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Pharmacy Law > Exam 1 > Flashcards

Exam 1 Flashcards

1
Q

pharmacy errors may be responsible for ____ deaths per year

A

7,000

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2
Q

_____% of all prescription errors are discovered during patient counseling

A

83%

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3
Q

82% of errors are ___

A

mechanical (dispensing)

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4
Q

Thomas v. Winchester

A

pharmacist responsible for the consequences of mistake

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5
Q

CT definition of error:

A

act or omission of clinical significance relating to dispensing of a drug that results in or may reasonably be expected to result in injury to or death of a patient

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6
Q

CT Error Reporting Regulations: (3)

A
  1. implement QA program to detect and prevent errors
  2. Notify patient and practitioner if error discovered, communicate method for minimizing consequences of error
  3. Post sign - “if you have a concern that an error may have occurred…” - this also appears on receipt or bag
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7
Q

QA review for each prescription error within ___ days of discovery

A

2

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8
Q

QA review of errors maintained for ____

A

3 years

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9
Q

List four elements that must be present for civil lawsuit:

A

duty, breach of duty, causation, damages

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10
Q

_________: a dereliction of professional duty or a failure to exercise an accepted degree of professional skill or learning by one rendering professional services which results in injury, loss, or damage

A

malpractice

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11
Q

______: a legally enforceable obligation to conform to a particular standard of conduct

A

duty

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12
Q

negligence per se:

A

violation of statutes or regulations

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13
Q

does causation need to be direct?

A

no

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14
Q

Speer v. US

A

superseding cause: patient stockpiled drugs and committed suicide - not foreseeable, so pharmacist not liable

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15
Q

Emerging duty

A

“institutional controls” - requires pharmacy owner or chain to institute a system of risk management to reduce number of errors in its pharmacies

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16
Q

vicarious liability

A

pharmacy liable for damages caused by its employees if they are acting within the course and scope of their duties for the pharmacy

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17
Q

Harco v Holloway

A

vicarious liability of pharmacy for damages caused by employees

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18
Q

Duensing v Huscher

A

child gets phenobarb suppositories instead of aspirin suppositories, 22K for damages, 15K for punitive. Rx filled by non pharmacist, no pharmacist present

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19
Q

Orzell v Scott Drug

A

plaintiff who is harmed due to own illegal conduct may have responsibility, may be barred from recovery or damages may be reduced

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20
Q

statute of limitations: in CT, _____

A

2 years from discovery, 3 years from act

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21
Q

are retail sellers liable for faulty products?

A

yes, under some circumstances

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22
Q

_________: Rx manufacturer owes duty to patient to warn physician but not the patient directly

A

learned intermediary

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23
Q

exception to learned intermediary protection for pharmacists:

A

compounding

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24
Q

Fleet and Semple v Hollenkemp

A

it is the duty of druggists to know the properties of the medicine which they vend, and to employ people who can discriminate and compound according to prescription and they are responsible for any consequences if they depart from the prescription, even if they are in general very careful

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25
Q

what does malpractice insurance generally cover?

A

cost of defense and payment of claims

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26
Q

what does malpractice insurance generally not cover?

A

damages due to willful violations or violations of store/chain policy

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27
Q

Kampe case

A

upheld traditional view that the pharmacist has a duty only to give the right medication

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28
Q

Horner v Spalitto

A

pharmacist should have applied knowledge but they need more info on case to say… ?

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29
Q

Hooks SuperX v McLaughlin:

A

CT: Pharmacists possessing superior knowledge needed by patients have a duty to warn of known risks

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30
Q

Springhill Memorial Hospital v Larrimore

A

learned intermediary shields the pharmacist

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31
Q

DiGiovanni v Albertson’s

A

learned intermediary shields the pharmacist

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32
Q

Plante v Lomibiao, Deed v Walgreen, Robles v AstraZeneca show that

A

CT apparently adheres to traditional LI principle

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33
Q

Dietary Supplement Health and Education Act of 1994 (DSHEA)

A

Enacted in 1994, applies to dietary supplements and ingredients. Manufactures wishing to use new dietary ingredients must notify FDA 75 days before marketing the product and provide FDA with evidence showing that ingredient will reasonably be expected to be safe. FDA does not need to approve application.

