P3 Law Semester Flashcards
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.
2
Q
What are the 4 market failures?
A
Public Goods Externalities Natural monopolies Information asymmetry A market failure justifies government regulation
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.)
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
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
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
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)
8
Q
Legislature makes what kind of law?
A
Statutes
9
Q
Administrative agencies create laws through…
A
Hearings
10
Q
Who creates administrative agencies?
A
Congress has a say in administrative agency appointments and appropriations
Significant influence
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)
12
Q
Definition of information asymmetry
A
when a consumer is uninformed about the true value of a good
13
Q
What are the two state level administrative agencies that regulate pharmacy practice?
A
State Boards of Pharmacy
State Department of Health Services
14
Q
What is the Federal Register?
A
Basically the “Daily news paper of the Federal Government”
15
Q
What is in the Federal Register?
A
Proposed and Final regulations and notices
16
Q
How often is the Federal Register Published?
A
Daily
17
Q
What does CFR stand for?
A
Code of Federal Regulations
18
Q
What is in the CFR?
A
Final regulations divided and indexed by subject matter
19
Q
How often is the CFR published?
A
Yearly
20
Q
Type of law made by the courts
A
Judicial Opinion
21
Q
4 Origins of a Bill
A
Lobbying Groups
Citizens
Government officials
President
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.
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
24
Q
Definition of Administrative Action
A
Violation of a statute or regulation
OR
an act that warrants an investigation
25
What did the Nutrition Labeling and Education Act of 1990 do?
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
26
Definition of cGMP
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
27
What did the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 do? (DSHEA)
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)
28
What disclaimer must accompany any structure or function claim made by a dietary supplement?
the FDA has not evaluated the claim and the dietary supplement is not intended to diagnose, treat, cure, or prevent any disease
29
what is the USP?
United States Pharmacopeia.
Establishes approved titles, definitions, and descriptions for drugs.
Sets standards for identity, quality, strength, purity, packaging, stability, and labeling
30
What is the USPC?
United States Pharmacopeial Convention
Independent of FDA, publishes the USP
Publishes compendiums that are used as legal resources of drug standards
31
What is the USP-NF?
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
32
What is the USP-FCC?
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
33
What is HPUS?
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
34
Class I Product Recall
Issued when there is reasonable probability that the product will cause serious, adverse health consequences of death
35
Class II Product Recall
Occurs when the product may cause temporary or medically reversible adverse health consequences, but the probability of serious adverse consequences is remote
36
Class III Product Recall
Applies to products that are not likely to cause adverse health consequences
37
What did the Medical Device Amendment of 1976 do?
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
38
FDCA Definition of Adulteration
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
39
FDCA definition of misbranding
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
40
Breakdown of NDC code sections
5-4-2
5 - Manufacturer/Distributor code
4 - Specifies strength, dosage form, and formulation
2 - Packaging size and/or type of drug
41
FDCA definition of a new drug
a drug that is not generally recognized among experts as safe and effective for use
42
Definition of GRASE
Generally Recognized as Safe and Effective
| If manufacturers can prove this, their product may not be considered a new drug
43
5 ways for an approved drug to become a new drug
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
44
Phase I Clinical Trials
Small number of people
look at basic pharmacology (metabolism, BA, Toxicity)
Purpose is to detect adverse effects of Drug
45
Phase II Clinical Trials
Small number of patients who actually have the disease
| Purpose is to determine efficacy of the drug and dosage
46
Phase III Clinical Trials
Large sample size
Performed in actual clinical settings
Usually double-blinded with control group (placebo)
Purpose is to test drug for safety and efficacy
47
Phase IV Clinical Trials
Post-marketing studies
48
Process for a new drug to become an approved drug
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
49
Definition of REMS
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
50
Definition of ETSAU
```
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
```
51
2 things the Durham Humphrey Amendment of 1952 did
Establish 2 classes of Drugs (OTC/RX)
| Authorized Oral Rx Refills
52
Expiration Date Definition
Final day the drug is expected to meet the requirements of the USP drug monograph for the drug
53
Definition of BUD
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)
54
Definition of CPA
Written contractual agreements in the form of protocols and procedures
55
Definition of NTI
Narrow Therapeutic Index
| Safe and effective use of these drugs requires careful titration and patient monitoring
56
2 things the Prescription Drug Marketing Act of 1987 did
Prohibit resale of prescription drugs purchased by hospitals and health systems
Wholesale distributors of prescription drugs required to be licensed by the state
57
Definition of Pedigree
Record containing information on every transaction changing the ownership of the drug
58
3 components of OBRA '90
Rebates
Demonstration projects
Drug Use Reviews (DUR)
59
3 components of DUR
Retrospective review
Educational programs
Prospective review
60
What does Pro-DUR stand for?
Prospective Drug Use Review
61
Definition of "Best Price"
lowest price at which the manufacturer sells the product to any customer
62
Definition of AMP
Average Manufacturer Price
| On average, how much the manufacturer charges the wholesaler in a quarter
63
OBRA '90 Rebate
Requires manufacturers to provide drug products to the medicaid program at their best price
64
What were the OBRA '90 Demonstration Projects
OBRA-funded demonstration projects to evaluate whether the DUR requirements would result in improved patient care and decreased cost
65
What are the OBRA '90 Retrospective DUR?
