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Law > P3 Law Semester > Flashcards

P3 Law Semester Flashcards

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1
Q

General Definition of Law

A

Requirements for human conduct applying to all persons within their jurisdiction.
Provides framework for people to resolve their disputes.
Must remain flexible/vague to allow for individual differences, varying contexts of situations, and because they are based on human relationships.

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2
Q

What are the 4 market failures?

A 
Public Goods
Externalities
Natural monopolies
Information asymmetry
A market failure justifies government regulation
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3
Q

Definition of public good

A

necessary and beneficial commodities that private entities will not supply because there is no incentive
(orphan drugs, vaccines, etc.)

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4
Q

Definition of an Orphan Drug

A

a drug that is sufficiently safe and effective to be marketed, but the number of patients who need it is so small that it is not commercially feasible for a manufacturer to market it.
Not enough demand, thus no profit
Government steps in to ensure availability

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5
Q

Definition of externality

A

When the production or consumption of a good affects people who do not fully consent to the effect, and when the costs of the good are not fully incorporated in the price of the good
Government regulates this to ensure that an individual’s behaviors do not create an indirect cost for someone else
Ex: air pollution from pharmaceutical manufacturers

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6
Q

Definition of natural monopoly

A

when the fixed cost of providing a good are high relative to the variable costs of producing the good
Government regulates this market failure to encourage companies to build new infrastructures, created jobs, and create new innovations

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7
Q

What makes up the legislature?

A

It is an elected body of people with the primary responsibility to enact laws
Legislative power of the federal government is vested in Congress (Senate and House of Reps)

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8
Q

Legislature makes what kind of law?

A

Statutes

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9
Q

Administrative agencies create laws through…

A

Hearings

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10
Q

Who creates administrative agencies?

A

Congress has a say in administrative agency appointments and appropriations
Significant influence

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11
Q

What are the 3 federal administrative agencies that influence pharmacy law?

A

Department of Health and Human Services (DHHS)
Federal Trade Commission (FTC)
Drug and Enforcement Administration (DEA)

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12
Q

Definition of information asymmetry

A

when a consumer is uninformed about the true value of a good

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13
Q

What are the two state level administrative agencies that regulate pharmacy practice?

A

State Boards of Pharmacy

State Department of Health Services

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14
Q

What is the Federal Register?

A

Basically the “Daily news paper of the Federal Government”

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15
Q

What is in the Federal Register?

A

Proposed and Final regulations and notices

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16
Q

How often is the Federal Register Published?

A

Daily

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17
Q

What does CFR stand for?

A

Code of Federal Regulations

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18
Q

What is in the CFR?

A

Final regulations divided and indexed by subject matter

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19
Q

How often is the CFR published?

A

Yearly

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20
Q

Type of law made by the courts

A

Judicial Opinion

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21
Q

4 Origins of a Bill

A

Lobbying Groups
Citizens
Government officials
President

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22
Q

Definition of Criminal Law

A

Government vs. a private party
Uses probable cause and a grand jury
Burden of proof must be “Beyond a Reasonable Doubt” in order to convict.

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23
Q

Definition of Civil Law

A

Private party vs. Private party

Alleging injury, based upon statute or common law legal rights with the objective to compensate the injured party

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24
Q

Definition of Administrative Action

A

Violation of a statute or regulation
OR
an act that warrants an investigation

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25
Q

What did the Nutrition Labeling and Education Act of 1990 do?

A

Mandated nutrition labeling on food products and authorized health or disease-prevention claims on product labeling (only if the product has obtained FDA approval). Only as long as they were made in compliance with FDA regulations

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26
Q

Definition of cGMP

A

Current Good Manufacturing Practice
Establishes the minimum requirements for the methods, facilities, or controls used in the manufacture, processing, packaging, or holding of a drug product

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27
Q

What did the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 do? (DSHEA)

A

Implemented mandatory reporting of serious adverse events through the FDA’s MedWatch program
Applies to Manufacturers, packagers/distributors whose name appears on product label
The Issue: Anyone can report and the AEs are not verified. Voluntary reporting (some report and some don’t know how to)

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28
Q

What disclaimer must accompany any structure or function claim made by a dietary supplement?

A

the FDA has not evaluated the claim and the dietary supplement is not intended to diagnose, treat, cure, or prevent any disease

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29
Q

what is the USP?

