Reading 12

Question 1

How must a prescriber sign a written or faxed prescription?

Answer 1

manually with a pen or indelible pencil (wet signature)

Question 2

How must a prescriber sign an electronic prescription?

Answer 2

electronic signature with two-factor authentication (fingerprint or biometric scan + password, etc.)

Question 3

When may a prescriber be allowed to fax in a C-II?

Answer 3

to get the prescription ready for a patient (patient must present the actual prescription prior to dispensing)

Question 4

Can C-IIs be dispensed/administered without a prescription?

Answer 4

yes

Question 5

Institutional practitioners, which are hospitals or other institutions, may administer or dispense (but not prescribe) a C-II drug based on a prescription or order from an individual practitioner if it is dispensed for ___________ administration to the ultimate user.

Answer 5

immediate

Question 6

How can a CIII-V be sent into the pharmacy?

Answer 6

• written
• electronic
• fax
• oral

Question 7

Institutional practitioners, which as a reminder is a hospital or institution, may administer or dispense (but not prescribe) C-III through C-V drugs based on a prescription or order from an individual practitioner if it is dispensed for __________ administration to the ultimate user.

Answer 7

immediate

Question 8

Schedule II prescriptions expire _________ from the date written or issued and cannot be refilled.

Answer 8

1 year

Question 9

What is the maximum amount (time-wise) that a single C-II can be written for?

Answer 9

no max; a prescriber could write for 365 days if they wanted

Question 10

While refills aren’t allowed on C-II prescriptions, a prescriber can authorize multiple prescriptions for a patient to receive up to a ___-day supply of a controlled substance at one time if they choose.

Answer 10

90

Question 11

True or false: prescribers may write multiple C-II prescriptions to prevent patients from needing to come back to the office each month.

Answer 11

true

Question 12

What requirements must be met for a prescriber to issue multiple C-II prescriptions for the same patient (same drug)?

Answer 12

1. issued for a legitimate medical purpose by a prescriber acting in the usual course of practice
2. prescriber must date the prescription with the date it was issued to the patient and provide written instructions on each prescription indicating the earliest date the pharmacy can fill each prescription
3. prescribed must decide that providing multiple prescriptions does not create a risk of diversion or abuse
4. issuance of multiple prescriptions must be legal in that given state
5. all prescriptions must meet the requirements for C-II prescriptions

Question 13

Can prescribers post-date their prescriptions?

Answer 13

no; must write a statement like “do not dispense before _________”

Question 14

CIII-V prescriptions are valid for _________ from the date issued and _____ be refilled.

Answer 14

6 months; can

Question 15

What is the maximum number of refills for a CIII-V?

Answer 15

5 refills (6 total fills)

Question 16

True or false: if a practitioner originally authorizes fewer than five refills, they cannot later decide to authorize additional refills on the original prescription.

Answer 16

false; this is allowed as long as the total quantity of refills authorized, including the amount of the original prescription, does not exceed five refills nor extend beyond six months from the date the prescription was originally issued

Question 17

Refill information should be written on the ______ of the prescription or kept in another computerized record.

Answer 17

back

Question 18

How should pharmacies maintain their records of controlled substance refills?

Answer 18

either print them out and have them signed by the pharmacist, or maintains a bound logbook that each pharmacist signs noting when they were on duty

Question 19

What is a partial fill defined as?

Answer 19

any amount less than the face amount of the prescription

Question 20

What did the Comprehensive Addiction and Recovery Act of 2016 achieve?

Answer 20

first began to allow the partial filling of C-IIs

Question 21

The Comprehensive Addiction and Recovery Act of 2016 states that C-IIs may be partially filled as long as what 5 rules are followed?

Answer 21

1. it is not prohibited by state law
2. the partial fill is requested by the patient or practitioner who wrote the prescription
3. the total quantity dispensed by all partial fillings doesn’t exceed the total quantity
4. the remaining portions are filled no later than 30 days after the prescription was written
5. doesn’t apply in emergency situations (72-hour rule)

Question 22

Indiana only allows C-II partial fills for ________.

