EXAM 2 Federal Controlled Substance Law Pt3

Question 1

What is 1306-03 about?

Answer 1

Persons entitled to ISSUE Rx
-> Practitioners

Question 2

Who decides what a practitioner is?

Answer 2

left to the state
-> so the CFR 1306 doesn’t define who actually is entitled to issue Rx???

Question 3

What does anyone need to issue Rx?

Answer 3

need to be registered or exempt
exempts:
-Public Health Service
-Federal Bureau of Prisons
-military practitioners

Question 4

When is a Rx considered issued?

Answer 4

decision-making process (verifying) by a physician for example

-an agent (nurse) can write it or call it in -> but in order to be issued it has to be signed by the physician (prescriber)
-could be a pharmacist (with a practitioner contract???)

Question 5

What are the Purposes of Issues of a prescription (Rx)?

Answer 5

-has to be a Legitimate medical purpose
-has to be issued by an Individual practitioner (not an institutional practitioner which would be a hospital)
-has to be under the usual course of practice (a vet cant prescribe for humans)

-Corresponding Responsibility: practitioner and pharmacist must make sure the Rx is legit and complete

Question 6

What are NO Purposes of Issues of a prescription (Rx)?

Answer 6

-CANNOT issue a prescription for general office
dispensing -> but you may sell it to them (not more than 5%)
-CANNOT normally issue a prescription for narcotic
controlled substance for maintenance or detoxification (can only be dispensed in a SUD clinic)

Maintenace-administering: not trying to get to a drug-free state

Detoxification: decreasing the dose -> trying to get into a drug-free state
-short-term: up to 30 days
-long-term: 31-180 days, if longer than 180 it is maintenance

Question 7

What are the 12 Manners of Issuance?
When is a prescription considered valid for a controlled substance?

Answer 7

Patient: 1. and 2.
1. Name of patient
2. Adresse of patient

3. Date of Issue

Drug: 4 to 8
4. Drug name
5. Strength (if applicable)
6. Dosage form
7. Quantity
8. Direction of use (no matter how incomplete)

Prescriber: 9 and 12
9. Name of the prescriber
10. Address of the prescriber

11. DEA number of prescribers
12. signature (if written)

Question 8

When must the prescription be signed for controlled substances?

Answer 8

On the date of issue

Question 9

When is a signature required on a prescription with controlled substances?

Answer 9

-written prescription
-computer-generated or printed
-fax

-not needed when it is verbal

Question 10

Who is exempt from having their own DEA number while prescribing controlled substances?

Answer 10

if they work within the hospital -> use the hospital DEA number
-must include internal code at the end of the DEA number (links them to the hospital)
-must have the name of the prescriber hand stamped, typed or handwritten in addition to the signature

-often seen with doctor residents or hospitalists

Question 11

Who is entitled to fill prescriptions?

Answer 11

Pharmacists - in pharmacies

-not urgent care
-not physician’s office
-> they can dispense though
->filling medication orders in a hospital is something different

Question 12

Who is allowed to administer controlled substances for maintenance or detox?

Answer 12

Narcotic-treatment programs - but not PRESCRIBE

-if not a Treatment program: you can dispense for up to 3 days or until a patient is submitted to a treatment center
-> 1 day at a time, cannot repeat 3 days

Question 13

Are E-prescription for controlled substances allowed?

Answer 13

Yes
-same rules apply as for normal prescriptions
-No manual signature required
-needs certification of prescriber and dispenser end
-> third party has to certify that the prescription is correct, is stored correct, etc

Question 14

What are the allowed forms of a prescription with a controlled substance?

Answer 14

typically written and signed (there are exceptions)
-phone prescriptions require an emergency

-fax and phone prescription are for convenience, if they are sending a patient with a prescription and the pharmacy can handle it in the meantime
-> STILL NEED THE PRESCRIPTION before it can be dispensed

Question 15

What are emergencies to allow for a phone Rx for dispensing C-II without a written Rx?

Answer 15

-needs immediate administration
-no appropriate alternative to the C-II
-it is not possible for the practitioner to provide a written Rx before dispensing

-it has to be the prescriber on the phone (no agent (nurse))

ALL of these 3 have to apply!

