Reading 16

Question 1

What does the Indiana Legend Drug Act talk about?

IC 16-42-19

Answer 1

• Drug orders, prescriptions, labeling, and many other important things that impact pharmacies and pharmacist

Question 2

What is the definition of Drug Order within the Legend Drug Act?

Answer 2

• For inpatient in institution
• I.e: hospital, LTCF, other inpatient places

Question 3

What are some of the things that need to be on a drug order?

Answer 3

• Name/Bed # of patient
• Name/Strength of drug
• Amount
• Direction
• Name of Dr

Question 4

What is the definition of Pracitioner within the Legend Drug Act?

Who?

Answer 4

• Those that can prescribe in Indiana [Physician, Vets, Dentists, Podiatrists, Optometrists, APNs, PAs]

Question 5

What is the definition of Prescription within the Legend Drug Act?

What needs to be on it?

Answer 5

• Name/Address of Patient
• Name/Strength of Drug
• Amount
• Directions
• Name of Dr
• Signature [written or electronic]

Can be called in, electronically sent, written or faxed

Question 6

What information MUST be on a prescription for it to be Legal?

Answer 6

• Name, Address, Number of Pharmacy
• Date filled
• Rx number
• Name of Dr
• Patients Name
• Directions
• Its a opioid

Question 7

What information MUST be on a label when dispensed from a Pracitioners Office?

Answer 7

• Directions
• Name and Address of Dr
• Name of Patient
• Animal species [if animal]

Question 8

What is the important thing to note about refilling prescriptions and drug orders within the Legend Drug Act section>

IC 16-42-19-12

Answer 8

• Prescriptions and Drug Orders CANNOT be refilled unless the Dr says so

Question 9

What does the Legend Drug Act say are Unlwful Acts?

Answer 9

• Getting a legend drug [by: fraud, forgery, concealment, false name]
• Telling Dr false things to get meds
• Falsely titling self as whatever to get meds
• Utter false or forged Rx
• False or forged on Label

Question 10

What does the Legend Drug Act say about the use of Anablic Steroids?

Can you get without Rx? What are the two reasons to NOT get filled?

Answer 10

• NO patient is able to get without an Rx
• CANNOT get them for the enhancment of preformence or hormonal manipulaiton (increasing muscle mass)

Question 11

What does the Legend Drug Act say about the Validity of Prescriptions?

Answer 11

• Rx or Drug Orders are NOT VAILD unless for a legit medical purpose by Dr

Question 12

What does the Legend Drug Act say about the use of Mechanical Storage Devices?

Where can they be used?

Answer 12

• Increase the availability of Drugs [Omincell or Pyxis]
• These can be used in institutions with pharmacy permits, if device is held in remote locations, or if device is in licenesed healthcare place

Question 13

What does the Legend Drug Act say about the requirement of prescription for retail sale of insulin?

Answer 13

• Insulin can bow be purchased OTC by anyone as of 01/01/2021

Question 14

What does the Chapter about Drugs: Enforcement of Pharmacy Law and Rules talk about?

-

Answer 14

• Members of the board enforce it; they can carry guns, execute warrents, make arrests without warrents, sieze property, do other law enforcement duties that the board says

Basically dont mess around with the Board or else you get shot

Question 15

What does the Chapter about Drugs: Drug Samples talk about?

About PAs? What can you NOT do?

Answer 15

• Practitioner doesnt list PAs; but they have the power through their physician (why they can do samples)
• CANNOT: remove from OG package and repackage it to resell or give when its expired

These apply to manufacturers, wholesalers, practitioners, pharmacist…

Question 16

What does the Chapter about Drugs: Generic Drugs talk about?

Answer 16

• Orange Book is for generic substitution for which are pharmaceutical or therapeutic equal
• This chapter is ONLY for Brand –> Generic
• DOESNT cover biologics

Question 17

What does the Practitioner section talk about within Generic Drug Section (IC 16-42-22)?

Who? Whos not included and why?

Answer 17

• Includes Physicians, Dentists, Podiatrists, optometrists, APNs [NOT Vets]
• PAs: get their authority from Physicains
• Vets: we dont know how drugs work in animals [they write brand, we give brand]

Can give generic instead of brand for others tho

Question 18

What does the Prescription Forms section of the Legend Drugs Acts chapter talk about?

Answer 18

• Two signature lines: “Dispense as Written” or “May Substitute”
• When “Dispense as Written” we MUST dispense as written, no if and or buts
• When “May Substitute” we CAN sub

“May Substitute” doesnt mean to another class

Question 19

For an electronic prescription, are the “Dispense as Written” and “May Substitute” suppose to be there?

Answer 19

• NO
• Electronics must say instruction on dispense as written or substitute; what the Dr wants

Question 20

What are some of the exceptions to the “Dispense as Written” and “May Substitute”?

Answer 20

• Patient enrolled in Medicaid, Childerns Health Insureance, Medicare = MUST sub to the lowest cost
• If Dr wants the Brand they MUST write Brand Medically Necessary in there handwritting [same for eletronic and orally]

Question 21

What does the chapter over identification of product state within the Legend Drug Act?

Answer 21

• If substituting, labels must say ____ generic for ____
• Must also state the manufacturer, distribuotr or both for dispensed product

Question 22

What does the chapter over Drugs: Biosimilar Biological Products state within the Legend Drug Act?

When can we substitute a biologic?

Answer 22

• Product deemed interchangeable by Purple Book
• Dr signed “May Substitute”
• Inform the patient

The FDA must maintain a link to the website of all current biologicals that are interchangable

Question 23

What does the chapter over Drugs: Overdose Intervention Drugs state within the Legend Drug Act?

What must we do for it?

Answer 23

• Allows pharmacist to dispense overdose intervention [Naloxone] if at risk of opioid overdose
• Must educate on overdose; adminstering, when to call 911, info on drug programs

Question 24

Practice Question 1

A pharmacist must always substitute a generic product when a prescription for a Medicaid patient is written for the brand name?

a. True
b. False

Answer 24

• b. False

Question 25

# Practice Question 2 Considering the Generic Drug Act, all of the following are true except: ## Footnote a. A pharmacist cannot substitute a generic medication if a Veterinarian writes for a brand-name medication b. The Generic Drug Act does not apply if a prescription is written for a generic drug c. The Orange Book is used to determine drugs are substitutable d. When substituting a generic drug for a brand name drug, a prescription label must say "generic name" substituted for "brand name" e. A Medicaid patient can never receive a brand-name medication

Answer 25

- e. A Medicaid patient can never receive a brand-name medication ## Footnote unless the Dr. write brand medically necessary

Question 26

# Practice Question 3 Select all of the following that are required on a drug order ## Footnote a. Patient b. Bed number and location c. Drug Name d. Drug Strength e. Prescriber Name

Answer 26

- A, B, C, D, E

Question 27

# Practice Question 4 It is illegal for a prescriber to exchange a drug sampe for a good or service, even if they are not accepting money for the same ## Footnote a. True b. False

Answer 27

- a. True

Question 28

# Practice Question 5 There is no situation where a patient could be prescribed an anabolic steroid ## Footnote a. True b. False

Answer 28

- b. False