Ch. 2 - Drug Approval Process Flashcards Preview

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Flashcards in Ch. 2 - Drug Approval Process Deck (24)
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1
Q

Pharmacology

A

study of effects of chemical substances on living tissue

2
Q

Sources of Drugs:

A
  1. ) Natural sources:
    * Animals
    * Plants
  2. ) Synthetic:
    * in laboratory
3
Q

Drug Standards:

A

United States Pharmacopeia National Formulatory:

     * Current authoritative source of drug standards 
     * Revised every 5 yrs
4
Q

Drugs = High Standards:

A
  • Therapeutic use
  • Client safety
  • Quality, purity, strength
  • Dosage form
5
Q

1906 - Food & Drug Act:

A

minimal standards of strength, purity & quality

6
Q

1938 - Federal Food, Drug, & Cosmetic Act:

A

Added requirement that drug be safe

7
Q

1952 - Durham-Humphrey Amendment:

A

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

^^^ on every prescription bottle

8
Q

1962 - Kefauver-Harris Amendment:

A

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
9
Q

1970 - Comprehensive Drug Abuse Prevention & Control Act:

A

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

10
Q

Controlled substance schedule:

A

1 & 2 = highest schedule for abuse

5 = lowest schedule for abuse

11
Q

Nursing Interventions: Controlled Substances

A

Have ability to cause physical or psychological dependence

    * Must be renewed q 48-72 hrs.
    * Double-locked storage
12
Q

Nursing Interventions: Controlled Substances … cont…

A

Special records kept:

  * Countersign all discarded or wasted medication
  * Record of med adm. & drug count must match
13
Q

Nurse Practice Acts:

A

Laws re: drug admin by nurses varies by state

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

14
Q

Nurse can be Prosecuted:

A
  1. ) Giving wrong drug
  2. ) Wrong dosage
  3. ) Omitting a drug dose
  4. ) Giving drug by wrong route
15
Q

Misfeasance:

A

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

16
Q

Nonfeasance:

A

Omission - omitting drug abuse –> client’s death

17
Q

Malfeasance:

A

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

18
Q

Drug names (1):

A

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

19
Q

Drug Names (2):

A

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
20
Q

Example……

A

acetaminophen (generic) = not capitalized

Tylenol (brand) = Captalized

21
Q

Drug Resources:

A

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

22
Q

Food & Drug Admin. Pregnancy Categories (1):

A

effect of drugs on fetus

Categories A & B:
*Within safe limits during pregnancies

[see table 12-4, p. 130]

23
Q

Food & Drug Admin. Pregnancy Categories (2):

A

Categories C, D:

* Risk to fetus
* Must weigh risk vs. benefit

Category X:

* Risk to fetus has been proven
* Drug should be avoided
24
Q

Ethical Considerations:

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