Jurisprudence Exam 3 Flashcards
1
Q
What is the purpose of state laws?
A
They fill in the gaps in the more general federal laws
2
Q
The Indiana Legislature passes what?
A
Laws
(think L = Law)
3
Q
The Indiana Board of Pharmacy passes what?
A
Rules
4
Q
Where are Indiana laws listed?
A
Indiana Code
5
Q
Where are Indiana rules listed?
A
Indiana Administrative Code
(tip: rules are passed by the Board of Pharmacy which is an administration)
6
Q
How do we cite Indiana Code?
A
IC Title-Article-Chapter-Section
Example: IC 25-26-23-15
7
Q
What is the first number in an Indiana citation?
A
Title
8
Q
What is the second number in an Indiana Citation?
A
Article
9
Q
What is the 3rd number in an Indiana Citation?
A
Chapter
10
Q
What is the 4th number in an Indiana Citation?
A
Section
11
Q
How do we cite Indiana Administrative Code?
A
Title IAC Article-Chapter(Rule)-Section
Example: 856 IAC 1-3.1-11
*note that the types of numbers in this are the same as Indiana Code
12
Q
Title 856 Article 1 of Indiana Administrative Code focuses on what?
A
Pharmacies and Pharmacists
13
Q
Title 856 Article 2 of Indiana Administrative Code focuses on what?
A
Controlled Substances
14
Q
Title 856 Article 4 of Indiana Administrative Code focuses on what?
A
Pharmacist Vaccinations administered via protocol authority
15
Q
What is the definition of “Sale”?
A
It means “every sale” including the following:
-Manufacturing, processing, transporting, handling, packaging, or any other production, preparation, or repackaging
-Exposure, offer, or any other proffer
-Holding, storing, or any other possession
-Dispensing, giving, delivering, or any other supplying
-Applying, administering, or any other using
(remember: manufacturing, transporting, repackaging, proffer, possession, supplying, and using)
16
Q
What are 3 examples of a sale?
A
Placing a legend drug outside the pharmacy in a publicly accessible area
Administering a medication to a patient
Transporting a drug from one pharmacy to another
17
Q
What is the limitation to be aware of with veterinarians prescribing medications?
A
We cannot substitute a veterinarian-prescribed medication for generic without calling them first
*even if they sign on the “may substitute” line
18
Q
What is the most generally accepted definition of a “practitioner”?
A
- A physician
- A veterinarian
- A dentist
- A podiatrist
- An optometrist
- An advanced practice registered nurse
- A physician’s assistant
19
Q
What are the big four prescribers?
A
Physician
Veterinarian
Dentist
Podiatrist
20
Q
What are the general rules surrounding prescriptions written by the big four?
A
Prescriptions written by these providers in ANY STATE are valid to be filled in Indiana
This is true as long as they are:
-licensed appropriately
-working within their scope
-following applicable laws of the state they are licensed in
21
Q
What are the 3 types of Advanced Practice Registered Nurses (APRNs)?
A
Nurse Practitioner
Certified Nurse Midwife
Clinical Nurse Specialist
22
Q
Advanced Practice Registered Nurses (APRNs) must work under a supervising practitioner. What practitioners can this be?
A
Physicians
Podiatrists
Dentists
(remember: can work under all big 4 prescribers EXCEPT veterinarians)
23
Q
APRNs must do what 3 things?
A
- Work under a supervising practitioner
- Apply for prescribing authority with the state
- Have a collaborative practice agreement on file with the Indiana state board of nursing
24
Q
What are the limitations put onto APRNs regarding prescribing?
A
They are limited to prescribing within the scope and specialty of their supervising practitioner
-may be further limited by collaborative practice agreement
25
True or False: APRNs can prescribe controlled substances
True
26
What are the requirements for an APRN to prescribe a controlled substance?
Must have both of these:
-DEA number
-Indiana Controlled Substance Registration (CSR)
27
True or False: APRNs can practice separately from their supervising practitioner
True
28
When prescribing, APRNs must do what?
Sign their own name, their credentials, and their board-assigned ID
29
True or False: In Indiana, prescriptions written by APRNs from any state are honored
True
30
What are the limitations placed on physician assistants regarding how they practice?
They must work with a supervising physician (Like APRNs)
*They must be directly supervised by a physician in person
-where the physician could immediately step in if needed
31
What are the 2 ways a Physician Assistant can be directly supervised?
The physician is in the same location as the PA
The physician is immediately available via telecommunication to see the patient in a medically appropriate time frame
32
What are physician assistants allowed to prescribe?
Only things directly delegated by their collaborative practice agreement on file with the medical licensing board of Indiana
33
What are physician assistants not allowed to prescribe?
Opthalmic devices
General anesthesia or deep sedation
34
APRNs must have their collaborative practice agreement on file with who?
Indiana state board of nursing
35
Physician Assistants must have their collaborative practice agreement on file with who?
The Medical Licensing Board of Indiana
36
True or False: Physician Assistants can prescribe controlled substances
True
37
When prescribing, physician assistants must do what?
Sign their own name, credentials, and provide their state license number
38
True or False: In Indiana, prescriptions written by Physician Assistants in any state are honored
True
39
Which one is the physician: an optometrist or ophthalmologist
The ophthalmologist is the physician
An optometrist is a midlevel practitioner
(hint: ophthalmologist is a longer/fancier word, and they have the fancier degree)
40
What are the limitations placed on optometrists regarding prescribing?
Can prescribe independently* but only according to a formulary
*MUST BE LICENSED IN INDIANA*
41
What are the 3 tiers to the optometrist prescribing formulary?
1. Independent prescribing (most common)
2. Dependent prescribing by notification (notify the patient's PCP of their prescribing)
3. Dependent prescribing by consult: must call AND consult the patient's PCP before prescribing a listed medication
42
The optometrist formulary is limited to which drugs?
Drugs for the treatment of the eye or associated structures of the eye
-these are listed by the Indiana Board of Optometry
43
True or False: All formulary drugs may be independently prescribed by an optometrist
True
44
True or False: optometrists can prescribe controlled substances
FALSE
-they are prohibited from use by an optometrist
45
What is the only controlled substance that optometrists can prescribe?
Tramadol (Ultram)
46
What are the requirements for an optometrist to be able to prescribe tramadol?
