64B16-27.800. Requirement for Patient Records

(1) A patient record system shall be maintained by all pharmacies for patients to whom new or refill prescriptions are dispensed. The patient record system shall provide for the immediate retrieval of information necessary for the dispensing pharmacist to identify previously dispensed drugs at the time a new or refill prescription is presented for dispensing. The pharmacist shall ensure that a reasonable effort is made to obtain, record and maintain the following information:

(a) Full name of the patient for whom the drug is intended;

(b) Address and telephone number of the patient;

(c) Patient’s age or date of birth;

(d) Patient’s gender;

(e) A list of all new and refill prescriptions obtained by the patient at the pharmacy maintaining the patient record during the four (4) years immediately preceding the most recent entry showing the name of the drug or device, prescription number, name and strength of the drug, the quantity and date received, and the name of the prescriber; and

(f) Pharmacist comments relevant to the individual’s drug therapy, including any other information peculiar to the specific patient or drug.

(2) The pharmacist shall ensure that a reasonable effort is made to obtain from the patient or the patient’s agent and shall record any known allergies, drug reactions, idiosyncrasies, and chronic conditions or disease states of the patient and the identity of any other drugs, including over-the-counter drugs, or devices currently being used by the patient which may relate to prospective drug review. The pharmacist shall record any related information indicated by a licensed health care practitioner.

(3) A patient record shall be maintained for a period of not less than four (4) years from the date of the last entry in the profile record. This record may be a hard copy or a computerized form.

(4) Patient records shall be maintained for prescriptions dispensed subsequent to the effective date of this regulation.

Rulemaking Authority 465.022, 465.0155 FS. Law Implemented 465.0155, 465.022 FS. History–New 8-18-93, Formerly 21S-27.800, 61F10-27.800, 59X-27.800, Amended 6-15-98, 3-18-15.