Controlled substances filling, partials and labeling Flashcards
Refilling Prescriptions
A refill is filling the prescriptions face amount after the initial fill has already been dispensed.
60mL x 1 (original fill) + 60mL x 3 (refills) = 240mL (total fills)
The example to the right has three refills. This prescription can be filled four times
C-II Refills
Refills are not allowed on C-II prescriptions…ever…never ever!
NOTE
C-II Prescriptions are good for a year from the date written
There is no limit on the amount a C-II can be prescribed for, meaning a prescriber could write a prescription for 365 days (good luck getting that filled)
In lieu of refills, prescribers may authorize multiple prescriptions for a patient to receive up to a 90-day supply of a controlled substance
Prescribing Multiple C-IIs Simultaneously*
*Remember, this only applies when a prescriber decides to write multiple prescriptions at once
1.Each prescription must be written in accordance with controlled substance prescribing responsibilities
2.Prescriber must date each prescription with the date it was issued, and provide written instructions on each prescription indicating the earliest date of fill
3.Prescriber must decide that multiple prescriptions to a patient does not create a risk of diversion
4.Must adhere to state statutes and regulations
5.Must meet all other C-II prescription requirements
C-III, C-IV, and C-V Refills
C-III, C-IV, and C-V prescriptions may have up to 5 refills (six total fills), regardless of day supply
A prescriber who authorizes fewer than 5 refills initially may authorize additional refills on the original
prescription.
The total refills may not exceed 5, nor extend beyond six months from the original issue date*
C-III & C-IV Refill Documentation
All refill information must be documented, either by:
1.Writing on the back of the prescription or another appropriate document
2.Documenting in an electronic prescription record
Required documentation must be uniformly maintained and readily retrievable by the prescription number, and includes:
1.Name and dosage form of controlled substance
2.Date filled or refilled
3.Quantity dispensed
4.Initials of dispensing pharmacist for each refill
5.Total number of refills for that prescription
C-III & C-IV Refill Documentation: Alternative Record
An alternative computer application may be used for storage and retrieval of refill information for controlled substances. It must include:
-Original prescription number
-Date of issue
-Name and address of patient
-Name, address and DEA of prescriber
-Name, strength, dosage form, quantity prescribed (and dispensed if different than prescribed) of drug
-Refills authorized
-Refill history
C-III & C-IV Refill Documentation: Alternative Record
If an alternative record system is utilized, the pharmacies must employ one of the following recordkeeping methods for refills:
Print out all controlled substance refills with the information of the pharmacist who refilled the prescription. The printout must be reviewed and signed by the pharmacist who refilled the prescription, and stored for a period of two years, OR
Maintain a bound logbook that each pharmacist involved in dispensing shall sign each day, attesting to the fact that the refill information entered has been reviewed and is correct
Partial Filling C-IIs
There are three circumstances in which you may partially fill a C-II prescription:
At the request of the patient, patient representative, or prescribing practitioner
If the pharmacy cannot provide the full amount of the prescription
For a patient in a long-term care facility or who has a medical diagnosis documenting terminal illness
C-II Partial Fill: Request of Patient, Representative or Prescriber
The Comprehensive Addiction and Recovery Act of 2016 allowed for partial filling of C-II prescriptions, so long as the following criteria are met:
-It is not prohibited by state law
-The patient, representative, or prescriber requested the partial fill
-The total quantity of all partial fillings does not exceed the total quantity prescribed
-The remaining portions are filled no later than 30 days from the date the prescription is written
-Does not apply related to stock shortages or insurance limitations
C-II Partial Fill: Pharmacy Out-of-stock
The remainder must be ready for pick up within 72 hours of the partial fill.
If the remainder cannot be prepared within 72 hours, the pharmacist must notify the prescriber of the partial fill, including quantity and reason for partial. The remainder of the prescription is then voided.
C-II Partial Fill: LTCF/Terminal Illness
If a prescription is written for a patient in a long-term care facility or a patient with a medical diagnosis documenting a terminal illness, it may be partially filled for up to 60 days from the date issued.
