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PA Bulletin, Doc. No. 99-1668

PROPOSED RULEMAKING

STATE BOARD OF MEDICINE

STATE BOARD OF NURSING

[49 PA. CODE CHS. 18 AND 21]

Certified Registered Nurse Practitioners Prescriptive Authority

[29 Pa.B. 5101]

   The State Boards of Medicine and Nursing (Boards) propose to amend their regulations governing certified registered nurse practitioners (CRNPs) Chapters 18 and 21 (relating to State Board of Medicine; and State Board of Nursing), to read as set forth in Annex A, relating to CRNP prescriptive authority.

A.  Effective Date

   The proposed regulations will be effective upon publication of final-form regulations in the Pennsylvania Bulletin.

B.  Statutory Authority

   Section 15(b) of the Medical Practice Act of 1985 (63 P. S. § 422.15(b)) authorizes the Boards to jointly promulgate regulations authorizing CRNPs to perform acts of medical diagnoses and prescription of medical, therapeutic, diagnostic or corrective measures. Section 2(1) of the Professional Nursing Law (63 P. S. § 212(1)) similarly indicates that a professional nurse may perform acts of medical diagnosis or prescription of medical therapeutic or corrective measures only if the Boards promulgate regulations authorizing these acts. These provisions were originally enacted in the practice acts of 1974. Under the 1974 laws, the Boards jointly promulgated the current regulations which provide for certification of nurse practitioners.

C.  Background and Purpose

   In accordance with their statutory authority the Boards have negotiated rulemaking which would authorize CRNPs to prescribe and dispense drugs. CRNPs are advanced practice nurses who are certified by the Boards in a particular clinical specialty area. See §§ 18.21 et seq. and 21.251 et seq. An applicant for certification as a CRNP shall be a currently licensed professional or registered nurse who has successfully completed a course of study of at least 1 academic year in a program approved by the Boards. See §§ 18.41 and 21.271. Almost all nurse practitioner programs grant a master's degree and include a course in advanced pharmacology. The proposed regulations will enable Pennsylvania CRNPs to make full use of their advanced education and skills.

   At the present time CRNPs in most states have varying degrees of prescriptive and dispensing authority. Only about eight states do not permit CRNPs to prescribe or dispense drugs.1 The remaining states authorize CRNPs to prescribe or dispense, or both, with varying degrees of regulation or limitation. Of the states permitting CRNPs to prescribe drugs, 32 states require the authority to be identified in the collaborative agreement, 13 states limit prescribing authority to substances which are not controlled, and 27 allow prescription of controlled substances, but with varying degrees of regulation or limitation.2

D.  Description of Proposed Regulations

   The proposal would add two new sections to the existing regulations regarding CRNPs. The first section, §§ 18.53 and 21.283, of the State Board of Medicine and the State Board of Nursing, would establish the requirements a CRNP shall meet to prescribe and dispense drugs: completion of a CRNP program approved by the Boards, which includes a course in advanced pharmacology, and adherence to standards for prescribing already established by the State Board of Medicine and the Department of Health.

   The second sections, §§ 18.54 and 21.284, specify categories of drugs which a CRNP may prescribe and dispense without restriction, those which the CRNP may prescribe and dispense with limitations, and those which the CRNP may not prescribe or dispense. The first category contains those drugs a CRNP will be able to prescribe and dispense without specific limits (§§ 18.54(b) and 21.284(b)). The second category contains those drugs a CRNP will be able to prescribe and dispense only if the collaborative agreement between the physician and CRNP authorizes prescribing and dispensing those drugs (§§ 18.54(c) and 21.284(c)). The third category contains those drugs which a CRNP may not prescribe or dispense (§§ 18.54(d) and 21.284(d)). This section also establishes the parameters for prescribing and dispensing controlled substances (§§ 18.54(f) and (g) and 21.284(f) and (g)). Further provisions would establish procedures to deal with an inappropriately prescribed or dispensed drug (§§ 18.54(e) and 21.284(f)), requirements pertaining to prescription blanks (§§ 18.54(h) and 21.284(h)) and documentation of the prescription in a patient's medical record (§§ 18.54(i) and 21.284(i)).

