CHAPTER 16.5. DRUG REGIMENS IN HEALTH FACILITIES
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 underIC 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 aphysician licensed under IC 25-22.5 who is responsible for theongoing health care of an individual who resides in a health facility.
(b) The medical director of a health facility to which theindividual is admitted may not serve as the individual's attendingphysician unless the medical director meets the requirements setforth 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 adjustmentof a patient's drug regimen as allowed under this chapter by apharmacist 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 adrug 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 effectsand adverse reaction profiles when administered to patients intherapeutically 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 drugregimen if the pharmacist:
(1) changes the duration of treatment for a current drug therapy;
(2) adjusts a drug's strength, dosage form, frequency ofadministration, 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 protocoladopted by a hospital applies to a specific patient
Sec. 6. At the time an individual is admitted to a health facilitythat has adopted a protocol under this chapter, the individual'sattending physician shall signify in writing in the form and mannerprescribed by the health facility whether the protocol applies in thecare 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 ofthe individual under:
(1) the written authorization of the individual's attendingphysician under section 6 of this chapter;
(2) the health facility's protocols; and
(3) this chapter.
(b) The pharmacist shall review the appropriate medical recordsof the individual to determine whether the attending physician hasauthorized the use of a specific protocol before the pharmacistadjusts the individual's drug therapy regimen.
(c) Notwithstanding subsection (a), if a protocol involvesparenteral nutrition of the patient, the pharmacist shall communicatewith the attending physician to receive approval to begin theprotocol. The pharmacist shall document the authorization of theattending physician to use the protocol immediately in theindividual'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 aprotocol under this chapter, the health facility shall establish a drugregimen 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 authorizedphysicians and pharmacists, a modification to a written protocolrequires 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 thischapter must be:
(1) based on clinical considerations; and
(2) reviewed by the health facility's drug regimen committee atleast quarterly.
(b) A protocol of a health facility developed under this chaptermay not:
(1) prohibit the attending physician from approving onlyspecific parts of a protocol; or
(2) provide for an adjustment to an individual's drug regimenfor the sole purpose of achieving a higher reimbursement for thesubstituted drug therapy than what would have been receivedfor 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 thefollowing:
(1) The identification of:
(A) the individual whose drug regimen may be adjusted;
(B) the attending physician who is delegating the authorityto adjust an individual's drug regimen; and
(C) the pharmacist who is authorized to adjust theindividual'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 alternativesthat may be substituted for a drug prescribed by a physician;
(B) the minimum and maximum dosage levels within thetypes 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 regimenand any adjustment to the drug regimen; and
(G) exceptions to the application of the drug regimen or theadjustment to the drug regimen;
for which the pharmacist may adjust the individual's drugregimen.
(4) A requirement that: (A) the individual's medical records be available to both theindividual's attending physician and the pharmacist; and
(B) the procedures performed by the pharmacist relate to adisease or condition for which the patient has been under theattending 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 isimplemented for a Medicaid recipient must comply with any statutes,regulations, and procedures under the state Medicaid programrelating 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 apharmacist to substitute a therapeutic alternative for the drugprescribed by the individual's attending physician, the attendingphysician's authorization of the substitution is valid only for theduration 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 atherapeutic alternative for the drug prescribed by the individual'sattending physician unless the substitution is authorized by theattending 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 apatient of the physician at the physician's next visit to the healthfacility, and at each subsequent visit of the physician to thehealth facility; and
(2) may at any time modify or cancel a protocol by entering themodification 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 acurrent, consistent, and readily retrievable manner.
(b) After making an adjustment to an individual's drug regimen,the pharmacist shall immediately document the adjustment in thepatient's medical record. (c) The pharmacist shall notify the individual's attendingphysician of an adjustment at least one (1) business day before theadjustment 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 ofother statutes relating to the confidentiality of medical records.
(b) This chapter does not make any other licensed health careprovider or pharmaceutical manufacturer liable for the actions of apharmacist carried out under this section.
(c) A physician who approves the use of a protocol under thischapter and a pharmacist who adjusts a drug regimen of a patientpursuant to a protocol under this chapter do not violateIC 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 todiscipline under IC 25-1-9.
As added by P.L.75-2004, SEC.3.