Introduction to Pharmacology Flashcards
Passed to motivate development and provision of new, effective drugs for rare diseases
Orphan Drug Act
5 Sources of Drugs
- Plants
- Animals and Humans
- Minerals or Mineral Products
- Laboratory- Produced chemicals
- DNA- Produced drugs
Drug Approval Process
- Animal studies: tested on at least 2 animal species
- Clinical Trials:
a. Phase 1: tested in healthy volunteers to compare with animal data, safe doses
b. Phase 2: 50-300 patients in a double blind studies
c. Phase 3: Larger patient group (1000s) lasting several years to evaluate efficiency and side effects
d. Phase 4: “New drug submission” to HPFB (Health Products and Food Branched)
States it’s chemical composition and molecular structure
Chemical Name
Manufacturer that created the drug usually gives its name
Generic Name
Manufacturer registered a drug using a trademark
Trade Name
Pediatric Considerations
Pediatric patients may require smaller dosing of medications or smaller amount because of higher concentration. Commonly based on weight and body surface area
Geriatric Considerations
Geriatric patients may be taking multiple medications
Governs the productions, registration, distribution and, possession of narcotic and controlled substances
Controlled Drug and Substance Act
Controlled Substance/Narcotics must be:
- Under lock and key storage
- On an ACP person
- All narcotics must be accounted for:
a. Administration
b. Wasted
c. Expired
d. Broken
A mixture of one or more substances entirely dissolved in water.
Ex. Normal saline, Nitro, D50W
Solutions
A liquid with small particles of a solid dispersed, but not dissolved
Ex. Activated Charcoal
Suspensions
A gelatin container used for single dose drug administration
Capsules
A small solid mass of medicinal powder
Tablets
A mixtures of a drug that is formed into a firm semi-solid cylinder or cone shaped mass that melts at body temperature
Suppositories
A has or mixtures of gases or water vapours intended inhaled
Inhalants
A colloid or glue-like substance finely subdivided in the form of a mist
Aerosols
A small sealed single-dose container of liquid injectable
Ampules
A small glass or plastic bottle containing on or more doses of a liquid injectable drug
Vials
A single-dose glass cartridge containing a liquid injectable drug. Syringe supplied already containing the drug, ready for assembly and injection
Pre-filled Syringes
In the preparation the liquid and solvent vial is mixed with the powdered solute. The resulting reconstituted preparation is then drawn up and administered
Vial of Powder Solute and Vial of Liquid Solvent
A jet of fine particles of liquid medicine are discharged from an atomizer or other device for direct application to a surface
Spray