N.M. Admin. Code § 16.19.6.27

Current through Register Vol. 35, No. 23, December 10, 2024

Section 16.19.6.27 - AUTOMATED DRUG DISTRIBUTION SYSTEMS IN LICENSED HEALTH CARE FACILITIES

A. Scope: This section applies only to the use of automated drug distribution systems located within the facilities specified in Subsection B of this section.

B. Definitions as used in this section.

(1) "Automated drug distribution system", or "automated medication system" or, "system" means a mechanical system that performs operations or activities, other than compounding or administration, related to the storage, packaging, or dispensing of drugs, and collects, controls, and maintains transaction information and records.

(2) "Health care facility" means a facility licensed under 16.19.11 NMAC or an inpatient hospice facility licensed under 16.19.10.12 NMAC.

(3) "Managing pharmacy" means an in-state retail pharmacy licensed by the board, pursuant to 16.19.6 NMAC that controls and is responsible for the operation of an automated drug distribution system.

(4) "Multi-disciplinary committee" means the pharmacist-in-charge, or the consultant pharmacist, and one or more representatives of the health care facility.

(5) "Override medication" means:

(a) a drug that may be removed from an automated medication system prior to pharmacist review because the multi-disciplinary committee has determined that the clinical status of the patient would be compromised by delay;

(b)a drug determined by the multi-disciplinary committee to have a low risk of drug allergy, drug interaction, dosing error, or adverse patient outcome, which may be removed from an automated medication system independent of a pharmacist's review of the medication order or clinical status of the patient.

C. Authorization: A managing pharmacy may use an automated drug distribution system to supply medications for patients of a health care facility. The automated drug distribution system may be located in a health care facility that is not at the same location as the managing pharmacy. When located within a health care facility, the system is considered to be an extension of the managing pharmacy. When the automated drug distribution system is used to deliver routine doses of controlled substances, the managing pharmacy submit and maintain a separate registration with the drug enforcement administration.

D. Notification: At least 60 days prior to the initial use of an automated drug distribution system, the pharmacist-in-charge of the managing pharmacy must provide the board with written notification of the following:

(1) the physical address at which the automated drug distribution system will be located;

(2) the health facility's board of pharmacy registration type and number;

(3) the managing pharmacy's registration number, address, and pharmacist-in-charge;

(4) written policies and procedures that govern the operation of the system; the policies and procedures must address the requirements of Subsection F of this section and the rules of the board;

(5) the managing pharmacy pharmacist-in-charge must notify the board within 10 days whenever an automated drug distribution system is taken permanently out of service.

E. Operation of automated drug distribution systems: The pharmacist-in-charge shall assure compliance with all requirements of the Pharmacy Act, Drug Device and Cosmetic Act, Controlled Substances Act and be responsible for the following:

(1) maintaining a record of each transaction or operation;

(2) controlling access to the automated medication system;

(3) maintaining policies and procedures for:

(a) operating the automated medication system;

(b) training personnel who use the automated medication system;

(c) maintaining patient services whenever the automated medication system is not operating;

(d) defining a procedure for a pharmacist to grant access to the drugs in the automated medication system or to deny access to the drugs in the automated medication system;

(e) maintaining security of the automated medication system;

(f) assuring that a patient receives the pharmacy services necessary for appropriate pharmaceutical care;

(g) assuring that the automated medication system maintains the integrity of the information in the system and protects patient confidentiality;

(h) establishing a procedure for stocking or restocking the automated medication system; and

(i) insuring compliance with all requirements for packaging, storing, and labeling.

(4) A pharmacist shall perform prospective drug use review and approve each medication order prior to administration of a drug except an override medication.

(5) A pharmacist shall perform retrospective drug use review for an override medication.

(6) The pharmacist-in-charge shall convene or identify a multi-disciplinary committee, which is charged with advising on the operations of the automated medication system.

F.Stocking or restocking of an automated medication system:

(1) responsibility for accurate stocking and restocking of an automated medication system lies with the pharmacist-in-charge and with any pharmacist tasked with supervising such functions;

(2)the stocking or restocking of an automated medication system, where performed by someone other than a pharmacist, shall follow one of the following procedures to ensure correct drug selection:

(a) a pharmacist shall conduct and document a daily audit of drugs placed or to be placed into an automated medication system, which audit may include random sampling;

(b) a barcode verification, electronic verification, or similar verification process shall be utilized to assure correct selection of drugs placed or to be placed into an automated medication system; the utilization of a barcode, electronic, or similar verification process shall require an initial quality assurance validation, followed by a quarterly quality assurance review by a pharmacist; when a barcode verification, electronic verification, or similar verification process is utilized as specified in this section, stocking and restocking functions may be performed by a pharmacy technician or by a registered nurse trained and authorized by the pharmacist-in-charge.

(3) The pharmacist performing the quality assurance review shall maintain a record of the quality assurance process that occurred and the pharmacist approval of the drug stocking, restocking or verification process.

(4) Any drug that has been removed from the automated medication system shall not be replaced into the system unless: the drug's purity, packaging, and labeling have been examined according to established policies and procedures.

G.Quality Assurance Program: The pharmacist-in-charge shall be responsible for implementing and maintaining a quality assurance program for the automated medication system. The program shall provide for:

(1) review of override medication utilization;

(2) investigation and reporting of any medication error related to drugs distributed or packaged by the automated medication system;

(3) review of any discrepancy or transaction reports and identification of patterns of inappropriate use or access of the automated drug distribution system;

(4) review of the operation of the automated medication system;

(5) integration of the automated medication system quality assurance program with the overall continuous quality improvement program of the managing pharmacy; and

(6)assurance that individuals working with the automated medication system receive appropriate training on operation of the system and procedures for maintaining pharmacy services when the system is not in operation.

H.Records: The managing pharmacy pharmacist-in-charge shall maintain, for at least three years, the following records related to the automated medication system in a readily retrievable manner:

(1) managing pharmacy's distribution records for all dangerous drugs, including controlled substances, transferred to each automated medication system

(2) perpetual inventories of controlled substances contained within each automated medication system;

(3) at the time of any event involving the contents of the automated drug distribution system, the device shall automatically produce on demand, a written or electronic record showing:

(a) the date and time of transaction;

(b) the type of transaction;

(c) the nature of the emergency;

(d) the name, strength, and quantity of medication;

(e) the name of the patient for whom the drug was ordered;

(f) the name or identification code (electronic signature) of the person making the transaction;

(g) the name of the prescribing practitioner;

(h) the name of the pharmacist conducting the drug utilization review; and

(i) the identity of the device accessed.

(4) A delivery record shall be generated on demand for all drugs supplied to a facility for use by an automated drug distribution system which shall include:

(a) date of receipt;

(b) drug name;

(c) dosage form;

(d) strength;

(e) quantity;

(f) identity of device; and

(g) documentation of individual accepting delivery.

(5) Any report or analysis generated as part of the quality assurance program required by Subsection G of this section.

I.The multi-disciplinary committee shall:

(1) establish the criteria and process for determining which drug qualifies as an override medication;

(2) develop policies and procedures regarding the operation of the automated drug distribution system;

(3) conduct an annual review of override medications.

N.M. Admin. Code § 16.19.6.27

Reserved by New Mexico Register, Volume XXVI, Issue 10, May 29, 2015, eff. 6/7/2015; Adopted by New Mexico Register, Volume XXVI, Issue 16, August 28, 2015, eff. 9/6/2015