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RULE PROPOSALS
VOLUME 45, ISSUE 3
ISSUE DATE:FEBRUARY 4, 2013
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
STATE BOARD OF PHARMACY




Proposed Amendments: N.J.A.C. 13:39-1.2, 6.5, 6.15, 7.6, 9.19, and 12.2

Pharmacy Technician Duties and Pharmacist-Technician Ratios; Required Records and Documents; Records and Reports; Documentation; and General Requirements for Pharmacies Providing Radiopharmaceutical Service

Authorized By: State Board of Pharmacy, Anthony Rubinaccio, Executive Director.

Authority: N.J.S.A. 45:14-47, specifically, 45:14-80.

Calendar Reference: See Summary below for explanation of exception to calendar requirement.

Proposal Number: PRN 2013-022.

Submit comments by April 5, 2013 to:

Anthony Rubinaccio, Executive Director
Board of Pharmacy
PO Box 45013
Newark, NJ 07101

The agency proposal follows:

Summary

The Board of Pharmacy (Board) is proposing amendments to N.J.A.C. 13:39-6.5 and 6.15, clarifying the duties of pharmacy interns, pharmacy externs, pharmacy technicians, pharmacy technician applicants, and unlicensed and unregistered pharmacy personnel. Existing N.J.A.C. 13:39-6.15(a)2 provides that only pharmacy interns, pharmacy externs, pharmacists, pharmacy technicians, and pharmacy technician applicants may perform "data entry." The Board is aware that some confusion exists among members of the regulated community concerning the parameters of this "data entry" function, and whether all information related to a prescription must be collected and entered into a pharmacy's prescription record system by licensed or registered pharmacy personnel. The Board did not intend the use of the phrase "data entry" in N.J.A.C. 13:39-6.15(a)2 to preclude unlicensed or unregistered pharmacy personnel from obtaining certain basic demographic information from patients when prescriptions are presented for filling. Rather, the Board believes that the data entry function that may be performed only by licensed or registered pharmacy personnel involves the collection and recordation of prescription medication information.

Therefore, the Board is proposing new N.J.A.C. 13:39-6.5(b) and (c) and amendments to N.J.A.C. 13:39-6.15(a) to clarify the data entry function that may be performed only by pharmacy interns, pharmacy externs, pharmacy technicians, pharmacy technician applicants, and pharmacists.

As part of these clarifying amendments, the Board is relocating the regulation of the duties of pharmacy interns and pharmacy externs from N.J.A.C. 13:39-6.15(a) to new N.J.A.C. 13:39-6.5(b). N.J.A.C. 13:39-6.15 pertains to pharmacy technicians and pharmacy technician applicants and pharmacists as indicated in the heading. N.J.A.C. 13:39-6.5 pertains to prescription handling by pharmacy interns, pharmacy externs, and pharmacy technicians, and is proposed for amendment to also include pharmacy technician applicants and unlicensed or unregistered personnel. N.J.A.C. 13:39-6.15(a) is proposed for amendment to delete reference to pharmacy externs and pharmacy interns.

Proposed new N.J.A.C. 13:39-6.5(b) includes the tasks pharmacy interns and pharmacy externs may assist the pharmacist in performing, and is identical to N.J.A.C. 13:39-6.15(a)1 through 7, as proposed for amendment and discussed above and below, except that existing N.J.A.C. 13:39-6.15(a)5i, which pertains only to pharmacy technicians and pharmacy technician applicants is not included in new N.J.A.C. 13:39-6.5(b). Pharmacy interns and pharmacy externs are permitted to perform the tasks at existing N.J.A.C. 13:39-6.15(a)1 through 5, and that authority is not being changed as part of the relocation of this regulation.

The Board is also proposing new N.J.A.C. 13:39-6.5(b)4 and 6.15(a)4, which add transcription of scanned prescription or medication order information into the patient record to the tasks that can be performed by pharmacy interns and pharmacy externs, and pharmacy technicians and pharmacy technician applicants, respectively.

In order to further clarify the "data entry" provisions of N.J.A.C. 13:39-6.5(b)2, the Board is proposing new N.J.A.C. 13:39-6.5(b)3, which sets forth that the collection of demographic information, as separate from "data entry," as proposed for amendment and may be performed by pharmacy interns and pharmacy externs. The demographic information that may be collected pursuant to this new paragraph is a patient's name, address, and telephone number; age, general age group (infant, child, or adult), or date of birth; gender; any allergies and idiosyncrasies of the patient; or medical conditions. Proposed new N.J.A.C. 13:39-6.5(c) permits the demographic information collected pursuant to N.J.A.C. 13:39-6.5(b)3 to be performed by unlicensed or unregistered pharmacy personnel. Proposed new N.J.A.C. 13:39-6.15(a)3 is identical to N.J.A.C. 13:39-6.5(b)3, but pertains to pharmacy technicians and pharmacy technician applicants.

