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Healthcare > Exam 3 > Flashcards

Exam 3 Flashcards

1
Q

Tuskegee study purpose

A

What happens if we don’t treat syphillis? Difference between effects in white and black people.

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2
Q

Characteristics of the research subjects in the Tuskegee study

A

Poor, primarily black population in Alabama

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3
Q

Access to penicillin during the Tuskegee study

A

Physicians were told not to give people in the study penicillin

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4
Q

Implication of the Tuskegee study?

A

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created, creating the Institutional Review Board (IRB)
-Protect the rights and welfare of humans participating in the research study

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5
Q

Three Principles of the Belmont Report?

A
  1. Respect for Persons
    - Subjects choose to participate or drop out freely
    - Autonomy: people must be empowered to make decisions for their own well being
  2. Beneficence
    - Maximize possible benefits and minimize possible harms.
    - Physiological distress honored through the process of de-indentification and secure data storage
    - Physical harm honored through cross-over trial or comparative effectiveness trial
  3. Justice
    - Honored through the process of equitable subject selection
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6
Q

Four basic principles of ethical practice

A
  1. Autonomy: the patient’s ability to determine their care, free of coercion
  2. Beneficence: The treatment that the health care professional provides should benefit the patient
  3. Non-maleficence: Do no harm
  4. Justice: Fair distribution of scarce resources, competing needs, rights and obligations, and potential conflicts with established laws
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7
Q

Steps of the innovator drug approval process

A
  1. Drug Discovery
  2. Preclinical testing
  3. Investigational New Drug (IND): document describing preclinical test results, manufacturing information and clinical trial protocols
  4. Phase 1 Clinical Trials: to evaluate safety and determine the safe dosing range
  5. Phase II Clinical Trial: to determine efficacy/effectiveness of the compound, examine possible short-term side effects/risks, and identifying optimal dose and schedule
  6. Phase III Clinical Trial: to determine efficacy/effectiveness and safety of the compound in a longer term
  7. New Drug Application (NDA) review by the FDA
  8. Post Marketing Surveillance
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8
Q

Fixed Cost

A

Cost that does not change with an increase or decrease in the amount of goods produced (ex. cost to design, R&D, office desk, printer, website)

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9
Q

Variable (production) cost

A

A cost that changes following the quantity of goods produced (costs or material, labor, duties, transportation)

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10
Q

How is the cost structure set up for the drug industry

A

Not based on cost, it is based on demand

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11
Q

When are people more sensitive to price?

A

During times of high competition, when there are many alternatives available

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12
Q

When are people less sensitive to price?

A

During times of low competition when there are few or no alternatives available

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13
Q

Describe differential pricing practice by drug companies, specifically the effect on other countries

A

Companies’ pricing strategy is to charge the maximum price that the market can bear. Drug companies charge different prices for the same drug, to different countries

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14
Q

Where is the world’s single largest market for innovative drugs?

A

U.S. @ 33.9% of the world

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15
Q

Lab results; x-ray results, etc

A

Clinical outcomes

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16
Q

MD palpation during a physical examination; RN report of a vomitting episode

A

Clinician reported outcome

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17
Q

Total costs spent on cancer treatment, work days lost due to illness, etc.

A

Economic outcome

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18
Q

Patient reported symptoms/functions

A

Patient reported outcome

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19
Q

Why are PRO’s important?

A
  • Some treatment effects are known only to the patient
  • Mortality as the ultimate outcome indicator is becoming less attractive
  • Consumerism in health care where traditional assessments made by clinicians or lab values are not sufficient to evaluate patient preferences
  • Patient perspective may not coincide with objective assessments
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20
Q

What are PROs?

A

Patient reported outcome: any endpoint/observation derived from the patient

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21
Q

How are PROs used?

