Chapter 1: The Foundation of Pharmacology: Quality and Safety

Question 1

Brand (Trade) Name

Answer 1

Manufacturer’s chosen name for a drug, which is protected by a patent

Question 2

Controlled substances

Answer 2

Drugs that are categorized by federal law according to therapeutic usefulness and potential for abuse; scheduled drugs

Question 3

Drug classifications

Answer 3

Medications grouped according to their effects on particular body systems, therapeutic uses and chemical characteristics

Question 4

Generic Name

Answer 4

Chemical of official name of the drug that is independent of the manufacturer and often indicates the drug group

Question 5

OTC drugs

Answer 5

Medications available without a prescription

Question 6

Pharmacoeconomics

Answer 6

Cost of drug therapy, dispensing, administration, lab tests; consider losses due to expiration

Question 7

Pharmacogenomics

Answer 7

Study of how a person’s genetic heritage leads to variable responses to drugs

Question 8

Prototype

Answer 8

Often the first drug of a particular drug class to be developed; usually standard against which newer, similar drugs are compared

Question 9

Pharmacotherapy

Answer 9

Use of drugs to prevent, diagnose, or treat signs, symptoms, and disease processes

Question 10

Controlled substances: schedule I

Answer 10

No accepted medical use, lack of accepted safety, high abuse potentials (heroin, LSD, MDMA, Mescaline, peyote)

Question 11

Controlled Substances: Schedule II

Answer 11

Drugs that are used medically but have high abuse potentials (opioid analgesics, CNS stimulants, barbiturate sedative-hypnotics)

Question 12

Controlled Substances: Schedule III

Answer 12

Drugs with less potential for abuse than those in schedules I/II, but abuse of which may lead to psychological or physical dependence (androgens, anabolic steroids, some depressants, CNS stimulants and mixtures containing small amounts of controlled substances)

Question 13

Controlled substances: Schedule IV

Answer 13

Drugs with an accepted medical use in the US but with some potential for abuse (benzodiazepines, other sedative-hypnotics and some appetite suppressants

Question 14

Controlled Substances: Schedule V

Answer 14

Products contains moderate amounts of controlled substances. They may be dispensed by the pharmacist without a physician’s prescription but with some restrictions regarding amount, record keeping and other safeguards. (Cough suppressants, antidiarrheal drugs)

Question 15

Clinical trial five phases

Answer 15

Phase 0: drug testing occurs in animals and small groups of humans
Phase one: doses are given to a certain number of healthy volunteers (determine safe dosages, routes of administration, absorption, metabolism, excretion and toxicity)
Phase two: few doses are given to a certain number of subjects with the disease or symptoms for which the drug is being studied
Phase three: the drug is given to different populations and different dosages; do double blind placebo studies
Phase four: the FDA allows the drug to be marketed and requires manufacturers to continue post-marketing monitoring

Question 16

Role of the FDA in drug approval process?

Answer 16

The FDA is responsible for ensuring new drugs are safe and effective before approving them to be marketed. Reviews test results of phase 0. In phase 4 the FDA allows the drug to be marketed and requires manufacturers to keep monitoring with electronic report submissions. Does not test the drugs.

Question 17

RIghts of Medical Administration

Answer 17

Right drug 
Right dose 
Right patient 
Right route
Right time
Right reason
Right documentation 
Right patient education 
Right evaluation
Right to refuse the medication

Question 18

High-Alert Medication

Answer 18

Drugs that when used in error have a heightened risk of causing significant patient harm (Adrenergic agonists, adrenergic antagonists, anesthetic agents, antidysrhythmics,etc.)

Question 19

The American Geriatric Society Beers Criteria

Answer 19

A list of medications that are generally considered best avoided in older adults, specifically those with certain diseases.

Question 20

Medications

Answer 20

Drugs given for therapeutic purposes