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MHA 707 Exam B with Solutions| Verified exam Questions and Answers
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MHA 707 Exam B with Solutions| Verified exam Questions and Answers
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MHA 707 Exam B with Solutions| Verifiedexam Questions and Answers
Biological Products - ✔✔complex mixtures of "big molecule drugs" produced
through biotechnology in a living system, such as a microorganism, plant cell, or
animal cell are not easily identified or characterized.
Biological Products - ✔✔regulated by the Food and Drugs. Administration
(FDA) are used to diagnose, prevent, treat, and cure diseases and medical
conditions
Biologics - ✔✔a product that is produced from living organisms or contains
components of living organisms
Biologics Characteristics - ✔✔•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")
•considered a "specialty" drug
•In 2018, biologic market est. at $125 B (up 50% from 2014)
•represent the cutting edge of biomedical research
17% of all drug approvals
•is 3 of the top selling medicines in 2017
Blacks working in HC - ✔✔12.3% US Employed Population
RN (13%)
,Practitioner Support Tech/Tech (14%)
LPN/LVN: (30%)
Nursing, Psychiatric, Home Health (35.8%)
CDC (Center for Disease Control) - ✔✔National public health agency primarily
responsible for health promotion and disease an injury prevention efforts
CHIP - ✔✔Childrens Health Insurance Program - health insurance for children
under 18 whose parents earn too much to qualify for Medicaid, but not enough to
afford private insurance.
Class I - ✔✔.
•Manufacturers simply need to register the device before bringing it to market
(pre-approval is not required)
Includes elastic bandages, handheld surgical instruments, etc
Class II - ✔✔includes surgical drapes, infusion pumps, etc.
•Pre-approval is required but manufacturers only need to demonstrate that the
medical device is substantially equivalent to a device already on the market
Class III - ✔✔•includes heart valves, implanted pacemakers, etc.
, •Devices are generally required to demonstrate that they are safe and effective
before they may be marketed though evaluations typically not as rigorous as drug
studies
Have limited competition and hard to negotiate price
CMS (Centers for Medicare and Medicaid Services) - ✔✔Federal agency in the
Department of Health and Human Services that runs Medicare, Medicaid, clinical
laboratories, and other government health programs; responsible for enforcing all
HIPAA standards other than the privacy and security standards.
Community Based Care - ✔✔types of person-centered care delivered in the
home and community. A variety of health and human services can be provided.
HCBS programs address the needs of people with functional limitations who need
assistance with everyday activities, like getting dressed or bathing.
Compounding pharmacies - ✔✔Specialized pharmacies that prepare
compounded medications
Compounds approved by FDA presenting in different ways to cut cost and provide
a different format of the drug (cream vs pill)
Conventional Devices Medical Devices - ✔✔are products that are easy to
manufacture with relatively few barriers for entry for new companies and
relatively little product differentiation (e.g., an IV pole)
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