E.  Compliance with Executive Order 1996-1

   In accordance with the requirements of Executive Order 1996-1 (February 6, 1996), in drafting and promulgating the proposed regulations the Boards solicited input and suggestions from the regulated community. The Boards mailed a draft on June 26, 1998, to 54 organizations, entities and individuals who had an interest in CRNP prescribing. The Boards received 373 responses to the solicitation. The Boards revised the draft as a result of the responses.

F.  Fiscal Impact and Paperwork Requirements

   There will not be an adverse fiscal impact or additional paperwork imposed on the Commonwealth, political subdivisions or the private sector. Citizens of this Commonwealth will benefit from having more ready access to cost-effective, quality health care.

   There will be a very slight increase in paperwork to the regulated community in regard to certain categories of drugs because a CRNP would be authorized to prescribe or dispense from these categories only if the authorization is documented in the collaborative agreement.

G.  Sunset Date

   The Boards continuously monitor their regulations. Therefore, no sunset date has been assigned.

H.  Regulatory Review

   Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on September 17, 1999, the Boards submitted a copy of these proposed regulations to the Independent Regulatory Review Commission (IRRC) and the Chairpersons of the House Professional Licensure Committee and the Senate Consumer Protection and Professional Licensure Committee. In addition to submitting the proposal, the Boards have provided IRRC and the Committees with a copy of a detailed regulatory analysis form prepared by the Boards in compliance with Executive Order 1996-1, ''Regulatory Review and Promulgation.'' A copy of this material is available to the public upon request.

   If IRRC has objections to any portion of the proposed regulations, it will notify the Boards within 10 days after the expiration of the Committees' review 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 proposed regulations by the Boards, the General Assembly and the Governor of objections raised.

I.  Public Comment

   Interested persons are invited to submit written comments, suggestions or objections regarding the proposed regulations to Cindy Warner, Health Licensing Division, Bureau of Professional and Occupational Affairs, P. O. Box 2649, Harrisburg, PA 17105-2649 within 30 days following publication of the proposed regulations in the Pennsylvania Bulletin. Please cite to CRNP Prescriptive Authority when submitting comments. Please do not send copies of the same comment to both Boards.

DANIEL B. KIMBALL, Jr., M.D.,   
Chairperson
State Board of Medicine
and

CHRISTINE ALICHNIE, Ph.D., R.N.,   
Chairperson
State Board of Nursing

   Fiscal Note:  16A-499. 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 18.  STATE BOARD OF MEDICINE--PRACTITIONERS OTHER THAN MEDICAL DOCTORS

Subchapter C.  CERTIFIED REGISTERED NURSE PRACTITIONERS

CRNP PRACTICE

§ 18.53.  Prescribing and dispensing drugs.

   A CRNP may prescribe and dispense drugs if:

   (1)  The CRNP has completed a CRNP program which is approved by the Boards or, if completed in another state, is equivalent to programs approved by the Boards.

   (2)  The CRNP program includes a core course in advanced pharmacology.

   (3)   In prescribing and dispensing drugs a CRNP shall comply with standards of the State Board of Medicine in §§ 16.92--16.94 (relating to prescribing, administering and dispensing controlled substances; packaging; and labeling of dispensed drugs) and the Department of Health in 28 Pa. Code § 25.51--25.58, 25.61--25.81 and 25.91--25.95 (relating to prescriptions and labeling of drugs, devices and cosmetics and controlled substances).

§ 18.54.  Prescribing and dispensing parameters.

   (a)  The Board adopts the American Hospital Formulary Service Pharmacologic-Therapeutic Classification to identify drugs which the CRNP may prescribe and dispense subject to the parameters identified in this section.

   (b)  A CRNP may prescribe and dispense a drug from the following categories without limitation (unless the drug is limited or excluded under other subsections):

   (1)  Antihistamines.

   (2)  Anti-infective agents

   (3)  Cardiovascular drugs.

