MHA 707 Chapter 4 Review questions with verified
answers
________ and _______ encompass the products and technology unique to health
care delivery. Ans✓✓✓ Pharmaceuticals and Medical Devices
"Orphan Diseases" Ans✓✓✓ Diseases that occur in less than 200,000 people in
the US.
- Diseases or defects that occur in less than 1:2,000 people.
- Drugs for these diseases would not be economically feasible to develop unless
subsidized.
-Includes most "biologicals".
Biologics Ans✓✓✓ 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.
Biologics info Ans✓✓✓ -Grew 8% of all drug approvals in 2005 to 17% in 2017,
and three of the top-selling medicines in 2017 were biologics.
-It is challenging to ensure the product remains consistent because of the
complex ingredients. "the product is the process"
-Considered a specialty drug.
-2018 market for biologics- 125 Billion.
Class III devices competition is already limited and devices not completely
interchangeable making it difficult for purchasers to negotiate prices Ans✓✓✓
TRUE
, Compounding pharmacies Ans✓✓✓ Specialized pharmacies that prepare
compounded medications
Conventional Medical Devices Ans✓✓✓ Much simpler. easy to manufactor
DEA drug schedules Ans✓✓✓ Schedule I: no accepted medical use and a high
potential for abuse and therefore cannot be prescribed or dispensed. (Heroin)
Schedule II-V: vary controls on their manufacture, distribution, and sales.
Unscheduled: no DEA restrictions. (Vast majority of drugs)
Development of New drugs Ans✓✓✓ -Generally accepted that the process can
take up to 15 years from identification to compound to FDA approval.
-Patents usually last 20 years from date of filing.
Drugs approved by FDA can be Ans✓✓✓ >OTC
>By prescription
Drugs must be available "OTC" Ans✓✓✓ if consumers can make it safely and
effectively without professional guidance per package labelling. GRASE.**
FDA Approval of Medical Devices Ans✓✓✓ Broken into 3 tiers;
FDA Drugs that Cannot be "OTC" Ans✓✓✓ Drugs that are habit-forming or toxic
have too great a potential for harmful effects, are for medical conditions that
cannot be self-diagnosed, and/or believed cannot be used safely without
professional supervision, can only be dispensed with a prescription.
answers
________ and _______ encompass the products and technology unique to health
care delivery. Ans✓✓✓ Pharmaceuticals and Medical Devices
"Orphan Diseases" Ans✓✓✓ Diseases that occur in less than 200,000 people in
the US.
- Diseases or defects that occur in less than 1:2,000 people.
- Drugs for these diseases would not be economically feasible to develop unless
subsidized.
-Includes most "biologicals".
Biologics Ans✓✓✓ 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.
Biologics info Ans✓✓✓ -Grew 8% of all drug approvals in 2005 to 17% in 2017,
and three of the top-selling medicines in 2017 were biologics.
-It is challenging to ensure the product remains consistent because of the
complex ingredients. "the product is the process"
-Considered a specialty drug.
-2018 market for biologics- 125 Billion.
Class III devices competition is already limited and devices not completely
interchangeable making it difficult for purchasers to negotiate prices Ans✓✓✓
TRUE
, Compounding pharmacies Ans✓✓✓ Specialized pharmacies that prepare
compounded medications
Conventional Medical Devices Ans✓✓✓ Much simpler. easy to manufactor
DEA drug schedules Ans✓✓✓ Schedule I: no accepted medical use and a high
potential for abuse and therefore cannot be prescribed or dispensed. (Heroin)
Schedule II-V: vary controls on their manufacture, distribution, and sales.
Unscheduled: no DEA restrictions. (Vast majority of drugs)
Development of New drugs Ans✓✓✓ -Generally accepted that the process can
take up to 15 years from identification to compound to FDA approval.
-Patents usually last 20 years from date of filing.
Drugs approved by FDA can be Ans✓✓✓ >OTC
>By prescription
Drugs must be available "OTC" Ans✓✓✓ if consumers can make it safely and
effectively without professional guidance per package labelling. GRASE.**
FDA Approval of Medical Devices Ans✓✓✓ Broken into 3 tiers;
FDA Drugs that Cannot be "OTC" Ans✓✓✓ Drugs that are habit-forming or toxic
have too great a potential for harmful effects, are for medical conditions that
cannot be self-diagnosed, and/or believed cannot be used safely without
professional supervision, can only be dispensed with a prescription.
