Ch. 2 - Drug Approval Process Flashcards Preview

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

Pharmacology

study of effects of chemical substances on living tissue

2

Sources of Drugs:

1.) Natural sources:
*Animals
*Plants

2.) Synthetic:
*in laboratory

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Drug Standards:

United States Pharmacopeia National Formulatory:
*Current authoritative source of drug standards
*Revised every 5 yrs

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Drugs = High Standards:

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

5

1906 - Food & Drug Act:

minimal standards of strength, purity & quality

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1938 - Federal Food, Drug, & Cosmetic Act:

Added requirement that drug be safe

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1952 - Durham-Humphrey Amendment:

Legend Drugs:
*labeled "Caution -- Federal law prohibits dispensing without prescription

^^^ on every prescription bottle

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1962 - Kefauver-Harris Amendment:

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

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1970 - Comprehensive Drug Abuse Prevention & Control Act:

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

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Controlled substance schedule:

1 & 2 = highest schedule for abuse

5 = lowest schedule for abuse

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Nursing Interventions: Controlled Substances

Have ability to cause physical or psychological dependence
* Must be renewed q 48-72 hrs.
* Double-locked storage

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Nursing Interventions: Controlled Substances ... cont...

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

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Nurse Practice Acts:

Laws re: drug admin by nurses varies by state

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

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Nurse can be Prosecuted:

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

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Misfeasance:

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

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Nonfeasance:

Omission - omitting drug abuse --> client's death

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Malfeasance:

Giving correct drug but by wrong route --> client's death

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Drug names (1):

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

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Drug Names (2):

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

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Example......

acetaminophen (generic) = not capitalized

Tylenol (brand) = Captalized

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Drug Resources:

American Hospital Formulary Service (AHFS) Drug Information
------------------------------------------------------
The Physician's Desk Reference
***Nursing 2016 Drug Handbook
*Internet sources

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Food & Drug Admin. Pregnancy Categories (1):

effect of drugs on fetus

Categories A & B:
*Within safe limits during pregnancies

[see table 12-4, p. 130]

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Food & Drug Admin. Pregnancy Categories (2):

Categories C, D:
*Risk to fetus
*Must weigh risk vs. benefit

Category X:
* Risk to fetus has been proven
* Drug should be avoided

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Ethical Considerations:

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