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IC 35-48-7-1
"Advisory committee" defined
Sec. 1. As used in this chapter, "advisory committee" refers to the
controlled substances advisory committee established by
IC 35-48-2-1.
As added by P.L.163-1994, SEC.5.
IC 35-48-7-2
Repealed
(Repealed by P.L.65-2006, SEC.18.)
IC 35-48-7-2.9
"Dispense" defined
Effective 1-1-2009.
Sec. 2.9. (a) As used in this chapter, "dispense" has the meaning
set forth in IC 35-48-1-12.
(b) The term does not apply to the following:
(1) A drug administered directly to a patient.
(2) A drug dispensed by a practitioner, if the quantity dispensed
is not more than a seventy-two (72) hour supply of a controlled
substance listed in schedule II, III, IV, or V as set forth in
IC 35-48-3-9.
As added by P.L.105-2008, SEC.65.
IC 35-48-7-3 Version a
"Dispenser" defined
Note: This version of section effective until 1-1-2009. See also
following repeal of this section, effective 1-1-2009.
Sec. 3. As used in this chapter, "dispenser" has the meaning set
forth in IC 35-48-1-13. However, the term does not include the
following:
(1) A Type II pharmacy (as defined in IC 25-26-13-17) operated
by a hospital licensed under IC 16-21.
(2) A nurse registered or licensed under IC 25-23 or a
medication aide who administers a controlled substance at the
direction of a physician licensed under IC 25-22.5.
(3) A person who administers or dispenses a controlled
substance ordered for a bona fide patient in a facility licensed
under IC 16-28.
(4) A pharmacy licensed under IC 25-26-13 when it dispenses
prescriptions ordered for bona fide enrolled patients in facilities
licensed under IC 16-28.
(5) A practitioner who dispenses not more than a forty-eight
(48) hour supply of a controlled substance listed in either
schedule II, III, or IV as set forth in IC 35-48-3-9.
As added by P.L.163-1994, SEC.5.
IC 35-48-7-4
"Exception report" defined
Sec. 4. As used in this chapter, "exception report" means a record
of data concerning:
(1) a practitioner practicing a particular specialty or field of
health care;
(2) a dispenser doing business in a particular location; or
(3) a recipient;
that indicates dispensing or receiving of controlled substances
outside norms for dispensing or receiving controlled substances
established by the advisory committee under this chapter.
As added by P.L.163-1994, SEC.5.
IC 35-48-7-5
"Identification number" defined
Sec. 5. As used in this chapter, "identification number" refers to
the following:
(1) The unique number contained on any of the following:
(A) A valid driver's license of a recipient or a recipient's
representative issued under Indiana law or the law of any
other state.
(B) A recipient's or a recipient representative's valid military
identification card.
(C) A valid identification card of a recipient or a recipient's
representative issued by:
(i) the bureau of motor vehicles as described in
IC 9-24-16-3; or
(ii) any other state and that is similar to the identification
card issued by the bureau of motor vehicles.
(D) If the recipient is an animal:
(i) the valid driver's license issued under Indiana law or
the law of any other state;
(ii) the valid military identification card; or
(iii) the valid identification card issued by the bureau of
motor vehicles and described in IC 9-24-16-3 or a valid
identification card of similar description that is issued by
any other state;
of the animal's owner.
(2) The identification number or phrase designated by the
central repository.
As added by P.L.163-1994, SEC.5. Amended by P.L.204-2005,
SEC.22.
IC 35-48-7-5.4
"Interoperability" defined
Sec. 5.4. As used in this chapter, "interoperability" refers to the
INSPECT program electronically sharing reported information with
another state concerning the dispensing of a controlled substance:
(1) to a recipient who resides in the other state; or
(2) prescribed by a practitioner whose principal place of
business is located in another state.
As added by P.L.65-2006, SEC.4.
IC 35-48-7-5.6
"Patient" defined
Sec. 5.6. As used in this chapter, "patient" means an individual
who has requested or received health care services from a provider
for the examination, treatment, diagnosis, or prevention of a physical
or mental condition.
