7.1 Patient Counseling: Triggers, Who May Offer or Accept a Refusal & Documentation

Why this matters

Area 2.3 covers "counseling or offering to counsel" and "documenting counseling or documenting offering to counsel." Oregon's rule is OAR 855-115-0145. It is stricter than the federal OBRA '90 Medicaid baseline in some ways and different from many states in others. Exam items focus on when an offer is required, who may make the offer or accept a refusal, and how it is documented.

The federal baseline

The Omnibus Budget Reconciliation Act of 1990 (OBRA '90) required states, as a condition of Medicaid participation, to ensure that pharmacists offer to counsel Medicaid outpatients, perform prospective DUR and maintain patient profiles. Oregon's rules apply those concepts to all patients, regardless of payer.

When counseling must be provided or offered (OAR 855-115-0145(2))

Counseling on the use of a drug or device must be provided or offered to the patient or patient's agent:

1. When the drug or device has not previously been dispensed to the patient by this drug outlet pharmacy.
2. When there has been a change in the dose, formulation or directions.
3. When the prescription has been transferred to this pharmacy, by oral, written or electronic means.
4. For any refill for which the pharmacist decides counseling is necessary.

Regardless of these triggers, the pharmacist must also:

• Decide, for each prescription, the manner and amount of counseling reasonable and necessary for safe and effective use (OAR 855-115-0145(1)).
• Counsel on request (OAR 855-115-0145(4)).

Who may do what

Oregon technicians are licensed by the Board, so they are licensees. They may offer counseling and accept a refusal, but they may never counsel. The common trap is a cashier or other non-licensed employee who asks "Any questions for the pharmacist?" and records a decline. That violates the rule.

Refusals and withholding (OAR 855-115-0145(7))

A pharmacist need not counsel a patient or agent who refuses. If they refuse:

• Only a licensee can accept the request not to be counseled when counseling is required.
• The pharmacist may choose not to release the prescription until counseling is completed, for example for a high-risk drug or a new insulin user.

Documentation (OAR 855-115-0145(9))

Counseling, offers to counsel and declinations must all be documented with the licensee's identity. The Board's self-inspection form asks the PIC to show how this is documented. A signature-pad entry is acceptable only if it records which licensee made the offer or accepted the decline.

Content and setting

The pharmacist decides the content, which typically covers:

• The drug's name and purpose, and the dose, route, duration and technique.
• Special precautions, common and severe side effects and what to do about them.
• Interactions, missed doses, storage, refills and self-monitoring.

Counseling must occur under conditions that maintain privacy and confidentiality (OAR 855-115-0145(8)). Medication Guides, patient package inserts and instructions for use must be provided to supplement counseling when federal law requires them (OAR 855-115-0145(10)). They do not replace it.

Written-only counseling and delivered prescriptions

For mail-order, delivery, locker or kiosk prescriptions where counseling has been given only in writing, the pharmacist must give drug information in a format accessible to the patient. That information must include when the pharmacist is available and how the patient may contact the pharmacist (OAR 855-115-0145(6)).

Specialty settings have their own mechanics:

• Kiosks and lockers: a pharmacist or intern counsels before the drug is released when counseling is required or requested, through telepharmacy for kiosks (OAR 855-141, 855-143).
• Remote dispensing site pharmacies: the pharmacist counsels by real-time audio-video (OAR 855-139).

Language and accessibility

When the patient prefers a language other than English, or communicates in signed language, the pharmacist must work with an OHA-registered health care interpreter unless the pharmacist is proficient in that language (OAR 855-115-0145(5)). The full language-access rules are in section 7.2.

Exam scenario

A patient picks up a refill of atorvastatin that the prescriber has changed from 20 mg to 40 mg. A COPT at the register says, "Your dose changed. Would you like to talk with the pharmacist?" The patient declines. The COPT documents the decline with their own identity. That is lawful: a dose change triggers an offer, the offer and decline were handled by a licensee, and they were documented with the licensee's identity. If a non-licensed cashier had done the same thing, the decline would not be valid, and the pharmacist would have to make or arrange a licensee's offer before release.