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34
Q

Label of Dietary Supplement:

A

name, including the word supplement, quantity of contents, name and place of manufacturer, directions for use, serving size, dietary ingredients, amount per serving size, %DV, scientific name of any botanical, other ingredients, “this statement not evaluated by FDA. Not intended to…”

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35
Q

what claims are permitted on dietary supplements?

A

“structure-function” claims, general well-being, describe benefit related to nutrient deficiency disease as long as statement tells how widespread the disease is in US

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36
Q

Structure-Function claims:

A

describe the role of a nutrient or dietary ingredient: calcium builds strong bones

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37
Q

Proposed new dietary supplement guidelines:

A

Safety of supplements would be evaluated according to:

  • documented history of use
  • formulation and proposed daily dose
  • recommended duration of use
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38
Q

would proposed new dietary supplement guidelines require any human studies?

A

no

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39
Q

Under DSHEA, FDA may remove a dietary supplement from the market if:

A

it presents a significant or unreasonable risk of illness or injury when used according to its labeling or under ordinary conditions of use

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40
Q

lazy cakes =

A

adulterated food

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41
Q

Poison Prevention Packaging Act:

A

1970 - protect children under 5 from poisoning from ingestion of hazardous substances from open containers

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42
Q

Child-Resistant Container:

A

80% of children under 5 cannot open and at least 90% of adults can open

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43
Q

child resistant container exemptions:

A

elderly or handicapped - label says not child resistant. Also unflavored powder or effervescent tablets of aspirin or acetaminophen

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44
Q

Collaborative Drug Therapy Management (CDTM)

A

prescribers authorize pharmacists to engage in specific activities such as initiating, adjusting, or evaluating drug therapy. Generally requires a written guideline or protocol

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45
Q

T/F: Authorization for collaborative practice agreements usually requires amending the definition of the practice of pharmacy at the state level to authorize agreements

A

T

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46
Q

In most states, collaborative practice agreements must be filed with and approved by ______

A

The Pharmacy Commission

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47
Q

Washington Program (Collaborative Practice Agreement):

A

Pilot program to provide emergency contraceptives through pharmacies

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48
Q

CT Collaborative Practice. Are there restrictions on practice settings? On drugs? On conditions?

A

No no no

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49
Q

NY Collaborative Practice:

A

teaching hospitals only

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50
Q

ME Collaborative Practice:

A

Nope

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51
Q

NH Collaborative Practice:

A

hospital, ambulatory clinic, LTC, hospice

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52
Q

When deciding whether to make medication OTC, FDA usually seeks recommendation of a joint advisory committee made up of members of the agency’s ____. Are they bound by the advisory’s counsel?

A

Nonprescription Drugs Advisory Committee. No

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53
Q

the FDA has approved the switch of a number of drugs from prescription to OTC status under ____

A

NDAs

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54
Q

Durham-Humphrey Law

A

two system dichotomy - OTC or Rx

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55
Q

HIPAA is enforced by _____________

A

the Office of Civil Rights of HHS

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56
Q

PHI =

A

protected health information

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57
Q

HIPAA says pharmacy must develop and distribute a notice of privacy and must make a good faith effort to

A

obtain a written acknowledgement that the patient received it. They also have to post the privacy notice in a prominent area of the pharmacy

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58
Q

How long is privacy acknowledgement retained for?

A

6 years

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59
Q

can information be disclosed without consent if it concerns a victim of abuse, neglect, or domestic violence?

A

yes

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60
Q

Incidental disclosure:

A

A disclosure that cannot reasonably be prevented, is limited in nature, and that occurs as a result of another use or disclosure that is permitted by the rule

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61
Q

What privacy rules govern suits?

A

State privacy rules, not HIPAA

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62
Q

New Self Reporting regulations

A

must notify patients when breach of PHI is discovered. Give plain language notice by mail or email within 60 days

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63
Q

written accountings for information not subject to the exemptions must include for each disclosure:

A
  • date of disclosure
  • name of the entity who received PHI, and address
  • description of PHI disclosed
  • statement of purpose of disclosure
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64
Q

covered entities have _____ to meet requests for accounts of PHI disclosures

A

60 days, additional 30 day extension is allowed

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65
Q

individuals are entitled to accounts that list PHI disclosures for the past _____. Frequency of accounting without charge is ____.

