RULES AND REGULATIONS
Title 49--PROFESSIONAL AND VOCATIONAL STANDARDS
STATE BOARD OF PHARMACY
[49 PA. CODE CH. 27]
Facsimile Machines
[27 Pa.B. 2931] The State Board of Pharmacy (Board) by this order adopts amendments to Chapter 27 (relating to State Board of Pharmacy) to read as set forth in Annex A.
A. Effective Date
The amendments are effective upon publication in the Pennsylvania Bulletin.
B. Statutory Authority
The amendments are adopted 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)).
C. Background
On May 19, 1994, the Federal Drug Enforcement Administration (DEA) amended its regulations to allow for the transmission of controlled substance prescriptions between the prescriber and the dispenser by facsimile machine. See, 59 F. R. 26109 et seq. The Board has determined to adopt the DEA standards in this Commonwealth. Likewise, the Board has received numerous questions from its licensees regarding the legality of filling a prescription which was received in a pharmacy by means of facsimile equipment.
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 which is an original or direct copy of the original issued by a prescriber who may be using electronic or computerized equipment. Even before the promulgation of the DEA regulations in 1994 the Board had interpreted this section to mean that it was lawful for a pharmacist to fill a prescription received on a facsimile machine for a drug other than a controlled substance. The Board, by this order, clarifies this lawful practice and adds rules pertaining to filling a prescription for a controlled substance received on a facsimile machine to track the DEA regulations.
The Board believes that the use of a facsimile machine to transmit a prescription from prescriber to pharmacist may result in fewer errors than telephone transmission of prescriptions. When a prescription 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 transmission and reception of a prescription transmitted by facsimile machine for the pharmacist will read an exact copy of the prescription. For this reason, the Board believes that the public health and safety will be as well if not better protected than under the current methods of prescription transmission. Moreover, all consumers of health care requiring pharmaceutical treatment will benefit from the cost and time savings inherent in quicker transmission of drug prescriptions, reduced errors and freed up pharmacist time to devote to counseling patients on appropriate drug use.
D. Summary of Comments and Responses on Proposed Rulemaking
Notice of proposed rulemaking was published at 26 Pa.B. 1030 (March 9, 1996). The Board received comments from several public commentators, the House Professional Licensure Committee and the Independent Regulatory Review Commission (IRRC). Responses to these comments follow.
Most institutional commentators, including IRRC, questioned the propriety of requiring the prescriber's signature on a prescription which is faxed for dispensing by an institutional pharmacy prior to actual dispensing of the drug. The commentators noted that drug orders affecting patients/residents in an institution often involve the treatment of severe pain requiring immediate dispensing of the drug for administration to the patient. The commentators noted that institutions have established protocols which are consistent with regulations affecting the individual institutions to obtain the prescriber's signature within 24 or 48 hours for drug orders placed on the patient's medical chart in the institution.
The commentators believed that the proposed rulemaking in § 27.20(b) (relating to facsimile machines) requiring an institutional pharmacist to view the actual prescriber's signature prior to dispensing any nonproprietary drug, including a Schedule II, III, IV or V controlled substance, prior to dispensing the drug, would create undue delays in necessary patient care. IRRC suggested that proposed § 27.20(b), relating to institutional pharmacies, be eliminated to resolve this concern. The remaining institutional commentators, including the Pennsylvania Society of Health-System Pharmacists, suggested that the section be amended to permit at least a 24 to 48 hour period of time within which to obtain a signature on the patient chart related to the prescription or drug order.
The Board has considered these comments and determined that the elimination of proposed § 27.20(b) would best serve the public interest and the Board's interest in protecting patient health while preserving an efficient method for drug dispensing in an institutional setting. To this end, in final rulemaking, the Board has eliminated proposed § 27.20(b), relating to institutional pharmacies, and has added a new paragraph (4) to subsection (c), relating to general issues surrounding facsimile transmission of prescriptions. The new subsection reads:
For purposes of this section, a prescription may not include an order for medication which is dispensed for immediate administration to a patient in an institution.
By this language, the Board clarifies that facsimile transmissions within a particular institution of drug orders reduced to writing on the patient's medical chart, subsequently signed by the prescriber within 24 to 48 hours as required by regulations affecting the particular institution, would not be subject to the requirements related to facsimile transmissions of prescriptions generally.
The Board notes, however, that prescriptions received by a facsimile machine to an institutional pharmacy for dispensing of drugs to persons outside of the particular institution, that is, for a patient discharged to another institution or to home or hospice, even if within a larger health system, must adhere to the requirements established in § 27.20. The Board notes that, with these changes, the section exactly tracks the DEA regulations.
Moreover, the Board notes that it has not, as IRRC had suggested, deferred control of institutional pharmacies to the Department of Public Welfare and the Department of Health. On the contrary, § 27.18(o) outlines the Board's requirements for drug orders in institutions. Neither does the Board relinquish control of institutional pharmacies by the changes which it has made to § 27.20.
Proposed § 27.20(a) outlined two exceptions to the requirements that a pharmacist review the original of a prescription received on a fax machine before dispensing a Schedule II controlled substance. Those exceptions are:
(i) 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.
