Controlled substance transfers and unique scenarios Flashcards
Electronic Controlled Substance Transfers
There are many limitations when it comes to controlled substance transfers, but some recent updates have allowed for more transfer opportunities:
In 2023, the DEA noted that electronic prescriptions may be transferred to another pharmacy, even if they have never been filled. This applies to all schedules, and is allowed if:
Allowed by state law
The prescription was electronically prescribed
If communicated between two licensed pharmacists
If the prescription is maintained in an electronic format
These are one-time transfers, but refills can be honored at the new pharmacy
Non-electronic Controlled Substance Transfers
Any non-electronic transfers are limited to C-III, C-IV, and C-V prescriptions.
These prescriptions must have been filled at least once before being eligible to be transferred.
May only be transferred one time unless the two pharmacies share a real-time online database (may transfer up to the maximum refills in this case)
Transfers must be communicated directly between two licensed pharmacists
Controlled Substance Transfer Documentation
The transferring pharmacist must:
Write ‘VOID’ on the face of the invalidated prescription, or for an electronic prescription, note that the prescription has been transferred in the prescription record
Record the name, address, and DEA number of the receiving pharmacy
Record the date of transfer and the name of the transferring pharmacist
Controlled Substance Transfer Documentation
The receiving pharmacist for a controlled substance transfer must note:
The date of issue of original prescription
Original number of refills authorized
Date of original dispensing
Number of refills remaining, and the dates and locations of previous refills
Transferring pharmacy name, address, DEA number, and prescription number
Name of transferring pharmacist
Original pharmacy name, address, DEA number, and prescription number
Substance Use Disorder (SUD) Treatment
“A prescription may not be issued for ‘detoxification treatment’ or ‘maintenance treatment’ unless it is a C-III, C-IV, or C-V narcotic drug approved by the FDA specifically for use in maintenance or detoxification treatment and the practitioner complies with requirements”
This provision is intended to ensure patients receive treatment appropriately, but there are four situations related to SUD treatment outside the above definition:
Practitioner registered with DEA as a narcotic or opioid treatment program
Practitioner dispensing from their office supply
Hospitalized patient
Prescription for direct administration
Substance Use Disorder (SUD) Definition and Terms
Substance use disorder: the problematic pattern of using a substance that results in impairment in daily life or noticeable distress. We will discuss this disorder in relation to narcotic controlled substances
Detoxification: dispensing a narcotic drug in decreasing doses to bring a patient to a drug-free state.
Short-term detoxification: 30 days or less
Long-term detoxification: 30 – 180 days
Maintenance: maintaining a patient on a stable dose of a narcotic drug for more than 180 days
SUD: Practitioner Registered as an NTP or OTP
If the practitioner is registered as a narcotic or opioid treatment program (NTP or OTP), and complies with DEA regulations, they may administer or dispense (not prescribe) a narcotic listed in any schedule for maintenance or detoxification treatment.
Often referred to as methadone clinics
Patients receive daily doses at first, and may be given greater days’ supplies over time
Methadone is not approved for detoxification or maintenance treatment by the FDA, cannot fill a prescription for this indication
SUD: Practitioner Dispensing from Office Supply
A practitioner may dispense, but not prescribe, a narcotic drug to one person or for one person at one time for the purpose of initiating maintenance treatment and/or detoxification treatment.
Limited to a three-day supply of medication to be dispensed
No extensions on the three days, it is one-and-done.
SUD: Hospitalized Patient
If a patient who is currently being maintained or detoxified is hospitalized, the prescriber may administer or dispense a narcotic drug to maintain or detoxify the hospitalized patient.
Patient must be hospitalized due to an issue outside of substance use disorder
Goal is not to interrupt their treatment
A patient admitted for SUD cannot be treated in this manner
SUD: Prescription for Direct Administration
A pharmacist may deliver a controlled substance based on a prescription for an individual patient to a practitioner’s office for the practitioner to administer to the patient
The controlled substance must be administered by injection or implantation
It must be administered to the patient named in the prescription within 14 days of receiving the product from the pharmacy
Cannot be for “office use,” must be linked to an individual patient
Distributing to Another Registrant for Dispensation
A Dispensing Registrant may distribute a controlled substance to another registrant, so long as:
that registrant is appropriately registered with the DEA (2, 2N, 3, 3N, 4, 5, etc.),
The pharmacy records the distribution and receiving registrant as required,
If a C-I or C-II, a DEA Form 222 is completed by both parties, and
The number of dosage units does not exceed 5% of the total dosage units of all controlled substances distributed and dispensed in the same calendar year.*
*Distributions to an automated dispensing system in a LTCF don’t count towards the 5%
Destruction or Disposal of Controlled Substances
Many requirements are associated with this practice to ensure products are not diverted during destruction. There are four methods of disposal:
On-site destruction: two employees handle the destruction, which renders the substance non-retrievable (also known as “wasting”)
Delivery to a reverse distributor: see previous slide
Sending product back to distributor, warehouse, or manufacturer: only done related to a recall or return
Request assistance directly from local DEA field office: only done by practitioners
Distributing to a Reverse Distributor
A reverse distributor is a person which accepts controlled substances for destruction. To complete this process:
The pharmacy contacts the reverse distributor with a list of all drugs needing disposal
The reverse distributor creates an invoice to the pharmacy with exact quantities of substances to be destroyed (DEA Form 222 for C-I/C-II)
Pharmacy completes suppliers’ requirements and sends drugs to the reverse distributor for destruction.
Reverse distributor fills out a DEA Form 41 and complete other records as required
DEA Form 41
Must be completed with any type of controlled substance destruction. Includes the following sections:
Registrant number, name, address, telephone, and contact name
Inventory information (name, strength, form, and quantity of each destroyed substance)
Method of destruction (date, location and method)
Witnesses (if any) required for destruction
Once completed, this form is maintained with other CS records. It does not need to be sent to the DEA unless requested.
Theft or Significant Loss
Sometimes robberies and accidents happen. When they do, and they involve controlled substances, you must involve the DEA and the state Board of Pharmacy
Any theft or significant loss must be reported to the local DEA field office and Board of Pharmacy within one day of discovery
A DEA Form 106 must be filed within 45 days of discovery (electronic submission)
All theft (1 tablet or 10,000) must be reported, but only significant (non-theft) losses must be reported.
What is a Significant Loss?
Actual quantity lost in relation to the type of business
Specific controlled substances lost
Whether the loss can be attributed to specific individuals or unique activities
If a pattern of loss is present, and the results of efforts taken to resolve losses
Whether the substance is a likely candidate for diversion
Local trends/indicators of diversion potential of the missing substance
DEA Form 106
Any registrant who suffers a controlled substance theft or significant loss must fill out a DEA Form 106, which includes:
Date of issue occurrence or discovery
Theft or significant loss. If theft, requires recap of what happened, if police were notified, and if anyone was injured
Name, dosage form, strength, and quantity of all controlled substances lost or stolen
Any executed DEA Form 106 should be forwarded to the DEA field office, and likely the state Board of Pharmacy as well.
