SOURCE: IC 25-26-13-2; (07)HE1468.1.1. -->
SECTION 1. IC 25-26-13-2, AS AMENDED BY P.L.98-2006,
SECTION 2, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2007]: Sec. 2. As used in this chapter:
"Administering" means the direct application of a drug to the
body of a person by injection, inhalation, ingestion, or any other
means.
"Board" means the Indiana board of pharmacy.
"Controlled drugs" are those drugs on schedules I through V of the
Federal Controlled Substances Act or on schedules I through V of
IC 35-48-2.
"Counseling" means effective communication between a pharmacist
and a patient concerning the contents, drug to drug interactions, route,
dosage, form, directions for use, precautions, and effective use of a
drug or device to improve the therapeutic outcome of the patient
through the effective use of the drug or device.
"Dispensing" means issuing one (1) or more doses of a drug in a
suitable container with appropriate labeling for subsequent
administration to or use by a patient.
"Drug" means:
(1) articles or substances recognized in the official United States
Pharmacopoeia, official National Formulary, official
Homeopathic Pharmacopoeia of the United States, or any
supplement to any of them;
(2) articles or substances intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man or animals;
(3) articles other than food intended to affect the structure or any
function of the body of man or animals; or
(4) articles intended for use as a component of any article
specified in subdivisions (1) through (3) and devices.
"Drug order" means a written order in a hospital or other health care
institution for an ultimate user for any drug or device, issued and
signed by a practitioner, or an order transmitted by other means of
communication from a practitioner, which is immediately reduced to
writing by the pharmacist, registered nurse, or other licensed health
care practitioner authorized by the hospital or institution. The order
shall contain the name and bed number of the patient; the name and
strength or size of the drug or device; unless specified by individual
institution policy or guideline, the amount to be dispensed either in
quantity or days; adequate directions for the proper use of the drug or
device when it is administered to the patient; and the name of the
prescriber.
"Drug regimen review" means the retrospective, concurrent, and
prospective review by a pharmacist of a patient's drug related history
that includes the following areas:
(1) Evaluation of prescriptions or drug orders and patient records
for drug allergies, rational therapy contradictions, appropriate
dose and route of administration, appropriate directions for use,
or duplicative therapies.
(2) Evaluation of prescriptions or drug orders and patient records
for drug-drug, drug-food, drug-disease, and drug-clinical
laboratory interactions.
(3) Evaluation of prescriptions or drug orders and patient records
for adverse drug reactions.
(4) Evaluation of prescriptions or drug orders and patient records
for proper utilization and optimal therapeutic outcomes.
"Drug utilization review" means a program designed to measure and
assess on a retrospective and prospective basis the proper use of drugs.
"Device" means an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related article
including any component part or accessory, which is:
(1) recognized in the official United States Pharmacopoeia,
official National Formulary, or any supplement to them;
(2) intended for use in the diagnosis of disease or other conditions
or the cure, mitigation, treatment, or prevention of disease in man
or other animals; or
(3) intended to affect the structure or any function of the body of
man or other animals and which does not achieve any of its
principal intended purposes through chemical action within or on
the body of man or other animals and which is not dependent
upon being metabolized for the achievement of any of its
principal intended purposes.
"Electronic data intermediary" means an entity that provides the
infrastructure that connects a computer system or another electronic
device used by a prescribing practitioner with a computer system or
another electronic device used by a pharmacy to facilitate the secure
transmission of:
(1) an electronic prescription order;
(2) a refill authorization request;
(3) a communication; and
(4) other patient care information;
between a practitioner and a pharmacy.
"Electronic signature" means an electronic sound, symbol, or
process:
(1) attached to or logically associated with a record; and
(2) executed or adopted by a person;
with the intent to sign the record.
"Electronically transmitted" or "electronic transmission" means the
transmission of a prescription in electronic form. The term does not
include the transmission of a prescription by facsimile.
"Investigational or new drug" means any drug which is limited by
state or federal law to use under professional supervision of a
practitioner authorized by law to prescribe or administer such drug.
