Authority: IC 25-26-13-4

Affected: IC 25-26-13-16

Sec. 2. (a) Upon the receipt of a prescription or upon the subsequent refilling of a prescription, and following a review of the patient's prescription medication profile, the pharmacist shall be responsible for the initiation of an offer, as set forth in section 1.5(a) of this rule, to counsel the patient on matters that, in the pharmacist's professional judgment, are significant to optimizing drug therapy. Depending upon the situation, these matters may include, but are not necessarily limited to, the following:

1. (1) The name and description of the medicine.
2. (2) The route, dosage form, dosage, route of administration, and duration of drug therapy.
3. (3) Special directions and precautions.
4. (4) Common adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance and the action required if they occur.
5. (5) Techniques for self-monitoring drug therapy.
6. (6) Proper storage.
7. (7) Prescription refill information.
8. (8) Action to be taken in the event of a missed dose.

(b) Counseling shall be in person, whenever practicable, or through access to a telephone service that is toll-free for long distance calls and be held with the patient, the patient's caregiver, or the patient's representative.

(c) Alternative forms of patient information may be used to supplement verbal counseling when appropriate. Examples include written information leaflets, pictogram labels, and video programs. Nothing in this subsection shall be construed to mean that supplements may be a substitute for verbal counseling when verbal counseling is practicable.

(d) Nothing in this rule shall be construed as requiring a pharmacist to provide counseling when a patient knowingly declines (waives) the offer to counsel.

(e) Requesting or accepting, or both, a waiver for counseling for all prescriptions both present and future is not permitted. An offer must be made with each prescription-dispensing visit.

(f) The patient's declining of counseling must be documented in either written or electronic format. The required documentation may be on the same form as or with another pharmacy-related authorization, only if it is clear to the patient that the documentation form also contains the patient's intent to decline (waive) counseling. The documentation subject to this section shall be retained in the pharmacy licensed area or in a secure area under the pharmacy's control, which is readily available for inspection, for a period of not less than two (2) years.

(Indiana Board of Pharmacy; 856 IAC 1-33-2; filed Dec 1, 1992, 5:00 p.m.: 16 IR 1176; readopted filed Nov 13, 2001, 3:55 p.m.: 25 IR 1330; filed Jun 7, 2004, 4:45 p.m.: 27 IR 3073; readopted filed Nov 17, 2010, 9:52 a.m.: 20101215-IR-856100407RFA; readopted filed Nov 22, 2016, 12:27 p.m.: 20161221-IR-856160320RFA; readopted filed Nov 22, 2022, 12:28 p.m.: 20221221-IR- 856220258RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)