5.2 Non-Controlled Prescriptions: Required Elements, Signatures, Expiration & Refills

Why this matters

Area 2.1 covers the "requirements for issuing non-controlled prescriptions" and the "authority limitations of practitioners' ability to authorize refills." Oregon's rules are specific and differ from the federal baseline in tested ways. The patient's date of birth is a required element, a prescriber's agent may sign some orders, a prescription expires after one year, and "PRN" has a defined meaning.

Required elements for every new or refilled prescription (OAR 855-041-1105(2))

Valid signatures for non-controlled prescriptions

• Hard-copy written prescription: a manual signature of the prescriber or the prescriber's agent.
• Fax: a manual or electronic signature of the prescriber or agent.
• Electronic prescription: the electronic signature of the prescriber or agent.

Controlled substances are stricter: an original manual signature of the prescriber on paper and fax, or a DEA-compliant digital signature for electronic orders. "Manually signed" excludes a signature stamp (OAR 855-041-1105(2)(g)(C)).

Oral, electronic and standing-order prescriptions

• An oral prescription must be promptly reduced to writing or entered electronically. The record must show the name, initials or electronic identifier of the licensee receiving it and the name of the person transmitting it (OAR 855-041-1105(3)).
• Electronic transmission must come from an authorized practitioner directly to the pharmacy of the patient's choice, with no intervening person having access to the order (ORS 475.188).
• When a patient relies on an OHA standing order, issued by the Public Health Officer or an OHA-employed physician (for example, for naloxone), the pharmacy need not confirm a patient–practitioner relationship or record the patient's name and date of birth (OAR 855-041-1105(7)).
• Under federal Medicaid law, a written, non-electronic outpatient prescription paid by Medicaid must be on tamper-resistant paper. OAR 855-041-1110 uses the Board's definition of that term.

Alterations and authenticity

Under OAR 855-041-1115, a written prescription altered by anyone other than the pharmacist or practitioner, in any way, is an invalid order unless verified with the prescriber. A pharmacist who clarifies an element by calling the prescriber documents the conversation, the change and the person authorizing it.

How long a prescription lasts (OAR 855-041-1125)

• A non-controlled prescription becomes invalid one year after the date of issue and must be reauthorized.
• "PRN" used alone on a non-controlled prescription means refills in proper context for one year.
• "PRN" used alone on a controlled substance means refills for six months or five refills, whichever comes first.
• "PRN" combined with a definite period or number of refills on a non-controlled prescription still cannot exceed one year.
• No prescription may be refilled out of context with the dosage schedule unless the prescriber specifically authorizes it.

Refill rules (OAR 855-041-1120)

1. Documentation: when refill authority is given other than on the original prescription, record the authorization, its date and the name of the prescriber or agent who gave it.
2. Refill records: each refill is documented with the responsible pharmacist, patient, medication, date and quantity, and kept for three years.
3. Combining refills: refill quantities may be combined into a single fill only if the drug is not a controlled substance or a psychotherapeutic drug and the prescriber is notified.
4. Patient request: a retail pharmacy may refill only on request of the patient or agent, specific to each prescription, unless the refill is part of an auto-refill program.
5. Auto-refill programs, excluding long-term-care cycle fill, are allowed only if:
   • The patient enrolls each prescription.
   • The drug is not a controlled substance.
   • Enrollment ends on request.
   • A prescription that is returned to stock or refused is removed from the program.

Practitioner and pharmacist responsibilities

Under OAR 855-115-0130(1)(c), the pharmacist ensures that every prescription contains the elements in OAR 855-041 before dispensing. A missing element does not always void the order. Missing directions, quantity or strength must be clarified with the prescriber and documented. A missing patient date of birth may be obtained from the patient and recorded.

Exam scenario

A physician's medical assistant faxes a prescription for amoxicillin bearing the assistant's electronic signature as the prescriber's agent. For a non-controlled drug sent by fax, Oregon accepts a manual or electronic signature of the prescriber or the prescriber's agent, so the order is valid if the other elements are present. The same fax for hydrocodone/acetaminophen, a Schedule II drug, would be invalid. A fax for a Schedule II drug is acceptable only in the federal hospice, LTCF and home-infusion exceptions, and only with the prescriber's original manual signature.