§ 27.302. Collaborative agreement for management of drug therapy in a non-institutional setting.
(a) Before practicing the management of drug therapy in a non-institutional setting, a pharmacist shall enter into a written collaborative agreement with a physician authorizing the management of drug therapy for diseases or for conditions or symptoms of diseases.
(b) The collaborative agreement must be between a physician and a pharmacist.
(c) A pharmacist may not provide economic or other incentives, inducements or benefits to a physician for the purpose of entering into a collaborative agreement for the management of drug therapy.
(d) A pharmacist who is employed by a physician under a collaborative agreement for the purpose of management of drug therapy may not engage in retail dispensing while in the health care practice or within the context of employment.
(e) Participation in a collaborative agreement authorizing the management of drug therapy is voluntary. A physician or pharmacist is not required to participate.
(f) The collaborative agreement must contain:
(1) A statement identifying the physician responsible for authorizing the management of drug therapy.
(2) A statement identifying the pharmacist authorized to perform the management of drug therapy.
(3) A statement requiring that regimens for the management of drug therapy be initiated by a physician for patients referred to a pharmacist for management of drug therapy.
(4) A statement identifying the types of decisions regarding the management of drug therapy that the pharmacist is authorized to make within the physician’s scope of practice and types of management of drug therapy authorized.
(5) A statement identifying the terms under which a pharmacist providing the management of drug therapy is permitted to: adjust the drug regimen, the drug strength and the frequency of administration or the route of administration; administer drugs; order laboratory tests; and order and perform other diagnostic tests necessary in the management of drug therapy without prior written or oral consent by the collaborating physician. This paragraph does not provide prescriptive authority to a pharmacist.
(6) A statement of the functions and tasks the pharmacist shall follow in the course of exercising management of drug therapy, including the method for documenting decisions made and a plan for communication or feedback to the authorizing physician concerning specific decisions made. Documentation of each intervention shall occur as soon as practicable, but no later than 72 hours after the intervention, and be recorded in the pharmacist’s records.
(7) A statement that requires notification to the authorizing physician of changes in dose, duration or frequency of medication prescribed as soon as practicable but no longer than 72 hours after the change.
(8) A provision for implementation of the collaborative agreement when a physician or pharmacist who is a party to the agreement is temporarily unavailable to participate in its implementation.
(9) A provision for notification of the role of the pharmacist by a physician to each referred patient the management of whose drug therapy may be affected by the collaborative agreement and providing an opportunity for the patient to refuse management of drug therapy by a pharmacist.
(10) The signatures of the physicians and pharmacists who are entering into the collaborative agreement and the dates signed.
(11) A statement allowing for the termination of the collaborative agreement at the request of a party to it at any time.
(g) The collaborative agreement must be available:
(1) At the practice site of each physician who is a party to the collaborative agreement.
(2) At the practice site of each pharmacist who is a party to the collaborative agreement.
(3) To any patient the management of whose drug therapy is affected by the agreement, upon request of the patient.
(4) Upon request, to representatives of the Bureau and the Department of Health.
(h) The collaborative agreement shall be filed with the Bureau.
(i) The collaborative agreement must be maintained on the premises of the pharmacy for review during inspection by or upon request of representatives of the Bureau and the Department of Health.
(j) The collaborative agreement must be effective for no more than 2 years from the date of execution. At the end of the 2-year period, or sooner, the parties shall review the collaborative agreement and make a determination as to its renewal, necessary modifications or termination.
(k) A pharmacist who is party to a collaborative agreement authorizing the management of drug therapy shall:
(1) Utilize an area for in-person, telephonic or other approved electronic consultations regarding the management of drug therapy that ensures the confidentiality of the patient information being discussed.
(2) Initiate the management of drug therapy only upon a written referral to the pharmacist from the physician. The written referral must include the minimum frequency in which the pharmacist shall conduct the management of the drug therapy in person.
(3) Confirm that the physician who is a party to the collaborative agreement holds an active and unrestricted license and that the terms of the collaborative agreement are within the scope of the physician’s current practice at the time of the execution of the collaborative agreement.
(l) Patient records regarding the management of drug therapy may be maintained in a computerized recordkeeping system which meets the requirements for Federal and State-certified electronic health care records, subject to the following:
(1) The pharmacist who is a party to the collaborative agreement shall have access to the records of the patient who is the recipient of the management of drug therapy.
(2) The physician who is a party to the collaborative agreement shall have access to the pharmacy records of the patient who is the recipient of the management of drug therapy.
(3) The handling of patient records by the pharmacist providing the management of drug therapy shall comply with the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191, 110 Stat. 1936), the Health Information Technology for Economic and Clinical Health Act (Pub. L. No. 111-5, Div. A, Title XIII, Div. B, Title IV, 123 Stat. 226, 467), and associated rules and regulations.
Source The provisions of this § 27.302 adopted August 21, 2015, effective August 22, 2015, 45 Pa.B. 4911.
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