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fl 2* > RXPREP Chapter 2: Pharmacy Laws & Regulations > Flashcards

RXPREP Chapter 2: Pharmacy Laws & Regulations Flashcards

1
Q

Which body reviews the drug data provided by the manufacturer to make sure that drugs marketed in the US are safe and effective?

A

Center for Drug Evaluation & Research (the largest of FDA’s 6 centers)

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2
Q

The drug approval process consists of how many phases?

A

four phases

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3
Q

Which phase of the drug approval process?

  • on animals
  • relative safety
  • therapeutic potential
A

pre clinical testing

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4
Q

Between which phases is the IND present?

A

between pre-clinical and phase I

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5
Q

Which phase of the drug approval process?

  • 20-100 healthy volunteers or people with the disease
  • safety
  • side effects
  • PK and PD
A

phase I

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6
Q

Which phase of the drug approval process?

  • 100-300 people with the disease
  • efficacy and safety
  • find optimum dose or dose range
A

phase II

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7
Q

Which phase of the drug approval process?

  • 300-3000 people with the disease
  • efficacy compared to placebo or standard-of-care
  • AE
A

phase III

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8
Q

Which phase of the drug approval process?

  • lon term efficacy and safety
  • high risk patient monitoring
  • other peopulations and new uses
A

phase IV

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9
Q

Between which clinical phases is the NDA present?

A

between phase III and IV

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10
Q

If animal research indicates a relatively safe drug with potential therapeutic use, the manufacterer will file an

A

Investigational new drug (IND)

files to the FDA

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11
Q

What phase of the drug approval process assesses the drug’s safety?

A

ALL phases

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12
Q

what does IND approval represent?

A

the FDA’s permission to begin phase I clinical studies in HUMAN subjects

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13
Q

In what phase would you apply for FDA approval if your drug is proving to be promising?

A

phase III (NDA)

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14
Q

the ________ is used for drugs, and a ___________ is used for biologics

(NDA)

A

NDA

biologics license application

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15
Q

in order to change a label, add a new indication, add a new dosage strength of a drug or change drug manufacturing processes, a company must submit a

A

supplemental new drug application (sNDA); or a supplemental biolgoics license application (sBLA)

*this is how off-label uses become official indications

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16
Q

Each OTC category has an OTC monograph that dictates the specific conditions (dosing, labeling, indications) for drugs to be:

A

“generally recognized as safe and effective”

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17
Q

Which act created an administrative order that allowed the FDA to more easily publish and update OTC monographs? (previously was a 3 phase process)

A

the CARES act

3/2020

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18
Q

Which adminstrative order process?

requester submits OMOR

FDA files OMOR

FDA issues proposed order

public comments on proposed oder

FDA issues final order

A

industry-initiated order

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19
Q

Which adminisrtative order process?

FDA issues proposed order

public comments on proposed order

FDA issues final order

A

FDA-initiated order

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20
Q

Generic drug companies can file one of two abbreviated applications for generic drug approval:

A

abbreviated new drug application (ANDA)

505 (b)(2) application

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21
Q

This generic drug approval process requires a review of the generic product’s chemistry, the manufacturing controls and the labeling

A

ANDA

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22
Q

Under an ANDA, a generic drug company must provide study data to establish that the generic drug has the same:

A

active ingredient
route of adminisrtation
dosage form
strength

as te branded drug!

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23
Q

What is it called when drugs have the same rate and extent of availability at the site of action in the body to the brand drug?

A

bioequivalent

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24
Q

What can be different between generic and brand?

A

inactive ingredients (coloring, excipients, binders)

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25
Q

this generic drug approval process allows the manufacturer to submit previously published reports of safety and effectiveness

A

505b2

*unlike a generic approved by the ANDA, the drug can be marketed in a different strength or formulation than the previously approved product

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26
Q

un approved drug will have an NDC number but will not be lsited in the FDA’s approved drug products with therapeutic equivalence evaluations, commonly known as the

A

orange book

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27
Q

All drugs can cause some adverse events, which should be reported to the

A

FDA’s medwatch program

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28
Q

Medwatch interacts with FDA’s…

A

FDA’s adverse event reporting system (FAERS)

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29
Q

___________ is designed to identify AE NOT found in clinical trials

A

medwatch

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30
Q

Who can submit reports to medwatch?

A

healthcareprofessionals, includin rph; patients, and consumers

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31
Q

What is the post marketing surveillance component of phase IV?

