Section 1140-03-.17 - COLLABORATIVE PHARMACY PRACTICE(1) Definitions-In addition to the definitions contained in Tenn. Code Ann. Title 63, Chapter 10, Part 2, the following definitions are applicable to collaborative pharmacy practice:(a) "Active practice", for purposes of the qualifications of a pharmacist under (4)(b) of this rule, means engagement in paid, unpaid, or volunteer activity which requires a pharmacist's license under Tennessee law, for at least 2,000 hours within the 24-month period immediately preceding the date of the agreement. "Active practice" is not limited to direct patient care and includes supervisory, educational or consultative activities or responsibilities for the delivery of such services.(b) "Agreement" means the collaborative pharmacy practice agreement.(c) "Authorizing physician" means a medical doctor or osteopathic physician with an unencumbered Tennessee license who has a direct provider/patient relationship with the patients served under a collaborative pharmacy practice agreement or who is the supervising physician of an advanced practice nurse or physician assistant who has such direct relationship or who, in the case of a multi-specialty practice, is the representative or chief responsible for particular specialty care within that multi-specialty practice recognized and certified by the American Board of Medical Specialties (hereinafter "ABMS") or the American Osteopathic Association Bureau of Osteopathic Specialists (hereinafter "AOABOS").(d) "Collaborating prescriber" means the physician, advanced practice nurse or physician assistant who is a party to a collaborative pharmacy practice agreement, who has a direct provider/patient relationship with the patient served by the agreement and who has prepared the patient specific, drug specific, disease or condition specific plan of care based on a physical examination of the patient where required under these rules.(e) "Hospice patient" means an individual who has been diagnosed as terminally ill, has been certified in writing by a physician to have an anticipated life expectancy of six (6) months or less and who has voluntarily requested admission to, and been accepted by, a licensed hospice as defined in T.C.A. § 68-11-201.(f) "Institutional-based pharmacy setting" means any institutional facility or long-term care facility, as defined in 1140-01-.01, or an academic health care institution, and where the pharmacist is responsible for the care of patients within that facility, including prescriptive practices, under the terms of a collaborative agreement.(g) "Patient care services" means services rendered by physicians and members of the healthcare profession under their supervision, including advanced practice nurses, physician assistants and pharmacists for the benefit of the patient and which must be within the professional training and experience of the healthcare practitioner and be covered by the collaborative pharmacy practice agreement.(h) "Routine scope of practice and services" means any patient care service provided by the authorizing physician and their practice in compliance with the respective applicable licensing board's laws, rules, policies and procedures. In addition, the services to be provided by the pharmacist shall be services that the authorizing physician generally provides to his or her patients in the normal course of his or her clinical medical practice. The pharmacist should only provide services to the patients whom the authorizing physician or collaborating prescriber routinely treats in the course of his or her clinical medical practice.(i) "Unencumbered", for the purpose of this rule, means an active license that is not revoked, suspended or on probation at the time and is not subject to any conditions, restrictions, or limitations imposed by the applicable licensing board, which relate directly to the delivery of health care services. A condition, restriction or limitation directly relates to the delivery of health care services when it prevents a provider from treating certain types of patients or certain types of ailments or injuries, or otherwise limits a provider from fully engaging in the practice which would otherwise be authorized pursuant to his or her license.(2) Physicians, advanced practice nurses and physician assistants may only engage in collaborative pharmacy practice agreements with pharmacists when an appropriately executed collaborative pharmacy practice agreement has been executed and a written attestation has been filed with the licensing boards for all practitioners participating in the agreement notifying those boards of the existence of such agreement; and when the patient or the patient's authorized representative has signed a general consent that the patient is to receive services from a healthcare team, including a pharmacist. However, no such general consent shall be required in an institutional based pharmacy setting where consent to treatment has already been given. All consent given related to treatment at an institutional facility or to treatment under a collaborative pharmacy practice agreement is to be made part of the patient record. (a) Any pharmacist who is a participant in a collaborative pharmacy practice agreement must be provided a copy of said agreement by the director of pharmacy, pharmacist in charge, or designated pharmacist in a group.(b) The written attestation shall include the names of all signatories and practitioners participating in the collaborative pharmacy practice agreement, the date of the Agreement and a description of the scope of the services covered by the Agreement.(c) In the event that an advanced practice nurse or physician assistant is a party to a collaborative pharmacy practice agreement, the physician with responsibility for supervision and control of that advanced practice nurse or physician assistant must approve and sign the Agreement.(d) In addition, for those Agreements not involving the institutional-based pharmacy setting, the written attestation shall include a formulary of the categories of drugs and services authorized by the Agreement.(e) The written attestation must be provided to the appropriate licensing boards of the signatories no later than thirty (30) days following the effective date of the Agreement.