Rpharmy Rhazdrugs • abacavir

Administration Patient Care Activities Disposal Receiving and Storage Preparation Transport Assessment of Risk Black Box Warning Additional Information Education PPE Mechanism of Action Exposure Risk Safety Data Sheet(s) Supplemental Information Approval

abacavir

Trade Name(s): Abacavir Sulfate; Ziagen
Group 2: Non-Antineoplastic Hazardous	AHFS Class: HIV Nucleoside and Nucleotide Reverse Transcriptase Inhibitors
Formweb: abacavir
Info Links: Chemotherapy Extravasation Policy

Administration:

Oral Liquid
Oral Solid - Group 2 & 3 (OH)

Oral Liquid

Handling	Gloves (ASTM D6978)	Gown (Fluid resistant, ASTM rated)	Eye/Face Protection	Mask	Shoe Covers	Notes/Instructions
Preparation at Bedside (Contact pharmacy)			for splash concerns			Place and prepare on a disposable chemo prep pad. Deactivate, decontaminate, clean, and disinfect area and equipment after use and between HazDs.
Administration			for splash concerns
Deactivating, decontaminating, cleaning, and disinfecting						Deactivate, decontaminate, clean, and disinfect area and equipment after use and between HazDs by wiping twice with Peridox® RTU and allow a 3-minute dwell time after the second wipe. Follow wiping with 70% Isopropyl Alcohol
Handling Spills						Follow instructions on spill-kit package
PPE Disposal
Drug Disposal						Reference EPIC for Regulated/RCRA waste code or Ochsner Health Medication/Waste Handling Guide for disposal of HazDs.

Ochsner HD Handling PPE Guide

Oral Solid - Group 2 & 3 (OH)

Handling	Gloves (ASTM D6978)	Gown (Fluid resistant, ASTM rated)	Eye/Face Protection	Mask	Notes/Instructions
Administration of Intact Tablet/Capsule
Preparation (manipulation) at Bedside					Deactivate, decontaminate, clean, and disinfect area after administration.
Administration of manipulated (split, crushed, etc.) Tablet/Capsule
Deactivating, decontaminating, cleaning, and disinfecting					Deactivate, decontaminate, clean, and disinfect area and equipment after use and between HazDs by wiping twice with Peridox® RTU and allow a 3-minute dwell time after the second wipe. Follow wiping with 70% Isopropyl Alcohol
PPE Disposal
Drug Disposal					Reference EPIC for Regulated/RCRA waste code or Ochsner Health Medication/Waste Handling Guide for disposal of HazDs.

Ochsner HD Handling PPE Guide

Patient Care Activities:

Handling Patient Bodily Fluids (OH)

Handling Patient Bodily Fluids (OH)

Handling	Gloves (ASTM D6978)	Gown (Fluid resistant, ASTM rated)	Eye/Face Protection	Shoe Covers	Mask	Notes/Instructions
Patient Care Activities - Urine, feces, sweat, or vomit			for concerns of splash	for concerns of splash

Ochsner HD Handling PPE Guide

Disposal:

Hazardous Waste Guide (OH)

Hazardous Waste Guide (OH)

Reference EPIC for Regulated/RCRA waste code or Ochsner Health Medication Waste Guide.

Medication regulated by RCRA will be identified with a waste disposal code on the MAR or EHR. Waste codes include BKC, PBKC, SP, SPC, SPO, SPLP, CHEMO, DEA

