N.M. Admin. Code § 16.19.6.25

Current through Register Vol. 35, No. 21, November 5, 2024

Section 16.19.6.25 - CENTRALIZED PRESCRIPTION DISPENSING

The purpose of these regulations is to provide mandatory standards for centralized prescription dispensing by a retail or nonresident pharmacy.

A. Definitions as used in this section.

(1) "Centralized prescription dispensing" means the dispensing or refilling of a prescription drug order by a retail or nonresident pharmacy.

(2) "Dispensing" as defined in the NMSA, Section 61-11-2(1), and pursuant to 61-11-21(C) dispensing is limited to a registered pharmacist.

B.Operational standards and minimum requirements.

(1)A retail pharmacy may outsource prescription drug order dispensing to another retail or nonresident pharmacy provided the pharmacies:

(a) have the same owner or;

(b) have entered into a written contract or agreement which outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws and regulations; and

(c) share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to dispense or process a prescription drug order.

(2) The pharmacist-in-charge of the dispensing pharmacy shall ensure that:

(a) the pharmacy maintains and uses adequate storage or shipment containers and shipping processes to ensure drug stability and potency; such shipping processes shall include the use of appropriate packaging material or devices to ensure that the drug is maintained at an appropriate temperature range to maintain the integrity of the medication throughout the delivery process; and

(b) the dispensed prescriptions are shipped in containers which are sealed in a manner as to show evidence of opening or tampering.

(3)A retail or nonresidential dispensing pharmacy shall comply with the provisions of 16.19.6 NMAC and this section.

C. Notifications to patients.

(1) A pharmacy that out-sources prescription dispensing to another pharmacy shall prior to outsourcing the prescription:

(a) notify patients that their prescription may be outsourced to another pharmacy; and

(b) give the name of that pharmacy or if the pharmacy is part of a network of pharmacies under common ownership and any of the network of pharmacies may dispense the prescription, the patient shall be notified of this fact; such notification may be provided through a one-time written notice to the patient or through the use of a sign in the pharmacy; and

(2) if the prescription is delivered directly to the patient by the dispensing pharmacy upon request by the patient and not returned to the requesting pharmacy, the pharmacist employed by the dispensing pharmacy shall ensure that the patient receives written notice of available counseling; such notice shall include days and hours of availability and his or her right to request counseling and a toll-free number from which the patient or patient's agent may obtain oral counseling from a pharmacist who has ready access to the patient's record; for pharmacies delivering more that 50% of their prescriptions by mail or other common carrier, the hours of availability shall be a minimum of 60 hours per week and not less than 6 days per week; the facility must have sufficient toll-free phone lines and personnel to provide counseling within 15 minutes.

D. Prescription labeling.

(1) The dispensing pharmacy shall place on the prescription label the name and address or name and pharmacy license number of the pharmacy dispensing the prescription and the name and address of the pharmacy which receives the dispensed prescription;

(2) The dispensing pharmacy shall indicate in some manner which pharmacy dispensed the prescription (e.g., filled by ABC pharmacy for XYZ pharmacy); and comply with all other prescription labeling requirements.

E. Policies and Procedures.

(1) A policy and procedure manual as it relates to centralized dispensing shall be maintained at both pharmacies and be approved by the board or its' agent and be available for inspection. Each pharmacy is required to maintain only those portions of the policy and procedure manual that relate to that pharmacy's operations. The manual shall:

(a) outline the responsibilities of each of the pharmacies;

(b) include a list of the name, address, telephone numbers, and all license/registration numbers of the pharmacies involved in centralized prescription dispensing.

(2) The manual shall include policies and procedures for:

(a) notifying patients that their prescription may be outsourced to another pharmacy for centralized prescription dispensing and providing the name of that pharmacy;

(b) protecting the confidentiality and integrity of patient information;

(c) dispensing prescription drug orders when the filled order is not received or the patient comes in before the order is received;

(d) complying with federal and state laws and regulations;

(e) operating a continuous quality improvement program for pharmacy services designated to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care and resolve identified problems;

(f) procedure identifying the pharmacist responsible for each aspect of prescription preparation including, but not limited to, the drug regimen review, the initial electronic entry, any changes or modifications to the prescription record or patient profile, and the final check of the completed prescription;

(g) identify the pharmacist responsible for counseling the patient pursuant to the requirements of 16.19.4.16 NMAC; and

(h) annually reviewing the written policies and procedures and documenting such review.

F. Records.

(1) Records may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided:

(a) the records maintained in the alternative system contain all of the information required on the manual record; and

(b) the data processing system is capable of producing a hard copy of the record upon request of the board, its' representative, or other authorized local, state, or federal law enforcement or regulatory agencies within 48 hours.

(2) Each pharmacy shall comply with all the laws and rules relating to the maintenance of records and be able to produce an audit trail showing all prescriptions dispensed by the pharmacy and each pharmacist's or technician's involvement.

(3) The requesting pharmacy shall maintain records which indicate the date:

(a) the request for dispensing was transmitted to the dispensing pharmacy; and

(b) the dispensed prescription was received by the requesting pharmacy, including the method of delivery (e.g., private, common, or contract carrier) and the name of the person accepting delivery.

(4) The dispensing pharmacy shall maintain records which indicate:

(a) the date the prescription was shipped to the requesting pharmacy;

(b) the name and address where the prescription was shipped; and

(c) the method of delivery (e.g., private, common, or contract carrier).

N.M. Admin. Code § 16.19.6.25

16.19.6.25 NMAC - N, 06-30-06; Amended by New Mexico Register, Volume XXVI, Issue 10, May 29, 2015, eff. 6/7/2015; Amended by New Mexico Register, Volume XXVI, Issue 16, August 28, 2015, eff. 9/6/2015