Pharmacology legal stuff

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1906: Federal Food and Drug Act

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1906: Federal Food and Drug Act

Safe labeling of drugs & formation of the National Formulary &

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USP, as government standard for drug literature.

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1938: 1906 Act revised to create Federal Food, Drug, and Cosmetic Act, June 25, 1938

mandatory testing for safety prior to marketing!

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Sherley Amendment to Food and Drug Act

prohibits fraudulent therapeutic claims.

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Harrison Narcotic Act

Established legal term "narcotic".

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1951 Durham-Humphrey Amendment of Food & Drug Act

established "legend" drugs ( must be prescribed) versus OTC/over the counter and also specified that narcotics, etc not be refilled without a new prescription.

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1962 Kefauver-Harris Amendment

required that both safety & efficacy be proven prior to marketing new drug.

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1970 Controlled Substance Act

established schedules of drugs according to abuse potential (I/1 = highest; V/5= lowest).

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1983 Orphan Drug Act

enabled FDA to promote research and marketing of drugs used to treat rare disease.

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1991 Accelerated Drug Approval

Regulations to speed up the FDA drug review process for investigational new drugs to treat life threatening diseases

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U.S. Controlled Drug Schedule

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SCHEDULE I DRUGS

Dispensed only with approved protocol

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US Controlled Drug Schedule

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Schedule II Drugs

Written prescription required within 24 hours.

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•No prescription refills

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US Controlled Drug Schedule

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Schedule III Drugs

•Written or oral prescription

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•No more than five refills in 6 months

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•May lead to moderate or low physical dependence or high psychological dependence.

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US Controlled Drug Schedule

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Schedule IV Drugs

•Container must have warning label

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•Written or oral prescription

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•No more than five refills in 6 months

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•May lead to moderate or low physical dependence or high psychological dependence

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US Controlled Drug Schedule

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Schedule V Drugs

•Written or OTC

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•Varies with each state law

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Pharmacology and Nursing Practice

The nurse's responsibilities include knowledge & understanding of:

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What drug is ordered.

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Why the drug has been prescribed for the client.

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How the drug is supplied by the pharmacy.

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How the drug is administered, including dose ranges.

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What nursing process considerations r/t the drug apply to this patient.

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Chemical Name

According to the drug's chemical composition and molecular structure. i.e. acetylsalicylic acid/ASA

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Generic Name

  • Nonproprietary name that is short & simple. It is not capitalized.

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  • Given by the United States Adopted Name Council (USAN)

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  • Drug formularies are maintained by the generic name.

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i.e. aspirin

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Trade Name

-Propriety name

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-First letter is capitalized

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-Indicates drug has a registered trademark

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-Indicates the commercial use is restricted to the owner of the patent of the drug.

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i.e. Bayer aspirin

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Classification of Drugs: Therapeutic

describes what is being treated by the drug.

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Classification of Drugs: Pharmacologic

Describes how the drug acts.

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Drug Prototypes

The drug in which all others are compared

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Pharmaceutics

study of how various dosage "forms" influence pharmacokinetic and pharmacodynamics properties of drugs.

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Pharmacokinetics

study of what the body does to the drug

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Pharmacodynamics

study of what the drug does to the body

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Toxicology

Adverse Effects

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Route

is very important with regard to rate of availability. Topical, Sublingual, Parenteral and Enteral are the routes

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Pharmacokinetics: Absorption

Rate drug is absorbed from site of administration and extent to which it occurs

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Bioavailibility

expresses the "quantity" extent of drug absorption.

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Enteral route

Absorption occurs through gastric mucosa, small intestine, or rectum, and passes through the portal circulation into the liver

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First Pass Effect

Metabolism in the liver and return to circulation is the

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Percutaneous

(sublingual, buccal, vaginal) application to body surfaces and IV routes BYPASS the LIVER and go directly to site of action (NO FIRST-PASS EFFECT).

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Parenteral

(IM, IV, SUBQ)-IV fastest then IM and finally subq; depends upon blood flow (heat will increase). Suspensions are slower to absorb (Bicillin).

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METABOLISM(biotransformation)

results in transformation of drug into:

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  • Inactive metabolite

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  • More soluble compound

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  • Or more potent metabolite

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The enzyme systems (cytochrome P-450) of the liver are the primary site

  • Drugs as substrates

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  • Drugs as enzyme inhibitors

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  • Drugs as enzyme inducers

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Half-Life

time it takes for one half of the original amount of drug taken to be removed from body

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Rule of Thumb

when a drug is discontinued it takes approximately four half-lives before the agent is considered 'functionally" eliminated. (94% is eliminated).

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Onset of Action

Time required for drug to begin to take effect

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Peak Effect

Time it takes for the drug to take maximum effect

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Peak

highest concentration of drug in blood

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Trough:

Lowest concentration of drug in blood

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Duration of Action

The length of time the drug concentration is sufficient to continue to be effective

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Loading Dose

is a higher amount of drug, often given only once or twice to "prime" the bloodstream with a level sufficient to quickly induce a therapeutic response

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Maintenance Dose

before plasma levels drop back toward zero, intermittent doses are given to keep the plasma drug concentration in the therapeutic range

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therapeutic effect

Drug-induced change in normal physiologic function. A positive change in faulty physiologic system

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Therapeutic Index

describes a drug's margin of safety.

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the ratio of a drug's toxic level to the level that provides therapeutic effects

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Mechanism of Action

(therapeutic effect) produced in several ways: Receptor Interaction, Enzyme Interaction, Nonspecific Interaction

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Receptor

Selective joining of drug molecule with reactive sites on cell surface- "affinity"

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  • Agonists

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  • Antagonists

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  • Agonist-antagonists

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Enzyme Interaction

Drug binds with enzyme to create a therapeutic effect (ie., ACE inhibitors for HTN).

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Nonspecific Interactions

Direct cellular effect (cell wall destruction of some antibiotics; starvation of cells by oncology medications).

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Acute

Drugs used to treat a disorder of sudden onset.

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Maintenance

Drugs used to treat chronic conditions.

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Supplemental

Drug used to maintain normal function.

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Palliative

Drugs used to make client comfortable during a terminal illness.

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Supportive

therapy maintains integrity of body functions while patient is recovering (ie., fluids & electrolytes, blood products).

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Prophylactic

drugs used to prevent a disease.

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Empiric

Drugs used to treat a symptom of an illness

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Side Effects

predictable, adverse drug reactions

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Adverse Drug Reaction

unexpected, unintended, undesired or excessive response

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Drug Concentration

measuring concentration in the body for therapeutic vs. toxic effect (Use peak & trough levels)

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Idiosyncratic Reactions

not a result of a known pharmacologic property of drug (G6PD deficiency)

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Teratogenic Effect

causes structural defects in unborn fetus

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Mutagenic Effect

permanent changes in genetic composition of living organism

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Carcinogenic Effect

can cause cancer particularly when taken over extended period of time

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Drug Interactions

When action of one drug is altered by a second drug

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ADDITIVE

two drugs with similar effect given together so each can be given in smaller doses

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SYNERGISTIC

effect greater than that of each given individually.

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