Tenn. Comp. R. & Regs. 1140-03-.01

Current through September 10, 2024

Section 1140-03-.01 - RESPONSIBILITIES FOR PHARMACEUTICAL CARE

(1) Patient counseling

(a) Upon the receipt of a medical or prescription order and following a review of the patient's record, a pharmacist shall personally counsel the patient or caregiver "face-to-face" if the patient or caregiver is present. If the patient or caregiver is not present, a pharmacist shall make a reasonable effort to counsel through alternative means.

(b) Alternative forms of patient information may be used to supplement, but not replace, face-to-face patient counseling.

(c) Patient counseling, as described herein, shall also be required for outpatients of hospitals or other institutional facilities dispensing medical and prescription orders and for patients when medications are dispensed on discharge from the hospital or other institutional facility.

(d) Patient counseling as described in this rule shall not be required for inpatients of an institutional or long term care facility.

(e) Patient counseling shall cover matters, which in the exercise of the pharmacist's professional judgement, the pharmacist deems significant including:

1. The name and description of the medication;

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

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

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

5. Techniques for self-monitoring drug therapy;

6. Proper storage;

7. Prescription refill information; and

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

(f) Upon the receipt of a request for a refill of a medical or prescription order, a pharmacist or a person designated by the pharmacist shall offer for the pharmacist to personally counsel the patient or caregiver. Counseling as described in (e) above is not required unless requested by the patient or deemed necessary in the professional judgment of the pharmacist.

(g) A pharmacist shall not be required to counsel a patient or caregiver when the patient or caregiver refuses such counseling.

(2) Patient Profiling.

(a) A patient's record system shall be maintained by all pharmacy practice sites for patients for whom medical and prescription orders are dispensed. The patient's record system shall provide for the immediate retrieval of information necessary for the pharmacist to identify previously dispensed medical and prescription orders at the time a medical or prescription order is presented.

(b) In order to effectively counsel patients, the pharmacist or a person designated by the pharmacist shall, through communication with the patient, caregiver, or agent make a reasonable effort to obtain, record, and maintain the following information for each patient of the individual pharmacy practice site.

1. Name, address, telephone number.

2. Date of birth (age), gender.

3. An individual history where significant, including disease state or states, known allergies and drug reactions, and a comprehensive list of medications and relevant devices.

4. Pharmacist's comments as deemed relevant. This may be done manually or by computer.

(3) Drug Regimen Review.

(a) A pharmacist shall be responsible for a reasonable review of a patient's record prior to dispensing each medical or prescription order. The review shall include evaluating the medical and prescription order for:

1. Over-utilization or under-utilization;

2. Therapeutic duplication;

3. Drug-disease contraindication;

4. Drug-drug interactions;

5. Incorrect drug dosage or duration of drug treatment;

6. Drug-allergy interactions;

7. Clinical abuse/misuse.

(b) Upon recognizing any of the above, the pharmacist shall take appropriate steps to avoid or resolve the problem.

(4) Implementation of Pharmaceutical Care.

(a) As a necessary health care provider, pharmacists shall carry out, in addition to the responsibilities in paragraphs (1) through (3) of this rule, those professional acts, professional decisions and professional services necessary to maintain a patient's pharmacy-related care and to implement and accomplish the medical and prescription orders of licensed practitioners, including but not limited to:

1. Developing a working and collaborative relationship with licensed practitioners to enable the pharmacist to accomplish comprehensive management of a patient's pharmacy related care and to enhance a patient's wellness, quality of life and optimize outcomes; and

2. Communicating to the health care provider any knowledge of unexpected or adverse response to drug therapy, or resolving unexpected or adverse response; and

3. Having a pharmacist accessible at all times to patients and healthcare providers to respond to their questions and needs.

4. Where formally defined, providing patient care services consistent with a collaborative pharmacy practice agreement.

Tenn. Comp. R. & Regs. 1140-03-.01

Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendments filed November 22, 2016; effective 2/20/2017.

Authority: T.C.A. §§ 63-10-204, 63-10-217, 63-10-304, 63-10-404(19), (22), (23), (26), and (34), 63-10-504(b)(1) and (2), 63-10-504(j), and 63-10-504(c).