[30 Pa.B. 5943]
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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
Subchapter C. CERTIFIED REGISTERED NURSE PRACTITIONERS
CRNP PRACTICE § 18.53. Prescribing and dispensing drugs.
A CRNP may prescribe and dispense drugs if the following requirements are met:
(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 has successfully completed at least 45 hours of course work specific to advanced pharmacology in accordance with the following:
(i) The course work in advanced pharmacology may be either part of the CRNP education program or, if completed outside of the CRNP education program, an additional course or courses taken from an educational program or programs approved by the Boards.
(ii) The course work in advanced pharmacology must be at an advanced level above a pharmacology course required by a professional nursing (RN) education program.
(3) A CRNP who has prescriptive authority shall complete at least 16 hours of State Board of Nursing approved continuing education in pharmacology in the 2 years prior to the biennial renewal date of his or her CRNP certification. The CRNP shall show proof that she completed the continuing education when submitting a biennial renewal.
(4) 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.
§ 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 relevant to the area of practice of the CRNP from the following categories if that authorization is documented in the collaborative agreement (unless the drug is limited or excluded under this or another subsection):
(1) Antihistamines.
(2) Anti-infective agents.
(3) Antineoplastic agents, unclassified therapeutic agents, devices and pharmaceutical aids if originally prescribed by the collaborating physician and approved by the collaborating physician for ongoing therapy.
(4) Autonomic drugs.
(5) Blood formation, coagulation and anticoagulation drugs, and thrombolytic and antithrombolytic agents.
(6) Cardiovascular drugs.
(7) Central nervous system agents, except that the following drugs are excluded from this category:
(i) General anesthetics.
(ii) Monoamine oxidase inhibitors.
(8) Contraceptives including foams and devices.
(9) Diagnostic agents.
(10) Disinfectants for agents used on objects other than skin.
(11) Electrolytic, caloric and water balance.
(12) Enzymes.
(13) Antitussive, expectorants and mucolytic agents.
(14) Gastrointestinal drugs.
(15) Local anesthetics.
(16) Eye, ear, nose and throat preparations.
(17) Serums, toxoids and vaccines.
(18) Skin and mucous membrane agents.
(19) Smooth muscle relaxants.
(20) Vitamins.
(21) Hormones and synthetic substitutes.
(c) A CRNP may not prescribe or dispense a drug from the following categories:
(1) Gold compounds.
(2) Heavy metal antagonists.
(3) Radioactive agents.
(4) Oxytocics
(d) If a collaborating physician determines that the CRNP is prescribing or dispensing a drug inappropriately, the collaborating physician shall immediately take corrective action on behalf of the patient and notify the patient of the reason for the action and advise the CRNP as soon as possible. This action shall be noted by the CRNP or the collaborating physician, or both, in the patient's medical record.
(e) 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 as soon as possible but in no event longer than 24 hours.
(2) A CRNP may prescribe a Schedule III or IV controlled substance for up to 30 days. The prescription is not subject to refills unless the collaborating physician authorizes refills for that prescription.
(f) 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 approved by the United States Food and Drug Administration without approval of the collaborating physician.
(3) Delegate prescriptive authority specifically assigned to the CRNP by the collaborating physician to another health care provider.
(g) A prescription blank shall bear the certification number of the CRNP, 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).
(h) 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.
§ 18.55. Collaborative agreement.
(a) A collaborative agreement is the signed written agreement between a CRNP and a collaborating physician in which they agree to the details of the collaborative arrangement between them with respect to the care of CRNP patients.
(b) The collaborative agreement between a physician and a CRNP who will prescribe drugs shall satisfy the following requirements. The agreement shall:
(1) Identify the parties, including the collaborating physician, the CRNP and a substitute physician who will provide collaboration and direction for up to 30 days if the collaborating physician is unavailable.
(2) Identify the area of practice in which the CRNP is certified.
(3) Identify the categories of drugs from which the CRNP may prescribe or dispense in accordance with § 18.54.
(4) Contain attestation by the collaborating physician that the CRNP has knowledge and experience with any drug that the CRNP will prescribe.
