(a) The following words and terms, as used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise. "Bona fide physician-patient relationship" means a relationship in which the physician has ongoing responsibility for assessment, care, and treatment of the patient's medical condition for which collaborative drug therapy management is utilized. For purposes of this definition, "ongoing responsibility" means:
1. The physician-patient relationship has existed for at least one year;2. The physician has seen and/or assessed the patient on at least four visits; or3. The physician assumes responsibility for providing management and care of the patient's condition after conducting a comprehensive medical history and physical examination. "Collaborative drug therapy management" means the cooperative management of a patient's drug, biological, and device-related health care needs, pursuant to a written protocol directed on a voluntary basis by a patient's physician with the patient's informed consent, by the patient's physician and a pharmacist who has signed a collaborative practice agreement with the physician.
"Collaborative practice" means that practice whereby one or more physicians have jointly agreed to work in conjunction with one or more pharmacists for the purpose of collaborative drug therapy management of patients.
"Collaborative practice protocol" means a written document that identifies the collaborative drug therapy management actions that a pharmacist is authorized to perform for a patient and that is developed jointly by the pharmacist and the physician, and meets the requirements set forth at (c) below.
"Informed consent" means the written document that is signed by a patient whereby the patient agrees to collaborative drug therapy management by the patient's physician and a pharmacist who has entered into a collaborative practice agreement with the physician.
"Therapeutic interchange" means the substitution and dispensing of a drug chemically dissimilar from the prescription drug originally prescribed.
(b) A physician may enter into a collaborative practice agreement with one or more licensed pharmacists, as provided in 45:14-61 of the Pharmacy Practice Act, provided the collaboration that the physician agrees to conduct with the pharmacist is within the scope of the physician's practice and the pharmacist is authorized to engage in such activities pursuant to Board of Pharmacy requirements set forth at N.J.A.C. 13:39-13.(c) A physician who engages in collaborative practice with one or more pharmacists shall provide the Board, upon request, with a signed copy of a collaborative practice agreement. The collaborative practice agreement shall be consistent with the example contained in 13:35-6.27 Appendix, which is incorporated herein by reference. The written agreement shall: 1. Identify, by name and title, each physician and each pharmacist who is permitted to participate in a patient's collaborative drug therapy management, including all covering physicians and/or pharmacists. Each covering physician shall meet the requirements of (b) above and each covering pharmacist shall meet the requirements of 13:39-13.3. The agreement shall establish the means by which the physician and/or pharmacist will be notified about covering practitioners for collaborative practice purposes;2. Specify the functions and responsibilities, including the scope of practice and authority, to be exercised by the pharmacist;3. Indicate any restrictions placed on the use of certain types or classes of drugs or drug therapies;4. Indicate any diagnosis or types of diseases that are specifically included or excluded;5. Include copies of all protocols to be used in the collaborative practice;6. Contain an effective date for the agreement; and7. Be signed and dated by the physician(s) and pharmacist(s).(d) Any changes, additions, or deletions to the collaborative practice agreement shall be submitted to the Board upon request.(e) The physician shall establish a method for monitoring both the compliance with the collaborative practice agreement and the clinical outcomes of the patients.(f) Collaborative practice protocols shall be developed for each different type of collaborative drug therapy management authorized by the physician under the collaborative practice agreement and shall identify those activities that may be performed by the collaborating pharmacist. Each protocol shall:1. Be jointly developed by the physician and the pharmacist, consistent with standards and practices that are deemed commonly accepted and recognized by national standard setting organizations, or national or State professional organizations of the same discipline as the treating physician, and signed and dated by both the physician and the pharmacist;2. Be initiated and utilized at the sole discretion of the physician for a specific patient with whom the physician has a bona fide physician-patient relationship;3. Be agreed to by both the physician and the pharmacist with the written informed consent of the patient consistent with (g) below;4. Be available at the practice sites of the pharmacist and physician and made available at each site to the patient;5. Establish the means by which the patient will be advised of the right to elect to participate in and withdraw from the collaborative drug therapy management;6. Establish when physician notification is required, the physician chart update interval, and an appropriate time frame within which the pharmacist shall notify the physician of any change in dose, duration, or frequency of medication prescribed. Written notification, by either facsimile or electronic means, shall be provided to the physician no later than eight hours after any change in prescribed medication is made by the pharmacist;7. Identify the method and time frame for notification of the physician if an adverse event occurs; and8. Be reviewed at least once per year by the parties to determine whether the protocol should be renewed, modified or terminated.