Code	Notes/Instructions	Container
BKC	Nurse shall dispose in appropriately labeled BLACK BKC container
CHEMO	Nurse/pharmacy shall place chemo waste in either a YELLOW trace chemo container or a BLACK “Bulk” chemo waste container. BLACK container labeled for BULK CHEMO waste shall be utilized for chemotherapy waste with residual of 3% or more drug remaining. All chemotherapy is considered regulated/RCRA by EPA/RCRA and USP 800 regulations. Waste vendor picks up. Yellow “Trace” Chemo containers are ordered through Lawson and picked up by the vendor or the department with responsibility for biohazard waste in each facility (along with regulated medical waste, red sharps, and non-regulated Rx waste). Containers shall be used for “empty” chemotherapy vials, IV bags, syringes, along with any material used during the preparation, administration and handling of the chemotherapy, including all personal protective equipment (PPE).
DEA	Controlled substance medication waste shall be placed in "Cactus" system, or in "RxDestroyer" system.
PBKC	Nurse shall place package/wrapper of medication in a zipper sealed bag, then dispose in appropriately labeled BLACK PBKC container in facilities where PBKC container is available. Until available, nurse shall send bag back to the pharmacy for disposal. Off site clinics do not return pharmaceutical waste to pharmacy Arsenic Trioxide (Trisenox) vials, IV bags, tubing, syringes and other materials used in preparation and administration shall be disposed of a segregated "PBKC" listed waste in 8-gallon black waste containers and labels provided by hazardous waste vendor. Under NO circumstances can arsenic trioxide be combined with other hazardous waste* Examples of P-listed waste: Coumadin, Warfarin, Nicotine patches and their packaging
SP	Nurse shall place the aerosol/inhaler in a zipper sealed bag and send to pharmacy for disposal in appropriately labeled BLACK container. Off site clinics to not return pharmaceutical waste to pharmacy	PHARMACY
SPC	Nurse shall place corrosive in zipper sealed bag and send to pharmacy for disposal in appropriately labeled BLACK SPC container. *Off-site locations do not return pharmaceutical waste to pharmacy	PHARMACY
SPO	Nurse shall place oxidizer in a zipper sealed bag and send to pharmacy for disposal in appropriately labeled BLACK SPO container. *Off-site locations do not return pharmaceutical waste to pharmacy.	PHARMACY
SPLP	Nurse shall place SPLP waste in a zipper sealed bag and send to pharmacy for disposal in appropriately labeled BLACK SPLP container. *Off-site locations do not return pharmaceutical waste to pharmacy.	PHARMACY
No waste code (ON site)	Shall be disposed of in a BLUE pharmaceutical waste container, with the exception of off-site provider-based clinics and freestanding emergency departments which shall use only black pharmaceutical waste containers. Facility based (on-site) clinics may use containers in the same manner as inpatient.
No waste code (OFF-site)	OFF-site provider-based clinics and freestanding emergency departments which shall use only black pharmaceutical waste containers.

Disposal Determination	Notes/Instructions	Container
Non-chemo medication packages containing less than 3% of the pharmaceutical	Shall be considered “empty” and shall be disposed of in regular trash containers or BLUE non-regulated Rx waste containers.
Medications and/or medication containers (vials, ampoules, cups, IV bags) with 3% or more than 3% medication remaining	Shall be disposed of in pharmaceutical waste containers indicated by the EPIC system, or in Pyxis and shall appear on the medication labels printed by pharmacy.	Drug Specific
Empty sharps	Shall be disposed of in RED sharps containers.
Sharps with medication	Shall be disposed of in a BLACK 2-gallon sharps container
Free flowing liquids or pharmaceutical packages with the potential to leak	Shall be placed in a zipper sealed bag prior to disposal in designated pharmaceutical waste container	Drug Specific

Regulated/RCRA Pharmaceutical Waste Disposal

Ochsner Health Medication/Waste Handling Guide

Receiving and Storage:

Group 2 & 3 (OH)

Group 2 & 3 (OH)

Handling	Gloves (ASTM D6978)	Gown (Fluid resistant, ASTM rated)	Shoe Covers (white polyethylene)	Mask (N95)	Eye/Face	Notes/Instructions
Receiving						unpack using same procedures as non-HazDs
Storage						May be stored with non-hazardous inventory May be stored in pharmacy carousel Stored n resealable clear plastic bags or in bins identified by blue HazD labels or stickers. HazDs may be stored in automated dispensing machine (bins shall be identified by yellow (chemotherapy, cytotoxic) hazardous drug or blue HazD labels or stickers OHS.PHARM.SOP.055 USP 800: Storage
Storage waiting for patient pickup *Retail/Specialty Only						Drugs shall be stored in a resealable clear plastic bag with blue HazD labeling or stickers. Use additional pharmacy paper bag if needed for delivery to patient.
Prepackaging area(s)			if in negative pressure room		if concerns for splash	Automated Repackaging equipment shall not be used for repackaging HazDs. Manually prepack and count in a designated area with dedicated equipment. Prepacking in negative pressure room within a powder containment hood is preferred. Prepacking in negative pressure room within a powder containment hood is preferred. If prepackaging in a neutral pressure area, reasonable efforts should be made to minimize the production of powder/dust and aerosolization of any particulate, as well as any residual dust present in the tray. Only the number or tablets/pills/capsules necessary to accomplish the task should be emptied from the bottle into the tray. Deactivate, decontaminate, clean, and disinfect area and equipment after use and between HazDs.
Handling Spill						Follow instructions on spill kit package.
Deactivating, decontaminating, cleaning, and disinfecting						Deactivate, decontaminate, clean, and disinfect area and equipment after use and between HazDs by wiping twice with Peridox® RTU and allow a 3-minute dwell time after the second wipe. Follow wiping with 70% Isopropyl Alcohol.

