Exam 3 - Indiana Food, Drugs, and Cosmetics Flashcards

1
Q

If a prescription for a drug does not indicate how many times the prescription may be refilled…

A

the prescription may not be refilled unless the pharmacist receives authorization from the practitioner

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2
Q

definition of drug order

A

written order for a drug or device for a patient in an inpatient institution

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3
Q

definition of a prescription

A

written order for a drug or device for an outpatient

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4
Q

what is required for a drug order

A

-name and bed number of the patient
-name and strength/size of the drug
-amount to be dispensed in quantity or days
-adequate directions for the proper use of the drug
-name of the prescriber

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5
Q

what is required for a prescription

A

-name and address of the patient
-name and strength/size of the drug or device
-amount to be dispensed
-adequate directions
-name of practitioner
-written or electronic signature of practitioner

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6
Q

what MUST be on a prescription label

A

-name, address, and phone number of dispensing pharmacy
-date on which the prescription was filled
-the prescription number
-the name of the practitioner who prescribed the drug
-the name of the patient (if animal name of species)
-directions for use as provided in Rx
-if opium, stating its from opium
-name of the drug
-if animal, owner’s name

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7
Q

what are two additional things that must be on an vet prescription label

A

name of the species
owner’s name

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8
Q

what must be on a practitioner label

A

directions for use of the drug
name and address of practitioner
name of the patient
if animal, species

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9
Q

prescription and drug orders are only valid if…

A

they are issued for a legitimate medical purpose

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10
Q

what is Indiana stance on anabolic steroids

A

enhancing performance in exercise, sport or game, and hormonal manipulation to increase muscle mass are not a medical necessity and prohibited indications

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11
Q

what are the mechanical storage devices

A

pyxis or omnicell

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12
Q

mechanical storage devices can only be utilized within a…

A

-pharmacy that holds a permit issued by the Indiana BoP
-remote location under the jurisdiction of the Indiana BoP
-licensed health care facility

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13
Q

how to ensure legitimate use of storage devices

A

maintained by registered pharmacist or practitioner
may be inspected by BoP

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14
Q

Can insulin be sold OTC

A

ONLY regular insulin, NPH, or combination regular/NPH insulin

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15
Q

Enforcement officers of the BoP can do the following:

A

-carry a firearm for official duties
-execute and serve warrants and subpoenas
-make arrests w/o a warrant for suspected controlled substance felony
-seize property
-perform other enforcement duties as designated by the BoP
-audit controlled substance inventory and supply

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16
Q

How can practitioners obtain samples

A

must ask for drug samples in writing

17
Q

can community pharmacies have samples

A

cannot have samples at anytime

18
Q

what is required for drug samples

A

recordkeeping
storage
handling requirements

19
Q

are OTCs and starter packs considered samples

20
Q

are PAs covered as practitioners under PDMA

A

yes, under the authority of their collaborating physician

21
Q

what are two specific quirks for indiana samples PDMA

A

you cannot remove sample from original packaging, repackage it, and then sell it/exchange it
you cannot deliver a drug sample to someone after its expiration date

22
Q

define generic substitution

A

brand name to generic

23
Q

practitioners for which a generic substitution can be performed

A

physicians
dentists
podiatrist
optometrists
APRNs
PAs

24
Q

can generic substitutions be completed for an Rx written by a vet

25
how many signature lines are on prescription
two
26
when are the signature lines on an Rx NOT required
electronic or verbal prescriptions
27
If the prescriber signs on dispense as written, we must...
dispense the brand-name product
28
if the prescriber signs on may substitute, we may...
dispense a generic equivalent
29
what institute under Indiana law has some quirks w/ generic substitutions
Medicaid children's health insurance program (CHIP)
30
under medicaid/CHIP, the pharmacist must substitute the product that results in the lowest price unless...
1. words "Brand Medically Necessary" in practitioner's own handwriting 2. orally stating there cannot be a substitution and subsequent forwarding a covering prescription that has "Brand Medically Necessary" included
31
If pharmacist swaps generic equivalent, the prescription label must identify it as the following...
_____ Generic for ______
32
where can you look for biosimilar products
purple book
33
when can a biologic be substituted
-product has been determined to be interchangeable by the FDA -prescribing practitioner has indicated "may substitute" -pharmacist has informed the customer of the substitution -after completing the substitution, the prescriber is informed of the name and manufacturer of the biologic dispensed
34
Pharmacists and Pharmacies may register as nalaxone entitites as long as they follow the requirements associated w/ dispensing naloxone and provide these drugs to...
-a person at risk of experiencing an opioid-related overdose -a family member, friend, or any other individual in a position to assist an overdose
35
naloxone entity requirements
-register annually w/ state department or local health department -instruct the individual receiving the product to summon emergency services immediately -provide education and training on drug overdose response and treatment -provide drug addiction treatment and referral information
36
naloxone advocate protections
as long as they get the drug, admin, and attempt to summon emergency services immediately is immune from -prosecution related to practicing medicine -remains at the scene, cooperates with and provides info to law enforcement = immune to criminal prosecution