Chapter 22 (Not the spelling words) Flashcards
drug
Any substance that when taken into the body, may modify one or more of its functions
Food, Drug, and Cosmetic Act (FDCA)
- 1938
- Regulates quality, purity, potency, effectiveness, safety, labeling, and packaging of food, drug, and cosmetic products
- Enforced by the Food and Drug Administration (FDA)
Controlled Substances Act
- Regulates manufacture, distribution, and dispensing of controlled substances
- Drugs that have the potential of being abused and of causing physical or psychological dependence
- Enforced by the Drug Enforcement Administration (DEA)
Schedule I drugs
- Not considered to be legitimate for medical use in the United States
- Used for research only and cannot be prescribed
- High risk for abuse
- Examples: LSD, heroin, marijuana
Schedule II drugs
- Accepted medical use but have a high potential for abuse or addiction
- Must be ordered by written prescription
- Cannot be refilled without a new, written prescription
- Examples: morphine, cocaine, codeine, Demerol, Dilaudid
Schedule III drugs
- Moderate potential for abuse or addiction, low potential for physical dependence
- May be ordered by written prescription or by telephone order
- Prescription expires in 6 months – may not be refilled more than 5 times in 6-month period
- Examples: Tylenol with codeine, Butisol, Hycodan
Schedule IV drugs
- Less potential for abuse or addiction than those of Schedule III, with limited physical dependence
- May be ordered by written prescription or by telephone order
- May be refilled up to 5 times in a 6-month period – prescription expires in 6 months
- Examples: Librium, Valium, Darvon, Equanil
Schedule V drugs
- Have a small potential for abuse or addiction
- May be ordered by written prescription or by telephone order
- No limit on prescription refills
- Some of these drugs may not need prescription
- Examples: Robitussin-AC, Donnagel-PG, Lomotil
Drug Standards
-Rules established to control strength, quality, and purity of medications prepared by various manufacturers
-Require all preparations called by the same drug name to be of a uniform strength, quality, and purity
-United States Pharmacopeia/National Formulary (USP/NF)=Contains formulas and information that provide standards for preparation and dispensation of drugs.
Recognized by U.S. government as the official listing of standardized drugs in the United States.
FDCA specifies a drug is official when it is listed in USP/NF
Drug References
- Available for health professionals responsible for safe administration of medications
- Provide the following information: Composition, action, indications for use, contraindications for use, precautions, side effects, adverse reactions, route of administration, dosage range, and what forms are available
Physicians’ Desk Reference
-Published yearly by Thomson Reuters
-Manufacturers pay to list information about their products in the PDR
-Same information that appears on package inserts (as required by the FDA)
-Generic name, indications, contraindications, adverse effects, dosage, and route of administration
-Additional references:
Physicians’ Desk Reference for Nonprescription Drugs
Physicians’ Desk Reference for Ophthalmology
Drug Interactions and Side Effects Index
Indications Index
Drug Facts and Comparisons
- drugs according to their therapeutic classification
- Same basic facts as other drug references
- Particularly helpful in comparing the various drugs within each category to other products
- In reference to effectiveness, content, and cost
Drug sources
Plants
Minerals
Animals
Synthetic
generic name
- Name that was established when drug was first manufactured
- Written in lowercase letters
- Official name of a drug
- Each drug has only one generic name
- Original manufacturer is only company that can use generic name for the first 17 years
brand name
- Name under which the drug is sold by a specific manufacturer
- Spelling always begins with a capital letter
- Also known as the trade name
- Name is owned by the drug company and no other company may use that name
- Each brand name carries a registered trademark symbol ®