Chapter 2: Pharmaceuticals: Development, Safeguard and Delivery

Question 1

Chemical Composition

Answer 1

Describes the chemical base of a drug. (Ex. In the case of Morphine sulfate the chemical composition is described as opium, and therefore it is an opiate or opioid).

Question 2

Chemical Name

Answer 2

Precisely describes a drugs atomic and molecular structure, with exact chemical nomenclature and terminology.

Question 3

Clinical Trials

Answer 3

If approved, an investigational new drug will then undergo clinical trials. There are 4 phases to the clinical trial and it usually lasts from 4-10 years.

Phase I thru III take place before a new drug is marketed.
Phase IV is completed after marketing begins.

Question 4

Controlled Substance

Answer 4

Drugs with a high risk of abuse and addiction are ranked on a scale of I thru based on abuse potential and medical usefulness - thus the term a controlled substance.

Question 5

Drug Classifications (Drug Families)

Answer 5

Groups of drugs that share similar characteristics.

Question 6

Generic Name

Answer 6

A non-proprietary drug name which identifies the drug’s active ingredient.

Question 7

Legend Drugs

Answer 7

Prescription drugs, that must be identified by the “legend” or description on the side. All of these drugs must have the legend and the this necessitates a prescription, which can only be filled out by a NP.

Question 8

National Formulary

Answer 8

After a generic drug name is determined by the United States Adopted Names Council, it is published in both the United States Pharmacopeia and the National Formulary.

Question 9

Orphan Drugs

Answer 9

A drug that a company invests in, which treats a relatively rare disease. Generally these companies receive a tax compensation for doing so.

Question 10

Pharmacogenetics

Answer 10

The study of how a patients genetic variable effects the pharmacodynamics of a drug.

Question 11

Pharmacogenomics

Answer 11

The prediction of the sensitivity or resistance of an individual patients disease to a specific drug or group of drugs.

Question 12

Physiological Classification

Answer 12

Classification of drugs based on which body system(s) they effect.

Question 13

Placebo Response

Answer 13

The positive response by a patient based (perhaps only) on the fact that they are receiving therapeutic interventions by an interested health care person(el).

Question 14

Preclinical Trials

Answer 14

Designed to provide basic safety, bioavailability, pharmacokinetic and initial efficacy data about a drug.

These trials are performed on animals and last about 3 and 1/2 years. About 1 in every 1,000 new substance that comes into a lab makes it to human trial.

Question 15

Therapeutic Classification

Answer 15

This classification groups the drug according to it’s therapeutic implementation.

Question 16

Trade Name

Answer 16

The brand name, or proprietary name of a drug. For example, Lopressor.

Question 17

United States Pharmacopeia

Answer 17

After a generic drug name is determined by the United States Adopted Names Council, it is published in both the United States Pharmacopeia and the National Formulary.