Must:
1. Hold an Indiana license
2. Meet the requirements for certification to administer, dispense, or prescribe a legend drug
3. Maintain a controlled substance registration
47
When Indiana Administrative Code and Indiana Code are in conflict, which one supersedes?
Indiana Code
48
What is are the 2 biggest differences between Optometrist prescribing, and APRN/PA prescribing?
Optometrists cannot prescribe controlled substances besides tramadol
Optometrists MUST be licensed in Indiana for their prescriptions to be filled
(do not fill if they are from another state)
49
What are the products that a pharmacist may prescribe?
-Inhalation spacer
-Nebulizer
-Supplies for medical devices
-Normal saline and sterile water for irrigation
-Diabetes blood sugar testing supplies
-Pen Needles
-Syringes for medical use
-Hormonal contraceptives
50
What additional items can a pharmacist prescribe based on statewide standing orders?
Auto-Injectable Epinephrine
Vaccines
Naloxone
Tobacco Cessation
51
How often must standing orders be renewed?
Every year
52
Besides independent prescribing and standing orders, what is the only other time a pharmacist may act as a prescriber?
Under a collaborative practice agreement (aka "protocols")
53
Outside of a hospital, who may a pharmacist enter a protocol (collaborative practice agreement) with?
A physician
An APRN
A Physician Assistant
54
What are the caveats to a pharmacist entering a collaborative practice agreement?
*It must be signed by a physician regardless of the provider it is with
*It must apply to a single patient or specific group of patients specified by the physician
55
True or False: Pharmacists must be licensed in Indiana for their prescriptions to be filled here
TRUE
-do not fill prescriptions written by pharmacists not licensed in Indiana
56
What is the rule regarding other midlevel practitioners and their prescriptions?
Do not fill any prescriptions written by a midlevel practitioner besides APRNs, PAs, Indiana Optometrists, and Indiana pharmacists
-no other midlevel practitioners are recognized as prescribers in Indiana
57
Who has broad authority over the practice of pharmacy in Indiana and is responsible for establishing the professional standards for pharmacists?
The Indiana Board of Pharmacy
58
What is the Main Goal of the Indiana Board of Pharmacy?
Protecting the public* and enforcing the laws and rules that govern pharmacy
59
What are the professional standard violations that the Board of Pharmacy must act on?
1. Fraud
2. Conviction of a crime with direct bearing on competent practice or public safety
3. Knowing violation of statute, rule, or regulation
4. Continuing to practice while unfit
5. Lewd/Immoral conduct connected to delivery of services to the public
6. Improper use of name or license (outside of scope)
7. Disciplinary action in any state or jurisdiction
8. Drug diversion
9. Aiding/abetting an addiction or habit
10. Failure to comply with a sanction issued
11. Sexual contact with patient (spouses exempted)
12. Improper payment collection
13. Assisting another person in committing one of these violations
14. Failure to report suspected child abuse
15. Failure to report suspected human trafficking
60
How does a sanction work?
The state must show that a practitioner has done something wrong that requires a sanction
-Have a hearing
-Practitioner is allowed to have legal representation
-If a sanction is imposed, the practitioner can appeal to a court of law
(only check if the board followed appropriate procedures and the law, not at the case itself)
61
What are the types of sanctions that can be imposed?
Revocation
Suspension
Probation
Letter of Reprimand
Censure
Dine
62
If a pharmacist receives a REVOCATION sanction, what does this mean?
License is taken away permanently
63
If a pharmacist receives a SUSPENSION sanction, what does this mean?
License is taken away temporarily
64
If a pharmacist receives a PROBATION sanction, what does this mean?
They can practice but with limits or additional requirements
65
If a pharmacist receives a LETTER OF REPRIMAND sanction, what does this mean?
Written expression of disapproval describing what the practitioner did wrong
66
If a pharmacist receives a CENSURE sanction, what does this mean?
Verbal expression of disapproval
67
How much can pharmacists be fined for a sanction?
Up to $1000 for each violation
68
Which sanctions result in a pharmacist not being able to practice?
Suspension
Revocation
69
If your license has been suspended, how can you get it back?
*Licenses are typically suspended indefinitely
-The board will set a minimum amount of time before you can apply for reinstatement
-This may involve disciplinary or corrective measures or probation
70
If your license has been revoked how can you get it back?
You can't
-But you can apply for a NEW license after *7 years* from the date of revocation
*note that the board may or may not allow this
71
Which disciplinary action is NOT a sanction?
Surrender
-because the practitioner is the one who does this
-they typically petition the board to surrender their license instead of having a hearing
-board may accept/decline the request and impose additional conditions
72
What is a summary suspension?
An emergency suspension of a license that occurs if there is clear or immediate danger to public health and safety
73
How long can a summary suspension last?
90 days
-can be renewed but only for 90 days at a time
74
The board may require a physical or mental examination to determine if a practitioner is capable to practice. What are the requirements for this to occur?
Must stem from a disciplinary hearing where the practitioner's ability to practice is at issue
75
What are the situations where refusal of licensure may occur?
Applicant has been or could be disciplined by another state or jurisdiction
+
The violation has a direct bearing on the applicant's ability to practice in Indiana
Also: Anyone who has practiced without a license may be refused a license
76
What is the alternative to refusal of licensure?
Issuing a probationary license
77
If the board issues a probationary license, they may impose what conditions?
1. Report regularly to the board
2. Limit practice to certain areas prescribed by the board
3. Continue or renew professional education
4. Engage in community service
5. Perform, or refrain from performing, an act
78
What are the requirements for controlled substance prescribing in Indiana?
All controlled prescriptions must:
-Be in an electronic format
-Be transmitted electronically from the prescriber to the pharmacy
79
All prescribers are required to transmit controlled substances electronically except who?
Veterinarians
*Medical Residents
80
What are the exemptions that would allow a prescriber to issue a controlled substance in written, faxed, or oral form (not electronic)?
-Technology failure
-Prescription is issued to be filled outside of Indiana
-A pharmacist is the prescriber
-Another format must be issued due to legal requirements or a public health emergency
-Prescriber has a waiver from the board
-The board has determined that an electronic prescription would cause delay and adversely impact a patient
-Prescriber determines that it would be impractical for the patient to obtain an electronic prescription and that delay would adversely impact the patient
81
What extra requirement do prescribers with a controlled substance waiver have when writing a prescription for a controlled substance?
