• Preclinical Trials: tested on animals in lab
  
• Phase I:  uses human volunteers to test the drugs
  
• Phase II:  allows clinical investigators to try out the drug in patients who have the disease that the drug is designed to treat
  
• Phase III: Involves use of drug in a vast clinical market, prescribers are informed of all the known reactions to the drug and precautions required for safe use
  
• Phase IV: after drug is approved for marketing it enters a phas of continual evaluation

• Category A: no evidence of risk to fetus
• Category B: adequate studies have shown no risk in 1st trimester, no evidence of risk in later trimesters
• Category C: no adequate studies in pregnant women, animal studies have shown no adverse effects on fetus, or there are no adequate animal reproduction studies and no adequate human studies
• Category D: evidence of fetal risk in humans, but potential benefits may outweigh the risks
• Category X: evidence of fetal abnormalities or adverse effects in humans and animals - risk is not worth the benefit
  

Drug Schedules:

• Schedule I (C-I): high abuse potential and no accepted medical use
  
• Schedule II (C-II):  High abuse potential with sever dependence liability
  
• Schedule III (C-III):  less abuse potential than schedule II drugs and moderate dependence liability
  
• Schedule IV (C-IV):  less abuse potential than schedule III and limited dependence liability
  
• Schedule V (C-V):  limited abuse potential.
  

• may mask signs and symptoms of underlying disease
• taking with prescription meds my result in drug interactions
• taking incorrectly may result in serious overdose

• to replace or act as substitues for missing chemicals
• to increase or stimulate certain cellular activies (agonist drugs)
• to depress or slow certain cellular activities (beta-blockers)
• to interfer with the functioning of foreign cells (antibiotics)

• they react to certain chemicals
• the better fit between receptor site and chemical, the more pronounced the reaction
• Enzymes within the body are need to breakdown the chemicals to open up the receptor site

• absorption
• distribution
• biotransformation
• excretion

• IV - no affect on absorption
• IM - perfusion or blood flow to muscle, fat content, temp
• SubQ - perfusion of blood flow to tissue, fat content, temp
• Oral (PO) - acidity in stomach, time in stomach, blood flow to GI, presence of interacting foods or drugs
• Rectal (PR) - perfusion or blood flow to the retum, lesions in the rectum, length of time retained for absorptions
• Musous membrane (sublingual, buccal) - perfusion or blood flwo to the area, integrity of the mucous membranes, presence of food or smoking, length of time retained in area
• Topical (skin)- perfusion or blood flow to the area, integrity of the skin
• Inhalation - perfusion or blood flow to the area, intergrity of lung lining, ability to administer the drug properly
  

• absorption
• distribution
• metabolism
• excretion

1. weight

2. age

3. gender

4. physiologic factors

5. pathologic factors

6. genetic factors

7. immunologic factors

8. psychological factors

9. environmental factors

10. drug toleracne

11. cumulative effect

• site of absorption
• during distribution
• during biotransformation
• during excreation
• at the site of action

• Antagonistic: two drugs cancel eachother out 1+1=0 (ex. morphine & naloxone)
• Additive: two drugs with similar mechanisms "sum" their effects: 1+1=2 (alcohol & sedatives)
• Synergistic: two drugs with different mechanisms produce greater effect: 1+1=3 (codeine & ASA)

• Vitamin K antagonize the actions of oral anticoagulant (coumadin)
• Dairy (calcium rich) products & tertracycline form an insoluble compound
• Grapefruit juice affects the liver enzyme system up to 48 hours and results in increased or decreased serum levels of drugs

drugs may alter results of lab testing

example

*antibiotics such as carbencicillin can increase serum Na,

*use of fragmin can increase AST- liver funtion test

• Drug may have other effects on the body besides therapeutic effect
• patient is sensitive to the drug given
• drug's action on the body causes other responses
• patient is taking too much or too little of the drug

• Anaphylactic
• Cytotoxic
• Serum sickness
• Delayed allergic reaction
• Dermatologic

• Hives, rash
• difficulty breathing
• increased BP
• dilated pupils
• diaphoreses, "panic" feeling
• increased heart rate
• respiratory arrest

• CBC showing damage to blood-forming cells (decreased hematocrit, WBC count, and platelets),
• liver function test indicating elevated enzymes
• renal function test indicating decreased renal function