(g) Written informed consent shall be obtained from each individual patient participating in collaborative drug therapy management. Both the physician and the pharmacist shall retain a copy of the patient's written informed consent. The written informed consent shall: 1. Contain the specific patient's name;2. Identify the risks and benefits of collaborative drug therapy management, including the fact that services provided under collaborative drug therapy management may not be covered by the patient's insurance provider;3. Identify the fact that covering physicians and/or pharmacists may be utilized in the collaborative drug therapy management of the patient's care;4. Identify the patient's right to elect to participate in and withdraw from the collaborative drug therapy management; and5. Be signed and dated by the patient.(h) The collaborative practice agreement may be terminated at any time by either the physician or the pharmacist by written documentation. Upon termination of a collaborative practice agreement, the physician and the pharmacist shall provide notice of the termination to each individual patient who is undergoing collaborative drug therapy management. Upon termination of the agreement, the patient's informed consent for collaborative drug therapy management under the agreement shall be voided.(i) Collaborative drug therapy management shall be between a single patient with whom the physician has a bona fide physician-patient relationship, the physician, and the pharmacist and shall address that patient's specific condition, disease, or diseases.(j) Collaborative drug therapy management may include the collecting, analyzing, and monitoring of patient data; ordering or performing of laboratory tests based on the standing orders of a physician as set forth in the written collaborative practice protocols, consistent with (k) below; ordering of clinical tests based on the standing orders of a physician as set forth in the written collaborative practice protocols; modifying, continuing, or discontinuing drug or device therapy; and therapeutic drug monitoring with appropriate modification to dose, dosage regimen, dosage forms, or route of administration.(k) A pharmacist may perform laboratory tests that are granted waived status in accordance with the provisions of the "New Jersey Clinical Laboratory Improvement Act," P.L. 1975, c. 166 (45:9-42.2 6 et seq.), Department of Health and Senior Services' rules set forth at N.J.A.C. 8:44, and Department of Health and Senior Services CLIA Program requirements, available at http://www.state.nj.us/health/phel/instruct116.shtml, provided the tests are consistent with the pharmacy practice area or disease state covered by the collaborative practice agreement.(l) The interpretation of clinical or laboratory tests under a written collaborative practice protocol shall be performed by a pharmacist only in direct consultation with a physician.(m) Collaborative drug therapy management shall not include therapeutic interchange at the time of dispensing without the prior, specific informed consent of the patient and the consent of the patient's physician.(n) Participation in, or withdrawal from, a collaborative practice agreement shall be voluntary on the part of a physician and a pharmacist.(o) Participation in, or withdrawal from, collaborative drug therapy management shall be voluntary on the part of the individual patient.(p) All records relating to a collaborative practice agreement shall be maintained in either hard copy or electronic form for a period of not less than seven years from the date of termination of the agreement and shall be supplied to the Board upon request.(q) Any violation of the collaborative practice agreement or protocols on the part of the physician may be deemed professional misconduct and may subject the physician to discipline consistent with 45:1-21.APPENDIX
Collaborative Practice Agreement
The Pharmacist(s) and Physician(s) listed below are parties to this collaborative practice agreement, through which the pharmacist(s) receives authority, under the supervision of the physician(s) (or covering physician), to perform the functions outlined in accordance with applicable New Jersey statutes and regulations.
Physician:
Name: ____________________ Title:
Address:
Phone Number: ___________ License Number:
Type of Practice/Specialty:
Pharmacist:
Name:
Address:
Phone Number: ____________ License Number:
Qualifications for Collaborative Practice:
Describe the functions and responsibilities, including scope and authority, to be exercised by the pharmacist (attach extra sheets if needed):
Indicate any restrictions placed on the use of certain types or classes of drugs or drug therapies under this agreement (attach extra sheets if needed):
Indicate any diagnosis, or types of diseases which are specifically included or excluded under this agreement (attach extra sheets if needed):
Attach any protocols to be used in decision making or other activities contemplated under this agreement. This must include a protocol for treating an acute allergic or other adverse reaction related to drug therapy. Each protocol must establish when physician notification is required, the time frame within which the pharmacist must notify the physician of any change in dose, duration or frequency of medication prescribed, and the type of pharmacist documentation required. Written notification, by either facsimile or electronic means, shall be provided to the physician no later than eight hours after any change in prescribed medication is made by the pharmacist.
Physician Signature: _____________ Date:
Pharmacist Signature: _____________ Date:
N.J. Admin. Code § 13:35-6.27
New Rule, R.2013 d.017, effective 2/4/2013.
See: 44 N.J.R. 655(a), 45 N.J.R. 214(b).