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Pharmacy Law > EXAM 1 > Flashcards

EXAM 1 Flashcards

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1
Q

Why do we study law?

A
  • Tells us the minimal competency and actions that are acceptable
  • if we dont meet what is acceptable, we need to be held accountable
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2
Q

Laws enacted by Congress?

A

Federal

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3
Q

Laws enacted by Legislature?

A

State

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4
Q

What do regulations do?

A

administration enactments authorized by statutes (DEA, FDA, etc.)

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5
Q

What is common law?

A

-Body of principles based on custom and usage (UK)
- Basis for American Law

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6
Q

What is Judicial or Case Law derived from?

A

judicial decision and interpretations of statutes

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7
Q

What does the Federal Government regulate?

A

Manufacturing, packaging, storage, labeling, and labels, distribution and authorized use of pharmaceuticals

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8
Q

Why do we regulate drugs?

A
  • continue new drug development and creation of drugs that are public good
    -safe production and use of drugs
    -mitigate information asymmetry
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9
Q

What does the federal government require?

A

Label requirements; auxiliary labels and definitions
-clarify, provide additional information or reinforce primary label
- “shake well”, “refrigerate”, etc.

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10
Q

What does the federal government define?

A

Control substances act of 1970:
-defines agents, authorized possession and acquisition, storage and inventory, and limitations on distribution
-enforced by the DEA
-pharmacies needing to be registered with the DEA

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11
Q

What do the state governments do?

A

Defines the personnel and conditions for the storage and distribution of pharmaceuticals on an individual basis
-pharmacists, technicians, interns, assistants

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12
Q

What is the USP?

A

-United States Pharmacopoeia

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13
Q

Information for USP

A

-founded: 1820’s by M.D.s
-initial goal: standardized names and formulations of medicines
-effort: defined 217 products (today > 3200)

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14
Q

mission of USP?

A

promote public health by disseminating:
-standard of quality
-authoritative information

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15
Q

What is the “Standard of Quality”?

A

-strength, quality, purity, packaging and labeling of “drug products”
–inclusive of drug entity, dosage form, medical devices, diagnostic products
-information disseminated through official compendia: USP-NF

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16
Q

What is authoritative information?

A

1978-2004: The USP dispensing information series
Now: Periodic monographs

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17
Q

in authoritative information, what is the model guidelines for the medicare prescription drug act (medicare part d) for?

A

focus: establishing/monitoring outcomes in disease states where intervention/prevention can make a difference

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18
Q

What is the Basis of Authority?

A

-Vested in the Federal Law
–Federal food drug and cosmetic act of 1938 (OBRA ‘90); Medicare prescription drug, improvement and modernization act 2003
-adopted by individual state pharmacy acts

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19
Q

What is the APhA?

A

American pharmacist association
-oldest of pharmacy professional societies
represents all aspects of pharmacy
-established “mission” for pharmacy practice which sets the basis for “Pharmaceutical Care”
-involved in establishing policy for pharmacy practice and federal legislative and regulatory initiatives

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20
Q

What is the “Pure food and drug act of 1906”?

A

prohibited foods and drugs that were distributed though interstate commerce to be adulterated or misbranded

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21
Q

what wasn’t required according to the “pure food and drug act of 1906”?

A

-manufacturers listing ingredients
-manufacturers labeling directions for use
-regulation of cosmetic products and medical devices

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22
Q

Why was the “Food, drug and cosmetic act of 1938” written?

A

a result from 107 deaths that occurred from the liquid SULFANILAMIDE in 1937

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23
Q

What does the Food, drug and cosmetic act of 1938 require?

A

-any NEW DRUG can’t be marketed unless it’s been proven to be safe when used according to directions on the label
-labels needing adequate directions for use
-warnings about habit-forming drugs contained in the product

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24
Q

What does the food, drug and cosmetic act of 1938 apply to?

A

-medications
-cosmetic products
-medical devices

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25
Q

What drugs were “grand fathered” before 1938 (before the food, drug, and cosmetic act of 1938)?