   (4)  Contraceptives including foams and devices.

   (5)  Diagnostic agents.

   (6)  Disinfectants for agents used on objects other than skin.

   (7)  Electrolytic, caloric and water balance.

   (8)  Enzymes.

   (9)  Antitussive, expectorants and mucolytic agents.

   (10)  Gastrointestinal drugs.

   (11)  Local anesthetics.

   (12)  Serums, toxoid and vaccines.

   (13)  Skin and mucous membrane agents.

   (14)  Smooth muscle relaxants.

   (15)  Vitamins.

   (16)  Hypoglycemic agents.

   (17)  Endrocrine replacement agents.

   (c)  A CRNP may prescribe and dispense a drug from the following categories if that authorization is documented in the collaborative agreement:

   (1)  Autonomic drugs.

   (2)  Blood formation, coagulation and anticoagulation drugs, and thrombolytic and antithrombolytic agents.

   (3)  Central nervous system agents, except that the following drugs are excluded from this category:

   (i)  General anesthetics.

   (ii)  Monoamine oxidase inhibitors.

   (4)  Myotics and mydriatics.

   (5)  Antineoplastic agents originally prescribed by the collaborating physician and approved for ongoing therapy.

   (d)  A CRNP may not prescribe or dispense a drug from the following categories:

   (1)  Gold compounds.

   (2)  Heavy metal antagonists.

   (3)  Radioactive agents.

   (e)  If a collaborating physician learns that the CRNP is prescribing or dispensing a drug inappropriately, the collaborating physician shall immediately advise the CRNP and the CRNP shall stop prescribing or dispensing the drug and shall advise the pharmacy to stop dispensing the drug. The CRNP shall immediately advise the patient to stop taking the drug. This action shall be noted by the CRNP in the patient's medical record.

   (f)  Restrictions on CRNP prescribing and dispensing practices are as follows:

   (1)  CRNP may write for a Schedule II controlled substance for up to a 72-hour dose. The CRNP shall notify the collaborating physician immediately (within 24 hours).

   (2)  A CRNP may prescribe a Schedule III or IV controlled substance for up to 30 days. The prescription may not be refilled unless the collaborating physician authorizes refills.

   (g)  A CRNP may not:

   (1)  Prescribe or dispense a Schedule I controlled substance as defined in section 4 of the Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § 780-14).

   (2)  Prescribe or dispense a drug for a use not permitted by the United States Food and Drug Administration.

   (3)  Delegate prescriptive authority specifically assigned to the CRNP by the collaborating physician to another health care provider.

   (h)  A prescription blank shall bear the certification number of the CRNP, the name of the CRNP in printed format at the top of the blank and a space for the entry of the DEA registration number, if appropriate. The collaborating physician shall also be identified as required in § 16.91 (relating to identifying information on prescriptions and orders for equipment and service).

   (i)  The CRNP shall document in the patient's medical record the name, amount and dose of the drug prescribed, the number of refills, the date of the prescription and the CRNP's name.

CHAPTER 21.  STATE BOARD OF NURSING

Subchapter C.  CERTIFIED REGISTERED NURSE PRACTITIONERS

CRNP PRACTICE

§ 21.283.  Prescribing and dispensing drugs.

   A CRNP may prescribe and dispense drugs if:

   (1)  The CRNP has completed a CRNP program which is approved by the Boards or, if completed in another state, is equivalent to programs approved by the Boards.

   (2)  The CRNP program includes a core course in advanced pharmacology.

   (3)  In prescribing and dispensing drugs a CRNP shall comply with standards of the State Board of Medicine in §§ 16.92--16.94 (relating to prescribing, administering and dispensing controlled substances; packaging; and labeling of dispensed drugs) and the Department of Health in 28 Pa. Code §§ 25.51--25.58, 25.61--25.81 and 25.91--25.95 (relating to prescriptions and labeling of drugs, devices and cosmetics and controlled substances).

§ 21.284.  Prescribing and dispensing parameters.

