Patient Safety & Quality Assurance Quiz

Pure food and drugs act of 1906

prohibit the interstate transportation or sale of adulterated or misbranded food or drugs

Durham-Humphrey Act of 1951

Require all products to have adequate directions for use

Don't need to have adequate directions for use if the drug/products must be dispense with a prescription (not over-the-counter)

Separated drugs into Legend and Nonlegend (over the counter)

Allows verbal prescriptions over the phone

Allows refills to be called in from a doctors' office

Food, Drugs, and Cosmetic Act of 1938 (FDCA)

Created the US Food and Drug Administration (FDA)
Required all new drug applications be filed with the FDA
Clearly defined Adulteration and misbranding

Kefauver-Harris Amendment of 1962

Requires all medication in the US to be pure, safe, and effective

Comprehensive drugs abuse prevention and control act of 1970

Established "Controlled substance" rating

Created the Drug Enforcement Agency (DEA)

Separated the controlled substance into 5 Schedule based on potential for abuse and accepted medical use in the US

MedWatch

FDAs online voluntary reporting system for adverse drug reactions

USP 795

standards for NON STERILE COMPOUNDING

USP 797

standards for sterile compounding

Class III torsion balances

typically seen in pharmaciesE

Electronic balances

usually only used in pharmacies that do alot of compounding

Analytical balances

SUPER accurate, used to measure small amounts of material → typically in research facilities

Infusion pumps

used to deliver large volumes of bagged fluids to a patient

Syringe drivers/pumps

deliver small volumes of fluid to a patient directly from a compatible disposable syringe

What meds are packed in dark colored packagin

nitroglycerin, furosemide, and doxycycline

what is used to package infusion fluid

Polyvinyl chloride (PVC)