A

-levothyroxine
-digoxin
-nitroglycerin
-phenobarbital

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26
Q

What is the Durham-Humphrey Amendment of 1951?

A

-Amendment of FDCA
-2 classes of drugs:
–Legend drugs
–Over-the-counter drugs

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27
Q

What are legend drugs?

A

-required medical supervision
-don’t have to list “adequate directions for use”
-required to include the legend “Caution: federal law prohibits dispensing without a prescription” on the label

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28
Q

what are over-the-counter drugs (non-prescriptions)?

A

-don’t require medical supervision
-required label to have “adequate directions for use”

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29
Q

Why was the Kefauver-Harris Amendment of 1962 created?

A

resulted from public concern about birth defects from thalidomide

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30
Q

What is the Kefauver-Harris amendment of 1962?

A

all new drug marketed in the U.S. had to be SAFE and EFFECTIVE (new and all drugs approved between 1938-1962)
-regulation of RX drug advertising under the authority of the FDA
-creation of good manufacturing practices (GMP)

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31
Q

What does the Kefauver-Harris Amendment of 1962 require?

A

-informed consent by research subjects in clinical investigations
-reporting of adverse drug reactions

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32
Q

What is the Medical Device Amendment of 1976?

A

provides better classification of medical devices:
-according to specific function
-establishment of performance standards
-pre-market approval requirements
-conformance of GMP standards

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33
Q

the medical device amendment of 1976 is a requirement for?

A

adherence to record and reporting requirements

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34
Q

What is the Orphan Drug Act of 1983?

A

-used to treat diseases that affect relatively few people
-has limited potential for profitability
-provided various tax and licensing incentives to manufacturers to make development of orphan drugs more appealing

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35
Q

What is the “Drug Price Competition and Patent-Term Restoration Act of 2984”? What is it for?

A

-“Waxman-Hatch Amendment”
-attempted to resolve a dispute between generic and brand name
-streamlined drug approval process for generic drugs
-provided innovative drug manufacturers with incentives to develop new drugs

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36
Q

What is the “Prescription drug marketing act of 1987”?

A

-control distribution of prescription drug samples
-prevent hospitals and other healthcare entities from reselling pharmaceuticals to other businesses

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37
Q

what is the “FDA Modernization Act of 1997”?

A

-far-reaching piece of legislation
-nearly all of FDA activities
-for FAST-TRACK REVIEW of some NDA submissions (for serious or life-threatening conditions - AIDS, more modern, Covid)

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38
Q

How does the “FDA modernization act of 1997” affect compounding of prescriptions?

A

-indicating that individual states should regulate compounding
-pharmacies are exempt from the strict regulatory federal GMP standards and requirements for submission of new drug applications

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39
Q

What changes occurred due to the “FDA modernization act of 1997”?

A

-change of prescription drug legend:
–old: “Caution: federal law prohibits dispensing w/o a RX”
–new: “RX only”
-“Warning - May be habit forming” was eliminated

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40
Q

How did the “FDA modernization act of 1997” make changes for manufacturers?

A

-Encouraged to conduct research for new uses of current drugs and submit supplemental NDA’s for new uses

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41
Q

What is the Affordable Care Act (ACA)?

A

-require all individuals have health insurance
-require standards for financial and administrative transactions
-stop agreements between brand name and generic drug manufactures that limit or delay
-phase elimination of the catastrophic threshold

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42
Q

What is the “Inflation Reduction Act of 2022”?

A

-Required the federal government to negotiate prices for some drug coverage
-require drug companies to pay rebates to medicare
-cap out-of-pocket spending
-limit monthly cost sharing for insulin to $35 for people with medicare
-eliminate cost sharing for adult vaccine
-expand eligibility for full benefits under the Medicare Part D

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43
Q

What is the Official Compendia?

A

-US Pharmacopoeia/National Formulary (USP/NF)
-published by the U.S. pharmacopoeia convention (USPC)
-Contains monographs of recognized

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44
Q

What is the Investigational new drug application (IND)?

