REPRESENTATIVE Raga

To amend section 4729.25, to enact sections 4729.75

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to 4729.81, and to repeal sections 4729.63 and

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4729.64 of the Revised Code to require the State

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Board of Pharmacy to establish and maintain a

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dangerous drugs database to monitor the use,

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misuse, and diversion of dangerous drugs.

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BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:

Section 1. That section 4729.25 be amended and sections	7
4729.75, 4729.76, 4729.77, 4729.78, 4729.79, 4729.80, and 4729.81	8
of the Revised Code be enacted to read as follows:	9

Sec. 4729.25.  (A) The state board of pharmacy shall enforce,	10
or cause to be enforced, this chapter. If it has information that	11
any provision of this chapter has been violated, it shall	12
investigate the matter, and take such action as it considers	13
appropriate in accordance with its rules adopted under section	14
4729.26 of the Revised Code. With regard to violations of sections	15
4729.51 to 4729.62 of the Revised Code, the board's actions also	16
shall be taken in accordance with section 4729.63 of the Revised	17
Code.	18

(B) Nothing in this chapter shall be construed to require the	19
state board of pharmacy to enforce minor violations of this	20
chapter if the board determines that the public interest is	21
adequately served by a notice or warning to the alleged offender.	22

Sec. 4729.75. The state board of pharmacy shall establish and	23
maintain a dangerous drugs database. The board shall use the	24
dangerous drugs database to monitor the use, misuse, and diversion	25
of dangerous drugs. The board shall electronically collect and	26
disseminate information pursuant to section 4729.79 of the Revised	27
Code and rules adopted under section 4729.81 of the Revised Code.	28

Sec. 4729.76. The executive director of the state board of	29
pharmacy shall do all of the following:	30

(A) Employ an administrator to manage and direct the duties	31
of staff employed to operate the dangerous drugs database. The	32
administrator shall be a person who has had training and	33
experience in areas related to the duties of the dangerous drugs	34
database.	35

(B) Employ such professional, technical, and clerical	36
employees as are necessary, and employ or hire on a consulting	37
basis other technical services required for the operation of the	38
dangerous drugs database;	39

(C) Fix the compensation of the administrator and all other	40
staff employed to operate the dangerous drugs database.	41

Sec. 4729.77. (A) Each licensed terminal distributor of	42
dangerous drugs delivered in the state that is required to submit	43
prescription information to the state board of pharmacy shall	44
submit to the board all of the following information:	45

(1) Terminal distributor identification;

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(2) Patient identification;

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(3) Prescriber identification;

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(4) Date prescription was issued by prescriber;

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(5) Date prescription was dispensed;

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(6) Indication of whether prescription dispensed is new or a	51
refill;	52

(7) Name, strength, and national drug code of the drug	53
dispensed;	54

(8) Quantity of drug dispensed;

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(9) Number of days' supply of drug dispensed;

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(10) Serial or prescription number assigned by the terminal	57
distributor;	58

(11) Source of payment for the prescription.

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(B) Information shall be submitted electronically in the	60
format specified by the board unless a waiver has been granted by	61
the board to the terminal distributor.	62

(C) Information shall be transmitted as designated by rule of	63
the board, unless the board grants an extension.	64

An extension may be granted if either of the following	65
occurs:	66

(1) The distributor suffers a mechanical or electronic	67
failure, or cannot meet the deadline established by this division	68
for other reasons beyond the distributor's control.	69

(2) The board is unable to receive electronic submissions.

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(D) This section does not apply to a prescriber personally	71
furnishing or administering dangerous drugs to the prescriber's	72
patient.	73

Sec. 4729.78. (A) Each wholesale distributor of dangerous	74
drugs delivered in the state that is required to submit purchase	75
information to the state board of pharmacy shall submit to the	76
board all of the following information:	77

(1) Purchaser identification;

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(2) Identification of the drug sold;

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(3) Quantity of the drug sold;

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(4) Date of sale;

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(5) The wholesale distributor's license number issued by the	82
board.	83

(B) The information shall be submitted electronically in the	84
format specified by the state board of pharmacy unless a waiver	85
has been granted by the board to the distributor.	86

(C) Information shall be transmitted as designated by rule of	87
the board unless the board grants an extension.	88

An extension may be granted if either of the following	89
occurs:	90

(1) The distributor suffers a mechanical or electronic	91
failure, or cannot meet the deadline established by this division	92
for other reasons beyond the distributor's control.	93

(2) The board of pharmacy is unable to receive electronic	94
submissions.	95

Sec. 4729.79. (A) The state board of pharmacy may provide	96
information from the dangerous drugs database to all of the	97
following:	98

(1) A person who is a designated representative of a	99
government entity responsible for the licensure, regulation, or	100
discipline of licensed health care professionals authorized to	101
prescribe drugs and is involved in an investigation of a person	102
licensed, regulated, or subject to discipline by the entity;	103

(2) A federal, state, county, township, or municipal officer	104
of this or any other state, or the United States, whose duty is to	105
enforce the laws relating to drugs and who is actively engaged in	106
a specific investigation of a specific person or drug specified by	107
the officer;	108

(3) A properly convened grand jury pursuant to a subpoena	109
properly issued;	110

(4) A pharmacist or prescriber who requests the information	111
and certifies in a form specified by the board that it is for the	112
purpose of providing medical or pharmaceutical treatment to a	113
current patient of the pharmacist or prescriber;	114

(5) An individual who requests the individual's own dangerous	115
drugs database information in accordance with the procedure	116
established in rules adopted under section 4729.81 of the Revised	117
Code.	118