Question 16

Other requirements for prescribing a C-II on the phone

Answer 16

-it has to be the prescriber on the phone (no agent (nurse))
-Quantity of the prescribed C-II must be for the period of emergency
-> any other quantities must be on a new Rx

-practitioner must deliver a covering Rx within 7 days

-the covering prescription must be identical to phone Rx
-must say “authorization for emergency dispensing” on the face of the covering Rx
-two copies are attached and kept for 2 years

Question 17

How long should you keep the copy for an authorized emergency prescription?

Answer 17

2 years

Question 18

A prescriber issues a C-II Rx on the phone, within how many days does he need to provide the covering Rx?

Answer 18

7 days

Question 19

When can a fax serve as an original prescription (in an emergency???)?

Answer 19

a fax can serve as an original Rx if:

e): the Rx is for a direct administration of a narcotic C-II (opioids) given via a non-oral route for pain

f): a C-II drug (any C-II drug) for a resident of a long-term care facility

g): for a C-II narcotic for a patient enrolled in a hospice care program

-> so C-II narcotics can only be given for a non-oral route or in a hospice care program for pain

Question 20

Refills are allowed for C-II drugs. T/F

Answer 20

False.

Question 21

How can prescriptions for future refills be handled?

Answer 21

patients can get multiple prescriptions for the same C-II drug for a supply up to 90 days of therapy (3x30, 6x15) - may write to the pharmacist not to refill early -> given the date of earliest authorized filling

-it CAN NOT have prescriptions with future issuing dates, the dates have to be day the prescription has been written

Question 22

Is partial filling of C-II allowed?

Answer 22

Yes

if the pharmacy is not able to fill the full prescription, the remainder has to be filled within 72h –> the patient doesn’t have to pick it up within 72h, the Rx has to be ready for pick up within 72h

Question 23

When does the pharmacist need to complete a partial fill within 72 hours?

Answer 23

-out of stock in the pharmacy
-emergency fill

(usually, the patient has 30 days to get the remainder of the partial fill)

Question 24

In terms of partial filling, what needs to be considered according to the Comprehensive Addiction Recovery Act (CARA)?

Answer 24

if the prescriber requests partial filling:

-dispense the requested partial fill
-the remainder can be filled for up to 30 days after date of issue
-after 30 the prescription is void
-in an emergency: 72h limit

Question 25

What are the exceptions of partial filling?
Allowing partial fills to be dispensed beyond 30 days.

Answer 25

-Long-term-care facility
-terminal illness
-> we do not want to prescribe a lot of C-II for terminally ill patients who may not live for very long

-do not dispense more than on the Rx
-no dispense after 60 days of issuing
-write on Rx: Terminal ill or LTCF
-keep records of dispensing

Question 26

When can Rx with a controlled substance be partially filled within 30 or 60 days?

Answer 26

30 days: prescriber request the pharmacy to partial fill

60 days: in LTCF or terminal ill

Question 27

What has to be on the label of C-II drugs?

Answer 27

-DATE OF FILL
-Rx number

-the pharmacy name
-the pharmacy address

-name of the patient
-name of the prescribing practitioner

-and directions for use
-cautionary statements

Question 28

When it comes to labeling what are the differences of requirement on what has to be on the label?

Answer 28

for all drugs (controlled and non-controlled) -> covered in the US Code

for C-II drugs: covered in the CFR

they are pretty much the same:
for the C-II drugs there has to be the Date of Fill
and for the non-controlled, it is the Date of Issue or initial Fill

Question 29

Who is exempt from the rules for labeling C-II drugs?

Answer 29

Institutionalized patients (like LTCF)
often the container doesn’t have enough space to put all the information on the label

requirements:
-<7 day supply
-not in possession of the ultimate user
-institutional safeguards
-can identify supplier, drug, patient, direction, cautionary statements

Question 30

Rules to consider for Central fills

Answer 30

Scenario: the pharmacy sends a prescription to a central fill to fill it -> and they send it back to the pharmacy to dispense it

-must write “Central Fill” on the Rx and record lots of additional info (DEA number)
-retail pharmacy needs to keep original for 2 years