"Legend drug" has the meaning set forth in IC 16-18-2-199.
"License" and "permit" are interchangeable and mean a written
certificate from the Indiana board of pharmacy for the practice of
pharmacy or the operation of a pharmacy.
"Nonprescription drug" means a drug that may be sold without a
prescription and that is labeled for use by a patient in accordance with
state and federal laws.
"Person" means any individual, partnership, copartnership, firm,
company, corporation, association, joint stock company, trust, estate,
or municipality, or a legal representative or agent, unless this chapter
expressly provides otherwise.
"Practitioner" has the meaning set forth in IC 16-42-19-5.
"Pharmacist" means a person licensed under this chapter.
"Pharmacist intern" means a person who is:
(1) permitted by the board to engage in the practice of pharmacy
while under the personal supervision of a pharmacist and who is
satisfactorily progressing toward meeting the requirements for
licensure as a pharmacist;
(2) a graduate of an approved college of pharmacy or a graduate
who has established educational equivalency by obtaining a
Foreign Pharmacy Graduate Examination Committee Certificate
and who is permitted by the board to obtain practical experience
as a requirement for licensure as a pharmacist;
(3) a qualified applicant awaiting examination for licensure; or
(4) an individual participating in a residency or fellowship
program.
"Pharmacy" means any facility, department, or other place where
prescriptions are filled or compounded and are sold, dispensed, offered,
or displayed for sale and which has as its principal purpose the
dispensing of drug and health supplies intended for the general health,
welfare, and safety of the public, without placing any other activity on
a more important level than the practice of pharmacy.
"The practice of pharmacy" or "the practice of the profession of
pharmacy" means a patient oriented health care profession in which
pharmacists interact with and counsel patients and with other health
care professionals concerning drugs and devices used to enhance
patients' wellness, prevent illness, and optimize the outcome of a drug
or device, by accepting responsibility for performing or supervising a
pharmacist intern or an unlicensed person under section 18(a)(4) of this
chapter to do the following acts, services, and operations:
(1) The offering of or performing of those acts, service operations,
or transactions incidental to the interpretation, evaluation, and
implementation of prescriptions or drug orders.
(2) The compounding, labeling, administering, dispensing, or
selling of drugs and devices, including radioactive substances,
whether dispensed under a practitioner's prescription or drug
order or sold or given directly to the ultimate consumer.
(3) The proper and safe storage and distribution of drugs and
devices.
(4) The maintenance of proper records of the receipt, storage,
sale, and dispensing of drugs and devices.
(5) Counseling, advising, and educating patients, patients'
caregivers, and health care providers and professionals, as
necessary, as to the contents, therapeutic values, uses, significant
problems, risks, and appropriate manner of use of drugs and
devices.
(6) Assessing, recording, and reporting events related to the use
of drugs or devices.
(7) Provision of the professional acts, professional decisions, and
professional services necessary to maintain all areas of a patient's
pharmacy related care as specifically authorized to a pharmacist
under this article.
"Prescription" means a written order or an order transmitted by other
means of communication from a practitioner to or for an ultimate user
for any drug or device containing:
(1) the name and address of the patient;
(2) the date of issue;
(3) the name and strength or size (if applicable) of the drug or
device;
(4) the amount to be dispensed (unless indicated by directions and
duration of therapy);
(5) adequate directions for the proper use of the drug or device by
the patient;
(6) the name of the practitioner; and
(7) if the prescription:
(A) is in written form, the signature of the practitioner; or
(B) is in electronic form, the electronic signature of the
practitioner.
"Qualifying pharmacist" means the pharmacist who will qualify the
pharmacy by being responsible to the board for the legal operations of
the pharmacy under the permit.
"Record" means all papers, letters, memoranda, notes, prescriptions,
drug orders, invoices, statements, patient medication charts or files,
computerized records, or other written indicia, documents, or objects
which are used in any way in connection with the purchase, sale, or
handling of any drug or device.
