Chapter 1

Question 1

Drug Standards

Answer 1

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.

Question 2

Drug Standardization

Answer 2

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.

Question 3

1906 Pure Food and Drug Act

Answer 3

• 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)

Question 4

1938 Federal Food, Drug, and Cosmetic Act and Amendments of 1951, 1962 and 1972

Answer 4

•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

Question 5

National Drug Code (NDC) Directory

Answer 5

• Established in 1972

* Provided the FDA with a list of all drugs manufactured

Question 6

Each drug is identified by an NDC number

Answer 6

•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

Question 7

NDC Number Example

Answer 7

0777-3105-02
•0777 (labeler) (Dista Products)
•3105 (product code) (Prozac Capsules 20mg)
•02 (package code) (total 100)

On page 6 in book

Question 8

USP/NF

Answer 8

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

Question 9

1970 Controlled Substances Act

Answer 9

• 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

Question 10

1970 Controlled Substances Act

Guidelines

Answer 10

• 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

Question 11

DEA Number

Answer 11

All prescribers and drug manufacturers must be registered with the DEA and have their own DEA number

Question 12

CI

Schedule 1

Answer 12

•High abuse potential
•Not approved for medical use in the US
Ex. Heroin, LSD, mescaline, ecstasy

Question 13

CII

Schedule 2

Answer 13

•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

Question 14

CIII

Schedule 3

Answer 14

•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

Question 15

CIV

Schedule 4

Answer 15

•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

Question 16

CV

Schedule 5

Answer 16

•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

Question 17

Review Page 10 in Book

Answer 17

Responsibilities you have

Question 18

Three Major Drug Laws

Answer 18

• 1906 Pure Food and Drug Act
• 1938 Federal Food, Drug and Cosmetic Act and Amendments of 1951 and 1962
• 1970 Controlled Substances Act

Question 19

Controlled Substances

Answer 19

Drugs controlled by additional prescription requirement because of the danger of addiction or abuse

Question 20

Drug Enforcement Administration (DEA)

Answer 20

A bureau of the Department of Justice that enforces the Controlled Substances Act

Question 21

Food and Drug Administration (FDA)

Answer 21

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

Question 22

Orphan Drugs

Answer 22

Medication for diseases that only affect a small number of people

Question 23

Over-the-counter (OTC) Medication

Answer 23

Medication available without a prescription