The Board is also proposing amendments to the audit trail requirements set forth in N.J.A.C. 13:39-7.6(a) to provide that not all of the steps performed by unlicensed or unregistered pharmacy personnel need to be documented in the audit trail, such as the collection of demographic information for the patient profile. N.J.A.C. 13:39-7.6(a) continues to require that all entries to the audit trail made by a pharmacy technician, intern, or extern be reviewed and approved by a pharmacist.

For clarification purposes, the Board is also proposing to amend N.J.A.C. 13:39-7.6(a) to delete the reference to "the steps of prescription handling" to instead refer to the actual steps that must be documented in the audit trail: intake, processing, fulfillment, and dispensing. The cross-reference to N.J.A.C. 13:39-4.18 in N.J.A.C. 13:39-6.5 and 7.6(a) is also being amended to refer to N.J.A.C. 13:39-4.19, in order to reflect the 2010 recodification of this rule. The Board is also proposing to amend N.J.A.C. 13:39-7.6(a) to expressly provide that the pharmacist shall be responsible for the accuracy and appropriateness of the filled prescriptions and for the functions that he or she personally performed. This provision, which was originally contained in N.J.A.C. 13:39-6.5, was inadvertently deleted from the rule when the Board proposed amendments to N.J.A.C. 13:39-6.5 as part of the Board's readoption of Chapter 39 in 2010. See 42 N.J.R. 132(a); 43 N.J.R. 1203(a). The Board believes that this provision is more appropriately included in N.J.A.C. 13:39-7.6(a). Additional amendments to N.J.A.C. 13:39-7.6(a) also clarify that when more than one pharmacist is involved in prescription handling, each pharmacist is responsible for the accuracy and [page=202] appropriateness of any steps he or she performed, or that he or she reviewed and approved.

Comparable amendments as proposed at N.J.A.C. 13:39-7.6(a) are also proposed at N.J.A.C. 13:39-9.19 for institutional pharmacies and N.J.A.C. 13:39-12.2 for nuclear pharmacies.

The Board is also proposing to amend N.J.A.C. 13:39-1.2 to add definitions of pharmacy extern and pharmacy intern by providing a cross-reference to the definitions in N.J.A.C. 13:39-2.6(a).

The Board has provided a 60-day comment period for this notice of proposal; therefore, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.

Social Impact

The Board believes that the proposed amendments may have a positive impact upon pharmacies by clarifying what activities related to prescription data collection may be performed by a pharmacy's unlicensed or unregistered employees, and by clarifying a pharmacy's responsibility with respect to documenting such activities in its audit trail.

Economic Impact

The Board believes that the proposed amendments may have a positive economic impact upon pharmacies to the extent that the amendments to N.J.A.C. 13:39-6.15 may offer pharmacies increased flexibility in the use of unlicensed or unregistered pharmacy personnel, potentially resulting in cost savings. The Board also believes that the proposed amendments to the audit trail requirements in N.J.A.C. 13:39-7.6, 9.19, and 12.2 may permit pharmacies to streamline their current audit trail procedures, which may result in cost savings.

Federal Standards Statement

A Federal standards analysis is not required because the proposed amendments are governed by N.J.S.A. 45:14-47 of the Pharmacy Practice Act. The proposed amendments are not subject to any Federal requirements or standards.

Jobs Impact

The Board does not believe that the proposed amendments will result in the creation or loss of jobs in the State.

Agriculture Industry Impact

The proposed amendments will have no impact on the agriculture industry in the State.

Regulatory Flexibility Analysis

Currently, the Board licenses approximately 13,000 pharmacists, registers approximately 11,000 pharmacy technicians and issues permits to approximately 2,000 pharmacies. If Board licensees, registrants, and permit holders are considered "small businesses," within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., then the following analysis applies.

The proposed amendments to N.J.A.C. 13:39-6.5, 6.15, 7.6, 9.19, and 12.2 will clarify the recordkeeping and compliance requirements upon pharmacy externs, pharmacy interns, pharmacists, pharmacy technicians, pharmacy technician applicants, and pharmacies. These requirements are discussed in the Summary above.

No additional professional services will be needed to comply with the proposed amendments. There will be no additional costs as a result of the proposed amendments; the increased flexibility in the use of unlicensed and unregistered pharmacy personnel and streamlined audit trail procedures may result in a possible savings. The Board believes that the proposed amendments should be uniformly applied to all pharmacists, technicians, and pharmacies in order to ensure the health, safety, and welfare of the general public in the filling of prescriptions and, therefore, no differing compliance requirements for any licensee, registrant, or permit holder are provided based upon the size of the business.