A

the manufacturer sends collected reports to the FDA quarterly in the first 3 years, then every year

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32
Q

A drug recall is carried out by the drug company and can be intiated by

A

the manufacterer or the fda

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33
Q

manufacterers should notify the FDA ___ days prior the withdrawin an approved drug from sale

A

180 days

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34
Q

prescription drug advertising is regulated by the:

OTC drug advertising is overseen by

A

FDA

federal trade comission (FTC)

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35
Q

the fda requires an advertisement to contain three items:

A

the name of the drug (Brand and generic)
at least one FDA approved use for the dru
the most significant risks of the drug

36
Q

any false or misleadin statements in the advertisement could be considered: adulterated or misbrandin?

A

misbranding

37
Q

this law required that the food or drug label could not be false or misleading

and required that no adulterated or misbranded drugs could be sent through interstate commerce

A

wiley act/pure food and drug act of 1906

38
Q

this law led to requirements for drugs to demonstrate safety prior to release

A

food, drug, and cosmetic act (FDCA) in 1938

*birth of the FDA

39
Q

this act required that the manufacterer prove the safety of a drug before it could be marketed. adequate directions for safe use and a list of all ingredients had to be included on the label and product claims had to be accurate

A

FDCA

40
Q

filthy, putrid or decomposed

A

adulterated

41
Q

lack of required information on the package

A

misbranded

42
Q

false or misleading information

A

misbranded

43
Q

prepared or stored in unsanitary conditions

A

adulterated

44
Q

contaminated

A

adulterated

45
Q

drug is recognized in official compendia but its strength is different from official standards, or the purity or quality is lower than the official standards

A

adulterated

46
Q

drug is not recognized in the official compendia but its strength is different from that listed on the label

A

adulterated

47
Q

example: a vaccine which must be stored in the freezer has been stored in the fridge for the past week; vials of injectable pain mediction are found to contain glass shards; a manufacterer does not perform adequate sterility tests before distributing an IV drug

A

adulterated

48
Q

examples: an herbal product claims that it cures cancer; a product’s labeling does not include information about risk in pregnancy; an OC product is dispensed without the required patient package insert

A

misbranded

49
Q

example: a bottle of thyroid tablets are labeled as containing 60m but actually contain 30mg as determined by USP testing standards – adulterated or misbranded?

A

both!

the strength is lower than the standard (adulterated) and the product is falsely labeled (misbranded)

50
Q

this was the first time that a clear distinction was made between OTC and rx drugs and the labeling requirements for each were differentiated

A

durham-humprey amendment of 1951

51
Q

this amendment named three conditions that would make a drug available only by rx:

  • drugs that are habit formin
  • drugs considered unsafe for use except under supervision due to toxicity concerns
  • drugs limited to rx use only under a manufacterer’s new durg application
A

durham-humphrey amendment

52
Q

this amendment dealt with thalidomide

A

kefavuer-harris ammendment of 1962

“the first safe sleeping pill” used in pregnancy

// aka drug efficacy amendment

53
Q

this amendment implemented:

  • manufacterers must prove that a drug is both SAFE and EFFECTIVE before it can be fda approved
  • after the drug is on market, manufacterer’s must continue to report serious SE to the FDA
  • individuals must give their informed consent when they are study subjects of a clinical trial
A

kefauer-harris amendment of 1962

54
Q

what did the fda conduct in order to determine the effectiveness of drugs approved between 38 and 62?

A

retrorespective evaluation

“DESI program”

55
Q

the FDA was allowed to establish _____ for drug manufacturing and to perform inspections

A

current good manufacturing practice (CGMPs)

assured the identity, strength, quality, purity, prevention of errors

56
Q

this act established regulations surroundin controlled substances that all manufacterers, importers, exporters, distributors, researchers, hospitals, pharmacies, prescribers, and pharmacists must follow

A

controlled substance act of 1970

  • this act established a closed system for manufacturing, distributing, and dispensing drugs to reduce drug diversion
57
Q

Who enforces the CSA?

A

DEA

58
Q

this act requires a numer of household subtances and drugs to be packaged in children-resistant packaging

A

poison prevention packaging act of 1970

difficult for ages <5

59
Q

this act amended the FDCA to require drug establishments that are engaged in manufacturing, preparation, propagation, compounding or processing of a drug to register all of their drugs with the FDA. (NDC)

A

drug listing act of 1972

60
Q

the NDC number (10-11 digit code) has three segments:

A

labeler code (manufacterer, repackaer, or distributor)

product code (identifies the strength, dosage, and formulation)

package code (package size and type)

61
Q

this act made it a federal crime to tamper with OTC products, and required tamper-resistant features on OTC meds

A

federal anti-tampering act of 1982

62
Q

which products are exempt from using tamper resistant features in the packaging?

