lecture 17

Question 1

Drug order requirements

Answer 1

Name and bed number of the patient
Name and strength/size of drug
Amount to be dispensed in quantity or days
Adequate directions for the proper use of the drug
Name of the prescriber

Question 2

Prescription requirements

Answer 2

Name and address of the patient
Name and strength/size of the drug or device
Amount to be dispensed
Adequate directions for use
Name of the practitioner
Written or electronic signature of practitioner

Question 3

Prescription Label
10 requirements

Answer 3

Name, address, and phone number of the 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 it’s an animal, the name of the species)
The directions for use as provided in the prescription
If the drug contains or is derived from opium, a statement that the drug is an opioid
Unique to Indiana are the two below
The name of the drug (trade or generic or both) in compliance with IC 16-42-22
For an animal, the owner’s name

Question 4

Medical storage devices

Answer 4

can only be utilized in
pharmacy, remote location under jurisdiction of the indiana BoP, and licensed health care facilities

Must maintian registration with the BoP and must be able to be inspected at any time by the BoP

Question 5

Drugs: Enforcement of Pharmacy Laws and Rules
Enforcement of the law falls to members of the Indiana BoP, designated BoP employees, and all law enforcement officers in Indiana. These individuals may:

Answer 5

Carry a firearm when performing official duties
Execute and serve warrants and subpoenas
Make arrests without a warrant for suspected controlled substance felony
Seize property
Perform other enforcement duties as designated by the BoP

Question 6

PDMA – Samples and Coupons

Answer 6

Bans the sale, purchase, or trade of a drug sample or drug coupon, and bans counterfeiting of drug coupons.
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

Question 7

Two things Indiana specifies in addition to the PDMA:
Drug samples

Answer 7

you cannot remove a sample from its original packaging, repackage it, and then sell it/exchange it.

You cannot deliver a drug sample to someone after its expiration date

Question 8

Generic Substitution: Medicaid and CHIP
There are some unique requirements when considering generic substitution for Medicaid and the children’s health insurance program (CHIP):

Answer 8

The pharmacist must substitute the product that results in the lowest price unless:
1. The words “Brand Medically Necessary” are written or electronically transmitted on the prescription in the practitioner’s own handwriting
2.Orally stating that a generic equivalent may not be substituted, and subsequently forwarding a covering prescription that has “Brand Medically Necessary” included

Question 9

Prescription label requirement if a generic substitution is made

Answer 9

“_______ Generic for_________“

(e.g., “lisinopril Generic for Zestril”, “rivaroxaban Generic for Xarelto”)

Question 10

Biosimilar Products
While biosimilar products are not the same as brand-generic, they are treated somewhat similarly in Indiana law. A biologic can be substituted if:

Answer 10

1.The product has been determined to be interchangeable by the FDA in the 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 the name and manufacturer of the biologic product dispensed