6 Colo. Code Regs. § 1011-1-5-19

Current through Register Vol. 47, No. 11, June 10, 2024

Section 6 CCR 1011-1-5-19 - PHARMACEUTICAL SERVICES

19.1 ORGANIZATION

The pharmaceutical services of the facility shall be organized and maintained exclusively for the benefit of the facility's residents.

A) The pharmaceutical service shall be supervised by a consultant pharmacist licensed to practice pharmacy in the State of Colorado.

1) In the event of a conflict between the rules in this section regarding pharmaceutical services and the Colorado Board of Pharmacy rules at 3 CCR 719-1, the latter shall control.

B) All compounding and dispensing shall be from a pharmacy licensed by the Colorado Board of Pharmacy in accordance with all pharmacy laws and regulations.

19.2 ADVISORY COMMITTEES

A) The facility shall establish a pharmaceutical advisory committee that includes a registered nurse, the consulting pharmacist and the medical director, to assist in the formulation of professional policies and procedures relating to pharmaceutical service in the facility.

B) The facility shall establish a psychotropic advisory committee that includes, at a minimum, a registered nurse, the consulting pharmacist, the medical director and a social worker.

19.3 MEDICATION REQUISITION AND STORAGE POLICIES

The facility shall designate in written policies, approved by the governing body, the person authorized to requisition, receive, control and manage medications.

A) Resident medications shall be obtained from a licensed pharmacy on an individual prescription basis for each resident.

B) Medications brought into a facility by a resident shall be in the original packaging with legible directions for administration.

C) Unless the facility uses a unit dose system, each resident medication shall be stored in individual, originally received containers or "blister" or "bubble" cards that are clearly and legibly labeled with the medication name, strength, dosage frequency and mode of administration; date of issue and expiration; name of prescribing practitioner or dentist; dispensing pharmacy name, address and telephone number; and the full name of the resident for whom the medication is prescribed.

D) The facility shall protect each resident's medications from use by other residents, visitors, and staff.

19.4 CONSULTING PHARMACIST

The facility shall contract in writing with a licensed pharmacist or pharmacy to provide consultant pharmacist service to be responsible for all pharmaceutical matters in the facility. The contract shall set forth the fees to be paid for services and the pharmacist's responsibilities, including at least the following:

A) Legal compounding;

B) Prompt dispensing of properly labeled individual resident prescriptions;

C) Inventory control;

D) Establishment of necessary records;

E) Periodic inspection of all pharmaceutical supplies, medications and procedures on all resident care units including inspection of prescription labels, expiration dates, storage and emergency kit procedures;

F) Provision of an emergency medical kit, which remains the property of a licensed pharmacy approved by the pharmaceutical advisory committee and the Colorado State Board of Pharmacy;

G) Regularly scheduled visits and consultations and at least annual in-service training to staff;

H) Determination of proper procurement and maintenance of all prescriptions and other medications;

I) Development of proper accounting procedures for controlled substances and legend medications;

J) Evaluation of the policies of the pharmaceutical advisory committee; and

K) Quarterly reports to the pharmaceutical advisory committee on the status of pharmacy services.

19.5 TELEHEALTH

The consulting pharmacist may utilize telehealth for the performance of any task set forth in these regulations except those tasks where the regulations specifically require in-person inspection or face to face evaluation.

19.6 CONTROLLED SUBSTANCES

Only practitioners authorized under the laws of the State of Colorado and properly registered with the federal government shall prescribe controlled substances. The facility shall comply with all federal and state laws and regulations relating to procurement, storage, administration and disposal of controlled substances. Unless the facility uses a unit dose system, it shall maintain a record on a separate sheet for each resident receiving a controlled substance, which contains the name of the controlled substance; strength and dosage; date and time administered; resident name; name of prescribing physician or advance practice nurse; signature of person administering and the quantity of the controlled substance remaining.

19.7 INVESTIGATIONAL MEDICATIONS

A) If investigational medications are used, policies and procedures shall be developed and implemented for safe and proper use.

B) Investigational medications shall be used only:

1) When there is written approval of an Institutional Review Board (IRB), established in accordance with federal law and regulation; and

2) Under the supervision of a member of the medical staff and administered in accordance with an IRB approved protocol.

19.8 DISPOSITION OF MEDICATIONS, MEDICAL DEVICES AND MEDICAL SUPPLIES

A) If controlled substances (Schedules 2 through 5) are being held by a facility on behalf of a resident and the controlled substances are no longer needed, the facility shall conduct on-site destruction of the controlled substances as follows:

1) The facility shall properly inventory the destruction and keep the inventory copy on file for at least two years;

2) Destruction of controlled substances shall be witnessed and documented in writing by the administrator or designee and two clinically licensed individuals; and

3) The destruction shall be performed in a manner that renders the controlled substances totally irretrievable.

B) Once a DEA controlled substance, or any medication requiring disposal, has been rendered totally irretrievable, the facility shall comply with all applicable federal, state, and local laws including solid and hazardous waste disposal regulations.

C) If a facility meets the criteria in 6 CCR 1011-1, Chapter 2, Part 7.202, it may return unused medications or medical supplies and used or unused medical devices to a pharmacist within the facility or to a prescription drug outlet in order for the materials to be re-dispensed to another resident or patient, or donated to a nonprofit entity that has the legal authority to possess the materials or to a practitioner authorized by law to dispense the materials.

1) A person or entity is not subject to civil or criminal liability or professional disciplinary action for donating, accepting, dispensing or facilitating the donation of material in good faith, without negligence, and in compliance with Colorado law.

19.9 MEDICATION RELEASE

Upon discharge, the facility staff shall release medications to a resident only with written practitioner authorization.

19.10 RESIDENT MEDICATION PROFILE RECORD

The dispensing pharmacist shall maintain medication profile records on each resident for whom medications are dispensed.

6 CCR 1011-1-5-19