Pharmacology Flashcards
(21 cards)
What are controlled substances?
Drugs controlled by additional prescription requirements because of the danger of addiction or abuse.
What is the Drug Enforcement Administration (DEA)?
A bureau of the Department of Justice that enforces the Controlled Substances Act.
What are drug standards?
Federally approved requirements for the specified strength, quality, and purity of drugs. The law says that all preparations called by the same drug name must be of uniform strength, quality, and purity.
What is the Food and Drug Administration (FDA)?
An agency within the Department of Health and Human Services that enforces the provisions of the Federal Food, Drug, and Cosmetic Act and amendments of 1951 and 1962.
What is the National Drug Code (NDC) Directory?
Provides the FDA with a list of all drugs manufactured for commercial distribution.
What are orphan drugs?
Drugs or biological products used for the diagnosis, treatment, or prevention of a rare disease or condition, that is, one affecting fewer than 200,000 persons in the United States, or greater than 200,000 persons where the cost of developing the drug is probably not recoverable in the United States.
USP/NF - 1906 legislation specified the official U.S. standards for making each drug
United States Pharmacopeia (USP)
National Formulary (NF)
What is the abuse potential and medical approval status of Schedule I drugs?
High abuse potential. Not approved for medical use in the United States.
Examples: heroin, LSD, methamphetamine, ecstasy.
What are the characteristics of Schedule II drugs?
High abuse potential, may lead to severe dependence. Written prescription only (or electronic prescription that meets DEA standards). No refills without new written prescription.
Examples: morphine, codeine, methadone, Percocet, Dilaudid, Ritalin, Oxycontin, meperidine (Demerol), hydrocodone with Tylenol.
What are the characteristics of Schedule III drugs?
May lead to moderate dependence. Written, faxed, or verbal (phoned in) prescription by physician only. May be refilled up to five times in six months.
Examples: codeine, anabolic (muscle-building) steroids.
What are the characteristics of Schedule IV drugs?
Lower abuse potential than the previous schedules. Prescription may be written out by the health care professional but must be signed by the physician. May be refilled up to five times in six months.
Examples: Valium, Ativan, Xanax, phenobarbital, Librium, Restoril, Ambien.
What are the characteristics of Schedule V drugs?
Low abuse potential compared to the previous schedules. Consists primarily of preparations for cough suppressants containing codeine and preparations for diarrhea (e.g., diphenoxylate). May be refilled up to five times in six months.
Examples: promethazine with codeine, Cheratussin AC, Lomotil
What act established the Drug Enforcement Administration (DEA)?
The 1970 Controlled Substances Act established the DEA as a bureau of the Department of Justice.
What is the purpose of the Controlled Substances Act?
The act set much tighter controls on drugs being abused by society.
What types of substances are included in the Controlled Substances Act?
The act includes depressants, stimulants, psychedelics, narcotics, and anabolic steroids.
How are controlled substances categorized under the act?
They are isolated into five schedules (C-I, C-II, C-III, C-IV, C-V) based on medical value, harmfulness, and potential for abuse.
What security measures does the Controlled Substances Act demand?
It demands security and accountability for controlled substances, requiring special DEA forms for inventory and transactions.
What limitations does the CSA set on prescriptions?
The act establishes guidelines for each schedule, regulating the number of times a drug may be prescribed in a six-month period.
What is required of prescribers of controlled substances?
Each prescriber must register with the DEA and obtain a DEA registration number for their prescriptions.
Who else must register with the DEA?
Drug manufacturers, pharmacists, physicians, and veterinarians must also be registered with their own DEA numbers.