(3) No physician, advanced practice nurse, physician assistant or pharmacist may engage in a collaborative pharmacy practice agreement unless each collaborating provider holds an active, unencumbered license in Tennessee and possesses at least one million dollars ($1,000,000) in professional liability insurance coverage per occurrence.(4) In addition to the other requirements of these rules, a pharmacist must meet one of the following qualifications in order to engage in a collaborative pharmacy practice agreement:(a) Has been awarded a doctor of pharmacy degree from a program accredited by the Accreditation Council for Pharmacy Education; or(b) Has been awarded a bachelor of science in pharmacy and been in the active practice of pharmacy.(5) Each collaborative pharmacy practice agreement ("Agreement") shall contain the following elements, at a minimum: (a) Names and Titles of Collaborating Providers. The agreement must contain identification of all pharmacists and all physicians and other prescribers (collectively, "collaborating providers") who are parties to the Agreement. The Agreement shall state the procedure to be followed to indicate changes in the members of the group(s) participating in the Agreement. Unless expressly stated in the Agreement, changes to the list of collaborating providers bound by the Agreement shall not automatically void the Agreement. When the Agreement involves a group or groups of practitioners, the chief medical officer or medical director, where applicable, and the director of pharmacy or pharmacist in charge shall sign the Agreement, and the Agreement shall identify all collaborating providers in one or more addendums. In the case of a healthcare institution with an organized medical staff or a multi-specialty group with more than one ABMS or AOABOS recognized physician specialty, the signature of the authorizing physician representing or responsible for that specialty unit will suffice. Nevertheless, each collaborating provider must affirm understanding and acceptance of the terms of the Agreement by signing an addendum to the Agreement within thirty (30) days of the effective date of the agreement (or within thirty days of employment or association with such multi-specialty group) and all members of the medical staff or group must be provided a copy of the collaborative agreement within fifteen (15) days of execution, with a copy also made available via online access. Signatures may be handwritten, electronic, or any other method authorized by the Board of Pharmacy and the respective licensing board of the signatory.(b) Authorized Care and Services. The Agreement must contain a provision defining the nature and scope of patient care services and activities, including screening, prevention, assessment, management, and care, authorized or restricted to be provided by the pharmacist(s) under the collaborative pharmacy practice agreement. All care and services authorized to be provided shall be within the routine scope of practice and services delivered by the authorizing physician and the advanced practice nurse or physician assistant, where applicable. All care and services provided, except immunizations, opioid antagonists, ivermectin, and preventive care, must be pursuant to a diagnosis appropriately made and documented by the physician, advanced practice nurse or physician assistant. An Agreement which grants the collaborating pharmacist prescriptive authority, including authority for initiation and discontinuance of drug therapy, must be specifically authorized in the authorized care and services portion of the Agreement and must contain a listing of the drugs or categories of drugs that may be prescribed by the collaborating pharmacist under the terms of the Agreement.(c) Documentation and Communication. Any patient care services provided by a pharmacist or pharmacists pursuant to a collaborative pharmacy practice agreement shall be documented in a patient record accessible by the pharmacist(s) and the collaborating prescriber(s) or communicated in writing to the collaborating prescriber or prescribers within three (3) business days of the service. The Agreement shall describe the methods for maintenance and access to the records by the pharmacist(s) and the prescriber(s), for documentation of services performed pursuant to the Agreement and for communication and feedback between the pharmacist(s) and the collaborating prescriber(s). All such records shall be maintained by the collaborating prescriber(s) and pharmacist(s) for a period of not less than ten (10) years from the date of the last patient contact.(d) Override Clause. A provision must be included in the Agreement allowing the collaborating prescriber to override the actions taken by the collaborating pharmacist specific to services provided under the Agreement if he or she determines that the override is essential to the optimal health outcomes of the patient, and stating how such overrides shall be documented and communicated to the collaborating pharmacist and the patient in a timely manner, as defined in the agreement.(e) Expiration, Modification and Termination. The effective date of the Agreement shall be stated in the Agreement. Each agreement must contain a term or expiration date, upon which the agreement will expire if not renewed; however, in any event, all Agreements must be reviewed and updated at least every two (2) years as evidenced by signatures of the parties. Every Agreement must contain a provision stating the process for modification or termination of the agreement by either party. This process shall include written notification to all affected parties when modification or termination is sought. An Agreement may be amended upon mutual approval by the collaborating prescriber, authorizing physician (where applicable) and pharmacist who have been duly authorized to execute, modify, or change the Agreement. Such amendments shall include, at a minimum, a description of the desired change and the effective date of the change. Additional prescriber(s) and additional pharmacist(s) may be added to an existing participating group through an addendum without affecting the effective date of the agreement. Any amendment executed shall not automatically void the terms and conditions of the existing Agreement unless expressly stated. Amendments to the authorized care and services not involving an institutional-based pharmacy setting which institute substantive additions or reductions to the scope of patient care services provided under the agreement including new therapeutic classes of drugs to the authorized formulary must be provided to the appropriate licensing boards no later than thirty (30) days from the effective date of the amendment.