Florida Regulations 59A-4.112: Pharmacy Services
Current as of: 2024 | Check for updates
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(1) The nursing home licensee must adopt procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals, to meet the needs of each resident.
(2) As required by the Department of Health, the facility shall employ, or obtain, the services of a state licensed consultant pharmacist. A consultant pharmacist is a pharmacist who is licensed by the Department of Health, Board of Pharmacy and registered as a consultant pharmacist by the Board of Pharmacy in accordance with Rules 64B16-26.300 and 64B16-28.501, F.A.C., and who provides consultation on all aspects of the provision of pharmacy services in the facility.
(3) The consultant pharmacist must establish a system to accurately record the receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation.
(4) The consultant pharmacist must determine that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled.
(5) Prescription drugs and biologicals used in the facility shall be labeled in accordance with currently accepted professional principles, Florida Statutes Chapter 499 and Rules 64B16-28.108 and 64B16-28.502, F.A.C., as required by the Department of Health.
(6) Prescription drugs and non-prescription medications requiring refrigeration must be stored in a refrigerator. The refrigerator must be locked or located within a locked medication room and accessible only to licensed staff.
(7) All controlled substances must be disposed of as required by the Department of Health, Fl. Admin. Code R. 64B16-28.303 All non-controlled substances may be destroyed in accordance with the facility’s policies and procedures. Records of the disposition of all substances shall be maintained in sufficient detail to enable an accurate reconciliation and a copy of the disposition must be filed in the resident’s record or maintained electronically in a readily accessible format.
(8) Non-controlled substances, in unit dose containers, may be returned to the dispensing pharmacy.
(9) If ordered by the resident’s physician, the resident or his or her representative may, upon discharge, take all current prescription drugs with him or her. An inventory list of the drugs released must be completed, shall be dated, and signed by both the person releasing the drugs and the person receiving the drugs, and must be placed in the resident’s record.
(10) The facility shall maintain an Emergency Medication Kit. The kit must contain a limited supply of medications in the facility for use during emergency or after-hours situations. The contents must be determined by the residents’ needs in consultation with the Medical Director, Director of Nursing and Pharmacist and it must be in accordance with facility policies and procedures. The kit must be readily available and kept sealed. All items in the kit must be properly labeled. The licensee must maintain an accurate log of receipt and disposition of each item in the Emergency Medication Kit. An inventory of the contents of the Emergency Medication Kit must be attached to the outside of the kit, which must include the earliest expiration date of the kit drugs. If the seal is broken, the kit must be restocked and resealed the next business day after use.
Rulemaking Authority 400.23, 400.142 FS. Law Implemented 400.141, 400.142, 400.23 FS. History-New 4-1-82, Amended 4-1-84, 7-10-91, Formerly 10D-29.112, Amended 4-18-94, 12-21-15.
(2) As required by the Department of Health, the facility shall employ, or obtain, the services of a state licensed consultant pharmacist. A consultant pharmacist is a pharmacist who is licensed by the Department of Health, Board of Pharmacy and registered as a consultant pharmacist by the Board of Pharmacy in accordance with Rules 64B16-26.300 and 64B16-28.501, F.A.C., and who provides consultation on all aspects of the provision of pharmacy services in the facility.
(3) The consultant pharmacist must establish a system to accurately record the receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation.
(4) The consultant pharmacist must determine that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled.
(5) Prescription drugs and biologicals used in the facility shall be labeled in accordance with currently accepted professional principles, Florida Statutes Chapter 499 and Rules 64B16-28.108 and 64B16-28.502, F.A.C., as required by the Department of Health.
(6) Prescription drugs and non-prescription medications requiring refrigeration must be stored in a refrigerator. The refrigerator must be locked or located within a locked medication room and accessible only to licensed staff.
(7) All controlled substances must be disposed of as required by the Department of Health, Fl. Admin. Code R. 64B16-28.303 All non-controlled substances may be destroyed in accordance with the facility’s policies and procedures. Records of the disposition of all substances shall be maintained in sufficient detail to enable an accurate reconciliation and a copy of the disposition must be filed in the resident’s record or maintained electronically in a readily accessible format.
(8) Non-controlled substances, in unit dose containers, may be returned to the dispensing pharmacy.
(9) If ordered by the resident’s physician, the resident or his or her representative may, upon discharge, take all current prescription drugs with him or her. An inventory list of the drugs released must be completed, shall be dated, and signed by both the person releasing the drugs and the person receiving the drugs, and must be placed in the resident’s record.
(10) The facility shall maintain an Emergency Medication Kit. The kit must contain a limited supply of medications in the facility for use during emergency or after-hours situations. The contents must be determined by the residents’ needs in consultation with the Medical Director, Director of Nursing and Pharmacist and it must be in accordance with facility policies and procedures. The kit must be readily available and kept sealed. All items in the kit must be properly labeled. The licensee must maintain an accurate log of receipt and disposition of each item in the Emergency Medication Kit. An inventory of the contents of the Emergency Medication Kit must be attached to the outside of the kit, which must include the earliest expiration date of the kit drugs. If the seal is broken, the kit must be restocked and resealed the next business day after use.
Rulemaking Authority 400.23, 400.142 FS. Law Implemented 400.141, 400.142, 400.23 FS. History-New 4-1-82, Amended 4-1-84, 7-10-91, Formerly 10D-29.112, Amended 4-18-94, 12-21-15.