E2 Lecture 14 Flashcards
Electronic Controlled Substance Transfers
Electronic transfers may be transferred to another pharmacy, even if they have never been filled
Applied to all schedules and 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
Non-electronic Controlled Substance Transfers
Any non-electronic transfers are limited to C-III, C-IV, and CVs
These prescriptions must have been filled at least once before being eligible for transfer
May only be transferred one time unless the two pharmacies share a real-time online database
Communicated directly between 2 pharmacists
Controlled Substance Transfer documentation (transferring pharmacist)
Transferring pharmacist is the one sending and the receiving pharmacist is the one receiving the transfer
The transfer 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 (receiving pharmacist)
Date of issue of original Rx
Original number of refills
Date of original dispensing
Number of refills remaining, and the dates and locations of previous refills
Name, address, DEA, Rx number of transferring pharmacy
Name of transferring pharmacist
Original pharmacy name, address, DEA, and Rx number
SUD
Short-term detoxification= 30 days
Long-term detoxification= 30-180 days
Maintenance: maintaining a patient on a stable dose of a narcotic drug for more than 180 days
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
4 situations of SUD treatment
Practitioner registered with DEA as a narcotic or opioid treatment program
Practitioner dispensing from their office supply
Hospitalized patient
Prescription for direct administration
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
- 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%
Distributing to a reverse distributer
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
Destruction or Disposal of Controlled Substances
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
DEA Form 41
Must be completed with any type of controlled substance destruction
- 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
Must involve DEA and BoP
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 DEA Form 106
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.
