Drug Safety Flashcards
What happened in the 1906 pure food and drug act
first attempt to protect consumers in manufacture of drugs/food
minimal standards
label if dangerous
2 references
What were the 2 references for the 1906 pure food and drug act
USP- United States Pharmacopeia
NF- National Formulary
what happened in the 1938 Federal food, drug, and cosmetic act
passed after sulfa drug incident
safety for new drugs, factory inspections, new standards for food
what happened in the 1951 FD &C Durham-Humphrey Amendment
Defined drugs that could only be purchased if the patients had a prescription from a licensed practitioner
what happened in the 1958 FD &C Food additives amendment
approval of new food additives
“No additive shall be deemed safe if it is found to induce cancer when ingested by man or animal”
What were the amendments to the FD & C food additives
GRAS (generally recognized as safe)
if FDA or USDA had previously approved them
what happened in the 1960 FD &C Color additives amendment
all colors must be approved
what happened in the 1962 FD &C Kefauver-Harris amendment
standard labeling for adverse reactions/ contraindications
what happened in the 1970 FD &C comprehensive drug abuse prevent and control act
controlled substances act
regulate dispensing of drugs
assigned 5 schedules
what happened in the 1994 Dietary supplements health and education act
FDA responsible for taking actin against any unsafe supplement after it reaches market
Schedule 1
high abuse potential
no medical use
Schedule 2
high abuse potential
accepted medical use
Schedule 3
moderate abuse potential
accepted medical use
Schedule 4
low abuse potential
accepted medical use
Schedule 5
limited abuse potential
accepted medical use
examples of schedule 1 drugs
heroin LSD marijuana ecstasy methaquaione peyote
examples of schedule 2 drugs
Vicodin cocaine dilaudid Demerol ocycontin Dexedrine Adderall ritalin
examples of schedule 3 drugs
tylonol with codeine
ketamine
anabolic steroids
testosterone
examples of schedule 4 drugs
Xanax soma Darvocet valium Ativan ambien tramadol
examples of schedule 5 drugs
robitussin AC (codeine) lomotil motofen lyrica parepectalin
Reinvestigation of 1996 Food quality protection act
pesticide tolerance levels
FDA
Food and drug administration
Food labeling food ingredients and packaging pharmaceuticals supplements medical devices vaccines animal food tabacco cosmetics
DEA
Drug Enforcement Administration
Controlled substances only
USDA
US Department of Agriculture
Food distribution
school lunch programs
EPA
Environmental protection agency
Agricultural and industrial chemicals
water
CPSC
Consumer products safety commission
Recalls
OSHA
Occupational safety and health administration
workplace chemical exposure
What are the 2 requirements FDA must meet prior to use in humans
1-efficacy
2-safety
LD50
lethal dose that will kill 50% of animals tested
TI
therapeutic index
LD50/ED50
used to establish dosage levels in animal trials
NOAEL
no observed adverse effect level
highest dose without any adverse effect
LOAEL
lowest observed effect level
lowest level which there was still a statistically significant observed adverse effect
Adverse effects are dependent on what
Dose
What are common adverse effects to oral drugs
GI issues N/V/D
What are teratogens
causes birth defects from maternal drug administration
what are carcinogens
promote growth of cancerous cells
what is a drug allergy
Drugs acts as an antigen and
body produces antibodies against the drug
histamine released from mast cells
What is a hypersensitivity
milder response, usually
rash, hives, itching, runny nose
What is anaphylaxis
severe, possibly fatal reaction
Urticaria, vascular collapse, low BP, shock, cyanosis, laryngeal edema, bronchoconstriction, dyspnea
What is an idiosyncasy
unique, unusual, or unexpected response because of genetic variations in enzymes altering drug metabolism
what is a paradoxical effect
opposite effect from what is expected
what is tolerance
decreased response that develops after repeated doses are given
what is dependence
acquired need for a drug, may produce psychological or physical symptoms of withdrawal when discontinued
Most susceptible to direct toxic action
liver-metabolically active
kidneys-filter waste
lungs-position and function
Why is an organ targeted for direct toxic action
Blood flow
particular enzymes
organ specialization
detoxification system
How much CO does the liver receive
2%
What is steatosis
fatty liver
increase in triglycerides
What is cytotoxic damage
cell death
What is cholestatic damage
damage to biliary system
What is cirrhosis
scaring of liver due to chronic damage/repair
What is proliferations of perioxisomes
modulation of gene expression
How do they detect liver damage
AST and ALT are both increased
bilirubin is increased
albumin is DECreased
AST
aspartate transaminase
ALT
alanine transaminase
How much CO does the kidney receive
25%
How do they detect kidney damage via bloodwork
BUN increased
creatine increased
BUN
blood urea nitrogen
how do they detect kidney damage via urinalysis
urine volume pH specific gravity Y-glutamyltransferase N-acetylglucosaminidase
How much CO do lungs receive
100%
Is there a biochemical test for lung damage
NO
How do they test for lung damage
Forced expiratory vol
forced vital capacity
biopsy
Pharmacokinetic based effects
increased concentration of the compound or active metabolite
pharmacodynamic based
altered responsiveness of the target site
What causes respiratory failure
insecticides and nerve gases
what causes CNS disturbances
organophsophates
insecticides
What alters BP
RX meds
What alters blood glucose
RX meds industrial solvent (hydrazine)
what causes anesthesia
toxic solvents
carbon tetrachloride
vinyl chloride
what causes electrolyte imbalances
furosemide
caffeine
ethanol
mercury
When is a fetus most susceptible to gross anatomical abnormalities from teratogens
organogenesis
days 18-55
Common immunotoxicity: drugs
penicillin
Common immunotoxicity: industrial chemicals
toluene
Common immunotoxicity: natural chemicals
pentadecylcatechol
Common immunotoxicity: food additives
tartrazine
FD&C yellow 5
Common immunotoxicity: food constituents
egg white (albumin)
Mutagenesis
drug interacts directly with DNA → DNA damage
clastogenesis
chromosomal damage
aneugenesis
acquisition or loss of complete chromosomes
