Pcs

Front 1

Kefauver-Harris Amendment to the Food, Drug and Cosmetic Act

Back 1

All new drugs must be approved by the FDA as being both SAFE and EFFECTIVE.

Front 2

Institutional Review Board (IRB)

Back 2

Local scientists and non-scientists that oversee clinical research and approve the clinical trial protocols.

Front 3

informed consent

Back 3

a document, NOT a contract, that includes details (risks/benefits) of the clinical study for participants to know.

Front 4

FDA's Division of Scientific Investigations (DSI)

Back 4

conducts inspections of clinical study sites and makes sure study was conducted according to the plan.

Front 5

Clinical Study Phase I

Back 5

- small group of healthy subjects (20-80)
- safe dosage range, route, and adverse effects, safety, initial tolerable dose.

Front 6

Clinical Study Phase II

Back 6

- 100 to 300 volunteers with disease.
- effectiveness, side effects, initial dose and usual dose
- Most important phase.

Front 7

Clinical Study Phase III

Back 7

- 1000-3000 volunteers
- verify effectiveness, monitor adverse reactions from long-term use.

Front 8

Clinical Study Phase IV

Back 8

- Post-marketing surveillance (after the product has been approved)

Front 9

Within how many days sponsors must report adverse drug events to FDA?

Back 9

15 days.

Front 10

Waxman-Hatch Act

Back 10

provided for an Abbreviated New Drug Application (ANDA) and an accelerated procedure for approval of generic versions.

Front 11

Orphan Drug Act (ODA)

Back 11

Incentives for sponsors to develop products for rare diseases.

Front 12

pharmaceutical care

Back 12

the responsible provision of a drug therapy for achieving specific outcomes that improve a patient's quality of life.

Front 13

Key differences between Orkin person and pharmacist?

Back 13

- higher consequences of action
- autonomy

Front 14

What define a profession?

Back 14

• Autonomy
• Specialized knowledge
• Community sanction
• Ethical codes
• Culture that members subscribe to – professionalism
• Prestige
• Long schooling

Front 15

Role strain

Back 15

Frustration due to lack of education/training, focusing on job instead of profession, automation technology.

Front 16

Role Ambiguity

Back 16

the job expectations are ill-defined

Front 17

Person-role conflict

Back 17

the values, attitudes or personal needs of the individual are not congruent or in opposition to the role expectations of a job.

Front 18

Intrarole conflict

Back 18

different individuals define the job expectations for a person

good guy - bad guy role,

Front 19

Interrole conflict

Back 19

too many different roles to fulfill

Front 20

seven processes that make up the medication-use system

Back 20

1. Physician drug therapy decision process
2. Physician Order Process
3. Pharmacy Order Input Process
4. Pharmacy Dispensing Process
5. Medication Administration Process
6. Medication Use Documentation Process
7. Drug Therapy Outcome Evaluation Process.

Front 21

What is the strongest predictor of good health?

Back 21

Education (part of Socioeconomic status)

Front 22

Indicators of Socioeconomic status

Back 22

Education
Occupational Status
Income

Front 23

Main difference between medical model and biopsyschosocial model

Back 23

Medical model doesn't include social well-being, while biopsychosocial model does include social well-being.

Front 24

Parson's socio-cultural model

Back 24

- health is defined as the capacity to function socially.
- illness is a disturbance of the capacity to perform expected tasks or roles.
- illness is non-tolerated.
- people can be optimal in functioning, and be biologically ill (Ex. diabetic worker)
- Sick Role

Front 25

Stress model

Back 25

stress is cumulative and may cause illness; degree of stress measured as a mount of readjustment.

Front 26

definition of health

Back 26

state of complete physical, mental, and social well being and not merely the absence of disease or infirmity.

Front 27

medical model

Back 27

health as the absence of signs and symptoms.

Front 28

health behavior

Back 28

things we do to prevent illness

Front 29

illness behavior

Back 29

things we do when we are ill.

Front 30

4 aspects of Sick Role

Back 30

1. Non-responsibility of the individual for the condition. (patient didn't choose to get sick)
2. Exemption from normal obligation (time off work)
3. Being sick is undesirable (must try to get better 1st thing)
4. Obligation to seek competent help.