A

United States Pharmacopeia.
Establishes approved titles, definitions, and descriptions for drugs.
Sets standards for identity, quality, strength, purity, packaging, stability, and labeling

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30
Q

What is the USPC?

A

United States Pharmacopeial Convention
Independent of FDA, publishes the USP
Publishes compendiums that are used as legal resources of drug standards

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31
Q

What is the USP-NF?

A

United States Pharmacopeia - National Formulary Standards

contains monograph of active and inactive ingredients and serves as the official compendium for drug standards in the US

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32
Q

What is the USP-FCC?

A

United States Pharmacopeia - Food Chemicals Codex
sets standards for purity and quality of food ingredients
includes preservatives, flavorings, colorings, and nutrients
Published every 2 years

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33
Q

What is HPUS?

A

Homeopathic Pharmacopeia of the United States
Sets the standard for homeopathy products
This is the other official compendium under the FDCA
Regulated by FDCA, recognized by FDA

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34
Q

Class I Product Recall

A

Issued when there is reasonable probability that the product will cause serious, adverse health consequences of death

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35
Q

Class II Product Recall

A

Occurs when the product may cause temporary or medically reversible adverse health consequences, but the probability of serious adverse consequences is remote

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36
Q

Class III Product Recall

A

Applies to products that are not likely to cause adverse health consequences

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37
Q

What did the Medical Device Amendment of 1976 do?

A

Devices could not be classified as drugs anymore
Required:
Classification of devices according to their function
Premarket approval
Establishment of performance standards
Conformance with GMP regulations
Adherence to record and reporting requirements

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38
Q

FDCA Definition of Adulteration

A

FDCA states that a drug is adulterated if it is:
Prepared, packaged, or held in conditions where it may have been contaminated, exposed to a container that may have contaminated it, or manufactured under conditions that do not conform to current GMP
Consists of any filthy, putrid, decomposed substance, in part or whole
Prepared, Packaged, or held in unsanitary conditions which cause contamination
Creation or storage of drug do not comply with GMP
Product represents a drug in the official compendium, but it’s strength differs or quality is below what is stated in the official compendium
Product is mixed or packaged as to decrease quality or strength
Product contains an unsafe coloring Additive

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39
Q

FDCA definition of misbranding

A

labeling is false or misleading
any word or statement is not prominently placed on the label or tricky wording is used
Label should contain name and place of manufacturing, quality in terms of weight, measure, or numerical count, proportion of each active ingredient, and name of inactive ingredients in alphabetical order on outside of packaging

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40
Q

Breakdown of NDC code sections

A

5-4-2
5 - Manufacturer/Distributor code
4 - Specifies strength, dosage form, and formulation
2 - Packaging size and/or type of drug

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41
Q

FDCA definition of a new drug

A

a drug that is not generally recognized among experts as safe and effective for use

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42
Q

Definition of GRASE

A

Generally Recognized as Safe and Effective

If manufacturers can prove this, their product may not be considered a new drug

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43
Q

5 ways for an approved drug to become a new drug

A

Drug contains a new substance
There is a new combination of approved drugs
Proportion of ingredients in combination has changed
new intended use for the drug
Dosage, method, or duration of administration has changed

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44
Q

Phase I Clinical Trials

A

Small number of people
look at basic pharmacology (metabolism, BA, Toxicity)
Purpose is to detect adverse effects of Drug

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45
Q

Phase II Clinical Trials

A

Small number of patients who actually have the disease

Purpose is to determine efficacy of the drug and dosage

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46
Q

Phase III Clinical Trials

A

Large sample size
Performed in actual clinical settings
Usually double-blinded with control group (placebo)
Purpose is to test drug for safety and efficacy

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47
Q

Phase IV Clinical Trials

A

Post-marketing studies

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48
Q

Process for a new drug to become an approved drug

A

FDA can terminate at any phase of trials
FDA’s determination is final and cannot be subject to appeal or judicial review
about 1 in 10 drugs make it through the IND application. If FDA approves, the manufacturer then applies for an NDA to the FDA