Preparation:

Oral Liquid - Group 2 & 3 (OH)
Oral Solid - Group 2 & 3 (OH)

Oral Liquid - Group 2 & 3 (OH)

Handling	Gloves (ASTM D6978)	Gown (Fluid resistant, ASTM rated)	Shoe Covers (white polyethylene)	Mask (N95)	Eye/Face	Notes/Instructions
Prepackaging area(s)						If an AoR permits, compounding, manipulation, and repackaging can occur in a designated neutral pressure HazD handling area on a disposable chemo prep pad.
Preparation/compounding in Pharmacy (manipulation)			if in negative pressure room	if in negative pressure room or if risk of spill or splash and NOT working in C-PEC.	if risk of spill or splash and NOT working in C-PEC.	Utilize disposable or designated equipment for HazD compounding, such as mortars, pestles, or spatulas. Upon completion of compounding and manipulation, clean the C-PEC, equipment, and surrounding area.
Deactivating, decontaminating, cleaning, and disinfecting						Deactivate, decontaminate, clean, and disinfect area and equipment after use and between HazDs by wiping twice with Peridox® RTU and allow a 3-minute dwell time after the second wipe. Follow wiping with 70% Sterile Isopropyl Alcohol. Doff PPE and discard in Yellow trace RCRA waste container Wash hands with soap and water.
Handling Spills						Follow instructions on spill kit package.

OHS.PHARM.SOP.056 - USP 800: Hazardous Drug (HazD) Compounding, Manipulation, and Repackaging

Oral Solid - Group 2 & 3 (OH)

Handling	Gloves (ASTM D6978)	Gown (Fluid resistant, ASTM rated)	Shoe Covers (white polyethylene)	Mask (N95)	Eye/Face	Notes/Instructions
Counting				if reasonable risk of exposure to dust		Count in a designated area with dedicated equipment. Only the number of pills, capsules, or tablets necessary to accomplish this task should be emptied from the bottle onto the counting tray. Deactivate, decontaminate, clean, and disinfect area and equipment after use and between HazDs.
Splitting or crushing tablets			if in Negative Pressure Room	if in neutral pressure and/or not within a powder containment hood		Splitting or crushing in negative pressure room within a powder containment hood is preferred. Perform work on a chemo prep pad (plastic backed pad). When crushing, place tablet in a resealable plastic bag and utilize an appropriate crushing device. Add appropriate diluent for mixing. Deactivate, decontaminate, clean, and disinfect area and equipment after use and between HazDs.
Opening Capsules for compounding or manipulation			if entering Negative Pressure Room	if in neutral pressure and/or not within a powder containment hood		Opening capsules in negative pressure room within a powder containment hood is preferred. Perform work on a chemo prep pad (plastic backed pad). Open capsule and place contents in container appropriate for preparation and administration. Combine with vehicle for administration. Deactivate, decontaminate, clean, and disinfect area and equipment after use and between HazDs.
Repackaging			if entering Negative Pressure Room	if in neutral pressure and/or not within a powder containment hood		Automated Repackaging equipment shall not be used for repackaging HazDs. Manually prepack and count in a designated area with dedicated equipment. Prepacking in negative pressure room within a powder containment hood is preferred. Prepacking in negative pressure room within a powder containment hood is preferred. If prepackaging in a neutral pressure area, reasonable efforts should be made to minimize the production of powder/dust and aerosolization of any particulate, as well as any residual dust present in the tray. Only the number or tablets/pills/capsules necessary to accomplish the task should be emptied from the bottle into the tray. Deactivate, decontaminate, clean, and disinfect area and equipment after use and between HazDs.
Handling Spills						Follow instructions on spill kit package.
Deactivating, decontaminating, cleaning, and disinfecting						Deactivate, decontaminate, clean, and disinfect area and equipment after use and between HazDs by wiping twice with Peridox® RTU and allow a 3-minute dwell time after the second wipe. Follow wiping with 70% Isopropyl Alcohol.

