| (vi) drug-allergy interactions; and
(vii) clinical abuse/misuse.
(B) Upon identifying any clinically significant conditions,
situations, or items listed in subparagraph (A) of this paragraph,
the pharmacist shall take appropriate steps to avoid or resolve the
problem including consultation with the prescribing practitioner.
The pharmacist shall document such occurrences.
(3) 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) the 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; and
(iv) reinforced with written information. 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 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 product 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 orally provide drug information
to a patient or patient's agent and answer questions concerning prescription
drugs. Non-pharmacist personnel may not ask questions of a patient
or patient's agent which are intended to screen and/or limit interaction
with the pharmacist.
(D) 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.
(E) 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 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)."
(F) 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).
(G) Upon delivery of a refill prescription, a pharmacist
shall ensure that the patient or patient's agent is offered information
about the refilled prescription and that a pharmacist is available
to discuss the patient's prescription and provide information.
(H) 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.
(4) Labeling. At the time of delivery, the dispensing
container shall bear a label that contains the following information:
(A) the name, physical address, and phone number of
the pharmacy;
(B) if the drug is dispensed in a container other than
the manufacturer's original container, the date after which the prescription
should not be used or beyond-use-date. Unless otherwise specified
by the manufacturer, the beyond-use-date shall be one year from the
date the drug is dispensed or the manufacturer's expiration date,
whichever is earlier. The beyond-use-date may be placed on the prescription
label or on a flag label attached to the bottle. A beyond-use-date
is not required on the label of a prescription dispensed to a person
at the time of release from prison or jail if the prescription is
for not more than a 10-day supply of medication;
(C) either on the prescription label or the written
information accompanying the prescription, 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; and
(D) any other information that is required by the pharmacy
or drug laws or rules in the state in which the pharmacy is located.
(c) Substitution requirements.
(1) Unless compliance would violate the pharmacy or
drug laws or rules in the state in which the pharmacy is located a
pharmacist in a Class E pharmacy 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) and §309.7 of this title (relating to Dispensing
Responsibilities).
(2) The pharmacy must include on the prescription order
form completed by the patient or the patient's agent information that
clearly and conspicuously:
(A) states that if a less expensive generically equivalent
drug or interchangeable biological product is available for the brand
prescribed, the patient or the patient's agent may choose between
the generically equivalent drug or interchangeable biological product
and the brand prescribed; and
(B) allows the patient or the patient's agent to indicate
the choice of the generically equivalent drug or interchangeable biological
product or the brand prescribed.
(d) 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 subsection does not apply to generic substitution. For generic
substitution, see the requirements of subsection (c) of this section.
(1) 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:
(A) a description of the change;
(B) the reason for the change;
(C) whom to notify with questions concerning the change;
and
(D) instructions for return of the drug if not wanted
by the patient.
(2) The pharmacy shall maintain documentation of patient
notification of therapeutic drug interchange which shall include:
(A) the date of the notification;
(B) the method of notification;
(C) a description of the change; and
Cont'd... |
