HCM 301 Chapter 4
questions and answers
pharmaceuticals and medical devices encompass
the products and technology unique to health care
delivery - answer •Pharmaceuticals: products that
work on a biochemical level
•Medical supplies: products typically used once
•Medical equipment: products designed to be used
repeatedly
Also important in the delivery system's supply
chain are the goods and services typically needed
by of all industries including structures such as
offices and buildings, computers and other
information technology tools, paper and other
supplies, consulting and other business services,
etc. - answer These expenditures total about 20%
of the national health expenditures.
Pharmaceuticals - answer FDA definition: Products
intended to cure, treat, mitigate, diagnose, or
prevent disease in humans or otherwise affect the
structure or function of the human body through
chemical action in and/or metabolized by the
human body are considered human drugs or
biological products.
, Two major classes: - answer •"Conventional" or
"small molecule" drugs typically contain an "active
pharmaceutical ingredient" (or sometimes several)
that generally have well-defined chemical
structures
"Biological products" (aka "biologics") are complex
mixtures produced through biotechnology in a
living system, such as a microorganism, plant cell,
or animal cell that are not easily identified or
characterized
•Biologics "represent the cutting-edge of
biomedical research and, in time, may offer the
most effective means to treat a variety of medical
illnesses and conditions that presently have no
other treatments available" (FDA, 2018). - answer
•Grew from 8% of all drug approvals in 2005 to
17% in 2017, and three of the top medicines in
2017 were biologics
•Due to their complex nature, it is challenging to
ensure the product remains consistent, and so the
production process becomes critical ("the product
is the process") - answer •Biologics are also
considered a "specialty" drug.
Specialty drugs are those that meet one or more of
these criteria: - answer •Available in very limited
supply
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