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H. B. No. 71 As IntroducedAs Introduced
129th General Assembly | Regular Session | 2011-2012 |
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Cosponsor:
Representative Boyd
A BILL
To amend sections 4729.75, 4729.79, 4729.83, and
4729.99 and to enact sections 4729.791, 4729.85,
4729.86, 4729.861, 4729.87, 4729.871, 4729.88,
4729.89, 4729.90, 4729.91, and 4729.92 of the
Revised Code to create the Ohio Official
Prescription Program and to require prescribers
and pharmacists to obtain information from the
Ohio Automated Rx Reporting System.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:
Section 1. That sections 4729.75, 4729.79, 4729.83, and
4729.99 be amended and sections 4729.791, 4729.85, 4729.86,
4729.861, 4729.87, 4729.871, 4729.88, 4729.89, 4729.90, 4729.91,
and 4729.92 of the Revised Code be enacted to read as follows:
Sec. 4729.75. The state board of pharmacy may establish and
maintain a drug database. The board shall use the drug database to
monitor the misuse and diversion of controlled substances, as
defined in section 3719.01 of the Revised Code, and other
dangerous drugs the board includes in the database pursuant to
rules adopted under section 4729.83 of the Revised Code. In
establishing and maintaining the database, the board shall
electronically collect information pursuant to sections 4729.77
and 4729.78 of the Revised Code and shall disseminate information
as authorized or required by sections section 4729.79 and as
required by sections 4729.791 and 4729.80 of the Revised Code. The
board's collection and dissemination of information shall be
conducted in accordance with rules adopted under section 4729.83
of the Revised Code.
Sec. 4729.79. (A) If the state board of pharmacy establishes
and maintains a drug database pursuant to section 4729.75 of the
Revised Code, the board may provide information from the database
in accordance with the following:
(1) On receipt of a request from a designated representative
of a government entity responsible for the licensure, regulation,
or discipline of licensed health care professionals authorized to
prescribe drugs, the board may provide to the representative
information from the database relating to the professional who is
the subject of an active investigation being conducted by the
government entity.
(2) On receipt of a request from a federal officer, or a
state or local officer of this or any other state, whose duties
include enforcing laws relating to drugs, the board may provide to
the officer information from the database relating to the person
who is the subject of an active investigation being conducted by
the officer's employing government entity.
(3) Pursuant to a subpoena issued by a grand jury, the board
may provide to the grand jury information from the database
relating to the person who is the subject of an investigation
being conducted by the grand jury.
(4) On receipt of a request from a pharmacist or prescriber,
the board may provide to the requestor information from the
database relating to a current patient of the requestor, if the
requestor certifies in a form specified by the board that it is
for the purpose of providing medical or pharmaceutical treatment
to the patient who is the subject of the request.
(5) On receipt of a request from an individual seeking the
individual's own database information in accordance with the
procedure established in rules adopted under section 4729.83 of
the Revised Code, the board may provide to the individual the
individual's own database information.
(B) The state board of pharmacy shall maintain a record of
each individual or entity that requests information from the
database pursuant to this section. In accordance with rules
adopted under section 4729.83 of the Revised Code, the board may
use the records to document and report statistics and law
enforcement outcomes.
The board may provide records of an individual's requests for
database information to the following:
(1) A designated representative of a government entity that
is responsible for the licensure, regulation, or discipline of
licensed health care professionals authorized to prescribe drugs
who is involved in an active investigation being conducted by the
government entity of the individual who submitted the requests for
database information;
(2) A federal officer, or a state or local officer of this or
any other state, whose duties include enforcing laws relating to
drugs and who is involved in an active investigation being
conducted by the officer's employing government entity of the
individual who submitted the requests for database information.
(C) Information contained in the database and any information
obtained from it is not a public record. Information contained in
the records of requests for information from the database is not a
public record. Information that does not identify a person may be
released in summary, statistical, or aggregate form.
(D) Nothing in this section requires a pharmacist or
prescriber to obtain information about a patient from the
database. A pharmacist or prescriber shall not be held liable in
damages to any person in any civil action for injury, death, or
loss to person or property on the basis that the pharmacist or
prescriber did or did not seek or obtain information from the
database.
Sec. 4729.791. (A) If the state board of pharmacy establishes
and maintains a drug database pursuant to section 4729.75 of the
Revised Code, the board shall grant access to the information in
the database to each licensed health professional authorized to
prescribe drugs and to each pharmacist practicing in this state.
The board shall grant access to the database in a manner that
enables each prescriber and pharmacist to comply with division (B)
of this section.
