Test 2 Flashcards
Category B
Animal studies have revealed no evidence of harm to the fetus; however, there are no adequate and well- controlled studies in pregnant women. Or animal studies have shown an adverse effect, but adequate and well- controlled studies in pregnant women have failed to demonstrate a risk to the fetus.
Category C
Animal studies have shown an adverse effect and there are no adequate and well- controlled studies in pregnant women. Or no animal studies have been conducted and there are no adequate and well- controlled studies in pregnant women.
Category D
Studies, adequate well- controlled or observational, in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk.
Category X
Studies, adequate well- controlled or observational, in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. The use of the product is contraindicated in women who are or may become pregnant.
Schedule I (C-I)
Potential for abuse is so high as to be unacceptable. May be used for research with appropriate limitations. Examples are LSD and heroin.
Schedule II (C-II)
High potential for abuse and extreme liability for physical and psychological dependence (amphetamines, opioid analgesics, dronabinol, certain barbiturates). Outpatient prescriptions must be in writing. In emergencies, telephone orders may be acceptable if a written prescription is provided within 72 hr. No refills are allowed.
Schedule III (C-III)
Intermediate potential for abuse (less than C-II) and intermediate liability for physical and psychological dependence (certain nonbarbiturate sedatives, certain nonamphetamine CNS stimulants, and certain opioid analgesics). Outpatient prescriptions can be refilled 5 times within 6 mo from date of issue if authorized by prescriber. Telephone orders are acceptable.
Schedule IV (C-IV)
Less abuse potential than schedule III with minimal liability for physical or psychological dependence (certain sedative/hypnotics, certain antianxiety agents, some barbiturates, benzodiazepines, chloral hydrate, pentazocine, and propoxyphene). Outpatient prescriptions can be refilled 6 times within 6 mo from date of issue if authorized by prescriber. Telephone orders are acceptable.
Schedule V (C-V)
Minimal abuse potential. Number of outpatient refills determined by prescriber. Some products (cough suppressants with small amounts of codeine, antidiarrheals containing paregoric) may be available without prescription to patients > 18 yrs. of age.
Category A
Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities.
Pharmacokinetics
Is the study of how medications enter the body, reach their site of action, metabolize, and exit the body.
Pharmacodynamics
Is the study of the way drugs affect the body.
Pharmacogenetics
The scientific discipline studying how the effect of a drug action varies from the predictive drug response because of genetic factors or hereditary influence.
Toxicity
Amount of drug left in body undesirable.