Controlled substance prescribing Flashcards
Controlled Substance Prescription Issuance
Can only be done by practitioners authorized to prescribe
Controlled substance prescribers must have a DEA number or be exempt from registration.
Importantly, agents cannot communicate C-II emergency prescriptions, as the DEA notes a prescriber cannot give agency to anyone for this type of prescription
Responsibilities of Issuing a Prescription
A prescriber must ensure prescriptions are “issued for a legitimate medical purpose by a…practitioner acting in the usual course of…practice.”
-Legitimate medical purpose: patient has a medical need for the medication
-Usual course of practice: prescriber has a valid patient-provider relationship*
*This used to require at least one in-person patient evaluation, but since COVID-19, this has included telemedicine visits
“The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.”
Corresponding Responsibility
This doctrine holds that pharmacists are accountable in making sure controlled substances are prescribed and dispensed appropriately.
Must have knowingly filled a fraudulent prescription to violate the law. Knowingly means:
Pharmacist recognized the possibility of wrongdoing but refused to conduct a proper investigation.
DEA List of Potential Concerns
Prescriber writes more prescriptions than other prescribers
Prescriber writes for larger quantities than other prescribers
Patient attempts to fill their prescription too frequently
Prescriber writes for antagonistic drugs at the same time
Patient presents prescriptions written for other people
Multiple patients attempt to fill prescriptions at the same time from the same prescriber
Patients who don’t regularly use your pharmacy and are not members of your community present prescriptions from the same prescriber
Prescription looks “too good,” perfect handwriting
Quantities, directions, or dosages differ from usual use
Prescription does not utilize standard abbreviations
Prescription appears to be photocopied
Prescription is written in different inks or different handwriting
Refusal to Fill a Controlled Substance
When documenting issues, it is important not to deface the prescription, as that is the property of the patient.
Small notes are okay as appropriate.
If you determine not to fill a prescription, the prescription should be returned to the patient, unless the prescriber asks you to destroy it.
With electronic prescriptions, you may need to call the provider and tell them to send the prescription to another pharmacy
Use your professional judgement when determining whether to fill a controlled substance, and document your rationale for filling or refusing to fill a prescription
Controlled Substance Prescription Signatures
Written prescription: wet signature required (signed by hand by prescriber)
Fax prescription: wet signature required
Electronic prescription: electronic signature required (utilizes a two-factor authentication to verify identity in an electronic system)
Telephone prescription: transcribed by a pharmacist or intern when received at the pharmacy. Can be called in by prescriber or an agent.
C-II Prescriptions: Federal Law
C-II prescriptions may be dispensed pursuant to each of the following prescription types:
-A written, paper prescription signed by the prescriber
-An electronic prescription transmitted by the prescriber
-A fax prescription, if the patient presents the manually signed prescription to the pharmacist prior to dispensing.
There are exceptions for other types of acceptable faxes and telephone prescriptions. We will cover the faxes next, and the telephone scripts later under the emergency prescriptions section.
States may have different requirements, but not more lenient than federal law.
Acceptable C-II Faxed Original Prescriptions
C-II “narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion.”
C-II “for a resident of a Long Term Care Facility.”
C-II “narcotic substance for a patient enrolled in a hospice care program…”
C-III, C-IV, & C-V Prescriptions: Federal Law
A written, paper prescription signed by the prescriber
An electronic prescription transmitted by the prescriber
A fax prescription transmitted by the prescriber or the prescriber’s agent
A telephone prescription promptly reduce to writing by the pharmacist
Controlled Substance Prescription Quirks
Any C-II through C-V may be dispensed or administered without a prescription by an individual prescriber.
Institutions may administer or dispense (not prescribe) C-II through C-V drugs based on a prescription or order from an individual practitioner if it is dispensed for immediate administration to the ultimate user.
Required Information for Controlled Substance Prescriptions
Date the prescription was issued
Full name and address of patient
Drug name, strength, and dosage form
Quantity prescribed
Directions for use
Name, address, and DEA number of prescriber
Signature of prescriber
Correcting C-II Prescriptions
Despite some confusion, the DEA has confirmed that pharmacists can make changes to C-II prescriptions so long as state laws are followed, including:
Adding or correcting patient’s address
Adding or changing dosage form, strength, quantity, or directions for use after confirming with prescriber
Importantly, you CANNOT update:
Name of the patient
Name of the drug (except for generic substitution)
Name of the prescriber, including signature
A new prescription must be issued for any mistake that cannot be updated
Correcting C-III – C-V Prescriptions
C-III, C-IV, and C-V prescriptions have the same rules related to correction as C-II prescriptions. The difference is because we can accept verbal orders for these prescriptions, we can convert erroneous written prescriptions into telephone prescriptions.
Who is entitled to fill prescriptions?
“A prescription for controlled substances may only be filled by a pharmacist, acting in the usual course of their professional practice and either registered individually or employed in a registered pharmacy, a registered central fill pharmacy, or a registered institutional practitioner.”
For this section, “Pharmacist” includes any person authorized to dispense controlled substances under the supervision of a pharmacist.
Important to remember prescribers cannot fill prescriptions. They may dispense controls, but not pursuant to a prescription.