21 NCAC 46 .1418             SUPERVISION OF UNIT DOSE MEDICATION SYSTEMS

(a)  The purpose of this Section is to set out requirements in the event that pharmacists elect to supervise designated pharmacy technicians' validation of stocking and prepackaging functions in acute care hospital pharmacy practice settings as a means of facilitating pharmacists' delivery of clinical services.

(b)  A Hospital's pharmacist-manager is responsible for the oversight of all validation of floor stock and unit dose distribution systems, and that responsibility may not be delegated pursuant to 21 NCAC 46 .1411. In the event that the Hospital's pharmacist-manager elects to utilize Validating Technicians in the filling of floor stock and unit dose distribution systems, the pharmacist-manager shall develop written policies and procedures that:

(1)           permit a Validating Technician to validate only the following functions of other registered pharmacy technicians in filling floor stock and unit dose distribution systems for inpatients in a Hospital:

(A)          stocking of patient care unit medication inventories;

(B)          stocking of ancillary drug cabinet inventories;

(C)          stocking of automated dispensing or drug supply devices;

(D)          stocking of emergency kits; and

(E)           prepackaging of prescription drugs within the Hospital pharmacy;

(2)           establish the parameters for pharmacist supervision of pharmacy technician validation functions;

(3)           establish facility-specific training for pharmacy technician validation functions;

(4)           establish an ongoing evaluation and assessment program to ensure that pharmacy technician validation functions are performed safely and accurately; and

(5)           establish a recordkeeping system that shall permit the identification of the Validating Technician who performs activities authorized by this Rule. Readily retrievable records generated by this system shall be maintained for the period of time specified in 21 NCAC 46 .1414(j)(1) and (2).

(c)  With respect to compounded or admixed prescription drugs (whether sterile or non-sterile), a Validating Technician may validate the filling of floor stock and unit dose distribution systems only after a pharmacist has verified that the compounded or admixed prescription drugs have been prepared correctly.

(d)  This Rule does not authorize a pharmacy technician to perform any act requiring the exercise of professional judgment by a pharmacist.

(e)  Validating Technician. For the purposes of this Rule, a Validating Technician shall be a pharmacy technician who:

(1)           is registered with the Board and trained as specified in G.S. 90-85.15A;

(2)           is a certified technician;

(3)           holds either:

(A)          an associate's degree in pharmacy technology conferred by either an institution within the North Carolina Community College System or System;

(B)          an associate's degree in pharmacy technology conferred by an institution accredited by one of the regional accrediting agencies recognized by the United States Department of Education; or

(C)          an associate's degree in pharmacy technology conferred by a program accredited by the American Society of Health System Pharmacists; and

(4)           assists pharmacists with the preparation, dispensing and distribution of prescription medications that will be administered by a licensed health care provider to an inpatient in a Hospital under this Rule.

(f)  Hospital. For the purposes of this Rule, a Hospital is either:

(1)           a hospital licensed by the North Carolina Medical Care Commission; or

(2)           a psychiatric hospital operated by the Secretary of the Department of Health and Human Services.

(g)  Pursuant to G.S. 90-85.15A(c), the Board approves a pharmacist's supervision of more than two pharmacy technicians where the additional technicians are Validating Technicians. This Rule does not relieve the pharmacist-manager of the obligation to request and receive written Board approval for a pharmacist's supervision of more than two pharmacy technicians where the additional technicians are certified pharmacy technicians but are not Validating Technicians.

(h)  A pharmacy technician performing validation functions described in this Rule as part of a Board-approved 21 NCAC 46 .2510 pilot project at Broughton State Hospital or Wake Forest University Baptist Medical Center may continue to perform such functions for a period of three years from this Rule's original effective date, after which time the pharmacy technician must meet all of the requirements specified in Paragraph (e) of this Rule to continue performing such functions.

History Note:        Authority G.S. 90-85.6; 90-85.15A; 90-85.21; 90-85.26; 90-85.32; 90-85.33; 90-85.34;

Eff. June 18, 2011;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. October 3, 2017.