HEALTHCARE EXAM 3 COMPREHENSIVE STUDY GUIDE // A+
GRADED PRESENTATION // HEALTH SYSTEMS POLICY
CLINICAL PRACTICE QUALITY CARE AND ORGANIZATIONAL
MANAGEMENT FOR STUDENT SUCCESS // ACADEMIC YEAR
2025/2026
Origins of the Pharmaceutical Industry
Stemmed largely from advances in organic chemistry during the 18th
century
Development of organic chemistry and early drug synthesis
The pharmaceutical industry stemmed through advances of orgo which
produced methods needed to synthesize and extract pharmaceutical
agents.
• Friedrich Sertürner and the isolation of morphine
· First to create a drug using his knowledge of organic chemistry
· Morphine is one of the key drugs that was isolated through organic
chemistry (used to control pain and pleasure)
Food and Drug Administration (FDA) mission and authority
• "protecting the public health by ensuring the safety, efficacy, and security
of human and veterinary drugs, biological products, and medical devices" •
"ensuring the safety of the nation's food supply, cosmetics, and products
that emit radiation" • "regulating the manufacturing, marketing, and
distribution of tobacco products."
• Center for Drug Evaluation and Research (CDER) responsibilities
The FDA's CDER is the federal "watchdog" group responsible for carefully
evaluating new pharmaceuticals, both generic and brand name, before they
can be sold in the United States.
• This activity aims to prevent quackery and provides doctors as well as
patients with important information about the safe and effective use of
medications.
, • Federal Trade Commission (FTC) advertising oversight
Protects consumers from unfair or deceptive practices on the
marketplace
FDA drug approval process (Phases 1-4)
• Phase 1 studies the potential side effects and toxicity of the medication in
healthy volunteers. • Phase 2 helps determine the effectiveness and
appropriate dosing for the medications. • Phase 3 involves larger-scale
studies of the safety and efficacy of the drug in the target population. •
Phase 4 involves postmarket surveillance of the medication
Accelerated approval and fast-track pathways (for FDA drug approval
process)
- increases access to more populations
-The FDA offers special classifications for accelerated review of
medications that show significant promise in treating serious illnesses that
have few if any alternative treatments.
• Over-the-Counter (OTC) drugs and Rx-to-OTC switches
-The FDA is also responsible for approving over-the-counter (OTC)
medicine, or medicine that can be purchased without a prescription.
-OTC drugs are sold by many companies under a variety of brand names.
• All must be standardized, labeled, and produced in safe and effective
doses as required by the FDA.
-Manufacturers usually see an Rx-to-OTC switch as a significant market
opportunity, because OTC status often leads to an increase in sales.
• The FDA regards the switch as a potential way to reduce healthcare costs
without compromising safety
Off-label drug use and prescribing
illegal to promote off-label drug use however doctors can prescribe drugs
for off-label use (label says it's for one thing but doc can prescribe it for
another, against rules for prescription companies to do that though)
• Pharmaceutical pricing and cost drivers
Pharmaceutical pricing and cost drivers
GRADED PRESENTATION // HEALTH SYSTEMS POLICY
CLINICAL PRACTICE QUALITY CARE AND ORGANIZATIONAL
MANAGEMENT FOR STUDENT SUCCESS // ACADEMIC YEAR
2025/2026
Origins of the Pharmaceutical Industry
Stemmed largely from advances in organic chemistry during the 18th
century
Development of organic chemistry and early drug synthesis
The pharmaceutical industry stemmed through advances of orgo which
produced methods needed to synthesize and extract pharmaceutical
agents.
• Friedrich Sertürner and the isolation of morphine
· First to create a drug using his knowledge of organic chemistry
· Morphine is one of the key drugs that was isolated through organic
chemistry (used to control pain and pleasure)
Food and Drug Administration (FDA) mission and authority
• "protecting the public health by ensuring the safety, efficacy, and security
of human and veterinary drugs, biological products, and medical devices" •
"ensuring the safety of the nation's food supply, cosmetics, and products
that emit radiation" • "regulating the manufacturing, marketing, and
distribution of tobacco products."
• Center for Drug Evaluation and Research (CDER) responsibilities
The FDA's CDER is the federal "watchdog" group responsible for carefully
evaluating new pharmaceuticals, both generic and brand name, before they
can be sold in the United States.
• This activity aims to prevent quackery and provides doctors as well as
patients with important information about the safe and effective use of
medications.
, • Federal Trade Commission (FTC) advertising oversight
Protects consumers from unfair or deceptive practices on the
marketplace
FDA drug approval process (Phases 1-4)
• Phase 1 studies the potential side effects and toxicity of the medication in
healthy volunteers. • Phase 2 helps determine the effectiveness and
appropriate dosing for the medications. • Phase 3 involves larger-scale
studies of the safety and efficacy of the drug in the target population. •
Phase 4 involves postmarket surveillance of the medication
Accelerated approval and fast-track pathways (for FDA drug approval
process)
- increases access to more populations
-The FDA offers special classifications for accelerated review of
medications that show significant promise in treating serious illnesses that
have few if any alternative treatments.
• Over-the-Counter (OTC) drugs and Rx-to-OTC switches
-The FDA is also responsible for approving over-the-counter (OTC)
medicine, or medicine that can be purchased without a prescription.
-OTC drugs are sold by many companies under a variety of brand names.
• All must be standardized, labeled, and produced in safe and effective
doses as required by the FDA.
-Manufacturers usually see an Rx-to-OTC switch as a significant market
opportunity, because OTC status often leads to an increase in sales.
• The FDA regards the switch as a potential way to reduce healthcare costs
without compromising safety
Off-label drug use and prescribing
illegal to promote off-label drug use however doctors can prescribe drugs
for off-label use (label says it's for one thing but doc can prescribe it for
another, against rules for prescription companies to do that though)
• Pharmaceutical pricing and cost drivers
Pharmaceutical pricing and cost drivers
