N.M. Admin. Code § 16.19.7.11

Current through Register Vol. 35, No. 20, October 22, 2024

Section 16.19.7.11 - DRUG DISTRIBUTION AND CONTROL

A. In hospitals where there is not a pharmacy, prelabeled, prepackaged medications shall be stored in and distributed from a drug storage area or automated medication management system, which is under the supervision of a pharmacist.

B. The pharmacist-in-charge shall have the responsibility for the procurement and storage of all drugs.

C. All medications, with the exception of those for emergency use, shall be issued for inpatients use pursuant to the review of the physician's order or direct copy thereof, prior to dispensing. If the pharmacy is closed when the order is written, the pharmacist shall review the order within 24 hours.

D. A medication profile for all inpatients and outpatients shall be maintained and used. The medication profile shall serve as the distribution record for inpatient medications. Dangerous drug distribution records, for inpatient use, must include the following information:

(1) the patient's name and room (or bed) number;

(2) the name, strength, quantity and dosage form of the drug distributed;

(3) the name of the technician filling the drug order and pharmacist responsible for checking the technician's work; or

(4) the name of the pharmacist or pharmacist intern filling the drug order;

(5) the date filled; and

(6) the date and amount of unwanted/ unused drug returned to the pharmacy stock;

(7) records for schedule II controlled substances must be kept separate; and

(8) schedule III-V must be kept separate or if stored with non-controlled records, readily retrievable.

E. Floor stock dangerous drug distribution records must include the following:

(1) name, strength, dosage form, and quantity of the drug distributed;

(2) date of filling;

(3) a name of technician filling the drug order and the supervising pharmacist; or

(4) the name of the pharmacist or pharmacist intern filling the drug order;

(5) the destination location of the drug in the hospital; and

(6) the date and quantity of unwanted/ unused drug returned to the pharmacy's stock;

(7) schedule II controlled substance records must be kept separate from all other records; and

(8) schedule IV controlled substance records must either be kept separate from other non-controlled substances records or are readily retrievable.

F. Dangerous drug distribution records, inpatient and floor stock, and medication profiles may be stored electronically if such system is capable of producing a printout of all the required information and the information is retrievable within 72 hours upon demand. The pharmacist stating that it is a true and accurate record must certify the printout. Hospitals utilizing automated drug distribution must comply with Subsection M of 16.19.7.11 NMAC in lieu of the above. Hospital pharmacies are subject to all applicable state and federal record keeping requirements when a prescription from a licensed practitioner is filled.

G. A distribution system for controlled substances shall be maintained including perpetual inventory of all schedule II controlled substances. All schedule II controlled substances that are stored in the pharmacy will be kept in a locked storage area in the pharmacy.

H. Drug storage and preparation areas within the facility shall be the responsibility of the pharmacist-in-charge. All areas shall be inspected on a monthly basis and documented by a pharmacist, intern or technician.

I. All pharmacy preparations of sterile products shall be performed in accordance with the sterile products regulations, 16.19.36 NMAC.

J. Floor stock drugs, including those issued from automated medication management systems, shall be limited to drugs for emergency use and routinely used items as listed in the pharmacy policy and procedure manual and approved by the pharmacy and therapeutics committee. Floor stock drugs shall be supplied in individual doses unless the bulk container cannot be individualized. Dangerous drug floor stock must be reviewed by the pharmacist or pharmacist intern on a routine basis to insure appropriate use.

K. Where such committees exist, the pharmacist-in-charge or designated pharmacist shall be a voting member of the pharmacy and therapeutics committee or its equivalent.

L. Medications dispensed in the emergency room will be dispensed only by a licensed pharmacist, a licensed pharmacist intern or a licensed practitioner and shall comply with the following:

(1) a record shall be kept of all medications dispensed from the emergency room of a hospital; the record shall include:

(a) the date the drug was dispensed;

(b) name and address of the patient;

(c) name of the prescribing physician;

(d) the name of the drug;

(e) the strength of the drug;

(f) the quantity of drug dispensed;

(g) initials of the person recording the information if not a physician;

(2) a separate record shall be kept for schedule II controlled substances;

(3) the following will be recorded in the patient's medical chart:

(a) the name of the drug(s) prescribed;

(b) the strength of the drug;

(c) the quantity of the drug dispensed;

(4) when medications are prescribed by the physician and dispensed to the patient in the emergency room of the hospital the dispensing label shall contain the following information:

(a) the name of the patient;

(b) the name of the prescribing physician;

(c) name of the drug;

(d) strength of the drug;

(e) quantity of the drug;

(f) name and address of the hospital;

(g) date the drug is dispensed;

(h) directions for use;

(i) expiration date of medication.