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49
Q

Definition of REMS

A

Risk Evaluation and Mitigation Strategy
Risk management programs established under FDAAA 2007 to manage patient safety in high risk drugs
Various “elements to assure safe use” may be required to ensure patient safety:
- Medication Guide, PPI, Communication plan
- Special training or experience for HCP
- Use/Dispense only in specified setting
- Patient enrollment or registration
- Required monitoring and testing

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50
Q

Definition of ETSAU

A 
Elements to Assure Safe Use
May be required under REMS to ensure patient safety
Includes:
- medguide, PPI, Communication plan
- Special training or experience for HCP
- Use/dispense only in specified settings
- Patient enrollment or registration
- Required monitoring and testing
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51
Q

2 things the Durham Humphrey Amendment of 1952 did

A

Establish 2 classes of Drugs (OTC/RX)

Authorized Oral Rx Refills

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52
Q

Expiration Date Definition

A

Final day the drug is expected to meet the requirements of the USP drug monograph for the drug

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53
Q

Definition of BUD

A

Beyond Use Date
Established by Pharmacies
Drug Stability not guaranteed after the BUD
Should not exceed expiration date (usually 6 months to 1 year after made/filled or drug/ingredient expiration date, whichever is earlier)

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54
Q

Definition of CPA

A

Written contractual agreements in the form of protocols and procedures

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55
Q

Definition of NTI

A

Narrow Therapeutic Index

Safe and effective use of these drugs requires careful titration and patient monitoring

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56
Q

2 things the Prescription Drug Marketing Act of 1987 did

A

Prohibit resale of prescription drugs purchased by hospitals and health systems
Wholesale distributors of prescription drugs required to be licensed by the state

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57
Q

Definition of Pedigree

A

Record containing information on every transaction changing the ownership of the drug

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58
Q

3 components of OBRA ‘90

A

Rebates
Demonstration projects
Drug Use Reviews (DUR)

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59
Q

3 components of DUR

A

Retrospective review
Educational programs
Prospective review

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60
Q

What does Pro-DUR stand for?

A

Prospective Drug Use Review

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61
Q

Definition of “Best Price”

A

lowest price at which the manufacturer sells the product to any customer

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62
Q

Definition of AMP

A

Average Manufacturer Price

On average, how much the manufacturer charges the wholesaler in a quarter

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63
Q

OBRA ‘90 Rebate

A

Requires manufacturers to provide drug products to the medicaid program at their best price

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64
Q

What were the OBRA ‘90 Demonstration Projects

A

OBRA-funded demonstration projects to evaluate whether the DUR requirements would result in improved patient care and decreased cost

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65
Q

What are the OBRA ‘90 Retrospective DUR?

A

Performed by a DUR board made up of physicians and pharmacists.
Review medication use trends and data over specified time periods
Attempt to evaluate medication use

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66
Q

What are the OBRA ‘90 Educational Programs?

A

Conferences
Face-to-face meetings with prescribers or pharmacists
written materials

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67
Q

3 components of OBRA ‘90 Pro-DUR

A

Screening (7 categories of potential problems)
Counseling
Documentation

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68
Q

Elements of Counseling in Pro-DUR

A

Name/description of drug
Dosage form/dosage/ROA/Duration
Special precautions/directions for handling and storage
Common or severe SE, interactions and CI, and what to do
Techniques for self-monitoring
Refill information
What to do if a dose is missed

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69
Q

Elements of Screening in Pro-DUR

A 
Therapeutic duplication
Drug-disease interaction
Drug-drug interaction
Allergies
Incorrect dosage
duration of therapy
clinical abuse/misuse
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70
Q

OBRA ‘90 3 requirements for documentation

A

to serve as a reminder to the pharmacist
provide reference to colleagues
show law enforcement officials that OBRA ‘90 requirements are being met

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71
Q

What are the 4 purposes of OBRA ‘90 documentation requirements

A

Serve as a reminder to the pharmacist
provide reference to other pharmacists
show enforcement officials that OBRA ‘90 requirements are being met
show surveyors who need records for what was done in connection to outcome of interest

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72
Q

What does HIPAA Stand for?

