Hazardous Storing

USP 800 definition, and 3 focuses? (prots?)

non sterile and sterile HAZARDOUS preparations (797 is sterile, 5 non sterile)

Focus on patient safety, worker safety, and enviromental protection

Usp 797 for hazardous compounding aseptic technique

9 Things USP 800 covers

Receipt

Disposal

Dispensing

Storage

cleaning

Administration

Compounding

Medical surveillance

PPE

Points of exposure? How? Symptoms and other issues? how protect?

Multiple points of potential exposure no matter where

Can occur thorugh inhalation, accidental injection, ingestion, dermal absorption

Can have sore throat, CHRONIC cough, infection, rash, dizziness, eye, headache, etc.

Can have reproductive risks

Gotta educate, attest and monitor

Hazardous drug definition

Identified in package insert to have manufacturer speical handling info/MSHI to handle meds

Or identified as carcinogenic, developmental, reproductive, genetoxic, or other toxicities

Group 1 Description

MSHI or meet one+criteria of:

Classified by national tox program as human carcinogen

Classified by internationl agency for research on cancer as Group 1 (carcinogenic)or Group 2A (probably carcinogenic)

More dangerous

Group 2 description

Does nto have MSHi

Not classified as NTP

Not classified as IARC as 1 or 2A

NIOSH list descriptio nand two options for compliance?

Med list expand beyond traditional chemotherapy, shows what need to handle and stuff

For compliance:

All hazardous drugs on NIOSH must be handled following USP 800

Assessment or risk can be performed for dosage form that may not have risk of occupational exposure

Risk assessment approach?

Must document containment strategies, and CAN'T DO RISK ASSESSMENT FOR ANTINEOOPLASTIC MEDS

Gotta have dosage form, exposure risk, PK/PD, unit dose available, type of hazardous drugs, lit review, manipulation by pharmacy, route of admin and nursing manipulation

Highest place of risk and stuff imp how?

All staff handling gotta be trained, and being exposure control ASAP

Risk highest during distribution and transport from spills cause of damage, so:

Gotta make sure staff is wearing PPE and know where containment kit is

how receive hazardous materials (4 things) (pressure? what first? where x2)

Must be done in NEGATIVE OR NEUTRAL PRESSURE AREA

Visual examination always first

Med be in a sealed bag with a tag on it

Broken vials must be quarintined

how store haz drug (4 things) (pressure x2, position, what thing need/)

Externally ventilated negative pressure

prevent contamination through positioning

Dedicated refrig in negative pressure

risk assessment

Repackaging how? (how treat trays, what needed to wear, and where be if have powder risk?)

Caution when repackage, if used equipment to count GOTTA COMPLETELY DECONTAMINATE (bleach=>sterile water=> sterile alcohol) b4 reuse (use designated trays if possible)

Double gloves and mask needed (pre pakcaged hazardous meds preferred unless otherwise)

If have powder residue risk, gotta be in a negative pressure place

Non sterile compounding for haz drugs

Split or crush doses or drawing up loral liquids

Must be done in negative pressure with ventilated cabinet with double gloving with chemo gloves

Hazardous compounding clean room lay out

Gotta have a hazardous buffer room, then ante room, and buffer room behind pharmacy

basically hazardous stuff as far away from pharmacy as possible

haz garbing diff how?

Head cover, face mask, beard cover, clean glasses same

BUT DON 2 SHOE COVERS (not 1), and then step over LOD

Hand and nail for 30 seconds same

Don back closing HD gown over non HD gown (diff)

Enter hazardous buffer room

Put on alcohol based hand rub

2 pairs of sterile gloves sandwiched between cuffs(DIFF)

haz compounding doffing

remove outer gloves WHILE IN HOOD AND LEAVE THEM IN HOOD

Remove chemo gown

remove outer shoe cover one at a time (only first layer) and pass LOD

remove INNER gloves

Exit buffer room

Remove non hazardous gown

Perform handwashing

Remove hair cover and face mask

remove ONE SHOE COVER AT a time and then pass second LOD

ALL Chemo garb into yellow waste containers

Shoe cover diff why?

