PROPOSED RULEMAKING
STATE BOARD
OF MEDICINE
[ 49 PA. CODE CHS. 16 AND 18 ]
Nurse Midwife Prescriptive Authority
[37 Pa.B. 6539]
[Saturday, December 15, 2007]The State Board of Medicine (Board) proposes to amend §§ 16.11, 16.13, 18.1, 18.2, 18.3, 18.5 and 18.6 and to add §§ 18.6a and 18.9 (relating to prescribing, dispensing and administering drugs; and notification of changes in collaboration), to read as set forth in Annex A.
A. Effective Date
The amendments will be effective upon publication as final-form rulemaking in the Pennsylvania Bulletin.
B. Statutory Authority
The amendments implement the act of July 20, 2007, (P. L. 324, No. 50) (Act 50) which directs the Board to adopt, promulgate and enforce regulations that establish requirements for prescriptive authority for midwives to be met by individuals so licensed who elect to obtain prescriptive authority in this Commonwealth.
C. Background and Purpose
Act 50, which became effective September 18, 2007, amended the Medical Practice Act of 1985 (act) (63 P. S. §§ 422.1--422.51.1) by amending section 2 of the act (63 P. S. § 422.2) to define ''legend drug,'' by adding section 35(c) of the act (63 P. S. § 422.35(3)) authorizing prescriptive authority and by adding section 35(d) of the act providing for collaborative agreements with physicians. Section 8 of the act (63 P. S. § 422.8) and section 35(a) of the act authorize the Board to promulgate regulations as necessary to carry out the purposes of the act. In addition, section 3 of the act (63 P. S. § 422.3) requires the Board to promulgate regulations within 12 months of its effective date.
D. Description of Proposed Amendments
Section 16.11 (relating to licenses, certificates and registrations) is proposed to be amended by adding the issuance of a certificate of prescriptive authority for nurse midwives.
Section 16.13 (relating to licensure, certification, examination and registration fees) is proposed to be amended by adding fees relating to licensure and prescriptive authority for nurse midwives.
Section 18.1 (relating to definitions) is proposed to be amended by revising the name of the National certifying organization recognized by the Board. The definition of ''midwife'' is proposed to be amended to reflect that the midwife would practice in collaboration with a Board-licensed physician. The definitions of ''midwife examination'' and ''midwife program'' are proposed to by amended to reflect the name change of the National certifying organization. A definition of ''midwife colleague'' is proposed to be amended to refer to another midwife who is available to substitute for the midwife who has primary responsibility for a pregnant woman under that midwife's care. The definition of ''legend drug'' is proposed to be added as delineated by statute. Section 18.2 (relating to licensure requirements) is also proposed to be amended to reflect the recent name change of the National certifying organization.
Subsection 18.3(b) (relating to biennial registration requirements) is proposed to be amended to reflect that a midwife shall complete the continuing education requirements required under section 12.1 of the Professional Nursing Law (63 P. S. § 222). This section also requires that in the case of a midwife who has prescriptive authority, 16 of those continuing education hours must include at least 16 hours in pharmacology.
Section 18.5 (relating to collaborative agreements) is proposed to be amended by adding subsection (f) to require that a physician with whom a midwife has a collaborative agreement must have hospital clinical privileges in the same specialty area of care. The Board also proposes to add subsection (g) to require review of the collaborative agreement by the Board, and subsection (h) to require that the midwife or collaborating physician provide immediate access to the collaborative agreement to anyone seeking to confirm the scope of the midwife's authority.
Section 18.6 (relating to practice of midwifery) is proposed to be amended by adding in paragraph (5) the authority to prescribe, dispense, order and administer medical devices, immunizing agents, laboratory tests and therapeutic, diagnostic and preventative measures, so long as those activities are in accordance with the midwife's collaborative agreement and consistent with the midwife's education and National certification. Paragraph (6) is proposed to be added to set forth the criteria for qualifications of the midwife to obtain prescriptive authority from the Board. This section would permit the prescribing, dispensing, ordering and administration of legend drugs, and Schedule II through Schedule V controlled substances by a midwife who possesses a master's degree or its substantial equivalent, and National certification. Paragraph (6)(i) would require that the midwife demonstrate to the Board that the midwife has successfully completed at least 45 hours of course-work specific to advanced pharmacology at a level above that required by as professional nursing education program. In paragraph (6)(ii), the proposed requirement is that the midwife act in accordance with a collaborative agreement with a physician that at a minimum identifies the categories of drugs the midwife may prescribe or dispense, as well as the drugs that require referral, consultation or co-management. Paragraph (7) would be amended to delete the prohibition against prescribing or dispensing of drugs.