A

Health Insurance Portability and Accountability Act of 1996

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73
Q

What are the 4 targets of HIPAA

A

Transaction and code sets
National provider identities
Security of health information
Privacy of health information

74
Q

HIPAA Definition of covered entities

A

Health plans and health care providers that conduct transactions electronically

75
Q

HIPAA Definition of PHI

A

Includes electronic and hard copy health information that relate to past, present, or future physical or mental health, provision of care, or payment for care, and could identify the patient

76
Q

Definition of Personal Representative

A

Either power of attorney or parent for child (under 18 years)

77
Q

HIPAA Definition of minimum necessary requirement

A

a limited data set - exclusion of direct patient identifiers

78
Q

HIPAA Definition of “Breach of PHI”

A

Acquisition, access, use, or disclosure of PHI in an unpermitted manner which compormises the security or privacy of PHI

79
Q

HIPAA definition of disposal of PHI

A

reasonable policied and procedures for disposal to protect PHI (shredding, burning, purging electronic media, contracting with a disposal vendor)

80
Q

HIPAA Definition of marketing communication

A

Communication about a product or service that encourages the recipient to purchase or use the product or service (refill reminder programs are not considered marketing)

81
Q

HIPAA Exception to marketing communication

A

regarding general health issues, face-to-face, case management or care coordination, direct or recommend alternative treatments, providers, or settings of care unless being paid to make the communication, about services offered by pharmacy or health plan

82
Q

HIPAA Definition of business associate

A

Person or entity who, on behalf of a covered entity performs or assists in performance of a function or activity involving the use or disclosure of individually identifiable health information or perform legal, actuarial, accounting, etc. to or for covered entity

83
Q

When was Medicare established?

A

1965

84
Q

What does Medicare Part A cover?

A

Hospital coverage: institutional health care services provided by hospitals, skilled nursing facilities, home health agencies, renal dialysis, and hospice services

85
Q

What does Medicare Part B cover?

A

Physicians and other providers: Outpatient services, physician services, lab and diagnostic tests, and DME

86
Q

What does MMA Stand for?

A

Medicare Modernization Act

87
Q

When was the MMA Established?

A

2003

88
Q

When was the prescription drug benefit completely implemented? (Part D)

A

2006

89
Q

Which functions of medicare do beneficiaries pay a monthly premium?

A

Parts B, C, and D

90
Q

What types of patients are pharmacists reimbursed for providing MTM services?

A

Multiple chronic diseases
Multiple medications
High drug expenses

91
Q

What does MIPPA Stand for?

A

Medicare Improvements for Patients and Providers Act

92
Q

The MIPPA established incentives for…

A

E-prescribers beginning January 1, 2009

93
Q

What services does Medicaid cover?

A 
Physician care
Dental Health
Nursing Care
IP and OP Hospital care
Home health care
Optometry
Lab tests and x-rays
Outpatient prescription drugs (state has the option to include this or not)
94
Q

How is medicaid eligibility determined?

A

by income AND assets

95
Q

Definition of Duel Eligible

A

Eligible for Medicare and Medicaid

96
Q

Who administers Medicaid?

A

The state

97
Q

Who regulates Medicaid?

A

CMS

98
Q

Definition of License

A

Credential granted by a state or federal agency to document that a person meets the minimal government-specified professional requirements and is competent to engage in an occupation

99
Q

Why are pharmacists licensed

A

improves the quality of health care
reduces the cost of health care
deters abuse and misuse of drugs

100
Q

Requirements for pharmacy license

A

Graduation from an accredited pharmacy school
Completion of specific internship requirements
Passing score on licensure exams (NAPLEX and MPJE)
Demonstration of good moral character
Age
Renewal
Continuing Education
Fee

101
Q

4 reasons why defining pharmacy practice in each state is important

A

Identifying professional identity to courts and society
Distinguish pharmacy from medicine
Distinguish pharmacy from ancillary personel
Distinguishing pharmacists from unlicensed persons performing pharmacy-related roles

102
Q

Iowa’s definition of pharmacy practice

A

Dynamic patient-oriented health service profession that applies a scientific body of knowledge to improve and promote patient health by means of appropriate drug use and related drug therapy

103
Q

Iowa’s definition of “Impairment”

A

Inability to practice pharmacy or preform related technical functions with reasonable safety and skill as a result of alcohol or drug use or dependency

104
Q

Iowa’s definition of recovery contract

A

the written document establishing terms for an individual professional’s or technician’s participation in the recovery program

105
Q

What is Iowa’s program committee/committee?

