Med types, Schedule Controlled Substances, Pregnancy Categories, & Phase Study

Which type of phase studies:

• Cause unacceptable adverse effects.

• Are highly teratogenic.

• Lack evidence of potential therapeutic effect in humans.

Phase I

Which type of phase studies:

• Less effective than anticipated.

• Too toxic when used patients.

• Produces unacceptable adverse effects.

• Low benefit-to-risk ratio.

• No more effective than other drugs already on the market.

Phase II

Which type of phase studies:

• Produce unacceptable side effects

• Produce unexpected responses

Phase III

Which type of phase studies:

• Some drugs cause unexpected effects that are not seen until wide distribution occurs.

• Sometimes, those effects are therapeutic.

Phase IV

Which category of pregnancy drugs:

• Adequate studies show no risk to fetus in the first trimester.

• No evidence of risk in later trimesters.

Category A

Which category of pregnancy drugs:

• Animal studies have not demonstrated a risk to the fetus.

• No adequate studies in pregnant people, or animal studies have shown an adverse effect.

• Adequate studies in pregnant people have not demonstrated a risk to the fetus during the first trimester of pregnancy.

• There is no evidence of risk in later trimesters.

Category B

Which category of pregnancy drugs:

• Animal studies have shown an adverse effect on the fetus.

• There are no adequate studies in humans.

• Benefits from the use of the drug in pregnant people may be acceptable despite its potential risks.

• There are no animal reproduction studies and no adequate studies in humans.

Category C

Which category of pregnancy drugs:

• There is evidence of human fetal risk.

• Potential benefits from the use of the drug in pregnant people may be acceptable despite its potential risks.

Category D

Which category of pregnancy drugs:

• Studies in animals or humans demonstrate fetal abnormalities or adverse reactions; reports indicate evidence of fetal risk.

• Risk of use in a pregnant person clearly outweighs any possible benefit.

Category X

Which type of schedule of controlled substances:

• High abuse potential and no accepted medical use.

• Ex: heroin, lysergic acid diethylamide.

Schedule I (C-I)

Which type of schedule of controlled substances:

• High abuse potential with severe dependence liability.

• Ex: narcotics, amphetamines, and barbiturates.

Schedule II (C-II)

Which type of schedule of controlled substances:

• Less abuse potential than schedule II drugs and moderate dependence liability.

• Ex: nonbarbiturate sedatives, nonamphetamine stimulants, limited amounts of certain narcotics.

Schedule III (C-III)

Which type of schedule of controlled substances:

• Less abuse potential than schedule III and limited dependence liability.

• Ex: some sedatives, antianxiety agents, and nonnarcotic analgesics.

Schedule IV (C-IV)

Which type of schedule of controlled substances:

• Limited abuse potential.

• Primarily small amounts of narcotics (codeine) used as antitussives or antidiarrheals.

• The purchaser must be at least 18 years of age and must furnish suitable identification.

• All such transactions must be recorded by the dispensing pharmacist.

Schedule V (C-V)

Which drug type:

• Are chemicals that are produced by companies involved solely in the manufacturing of drugs.

• Must have the same strength of the active ingredient as brand name.

• Must use the same dosage form (tablet, capsule, or liquid) as brand name.

• Must have the same route of administration (oral, topical, or injectable) as brand name.

Generic Drugs

Which drug type:

• Treat rare diseases or conditions but are not financially viable

• Have not been “adopted” by any drug company.

Orphan Drugs

Which drug type:

• Are products that are available without prescription for self-treatment of a variety of complaints.

• Some of these agents were approved as prescription drugs but later were found to be very safe and useful for patients without the need of a prescription.

• Some were not rigorously screened and tested.

Over-the-Counter (OTC) Drugs

Which drug type:

• Do not require a prescription but have more restrictions than OTC medications.

• Must be kept in a secure location in the store (such as in a locked cabinet or within the pharmacy).

• Must be sold by pharmacy staff to the customer.

Behind-the-Counter (BTC) drugs