OHS.PHARM.SOP.056 - USP 800: Hazardous Drug (HazD) Compounding, Manipulation, and Repackaging

Transport:

Group 2 & 3 (OH)

Group 2 & 3 (OH)

Dosage Form	Transport Within Pharmacy	Transport to Area(s) Within Facility	Transport to Holding Area For Patient Pick-up. (Retail/Specialty Pharmacies Only)	Transport to Off-site Administration Areas	Ship Prescription Product to Locations Outside of Entity (Retail/Specialty Pharmacies Only)
Oral Solid (intact)	Transport in appropriate resealable clear plastic bag or bin to reduce risk of breakage, and facilitate spill containment.	Transport in appropriate resealable clear plastic bag with blue HazD labeling or sticker. Pneumatic Tube allowed.	Transport in appropriate resealable clear plastic bag with blue HazD labeling or sticker. Pneumatic Tube allowed.	Refer to OHS.PHARM.SOP.054 USP 800: Hazardous Drug (HazD) Transport	Ensure that labels and accessory labeling for the HazD include storage, disposal, and HazD category information in a format consistent with carrier's policy.
Oral Solid (manipulated)	Transport in appropriate resealable clear plastic bag or bin to reduce risk of breakage, and facilitate spill containment.	Transport in appropriate resealable clear plastic bag with blue HazD labeling or sticker. Pneumatic Tube NOT allowed.	Transport in appropriate resealable clear plastic bag with blue HazD labeling or sticker. Pneumatic Tube NOT allowed.	Refer to OHS.PHARM.SOP.054 USP 800: Hazardous Drug (HazD) Transport	Ensure that labels and accessory labeling for the HazD include storage, disposal, and HazD category information in a format consistent with carrier's policy.
Oral Liquid	Transport in appropriate resealable clear plastic bag or bin to reduce risk of breakage, and facilitate spill containment.	Transport in appropriate resealable clear plastic bag with blue HazD labeling or sticker. The bag must be placed into a hard-sided closable container that reduces the risk of breakage, and facilitates spill containment. The container must be clearly marked with the appropriate hazardous drug label or sticker. Refer to OHS.PHARM.SOP.054-USP 800: Transport for instructions regarding container and disposal of gloves. Pneumatic Tube NOT allowed.	Transport in appropriate resealable clear plastic bag with blue HazD labeling or sticker. The bag must be placed into a hard-sided closable container that reduces the risk of breakage, and facilitates spill containment. The container must be clearly marked with appropriate Pneumatic Tube NOT allowed.	Refer to OHS.PHARM.SOP.054 USP 800: Hazardous Drug (HazD) Transport	Ensure that labels and accessory labeling for the HazD include storage, disposal, and HazD category information in a format consistent with carrier's policy.
Injectable	Transport in appropriate resealable clear plastic bag or bin to reduce risk of breakage, and facilitate spill containment.	Transport in appropriate resealable clear plastic bag with blue HazD labeling or sticker. If HazD is in liquid form or has been manipulated, resealable plastic bag must be placed into a hard-sided closable container that reduces the risk of breakage, and facilitates spill containment. The container must be clearly marked with the appropriate hazardous drug label or sticker. Refer to OHS.PHARM.SOP.054-USP 800: Transport for instructions regarding container and disposal of gloves. Pneumatic Tube NOT allowed for drugs that have been manipulated/compounded into their final dosage form.	Transport in appropriate resealable clear plastic bag with blue HazD labeling or sticker. If HazD is in liquid form or has been manipulated, resealable plastic bag must be placed into a hard-sided closable container that reduces the risk of breakage, and facilitates spill containment. The container must be clearly marked with appropriate hazardous drug label or sticker. Pneumatic Tube NOT allowed for drugs that have been manipulated/compounded into their final dosage form.	Refer to OHS.PHARM.SOP.054 USP 800: Hazardous Drug (HazD) Transport	Ensure that labels and accessory labeling for the HazD include storage, disposal, and HazD category information in a format consistent with carrier's policy.
Topical gel/cream/powder, suppository, vaginal inserts/creams, transdermal, subcutaneous implant.	Transport in appropriate resealable clear plastic bag or bin to reduce risk of breakage, and facilitate spill containment.	Transport in appropriate resealable clear plastic bag with blue HazD labeling or sticker. If HazD is in liquid form or has been manipulated, resealable plastic bag must be placed into a hard-sided closable container that reduces the risk of breakage, and facilitates spill containment. The container must be clearly marked with appropriate hazardous drug label or sticker. Refer to OHS.PHARM.SOP.056-USP 800: Transport for instructions regarding container and disposal of gloves. Pneumatic Tube NOT allowed for drugs that have been manipulated/compounded into their final dosage form.	Transport in appropriate resealable clear plastic bag with blue HazD labeling or sticker. If HazD is in liquid form or has been manipulated, resealable plastic bag must be placed into a hard-sided closable container that reduces the risk of breakage, and facilitates spill containment. The container must be clearly marked with appropriate hazardous drug label or sticker. Pneumatic Tube NOT allowed for drugs that have been manipulated/compounded into their final dosage form.	Refer to OHS.PHARM.SOP.054 USP 800: Hazardous Drug (HazD) Transport	Ensure that labels and accessory labeling for the HazD include storage, disposal, and HazD category information in a format consistent with carrier's policy.