A

Program committee means an impairment program provider, which may be a peer review committee or a committee of a professional pharmaceutical society, which has been contracted with the board to provide an impairment program for the assistance of impaired Iowa pharmacy professionals (pharmacists and techs)

106
Q

Who makes up the Iowa’s Program Committee?

A

One licensed Pharmacist
One representative from Drake CPHS
One representative from the University of Iowa’s COP
One recovery professional
The executive secretary of the board or a designee
One representative from the program provider

107
Q

Two types of referrals to the program committee

A

Individual was not involved in the distribution of controlled substances or legend drugs to other people
Individual agrees to participate in the recovery program with completion of a recovery contract and abiding by terms of said contract

108
Q

Does a pharmacist automatically get his or her license revoked if he or she voluntarily refers themselves to the state board for impairment programs?

A

No

109
Q

What is Iowa’s definition of a recovery contract?

A

written document establishing terms for an individual pharmacist or technician’s participation in the recovery program

110
Q

What type of pharmacies are excluded from Iowa’s Regulation of Hospital Pharmacies?

A

Does not apply to a pharmacy located within such a facility for the purpose of providing outpatient refills (657-7.1 (155A))

111
Q

In Iowa, what information is the pharmacist responsible for obtaining, recording, and maintaining?

A 
Full name
Address
Phone #
Age/DOB
Gender
Significant Patient Information including all Rxs for the past 2 years
Prescription name, strength, quality, date, and prescriber
pharmacist's comments to drug therapy
112
Q

In Iowa, how long must a patient’s records be maintained and in what form?

A

not less than 2 years

hard copy

113
Q

What is a stop order?

A

An order entered to ensure drug orders do not continue inappropriately for situations when they are ordered indefinitely (without a set number of doses or duration of therapy)

114
Q

Who is responsible for developing and implementing an automatic stop order policy?

A

Consultant pharmacist and provider pharmacist, medical director, and representative of the facility

115
Q

What is Iowa’s definition of a pharmacy support person?

A

Person other than a licensed pharmacist, registered pharmacist intern, or a registered pharmacy technician who may perform non-technical duties assigned by a supervising pharmacist under their pharmacist responsibility supervision

116
Q

2 tasks a support person must NOT perform

A

Final verification
DUR
Counseling

117
Q

Iowa’s definition of pharmacy technician certification

A

process by which an association or other non-governmental agency recognizes qualification

118
Q

3 tasks a pharmacy technician must NOT perform

A

counseling
DUR
Final verification

119
Q

Who administers and enforces the CSA?

A

DEA and FDA

120
Q

Definition of a schedule I substance (CI)

A

high abuse potential
no current medicinal use in the US
Lack of accepted information for safety even with medical supervision

121
Q

Definition of a schedule II substance (CII)

A

high abuse potential
accepted medical use
abuse may lead to physical or psychological dependence

122
Q

Definition of a schedule III substance (CIII)

A

potential for abuse less than that of CI and CII
Accepted medical use
abuse may lead to low physical and high psychological dependence

123
Q

Definition of schedule IV substance (CIV)

A

Potential for abuse less than CIII
Currently accepted medicinal use
may lead to limited physical dependence relative to CIII and limited psychological dependence compared to CIII

124
Q

Definition of Schedule V substance (CV)

A

Potential for abuse less than CIV
Current medicinal use in US
May lead to limited physical and psychological dependence less than CIV

125
Q

Definition of “dispenser” according to CSA

A

A practitioner who administers/delivers a controlled substance to an ultimate user or research subject

126
Q

4 violation of CSA

A

Drug trafficking
Distributing or dispensing in violation
Order form 222 violation
Illegal posession

127
Q

Does a pharmacist dispensing a controlled substance have to register with the DEA if the pharmacy he/she works at is already registered?

A

no

128
Q

Pharmacy security requirements for controlled substances (CII-V)

A

“Registrants (the pharmacy) shall provide effective controls and procedures to guard against theft and diversion of controlled substances”

Pharmacies must store scheduled drugs in a securely locked, substantially constructed cabinet, or may disperse these substances throughout their stock of non-controlled substances in a manner that will obstruct theft or diversion

129
Q

Two types of DEA inspections

A

Normal inspection

AIW

130
Q

DEA Inspector procedure to assess pharmacy

A

Inspector must:
State purpose of inspection
Present credentials and written notice of inspection
Obtain a written statement of informed consent from the owner or pharmacist in charge
Consent must be voluntary and can be withdrawn during any part of the inspection

131
Q

Which is harder to get, search warrant or AIW?