They must write their waiver number on the prescription
-Along with their DEA number and Indiana Controlled Substance Registration Numbers (CSR)
82
True or False: If a prescription is going out of state OR is received from another state, the controlled substance prescription does not have to be electronic
True
83
What is the rule regarding pharmacists AND pharmacies who accidentally fill controlled substance prescriptions without realizing they go against prescribing rules?
The pharmacist and pharmacy are protected as long as they were unaware that the prescription does not fall within an allowable exception
-does not cover gross negligence or knowingly doing so
84
Who is allowed to prescribe through telehealth visits?
Physicians
Physician Assistants
APRNs
Optometrists
Podiatrists
Dentists
Veterinarians
(everyone except pharmacists, medical residents?)
85
What are the approved telehealth modalities?
Secure videoconferencing
Store and forward technology
Remote patient monitoring technology
86
What are the UNAPPROVED modalities for telehealth?
Email
Instant messaging
Fax
Internet Questionnaire
Internet Consultation
87
What drugs are not allowed to be prescribed through telehealth?
OPIOIDS
-unless it is a partial agonist that is used to treat or manage opioid dependence
88
What are the limitations regarding opioid prescriptions?
May not be written for greater than 7 days if:
-The prescription is for an adult being prescribed an opioid for the first time by the prescriber
-The prescription is for a child < 18 yrs old
-The prescription is for an animal written for the first time by the veterinarian
89
Who does the 7-day prescribing limit on opioids NOT apply to?
Cancer
Palliative Care
Medication-assisted treatment for a substance use disorder
A condition that is exempted by the medical licensing board
OR: if in the prescriber's professional judgement, a patient requires more than this prescription limit
90
Who is allowed to request that an opioid prescription be partially filled?
Patient
Representative of the patient
Guardian of the patient
91
If an opioid prescription is partially filled, what must the pharmacist do?
Comply with 21 USC 829
Document that a request for partial full was made by one of the people listed above
92
What is the one difference in Indiana law regarding Adulteration/Misbranding that we must know?
If a prescription does not indicate how many times it may be refilled, the prescription MAY NOT BE REFILLED unless the pharmacist is given subsequent authorization to do so by the prescriber
93
What is the difference between a drug order and a prescription?
Drug Order: a written order for a drug or device for a patient in an INPATIENT INSTITUTION
Prescription: a written order for a drug or device for an OUTPATIENT
94
What are the prescription requirements for both a drug order and a prescription?
Drug Order:
-Name + Bed # of patient
-Name + Strength/Size of drug
-Amount to be dispensed in quantity or days
-Adequate directions for use
-Name of prescriber
Prescription:
-Name + Address of patient
-Name and Strength/Size of drug/device
-Amount to be dispensed
-Adequate directions for use
-Name of practitioner
*Written/Electronic signature of practitioner
95
What is NOT a requirement for drug orders and prescriptions?
Name of the pharmacy
96
What does not need to be written on a prescription label?
Strength of the drug
97
If a prescription label is for an animal, what must be included?
Species
Name of the owner
98
What are the things that NO ONE in Indiana can do related to drugs?
-Obtain/ attempt to obtain a legend drug in a fraudulent manner
-Communicate information to a physician to unlawfully receive a legend drug
-Intentionally make a false statement in a health record
-Falsely represent themself as a person who could legally obtain a legend drug
-Falsify or forge a prescription or drug order
-Falsify or forge a label and affix it to a receptable containing legend drugs
-Dispense a legend drug outside of the bounds of Indiana code
99
Both prescriptions and drug orders are only valid if what?
They are issued for a legitimate medical purpose
100
What additional rules does Indiana have regarding anabolic steroids (testosterone)?
Enhancing performance in an exercise, sport, or game, and hormonal manipulation intended to increase muscle mass, strength, or weight not related to a medical necessity are PROHIBITED INDICATIONS
101
Mechanical Storage Devices (Pyxis or Omnicell machines) can only be utilized where?
1. Pharmacy that holds a permit issued by the Indiana BoP
2. Remote location under the jurisdiction of the Indiana BoP
3. A licensed health care facility
102
Mechanical Storage Devices (Pyxis or Omnicell) must be maintained by who?
A registered pharmacist
or
A registered practitioner
102
Individuals enforcing pharmacy laws in Indiana may do what things?
Carry a firearm when performing official duties
Execute and serve warrants and subpoenas
Make arrests without a warrant for a suspected controlled substance felony
Seize property
Perform other enforcement duties designated by the BoP
Also: audit controlled substance inventory and supply
103
The Prescription Drug Marketing Act (PDM) does what regarding samples and coupons?
It bans the sale, purchase, or trade of a drug sample or coupon
It also bans counterfeiting of drug coupons
103
What are the requirements for drug samples/coupons put into place by the PDMA?
-Practitioners must ask for drug samples in WRITING
-Community pharmacies CANNOT have drug samples ever
-Established recordkeeping, storage, and handling requirements for drug samples
103
Who is allowed to enforce pharmacy laws in Indiana?
Members of the Indiana BoP
Designated BoP employees
Law enforcement officers
104
What is a drug sample?
A unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug
105
What 2 additional requirements does Indiana put on drug samples outside of the PDMA?
-You cannot remove a sample from its original packaging, repackage it, and then sell/exchange it
-You cannot deliver a drug sample to someone after its expiration date
106
Sections of the law covering generic substitution DO NOT include what two things?
Generic-Generic substitution
Biosimilar products
107
What is the only practitioner we cannot perform a substitution of generic for brand name for?
Veterinarians
108
What is the Left signature line on a prescription?
Dispense as Written
109
What is the Right signature line on a prescription?
May Substitute
110
Signature lines are not required on which prescriptions?
Electronic
Verbal
111
If the prescriber signs on the Dispense as Written line, what does this mean?
We must dispense the brand-name product
112
What 2 organizations have unique requirements on what can be substituted?
Medicaid*
Children's Health Insurance Program (CHIP)
113
What are the dispensing requirements for Medicaid and CHIP?
The pharmacist must substitute the product that results in the lowest price unless:
114
What are the 2 situations where the pharmacist does not have to substitute the lowest cost product for Medicaid and CHIP patients?
