​​​​50 N.J.R. 9(a)

VOLUME 50, ISSUE 1, JANUARY 2, 2018
RULE PROPOSALS

NJ - New Jersey Register  >  2018  >  JANUARY  >  JANUARY 2, 2018  >  RULE PROPOSALS  >  LAW AND PUBLIC SAFETY -- DIVISION OF CONSUMER AFFAIRS

Interested Persons Statement

INTERESTED PERSONS
Interested persons may submit comments, information or arguments concerning any of the rule proposals in this issue until the date indicated in the proposal. Submissions and any inquiries about submissions should be addressed to the agency officer specified for a particular proposal.

The required minimum period for comment concerning a proposal is 30 days. A proposing agency may extend the 30-day comment period to accommodate public hearings or to elicit greater public response to a proposed new rule or amendment. Most notices of proposal include a 60-day comment period, in order to qualify the notice for an exception to the rulemaking calendar requirements of    N.J.S.A. 52:14B-3. An extended comment deadline will be noted in the heading of a proposal or appear in a subsequent notice in the Register.
At the close of the period for comments, the proposing agency may thereafter adopt a proposal, without change, or with changes not in violation of the rulemaking procedures at    N.J.A.C. 1:30-6.3. The adoption becomes effective upon publication in the Register of a notice of adoption, unless otherwise indicated in the adoption notice. Promulgation in the New Jersey Register establishes a new or amended rule as an official part of the New Jersey Administrative Code.

Agency
LAW AND PUBLIC SAFETY > DIVISION OF CONSUMER AFFAIRS > OFFICE OF THE DIRECTOR

Administrative Code Citation

Proposed Amendments: N.J.A.C. 13:45A-35.1, 35.3, 35.4, and 35.6
Prescription Monitoring Program
Purpose and Scope; Pharmacy Reporting Requirements; Electronic Format; Requests for Exemption or Waiver; Access to Prescription Monitoring Information; Retention of Information

Authorized By: Sharon Joyce, Acting Director, Division of Consumer Affairs.

Authority: N.J.S.A. 45:1-47.

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

Proposal Number: PRN 2018-002.

Submit written comments by March 3, 2018, to:

   Maryann Sheehan, Director Legislative and Regulatory Affairs
   Division of Consumer Affairs
   124 Halsey Street, 7th Floor
   PO Box 45027
   Newark, NJ 07101
   or electronically at: http://www.njconsumeraffairs.gov/Proposals/Pages/default.aspx.

