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TITLE 22EXAMINING BOARDS
PART 15TEXAS STATE BOARD OF PHARMACY
CHAPTER 291PHARMACIES
SUBCHAPTER BCOMMUNITY PHARMACY (CLASS A)
RULE §291.33Operational Standards

      (i) The prescription department must be secured with procedures for entry during the time that a pharmacy is not under the continuous on-site supervision of a pharmacist and the pharmacy is not open for pharmacy services.

      (ii) Pharmacy technicians and pharmacy technician trainees may not perform any duties of a pharmacy technician or pharmacy technician trainee during the time that the pharmacist is off-site.

      (iii) A pharmacy may use an automated storage and distribution device as specified in subsection (i)(4) of this section for pick-up of a previously verified prescription by a patient or patient's agent.

      (iv) An agent of the pharmacist may deliver a previously verified prescription to a patient or patient's agent during short periods of time when a pharmacist is off-site, provided the following conditions are met:

        (I) short periods of time may not exceed two consecutive hours in a 24 hour period;

        (II) a notice is posted which includes the following information:

          (-a-) the pharmacist is off-site and not present in the pharmacy;

          (-b-) no new prescriptions may be prepared at the pharmacy but previously verified prescriptions may be delivered to the patient or the patient's agent; and

          (-c-) the date/time when the pharmacist will return;

        (III) the pharmacy must maintain documentation of the absences of the pharmacist(s); and

        (IV) the prescription department is locked and secured to prohibit unauthorized entry.

      (v) During the time a pharmacist is absent from the prescription department and is off-site, a record of prescriptions delivered must be maintained and contain the following information:

        (I) date and time of the delivery;

        (II) unique identification number of the prescription drug order;

        (III) patient's name;

        (IV) patient's phone number or the phone number of the person picking up the prescription; and

        (V) signature of the person picking up the prescription.

      (vi) Any prescription delivered to a patient when a pharmacist is not on-site at the pharmacy must meet the requirements for a prescription delivered to a patient as described in subsection (c)(1)(F) of this section.

(c) Prescription dispensing and delivery.

  (1) Patient counseling and provision of drug information.

    (A) To optimize drug therapy, a pharmacist shall communicate to the patient or the patient's agent information about the prescription drug or device which in the exercise of the pharmacist's professional judgment the pharmacist deems significant, such as the following:

      (i) name and description of the drug or device;

      (ii) dosage form, dosage, route of administration, and duration of drug therapy;

      (iii) special directions and precautions for preparation, administration, and use by the patient;

      (iv) common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;

      (v) techniques for self-monitoring of drug therapy;

      (vi) proper storage;

      (vii) refill information; and

      (viii) action to be taken in the event of a missed dose.

    (B) Such communication shall be:

      (i) provided to new and existing patients of a pharmacy with each new prescription drug order. A new prescription drug order is one that has not been dispensed by the pharmacy to the patient in the same dosage and strength within the last year;

      (ii) provided for any prescription drug order dispensed by the pharmacy on the request of the patient or patient's agent;

      (iii) communicated orally in person unless the patient or patient's agent is not at the pharmacy or a specific communication barrier prohibits such oral communication;

      (iv) documented by recording the initials or identification code of the pharmacist providing the counseling in the prescription dispensing record as follows:

        (I) on the original hard-copy prescription, provided the counseling pharmacist clearly records his or her initials on the prescription for the purpose of identifying who provided the counseling;

        (II) in the pharmacy's data processing system;

        (III) in an electronic logbook; or

        (IV) in a hard-copy log; and

      (v) reinforced with written information relevant to the prescription and provided to the patient or patient's agent. The following is applicable concerning this written information:

        (I) Written information must be in plain language designed for the patient and printed in an easily readable font size comparable to but no smaller than ten-point Times Roman. This information may be provided to the patient in an electronic format, such as by e-mail, if the patient or patient's agent requests the information in an electronic format and the pharmacy documents the request.

        (II) When a compounded preparation is dispensed, information shall be provided for the major active ingredient(s), if available.

        (III) For new drug entities, if no written information is initially available, the pharmacist is not required to provide information until such information is available, provided:

          (-a-) the pharmacist informs the patient or the patient's agent that the product is a new drug entity and written information is not available;

          (-b-) the pharmacist documents the fact that no written information was provided; and

          (-c-) if the prescription is refilled after written information is available, such information is provided to the patient or patient's agent.

        (IV) The written information accompanying the prescription or the prescription label shall contain the statement "Do not flush unused medications or pour down a sink or drain." A drug product on a list developed by the Federal Food and Drug Administration of medicines recommended for disposal by flushing is not required to bear this statement.

    (C) Only a pharmacist may verbally provide drug information to a patient or patient's agent and answer questions concerning prescription drugs. Non-pharmacist personnel and/or the pharmacy's computer system may not ask questions of a patient or patient's agent which are intended to screen and/or limit interaction with the pharmacist.

    (D) Nothing in this subparagraph shall be construed as requiring a pharmacist to provide consultation when a patient or patient's agent refuses such consultation. The pharmacist shall document such refusal for consultation.

    (E) In addition to the requirements of subparagraphs (A) - (D) of this paragraph, if a prescription drug order is delivered to the patient at the pharmacy, the following is applicable:

      (i) So that a patient will have access to information concerning his or her prescription, a prescription may not be delivered to a patient unless a pharmacist is in the pharmacy, except as provided in subsection (b)(3) of this section.

      (ii) Any prescription delivered to a patient when a pharmacist is not in the pharmacy must meet the requirements described in subparagraph (F) of this paragraph.

    (F) In addition to the requirements of subparagraphs (A) - (D) of this paragraph, if a prescription drug order is delivered to the patient or his or her agent at the patient's residence or other designated location, the following is applicable:

      (i) The information as specified in subparagraph (A) of this paragraph shall be delivered with the dispensed prescription in writing.

      (ii) If prescriptions are routinely delivered outside the area covered by the pharmacy's local telephone service, the pharmacy shall provide a toll-free telephone line which is answered during normal business hours to enable communication between the patient and a pharmacist.

      (iii) The pharmacist shall place on the prescription container or on a separate sheet delivered with the prescription container in both English and Spanish the local and, if applicable, toll-free telephone number of the pharmacy and the statement: "Written information about this prescription has been provided for you. Please read this information before you take the medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions at (insert the pharmacy's local and toll-free telephone numbers)."

Cont'd...

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