A

Search Warrant

132
Q

Can a pharmacist/pharmacy refuse a DEA inspection if the DEA has an AIW?

A

No

133
Q

Definition of Administrative Inspection Warrant

A

a piece of paper letting the DEA into the pharmacy without permission

134
Q

What is the probable cause requirement for an AIW?

A

May be issued if a “Valid public interest” exists
any incriminating evidence found may be seized and used in a criminal prosecution
registrant can not refuse if an inspector shows up with such a warrant or durring an arrest

135
Q

Differeneces between FDA inspection and DEA inspection procedures to access pharmacy

A

FDA Inspector must:
State the purpose of the inspection
present credentials and hand written notice of inspection
obtain a written statement of informed consent from the owner or PIC
consent must be voluntary and can be withdrawn during any part of the inspection

136
Q

requirements for mailing controlled substances

A

inner container must be properly labeled
Outer container must be plain or wrapped in a plain wrapper
no indication of nature of contents

137
Q

CSA definition of “prescription”

A

An order for a medication which is dispensed to or for an ultimate user, but does NOT include an order for medication which is dispensed for immediate administration to the ultimate user

138
Q

Two criteria to be authorized to describe controlled substances

A

authorized to prescribe controlled substances in the state where licensed to practice
registered under the CSA

139
Q

How to check if a DEA registration number may be legitimate

A

First letter (ABFM) describes what type of practitioner it is for
Second letter is the first letter of the practitioner’s last name (or of the group)
Add #’s 1, 3, and 5 together
Add #’s 2, 4, and 6 together and multiply by 2
Add these two sums together, the last digit of this number is the 7th digit

140
Q

CSA’s regulation on Schedule II dispensing

A

Pharmacist may dispense CII Only with a written prescription, signed by the individual practitioner, with no refills

141
Q

What are the procedures for how to fill a controlled substance in an “emergency situation”?

A

Limit quantity prescribed and dispensed to the amount necessary
Reduce prescription to writing immediately
make a reasonable good faith effort to verify, if prescriber unknown
receive written prescription within 7 days
must have “Authorization for Emergency Dispensing’ and date of oral order written on the prescription

142
Q

CSA’s regulation for CIII-IV refills

A

restricted to 6 months or 5 refills, whichever comes first

143
Q

CSA’s label requirements for CII

A

Date of filling
Caution label “Caution: Federal Law prohibits the transfer of this drug to any person other than the person for whom it was prescribed”

144
Q

CSA’s label requirements for CIII-CIV

A

Date of initial fill AND refill date
Caution label “Caution: Federal Law prohibits the transfer of this drug to any person other than the person for whom it was prescribed”

145
Q

CSA’s label requirements for CV

A

Date of initial filling
Caution Label “Caution: Federal Law prohibits the transfer of this drug to any person other than the person for whom it was prescribed”

146
Q

What are the 3 types of documents that must be recorded and kept according to the CSA

A

Inventory
Drugs received
Drugs dispensed

147
Q

Definition of Negligence

A

an unintentional act that causes harm

148
Q

What is the DEA Form 222 used for and how does a registrant obtain it?

A

this form is required for the purchase of CI or CII substances, and can only be obtained by registrants and only from the DEA
Serially numbered and issued with the name, address, and registration number of the registrant, authorized activity, and schedules authorized to handle

149
Q

What is the DEA Form 41 used for and how is it obtained

A

record of disposal, used to record if something is broken or split
obtained online

150
Q

What is the DEA form 106 used for and how is it obtained?

A

record of theft and loss

obtained online

151
Q

How long muse controlled substance records be kept

A

2 years

152
Q

how often must a pharmacy perform an inventory of controlled substances according to the CSA?

A

biennially (every 2 years after date of initial inventory)

153
Q

How often must a pharmacy perform an inventory of controlled substances according to the Iowa law?

