IC 25-26-16.5
Chapter 16.5. Drug Regimens in Health Facilities
IC 25-26-16.5-1 Application
Sec. 1. This chapter applies to a health facility licensed under
IC 16-28. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-2 "Attending physician"
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 health facility.
(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). As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-3 "Protocol"
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. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-4 "Therapeutic alternative"
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; and
(3) usually can be expected to have similar therapeutic effects
and adverse reaction profiles when administered to patients in
therapeutically equivalent doses as;
another drug. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-5 Adjustment of a drug regimen by a pharmacist
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 therapy;
(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. As added by P.L.75-2004, SEC.3. IC 25-26-16.5-6 Attending physician's duty to determine whether a protocol
adopted by a hospital applies to a specific patient
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. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-7 Authority of a pharmacist to adjust a drug regimen
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. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-8 Drug regimen review committee
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. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-9 Modification of written protocol requires new protocol; exception
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. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-10 Basis and review of 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
may not:
(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 attending physician. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-11 Required elements of a protocol
Sec. 11. A protocol developed under this chapter must include the
following:
(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
types and:
(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
regimen.
(4) A requirement that:
(A) the individual's medical records be available to both the
individual's attending physician and the pharmacist; and
(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. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-12 Protocol must comply with certain Medicaid requirements
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 IC 12-15-35-28. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-13 Duration of authorization of therapeutic alternative
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. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-14 Unauthorized therapeutic alternatives prohibited
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 this chapter. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-15 Attending physician's duty to review an implemented protocol
Sec. 15. The individual's attending physician:
(1) shall review a protocol approved and implemented for a
patient of the physician at the physician's next visit to the health
facility, and at each subsequent visit of the physician to the
health facility; and
(2) may at any time modify or cancel a protocol by entering the
modification or cancellation in the individual's medical record. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-16 Protocol documentation required
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 immediately document the adjustment in the
patient's medical record.
(c) The pharmacist shall notify the individual's attending
physician of an adjustment at least one (1) business day before the
adjustment is made. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-17 Confidentiality; liability
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 or pharmaceutical manufacturer liable for the actions of a
pharmacist carried out under this section.
(c) A physician who approves the use of a protocol under this
chapter and a pharmacist who adjusts a drug regimen of a patient
pursuant to a protocol under this chapter do not violate
IC 25-22.5-1-2(d). As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-18 Pharmacist subject to discipline for violations
Sec. 18. A pharmacist who violates this chapter is subject to
discipline under IC 25-1-9. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5
Chapter 16.5. Drug Regimens in Health Facilities
IC 25-26-16.5-1 Application
Sec. 1. This chapter applies to a health facility licensed under
IC 16-28. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-2 "Attending physician"
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 health facility.
(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). As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-3 "Protocol"
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. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-4 "Therapeutic alternative"
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; and
(3) usually can be expected to have similar therapeutic effects
and adverse reaction profiles when administered to patients in
therapeutically equivalent doses as;
another drug. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-5 Adjustment of a drug regimen by a pharmacist
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 therapy;
(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. As added by P.L.75-2004, SEC.3. IC 25-26-16.5-6 Attending physician's duty to determine whether a protocol
adopted by a hospital applies to a specific patient
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. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-7 Authority of a pharmacist to adjust a drug regimen
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. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-8 Drug regimen review committee
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. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-9 Modification of written protocol requires new protocol; exception
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. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-10 Basis and review of 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
may not:
(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 attending physician. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-11 Required elements of a protocol
Sec. 11. A protocol developed under this chapter must include the
following:
(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
types and:
(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
regimen.
(4) A requirement that:
(A) the individual's medical records be available to both the
individual's attending physician and the pharmacist; and
(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. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-12 Protocol must comply with certain Medicaid requirements
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 IC 12-15-35-28. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-13 Duration of authorization of therapeutic alternative
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. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-14 Unauthorized therapeutic alternatives prohibited
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 this chapter. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-15 Attending physician's duty to review an implemented protocol
Sec. 15. The individual's attending physician:
(1) shall review a protocol approved and implemented for a
patient of the physician at the physician's next visit to the health
facility, and at each subsequent visit of the physician to the
health facility; and
(2) may at any time modify or cancel a protocol by entering the
modification or cancellation in the individual's medical record. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-16 Protocol documentation required
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 immediately document the adjustment in the
patient's medical record.
(c) The pharmacist shall notify the individual's attending
physician of an adjustment at least one (1) business day before the
adjustment is made. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-17 Confidentiality; liability
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 or pharmaceutical manufacturer liable for the actions of a
pharmacist carried out under this section.
(c) A physician who approves the use of a protocol under this
chapter and a pharmacist who adjusts a drug regimen of a patient
pursuant to a protocol under this chapter do not violate
IC 25-22.5-1-2(d). As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-18 Pharmacist subject to discipline for violations
Sec. 18. A pharmacist who violates this chapter is subject to
discipline under IC 25-1-9. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5
Chapter 16.5. Drug Regimens in Health Facilities
IC 25-26-16.5-1 Application
Sec. 1. This chapter applies to a health facility licensed under
IC 16-28. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-2 "Attending physician"
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 health facility.
(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). As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-3 "Protocol"
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. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-4 "Therapeutic alternative"
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; and
(3) usually can be expected to have similar therapeutic effects
and adverse reaction profiles when administered to patients in
therapeutically equivalent doses as;
another drug. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-5 Adjustment of a drug regimen by a pharmacist
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 therapy;
(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. As added by P.L.75-2004, SEC.3. IC 25-26-16.5-6 Attending physician's duty to determine whether a protocol
adopted by a hospital applies to a specific patient
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. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-7 Authority of a pharmacist to adjust a drug regimen
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. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-8 Drug regimen review committee
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. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-9 Modification of written protocol requires new protocol; exception
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. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-10 Basis and review of 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
may not:
(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 attending physician. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-11 Required elements of a protocol
Sec. 11. A protocol developed under this chapter must include the
following:
(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
types and:
(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
regimen.
(4) A requirement that:
(A) the individual's medical records be available to both the
individual's attending physician and the pharmacist; and
(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. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-12 Protocol must comply with certain Medicaid requirements
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 IC 12-15-35-28. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-13 Duration of authorization of therapeutic alternative
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. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-14 Unauthorized therapeutic alternatives prohibited
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 this chapter. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-15 Attending physician's duty to review an implemented protocol
Sec. 15. The individual's attending physician:
(1) shall review a protocol approved and implemented for a
patient of the physician at the physician's next visit to the health
facility, and at each subsequent visit of the physician to the
health facility; and
(2) may at any time modify or cancel a protocol by entering the
modification or cancellation in the individual's medical record. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-16 Protocol documentation required
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 immediately document the adjustment in the
patient's medical record.
(c) The pharmacist shall notify the individual's attending
physician of an adjustment at least one (1) business day before the
adjustment is made. As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-17 Confidentiality; liability
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 or pharmaceutical manufacturer liable for the actions of a
pharmacist carried out under this section.
(c) A physician who approves the use of a protocol under this
chapter and a pharmacist who adjusts a drug regimen of a patient
pursuant to a protocol under this chapter do not violate
IC 25-22.5-1-2(d). As added by P.L.75-2004, SEC.3.
IC 25-26-16.5-18 Pharmacist subject to discipline for violations
Sec. 18. A pharmacist who violates this chapter is subject to
discipline under IC 25-1-9. As added by P.L.75-2004, SEC.3.
