VOLUME 44, ISSUE 21
ISSUE DATE: NOVEMBER 5, 2012
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
ADMINISTRATIVE RULES OF THE DIVISION OF CONSUMER AFFAIRS
44 N.J.R. 2453(a)
Proposed Amendments: N.J.A.C. 13:45A-27.1, 27.3, 27.4, 27.8, and 27.9
New Jersey Uniform Prescription Blanks Program
NJPB Printing Specifications
Authorized By: Eric T. Kanefsky, Acting Director, Division of Consumer Affairs.
Authority: P.L. 2007, c. 244 (N.J.S.A. 45:14-59).
Calendar Reference: See Summary below for explanation of exemption to calendar requirement.
Proposal Number: PRN 2012-153.
Submit written comments by January 4, 2013 to:
Eric T. Kanefsky
New Jersey Division of Consumer Affairs
124 Halsey Street
P.O. Box 45027
Newark, NJ 07101
The agency proposal follows:
The abuse of prescription drugs has reached epidemic proportions nationwide. New Jersey is not immune. Prescription drug abuse is growing at an alarming rate. The number of admissions to New Jersey addiction treatment programs due to prescription drug abuse rose by 230 percent from 2005 to 2010. The increasing demand for controlled dangerous substance (CDS) prescription drugs makes prescription blanks extremely valuable to black market dealers in these drugs.
Since the New Jersey Prescription Blank (NJPB) format and specifications were developed in 1997 and updated in 2004, computer software and color printing and copying technology have become much more sophisticated and less expensive, making the tools for counterfeiting NJPBs available and more accessible to those who would capitalize on the black market for prescription drugs. The Division believes that the format and specifications for NJPBs must be changed to include additional security measures to make altering issued prescriptions and counterfeiting NJPBs more difficult.
Security measures can be print-based (printed on plain paper stock) or paper-based (incorporated into the paper as part of the manufacturing process). Because using paper-based security measures would change the entire NJPB procurement process, the Division believes that print-based security measures can be instituted sooner than paper-based measures.
The Division believes that multiple layers of security afford the best chance of deterring counterfeiting and forging of NJPBs. The Division is proposing amendments to N.J.A.C. 13:45A-27 to require that NJPBs be printed with the following security measures: prescriber's telephone number in reverse print, a 14-digit identifier (in place of the currently required batch and serial number) with barcode, a hollow "void" pantograph, microprinting, thermochromic ink, tamper evident coating with hidden void feature, and a listing of security features.
Written prescriptions for outpatient medications prescribed to Medicaid beneficiaries are required to be printed on paper that meets Centers for Medicaid and Medicare Services (CMS) guidelines for copy resistance, erasure/modification resistance and counterfeit resistance. CMS guidelines require that blanks contain at least one CMS-recommended feature for each of the three categories. The security features in the proposed amendments meet the CMS tamper-resistant prescription requirements.
The Division is proposing an amendment to N.J.A.C. 13:45A-27.3(c) to require that NJPBs be pre-printed with the licensed prescriber's Drug Enforcement Administration (DEA) registration number. The proposed amendment is being made pursuant to N.J.S.A. 45:1-45 et seq., which created the Division's Prescription Monitoring Program, an electronic database for collecting, tracking, and monitoring information about CDSs that are dispensed in New Jersey by licensed pharmacists in outpatient settings. The proposed amendments to N.J.A.C. 13:45A-27.3(e) and (f), changing a citation to the rules of the Board of Pharmacy, reflect a 2005 recodification of certain such rules dealing with facsimile and electronic transmission of prescriptions.
N.J.A.C. 13:45A-27.4 concerns recordkeeping for licensed prescribers, health care facilities and pharmacists. The proposed amendment to paragrah (a)3 requires that records of licensed prescribers and health care facilities relating to NJPB pads include the unique 14-digit identifiers of the pads provided in N.J.A.C. 13:45A-27.9(g) instead of the batch number currently required.
N.J.A.C. 13:45A-27.8 contains the printing specifications for NJPBs. N.J.A.C. 13:45A-27.8(a) is proposed to be amended to provide that the Division will provide specifications and artwork disks to approved printer vendors; vendors are required to manufacture NJPBs using the artwork and specifications supplied by the Division.
Proposed amendments to N.J.A.C. 13:45A-27.8(c), (d), and (g) reverse the colors on the front and back of NJPBs: green on the front and blue on the back. N.J.A.C. 13:45A-27.8(e)1 and 2, which currently require the batch number and a consecutive or serialized number on NJPBs, are proposed for deletion. Proposed new paragraph (e)1 provides for a unique 14-digit identifier and a corresponding barcode; paragraphs (e)3, 4, and 5 are proposed to be recodified as paragraphs (e)2, 3, and 4. Proposed new paragraph (e)5 requires that the prescriber's telephone number be pre-printed on the blank in reverse print.
