Iowa Admin. Code r. 657-6.14

Current through Register Vol. 47, No. 8, October 30, 2024

Rule 657-6.14 - Patient counseling and instruction

Every pharmacy that is open to the public and located in Iowa shall post in every prescription pickup area, including in every drive-through prescription pickup lane, in a manner clearly visible to patients, a notice that Iowa law requires the pharmacist to discuss with the patient any prescriptions dispensed to the patient that are new or a change in drug therapy.

(1)Counseling required. Upon receipt of a new prescription drug order, or upon receipt of a change in drug therapy including but not limited to a change of dose, directions, or drug formulation, and following a prospective drug use review pursuant to rule 657-8.21 (155A), a pharmacist or pharmacist-intern shall counsel each patient or patient's caregiver. An offer to counsel shall not fulfill the requirements of this rule. Patient counseling shall be on matters which, in the pharmacist's professional judgment, will enhance or optimize drug therapy. Appropriate elements of patient counseling may include:

a. The name and description of the drug;

b. The dosage form, dose, route of administration, and duration of drug therapy;

c. Intended use of the drug, if known, and expected action;

d. Special directions and precautions for preparation, administration, and use by the patient;

e. Common severe side effects or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;

f. Techniques for self-monitoring drug therapy;

g. Proper storage;

h. Prescription refill information;

i. Action to be taken in the event of a missed dose;

j. Pharmacist comments relevant to the individual's drug therapy including any other information peculiar to the specific patient or drug.

(2)Instruction. A pharmacist may instruct patients and demonstrate procedures for self-monitoring of medical conditions and for self-administration of drugs.

(3)Counseling area. A pharmacy shall contain an area which is suitable for confidential patient counseling. Such area shall:

a. Be easily accessible to both patient and pharmacists and not allow patient access to prescription drugs;

b. Be designed to maintain the confidentiality and privacy of the pharmacist/patient communication.

(4)Remote counseling. Patient counseling that is provided by the pharmacy via a pharmacist who is at a location other than the licensed pharmacy shall be provided via a real-time interactive communication mechanism.

(5)Oral counseling not practicable. If in the pharmacist's professional judgment oral counseling is not practicable, the pharmacist may select and use alternative forms of patient information which shall include information for the patient or patient's caregiver to contact the pharmacist for further consultation. The manner in which the patient or caregiver contacts the pharmacist shall not cause the patient to incur any expense. "Not practicable" refers to patient variables including, but not limited to, the absence of the patient or patient's caregiver, the patient's or caregiver's hearing disorder, or a language barrier. "Not practicable" does not include pharmacy variables such as inadequate staffing, technology failure, or high prescription volume. A combination of oral counseling and alternative forms of counseling is encouraged.

(6)Exception. Patient counseling, as described above, shall not be required for inpatients of an institution where other licensed health care professionals are authorized to administer the drugs.

(7)Refusal of consultation. A pharmacist shall not be required to counsel a patient or caregiver when the patient or caregiver refuses such consultation. A patient's or caregiver's refusal of consultation shall be documented by the pharmacist. The absence of any record of a refusal of the pharmacist's attempt to counsel shall be presumed to signify that counseling was provided.

Iowa Admin. Code r. 657-6.14

ARC 8540B, IAB 2/24/10, effective 4/1/10;ARC 9910B, IAB 12/14/11, effective 1/18/12

Amended by IAB February 14, 2018/Volume XL, Number 17, effective 3/21/2018

Amended by IAB September 22, 2021/Volume XLIV, Number 6, effective 10/27/2021

Amended by IAB July 27, 2022/Volume XLV, Number 2, effective 8/31/2022