Section 18.6a sets forth the parameters of the prescriptive authority of the midwife. Subsection (a) prohibits the prescribing or dispensing of Schedule I controlled substances and restricts the prescribing, dispensing, ordering or administration of a controlled substance except for a woman's acute pain. The proposal also includes a provision in subsection (a)(2)(ii) which would limit the prescribing, dispensing, ordering or administration of a Schedule II drug to 72 hours, and would prohibit the extension of that time limit except with the approval of the collaborating physician.
Subsection (a)(1)(iii) also sets forth the requirement that prescribing, dispensing, ordering or administration of psychotropic drugs only be undertaken after consulting with the collaborating physician. The proposal also includes a provision in subsection (a)(1)(iv) to prohibit the prescribing or dispensing of a drug unless it is in accordance with the collaborative agreement. Subsection (a)(3) specifically requires that a midwife who is authorized to prescribe or dispense, or both, controlled substances be registered with the United States Drug Enforcement Administration (DEA).
Section 18.6a(b) sets forth the requirements for prescription blanks. It would require that the name and license number of the midwife in addition to a designation that the signer is a midwife be included on the prescription blank. As appropriate, space on prescription blanks must be provided for the midwife to record the midwife's DEA number, when appropriate. This reminds the midwife of the requirement to register with the DEA and serves to bring the midwife's practice into conformance with Federal law. Subsection (b)(3) would permit a midwife to use a prescription blank generated by a hospital provided that the name and license number of the midwife is on the blank.
Subsection 18.6a(c) sets forth the process that a collaborating physician shall follow in the event the midwife prescribes or dispenses a drug inappropriately. The collaborating physician is required to advise the patient, notify the midwife or midwife colleague, if any, and in the case of a written prescription, advise the pharmacy of the inappropriate prescribing. The midwife, midwife colleague or collaborating physician would also be required under this proposed rulemaking to advise both the patient and the midwife to discontinue the drug use, and advise the pharmacy if there was a written prescription. The order discontinuing use of the drug would be required to be noted in the patient's medical record.
In § 18.6a(d), the Board proposes to establish recordkeeping requirements which detail the maintenance of information on any drug prescribed by the midwife and number of refills, if any. If a midwife dispenses a drug, the midwife's name and the name, amount, dose and date dispensed of the medication are to be a part of the patient's medical record.
Section 18.6a(e) mandates compliance by the midwife with other sections of Chapter 16 (relating to State Board of Medicine--general provisions), as well as with Department of Health regulations in 28 Pa. Code (relating to health and safety) relating to prescribing, administering, dispensing, packaging and labeling of drugs.
Section 18.9 (relating to notification of changes in collaboration) proposes a requirement that the midwife notify the Board in writing of any change regarding the midwife's collaborative agreement, as well as notifying the Board of a change in address. A change in collaboration requires inclusion of the name of the new registered collaborating physician. Subsection (b) requires the collaborating physician to notify the Board in writing within 30 days of a change or termination of collaboration with a midwife. The midwife's failure to notify the Board of changes in employment would subject the midwife's license to discipline. Finally, subsection (d) would require that a midwife with prescriptive authority notify the Board within 30 days if the midwife cannot continue to fulfill the requirements for prescriptive authority.
E. Fiscal Impact and Paperwork Requirements
The proposed rulemaking will have no quantifiable adverse fiscal impact on the Commonwealth or its political subdivisions.
F. Sunset Date
The Board continuously monitors the effectiveness of its regulations. Therefore, no sunset date has been assigned.
G. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on December 5, 2007, the Board submitted a copy of this proposed rulemaking and a copy of a Regulatory Analysis Form to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the Senate Consumer Protection and Professional Licensure Committee and the House Professional Licensure Committee. A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, IRRC may convey any comments, recommendations or objections to the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections must specify the regulatory review criteria that have not been met. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the rulemaking, by the Board, the General Assembly and the Governor of comments, recommendations or objections raised.
H. Public Comment
Interested persons are invited to submit written comments, recommendations or objections regarding the proposed rulemaking to Sabina I. Howell, Board Counsel, P. O. Box 2649, Harrisburg, PA 17105-2649 within 30 days following publication for the proposed rulemaking in the Pennsylvania Bulletin.
CHARLES D. HUMMER, Jr., M. D.,
ChairpersonFiscal Note: 16A-4926. 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 16. STATE BOARD OF MEDICINE--
GENERAL PROVISIONS
Subchapter B. GENERAL LICENSE, CERTIFICATION AND REGISTRATION PROVISIONS § 16.11. Licenses, certificates and registrations.
* * * * * (b) The following nonmedical doctor licenses and certificates are issued by the Board:
(1) Midwife license.
(2) Midwife certificate of prescriptive authority.
(3) Physician assistant license.
* * * * * § 16.13. Licensure, certification, examination and registration fees.