A

6 years/ 12 months

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66
Q

pharmacy must designate a ______ responsible for development and implementation of privacy policies and procedures as well as a ______ to the public to receive complaints.

A

privacy officer/ contact person

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67
Q

PHI disclosure penalty system: __/ incident, __/ year for innocent breach

A

100/ 25,000

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68
Q

PHI disclosure penalty system: __/ incident, __/ year for non-innocent breach

A

1,000/ 100,000

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69
Q

PHI disclosure penalty system: __/ incident, __/ year for willful breach

A

50,000/ 1.5 million

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70
Q

criminal: _____ v___

A

govt/ private party

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71
Q

civil: _____ v_____

A

private party/ private party (or govt)

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72
Q

administrative: __ v__

A

agency/ private party

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73
Q

___: statute, act, ordinance

A

law

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74
Q

laws are enacted by

A

a legislative body

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75
Q

regulation: _____

A

derives from and interprets law

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76
Q

regulations are enacted by

A

administrative agencies such as the FDA or the Pharmacy Commission

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77
Q

___ fills in “gaps”

A

regulation

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78
Q

common law: ______

A

court decisions

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79
Q

common law is enacted by

A

judicial body

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80
Q

_______ acts as quasi-judicial role (e.g. hearing to suspend license)

A

administrative agency

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81
Q

Pharmacy law derives from _______

A

police power

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82
Q

_______: power of a state to enact laws promoting public health, safety, morality and welfare. Must be reasonably related to protecting the public

A

police power

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83
Q

In CT, Pharmacy is regulated by ______

A

Department of Consumer Protection

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84
Q

______ is a board that advises and assists DCP in adopting regulations and enforcing laws and rules

A

Commission of Pharmacy

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85
Q

Practice Act defines

A
  • pharmacy
  • how it is practiced
  • by whom
  • where it is practiced
  • conditions of practice
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86
Q

Describe the composition of CT Pharmacy Commission:

A

6 members appointed by the Governor, 4 pharmacists (at least 2 community, 1 hospital), 2 public members

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87
Q

How often must pharmacy license be renewed?

A

every 2 years

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88
Q

how often does the CT Pharmacy Commission meet?

A

at least 6 times per year

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89
Q

T/F: A copy of meeting records from pharmacy commission meeting can be admitted as evidence in a civil or criminal case.

A

T

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90
Q

Are pharmacy commission meeting records available to the public on request?

A

yes

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91
Q

Which of the following are not licensed by the CT commission? Long term care, infusion therapy, nuclear pharmacy, hospital pharmacy, community, specialty pharmacy

A

hospital pharmacy

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92
Q

CT Pharmacy Commission can compel attendance at ______

A

hearings

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93
Q

CT Pharmacy Commission can produce documents by _____

A

subpoena

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94
Q

CT Pharmacy Commission can administer _______

A

oaths

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95
Q

CT Pharmacy Commission can grant temporary and permanent ______

A

injunctions

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96
Q

CT Pharmacy Commission can grant temporary ________ pending a hearing

A

restraining orders

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97
Q

how often does the commissioner inspect retail pharmacies?

A

every four years

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98
Q

are pharmacist recognized as health care providers by the state of Connecticut?

A

yes

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99
Q

what do pharmacists do?

A

dispense

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100
Q

does dispensing include delivering a drug to a patient?

A

no

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101
Q

does dispensing include administering a drug to the patient?

A

no

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102
Q

what is the required intern experience for a pharmacist’s license in CT?

A

1500 hours, NMT 40 hours/ week

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103
Q

is a written application required for a CT pharmacy license?

A

yes

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104
Q

how often are pharmacy licensing exams given?

A

twice a year

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105
Q

The pharmacy license form is furnished by

A

the department of consumer protection

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106
Q

how far in advance must the application be submitted prior to the pharmacy licensing exam?

