(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)."
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