A

annually

154
Q

General regulations for Central Fill pharmacies

A

Can fill prescriptions for retail pharmacies, must have a contract
cannot accept prescriptions directly from or deliver directly to the patient
pharmacies using this central fill pharmacy must have its DEA# readily available

155
Q

4 elements of negligence

A

Duty
Breach of Duty
Causation
Damages

156
Q

5 ways in which pharmacists are risk managers

A

takes all inquiries seriously
take all allergy computer prompts seriously
confirm an unusually high dose
let patients know that a mistake has been made (document)
patient educaion

157
Q

definition of acutal damages

A

(law) compensation for losses that can readily be proven to have occurred and for which the injured party has the right to be compensated

158
Q

Definition of punative damages

A

damages exceeding simple compensation and awarded to punish the defendant

159
Q

Definition of Actual cause

A

acutal cause refers to the cause or factor without which the event could not have occurred

160
Q

Definition of proximate cause

A

an act from which an injury results as a natural, direct, uninterrupted consequence and without which the injury would not have occurred

161
Q

definition of nonjudgmental acts

A

mechanical type acts that do not require professional judgement

162
Q

How many members on the Iowa BOP?

A

Seven

163
Q

How many members of Iowa BOP are pharmacists?

A

Five

164
Q

How many members of Iowa BOP are public members?

A

two

165
Q

Who are the members of the Iowa BOP appointed by?

A

the Govenor

166
Q

What is the mission of the IBPE to the public of Iowa?

A

The Iowa Board of Pharmacy promotes, preserves, and protects the public health, safety, and welfare by fostering the provision of pharmaceutical care to all Iowans through the effective regulation of practice of pharmacy, the operation of pharmacies, the appropriate utilization of pharmacy technicians, the distribution of prescription medications and devices, and the education and training of pharmacists

167
Q

Who can the board license and regulate?

A

pharmacists
student pharmacists
pharmacy technicians

168
Q

Are board meetings open to the public?

A

all meetings of the Board are open to the public except, as provided by statute, for some exceptional reason so compelling as to override the general public policy in favor of public meetings and as permitted by Iowa Code section 21.5

169
Q

Define Quorum of BOP

A

a majority of the members of the board shall constitute a quorum

170
Q

what national group administers pharmacist licensure?

A

NABP

171
Q

What 2 tests are needed by Iowa to be licensed?

A

NAPLEX and MPJE

172
Q

What scaled score is needed to pass each of the state licensing exams?

A

a total scaled score of no less than 75 is required to pass each exam

173
Q

what are the requirements for original (non-transfer reciprocity) pharmacy licensure in Iowa

A

take and pass the NAPLEx, MPJE Iowa Edition, both with a total scaled score of no less than 75.
must pass both within a year of passing the first one taken

174
Q

How often does a pharmacist need to renew his or her license?

A

a license to practice pharmacy shall expire on the second thirtieth day of June following the date of issuance of the license, with the exception that a new pharmacist license issued between April 1 and June 29 shall expire on the third thirtieth day of June following the date of issuance. The license renewal certificate shall be issued upon completion of the renewal application and timely payment of a $200 fee plus applicable surcharge pursuant to 657-30.8

175
Q

Regarding CE, what national proficer’s CE courses are always approved by the IbpE?

A

with a seal of an ACPE-accredited provider

176
Q

Can I just use a cheap non-ACPE accredited source?

A

a maximum of 50% of the total CE credits erquired pursuant to subrule 2.12(4) may be obtained through completion of non-ACPE provider activities if such activities are provided by an accredited health-professional CE provider, such as a continuing medical education (CME) provider, and if the activity content directly relates to the pharmacist’s professional practice

177
Q

How many CEUs are required per renewal period (Q2 years)

A

3.0 CEUs

178
Q

Specific to the CE hours I get, are there specific Subject requirements I must maintain?

A

Drug therapy (1.5 CEUs), Pharmacy law (0.2 CEUs), and patient or medication safety (0.2 CEUs)

179
Q

How do I know they are Drug Therapy Topics?

A

with include the ACPE topic designatore “01” or “02” followed by the letter “P” at the end of the universal activity number

180
Q

A pharmacy badge, at the minimum, must contain:

A

A pharmacist shall wear a visible identification badge while on duty that clearly identifies the person as a pharmacist and includes at least the pharmacist’s first name

Law (3 decks)

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