(5) Specify the circumstances and how often the collaborating physician will personally see the patient, based on the type of practice, sites of service and condition of the patient, whether the treatment is for an ongoing or new condition, and whether the patient is new or continuing.
(6) Specify the conditions under which the CRNP may prescribe a Schedule II controlled substance for up to 72 hours.
(7) Be kept at the primary practice location of the CRNP and a copy filed with the Bureau of Professional and Occupational Affairs.
(8) Be made available for inspection to anyone seeking to confirm the scope of practice of the CRNP.
(9) Be updated by the collaborating physician and the CRNP whenever it is changed substantively.
(10) Specify the amount of professional liability insurance carried by the CRNP.
(c) The CRNP shall notify the Bureau whenever a collaborative agreement of a CRNP who prescribes and dispenses drugs is updated or terminated.
§ 18.56. Identification of the CRNP.
(a) A patient shall be informed at the time of making an appointment that the patient will be seen by a CRNP.
(b) A CRNP shall wear a name tag that clearly identifies the CRNP with the title ''Certified Registered Nurse Practitioner.''
(c) A CRNP who holds a doctorate should take appropriate steps to inform patients that the CRNP is not a doctor of medicine or doctor of osteopathic medicine.
§ 18.57. Physician supervision.
(a) At any time a physician may not supervise more than four CRNPs who prescribe and dispense drugs. This subsection does not limit the number of collaborative agreements that a physician may have with prescribing CRNPs. By way of example, a physician may supervise four prescribing CRNPs who work in the morning and four other prescribing CRNPs who work in the afternoon as long as the physician has a collaborative agreement with each CRNP.
(b) A physician may apply for a waiver of the supervision requirements expressed in subsection (a) for good cause, as determined by the Boards.
(c) The limit of the general rule of not more than four prescribing CRNPs to one physician does not apply to CRNPs who do not prescribe or dispense drugs. By way of example, a physician may supervise at the same time four CRNPs who prescribe and dispense drugs and one or more CRNPs who do not prescribe and dispense drugs.
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 the following requirements are met:
(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 has successfully completed at least 45 hours of course work specific to advanced pharmacology in accordance with the following:
(i) The course work in advanced pharmacology may be either part of the CRNP education program or, if completed outside of the CRNP education program, an additional course or courses taken from an educational program or programs approved by the Boards.
(ii) The course work shall be at an advanced level above a pharmacology course required by a professional nursing (RN) education program.
(3) A CRNP who has prescriptive authority shall complete at least 16 hours of State Board of Nursing approved continuing education in pharmacology in the 2 years prior to the biennial renewal date of the CRNP certification. The CRNP shall show proof that the CRNP completed the continuing education when submitting a biennial renewal.
(4) 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.
§ 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 relevant to the area of practice of the CRNP from the following categories if that authorization is documented in the collaborative agreement (unless the drug is limited or excluded under this or another subsection):
(1) Antihistamines.
(2) Anti-infective agents.
(3) Antineoplastic agents, unclassified therapeutic agents, devices and pharmaceutical aids if originally prescribed by the collaborating physician and approved by the collaborating physician for ongoing therapy.
(4) Autonomic drugs.
(5) Blood formation, coagulation and anticoagulation drugs, and thrombolytic and antithrombolytic agents.
(6) Cardiovascular drugs.
(7) Central nervous system agents, except that the following drugs are excluded from this category:
(i) General anesthetics.
(ii) Monoamine oxidase inhibitors.
(8) Contraceptives including foams and devices.
(9) Diagnostic agents.
(10) Disinfectants for agents used on objects other than skin.
(11) Electrolytic, caloric and water balance.
(12) Enzymes.
(13) Antitussive, expectorants and mucolytic agents.
(14) Gastrointestinal drugs.
(15) Local anesthetics.
(16) Eye, ear, nose and throat preparations.
(17) Serums, toxoids and vaccines.
(18) Skin and mucous membrane agents.
(19) Smooth muscle relaxants.
(20) Vitamins.
