Exam 3 Flashcards
“‘sale’ means every sale and includes the following…”
-manufacturing, processing, transporting, handling, packing, 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
What prescribers may write valid prescriptions to be filled in Indiana?
-physicians
-dentists
-podiatrists
-veterinarians
What are the types of advanced practice registered nurses (APRNs)?
-nurse practitioners
-certified nurse midwives
-clinical nurse specialists
What supervising practitioners must APRNs work under?
-physicians
-podiatrists
-dentists
What are the limitations of a physician assistant?
-must work with supervising physician
-must be directly supervised by physician in person
-can only prescribe things directly delegated by collaborative practice agreement on file with the medical licensing board of Indiana
-cannot prescribe ophthalmic devices under any circumstance or administer general anesthesia or deep sedation
What are the conditions for optometrist prescribing?
can prescribe independently without a supervising practitioner but only according to a formulary
What controlled substance may optometrists prescribe?
tramadol
When there is a conflict of law, which law should be followed in Indiana?
Indiana Code
Can prescriptions written by an optometrist not licensed in Indiana be filled in Indiana?
No
What devices and supplies may pharmacists prescribe in Indiana?
-inhalation spacer
-nebulizer
-supplies for medical devices
-normal saline and sterile water for irrigation
-diabetes blood sugar testing supplies
-pen needles
-syringes for medication use
What types of prescribers may pharmacists enter a protocol with to act as prescribers?
-physician
-APRN
-physician assistant
Can prescriptions written by a pharmacist not licensed in Indiana be filled in Indiana?
No
Can prescriptions written by midlevel practitioners be filled in Indiana?
No
What is the main goal of the board of pharmacy?
protecting the public and enforcing the laws and rules that govern pharmacy
What sanctions can be taken on a pharmacist?
-revocation
-suspension
-probation
-letter of reprimand
-censure
-fine
revocation
license taken away permanently
suspension
license taken away temporarily
probation
can practice but with limits or additional requirements
letter of reprimand
written expression of disapproval
censure
verbal expression of disapproval
How much can be fined for each violation?
≤ $1000
When can a pharmacist apply for a new license after revocation?
7 years from date of revocation
What are conditions the board of pharmacy can impose for probationary licensure?
-report regularly to board on matters requiring probationary license
-limit practice to areas prescribed by board
-continue or renew professional education
-engage in community service as directed by board
-perform, or refrain from performing, act board considers appropriate to public interest
What prescribers are not required to transmit controlled substances electronically?
-veterinarians
-medical residents
What must a prescriber with a controlled substance waiver write on prescriptions?
-waiver number
-DEA number
-Indiana Controlled Substance Registration (CSR) number
What prescribers may prescribe through telehealth appointments?
-physician
-physician assistant
-advanced practice registered nurse
-optometrist
-podiatrist
-dentist
-veterinarian
What are approved telehealth modalities?
-secure videoconferencing
-store and forward technology
-remote patient monitoring technology
What are unapproved telehealth modalities?
-email
-instant messaging
-fax
-internet questionnaire
-internet consultation
What controlled substance cannot be prescribed via telehealth?
opioid
What are limitations for opioid prescriptions?
-adult or animal being prescribed opioid for first time
-< 18 y/o
When do the opioid limitations not apply?
-cancer
-palliative care
-medication-assisted treatment for SUD
-condition exempted by medical licensing board
Who can request a partial fill of an opioid?
-patient
-patient representative
-patient guardian
What must a pharmacist do if partially filling an opioid?
-comply with 21 USC 829
-document who request for partial fill was made by
What institution are drug orders administered in?
inpatient
What institutions are prescriptions dispensed in?
outpatient
What are the requirements for drug orders?
-name and bed number of patient
-name and strength/size of drug
-amount to be dispensed (quantity or days)
-adequate directions for proper use of drug
-name of prescriber
What are the requirements for prescriptions?
-name and address of patient
-name and strength/size of drug
-amount to be dispensed
-adequate directions for use
-name of practitioner
-written or electronic signature of practitioner
What must a prescription label contain?
-name, address, and phone number of dispensing pharmacy
-date filled
-prescription number
-name of prescriber
-name of patient (if animal, species)
-directions for use
-statement that drug is opioid (if applicable)
-name of drug
-owner’s name (if animal)
Where can mechanical storage devices be utilized within?
-pharmacy that holds permit issued by Indiana BoP
-remote location under jurisdiction of Indiana BoP
-licensed healthcare facility
What may law enforcement do in terms of the pharmacy?
-carry firearm when performing official duties
-execute and serve warrants and subpoenas
-make arrests without warrant for suspected controlled substance felony
-seize property
-perform other enforcement duties as designated by BoP
Prescription Drug Marketing Act (PDMA)
-practitioners must ask for drug samples in writing
-community pharmacies cannot have drug samples at anytime
-established recordkeeping, storage, and handling requirements for drug samples
What are Indiana laws in regards to the PDMA?
