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(125th General Assembly)
(Substitute House Bill Number 377)
AN ACT
To amend sections 4729.25 and 4729.26, to enact
sections 4729.75 to
4729.84, and to repeal sections 4729.63 and 4729.66
of the Revised Code to
permit the State Board of
Pharmacy to establish
and maintain a drug database to monitor
the misuse and
diversion of controlled substances and certain dangerous drugs.
Be it enacted by the General Assembly of the State of Ohio:
SECTION 1. That sections 4729.25 and 4729.26 be amended and
sections
4729.75, 4729.76, 4729.77, 4729.78, 4729.79, 4729.80, 4729.81, 4729.82, 4729.83, and 4729.84
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. 4729.26. The state board of pharmacy
may adopt rules in accordance
with Chapter 119. of the Revised Code, not
inconsistent with the law, as may be necessary to carry out the
purposes of and to enforce the provisions of this chapter
pertaining to the practice of pharmacy. The rules
shall be published and made available by the board
to each pharmacist licensed under this chapter.
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 4729.79 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. 4729.76. If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, the executive director of the board shall do all of the
following: (A) Employ an administrator to manage and direct the duties
of staff employed to operate the drug database. The
administrator shall be a person who has had training and
experience in areas related to the duties of the
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 database; (C) Fix the compensation of the administrator and all other
staff
employed to operate the database.
Sec. 4729.77. (A) If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, each pharmacy licensed as a terminal
distributor of
dangerous
drugs that dispenses drugs to patients in this state and is included in the types of pharmacies specified in rules adopted under section 4729.83 of the Revised Code shall submit to the board the following
prescription 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) The information shall be transmitted as specified by the board in rules adopted under section 4729.83 of the Revised Code. (1) The information shall be submitted electronically in the
format
specified by the board, except that the board may grant a waiver allowing the distributor to submit the information in another format. (2) The information shall be submitted in accordance with any time limits specified by the board, except that the board may grant an extension if either of the following
occurs: (a) The distributor suffers a mechanical or electronic
failure,
or cannot meet the deadline for
other reasons beyond the distributor's control. (b) The board is unable to receive electronic submissions.
(C) This section does not apply to a prescriber personally
furnishing or administering dangerous drugs to the prescriber's
patient.
Sec. 4729.78. (A) If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, each wholesale distributor of dangerous
drugs that delivers drugs to prescribers in this state shall submit to the board the following purchase
information: (1) Purchaser identification; (2) Identification of the drug sold; (3) Quantity of the drug sold; (4) Date of sale; (5) The wholesale distributor's license number issued by the
board. (B) The information shall be transmitted as specified by the board in rules adopted under section 4729.83 of the Revised Code. (1) The information shall be submitted electronically in the
format specified by the board, except that the board may grant a waiver
allowing the distributor to submit the information in another format. (2) The information shall be submitted in accordance with any time limits specified by the board, except that the board may grant an extension if either of the following
occurs: (a) The distributor suffers a mechanical or electronic
failure, or cannot meet the deadline
for other reasons beyond the distributor's control. (b) The board is unable to receive electronic
submissions.
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. 4729.80. If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, the board shall review the
information in the drug database. If the board
determines from the review that a
violation of law may have occurred, it shall
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 by the agency or entity for an investigation of the violation of law that may have occurred.
Sec. 4729.81. If the state board of pharmacy establishes a drug database pursuant to section 4729.75 of the Revised Code, the information collected for the database
shall be retained
in the database for two years.
The information 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 section 4729.83 of the Revised Code.
Sec. 4729.82. If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, the board shall not impose any charge
on a terminal distributor of dangerous drugs, pharmacist, or prescriber for the establishment or maintenance
of the database. The board shall not charge any
fees for the transmission of data to the database
or for the receipt of information from the
database, except that the board may charge a fee in accordance
with rules adopted under section 4729.83 of the Revised Code to an
individual who requests the individual's own
database information under section 4729.79 of the Revised Code.
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.
Sec. 4729.84. (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 present a biennial report to the
standing committees of the house of representatives and the senate
that are primarily responsible for considering health and human
services issues. The initial report shall be presented not later than two years after the database is established. (B) Each report presented under this section shall include all of the following:
(1) The cost to the state of establishing and maintaining
the database; (2) Information from terminal distributors of dangerous drugs, prescribers, and the
board regarding the board's effectiveness in providing
information from the database; (3) The board's timeliness in transmitting information from
the database.
SECTION 2. That existing sections 4729.25 and 4729.26 and sections Sec. 4729.63.
and Sec. 4729.66. of the
Revised Code are hereby repealed.
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