1. (1) Upon receipt of a new or refill prescription, the pharmacist shall ensure that a verbal and printed offer to counsel is made to the patient or the patient’s agent when present. If the delivery of the drugs to the patient or the patient’s agent is not made at the pharmacy the offer shall be in writing and shall provide for toll-free telephone access to the pharmacist. If the patient does not refuse such counseling, the pharmacist, or the pharmacy intern, acting under the direct and immediate personal supervision of a licensed pharmacist, shall review the patient’s record and personally discuss matters which will enhance or optimize drug therapy with each patient or agent of such patient. Such discussion shall be in person, whenever practicable, by toll-free telephonic communication, or by an interactive audio and digital image format, and shall include appropriate elements of patient counseling. Such elements may include, in the professional judgment of the pharmacist, the following:

   1. (a) The name and description of the drug;
   2. (b) The dosage form, dose, route of administration, and duration of drug therapy;
   3. (c) Intended use of the drug and expected action (if indicated by the prescribing health care practitioner);
   4. (d) Special directions and precautions for preparation, administration, and use by the patient;
   5. (e) Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;
   6. (f) Techniques for self-monitoring drug therapy;
   7. (g) Proper storage;
   8. (h) Prescription refill information;
   9. (i) Action to be taken in the event of a missed dose;
   10. (j) The potential for physical dependence, addiction, misuse, or abuse; and
   11. (k) Pharmacist comments relevant to the individual’s drug therapy, including any other information peculiar to the specific patient or drug.
2. (2) Patient counseling as described herein, shall not be required for inpatients of a hospital or institution where other licensed health care practitioners are authorized to administer the drug(s).
3. (3) A pharmacist shall not be required to counsel a patient or a patient’s agent when the patient or patient’s agent refuses such consultation.

Rulemaking Authority 465.022, 465.0155 FS. Law Implemented 465.0155 FS. History–New 8-18-93, Formerly 21S-27.820, 61F10-27.820, 59X-27.820, Amended 7-11-18.