1906: Pure Food and Drug Act
Prevented misbranding and adulteration of drugs.
1938: Federal Food, Drug, and Cosmetic Act
Required drug safety testing before approval.
1951: Amendment
Distinguished between prescription drugs and over-the-counter (OTC) drugs.
1970: Controlled Substance Act
Created drug schedules based on potential for abuse and medical use.
C-I:
Examples: Heroin, LSD
Characteristics: No accepted medical use, high potential for abuse.
C-II:
Example: Oxycodone
Characteristics: High risk of abuse, tightly regulated.
C-III:
Example: Tylenol with Codeine
Characteristics: Moderate abuse risk.
C-IV:
Example: Lorazepam
Characteristics: Low risk of abuse.
C-V:
Example: Cough medications with codeine
Characteristics: Lowest risk of abuse.
State-run systems that track the prescriptions of controlled substances.
Information on scheduled drugs must be uploaded to the PDMP.
Indications:
The diseases or conditions a drug is used to treat.
Actions:
How the drug works at a physiological level.
Cautions:
Warnings about potential side effects, adverse reactions, or interactions.
Drug Classes:
Groups of drugs that have similar chemical structures, mechanisms of action, and/or therapeutic uses.
Using an approved drug for a condition or in a way that is not approved by the FDA.
Off-label use means the drug is being used for an unapproved condition.
Use of mixed-case letters to help distinguish between drug names that look alike.
Example: CeleBREX vs. CeleXA
The '3' in Tylenol No. 3 indicates the amount of codeine present in the medication.
Specifically, it means that each tablet contains 30 mg of codeine.
Right Route:
Ensuring the drug is administered via the correct route of administration (e.g., oral, intravenous, intramuscular, subcutaneous).
Administering a drug via the incorrect route constitutes a medication error.
Other Rights:
Right client
Right time
Right dose