TITLE 16 OCCUPATIONAL AND PROFESSIONAL LICENSING
CHAPTER 19 PHARMACISTS
PART 22 SUPPORT
PERSONNEL AND PHARMACY TECHNICIANS
16.19.22.1 ISSUING
AGENCY: Board of Pharmacy.
[16.19.22.1 NMAC
- Rp, 16 NMAC 19.22.1, 6/27/2001; A, 11/15/2010; A, 11/30/2021]
16.19.22.2 SCOPE: All Pharmacy technicians and non-technicians supportive personnel, supervising pharmacists and pharmacists in charge of entities that utilize supportive personnel.
[16.19.22.2 NMAC - Rp, 16. NMAC 19.22.2, 6/27/2001]
16.19.22.3 STATUTORY AUTHORITY: Subsection A of Section 61-11-6 NMSA 1978 authorizes the Board of pharmacy to register and regulate qualifications, training and permissible activities of pharmacy technicians.
[16.19.22.3 NMAC - Rp, 16 NMAC 19.22.3, 6/27/2001; A, 11/30/2021]
16.19.22.4 DURATION: Permanent.
[16.19.22.4 NMAC - Rp, 16 NMAC 19.22.4, 6/27/2001]
16.19.22.5 EFFECTIVE DATE: June 27, 2001, unless a later date is cited at the end of a section.
[16.19.22.5 NMAC - Rp, 16 NMAC 19.22.5, 6/27/2001]
16.19.22.6 OBJECTIVE: The objective of Part 22 of Chapter 19 is to promote responsive delivery of pharmaceutical products and services to the public by establishing standards for training and supervision of support personnel and limitations on their use.
[16.19.22.6 NMAC - Rp, 16 NMAC 19.22.6, 6/27/2001]
16.19.22.7 DEFINITIONS:
A. “Direct
supervision” means that the pharmacist onsite shall observe and direct to a
degree sufficient to assure the accurate completion of the activities of the
pharmacy technicians and must provide a final check of all aspects of the
prepared product and document the final check before dispensing.
B. “Indirect supervision” means that the pharmacist
offsite shall observe via live surveillance cameras and direct pharmacy
activity remotely via remote tele-pharmacy communication technology to a degree
sufficient to assure the accurate completion of the activities of the pharmacy
technicians and must provide a final check of all aspects of the prepared
product and document the final check before dispensing.
C. “Pharmacy technician” means a person who, under the supervision of a licensed pharmacist, performs repetitive tasks not requiring the professional judgment of a pharmacist. This includes assisting in various technical activities associated with the preparation and distribution of medications.
(1) “Certified pharmacy technician” means a pharmacy technician who has completed the training and certification outlined in 16.19.22.9 NMAC, completed a board approved certification exam, is registered by the board of pharmacy and maintains current board approved certification.
(2) “Non-certified pharmacy technician” means a pharmacy technician who is in the process of completing the training and education outlined in 16.19.22.9 NMAC and is registered by the board of pharmacy.
(3) “Remote pharmacy technician” means a certified pharmacy technician who meets the special requirements for indirect supervision at a remote dispensing site as specified in the board of pharmacy tele-pharmacy regulations.
D. “Prescription drug” means and human drug required by federal or state law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to Section 503(b) of the Federal Food, Drug and Cosmetic Act.
E. “Professional judgment” means a cognitive process, by a licensed professional, that takes education, experience, current primary literature and current standards of practice into consideration when drawing conclusions and reaching decisions.
F. “Stocking” means placing prescription drugs on pharmacy shelf, in bin or dispensing technology system.
G. “Supervision” means that the pharmacist shall observe and direct to a sufficient degree to assure the accurate completion of the activities of the pharmacy technicians and must provide a final check of all aspects of the prepared product and document the final check before dispensing.
H. “Support personnel” means pharmacy personnel other than pharmacy technicians, which may include clerks, secretary’s and delivery personnel, who under the supervision of a pharmacist, may perform duties associated with the practice of pharmacy, excluding the direct processing and filling of prescriptions, stocking prescription drugs, in sites that do not utilize a barcode verification, electronic verification or similar verification process to ensure correct selection of medication or duties restricted to only a pharmacist, pharmacist intern, or pharmacy technician.
I. “Technician training sponsor” means pharmacist-in-charge, pharmacist or designated administrator at a pharmacy technician training program who assumes responsibility for training and duties performed by a non-certified technician.