As added by P.L.65-2006, SEC.5.
IC 35-48-7-5.8
"Practitioner" defined
Sec. 5.8. As used in this chapter, "practitioner" means a physician,
dentist, veterinarian, podiatrist, nurse practitioner, scientific
investigator, pharmacist, hospital, or other institution or individual
licensed, registered, or otherwise permitted to distribute, dispense,
conduct research with respect to, or administer a controlled
substance in the course of professional practice or research in the
United States.
As added by P.L.65-2006, SEC.6.
IC 35-48-7-6
"Recipient" defined
Sec. 6. As used in this chapter, "recipient" means an individual for
whom a controlled substance is dispensed.
As added by P.L.163-1994, SEC.5.
IC 35-48-7-7
"Recipient representative" defined
Sec. 7. As used in this chapter, "recipient representative" means
the individual to whom a controlled substance is dispensed if the
recipient is either less than eighteen (18) years of age or unavailable
to receive the controlled substance.
As added by P.L.163-1994, SEC.5.
IC 35-48-7-8
Repealed
(Repealed by P.L.3-2008, SEC.269.)
IC 35-48-7-8.1
Controlled substance prescription monitoring program;
information; prescription forms
Sec. 8.1. (a) This section applies after June 30, 2007.
(b) The advisory committee shall provide for a controlled
substance prescription monitoring program that includes the
following components:
(1) Each time a controlled substance designated by the advisory
committee under IC 35-48-2-5 through IC 35-48-2-10 is
dispensed, the dispenser shall transmit to the INSPECT
program the following information:
(A) The controlled substance recipient's name.
(B) The controlled substance recipient's or the recipient
representative's identification number or the identification
number or phrase designated by the INSPECT program.
(C) The controlled substance recipient's date of birth.
(D) The national drug code number of the controlled
substance dispensed.
(E) The date the controlled substance is dispensed.
(F) The quantity of the controlled substance dispensed.
(G) The number of days of supply dispensed.
(H) The dispenser's United States Drug Enforcement Agency
registration number.
(I) The prescriber's United States Drug Enforcement Agency
registration number.
(J) An indication as to whether the prescription was
transmitted to the pharmacist orally or in writing.
(K) Other data required by the advisory committee.
(2) The information required to be transmitted under this
section must be transmitted not more than seven (7) days after
the date on which a controlled substance is dispensed.
(3) A dispenser shall transmit the information required under
this section by:
(A) uploading to the INSPECT web site;
(B) a computer diskette; or
(C) a CD-ROM disk;
that meets specifications prescribed by the advisory committee.
(4) The advisory committee may require that prescriptions for
controlled substances be written on a one (1) part form that
cannot be duplicated. However, the advisory committee may not
apply such a requirement to prescriptions filled at a pharmacy
with a Type II permit (as described in IC 25-26-13-17) and
operated by a hospital licensed under IC 16-21, or prescriptions
ordered for and dispensed to bona fide enrolled patients in
facilities licensed under IC 16-28. The committee may not
require multiple copy prescription forms and serially numbered
prescription forms for any prescriptions written. The advisory
committee may not require different prescription forms for any
individual drug or group of drugs. Prescription forms required
under this subdivision must be jointly approved by the
committee and by the Indiana board of pharmacy established by
IC 25-26-13-3.
(5) The costs of the program.
As added by P.L.65-2006, SEC.9.
IC 35-48-7-9
Repealed
(Repealed by P.L.65-2006, SEC.18.)
IC 35-48-7-10
Repealed
(Repealed by P.L.3-2008, SEC.269.)
IC 35-48-7-10.1
INSPECT program; designation; powers and duties; funding
Sec. 10.1. (a) This section applies after June 30, 2007.
(b) The INSPECT program must do the following:
(1) Create a data base for information required to be transmitted
under section 8.1 of this chapter in the form required under
rules adopted by the advisory committee, including search
capability for the following:
(A) A controlled substance recipient's name.
