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PHA373 > Foundation of Law Presentation 1 > Flashcards

Foundation of Law Presentation 1 Flashcards

1
Q

System of enforceable rules.

Is a code that is official

A

Law

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2
Q

Guidelines determined by an administrative agency that provides info to greater define the law and how to follow the law

A

Rules and Regulation

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3
Q

Guideline or blueprint implemented to reach a common goal.

A

Policy

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4
Q

Is a civil or personal wrong, that occurs when an individual is careless and deviates from the standard of care.

A

Negligence

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5
Q

Administering the wrong medication, wrong dose, wrong patient.

A

Commission (doing)

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6
Q

Failing to administer, asses, counsel.

A

Omission (not doing)

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7
Q

What are 4 elements that plaintiff (patient) must prove for negligence?

A
  1. Duty to care
  2. Breach of duty
  3. Injury/actual damages
  4. Causation/proximate cause
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8
Q

Legal obligation to care

A

Duty to care

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9
Q

Failure to conform to or a departure from a required obligation

A

Breach of duty

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10
Q

Includes more than physical harm

A

Injury/actual damages

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11
Q

A reasonable, close, and casual connection or relationship between the defendant’s negligent behavior and the resulting damages.

A

Causation/Proximate cause

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12
Q

Sources and types of law

A

US constitution
Statutory law
Administrative law
Common law

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13
Q

Administrative Law

A

Not truly a law. It provides rules and regulations.

Ex: GABOP

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14
Q

Examples of administrative Agencies that affect pharmacy

A
  1. State Boards of Pharmacy (BOP)
  2. Centers for Medicare and Medicaid Services.
  3. Food and drug Administration
  4. Federal Trade Commission
  5. Drug Enforcement Administration
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15
Q

Common Law

A

Laws made by courts through judicial opinions.

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16
Q

Opinions:

A

Are rules of law that are enforceable and binding on lower court rulings.

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17
Q

Types of law and the Pharmacist:

A

Criminal, Law, and Administrative

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18
Q

Being charged. (Criminal)

A

Criminal

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19
Q

Being sued

A

Civil law

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20
Q

actions or hearings.

A

Administrative

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21
Q

Federal law vs State law

A

Practice of pharmacy and drug distribution is regulated by federal and state statutes, rules, and regulations.

State law may not conflict with federal law.

Must follow the stricter law.

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22
Q

Passed because of concerns of unsanitary conditions and poor labeling. Adulteration and misbranding in interstate commerce was prohibited. It did not prevent false or misleading efficacy claims.

A. Food, Drug and Cosmetic Act of 1938.
B. Pure Food and Drug Act 1906.
C. Kefauver-Harris Amendment of 1962.
D. Durham-Humphrey Amendment of 1951.

A

B. Pure Food and Drug Act 1906

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23
Q

Required all new drugs prove safety before marketing, Adequate directions for use on all labeling, and habit-forming warnings. This was applied to drugs, cosmetics and devices.

A. Comprehensive Drug Abuse Prevention Control Act of 1970.
B. Pure Food and Drug Act of 1906.
C. Poison Prevention Packaging Act of 1970.
D. Food, Drug, and Cosmetic Act of 1938

A

D. Food, Drug, and Cosmetic Act of 1938

24
Q

Established two classes of drugs (Rex and otc), required Rex labels to contain a legend “caution: federal law prohibits dispensing without prescription”

A. Durham-Humphrey Amendment of 1951.
B. Kefauver-Harris Amendment of 1962
C. Poison Prevention Packaging Act of 1970.
D. Orphan Drug Act 1983.

A

A. Durham-Humphrey Amendment of 1951.

25
Q

Required proof of drug safety and efficacy. FDA comes to inspect manufactures , FDA regulated advertisements for Rex drugs, and FTC regulated advertisements for OTC products.

A. Durham-Humphrey Amendment of 1951
B. Kefauver-Harris Amendment of 1962
C. Poison Prevention Packaging Act of 1970.
D. Orphan Drug Act of 1983.

A

B. Kefauver-Harris Amendment of 1962

26
Q

Controlled Substance Act (CSA), legal foundation to fight against drug abuse, created 5 schedules of controlled substances based on physical and psychological dependence, established record keeping and violation penalties.

A. Durham-Humphrey Amendment of 1951
B. Kefauver-Harris Amendment of 1962
C. Orphan Drug Act of 1983.
D. Comprehensive Drug Abuse Prevention Control Act of 1970.

A

D. Comprehensive Drug Abuse Prevention Control Act of 1970.

27
Q

Failure to comply with packaging requirements and misbranding, legend drugs and controlled substances must be packaged in child-resistant containers.

A. Comprehensive Drug Abuse Prevention Control Act of 1970.
B. Medical Device Amendment of 1976.
C. Poison Prevention Packaging Act of 1970.
D. Orphan Drug Act of 1983.