-"Brand Medically Necessary" is written or electronically transmitted on the prescription in the PRACTITIONER'S OWN HANDWRITING
-Orally stating that a generic equivalent may not be substituted and subsequently forwarding a covering prescription that has "Brand Medically Necessary" included
115
True or False: Even if a prescriber signs on the Dispense as Written line of a Medicaid or CHIP patient's prescription, we still have to substitute for the lowest cost product
True
116
When a pharmacist substitutes a generic equivalent, what information must be put on the drug label?
The prescription must also identify the brand name drug such as:
"_______ Generic for ________"
117
A biologic can be substituted for a biosimilar if what criteria are met?
1. The product has been determined to be interchangeable by the FDA (purple book)
2. The prescribing practitioner has indicated "may substitute"
3. The pharmacist has informed the customer of the substitution
4. After completing the substitution, the prescriber is informed of: name and manufacturer of the biologic dispensed
118
What are the requirements for a pharmacist or pharmacy entity who dispenses naloxone?
1. Register annually with the state department or local health department
2. Instruct the individual receiving the product to call emergency services immediately
3. Provide education and training on drug overdose response and treatment
4. Provide drug addiction treatment and referral information
119
What is "counseling"?
Effective communication between a pharmacist and patient concerning:
-The contents
-Drug to drug interactions
-Route
-Dose
-Form
-Directions for use
-Precautions
-Effective use
of a drug or device
120
What is the caveat to successful counseling?
You must communicate effectively with a patient to successfully counsel them. If the patient does not get the information they need, you did not successfully counsel that patient
121
What is a "Drug Regimen Review"?
The retrospective, concurrent, or prospective review by a pharmacist of a patient's drug related history
122
A Drug Regimen Review may include evaluation of prescriptions or drug orders for what?
Allergies, Contraindications, Appropriate Use, and Duplicative Therapy
Interactions
Adverse Drug Reactions
Proper utilization and therapeutic outcomes
123
What is a "Drug Utilization Review"?
A program designed to measure and assess on a RETROSPECTIVE and PROSPECTIVE basis the proper use of drugs
124
Completing what kind of review satisfies OBRA '90 Prospective DUR?
Drug Regimen Review (DRR)
125
Completion of what kind of review satisfies OBRA '90 Retrospective DUR?
Drug Utilization Review (DUR)
126
What is the definition of "Pharmacy"?
Any facility, department, or other place where prescriptions are filled or compounded*
-and are sold, dispensed, offered, or displayed for sale
-and that has a principal purpose of dispensing the drug or health supplies intended for the general health, welfare, and safety of the public*
-without placing any other activity at a more important level than the practice of pharmacy
127
What is the definition of the "Practice of Pharmacy"?
A patient-oriented health care profession in which pharmacists interact with and counsel patients and other healthcare professionals concerning drugs and devices used to enhance the patient's wellness, prevent illness, and optimize the outcome of the drug or device
128
The practice of pharmacy includes what main 3 things?
1. Compounding, labeling, administering, dispensing, or selling of drugs and devices for the ultimate consumer
2. Provision of acts, decisions, and services necessary to maintain all areas of a patient's pharmacy related care
3. Provision of MTM services
(note that this is not an all-inclusive list, only what was highlighted on the slide)
129
What is the important distinction to make between "pharmacy" and "the practice of pharmacy"?
Pharmacy is a space
The practice of pharmacy is the description of the profession and what pharmacists do
130
What is the law regarding pharmacists and administering medications?
Pharmacists may independently administer medications
131
The practice of pharmacy allows pharmacists to do many things as long as they all pertain to what?
A patient's pharmacy-related care
132
What is "Medication Therapy Management"?
A distinct service or group of services that optimize therapeutic outcomes for individuals
133
Medication Therapy Management includes what 10 things?
1. Performing/obtaining an assessment of an individual's health
2. Formulating a medication treatment plan
3. Selecting, initiating, modifying, or *administering* medication therapy
4. Monitoring patient response to therapy
5. Comprehensive medication reviews
6. Documenting care provided and communicating with other health care providers
7. Educating and training patients on their medications
8. Increasing patient adherence through training and support
9. Coordinating care with broader health care services
10. Providing other patient care services allowable by law
134
What is a "qualifying pharmacist"?
The pharmacist who will qualify the pharmacy by being responsible to the board for the legal operations of the pharmacy under the permit
*note that this has been removed from Indiana code*
135
The Indiana Board of Pharmacy is made up of how many members?
7
136
Who are the members of The Indiana Board of Pharmacy?
1 representative of the general public (not at all pharmacy related)
5 pharmacists (at least one must be a practicing hospital pharmacist)
1 pharmacy technician
137
What are the important duties of the board?
Adopt rules (Indiana Administrative Code)
Refuse to issue, deny, suspend, revoke, or place on probation a license or permit
Prevent distribution of drugs or devices deemed unfit for use or dangerous to health
Establish minimum standards of the physical characteristics of a pharmacy
Subpoena witnesses and schedule + conduct hearing on public behalf
138
The board MUST adopt rules to establish standards for what?
-The competent practice of pharmacy
-A pharmacist to counsel a patient
-To ensure a pharmacist has an agreement for the return of expired legend and controlled drugs
-The electronic transmission of prescriptions
-The OTC sale of ephedrine and/or pseudoephedrine
139
When the board works to rehabilitate a pharmacist, all information shared is privileged and confidential unless what?
Disciplinary or criminal proceedings are instituted
-information may only be used in the exercise of the proper functions of the board
140
The board may do what to assist an impaired pharmacist?
Designate a rehabilitation program
141
A rehabilitation program for an impaired pharmacist appointed by the board is required to do what?
Immediately report to the board any pharmacist that the program believes is an imminent danger to the public or themself
Report in a timely manner any pharmacist who refuses to cooperate, submit to treatment, or is not substantially alleviated through treatment
142
What is the primary rehabilitation program that partners with the Indiana BoP?
Indiana Professionals Recovery Program (IPRP)
143
Regarding impaired pharmacists, what requirements must you meet to be able to continue to practice without an impact on your license?
Voluntarily working with IPRP
+
Not a danger to yourself or others
144
What are the requirements for pharmacy intern licensure?