-cannot remove sample from original packaging, repackage it, and then sell/exchange it
-cannot deliver drug sample after expiration date
For which practitioner can pharmacists not perform generic substitutions?
veterinarians
What are the two signature lines that Indiana written prescriptions must have?
-dispense as written
-may substitute
What are the exceptions for a pharmacist not substituting the cheapest drug for Medicaid and CHIP patients?
-“Brand Medically Necessary” in practitioner’s handwriting
-oral statement, then forwarding covering prescription with “Brand Medically Necessary”
What are the conditions for biologics substitution?
-product determined to be interchangeable by FDA
-prescribing practitioner indicated “may substitute”
-pharmacist informed customer of substitution
-prescriber is informed of name and manufacturer of subtitute
What must a pharmacist do if they dispense naloxone?
-register annually with state department or local health department
-instruct individual receiving product to summon emergency services immediately
-provide education and training on drug overdose response and treatment
-provide drug addiction treatment and referral information
What do drug regimen reviews (DRRs) review?
-allergies, contraindications, appropriate use, and duplicative therapies
-interactions
-adverse drug reactions
-proper utilization and therapeutic outcomes
What requirement does DRR in Indiana satisfy?
OBRA ‘90 Prospective DUR
What requirement does DUR in Indiana satisfy?
OBRA ‘90 Retrospective DUR
Who makes up the Indiana Board of Pharmacy?
-general public representative (1)
-pharmacists (5)
-pharmacy technician (1)
What are the requirements for a pharmacy intern?
-actively enrolled in ACPE accredited college of pharmacy OR
-obtained a Foreign Pharmacy Graduate Examination Committee Certificate (FPGECC) OR
-awaiting examination for licensure as pharmacist
What are the requirements to apply for a pharmacy technician license?
-18 years old
-graduated high school or received GED
-not convicted of crime with direct bearing on ability to practice
When do pharmacy technician licenses expire?
biennially on June 30th of even-numbered years
Are technician in training licenses renewable?
No
When do technician in training licenses expire?
12 months after issuance
What are the requirements for Indiana reciprocal licensing?
-must be registered with the National Association of Boards of Pharmacy (NABP)
-graduated from ACPE-accredited U.S. college or graduated from another program and obtained FPGECC
-successfully completed exam on federal and Indiana statutes and regulations governing practice of pharmacy
When do pharmacist licenses expire?
biennially on June 30th of even-numbered years
Category I
a pharmacy that provides pharmaceutical care to the general public by dispensing of a drug or device
Category II
a pharmacy that provides inpatient care under a drug order or to an outpatient of the institution under a prescription
Category III
a pharmacy that provides closed door operations that are not open to the general public
When do pharmacy permits expire?
biennially on December 31st of odd-numbered years
What facilities may Category I pharmacies offer prescriptions to?
-long-term care facility
-health facility
-assisted living facility
Who may Category II pharmacies offer prescriptions to?
-employee, student, or volunteer of hospital or health system
-retiree participating in retirement or benefit program administered by hospital
-independent contractor exclusively working with hospital
-member of hospital’s governing board
-member of hospital’s medical staff
-dependents of personnel above
What are physical requirements of a pharmacy?
-stationary
-sufficiently secure and able to detect and deter entry when pharmacy is closed
-well-lit, ventilated, and clean
-equipped with a sink with hot and cold running water, proper sewage outlet, and refrigeration
-sufficient size to allow for practice of pharmacy
-have other equipment as required by board to operate in compliance with state and federal law
What does a pharmacy permit application include?
-name and occupation of persons requesting permit
-location of pharmacy
-any other information board requires
What are limits to pharmacist supervision?
-≤ 8 pharmacy interns, technicians, or technicians in training at one time
-≤ 3 individuals are technicians in training
When may a Category I or III pharmacy request to be open to the general public without a pharmacist on duty?
-obtain approval from board
-securely lock all legend drugs and other merchandise only dispensed by pharmacist
-prominently display 20” x 30” sign stating “Prescription Department Closed, No Pharmacist on Duty”
-only pharmacist has access to secured area
What is the timeframe for submitting an application to transfer pharmacy ownership?
within 10 days of change of ownership of pharmacy
What is the timeframe for pharmacy closure in which the board must be notified?
≥ 5 days
How long should original prescriptions be organized, maintained, and accessible at the pharmacy for?
≥ 2 years
When may a prescription be refilled without written, electronically transmitted, or oral authorization of a licensed practitioner?
-pharmacist made reasonable effort to obtain authorization to refill from prescriber
-pharmacist believes that failure to provide refill would be detrimental to patient’s health
-original prescription authorized refill(s), but all refills were dispensed or prescription is expired
-prescription was originally filled at pharmacy where refill request is received or affiliate sharing real-time online database
-drug is pre