Ochsner Health Guide for Oral Solid Hazardous Drugs

Ochsner Health Guide for Oral Liquid Hazardous Drugs

Ochsner Health Guide for Injectable Hazardous Drugs

Ochsner Health Guide for (Topical, Suppository, Transdermal Patches, Subcutaneous Implants)Hazardous Drugs

Assessment of Risk:

Low Risk

Oral Solid - Reason for exemption: Unit dose packaged by manufacturer or pharmacy. Dispensed as unit dose. No manipulation required
Oral Liquid - Reason for exemption: Dispensed from pharmacy as final dosage form requiring no manipulation for administration. Practical alternative containment strategies and work practices can be implemented to limit the exposure and protect personnel from ingesting, inhaling or touching this HazD.

Black Box Warning:

Hypersensitivity Reactions, Lactic Acidosis and Severe Hepatomegaly; Exacerbations of Hepatitis B

Additional Information:

Hospital policies and guidelines:

Education:

USP Education and Training

PPE:

PPE Guidelines

PPE Guidelines


Chemotherapy rated/tested (tested to ASTM D6978-05 (2013), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs)	Disposable must not be reused	Should be worn in situations where eye, mouth, or nasal splashing is possible (i.e., during a bladder instillation of a hazardous drug)	Goggles protect the eyes, but not the face, against spraying.	Certified N95	Powered air purifying respirator	required for compounding sterile and nonsterile hazardous drugs	required for compounding sterile and nonsterile hazardous drugs
Powder-free	Shown to resist permeation by hazardous drugs material: polyethylene-coated polypropylene or other laminate materials			N95 offers no protection against gases and vapors.	For events such as large spills when an IV bag breaks or a line disconnects and leaks, or where there is known or suspected airborne exposure to vapors or gases		Double booties required for HD preparation areas, top layer is doffed before exiting the HD buffer room.
Inspect for visible defects	Must close in the back (no open front)			Surgical masks do NOT provide respiratory protection from drug exposure	Hazardous drugs with potential to vaporize at room temperature: • Carmustine • Cisplatin •Cyclophosphamide • Etoposide • 5-Fluorouracil • lfosfamide • Thiotepa
Double gloving is recommended for all activities involving hazardous drugs except for handling intact, unit-dose oral agents, when one pair of chemotherapy-tested gloves is acceptable	Long sleeves with closed cuffs that are elastic or knit
When wearing double gloves, tuck the cuff of the inner glove under the gown sleeve and the cuff of the outer glove over the gown sleeve.	No seams or closures that could allow hazardous drugs to pass through
During medication manipulation/compounding the outer layer should be sterile	In preparation areas gowns should be changed every 2-3 hours or immediately after a spill or splash
Change gloves every 30 minutes unless permeation testing has noted shorter time limits change gloves immediately if damaged or contaminated	Gowns worn in hazardous drug handling areas must NOT be worn to other areas

Sequence for Donning & Doffing PPE

References: Oncology Nursing Society, NIOSH

Mechanism of Action:

Abacavir is a carbocyclic synthetic nucleoside analogue and an antiviral agent. Intracellularly, abacavir is converted by cellular enzymes to the active metabolite carbovir triphosphate, an analogue of deoxyguanosine-5'-triphosphate (dGTP). Carbovir triphosphate inhibits the activity of HIV-1 reverse transcriptase (RT) both by competing with the natural substrate dGTP and by its incorporation into viral DNA. Viral DNA growth is terminated because the incorporated nucleotide lacks a 3'-OH group, which is needed to form the 5′ to 3′ phosphodiester linkage essential for DNA chain elongation.

Reference: Drug Bank

Exposure Risk: