Bcps - Policy, Practice, And Regulatory Issues

Front 1

Why was HIPAA designed?

Back 1

To protect the privacy of medical information for all Americas, as well as to improve the portability of continuity of health insurance coverage

Front 2

HIPAA stands for -

Back 2

Health Insurance Portability and Accountability Act

Front 3

What happens to copies of date use agreements for research of Limited Data?

Back 3

it has to be submitted to the IRB with applications for initial review, exemption or change of protocol.

Front 4

What are some consequences of not complying with HIPAA?

Back 4

Fines ranging from $100 - $200,00 and 10 years in jail

Front 5

Food and Drug Law of 1906

Back 5

First law requiring food purity

Front 6

Food, Drug, and Cosmetic Act of 1938

Back 6

1st law requiring the establishment of drug safety prior to marketing

Front 7

Durham-Humphrey Amendment of 1951

Back 7

Provides statutory basis and criteria for differentiating prescription and nonprescription drugs

Front 8

Kefaufer-Harris Amendments

Back 8

Establishes efficacy, safety, and purity of drugs
Obtained informed consent from research subjects

Front 9

Belmont Report of 1979

Back 9

Federally funded review that resulted in increased protection for human research subjects, attention to beneficence, and justice for human research

Front 10

Dietary Supplement Health and Education Act (DSHEA) of 1994

Back 10

Regulation of nutritional supplements and vitamins
- Must be safe for human consumption under ordinary conditions of use

Front 11

FDA Modernization Act of 1997

Back 11

Helps streamline clinical research of drugs
- Helped established pharmacy compounding exemption and rules
- Pediatric clinical studies
- Expedite fast track drugs

Front 12

Institutional Review Board (IRB)

Back 12

Helps protect the rights, safety, and well being of all study subjects

Front 13

The IRB is made up of what?

Back 13

- at least 5 members
- One member w/primarily nonscientific interests
- One member that is independent of the institution
- Only members that are independent of the investigator and sponsor may vote

Front 14

What is the purpose of the IRB?

Back 14

To assure that the appropriate steps are taken to protect the rights and welfare of humans participating as subjects in research

Front 15

What type of research requires IRB approval?

Back 15

- retrospective chart reviews
- observational studies
- experimental studies

Front 16

What is an expedited review?

Back 16

A review procedure that consists of a review of research involving human subjects by the IRB chairperson or by one or more experience reviewers designated by the chairperson from among members of the IRB

Front 17

When does the IRB use an expedited procedure?

Back 17

- To review minor changes in previously approved research during the period covered by the original approval
- Can be carried out by the IRB chairperson or by one of the more experienced members of the IRB

Front 18

What CAN'T the reviewers of an expedited procedure do?

Back 18

They can exercise all authorities of the IRB except disapproval

Front 19

When can disapproval be accepted?

Back 19

When it is reviewed by the entire IRB committee

Front 20

What type of research have an expedited review?

Back 20

- Research on drugs in which an IND is not required
- Collection of blood samples by fingerstick, heel stick, ear stick, etc.
- research that has data that has been collected, or will be collected solely for non-research purposes
- Collection of data form voice, video, digital, and image recording made for research purposes
- Research on ind. or group characteristics, behavior, research employing survey, oral history, etc.

Front 21

FDA Modernization Act of 1997

Back 21

Helps streamline clinical research of drugs
- Helped established pharmacy compounding exemption and rules
- Pediatric clinical studies
- Expedite fast track drugs

Front 22

Institutional Review Board (IRB)

Back 22

Helps protect the rights, safety, and well being of all study subjects

Front 23

The IRB is made up of what?

Back 23

- at least 5 members
- One member w/primarily nonscientific interests
- One member that is independent of the institution
- Only members that are independent of the investigator and sponsor may vote

Front 24

What is the purpose of the IRB?

Back 24

To assure that the appropriate steps are taken to protect the rights and welfare of humans participating as subjects in research

Front 25

What type of research requires IRB approval?

Back 25

- retrospective chart reviews
- observational studies
- experimental studies

Front 26

What is an expedited review?

Back 26

A review procedure that consists of a review of research involving human subjects by the IRB chairperson or by one or more experience reviewers designated by the chairperson from among members of the IRB

Front 27

When does the IRB use an expedited procedure?