1. Are actively enrolled in an ACPE accredited college of pharmacy
2. Has obtained a Foreign Pharmacy Graduate Examination Committee Certificate (FPGECC)
OR
3. Are awaiting examination for licensure as a pharmacist
145
How long is pharmacy intern licensure valid for?
1 year
146
What is the expiration date of the Pharmacy Intern License every year?
September 30th
147
What are the requirements to apply for a pharmacy technician license?
1. 18 years old
2. Graduated high school or received GED
3. Not convicted of a crime with a direct bearing on the ability to practice
148
What criteria can be met to be eligible for direct licensure as a pharmacy technician?
1. Graduated from a competency-based pharmacy technician education and training program
2. Completed an employer training program approved by the board
3. Successfully passed the Pharmacy Technician Certification Board (PTCB) exam or another nationally recognized certificate approved by the board
149
On what day and how often do pharmacy technician licenses expire?
They expire biennially on June 30th of even-numbered years
150
When do tech-in training licenses expire?
12 months after date of issuance
*These CANNOT be renewed*
151
To be eligible for pharmacist licensure, what criteria must be met?
1. Be at least 18 years old
2. Not convicted of a crime with direct bearing on pharmacy practice
3. Graduated from an ACPE accredited U.S. college or graduated from another (international) program and obtained an FPGECC
4. Satisfactorily completed a board approved pharmacist intern program
then apply and successfully complete exams
152
What are the requirements for reciprocal pharmacist licensure (obtaining a pharmacist license in Indiana when you already have a license in another state)?
1. Must be registered with the National Association of Boards of Pharmacy (NABP)
2. Graduated from an ACPE accredited U.S. college or graduated from another (international) program and obtained an FPGEEC
3. Successfully completed an examination on federal statutes and regulations as well as Indiana statutes and rules governing the practice of pharmacy
153
What is an active pharmacist?
A pharmacist who pays their fees and is complying with continuing education requirements
154
What is an inactive pharmacist?
A pharmacist who pays their fees BUT is not completing continuing education requirements (CE)
-must indicate inactive status on renewal
155
When do pharmacist licenses expire?
Biennially on June 30th of even numbered years
**note that this is the same as technicians
**only difference is that pharmacists must attest to completion of required CE
(if not renewed, licenses expire July 1st of even numbered years and you cannot practice)
156
A pharmacist is immune from criminal prosecution or civil liability if the pharmacist, in good faith, refuses to honor a prescription in his professional judgment because honoring the prescription would do what?
1. Be contrary to law
2. Be against the best interest of the patient
3. Air or abet an addiction or habit
4. Be contrary to the health and safety of the patient
157
What are the 3 types of pharmacy permits in Indiana?
Category I
Category II
Category III
158
What is a Category I pharmacy permit?
A pharmacy that provides pharmaceutical care to the GENERAL PUBLIC by dispensing of a drug or device
159
What is a Category II pharmacy permit?
A pharmacy that provides INPATIENT CARE under a drug order or to an OUTPATIENT OF THE INSTITUTION under a prescription
160
What is a Category III pharmacy permit?
A pharmacy that provides CLOSED DOOR operations that are not open to the general public
-can include traditional or non-traditional pharmacy functions
161
When do pharmacy permits expire?
Every 2 years on December 31st of odd-numbered years
*note pharmacist and technician licenses expire on even years
162
Category I pharmacies are typically what type of pharmacy?
Community Pharmacies
163
What are the unique circumstances where a Category I pharmacy may fill inpatient prescriptions?
-Long term care facility
-A health facility
-An assisted living facility
164
Category II Pharmacies are generally what type of pharmacy?
Institutional pharmacies
-hospitals, health care facilities, nursing homes, etc
165
What are the unique circumstances where a Category II pharmacy may fill outpatient prescriptions?
-An employee, student, or volunteer of the hospital/health system
-A retiree participating in a retirement or benefit program administered by the hospital
-An independent contractor exclusively working with the hospital
-A member of the hospital's governing board OR member of the medical staff
***Any dependents of the individuals listed above**
166
What are the physical requirements a pharmacy must meet to be eligible for a pharmacy permit?
Be stationary
Be sufficiently secure, and able to detect and deter entry when the pharmacy is closed
Be well light and ventilated and clean
Be equipped with a sink with hot + cold running water, proper sewage, and refrigeration
Be of sufficient size
Have other equipment as required by the board
167
What is included on a pharmacy permit application form?
1. Name and occupation of the person requesting the permit
2. Location of the pharmacy
3. Any other information the board requires
168
At what point in the pharmacy permit application process must the pharmacy submit to an inspection by a representative of the board?
After application approval but before the pharmacy is open
169
Pharmacists must be on duty all times that a pharmacy is open and have "immediate and personal supervision" of any other pharmacy personnel. What does this mean?
Within reasonable visual and vocal distance of the pharmacist
170
A pharmacist may not supervise more than:
8 pharmacy interns, technicians, or technicians in training at any time
*No more than 3 of the 8 individuals may be techs in training
171
Which categories of pharmacy can request to be open to the general public without a pharmacist on duty?
Category I
Category III
172
If a pharmacy wants to request to be open to the general public without a pharmacist on duty, what criteria must they meet?
-Obtain approval from the board
-Securely lock all legend drugs and other merchandise that can only be dispensed by a pharmacist
-Prominently display a 20" x 30" sign stating: Prescription Department Closed, No Pharmacist on Duty
-Only a pharmacist can have access to the secured area
173
What are the 2 certificates needed to practice pharmacy?
Pharmacist license
Pharmacy permit
174
What happens with pharmacy permits if there is a transfer of pharmacy ownership?
*Pharmacy permits cannot be transferred
-Within 10 days of change of ownership, an application must be submitted to transfer the ownership
-When the new permit is issued, the old permit must be returned to the board within 10 days
*note that if the new owner moves the pharmacy, a new application for the new location must be filed
175
A pharmacy permit holder must notify the board of closure and secure drugs as directed if they are going to be closed for how many days?
5 days or more
176
If a pharmacy is going to permanently close, what must the owner do?
-Notify the board at least 20 days before
-Remove all legend drugs
-Submit the premises to inspection by the board
-Remove all signs alluding to pharmacy practice
-Return pharmacy permit to the board within 10 days after all drugs + devices are removed from the premises
177
What are the situations where a pharmacy could not transfer a prescription?