Housing Affordability Impact Analysis

The proposed amendments will have an insignificant impact on affordable housing in New Jersey and there is an extreme unlikelihood that the amendments would evoke a change in the average costs associated with housing because the proposed amendments concern the duties of pharmacists and pharmacy interns, pharmacy externs, pharmacy technicians, pharmacy technician applicants, and unlicensed or unregistered personnel, and the filling of prescriptions.

Smart Growth Development Impact Analysis

The proposed amendments will have an insignificant impact on smart growth and there is an extreme unlikelihood that the amendments would evoke a change in housing production in Planning Areas 1 or 2, or within designated centers, under the State Development and Redevelopment Plan in New Jersey because the proposed amendments concern the duties of pharmacists and pharmacy interns, pharmacy externs, pharmacy technicians, pharmacy technician applicants, and unlicensed or unregistered personnel, and the filling of prescriptions.

Full text of the proposal follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):

SUBCHAPTER 1. GENERAL PROVISIONS

13:39-1.2 Definitions

The following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise.

. . .

"Pharmacy extern" or "extern" means a "pharmacy extern" as defined at N.J.A.C. 13:39-2.6(a).

"Pharmacy intern" or "intern" means a "pharmacy intern" as defined at N.J.A.C. 13:39-2.6(a).

. . .

SUBCHAPTER 6. PHARMACIST-IN-CHARGE; PHARMACY PERSONNEL

13:39-6.5 Prescription handling by pharmacy externs, pharmacy interns, [or] pharmacy technicians, pharmacy technician applicants, or unlicensed or unregistered personnel

(a) A pharmacy intern, pharmacy extern, [or] pharmacy technician, or pharmacy technician applicant in any pharmacy may perform the component functions of prescription handling described in N.J.A.C. 13:39-[4.18]4.19, consistent with the requirements of this chapter. On or after April 5, 2011, all steps performed by a pharmacy technician, pharmacy technician applicant, pharmacy intern, or pharmacy extern shall be documented in the pharmacy audit trail consistent with the requirements of N.J.A.C. 13:39-7.6.

(b) Pharmacy interns and pharmacy externs may assist the pharmacist in performing the following tasks:

1. Retrieval of prescription files, patient files, and profiles and other such records pertaining to the practice of pharmacy;

2. Data entry of prescription medication information, including the original or refill date of the prescription, the number or designation identifying the prescription, the practitioner's information, and the name, strength, and quantity of the prescribed medication;

3. The collection of the following demographic information for the patient profile: the name, address, and telephone number of the patient; the patient's age, date of birth; or age group (infant, child, adult); gender; any allergies and idiosyncrasies of the patient; and any medical conditions that may relate to drug utilization;

4. Transcription of scanned prescription or medication order information into the patient record;

5. Label preparation;

6. The counting, weighing, measuring, pouring, and compounding of prescription medication or stock legend drugs and controlled substances, including the filling of an automated medication system; and

7. Accepting authorization from a patient for a prescription refill, or from a practitioner or his or her agent for a prescription renewal, provided that the prescription remains unchanged.

(c) The collection of the demographic information under (b)3 above may be performed by unlicensed or unregistered personnel.

13:39-6.15 Pharmacy technician duties and pharmacist-technician ratios

(a) [In addition to externs and interns, only pharmacy] Pharmacy technicians and pharmacy technician applicants may assist the pharmacist in performing the following tasks:

1. (No change.)

[page=203] 2. Data entry[;] of prescription medication information, including the original or refill date of the prescription, the number or designation identifying the prescription, the practitioner's information, and the name, strength, and quantity of the prescribed medication;

3. The collection of the following demographic information for the patient profile: the name, address, and telephone number of the patient; the patient's age, date of birth; or age group (infant, child, adult); gender; any allergies and idiosyncrasies of the patient; and any medical conditions that may relate to drug utilization;

4. Transcription of scanned prescription or medication order information into the patient record;

Recodify existing 3.-4. as 5.-6. (No change in text.)

[5.] 7. Accepting authorization from a patient for a prescription refill, or from a practitioner or his or her agent for a prescription renewal, provided that the prescription remains unchanged, consistent with [(a)5i] (a)7i below:

i. (No change.)

(b)-(h) (No change.)

