Week 5: Hazardous Drugs

group 1

antineoplastic drugs (chemo)

group 2

non-antineoplastic drugs

group 3

drugs that pose a reproductive risk to men and women who are actively trying to conceive, and women who are either pregnant or breastfeeding

hazardous drug

a drug that exhibits one or more of the following characteristics in humans or animals:

1) carcinogenicity

2) teratogenicity

3) reproductive toxicity

4) organ toxicity (at low doses)

5) genotoxicity

6) new drugs with structure/toxicity profiles similar to existing hazardous drugs

carcinogenicity

an agent that can cause cancer; tumors present in more than one species and gender of animals (can't just be rodents)

carcinogens

Ex: estrogens (endometrial cancer, cardiovascular risk); valganciclovir, various antineoplastic agents

tetratogenicity

an agent that disturbs or causes a malformation in the development of an embryo or fetus (birth defects, termination of the pregnancy); don't necessarily cause sterility

tetratogens

Ex: thalidomide; warfarin (fetal warfarin syndrome - saddle nose, retarded growth, defects of limbs, eyes, and CNS)

reproductive toxicity

an agent that damages reproductive organs and can cause sterility or birth defects

category A

FDA category in which adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and no evidence of risk in later trimesters)

category B

FDA category in which animal reproduction studies have failed to demonstrate a risk to the fetus and here are no adequate and well-controlled studies in pregnant women

category C

FDA category in which animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

category D

FDA category in which there is postive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits my warrant use of the drug in pregnant women despite potential risks

category X

FDA category in which studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits

do not

effects noted in doses greater than the maximum recommended human dose (MRHD) _______ count as hazardous

do

effects noted in doses less than the maximum recommended human dose (MRHD) _______ count as hazardous

organ toxicity

damage to organs at low doses of the drugs: up to 10 mg/day or up to 1 mg/kg/day

genotoxicity

something that can cause DNA or chromosomal damage in vivo or in vitro

Ex: methotrexate

Hazardous drug resources

ASHP, USP 800, ISMP, NIOSH, US Environmental Protection Agency, your employer

protection

__________ against hazardous drugs: PPE, policy and procedure, training, product labeling, safety data sheets, product disposal

PPE

goal is to completely prevent exposure; wear double gloves, gown, hairnet, mask or respirator, double shoe covers; use biological safety cabinet (BSC) or compounding aseptic containment isolator (CAIC)

handling

PPE required for ________________: gown, head and hair protection, single chemo gloves, single shoe covers, respiratory protection if unpacking HDs that aren't wrapped in plastic until packing can be assessed

compounding

PPE required for __________________: gown, head and hair protection, double chemo gloves, double shoe covers, ventilated engineering controls (fume hood or BSC), eye, face, and respiratory protection if risk of spills/splashes/inhalation

labeled

ALL hazardous drugs must be __________ as hazardous with bright colors that are easily seen

yellow

___________ bins are for disposal of remnants of chemotherapy; small volumes and empty packages

black

____________ bins are for disposal of all hazardous drugs and spill kids