REPRESENTATIVES Raga, Calvert, Carmichael, Cirelli, Clancy, Daniels, C. Evans, D. Evans, Flowers, Hagan, Martin, T. Patton, Schaffer, Schlichter, Schneider, Slaby, G. Smith, J. Stewart, Willamowski

To amend sections 4729.25 and 4729.26, to enact

1

sections 4729.75 to 4729.81, and to repeal

2

sections 4729.63 and 4729.66 of the Revised Code

3

to require the State Board of Pharmacy to

4

establish and maintain a drug database to monitor

5

the misuse and diversion of controlled substances

6

and certain dangerous drugs.

7

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

Section 1. That sections 4729.25 and 4729.26 be amended and	8
sections 4729.75, 4729.76, 4729.77, 4729.78, 4729.79, 4729.80, and	9
4729.81 of the Revised Code be enacted to read as follows:	10

Sec. 4729.25.  (A) The state board of pharmacy shall enforce,	11
or cause to be enforced, this chapter. If it has information that	12
any provision of this chapter has been violated, it shall	13
investigate the matter, and take such action as it considers	14
appropriate in accordance with its rules adopted under section	15
4729.26 of the Revised Code. With regard to violations of sections	16
4729.51 to 4729.62 of the Revised Code, the board's actions also	17
shall be taken in accordance with section 4729.63 of the Revised	18
Code.	19

(B) Nothing in this chapter shall be construed to require the	20
state board of pharmacy to enforce minor violations of this	21
chapter if the board determines that the public interest is	22
adequately served by a notice or warning to the alleged offender.	23

Sec. 4729.26.  The state board of pharmacy may adopt rules in	24
accordance with Chapter 119. of the Revised Code, not inconsistent	25
with the law, as may be necessary to carry out the purposes of and	26
to enforce the provisions of this chapter pertaining to the	27
practice of pharmacy. The rules shall be published and made	28
available by the board to each pharmacist licensed under this	29
chapter.	30

Sec. 4729.75. The state board of pharmacy shall establish and	31
maintain a drug database. The board shall use the drug database to	32
monitor the misuse and diversion of controlled substances, as	33
defined in section 3719.01 of the Revised Code, and other	34
dangerous drugs the board includes in the database pursuant to	35
division (A)(10) of section 4729.81 of the Revised Code. The board	36
shall electronically collect and disseminate information pursuant	37
to sections 4729.79 and 4729.80 of the Revised Code and rules	38
adopted under section 4729.81 of the Revised Code.	39

Sec. 4729.76. The executive director of the state board of	40
pharmacy shall do all of the following:	41

(A) Employ an administrator to manage and direct the duties	42
of staff employed to operate the drug database. The administrator	43
shall be a person who has had training and experience in areas	44
related to the duties of the database.	45

(B) Employ such professional, technical, and clerical	46
employees as are necessary, and employ or hire on a consulting	47
basis other technical services required for the operation of the	48
database;	49

(C) Fix the compensation of the administrator and all other	50
staff employed to operate the database.	51

Sec. 4729.77. (A) Each pharmacy licensed as a terminal	52
distributor of dangerous drugs that dispenses drugs to patients in	53
the state shall submit the following prescription information to	54
the state board of pharmacy:	55

(1) Terminal distributor identification;

56

(2) Patient identification;

57

(3) Prescriber identification;

58

(4) Date prescription was issued by prescriber;

59

(5) Date prescription was dispensed;

60

(6) Indication of whether prescription dispensed is new or a	61
refill;	62

(7) Name, strength, and national drug code of the drug	63
dispensed;	64

(8) Quantity of drug dispensed;

65

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

66

(10) Serial or prescription number assigned by the terminal	67
distributor;	68

(11) Source of payment for the prescription.

69

(B) Information shall be submitted electronically in the	70
format specified by the board unless a waiver has been granted by	71
the board to the terminal distributor.	72

(C) Information shall be transmitted as designated by rule of	73
the board, unless the board grants an extension.	74

An extension may be granted if either of the following	75
occurs:	76

(1) The distributor suffers a mechanical or electronic	77
failure, or cannot meet the deadline established by this division	78
for other reasons beyond the distributor's control.	79

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

80

(D) This section does not apply to a prescriber personally	81
furnishing or administering dangerous drugs to the prescriber's	82
patient.	83

Sec. 4729.78. (A) Each wholesale distributor of dangerous	84
drugs that delivers drugs to prescribers in the state shall submit	85
the following purchase information to the state board of pharmacy:	86

(1) Purchaser identification;

87

(2) Identification of the drug sold;

88

(3) Quantity of the drug sold;

89

(4) Date of sale;

90

(5) The wholesale distributor's license number issued by the	91
board.	92

(B) The information shall be submitted electronically in the	93
format specified by the state board of pharmacy unless a waiver	94
has been granted by the board to the distributor.	95

(C) Information shall be transmitted as designated by rule of	96
the board unless the board grants an extension.	97

An extension may be granted if either of the following	98
occurs:	99

(1) The distributor suffers a mechanical or electronic	100
failure, or cannot meet the deadline established by this division	101
for other reasons beyond the distributor's control.	102

(2) The board of pharmacy is unable to receive electronic	103
submissions.	104

Sec. 4729.79. (A) The state board of pharmacy may provide	105
information from the drug database to all of the following:	106

(1) A person who is a designated representative of a	107
government entity responsible for the licensure, regulation, or	108
discipline of licensed health care professionals authorized to	109
prescribe drugs and is involved in an investigation of a person	110
licensed, regulated, or subject to discipline by the entity;	111

(2) A federal, state, county, township, or municipal officer	112
of this or any other state, or the United States, whose duty is to	113
enforce the laws relating to drugs and who is actively engaged in	114
a specific investigation;	115

