Hazardous Drug Safety 2008
Many drugs used in the hospital setting are
considered to be hazardous to healthcare workers. It is essential to
minimize exposure to all hazardous drugs. This applies to many of the
chemotherapy drugs.
Chemotherapy drugs are the most commonly handled
hazardous drugs at MMH. The module will focus on this class of medications
even though the precautions may be utilized in handling other hazardous
drugs. The term hazardous refers to drugs that require special handling
because of potential health risks that are the result of their inherent
toxicities. A patient receiving a chemotherapy drug is identifiable to
healthcare workers to ensure safe work practices while preserving
confidentiality and dignity by placing a completed yellow label above the
patient’s bed, in the patient’s bathroom and on the front of the
patient’s chart.
Hazardous drugs are defined as those that meet one or
more of the following criteria:
Ø Carcinogenicity
Ø Teratogenicity or developmental toxicity
Ø Reproductive toxicity
Ø Organ toxicity at low doses
Ø Genotoxicity
Ø Drugs similar in structure or toxicity to drugs classified as hazardous using these criteria
CCarcinogenic
potential
Ø Adverse reproductive outcomes such as spontaneous abortion and infertility have been reported
Ø Many cytotoxic drugs are known to be toxic to skin, mucous membranes, and corneas; others are known to cause organ damage
Ø Chromosomal damage has been documented following exposure to cytotoxic agents
Ø Exposure during pregnancy may cause structural defects in fetuses
Ø Acute symptoms (headache, nausea, dizziness, or skin, eye, or throat irritation) have occurred
from accidental exposure
Potential occupational health risks associated
with biotherapy agents
Ø Little data are available regarding the effects of handing biological agents
Ø Most biologicals do not affect DNA and do not cause genetic changes
Ø
Interferon is considered a hazardous drug because of its
reproductive toxicity
Potential routes of exposure to hazardous drugs
Ø Absorption through skin or mucous membranes after direct contact with drug or from surfaces or objects that are contaminated with hazardous drugs
Ø Injection by inadvertent injury from a needle stick or contaminated sharps
Ø Inhalation of drug aerosols, dust, or droplets
o Multiple studies have demonstrated environmental contamination in drug preparation and administration areas
Ø Ingestion through contaminated food, beverage, tobacco products, or other hand-to-mouth behaviors
Personal protective equipment
Gloves:
Ø Wear disposable gloves that are powder-free and have been tested for use with hazardous drugs.
Ø Inspect gloves for physical defects before use.
Ø Latex gloves provide protection but should be used with caution because of the risk of latex sensitivity. Gloves made of other materials, such as nitrile, polyurethane, or neoprene also provide protection.
Ø Double gloves are recommended for all handling activities (NIOSH, 2004).
Ø Change gloves immediately after each use; if a tear, puncture, or drug spill occurs; or after 30 minutes of wear (American Society of Hospital Pharmacists, 1990; NIOSH, 2004).
Gowns:
Ø Wear a disposable, lint-free gown made of a low-permeability fabric, such as polyethylene-coated materials
Ø The gown should have a solid front, long sleeves, tight cuffs, and a back closure.
Ø Inner glove cuffs should be worn under the gown cuffs outer glove cuffs should extend over the gown cuffs.
Ø Discard the gown if it is visibly contaminated, before leaving drug preparation areas, and after handling hazardous drugs.
Ø
Gowns should not be re-used
Respirators:
Ø Wear a NIOSH-approved respirator mask (such as a non-powered, air-purifying, particulate-filter respirator) when cleaning hazardous drug spills.
Ø Consult the material safety data sheet (MSDS) for the respirator appropriate to the situation
Surgical masks do not provide respiratory protection.
Eye and face protection:
Ø
Wear a face shield whenever there is a possibility of
splashing.
Situations requiring PPE:
Ø Wear PPE whenever there is a risk of hazardous drugs being released into the environment, such as in the following situations (NIOSH, 2004).
o Introducing or withdrawing needles from vials
o Transferring drugs using needles or syringes
o Opening ampules
o Expelling air from a drug-filled syringe
o Administering hazardous drugs by any route
o Spiking IV bags and changing IV tubing
o Priming IV tubing
o Handling leakage from tubing, syringe, and connection sites
o Disposing of hazardous drugs and items contaminated by hazardous drugs
o Handling the body fluids of a patient who received hazardous agents in the
past 48 hours
o Cleaning hazardous drug spills
Storage and labeling of chemotherapeutic agents
On the clinical unit
Ø Store chemotherapy drug containers in a location that permits appropriate temperature and safety regulation.
Ø Label all drug containers to indicate the hazardous nature of their contents
(OSHA, 1995).
Ø Have access to instructions (i.e. MSDS) regarding what to do in the event of accidental exposure.
Ø
Check hazardous drug containers before taking them from the
storage area to ensure that the packaging is intact and to detect any
breakage or leakage.
Safe handling while mixing hazardous drugs:
Safe handling while mixing hazardous drugs:
Chemotherapeutic drugs
Ø Prepare cytotoxic drugs, including oral drugs that must be compounded or crushed, in a biological safety cabinet (BSC) (American Society of Hospital Pharmacists, 1990; NIOSH, 2004). The BSC should
o Provide vertical laminar airflow.
o Eliminate exhaust through a high-efficiency particulate air (HEPA) filter. Ideally, a BSC should be vented to the outside (NIOSH, 2004).
o Have a blower that operates continuously (American Society of Hospital Pharmacists, 1990).
o Be located in a low-traffic area to reduce interference with airflow.
o Be used by individuals trained to employ techniques that reduce interference with airflow.
o Be serviced according to the manufacturer’s recommendations.
o Be recertified every six months (American Society of Hospital Pharmacists, 1990).