(f) Automatic Exclusions. A provision must be included in the Agreement which identifies any terms under which a provider will be automatically excluded from participation in the Agreement, which may include but need not be limited to death, suspension, surrender, revocation, or retirement of license; loss or restriction of prescriptive authority; the suspension or revocation of a Drug Enforcement Administration registration; exclusion from any federally funded health programs, or the formal termination of the supervising relationship between an advanced nurse practitioner or physician assistant and his or her supervising physician. Any Agreement involving an advanced practice nurse or physician assistant participating in a collaborative pharmacy practice agreement shall contain a procedure for immediate notification to the collaborating pharmacist(s) if that supervisory relationship is terminated for any reason.(g) Quality Assessment. The authorizing physician(s) and pharmacist(s) shall create written measurable and objective performance goals for evaluating the quality of care provided for the patients treated pursuant to the Agreement. The Agreement must provide for such goals and data as identified by the collaborating providers, to be aggregated and reviewed by the participants to the Agreement at least quarterly. Such quarterly review shall include consideration of any changes necessary to the Agreement, authorized formulary, and patient orders, in addition to strategies regarding patient education and medication adherence, increased or improved monitoring of side effects and the need for further screening/testing. The Agreement shall also provide at a minimum for monthly patient record review by the authorizing physician(s) of at least five percent (5%) of the patients treated pursuant to the Agreement. The quality assessment review shall be properly documented, retained by the participating parties of the Agreement, and available for review by representatives of the various licensing boards for at least ten (10) years.(6) The scope of a collaborative pharmacy practice agreement shall NOT include:(a) Any patient of the collaborating prescriber for whom such collaborating prescriber has not prepared a patient-specific, drug-specific, disease- or condition-specific plan of care based on a physical examination of the patient by the collaborating prescriber, with the exception of immunizations, dispensing of ivermectin, and screening/testing which do not require such patient-specific plans, as well as the dispensing of opioid antagonists as defined in T.C.A. § 63-1-152, which require neither a physical examination nor a patient-specific plan;(b) The prescribing of controlled substances, except by a pharmacist practicing within an institutional-based pharmacy setting or for hospice patients.(7) A copy of the Agreement, including any addendum, modification or termination shall be accessible at each practice site and shall be made available to the applicable regulatory board for review upon request.(8) Pharmacists engaging in the collaborative pharmacy practice must utilize an area for in-person, telephonic or other approved consultations with patients that ensures the confidentiality of the communication.(9) Physicians, advanced practice nurses and physician assistants engaged in a collaborative pharmacy practice agreement shall:(a) Retain professional responsibility to his/her patients for the management of their drug therapy;(b) Establish and maintain a physician-patient relationship with each patient subject to the collaborative pharmacy practice agreement;(c) Be available at all times through direct telecommunication for consultation, assistance and direction, or shall make arrangements for a substitute physician to be available.(10) Any pharmacist issuing a prescription order, as defined in T.C.A. § 63-10-204, or medical order, as defined in T.C.A. § 63-10-204, pursuant to an Agreement shall issue the prescription order or medical order in accordance with the requirements set forth in Tenn. Comp. Rules and Regs. 1140-03-.03 and within the terms set forth in the collaborative pharmacy practice agreement.(11) All collaborative pharmacy practice agreements authorizing pharmacists to provide services and activities shall include language that ensures compliance with all applicable by-laws, policies, and procedures of that facility.(12) For patient care services performed by a pharmacist and authorized only pursuant to a collaborative pharmacy practice agreement, the Board of Pharmacy expressly adopts the guidelines, rules, and standards of practice of the Board of Medical Examiners, Board of Osteopathic Examiners, or other Tennessee Health Related Boards, as applicable.(13) Pharmacists engaged in the collaborative pharmacy practice are strongly encouraged to complete ten (10) hours of the biennially required thirty (30) hours of continuing education in topics related to the clinical practice of pharmacy.(14) All signatories and other parties engaging in a collaborative pharmacy practice shall be subject to disciplinary action by their licensing boards if the licensee violates the terms of these rules or the terms of the collaborative pharmacy practice agreement. Each board with jurisdiction over any of the signatories to the agreement shall report to the other appropriate board any conduct which it believes to be in violation of any such agreement.(15) Pharmacists who hold a current federal drug enforcement administration ("DEA") license must complete a minimum of two (2) hours biennially of continuing education related to controlled substance prescribing, which must include instruction in the Department's treatment guidelines on opioids and chronic pain and may include such other topics as medicine addiction, risk management tools, and other topics as approved by the Board of Pharmacy. Such continuing education hours shall be counted toward the pharmacist's mandatory continuing education requirement.Tenn. Comp. R. & Regs. 1140-03-.17
New rule filed November 22, 2016; effective February 20, 2017. Amendments filed December 15, 2023; effective 3/14/2024.Authority: T.C.A. §§ 63-10-217, 63-10-224, and 63-10-308.