The agency proposal follows:
Summary
The Division of Consumer Affairs (Division) is proposing to amend the Prescription Monitoring Program (PMP) rules at N.J.A.C. 13:45A to require New Jersey licensed pharmacies and registered out-of-State pharmacies to electronically transmit information to the Division about prescriptions filled for gabapentin.
Under N.J.S.A. 45:1-47, the Director (Director) of the Division may expand the PMP to require the collection and tracking of information about a prescription drug that is not a controlled dangerous substance (CDS) if the Director determines that there is potential for abuse of the drug. A non-CDS prescription drug may be added to the PMP for a defined period of time, at the conclusion of which, the Director may determine whether the drug's inclusion in the PMP should be permanent.
Gabapentin is not a controlled dangerous substance. It is an anticonvulsant medication that is commonly prescribed for epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome, and alcoholism. When taken alone and as prescribed, there is little potential for abuse or addiction. However, when taken in combination with other medications, such as muscle relaxants, opioids, or anxiety medications, gabapentin is known to enhance the euphoric effect of such medications and its potential for abuse and addiction significantly increases. Concerns have arisen in recent years over increasing instances of gabapentin abuse.
Researchers from ARIA Diagnostics presented the results of their study "Prevalence of Gabapentin Abuse Among Clinical Patients" during the 68th annual American Association for Clinical Chemistry's meeting in August 2016. The study found that one in five patients who are using opioid pain medications and being monitored for compliance or illicit drug use tested positive for gabapentin even though they did not have a prescription for the drug. Prior to this study finding on the high rate of misuse of gabapentin, the Drug Abuse Warning Network reported that, between 2008 and 2011, the number of emergency room visits in metropolitan areas for misuse or abuse of gabapentin increased by nearly five times. A report by IMS Health found that 57 million prescriptions for gabapentin were written in the United States in 2015, a 42 percent increase since 2011. In New Jersey, when comparing data for toxicology cases for 2016 through July 2017, with data from 2015, the number of cases in which gabapentin was present increased by more than 1,000 percent. Recent studies suggest that gabapentin is now prevalent as a drug of abuse as access to drugs like Oxycontin and Xanax become increasingly restricted.
Gabapentin and pregabalin make up a class of drugs called gabapentinoids. The Division currently receives dispensing information for pregabalin because it is a Schedule V controlled dangerous substance. However, as gabapentin is not a controlled dangerous substance this dispensing information is not reported. With the increased prevalence of gabapentin in toxicology cases and the potential for abuse, the Division believes it is necessary to capture the dispensing information for gabapentin. New Jersey is not alone. As of August 1, 2017, seven states now require the reporting of dispensing information for gabapentin.
Consistent with the Director's statutory authority, the proposed amendments require pharmacies to transmit information to the PMP, for a one-year period, about prescriptions filled for gabapentin. At the conclusion of this one-year period, the Director will determine whether prescriptions for gabapentin should be monitored under the PMP permanently. The Director believes that the monitoring of prescriptions issued for gabapentin is warranted in light of growing concerns about the use of gabapentin for purposes other than those authorized under Federal law, and the potential side effects associated with the misuse of this medication.
The Division 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 Division believes that the proposed amendments will have a positive social impact on the consumers of New Jersey by helping to combat prescription drug abuse and diversion.

Economic Impact
The Division does not believe that the proposed amendments will have any economic impact upon licensed pharmacies in New Jersey and registered out-of-State pharmacies because there is no additional cost to electronically transmit prescription drug information about gabapentin to the Prescription Monitoring Program. To the extent there are any additional costs, the Division believes that they are outweighed by the interest in reducing the risk of drug addiction, and protecting the public health and safety.

Federal Standards Statement
A Federal standards analysis is not required because the amendments are not proposed under the authority of, or in order to implement, [page=10] comply with, or participate in any program under Federal law. The proposed amendments are governed by N.J.S.A. 45:1-47.

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

Agriculture Industry Impact
The Division does not believe that the proposed amendments will have any impact on the agriculture industry of the State.

Regulatory Flexibility Analysis
Currently, the Division licenses approximately 2,200 pharmacies in New Jersey and registers approximately 1,000 out-of-State pharmacies. If these pharmacies 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 will impose additional reporting requirements on licensed New Jersey pharmacies and registered out-of-State pharmacies. Those requirements are detailed in the Summary above.
No additional professional services will be needed to comply with the proposed amendments. The costs to comply with the proposed amendments are discussed in the Economic Impact statement above. The Division believes that the proposed amendments must be uniformly applied to all licensed pharmacies in New Jersey and all registered out-of-State pharmacies dispensing prescriptions for gabapentin, in order to reduce the risk of drug addiction, and protect the public health and safety. Therefore, no differing compliance requirements for any pharmacy is provided based upon the size of the business.

Housing Affordability Impact Analysis
The proposed amendments will have an insignificant impact on the affordability of housing in New Jersey and there is an extreme unlikelihood that the proposed amendments would evoke a change in the average costs associated with housing because the proposed amendments concern reporting gabapentin to the Prescription Monitoring Program.

Smart Growth Development Impact Analysis
The proposed amendments will have an insignificant impact on smart growth and there is an extreme unlikelihood that the proposed 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 reporting gabapentin to the Prescription Monitoring Program.

