Chapter 1 - Consumer Safety And Drug Regulations Flashcards Preview

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Flashcards in Chapter 1 - Consumer Safety And Drug Regulations Deck (10)
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1
Q

Over-the-counter medication (OTC)

P. 592

A

Medication available without a prescription

2
Q

Drug standards

P. 4

A
  • Are rules set to assure consumers that they get what they pay for.
  • must be of uniform strength, quality and purity.
    * federally approved requirements
3
Q

1906 Pure Food and Drug Act

P.5

A

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

4
Q

Orphan Drugs

P. 7

A

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

5
Q

National Drug Code (NDC) Directory

P. 5

A

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.

6
Q

Omnibus Budget Reconciliation Act (OBRA) of 1990

P. 7

A

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.

7
Q

Drug Enforcement Administration (DEA)

P. 7

A

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.

8
Q

1970 Controlled Substances

P. 7

A

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.
9
Q

Food and Drug Administration (FDA)

P. 9

A
  • 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.
10
Q

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

(P. 5)

A
  • 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