Sterile Compounding - 04/05 Hazardous Compounding

What is USP 800 basically?

Compounding nonsterile and sterile hazardous preps

Implemented by 12/02/19 and enforced by NJ BOP

Focuses on pt safety, worker safety, environmental protection

What is the difference of USP 800 vs other chapters?

Expands beyond pharmacy activity

• Receipt

• Storage

• Compounding

• Disposal

• Cleaning

• Medical Surveillance

• Dispensing

• Admin

• PPE

What are the hazardous drug classes according to NIOSH?

Group 1: antineoplastics

Group 2: non-antineoplastic drugs that are carcinogenic, reproductive tox, genotox, teratogenic, developmental tox, organ tox at low dose, new drugs that mimic existing hazardous drugs

Group 3: risk to males and females of reproductive age

What are the examples of drugs on NIOSH list?

Hormones: estrogen/progestins, oxytocin, dinoprostone, misoprostol

Immunosuppressants: tacrolimus, mycophenolate, cyclosporine

Psych: carbamazepine

HIV: zidovudine, abacavir

Antiseizure: phenytoin, fosphenytoin, valproic acid, divalproex, carbamazepine

Chemo

Clonazepam, spironolactone, warfarin, fluconazole

What are the options for compliance to USP 800?

Handle all NIOSH hazardous drugs w/ all the containment strategies of USP 800

Perform risk assessment for certain dosage forms that may not pose sig risk of directional occupational exposure

What is required for receiving, unpacking, placing drugs in storage?

No chemo gloves unless spill

Gown only if spill

No eye/face protection

Resp protection if spill

No ventilated engineering control

What is required for admin of hazardous drug in unit-dose package?

Single glove

No gown

No eye/face protection

No resp protection

Not ventilated engineering control

What is required for cutting, crushing, manipulating, handling uncoated hazardous drug?

Double gloves

Protective gown

No eye/face protection

Rep protection if not done in control device

Ventilated engineering control

What is required for administering uncoated hazardous drug?

Single glove

No gown

Need eye/face protection if vomit/spit up potential

No resp protection

Not ventilated engineering control

What are the sources of exposure while handling hazardous meds?

Receipt: residue on containers, floors, surfaces

Dispensing: counting

Compounding and other manipulations

Administering: aerosol formation, priming IV

Pt-care: body fluids or body fluid-contaminated things

Spills

Transport

Waste

How can you get exposed to hazardous drugs?

Inhalation

Accidental inj

Ingestion through contaminated hands

Dermal absorption

What are the symptoms of hazardous drugs?

ST

Chronic cough

Infection

Rash

Dizzy

Eye irritation

HA

Fetal abnormalities

Fetal loss

Fertility impairment of reproductive age

What needs to be done to protect workers from hazardous drugs?

Education about proper handling, storage, transport, disposal

Attestation

Monitoring

What must be done if risk assessment is done for USP 800?

Institution must document alternate containment strategies and work practices being employed for specific dosage form to minimize occupational expsoure

What are the risk assessment criteria of USP 800?

Dosage form

Unit dose available from manufacturing/packaging

Manipulation required by pharmacy

Exposure risk

Type of hazardous drug

Route of admin

PK/PD

Lit review of human toxicity

Manipulation ny nursing

DONE EVERY 12M OR NEW FORMULARY ADDITION OR NEW NIOSH ADDITION

What is the most significant exposure risk during distribution and transport of hazardous medications and what must be done?

Spills from damaged containers

Wear PPE for task + know closest chemo spill kit

What needs to be done when receiving hazardous medications?

Open in negative or neutral pressure area

Visual exam must be 1st step

Recommended to decontaminate outside containers

Hazardous agents have sealed bag IDing it

Quarantine broken vials from stock

What needs to be done when storing hazardous medications?

External ventilation, negative pressure room w/ at least 12 air changes per hour

Dedicated fridge in neg pressure room

CAN USE RISK ASSESSMENT INSTEAD

What needs to be done when repackaging hazardous medications?

Completely decontaminate before re-use for non hazardous drugs by using bleach/deactivating agent then sterile water then sterile 70% IPA

Double gloves and masks when prepackaging

If powder aerosolization risk: work in BSC, CACI in sterile neg pressure room or CVE in non-sterile neg pressure room

Where should non-sterile compounding of hazardous drugs be done?

Ventilated cabinet (BSC) in IV room w/ PPE and double gloved

What are examples of non-sterile compounding of hazardous drugs?

Splitting doses of:

Azathioprine

Carbamazepine

6MP

Methimazole

Misoprostol

Spironolactone

Warfarin

Drawing up PO liquids:

Risperidone

Megestrol

VPA

Phenytoin

What are the characteristics of anteroom, buffer room, and PEC for hazardous drug compounding?

