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H. B. No. 377As IntroducedAs Introduced
125th General Assembly | Regular Session | 2003-2004 |
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REPRESENTATIVE Raga
A BILL
To amend section 4729.25, to enact
sections 4729.75 to
4729.81, and to repeal sections 4729.63 and 4729.64
of the Revised Code to
require the State Board of
Pharmacy to establish
and maintain a dangerous
drugs database to monitor
the use, misuse, and
diversion of dangerous drugs.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:
Section 1. That section 4729.25 be amended and
sections
4729.75, 4729.76, 4729.77, 4729.78, 4729.79, 4729.80, and
4729.81
of the Revised Code be enacted to read as follows:
Sec. 4729.25. (A) The state board of pharmacy shall
enforce, or cause to be
enforced, this chapter. If it has
information that
any provision of this chapter has been violated,
it shall investigate
the matter, and take such action as it
considers appropriate in accordance
with its rules adopted under
section 4729.26 of the Revised Code.
With regard to violations of
sections
4729.51 to 4729.62 of the Revised Code, the board's
actions also shall be
taken in accordance
with section 4729.63 of
the Revised Code. (B) Nothing in this chapter shall be construed to require
the state board of
pharmacy to enforce minor violations of this
chapter if the board determines
that the public interest is
adequately served by a notice or warning to the
alleged offender.
Sec. 4729.75. The state board of pharmacy shall establish and
maintain a dangerous drugs database. The board shall use the
dangerous drugs database to monitor the use, misuse, and diversion
of dangerous
drugs. The board shall electronically collect and
disseminate
information pursuant to section 4729.79 of the Revised
Code and
rules adopted under section 4729.81 of the Revised Code.
Sec. 4729.76. The executive director of the state board of
pharmacy shall do all of the
following: (A) Employ an administrator to manage and direct the duties
of staff employed to operate the dangerous drugs database. The
administrator shall be a person who has had training and
experience in areas related to the duties of the dangerous drugs
database. (B) Employ such professional, technical, and clerical
employees as are necessary, and employ or hire on a consulting
basis other technical services required for the operation of the
dangerous drugs database; (C) Fix the compensation of the administrator and all other
staff
employed to operate the dangerous drugs database.
Sec. 4729.77. (A) Each licensed terminal
distributor of
dangerous
drugs delivered in the state that is required to submit
prescription information to the
state
board of pharmacy shall
submit to the board all of the
following
information: (1) Terminal distributor identification;
(2) Patient identification;
(3) Prescriber identification;
(4) Date prescription was issued by prescriber;
(5) Date prescription was dispensed;
(6) Indication of whether prescription dispensed is new or a refill;
(7) Name, strength, and national drug code of the drug dispensed;
(8) Quantity of drug dispensed;
(9) Number of days' supply of drug dispensed;
(10) Serial or prescription number assigned by the terminal distributor;
(11) Source of payment for the prescription. (B) Information shall be submitted electronically in the
format
specified by the board unless a waiver has been granted by
the
board to the terminal distributor. (C) Information shall be transmitted as designated by rule
of the board, unless the board grants an
extension. An extension may be granted if either of the following
occurs: (1) The distributor suffers a mechanical or electronic
failure,
or cannot meet the deadline established by this division
for
other reasons beyond the distributor's control. (2) The board is unable to receive electronic submissions.
(D) This section does not apply to a prescriber personally
furnishing or administering dangerous drugs to the prescriber's
patient.
Sec. 4729.78. (A) Each wholesale distributor of dangerous
drugs delivered in the state that is required to submit purchase
information to the state board
of pharmacy shall submit to
the
board all of the following
information: (1) Purchaser identification; (2) Identification of the drug sold; (3) Quantity of the drug sold; (5) The wholesale distributor's license number issued by the
board. (B) The information shall be submitted electronically in the
format specified by the state board of pharmacy unless a waiver
has been granted by the board to the distributor. (C) Information shall be transmitted as designated by rule
of the board unless the board grants an
extension. An extension may be granted if either of the following
occurs: (1) The distributor suffers a mechanical or electronic
failure, or cannot meet the deadline established by this division
for other reasons beyond the distributor's control. (2) The board of pharmacy is unable to receive electronic
submissions.