1. Prohibited in writing by the prescriber
2. Prohibited by federal law
178
If pharmacies do not share a common database, how may prescriptions be transferred?
Electronically
Fax
179
True or False: Technicians can transfer prescriptions
True
-including verbal transfers
180
What is the rule on transferring prescriptions that have never been filled?
-They may be transferred electronically
-This applies to ALL schedules
Is allowed if:
-Allowed by state
-*Prescription was electronically prescribed
-*If communicated between two licensed pharmacists
-If prescription is maintained in an electronic format
181
How many times can a prescription that has never been filled before be transferred?
Only once
-unless the pharmacies share a real-time online database
182
Non-electronic transfers are limited to what controlled substance levels?
C-III
C-IV
C-V
183
True or False: We can transfer non-electronic controlled substance prescriptions without them being previously filled
FALSE
-this is only for electronic prescriptions
184
How many times can a non-electronic controlled substance be transferred?
Only once
-unless they share a real-time online database
185
Who can communicate non-electronic controlled substance prescriptions?
Only two licensed pharmacists
186
How long should original prescriptions be kept at the pharmacy?
2 years
-mist be organized, maintained, and accessible
-must be available for inspection by the board
187
A prescription may not be refilled without what?
Written, electronically transmitted, or oral authorization by the provider
188
A prescription may be refilled by a pharmacist without authorization by the provider if what conditions are met?
1. Pharmacist made every reasonable effort to obtain authorization
2. Pharmacist believes that failure to provide a refill would be detrimental to patient's health
3. The original refill authorized refills, but they were all dispensed or the prescription expired
4. The prescription was originally filled at that pharmacy or an affiliate site with a real-time online database
5. Drug is prescribed for continuous and uninterrupted use + has been taken properly by the patient
6. The pharmacists fills out documentation
7. The pharmacist notifies the prescriber by the prescriber's next business day
8. Refill quantity is limited to the most recent fill quantity or a 30-day supply (whichever is less)
****Max of 1 pharmacist-initiated refill every 6 months***
10. Drug is not a controlled substance
189
When can you NOT offer an emergency refill without a prescriber's authorization?
If the prescriber notes "No Emergency Refill" on the prescription
190
When can a pharmacist dispense a 90-day supply?
1. Patient requests a supply of more than 30 days
2. Prescription is not a controlled substance
3. Prescriber does not indicate that the quantity cannot be changed
4. Patient has completed an initial 30-day supply
5. The prescription + refills allow for a 90-day supply
191
How long are prescriptions valid for?
1 year after original date of issue
192
What are the rules regarding dispensing prescriptions and the demise of the prescriber?
Pharmacists may not knowingly dispense a prescription after the demise of the prescriber
UNLESS the pharmacist judges it to be in the best interest of the patient's health
193
What are the only scenarios where a medication may be resold, reused, or redistributed after being returned to the pharmacy?
1. Dispensed to a patient in an institutional facility, hospice, or county jail/ department of correction
2. Was properly stored and securely maintained
3. Is returned unopened and was dispensed in the manufacturer's original container or in a multiple dose blister container or unit dose package supplied by the dispenser
4. Was dispensed by the same pharmacy accepting the return
5. Is not expired
6. Is NOT a controlled substance
194
What things is a pharmacist allowed to change on a prescription?
Medication quantity
Dosage form (and modify directions if needed)
Complete missing information on a prescription if there is sufficient evidence to support the change
Extend a maintenance drug for the limited quantity necessary to coordinate a patient's refills in a med synch program
195
What are the requirements for a pharmacist to be able to dispense epinephrine/glucagon?
Product expires in >/= 12 months from date dispensed
Person consents to a shorter expiration date
196
What are the rules around pharmacist substitution of epinephrine products?
Pharmacists MAY substitute therapeutic alternatives
*This is not a generic substitution, this is changing to a different chemical structure in the same drug class
197
If a pharmacist is dispensing epinephrine as a result of a standing order, what criteria must be met?
The individual has completed training and can administer the drug to patients experiencing anaphylaxis
198
A pharmacist administering immunizations according to protocol approved by a physician must do what things?
1. Notify the physician who authorized the immunization and the patient's PCP
2. Not administer immunizations to anyone younger than 11, and not administer the pneumonia vaccine if under 50
3. Must receive consent from patient or if under 18, their parent or legal guardian
199
Pharmacists cannot administer vaccines to patients under what age?
11
200
Pharmacists cannot administer the pneumonia vaccine to patients under what age?
50
201
Both pharmacy technicians and interns can administer immunizations if they are directly supervised.
Who can supervise a pharmacy intern but not a technician?
Registered nurses
202
What does "in personal attendance," relating to the presence of the pharmacist in the pharmacy, mean?
Being physically present in the area specified as the dimensions of the pharmacy in the pharmacy permit application
203
What does "reasonable visual and vocal distance" mean in regard to pharmacist supervision?
A pharmacist being physically present within the licensed permitted area or by a means that provides for adequate supervision of technicians as individually approved by the board
204
What are the 2 ways that individuals may be directly supervised by a pharmacist?
A direct line of sight and hearing
Technological means
205
Supervision rules regarding pharmacists are focused on who?
Management in the pharmacy
-Pharmacists in non-management roles are only responsible for what happens under them while on duty
206
What is included in "Pharmaceutical Care"?
Dispensing legend drug products
Delivery of cognitive services
207
"Cognitive services" includes many things EXCEPT?
Dispensing a product and the processes involved in dispensing
208
What is a real-time online database?
A database that is:
-continuously updated in real time
-allows users to share and store patient information
-allows users to interface with each other in a secure environment
-done over the internet or intranet
209
What is the definition of an "unlicensed person"?
1. Is not HIPAA trained
and
2. Does not hold a valid license, certification, permit, or registration issued by the board
210
An unlicensed person cannot do what regarding pharmacy?
Perform any pharmacy dispensing functions related to legend drugs
*note that they CAN sell prescriptions because the dispensing process is over at this point
211
What are the requirements regarding pharmacist's licensure?
1. Must be "conspicuously displayed"
-if not, this is grounds for suspension or revocation of licensure
2. If the pharmacist's licensure is displayed by a company at which they no longer work, that license may be revoked
3. Licensee must notify the board when their address changes
212
When does the board meet its obligation for notice?
