. How can YOU be exposed to HDs?
Exposure from dust, powder or any type of aerosol that is created
INHALATION
HD contact followed by eating, drinking, smoking or applying cosmetics
INGESTION
Injection (accidental finger sticks)
General touch/contact (including soiled linen or PPE)
Body fluids (some HDs can be excreted in urine, feces, emesis, tears, sweat, etc.)
OTHER EXPOSURE

4. How do YOU protect YOURSELF?
#1: IDENTIFICATION OF RISK
Recognize YELLOW chemotherapy containers (HD waste, whether “chemo” or not, will be placed into these buckets)
#2: IDENTIFICATION OF PERSONAL PROTECTIVE EQUIPMENT (PPE) NEEDED
A PPE table has been created that states what type of PPE is required
This table will be colored in YELLOW and will be highly visible in various areas, including disposal areas

5. STEP #1: IDENTIFICATION OF HAZARDOUS DRUGS
Nursing staff will know that a drug is hazardous if there is a YELLOW sticker on it, such as the ones below.
Antineoplastic Drugs (Chemotherapy)
Non-Antineoplastic Drugs & Drugs with Reproductive Consequences
This sticker is an indication for the nurse to STOP and review the PPE Chart!

6. STEP #2: IDENTIFICATION OF PPE
“Personal Protective Equipment and Engineering Controls for Working with Hazardous Drugs in Healthcare”
Formulation
Activity
Gloves
Gown
Eye/face Protection
Repiratory Protection
Ventilated Engineering Control
Intact tablet or capsule
Administration
Chemo Glove
No, unless potential for spit up/vomit No
N/A
Liquid, Crush, Cut or Open (when no other alternatives)
Chemo Glove & Regular Glove
Nonpermeable
No, unless Feeding Tube or potential for spit up/vomit
No, unless crush/cut/open,2, 7
Topical, Intravaginal
No, unless liquid that may splash
No, unless inhalation potential
SubQ/IM/IV injection from a Vial, Kit or Bag for Tables 2-36
Preparation/ Mixing/ Spiking
Double (Nonpermeable & Regular)
Yes, unless BSC I3 or PAPR used
Yes (PAPR), unless BSC I used
Yes (BSC I), unless PAPR used
SubQ/IM/IV/ Irrigation
Administration (Start to Finish)
Yes
Contaminated Waste *CHEMO PRECAUTIONS CONTINUED PER PROTOCOL*
Disposal
Chemo Glove & Regular Gloves
No, unless deemed appropriate
1 This guidance applies to the drugs in Tables 1–3
2 Avoid unless no other alternatives
3 BSC I = Class I biological safety cabinet, Non-Sterile Hazardous
4 BSC II = Class II biological safety cabinet, Sterile Hazardous Compounding (negative pressure)
5 Trastuzumab= BSC II (Chemo RM) w/Table 1 Medication. Fosphenytoin,Phenytoin,Fluconazole,GanciclovirValproic Acid,Voriconazole,Zoledronic Acid= BSC II (Clean RM)
6 Eligard due to stability. Spiking as part of administration for Fosphenytoin, Phenytoin, Fluconazole, Ganciclovir, Valproic Acid, Voriconazole, Zoledronic Acid
7 Plastic Pouch, PAPR or BSC I
These guidelines will be visible in various locations!

7. PPE: Do we really need it?
Hazardous Drug Exposure in Healthcare- CDC
Acute effects of occupational exposure
20+ studies showing: Nausea, rashes, hair loss, liver and kidney damage, hearing loss, cardiac and hematopoietic toxicities and others
Chronic effects of occupational exposure
7+ studies have examined chronic health effects related to occupational exposure to antineoplastic agents. However, chronic effects in patients treated with these agents are well documented. Chronic effects may be seen in the observation of cancer in health care workers handling it.
Fertility and Reproductive effects of occupational exposure
30+ studies showing effects on fertility and reproductive health
Chemo Is “Invisible Threat” to Cancer Clinic Staff- Medscape 3/26/2019
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8. POWERED AIR-PURIFYING RESPIRATOR (PAPR): What is it?
A wearable hood with filter and fan unit that provides a constant supply of filtered, positive-pressure air
Battery operated
Provides a higher level of protection than other types of disposal respirators (n95 masks are not sufficient enough for HD exposure)
Uses reusable, single-use and single-user elements
Training is required (provided by safety department)
Review PPE chart for guidance as to when PAPR use is required

9. BIOLOGICAL SAFETY CABINET: What is it?
An enclosure where hazardous medication can be handled safely
Review PPE chart for guidance as to when BSC use is required
A BSC may not be located on every ward/unit/clinic. Locations that a BSC will be located on include:
4N- Oncology and Infusion
Inpatient Pharmacy
Urology
BSCs could be on wheels or set on a countertop.

