Pharmacology Chapter 1

FDA

chemicals identified that might have therapeutic activity tested in animals

Fail: inactive, too toxic, terotogenic, narrow safety margins

human volunteers that are young, healthy, male

Fail: inactive, too toxic, teratogenic, too many adverse effects

human volunteers who have target disease or condition

Fail: less effective, too toxic, too many adverse effects, low benefit to risk ratio, no more effective than current (cost prohibitive for further marketing)

use clinically with perscribers, Info collected by drug company and shared with FDA

continual monitoring by perscribers with reporting to FDA

Prevented the marketing of adulterated drugs; required labeling to elimanate false or misleading claims

1906

1938

Mandated tests for drug toxicity and provided menas for recall of drugs; established procedures for introducing new drugs; gave Food and Drug Administration (FDA) the power of enforcement

1951

Tightened control of certain drugs; specified drugs to be labeled "may not be distributed without a prescription"

1962

Tightened control over the quality of drugs; gave FDA regulatory power over the procedure of drug investigations; stated that efficacy as well as safety of durgs had to be established

1970

Defined drug abuse and classified drugs as to their potential for abuse; provided strict controls over the distribution, storage, and use of these drugs. Gave enforcement to the DEA

1983

Provided incentives for the development of orphan drugs for treatment of rare diseases

having an adverse effect on the fetus

adequate studies in pregnant women with no demonstrated risk to fetus

animal studies have not demonstrated a risk to the fetus, but no studies in pregnancy OR animal studies adverse, but studies in pregnant women okay

animal studies have shown an adverse effect on the fetus, but no adequate human studies

Evidence of human fetal risk, but benefits to pregnant women may be acceptable

all risk no benefit

High abuse potential and no acceptable medical use 

Example: Heroine, LSD

High abuse potential with sever dependence liability 

Examples: Morphine, Demerol, Oxycodone

• less abuse potential than schedule II with moderate dependence
• Examples:  Codeine with acetaminophen (Tylenol #3)
•  

• Less abuse potential than Schedule II with limited dependence liability
• Examples: Xanax (alprazolam)

• Limited abuse potential and dependence. 
• Examples: cough meds

medicines that a company hasnt adopted because the demand is so small that it will not be much of a profit

• Example:  
• Cinryze 1,000 units every 3-4 days.
•        1 vile has 500 units
•         cost per vile $2411.58 with coupon 

• PDR
• Package Inserts
• Medical Letter
• Journal Reviews
• Drug Facts and Comparisons
• Pharmacist
• Internet Sources