pharm Flashcards
pharmacodynamics
what the drug does to the body, the intensity of its effect and side effects
pharmacokinetics
what the body does to the drug, rate and extent of absorption, rate of elimination
Adverse Drug Events
includes adverse drug reactions as a subset, plus all other bad outcomes such as errors in prescribing, pharmacy, administration; greater than one day in hospital and cost of at least $9000; most occur on prescribing or at administration of meds
Adverse drug reaction
a type of adverse drug event; may be based on specific drug action (predictable) or from action on off target receptors/atypical processing by body; drug-drug interactions, drug-food, hepatic, renal, idiosyncratic (individual differences) due to genetics or immunological (allergies)
Pharmagenomics
the effects of an individual’s genetics on how they will respond to a drug
IND
Investigational New Drug, permission to start human trials; after completion of pre-clinical testing, this is filed with the FDA to get permission to begin human testing
NDA
New Drug Application, permission to market after passing clinical trials
BLA
Biological License Application, permission to market biologicals after passing clinical trials
NCE
new chemical entity, many fail during development or trial phases because they have unacceptable toxicity or they do not work in clinical trials
NBE
new biological entity; subtype of NDA
Proprietary drug
new drug that is protected by a patent to prevent anyone else from making/selling it; contrast with generics, which are cheaper forms of the drug which can be produced after patent expires (20 years)
Polypharmacy
patients taking large number of medications; poses challenges in preventing drug-drug interactions; major problem for geriatric patients
Requirements for drug to be approved by FDA
must be effective; may be toxic if benefits outweigh risks
FDA approval process
in vitro studies, then animal studies- if success then submit IND; then clinical testing: Phase 1-3, if success- submit NDA; if approved, drug enters market and phase 4 (surveillance) starts; patent expires after 20 years and then generics become available
Pre-clinical phase
cell, tissue, animal testing; used to figure out how a drug affects body systems; figure out drug’s mechanism of action; test using animal models for toxic effects- carcinogenic (can it cause cancer?) or can it cause fetal abnormalities
Phase I clinical trials
carried out in small group, less than 100 healthy volunteers; Is this drug SAFE? Looks at pharmacokinetics- how the drug is absorbed, used, and excreted in the body
Phase II
a few hundred patients who have the disorder the drug was intended for; does the drug work? Drug must be safe and EFFECTIVE to pass phase
Phase III
larger more diverse group of patients; confirm efficacy of new drug compared to known drugs and track effects over time; safety, dosage, effectiveness
what the FDA regulates
foods, human and vet drugs, biological products, medical devices, cosmetics, radiation producing products, advertising on Rx drugs; doesn’t regulate neutraceuticals/dietary supplements, water, OTC advertising, alcohol
Phase IV
market experience; ensures that unexpected drug reactions are detected, reported, and evaluated; MedWatch, FDA Safety, Adverse Event Reporting
Black Box Warning
reports the most serious or life threatening adverse events; FDA requires this to be on the box for a med that may cause significant risks, even if rare
Orphan drug products
rare diseases affecting fewer than 200,000 people in the US; Orphan Drug Act passed to incentivize drug companies to make these drugs
Right to Try laws
allow terminally ill patients to try meds that are not yet approved by the FDA as a last attempt
-omab
mouse MAB, not commonly used in humans
