SB 111-1_ Filed 01/29/2004, 08:23
The Senate Committee on Health and Provider Services, to which was referred Senate Bill No. 111,
has had the same under consideration and begs leave to report the same back to the Senate with the
recommendation that said bill be AMENDED as follows:
SOURCE: Page 1, line 1; (04)AM011101.1. -->
Page 1, delete lines 1 through 17, begin a new paragraph and insert:
SOURCE: IC 25-26-16.5; (04)AM011101.1. -->
"SECTION 1. IC 25-26-16.5 IS ADDED TO THE INDIANA CODE
AS A NEW
CHAPTER TO READ AS FOLLOWS [EFFECTIVE JULY
Chapter 16.5. Drug Regimens in Health Facilities
Sec. 1. This chapter applies to a health facility licensed under
Sec. 2. (a) As used in this chapter, "attending physician"
means a physician licensed under IC 25-22.5 who is responsible
for the ongoing health care of an individual who resides in a
(b) The medical director of a health facility to which the
individual is admitted may not serve as the individual's attending
physician unless the medical director meets the requirements set
forth in subsection (a).
Sec. 3. As used in this chapter, "protocol" means a policy,
procedure, or protocol of a health facility concerning the
adjustment of a patient's drug regimen as allowed under this
chapter by a pharmacist licensed under this article.
Sec. 4. As used in this chapter, "therapeutic alternative"
means a drug product that:
(1) has a different chemical structure from;
(2) is of the same pharmacological or therapeutic class as;
(3) usually can be expected to have similar therapeutic
effects and adverse reaction profiles when administered to
patients in therapeutically equivalent doses as;
Sec. 5. For purposes of this chapter, a pharmacist adjusts a
drug regimen if the pharmacist:
(1) changes the duration of treatment for a current drug
(2) adjusts a drug's strength, dosage form, frequency of
administration, or route of administration;
(3) discontinues the use of a drug; or
(4) adds a drug to the treatment regimen.
Sec. 6. At the time an individual is admitted to a health facility
that has adopted a protocol under this chapter, the individual's
attending physician shall signify in writing in the form and
manner prescribed by the health facility whether the protocol
applies in the care and treatment of the individual.
Sec. 7. (a) A pharmacist may adjust the drug therapy regimen
of the individual under:
(1) the written authorization of the individual's attending
physician under section 6 of this chapter;
(2) the health facility's protocols; and
(3) this chapter.
(b) The pharmacist shall review the appropriate medical records
of the individual to determine whether the attending physician has
authorized the use of a specific protocol before the pharmacist
adjusts the individual's drug therapy regimen.
(c) Notwithstanding subsection (a), if a protocol involves
parenteral nutrition of the patient, the pharmacist shall
communicate with the attending physician to receive approval to
begin the protocol. The pharmacist shall document the
authorization of the attending physician to use the protocol
immediately in the individual's medical record.
Sec. 8. If a health facility elects to implement, revise, or renew
a protocol under this chapter, the health facility shall establish a
drug regimen review committee consisting of:
(1) the health facility's medical director;
(2) the health facility's director of nursing; and
(3) a consulting pharmacist licensed under this article;
for the implementation, revision, or renewal of a protocol.
Sec. 9. Except for the addition or deletion of authorized
physicians and pharmacists, a modification to a written protocol
requires the initiation of a new protocol.
Sec. 10. (a) A protocol of a health facility developed under this
chapter must be:
(1) based on clinical considerations; and
(2) reviewed by the health facility's drug regimen committee
at least quarterly.
(b) A protocol of a health facility developed under this chapter
(1) prohibit the attending physician from approving only
specific parts of a protocol; or
(2) provide for an adjustment to an individual's drug regimen
for the sole purpose of achieving a higher reimbursement for
the substituted drug therapy than what would have been
received for the original drug therapy ordered by the
Sec. 11. A protocol developed under this chapter must include
(1) The identification of:
(A) the individual whose drug regimen may be adjusted;
(B) the attending physician who is delegating the authority
to adjust an individual's drug regimen; and
(C) the pharmacist who is authorized to adjust the
individual's drug regimen.
(2) The attending physician's diagnosis of the individual's:
(A) condition; or
(B) disease state;
whose drug regimen may be adjusted.
(3) A statement regarding:
(A) the types and:
(i) categories; or
(ii) therapeutic classifications;
of medication, including the specific therapeutic
alternatives that may be substituted for a drug prescribed
by a physician;
(B) the minimum and maximum dosage levels within the
(i) categories; or
(ii) therapeutic classifications;
of medications described in clause (A);
(C) the dosage forms;
(D) the frequency of administration;
(E) the route of administration;
(F) the duration of the administration of the drug regimen
and any adjustment to the drug regimen; and
(G) exceptions to the application of the drug regimen or
the adjustment to the drug regimen;
for which the pharmacist may adjust the individual's drug
(4) A requirement that:
(A) the individual's medical records be available to both
the individual's attending physician and the pharmacist;
(B) the procedures performed by the pharmacist relate to
a disease or condition for which the patient has been
under the attending physician's medical care.
Sec. 12. A protocol developed under this chapter that is
implemented for a Medicaid recipient must comply with any
statutes, regulations, and procedures under the state Medicaid
program relating to the preferred drug list established under
Sec. 13. If a protocol developed under this chapter allows a
pharmacist to substitute a therapeutic alternative for the drug
prescribed by the individual's attending physician, the attending
physician's authorization of the substitution is valid only for the
duration of the prescription or drug order.
Sec. 14. This chapter does not allow a pharmacist to substitute
a therapeutic alternative for the drug prescribed by the
individual's attending physician unless the substitution is
authorized by the attending physician under a valid protocol under
Sec. 15. The individual's attending physician:
(1) shall review a protocol approved for a patient of the
physician at least quarterly; and
(2) may at any time modify or cancel a protocol by entering
the modification or cancellation in the individual's medical
Sec. 16. (a) Documentation of protocols must be maintained in
a current, consistent, and readily retrievable manner.
(b) After making an adjustment to an individual's drug
regimen, the pharmacist shall notify the individual's attending
physician of the adjustment not later than one (1) business day
after the adjustment is made.
Sec. 17. (a) This chapter does not modify the requirements of
other statutes relating to the confidentiality of medical records.
(b) This chapter does not make any other licensed health care
provider liable for the actions of a pharmacist carried out under
Sec. 18. A pharmacist who violates this chapter is subject to
discipline under IC 25-1-9.
Delete pages 2 through 3.
(Reference is to SB 111 as introduced.)
and when so amended that said bill do pass .
Committee Vote: Yeas 9, Nays 0.
Senator Miller, Chairperson
AM 011101/DI 104 2004