(ii) A prescription for a Schedule II controlled substance for a resident of a long-term care facility.
IRRC suggested that long-term care facilities should be included under the first exception, citing a DEA distinction between Schedule II narcotic substances and Schedule II substances, and the fact that there are potentially urgent needs of patients in long-term care facilities to receive Schedule II narcotic substances for the relief of pain. A Schedule II narcotic controlled substance is a subset of a Schedule II controlled substance already covered by the second exception involving long-term care facilities. The Board therefore declines to create a redundancy by adding long-term care facilities to the first exception.
IRRC also recommended that the Board add provisions in final rulemaking related to emergency situations. The Board notes, as has DEA, that the exceptions related to Schedule II prescriptions in § 27.20(a)(2)(i) and (ii) eliminate the need for redundant language related to emergency prescriptions. The Board adopts DEA's interpretation of the language. The Board further notes that pharmacists dispensing scheduled controlled substances always do so subject to DEA requirements, including requirements related to emergency prescriptions.
In response to one commentator who asked the Board to clarify what is meant by the term ''narcotic,'' the Board notes that Pennsylvania law under the Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §§ 780-101--780-144) defines a ''narcotic'' in section 2 thereof (35 P. S. § 780-102). This definition tracks that of the Federal Controlled Substances Act and has been incorporated in the Board's standards of practice regulation in § 27.18(u).
Several commentators believed that the Board intended under proposed § 27.20(c) to require pharmacies to maintain fax transmissions in addition to original prescriptions and drug orders. It was never the Board's intention to require duplicate recordkeeping. On the contrary, the Board intends only that if the facsimile copy will be maintained as the original pharmacy record under section 4(a)(3) of the act, then the paper on which the transmission is made must last for at least that long. To avoid any misconceptions about the provision, the Board has revised § 27.20(c)(2) to make this clarification.
Likewise, IRRC and the House Committee suggested a revision to § 27.20(c)(3) which characterizes as unlawful conduct a contribution of a pharmacist or pharmacy to the installation of a facsimile machine in an institution or medical office. The Board's proposal was initially justified by its reference to section 5(a)(9) of the act (63 P. S. § 390-5(a)(9)), which declares kickbacks between pharmacists and medical practitioners to be grossly unprofessional conduct subjecting a pharmacist's license to discipline. IRRC and the House Committee distinguished this characterization from the term ''unlawful'', which implicates criminal penalties. IRRC therefore suggested that the Board reference this statutory provision in the language of § 27.20(c)(3).
In redrafting § 27.20(c)(3) to accommodate the concerns expressed by IRRC and the House Committee (with which the Board agrees), the Board finds instructive the decision of the Pennsylvania Supreme Court in Pennsylvania State Board of Pharmacy v. Cohen, 448 Pa. 189, 292 A.2d 277 (1972). The court there said:
. . . sections 390-5(a)(6) and (b)(2) both provide for suspension or revocation of licenses and permits respectively upon proof of violation of any properly adopted rules or regulations promulgated by the Board. It is only by means of these statutorily granted rulemaking powers that the Legislature has empowered the Board to provide additional grounds for sanctions.448 Pa. 197-98, 292 A.2d 281-82.
Section 5(a)(6) and (b)(2) of the act (63 P. S. § 390- 5(a)(6) and (b)(2)) provides for disciplinary action against pharmacist licenses and pharmacy permits, respectively, for violations of the act or regulations of the Board. Accordingly, the Board has revised § 27.20(c)(3) to read:
A pharmacist or pharmacy may not contribute in any way to the installation of a facsimile machine in the office of a medical practitioner or in an institution.A pharmacist or pharmacy who engages in this prohibited conduct could be disciplined under section 5(a)(6) or (b)(2) of the act, respectively.
Finally, several commentators suggested that the amendments should be broadened to include all forms of electronic prescription transmission, together with regulating adequate security measures for the same. The Board notes that, because the proposed regulation was limited to facsimile machine transmission of drug prescriptions, it would be both improper and inconsistent with the law to expand the scope of the regulation on final rulemaking to include transmission of prescriptions through other electronic means.
The Board has also incorporated several technical revisions suggested by IRRC in final rulemaking.
E. Compliance with Executive Order 1996-1, Regulatory Review and Promulgation
The Board reviewed this rulemaking and considered its purpose and likely impact upon the public and the regulated population under the directives of Executive Order 1996-1, Regulatory Review and Promulgation. The final form regulations address a compelling public health interest in assuring that drug dispensing is accurate, efficient and cost-effective as described in this Preamble, and it otherwise complies with Executive Order 1996-1.
F. Fiscal Impact and Paperwork Requirements
The regulatory amendments will not have a negative fiscal impact on the Commonwealth, political subdivisions or the private sector. In fact, cost savings in time and money can be anticipated through increased efficiency in drug dispensing.
The amendments will not affect paperwork requirements for the Commonwealth or political subdivisions. Paperwork in the public sector relative to drug dispensing and recordkeeping will be reduced.
G. Sunset Date
The Board continually monitors the effectiveness of its regulations through communications with the regulated population; accordingly, no sunset date has been set.
H. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on March 9, 1996, the Board submitted a copy of the notice of proposed rulemaking, published at 26 Pa.B. 1030 (March 9, 1996), to IRRC and the Chairpersons of the House Professional Licensure Committee and the Senate Consumer Protection and Professional Licensure Committee for review and comment. In compliance with section 5(b.1) of the Regulatory Review Act, the Board also provided IRRC and the Committees with copies of the comments received, as well as other documentation.
In preparing these final-form regulations the Board has considered the comments received from IRRC, the Committees and the public.
These final-form regulations were approved by the House Committee on May 14, 1997, and approved by the Senate Committee on May 13, 1997. IRRC met on May 22, 1997, and approved the final-form regulations in accordance with section 5(c) of the Regulatory Review Act.
I. Contact Person
Further information may be obtained by contacting W. Richard Marshman, Executive Secretary, State Board of Pharmacy, at P. O. Box 2649, Harrisburg, PA 17105-2649 (717) 783-7157.
J. Findings
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and the regulations promulgated thereunder at 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments were considered.
(3) These amendments do not enlarge the purpose of proposed rulemaking published at 26 Pa.B. 1030.
(4) These amendments are necessary and appropriate for administration and enforcement of the authorizing act identified in Part B of this Preamble.
K. Order
The Board, acting under its authorizing statute, orders that:
(a) The regulations of the Board, 49 Pa. Code Chapter 27, are amended by amending § 27.1 and by adding § 27.20 to read as set forth in Annex A.
(b) The Board shall submit this order and Annex A to the Office of General Counsel and to the Office of Attorney General as required by law.
(c) The Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(d) This order shall take effect on publication in the Pennsylvania Bulletin.
PAULA L. CASTOR, R.Ph.,
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 27 Pa.B. 2790 (June 7, 1997).)
Fiscal Note: Fiscal Note 16A-543 remains valid for the final adoption of the subject regulations.
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:
ACPE--The American Council of Pharmaceutical Education.
Act--The Pharmacy Act (63 P. S. §§ 390-1--390-13).
BNDD--The Federal Bureau of Narcotics and Dangerous Drugs.
Board--The State Board of Pharmacy.
Caution legend drug or device--Controlled substances and other drugs or devices which by statute or regulation may be dispensed to a patient by a pharmacist only upon the prescription of a medical practitioner.
CEU--Continuing Education Units--The unit of measuring contact hours of continuing education provided by ACPE accredited providers. Ten contact hours are equivalent to 1.0 CEU.
Commissioner--The Commissioner of Professional and Occupational Affairs in the Department.
Contact hours--Continuing education units of measure equivalent to 50 to 60 minutes of participation in an approved organized learning experience, including home study with approved educational materials.
Continuing education--Professional education obtained to maintain, improve or expand current skills or knowledge, or to develop new skills or knowledge.
Department--The Department of State of the Commonwealth.
Institutions--Extended care facilities, nursing homes, nursing care facilities, convalescent homes, resident care facilities, hospitals or another place which offers medical treatment to patients who require food, board and overnight sleeping facilities and care.
Long term care facility--A nursing home, retirement care, mental care or other institution that provides extended health care to resident patients.
Pharmacist manager--The pharmacist in charge of a pharmacy who is responsible for operations involving the practice of pharmacy under section 4 of the act (63 P. S. § 390-4).
Pharmacy--The store or other place licensed by the Board where the practice of pharmacy is conducted.
Practice of pharmacy--The practice of that profession concerned with the art and science of preparing, compounding and dispensing of drugs and devices, whether dispensed on the prescription of a medical practitioner or legally dispensed or sold directly to the ultimate consumer. The term includes the proper and safe storage and distribution of drugs, the maintenance of proper records therefor and the responsibility of relating information as required concerning the drugs and medicines and their therapeutic values and uses in the treatment and prevention of disease.
Prescription area--That area of the pharmacy used for compounding, legend drug storage and other activities necessary to the practice of pharmacy. The term does not include waiting counters or display space attached to the waiting counters.
STANDARDS § 27.20. Facsimile machines.
(a) Schedule II controlled substances.
(1) A pharmacist 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 original pharmacy record.
(2) 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 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:
(i) 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.
(ii) A prescription for a Schedule II controlled substance for a resident of a long term care facility.
(b) Schedule III, IV and V controlled substances and other nonproprietary drugs. A pharmacist may fill and dispense a prescription signed by a medical practitioner 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.
(c) General.
(1) A pharmacist shall exercise professional judgment regarding the accuracy and authenticity of the facsimile copy of a prescription.
(2) Unless the original prescription will be maintained as the original pharmacy record, the quality of paper on which a facsimile copy of a prescription 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) A pharmacist or pharmacy may not contribute in any way to the installation of a facsimile machine in the office of a medical practitioner or in an institution.
(4) For purposes of this section, a prescription may not include an order for medication which is dispensed for immediate administration to a patient in an institution.
[Pa.B. Doc. No. 97-974. Filed for public inspection June 20, 1997, 9:00 a.m.]
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