Arcangelo Chapter 1 - Issues for the Practitioner Flashcards Preview

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Flashcards in Arcangelo Chapter 1 - Issues for the Practitioner Deck (31)
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1
Q

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

A

A pre-clinical trial

2
Q

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

A

Four

Nine

3
Q

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

A

Phase I

4
Q

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

A

Phase II

5
Q

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

A

Phase III

6
Q

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

A

Phase IV

7
Q

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

A

Schedule 1 drugs

8
Q

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

A

Schedule 2 drugs

9
Q

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

A

Schedule 3 drugs

10
Q

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

A

Schedule 4 drugs

11
Q

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

A

Schedule 5 drugs

12
Q

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

A

Schedule 2 drugs

13
Q

Prescriptions for these drugs cannot be refilled

A

Schedule 2 drugs

14
Q

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

A

Schedule 3 drugs

15
Q

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

A

The US Drug Enforcement Agency (DEA) number

16
Q

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

A

The National Provider Identifier (NPI)

17
Q

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

A

OTC

18
Q

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

A

Generic drugs

19
Q

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

A

80, 125

20
Q

What is found on the label of herbal products

A

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

21
Q

Prescribing practices of practitioners are regulated by whom

A

The state in which the practitioner practices

22
Q

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

A

Independent

23
Q

What type of practice requires a formal agreement with a physician

A

Collaborative

24
Q

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

A

Supervised

25
Q

What type of practice involves a delegated medical act

A

Delegated

26
Q

What directs the receipt and dispensing of drug samples to patients

A

The Prescription Drug Marketing Act (PDMA) of 1988

27
Q

Give an example of drug underuse

A

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

28
Q

Give an example of drug overuse

A

Prescribing an antibiotic for a cold

29
Q

Give an example of drug misuse

A

Prescribing HCTZ to someone with a sulfa allergy

30
Q

The inherited variation in genes that dictate drug response

A

Pharmacogenomics

31
Q

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

A

First-line therapy