64B16-27.410: Pharmacy Technician 1:1 Ratio
PURPOSE AND EFFECT: The Board proposes the rule amendment to provide a substantial re-write of the rule.
SUMMARY: Substantial re-write of the rule.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared. The Board determined the proposed rule will not have an impact on small business.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 465.005 FS.
LAW IMPLEMENTED: 465.014, 893.07(1)(b) FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca R. Poston, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3253
THE FULL TEXT OF THE PROPOSED RULE IS:
64B16-27.410 Registered Pharmacy Technician, to Pharmacist 1:1 Ratio.
(1) Registered pPharmacy technicians may assist a Florida licensed pharmacist in performing professional services within a community pharmacy or institutional pharmacy environment provided that no licensed pharmacist shall supervise more than one registered pharmacy technician unless otherwise permitted by the Florida Board of Pharmacy. A pharmacist’s supervision of a registered pharmacy technician in a 1:1 ratio working environment requires that a registered pharmacy technician be under the direct and immediate personal supervision of a Florida licensed pharmacist. All pharmacy technicians shall identify themselves as pharmacy technicians by wearing a type of identification badge that is clearly visible which specifically identifies the employee by name and by status as a “pharmacy technician”, and in the context of telephone or other forms of communication, pharmacy technicians shall state their names and verbally identify themselves (or otherwise communicate their identities) as pharmacy technicians. Pursuant to the direction of the licensed pharmacist, pharmacy technicians may engage in the following functions to assist the licensed pharmacist:
(1) Prepackaging and labeling of unit and multiple dose packages pursuant to appropriate procedures. The pharmacist shall directly supervise and conduct in-process and final checks, and affix his/her initials to the record. Such pharmacy technician activities would include the maintenance of control records;
(2) The prescription department manager or consultant pharmacist of record is required to submit a written request and receive approval prior to the pharmacy’s allowing a pharmacist to supervise more than one registered pharmacy technician as permitted by law. Such requests shall be reviewed and pre-approved by Board staff according to the guidelines adopted herein, and submitted to the Board for ratification. Assist the pharmacist in the preparation of the prescription. Such pharmacy technician functions include the typing of prescription labels on a typewriter or through entry into a computer system and the entry of prescription information or physicians’ orders into a computer system. The pharmacist, however, must complete the dispensing act and initial the prescription;
(3) The request to practice with a ratio greater than 1:1 shall include a brief description of the workflow needs that justify the ratio request. The brief description of workflow needs shall include the operating hours of the pharmacy, number of pharmacists, registered interns, and registered pharmacy technicians employed. Assist in the preparation of products in a pharmacy where such products are not directly dispensed and administered to the patient and when done pursuant to appropriate procedures under the direct and immediate supervision of a pharmacist who shall conduct in-process and final checks;
(4) A pharmacy that employs pharmacy technicians shall meet the following conditions: Issue supplies and other products from an institutional pharmacy to physicians, nursing homes, and other departments in institutions, pursuant to appropriate procedures.
(a) Establish written job descriptions, task protocols, and policies and procedures that pertain to duties performed by the registered pharmacy technician and provide this information to the Board upon request;
(b) Establish that each registered pharmacy technician is knowledgeable in the established job descriptions, task protocols, and policy and procedures in the pharmacy setting in which the technician is to perform his or her duties;
(c) Ensure that the duties assigned to any registered pharmacy technician do not exceed the established job descriptions, task protocols, and policy and procedures, nor involve any of the prohibited tasks in Rule 64B16-27.420, F.A.C.; or
(d) Ensure that each registered pharmacy technician receives employer-based or on-the-job training in order for the registered pharmacy technician to assume his or her responsibilities and maintain documentation of the training.
(5) The pharmacy shall maintain a policy and procedure manual with regard to registered pharmacy technicians which shall include the following: Initiate communication to a prescribing practitioner or their medical staffs (or agents) regarding patient prescription refill authorization requests. Such pharmacy technician activities allow initiating calls to the practitioner or agent, communicating the refill request and confirming the patients’ name, medication, strength, quantity, directions and date of last refill. Any response to the above refill request that indicates a change in the order must be directly received by the pharmacist and/or pharmacy intern.
(a) Supervision by a pharmacist;
(b) Minimum qualifications as established by law;
(c) Documentation of in-service education and/or on-going training and demonstration of competency, specific to practice site and job function;
(d) General duties and responsibilities of registered pharmacy technicians;
(e) Retrieval of prescription files, patient files, patient profile information and other records pertaining to the practice of pharmacy;
(f) All functions related to prescription processing;
(g) All functions related to prescription legend drug and controlled substance ordering and inventory control, including procedures for documentation and recordkeeping;
(h) Prescription refill and renewal authorization;
(i) Registered pharmacy technician functions related to automated pharmacy systems; and
(j) Continuous quality improvement program.
(6) Under the direction and supervision of a licensed pharmacist, initiate communication to a prescribing practitioner or their medical staff (or agents) to obtain clarification on missing or illegible dates, prescriber name, brand/generic preference, quantity or DEA and/or license numbers. Nothing in this rule shall be construed to allow a technician to obtain information which will result in a change concerning a dosage or directions to the patient.
Rulemaking Specific Authority 465.005 FS. Law Implemented 465.014, 893.07(1)(b) FS. History–New 2-14-77, Amended 3-31-81, Formerly 21S-4.02, Amended 8-31-87, Formerly 21S-4.002, Amended 9-9-92, Formerly 21S-27.410, 61F10-27.410, Amended 1-30-96, Formerly 59X-27.410, Amended 2-23-98, 10-15-01, ________.