Ø Wash hands before putting on PPE.
Ø Wear appropriate PPE.
Ø If desired, place a sterile, plastic-backed absorbent pad on the work surface. Such pads may interfere with airflow in the BSC
Ø Use safe technique when opening ampules (American Society of Hospital Pharmacists, 1990).
o Clear fluid from the ampule neck.
o Tilt the ampule away from your self.
o Wrap gauze or an alcohol pad around the neck of the ampule.
o Break the ampule in the direction away from yourself
o Use a filtered needle to withdraw fluid.
Ø When reconstituting drugs packaged in vials, avoid pressure buildup, which can result in the release of drug aerosols. Use a closed-system device if available (NIOSH, 2004).
Ø Use tubing and syringes with Luer lock fittings.
Ø Avoid overfilling syringes. A syringe that is too full may separate from the plunger end (OSHA, 1995).
Ø Prime all tubing with fluid that does not contain the drug before adding cytotoxic drugs, preferably in a BSC (American Society of Hospital Pharmacists 1990; OSHA, 1995) or use a closed-system device to minimize the risk of exposure
Ø Place a label on each container that says “Cytotoxic Drug” or a similar warning.
Ø Wipe the outside of the container with moist gauze before placing it in a sealable bag for transport.
Ø Dispose of all material that has come into contact with a cytotoxic drug by placing the material into a waste container designated for cytotoxic waste.
Ø Remove and discard outer gloves and gown. Then remove inner gloves.
Ø Wash hands before leaving the work area.
Safe handling while mixing biotherapy
Ø Use safe handling precautions for biotherapy agents that are considered hazardous (e.g., interferon) (NIOSH, 2004).
Ø Wear gloves when mixing biotherapy agents that are irritating to skin (e.g., rituximab ).
Ø A nuclear pharmacist prepares radiolabeled monoclonal antibodies for infusion. Note: Federal and state laws require that radiation-safety warning signs designate the areas in which radioisotopes are stored or used (Bruner, Haas, & Gosselin-Acomb, 2005).
Transporting chemotherapeutic drugs (OSHA, 1995)
Ø Transport syringes containing hazardous drugs in a sealed container, with the Luer lock end of the syringe capped.
Ø Do not transport syringes with needles in place.
Ø Select a transport receptacle that can contain spillage if dropped (e.g., a Leak proof, sealable bag) and additional impervious packing material as necessary to avoid damage during transport.
Ø Chemotherapy drugs can be transported via the pneumatic tube system by using special leak proof tubes
Ø Label the outermost receptacle to indicate that its contents are hazardous.
Ø Transported only by employees trained in the appropriate procedures and hazards associated with chemotherapy drugs.
Ø Ensure that whoever will be transporting the drugs has received proper education to handle a spill.
Safe handling considerations during administration of hazardous drugs (American Society of Hospital Pharmacists, 1990; OSHA, 1995)
Ø Always wear PPE.
Ø Work below eye level.
Ø Ensure that a spill kit and hazardous waste container are available.
Ø Use a closed-system device (NIOSH, 2004), or place a disposable, absorbent, plastic-backed pad underneath the work area to absorb droplets of the drug that may spill.
Ø Use a closed-system device, or place a gauze pad under the syringe at injection ports to catch droplets during administration.
Use needles, syringes, and tubing with Luer lock connectors.Ø If priming occurs at the administration site, prime IV tubing with a fluid that does not contain the drug or by using the backflow method.
Ø After drug administration, remove the IV bag or bottle with the tubing attached (NIOSH, 2004). Do not remove the spike from IV containers or reuse tubing.
Ø Use detergent and water to wash surfaces that come into contact with hazardous drugs
Discard all contaminated material and PPE in a hazardous waste containerHandling a patient’s body fluids
© After chemotherapy
o Institute universal (standard) precautions (double gloves and disposable gown) when handling the blood, emesis, or excreta of a patient who has received chemotherapy within the previous 48 hours. Wear a face shield if splashing is possible (NIOSH, 2004).
o For an incontinent child or adult: Clean the patient’s skin well with each diaper change. Apply a protective barrier ointment to the skin of the patient’s diaper area to decrease the chance of skin irritation from contact with urinary metabolites.
o Flush the toilet with the lid down after disposing of excreta from a patient who has received cytotoxic agents within the past 48 hours. If there is no toilet lid the toilet should be covered with a disposable pad prior to flushing.
o There is no research to support the effectiveness of double flushing. Double flushing has been suggested in the literature and may be helpful with low volume per flush toilets.
Handling a patient’s linens
© After chemotherapy
o To the extent possible, preclude the need for laundering linens and clothing by using disposable linens or leak proof pads to contain body fluids.
o If body fluids are present, use universal (standard) precautions when handling the linens of a patient who has received chemotherapy within 48 hours.
o Place linens into a yellow plastic Chemotherapy soiled linen bag available from laundry
§ Store in patients room until full or patient is discharged
§ Notify laundry at x1430 when linen is to be removed from room
o Linens should be pre-washed before they are added to other hospital laundry for a second washing (OSHA, 1995).
