VALID PRESCRIPTION REQUIREMENTS Flashcards
To dispense controlled substances, a pharmacist must know:
a pharmacist must know the requirements for a
valid prescription
A prescription is an
order for medication which is dispensed to or for an ultimate user.
A prescription is not an order
for medication which is dispensed for immediate administration to the ultimate user (i.e., an order to dispense a drug to an inpatient for immediate administration in a hospital is not a prescription).
A prescription for a controlled substance must be dated and signed on
the date when issued.
The prescription must include
the patient’s full name and address, and the practitioner’s full name, address, and DEA registration number.
Besides the patient’s full name and address, and the
practitioner’s full name, address, and DEA registration number the prescription must also include
- Drug name
- Drug strength
- Dosage form
- Quantity prescribed
- Directions for use
- Number of refills authorized (if any)
A paper prescription must be written in
ink or indelible pencil or typewritten, or printed on
a computer printer, and must be manually signed by the practitioner on the date when issued.
An individual (i.e., secretary or nurse) may or may not prepare prescriptions for the practitioner’s signature.
may
The practitioner is responsible for
for ensuring the prescription conforms to all requirements of the law and regulations, both federal and state.
A corresponding liability rests upon the pharmacist, including a pharmacist employed by a central fill pharmacy, who fills
who fills a prescription not prepared in the form prescribed by DEA regulations.
A prescription for a controlled substance may only be issued by a physician, dentist, podiatrist, veterinarian, mid-level practitioner, or other registered practitioner who is:
- Authorized to prescribe controlled substances by the jurisdiction in which the practitioner is licensed to practice, and
- Registered with DEA or exempted from registration (e.g., Public Health Service, Federal Bureau of Prisons, military practitioners), or
- An agent or employee of a hospital or other institution acting in the normal course of business or employment under the registration of the hospital or other institution which is registered in lieu of the individual practitioner being registered, provided that additional requirements as set forth are met.
To be valid, a prescription for a controlled substance must be issued for
a legitimate medical purpose by a practitioner acting in the usual course of professional practice.
The practitioner is responsible for the proper prescribing and dispensing of controlled substances, but
but a corresponding responsibility rests with the pharmacist who fills the prescription.
An order purporting to be a prescription that is not issued for a legitimate medical purpose in the usual course of professional treatment or in legitimate and authorized research is not
a prescription within the meaning and intent of 21 U.S.C. 829.
The person knowingly filling a prescription that is not legally valid, as well as the person issuing it, shall be:
shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.
A prescription may or may not not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients?
may not
An individual practitioner may or may not authorize an agent to perform a limited role in communicating such prescriptions to a pharmacy in order to make the prescription process more efficient?
may
Even though the CSA established a closed system in which all persons in the distribution chain are required to be registered and are held accountable for every controlled substance transaction, Congress recognized
a role for agents under the Act
Does the CSA exempt agents of registrants, including practitioners, from the requirement of registration.
yes
The CSA statute defines an “agent” as
“an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser.”
The CSA does not permit a prescribing practitioner, however, to delegate to an agent or any other person
the practitioner’s authority to issue a prescription for a
controlled substance.
A practitioner acting in the usual course of his or her professional practice must determine that there is a legitimate medical purpose for a controlled substance prescription; an agent
may not make this determination.
The common means to communicate a prescription to a pharmacy include
hand delivery, facsimile, phone call, or an electronic transmission
The proper role of an agent is fact specific and depends upon the
schedule of the controlled substance prescribed, the circumstances of the ultimate user, and the method of communication, among other things.
Summary of the acts that an agent may execute in connection with controlled substance prescriptions:
- An authorized agent of an individual practitioner may prepare a written prescription for the signature of the practitioner, provided that the practitioner, in the usual course of professional practice, has determined that there is a legitimate medical purpose for the prescription and has specified to the agent the required elements of the prescription.
- Where a DEA registered individual practitioner has made a valid oral prescription for a controlled substance in schedules III-V by conveying all the required prescription information to the practitioner’s authorized agent, that agent may telephone the pharmacy and convey that prescription information to the pharmacist.
- In those situations in which an individual practitioner has issued a valid written prescription for a controlled substance, and the regulations permit the prescription to be transmitted by facsimile to a pharmacy, the practitioner’s agent may transmit the practitioner-signed prescription by facsimile.
DEA believes it is in the best interest of the practitioner, the agent, and the dispensing pharmacist that the
designation of those persons authorized to act on behalf of the practitioner and the scope of any such authorization be reduced to writing.
A signed copy authorization should also be provided to
the practitioner’s designated agent, the agent’s employer (if other than the practitioner), and any pharmacies that regularly receive communications from the agent pursuant to the agreement.
Providing a copy of agent authorization to pharmacies likely to receive prescriptions from the agent on the practitioner’s behalf may assist those pharmacists with their…
corresponding responsibility regarding the dispensing of controlled substances.
However, even where the pharmacist has a copy
of an agency agreement, the pharmacist may also have a duty to inquire further depending on
depending upon the particular circumstances.
Does a pharmacist has a corresponding responsibility for the proper dispensing of controlled substances .
yes
An order purporting to be a prescription that is not issued for a legitimate medical purpose in the usual course of professional treatment or in legitimate and authorized research is
an invalid prescription within the meaning and intent of the CSA.
The person knowingly filling such an invalid prescription, as well as the person issuing it, shall be subject to
the penalties provided for violations of the provisions of law relating to controlled substances.
A pharmacist is required to exercise sound professional judgment, and to adhere to
professional standards, when making a determination about the legitimacy of a controlled substance prescription
A determination about the legitimacy of a controlled substance prescription is made before
the prescription is dispensed.
The law does not require a pharmacist to dispense a prescription of
doubtful, questionable, or suspicious medical legitimacy.
The pharmacist who deliberately ignores the high probability that a prescription was not issued for a legitimate medical purpose and fills the prescription, may be
prosecuted along with the issuing practitioner, for knowingly and intentionally distributing controlled substances
Deliberately ignoring the high probability that a prescription was not issued for a legitimate medical purpose and filling the prescription is a
felony offense, which upon conviction, may result in a term of imprisonment and a fine
Unlawful dispensing of controlled substances by a pharmacist may also be subject to criminal actions against the
pharmacy or pharmacist, and to civil enforcement actions against the pharmacy or pharmacist for money penalties or injunctions.
The DEA may revoke a pharmacy’s registration based on a finding that its pharmacists have violated the corresponding responsibility rule and
both the pharmacy and pharmacists may be the subject of proceedings against their state licenses.
Electronic Prescriptions
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