A

-extensive testing process to assure that a new drug is SAFE AND EFFECTIVE
-must be submitted to FDA before new drug is marketed
-Completed by sponsor (manufacturer)
-before drug given to humans

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45
Q

How long does the FDA have to decide if the IND is suitable for clinical trials in humans?

A

30 Days

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46
Q

What does the IND application include?

A

-all preclinical data on safety and use
-clinical protocols for human testing

47
Q

Why do we need to have a process to bring new drugs to market?

A

-FDA finalized rule in December 1998 requiring information on safe and effective use in children to prevent problems

48
Q

Phase 1 of clinical trials

A

-SMALL groups
-HEALTHY subjects
-direct supervision of sponsor
Purpose:
-evaluation of TOXICOLOGY, PHARMACOKINETICS, and PHARMACOLOGICAL PROPERTIES
-assessment of SAFETY

49
Q

Phase 2 of clinical trials?

A

-LARGE group (>100)
-patients have DISEASE or CONDITION
-direct supervision of sponsor
purpose:
-determine:
–EFFECTIVENESS
–DOSAGE
–RELATIVE SAFETY
–ADVERSE EFFECTS

50
Q

Phase 3 of clinical trials?

A

-LARGE group
-multiple locations
-double-blind
-done by independent investigators at multiple locations
-COSTLY
-long time
purpose:
-obtain data on EFFECTIVENESS vs. placebo

51
Q

What is important about treatment INDs?

A

-allow administration of IND to patients not enrolled in the new drug clinical trial program
-patients must be in an imminent life-threatening stage of illness
-drugs MUST be in phase 2 or 3!!
“treatment protocol” -> designated patients must be approved by FDA

52
Q

What is important about the New Drug Application (NDA) process?

A

-thousands of pages of data and information
-very COSTLY and TIME-CONSUMING
-review: 6 months
-FDA provides opportunity for comment to experts and other interested parties
-approved? yes? drug can be marketed

53
Q

Phase 4 of clinical trial?

A

-post-marketing surveillance
-health professionals encouraged to report issues
-manufacturer MUST submit annual reports to FDA
-this data will determine if drug can stay on the market

54
Q

When can we use an FDA Expedited review program?

A

-therapy that treat serious or life-threatening diseases
-priority review
-fast track
-breakthrough therapy
accelerated approval

55
Q

what does the Abbreviated New Drug Application (ANDA) do?

A

-for after patent protection expires
-secondary companies may use the generic game or brand
-secondary can submit ANDA

56
Q

What does ANDA require?

A

-less data
-pharamcokinetic data
-bioavailability
-proof of similar clinical activity to innovator’s product

57
Q

What is the Supplemental New Drug Application (SNDA)?

A

-ABBREVIATED application
-after marketing a drug product
-for changes in drug’s synthesis, production procedures, manufacturing, etc.

58
Q

What happened after the Waxman-Hatch Amendment/Drug price competition and patent-term restoration act?

A

-Brand Manufacturers were granted longer patent protection (5 years)
-generic manufacturers given easier access to approval of ANDAs

59
Q

What is the Good Manufacturing Practices (GMP)?

A

-regulations that specify the minimum requirements to manufacture products
-registered with FDA
-describe making process
FDA inspects facilities approximately once every 2 years (more if history of deficiencies)

60
Q

When is a drug considered “adulterated”?

A

-contains any filthy, putrid, or decomposed substances
-prepared, package, etc. under unsanitary conditions
-doesn’t meet GMP standards
-unapproved color additive

61
Q

What is the Prescription Drug Marketing act 1987?

A

-used to correct problem of drug diversion from normal distribution channels
-require proper storage of drugs and maintenance of appropriate distribution records
-restrict sale, purchase, or trade of prescription

62
Q

Why does REMS exist?

A

Established to regulate potential harmful side effects where benefits could outweigh risks
-FDA administrative amendments act of 2007

63
Q

What are the 5 levels of risk mitigation?

