Week 1 - Clinical Judgment and Safety

Question 1

List three most important properties of drugs. Which is the most important?

Answer 1

Effectiveness, safety, selectivity.

Effectiveness most important.

Question 2

What does selectivity mean?

Answer 2

Produces only desired responses for which it is given.

Question 3

List three types of drug names. Which is the best for communicating between health professionals?

Answer 3

Chemical, generic, trade

Generic name is the best.

Question 4

What factor primarily determines the drug concentration at the receptor?

Answer 4

Administration.

Question 5

Pharmacokinetics determines what?

Answer 5

How much of a drug reaches the sites of action

Question 6

List four processes of pharmacokinetics.

Answer 6

Absorption, distribution, metabolism, excretion`

Question 7

How does changing the route from intravenous to oral influence dosage?

Answer 7

Oral dosages are usually higher than intravenous dosages, because there is a barrier to absorption.

Question 8

Pharmacodynamics refers to what action?

Answer 8

The nature and intensity of response at its site of action.

Question 9

Name the six rights of safe medication administration.

Answer 9

Right patient, right drug, right dose, right route, right time, right documentation

Question 10

Explain the difference between a contraindication and precaution.

Answer 10

A contraindication prevents the drug use under all but the most severe circumstances. A precaution increases the likelihood of an adverse reaction, but not a life–threatening one.

Question 11

The Federal Food, Drug, and Cosmetic Act of 1938 resulted in what mandate?

Answer 11

Testing for toxicity

Question 12

The Harris-Kefauver Amendment of 1962 mandated what two requirements?

Answer 12

Proof of effectiveness and rigorous testing procedures.

Question 13

The Controlled Substances Act of 1970 identified drugs with a potential for what? What was developed?

Answer 13

Potential for abuse.

Developed Schedules I – V

Question 14

Schedule I includes what types of drugs? Schedule II?

Answer 14

Schedule I- Drugs with no acceptable medical use and high abuse potential.
Schedule II- Drugs with therapeutic use, but high abuse potential.

Question 15

THE FDA Amendments Act (FDAAA) of 2007 allowed the FDA oversight over what?

Answer 15

Safety oversight over drugs that had been approved. Specifically gave the FDA the authority to require postmarketing safety studies, labeling changes to include new safety information, and restricting the distribution of drugs with safety concerns.

Question 16

What does “off-label” mean?

Answer 16

Taking a drug approved by the FDA for as different reason. The FDA did not approve it for this alternative use.

Question 17

The Randomized Controlled Trial (RCT) requires what three features in drug testing?

Answer 17

Controls, randomization, blinding

Question 18

Preclinical testing of a drug is done on whom?

Answer 18

Animals

Question 19

List the four phases of clinical testing and identify the sample and goal. Which is post-marketing?

Answer 19

Phase I – healthy volunteers, evaluation of drug metabolism, pharmacokinetics, and biologic effects
Phase II & III– patients, therapeutic use and dosage, safety and effectiveness
Phase IV – patients, postmarketing surveillance of a large population

Question 20

What is the best human resource for drug information?

Answer 20

Pharmacists.

Question 21

Define an adverse drug reaction.

Answer 21

Any noxious, unintended, and undesired effect that occurs at NORMAL drug doses.

Question 22

List 4 risk factors for adverse drug reactions.

Answer 22

Elderly, very young, severe illness, multiple drug use

Question 23

Define side effect.

Answer 23

A nearly unavoidable secondary drug effect produced at therapeutic doses.

Question 24

Define toxicity.

Answer 24

An adverse drug reaction caused by excessive dosing.

Question 25

Define allergic reaction.

Answer 25

An immune response triggered by a previous sensitizing administration.

Question 26

Define idiosyncratic effect.

Answer 26

An uncommon response resulting from a genetic predisposition.

Question 27

Define iatrogenic disease.

Answer 27

A disease produced by a healthcare provider or by a drug.

Question 28

Define physical dependence.

Answer 28

A state in which the body has adapted to prolonged drug exposure and will result in an abstinence syndrome if the drug is abruptly discontinued.

Question 29

Define carcinogenic effect.

Answer 29

The ability to cause cancer.