DH206 Self-test questions Chapter 1

Which conditions must be met for a drug to be approved as a generic substitution for the patented trade name drug?

Biologically equivalent and Chemically equivalent

All are important reasons for a dental hygienist to have knowledge of pharmacology except:

Prescribing drugs to the dental patient

All are trade names of drugs except:

lidocaine

The study of the action of drugs on living organisms.

pharmacodynamics

The study of what the body does to a drug: the measurement of the absorption, distribution, metabolism, and excretion of drug from the body.

pharmacokinetics

Package Inserts (PIs) contain information aboaut the drug that has been negotiated between the manufacturer and the FDA. What information about the drug must be provided?

Chemical makeup of the drug FDA-approved indications for use, contraindications and warnings, and adverse reactions Drug interactions, dosage and administration

Literature about a drug that is negotiated between the manufacturer and the FDA

Package inserts

A black box warning is most likely to be issued for a drug during which Food and Drug Administration (FDA) clinical phase?

Phase 4

When writing a prescription for opioids or other controlled substances, what is advisable to ensure correct dosage?

Add the number of tablets written in Roman numerals or longhand.

Specific warning to make sure prescriber and patient understand the serious safety concerns associated with that drug

Black box

The __________ of the prescription contains the symbol Rx, name and dose size or concentration (liquids) of the drug, the amount to be dispensed, and the directions to the patient.

Body

A drug may have more than one generic name, but only one trade or propriety name.

Both parts of the statements are false.

All off-label uses of drugs must contain a Black Box warning. The Black Box Warning must contain the FDA indications for the use of the drug, contraindications, warnings, adverse reactions, drug interactions, dose and administrtion, and how the drug is supplied.

Both statements are false.

The use of medications to treat different disease states

pharmacotherapy

The practice of compounding, preparing, dispensing, and counseling patients about their medications.

pharmacy

Which abbreviation stands for every?

q

The study of the the harmful effects of drugs on living tissues

toxicology

All are required on a prescription labels except:

Age of the patient

All statements about generic drugs are true except:

All ingredients in the generic drug must be exactly the same as for the brand name.

When a generic drug is prescribed, then the generic name of the drug and the company that manufactures it are not required on the label. If the trade drug is used, the trade name and the name of the company that manufactures the drug are required on the label.

Both statements are false.

Agency that regulates the trade practices of drug companies and prohibits false advertising

Federal Trade Commission

Which agency grants approval for drugs marketed in the United States after determining the safety and efficiency of the drugs?

Food and Drug Administration

Preclinical testing by the Food and Drug Administration (FDA) is used to determine

a, c, and d only

The abbreviation that means "before meals" is

ac

Which federal regulation requires manufacturers to demonstrate drug effectiveness through strict testing, and submit reports of adverse drug effects of drugs already on the market to the FDA?

Drug Amendments of 1962

Actions initiated by the Food and Drug Administration (FDA) and manufacturer to remove drug or products from the market

Drug recall

Which name is considered the official name of a new drug?

Generic name

Use of a drug outside of the labeled indications approved by the FDA

Off-label use

Mandates that pharmacists must provide patient counseling and prospective drug utilization review for Medicaid patients

Omnibus Budget Reconciliation Act

Encourages development and marketing of products for rare diseases affecting fewer than 200,000 people in the United States

Orphan Drug Program

The abbreviation that means "by mouth" is

PO

Small and then increasing doses administered to a limited number of health human volunteers

Phase I testing

Which schedule of controlled substances has the highest potential for abuse?

Schedule I

All are true of scheduled drugs except:

Schedule II prescriptions can be telephoned to the pharmacist.

Tylenol with added codeine is listed in what schedule of controlled substances?

Schedule III

Which categories of drugs refer to those with the potential for abuse?

Schedule drugs

Metric units are used in prescription writing. All statements are true concerning metric measurements except:

The basic metric unit for volume is the gram (g).

Certain states require the use of triplicate or duplicate prescription blanks for schedule II drugs. Prescriptions for schedule III and IV drugs may be telephoned to the pharmacist and may not be refilled.

The first statement is true; the second statement is false.

Marijuana is a schedule I drug. This designation means that dentists may prescribe it if a dental indication exists.

The first statement is true; the second statement is false.

For a drug to gain Food and Drug Administration approval, which is true concerning animal studies?

The median lethal dose is determined for several species of animals. Animal studies measure both acute and chronic toxicity. Long-term animal studies continue, including a search for teratogenic effects.

The clinic dentist can write a prescription for all situations except...?

Xanax for fear of flying

Which criteria must be met before a dentist can prescribe a medication?

a and c only