(3) A properly convened grand jury pursuant to a subpoena	116
properly issued;	117

(4) A pharmacist or prescriber who requests the information	118
and certifies in a form specified by the board that it is for the	119
purpose of providing medical or pharmaceutical treatment to a	120
current patient of the pharmacist or prescriber;	121

(5) An individual who requests the individual's own database	122
information in accordance with the procedure established in rules	123
adopted under section 4729.81 of the Revised Code.	124

(B) The state board of pharmacy shall maintain a record of	125
each individual or entity that requests information from the	126
database. Pursuant to rules adopted by the board under section	127
4729.81 of the Revised Code, the board may use the records to	128
document and report statistics and law enforcement outcomes.	129

The board may provide records of an individual's requests for	130
database information to the following individuals:	131

(1) A designated representative of a government entity that	132
is responsible for the licensure, regulation, or discipline of	133
licensed health care professionals authorized to prescribe drugs	134
who is involved in a specific investigation of the individual who	135
submitted the request;	136

(2) A federal, state, county, township, or municipal officer	137
of this or any other state, or the United States, whose duty is to	138
enforce the laws relating to drugs and who is actively engaged in	139
a specific investigation of the individual who submitted the	140
request.	141

(C) Information contained in the database and any information	142
obtained from it is not a public record. Information contained in	143
the records of requests for information from the database is not a	144
public record.	145

(D) Information collected for the database shall be retained	146
in the database for two years. It shall then be destroyed unless a	147
law enforcement agency or a government entity responsible for the	148
licensure, regulation, or discipline of licensed health care	149
professionals authorized to prescribe drugs has submitted a	150
written request to the board for retention of specific information	151
in accordance with rules adopted by the board under this chapter.	152

(E) Nothing in this section requires a pharmacist or	153
prescriber to obtain information about a patient from the	154
database. A pharmacist or prescriber shall not be held liable in	155
damages to any person in any civil action for injury, death, or	156
loss to person or property on the basis that the pharmacist or	157
prescriber did or did not seek or obtain information from the	158
database.	159

(F) The state board of pharmacy shall not impose any charge	160
on a terminal distributor of dangerous drugs, pharmacist, or	161
prescriber for the establishment or maintenance of the database.	162
The board shall not charge any fees for the transmission of data	163
to the database or for the receipt of information from the	164
database, except that the board may charge a fee in accordance	165
with rules adopted under section 4729.81 of the Revised Code to an	166
individual who requests the individual's own database information.	167

Sec. 4729.80. The state board of pharmacy shall review the	168
information in the drug database. If the board determines that a	169
violation of law may have occurred, it shall notify the appropriate	170
law enforcement agency or a government entity responsible for the	171
licensure, regulation, or discipline of licensed health care	172
professionals authorized to prescribe drugs and supply information	173
required for an investigation.	174

Sec. 4729.81. (A) In addition to rules adopted under section	175
4729.26 of the Revised Code, the state board of pharmacy shall	176
adopt rules in accordance with Chapter 119. of the Revised Code to	177
carry out the purposes of and enforce sections 4729.75 to 4729.80	178
of the Revised Code. The rules shall specify all of the following:	179

(1) A means of identifying each patient, terminal	180
distributor, and each purchase at wholesale of dangerous drugs	181
about which information is entered into the drug database;	182

(2) An electronic format for the submission of information	183
from terminal distributors and wholesale distributors of dangerous	184
drugs;	185

(3) A procedure whereby a terminal distributor or a wholesale	186
distributor of dangerous drugs unable to submit information	187
electronically may obtain a waiver to submit information in	188
another format;	189

(4) A procedure whereby the board may grant a request from a	190
law enforcement agency or a government entity responsible for the	191
licensure, regulation, or discipline of licensed health care	192
professionals authorized to prescribe drugs that information that	193
has been stored for two years be retained when the information	194
pertains to an open investigation being conducted by the agency or	195
entity;	196

(5) A procedure whereby a terminal or wholesale distributor	197
may apply for an extension to the time by which information must	198
be transmitted to the board;	199

(6) A procedure whereby a person or government entity to	200
which the board is authorized to provide information may submit a	201
request to the board for the information and the board may verify	202
the identity of the requestor;	203

(7) A procedure whereby the board can use the database	204
request records required by division (B) of section 4729.77 of the	205
Revised Code to document and report statistics and law enforcement	206
outcomes;	207

(8) A procedure whereby an individual may request the	208
individual's own database information and the board may verify the	209
identity of the requestor;	210

(9) A reasonable fee that the board shall assess for	211
providing an individual with the individual's own database	212
information pursuant to division (A)(5) of section 4729.79 of the	213
Revised Code.	214

(10) The specific dangerous drugs other than controlled	215
substances that must be included in the database.	216

(B) The board shall designate which types of terminal	217
distributors of dangerous drugs shall be required to submit	218
prescription information to the board pursuant to section 4729.77	219
of the Revised Code.	220

(C) Two years after the effective date of this section and	221
every two years thereafter, the board shall present to the	222
standing committees of the house of representatives and the senate	223
that are primarily responsible for considering health and human	224
services issues a report of the following:	225

(1) The cost to the state of implementing and maintaining the	226
database;	227

(2) Information from terminal distributors, prescribers, and	228
the state board of pharmacy regarding the board's effectiveness in	229
providing information from the database;	230

(3) The board's timeliness in transmitting information from	231
the drug database.	232

Section 2. That existing sections 4729.25 and 4729.26 and	233
sections        Sec. 4729.63.  and        Sec. 4729.66.  of the Revised Code are hereby	234
repealed.	235