Answer 22

opioids

Question 23

Can C-II partial fill requests be made by patient representatives?

Answer 23

no; only the patient or practitioner

Question 24

C-II partial fills must be completed ___ days from the date the prescription was written.

Answer 24

30

Question 25

If a pharmacy cannot provide the full amount of a C-II due to stock issues, need for additional verification, or insurance issues, the pharmacist must document the partial fill amount on the _____ of the prescription and provide the remaining portion within _____ of the partial filling

Answer 25

face; 72 hours

Question 26

How do we address C-II partial fills for LTCFs or a patient with a terminal illness?

Answer 26

pharmacist must document either “terminally ill” or “LTCF patient” on the prescription and can partially fill the prescription for up to 60 days from the issue date (unless terminated sooner)

Question 27

True or false: you cannot partially fill a CIII-V more than 5 times

Answer 27

false

Question 28

What makes an “emergency situation” worthy of taking a C-II over the phone?

Answer 28

• immediate administration is necessary
• there is no appropriate alternative available (including non-controlled options)
• it’s not possible for the prescriber to provide a written prescription before dispensing the medication

Question 29

What quantity can be dispensed in an emergency prescription?

Answer 29

only the amount sufficient to treat the patient during their emergency period

Question 30

What must be done within 7 days of authorizing an emergency C-II?

Answer 30

the prescriber must write a “covering prescription” for the exact amount and directions authorized in the emergency prescription with the phrase “Authorization for Emergency Dispensing” on the face

Question 31

Why is it necessary to notify the DEA if a covering prescription isn’t received?

Answer 31

it voids the prescription; if you’ve dispensed a drug on an invalid prescription, you’ve not only misbranded the drug but also distributed it and can face huge fines

Question 32

True or false: central fill pharmacies can fill emergency prescriptions.

Answer 32

false; must be filled by the pharmacy they are called into

Question 33

What must be done so that a C-II can be sent to a central pharmacy for filling?

Answer 33

pharmacist must “write the words ‘CENTRAL FILL’ on the face of the original paper prescription and record the name, address, and DEA registration number of the central fill pharmacy to which the prescription has been transmitted, the name of the retail pharmacy pharmacist transmitting the prescription, and the date of transmittal

Question 34

What MUST be included on a C-II label?

Answer 34

• fill date
• dispensing pharmacy name and address
• prescription serial number
• patient name
• prescriber name
• directions
• cautionary statements (if any)

Question 35

What MUST be included on a CIII-V prescription label?

Answer 35

• fill date
• pharmacy name and address
• prescription serial number
• patient name
• prescriber name
• directions
• cautionary statements (if any)

Question 36

Prescription labeling rules for C-IIs do not apply for drugs prescribed for administration in an institution as long as no more than a _____ supply of medication is dispensed at one time, the medication is not in possession of the ultimate user before administration, the institution maintains proper safeguards and records regarding administration, control, dispensing, and storage, and the system employed by the pharmacist identifies the supplier, the product, the patient, and directions for use and any cautionary statements.

Answer 36

7-day

Question 37

Prescription label requirements for CIII-Vs do not apply for administration in an institution as long as no more than a ________ supply of medication or no more than 100 dosage units are dispensed at one time, the medication is not in possession of the ultimate user before administration, the institution maintains proper safeguards and records regarding administration, control, dispensing, and storage, and the system employed by the pharmacist identifies the supplier, the product, the patients, and directions for use and any cautionary statements.

Answer 37

34-day

Question 38

What is a “no transfer” label?

Answer 38

On prescription labels for all controlled substances in schedules II, III, or IV dispensed to a patient, there must be a statement noting that the patient cannot give the medication to anyone else.

Question 39

When does a no transfer label NOT need to be placed on a prescription label for a controlled substance?

Answer 39

controlled substances in a clinical investigation where the patients are blind to treatment and does not need to be listed on the label for products in schedule V