Question 1

Which of the following is true concerning generic and trade names of drugs?

Accepted Answer

Each drug has only one generic name, but it may have multiple trade names. The generic name is the official scientific name of the drug, while the trade name (also known as the brand name) is the name given to the drug by the pharmaceutical company that manufactures it. Multiple companies may produce the same drug under different trade names, but they all share the same generic name.

Question 2

An investigational new drug application (INDA)is submitted _____ trials.

Accepted Answer

An investigational new drug application (INDA) is submitted before phase 1 clinical trials. Once the IND is accepted, clinical trials can begin. Therefore, the correct answer is before phase 1 clinical trials.

Question 3

Which type of drug name usually begins with a lowercase letter?

Accepted Answer

Generic drug names typically begin with a lowercase letter. This is to distinguish them from brand names and trade names, which usually begin with a capital letter. Code names are internal names used during drug development and may or may not follow specific naming conventions.

Question 4

Which of the following is the most common reference book in the dental office?

Accepted Answer

The answer of Which of the following is the most...

Question 5

Nutritional or herbal supplements:

Accepted Answer

Nutritional or herbal supplements can cause adverse effects, and patients should be cautious when taking them. It is important for healthcare providers to be aware of any supplements their patients are taking to avoid potential interactions with prescription medications.

Question 6

An "orphan drug" is:

Accepted Answer

An orphan drug is a medication developed specifically to treat a rare medical condition, often a disease that affects fewer than 200,000 people in the United States. The Orphan Drug Act of 1983 provides incentives for the development of orphan drugs, as there is typically limited potential for profit due to the small patient population.

Question 7

Which federal regulatory body is part of the U.S. Department of Health and Human Services (DHHS)?

Accepted Answer

The FDA (Food and Drug Administration) is a federal regulatory body that is part of the US Department of Health and Human Services. The FDA is responsible for regulating and supervising various products and services related to public health, such as food, medications, medical devices, and cosmetics.

Question 8

Which federal regulatory body regulates the trade practices of drug companies and prohibits false advertising of foods, nonprescription drugs, and cosmetics?

Accepted Answer

The Federal Trade Commission (FTC) regulates the trade practices of drug companies and prohibits false advertising of foods, nonprescription drugs, and cosmetics. The FDA (A) regulates the safety and efficacy of drugs, medical devices, and food products. The DEA (C) enforces laws related to controlled substances. OBRA (D) stands for the Omnibus Budget Reconciliation Act of 1990, which implemented various provisions related to healthcare. While OBRA includes regulations related to medication use and pharmacy practice, it does not regulate trade practices of drug companies or advertising.

Question 9

How many years must pass after a drug patent expires before other drug companies can market the same compound as a generic drug?

Accepted Answer

After a drug patent expires, other drug companies can immediately market the same compound as a generic drug, meaning there is no waiting period.

Question 10

Schedule III controlled substances may be telephoned to the pharmacist and may be refilled no more than five times in 6 months.

Accepted Answer

Both parts of the statement are true.Schedule III controlled substances may be telephoned to the pharmacist and may be refilled as many as five times in 6 months.Both parts of the statement are true for schedule III and schedule IV controlled substances.Schedule I controlled substances have no accepted medical use.Schedule II controlled substances require a written prescription with the provider's signature,and no refills are permitted.Schedule V controlled substances can be bought OTC in some states.

Question 11

Which of the following is a schedule II controlled substance?

Accepted Answer

Correct: Amphetamine, oxycodone, morphine, and secobarbital are all schedule II controlled substances.
Incorrect choices: Heroin is a schedule I substance. Propranolol is a nonscheduled prescription drug. Dextropropoxyphene is a schedule IV substance.

Question 12

Which of the following is determined during a phase 3 clinical evaluation of a new drug?

Accepted Answer

The answer of Which of the following is determined during...

Question 13

Two drug formulations that produce similar concentrations in the blood and tissues after drug administration are termed _____ equivalent.

Accepted Answer

Biologic equivalence refers to identical pharmacokinetic parameters of two drug formulations (bioequivalence,for short).Chemical equivalence indicates that two formulations of a drug meet the chemical and physical standards established by the regulatory agencies.Therapeutic equivalence means that two formulations produce the same therapeutic effects over the same duration.

Question 14

What is the purpose of a "black box warning" on a package insert?

Accepted Answer

A black box warning is used to draw attention to potentially fatal, life threatening, or disabling adverse effects for different medications. It is considered the strongest warning that the FDA can require and is used to make sure healthcare providers and patients are aware of serious side effects that can occur with the use of a medication.

Question 15

The federal body that determines whether a drug is considered a controlled substance and to which schedule it belongs is the:

Accepted Answer

The Drug Enforcement Administration (DEA) is responsible for determining whether a drug is considered a controlled substance and to which schedule it belongs. The DEA has five schedules of controlled substances, ranging from Schedule I (high potential for abuse, no accepted medical use) to Schedule V (low potential for abuse, accepted medical use). The FDA is responsible for approving drugs for safety and efficacy, but does not determine their controlled substance status. The FTC regulates trade practices in the pharmaceutical industry, and the USP sets standards for the quality, strength, and purity of drugs.

Question 16

Controlled substances in schedule _____ require a written prescription with the provider's signature and do not permit refills.

Accepted Answer

Correct: Controlled substances in schedule II require a written prescription with the provider's signature and do not permit refills. Any prescription for schedule II drugs must be written in pen or indelible ink or typed. A designee of the dentist, such as the dental hygienist, may write the prescription, but the prescriber must personally sign the prescription in ink and is responsible for what any designee has written.
Incorrect choices: Prescriptions for controlled substances in both schedule III and schedule IV may be telephoned, and no more than five prescriptions in 6 months are permitted.

Question 17

Which of the following statements is true regarding planning appointments?

Accepted Answer

The answer of Which of the following statements is true...

Question 18

A drug's generic name is selected by the:

Accepted Answer

The U.S. Adopted Name Council (USAN) is responsible for selecting generic names for drugs in the United States. The USAN is a joint effort between the American Medical Association (AMA), the United States Pharmacopeial Convention (USP), and the FDA. The pharmaceutical company manufacturing the drug may propose a name, but it is ultimately up to the USAN to approve or reject the proposed name. The FDA approves the use of the generic name on drug labels, but it is not responsible for selecting the name. The Federal Patent Office is responsible for granting patents for inventions and discoveries, but is not involved in naming drugs.

Question 19

Phase 1 clinical trials involve all of the following except which one?

Accepted Answer

Phase 1 clinical trials are primarily focused on determining the safe dose range, evaluating potential toxic effects of the drug, and assessing its metabolism in the body. However, effectiveness is not typically evaluated until later phases of clinical trials.

Question 20

Knowledge of pharmacology aids the dental professional in:

Accepted Answer

Knowledge of pharmacology is essential for dental professionals in obtaining a patient's health history, administering drugs in the office, handling emergency situations, and continuing lifelong learning. Therefore, option E, which includes all of these choices, is the best answer.

Quiz 1: Information Sources, Regulatory Agencies, Drug Legislation, and Prescription Writing