Florida Regulations 59A-3.241: Pharmacy Services
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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.
(15) Each hospital shall have a system for the ongoing monitoring of each patient for medication effectiveness and actual or potential adverse effects or toxicity which includes:
(a) A collaborative assessment of the effect of the medication on the patient based on observation and information gathered and maintained in the patient’s medical record and medication profile;
(b) A process for the definition, identification, and review of significant medication errors and adverse drug reactions are reported in a timely manner in accordance with written procedures. Significant adverse drug reactions shall be reported promptly to the Food and Drug Administration;
(c) Information from the medication monitoring is used to assess the continued administration of the medication; and
(d) Conclusions and findings of the medication monitoring are communicated to the appropriate health care personnel involved in the patient’s care.
(16) Each hospital shall have written policies and procedures governing the selection, procurement, distribution, administration, and record-keeping of all drugs, including provision for maintaining patient confidentiality. The policies and procedures shall be reviewed at least annually, dated to indicate time of last review, revised as necessary, and enforced.
(17) Parenteral nutrition services, when provided, shall be designed, implemented, and maintained to address assessment and reassessment of the patient, initial ordering and ongoing maintenance of medication orders, preparation and dispensing, administration, and assessing the effects on the patient.
Rulemaking Authority 395.1055 FS. Law Implemented Florida Statutes § 395.1055. History-New 8-15-18.
Terms Used In Florida Regulations 59A-3.241
- Contract: A legal written agreement that becomes binding when signed.
- Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
(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.
(15) Each hospital shall have a system for the ongoing monitoring of each patient for medication effectiveness and actual or potential adverse effects or toxicity which includes:
(a) A collaborative assessment of the effect of the medication on the patient based on observation and information gathered and maintained in the patient’s medical record and medication profile;
(b) A process for the definition, identification, and review of significant medication errors and adverse drug reactions are reported in a timely manner in accordance with written procedures. Significant adverse drug reactions shall be reported promptly to the Food and Drug Administration;
(c) Information from the medication monitoring is used to assess the continued administration of the medication; and
(d) Conclusions and findings of the medication monitoring are communicated to the appropriate health care personnel involved in the patient’s care.
(16) Each hospital shall have written policies and procedures governing the selection, procurement, distribution, administration, and record-keeping of all drugs, including provision for maintaining patient confidentiality. The policies and procedures shall be reviewed at least annually, dated to indicate time of last review, revised as necessary, and enforced.
(17) Parenteral nutrition services, when provided, shall be designed, implemented, and maintained to address assessment and reassessment of the patient, initial ordering and ongoing maintenance of medication orders, preparation and dispensing, administration, and assessing the effects on the patient.
Rulemaking Authority 395.1055 FS. Law Implemented Florida Statutes § 395.1055. History-New 8-15-18.