A

C. Poison Prevention Packaging Act of 1970.

28
Q

Required medical devices be classified based on function and receive pre-market approval. Manufacturing in accordance with GMP standards.
Established performance standards.
Outlined record keeping and reporting requirements.

A. Medical Device Amendment of 1976.
B. Safe Medical Devices of 1990.
C. Omnibus Reconciliation Act of 1990.
D. Orphan Drug Act of 1983.

A

A. Medical Device Amendment of 1976.

29
Q

Provided tax and exclusive licensing incentives to manufacturers to develop and market drugs to treat rare disease.

A. Safe medical Devices of 1990
B. Orphan Drug Act of 1983
C. Medical Device Amendment of 1976
D. Omnibus Reconciliation Act of 1990

A

B. Orphan Drug Act of 1983

30
Q

Waxman-Hatch Amendment
Streamlined the generic drug approval process so that generic drugs could be more readily available to the public. ANDA requires manufacturer to prove bio equivalence between brand (innovator) and generic .

A. Poison Prevention Packaging Act of 1970.
B. Comprehensive Drug Abuse Prevention Control Act of 1970.
C. Drug Price Competition and Patent Term Restoration Act of 1984.
D. Non of above.

A

C. Drug Price Competition and Patent Term Restoration Act of 1984.

31
Q

Placed controls on distribution of prescription drugs and samples, banned reimportation of prescription drugs, specified storage, handling and record keeping requirements for drug samples, prohibited resale of prescription purchased in hospitals or other healthcare facilities.

A. Nutrition Labeling and Education Act of 1990.
B. Omnibus Reconciliation Act of 1990.
C. Prescription Drug Marketing Act of 1987.
D. Food and Drug Modernization Act of 1997.

A

C. Prescription Drug Marketing Act of 1987.

32
Q

Strengthened (mas fuerte) the Medical Device Amendment of 1976, required manufacturers to report complains of device malfunction, serious injuries, or deaths associated with devices.

A. Safe Medical Devices Act of 1990.
B. Nutrition Labeling and Education Act of 1990.
C. Food and Drug Modernization Act 1997.
D. Medical Device User Fee and Modernization Act 2002.

A

A. Safe Medical Devices Act of 1990.

33
Q

Mandated nutrition labeling on food products, authorized heath claims on products labels so long as claims made were in compliance with FDA regulations. Ex: probiotics.

A. Omnibus Reconciliation Act 1990
B. Prescription Drug Marketing Act of 1987.
C. Nutrition Labeling and Education Act of 1990.
D. Dietary Supplement Health and Education Act of 1994.

A

C. Nutrition Labeling and Education Act of 1990.

34
Q

Outlined expectations of pharmacist and patient interaction, had a goal of saving money and improving therapeutic outcomes,pharmacist counseling obligations, prospective drug utilization review requirements and record keeping requirements.

A. Dietary Supplement Heath and Education Act of 1994.
B. Omnibus Reconciliation Act of 1990
C. Medicare Modernization Act of 2003.
D. Food and Drug Administration Amendment Act of 2007.

A

B. Omnibus Reconciliation Act of 1990

35
Q

Defined dietary supplements and permitted manufactures to make claims that would have been illegal otherwise.
Required FDA to regulated supplements more as food than drugs.Were not satisfied with the Nutrition Labeling and Education Act of 1990.

A. Prescription Drug Marketing Act of 1987.
B. Heath Insurance Portability and Accountability Act of 1996 (HIPAA)
C. Food and Drug Modernization Act of 1997
D. Dietary Supplement Heath and Education Act

A

D. Dietary Supplement Heath and Education Act of 1994.

36
Q

Created a fast-track approval process for drug intended for serious or life-threatening disease. Established a databank of information on clinical trials, and authorized scientific panels to review clinical investigation.

A. Medical Device User Fee and Modernization Act of 2002.
B. Food and Drug Modernization Act of 1997.
C. Omnibus Reconciliation Act of 1990.
D. Safe Medical Devices of 1990.

A

B. Food and Drug Modernization Act of 1997.

37
Q

Privacy rule component took effect on April 14, 2003. Designed to safeguard the privacy of protected health information.
Imposed 5 key provisions for pharmacist/pharmacies

A. Omnibus Reconciliation Act 1990.
B. Health Insurance Portability and Accountability Act (HIPAA) 1996
C. Dietary Supplement Health and Education Act of 1994.

A

B. Health Insurance Portability and Accountability Act (HIPAA) 1996

38
Q

5 key provisions for pharmacist/pharmacies of HIPAA:

A
  1. Must take reasonable steps to limit the use of, disclosure of, and requests for PHI.
  2. Must inform patients of privacy practices
  3. Compliance officer must be identified and manage/ensure compliance
  4. All employees must receive HIPAA training
  5. When PHI is discloser, it is only for the purposes of which the party is engaged by the pharmacy.
39
Q

Established four Medicare program: Medicare Parts A, B, C, D. And established formal medication therapy management programs.