[16.19.22.7 NMAC - Rp, 16 NMAC 19.22.7, 6/27/2001; A, 11/15/2010; A, 11-27-11; A, 6/29/2013]
16.19.22.8 PERMISSIBLE ACTIVITIES: Pharmacy technician activities under the direct supervision of a pharmacist shall be limited to tasks enumerated in policies and procedures implemented by the pharmacist-in-charge that do not require professional judgment.
[16.19.22.8 NMAC - Rp, 16 NMAC 19.22.8, 6/27/2001; A, 11/15/2010]
16.19.22.9 TRAINING AND EDUCATION:
A. The pharmacist-in-charge shall ensure that the pharmacy technician has completed initial training which includes:
(1) federal and state laws and regulations that affect pharmacy practice; specific regulations which address the use of supportive personnel and technicians;
(2) ethical and professional standards of practice;
(3) medical and pharmaceutical terminology, symbols and abbreviations used in the practice of pharmacy and components of a prescription;
(4) pharmaceutical calculations necessary for the preparation and dispensing of drug products;
(5) manufacturing, preparation, packaging, labeling and proper storage of drug products;
(6) dosage forms and routes of administration; and
(7) trade and generic names for medications frequently dispensed by the pharmacy;
(8) basic comprehension of pharmacology;
(9) basic knowledge of appropriate pharmacy references.
B. If the duties of the technician will include the preparation of sterile products then, in addition to the training and education requirements listed in this section, the technician will complete training outlined in Subsection C of 16.19.36.13 NMAC.
C. A written record of training and education will be maintained by the pharmacy technician and contain the following:
(1) name of person receiving the training;
(2) date(s) of the training;
(3) description of the topics covered;
(4) names of the person(s) who provided the training; and
(5) signature of the technician and the technician training sponsor.
D. A written record of training and education must be submitted to the board with certification exam documentation to obtain certified pharmacy technician registration.
E. All technicians are required to obtain board approved certification within one year of registration with the board as a technician. Extensions will no longer be granted to pharmacy technicians registered on or after November 15, 2010.
F. The pharmacist-in-charge shall be responsible for the implementation of policies and procedures for additional training appropriate to duties and responsibilities performed by a pharmacy technician as well as an ongoing quality assurance plan to assure competency.
[16.19.22.9 NMAC - Rp, 16 NMAC 19.22.9, 6/27/2001; A, 11/15/2010; A, 11-27-11; A, 06-08-16]
16.19.22.10 RATIO OF TECHNICIANS TO PHARMACISTS:
A. The permissible ratio of pharmacy technicians to pharmacists on duty is to be determined by the pharmacist in charge.
B. The board reserves the right to impose a ratio of pharmacy technicians to pharmacists if circumstances so dictate.
[16.19.22.10 NMAC - Rp, 16 NMAC 19.22.10, 6/27/2001; A, 6/29/2013]
16.19.22.11 IMPROPER
ACTIVITIES OF PHARMACY TECHNICIANS:
A. The supervising pharmacist and the pharmacist-in-charge are responsible for the actions of pharmacy technicians. Performance of tasks by the pharmacy technician and support personnel outside the limits of the regulations that are authorized by the supervising pharmacist shall constitute unprofessional conduct on the part of the pharmacist and the pharmacist-in-charge.
(1) The following responsibilities require the use of professional judgment and therefore shall be performed only by a pharmacist or pharmacist intern:
(a) receipt of all new verbal prescription orders and reduction to writing;
(b) evaluation and interpretation of the prescription order and any necessary clinical clarification prior to dispensing;
(c) clinical consultation with a patient or his agent regarding a prescription or over-the-counter drug;
(d) evaluation of available clinical data in patient medication record system;
(e) oral communication with the patient or patient’s agent of information, as defined in the section under patient counseling, in order to improve therapy by ensuring proper use of drugs and devices;
(f) professional consultation with the prescriber, the prescriber’s agent, or any other health care professional or authorized agent regarding a patient and any medical information pertaining to the prescription.
(2) ONLY A PHARMACIST SHALL PERFORM THE FOLLOWING DUTIES:
(a) final check on all aspects of the completed prescription including sterile products and cytotoxic preparations, and assumption of the responsibility for the filled prescription, including, but not limited to, appropriateness of dose, accuracy of drug, strength, labeling, verification of ingredients and proper container;
(b) evaluation of pharmaceuticals for formulary selection within the facility;
(c) supervision of all pharmacy technicians and support personnel activities including preparations, mixing, assembling, packaging, labeling and storage of medication;
(d) ensure the pharmacy technicians and support personnel have been properly trained for the duties they may perform;
(e) any verbal communication with a patient or patient’s representative regarding a change in drug therapy or performing therapeutic interchanges (i.e. drugs with similar effects in specific therapeutic categories); this does not apply to substitution of generic equivalents;
(f) any other duty required of a pharmacist by any federal or state law.