Sec. 4729.79. (A) The state board of pharmacy may provide
information from the dangerous drugs database to all of the
following: (1) A person who is a designated representative of a
government entity responsible for the licensure, regulation, or
discipline of licensed health care professionals authorized to
prescribe drugs and is involved in an investigation of a person
licensed, regulated, or subject to discipline by the entity; (2) A federal, state, county, township, or municipal officer
of this or any other state, or the United States, whose duty is to
enforce the laws relating to drugs and who is actively engaged in
a specific
investigation of a specific person or drug specified
by the officer; (3) A properly convened grand jury pursuant to a subpoena
properly issued; (4) A pharmacist or prescriber who requests the information
and certifies in a form
specified by the board that it is for
the
purpose of providing
medical or pharmaceutical treatment to a
current patient of the
pharmacist or prescriber; (5) An individual who requests the individual's own dangerous
drugs database information in accordance with the procedure
established in rules adopted under section 4729.81 of the Revised
Code. (B) The state board of pharmacy shall maintain a record of
each individual or entity that requests information from the
dangerous drugs database. Pursuant to rules adopted by the board
under section 4729.81 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 dangerous
drugs database information to the following individuals:
(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 a specific investigation of the individual who
submitted the dangerous drugs database information request;
(2) A federal, state, county, township, or municipal officer
of this or any other state, or the United States, whose duty is to
enforce the laws relating to drugs and who is actively engaged in
a specific investigation of the individual who submitted the
dangerous drugs database information request. (C) Information contained in the dangerous drugs database and
any information obtained from it is not a public record.
Information contained in the records of requests for information
from the dangerous drugs database is not a public record. (D) Information collected for the dangerous drugs database
shall be retained
in the dangerous drugs database for two years.
It shall then be
destroyed unless a
law enforcement agency or a
government entity
responsible for the licensure, regulation, or
discipline of
licensed health care professionals authorized to
prescribe drugs
has submitted a
written request to the
board for
retention of
specific information
in accordance with
rules adopted
by the board
under this chapter. (E) Nothing in this section requires a pharmacist or
prescriber to obtain information about a patient from the
dangerous
drugs
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 dangerous drugs database. (F) The state board of pharmacy shall not impose any charge
on a pharmacist or prescriber for the establishment or maintenance
of the dangerous drugs database. The board shall not charge any
fees for the transmission of data to the dangerous drugs database
or for the receipt of information from the dangerous drugs
database, except that the board may charge a fee in accordance
with rules adopted under section 4729.81 of the Revised Code to an
individual who requests the individual's own dangerous drugs
database information.
Sec. 4729.80. The state board of pharmacy shall review the
information in the dangerous drugs database. If the board
determines that a
violation of law may have occurred, it may
notify the appropriate
law enforcement agency or a government
entity responsible for the licensure, regulation, or discipline of
licensed health care professionals authorized to prescribe drugs
and supply
information required for an
investigation.
Sec. 4729.81. (A) In addition to rules adopted under
sections
4729.26 and 4729.66 of the Revised Code, the state board
of
pharmacy shall adopt rules in accordance with Chapter 119. of
the
Revised Code to carry out the purposes of and enforce
sections
4729.75 to 4729.80 of the Revised Code. The rules shall
specify
all of the following: (1) A means of identifying each patient, terminal distributor, and each purchase at
wholesale of dangerous
drugs about which information is entered
into the database; (2) An electronic format for the submission of information
from terminal distributors and wholesale distributors of dangerous
drugs; (3) 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; (4) 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
board; (5) 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; (6) 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; (7) A procedure whereby the board can use the dangerous
drugs database request records required by division (B) of section
4729.77 of the Revised Code to document and report statistics and
law enforcement outcomes; (8) A procedure whereby an individual may request the
individual's own dangerous drugs database information and the
board may verify the identity of the requestor;
(9) A reasonable
fee that the board shall assess for
providing an individual with
the individual's own dangerous drugs
database information pursuant
to division (A)(5) of section
4729.79 of the Revised Code.
(B) The board shall designate which types of terminal
distributors of dangerous drugs shall be required to submit
prescription information to the board pursuant to section 4729.77
of the Revised Code. (C) The board shall specify the dangerous drugs required to
be monitored by the database, either by schedule or by specific
dangerous drug. (D) Two years after the effective date of this section and
every two years thereafter, the board shall present to the
standing committees of the house of representatives and the senate
that are primarily responsible for considering health and human
services issues a report of the following:
(1) The cost to the state of implementing and maintaining
the dangerous drugs database; (2) Information from terminal distributors, prescribers, and the state
board of pharmacy regarding the board's effectiveness in providing
information from the dangerous drugs database; (3) The board's timeliness in transmitting information from
the dangerous drugs database.
Section 2. That existing section 4729.25 and sections 4729.63
and 4729.64 of the
Revised Code are hereby repealed.
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