Proposed new N.J.A.C. 13:45A-27.8(h) implements P.L. 2009, c. 280 (N.J.S.A. 45:14-57), which permits a practitioner or health care facility to use an electronic health records system to print the prescriber's name, address, or National Provider Identifier (NPI) number or the unique provider number of the health care facility in lieu of having that information pre-printed on the blank. Paragraph (h)1 requires a vender to document that the practitioner or health care facility in fact uses an electronic health records system.
Proposed new subsections (i), (j), (k), (l), and (m) specify additional security measures to be printed on NJPBs: a safety hollow "VOID" pantograph background on the face of each NJPB; microprinting; thermocrhromic ink; tamper resistant coating with a hidden "void" feature; and a list of all security features on the blanks, respectively. Existing subsections (h) through (o) are proposed to be recodified as subsections (n) through (u), with appropriate amended cross-references to reflect recodifications.
N.J.A.C. 13:45A-27.9 sets forth requirements for NJPB vendors. Subsection (g) is proposed for amendment to require printing of the 14-digit unique identifier instead of batch numbers and states what each of the 14 digits represent.
The Division intends to adopt the proposed amendments with an operative date of three months from the effective date of the proposed amendments, thus permitting vendors to sell NJPBs in the current form until three months from the effective date of the proposed amendments. The Division proposes to amend N.J.A.C. 13:45A-27.1 by adding subsection (c) to permit prescribers until six months from the effective date of the proposed amendments to use NJPBs in the current form (old form NJPBs) that they purchased before three months from the effective date of the proposed amendments. Vendors are cautioned not to print and add to inventories more old form NJPBs than they expect to sell before the expiration of the three-month period. Prescribers are cautioned not to order more old form NJPBs than they can use, together with their existing inventories of old form NJPBs, before the expiration of the six-month period.
The Division believes that paper-based security measures offer even better security than print-based measures. The Division is giving advance notice that it will amend its rules to implement specifications for NJPBs printed on security paper after the present proposed amendments have been in effect for at least 30 months from their effective date. The Division intends to issue a Request for Proposal (RFP) for the production of security document paper for NJPBs. Based on the RFP, the Division expects to approve a single manufacturer from which State-approved printer-vendors will purchase security paper to print the NJPB template and identifying information and produce NJPBs for prescribers.
[page=2454] The Director has determined that the comment period for this notice of proposal shall be 60 days. Therefore, pursuant to N.J.A.C. 1:30-3.3(a)5, this notice is excepted from the rulemaking calendar requirement.
The proposed amendments should make it more difficult to forge or counterfeit an NJPB, reducing the availability of black market prescription drugs and thus will have a positive social impact on the health and safety of the public.
The Division believes that printing NJPBs with the new specifications will increase the printers' cost of producing NJPBs. Reducing the number of variations of the NJPBs should offset slightly the increase in the cost of production. The Division believes that the cost will vary from printer to printer, depending on the capabilities it currently has. It is expected that any additional costs of printing NJPBs with the additional security measures will be passed on to prescribers. The Division believes that the benefits from the expected reduction in forged and counterfeit NJPBs and the concomitant reduction in the availability of black market CDS prescription drugs outweigh the additional costs. Reducing the number of counterfeit or forged NJPBs should reduce costs to health insurance companies.
Federal Standards Statement
A Federal standards analysis is not required because the proposed amendments are governed by P.L. 2007, c. 244, codified as N.J.S.A. 45:14-59, and are not subject to any Federal requirements or standards. However, the security measures required by the proposed amendments meet the Centers for Medicaid and Medicare Services (CMS) guidelines. CMS is a branch of the U.S. Department of Health and Human Services.
The Division does not anticipate that the proposed amendments will increase or decrease 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 Division licenses approximately 41,390 healthcare practitioners who must use NJPBs when writing prescriptions. The Division has contracted with 41 vendors to print NJPBs for licensed prescribers and healthcare facilities in the State. If licensed prescribers and healthcare facilities and approved vendors 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 not impose any reporting requirements upon licensed prescribers, healthcare facilities, or approved vendors. The proposed amendments will impose compliance requirements upon approved vendors because the proposed amendments will change the specifications for printing NJPBs. Also, vendors will be required to document that a prescriber or health care facility that orders NJPBs without the name, address, or NPI number or unique provider number of the health care facility pre-printed on the blank uses an electronic health records system to print the information on the NJPB. Prescribers will be required to use the new NJPBs after six months from the effective date of the proposed amendments.