Need double shoe cover to stop spread of contamination, also why have two LOD

Have Glo germ testing, and regular shoe covers are porous, have seams and anti skid bottoms that can cause contamination

Seamless wtaer proof shoe covers are best

Why gloves diff?

Double glvoed when handling drug in any capacity not just compounding, outer glove gotta be sterile

Gloves gotta be chemotherapy tested by ASTM

Powder free gloves preferred, have one pair under gown cuff and second pair over (sandwich)

B4 compound sterilize outside of gloves, and after remove outer glove INSIDE BSC, inner gloves to affix labels and place meds in bag for transport

Gloves gotta change with each batch prep

Gown diff how?

Gotta be disposable and tested to resist hazardous meds

Must close in black, have long sleeves and no seams (absorbent material bad), if have no permeation info then change every 2-3 hours or immediately after spill

WHen handlng, gowns must be designated to area to stop spread

Eye and face protection 4 things, and resp protection when?

Full face piece respirator, goggles with face shield, eye glasses or safety glass NOT ENOUGH, face shields alone not enough either

Respiration protection when cleaning up spills, cleaning, or airborn exposure

5 requirements needed for place where compound haz drug/ 2 things for when to compound WHAT PRESSURE

External ventilated cabinet/chemotherapy hood

negative pressure (-0.01-0.03)

PPE double glove

IV medication compounding

Oral med manipulation: split tablets, draw up liquids, crush meds

Sterile compounding diff for haz drug how? (Negative pressure...? Use what instead)

Negative pressure before, but honestly not good, a little risky

Now use CLosed system transfer device, best practice

4 Steps to cleaning hazardous areas, and one thing absolutely do not use?

1: Deactivation using bleach, H2O2 or peridox

2: decontaminate using bleach, H2O2, peridox (remvoe hazardous residue from deactivation)

3: Cleaning: use sterile water

4: Disinfection: steirle 70% isopropyl alcohol

DO NOT USE SPRAY BOTTLES, use pour bottles or pre saturated wipes

Cleaning order for biological safety cabinet?

Ceiling

Bar

Back

sides

Floor

Window

P vs U listed medications

P list=acute hazardous med (like nicotine, warfarin, nitroglycerin, physostigmine

U=Toxic (CHEMOTHERAPY)

includes hazardous waste meeting criteria than can contaminate environmental water, so disposal gotta be different

If med not used, still discard in designated containers, and wrappers also discard same way

P list vs U list examples

P list: nicotine, warfarin, physostigmine, nitrogylcerin

U: chemotherapy

Chemotherapy disposal how? (yellow vs black bucket) What percentages

Trace contam hazardous waste include everything that come in contact with haz material

Sharps in sharps containers (designated)

Yellow bucket for chemoterhapy waste for containers with <3% RESIDUAL TRACE OF INGREDIENT, supplies and PPE used during compounding and admin

Black waste: For bullk chemotherapy and hazardous product waste (vials with >3% RESIDUE or unused/partially used IV products)

Oral drugs be put in black waste

All PPE in yellow

Blue vs red bucket

Blue for non toxic stuff

Red=sharps

Spill management who in charge? Spill Kits 7 components (4 absorbent things/how much? 2 trash things)

Each facility gotta have a fall guy for everything, only trained workers can clean spill.

Spill kits: gotta know where it is in case of emergency, and should be able:

to absorb 1000mL of material, PPE stuff, absorbent spill pads, towels, two hazardous waste bags, scoop for glass fragments and puncutre resistant container for glass fragments

Commercially avialble spill kits

Spill management 11 steps (what for liquid vs powders?)

Assess size and scope of skill, if 2 spill kits ain't enough get assistance

Post signs to limit access

Get spill kit and don PE

Absorb liquids using pads and powders with towels

Clean from lesser => greater areas of contamination

Completely remove and place all contaminated material in didsposal bag

Rinse area with water then clean with bleach and alcohol, rinse area several times

When complete, seal bags and dispose into container

Remove PPE starting with otuer gloves and put into disposal bag and then container

Remove inner gloves and put in small disposal bag then container

wash hands

get housekeeping service to reclean