A

45 days

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107
Q

list the three parts of the pharmacy licensing exam:

A

NAPLEX, Contemporary Pharmacy Practice, Jurisprudence (MPJE and State specific)

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108
Q

what are the competency areas tested on the NAPLEX (3)

A
  • manage drug therapy to optimize patient outcomes
  • assure safe and accurate preparation and dispensing of medications
  • provide drug information and promote public heath
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109
Q

What covers licensing of pharmacists and pharmacies?

A

CT Pharmacy Practice Act

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110
Q

What is the MPJE?

A

Multistate Pharmacy Jurisprudence Examination

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111
Q

What are the 3 competency areas of the MPJE?

A
  • pharmacy practice
  • licensure, registration, certification & operational requirements
  • regulatory structure and terms
112
Q

is the MPJE in the kind of testing format you like?

A

no

113
Q

what are the additional requirements for foreign graduates?

A
  • pass TOEFL

- pass FPGEE

114
Q

How many CE hours must you have per year?

A

15

115
Q

how many CEU/year?

A

1.5

116
Q

how many CE hours must be live each year?

A

5

117
Q

how many CE hours must be in pharmacy law?

A

1

118
Q

can CE credits be carried forward?

A

yes

119
Q

for how long are records of CE credits retained?

A

3 years

120
Q

are CE credits required for first time license renewal?

A

no

121
Q

a retired pharmacist holding an inactive license may obtain a CE waiver. To reinstate, need _____ hours ( __ live)

A

30/ 10

122
Q

What covers registering pharmacy interns and technicians?

A

CT Pharmacy Practice Act

123
Q

Reciprocity: has practiced for ____ year in the last ___ or has been licensed by exam within the last ___

A

1/ 5/ 12 months

124
Q

reciprocity: must pass _____ exam and sit for ___

A

CT pharmacy law/ interview

125
Q

Temporary permit to practice pharmacy - expires when licensed in CT or not later than ____ from date of issuance, whichever comes first

A

3 months

126
Q

pharmacy interns must have completed at least ___ years of college and be enrolled in accredited SOP

A

2

127
Q

supervising pharmacist may supervise training of how many interns?

A

one

128
Q

ratio of technicians to pharmacist: retail:

A

3:1 - one must be certified technician or else 2:1

129
Q

ratio of technicians to pharmacist: IV, unit dose, compounding:

A

3:1

130
Q

pharmacist may refuse to supervise 3 in _____ setting only

A

retail

131
Q

can techs accept new phoned prescriptions?

A

no

132
Q

can techs consult with patients or practitioners?

A

no

133
Q

Penalties for Violation of Practice Act:

A

suspension or revocation of license, up to 5K fine for each offense, up to 5 years in jail

134
Q

what must be on a prescription?

A

name and address of prescriber and patient, date, name, dosage form, strength, and amount of drug, directions, refills, any cautionary statements, serial number, date filled, refills recorded on back

135
Q

how long must prescriptions be kept on file?

A

3 years

136
Q

what must be on a label?

A

name and address of pharmacy, name of patient, name of prescriber, serial number of prescription, directions, name of drug, drug quantity and expiration date

137
Q

What covers investigation of pharmacy complaints?

A

CT Pharmacy Practice Act

138
Q

a pharmacy receiving a transferred Rx must note:

A

names of transferring pharmacy and pharmacist, date of issuance, serial number of original Rx, date original was first dispensed, number of refills authorized, complete refill record, number of valid refills remaining

139
Q

for non-controlled substances, a fax

A

may be saved as original if non-fading and durable, otherwise, reduce to writing, photocopy or convert into hard copy printout

140
Q

in an emergency situation, a prescription may be refilled ___ for a quantity of drug not to exceed a ______ supply

A

once, 72 hour

141
Q

you need an Rx for >___ hypodermic needles

A

10

142
Q

how long is a prescription for hypodermic needles good for?

A

1 year, but seller must confirm continuing need with prescriber every 6 months

143
Q

how long do you keep an Rx for hypodermic needles?

A

3 years

144
Q

how many pharmacies can one pharmacist manage at the same time?

A

one

145
Q

how many hours per week must a pharmacy be open?

