| (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)."
(iv) The pharmacy shall maintain and use adequate storage
or shipment containers and use shipping processes to ensure drug stability
and potency. Such shipping processes shall include the use of appropriate
packaging material and/or devices to ensure that the drug is maintained
at an appropriate temperature range to maintain the integrity of the
medication throughout the delivery process.
(v) The pharmacy shall use a delivery system which
is designed to ensure that the drugs are delivered to the appropriate
patient.
(G) The provisions of this paragraph do not apply to
patients in facilities where drugs are administered to patients by
a person required to do so by the laws of the state (i.e., nursing
homes).
(2) Pharmaceutical care services.
(A) Drug regimen review.
(i) For the purpose of promoting therapeutic appropriateness,
a pharmacist shall, prior to or at the time of dispensing a prescription
drug order, review the patient's medication record. Such review shall
at a minimum identify clinically significant:
(I) known allergies;
(II) rational therapy-contraindications;
(III) reasonable dose and route of administration;
(IV) reasonable directions for use;
(V) duplication of therapy;
(VI) drug-drug interactions;
(VII) drug-food interactions;
(VIII) drug-disease interactions;
(IX) adverse drug reactions; and
(X) proper utilization, including overutilization or
underutilization.
(ii) Upon identifying any clinically significant conditions,
situations, or items listed in clause (i) of this subparagraph, the
pharmacist shall take appropriate steps to avoid or resolve the problem
including consultation with the prescribing practitioner. The pharmacist
shall document such occurrences as specified in subparagraph (C) of
this paragraph.
(iii) The drug regimen review may be conducted by remotely
accessing the pharmacy's electronic database from outside the pharmacy
by:
(I) an individual Texas licensed pharmacist employee
of the pharmacy provided the pharmacy establishes controls to protect
the privacy of the patient and the security of confidential records;
or
(II) a pharmacist employed by a Class E pharmacy provided
the pharmacies have entered into a written contract or agreement which
outlines the services to be provided and the responsibilities and
accountabilities of each pharmacy in compliance with federal and state
laws and regulations.
(iv) Prior to dispensing, any questions regarding a
prescription drug order must be resolved with the prescriber and written
documentation of these discussions made and maintained as specified
in subparagraph (C) of this paragraph.
(B) Other pharmaceutical care services which may be
provided by pharmacists include, but are not limited to, the following:
(i) managing drug therapy as delegated by a practitioner
as allowed under the provisions of the Medical Practice Act;
(ii) administering immunizations and vaccinations under
written protocol of a physician;
(iii) managing patient compliance programs;
(iv) providing preventative health care services; and
(v) providing case management of patients who are being
treated with high-risk or high-cost drugs, or who are considered "high
risk" due to their age, medical condition, family history, or related
concern.
(C) Documentation of consultation. When a pharmacist
consults a prescriber as described in subparagraph (A) of this paragraph,
the pharmacist shall document on the prescription or in the pharmacy's
data processing system associated with the prescription such occurrences
and shall include the following information:
(i) date the prescriber was consulted;
(ii) name of the person communicating the prescriber's
instructions;
(iii) any applicable information pertaining to the
consultation; and
(iv) initials or identification code of the pharmacist
performing the consultation clearly recorded for the purpose of identifying
the pharmacist who performed the consultation.
(3) Substitution of generically equivalent drugs or
interchangeable biological products. A pharmacist may dispense a generically
equivalent drug or interchangeable biological product and shall comply
with the provisions of §309.3 of this title (relating to Substitution
Requirements).
(4) Substitution of dosage form.
Cont'd... |