B. In accordance with Section 61-11-20 NMSA 1978 a pharmacy technicians registration may be revoked, denied, or suspended for grounds stated in Subsection A of Section 61-11-20 NMSA 1978.
[16.19.22.11 NMAC - Rp, 16 NMAC 19.22.11, 6/27/2001; A, 11/15/2010]
16.19.22.12 IDENTIFICATION OF PHARMACY PERSONNEL: All personnel in pharmacy restricted area shall wear an identification badge which must include name and job title.
[16.19.22.12 NMAC - Rp, 16 NMAC 19.22.12, 6/27/2001]
16.19.22.13 (RESERVED)
[16.19.22.13 NMAC - Rp, 16 NMAC 19.22.13, 6/27/2001]
16.19.22.14 REGISTRATION
OF PHARMACY TECHNICIANS:
A. Application (and required registration fee) shall be submitted to the board prior to performing any technician duties. Non-certified pharmacy technicians must:
(1) Complete requirements for certified pharmacy technician within one year of original application.
(2) Not re-apply with the board of pharmacy as a non-certified pharmacy technician unless enrolled in a board recognized technician training program.
(3) Provide the name of the technician training sponsor responsible for training and education with application.
(4) Provide documentation of training and completion of certification exam to be registered as a certified pharmacy technician.
B. Registration for certified pharmacy technicians will expire biennially on the last day of their birth month and must be renewed prior to expiration. Registration renewal applications must include documentation of current national certification.
[16.19.22.14 NMAC - Rp, 16 NMAC 19.22.14, 6/27/2001; A, 11/15/2010; A, 6/29/2013]
16.19.22.15 CHANGE OF ADDRESS: Pharmacy technicians shall report in writing or through the online process available on the board’s website of any change of address or employment to the board within 10 days.
[16.19.22.15 NMAC - Rp, 16 NMAC 19.22.15, 6/27/2001; A, 11/15/2010]
16.19.22.16 PHARMACY TECHNICIAN ADMINISTRATION OF VACCINES: A certified pharmacy technician may administer vaccines prescribed by and under the direct supervision of a New Mexico licensed pharmacist with current immunization prescriptive authority “qualified pharmacist,” if all requirements of this section are met.
A. Training and education:
(1) The pharmacy technician must successfully complete an accreditation council for pharmacy education (ACPE) accredited immunization certification course for pharmacy technicians. This training must include study materials, hands-on injection technique, and the recognition and treatment of emergency reactions to vaccines. Pharmacy technicians who successfully completed said training prior to the enactment date of this section will be grandfathered.
(2) The pharmacy technician must complete and maintain current basic life support/cardiopulmonary resuscitation (BLS/CPR) certification.
(3) Continuing Education: Any pharmacy technician engaging in administration of vaccines shall complete a minimum of 0.2 CEU of ACPE accredited vaccine related continuing education during each registration period.
B. Competency assurance:
(1) The pharmacist-in-charge is responsible for ensuring that the technician has completed the required training; and possesses the knowledge, skills and abilities to appropriately engage in vaccine administration.
(2) The pharmacist-in-charge is responsible for developing, implementing and maintaining proper policies and procedures, which must include training and competency oversight to ensure compliance with the requirements of this section. Such procedures shall include an initial observation by a qualified pharmacist to ensure proper administration technique.
(3) The pharmacist-in-charge and technician are responsible for maintaining training and education documentation.
C. Oversight and activities:
(1) While the pharmacy technician may draw up the vaccine into a syringe, the supervising qualified pharmacist is responsible for final verification.
(2) The qualified pharmacist must provide patient counseling, as appropriate.
(3) The identity of the pharmacy technician who administered each dose of vaccine will be documented. The qualified pharmacist is responsible for ensuring proper documentation.
(4) Supervision: A qualified pharmacist may not supervise more than two pharmacy technicians administering vaccines in a pharmacy setting. A pharmacist whose duties are dedicated to vaccination (e.g. vaccination clinic) may not supervise more than six qualified pharmacy technicians administering vaccines at one time. It is the responsibility of the pharmacist in charge to ensure adequate staffing levels for duties performed.
D. All records required under this section shall be readily available for inspection and produced to the board or the board’s agent upon request.
[16.19.22.16 NMAC – N, 11/30/2021]
HISTORY of 16.19.22 NMAC:
Pre-NMAC History:
Regulation 22, Supportive Personnel, filed 1/29/1993.
History of Repealed Material:
16 NMAC 19.22, Supportive Personnel, filed 2/2/1996.