PROPOSED RULEMAKING
STATE BOARD OF PHARMACY
[49 PA. CODE CH. 27]
Facsimile Machines
[26 Pa.B. 1030] The State Board of Pharmacy (Board) proposes to amend § 27.1 (relating to definitions) by adding a definition of ''long-term care facility'' and proposes to adopt § 27.20 (pertaining to facsimile machines). The Board proposes these amendments under the authority of sections 4(j) and 6(k)(1) and (9) of the Pharmacy Act (act) (63 P. S. §§ 390-4(j) and 390-6(k)(1) and (9)).
The Board proposes these changes for two principal reasons. First, the Federal Drug Enforcement Administration (DEA) amended its regulations, effective May 19, 1994, to allow for the transmission of controlled substance prescriptions between the prescriber and the dispenser by facsimile machine. See 59 FR 26109 (May 19, 1994). The Board believes that it should adopt the standards promulgated by the DEA. Second, the Board has received numerous questions from its licensees regarding the legality of filling a prescription or drug order which was received in a pharmacy by means of facsimile machine.
Section 27.18(o) (relating to standards of practice) already authorizes a pharmacist to dispense a drug on the basis of a prescription or order as long as the prescription or order is an original prescription or order or direct copy issued by a prescriber who may be using electronic or computerized equipment. Even before the promulgation of the DEA regulations on May 19, 1994, the Board had interpreted this section to mean that it was lawful for a pharmacist to fill a prescription or order received on a facsimile machine for a drug other than a controlled substance. The Board proposes to clarify this lawful practice and add rules pertaining to filling a prescription or order for a controlled substance received on a facsimile machine.
The Board believes that the use of a facsimile machine to transmit an order or prescription from prescriber to pharmacist does not increase the risk to public health and safety. The Board believes that facsimile transmission may result in fewer errors than telephone transmission of a prescription or order. When a prescription or order is transmitted by means of telephone, it is possible for the pharmacist or for the person who makes the call to make an error. There may well be less possibility for error in both the transmission and reception of a prescription or order transmitted by facsimile machine, for the pharmacist will read an exact copy of the prescription.
§ 27.1 (relating to definitions)
The proposal would add a definition of ''long-term care facility'' based on the DEA definition found at 21 CFR 1306.01(e) (relating to definitions).
The standards adopted by the DEA generally forbid a pharmacist from dispensing a prescription for a Schedule II controlled substance received on a facsimile machine prior to also receiving and reviewing the original signed prescription. The DEA regulations created two exceptions to the requirement that the pharmacist first review the original of a prescription for a Schedule II controlled substance. Under one of these exceptions, a pharmacist would be permitted to dispense a prescription for a Schedule II controlled substance received on a facsimile machine for a patient in a long-term care facility and use the facsimile as the original written prescription. The proposal would adopt the DEA definition of ''long-term care facility'' so that a pharmacist will know for what kind of institution the pharmacist may dispense a prescription for a Schedule II controlled substance received on a facsimile machine without first reviewing the original.
§ 27.20 (relating to facsimile machines)
The Board proposes to establish standards for filling a prescription or drug order received on a facsimile machine in § 27.20. Subsection (a) deals with a pharmacist in a noninstitutional practice.
Subsection (a)(1) deals with Schedule II controlled substances. In paragraph (1)(i) of this subsection the Board proposes to authorize a pharmacist to fill a prescription for a Schedule II controlled substance which was received on a facsimile machine if the pharmacist reviews the original prescription signed by the medical practitioner before the pharmacist actually dispenses the medication. The original signed prescription will serve as the pharmacy record. In paragraph (1)(ii) of this subsection, the Board identifies two circumstances in which the pharmacist may dispense a prescription for a Schedule II controlled substance received on a facsimile machine while using the facsimile as the original pharmacy record: (A) a prescription for a narcotic which will be administered to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion in the patient's home or hospice; and (B) a prescription for any Schedule II controlled substance for a resident of a long-term care facility.
Subsection (a)(2) deals with Schedule III--V controlled substances and other nonproprietary drugs. In this subsection, the Board proposes to allow a pharmacist to dispense a prescription for a Schedule III--V controlled substance or other nonproprietary drug received on a facsimile machine and use the facsimile as the original pharmacy record. This proposal is consistent with the recent change to DEA regulations. See 21 CFR 1306.21(a) (relating to requirement of prescription).
Subsection (b) deals with a pharmacist in an institutional practice. The Board proposes to authorize a pharmacist to dispense a drug order received on a facsimile machine as long as the medical practitioner who issued the order wrote and signed the original.
In subsection (c)(1), the Board proposes to require a pharmacist to exercise professional judgment regarding the accuracy and authenticity of the facsimile. Current State and Federal regulations already make the pharmacist responsible for making professional determinations and ensuring that a prescription for a controlled substance has been issued for a legitimate medical purpose. See §§ 27.12(a)(1), 27.18(b) and (c) and 21 CFR 1306.04(a) (relating to purpose of issue of prescription).
