Chapter 1 Flashcards
Drug Standards
Rules set to assure consumers that they get what they pay for. The law says that all preparations called by the same drug name must be uniform, strength, quality, and purity.
Drug Standardization
Because of drug standardization, when you take a prescription to be filled, you are assured of getting the same basic drug, in the same quality and amount, no matter what pharmacy or what part of the country you take the prescription to.
1906 Pure Food and Drug Act
- First government attempt to establish consumer protection in the manufacture of food and drugs.
- Required all drugs to meet the minimal standards of strength, quality and purity.
- Demanded labeling for preparations containing dangerous ingredients
- Originally there were 11 “dangerous” drugs, such as morphine
- Established United States Pharmacopeia (USP) and National Formulary (NF)
1938 Federal Food, Drug, and Cosmetic Act and Amendments of 1951, 1962 and 1972
•Established the Food and Drug Administration (FDA) under the Department of Human Services to enforce provisions of the act
•Established more specific regulations to prevent tampering with drugs foods and cosmetics:
-All labels must be accurate and must include a listing of all active and inactive ingredients
-New products must be FDA approved before public release
-“Warning” labels must be present on certain meds. Ex. “May cause drowsiness”
-Certain drugs must be labeled with the legend(inscription): “Caution— federal law prohibits dispensing without a prescription”
-prescription and nonprescription drugs must be proved safe as well as effective
National Drug Code (NDC) Directory
- Established in 1972
* Provided the FDA with a list of all drugs manufactured
Each drug is identified by an NDC number
•3 parts:
- The first part is five numbers and identifies the manufacturer
- The second part is 4 numbers and identifies the drug
- The third part is 2 digits and identifies the package
NDC Number Example
0777-3105-02
•0777 (labeler) (Dista Products)
•3105 (product code) (Prozac Capsules 20mg)
•02 (package code) (total 100)
On page 6 in book
USP/NF
United States Pharmacopeia (USP) and National Formulary (NF) are references that specified the official standards of making each drug
• Those 2 books have been combined into one, referred to as the USP/NF
1970 Controlled Substances Act
- Established the Drug Enforcement Administration (DEA)
- Set tighter controls on a specific group of drugs: those being abused by society. Includes depressants, stimulants, psychedelics, narcotics, and Anabolic steroids
1970 Controlled Substances Act
Guidelines
- Isolated the abused and addicting drugs into 5 levels or scheduled. Based on med value, harmfulness, and potential for abuse: C-I, C-II, C-III, C-IV and C-V
- Any professional who dispenses, receives, sells or destroys controlled substances must keep on hand special DEA forms indicating inventory and a 2 year inventory of every controlled substance transaction.
- regulated number of times a drug may be prescribed within 6 months as well as phoned in
- each prescriber has to be registered with the DEA
DEA Number
All prescribers and drug manufacturers must be registered with the DEA and have their own DEA number
CI
Schedule 1
•High abuse potential
•Not approved for medical use in the US
Ex. Heroin, LSD, mescaline, ecstasy
CII
Schedule 2
•High abuse potential
•May lead to severe dependence
•Written prescription only ( or electronic prescriptions that meet DEA standards)
•no phoning in by the office health care professional, in emergency the physician can phone in, but handwritten prescription must go to pharmacy within 7 days
•no refills without a new prescription
•prescription can be faxed but the original must be handed in to pick up
Ex. Morphine, Codeine, Methadone, Percocet, Dilaudid, Ritalin, OxyContin, meperidine (Demerol), Hydrocodone with Tylenol
CIII
Schedule 3
•May lead to moderate dependence
•written, faxed, or verbal(phoned in) prescription, by physician only
•May be refilled up to 5 times in 6 months
Ex. Codeine and anabolic (muscle building) steroids
CIV
Schedule 4
•lower abuse potential that previous Schedules
•prescription may be written out by the health care professional but must be signed by physician
•prescription may be phoned or faxed in by health care professional
•May be refilled up to 5 times in 6 months
Ex. Valium, Ativan, Xanax, phenobarbital, Librium, Restoril and ambien
CV
Schedule 5
•low abuse potential compared to the previous schedules
•consists primarily of preparations for cough suppressants containing codeine and preparations for diarrhea (ex. Diphenoxylate)
•May be refilled up to 5 times in 6 months
Ex. Promethazine with codeine, Cheratussin AC, Lomotil
Review Page 10 in Book
Responsibilities you have
Three Major Drug Laws
- 1906 Pure Food and Drug Act
- 1938 Federal Food, Drug and Cosmetic Act and Amendments of 1951 and 1962
- 1970 Controlled Substances Act
Controlled Substances
Drugs controlled by additional prescription requirement because of the danger of addiction or abuse
Drug Enforcement Administration (DEA)
A bureau of the Department of Justice that enforces the Controlled Substances Act
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, 1962
Orphan Drugs
Medication for diseases that only affect a small number of people
Over-the-counter (OTC) Medication
Medication available without a prescription
