Basic Principles of Pharmacology Flashcards
Endobiotics
agents normally produced within the body that are used therapeutically
Xenobiotics
agents NOT normally produced within the body
*Largest proportion of medications
Pure Food and Drug Act
Label active ingredients (1906)
Harrison Narcotic Act
Ban OTC sale of addictive drugs (1914)
Food, Drug, and Cosmetic Act
Document safety
Label inactive ingredients (1938)
Durham-Humphrey Amendments to Food, Drug and Cosmetic Act
2 categories of drugs created:
1)Legend Drugs-need prescription
2)OTC Drugs
(1951)
Kefauver-Harris Amendments to Food, Drug and Cosmetic Act
Must demonstrate effectiveness (1962)
Controlled Substances Act
-Schedule 1: Drugs w/out legal use
-Schedule 2: Drugs w/highest abuse potential
-Schedule 3-5: Decreasing abuse potential
(1970)
Dietary Supplement Health & Education Act
Removed vitamins, minerals, herbals, botanicals, amino acids, and metabolites from FDA control
- No longer approved/regulated by FDA
- No responsibility for ensuring effectiveness
- Manufacturer responsible for ensuring safety
- Marketing and Advertising restrictions implemented
Name the 3 Categories of OTC Drug Safety
Category 1: Safe and Effective
Category 2: Not safe, Not Effective, or Both
Category 3: Safety and effectiveness inconclusive
Development and Marketing of New Drugs
1) Preclinical Trials: Checks effects and safety in animals
2) Clinical Studies (Require FDA approval)
- Phase 1: Initial dose range and safety w/healthy volunteers
- Phase 2: Efficacy in diseased volunteers and effective dose
- Phase 3: Compare w/best current treatment
3) New Drug Application (NDA) (Require FDA approval)
- Phase 4: Post-marketing monitoring for rare adverse effects
What is First Pass Effect?
A phenomenon in which a drug gets metabolized at a specific location in the body that results in a reduced concentration of the active drug upon reaching its site of action or the systemic circulation.
Often the Liver.
Name the 5 ways drugs move across the cell layers.
1) Passive Diffusion
2) Facilitated Diffusion
3) Active Transport
4) Aqueous Diffusion
5) Pinocytosis/Exocytosis
What is Passive Diffusion?
Movement from high concentration to low concentration via lipid solubility
What is Facilitated Diffusion?
Movement down the concentration gradient via a membrane carrier protein *No energy source
What is Active Transport?
Movement against the concentration gradient via membrane carrier protein *REQUIRES energy source
What is Aqueous Diffusion?
Movement via channels between cells
- Glomerulus filtration has the largest gaps
- BBB has NO gaps
What is Pinocytosis? What is Exocytosis?
- Method by which a cell absorbs small particles outside the cell and brings them inside
- Process by which the contents of a cell vacuole are released to the exterior through fusion of the vacuole membrane with the cell membrane
Is the Henderson-Hasselbalch equation below for Acids or Bases?
pH=pKa +log([ionized]/[non-ionized])
Acids
Is the Henderson-Hasselbalch equation below for Acids or Bases?
pH=pKa +log([non-ionized]/[ionized])
Bases
Write the Ionization equation for Acids
HA π H+ + A-
Write the Ionization equation for Bases
BH+ π B + H+
Acids are (Ionized/Non-Ionized) in Acidic pHs?
Non-Ionized
Bases are (Ionized/Non-Ionized) in Acidic pHs?
Ionized