(B) Before a prescriber issues a prescription to a patient
for a drug included in the database and before a pharmacist
dispenses such a drug, the prescriber and pharmacist shall review
information in the database that pertains to the patient. At any
other time, a prescriber or pharmacist may review information in
the database pertaining to a patient for the purpose of providing
medical treatment or pharmacist services to the patient.
(C) A prescriber or pharmacist shall not be held liable in
damages to any person in a civil action for injury, death, or loss
to person or property on the basis that the prescriber or
pharmacist did or did not review information in the database
pertaining to a patient.
Sec. 4729.83. For purposes of establishing and maintaining a
drug database pursuant to section 4729.75 of the Revised Code, the
state board of pharmacy shall adopt rules in accordance with
Chapter 119. of the Revised Code to carry out and enforce sections
4729.75 to 4729.82 of the Revised Code. The rules shall specify
all of the following:
(A) A means of identifying each patient, terminal distributor
of dangerous drugs, and each purchase at wholesale of dangerous
drugs about which information is entered into the drug database;
(B) Requirements for the transmission of information from
terminal distributors and wholesale distributors of dangerous
drugs for purposes of the database;
(C) An electronic format for the submission of information
from terminal distributors and wholesale distributors of dangerous
drugs;
(D) A procedure whereby a terminal distributor or a wholesale
distributor of dangerous drugs unable to submit information
electronically may obtain a waiver to submit information in
another format;
(E) A procedure whereby the board may grant a request from a
law enforcement agency or a government entity responsible for the
licensure, regulation, or discipline of licensed health care
professionals authorized to prescribe drugs that information that
has been stored for two years be retained when the information
pertains to an open investigation being conducted by the agency or
entity;
(F) A procedure whereby a terminal or wholesale distributor
may apply for an extension to the time by which information must
be transmitted to the board;
(G) A procedure whereby a person or government entity to
which the board is authorized to provide information may submit a
request to the board for the information and the board may verify
the identity of the requestor;
(H) A procedure whereby the board can use the database
request records required by division (B) of section 4729.79 of the
Revised Code to document and report statistics and law enforcement
outcomes;
(I) A procedure whereby an individual may request the
individual's own database information and the board may verify the
identity of the requestor;
(J) A reasonable fee that the board may charge under section
4729.82 of the Revised Code for providing an individual with the
individual's own database information pursuant to section 4729.79
of the Revised Code;
(K) The specific dangerous drugs other than controlled
substances that must be included in the database;
(L) The types of pharmacies licensed as terminal distributors
of dangerous drugs that are required to submit prescription
information to the board pursuant to section 4729.77 of the
Revised Code;
(M) The manner in which prescribers and pharmacists are to be
granted access to information in the database for purposes of
section 4729.791 of the Revised Code.
Sec. 4729.85. (A) There is hereby created the Ohio official
prescription program. The state board of pharmacy shall implement
and administer the program in accordance with sections 4729.85 to
4729.92 of the Revised Code.
(B) The board may establish an advisory committee to assist
the board with the implementation and administration of the
program. If the board establishes the committee, the board shall
appoint members in such a manner that the constituencies with
interests in the program, as determined by the board, have
representation on the committee.
Sec. 4729.86. (A) The state board of pharmacy shall prepare
an official prescription form that meets all of the following
requirements:
(1) Contains one or more industry-recognized features
designed to prevent the unauthorized copying of a completed or
blank prescription form;
(2) Contains one or more industry-recognized features
designed to prevent the erasure or modification of information
written on the prescription form;
(3) Contains one or more industry-recognized features
designed to prevent the use of counterfeit prescription forms;
(4) Contains a unique identification number;
(5) Any other requirement necessary for compliance with 42
U.S.C. 1396b(i)(23).
(B) Beginning twelve months after the effective date of this
section, the board shall do all of the following:
(1) On the request of a prescriber who is practicing in this
state and has paid the program maintenance fee in accordance with
section 4729.88 of the Revised Code, issue official prescription
forms to the prescriber in quantities and at intervals the board
determines appropriate;
(2) Keep records indicating which unique identification
numbers are issued with the official prescription forms and which
prescribers received those numbers;
(3) Cease to issue official prescription forms to prescribers
if the board determines that at least ninety per cent of the
prescriptions issued in this state are being transmitted to
pharmacies through electronic prescription transmission systems.
(C) For purposes of determining under division (B)(3) of this
section, the percentage of prescriptions that are transmitted
through electronic prescription transmission systems, the board
shall select the criteria to be used in making the determination,
including the period of time that is to be represented by the
percentage.
