856 IAC 1-33-2 - Patient counseling requirements
Authority: IC 25-26-13-4
Affected: IC 25-26-13-16
Sec. 2.
(a) Upon the
receipt of a prescription or upon the subsequent refilling of a prescription,
and following a review of the patient's prescription medication profile, the
pharmacist shall be responsible for the initiation of an offer, as set forth in
section 1.5(a) of this rule, to counsel the patient on matters that, in the
pharmacist's professional judgment, are significant to optimizing drug therapy.
Depending upon the situation, these matters may include, but are not
necessarily limited to, the following:
(1) The
name and description of the medicine.
(2) The route, dosage form, dosage, route of
administration, and duration of drug therapy.
(3) Special directions and
precautions.
(4) Common adverse
effects or interactions and therapeutic contraindications that may be
encountered, including their avoidance and the action required if they
occur.
(5) Techniques for
self-monitoring drug therapy.
(6)
Proper storage.
(7) Prescription
refill information.
(8) Action to
be taken in the event of a missed dose.
(b) Counseling shall be in person, whenever
practicable, or through access to a telephone service that is toll-free for
long distance calls and be held with the patient, the patient's caregiver, or
the patient's representative.
(c)
Alternative forms of patient information may be used to supplement verbal
counseling when appropriate. Examples include written information leaflets,
pictogram labels, and video programs. Nothing in this subsection shall be
construed to mean that supplements may be a substitute for verbal counseling
when verbal counseling is practicable.
(d) Nothing in this rule shall be construed
as requiring a pharmacist to provide counseling when a patient knowingly
declines (waives) the offer to counsel.
(e) Requesting or accepting, or both, a
waiver for counseling for all prescriptions both present and future is not
permitted. An offer must be made with each prescription-dispensing
visit.
(f) The patient's declining
of counseling must be documented in either written or electronic format. The
required documentation may be on the same form as or with another
pharmacy-related authorization, only if it is clear to the patient that the
documentation form also contains the patient's intent to decline (waive)
counseling. The documentation subject to this section shall be retained in the
pharmacy licensed area or in a secure area under the pharmacy's control, which
is readily available for inspection, for a period of not less than two (2)
years.
Notes
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