Back 27

- To review minor changes in previously approved research during the period covered by the original approval
- Can be carried out by the IRB chairperson or by one of the more experienced members of the IRB

Front 28

What CAN'T the reviewers of an expedited procedure do?

Back 28

They can exercise all authorities of the IRB except disapproval

Front 29

When can disapproval be accepted?

Back 29

When it is reviewed by the entire IRB committee

Front 30

What type of research have an expedited review?

Back 30

- Research on drugs in which an IND is not required
- Collection of blood samples by fingerstick, heel stick, ear stick, etc.
- research that has data that has been collected, or will be collected solely for non-research purposes
- Collection of data form voice, video, digital, and image recording made for research purposes
- Research on ind. or group characteristics, behavior, research employing survey, oral history, etc.

Front 31

What is the difference between ED50 and LD 50?

Back 31

ED 50 = amount of drug required to produce a specific effect in 50% of animals tested
LD 50 = amt of drug required to cause death in 50% of animals tested

Front 32

What does preclinical studies consist of?

Back 32

- Laboratory and clinical studies (LD 50 and ED 50)
- Toxicological signals (establishing basis for pregnancy categories)

Front 33

What happens once the preclinical studies are completed?

Back 33

- A New Drug Application is drafted and submitted to the FDA
- This has to be approved prior to human experimentation

Front 34

What occurs during Phase I of the Drug Approval process?

Back 34

- Tested on usually healthy young male adults
- Small number of people
- Evaluate pharmacokinetic profile to determine a safe dosage
- Not structured to detect most adverse effects
- Determine the MOA of humans

Front 35

What occurs during Phase II of the Drug Approval Process?

Back 35

- Study the drug in patients with the particular disease or condition its supposed to be treating
- Larger group of people tested (80 - a few hundred)
- Preliminary data of effectiveness
- Identify most common short-term adverse effects

Front 36

What occurs during Phase III of the Drug Approval Process?

Back 36

- Tested on hundreds to thousands of patients
- Should be geared to detect differences in efficacy
- Collect info on safe usage
- Need enough information to weigh benefits and risks

Front 37

What happens to a medication once it gets through the phase III of the DAP?

Back 37

A New Drug Application (NDA) is submitted

Front 38

What happens during Phase IV of the Drug Approval process?

Back 38

This is after the drug has been marketed
- Focuses on special populations
- Identify rare, but serious side effects
- Sequelae and outcomes of long-term use

Front 39

Drugs that meet unmet medical needs and that are for patients with serious life threatening conditions are called what?

Back 39

Fast-tracked drugs

Front 40

What is the Purpose of the Investigation Drug Service?

Back 40

To ensure that the use of the investigational drugs i conducted ethically, and in application of the rules and regulations

Front 41

What is technically considered to be an Investigational Drug?

Back 41

Any drug that is not approved by the FDA for use in humans.

Front 42

A 3 day process which is a method of evaluation during and on-site visit which traces the health care of a patient while in the hospital

Back 42

Tracer Methodology

Front 43

What is ORYX?

Back 43

A JCAHO initiative that integrates outcomes and other performance measurement data into the accreditation process; a component of the ORYX initiative is the Standardized Core Measures.

Front 44

What are the Core Measures of the ORYX?

Back 44

1. Acute MI
2. Heart Failure
3. Community-Acquired
pneumonia
4. Pregnancy and related conditions

Front 45

What is NCQA? and it what 3 ways does it evaluate healthcare?

Back 45

1. Rigorous on-site review of key clinical and administrative processes
2. Health Plan Employer Data and Information Set
3. Comprehensive member satisfaction survey

Front 46

In what key areas does HEDIS has performance measures for?

Back 46

Immunization rates
Mammography screening
Cholesterol management
Customer Satisfaction
Other

Front 47

What is NCQA? and it what 3 ways does it evaluate healthcare?

Back 47

1. Rigorous on-site review of key clinical and administrative processes
2. Health Plan Employer Data and Information Set
3. Comprehensive member satisfaction survey

Front 48

In what key areas does HEDIS has performance measures for?

Back 48

Immunization rates
Mammography screening
Cholesterol management
Customer Satisfaction
Other