No additional professional services will be needed to comply with the proposed amendments. The costs of compliance with the proposed amendments are discussed in the Economic Impact above. The Division believes that the proposed amendments must be uniformly applied to all licensed prescribers and healthcare facilities and all approved vendors in order to ensure that NJPBs utilized in New Jersey comply with the requirements of P.L. 2007, c. 244. Therefore, no differing compliance requirements for any licensed prescriber, healthcare facility, or vendor is 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 rules would evoke a change in the average costs associated with housing because the proposed amendments concern security measures for NJPBs.
Smart Growth Development Impact Analysis
The proposed amendments will have an insignificant impact on smart growth and there is an extreme unlikelihood that the rules 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 security measures for NJPBs.
Full text of the proposal follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):
SUBCHAPTER 27. NEW JERSEY UNIFORM PRESCRIPTION BLANKS PROGRAM
13:45A-27.1 Purpose and scope
(a)-(b) (No change)
(c) Until (six months from the effective date of these proposed amendments), licensed healthcare practitioners authorized to write prescriptions for controlled dangerous substances, legend drugs, or other items shall be permitted to issue written prescriptions on NJPBs purchased by them on or before (three months from the effective date of these proposed amendments).
(d) Until (six months from the effective date of these proposed amendments), healthcare facilities licensed pursuant to N.J.S.A. 26:2H-1 et seq., that are authorized to issue prescription blanks shall be permitted to issue written prescriptions on NJPBs purchased by them on or before (three months from the effective date of these proposed amendments).
13:45A-27.3 NJPB required for prescriptions
(a)-(b) (No change.)
(c) A separate NJPB shall be utilized for each prescription written for a controlled dangerous substance. The licensed prescriber's Federal DEA registration number shall be pre-printed, legibly written, typed, stamped, or otherwise affixed to the NJPB. No other medication shall appear on the prescription.
(d) (No change.)
(e) A prescription transmitted verbally or transmitted electronically by telephone, facsimile, modem, or other means to a pharmacy by a licensed prescriber shall be exempt from the requirement of utilizing an NJPB if the licensed prescriber provides the pharmacist with his or her license number, DEA number, as appropriate to the particular prescription and NPI number, if the prescriber has obtained an NPI number, at the time of transmission of the prescription, and the pharmacist satisfies the requirements of N.J.A.C. 13:39-[5.8, 5.8A or 5.8B]7.10, 7.11, or 9.27.
1. (No change.)
(f) A licensed prescriber writing a prescription for a Schedule II narcotic substance to be compounded for direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion, or a prescription for a Schedule II narcotic substance for a hospice patient, or a prescription for any Schedule II substance for a long-term care facility resident, shall be exempt from the requirement of utilizing an NJPB if the prescription is transmitted or prepared in compliance with DEA regulations as set forth in 21 [C.F.R.] CFR 1306.11(d), (e), (f), and (g), consistent with the requirements set forth at N.J.A.C. 13:39-[5.8, 5.8A or 5.8B]7.10, 7.11, or 9.27.
1. (No change.)
13:45A-27.4 Recordkeeping, reporting, and security requirements for licensed prescribers, health-care facilities, and pharmacists
(a) Licensed prescribers and healthcare facilities shall maintain records indicating the ordering, receipt, storage, maintenance, and distribution of NJPB pads. Such records shall include, at a minimum, the following:
1.-2. (No change.)
[3. The batch numbers of the NJPB pads;]
3. The unique 14-digit identifiers of the NJPB pads as provided in N.J.A.C. 13:45A-27.9(g);
4.-6. (No change.)
[page=2455] (b)-(d) (No change.)
13:45A-27.8 NJPB printing specifications
(a) Vendors shall manufacture all NJPBs [utilizing] consistent with the requirements set forth in this subchapter and the printing specifications approved by the Division and supplied to each approved vendor. Vendors shall also manufacture all NJPBs using artwork disks [obtained from] supplied by the Division.
(b) (No change.)
(c) The front side of each NJPB shall be printed with the body copy (line work) in PMS [299 blue] 332 green overprinted on a background of five percent of the [blue] green (with an allowable variance no darker than PMS [300 blue] 333 green).
(d) The background of the front side of each NJPB shall be a pantograph of the New Jersey State Seal reversed out of the [blue] green screen and shall bleed on all four sides. A one and one-half inch State Seal shall be positioned centrally within the pantograph of State seals.
