Ch. 2 - Drug Approval Process

Question 1

Pharmacology

Answer 1

study of effects of chemical substances on living tissue

Question 2

Sources of Drugs:

Answer 2

1. ) Natural sources:
   * Animals
   * Plants
2. ) Synthetic:
   * in laboratory

Question 3

Drug Standards:

Answer 3

United States Pharmacopeia National Formulatory:

     * Current authoritative source of drug standards 
     * Revised every 5 yrs

Question 4

Drugs = High Standards:

Answer 4

• Therapeutic use
• Client safety
• Quality, purity, strength
• Dosage form

Question 5

1906 - Food & Drug Act:

Answer 5

minimal standards of strength, purity & quality

Question 6

1938 - Federal Food, Drug, & Cosmetic Act:

Answer 6

Added requirement that drug be safe

Question 7

1952 - Durham-Humphrey Amendment:

Answer 7

Legend Drugs:
*labeled “Caution – Federal law prohibits dispensing without prescription

^^^ on every prescription bottle

Question 8

1962 - Kefauver-Harris Amendment:

Answer 8

Amendment to the 1938 Food, Drug, & Cosmetic Act

* D/t thalidomide tragedy of the 1950s:
     - Babies born with severe limb deformities 
     - Include adverse reactions & contraindications

Question 9

1970 - Comprehensive Drug Abuse Prevention & Control Act:

Answer 9

Further classified drugs for potential for causing abuse –> all drugs classified into 1 of 4 categories (schedules)

Question 10

Controlled substance schedule:

Answer 10

1 & 2 = highest schedule for abuse

5 = lowest schedule for abuse

Question 11

Nursing Interventions: Controlled Substances

Answer 11

Have ability to cause physical or psychological dependence

    * Must be renewed q 48-72 hrs.
    * Double-locked storage

Question 12

Nursing Interventions: Controlled Substances … cont…

Answer 12

Special records kept:

  * Countersign all discarded or wasted medication
  * Record of med adm. & drug count must match

Question 13

Nurse Practice Acts:

Answer 13

Laws re: drug admin by nurses varies by state

-Cannot prescribe or administer drugs without a health care provider’s order

Question 14

Nurse can be Prosecuted:

Answer 14

1. ) Giving wrong drug
2. ) Wrong dosage
3. ) Omitting a drug dose
4. ) Giving drug by wrong route

Question 15

Misfeasance:

Answer 15

type of Negligence - giving wrong drug or dose –> clients death

Question 16

Nonfeasance:

Answer 16

Omission - omitting drug abuse –> client’s death

Question 17

Malfeasance:

Answer 17

Giving correct drug but by wrong route –> client’s death

Question 18

Drug names (1):

Answer 18

Chemical name:
*chemical composition
————————————————–
Nonproprietary / Generic name:
*Official name of drug
*Important pharm/chemical characteristic
—————————————————
Most drugs: ordered by GENERIC NAMES

Question 19

Drug Names (2):

Answer 19

Brand/Trade name –> (R w/ circle) [Proprietary name]

  * Registered by US PATENT OFFICE
  * Patent lasts 17 yrs
  * After 17 yrs --> others allowed to manufacture the drug

Question 20

Example……

Answer 20

acetaminophen (generic) = not capitalized

Tylenol (brand) = Captalized

Question 21

Drug Resources:

Answer 21

The Physician’s Desk Reference
***Nursing 2016 Drug Handbook
*Internet sources

Question 22

Food & Drug Admin. Pregnancy Categories (1):

Answer 22

effect of drugs on fetus

Categories A & B:
*Within safe limits during pregnancies

[see table 12-4, p. 130]

Question 23

Food & Drug Admin. Pregnancy Categories (2):

Answer 23

Categories C, D:

* Risk to fetus
* Must weigh risk vs. benefit

Category X:

* Risk to fetus has been proven
* Drug should be avoided

Question 24

Ethical Considerations:

Answer 24

Nurses:
    *Morally & ethically responsible
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ANA Code of Ethics: 
    *Code re: care of clients