10. PPE Storage: HD Storage:
PPE may be stored in various locations depending on area. Standardization and accessibility is the goal.
Hazardous drugs will be stored in limited access areas of medication rooms to limit risk of exposure.
Example: PPE wall mount caddy for medication rooms
Example: Inpatient pharmacy HD storage areas

11. WASTE: Is it considered hazardous?
YES, Any contaminated PPE is considered hazardous waste and needs to be disposed of in an appropriate waste receptacle.
ANSWER: YELLOW BIN
HOMEWORK: Which type of receptacle would be practical and fit logistically in your area?

12. WASTE: What about medications?
YES, any contaminated medication preparation/administration accessories are considered hazardous and needs to be disposed of in an appropriate waste receptacle.
ANSWER: YELLOW BIN

13. HD Waste Process TRACE WASTE
TRACE WASTE
DRUG NOT USED/SOME DRUG REMAINS/EXPIRED DRUG
CONTAMINATED PPE/ PACKAGING
TABLES 1-3 HAZARDOUS DRUGS
Yellow Waste Receptacle
*** TABLES 1-3 CONTROLLED SUBSTANCES
Rx Destroyer
*** TABLES 1-3 CONTAMINATED SHARPS
Sharps Container
*** EPA-RCRA Hazardous Waste
Hazardous Waste Receptacle (BLACK Box)
***EPA-RCRA Hazardous Drug List Posted in Med Rooms***

14. Spill kits will be accessible for all locations. These kits include:
Hazardous Drug Spills
ALL Nurses and EMS Staff will be competent at handling a HD spill.
Spill kits will be accessible for all locations. These kits include:
PPE (gown, gloves x2, shoe covers, mask, goggles [will need to get PAPR])
Caution signs
Scoop and brush
“1-2-3” Wipes (on order currently)
Absorbent towels and spill control pillows
Waste bags and labels
Exposure report form
NOTE: For regular everyday deactivating and cleaning of HD contamination, “Oxivir” 0.5% hydrogen peroxide wipes or equivalent must be used.

15. Occupational Health & Medical Surveillance
WHAT:
WHO:
WHY:
Medical Surveillance:
An assessment of employees exposed or potentially exposed to occupational hazards (such as hazardous drugs)
Occupational Health Team:
Any employee who has the potential to handle hazardous drugs must complete a medical surveillance questionnaire annually, coordinated by the VA Maine occupational health team
Answering surveillance questions is optional however acknowledgement of risk of exposure is mandatory
FOR YOU:
Surveillance monitors individuals for adverse health effects
Findings assist in determining effectiveness of exposure prevention strategies

16. Frequently Asked Questions
Who is on the USP 800 Implementation Team?
Quality Management, Pharmacy, Nursing, EMS, Safety, Infection Control, Occupational Health, and various subject matter experts
What is the process if you don’t want to handle HDs without proper PPE in place?
The first action would be to talk to a direct supervisor. There may be opportunity for accommodations to be made, such as changing assignment or requesting another staff member to handle HD waste. If concerns are not resolved, staff should speak to occupational health.
What if you don’t want to wear PPE to handle HDs?
USP 800 is concerned with protecting the healthcare worker. We must create an environment where we can politely and respectfully remind each other about the PPE required to handle HDs. Also remember that the “chain of exposure” doesn’t stop at the nurse who is handling the drug. All pieces of the “chain” can be exposed, including other nurses or NAs, pharmacy and EMS (for example).
What if we don’t have PPE yet?
A majority of the PPE that is needed is either on order or about to be ordered (June 2019). Until all PPE can be in place all PPE that can be used, should be used. Examples include using chemo gloves and gowns and eye/face masks starting NOW. Logistics and EMS have been involved with the supply chain and are ready to increase supply as needed.

17. REFERENCES Content Contributors: Content References:
James P. Morgan, PharmD (VA Maine Healthcare System)
Daniel Heser, PharmD (Sheridan VA Medical Center)
Content References:
VHA Directive Management and Monitoring of Pharmaceutical Compounded Sterile Preparations
Picture References: