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49 Pa. Code § 27.301. Written protocol for the management of drug therapy in an institutional setting.

MANAGEMENT OF DRUG THERAPY


§ 27.301. Written protocol for the management of drug therapy in an institutional setting.

 (a)  The management of drug therapy under section 9.1 of the act (63 P. S. §  390-9.1) shall be performed under a written protocol consistent with the institution’s assignment of clinical duties. Ordering of laboratory tests and ordering or performing other diagnostic tests necessary in the management of drug therapy shall be consistent with the testing standards of the institution.

 (b)  The written protocol for management of drug therapy between physicians and pharmacists must contain:

   (1)  A statement identifying the physician responsible for authorizing management of drug therapy.

   (2)  A statement identifying the pharmacist authorized to perform 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, including a statement of the ailments or diseases involved within the physician’s scope of practice, and types of management of drug therapy authorized.

   (5)  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 in the patient’s medical record and shall also be recorded in the pharmacist’s records.

   (6)  A statement that requires notification to the authorizing physician of any changes in dose, duration or frequency of medication prescribed as soon as practicable but no longer than 72 hours after the change.

   (7)  A provision for implementation of the written protocol when a physician or pharmacist who is a party to the protocol is temporarily unavailable to participate in its implementation.

   (8)  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 written protocol and providing an opportunity for the patient to refuse management of drug therapy by a pharmacist.

   (9)  The signatures of the physicians and pharmacists who are entering into the written protocol, and the dates signed.

   (10)  A statement allowing for the termination of the written protocol at the request of any party to it at any time.

 (c)  The written protocol must be available as follows:

   (1)  At the practice site of each physician who is a party to the written protocol.

   (2)  At the practice site of each pharmacist who is a party to the written protocol.

   (3)  At the institution where a written protocol is in place.

   (4)  To any patient the management of whose drug therapy is affected by the written protocol, upon request of the patient.

   (5)  Upon request, to representatives of the Bureau and the Department of Health.

 (d)  The written protocol shall be filed with the Bureau.

 (e)  The written protocol must be effective for a period not to exceed 2 years from the date of execution. At the end of the 2-year period, or sooner, the parties shall review the written protocol and make a determination as to its renewal, necessary modifications or termination.

Authority

   The provisions of this §  27.301 amended under sections 6(k)(9) and 9.3 of the Pharmacy Act (63 P. S. § §  390-6(k)(9) and 390-9.3).

Source

   The provisions of this §  27.301 adopted June 30, 2006, effective July 1, 2006, 36 Pa.B. 3237; amended August 21, 2015, effective August 22, 2015, 45 Pa.B. 4911. Immediately preceding text appears at serial pages (347434) and (347735) to (347736).



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