Front 31

5 problems with illness behavior

Back 31

1. Shopping for doctors
2. Fragmentation (treatment by different doctors)
3. Procrastination
4. Self-medication
5. Discontinuity (interrupting treatment)

Front 32

Suchman’s Stages of Illness and Medical Care Model

Back 32

1. Symptom Experience
2. Assumption of Sick Role
3. Medical Care Contact
4. Dependent Patient Role
5. Recovery or Rehabilitation.

Front 33

Health Belief Model

Back 33

health behavior theory that describes the likelihood an individual will take an action to change a behavior. Components of this theory include susceptibility and severity of disease, perceived benefits and barriers, cues to action, self-efficacy, and demographic, socio-psychological variables.

Front 34

Social Cognitive Theory Model

Back 34

Healthy behaviors are a function of individual's perception of the advantage of a a positive outcome. belief that a certain outcome will result from particular behavior

Front 35

Readiness to Change Model

Back 35

desires to change a patient's health behavior must be specific to the stage in which they are in.

Front 36

Locus of Control Model

Back 36

based on the idea that an individual's success at reaching a desired outcome is a function of whether or not he believes the outcome is within their control.

Front 37

What core clinical services have the highest number of favorable association because they focus on a smaller group of patients.

Back 37

1. Clinical Pharmacists
2. Decentralized Pharmacy
3. Drug Protocol Management

Front 38

In the early 20th century, many "patent medicines" were considered dangerous and fradulent in their claims and led to the passage of what act?

Back 38

Pure Food and Drug Act

Front 39

Dichter Institute Study commissioned by APhA

Back 39

report found that most respondents saw pharmacists as businessmen rather than health care providers.

Front 40

Durham-Humphrey Amendment to the Food, Drug and cosmetic Act

Back 40

created the “legend” drug, required label to state that it could not be dispensed without a prescription

Front 41

major piece of legislation to affect the efficacy of prescription drug

Back 41

Food, Drug and Cosmetic Act of 1938

Front 42

HIPAA

Back 42

Health Insurance Portability and Accountability Act

enacted to decrease the number of uninsured person; specified that employers or insurers of new
employees could impose a waiting period of no more than 12 month before covering them under the employer’s health plan.

Front 43

definition of quality

Back 43

the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge

Front 44

Millis Commission’s report

Back 44

pharmacists inadequately prepared in systems analysis and management skills

Front 45

Medicare Prescription Drug Improvement and Modernization Act (MMA 2003)

Back 45

recognizes the need for medication therapy management services in ambulatory care; positions pharmacy to fulfill role in reducing drug-related morbidity and educating older adults on proper pharmacologic and nonpharmacologic management of comorbid diseases

Front 46

JCAHO

Back 46

Joint Commission on Accreditation of Health Organizations

Front 47

T/F. drug ordering process is the single greatest source of preventable problems

Back 47

True

Front 48

Multidisciplinary care

Back 48

many different professionals work for the good of the patient, albeit somewhat independently

Front 49

Interdisciplinary care

Back 49

many different professionals working together for the patient’s good also communicate effectively among themselves and with the patient

Front 50

What is discounting?

Back 50

the process of converting dollars, either paid out or received over time periods of more than one year, to their present value. the purpose is to incorporate the time preference for money into the analysis

Front 51

Kerr-Mills Act

Back 51

Amendments to the Social Security Act in 1960 provided health care coverage to elderly indigent individuals
Kerr-Mills did not provide health care coverage to the nonindigent elderly or the indigent nonelderly.

Front 52

4 P's of marketing

Back 52

Product
Place
Price
Promotion

Front 53

One other thing that separates the pharmaceutical industry from other consumer goods is that purchase decisions are not made based on emotion, but on _________.

Back 53

Knowledge!

Front 54

Pharmacy Benefit Manager (PBM)

Back 54

a company that adjudicates rx drug claims and manages the rx drug coverage for third party payer by containing costs and influencing the quality of services provided.

