Chapter 1 - Consumer Safety And Drug Regulations

Question 1

Over-the-counter medication (OTC)

P. 592

Answer 1

Medication available without a prescription

Question 2

Drug standards

P. 4

Answer 2

• Are rules set to assure consumers that they get what they pay for.
• must be of uniform strength, quality and purity.
  * federally approved requirements

Question 3

1906 Pure Food and Drug Act

P.5

Answer 3

In 1906, government attempt to establish consumer protection in the manufacture of drugs and Foods.

  * United States pharmacopeia (USP)
  * National formulary (NF)

Today it is in one book - USP/NF

Question 4

Orphan Drugs

P. 7

Answer 4

1983 orphan Drug Act gives pharmaceutical companies financial incentives to develop medications for diseases that affect only a small number of people.

Question 5

National Drug Code (NDC) Directory

P. 5

Answer 5

Was established in 1972. This provided the FDA with a list of all drugs manufactured for commercial distribution. Each drug is identified by in NDC number, made up of three parts:

• first part is 5 numbers and identifies the manufacturer.
• second part is 4 numbers and identifies the drug.
• third part is two digits and identifies the package size.

Example: 00406-0123-01 ( it is common practice to Omit a leading zero in the first and second part of the NDC number.

Question 6

Omnibus Budget Reconciliation Act (OBRA) of 1990

P. 7

Answer 6

This act mandates that all OTC drugs a patient is taking must be documented as part of the medical record. Also, mandates pharmacists provide drug use review and patient counseling before dispensing prescriptions to a patient.

Question 7

Drug Enforcement Administration (DEA)

P. 7

Answer 7

The 1970s controlled substance act established the Drug Enforcement Administration (DEA) as a Bureau of the Department of Justice to enforce the provisions of the act.

• set much tighter controls on a specific group of drugs: those that were being abused by Society; the ACT indicates that such substances needed to be controlled.

Question 8

1970 Controlled Substances

P. 7

Answer 8

Established the Drug Enforcement Administration (DEA)

• isolated the abused and addicting drugs into 5 levels, or schedules; medical value, harmfulness, potential for abuse or addiction:

• C I
• C II
• C III
• C IV
• C V
• demanded security and accountability of.
• set limitations on the use of prescription; guidelines established for each of the 5 schedules of substances.
• demanded that each prescriber of these substances register with the DEA and obtain DEA regulation number to be present all controlled substances; also drug manufacturers.

Question 9

Food and Drug Administration (FDA)

P. 9

Answer 9

• overseas testing of all proposed new drugs before they are released into the U.S. market.
• inspecting plants where Foods, drugs, medical devices, or Cosmetics are made.
• reviewing new drug applications and petitions for food additives.
• Investigating and removing unsafe drugs from the market.
• ensuring proper labeling of foods, cosmetics, and drugs.

Question 10

1938 Federal Food, Drug, and cosmetic act and Amendments of 1951, 1962 and 1972

(P. 5)

Answer 10

• Established the Food and Drug Administration (FDA) under the Department of Health and Human Services to enforce the provisions of the Act.
• Established more specific regulations to prevent adulteration of (tampering with) drugs, foods and cosmetics:
• All labels must be accurate and must include a listing of all active and inactive ingredients.
• All new products must be approved by the FDA before public release.
• Warning labels must be present on certain preparations, for example, “may cause drowsiness”.
• Certain drugs must be labeled with the legend (inscription): caution-federal law prohibits dispensing without a prescription.
• Prescription and non-prescription drugs must be shown to be effective as well as safe.
• In 1972, National Drug Code (NDC) Directory