Florida Administrative Code › 59 - AGENCY FOR HEALTH CARE ADMINISTRATION › 59A - Health Facility and Agency Licensing › Chapter 59A-3 - HOSPITAL LICENSURE › Section 59A-3.241 - Pharmacy Services

Current through Reg. 50, No. 138; July 16, 2024
Each Class I and Class II hospital shall have on the
				  premises, and each Class III hospital shall have on the premises or by
				  contract, a pharmacy, pharmaceutical department or service, or similarly titled
				  unit, and, when applicable, shall present evidence that it holds a current
				  institutional or community pharmacy permit under the provisions of the Florida
				  Pharmacy Act, chapter 465, F.S. The pharmacy department shall have a licensed
				  pharmacist serve as pharmacy director on a full time or consulting basis. The
				  director shall develop and monitor procedures to ensure the proper use of
				  medications. Such procedures shall address prescription and ordering,
				  preparation and dispensing, administration, and patient monitoring for
				  medication effects.
(1) The director
				shall ensure a hospital formulary or drug list is developed, maintained, and
				regularly updated by authorized hospital staff. The formulary shall include the
				availability of non-legend medications, but does not preclude the use of
				unlisted drugs. Where unlisted drugs are used, there shall be a written policy
				and procedure for their prescription and procurement. Selection of medications
				for inclusion on the formulary shall be based on need, effectiveness, risks,
				and costs.
(2) The director shall
				ensure that individuals who prescribe or order medications are legally
				authorized through the granting of clinical privileges.
(3) All drugs shall be prepared and stored
				under proper conditions of sanitation, temperature, light, moisture,
				ventilation, security and segregation to promote patient safety and proper
				utilization and efficacy.
(4) All
				medications shall be appropriately labeled as to applicable accessory or
				cautionary statements and their expiration date, shall be dispensed in as
				ready-to-administer forms as possible, and in quantities consistent with the
				patient's needs which are designed to ensure minimization of errors and
				diversion.
(5) A pharmacist shall
				review each order before dispensing the medication, with the exception of
				situations in which a licensed independent practitioner with appropriate
				clinical privileges controls prescription ordering, preparation and
				administration of medicine. The pharmacist shall verify the order with the
				prescriber when there is a question.
(6) All medications shall be prepared and
				dispensed consistent with applicable law and rules governing professional
				licensure and pharmacy operation and in accordance with professional standards
				of pharmacy practice.
(7) A
				medication profile shall be developed and maintained by the pharmacy department
				for each patient and shall be available to staff responsible for the patient's
				care. The medication profile shall include the name, birth date, sex, pertinent
				health problems and diagnoses, current medication therapy, medication allergies
				or sensitivities, and potential drug or food interactions.
(8) The director shall develop and implement
				a process for providing medications when the pharmacy is closed that ensures
				control, accountability, and the appropriate use of medications.
(9) The director shall ensure there is an
				adequate and proper supply of emergency drugs within the pharmacy and in
				designated areas of the hospital.
(10) Receipt, distribution and administration
				of controlled drugs are documented by the pharmacy, nursing service and other
				personnel, to ensure control and accountability in accordance with state and
				federal law.
(11) The director
				shall ensure that the administration of drugs shall take place in accordance
				with written policies, approved by the professional staff and designed to
				ensure that all medications are administered safely and efficiently.
(12) The director may supervise satellite
				pharmacies. The director of the hospital pharmacy, or other licensed
				pharmacists who are properly designated, shall be available to the hospital at
				all times, whether on duty or on call.
(13) Administration of drugs shall be
				undertaken only upon the orders of authorized members of the professional
				staff, where the orders are verified before administration, the patient is
				identified, and the dosage and medication is noted in the patient's chart or
				medical record.
(14)
				Investigational medications shall be used only in accordance with specific
				hospital policy which addresses:
(a) Review
				and approval of hospital participation in investigational studies by the
				appropriate hospital committee;
(b)
				Requirements for informed consent by the patient;
(c) Administration in accordance with an
				approved protocol;
(d)
				Administration by personnel approved by the principal investigator after they
				have received information and demonstrated an understanding of the basic
				pharmacologic information about the medications; and
(e) Documentation of doses dispensed,
				administered and destroyed.