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Pharm 309 Quiz 2
Pharm Key Concepts
38
Nursing
Professional
07/16/2010

Additional Nursing Flashcards

 


 

Cards

Term

Federal Pure Food and Drug Act – 1906 

Definition

Food must be free of adulterants (unwanted food additive, illicit drug, or poinson)

Term

  Food, Drug and Cosmetic Act – 1938

Definition

  • People died who took antibiotic, d/t  (filler) ingredients were toxic
  • Required all new drugs undergo testing for toxicity

 

 

Term

Kefauver-Harris Amendments – 1962

Definition

  • Brought on by thalidomide – (European sedative), pregnant women & babies lacked legs/limbs
  • Now require proof of effectiveness/safety

Term

Controlled Substances Act – 1970

Definition

  • 1st law to strictly control manufacturing & dispense of drugs that have potential for abuse
  • Classified Drug Schedules (I-V)

Term

Orphan Drug Act – 1983

Definition

a drug (a drug for a disorder affecting fewer than 200,000 people in the United States) may sell it without competition for seven years. May get Tax incentives

Term

1992 – fast track drugs that treat certain diseases 

Definition

For diseases like aids or cancers

Term

Food and Drug Admin Modernization Act – 1997

Definition

  • Added more disease that we could fast track
  • Also had to do more drug testing on women and children
  • Also have to notify people if company going to discontinue a drug

Term
New Drug Development
Definition

  • Stages (preclinical/clinical)
  • Incorporate (controls, placebo, blinding, randomization)
  • Costly $$$$$

Term

Limitations and challenges of the drug development process 

Definition

ü  Women – childbearing women excluded for fetal safety. Ths don’t know if beneficial/adverse effects would be same as men, if affect menstrual cycle, or if MEAD will be the same.

ü  Children – been excluded from trials, therefore there is little info on how kids will react to drugs. 

Term

Preclinical testing of a drug

Definition

ü  Stages of drug development (remember costs are 200-800 million/drug)

ü  Preclinical testing (Animals) (1-5 years)

o   Parameters evaluated are

§  Toxicity

§  Pharmacokinetic (how it is MEAD)

§  Biological effects

Term

Clinical Testing (Whole process 2-10 years)

Phase I

Definition

 

  • Healthy adult volunteers (except antineplastic drugs)
  • Evaluation metabolism, pharmacokinetics’, biological effects
  • Determination of effects on humans
    • Toxicity, MEA, preferred route of admin, safe dose

 

 

Term

Clinical Testing

Phase II

Definition

ü  Phase II (patients 500-5000, on drug 3-6 yr)

o   Small select group of patients to determine potential use of the drug with respect to the disease

o   Compare results with Phase I for

§  Therapeutic utility and dosage range in diseased patients

Term

Clinical Testing

Phase III

Definition

ü  Phase III (patients 500-5000, on drug 3-6 yr)

o    after effective dose range estb’l, drug studied using large # of pts, multicenters using below techniques…

§  Double Blind

§  Crossover

§  Matched Adult Subjects

o   Apply for FDA for “New Drug Application”

Term

Clinical Testing

Phase IV

Definition

  • Post MARKETING Surveillance
  • With conditional approval form FDA, drug company controls release of the drug
  • Can be used by general population
  • New side effects may be discovered
  • Voluntary reporting by health professionals is essential

Term
Drug Names
Definition

ü  Chemical: Description and nomenclature of chemistry

ü  Generic (Non Propriety Name): assigned by the U.S. Adpobted Names Council or Pharmocopoeia (one generic name/drug)

ü  Trade (Propriety or Brand Name) : intended to make it easier for consumer/providers to remember, given by the company

o   1 drug has 1 generic name, but multiple trade names

Best to use generic name – for consistency sake

Term

Prescription vs non-prescription

Definition

ü  Prescription (need a physician order)

ü  Non-prescription (Over The Counte)

o   most illness (60% to 95%) initial therapy consists of self-care, including self med with an OTC drug

o   The average home medicine cabinet contains 24 OTC preperations

Term

Controlled vs non-controlled substances

Definition

ü  •Non-controlled substances

ü  •Controlled substances

o   Prescription drugs with high potential for drug dependence, abuse, ie barbiturates, morphine, amphetamines

o   These drugs are classified in schedule 1-5

o   Highest pain meds we use are schedule 2

o   Lower you go down (ie 5) hardly ever abusive

Term

Advantages & disadvantages of oral medication packaging

Tablets

 

Definition

ü  Pro – can be delivered orally

ü  Cons – fillers can cause difference in disintegration, thus bioavailability. 2 tablets w/same amt of drug can differ in intensity/onset of effect

 

Term

 

Advantages & disadvantages of oral medication packaging

Enteric Coated 

 

Definition

ü  Pro – coating allows dissolution in intestine not the stomach

ü  Cons – absorption can be even more variable than tablets, because gastric emptying can vary from minutes to 12 hours, coating can even allow NO dissolution

Term

Advantages & disadvantages of oral medication packaging

Sustained Release

Definition

 

ü  Pro – spheres dissolve at various rates, allows for reduced # of daily doses

ü  Cons – high $$$$ and potiential variable absporption

Term
Chemical equivalence: 
Definition

 2 tablets contain same amount of identical chemical coupound

Term

Bioavailability: 

Definition

Preparations are considered equal in bioavailability if the drug they contain is absorbed at the same rate and to the same extent.

