| (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 assure 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.
(A) As specified in §562.012 of the Act, a pharmacist
may dispense a dosage form of a drug product different from that prescribed,
such as a tablet instead of a capsule or liquid instead of tablets,
provided:
(i) the patient consents to the dosage form substitution;
and
(ii) the dosage form so dispensed:
(I) contains the identical amount of the active ingredients
as the dosage prescribed for the patient;
(II) is not an enteric-coated or time release product;
and
(III) does not alter desired clinical outcomes.
(B) Substitution of dosage form may not include the
substitution of a product that has been compounded by the pharmacist
unless the pharmacist contacts the practitioner prior to dispensing
and obtains permission to dispense the compounded product.
(5) Therapeutic Drug Interchange. A switch to a drug
providing a similar therapeutic response to the one prescribed shall
not be made without prior approval of the prescribing practitioner.
This paragraph does not apply to generic substitution. For generic
substitution, see the requirements of paragraph (3) of this subsection.
(A) The patient shall be notified of the therapeutic
drug interchange prior to, or upon delivery of, the dispensed prescription
to the patient. Such notification shall include:
(i) a description of the change;
(ii) the reason for the change;
(iii) whom to notify with questions concerning the
change; and
(iv) instructions for return of the drug if not wanted
by the patient.
(B) The pharmacy shall maintain documentation of patient
notification of therapeutic drug interchange which shall include:
(i) the date of the notification;
(ii) the method of notification;
(iii) a description of the change; and
(iv) the reason for the change.
(C) The provisions of this paragraph do not apply to
prescriptions for patients in facilities where drugs are administered
to patients by a person required to do so by the laws of this state
if the practitioner issuing the prescription has agreed to use of
a formulary that includes a listing of therapeutic interchanges that
the practitioner has agreed to allow. The pharmacy must maintain a
copy of the formulary including a list of the practitioners that have
agreed to the formulary and the signature of these practitioners.
(6) Prescription containers.
(A) A drug dispensed pursuant to a prescription drug
order shall be dispensed in a child-resistant container unless:
(i) the patient or the practitioner requests the prescription
not be dispensed in a child-resistant container; or
(ii) the product is exempted from requirements of the
Poison Prevention Packaging Act of 1970.
(B) A drug dispensed pursuant to a prescription drug
order shall be dispensed in an appropriate container as specified
on the manufacturer's container.
(C) Prescription containers or closures shall not be
re-used. However, if a patient or patient's agent has difficulty reading
or understanding a prescription label, a prescription container may
be reused provided:
(i) the container is designed to provide audio-recorded
information about the proper use of the prescription medication;
(ii) the container is reused for the same patient;
(iii) the container is cleaned; and
(iv) a new safety closure is used each time the prescription
container is reused.
(7) Labeling.
(A) At the time of delivery of the drug, the dispensing
container shall bear a label in plain language and printed in an easily
readable font size, unless otherwise specified, with at least the
following information:
(i) name, address and phone number of the pharmacy;
(ii) unique identification number of the prescription
that is printed in an easily readable font size comparable to but
no smaller than ten-point Times Roman;
(iii) date the prescription is dispensed;
(iv) initials or an identification code of the dispensing
pharmacist;
Cont'd... |