"Sale" means every sale and includes:
(1) manufacturing, processing, transporting, handling, packaging,
or any other production, preparation, or repackaging;
(2) exposure, offer, or any other proffer;
(3) holding, storing, or any other possession;
(4) dispensing, giving, delivering, or any other supplying; and
(5) applying, administering, or any other using.
SOURCE: IC 25-26-13-31.2; (07)HE1468.1.2. -->
SECTION 2. IC 25-26-13-31.2 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2007]: Sec. 31.2. (a) A pharmacist may
administer an immunization to an individual under a drug order
or prescription.
(b) A pharmacist may administer an immunization for influenza
to a group of individuals under a drug order, under a prescription,
or according to a protocol approved by a physician if the following
requirements are met:
(1) The physician specifies in the drug order, prescription, or
protocol the group of individuals to whom the immunization
may be administered.
(2) The physician who writes the drug order, prescription, or
protocol is licensed in Indiana and not employed by a
pharmacy.
(3) The pharmacist who administers the immunization is
responsible for notifying, not later than fourteen (14) days
after the pharmacist administers the immunization, the
physician who authorized the immunization and the
individual's primary care physician that the individual
received the immunization.
(4) If the physician uses a protocol, the protocol may apply
only to an individual or group of individuals who are at least:
(A) fourteen (14) years of age but less than eighteen (18)
years of age, if the pharmacist receives the consent of a
parent or legal guardian, and the parent or legal guardian
is present at the time of immunization; or
(B) eighteen (18) years of age.
(c) If the state department of health or the department of
homeland security determines that an emergency exists, a
pharmacist may administer any immunization in accordance with:
(1) the requirements of subsection (b)(1) through (b)(3); and
(2) any instructions in the emergency determination.
SOURCE: ; (07)HE1468.1.3. -->
SECTION 3. [EFFECTIVE UPON PASSAGE] (a) As used in this
SECTION, "state department" refers to the state department of
health established by IC 16-19-1-1.
(b) The state department shall, in consultation with health care
providers, evaluate the current immunization data registry system
under IC 16-38-5 and determine ways to make the registry easier
for health care providers to report to and use.
(c) Not later than November 1, 2008, the state department shall
orally report to the health finance commission established by
IC 2-5-23-3 concerning the state department's progress under this
SECTION. The report must include any recommendations of the
state department to make the immunization data registry easier for
health care providers to report to and use.
(d) This SECTION expires December 31, 2008.
SOURCE: ; (07)HE1468.1.4. -->
SECTION 4. [EFFECTIVE UPON PASSAGE] (a) As used in this
SECTION, "board" refers to the Indiana board of pharmacy
created by IC 25-26-13-3.
(b) The board shall study and make findings on the issue of the
application of technology in the dispensing of drugs, including the
reliance on bar code technology in long term care pharmacies. The
study must include the review of the use of pharmacy technicians
when using bar code technology.
(c) Not later than November 1, 2007, the board shall report to
the health finance commission established by IC 2-5-23-3 and the
legislative council regarding the board's findings under this
SECTION. The report to the legislative council must be in an
electronic format under IC 5-14-6.
(d) This SECTION expires December 31, 2008.
SOURCE: ; (07)HE1468.1.5. -->
SECTION 5. [EFFECTIVE JULY 1, 2007] (a) Before January 1,
2008, the Indiana board of pharmacy, in consultation with the
medical licensing board of Indiana, shall adopt rules under
IC 4-22-2 concerning the qualifications, protocols, and record
keeping requirements for a pharmacist to administer
immunizations under IC 25-26-13-31.2, as added by this act. The
rules must include the following requirements:
(1) The pharmacist must have completed an accredited
training program.
(2) The pharmacist must be certified in cardiopulmonary
resuscitation (CPR).
(3) The pharmacist must be prohibited from delegating the
administration of the immunization to another person.
(4) The pharmacist must report adverse events.
(5) The pharmacist may report the immunization of each
individual to the immunization data registry maintained by
the state department under IC 16-38-5.
(6) A pharmacist may not be required to administer an
immunization or complete the accredited training program if
the pharmacist chooses not to administer any immunization.
(b) This SECTION expires July 1, 2008.