A

35

146
Q

pharmacies may be closed on an unscheduled basis for ____ consecutive day(s), NMT __ in 30 days and NMT ______ times in a year

A

1/ twice/ 18

147
Q

pharmacy manager must report unscheduled closing to commission within ____ hours

A

72

148
Q

What covers disciplinary action (revocations and sanctions)

A

CT Pharmacy Practice Act

149
Q

T/F: if a pharmacy is located out of state and ships or mails Rx drugs to CT, it must register with the CT Pharmacy Commission

A

T

150
Q

Name 6 entities regulated by the Federal Food and Drug Law

A
  • manufacturer
  • wholesaler
  • packer
  • shipper
  • practitioner
  • drug retailer
151
Q

drugs are articles recognized in the _____, _______ or ______

A

US Pharmacopoeia, National Formulary, Homeopathic Pharmacopoeia

152
Q

A drug is considered new when:

A
  • new substance (active or excipient)
  • new combination of approved drugs
  • proportion of ingredients in combination has changed
  • new intended use for the drug
  • dosage, method, or duration of administration is changed
153
Q

a drug is considered adulterated if manufactured under non ______ conditions

A

GMP

154
Q

does the FDA have to prove that a drug is actually adulterated?

A

no

155
Q

_______ standards are officially recognized by FDCA and enforceable by FDA

A

USP

156
Q

if USP monograph exists for product, it must

A

conform to standards or say “Not USP” on it

157
Q

Prior to ____ there were no standards, no assurance of safety, no required labeling

A

1906

158
Q

the _________ enacted in 1906 prohibited the movement in interstate commerce of “adulterated” and “misbranded” food, drugs, cosmetics and devices

A

Pure Food and Drug Act

159
Q

the Pure Food and Drug Act required that labeling on drugs be ______

A

truthful

160
Q

the _________ in the Department of Agriculture was empowered to administer the Pure Food and Drug Act

A

Bureau of Chemistry

161
Q

Did the Pure Food and Drug Act require that ingredients be put on the label?

A

with some exceptions, no

162
Q

US v Johnson (1911)

A

Supreme Court: misbranding did not apply to false therapeutic claims of drugs

163
Q

Food Drug and Cosmetic Act required

A

1938 - filing of NDA and premarket evidence of safety for all drugs (approval by FDA). Drugs on the market prior to 1938 were grandfathered

164
Q

The FDCA eliminated the Sherley Amendment requirement to

A

prove intent to defraud in drug misbranding cases

165
Q

What covers maintenance of prescription records?

A

CT Pharmacy Practice Act

166
Q

the FDCA authorized ______ inspections

A

factory

167
Q

the FDCA added the remedy of _______ to the previous penalties of seizures and prosecutions

A

court injunctions

168
Q

the ______ to the FDCA formally distinguished between Rx and OTC drugs

A

Durham-Humphrey Amendment

169
Q

________ authorized oral Rx and refill

A

Durham-Humphrey Amendment

170
Q

Prescription drugs are exempt from the requirement of adequate directions for use by a lay person as long as the drug’s labeling bears a ______

A

statement (known as legend)

171
Q

the _________ required manufacturers to prove effectiveness of new drugs. It was precipitated by the thalidomide tragedy.

A

Kefauver-Harris Amendment

172
Q

____: First application a sponsor provides to FDA

A

IND

173
Q

IND includes all ___________ studies relating to safety and efficacy of drug

A

preclinical

174
Q

IND gives complete description of ____________ for testing on humans

A

clinical protocols

175
Q

IND describes ______ and quality control methods

A

manufacturing

176
Q

FDA has __________ to decide on an IND

A

30 days

177
Q

Phase _________ trial: small number of patients with indicated diseases. Tests effectiveness, dosing, safety, side effects.

A

2

178
Q

the _______ required manufacturers to report adverse events to FDA

A

Kefauver-Harris Amendment

179
Q

Phase ________ trial: small number of healthy volunteers, assess safety in humans, pharmacokinetic and pharmacologic properties. Usually males.

A

1

180
Q

Phase _____ trial: larger number of patients in several locations. Test effectiveness. Usually double-blind against placebo.

A

3

181
Q

Informed consent via writing for which phases of trials?