* * * * * (b) Midwife License:
[Application $ 30 Biennial renewal $ 40] Application for midwife license without prescriptive authority $ 50 Application for additional collaborative agreement without prescriptive authority $ 30 Application for midwife license with prescriptive authority $ 70 Application for additional collaborative agreement with prescriptive authority $ 50 Biennial renewal of midwife license $ 40 Biennial renewal of each prescriptive authority $ 25 Verification of licensure $ 15 * * * * *
CHAPTER 18. STATE BOARD OF MEDICINE--PRACTITIONERS OTHER THAN MEDICAL DOCTORS
Subchapter A. LICENSURE AND REGULATION OF MIDWIFE ACTIVITIES § 18.1. Definitions.
The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:
[ACNM--The American College of Nurse-Midwives.]
AMCB--The American Midwifery Certification Board.
* * * * * Legend drug--A drug:
(i) Limited by the Federal Food, Drug and Cosmetic Act (21 U.S.C.A. §§ 301--399) to being dispensed by prescription.
(ii) The product label of which is required to contain the following statement: ''Caution: Federal law prohibits dispensing without a prescription.''
Midwife--A person licensed by the Board to practice midwifery in collaboration with a physician licensed by the Board to practice medicine.
Midwife colleague--A midwife who is available to substitute for the midwife who has primary responsibility in the management of a pregnant woman under the midwife's care.
Midwife examination--An examination offered or recognized by the Board to test whether an individual has accumulated sufficient academic knowledge with respect to the practice of midwifery to qualify for a midwife license. The Board recognizes the certifying examination of the [ACNM] AMCB as a midwife examination.
Midwifery practice--[anagement] Management of the care of essentially normal women and their normal neonates--initial 28-day period. This includes ante- partum, intrapartum, postpartum and nonsurgically related gynecological care.
Midwife program--An academic and clinical program of study in midwifery which has been approved by the Board or by an accrediting body recognized by the Board. The Board recognizes the [ACNM] AMCB as an accrediting body of programs of study in midwifery.
* * * * * § 18.2. Licensure requirements.
The Board will grant a midwife license to an applicant who meets the following requirements. The applicant shall:
* * * * * (4) Have obtained one of the following:
(i) A passing grade on a midwife examination. The Board accepts the passing grade on the certifying examination of the [ACNM] AMCB as determined by the [ACNM] AMCB.
(ii) [ANCM certification] Certification as a midwife by the American College of Nurse-Midwives (ACNM) before the [ACNM] certification examination was first administered in 1971.
* * * * * § 18.3. Biennial registration requirements.
* * * * * (b) As a condition of biennial license renewal, a midwife shall complete the continuing education requirement in section 12.1 of the Professional Nursing Law (63 P. S. § 222). In the case of a midwife who has prescriptive authority under the act, the continuing education required by the Professional Nursing Law must include at least 16 hours in pharmacology completed each biennium.
(c) The [fee] fees for the biennial [registration] renewal of a midwife license [is] and prescriptive authority are set forth in § 16.13 (relating to licensure, certification, examination and registration fees).
§ 18.5. Collaborative agreements.
* * * * * (f) The physician with whom a midwife has a collaborative agreement shall have hospital clinical privileges in the specialty area of the care for which the physician is providing collaborative services.
(g) The collaborative agreement must satisfy the substantive requirements set forth in subsections (a)--(e) and as being consistent with relevant provisions of the act and this subchapter, and shall be submitted to the Board for review.
(h) A midwife or collaborating physician shall provide immediate access to the collaborative agreement to anyone seeking to confirm the scope of the midwife's authority, and the midwife's ability to prescribe or dispense a drug.
§ 18.6. Practice of midwifery.
The midwife is authorized and required to do the following:
* * * * * (5) A midwife may, in accordance with a collaborative agreement with a physician, and consistent with the midwife's academic educational preparation and National certification by the AMCB or its successor organizations, prescribe, dispense, order and administer medical devices, immunizing agents, laboratory tests and therapeutic, diagnostic and preventative measures.
(6) A midwife who possesses a master's degree or its substantial equivalent, and National certification, may be eligible to receive a certificate from the Board which will authorize the midwife to prescribe, dispense, order and administer drugs, including legend drugs and Schedule II through Schedule V controlled substances, as defined in The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §§ 780-101--780-144), in accordance with § 18.6a (relating to prescribing, dispensing and administering drugs) provided that the midwife demonstrates to the Board that:
(i) The midwife has successfully completed at least 45 hours of course-work specific to advanced pharmacology at a level above that required by a professional nursing education program.
(ii) The midwife acts in accordance with a collaborative agreement with a physician which must at a minimum identify:
(A) The categories of drugs from which the midwife may prescribe or dispense.
(B) The drugs which require referral, consultation or co-management.