Anteroom

Must be ISO 7 or better if next to negative pressure room

Buffer room

Iso class 7 or better w/ PEC

NEGATIVE PRESSURE (unlike non-hazardous which is positive pressure)

Has 2nd line of demarcation

PEC

Iso class 5: BCSs, compounding aseptic containment isolators (CACIs)

What are the steps of hazardous compounding donning?

Shoe cover

Hair cover, face mask, hair in ante

Handwashing

Gown

Enter hazardous buffer room w/ 2nd line of demarcation

2nd pair of shoe covers

Surgical hand scrub

Gloves (dont have to be sterile)

Chemo gown

Sterile chemo gown

What are the steps of hazardous compounding doffing?

Remove outer gloves and dispose

Remove chemo gown and keep in buffer for reuse

Remove 1 shoe cover while exiting buffer

Remove gloves and wash hands

Remove gown, hair cover, mask

Leave anteroom by removing 1 shoe cover at a time

Discard chemo garb in yellow hazardous waste containers

What are the characteristics of shoe covers for hazardous compounding?

Double to reduce spread

Regular ones allow penetration b/c porous, seams, anti-skid bottoms

Need seamless, waterproof shoe covers (based on Glo Germ testing)

What are the characteristics of gloves for hazardous compounding?

Doubling w/ 1 under chemo gown and 1 over chemo gown when compounding but at least 1 all the time

Need to be ASTM standard D6978 (chemo-tested)

Sterilize w/ sterile alcohol before compounding

Powder-free

How are gloves for hazardous compounding discarded?

Outer glove removed and contained inside BSC

Inner glove worn to affix labels and place meds in transport bags

Discarded/changed w/ each batch, or as needed if torn,punctured, contaminated, exit/re-entry to BSC

What are the characteristics of gowns for hazardous compounding?

Disposable and tested to resist permeability by hazardous meds

Closed in back

Long sleeves

No seams

Closed cuffs that are elastic of knit

Non-absorbent b/c increase exposure risk and contamination

Changed Q2to3h or immediately after spill/splash

What are the eye and face protection for spills and splashes?

Full-face piece respirator

Goggles w/ face shield (has to be both b/c eyeglasses, safety glass, face shield arent enough)

When is resp protection required for hazardous compounding?

Cleaning spills

Cleaning

Airborne exposure

What is the P and U lists basically?

Hazardous wastes according to EPA that meet certain criteria in which they contaminate environmental water

What is the P list of meds and examples?

Acutely hazardous meds

Nicotine gun and patch

Warfarin

Physostigmine

Nitroglycerin

What is the U list of meds and examples?

Toxic (chemotherapy meds)

According to EPA

How are P and U list meds disposed basically?

Different than other meds

Includes wrappers for listed meds

How are hazardous waste disposed of?

Trace-contaminated and <3% ingredient, PPE, supplies used during compounding and admin (besides syringe) into yellow chemo waste receptacles

Sharps in sharps container

If >3%, bulk chemo, hazardous product waste, black chemo waste receptacles

What are the steps of cleaning hazardous areas?

Deactivation (rendering inactive) by bleach, H2O2, Peridox

Decontamination (neutralizing or physically removing hazardous residue from deactivation) by bleach, H2O2, Peridox

Cleaning (removing contaminants mechanically) by sterile water

Disinfection (inhibiting/destroying pathogens) using sterile 70% IPA

USE POUR BOTTLES OR PRE-SATURATED WIPES (NO SPRAY BOTTLES

How are hazardous drug spills managed?

Each facility has policies and procedures to prevent spill and instruction on how to clean them

Also needs to address who is responsible for cleaning, size and scope

ONLY TRAINED WORKERS CAN CLEAN

What are the parts of hazardous drug spill kits?

Supplies to absorb 1000ml

Appropriate PPE and face shield

Absorbent spill pads

Disposable towels

At least 2 sealable hazardous waste bags

1 disposable scoop for glass fragment collection

1 puncture resistant containers for glass frags

What are the steps of hazardous drug spill management?

Assess size and scope (if >2 spill kits, need outside assistance)

Post sign to limit access

Obtain spill kit and don PPE

Contain spill by absorbing liquid w/ pads and powders w/ towels

Clean from lesser to greater contaminated

Rinse w/ water then bleach then alc several times

Seal bags and dispose of into container

Carefully remove PPE (start w/ outer gloves) and place into disposal bag and into container

Remove inner gloves and place into disposal bag then container

Wash hands w/ soap + water

Re-clean area by housekeeping services