A
  • Measuring drug effectiveness
  • Monitoring drug safety
  • Indicator of quality
  • Decision maker for treatment types
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22
Q

Two types of health related quality of life (HRQOL) instruments

A
  1. General instruments: broadly applicable to general population with a summarized range of basic domains (SF-36)
  2. Disease or condition specific instruments: Relevant to the patient with specific disease (Asthma quality of life questionnaire AQLQ)
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23
Q

What is health state utility?

A

Measures the patient preference of a specific health state or health outcome (higher is more desirable)

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24
Q

How is it different that HRQOL?

A

Rating scale from 0-100 to avoid small numbers

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25
Q

What is QLAYS and how do you calculate it?

A

(Additional life years gained) x (Utility of those life years)

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26
Q

Four categories of cost with examples

A
  1. Directed medical costs: diagnostic tests, drug costs, physician costs, etc.
  2. Direct nonmedical costs: costs directly associated with treatment but not medical in nature (traveling to doctor’s office)
  3. Indirect costs: cost that results from the loss of productivity because of illness (missing work days = wage x missed time)
  4. Intangible costs: cost of pain, suffering, anxiety, or fatigue due to illness or treatment
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27
Q

How is cost effectiveness used in the UK?

A

Drug price regulation, clinical guidelines

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28
Q

How is cost effectiveness used in the U.S?

A

Used as the decision criteria in prescription drug coverage - drug that achieves the higher drug outcome at a lower cost is preferred in the formulary

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29
Q

IND

A

Investigational new drug document describing preclinical test results, manufacturing information, and clinical trial protocols

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30
Q

Phase I Clinical trial purpose

A

Evaluate safety and determine the safe dosing range

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31
Q

Phase II Clinical trial purpose

A

Determine efficacy/effectiveness while looking at possible short-term side effects and optimal dosing schedule (months-2 years)

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32
Q

Phase III Clinical trial purpose

A

Determine efficacy/effectiveness, and safety of the compound in longer term (1-4 years)

33
Q

NDA Review

A

FDA reviews New Drug Application which documents the drug’s whole story (IND becomes part of NDA)
-Reviews safety, effectiveness, labeling, manufacturing

34
Q

What criteria must generic drugs meet to be approved?

A

Same active ingredients, route of administration, dosage form, strength, and indications as the original innovator (brand)

35
Q

ANDA

A

Abbreviated New Drug Application document demonstrating that the generic produce is bioequivalent to the innovator

36
Q

Why is placebo needed?

A

Creates a change from baseline to establish how the disease course would progress in the absence of intervention

37
Q

What is randomization?

A

Subjects are assigned to a group at random, which makes the baseline characteristics similar between two groups except treatment

38
Q

Three randomization methods and their description

A

Open label: both the investigators and the subjects know what treatment is being administered
Single blind: the investigators know which treatment is being administered
Double blind: neither the subjects or investigators know who is taking what

39
Q

Comparative effectiveness study

A

Using an active comparator instead of a placebo, which is useful when there are multiple drugs available under the same therapeutic class, to determine which drug works best among available choices

40
Q

Respect for Persons

A

Individuals should be treated as autonomous agents, and must freely choose to participate and can end at any time

41
Q

How is “respect for persons” honored?

A

Informed consent

42
Q

Beneficence

A

Maximize possible benefits and minimize possible harms

  • Psychological distress
  • Physical harms
43
Q

How is psychological distress beneficence honored?

A

De-identification and secure data storage

44
Q

How is physical harms beneficence honored?

A

Cross-over trial and comparative effectiveness trial

45
Q

Justice

A

No individual or population is exposed to the risks of harm while other individuals or populations receive the benefits
-directly related to Tuskegee Study

46
Q

How is Justice honored?

A

Through the process of equitable subject selection

47
Q

Four Basic principles of medical practice? No description

A

Autonomy
Beneficence
Non-maleficence
Justice

48
Q

Autonomy

A

Patient’s ability to determine their care, free of coercion

49
Q

Beneficence

A

Treatment that the health care professional provides should benefit the patient

50
Q

Non-maleficence

A

Do no harm

51
Q

Justice

A

Fair distribution of scarce resources, competing needs, rights and obligations, and potential conflicts with established laws

52
Q

Fixed cost

A

The same, regardless of how much of the patented new drug is produced and sold
-cost to design, office printer, desk, etc.