A

I, II

182
Q

Oral informed consent permissible for which phase(s) of trials?

A

III

183
Q

The _______ authorized the FDA to regulate Rx drug advertising and to require that advertising to physicians disclose risks as well as benefits

A

Kefauver-Harris Amendment

184
Q

_____: sponsor submits data from clinical trials along with documentation on toxicity, stability, production methods, packaging and proposed labeling

A

NDA

185
Q

_______: 1962 amendment that required FDA to conduct a retrospective evaluation of the effectiveness of the drug products that the FDA had approved as safe between 1938 and 1962

A

DESI

186
Q

__________: provides for review and approval of generic equivalents.

A

ANDA

187
Q

ANDA (Abbreviated New Drug Application) was established by the _______________, or _______

A

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

188
Q

ANDA requires proof of _____________ equivalence (3)

A

pharmacokinetic, bioavailibility, clinical

189
Q

bioequivalence: based on _________ data

A

pharmacokinetic

190
Q

bioequivalence: complex formula generally between ___ and ____ of reference compound

A

80%, 125%

191
Q

the ____ was mandated by the Waxman-Hatch Act. Actual title: Approved Drug Products with Therapeutic Equivalence Evaluations

A

Orange Book

192
Q

_______: abbreviated licensure pathway for biological products that are demonstrated to be interchangable with an FDA-licensed biological product. Includes vaccines, proteins, blood products, gene therapy

A

biosimilars

193
Q

_________ is an abbreviated application used for new synthesis, new production procedure, new manufacturing location, new packaging, labeling, or new use

A

supplemental NDA

194
Q

________ instituted NDA

A

Kefauver-Harris Amendment

195
Q

______________ allows administration of investigational new drug to patients not enrolled in the clinical trial

A

Treatment IND

196
Q

For Treatment IND, drug must be in _________ with preliminary evidence of efficacy

A

phase 2 or 3

197
Q

_______: drugs will have finished phase 1 and pharmacokinetic testing. There will be some data available on their interactions with drugs in common use. They will have shown sufficient efficacy to warrant wider release

A

Parallel Track

198
Q

Special Distribution Programs: ____ Isotretinoin (Accutane). Patient signs document about risks, agrees to monthly doctor visits, two forms of contraception, registered in national database, pharmacist checks database for identification code

A

iPLEDGE

199
Q

______ may only be prescribed and dispensed by physician and pharmacist registered with _________ National Registry. Must supply current blood results before dispensing

A

clozapine

200
Q

________ program for thalidomide: 28 day supply, no refill, use monitored by mandatory patient survey, pregnancy testing and birth control

A

STEPS

201
Q

_______ program for TYSABRI for MS (increased risk of progressive multifocal leukoencephalopathy PML)

A

TOUCH

202
Q

_____ (GHB, sodium oxybate) requires patient enrollment and review of educational materials on safe and appropriate use

A

Xyrem

203
Q

_______ clarified FDA authority on devices

A

Medical Device Act - 1976

204
Q

Medical Device Act Class _: requires pre-market approval: heart valves, pacemakers, soft contact lenses

A

Class III

205
Q

_________ instituted GMPs

A

Kefauver-Harris Amendment

206
Q

What needs to be on an OTC label?

A
  • active ingredients, including amount in each dosage unit
  • purpose of the medication
  • indications for the drug
  • specific warnings, including when not to use and when to consult health care provider
  • directions - when, how, how often to take
  • allergy information
207
Q

Rx drug label includes:

A
  • manufacturer’s name and address
  • name of drug
  • ingredient information
  • strength
  • net quantity
  • recommended or usual dose
  • legend
  • route if not oral
  • C if controlled
  • lot number
  • statement to pharmacist if special container is needed
  • expiration date
  • optional NDC
208
Q

T/F FDA requires NDC number on label

A

F: recommended but not required

209
Q

package insert includes

A
  • name and generic name
  • description
  • clinical pharmacology
  • indications and usage
  • contraindications
  • warnings
  • precautions
  • adverse reactions
  • overdosage
  • dosage and administration
  • how supplied
210
Q

are pharmacy generated consumer leaflets regulated by the FDA?

