EXAM 2 Federal Controlled Substance Law Pt3 Flashcards
What is 1306-03 about?
Persons entitled to ISSUE Rx
-> Practitioners
Who decides what a practitioner is?
left to the state
-> so the CFR 1306 doesn’t define who actually is entitled to issue Rx???
What does anyone need to issue Rx?
need to be registered or exempt
exempts:
-Public Health Service
-Federal Bureau of Prisons
-military practitioners
When is a Rx considered issued?
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???)
What are the Purposes of Issues of a prescription (Rx)?
-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
What are NO Purposes of Issues of a prescription (Rx)?
-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
What are the 12 Manners of Issuance?
When is a prescription considered valid for a controlled substance?
Patient: 1. and 2.
1. Name of patient
2. Adresse of patient
- 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
- DEA number of prescribers
- signature (if written)
When must the prescription be signed for controlled substances?
On the date of issue
When is a signature required on a prescription with controlled substances?
-written prescription
-computer-generated or printed
-fax
-not needed when it is verbal
Who is exempt from having their own DEA number while prescribing controlled substances?
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
Who is entitled to fill prescriptions?
Pharmacists - in pharmacies
-not urgent care
-not physician’s office
-> they can dispense though
->filling medication orders in a hospital is something different
Who is allowed to administer controlled substances for maintenance or detox?
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
Are E-prescription for controlled substances allowed?
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
What are the allowed forms of a prescription with a controlled substance?
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
What are emergencies to allow for a phone Rx for dispensing C-II without a written Rx?
-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!
Other requirements for prescribing a C-II on the phone
-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
How long should you keep the copy for an authorized emergency prescription?
2 years
A prescriber issues a C-II Rx on the phone, within how many days does he need to provide the covering Rx?
7 days
When can a fax serve as an original prescription (in an emergency???)?
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
Refills are allowed for C-II drugs. T/F
False.
How can prescriptions for future refills be handled?
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
Is partial filling of C-II allowed?
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
When does the pharmacist need to complete a partial fill within 72 hours?
-out of stock in the pharmacy
-emergency fill
(usually, the patient has 30 days to get the remainder of the partial fill)
In terms of partial filling, what needs to be considered according to the Comprehensive Addiction Recovery Act (CARA)?
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
What are the exceptions of partial filling?
Allowing partial fills to be dispensed beyond 30 days.
-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
When can Rx with a controlled substance be partially filled within 30 or 60 days?
30 days: prescriber request the pharmacy to partial fill
60 days: in LTCF or terminal ill
What has to be on the label of C-II drugs?
-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
When it comes to labeling what are the differences of requirement on what has to be on the label?
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
Who is exempt from the rules for labeling C-II drugs?
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
Rules to consider for Central fills
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
