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US Healthcare Exam 2 > Chapter 5 > Flashcards

Chapter 5 Flashcards

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1
Q

Drugs definition

A

Substances that produce a change in cellular or physiological functioning in humans.

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2
Q

Goals of manufacturing drugs:

A

Optimizing biochemical activity.

Increasing specificity (targeting specific conditions or processes).

Limiting negative effects or side effects.

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3
Q

Prescription drugs:

A

Medication requiring a prescription by an authorized licensed healthcare provider.

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4
Q

Non-prescription (Over-the-Counter) Medications:

A

Available to the general public without a prescription.

OTC

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5
Q

Who are “approved use” drugs approved by?

A

Medication or indication officially recognized by the FDA (Food and Drug Administration) for marketing.

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6
Q

Unapproved Use

A

Medication or indication without FDA permission for marketing. This might involve the use of a drug for a purpose not officially approved.

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7
Q

Unapproved Use Example

A

Ex: If Ozempic were to advertise itself as a weight loss drug without FDA approval or clinical trials

Note: physicians are still allowed to prescribe Ozempic for off-label use, but Ozempic themselves cannot promote it

  • this is an example im not sure how accurate this is*
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8
Q

Medicalization

A

Redefining or relabeling a personal or social problem as a medical condition, thus necessitating treatment in the healthcare system.

Ex: Conditions like anxiety, depression, attention-deficit/hyperactivity disorder (ADHD)

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9
Q

Why is medicalization controversial?

A

Critics argue that medicalizing certain aspects of life may pathologize normal variations in human experience and behavior, potentially leading to overdiagnosis and overmedicalization. It’s a complex sociocultural and medical phenomenon with both positive and negative implications.

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10
Q

Consumer’s Perspective on Healthcare:

A

Consumer beliefs often differ from those held by healthcare professionals.

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11
Q

Actions for Perceived Health Problems:

A

Do nothing
Take action and either begin self-care or seek care from a physician

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12
Q

Symptom Perception

A

Perceptions of symptoms and social knowledge influence the recognition of health problems.

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13
Q

Pharmacy as a Source for Consumers:

A

Pharmacies are the primary source of most drug products for consumers.

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14
Q

What are some factors for a patient choosing a certain pharmacy?

A

Convenience (location)
Price

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15
Q

Distribution of how OTCs are sold

A

– Pharmacy = 35%
– Mass merchandisers = 29%
– Food stores = 21%
– Other = 15%

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16
Q

Prescriber’s Perspective on Drug Therapy:

A

Drug therapy is a primary component of prescribed treatments by physicians.

Prescribing has a key aspect between physicians and patients.

Enhances and solidifies the interaction as a symbolic component to healing.

Provides satisfaction to the patient that something is being done

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17
Q

Factors Influencing Prescribing Behavior:

A

Education

Colleagues or Other Healthcare Providers.

Control and Regulatory Mechanisms.

Demands by Consumers and Society.

Promotional Activities by Drug Manufacturers.

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18
Q

Pharmacists & drug therapy

A

Pharmacists, as dispensers, face time constraints due to increased volume and regulatory pressures.

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19
Q

Dissatisfaction with the dispensing-centric role has led to rapid changes. What does this include?

A

Introduction of pharmacy technicians.

Integration of robotics.

Increased involvement in clinical activities.

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20
Q

Drug Development:

A

Pharmacy practice and professionals are mainly regulated at the state level.

Drug products and medical devices are regulated at the federal level by the FDA.

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21
Q

Food, Drug, and Cosmetic Act:

A

Regulates small molecules and hormones.

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22
Q

Public Health Service Act:

A

regulates biologics.

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23
Q
A

Slide title

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24
Q

Premarketing Clearance:

A

Clears all new products based on purity, safety, and effectiveness.

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25
Q

Labeling and Advertising Regulation:

A

Regulates the labeling and advertising of pharmaceutical products.

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26
Q

Manufacturing Practices and Recalls:

A

Regulates good manufacturing practices and oversees recalls if necessary.

27
Q

Bioequivalence Standards Regulation:

A

Regulates bioequivalence standards

28
Q

Postmarketing Surveillance:

A

Monitors unanticipated problems after approval.

29
Q

Blood Supply Monitoring

A

Monitors the blood supply for safety.

30
Q

Post-Approval Powers:

A

After approval, the FDA has limited powers to determine how a drug is ultimately used.

31
Q

Off-Label Indications:

A

Non-FDA-approved (“off-label”) indications are uses not approved by the FDA but shown value post-approval based on research.

32
Q

Promotion Limitations:

A

Manufacturers cannot promote non-FDA-approved indications.

33
Q

Drug Development Steps

A

Preclinical Research and Testing.
Clinical Testing (Phases I, II, III).
NDA Submittal for Approval.

34
Q

Preclinical Research:

A

Bench research to identify potentially useful compounds.

35
Q

Preclinical Testing:

A

Involves animal testing to assess safety and efficacy.

36
Q

Clinical Testing: Phase 1

A

Determines safe dosage range, preferred route of administration, absorption, distribution, elimination, and possible toxicities.
Involves healthy volunteers (<100).
Lasts approximately 1 year.

37
Q

Clinical Trials Phase 2

A

Assesses safety and efficacy in treating a specific disease or symptom.
Involves volunteers with that disease or symptom (<300).
Lasts approximately 2 years.

38
Q

Clinical Trials Phase 3:

A

Evaluates safety, efficacy, and dosage range under market conditions.

Involves a larger group of volunteers with the targeted disease or symptom (<3000).

Lasts approximately 3 years

39
Q

NDA Submission:

A

Sponsor submits a New Drug Application (NDA).

FDA has 60 days to decide whether to review or refuse for completeness.

40
Q

FDA Review:

A

If approved, FDA’s Center for Drug Evaluation and Research (CDER) conducts a review.

Routine review takes 10 months, priority review takes 6 months.

Inspection of manufacturing facility.

FDA may deny or request more information/testing.

41
Q

Post-Approval Activities:

A

If approved for market, the manufacturer continues to submit postmarketing information (Phase 4), including clinical trials on subgroups.

Supplemental NDA (sNDA) may be submitted for new indications, labeling changes, or new manufacturing procedures.

42
Q

Drug Pricing

Manufacturer’s Suggested Price:

A

Determined by the manufacturer.

Often much higher than the actual price paid out of pocket by consumers based on their insurance plan.

43
Q

Insurance Influence on drug pricing

A

Consumers with insurance may pay a significantly lower price.

Those without insurance are more likely to pay the full price.

44
Q

Determinants of Drug Price:

A

Determined by the costs and profits of the supply chain.

Includes discounts and economic forces.

45
Q

Supply Chain Components:

A

Manufacturer’s cost + profit (Research & Development incentivized).

Wholesaler’s cost + profit.

Retailer’s cost + profit.

46
Q

Additional Factors:

A

Discounts.
Influenced by supply and demand forces.

47
Q

Direct-to-Consumer (DTC) Advertising (1977)

A

FDA allows DTC advertising with “adequate provision” of information, requiring a fair balance of risks and benefits.

48
Q

Berndt, 2005 study on advertising

A

40% of physicians viewed it positively, 30% negatively, and 30% saw no effect

49
Q

Pros of DTC

A

Educates consumers about conditions and symptoms.
Increases compliance.
Enhances communication between physicians and patients.

50
Q

Cons of DTC

A

Increased promotional expenditures may increase prices.

Increased demand may raise prices and/or consumer expenditures.

51
Q

Globally, what countries allow for DTC?

A

Only the U.S. and New Zealand permit DTC advertising.

52
Q

Reimportation:

A

Some individuals may seek to purchase drugs at lower prices from other countries and then import them back into the United States. However, this practice raises various safety and regulatory concerns, such as ensuring the authenticity, safety, and efficacy of the imported drugs.

53
Q

Reimportation Concerns:

A

Concerns include safety, effectiveness (bioequivalence), fraud, counterfeiting, and patent infringement.

FDA requires inspection of the supply chain for legal importation approval.

Bans “reimportation” of drugs for resale through unapproved sources.

54
Q

Personal Importation:

A

Allowed for a three-month supply if:

A valid U.S. prescription is provided.

Intended use is unapproved and for a serious condition.

The product is not considered to represent an unreasonable risk.

55
Q

Counterfeiting Drugs

A

Counterfeits constitute 30% of the global drug market in the developing world (World Health Organization 2008).

56
Q

Consumer Risks of Counterfeits

A

Receive no benefit from a drug without an active ingredient.

Can experience adverse events, including death, from drugs with harmful chemicals.

Delay access to effective treatment.

57
Q

Foreign Clinical Trials:

A

Approximately 40-60% of trials occur outside the United States.

58
Q

Benefits of foreign trials:

A

Diverse trial sites allow for diverse populations.

59
Q

Concerns of foreign trials

A

Concerns include FDA capacity for inspecting numerous foreign trials and difficulty attributing patient outcome differences.

60
Q

IPRs

A

Intellectual Property Rights:

61
Q

What are IPRs

A

Intellectual property rights (IPRs) are laws and regulations protecting ideas and products of innovators.

62
Q

Hatch-Waxman Act.

A

Governs the intellectual property rights for small-molecule drugs in the United States.

Copies of small-molecule drugs are considered generics when produced by manufacturers other than the innovator company.

63
Q

Patent Protection and Affordable Care Act.

A

IPRs for Biologics:

Involves data exclusivity, and copies are considered biosimilars.

64
Q

Generics & ANDA Submission:

A

Generic manufacturers go through the Abbreviated New Drug Application (ANDA) process, demonstrating bioequivalence to the innovator drug.

This allows for a more streamlined approval process compared to the original new drug application.

US Healthcare Exam 2 (8 decks)

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