HCS Exam 2

first major regulation

pure food and drug act of 1906

what did FDCA require

new drugs proved safe before marketing, labelling with directions of use

hill burton act

construction and modernization of hospitals

1951 Durham Humphrey amendment to FDCA

created prescription category

what is ambulatory care

Care for people who aren’t bedridden or admitted in any healthcare institution → IE clinics, outpatient care

humanistic outcomes

Consequences of disease or treatment on patient’s functional status or quality of life

PRO

endpoints directly assessed by patients

HRQOL vs QOL

HRQOL is effect of illness or treatment on QOL

attributes of HRQOL

physical, mental, social

disease specific

specific info about outcomes uniquely associated a disease