A

skin products

insulin

lozenges

toothpaste (dentifrice)

63
Q

an ___ drug treats a disease that affects less tan 200k people in the US or offers no reasonable expectation that the sales revenue will recover the cost of research and development

A

orphan

  • this act offers incentives to manufacturers of orphan drugs, including a tax credit (50% of the clinical testing costs) and a SEVEN years of market exclusivity
64
Q

this act streamlined generic drug approvals and to grant patent protection to drug innovators

A

hatch-waxman act (drug price competition and patent term restoration act) of 1984

  • the purpose of the legislation was to increase the availability of generics and cut costs for the patient and the healthcare system
65
Q

Which legislation made it possible for generic drug companies to file one of two abbreviated applications for generic drug approval (ANDA) and the 505b2 application?

A

hatch-waxman act

66
Q

the hatch-waxman act grants up to how many years of market exlucisvity to the company that created the brand name drug to make up for the effort the company spent conducting clinical trials to establish safety and efficacy

A

hatch-waxman act, 5 years

67
Q

this act was enacted to reduce public health risks from adulterated, misbranded, counterfeit or expired drugs

A

prescirption drug marketing act of 1987

  • the law prohibits reimportation; prescription drug products manufactured in the US and subsequently exported to a forein country cannot be reimported back into the US

the sale of drug samples and coupons was prohibited

68
Q

patients cannot buy drugs in other countries and bring them into the us except under what conditions?

A

quantity is <90 day supply and is for the patient (cannot be resold)

an effective treatment is not available in the US and the condition is serious, and the drug being imported has no unreasonable risk

69
Q

conerns about improper medication use and inefficient use of federal dollars spent on healthcare led to

A

the omnibus budget reconciliation act

70
Q

OBRA requires pharmacists to perform prospective drug utilization review (DUR) and counseling for all medicaid beneficiaries before dispensing the prescription to the patient

A

omnibus budget reconciliation act of 1990

71
Q

this act established regulations for dietary supplements that were different from those for drugs or conventional foods

A

DSHEA

dietary supplement health and education act of 1994

72
Q

dietary supplements may only claim to address

A

a nutrient deficiency, support health or be linked to body functions

must include a disclaimer

73
Q

this act required the establisment of registry for clinical trials, enabled the manufactuter to discuss off-label drug use when requested, and extended an amendement previoulsy passed (prescription drug user fee act) that PERMITS the fda to charge a manufacturer fees to expedite the drug review process

A

fda modernization act of 1997

74
Q

under the FDAMA, wording was simplified to

A

rx only

75
Q

what are the four programs to help speed development and review of new drugs

A

fast track designation: drugs to treat serious conditions and fill unmet needs

breakthrough therapy designation: drugs showin substantial improvement over current therapy

accelerated approval: approval can be based on a surrogate endpoint to meet and urgent need

priority review designation: fda will review within six months

76
Q

DATA 2000 permitted _________ to prescribe through and dispense controlled substances in an office based setting

A

physicians

77
Q

in 2016, the comprehensive addiction recovery act allowed __________ and _____________ to treat patients for opioid dependence as well

A

NPs and PAs

78
Q

the risk evaluation and mitigation strategy (REMS) program was part of what legislation?

A

the FDA amendments act

79
Q

biologic interchange information can be found in what book

A

the purple book – called the lists of licensed biological rpducts with reference product exlusivity and biosimilarity or interchangability evaluations

80
Q

this act followed an outbreak of fugal meninigitis due to improper practices at the new england compounding center

A

drug quality and security act of 2013

81
Q

this act gave the FDA increase autority to regulate compounding

A

compounding quality act

503b= outsourcing facilities

82
Q

to prevent counterfeit drugs from entering the market, the drug supply chain security act established …. requirements to document trasactions of rx products through the supply distribution chain

A

track and trace

records must be kept for 6 years

83
Q

the pregnancy and lactation labeling final rule 2014 places information into three categories:

A

pregnancy:

lactation:

females and males of reproductive potential:

84
Q

True or false

CARA permits pharmacists to partially fill schedule II drugs at the request of the patient or prescriber

A

true

*in iowa, patient can request

85
Q

any remaining opioids must be filled within ___ days from the date the prescription was issued/written

A

30

partial fill are permitted for schedules III-V for up to six months from the issue date

fl 2* (9 decks)

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