5.4 Drug-Use Limitations & Special Prescriptions: REMS, Death with Dignity, EPT & Standing Orders

Why this matters

Area 2.1 begins with "requirements for drug uses, limitations, or restrictions." This part of the blueprint asks when a drug may lawfully be prescribed or dispensed for a particular use, and which Oregon programs change the usual prescription rules. Oregon has several unusual ones: the Death with Dignity Act, expedited partner therapy, OHA standing orders, and rules on cannabinoids and psilocybin.

FDA approval, off-label use and REMS

• The FDA approves a drug and its labeling. Once a drug is approved, a licensed prescriber may prescribe it for an unapproved (off-label) use within the practice of medicine. The pharmacist's DUR (OAR 855-115-0140) still asks whether the dose, duration and indication are appropriate.
• Drugs with a Risk Evaluation and Mitigation Strategy (REMS) may carry Elements to Assure Safe Use. These can include prescriber or pharmacy certification, patient enrollment, laboratory verification before dispensing, or restricted distribution. The iPLEDGE program for isotretinoin is a classic example. A pharmacy may dispense a REMS drug only if it meets the program's requirements.
• Medication Guides must be provided when FDA requires them. Oregon's counseling rule says these materials supplement counseling (OAR 855-115-0145(10)).

Oregon Death with Dignity Act (ORS 127.800–127.897)

Oregon lets a capable adult with a terminal disease obtain medication to end their life under strict procedural safeguards. Pharmacy-relevant rules:

1. The attending physician may dispense directly if registered as a dispensing physician with the Oregon Medical Board and holding a DEA registration. Otherwise, with the patient's written consent, the physician contacts a pharmacist about the prescription and delivers the written prescription personally or by mail. The pharmacist then dispenses to the patient, the attending physician, or an expressly identified agent of the patient (ORS 127.815).
2. Within 10 calendar days of dispensing, the dispensing provider files the OHA Pharmacy Dispensing Record Form with the State Registrar (OAR 333-009-0010). The form records the patient's name and date of birth, the prescriber, the dispensing provider, the medication and quantity, and the dates written and dispensed.
3. Death with Dignity dispensing is not reported to the PDMP (ORS 431A.860(2)), and the pharmacy must report under the Act (OAR 855-115-0130).
4. No health care provider has a duty to participate (ORS 127.885(4)). A provider may refuse, and a facility may bar participation on its premises if it has given notice. Good-faith participation is protected from civil, criminal and disciplinary liability (ORS 127.885(1)–(2)).

Expedited partner therapy (ORS 676.350)

Expedited partner therapy is prescribing or dispensing antibiotics for a sexually transmitted infection to a patient's partner without examining the partner. Boards may permit it by rule, in consultation with OHA. A prescription issued under expedited partner therapy is valid even if the partner's name is not on it. ORS 689.505(5)(d) waives the patient-name label requirement for such a prescription. The pharmacist still performs DUR and counseling to the extent possible.

Standing orders and public-health programs

• OHA's Public Health Officer, or an OHA-employed physician, may issue standing orders, for example for short-acting opioid antagonists (ORS 689.808). A pharmacy filling a standing order need not confirm a patient–practitioner relationship or record a patient name and date of birth (OAR 855-041-1105(7)).
• A pharmacist must dispense a short-acting opioid antagonist on request under an OHA standing order (ORS 689.808(3)).
• Local health department nurses may dispense certain drugs, for caries prevention, birth control and communicable disease, under joint Board–OHA rules (ORS 689.605(6)).

Cannabinoids, marijuana and psilocybin

• An Oregon pharmacist may dispense an FDA-approved prescription drug containing cannabinoids, such as dronabinol, pursuant to a prescription (ORS 689.692).
• A pharmacy does not dispense marijuana items. If a customer leaves a marijuana item at a retail drug outlet, staff follow the Board's disposal instructions, which require notifying law enforcement and destroying the item. ORS 689.557 exempts them from state criminal liability for possession while doing so.
• Psilocybin services are licensed by OHA under ORS chapter 475A. They are not a pharmacy activity, and psilocybin remains federally Schedule I.

Other limits on drug use

• A controlled substance may be dispensed only for a medical purpose, and a pharmacist dispenses controlled substances only in good faith in the course of professional practice (ORS 475.185(4)–(5)).
• Practitioners other than pharmacists who dispense drugs from their offices must register as a Dispensing Practitioner Drug Outlet (OAR 855-043) and follow labeling and record rules.
• Pharmacist prescribing is itself limited. A pharmacist may not prescribe under the formulary or protocols for themselves, and must refer whenever a protocol requires it (OAR 855-115-0335).

Exam scenario

An attending physician calls an Oregon pharmacy and says a terminally ill patient has completed the Death with Dignity process. The physician mails the written prescription, with the patient's written consent to involve the pharmacist. The pharmacist on duty has a conscientious objection. ORS 127.885(4) imposes no duty to participate, so the pharmacist may decline, and the pharmacy should arrange for another pharmacist or pharmacy if it chooses to participate. If a pharmacist dispenses the order, the dispensing record goes to OHA within 10 calendar days, and the prescription is not reported to the PDMP.