M. Automated Pharmacy Systems.

(1) General Statement: Automated devices for storage and distribution of floor stock or patient profile drugs or both, shall be limited to licensed health care facilities and shall comply with all the following provisions. Written policies and procedures, approved by the appropriate health care facility committee, shall be in place to ensure safety, accuracy, security, and patient confidentiality. Personnel allowed access to an automated dispensing device shall have a confidential access code that records the identity and electronic signature of the person accessing the device.

(2) Security/Access: The control of access to the automated device must be controlled by the pharmacist-in-charge. Proper identification and access control, including electronic passwords or other coded identification, must be limited and authorized by the pharmacist-in-charge. The pharmacist-in-charge must be able to stop or change access at any time. The pharmacist-in-charge must maintain a current and retrievable list of all persons who have access and the limits of that access. Review of user access reports shall be conducted at least quarterly as established by policy and procedures to ensure that persons who are no longer employed at the facility do not have access to the system.

(3) Records: The records kept by the automated drug delivery system must comply with all state, federal, and board requirements. Records must be maintained by the pharmacy and be readily retrievable. Records may be retained in hard copy or an alternative data retention system may be used where current technology allows.

(4) Automated Drug Distribution: An automated medication management system shall be under the control of the pharmacist-in-charge. If used for storage and dispensing of doses scheduled for administration, there shall be a procedure by which orders for a drug are reviewed and approved by the pharmacist before the drug may be withdrawn from the automated dispensing device. There shall be written procedures for downtime in the event of system malfunction or otherwise inoperable. A downtime log shall be maintained and include:

(a) date of transaction;

(b) patient;

(c) drug/dose;

(d) quantity of transaction;

(e) nurse signature;

(f) beginning count;

(g) ending count;

(h) wasted amount;

(i) witness signature, if needed; and

(j) prescriber (for controlled substances only).

(5) Quality Assurance: The pharmacist-in-charge shall be responsible for developing and implementing a quality assurance program which monitors total system performance. Quality monitors shall include:

(a) the proper loading/refilling of the device, including proof of delivery;

(b) the proper removal, return or waste of drugs;

(c) processes for recording, resolution, and reporting of discrepancies; and

(d) processes for conducting periodic audits to assure compliance with policies and procedures.

(6) Records: Transaction records: At the time of any event involving the contents of the automated device, 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 name, strength, and quantity of medication;

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

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

(f) the name of the attending, admitting or prescribing practitioner; and

(g) the identity of the device accessed.

(7) Delivery Records: A delivery record shall be generated on demand for all drugs filled into an automated dispensing device which shall include:

(a) date;

(b) drug name;

(c) dosage form

(d) strength;

(e) quantity;

(f) identity of device; and

(g) name or initials of the person filling the automated dispensing device.

(8) Filling: There shall be policies and procedures in place, utilizing either manual, bar coding or other electronic processing means of item identities as current technology allows, to ensure pharmacist verification of accuracy in the filling and refilling of the automated device. A delivery record of medications filled into an automated pharmacy system shall be maintained and shall include identification of the person filling the device.

(9) Labeling/Packaging: Drugs filled into automated dispensing devices shall be in manufacturers' sealed, original packaging or in repackaged containers in compliance with the requirements of the board regulations relating to packaging and labeling.

N. Outsourcing of Pharmaceutical Services: A hospital pharmacy may contract or enter into an agreement with another licensed pharmacy/pharmacist to provide pharmaceuticals and/or other pharmacist services under the following conditions:

(1) the contract pharmacy is licensed by the board of pharmacy;

(2) the pharmacist providing the services by the contracted pharmacy shall be licensed as a pharmacist in this state;

(3) the contract is incorporated into the pharmacy's policy and procedure manual and complies with the requirements of 16.19.7 NMAC;

(4) the contracted pharmacy/pharmacist must have complete access to the patient's profile in order to perform a drug regimen review;

(5) the contracted pharmacy/pharmacist must have access to the licensed practitioners of the hospital;

(6) records of all pharmaceuticals transferred from the contracted pharmacy to the hospital pharmacy comply with the requirements;

(7) documentation of the services provided by the contracted pharmacy/pharmacist.

N.M. Admin. Code § 16.19.7.11

08-16-99; 16.19.7.11 NMAC - Rn, 16 NMAC 19.7.11, 03-30-02; A, 01-31-07, Amended by New Mexico Register, Volume XXX, Issue 10, May 28, 2019, eff. 6/9/2019