Sec. 4729.861. The state board of pharmacy may fulfill its
duties under section 4729.86 of the Revised Code by contracting
with a vendor for the preparation and issuance of official
prescription forms. To be eligible for the contract, each printing
facility used by the vendor to print official prescription forms
must have a two-year history of audits conducted pursuant to the
statement on auditing standards number 70 of the American
institute of certified public accountants and must maintain annual
audits conducted pursuant to the statement on auditing standards
number 70.
If the board contracts with a vendor under this section, the
board shall establish security requirements for the procurement of
official prescription forms through the vendor.
Sec. 4729.87. (A) A prescriber shall notify the state board
of pharmacy when either of the following events occurs:
(1) Loss, destruction, theft, or unauthorized use of an
official prescription form issued to the prescriber under section
4729.86 of the Revised Code;
(2) Failure to receive official prescription forms requested
under section 4729.86 of the Revised Code.
(B) The notification required under division (A)(1) of this
section shall be made immediately. The notification required under
division (A)(2) of this section shall be made within a reasonable
time after the prescriber requests the forms from the board.
Sec. 4729.871. (A)(1) Beginning twelve months after the
effective date of this section, the state board of pharmacy shall
provide pharmacies or pharmacists in this state with a list of all
unique identification numbers marked on the official prescription
forms that are reported under section 4729.87 of the Revised Code
as being lost, destroyed, stolen, used without authorization, or
not received.
(2) A pharmacy or pharmacist shall not dispense a drug
pursuant to a prescription that is subject to the Ohio official
prescription program if the prescription contains a unique
identification number included on the list provided under division
(A)(1) of this section.
(B)(1) Beginning twelve months after the effective date of
this section or when the department of job and family services
determines it is capable of using the unique identification
numbers described in section 4729.86 of the Revised Code for
purposes of the prescription drug coverage provided under the
medicaid program established under Chapter 5111. of the Revised
Code, whichever is later, the board shall provide the department
with a list containing the following:
(a) All unique identification numbers marked on the official
prescription forms issued under section 4729.86 of the Revised
Code;
(b) All unique identification numbers marked on the forms
that are reported under section 4729.87 of the Revised Code as
being lost, destroyed, stolen, used without authorization, or not
received.
(2) When processing claims for payment under the medicaid
program for drugs dispensed pursuant to prescriptions that are
subject to division (B) of section 4729.89 of the Revised Code,
the department shall deny a claim that is associated with such a
prescription if the prescription was not written on an official
prescription form issued under section 4729.86 of the Revised Code
or the prescription contained a unique identification number
included pursuant to division (B)(1)(b) of this section on the
list provided under division (B)(1) of this section.
(C) Beginning twelve months after the effective date of this
section, the board may provide the list described in division
(B)(1) of this section to any entity that provides health care
coverage for prescription drugs, including a health insuring
corporation, sickness and accident insurer, or public or private
employer that offers health care benefits through a self-insurance
plan or other self-insurance system. The board may impose a fee
for providing the list under this division in an amount
established by the board in rules adopted under section 4729.92 of
the Revised Code.
(D) The lists provided by the board under this section shall
be provided in a format and at intervals established by the board
in rules adopted under section 4729.92 of the Revised Code. The
board may issue updates to the lists in a format and at intervals
established by the board in those rules.
Sec. 4729.88. (A) Except as provided in division (D) of this
section, each prescriber who is practicing in this state shall pay
to the state board of pharmacy a program maintenance fee. The
board shall not issue official prescription forms to a prescriber
who has not paid the fee in accordance with this section.
(B) In each of the five years immediately following the
effective date of this section, the board shall assess the program
maintenance fee on each prescriber who intends to practice in this
state during the year for which the fee is assessed. The board
shall select the date on which payment of the fee is due.
(C)(1) The amount of the program maintenance fee shall be as
follows:
(a) For prescribers who issue one hundred or more
prescriptions annually, one hundred dollars;
(b) For prescribers who issue fewer than one hundred
prescriptions annually, fifty dollars;
(c) For prescribers who serve primarily as instructors at the
university or college level, fifty dollars.
(2) For purposes of determining the amount of a prescriber's
program maintenance fee, each prescriber who is required to pay
the fee shall provide to the board, in a format selected by the
board, the total number of prescriptions issued by that prescriber
in the calendar year immediately preceding the year for which the
fee is being assessed.
(D) The program maintenance fee does not apply to a
prescriber who issues prescriptions only through an electronic
prescription transmission system except when the prescriber is
required to issue a written prescription because the drug being
prescribed is a controlled substance.
