§ 27.301. Written protocol.

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

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

   (2)  A statement identifying the pharmacist authorized to perform the drug therapy management.

   (3)  A statement requiring that drug therapy regimens be initiated by a licensed physician for patients referred to a pharmacist for drug therapy.

   (4)  A statement identifying the types of drug therapy management decisions 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 drug therapy management authorized.

   (5)  A statement of the functions and tasks the pharmacist shall follow in the course of exercising drug therapy management authority, 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 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 not longer than 72 hours after the change.

   (7)  A provision for execution of the agreement when any licensed physician or licensed pharmacist may be temporarily absent from a practice setting or temporarily unavailable to participate in its execution.

   (8)  A provision for notification of the role of the pharmacist by a licensed physician to each referred patient whose drug therapy management may be affected by the agreement and providing an opportunity for the patient to refuse drug therapy management by a pharmacist.

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

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

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

   (1)  At the practice site of any licensed physician who is a party to the agreement.

   (2)  At the practice site of any licensed pharmacist who is a party to the agreement.

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

   (4)  To any patient whose drug therapy management is affected by the agreement.

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

 (c)  The written protocol shall be filed with Bureau.

 (d)  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 agreement and make a determination as to its renewal, necessary modifications or termination.

   The provisions of this §  27.301 issued under sections 4(j), 6(k)(1) and (9), 9.1(d)(3) and (e) and 9.2(a) of the Pharmacy Act (63 P. S. § §  390-4(j), 390-6(k)(1) and (9), 390-9.1(d)(3) and (e) and 390-9.2(a)).

   The provisions of this §  27.301 adopted June 30, 2006, effective July 1, 2006, 36 Pa.B. 3237.

   This section cited in 49 Pa. Code §  27.32 (relating to continuing education).