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
66
What are the OBRA '90 Educational Programs?
Conferences
Face-to-face meetings with prescribers or pharmacists
written materials
67
3 components of OBRA '90 Pro-DUR
Screening (7 categories of potential problems)
Counseling
Documentation
68
Elements of Counseling in Pro-DUR
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
69
Elements of Screening in Pro-DUR
```
Therapeutic duplication
Drug-disease interaction
Drug-drug interaction
Allergies
Incorrect dosage
duration of therapy
clinical abuse/misuse
```
70
OBRA '90 3 requirements for documentation
to serve as a reminder to the pharmacist
provide reference to colleagues
show law enforcement officials that OBRA '90 requirements are being met
71
What are the 4 purposes of OBRA '90 documentation requirements
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
72
What does HIPAA Stand for?
Health Insurance Portability and Accountability Act of 1996
73
What are the 4 targets of HIPAA
Transaction and code sets
National provider identities
Security of health information
Privacy of health information
74
HIPAA Definition of covered entities
Health plans and health care providers that conduct transactions electronically
75
HIPAA Definition of PHI
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
Definition of Personal Representative
Either power of attorney or parent for child (under 18 years)
77
HIPAA Definition of minimum necessary requirement
a limited data set - exclusion of direct patient identifiers
78
HIPAA Definition of "Breach of PHI"
Acquisition, access, use, or disclosure of PHI in an unpermitted manner which compormises the security or privacy of PHI
79
HIPAA definition of disposal of PHI
reasonable policied and procedures for disposal to protect PHI (shredding, burning, purging electronic media, contracting with a disposal vendor)
80
HIPAA Definition of marketing communication
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
HIPAA Exception to marketing communication
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
HIPAA Definition of business associate
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
When was Medicare established?
1965
84
What does Medicare Part A cover?
Hospital coverage: institutional health care services provided by hospitals, skilled nursing facilities, home health agencies, renal dialysis, and hospice services
85
What does Medicare Part B cover?
Physicians and other providers: Outpatient services, physician services, lab and diagnostic tests, and DME
86
What does MMA Stand for?
Medicare Modernization Act
87
When was the MMA Established?
2003
88
When was the prescription drug benefit completely implemented? (Part D)
2006
89
Which functions of medicare do beneficiaries pay a monthly premium?
Parts B, C, and D
90
What types of patients are pharmacists reimbursed for providing MTM services?
Multiple chronic diseases
Multiple medications
High drug expenses
91
What does MIPPA Stand for?
Medicare Improvements for Patients and Providers Act
92
The MIPPA established incentives for...
E-prescribers beginning January 1, 2009
93
What services does Medicaid cover?
```
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
How is medicaid eligibility determined?
by income AND assets
95
Definition of Duel Eligible
Eligible for Medicare and Medicaid
96
Who administers Medicaid?
The state
97
Who regulates Medicaid?
CMS
98
Definition of License
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
Why are pharmacists licensed
improves the quality of health care
reduces the cost of health care
deters abuse and misuse of drugs
100
Requirements for pharmacy license
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
4 reasons why defining pharmacy practice in each state is important
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
Iowa's definition of pharmacy practice
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
Iowa's definition of "Impairment"
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
Iowa's definition of recovery contract
the written document establishing terms for an individual professional's or technician's participation in the recovery program
105
What is Iowa's program committee/committee?
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
Who makes up the Iowa's Program Committee?
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
Two types of referrals to the program committee
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
Does a pharmacist automatically get his or her license revoked if he or she voluntarily refers themselves to the state board for impairment programs?
No
109
What is Iowa's definition of a recovery contract?
written document establishing terms for an individual pharmacist or technician's participation in the recovery program
110
What type of pharmacies are excluded from Iowa's Regulation of Hospital Pharmacies?
Does not apply to a pharmacy located within such a facility for the purpose of providing outpatient refills (657-7.1 (155A))
111
In Iowa, what information is the pharmacist responsible for obtaining, recording, and maintaining?
```
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
In Iowa, how long must a patient's records be maintained and in what form?
not less than 2 years
| hard copy
113
What is a stop order?
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
Who is responsible for developing and implementing an automatic stop order policy?
Consultant pharmacist and provider pharmacist, medical director, and representative of the facility
115
What is Iowa's definition of a pharmacy support person?
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
2 tasks a support person must NOT perform
Final verification
DUR
Counseling
117
Iowa's definition of pharmacy technician certification
process by which an association or other non-governmental agency recognizes qualification
118
3 tasks a pharmacy technician must NOT perform
counseling
DUR
Final verification
119
Who administers and enforces the CSA?