Sec. 4729.89. (A) As used in this section, "institutional
facility" means either of the following at which medical care is
provided on site and medical records documenting episodes of care,
including drugs ordered and administered, are maintained:
(1) A hospital as defined in section 3727.01 of the Revised
Code;
(2) A facility licensed by the state board of pharmacy and by
the department of health, department of rehabilitation and
correction, or department of developmental disabilities.
(B)(1) Except as provided in division (B)(2) of this section,
beginning eighteen months after the effective date of this
section, no prescriber shall issue a prescription unless the
prescription is written on an official prescription form issued
under section 4729.86 of the Revised Code.
(2) Division (B)(1) of this section does not apply to any of
the following:
(a) A prescription that is transmitted to a pharmacy through
an electronic prescription transmission system;
(b) A prescription that is transmitted to a pharmacy by a
facsimile machine;
(c) A prescription that is an oral order for drugs that is
later reduced to writing;
(d) A prescription for a patient in an institutional
facility;
(e) A prescription issued outside this state.
(C) Beginning eighteen months after the effective date of
this section, no pharmacist shall dispense a drug pursuant to a
prescription that is subject to division (B) of this section if
the prescription is not written on an official prescription form
issued under section 4729.86 of the Revised Code.
(D) No prescriber shall fail to comply with section 4729.87
of the Revised Code.
(E) Beginning eighteen months after the effective date of
this section, no prescriber shall issue a written prescription on
a prescription form that was not issued to the prescriber under
section 4729.86 of the Revised Code.
(F) Beginning eighteen months after the effective date of
this section, no prescriber to whom an official prescription form
is issued under section 4729.86 of the Revised Code shall transfer
the form to another prescriber.
Sec. 4729.90. There is hereby created in the state treasury
the Ohio official prescription program fund. All moneys received
under sections 4729.85 to 4729.92 of the Revised Code shall be
deposited in the fund. The moneys in the fund shall be used solely
for purposes of implementing and administering the Ohio official
prescription program and, if a drug database is established and
maintained pursuant to section 4729.75 of the Revised Code, for
purposes of implementing and administering sections 4729.75 to
4729.84 of the Revised Code.
Sec. 4729.91. A pharmacy, pharmacist, or prescriber is not
liable for damages in a civil action or subject to disciplinary
action by the state board of pharmacy for acting in good faith in
complying with the Ohio official prescription program pursuant to
sections 4729.85 to 4729.92 of the Revised Code.
Sec. 4729.92. In accordance with Chapter 119. of the Revised
Code, the state board of pharmacy shall adopt rules that the board
considers necessary to implement and administer the Ohio official
prescription program under sections 4729.85 to 4729.92 of the
Revised Code.
Sec. 4729.99. (A) Whoever violates section 4729.16, division
(A) or (B) of section 4729.38, or section 4729.57 of the Revised
Code is guilty of a minor misdemeanor. Each day's violation
constitutes a separate offense.
(B) Whoever violates section 4729.27, 4729.28, or 4729.36 of
the Revised Code is guilty of a misdemeanor of the third degree.
Each day's violation constitutes a separate offense. If the
offender previously has been convicted of or pleaded guilty to a
violation of this chapter, that person is guilty of a misdemeanor
of the second degree.
(C) Whoever violates section 4729.32, 4729.33, or 4729.34 of
the Revised Code is guilty of a misdemeanor.
(D) Whoever violates division (A), (B), (D), or (E) of
section 4729.51 of the Revised Code is guilty of a misdemeanor of
the first degree.
(E)(1) Whoever violates section 4729.37, division (C)(2) of
section 4729.51, division (J) of section 4729.54, or section
4729.61 of the Revised Code is guilty of a felony of the fifth
degree. If the offender previously has been convicted of or
pleaded guilty to a violation of this chapter or a violation of
Chapter 2925. or 3719. of the Revised Code, that person is guilty
of a felony of the fourth degree.
(2) If an offender is convicted of or pleads guilty to a
violation of section 4729.37, division (C) of section 4729.51,
division (J) of section 4729.54, or section 4729.61 of the Revised
Code, if the violation involves the sale, offer to sell, or
possession of a schedule I or II controlled substance, with the
exception of marihuana, and if the court imposing sentence upon
the offender finds that the offender as a result of the violation
is a major drug offender, as defined in section 2929.01 of the
Revised Code, and is guilty of a specification of the type
described in section 2941.1410 of the Revised Code, the court, in
lieu of the prison term authorized or required by division (E)(1)
of this section and sections 2929.13 and 2929.14 of the Revised
Code and in addition to any other sanction imposed for the offense
under sections 2929.11 to 2929.18 of the Revised Code, shall
impose upon the offender, in accordance with division (D)(3)(a) of
section 2929.14 of the Revised Code, the mandatory prison term
specified in that division and may impose an additional prison
term under division (D)(3)(b) of that section.
