Basic Concepts Flashcards
What is the difference between chemical and brand names of drugs?
- Chemical name refers to compound’s structure
- Brand name is the proprietary name
What is a generic drug?
- Non-proprietary drug name that may be less well recognized
What type of medication does not require a prescription to be purchased by the consumer?
Over the Counter (OTC)
Why may a drug be sold OTC?
It is deemed safe without direct medical supervision
Can OTC drugs be involved in significant drug interactions?
Yes.
Whose authorization is required for a prescription medication?
Licensed Health Care Provider (HCP)
What is the purpose of drug scheduling?
- Organize drugs on their potential for abuse
- Used for prosecution
What level of government sets the standards for drug scheduling?
- Federal
What schedule of drug has a currently accepted medical use in the US, but has a high potential for abuse that may lead to severe psychological or physical dependence?
Schedule II
What schedule of drug has a low potential for abuse, but may be sold in limited amounts without a prescription at the discretion of a pharmacist?
Schedule V
What schedules of drugs have a medically accepted use?
Schedules II - V
What schedule of drugs may lead to a moderate or low physical dependence or high psychological dependence if abused?
Schedule III.
What schedule of drugs may lead to a limited physical or psychological dependence if abused>
Schedule IV.
What are 8 sources of drug information?
- E-facts and comparisons
- Clinical Pharamacology
- Lexi-comp
- Micromedex
- Product package insert
- National guidelines
- Primary literature
- www.dailymed.nlm.nih.gov
- URI library
What are 4 sources of new drug material?
- Plants/ natural products
- Synthesized in lab
- Human pooled blood products
- Animal products
What was the original birth control drug synthesized from?
- Conjugated estrogen from horse urine
What is the 7 step process of new drug testing?
- Compound discovery and “bench” testing/ evaluation
- Animal phase of testing
- Human phase I
- Human phase II
- Human phase III
- FDA approval with patent
- Human phase IV/ post marketing phase
Why are small animals used to test drugs?
- Save space and money
- Enough similarity with people that results are applicable
- Condense lifespan
- Genetically malleable
- Can look at different models
What is being examined during each stage of human phase drug testing?
I: Dosing safety
II: Efficacy
III: Clinical trials, large double blind/ single blind studies; (larger versions of 1 and 2
IV: Monitoring markets for adverse drug effects on a more diverse population
Who mandates the length of each stage of drug testing?
The FDA
Why do more adverse drug effects present themselves once human phase IV drug testing occurs?
- Larger, and more diverse population
- Prescription is more liberal, and/ or off-labeling
What is the major difference between all 4 stages of human phase drug testing?
- Sample size; form very small to very large
What is the pharmaceutical portion of drug administration?
- Disintegration of the “hard” drug to pharmaceutical form
What is pharmacokinetics? What are the 4 components?
- How the body acts on the drug
- Absorption
- Distribution
- Metabolism
- Excretion
What is pharmacodynamics?
- Biochemical and physiological effects of drugs and their mechanism of action
What are some preparations of drugs?
- Aqueous
- Alcohol
- Solid
- Powder
- Tablet
- Lozenge
- Capsule
- Delayed-release
- Suppositories
- etc…
What are the 2 general routes of drug administration?
- Parenteral
- Enteral
What is a parenteral drug administration? What are some examples?
- By any route that does not involve the GI tract
- Injections
- Transdermal patches
- IV
- Sprays/ inhalers
- Cream
- Suppository
What is an enteral drug administration? What are some examples?
- Drug travels directly to the gut by the small or large intestines
- Oral/ PO (Per os)
What is ADME?
- Absorption
- Distribution
- Metabolism
- Excretion
What is drug absorption?
- Entrance of drug into blood stream
What 2 factors affect the speed of drug absorption?
- Properties of drug
- Properties of environment
What are the 5 drug properties that affect absorption?
- Dosage form
- Drug water solubility
- Drug lipid solubility
- Drug particle size
- Drug concentration
What body structure acts as barriers to drug absorption?
- Membranes
What is the common cell membrane barrier? What is it impermeable to?
- Phospholipid bilayer
- Impermeable to water
What types of particles easily cross the phospholipid bilayer, and what types of particles cannot pass through the membrane?
- Small, uncharged particles pass through
- Large uncharged and/or small charged ions cannot pass through
What properties of the phospholipid bilayer make it impermeable to water or other charged particles?
- Hydrophilic heads
- Hydrophobic tails
How does the extracellular enviornment affect absorption of ASA?
- Basic environments ionize ASA making it difficult to pass through the plasma membrane
What is bioavailability?
- The percentage of the administered dose that is absorbed into systemic circulation
What are 3 factors that can influence bioavailability?
- Administration
- Target environment/ tissue
- Properties of a drug
What is drug distribution?
- Drug distribution to the organs and tissues of the body after it has been absorbed into the blood stream
What are the 4 main factors affecting drug distribution?
- Physical properties of the drug
- Lipid solubility
- Affinity/ receptors
- Drug protein complex
What are 4 special anatomical barriers to drug distribution?
- Blood brain barrier
- Plasma protein binding
- Blood flow
- Fetal-placental barrier
What is the blood brain barrier?
- An additional lipid barrier that protects the brain by restricting the passage of electrolytes and similar water soluble substances
What property must a drug possess to pass through the blood brain barrier?
- Lipid solubility
What type of cells make up the lipid coating of the blood brain barrier?
Glial
Drugs possessing what 3 properties have the best chance of passing the blood brain barrier?
- Small
- Unionized
- Lipophyllic
What property of the blood brain barrier prevents inionized substances from passing through?
- Tight junctions