 

Term

Absorption 

Definition
is the movement of a drug from its site of administration into the blood.. Rate of adsorption effects who soon effects begin.
Term

 

Ways to prevent absorption of oral meds

Definition

ü  Induce Vomiting

ü  Use of activated charcoal

ü  Induce catharsis 

Term
First pass effect 
Definition

-liver may produce significant decrease in amount of circulating drug due to liver biotransformation (Hepatic metabolism) – Extensive first pass effect

Term
routes of administration affected by first pass
Definition

o   enteral route (GI tract) stomach, small intestine, large intestine must go through the LIVER via the hepatic portal vein before getting to the heart to circulate

Term
Clinical Implication of first pass
Definition

Need to be aware of how dosing changes in regards to route (higher orally, lower IV)

Term
Over come first pass with these routes
Definition

  • Rectal
  • IV
  • Intramuscular
  • Inhalation
  • Sublingual
  • Buccal

Term

Routes of Administration (pros/cons)

PO, Oral

Definition

ü  Pros:

o   Oldest, safest, most convenient, most economical

o   Usual site of absorption is the small intestine - only a few drugs including ethanol are significantly absorbed from the stomach

ü  Cons:

o   Emesis: d/t irritant chemicals (take w/food to decrease irritation)

o   Variability: absorption highly variable

o   Destruction: (insulin destructed by enzymes)

o   Poor Absorption: d/t food interaction

o   Full Stomach: slow absorption= delayed emptying, decrease delivery to SI

o   Cooperation: patient has to be able to swallow

Term

Routes of Administration (pros/cons)

Sublingual, Buccal

 

Definition

ü  Pros

o   Rapid

o   Bypass hepatic destruction (a.k.a first pass) – utilizes venous return via veins to the heart rather than portal circulation to the liver

ü  Cons: Not useful for irritating/unpleasant tasting drugs

 

Term

Routes of Administration (pros/cons)

Topical

 

Definition

ü  Pros:

o   Local and Systemic effects (transdermal adhesive patches)

o   Topical drugs can utilize mucosal membranes as a site of administration

ü  Cons: Irritating to the skin

 

Term

Routes of Administration (pros/cons)

Rectal

 

Definition

ü  Pros

o   Useful when patient vomiting or unconscious, or pt has colon disease

o   By pass portal ciculation

ü  Cons:  Irritation of rectal mucosa; irregular/incomplete absorption, stigma

 

Term

Routes of Administration (pros/cons)

IV Push 

 

Definition

ü  drug admin into IV (usually small amount ie pain killer) via IV

ü  Pros: Rapid & uniform absorption

ü  Cons: No time to reverse, Less amount of time to dilute into the plasma

o   IV drugs given too rapidly can result in è Uncessary side effects

Term

Routes of Administration

IM, IV, Sub Q

Definition

ü  Pros: More rapid and uniform absorption (is 100%)

o   Better/accurate dosage

o   Use in unconscious/uncooperative patient

o   Can use large volumes of fluid

o   Can give drugs which are irritants

ü  Cons

o   High Cost, Difficulty & Inconvenience (special training) of Administration

o   Irreversibility (inject slowly if possible)

o   Fluid Overload (bad for pt with HTN, ESRD, CHF)

o   Infection (from contaminated drug or infection of site)

Embolism (injure venous wall causing a thrombus (clot))

 

Term

Routes of Administration (Pros/Cons)

IV Piggyback

Definition

ü  drug (in a separate mini bag) diluted in a prescribed amount of fluid and infused IV over an appropriate amount of time (15-30 min), Frequently used to administer IV antibiotics

ü  Pros: Uniform absorption

ü  Cons: IV drugs given too rapidly can result in è Uncessary side effects

Term

Route of Administration (Pros/Cons)

Epidural

Definition

ü  NOT IV,  above the dura, NOT into CSF, affects spinal roots as they exit/enter dural

Term

 

Route of Administration (Pros/Cons)

Intraventricular

 

Definition

ü  Not IV, but used to administer meds straight into the brain

ü  Pros: avoid the blood brain barrier, direct ot CSF

Term

 

Route of Administration (Pros/Cons)

Inhalation

 

Definition

ü  Pro: Large surface area to administer to & is extremely vascularized

o   Systemic achieve effects (ie give O2, or anesthesia)

ü  Con: hard to regulate in those that smoke (thickened scarring) 

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