Regulations
  

Full text of the proposal follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):
SUBCHAPTER 35.  PRESCRIPTION MONITORING PROGRAM
13:45A-35.1    Purpose and scope
(a) (No change.)
(b) The rules in this subchapter shall apply to the following:
1. A pharmacy filling prescriptions in New Jersey in an outpatient setting for a Schedule II, III, IV, or V controlled dangerous substance, [or] for human growth hormone, or gabapentin.
i. (No change.)
2. An out-of-State pharmacy registered with the Board of Pharmacy pursuant to N.J.A.C. 13:39-4.20 that ships, mails, distributes, or delivers a Schedule II, III, IV, or V controlled dangerous substance, [or] human growth hormone, or gabapentin into New Jersey in an outpatient setting pursuant to a prescription;
3.-10. (No change.)
(c) The reporting requirements of this subchapter shall not apply to the direct administration of a controlled dangerous substance, [or] human growth hormone, or gabapentin to the body of an ultimate user; or to the administration or dispensing of a controlled dangerous substance that is otherwise exempted as determined by the Secretary of Health and Human Services pursuant to the National All Schedules Prescription Electronic Reporting Act of 2005, Pub.L. 109-60.
(d) The reporting requirements of this subchapter shall not apply to any prescriptions filled by a pharmacy for a Schedule II, III, IV, or V controlled dangerous substance, [or] for human growth hormone, or gabapentin dispensed to an inpatient at a hospital, long-term care, or other facility in which the resident is provided with 24-hour nursing care.
13:45A-35.3    Pharmacy reporting requirements; electronic format
(a) A pharmacy filling a prescription for a Schedule II, III, IV, or V controlled dangerous substance, [or] for human growth hormone, as defined in N.J.A.C. 13:45A-35.1, or for gabapentin, in an outpatient setting, shall collect and electronically transmit to the Division's PMP vendor on a daily basis information for each prescription, as specified in the New Jersey PMP Data Collection Manual.
1. (No change.)
2. Consistent with the requirements of N.J.S.A. 45:1-47.a, information for gabapentin prescriptions shall be collected and electronically transmitted until (one year from the effective date of this amendment), a one-year period from the effective date of this regulation. At the conclusion of this one-year period, the Division shall determine and make public the decision whether the inclusion of gabapentin in the PMP shall be permanent.
13:45A-35.4    Requests for exemption or waiver
(a) A pharmacy that does not dispense Schedule II, III, IV, or V controlled dangerous substances, [or] human growth hormone, or gabapentin, or that dispenses Schedule II, III, IV, or V controlled dangerous substances, [or] human growth hormone, or gabapentin only to inpatients in a hospital, long-term or other facility in which the residents are provided with 24-hour nursing care, shall apply to the Division for an exemption from the PMP on a form supplied by the Division and available at www.njconsumeraffairs.gov.
(b)-(c) (No change.)
13:45A-35.6 Access to prescription monitoring information; retention of information
(a) The Division shall provide online access to prescription monitoring information submitted to the PMP to the following:
1. A pharmacist who is employed by a current pharmacy permit holder and is authorized to dispense controlled dangerous substances [or], human growth hormone, or gabapentin who certifies that the request is for the purpose of providing health care to or verifying information with respect to a new or current patient, or verifying information with respect to a prescriber;
2. A practitioner who has a current CDS registration and is authorized to prescribe, dispense, or administer controlled dangerous substances [or], human growth hormone, or gabapentin who certifies that the request is for the purpose of providing health care to or verifying information with respect to a new or current patient of the practitioner, or verifying information with respect to a prescriber;
3.-5. (No change.)
6. A designated representative of the State Board of Medical Examiners, New Jersey State Board of Dentistry, New Jersey Board of Nursing, New Jersey State Board of Optometrists, New Jersey State Board of Pharmacy, State Board of Veterinary Medical Examiners, or any other board in this State or another state that regulates the practice of persons who are authorized to prescribe or dispense controlled dangerous substances [or], human growth hormone, or gabapentin, as applicable, who certifies that he or she is engaged in a bona fide specific investigation of a designated practitioner whose professional practice was or is regulated by that board;
7.-9. (No change.)
(b)-(i) (No change.)