Arcangelo Chapter 1 - Issues for the Practitioner

Question 1

Application to the FDA for investigational use of a drug is made only after this portion of research is completed

Answer 1

A pre-clinical trial

Question 2

Clinical trials consist of ____ clinical phases and may last up to ____ years

Answer 2

Four

Nine

Question 3

This is the clinical phase in which healthy people are tested and concentrates on pharmacokinetics

Answer 3

Phase I

Question 4

In this clinical phase patients with the disease are tested for drug effects

Answer 4

Phase II

Question 5

Double-blind research is used to compare an effective drug with a new one in this clinical phase

Answer 5

Phase III

Question 6

Once on the market, a drug enters this clinical phase and everyone who takes it is monitored

Answer 6

Phase IV

Question 7

These drugs have a high potential for abuse and are not available for routine therapeutic use (heroin, LSD)

Answer 7

Schedule 1 drugs

Question 8

These drugs have a valid medical use but have a high potential for abuse, both physiologically and psychologically (amphetamines, barbiturates)

Answer 8

Schedule 2 drugs

Question 9

These drugs have a lower potential for abuse and contain controlled and non-controlled substances (narcotics such as codeine, non-barbiturate sedatives)

Answer 9

Schedule 3 drugs

Question 10

These drugs have a low potential for abuse but may cause psychological dependence (non-narcotic analgesics, anti-anxiety agents such as Ativan)

Answer 10

Schedule 4 drugs

Question 11

These drugs have the least potential for abuse and are used mainly as antitussives and antidiarrheals

Answer 11

Schedule 5 drugs

Question 12

Prescriptions for this level of drug may be prescribed by telephone only in an emergency and must be backed by a written proscription within 72 hours

Answer 12

Schedule 2 drugs

Question 13

Prescriptions for these drugs cannot be refilled

Answer 13

Schedule 2 drugs

Question 14

A verbal order may be given to the pharmacy for these drugs and the prescription may be refilled up to five times in six months

Answer 14

Schedule 3 drugs

Question 15

What must be included on the prescription for a controlled substance for the prescription to be valid

Answer 15

The US Drug Enforcement Agency (DEA) number

Question 16

What is used to uniquely identify a health care provider in standard transactions such a s health care claims and was created by CMS

Answer 16

The National Provider Identifier (NPI)

Question 17

What drugs approved by the FDA, are legally obtained without a prescription, are often self-prescribed, and may delay the diagnosis of potentially serious problems

Answer 17

OTC

Question 18

What drugs must demonstrate therapeutic equivalence to a brand name drug before being released for use

Answer 18

Generic drugs

Question 19

The AUC values obtained for a generic drug must be within ___% to ___% of those obtained for the brand name drug

Answer 19

80, 125

Question 20

What is found on the label of herbal products

Answer 20

The effect of the product on the body and a statement that the product has not been reviewed by the FDA

Question 21

Prescribing practices of practitioners are regulated by whom

Answer 21

The state in which the practitioner practices

Question 22

What type of practice has no requirements for physician collaboration or supervision

Answer 22

Independent

Question 23

What type of practice requires a formal agreement with a physician

Answer 23

Collaborative

Question 24

What type of practice is overseen or directed by a supervisory physician

Answer 24

Supervised

Question 25

What type of practice involves a delegated medical act

Answer 25

Delegated

Question 26

What directs the receipt and dispensing of drug samples to patients

Answer 26

The Prescription Drug Marketing Act (PDMA) of 1988

Question 27

Give an example of drug underuse

Answer 27

Not prescribing an inhaled steroid for an asthma patient that uses his albuterol daily

Question 28

Give an example of drug overuse

Answer 28

Prescribing an antibiotic for a cold

Question 29

Give an example of drug misuse

Answer 29

Prescribing HCTZ to someone with a sulfa allergy

Question 30

The inherited variation in genes that dictate drug response

Answer 30

Pharmacogenomics

Question 31

The most appropriate agent to treat a disease is also called what

Answer 31

First-line therapy