5.1 Patient Counseling: The Offer, Who May Counsel & Delivered Prescriptions

5.1 Patient Counseling: The Offer, Who May Counsel & Delivered Prescriptions

Blueprint item 2.3 covers "counseling or offering to counsel" and "documenting counseling or documenting offering to counsel." Utah's rules come from § 58-17b-613 and R156-17b-610. They are broader than the federal OBRA '90 Medicaid rules (42 U.S.C. § 1396r-8(g)), which were the original model for state counseling laws.

When the offer is required

Under § 58-17b-613(1), a pharmacy must verbally offer to counsel the patient or the patient's agent "in a personal face-to-face discussion regarding each prescription drug dispensed" if the patient or agent:

• delivers the prescription in person to the pharmacist or intern; or
• receives the drug in person at the time it is dispensed at the pharmacy.

R156-17b-610 adds the details:

• The offer must be oral and in person, unless the patient or agent is not at the pharmacy or a specific communication barrier prevents oral communication.
• Counseling may be provided through a telepharmacy system. Remote dispensing pharmacies must post a sign saying a pharmacist will counsel by audio and video on request (R156-17b-614g(9)).
• The pharmacy must offer, but it need not counsel a patient or agent who refuses.
• The offer to counsel must be documented. The documentation must be kept for five years and produced to DOPL within 7–10 business days of a request.

Who may counsel

• Only a pharmacist, pharmacy intern, or DMP may orally counsel a patient and answer questions about prescription drugs (R156-17b-610(5)).
• A technician may not counsel a patient about a prescription drug (R156-17b-601(2)(f)). A technician may counsel on OTC drugs and dietary supplements under the supervising pharmacist's direction (R156-17b-601(1)(j)).
• The statute puts the duty to offer on the "pharmacy." The counseling itself, and answering questions about the drug, must come from a pharmacist, intern, or DMP.

What counseling may cover (R156-17b-610(3))

Based on the professional judgment of the pharmacist, intern, or DMP, counseling may include:

1. the drug's name and description;
2. dosage form, dose, route, and duration of therapy;
3. intended use, if known, and expected action;
4. special directions and precautions for preparation, administration, and use;
5. common severe side effects, adverse effects, interactions, and contraindications, how to avoid them, and what to do if they occur;
6. techniques for self-monitoring;
7. proper storage;
8. refill information;
9. what to do about a missed dose;
10. pharmacist comments relevant to the patient's therapy; and
11. the date after which the drug should not be used (the beyond-use date).

When a drug product equivalent is substituted, the pharmacist or intern must counsel on the use and expected response of the drug, whether or not it is a substitute (§ 58-17b-605(2)(a)(iv)).

Delivered, mailed, and shipped prescriptions

If a pharmacy receives a prescription by means other than personal delivery and dispenses it by means other than personal delivery, it must give the patient (§ 58-17b-613(2)):

• for a Class D pharmacy, a toll-free telephone number for reaching a pharmacist or intern for counseling; or
• for a Class A pharmacy, a telephone number for reaching a pharmacist or intern.

R156-17b-610(6) adds that the counseling information in (3) must be delivered in writing with the prescription. If prescriptions are routinely delivered outside the pharmacy's local calling area, the pharmacy must also put its phone number and this statement on the container or an enclosed sheet: "Written information about this prescription has been provided for you. Please read this information before you take this medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions." The written information should be patient leaflets similar to USP-NF patient information monographs.

A pharmacy that delivers by USPS, common carrier, or its own supportive staff must also have a way to offer counseling by electronic, telephone, or written communication (R156-17b-608(1)(d)).

Exceptions and special cases

Physical setting and penalties

A Class A or B pharmacy must have a counseling area that allows confidential counseling, if applicable (R156-17b-614a(1)(i)). DOPL's fine schedule sets $500–$2,500 for a pharmacist's first failure to offer counseling, $5,000–$10,000 for a subsequent one, and $2,000 per occurrence for a pharmacy.

Scenarios

• In-person refill. A patient picks up the 12th refill of lisinopril at the counter. The pharmacy must still make a verbal offer to counsel and document it.
• Cashier asks "any questions?" A cashier may relay the pharmacy's offer. If the patient asks about the drug, only a pharmacist, intern, or DMP may answer.
• Mail order from Arizona. A Class D pharmacy shipping to Salt Lake City must send written information and give a toll-free number to reach a pharmacist or intern.