A

no

211
Q

advertising for over the counter drugs is regulated by

A

the Federal Trade Commission

212
Q

prescription drug advertising is regulated by

A

FDA thanks to FDCA

213
Q

Medical Device Act Class __: must meet specific performance standard: insulin syringe, tampons, thermometers, heating pads

A

Class II

214
Q

Medwatch is generally voluntary, but mandatory if ___

A

IND

215
Q

Class III recall:

A

unlikely to cause adverse health effects

216
Q

Class II recall:

A

temporary or reversible effects. Affects pharmacy stock

217
Q

Class I recall:

A

drug product may cause serious adverse health effects. Recall includes pharmacy stocks and letter to users

218
Q

Does FDA have statutory authority to order recall?

A

no

219
Q

Medical Device Act Class __: least regulation: needles, toothbrushes

A

Class I

220
Q

____________ regulates distribution of free samples, use of coupons redeemable for drugs at no cost or low cost, sale of deeply discounted drugs to hospitals and health care entities

A

Prescription Drug Marketing Act

221
Q

_____________________ mandated inspection of manufacturers every 2 years

A

Kefauver-Harris Amendment

222
Q

_____ limits outdoor tobacco advertising within 1000 ft of schools and playgrounds, ban sports and entertainment sponsorships, light or mild descriptions of cigarettes, ban candy or fruit flavors, allows FDA to limit amount of nicotine or other ingredients

A

Family Smoking Prevention and Tobacco Control Act

223
Q

Title I of Comprehensive Drug Abuse Prevention and Control Act of 1970:

A

rehab programs for drug abusers

224
Q

Title II of Comprehensive Drug Abuse Prevention and Control Act of 1970:

A

registration and distribution of controlled drugs

225
Q

Title III of Comprehensive Drug Abuse Prevention and Control Act of 1970:

A

Importation and exportation of controlled substances

226
Q

________: tax and importation act passed in 1914 to control opium trade. Provided for licensing and payment of a fee for manufacturers, importers, pharmacists, physicians.

A

Harrison Act

227
Q

____ put limits on narcotics in OTC products - larger quantities could be obtained by Rx

A

Harrison Act

228
Q

Harrison Act stated that treatment of ___ was not legitimate medical purpose

A

addicts

229
Q

___: Title II of Comprehensive Drug Abuse Prevention and Control Act of 1970

A

CSA

230
Q

CSA is enforced by ___

A

DEA of Federal Department of Justice

231
Q

Drug Scheduling: ___ requests from ___ a scientific and medical evaluation and recommendation as to control. ___ solicits info from ___ and ____, compiles this info, and gives it back to ___. If it is recommended not to be controlled, it can’t be controlled

A

DEA/HHS/ HHS/FDA/NIDA/DEA

232
Q

What schedule drug is GHB?

A

I

233
Q

what schedule drug is secobarbital?

A

II

234
Q

what schedule drug are long acting barbs such as phenobarb?

A

IV

235
Q

what schedule drug are benzos?

A

IV

236
Q

_______ allowed any chemical substantially similar to an illegal drug to be treated as illegal if intended for human consumption

A

Federal Analog Act

237
Q

Are there any federal laws or regulations that limit the quantity of controlled substances that may be prescribed?

A

no

238
Q

in CT, controlled drug must be filled within ___ of issue date

A

6 months

239
Q

are refills allowed for Schedule II drugs?

A

no

240
Q

refills for C III-V?

A

yes, up to 5 times in 6 month period from date of issue, record refill on back of Rx

241
Q

can CIII-V refills be authorized orally?

A

yes

242
Q

what needs to be on a controlled rx label?

A

name of pt, prescriber, name and address of pharmacy, serial number, directions, date, warning not to transfer to other person (except C-V)

243
Q

CIII-V may be transfered ___

A

once

244
Q

when transferring CIII-V,

A
  • write “void” on face of rx
  • record name, address, DEA number of receiving pharmacy and pharmacist on back
  • receiving pharmacy writes “transfer” on face
245
Q

can pharmacist dispense C-II on oral rx in emergency?

