Section 1330.700  Patient Counseling

a)         Upon receipt of a new or refill prescription, a prospective drug regimen review or drug utilization evaluation shall be performed.  Prior to dispensing a prescription to a new patient, a new prescription to an existing patient, or a medication that has had a change in the dose, strength, route of administration or directions for use, the pharmacist, or a student pharmacist directed and supervised by the pharmacist, shall provide verbal counseling to the patient or patient's agent on pertinent medication information.  An offer to counsel shall be made on all other prescriptions.  Counseling shall include, but is not limited to:

1)         Name and description of medication;

2)         Dosage form and dosage;

3)         Route of administration;

4)         Duration of therapy;

5)         Techniques for self-monitoring;

6)         Proper storage;

7)         Refill information;

8)         Actions to be taken in cases of missed doses;

9)         Special directions and precautions for preparation, administration and use;

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

b)         If, in the pharmacist's professional judgment, oral counseling is not practicable for the patient or patient's agent, the pharmacist shall use alternative forms of patient information. When used in place of oral counseling, alternative forms of patient information shall advise the patient or agent that the pharmacist may be contacted for consultation in person at the pharmacy or by toll-free or collect telephone service.

c)         Every licensed pharmacy directly serving patients at a physical location must conspicuously post a sign provided by the Division containing a statement that the patient has the right to counseling, the Division's consumer hotline number, information on how to file a complaint for failure to counsel, and any other information the Division deems appropriate. The sign must be printed in color ink or displayed electronically in color, measure at least 8½ x 11 inches in size, and be posted at either a cashier counter or waiting area clearly visible to patients.  Licensed pharmacies that do not maintain a physical location directly serving patients must include a copy of the sign within any dispensed prescriptions.  The sign will be available to download on the Division's website.

d)         The pharmacist is responsible for maintaining patient profiles as defined in Section 3(s) of the Act.  A reasonable effort shall be made to obtain information, including, but not limited to, the following:

1)         Name, date of birth (age), gender, address and telephone number;

2)         Individual history, when significant, including disease state, known allergies, drug interactions, and a comprehensive list of medications and relevant devices; and

3)         Pharmacist's comments relevant to the individual's therapy.

e)         Patient identifiable information obtained by the pharmacist or the pharmacist's designee for the purpose of patient record maintenance, prospective drug review, drug utilization review and patient counseling shall be considered protected health information, as defined in Section 3(cc) of the Act. A pharmacist shall provide counseling related to protected health information in a discreet, supportive and informative manner.

f)         A pharmacist at an on-site or off-site institutional pharmacy shall not be required to provide patient counseling as required in this Section unless drugs are dispensed by the pharmacy upon a patient's discharge from the institution.

g)         Nothing in this Section shall be construed as requiring a pharmacist to provide counseling when a patient or patient's agent refuses such counseling.  When a patient or patient's agent refuses to accept patient counseling as provided in this Section, that refusal shall be documented.

h)         A pharmacist operating a remote pharmacy shall comply with the requirements of this Section.  Counseling in those circumstances shall be done by both video and audio means.

(Source:  Amended at 47 Ill. Reg. 8352, effective June 2, 2023)