When the notice has been mailed
*this is regardless of if the person concerned receives it
213
How many hours of practical experience must pharmacist applicants achieve?
1500 hours
214
What are the requirements to be licensed as a pharmacist in Indiana for pharmacist applicants?
Complete a school of pharmacy curriculum, including a minimum of 1500 hours of practical experience
Submit an application as required by the Board (this is required for authorization to take the NAPLEX and MPJE)
Take and pass the NAPLEX and MPJE in ENGLISH
215
If an applicant fails either the NAPLEX or MPJE they must do what?
Complete a new application
216
If an applicant fails to pass the NAPLEX or MPJE after 2 sittings they must do what?
Appear before the board for consultation and to receive written permission to sit for the exam again
217
What is the maximum number of attempts to pass both the NAPLEX and MPJE?
5
218
Pharmacists who are applying for licensure in Indiana after being licensed in another state (reciprocity) must complete what?
1. A complete application for licensure
2. Pass the Indiana law examination (MPJE)
3. If not actively practicing in the 12 months prior to the application, they must pass the NAPLEX
219
Who must decide what additional fixtures, facilities, and equipment is needed by a pharmacy to operate in compliance of the law?
The qualifying pharmacist
220
What are the 2 types of licensed pharmacy areas?
The pharmacy is the licensed area and within a store that is a non-licensed area
The pharmacy is within a store and both the pharmacy + store is the licensed area
*most common
221
Which Categories of pharmacy permits must file an application with the board and abide by the closing hours outlined in the application?
Categories I and III
*note that this applies to pharmacies where the whole store is the licensed area
222
A prescription department may be locked or secured while the remainder of the pharmacy remains open if:
1. There are reasonable barriers to prevent easy/quick access to legend drugs
2. The prescription department (if not completely enclosed from floor to ceiling and locked) is monitored by an electronic monitoring device
3. Violations and breaches are recorded + reported within 72 hours
4. If monitored electronically, backup power must be provided and capable of continuing for no less than 36 hours
5. The electronic monitoring system can be activated or inactivated only by key or combination
223
Any violation or breach of security while the prescription department is closed must be reported to the board within how long?
72 hours
224
If a prescription department is monitored electronically, it must be provided with enough backup power to last how long?
No less than 36 hours
225
When does a pharmacist need to record the hours a pharmacy was open without a pharmacist on duty?
If those hours vary from the hours listed on the application
*must be written in ink
226
How long must records regarding hours that the pharmacy was open without a pharmacist present be maintained?
No less than 2 years from the date of the last entry
227
What requirements must be met for a medication to be considered as "having been properly stored and securely maintained"?
The medication must have been under the control of licensed nursing personnel the entire time
228
What tasks are technicians prohibited from performing?
1. Duties required to be performed by a pharmacist by law
2. Provision of advice to a prescriber or health care provider
3. Provision of advice to a patient involving interpretation of a prescription or information in the patient profile
4. Dispensing prescription drug information to the patient (not including them handing the patient a packet/insert)
5. Receipt of a VERBAL prescription from a prescriber
6. Final check on all aspects of a completed prescription
229
Pharmacy technicians CAN do the final verification on what?
Drug orders
-must be checked by 2 technicians
230
What are the requirements for pharmacy technician identification?
1. Wear identification clearly stating that they are a technician
2. Identify themselves verbally in any telephone or electronic communication as a technician
231
How much CE are pharmacists required to complete to renew their license?
30 hours per biennium
232
What is the time frame that CE can be completed each biennia?
January 1st of even numbered years through December 31st of the following odd-number year
233
What can be done if a pharmacist fails to complete 30 hours of CE during a biennium?
They may use hours completed during a succeeding biennium and apply them to the previous biennium
234
Why are the 2 bienniums of CE and licensure offset by 6 months?
To allow for a CE catch-up window to make up any CE deficits
235
What are the required components of the 30 total hours of CE?
No more than 1/5 may be business, management, or computer related (6 hours)
At least 4/5 must be pharmacy practice related (24 hours)
1/2 of the hours must be ACPE approved (15)
236
If initial licensure occurs within a biennium, what should be done?
Accrue 1.25 hours of CE for each month you are licensed from the date of licensure to the end of the biennium
237
What is a cabinet?
A mechanical storage device for dispensing drugs
237
What is the only time you are not required to complete CE as a licensed and active pharmacist?
If you get your license in the last 6 months of the biennium
238
What is a consultant pharmacist?
A pharmacist who practices pharmacy at a LTCF or other residence other than as a supplying pharmacist
239
What is consulting?
Provision of NONSUPPLY related cognitive services
240
What are emergency drugs?
Drugs required to meet immediate therapeutic patient needs and which are not available from another source in sufficient time to prevent risk of harm to the patient
241
What is a "pharmacist in charge"?
Pharmacist who directs the activities of the institutional pharmacy
242
What is a quality-related event?
Inappropriate provision of pharmaceutical services which may result in adverse health incidents
243
What is a reversible condition?
A condition that requires intervention to resolve in a reasonable time
244
What is a sentinel event?
Unexpected occurrence involving a serious adverse effect
245
What is a temporary condition?
Condition that resolves in a reasonable time without intervention
246
What are the responsibilities of a pharmacist in charge?
1. Establish and carry out a performance improvement project
2. Develop a policies + procedures manual of sufficient scope and detail to allow safe and effective pharmacy practice
3. Develop policies and procedures that specify duties to be performed by technicians
247
What are the requirements for drugs stored in cabinets when no pharmacist is present?
-All drugs must be labeled and prepackaged in amounts sufficient for a maximum of 24 hrs of care
-Drugs used from the cabinet must be tied to a physician's order or accountability record
-Pharmacist must review the drugs in the cabinet within 24 hours of returning to duty
-Policies and procedures must be established
248
When a drug is not available from a cabinet and is required to treat a patient immediately but no pharmacist is present, who is allowed to access the pharmacy and remove drugs?
One supervisory licensed nurse in any shift
249
If a nurse gets immediately needed drugs out of a pharmacy without a pharmacist present, they must record what things?
1. Name + Strength of drug
2. Amount
3. Date + time
4. Signature
5. ***Copy of the order
250
True or False: emergency drugs do NOT need a physician's order
TRUE
*note that this does not apply to the nurse taking drugs out of the pharmacy
251
An emergency drug kit at a long-term care facility must have what labeling?