(B) The state board of pharmacy shall maintain a record of	119
each individual or entity that requests information from the	120
dangerous drugs database. Pursuant to rules adopted by the board	121
under section 4729.81 of the Revised Code, the board may use the	122
records to document and report statistics and law enforcement	123
outcomes.	124

The board may provide records of an individual's requests for	125
dangerous drugs database information to the following individuals:	126

(1) A designated representative of a government entity that	127
is responsible for the licensure, regulation, or discipline of	128
licensed health care professionals authorized to prescribe drugs	129
who is involved in a specific investigation of the individual who	130
submitted the dangerous drugs database information request;	131

(2) A federal, state, county, township, or municipal officer	132
of this or any other state, or the United States, whose duty is to	133
enforce the laws relating to drugs and who is actively engaged in	134
a specific investigation of the individual who submitted the	135
dangerous drugs database information request.	136

(C) Information contained in the dangerous drugs database and	137
any information obtained from it is not a public record.	138
Information contained in the records of requests for information	139
from the dangerous drugs database is not a public record.	140

(D) Information collected for the dangerous drugs database	141
shall be retained in the dangerous drugs database for two years.	142
It shall then be destroyed unless a law enforcement agency or a	143
government entity responsible for the licensure, regulation, or	144
discipline of licensed health care professionals authorized to	145
prescribe drugs has submitted a written request to the board for	146
retention of specific information in accordance with rules adopted	147
by the board under this chapter.	148

(E) Nothing in this section requires a pharmacist or	149
prescriber to obtain information about a patient from the	150
dangerous drugs database. A pharmacist or prescriber shall not be	151
held liable in damages to any person in any civil action for	152
injury, death, or loss to person or property on the basis that the	153
pharmacist or prescriber did or did not seek or obtain information	154
from the dangerous drugs database.	155

(F) The state board of pharmacy shall not impose any charge	156
on a pharmacist or prescriber for the establishment or maintenance	157
of the dangerous drugs database. The board shall not charge any	158
fees for the transmission of data to the dangerous drugs database	159
or for the receipt of information from the dangerous drugs	160
database, except that the board may charge a fee in accordance	161
with rules adopted under section 4729.81 of the Revised Code to an	162
individual who requests the individual's own dangerous drugs	163
database information.	164

Sec. 4729.80. The state board of pharmacy shall review the	165
information in the dangerous drugs database. If the board	166
determines that a violation of law may have occurred, it may	167
notify the appropriate law enforcement agency or a government	168
entity responsible for the licensure, regulation, or discipline of	169
licensed health care professionals authorized to prescribe drugs	170
and supply information required for an investigation.	171

Sec. 4729.81. (A) In addition to rules adopted under sections	172
4729.26 and 4729.66 of the Revised Code, the state board of	173
pharmacy shall adopt rules in accordance with Chapter 119. of the	174
Revised Code to carry out the purposes of and enforce sections	175
4729.75 to 4729.80 of the Revised Code. The rules shall specify	176
all of the following:	177

(1) A means of identifying each patient, terminal	178
distributor, and each purchase at wholesale of dangerous drugs	179
about which information is entered into the database;	180

(2) An electronic format for the submission of information	181
from terminal distributors and wholesale distributors of dangerous	182
drugs;	183

(3) A procedure whereby a terminal distributor or a wholesale	184
distributor of dangerous drugs unable to submit information	185
electronically may obtain a waiver to submit information in	186
another format;	187

(4) A procedure whereby the board may grant a request from a	188
law enforcement agency or a government entity responsible for the	189
licensure, regulation, or discipline of licensed health care	190
professionals authorized to prescribe drugs that information that	191
has been stored for two years be retained when the information	192
pertains to an open investigation being conducted by the agency or	193
board;	194

(5) A procedure whereby a terminal or wholesale distributor	195
may apply for an extension to the time by which information must	196
be transmitted to the board;	197

(6) A procedure whereby a person or government entity to	198
which the board is authorized to provide information may submit a	199
request to the board for the information and the board may verify	200
the identity of the requestor;	201

(7) A procedure whereby the board can use the dangerous drugs	202
database request records required by division (B) of section	203
4729.77 of the Revised Code to document and report statistics and	204
law enforcement outcomes;	205

(8) A procedure whereby an individual may request the	206
individual's own dangerous drugs database information and the	207
board may verify the identity of the requestor;	208

(9) A reasonable fee that the board shall assess for	209
providing an individual with the individual's own dangerous drugs	210
database information pursuant to division (A)(5) of section	211
4729.79 of the Revised Code.	212

(B) The board shall designate which types of terminal	213
distributors of dangerous drugs shall be required to submit	214
prescription information to the board pursuant to section 4729.77	215
of the Revised Code.	216

(C) The board shall specify the dangerous drugs required to	217
be monitored by the database, either by schedule or by specific	218
dangerous drug.	219

(D) Two years after the effective date of this section and	220
every two years thereafter, the board shall present to the	221
standing committees of the house of representatives and the senate	222
that are primarily responsible for considering health and human	223
services issues a report of the following:	224

(1) The cost to the state of implementing and maintaining the	225
dangerous drugs database;	226

(2) Information from terminal distributors, prescribers, and	227
the state board of pharmacy regarding the board's effectiveness in	228
providing information from the dangerous drugs database;	229

(3) The board's timeliness in transmitting information from	230
the dangerous drugs database.	231

Section 2. That existing section 4729.25 and sections        Sec. 4729.63.	232
and        Sec. 4729.64.  of the Revised Code are hereby repealed.	233