A
  1. Professional label and package insert
  2. REMS - medication Guide
  3. REMS - communication Plan
  4. Elements to assure safety use
  5. Implementation system
64
Q

What are the specific requirements for Thalidomide REMS?

A

-females MUST undergo pregnancy testing and use BCP
-males - use condoms
-MD and pharmacies registered to prescribe or dispense
-mandatory patient surveys

65
Q

How can Thalidomide be dispensed?

A

-28 day supply
-no refills
-filled within 7 days of being written

66
Q

How can Accutane be dispensed according to iPLEDGE?

A

-30 day supply
-no refills
-filled within 7 days of being written for females

67
Q

T/F: FDA considers prescribing and dispensing drugs for unapproved uses or doses illegal.

A

False

68
Q

What does the federal law prohibit in regards to off-label use?

A

prohibits anyone in the chain of distribution from suggesting to a patient or prescriber that an approved drug maybe used for an unapproved purpose

69
Q

What are the requirements for unit-dose packaging and labeling?

A

-generic and/or trade name
-amount of active drug/drugs
-manufacturer, packer, etc.
-re-packager’s lot number
-expiration date
-special storage requirements

70
Q

What is the expiration dates for customized patient med paks?

A

-no more than 60 days from when med pack was prepared

71
Q

What happens for drug recalls for class 1?

A

-stocks in pharmacies removed and notification of patients who were given the drugs
(cause serious, adverse health consequences)

72
Q

What happens with class 2 drug recalls?

A

-pharmacy stock removed
(cause temporary or reversible effects)

73
Q

What happens with Class 3 drug recalls?

A

-unlikely cause any adverse health consequences

74
Q

What are expiring dates for compounded prescription?

A

non liquids and solids: not more than 25% of time remaining on the product OR <6 months (whichever is less)
aqueous: 14 days if refrigerated
anything else: time of therapy use but <30 days

75
Q

What is the Drug Quality and Security Act of 2013?

A

requirements for trading partners regarding TRACING OF RX PRODUCTS
-interoperable, electronic tracing systems

76
Q

What are 2 types of facilities for compounding that follow the drug quality and security act of 2013?

A

503A: traditional pharmacy settings
503B: “outsourcing centers”; don’t require prescriptions

77
Q

What is the main difference between federal and state regulations when dispensing medications?

A

-restrictions on what is considered non-controlled and controlled may differ
-follow more strict regulations

78
Q

Who can prescribe RX?

A

each state varies who can or cant prescribe outside of MDs
(NPs, PAs, etc.)

79
Q

Can MDs self prescribe? what about controlled?

A

yes
some states PROHIBIT self-prescribing controlled meds

80
Q

What is important about RX refills?

A

-controlled: tight limitations
-non-controlled: MD must indicate # of refills/time limit (no indication = NO REFILLS)

81
Q

What is the duration of RX refills?

A

usually < 1 year

82
Q

Who owns the RX after its filled by a pharmacy?

A

legally owned by dispensing pharmacy
-can’t remove from files unless for court order
-if MD or PT wants prescription, we can ONLY GIVE COPY

83
Q

How long do we store the RX in the pharmacy?

A

2-5 years depending on state
NYS: 5 years

medicare modernization act of 2003: RX need to be kept for 10 years

84
Q

T/F: lot numbers and expiration dates are NOT required on the RX label (according to federal law).

A

True

85
Q

What is the purpose of Poison Prevention Packaging Act of 1970?

A

-provide special packaging to protect children < 5 years
-most RX, non-RX, and household products

86
Q

What is the Federal anti-tampering act of 1982?

A

-a barrier or indicator to limit access
-if disturbed, this is evidence of possible entry

87
Q

T/F: Individual states not regulate substitution for one drug product for another.

A

False

88
Q

Why would we want to have drug substitutions?

A

Provide lower cost drug products in place of the drug product prescribed

89
Q

what does it mean to dispense a PHARMACEUTICALLY equivalent drug in place of the original prescribed drug?