SUBCHAPTER 7. DRUG DISPENSING AND PRESCRIPTION RECORDS

13:39-7.6 Required records and documents

(a) On or after April 5, 2011, a pharmacy shall maintain an audit trail that records and documents the unique and secure user identifier(s) of the pharmacist(s), pharmacy technician(s), intern(s), or extern(s) performing the component functions of [each step of prescription handling,] intake, processing, fulfillment, and dispensing of prescriptions as defined in N.J.A.C. 13:39-[4.18]4.19, which are required to be performed by a pharmacist, pharmacy technician, intern, or extern pursuant to the requirements of this chapter. [All steps performed by a pharmacy technician, intern or extern shall be documented in the audit trail.] The collection of demographic information for the patient profile as provided for in N.J.A.C. 13:39-6.15(a)3 is not required to be, but may be, recorded in the audit trail. All entries to the audit trail made by a pharmacy technician, intern, or extern shall be reviewed and approved by the pharmacist. The pharmacist shall be responsible for the accuracy and appropriateness of the filled prescription. When more than one pharmacist is involved in the component functions of prescription handling, [the] each pharmacist shall be responsible for the accuracy and appropriateness of each component function he or she performed or reviewed and approved, and his or her unique and secure user identifier(s) [of the pharmacist(s) responsible for the accuracy and appropriateness of each component function(s)] shall be recorded in the audit trail. Audit trail documentation shall be generated at the time each component function(s) is performed.

(b)-(e) (No change.)

SUBCHAPTER 9. PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES

13:39-9.19 Records and reports

(a) Records of the pharmaceutical services of the provider pharmacy for the facility shall be the responsibility of the pharmacist-in-charge. On or after April 5, 2011, a pharmacy shall maintain an audit trail that records and documents the unique and secure user identifier(s) of the pharmacist(s), pharmacy technician(s), intern(s), or extern(s) performing the component functions of [prescription handling,] intake, processing, fulfillment, and dispensing of prescriptions as defined in N.J.A.C. 13:39-[4.18]4.19, which are required to be performed by a pharmacist, pharmacy technician, intern, or extern pursuant to the requirements of this chapter. [All steps performed by a pharmacy technician, intern or extern shall be documented in the audit trail.] The collection of demographic information for the patient profile as provided for in N.J.A.C. 13:39-6.15(a)2i is not required to be, but may be, recorded in the audit trail. All entries to the audit trail made by a pharmacy technician, intern, or extern shall be reviewed and approved by the pharmacist. The pharmacist shall be responsible for the accuracy and appropriateness of the filled prescription. When more than one pharmacist is involved in the component functions of prescription handling, [the] each pharmacist shall be responsible for the accuracy and appropriateness of each component function he or she performed or reviewed and approved, and his or her unique and secure user identifier(s) [of the pharmacist(s) responsible for the accuracy and appropriateness of each component function(s)] shall be recorded in an audit trail. Audit trail documentation shall be generated at the time the component function(s) is performed. All audit trail and medication order information shall be maintained or stored in original hard copy form or in any other media that facilitates the reproduction of the original hard copy and shall be maintained for a period of not less than five years. The oldest four years of information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of information shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but off-site facilities used to store such records shall be secure. Patient records shall be kept confidential, but shall be made available to persons authorized to inspect them under State and Federal statutes and regulations.

(b)-(f) (No change.)

SUBCHAPTER 12. NUCLEAR PHARMACIES

13:39-12.2 General requirements for pharmacies providing radiopharmaceutical service

(a) The application for a specialized retail permit to operate a pharmacy providing radiopharmaceutical services shall only be issued to a site employing a qualified nuclear pharmacist. All personnel performing tasks in the preparing and distribution of drugs shall be under the immediate personal supervision of the nuclear pharmacist who shall be responsible for all nuclear operations of the licensed area and shall be in personal attendance at all times when the nuclear pharmacy is open for business. On or after April 5, 2011, nuclear pharmacies shall maintain an audit trail that records and documents the unique and secure user identifier(s) of the pharmacist(s), pharmacy technician(s), intern(s), or extern(s) performing the radiopharmaceutical services, which are required to be performed by a pharmacist, pharmacy technician, intern, or extern pursuant to the requirements of this chapter. [All steps performed by a pharmacy technician, intern or extern shall be documented in the audit trail.] The collection of demographic information for the patient profile as provided for in N.J.A.C. 13:39-6.15(a)2i is not required to be, but may be, recorded in the audit trail. All entries to the audit trail made by a pharmacy technician, intern, or extern shall be reviewed and approved by the pharmacist. The pharmacist shall be responsible for the accuracy and appropriateness of the radiopharmaceutical services performed. When more than one pharmacist is involved in performing radiopharmaceutical services pursuant to this subchapter, [the] each pharmacist shall be responsible for the accuracy and appropriateness of the radiopharmaceutical services he or she performed or reviewed and approved, and his or her unique and secure user identifier(s) [of the pharmacist(s) responsible for the accuracy and appropriateness of the services performed] shall be recorded in the audit trail. Audit trail documentation shall be generated at the time each service is performed. Such documentation shall be maintained or stored in original hard copy form or in any other media that facilitates the reproduction of the original hard copy and shall be kept by the pharmacy for five years. The oldest four years of information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of information shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but off-site facilities used to store such records shall be secure. Patient records shall be kept confidential, but shall be made available to persons authorized to inspect them under State and Federal statutes and regulations.

(b)-(l) (No change.)



 

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