A. Medical Device User Fee and Modernization Act of 2002.
B. Food and Drug Modernization Act 1997.
C. Dietary Supplement Heath and Education Act of 1994.
D. Medicare Modernization Act of 2003.

A

D. Medicare Modernization Act of 2003.

40
Q

Regulated retail over-their-counter sales of ephedrine, pseudoephedrine, and phenylpropanolamine products.
Established sales limits and record keeping requirements. Regulated product placement in the pharmacy. Established minimum age requirements for purchasers. Required self-certification for sellers.

A. Orphan Drug Act of 1983.
B. Prescription Drug Marketing Act of 1987.
C. Combat Methamphetamine Epidemic Act of 2005.
D. Poison Prevention Packaging Act of 1970

A

C. Combat Methamphetamine Epidemic Act of 2005.

41
Q

Required use of electronic prescriptions or tamper-resistant prescription pads fro Medicaid patients.

A. Drug Quality and Security Act of 2013.
B. Medicaid Tamper-Resistant Prescription Law of 2007.
C. Patient Protection and Affordable Care Act of 2010.
D. Medicare Modernization Act of 2003.

A

B. Medicaid Tamper-Resistant Prescription Law of 2007.

42
Q

Provided the FDA with greater responsibility and authorization for drug safety. Mandated labeling changes
Required clinical trial data reporting and registries. Required additional post-markerting clinical studies to assess risks.

A. Food and Drug Administration Amendments Act of 2007.
B. Medicare Modernization Act of 2003.
C. Drug Quality and Security Act of 2013.
D. Non of above .

A

A. Food and Drug Administration Amendments Act of 2007.

43
Q

Required all individuals to have health insurance, patients could stay under their parents until the age of 26, phased out the “donut hole” for Medicare part D so patients didn’t have to come completely out of pocket.

A. Drug Quality and Security Act of 2013.
B. Orphan Drug Act of 1983.
C. Patient Protection and Affordable Care Act of 2010.
D. Omnibus Reconciliation Act of 1990.

A

C. Patient Protection and Affordable Care Act of 2010.

44
Q

Enhanced FDA oversight of pharmacies engaged in large-scale compounding and shipping of sterile products. Created “track and trace” for all entities in the chain of distribution.

A. Drug Quality and Security Act of 2013.
B. Patient Protection and Affordable Care Act of 2010.
C. Medicare Modernization Act of 2003.
D. Medical Device User Fee and Modernization Act of 2002.

A

A. Drug Quality and Security Act of 2013.

45
Q

Created new clinical trial design options and accelerated pathways for drug approval for serious or life-threatening disease. Opponents fear drugs approvals through this process will endanger public safety.

A. Drug Quality and Security Act of 2013.
B. The 21 Century Cures Act of 2016.
C. Medicaid Tamper-Resistant Prescription Law of 2007.
D. Food and Drug Administration Amendment Act of 2007

A

B. The 21 Century Cures Act of 2016.

46
Q

Authoritative list of drugs, formulas, and preparations that sets a standard for drug manufacturing and dispensing.

A

United States Pharmacopeia (USP)

47
Q

USP Chapters:

A
  1. USP 795
  2. USP 797
  3. USP 800
  4. USP 825
48
Q

Provides standards for compounding quality non-sterile products.
Categories of compounding: simple, moderate and complex.

A. USP 795
B. USP797
C. USP 800
D. USP 825

A

A. USP 795

49
Q

Provides standards for compounding quality sterile products.
Categories of compounding: low-, medium-, and high-risk.

A. USP795
B. USP 797
C. USP 800
D. USP 825

A

B. USP 797

50
Q

Provides practice and quality standards for handling hazardous drugs to promote patient safety, worker safety, and environmental protection.

A. USP795
B. USP797
C. USP800
D. USP825

A

C. USP 800

51
Q

Provides uniform minimum standards for the preparation, compounding, dispensing, and repackaging of sterile and non sterile radiopharmaceuticals for humans and animals.

A. USP795
B. USP797
C. USP 800
D. USP825

A

D. USP 825

52
Q

Allowed for establishment of regulatory requirements for reprocessed single-use devices.

A. Medicare Modernization Act 2003.
B. Safe Medical Devices of 1990.
C. Medical Device Amendment of 1976.
D. Medical Device User Fee and Modernization Act of 2002.

A

D. Medical Device User Fee and Modernization Act of 2002.

53
Q

From the Poison Prevention Packaging Act, What are the etc exceptions for child-resistant containers?

A

Sublingual nitroglycerin, anhydrous cholestyramine, oral contraceptives and pancrelipase.

54
Q

Made by state legislatures, city councils, districts, etc.

A

Statutory law

55
Q

State law has to adhere to federal law

A

US Constitution

PHA373 (4 decks)

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