(7) Perform medical services in the care of women and newborns that may go beyond the scope of midwifery, if the authority to perform those services is delegated by the collaborating physician in the collaborative agreement, and the delegation is consistent with standards of practice embraced by the midwife and the relevant physician communities in this Commonwealth[, and the delegated medical services do not involve the prescribing or dispensing of drugs].
[(6)] (8) Refer and transfer to the care of a physician, as provided for in the midwife protocol or a collaborative agreement, or both, those women and newborns whose medical problems are outside the scope of midwifery practice and who require medical services which have not been delegated to the midwife in a collaborative agreement.
[(7)] (9) Review and revise the midwife protocol and collaborative agreements as needed.
[(8)] (10) Carry out responsibilities placed by law or regulation upon a person performing the functions that are performed by the midwife.
§ 18.6a. Prescribing, dispensing and administering drugs.
(a) Prescribing, dispensing and administering drugs. A midwife who has prescriptive authority may prescribe, administer and dispense drugs as follows:
(1) A midwife may not prescribe or dispense Schedule I controlled substances as defined by section 4 of The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § 780-104).
(2) A midwife may prescribe, dispense or administer Schedule II through V controlled substances and legend drugs in accordance with the following restrictions:
(i) A midwife may not prescribe, dispense, order or administer a controlled substance except for a woman's acute pain.
(ii) In the case of a Schedule II controlled substance, the dose must be limited to 72 hours and may not be extended except with the approval of the collaborating physician.
(iii) A midwife shall prescribe, dispense, order or administer psychotropic drugs only after consulting with the collaborating physician.
(iv) A midwife shall only prescribe or dispense a drug for a patient in accordance with the collaborative agreement.
(3) A midwife authorized to prescribe or dispense, or both, controlled substances, shall register with the United States Drug Enforcement Administration (DEA).
(b) Prescription blanks. The requirements for prescription blanks are as follows:
(1) Prescription blanks must bear the license number of the midwife and the name of the midwife in a printed format at the heading of the blank.
(2) The signature of the midwife must be followed by the initials ''C.N.M.'' or similar designation to identify the signer as a midwife. When prescribing controlled substances, the midwife's DEA registration number must appear on the prescription.
(3) A midwife may use a prescription blank generated by a hospital provided the information in paragraph (1) appears on the blank.
(c) Inappropriate prescribing. The collaborating physician shall immediately advise the patient, notify the midwife or midwife colleague and, in the case of a written prescription, advise the pharmacy if the midwife is prescribing or dispensing a drug inappropriately. The midwife, midwife colleague or collaborating physician shall advise the patient to discontinue use of the drug and the midwife shall cease prescribing that drug for the patient. In the case of a written prescription, the midwife, midwife colleague or collaborating physician shall notify the pharmacy to discontinue the prescription. The order to discontinue the use of the drug or prescription must be noted in the patient's medical record.
(d) Recordkeeping requirements. Recordkeeping requirements are as follows:
(1) When prescribing a drug, the midwife shall do one of the following:
(i) Keep a copy of the prescription, including the number of refills, in a ready reference file.
(ii) Record the name, amount, directions for use and doses of the drug prescribed, the number of refills, the date of the prescription and the midwife's name in the patient's medical records.
(2) When dispensing a drug, the midwife shall record the following:
(i) The midwife's name.
(ii) The name of the medication dispensed.
(iii) The amount of medication dispensed.
(iv) The dose of the medication dispensed.
(v) The date dispensed in the patient's medical records.
(e) Compliance with regulations relating to prescribing, administering, dispensing, packaging and labeling of drugs. A midwife shall comply with §§ 16.92--16.94 (relating to prescribing, administering and dispensing controlled substances; packaging; and labeling of dispensed drugs) and Department of Health regulations in 28 Pa. Code §§ 25.51--25.58 (relating to prescriptions) and regulations regarding packaging and labeling dispensed drugs. See § 16.94 and 28 Pa. Code §§ 25.91--25.95 (relating to labeling of drugs, devices and cosmetics).
§ 18.9. Notification of changes in collaboration.
(a) A midwife shall notify the Board, in writing, of a change in or termination of a collaborative agreement or a change in mailing address within 30 days. Failure to notify the Board, in writing, of a change in mailing address may result in failure to receive pertinent material distributed by the Board. The midwife shall provide the Board with the new address of residence, address of employment and name of registered collaborating physician.
(b) A collaborating physician shall notify the Board, in writing, of a change or termination of collaboration with a midwife within 30 days.
(c) Failure to notify the Board of changes in, or a termination in the collaborating physician/midwife relationship is a basis for disciplinary action against the midwife's license.
(d) A midwife with prescriptive authority who cannot continue to fulfill the requirements for prescriptive authority shall notify the Board within 30 days of the midwife's request to place the midwife's prescriptive authority on inactive status.
[Pa.B. Doc. No. 07-2309. Filed for public inspection December 14, 2007, 9:00 a.m.]
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