In subsection (c)(2), the Board proposes to require that a facsimile copy of a prescription or drug order used as a record be printed on paper that can survive for at least 2 years. The act requires that prescriptions be kept on file for at least 2 years. See 63 P. S. § 390-4(a)(3) and 21 CFR 1304.04(a) (relating to maintenance, reports and inventory).
In subsection (c)(3), the Board proposes to forbid a pharmacy or pharmacist from contributing to the installation of a facsimile machine in the office of a medical practitioner or institution.
Fiscal Impact
This proposed rulemaking will not have a negative fiscal impact on the Commonwealth, local government, licensees or consumers.
Paperwork Requirements
The proposed rulemaking will not have an impact on the paperwork of the Commonwealth, local government, the general public or licensees.
Statutory Authority
Section 4(j) of the act authorizes the Board to promulgate regulations governing standards of practice and operation of pharmacies, including regulations governing the standards for dispensing prescriptions to insure methods of operation and conduct which protect the public health, safety and welfare. Section 6(k)(1) of the act authorizes and requires the Board to regulate the practice of pharmacy. Section 6(k)(9) of the act authorizes and requires the Board to regulate the practice of pharmacy for the protection and promotion of the public health safety and welfare.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), the Board submitted a copy of these proposed amendments on February 28, 1996, to the Independent Regulatory Review Commission (IRRC) and the Chairpersons of the House Committee on Professional Licensure and the Senate Committee on Professional Licensure and Consumer Protection. In addition to submitting the proposed amendments, the Board has provided IRRC and the Committees with a copy of a detailed regulatory analysis form prepared by the Board in compliance with Executive Order 1982-2, ''Improving Government Regulations.'' A copy of the material is available to the public upon request.
If IRRC has objections to any portion of the proposed amendments, it will notify the Board within 30 days of the close of the public comment period. The notification shall specify the regulatory review criteria which have not been met by that portion. The Regulatory Review Act specifies detailed procedures for review of objections prior to final publication of the regulations by the Board, the General Assembly and the Governor.
Public Comment
Interested persons are invited to submit written comments, suggestions or objections regarding this proposed rulemaking to Richard Marshman, Executive Secretary, State Board of Pharmacy, P. O. Box 2649, Harrisburg, PA 17105-2649 within 30 days following publication of this proposed rulemaking in the Pennsylvania Bulletin.
JOHN P. MARIANI, R.Ph.,
ChairpersonFiscal Note: 16A-543. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 49. PROFESSIONAL AND
VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND
OCCUPATIONAL AFFAIRS
CHAPTER 27. STATE BOARD OF PHARMACY
GENERAL PROVISIONS § 27.1. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
* * * * * Long-term care facility--A nursing home, retirement care, mental care or other institution that provides extended health care to resident patients.
* * * * *
STANDARDS § 27.20. Facsimile machines.
(a) Noninstitutional pharmacies.
(1) Schedule II controlled substances.
(i) A pharmacist in a noninstitutional pharmacy may fill a prescription for a Schedule II controlled substance which was received on a facsimile machine if the original prescription signed by the medical practitioner is presented to the pharmacist for review prior to the actual dispensing of the controlled substance. The original prescription shall be maintained as the pharmacy record.
(ii) There are two exceptions to the requirement that the pharmacist review the original of the prescription received on a facsimile machine before dispensing a Schedule II controlled substance. A pharmacist in a noninstitutional pharmacy may fill and dispense a prescription for a Schedule II controlled substance which was received on a facsimile machine and may use the facsimile as the original pharmacy record of the following:
(A) A prescription for a Schedule II controlled narcotic substance which will be administered to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion in the patient's home or hospice.
(B) A prescription for a Schedule II controlled substance for a resident of a long-term care facility.
(2) Schedule III, IV and V controlled substances and other nonproprietary drugs. A pharmacist may fill and dispense a prescription for a Schedule III, IV or V controlled substance or other nonproprietary drug which was received on a facsimile machine. The pharmacist may use the facsimile as the original pharmacy record.
(b) Institutional pharmacies. A pharmacist in an institutional pharmacy may fill and dispense a drug order which was received on a facsimile machine, for a nonproprietary drug, including a Schedule II, III, IV or V controlled substance, if the original of the drug order was written and signed by the medical practitioner as defined in section 2(9) of the act (63 P. S. § 390-2(9)).
(c) General.
(1) A pharmacist shall exercise professional judgment regarding the accuracy and authenticity of the facsimile copy of a prescription or drug order.
(2) The quality of paper on which a facsimile copy of a prescription or drug order is printed shall be of a type that the facsimile copy can be maintained as a record for at least 2 years, as required under section 4(a)(3) of the act (63 P. S. § 390-4(a)(3)).
(3) It is unlawful for a pharmacist or pharmacy to contribute in any way to the installation of a facsimile machine in the office of a medical practitioner or in an institution.
[Pa.B. Doc. No. 96-350. Filed for public inspection March 8, 1996, 9:00 a.m.]
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