(B) A controlled substance recipient's or recipient
representative's identification number.
(C) A controlled substance recipient's date of birth.
(D) The national drug code number of a controlled substance
dispensed.
(E) The dates a controlled substance is dispensed.
(F) The quantities of a controlled substance dispensed.
(G) The number of days of supply dispensed.
(H) A dispenser's United States Drug Enforcement Agency
registration number.
(I) A prescriber's United States Drug Enforcement Agency
registration number.
(J) Whether a prescription was transmitted to the pharmacist
orally or in writing.
(2) Provide the advisory committee with continuing twenty-four
(24) hour a day online access to the data base.
(3) Secure the information collected and the data base
maintained against access by unauthorized persons.
(c) The advisory committee may execute a contract with a vendor
designated by the advisory committee to perform any function
associated with the administration of the INSPECT program.
(d) The INSPECT program may gather prescription data from the
Medicaid retrospective drug utilization review (DUR) program
established under IC 12-15-35.
(e) The advisory committee may accept and designate grants,
public and private financial assistance, and licensure fees to provide
funding for the INSPECT program.
As added by P.L.65-2006, SEC.11.
IC 35-48-7-11
Repealed
(Repealed by P.L.3-2008, SEC.269.)
IC 35-48-7-11.1
Confidentiality
Sec. 11.1. (a) This section applies after June 30, 2007.
(b) Information received by the INSPECT program under section
8.1 of this chapter is confidential.
(c) The advisory committee shall carry out a program to protect
the confidentiality of the information described in subsection (b).
The advisory committee may disclose the information to another
person only under subsection (d), (e), or (h).
(d) The advisory committee may disclose confidential information
described in subsection (b) to any person who is authorized to engage
in receiving, processing, or storing the information.
(e) Except as provided in subsections (f) and (g), the advisory
committee may release confidential information described in
subsection (b) to the following persons:
(1) A member of the board, the advisory committee, or another
governing body that licenses practitioners and is engaged in an
investigation, an adjudication, or a prosecution of a violation
under any state or federal law that involves a controlled
substance.
(2) An investigator for the consumer protection division of the
office of the attorney general, a prosecuting attorney, the
attorney general, a deputy attorney general, or an investigator
from the office of the attorney general, who is engaged in:
(A) an investigation;
(B) an adjudication; or
(C) a prosecution;
of a violation under any state or federal law that involves a
controlled substance.
(3) A law enforcement officer who is an employee of:
(A) a local, state, or federal law enforcement agency; or
(B) an entity that regulates controlled substances or enforces
controlled substances rules or laws in another state;
that is certified to receive information from the INSPECT
program.
(4) A practitioner or practitioner's agent certified to receive
information from the INSPECT program.
(5) A controlled substance monitoring program in another state
with which Indiana has established an interoperability
agreement.
(f) Information provided to an individual under:
(1) subsection (e)(3) is limited to information:
(A) concerning an individual or proceeding involving the
unlawful diversion or misuse of a schedule II, III, IV, or V
controlled substance; and
(B) that will assist in an investigation or proceeding; and
(2) subsection (e)(4) may be released only for the purpose of:
(A) providing medical or pharmaceutical treatment; or
(B) evaluating the need for providing medical or
pharmaceutical treatment to a patient.
(g) Before the advisory committee releases confidential
information under subsection (e), the applicant must be approved by
the INSPECT program in a manner prescribed by the advisory
committee.
(h) The advisory committee may release to:
(1) a member of the board, the advisory committee, or another
governing body that licenses practitioners;
(2) an investigator for the consumer protection division of the
office of the attorney general, a prosecuting attorney, the
attorney general, a deputy attorney general, or an investigator
from the office of the attorney general; or
(3) a law enforcement officer who is:
(A) authorized by the state police department to receive the
type of information released; and
(B) approved by the advisory committee to receive the type
of information released;
confidential information generated from computer records that
identifies practitioners who are prescribing or dispensing large
quantities of a controlled substance.
