Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Kelly > Policy, Practice, & Regulatory Issues > Flashcards

Policy, Practice, & Regulatory Issues Flashcards

1
Q

Authorization bills

A

grant authority for a program or agency to exist. Must be in place before funding decisions are made.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Appropriation

A

sum of money designated for a particular purpose by an act or bill

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Entitlement spending

A

for programs like Medicare, Medicaid, and Social Security are automatically set based on eligible recipients. Levels of spending can only be changed by eligibility criteria changes.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Discretionary spending

A

represents annual spending levels determined by Congress; spending is optional.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Continuing resolution

A

continues funding for a program if the congressional fiscal year, ending Sept 30, ends without a new appropriation in place

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Health information technology for economic and clinical health (HITECH) act

A

authorized US DHHS to create programs to improve health care quality, safety, and efficiency through the promotion of HIT, including EHRs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

The Standards and Certification Criteria Final Rule

A

initial approach to adopting standards, implementing specifications, and providing certification criteria to enhance the interoperability, functionality, utility, and security of HIT and to support its meaningful use

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

The incentive program for electronic health records

A

issued by CMS to provide a financial incentive to eligible professionals, eligible and critical access hospitals, and Medicare Advatage Orgs that are “meaningful users” of EHRs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

The Patient Protection and Affordable Care Act of 2010

A

several provisions, from protecting consumers to improving health care quality and lowering costs to increasing access to care

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Accountable care orgs (ACOs)

A

set of providers with a defined population of patients accountable for the quality and cost of care delivered to that population

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

The Food and Drug Administration Safety and Innovation Act of 2012

A

revised and extended the user-fee programs for prescription drugs and medical devices to establish user-fee programs for generic drugs and biosimilars and other purposes. Addresses and regulates drug shortages.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Agency for Healthcare Research and Quality (AHRQ)

A

supports research that helps people make better-informed decisions and improves the quality of health care services

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

The Administration Procedure Act of 1946

A

granted agencies of DHHS the power to promulgate rules and regulations that have the effect of substantive law

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Center for Drug Evlauation and Research (CDER)

A

part of the FDA that regulates prescription and nonprescription drugs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Center for biologics evaluation and research

A

part of the FDA that regulates vaccines, blood, and gene therapy

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Abbreviated New Drug Application (ANDA)

A

submitted to FDA’s CEDER, Office of Generic Drugs. Allows the review and ultimate approval of a generic drug product; do not reuire preclinical or clinical data, only bioequivalence

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

Authorized generic drug

A

a listed drug that is marketed, sold, or distributed directly or indirectly to retail class of trade with labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar for use in institutions), product code, labeler code, trade name, or trademark that differs from that of the listed drug

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

Investigational New Drug Application (IND)

A

submitted to FDA for a new drug, new indication, or an off-label use that will be used in a clinical investigation’s preclinical development for that new drug to be distributed across state lines before undergoing full FDA review

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

New Drug Application (NDA)

A

vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the US

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

Drug Importation Act of 1848

A

prohibited the importation of unsafe or adulterated drugs at key ports of entry

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

FD&C Act of 1938

A

required firms prove evidence of safety to the FDA before marketing; placed drug advertising under the jurisdiction of the Federal Trade Commission

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

Durham-Humphrey Amendment of 1951

A

amended the FD&C Act of 1938 to statutorily differentiate prescription and nonprescription drugs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

Kefauver-Harris Amendments of 1962

A

required drug firms to demonstrate efficacy as well as safety; requirement to obtain informed consent for research subjects; authorized FDA to regulate advertising of prescription drugs and establish good manufacturing practices

24
Q

The Orphan Drug Act of 1983

A

established grants, fed assistance for research, and tax incentives to develop drugs targeted for a patient population of less than 200,000

25
Q

FDA Modernization Act of 1997

A

Streamline clinical research on drugs and devices, exclusivity provisions for pediatric drugs, created clinicaltrials.gov

26
Q

Food and Drug Administration Amendments Act of 2007 (FDAAA)

A

Requires REMS

27
Q

Preclinical studies

A

laboratory and animal studies that assess safety and biologic activity in various model systems; toxicologic studies that assess effects of animal fetus. After these, IND is drafted and submitted to FDA.

28
Q

Phase I drug trial

A

introduction of IND to humans (20-100); garner info on the pharmacokinetic and pharmacodynamic properties of the drug to design a well-controlled and robust phase II trial

29
Q

Phase II drug trial

A

controlled clinical studies in no more than several hundred subjects; evaluated drug’s effectiveness for a particular indication in patients with the disease or condition under investigation and to determine the common short-term adverse effects and risks

30
Q

Phase III drug trial

A

several hundred to several thousand patients to determine safety, efficacy and dose. Afterwards, submit an NDA.