53
Q

Variable cost

A

The cost that changes following the quantity of goods produced (actual cost of producing the drug)
-Usually very small compared to fixed costs for new drugs

54
Q

When does high competition occur?

A

When there are many alternative choices available

*People are more sensitive to price

55
Q

When does low competition occur?

A

When there are few or no alternatives available

*People are less sensitive to price

56
Q

What are companies’ pricing strategies in a less sensitive market?

A

Charge the maximum price a market can bear

57
Q

How do drug companies handle pricing to multiple buyers (countries)

A

Charge different prices for the same drug, because resale from country to country is illegal

58
Q

When are manufactures willing to reduce price? (3)

A

Countries that can’t afford to pay as much
Countries with single payer system
Countries with a price-control policy

59
Q

Pro and Con of price-control policy

A

Pro: cheaper medications
Con: introduction of new drugs is delayed

60
Q

Clinical outcomes examples

A

Lab results, x-rays, etc

61
Q

Clinician reported outcome example

A

MD palpation during physical exam

RN report of a vomiting episode

62
Q

Economic outcome example

A

Total costs spent on cancer treatment

Work days lost due to illness

63
Q

Patient reported outcome

A

Patient reported symptoms/function

Health-Related Quality of Life (HRQL)

64
Q

Why are PROs important?

A

Captures how the patient feels or functions with respect to condition
Obtained directly from patient
Supposed to be without interpretation by clinician

65
Q

Drug effectiveness

A

Measuring research study endpoints in the development and evaluation of new therapies

66
Q

Drug safety

A

Monitoring adverse events in clinical research

67
Q

Quality

A

Hospital post patient satisfaction results to report quality of care

68
Q

Decision-Making

A

What the patient prefers will be the treatment of choice

69
Q

How are PROs used?

A

Drug effectiveness, drug safety, quality, decision making

70
Q

How to calculate quality-adjusted life years (QLAYs)

A

QAYLs = additional life years gained x utility of those life years

71
Q

Four different categories of cost

A

Direct medical costs
Direct non-medical costs
Indirect costs
Intangible costs

72
Q

Direct medical cost definition with examples

A

Medically related inputs used directly to provide treatment (drug costs, diagnostic tests, physician cost)

73
Q

Direct non-medical costs with examples

A

Costs directly associated with treatment but not medical in nature (costs of traveling to doctors office)

74
Q

Indirect costs with examples

A

Cost that result from the loss of productivity b/c of illness (cost of missing work days)

75
Q

Intangible costs with examples

A

Costs of pain, suffering, anxiety, or fatigue due to illness or treatment

76
Q

Which of the following is NOT the contributing factor of health disparities?

  1. Income
  2. Insurance status
  3. Age
  4. Education
  5. All of the above contribute to health disparities
A

All the above

77
Q

Which of the following is NOT the five key social determinants of health stated by Healthy People 2020?

  1. Economic status
  2. Individual’s alcohol consumption volume and frequency
  3. Education, social and community context
  4. Access to health care
  5. Neighborhood and physical environment
A

Individual’s alcohol consumption volume and frequency

78
Q

What is culturally competent patient care?

  1. It is a race/ethnicity group based care
  2. It is an individual level care that takes into account social and linguistic aspects
  3. It is a stereotype based care, and it strengthens pharmacist-patient relationships
A

It is individual level care that takes into account social and linguistic aspects

79
Q

Which of the following is TRUE about health literacy?

  1. It only applies to the non-native English speakers
  2. Low health literacy leads to poor treatment adherence
  3. Health literacy is defined as the ability to read and write English
  4. Health literacy is a matter of individual’s ability and its not related to the health care systems or professional’s skills
A

Low health literacy leads to poor treatment adherence

Healthcare (2 decks)

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