(21) Hormones and synthetic substitutes.
(c) A CRNP may not prescribe or dispense a drug from the following categories:
(1) Gold compounds.
(2) Heavy metal antagonists.
(3) Radioactive agents.
(4) Oxytocics.
(d) If a collaborating physician determines that the CRNP is prescribing or dispensing a drug inappropriately, the collaborating physician shall immediately take corrective action on behalf of the patient and notify the patient of the reason for the action and advise the CRNP as soon as possible. This action shall be noted by the CRNP or the collaborating physician, or both, in the patient's medical record.
(e) 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 as soon as possible but in no event longer than 24 hours.
(2) A CRNP may prescribe a Schedule III or IV controlled substance for up to 30 days. The prescription is not subject to refills unless the collaborating physician authorizes refills for that prescription.
(f) 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 approved by the United States Food and Drug Administration without approval of the collaborating physician.
(3) Delegate prescriptive authority specifically assigned to the CRNP by the collaborating physician to another health care provider.
(g) A prescription blank shall bear the certification number of the CRNP, 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).
(h) 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.
§ 21.285. Collaborative agreement.
(a) A collaborative agreement is the signed written agreement between a CRNP and a collaborating physician in which they agree to the details of the collaborative arrangement between them with respect to the care of CRNP patients.
(b) The collaborative agreement between a physician and a CRNP who will prescribe drugs shall satisfy the following requirements. The agreement shall:
(1) Identify the parties, including the collaborating physician, the CRNP, and a substitute physician who will provide collaboration and direction for up to 30 days if the collaborating physician is unavailable.
(2) Identify the area of practice in which the CRNP is certified.
(3) Identify the categories of drugs from which the CRNP may prescribe or dispense in accordance with § 21.284 (relating to prescribing and dispensing parameters).
(4) Contain attestation by the collaborating physician that the CRNP has knowledge and experience with any drug that the CRNP will prescribe.
(5) Specify the circumstances and how often the collaborating physician will personally see the patient, based on the type of practice, sites of service and condition of the patient, whether the treatment is for an ongoing or new condition, and whether the patient is new or continuing.
(6) Specify the conditions under which the CRNP may prescribe a Schedule II controlled substance for up to 72 hours.
(7) Be kept at the primary practice location of the CRNP and a copy filed with the Bureau of Professional and Occupational Affairs.
(8) Be made available for inspection to anyone seeking to confirm the scope of practice of the CRNP.
(9) Be updated by the collaborating physician and the CRNP whenever it is changed substantively.
(10) Specify the amount of professional liability insurance carried by the CRNP.
(c) The CRNP shall notify the Bureau whenever a collaborative agreement of a CRNP who prescribes and dispenses drugs is updated or terminated.
§ 21.286. Identification of the CRNP.
(a) A patient shall be informed at the time of making an appointment that the patient will be seen by a CRNP.
(b) A CRNP shall wear a name tag that clearly identifies the CRNP with the title ''certified registered nurse practitioner.''
(c) A CRNP who holds a doctorate should take appropriate steps to inform patients that the CRNP is not a doctor of medicine or doctor of osteopathic medicine.
§ 21.287. Physician supervision.
(a) At any time a physician may not supervise more than four CRNPs who prescribe and dispense drugs. This section, however, does not limit the number of collaborative agreements that a physician may have with prescribing CRNPs. By way of example, a physician may supervise four prescribing CRNPs who work in the morning and four other prescribing CRNPs who work in the afternoon as long as the physician has a collaborative agreement with each CRNP.
(b) A physician may apply for a waiver of the supervision requirements expressed in subsection (a) for good cause, as determined by the Boards.
(c) The limit of the general rule of not more than four prescribing CRNPs to one physician does not apply to CRNPs who do not prescribe or dispense drugs. By way of example, a physician may supervise at the same time four CRNPs who prescribe and dispense drugs and one or more CRNPs who do not prescribe and dispense drugs.
[Pa.B. Doc. No. 00-1974. Filed for public inspection November 17, 2000, 9:00 a.m.]
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