31
Q

Phase IV drug trial

A

aka postmarketing studies; may be required by the FDA to verify effectiveness or focus tx on special pops

32
Q

Drug Price Competition and Patent Term Restoration Act of 1984
aka Hatch-Waxman Act

A

defined bioequivalence as a means to approve a generic drug

33
Q

Health Insurance Portability and Accountability Act of 1996

A

provide protection of privacy of certain individually identifiable health data (PHI)

34
Q

Minimal risk

A

probability and magnitude of harm or discomfort anticipated in the research are no greater in and of themselves compared with those ordinarily encountered in daily life or during the performance of routine physical or psychological exams

35
Q

IRB members

A

at least 5; at least one who is primarily scientific; at least one who is primarily nonscientific; at least one who is not affiliated with the institution and is not an immediate family member of someone affiliated with the institution

36
Q

Investigational drug service

A

purpose is to procure, manage, prepare, dispense, and dispose of investigational drugs according to protocol and in compliance with the state and federal requirements that govern investigational drug activities

37
Q

Targeted solutions tool

A

created by Joint Commission; process for accredited hospitals to measure performance, identify barriers to excellent performance, and implement proven solutions

38
Q

Tracer methodology

A

used by Joint Commission on site surveyor to evaluate a patient’s medical record and evaluate its compliace with standards and systems to provide care and services

39
Q

The national committee for quality assurance (NCQA)

A

private, not-for-profit, mission to improve the quality of health care through measurement, transparency, and accountability; produces HEDIS

40
Q

Healthcare Effectiveness Data and Information Set (HEDIS)

A

tool that health plans use to measure performance and focus improvement efforts

41
Q

National Quality Forum (NQF)

A

nonprofit; improve quality through building consensus on national priorities; endorsing national standards; promoting national goals

42
Q

Comparative effectiveness research (CER)

A

systematic research comparing diff interventions and strategies to prevent, diagnose, treat, and monitor health conditions

43
Q

The consumer assessment of healthcare providers and systems (CAHPS)

A

assesses consumer experiences with healthcare.

44
Q

The Pharmacy Quality Alliance (PQA)

A

mission to improve the quality of med use across health care settings through collaborative process for measuring and reporting

45
Q

FDA Adverse Event Reporting System (FAERS)

A

database; Medwatch form fda 3500 for voluntary reporting by consumers and healthcare professionals

46
Q 
Code of Federal Regulations (definition)
Title 21
Title 37
Title 42
Title 45; common rule (part 46); part 160 and subparts A and E of 164
A

Agencies of DHHS make rules and adjudicate them. Final rules are published in the CFR and updated every year on a staggered basis.

Title 21: Food and Drugs

Title 37: Patents, trademarks, & copyrights

Title 42: Public Health

Title 45: Public welfare

Title 45, common rule (part 46): Federal Policy for the Protection of Human Subjects (defines research and human subjects)

Title 45, part 160 and subparts A and E of 164: Health Insurance Portability and Accountability Act

47
Q

Pure Food and Drug Act of 1906

A

Prohibited interstate commerce of adulterated or misbranded drugs.

Required labeling of selected dangerous and addictive substances.

Identified United States Pharmacopoeia and the National Formulary as official standards for drugs.

48
Q

Biologics Control Act of 1902

A

Mandated annual licensing of establishments to manufacture and sell vaccines, sera, antitoxins, and similar products in interstate commerce.

Authorized Hygienic Laboratory, precursor of the NIH, to conduct regular inspections for purity and potency.

49
Q

The Food and Drug Administration Act of 1988

A

officially established the FDA as an agency in DHHS

50
Q

Prescription Drug User Fee Act (PDUFA) of 1992

A

Requires drug, biologics, and medical device (MDUFA) manufactueres to pay fees for product applications, supplements, and other services.

Reathorized every 5 years.

51
Q

The Dietary Supplement Health and Eucation Act of 1994

A

allows nutritional supplements and vitamins to be regulated.

52
Q

The Family Smoking Prevention and Tobacco Control Act of 2009

A

gave the FDA authority to regulate tobacco products

53
Q

Act that established a regulatory approval pathway for biosimilars or follow-on biologics

A

The Patient Protection and Affordable Care Act of 2010

54
Q

The Reducing Prescription Drug Shortages Executive Order

A

signed by Obama on 10/31/11

Requires the FDA to:

  • broaden reportings of manufacturing discontinuances that may lead to shortages of drugs that are life-supporting or sustaining.
  • expedite regulatory review of suppliers and manufacturing sites to avoid drug shortages.
  • communicate to the department of justice any evidence of or behaviors by market participants that may have contributed to stockpiling or exorbitant prices.
55
Q

The Food and Drug Administration Safety and Innovation Act of 2012

A

Reathorized PDUFA

Kelly (12 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions