EDU-16-12-00015-P Form and Use of Electronic Prescriptions and Maintenance of Prescriptions by Pharmacists in a Secure Electronic Record

4/18/12 N.Y. St. Reg. EDU-16-12-00015-P

NEW YORK STATE REGISTER

VOLUME XXXIV, ISSUE 16

April 18, 2012

RULE MAKING ACTIVITIES

EDUCATION DEPARTMENT

PROPOSED RULE MAKING

NO HEARING(S) SCHEDULED

 

I.D No. EDU-16-12-00015-P

Form and Use of Electronic Prescriptions and Maintenance of Prescriptions by Pharmacists in a Secure Electronic Record

PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:

Proposed Action:

Amendment of sections 29.7(a) and 63.6(a)(7) of Title 8 NYCRR.

Statutory authority:

Education Law, sections 207 (not subdivided), 6504 (not subdivided), 6506(1), 6507(2)(a), 6509(9), 6802(23) and 6810(6)(a); L. 2011, ch. 590

Subject:

Form and use of electronic prescriptions and maintenance of prescriptions by pharmacists in a secure electronic record.

Purpose:

To implement Education Law sections 6802(23), as added, and section 6810(6)(a), as amended, by chapter 590 of the Laws of 2011.

Text of proposed rule:

1. Subdivision (a) of section 29.7 of the Rules of the Board of Regents is amended, effective July 11, 2012, as follows:

(a) The requirements of this section set forth for written prescriptions shall also be applicable to [electronically transmitted] electronic prescriptions, as defined in section [63.6(a)(7)] 63.6(a)(7)(i)(a) of this Title, unless otherwise indicated. For purposes of this section "signature" shall include an electronic signature, as defined in section 63.6(a)(7)(i)(c) of this Title, when applicable, and "sign" shall include the affixing of an electronic signature. Unprofessional conduct in the practice of pharmacy shall include all conduct prohibited by sections 29.1 and 29.2 of this Part except as provided in this section, and shall also include the following:

(1) …

(2) …

(3) …

(4) Refilling a prescription without entering on the reverse of the prescription or within the electronic record the date of the refill and the signature or readily identifiable initials of the pharmacist and of the intern, if applicable, dispensing the refill, except as provided in paragraph (8) of this subdivision. As a refill instruction, the pharmacist may accept a number of times, a time period, such as one year, or the Latin phrase pro re nata (abbreviated prn--meaning "as needed"). In the case of the latter, the pharmacist shall refill the prescription once only. The pharmacist receiving on oral order to refill a prescription shall reduce the order to writing or to an electronic record and shall sign or initial it legibly as the recipient of the oral order. When a prescription is refilled, the date placed on the label shall be the date of the refill.

(5) Using or substituting without authorization one or more drugs in the place of the drug or drugs specified in a prescription. Unauthorized use or substitution occurs if the same is done without the knowledge and consent of the prescriber. If other than the ingredients specified are utilized by the pharmacist in compounding or dispensing the prescription, improper substitution shall be presumed unless there shall be entered upon the reverse of the original prescription or within the electronic record information setting forth the facts of the substitution, the date, time and manner in which authorization for substitution was given and the signature of the pharmacist who received such authorization.

(6) …

(7) …

(8) Failure to maintain in a form which provides for ready retrieval of prescriptions a daily record of all prescriptions filled and refilled which identifies clearly the practitioner who ordered the prescription, the patient for whom the prescription is intended, the signature or readily identifiable initials of the pharmacist who filled or refilled the prescription, and the number assigned to the prescription where applicable. The record of the dispensing of a drug for an inpatient in a health care facility, including but not limited to general hospital, by the pharmacy of that facility may be maintained in a form which is consistent with the record of the total health service provided to the patient provided the information required by this paragraph is readily retrievable and available. Original prescriptions filed in accordance with the provisions of paragraph (7) of this subdivision may constitute the record of the initial filling of those prescriptions. The daily record may be maintained by a manual system or, alternatively, by an electronic data processing system which meets the following requirements:

(i) ...

(ii) ...

(iii) ...

(iv) A pharmacist, and a pharmacy intern, if applicable, using a computerized system shall sign or initial the original prescription at the time of the first dispensing as provided in paragraph (3) of this subdivision and the signature or initials of the pharmacist shall be entered into the computer record of the dispensing.

(v) For all refills of a prescription, the records introduced into the system shall be sufficient if:

(a) the signature or initials of the pharmacist who dispensed the refill are entered by such pharmacist at the time of dispensing; and

(b) a printout or electronic record is produced of all prescriptions filled and refilled each day and the pharmacist(s) whose signature or initials appear(s) on the printout sign(s), either manually or electronically, the printout or electronic record to indicate that it is an accurate record.

(9) …

(10) …

(11) …

(12) …

(13) …

(14) …

(15) …

(16) …

(17) …

(18) …

(19) …

(20) …

2. Paragraph (7) of subdivision (a) of section 63.6 of the Regulations of the Commissioner of Education is amended, effective July 11, 2012, as follows:

(7) [Electronically transmitted] Electronic prescriptions.

(i) For the purposes of this section:

[electronically transmitted] (a) the term electronic prescription means a prescription created, recorded [, transmitted] or stored by electronic means; issued and validated with an electronic signature; and transmitted by electronic means; [, including but not limited to facsimile but excluding any such prescription for a controlled substance under Article 33 of the Public Health Law ]

(b) the term electronic means of or relating to technology having electrical, digital, magnetic, wireless, optical, electromagnetic, or similar capabilities; and

(c) the term electronic signature means an electronic sound, symbol, or process, attached to or logically associated with an electronic prescription, executed or adopted by a person with the intent to sign the prescription, and effectively secured from alteration by an unauthorized third party.

(ii) A pharmacist may, based upon his or her professional judgment, accept an [electronically transmitted] electronic prescription from a prescriber, to the pharmacy of the patient's choice, subject to the following requirements:

(a) the prescription shall contain [the signature, or] the electronic [equivalent of a] signature[,] of the prescriber;

(b) in the case of an [electronically transmitted] electronic prescription, [other than facsimile transmission,] such prescription shall be electronically encrypted, meaning protected to prevent access, alteration or use by any unauthorized person;

(c) [a permanent hard copy of an electronically transmitted] an electronic prescription or a hard copy of an [electronically transmitted] electronic prescription stored securely and permanently [by electronic means] shall be [produced and] maintained at the pharmacy for a period of five years from the date of the most recent filling, provided that, if the prescription is maintained electronically, it shall be made available to the Department in hard copy upon request. [A permanent facsimile copy shall be considered a hard copy];

(d) except when the prescriber inserts an electronic direction to dispense the drug as written, the prescriber's electronic signature shall designate approval of substitution by a pharmacist of a drug product pursuant to section 206(1)(o) of the Public Health Law. Notwithstanding any other provision of this section or any other law to the contrary, when a generic drug is not available and the brand name drug originally prescribed is available and the pharmacist agrees to dispense the brand name product for a price that will not exceed the price that would have been charged for the generic substitute had it been available, substitution of a generic drug product will not be required. If the generic drug product is not available and a medical emergency exists, which for purposes of this section shall be defined as a condition requiring the alleviation of severe pain or a condition which threatens to cause disability or death if not promptly treated, the pharmacist may dispense the brand name product at the regular price. In such instances, the pharmacist shall record the date, hour and nature of the medical emergency on the back of the prescription or within the electronic record of the prescription and shall keep a hard copy or electronic record of all such prescriptions;

(e) such prescriptions shall be processed in accordance with the requirements of section 29.7 of this title, provided, however, that prescriptions for controlled substances shall be filled in accordance with the requirements of Article 33 of the Public Health Law; and

[(e)] (f) in accepting an [electronically transmitted] electronic prescription, the [pharmacists] pharmacist shall be subject to the applicable requirements of Part 29 of this Title relating to unprofessional conduct, including but not limited to section 29.1(b)(2) and (3) of this Title.

(iii) An original hard copy prescription that is created electronically or otherwise may be transmitted from the prescriber to the pharmacist by facsimile and must be manually signed, provided, however, that prescriptions for controlled substances shall be filled in accordance with the requirements of Article 33 of the Public Health Law. A permanent hard copy of a prescription transmitted by facsimile shall be stored securely and permanently in hard copy or by electronic means and shall be maintained at the pharmacy for a period of five years from the date of the most recent filling, provided that if the prescription is maintained electronically, it shall be made available to the Department in hard copy upon request.

Text of proposed rule and any required statements and analyses may be obtained from:

Mary Gammon, State Education Department, Office of Counsel, State Education Building, Room 148, 89 Washington Avenue, Albany, New York 12234, [phone], email: [e-mail]

Data, views or arguments may be submitted to:

Office of Professions, Office of Deputy Commissioner, State Education Department, 89 Washington Ave., 2M, Albany, New York 12234, [phone], email: [e-mail]

Public comment will be received until:

45 days after publication of this notice.

Regulatory Impact Statement

1. STATUTORY AUTHORITY:

Section 207 of the Education Law grants general rule-making authority to the Board of Regents to carry into effect the laws and policies of the State relating to education.

Section 6504 of the Education Law authorizes the Board of Regents to supervise the admission to and regulation of the practice of the professions.

Subdivision (1) of section 6506 of the Education Law authorizes the Board of Regents to promulgate rules regarding the admission to and practice of the professions.

Subparagraph (a) of subdivision (2) of section 6507 of the Education Law authorizes the Commissioner of Education to promulgate regulations regarding the admission to and practice of the professions.

Subdivision (9) of section 6509 of the Education Law authorizes the Board of Regents to define unprofessional conduct in the practice of the professions.

Subdivision (23) of section 6802 of the Education Law, as added by Chapter 590 of the Laws of 2011, defines the terms "electronic prescription" and "electronic signature," and authorizes the Commissioner of Education to promulgate regulations further defining the proper form of an electronic prescription and of an electronic signature used to validate such a prescription.

Paragraph (a) of subdivision (6) of section 6810 of the Education Law, as amended by Chapter 590 of the Laws of 2011, establishes the required elements and format of prescriptions written in New York State, including electronic prescriptions, and specifically authorizes the Commissioner of Education to promulgate regulations providing for the form and placement of the "dispense as written" direction on an electronic prescription.

Chapter 590 of the Laws of 2011 enacted Education Law § 6802(23), as added, and Education Law § 6810(6)(a), as amended, and clarified that such Chapter should not be construed to mean or imply that any other reference in statute or regulation to a prescription, signature, or writing does not include an electronic prescription, electronic signature, or entry of information by electronic means, respectively.

2. LEGISLATIVE OBJECTIVES:

The proposed amendment implements the intent of the aforementioned statutes, which collectively provide the State Education Department ("Department") with the authority to supervise the practice of the professions for the benefit and protection of the public. The proposed amendment will conform the Rules of the Board of Regents and the Regulations of the Commissioner of Education to Chapter 590 of the Laws of 2011, which provided for and clarified the valid form and proper use and transmission of electronic prescriptions and expressly required that pharmacists store these prescriptions in a secure electronic record. Although pharmacists are currently required to maintain detailed records of all prescriptions filled and refilled, Chapter 590 of the Laws of 2011 and the proposed amendment, accordingly, explicitly require that these records be properly maintained in a secure electronic record, which will further protect the public from an inadvertent disclosure of such information.

3. NEEDS AND BENEFITS:

The proposed amendment is necessary to conform the Rules of the Board of Regents and the Commissioner's regulations to Education Law § 6802(23), as added, and Education Law § 6810(6)(a), as amended, by Chapter 590 of the Laws of 2011, which provided for and clarified the valid form and proper use and transmission of electronic prescriptions. Chapter 590 was enacted to update the law governing the form and use of electronic prescriptions to reflect the current practice of using electronic prescriptions. The proposed amendment is needed to update the Rules of the Board of Regents and Commissioner's regulations to these current practices, in accordance with these statutory amendments.

In particular, the proposed rule will amend the Rules of the Board of Regents to provide that, when used in the disciplinary rules relating to the profession of pharmacy, the term "signature" will refer to and include an electronic signature. The proposed rule will also amend of the Commissioner's regulations to include the new terms and definitions of an electronic prescription and electronic signature, as set forth in Education Law § 6802(23); to provide for the proper use and form of such prescriptions; to authorize the use of an electronic direction to "dispense as written" in place of the prescriber's handwritten notation, when specifically issuing an electronic prescription for a brand name drug; and to require that a prescription transmitted by facsimile be manually signed.

4. COSTS:

(a) There are no additional costs to state government.

(b) There are no additional costs to local government.

(c) Cost to private regulated parties. The proposed amendments will not increase costs, and may provide cost-savings to regulated parties. Therefore, there will be no additional costs to private regulated parties.

(d) There are no additional costs to the regulating agency.

5. LOCAL GOVERNMENT MANDATES:

The proposed amendment relates solely to the requirements for electronic prescriptions and for the storage and maintenance of records required to be maintained by pharmacists in registered pharmacies. The amendment does not impose any additional program, service, duty, or responsibility upon local governments.

6. PAPERWORK:

The proposed amendment will not impose any new reporting requirements.

7. DUPLICATION:

The proposed amendment does not duplicate any other existing state or federal requirement.

8. ALTERNATIVES:

There are no viable alternatives to the proposed amendment and none were considered.

9. FEDERAL STANDARDS:

Federal standards do not apply, nor does the proposal exceed federal standards.

10. COMPLIANCE SCHEDULE:

Licensees using electronic prescriptions will need to comply with the proposed amendment as of the effective date of the amendments.

Regulatory Flexibility Analysis

The proposed amendment to the Rules of the Board of Regents and the Regulations of the Commissioner of Education relates to the practice of pharmacy, and specifically provides for and clarifies the form and use and transmission of an electronic prescription, as well as expressly requires pharmacists to maintain prescriptions in a secure electronic record. Pharmacists are currently required to maintain detailed records of all prescriptions filled and refilled. The proposed amendment merely amends the regulations to explicitly require that these records be properly maintained in a secure electronic record. The proposed amendment will not impose any additional reporting, recordkeeping, or other compliance requirement, or any adverse economic impact on small businesses or local governments. Because it is evident from the nature of the proposed amendment that it will not affect small businesses or local governments, no affirmative steps were needed to ascertain that fact and none were taken. Accordingly, a regulatory flexibility analysis for small businesses and local governments is not required and one has not been prepared.

Rural Area Flexibility Analysis

1. TYPES AND ESTIMATED NUMBER OF RURAL AREAS:

The regulations will apply to the 44 rural counties with less than 200,000 inhabitants and the 71 towns in urban counties with a population density of 150 per square mile or less. Of the 5,044 pharmacies registered to operate in New York State by the State Education Department, 779 pharmacies are located in a rural county.

2. REPORTING, RECORDKEEPING AND OTHER COMPLIANCE REQUIREMENTS; AND PROFESSIONAL SERVICES:

The proposed amendment will conform the Rules of the Board of Regents and the Commissioner's regulations to Education Law § 6802(23), as added, and Education Law § 6810(6)(a), as amended, by Chapter 590 of the Laws of 2011. These provisions will clarify the conditions under which pharmacists may accept electronic prescriptions from authorized prescribers, and maintain required records electronically subject to certain requirements. Although electronic prescriptions have been allowed for non-controlled substances for some time, the law regarding the prescribing of brand name drugs explicitly required a hand-written notation. The statutory amendments made by Chapter 590 remove this reference, and accordingly, the proposed rule amends section 63.6(a)(7) of the Commissioner's regulations to implement this change.

3. COSTS:

The proposed amendment does not impose any additional cost on regulated parties.

4. MINIMIZING ADVERSE IMPACT:

Following discussions, including obtaining input from practicing professionals, the State Board of Pharmacy has considered the terms of the proposed amendment to the Board of Regents and the Regulations of the Commissioner of Education and has recommended the changes. Additionally, the measures have been shared with educational institutions, professional associations, and practitioners representing the profession of pharmacy. The amendments are supported by representatives of these sectors. The proposed amendment makes no exception for individuals who live in rural areas. The Department has determined that such requirements should apply to all pharmacists and pharmacies, no matter their geographic location, to ensure a standard of practice across the State. Because of the nature of the proposed rule, alternative approaches for rural areas were not considered.

5. RURAL AREA PARTICIPATION:

Comments on the proposed amendment were solicited statewide from organizations representing all parties having an interest in the practice of pharmacy. Included in this group were members of the State Board of Pharmacy, educational institutions and professional associations representing the pharmacy profession, such as the Pharmacists Society of the State of New York and the New York State Council of Health System Pharmacists. These groups, which have representation in rural areas, have been provided notice of the proposed rule making and opportunity to comment on the proposed amendment.

Job Impact Statement

The proposed amendment implements Education Law § 6802(23), as added, and Education Law § 6810(6)(a), as amended, by Chapter 590 of the Laws of 2011, by providing for the valid form and proper use and transmission of electronic prescriptions and by expressly requiring that pharmacists store these prescriptions in a secure electronic record. The proposed amendment will not have a substantial adverse impact on jobs and employment opportunities. Because it is evident from the nature of the proposed amendment that it will not affect job and employment opportunities, no affirmative steps were needed to ascertain that fact and none were taken. Accordingly, a job impact statement is not required and one has not been prepared.