   (a)  The Board adopts the American Hospital Formulary Service Pharmacologic-Therapeutic Classification to identify drugs which the CRNP may prescribe and dispense subject to the parameters identified in this section.

   (b)  A CRNP may prescribe and dispense a drug from the following categories without limitation (unless the drug is limited or excluded under other subsections):

   (1)  Antihistamines.

   (2)  Anti-infective agents.

   (3)  Cardiovascular drugs.

   (4)  Contraceptives including foams and devices.

   (5)  Diagnostic agents.

   (6)  Disinfectants for agents used on objects other than skin.

   (7)  Electrolytic, caloric and water balance.

   (8)  Enzymes.

   (9)  Antitussive, expectorants and mucolytic agents.

   (10)  Gastrointestinal drugs.

   (11)  Local anesthetics.

   (12)  Serums, toxoid and vaccines.

   (13)  Skin and mucous membrane agents.

   (14)  Smooth muscle relaxants.

   (15)  Vitamins.

   (16)  Hypoglycemic agents.

   (17)  Endrocrine replacement agents.

   (c)  A CRNP may prescribe and dispense a drug from the following categories if that authorization is documented in the collaborative agreement:

   (1)  Autonomic drugs.

   (2)  Blood formation, coagulation and anticoagulation drugs, and thrombolytic and antithrombolytic agents.

   (3)  Central nervous system agents, except that the following drugs are excluded from this category:

   (i)  General anesthetics.

   (ii)  Monoamine oxidase inhibitors.

   (4)  Myotics and mydriatics.

   (5)  Antineoplastic agents originally prescribed by the collaborating physician and approved for ongoing therapy.

   (d)  A CRNP may not prescribe or dispense a drug from the following categories:

   (1) Gold compounds.

   (2)  Heavy metal antagonists.

   (3)  Radioactive agents.

   (e)  If a collaborating physician learns that the CRNP is prescribing or dispensing a drug inappropriately, the collaborating physician shall immediately advise the CRNP and the CRNP will stop prescribing or dispensing the drug and will advise the pharmacy to stop dispensing the drug. The CRNP shall immediately advise the patient to stop taking the drug. This action shall be noted by the CRNP in the patient's medical record.

   (f)  Restrictions on CRNP prescribing and dispensing practices are as follows:

   (1)  A CRNP may write a prescription for a Schedule II controlled substance for up to a 72-hour dose. The CRNP shall notify the collaborating physician immediately (within 24 hours).

   (2)  A CRNP may prescribe a Schedule III or IV controlled substance for up to 30 days. The prescription may not be refilled unless the collaborating physician authorizes refills.

   (g)  A CRNP may not:

   (1)  Prescribe or dispense a Schedule I controlled substance as defined in section 4 of the Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § 780-14).

   (2)  Prescribe or dispense a drug for a use not permitted by the United States Food and Drug Administration.

   (3)  Delegate prescriptive authority specifically assigned to the CRNP by the collaborating physician to another health care provider.

   (h)  A prescription blank shall bear the certification number of the CRNP, the name of the CRNP in printed format at the top of the blank and a space for the entry of the DEA registration number, if appropriate. The collaborating physician shall also be identified as required in § 16.91 (relating to identifying information on prescriptions and orders for equipment and service).

   (i)  The CRNP shall document in the patient's medical record the name, amount and dose of the drug prescribed, the number of refills, the date of the prescription and the CRNP's name.

[Pa.B. Doc. No. 99-1668. Filed for public inspection October 1, 1999, 9:00 a.m.]

_______

1  U.S. Department of Health and Human Services, Health Resources & Services Administration, ''Curriculum Guidelines & Regulatory Criteria for Family Nurse Practitioners Seeking Prescriptive Authority to Manage Pharmacotherapeutics in Primary Care, Summary Report, 1998 (Curriculum Guidelines),'' (Prepared by National Council of State Boards of Nursing and National Organization of Nurse Practitioner Faculties) page 14, Table 1.

2  Curriculum Guidelines, pages 17-18, Tables 3-4.



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