Drug Definitions, Standards, and Information Sources

These flashcards cover essential definitions, classifications, and regulations related to pharmacology, as discussed in the lecture notes.

What are the three types of drug names that can be differentiated?

Chemical, generic, and brand names.

What is the difference between prescription and nonprescription drugs?

Prescription drugs require an order from a licensed health professional, while nonprescription drugs can be purchased over-the-counter.

What are therapeutic methods used in pharmacology?

Approaches to treating illnesses including diet therapy, drug therapy, physiotherapy, and psychotherapy.

What is the meaning of biologic therapy?

A new class of drugs that transform the treatment of patients with disorders that attack the body's own organs, tissues, and cells.

How are drugs classified?

By body system classification, therapeutic use, or physiological/chemical action.

What constitutes a drug’s chemical name?

The name that provides the exact chemical constitution of the drug, understood by chemists.

What are the differences between generic and brand names of drugs?

Generic names are not capitalized and used in formularies; brand names are capitalized and trademarked by manufacturers.

What is the purpose of the United States Pharmacopeia (USP)?

It is the official source for American drug standards.

What is the average time it takes for a drug to go through clinical research and development?

It may require 2 to 10 years, with an average of 5 years.

What is a black box warning?

A warning that indicates a very serious life-threatening problem with a drug.

What is the Orphan Drug Act?

A law that promotes development of medicines for rare disorders.

What are the phases of new drug development according to FDA regulations?

Preclinical research, clinical research, New Drug Application review, and postmarketing surveillance.

What are controlled substances?

Drugs that require registration with the DEA and have specific legal requirements for their dispensing.

What Canadian legislation oversees drug safety and regulation?

Food and Drugs Act and Controlled Drugs and Substances Act.