La. Admin. Code tit. 48 § I-4557

Current through Register Vol. 50, No. 9, September 20, 2024

Section I-4557 - Pharmaceutical Services

A. The ASC shall provide pharmacy services commensurate with the needs of the patients and in conformity with state and federal laws. Pharmacy services may be provided directly by the ASC or under a contractual agreement as long as all regulatory requirements are met.

1. At a minimum, the ASC shall designate a qualified and licensed healthcare professional to provide direction to the ASCs pharmaceutical service.

B. All ASCs shall have a controlled dangerous substance license issued by the Board of Pharmacy and a Drug Enforcement Agency (DEA) license allowing for the ordering, storage, dispensing and delivery of controlled substances to patients.

C. Drugs and biologicals shall be provided safely and in an effective manner, consistent with accepted professional standards of pharmaceutical practice.

D. When the ASC provides pharmaceutical services, there shall be a current permit issued by the Board of Pharmacy.

E. The designated licensed healthcare professional responsible for pharmaceutical services shall maintain complete, current and accurate records of all drug transactions by the pharmacy.

1. Current and accurate records shall be maintained on the receipt, distribution, dispensing and/or destruction of all scheduled drugs in such a manner as to facilitate complete accounting for the handling of these controlled substances.

F. Dispensing of prescription legend or controlled substance drugs directly to the public or patient by vending machines is prohibited.

G. Medications are to be dispensed only upon written or verbal orders from a licensed medical practitioner. All verbal orders shall be taken by a licensed medical professional.

H. The designated licensed healthcare professional responsible for pharmaceutical services shall assist the center in the development of policies and procedures to:

1. address the distribution, storage and handling of drugs;

2. monitor drug and medication-related activities; and

3. immediately notify the director of nurses to return drugs to the pharmacy or contracted pharmacist for proper disposition in the event of a drug recall.

I. The designated licensed healthcare professional responsible for pharmaceutical services shall assist the ASC with drug administration errors, adverse drug reactions and incompatibilities of medications, and shall report data relative to these issues to the quality assessment performance improvement committee.

J. The designated licensed healthcare professional responsible for pharmaceutical services shall assist the ASC in developing a formulary of medications that will be available for immediate patient use.

K. The designated licensed healthcare professional responsible for pharmaceutical services shall ensure that medication and supplies are on-site at all times and immediately available for the management of malignant hyperthermia, where applicable, based upon the type and level of anesthesia delivered and all other anesthesia-related complications.

L. The consultant pharmacist shall provide consultation to the ASC on an as needed basis and consistent with provisions of the state Board of Pharmacy. The consultations shall be documented in writing showing the date, amount of time spent, subjects reviewed and recommendations made.

M. All drug errors, adverse drug reactions and incompatibilities of medications shall be entered into the patients medical record and reported according to federal and state laws and per ASC policy and procedure.

N. The ASC shall provide for a drug administration storage area which allows for the proper storage, safeguarding and distribution of drugs. All drug cabinets or drug storage areas at the nursing station(s) are to be constructed and organized to ensure proper handling and safeguard against access and removal by unauthorized personnel. All drug cabinets or drug storage areas are to be kept clean, in good repair and are to be inspected each month by a designated licensed healthcare professional responsible for pharmaceutical services. Compartments appropriately marked shall be provided for the storage of poisons and external use drugs and biological, separate from internal and injectable medications.

O. All drug storage areas shall have proper controls for ventilation, lighting and temperature. Proper documentation shall be maintained relative to routine monitoring of temperature controls.

P. Drugs and biologicals that require temperature controlled refrigeration shall be refrigerated separately from food, beverages, blood and laboratory specimens.

Q. Locked areas that maintain medications, including controlled substances, shall conform to state and federal laws and the ASCs policies and procedures.

R. Unit dose systems shall include on each unit dose the:

1. name of the drug;

2. strength of the drug;

3. lot and control number or equivalent; and

4. expiration date.

S. Outdated, mislabeled or otherwise unusable drugs and biologicals shall:

1. be separated from useable stock;

2. not be available for patient use or other use; and

3. be returned to an authorized agency for credit or destroyed according to current state and/or federal laws as applicable.

T. Abuses and losses of controlled substances shall be reported to the individual responsible for pharmaceutical services, the chief executive officer or administrator, the director of nurses, the Board of Pharmacy, and to the Regional DEA office, and according to ASC policy and procedure.

U. Any medications administered to a patient shall be administered only as ordered by a licensed medical practitioner and shall have documentation entered into the patients medical record of the name of the drug, amount, route, the date and time administered, response and/or any adverse reactions to medications.

La. Admin. Code tit. 48, § I-4557

Promulgated by the Department of Health, Bureau of Health Services Financing, LR 431746 (9/1/2017).

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:2131-2141.