DEA and FDA
120
Definition of a schedule I substance (CI)
high abuse potential
no current medicinal use in the US
Lack of accepted information for safety even with medical supervision
121
Definition of a schedule II substance (CII)
high abuse potential
accepted medical use
abuse may lead to physical or psychological dependence
122
Definition of a schedule III substance (CIII)
potential for abuse less than that of CI and CII
Accepted medical use
abuse may lead to low physical and high psychological dependence
123
Definition of schedule IV substance (CIV)
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
Definition of Schedule V substance (CV)
Potential for abuse less than CIV
Current medicinal use in US
May lead to limited physical and psychological dependence less than CIV
125
Definition of "dispenser" according to CSA
A practitioner who administers/delivers a controlled substance to an ultimate user or research subject
126
4 violation of CSA
Drug trafficking
Distributing or dispensing in violation
Order form 222 violation
Illegal posession
127
Does a pharmacist dispensing a controlled substance have to register with the DEA if the pharmacy he/she works at is already registered?
no
128
Pharmacy security requirements for controlled substances (CII-V)
"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
Two types of DEA inspections
Normal inspection
| AIW
130
DEA Inspector procedure to assess pharmacy
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
Which is harder to get, search warrant or AIW?
Search Warrant
132
Can a pharmacist/pharmacy refuse a DEA inspection if the DEA has an AIW?
No
133
Definition of Administrative Inspection Warrant
a piece of paper letting the DEA into the pharmacy without permission
134
What is the probable cause requirement for an AIW?
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
Differeneces between FDA inspection and DEA inspection procedures to access pharmacy
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
requirements for mailing controlled substances
inner container must be properly labeled
Outer container must be plain or wrapped in a plain wrapper
no indication of nature of contents
137
CSA definition of "prescription"
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
Two criteria to be authorized to describe controlled substances
authorized to prescribe controlled substances in the state where licensed to practice
registered under the CSA
139
How to check if a DEA registration number may be legitimate
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
CSA's regulation on Schedule II dispensing
Pharmacist may dispense CII Only with a written prescription, signed by the individual practitioner, with no refills
141
What are the procedures for how to fill a controlled substance in an "emergency situation"?
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
CSA's regulation for CIII-IV refills
restricted to 6 months or 5 refills, whichever comes first
143
CSA's label requirements for CII
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
CSA's label requirements for CIII-CIV
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
CSA's label requirements for CV
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
What are the 3 types of documents that must be recorded and kept according to the CSA
Inventory
Drugs received
Drugs dispensed
147
Definition of Negligence
an unintentional act that causes harm
148
What is the DEA Form 222 used for and how does a registrant obtain it?
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
What is the DEA Form 41 used for and how is it obtained
record of disposal, used to record if something is broken or split
obtained online
150
What is the DEA form 106 used for and how is it obtained?
record of theft and loss
| obtained online
151
How long muse controlled substance records be kept
2 years
152
how often must a pharmacy perform an inventory of controlled substances according to the CSA?
biennially (every 2 years after date of initial inventory)
153
How often must a pharmacy perform an inventory of controlled substances according to the Iowa law?
annually
154
General regulations for Central Fill pharmacies
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
4 elements of negligence
Duty
Breach of Duty
Causation
Damages
156
5 ways in which pharmacists are risk managers
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
definition of acutal damages
(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
Definition of punative damages
damages exceeding simple compensation and awarded to punish the defendant
159
Definition of Actual cause
acutal cause refers to the cause or factor without which the event could not have occurred
160
Definition of proximate cause
an act from which an injury results as a natural, direct, uninterrupted consequence and without which the injury would not have occurred
161
definition of nonjudgmental acts
mechanical type acts that do not require professional judgement
162
How many members on the Iowa BOP?
Seven
163
How many members of Iowa BOP are pharmacists?
Five
164
How many members of Iowa BOP are public members?
two
165
Who are the members of the Iowa BOP appointed by?
the Govenor
166
What is the mission of the IBPE to the public of Iowa?
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
Who can the board license and regulate?
pharmacists
student pharmacists
pharmacy technicians
168
Are board meetings open to the public?
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
Define Quorum of BOP
a majority of the members of the board shall constitute a quorum
170
what national group administers pharmacist licensure?
NABP
171
What 2 tests are needed by Iowa to be licensed?
NAPLEX and MPJE
172
What scaled score is needed to pass each of the state licensing exams?
a total scaled score of no less than 75 is required to pass each exam
173
what are the requirements for original (non-transfer reciprocity) pharmacy licensure in Iowa
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
How often does a pharmacist need to renew his or her license?
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
Regarding CE, what national proficer's CE courses are always approved by the IbpE?
with a seal of an ACPE-accredited provider
176
Can I just use a cheap non-ACPE accredited source?
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
How many CEUs are required per renewal period (Q2 years)
3.0 CEUs
178
Specific to the CE hours I get, are there specific Subject requirements I must maintain?
Drug therapy (1.5 CEUs), Pharmacy law (0.2 CEUs), and patient or medication safety (0.2 CEUs)
179
How do I know they are Drug Therapy Topics?
with include the ACPE topic designatore "01" or "02" followed by the letter "P" at the end of the universal activity number
180
A pharmacy badge, at the minimum, must contain:
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