Front 55

per diem

Back 55

hospitals are paid a flat rate for each day of hospital care provided to covered individuals without regard to the actual costs incurred.

Front 56

Managed Care Organization (MCO)

Back 56

manage the cost and quality of health insurance program.

This vs. fee-for-service plans is the use of provider network.

Front 57

Steps for Conducting a pharmacoeconomic analysis

Back 57

1. define problem/state objective
2. Perspective
3. Alternative Interventions
4. Identify and Measure outcomes
5. Identify Cost Elements
6. Measure and Value Costs

Front 58

What is Pharmacoeconomics?

Back 58

one type of OUTCOMES RESEARCH that is useful in selecting among ALTERNATIVE INPUTS to achieve HEALTH AND ECONOMIC CONSEQUENCES often called OUTCOMES.

Front 59

Four domains of Quality of Life

Back 59

Physical
Psychological
Social
Economics

Front 60

What is need and why is need difficult to measure?

Back 60

Need is the estimated amount of care based on the perceptions of an individual. If's difficult to measure because it's a perception.

Front 61

disease management

Back 61

process of case management of patients having selected chronic diseases at risk for high utilization of health care resources.

Front 62

3 demand-side markets.

Back 62

1. patient's demand for medical treatment
2. Institutional demand for manpower, capital, and supplies.
3. Demand for health professional education.

Front 63

3 supply-side markets

Back 63

1. Physician's decision on which institutional setting to use.
2. Supply of manpower that is produced by training programs.
3. Implementation of health profession education programs.

Front 64

Education has what effect on demand for medical services?

Back 64

Decreases

Front 65

demand for health

Back 65

health is like a consumption commodity: acquire it, consume it, and receive good outcome.

demand for health is behavioral.

Front 66

Barriers to disease management.

Back 66

lack of time
lack of good information system
third-party payer

Front 67

Donabedian's model of quality

Back 67

Structure --> Process --> Outcome

Structure (availability of capital resources, leadership, management systems, policies, procedures
Process (measurement of specific activity (error/100 dose dispensed)
Outcome: population based - satisfaction, # of hospital readmissions

Front 68

quality assurance

Back 68

measurement of the quality of care including both the assessment of care and feedback to the health care organization that recommends either a continuation or change in care

demonstrate that the service meets a set of pre-determined requirements or criteria

Front 69

quality control

Back 69

ensuring that a product conforms to a desired standard by emphasizing monitoring and measurement

Front 70

quality improvement

Back 70

measurement of defects; ensure that the effects of change to correct a problem

The most common QI methodologies used in health care are PDSA (plan-do-study-act), six-sigma and lean strategies.

Front 71

Total Quality Management

Back 71

a philosophy and management strategy.

Front 72

Framework for improving quality

Back 72

1. Design
2. Measure
3. Assess
4. Improve
5. Redesign

Front 73

PDSA

Back 73

Plan
Do
Study
Act

Front 74

LEAN

Back 74

LEAN focuses specifically on removing non-value activities which is called waste in Quality speak

Front 75

what is an indicator?

Back 75

A valid and reliable measurement.

Front 76

benchmarking

Back 76

process by which one organization identifies and studies superb performance of another organization and uses their performance as a standard to achieve.

Front 77

root-cause analysis (RCA)

Back 77

problems are best solved by correcting or eliminating the root cause rather than finding a quick fix that acts as a band-aid.

Front 78

FMEA

Back 78

Failure Mode and Effect Analysis

takes a broader view of the problem to see if there are external contributing factors.

Front 79

OBRA

Back 79

Omnibus Budget Reconciliation Act: repeal capitation for health professionals

Front 80

Prescription Drug Plan (PDP)

Back 80

Medicare part D

PDP’s are private insurance companies that contract with a prescription benefit manager (PBM) to offer a drug benefit that can have several tiers depending on the coverage

Front 81

Iron Triangle of Health Care

Back 81

access
quality
cost

Can't change one without changing the other.

Front 82

CDER

Back 82

Center for Drug Evaluation and Research: make sure drugs are safe and effective.