A

SAME:
-active ingredient
-dosage form
-route of administration
-strength or concentration
different:
-excipients

90
Q

What does it mean to be THERAPEUTICALLY equivalent?

A

pharmaceutically equivalent AND bioequivalent
-clinically evaluated and have been shown to have similar pharmacokinetic properties
-similar blood concentration vs. time curves (time to peak, peak concentrations, AUC)

91
Q

when will the FDA approve marketing of competing drug products?

A

-no problems with bioequivalence
OR
-if there is problems, they shown to meet appropriate bioequivalent standards

92
Q

What makes a drug a pharmaceutical alternative?

A

-drug contains same therapeutic moiety
BUT different in:
–salts
–esters/complexes
–dosage forms
–strengths

93
Q

T/F: most state DON’T allow substitution between pharmaceutical alternatives

A

True

94
Q

When can a therapeutic substitution be allowed?

A

pharmacy has a right to substitute a different drug for the one designated on the RX without contacting the prescriber
-limited to drug formulary

95
Q

What is the difference between closed and open formulary?

A

Closed: formulary where only the drug product listed may be used

open: formulary that permits some unlisted drugs to be dispensed

96
Q

What is a generic name?

A

-single specific name given by the USAN
-Each specific drug structure is given only one generic name in this country

97
Q

What is a trade/brand name?

A

-unique name is selected by a pharmaceutical company for its own brand of generic drug
-encourages prescribers to prescribe a specific company’s product exclusively

98
Q

What is a patent protection?

A

-new drug product have protections for a few years
-manufacturers right to market the drug
-“single source product” - no one else can market the same drug

99
Q

What is a multisource product?

A

-after patent expires
-other companies can submit ANDA to gain approval to market the same drug
-may use the generic name or make a brand name

100
Q

What is the Orange Book for?

A

-approved drug products with therapeutic equivalence evaluations
-bioequivalence info. from the FDA
-monthly supplements

101
Q

What 2 categories are part of the Orange Book?

A

“A” rated: bioequivalent AND therapeutically equivalent to brand name; MAY BE SUBSTITUTED FOR ONE ANOTHER

“B” rated: NOT bioequivalent; DON’T SUBSTITUTE

102
Q

T/F: most states limit substitution to interchanges between products that are the same dosage from.

A

True

cap can’t sub for tab;
ointment cant sub for cream, etc.

103
Q

Subcategories of “A” code?

A

-generally designate different dosage FORMS

104
Q

Subcategories for “AB” categories?

A

-have actual or potential bioequivalence problems
-may be acceptible substitutes if the equivalency problems has been resolved by in vivo and/or in vitro studies

105
Q

“B” codes?

A

-drugs that the FDA doesn’t currently consider to be therapeutically equivalent to other equivalent products
-bioequivalence problems often stem from dosage form problems

106
Q

what isn’t required to be in the orange book?

A

“Grandfather” Drugs
-drugs marketed before 1938
-codeine, ephedrine, levothyroxine, phenobarbital, peudoephedrine, quinine, etc.

107
Q

T/F: pharmacist can “generally” substitute more expensive products

A

False

108
Q

What does the narrow therapeutic index/ratio refer to ?

A

-drugs where the multiple between the minimum toxic concentration and minimum effective concentration is relatively low

109
Q

T/F: The federal government have regulation limiting the free substitution of different manufacturers’ prodcuts.

A

False

SOME STATES

110
Q

what does it mean to be “biosimilar”?

A

same route of administration, mechanism of action, strength, dosage form

111
Q

Definition: Reference Drug product.

A

biologic product that is the original innovator’s product

112
Q

Definition: Biosimilar product.

A

Approved by FDA as highly similar to product, but have allowable difference b/c they are made from living organisms

113
Q

Definition: Interchangeable agent.

A

-expected to produce the same clinical result as the reference product in any given patient

114
Q

What is the use of the Purple Book?

A

-lists biological products
-to determine if a product approved through 351(k) pathway is biosimilar/interchangeable to reference product approved through 351(a) pathway

Pharmacy Law (3 decks)

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