quality and safety review Flashcards
drug sources
where the drug comes from
plants, animals, synthetic, semisynthetic
classifications
comes from effects on the body system
describe american drug laws and standards
goal is to keep the public safe, can change over the years
describe the drug approval process
FDA approves drugs
there are 5 phases: preclinical, and phases 1-4
describe preclinical phase of the drug approval process
testing on animals
describe phase 1 of the drug approval process
trial on healthy volunteers
describe phase 2 of the drug approval process
trial on people that have the disease of condition
describe phase 3 of the drug approval process
larger number of people, looking for adverse effects and weighing risks and benefits
describe phase 4 of the drug approval process
drug has been approved and marketed and monitoring continues for safety
describe schedule 1 substances
-high potential for abuse and ot accepted for medical use
-heroin and LSD
describe schedule 2 substances
-high potential for abuse and accepted for medical use
-codeine, morphine, oxy
describe schedule 3 substances
-less potential for abuse
-CNS stimulants, adderall
describe schedule 4 substances
-even lower potential for abuse
-sedatives and anti-anxiety meds
describe schedule 5 substances
-even lower potential for abuse
-cough medicines with codeine
6 QSEN competencies
-patient cenetered care
-evidence based practice
-safety
-informatics
-quality improvement
-teamwork and collaboration