(i) The information described in subsection (h) may not be
released until it has been reviewed by:
(1) a member of the advisory committee who is licensed in the
same profession as the prescribing or dispensing practitioner
identified by the data; or
(2) the advisory committee's designee;
and until that member or the designee has certified that further
investigation is warranted. However, failure to comply with this
subsection does not invalidate the use of any evidence that is
otherwise admissible in a proceeding described in subsection (j).
(j) An investigator or a law enforcement officer receiving
confidential information under subsection (d), (e), or (h) may
disclose the information to a law enforcement officer or an attorney
for the office of the attorney general for use as evidence in the
following:
(1) A proceeding under IC 16-42-20.
(2) A proceeding under any state or federal law that involves a
controlled substance.
(3) A criminal proceeding or a proceeding in juvenile court that
involves a controlled substance.
(k) The advisory committee may compile statistical reports from
the information described in subsection (b). The reports must not
include information that identifies any practitioner, ultimate user, or
other person administering a controlled substance. Statistical reports
compiled under this subsection are public records.
(l) This section may not be construed to require a practitioner to
obtain information about a patient from the data base.
(m) A practitioner is immune from civil liability for an injury,
death, or loss to a person solely due to a practitioner seeking or not
seeking information from the INSPECT program. The civil immunity
described in this subsection does not extend to a practitioner if the
practitioner receives information directly from the INSPECT
program and then negligently misuses this information. This
subsection does not apply to an act or omission that is a result of
gross negligence or intentional misconduct.
(n) The advisory committee may review the records of the
INSPECT program. If the advisory committee determines that a
violation of the law may have occurred, the advisory committee shall
notify the appropriate law enforcement agency or the relevant
government body responsible for the licensure, regulation, or
discipline of practitioners authorized by law to prescribe controlled
substances.
As added by P.L.65-2006, SEC.13.
IC 35-48-7-12
Repealed
(Repealed by P.L.3-2008, SEC.269.)
IC 35-48-7-12.1
Rules to implement chapter
Sec. 12.1. (a) This section applies after June 30, 2007.
(b) The advisory committee shall adopt rules under IC 4-22-2 to
implement this chapter, including the following:
(1) Information collection and retrieval procedures for the
INSPECT program, including the controlled substances to be
included in the program required under section 8.1 of this
chapter.
(2) Design for the creation of the data base required under
section 10.1 of this chapter.
(3) Requirements for the development and installation of online
electronic access by the advisory committee to information
collected by the INSPECT program.
(4) Identification of emergency situations or other
circumstances in which a practitioner may prescribe, dispense,
and administer a prescription drug specified in section 8.1 of
this chapter without a written prescription or on a form other
than a form specified in section 8.1(b)(4) of this chapter.
IC 35-48-7-13
Repealed
(Repealed by P.L.3-2008, SEC.269.)
IC 35-48-7-13.1
Controlled substances data fund; establishment
Sec. 13.1. (a) This section applies after June 30, 2007.
(b) The controlled substances data fund is established to fund the
operation of the INSPECT program. The fund shall be administered
by the Indiana professional licensing agency.
(c) Expenses of administering the fund shall be paid from money
in the fund. The fund consists of grants, public and private financial
assistance, and sixteen percent (16%) of the controlled substances
registration fees imposed under rules adopted under IC 35-48-3-1.
(d) The treasurer of state shall invest the money in the fund not
currently needed to meet the obligations of the fund in the same
manner as other public money may be invested.
(e) Money in the fund at the end of a state fiscal year does not
revert to the state general fund.
As added by P.L.65-2006, SEC.17.
IC 35-48-7-14
Violations of chapter; misdemeanor offense
Sec. 14. A person who knowingly or intentionally violates this
chapter commits a Class A misdemeanor.
As added by P.L.163-1994, SEC.5.
IC 35-48-7-15
Repealed
(Repealed by P.L.214-2001, SEC.1.)