(3) Notwithstanding any contrary provision of section 3719.21
of the Revised Code, the clerk of court shall pay any fine imposed
for a violation of section 4729.37, division (C) of section
4729.51, division (J) of section 4729.54, or section 4729.61 of
the Revised Code pursuant to division (A) of section 2929.18 of
the Revised Code in accordance with and subject to the
requirements of division (F) of section 2925.03 of the Revised
Code. The agency that receives the fine shall use the fine as
specified in division (F) of section 2925.03 of the Revised Code.
(F) Whoever violates section 4729.531 of the Revised Code or
any rule adopted thereunder or section 4729.532 of the Revised
Code is guilty of a misdemeanor of the first degree.
(G) Whoever violates division (C)(1) of section 4729.51 of
the Revised Code is guilty of a felony of the fourth degree. If
the offender has previously been convicted of or pleaded guilty to
a violation of this chapter, or of a violation of Chapter 2925. or
3719. of the Revised Code, that person is guilty of a felony of
the third degree.
(H) Whoever violates division (C)(3) of section 4729.51 of
the Revised Code is guilty of a misdemeanor of the first degree.
If the offender has previously been convicted of or pleaded guilty
to a violation of this chapter, or of a violation of Chapter 2925.
or 3719. of the Revised Code, that person is guilty of a felony of
the fifth degree.
(I)(1) Whoever violates division (B) of section 4729.42 of
the Revised Code is guilty of unauthorized pharmacy-related drug
conduct. Except as otherwise provided in this section,
unauthorized pharmacy-related drug conduct is a misdemeanor of the
second degree. If the offender previously has been convicted of or
pleaded guilty to a violation of division (B), (C), (D), or (E) of
that section, unauthorized pharmacy-related drug conduct is a
misdemeanor of the first degree on a second offense and a felony
of the fifth degree on a third or subsequent offense.
(2) Whoever violates division (C) or (D) of section 4729.42
of the Revised Code is guilty of permitting unauthorized
pharmacy-related drug conduct. Except as otherwise provided in
this section, permitting unauthorized pharmacy-related drug
conduct is a misdemeanor of the second degree. If the offender
previously has been convicted of or pleaded guilty to a violation
of division (B), (C), (D), or (E) of that section, permitting
unauthorized pharmacy-related drug conduct is a misdemeanor of the
first degree on a second offense and a felony of the fifth degree
on a third or subsequent offense.
(3) Whoever violates division (E) of section 4729.42 of the
Revised Code is guilty of the offense of falsification under
section 2921.13 of the Revised Code. In addition to any other
sanction imposed for the violation, the offender is forever
disqualified from engaging in any activity specified in division
(B)(1), (2), or (3) of section 4729.42 of the Revised Code and
from performing any function as a health care professional or
health care worker. As used in this division, "health care
professional" and "health care worker" have the same meanings as
in section 2305.234 of the Revised Code.
(4) Notwithstanding any contrary provision of section 3719.21
of the Revised Code or any other provision of law that governs the
distribution of fines, the clerk of the court shall pay any fine
imposed pursuant to division (I)(1), (2), or (3) of this section
to the state board of pharmacy if the board has adopted a written
internal control policy under division (F)(2) of section 2925.03
of the Revised Code that addresses fine moneys that it receives
under Chapter 2925. of the Revised Code and if the policy also
addresses fine moneys paid under this division. The state board of
pharmacy shall use the fines so paid in accordance with the
written internal control policy to subsidize the board's law
enforcement efforts that pertain to drug offenses.
(J) Whoever violates section 4729.89 of the Revised Code is
guilty of a misdemeanor of the fourth degree.
Section 2. That existing sections 4729.75, 4729.79, 4729.83,
and 4729.99 of the Revised Code are hereby repealed.
Section 3. Section 4729.99 of the Revised Code, as amended
by this act, shall take effect eighteen months after the effective
date of this act.
Section 4. As used in this section, "prescriber" has the
same meaning as in section 4729.01 of the Revised Code.
Notwithstanding the provisions of section 4729.88 of the
Revised Code that require prescribers to pay an annual program
maintenance fee, each prescriber shall pay an initial prorated
program maintenance fee as determined by the State Board of
Pharmacy to cover the period between the effective date of this
act and the following June 30. Thereafter the fee shall be paid in
accordance with section 4729.88 of the Revised Code. The Board
shall issue official prescription forms in quantities that the
Board determines appropriate to prescribers who pay the fee
required by this section.
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