(e) The upper portion of the front side of each NJPB shall include the following information, printed in black ink:
[1. The batch number;
2. The consecutive or serialized number;]
1. A unique 14-digit identifier as provided in N.J.A.C. 13:45A-27.9(g), and a linear barcode (Code 39) that matches the unique 14-digit identifier for each blank;
Recodify existing 3. and 4. as 2. and 3. (No change in text.)
[5.] 4. The prescriber or healthcare facility address, which may be an address other than the address of record, but which shall not be a post office box; [and]
5. The prescriber's telephone number in reverse print; and
6. (No change.)
(f) (No change.)
(g) The reverse side of each NJPB shall contain a pantograph of the New Jersey State Seal printed in PMS [332 green] 299 blue screened down to five percent (with an allowable variance up to PMS [333 green] 300 blue), which shall bleed on all four sides. A one and one-half inch State Seal shall be positioned centrally as on the front, except that it shall not be in reverse.
(h) NJPBs may be printed without the practitioner's name, address, or NPI number, or the unique provider number of the health care facility, provided the practitioner or health care facility utilizes an electronic health records system to imprint such information on the blanks. Such blanks shall be pre-printed with all other information required to appear on an NJPB pursuant to (e) above, and shall comply with all other printing specifications set forth in this section.
1. Prior to manufacturing NJPBs without a practitioner's name, address, or NPI number or health care facility unique provider number, a vendor shall document that the practitioner or health care facility utilizes an electronic health records system. Such documentation shall include the name and manufacturer of the electronic health records system utilized by the practitioner or health care facility.
(i) A safety hollow "VOID" pantograph background that cannot be replicated by a black and white or color copier or by a scanner is required on each NJPB. A hollow "VOID" shall appear on the face of the NJPB. Areas intended for data entry shall be in lighter tones to permit easy reading of information without compromising copy protection.
(j) Microprint shall be included on each NJPB. The print shall be in 0.5 font or smaller and shall be readable when viewed at five times magnification or greater, but shall be illegible when photocopied or scanned.
(k) Each NJPB shall be printed with friction activated (thermochromic) ink, that shall appear in an Rx logo on the blank. The ink on the face shall change color or disappear when warmed (reacts to body heat). The ink should return to its original color when cooled.
(l) Each NJPB shall include a tamper evident coating containing a hidden void feature to prevent attempts to alter the prescription with acetone or other chemical agents. Under normal conditions, the feature is invisible. An erasure or abrasion attempt will activate the coating and the word VOID will appear and shall obscure the area where the prescription information is written.
(m) Each NJPB shall be printed with a complete list of all security features incorporated into the prescription pad in order to minimize tampering. The security features shall be listed visibly in a box, band, or border on the prescription.
[(h)] (n) Except as provided in [(i)] (o) below, the front side of an NJPB may be imprinted with the name and license number of more than one licensed prescriber in the same licensing category provided that:
1.-2. (No change.)
Recodify existing (i), (j), and (k) as (o), (p), and (q) (No change in text.)
[(l)] (r) In addition to the pre-printed requests set forth in [(k)] (q) above, NJPBs may be printed to include the following special order requests in black ink only:
1.-3. (No change.)
[(m)] (s) Any request for a pre-printed or special order NJPB not included in [(k) or (l)] (q) or (r) above shall be approved by the Division before the NJPBs are produced.
Recodify existing (n) and (o) as (t) and (u) (No change in text.)
13:45A-27.9 Vendor requirements
(a)-(e) (No change.)
(f) Vendors shall be capable of producing seven versions of NJPBs, each in the following forms:
1.-4. (No change.)
(g) Vendors shall assign and maintain a unique NJPB [batch number] 14-digit identifier for each order of NJPBs from a licensed prescriber or licensed healthcare facility. Re-orders of NJPBs shall contain [batch numbers] a unique identifier sequentially greater than the [batch number] unique identifier assigned to any previous order. [Batch numbers] The 14-digit unique identifier shall consist of:
1. [An] A two-digit alphabetic prefix assigned by the Division, which represents the identity of the vendor;
[2. The date of printing in the following order: year, month, and day; and
3. A number sequentially assigned by the vendor.]
2. A six-digit order number, of which two digits represent the vendor's prescriber identifier, and four digits that represent the month and year of the printing order; and
3. A six-digit sequential serial number, beginning with the number 1 and ending with 999,999. A zero shall be used as a placeholder for any unused digits to the left in the sequential serial number.
(h) Vendors shall maintain an on-site computerized database, which shall:
1. Include for each order the following data fields for each licensed prescriber and healthcare facility:
i.-v. (No change.)
[vi. Batch number;]
vi. 14-digit unique identifier;
vii.-x. (No change.)
2. (No change.)