chap 4

Question 1

The U.S. Food and Drug Administration regulates:

1. Prescribing of drugs by MDs and NPs
2. The official labeling for all prescription and over-the-counter drugs
3. Off-label recommendations for prescribing
4. Pharmaceutical educational offerings

Answer 1

2. The official labeling for all prescription and over-the-counter drugs

Question 2

The U.S. Food and Drug Administration approval is required for:

1. Medical devices, including artificial joints
2. Over-the-counter vitamins
3. Herbal products, such as St John’s wort

Answer 2

1. Medical devices, including artificial joints

Question 3

An Investigational New Drug is filed with the U.S. Food and Drug Administration:

1. When the manufacturer has completed phase III trials
2. When a new drug is discovered
3. Prior to animal testing of any new drug entity
4. Prior to human testing of any new drug entity

Answer 3

4. Prior to human testing of any new drug entity

Question 4

Phase IV clinical trials in the United States are also known as:

1. Human bioavailability trials
2. Postmarketing research
3. Human safety and efficacy studies
4. The last stage of animal trials before the human trials begin

Answer 4

2. Postmarketing research

Question 5

Off-label prescribing is:

1. Regulated by the U.S. Food and Drug Administration
2. Illegal by NPs in all states (provinces)
3. Legal if there is scientific evidence for the use
4. Regulated by the Drug Enforcement Administration

Answer 5

3. Legal if there is scientific evidence for the use

Question 6

The U.S. Drug Enforcement Administration:

1. Registers manufacturers and prescribers of controlled substances
2. Regulates NP prescribing at the state level
3. Sanctions providers who prescribe drugs off-label
4. Provides prescribers with a number they can use for insurance billing

Answer 6

1. Registers manufacturers and prescribers of controlled substances

Question 7

Drugs that are designated Schedule II by the U.S. Drug Enforcement Administration:

1. Are known teratogens during pregnancy
2. May not be refilled; a new prescription must be written
3. Have a low abuse potential
4. May be dispensed without a prescription unless regulated by the state

Answer 7

2. May not be refilled; a new prescription must be written

Question 8

Precautions that should be taken when prescribing controlled substances include:

1. Faxing the prescription for a Schedule II drug directly to the pharmacy
2. Using tamper-proof paper for all prescriptions written for controlled drugs
3. Keeping any pre-signed prescription pads in a locked drawer in the clinic
4. Using only numbers to indicate the amount of drug to be prescribed

Answer 8

2. Using tamper-proof paper for all prescriptions written for controlled drugs

Question 9

Strategies prescribers can use to prevent misuse of controlled prescription drugs include:

1. Use of chemical dependency screening tools
2. Firm limit-setting regarding prescribing controlled substances
3. Practicing “just say no” to deal with patients who are pushing the provider to prescribe controlled substances
4. All of the above

Answer 9

4. All of the above

Question 10

Behaviors predictive of addiction to controlled substances include:

1. Stealing or borrowing another patient’s drugs
2. Requiring increasing doses of opiates for pain associated with malignancy
3. Receiving refills of a Schedule II prescription on a regular basis
4. Requesting that only their own primary care provider prescribe for them

Answer 10

1. Stealing or borrowing another patient’s drugs

Question 11

Medication agreements or “Pain Medication Contracts” are recommended to be used:

1. Universally for all prescribing for chronic pain
2. For patients who have repeated requests for pain medication
3. When you suspect a patient is exhibiting drug-seeking behavior
4. For patients with pain associated with malignancy

Answer 11

1. Universally for all prescribing for chronic pain

Question 12

A prescription needs to be written for:

1. Legend drugs
2. Most controlled drugs
3. Medical devices
4. All of the above

Answer 12

4. All f the above