Pharmacist many not dispense more than total quantity prescribed
Must document
-Date of partial filling
-Quantity dispensed
-Remaining quantity to be dispensed
-Identification of dispensing pharmacist
Partial Filling C-III, C-IV, and C-Vs
Prescriptions may be partially filled so long as:
1.Total quantity dispensed does not exceed total quantity prescribed
2.No amount is dispensed after the prescription expires
Partial fills can be dispensed in any amount, and must be recorded in the same manner as refills
Unlike refills, you may partially fill a prescription more than five times
C-II Emergency Prescriptions
The only time a C-II prescription can be taken over the phone is in an emergency situation. An emergency situation occurs when:
1.The immediate administration of a controlled substance is needed,
2.There is no appropriate alternative available, including non-controls, and
3.It’s not possible for the prescriber to provide a written prescription before dispensing the medication
Prescribers are responsible for ensuring a C-II meets the requirements for an emergency prescription. Pharmacists should document information to ensure we meet our corresponding responsibility
C-II Emergency Prescriptions
Emergency prescriptions:
Should only be for the amount needed to cover the emergency period
Must be followed by a “covering prescription” sent by the prescriber within seven days or authorizing the emergency prescription
C-II Emergency Prescription Documentation/Follow-Up
For a paper covering prescription, attach the covering prescription to the emergency prescription previously dispensed
For an electronic covering prescription, the pharmacist must annotate the prescription with the oral order’s original authorization and date
IF a covering prescription is not received, the pharmacist must notify the nearest DEA office (if you don’t do this, you’ve misbranded and distributed a drug illegally, which is a PROBLEM for you)
If you don’t receive the covering prescription within 7 days, notify the DEA immediately. Shifts the burden to the prescriber, and covers you.
Controlled Substance Central Fill – Community Pharmacy Documentation
The pharmacist sending the prescription to a central fill pharmacy must:
Write the words “CENTRAL FILL” on the face of the original prescription
Record the name, address, and DEA number of the central fill pharmacy
Record their name and the date of the transmittal to the central fill pharmacy
If an electronic prescription, #2 and #3 above must be added to the electronic record
The original prescription must be kept at the local pharmacy for at least 2 years, as well as a record of receipt of the filled prescription
Controlled Substance Central Fill – Central Fill Documentation
A copy of the faxed prescription or electronic record with the name, address, and DEA number of the community pharmacy
The date the prescription was received, pharmacist filling the prescription, and the date the prescription was filled
The date the prescription was delivered to the community pharmacy and the delivery method
record for 2 years
Controlled Substance Central Fill - Refills
All of the central fill information applies to all controlled substances. For C-III, C-IV, and C-V prescriptions, we also need to consider refills. If the prescription is authorized to be refilled:
The community pharmacy must “indicate in the information transmitted the number of refills already dispensed and the refills remaining.”
The central fill pharmacy must record the dates the prescription was filled and refilled
Controlled Substance Prescription Labels
Date of filling
Dispensing pharmacy name and address
Prescription number
Name of the patient
Name of the prescriber
Directions for use
Cautionary statements contained in the prescription, if any*
*Cautionary statements are optional, everything else is required by law
Controlled Substance Prescription Labels
For all C-II, C-III, and C-IV prescription labels, there must be a statement with the following exact wording:
“Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed”
While you may see this on all prescription labels, it is only required for C-II, C-III, and C-IV prescription labels
Controlled Substance Prescription Label Quirks
If dispensed by a central fill pharmacy, the prescription label must also include a unique identifier, to indicate the prescription was filled at a central fill pharmacy
For a C-II prescription, these labeling requirements do not apply for administration in an institution so long as no more than a 7-day supply of medication is dispensed at a time, and the medication is not in possession of the ultimate user before administration
For a C-III, C-IV, or C-V prescription, these labeling requirements do not apply for administration in an institution so long as no more than a 34-day supply of medication, or no more than 100 dosage units, is dispensed at a time, and the medication is not in possession of the ultimate user before administration