A

yes, must have signed rx delivered to pharmacy within 7 days, needs to have “authorization for emergency dispensing” and date of oral order written on front

246
Q

when can fax serve as original C-II Rx?

A

resident of LTC facility, patient in licensed hospice, compounded for direct administration to patient by the parenteral route

247
Q

Schedule II partial orders:

A

note quantity supplied on face of Rx, balance must be filled within 72 hours (60 days if for pt in LTC with terminal illness)

248
Q

Schedule III-V partial orders:

A

partial filling recorded in same manner as a refill

249
Q

how often to take inventory in CT?

A

q 2 years

250
Q

how long to keep inventory in CT?

A

3 years

251
Q

fine for inadequate record keeping:

A

$25,000

252
Q

Which schedule counts can be estimated?

A

CIII-V, unless container holds more than 1,000 tablets or capsules

253
Q

what form do you use to order schedule I or II drugs?

A

DEA form 222

254
Q

what part of DEA form 222 does pharmacy keep? supplier? DEA?

A

3/1/2

255
Q

______: may authorize one or more persons to obtain or execute CII order form

A

Power of Attorney

256
Q

how to transfer CIII-V between pharmacies:

A

invoice

257
Q

how to transfer CII between pharmacies:

A

DEA Form 222

258
Q

if total number of dosage units distributed exceeds ___ of total units distributed and dispensed in one year, pharmacy required to register as a distributor

A

5%

259
Q

Form for reporting theft or loss to DEA:

A

DEA Form 106

260
Q

Form for destruction of controls:

A

DEA Form 41, at least 2 weeks in advance

261
Q

_________ establishes penalties for stealing drugs from people registered with the DEA, fines and jail time for killing pharmacists

A

Controlled Substance Registrant Protection Act of 1984

262
Q

US v Hughes

A

pharmacist should attempt to verify validity of questionable Rx

263
Q

VT & 110th Medical Arts Pharmacy v Board of Pharmacy

A

use common sense and professional judgement

264
Q

Lawson

A

court convicted pharmacist - he should have known not for legitimate purpose

265
Q

Anabolic Steroids Control Act made steroids schedule __

A

III

266
Q

Ryan Haight Online Pharmacy Consumer Protection Act

A

Amends CSA - prohibits dispensing controlled substances via the internet without a valid prescription

267
Q

______ makes it a crime to use the internet to advertise the illegal sale of a controlled substance by means of the internet

A

Ryan Haight Online Pharmacy Consumer Protection Act

268
Q

controlled substance prescription must have

A
  • name and address of patient and prescriber
  • name of drug and amount
  • indicate adult or child or age of patient
  • directions
  • date
  • DEA number of prescriber
  • be in ink, indelible pencil, or typed, no photocopy or rubber stamp
  • C-II only one Rx per blank
  • cannot be post dated
  • cannot be issued for an inanimate obect or thing
  • must be kept for 3 years in CT
269
Q

What info can, after proper consultation, be changed on a C-II prescription?

A
  • patient’s address
  • drug strength
  • drug quantity
  • directions for use
  • dosage form
270
Q

What info cannot be changed on C-II prescriptions?

A
  • patient’s name
  • substance prescribed (except for generic substitution if allowed)
  • prescriber’s signature
  • date
271
Q

Schedule V Exemptions: Rx not needed for

A

4 fl oz stokes expectorant,
4 fl oz brown mixture,
8 fl oz camphorated tincture of opium

272
Q

_________________: monitors the prescribing and dispensing of Schedule II-V controlled substances in CT

A

Connecticut Prescription Monitoring and Reporting System (CPMRS)

273
Q

_____ allows pharmacists and prescribers to review data online to check for patterns of misuse

A

CPMRS

274
Q

_________ regulates sale of large amounts of ephedrine, pseudoephedrine, and phenylpropanolamine

A

Comprehensive Methamphetamine Control Act (Federal)

275
Q

_________ prevent diversion of meth precursors - must be placed behind the counter

A

Combat Methamphetamine Epidemic Act

276
Q

How many grams of PSE can you buy per day? Per 30 days? Per 30 days by mail order?

A

3.6/ 8/ 7.5

Pharmacy Law (1 decks)

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