• Itchy rash
• high fever
• swollen lymph nodes
• swollen and painful joints
• edema of face and limbs

• rash
• hives
• swollen joints (similar reaction to poison ivy)

• abnormalities of the skin occur, red areas, blisters (rash/hives)-ex. antibiotics
• inflammation of the mucous membrane may occur (Stomatitis)- ex. antineoplastics

• destruction of the body's normal flora
• Assess for fever, diarrhea, and/or vaginal discharge

• bone marrow suppression (antineoplastics & antibiotics)
• Assess for fever, chills and weakness

• fever
• nausea
• jaundice
• change in color or urine or stool
• elevated liver enzymes

• change in urinary pattern or
• elevated BUM and creatinine

• Ocular toxicity (Chloroquin) - vision changes
• Auditory damage (ASA) - damage to 8th cranial nerve

• General CNS -altered level of consciousness
• Atropine-like (anticholinergic) effects - dry mouth, urinary retention, blurred vision
• Parkinson-like syndrome - muscle tremors and changes in gait
• Neuroleptic Malignant syndrome - extrapyramidal symptoms

• Assessment
• Administration of medications and therapy
• Assessment of reation/outcome to medications
• teaching
• evaluation of teaching effectiveness

• Medical history - centain conditions prevent pts use of some meds
• Surgical history - may require new med as a result of surgery
• social history - level of education, support, financial means
• Medications - drug to drug interactions
• Allergies - pts may have cross-sensitivity to meds

Right:

1. patient

2. drug

3. dosage

4. route

5. frequency & timing

6. recording

7. storage

8. preparation

• Name, dose, and action of drug
• Timing of administration
• Special storage and preparation instructions
• Specific OTC drugs or alternative therapies to avoid
• Special comfort or safety measures
• specific points about drug toxicity
• specific warnings about drug discontinuation

• date and time of order
• pt name, and ids (medical record #, date of birth)
• drug
• dosage
• route
• frequency
• special administration instructions

• pt name
• pt date of birth
• drug
• drug dosage
• drug route
• drug frequency
• any special instructions
• amount of meds to dispense
• number of refills

• Hypothalamus
• Medulla
• Spinal Cord

• the involuntary or visceral nervous system. 
• works closely with the endocrine system
• generally occurs with little conscious awareness of its activity.
• regulates and integrates the body's internal functions
• integrates parts of the CNS & PNS to reast to changes in the internal and external environment

• Blood Pressure
• Heart Rate
• Respirations
• Body temp
• water balance
• urinary excretion
• digestive functions

fight or flight - responsible for preparing the body to respond to stress.

Long axon and

transmits norepinephrine and epinephrine

MAO (Monoamine oxidase)

COMT (caterchol-O-methyltransferase)

• BP and HR increase
• Respiratory efficiency also increases
• bronchi are dilated and repiratory rate increases
• pupils dilate
• piloerection
• blood is diverted from the GI tract
• Blood is diverted from internal organs

• Vasoconstriction - increased peripheral resistance, increased BP
• Mydriasis
• Increased closure of external sphincter of the bladder

• Nerve membranes act as modulators of norepinephrine release
• Beta cells in pancreas help to moderate teh insulin release stimulated by SNS activation

• Heart has increased chrontropy and inotropy
• heart has increased AV node conduction and velocity
• Renal juxtaglomarular cells increase renin release

-responsible for increased lipolysis or breakdown of fat for energy in peripheral tissues

• vasodilation of the smooth muscle in blood vessels
• Dilation of bronchi
• incresed muscle and liver breakdown of glycogen and increased release of glucagon
• relaxed uterine smooth muscles

"rest and digest"

• increased motility & secretions in the GI tract
• decreased HR and contractility
• constriction of the bronchi with increased secretion
• relaxation of the GI and urinary bladder sphincters
• pupillary constriction

• All preganglionic nerves in the ANS, both PNS & SNS
• Postganglionic nerves in PNS and a few in SNS
• Motor nerves on skeletal muscles
• Cholinergic nerves within the CNS

• receptors stimulated by muscarine
• found in visceral effector organs
• found in sweat glands
• found in some vascular smooth muscle

• pupil constriction
• increased GI motility
• increased salivation
• increased urinary bladder consriction
• decreased HR

• Muscle contraction
• Autonomic response
• release of Norepinephrine and epinephrine from adrenal medulla