Drug Name
Strength/Size
Quantity included
Expiration date of the kit (earliest expiration)
252
Records of processes, analysis, and corrective measures related to sentinel/quality related events must be maintained for how long?
At least 2 years
253
What are the requirements for documenting quality related events and sentinel events?
1. Documented by the pharmacist to whom it is first described on the same day that it is described
2. Description of event sufficient to permit analysis
3. Pharmacist in charge should summarize efforts to improve processes
4. No patient or employee names included
5. Member of the board may review this documentation for compliance
254
Unit-of-Use packages (pixis) in an institutional setting must have what on their label to meet the bare minimum requirement?
Drug name
Strength
Control number and/or expiration date
255
A patient may only self-administer drugs in an institutional facility if what requirements are met?
-Specifically authorized by the treating or ordering physician
-The patient's knowledge has been evaluated
-The patient has received training in the proper manner of self-administration
-There is no risk of harm to the patient
256
What is the rule regarding patient's bringing their own medication into an institutional pharmacy?
The pharmacy may not tough drugs brought into the institution by the patient
257
What are the 2 criteria to permit use of a patient's home medications?
1. Patient can maintain their own medication at the bedside or under control of the nursing personnel
2. Nurses witness the administration of the medication and maintain records of use
258
What is a biological safety cabinet?
Specialized, enclosed, ventilated workspace suitable for preparation of low to moderate risk agents
259
What does cytotoxic mean?
Pharmaceutical capable of killing living human cells
260
What is a sterile pharmaceutical?
A drug that is free from living microbes and chemical or physical contamination
261
The designated area of the pharmacy must be able to maintain an environmental control of what level for sterile pharmaceuticals?
At least ISO Class 5
262
The buffer area of a pharmacy must be able to maintain an environmental control of what level for sterile pharmaceuticals?
At least ISO Class 8
263
Pharmacies preparing sterile products must have sufficient reference materials including?
1. The Handbook on Injectable Drugs
2. The King's Guide to Parenteral Admixtures OR another board-approved printed or electronic database
264
Pharmacies preparing hazardous drugs must have a copy of what?
The OSHA requirements for handling hazardous drugs
265
Which drug orders require expiration dates and which do not?
Sterile Pharmaceuticals: Always need the expiration date (this includes IV's)
Non-sterile drug orders: Do not need an expiration date (this includes po)
266
What additional requirement does Indiana law but on fax machines?
The receiving fax machine must be located in a nonpublic area of the licensed pharmacy
267
What unique requirement does Indiana have for records of transfers?
DEA numbers must be recorded for all typed of transfers, not just controls
268
When must an offer to counsel be made to a patient?
At each prescription-dispensing visit (at each fill and refill)
*No blanket waivers exist to forgo counseling
269
What drugs get reported to INSPECT every time they are dispensed?
Ephedrine
Pseudoephedrine
Controlled substances (*including gabapentin)
270
Information must be submitted within how long of dispensation to INSPECT?
24 hrs
271
What are considered suitable forms of identification by law?
Driver's license from any state
Military ID
ID card issued by the BMV
Photo-exempt ID issued by the BMV
ID designated by INSPECT
272
What form of ID is not considered suitable identification for prescription pick-up based on the law?
U.S. Passport
273
When are pseudoephedrine and ephedrine not reported to INSPECT?
If they are sold OTC without a prescription
274
What are the maximum limits for selling ephedrine or pseudoephedrine OTC?
3.6 g in one day
7.2 g in 30-days
61.2 g in one year
275
What are the requirements to be able to purchase ephedrine/pseudoephedrine?
18 years or older
Must have a relationship on record with the pharmacy or the pharmacist has deemed that it will be used for a legitimate purpose
276
Ephedrine/pseudoephedrine logs must be maintained for how long and contain what?
2 years
Must contain:
-Name + Address of purchaser
-ID
-Government entity issuing the ID
-ID Number
-Product purchased including grams, and date and time of transaction
277
C-II, C-III, and C-IV labels must contain what statement?
“Federal Law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed”
278
What is the maximum amount of a C-V that can be dispensed OTC?
8 oz or 48 doses of a substance containing opium
4 oz or 24 doses of any other C-V
279
What is the age restriction related to needle sales?
No age restriction
280
True or False: Patients do not need to show an ID to purchase syringes/needles
True
281
To administer vaccines, a pharmacist, intern, or technician must meet what requirements?
Complete an ACPE-accredited course of training
Be certified in cardiopulmonary resuscitation and maintain it
282
What are the requirements for immunization protocols?
Must be executed with a licensed physician who is actively practicing with a medical office in Indiana
Must be renewed annually
*note that this is not all the requirements
283
Adverse effects from immunizations must be reported within how much time and to where?
72 hours
to the Vaccine Adverse Events Reporting Systems
284
What additional requirements do pharmacist interns have to administer an immunization?
They must identify themself to the patient and receive consent
285
Who can pharmacists prescribe hormonal contraceptives to?
Patients 18 years and older
286
What hormonal contraceptive products are pharmacists able to prescribe?
Hormonal contraceptive patches
Self-administered hormonal contraceptives
287
What are the requirements for hormonal contraceptive prescribing by pharmacists?
1. Complete approved training program
2. Self-screening risk assessment
3. Refer patient to a PCP or women's healthcare practitioner upon prescribing
4. Provide written record of product and advise patient to consult with a PCP or women's health care practitioner
5. Suggest the patient see a physician, APRN, or PA if they work at the site
6. Prescription issued may only be for 6 months and no further prescriptions can be issued after 12 months unless they have been seen by a physician, PA, or APRN
288
What is the only thing that pharmacists are allowed to object to based on an ethical, moral, or religious ground according to the law?
Hormonal contraceptives
289
What is a remote dispensing facility?
A facility where prescription drugs are prepared or dispensed without the requirement of an onsite pharmacist, and where pharmacist supervision is provided remotely
290
How far away are remote dispensing facilities required to be from existing retail pharmacies?
10 miles
-Unless: they exclusively serve patients of a mental health center, hospital, or physician clinic OR the applicant demonstrates to the board how the facility will promote public health
291
What is the main consideration with remote dispensing facilities?
They cannot be open to the public
