S. B. No. 114 As Introduced

As Introduced

127th General Assembly

Regular Session

2007-2008

S. B. No. 114

Senator Coughlin

Cosponsors: Senators Gardner, Cafaro

A BILL

To amend sections 4729.38 and 4729.99 and to enact 1
section 4729.382 of the Revised Code regarding 2
substitution of drugs intended to treat epilepsy. 3

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

       Section 1. That sections 4729.38 and 4729.99 be amended and 4
section 4729.382 of the Revised Code be enacted to read as 5
follows: 6

       Sec. 4729.38. (A) Unless instructed otherwise by the person 7
receiving the drug pursuant to the prescription, a pharmacist 8
filling a prescription for a drug prescribed by its brand name may 9
select a generically equivalent drug, as defined in section 10
3715.01 of the Revised Code, subject to the following conditions: 11

       (1) The pharmacist shall not select a generically equivalent 12
drug if the prescriber handwrites "dispense as written," or 13
"D.A.W.," on the written prescription, or, when ordering a 14
prescription electronically or orally, the prescriber specifies 15
that the prescribed drug is medically necessary. These 16
designations shall not be preprinted or stamped on the 17
prescription. Division (A)(1) of this section does not preclude a 18
reminder of the procedure required to prohibit the selection of a 19
generically equivalent drug from being preprinted on the 20
prescription. 21

       (2) The pharmacist shall not select a generically equivalent 22
drug unless its price to the patient is less than or equal to the 23
price of the prescribed drug. 24

       (3) The pharmacist, or the pharmacist's agent, assistant, or 25
employee shall inform the patient or the patient's agent if a 26
generically equivalent drug is available at a lower or equal cost, 27
and of the person's right to refuse the drug selected. Division 28
(A)(3) of this section does not apply to any: 29

       (a) Prescription that is billed to any agency, division, or 30
department of this state which will reimburse the pharmacy; 31

       (b) Prescriptions for patients of a hospital, nursing home, 32
or similar patient care facility. 33

       (4) If the drug is prescribed to treat epilepsy, the 34
pharmacist receives the statement required by section 4729.382 of 35
the Revised Code. 36

       (B) Unless the prescriber instructs otherwise, the label for 37
every drug dispensed shall include the drug's brand name, if any, 38
or its generic name and the name of the distributor, using 39
abbreviations if necessary. When dispensing at retail a 40
generically equivalent drug for the brand name drug prescribed, 41
the pharmacist shall indicate on the drug's label or container 42
that a generic substitution was made. The labeling requirements 43
established by this division are in addition to all other labeling 44
requirements of Chapter 3715. of the Revised Code. 45

       (C) A pharmacist who selects a generically equivalent drug 46
pursuant to this section assumes no greater liability for 47
selecting the dispensed drug than would be incurred in filling a 48
prescription for a drug prescribed by its brand name. 49

       (D) The failure of a prescriber to restrict a prescription by 50
specifying "dispense as written," or "D.A.W.," pursuant to 51
division (A)(1) of this section shall not constitute evidence of 52
the prescriber's negligence unless the prescriber had reasonable 53
cause to believe that the health condition of the patient for whom 54
the drug was intended warranted the prescription of a specific 55
brand name drug and no other. No prescriber shall be liable for 56
civil damages or in any criminal prosecution arising from the 57
interchange of a generically equivalent drug for a prescribed 58
brand name drug by a pharmacist, unless the prescribed brand name 59
drug would have reasonably caused the same loss, damage, injury, 60
or death. 61

       Sec. 4729.382. (A) As used in this section: 62

       (1) "Epilepsy drug" means a drug prescribed for the treatment 63
of epilepsy or a drug prescribed to treat or prevent seizures. 64

       (2) "Epilepsy" means a neurological condition characterized 65
by recurrent seizures. 66

       (3) "Seizure" means a brief disturbance in the electrical 67
activity of the brain. 68

       (4) "Interchange" means the substitution of a generically 69
equivalent drug for the prescribed drug, or substitution of a 70
different drug for the drug prescribed, including any of the 71
following: 72

       (a) The substitution of a generic brand of the drug for the 73
brand prescribed; 74

       (b) The substitution of one generic brand of the drug for 75
another generic brand; 76

       (c) The substitution of one formulation of the drug for 77
another; 78

       (d) The substitution of one therapeutic drug treatment for 79
another. 80

       (B) A pharmacist shall not knowingly interchange a prescribed 81
epilepsy drug without notifying the prescriber and receiving a 82
signed statement consenting to the interchange from the prescriber 83
and either the patient or the patient's parent, legal guardian, or 84
spouse. 85

       Sec. 4729.99. (A) Whoever violates section 4729.16, division 86
(A) or (B) of section 4729.38, or section 4729.382 or 4729.57 of 87
the Revised Code is guilty of a minor misdemeanor. Each day's 88
violation constitutes a separate offense. 89

       (B) Whoever violates section 4729.27, 4729.28, or 4729.36 of 90
the Revised Code is guilty of a misdemeanor of the third degree. 91
Each day's violation constitutes a separate offense. If the 92
offender previously has been convicted of or pleaded guilty to a 93
violation of this chapter, that person is guilty of a misdemeanor 94
of the second degree. 95

       (C) Whoever violates section 4729.32, 4729.33, or 4729.34 of 96
the Revised Code is guilty of a misdemeanor. 97

       (D) Whoever violates division (A), (B), (D), or (E) of 98
section 4729.51 of the Revised Code is guilty of a misdemeanor of 99
the first degree. 100

       (E)(1) Whoever violates section 4729.37, division (C)(2) of 101
section 4729.51, division (J) of section 4729.54, or section 102
4729.61 of the Revised Code is guilty of a felony of the fifth 103
degree. If the offender previously has been convicted of or 104
pleaded guilty to a violation of this chapter or a violation of 105
Chapter 2925. or 3719. of the Revised Code, that person is guilty 106
of a felony of the fourth degree. 107

       (2) If an offender is convicted of or pleads guilty to a 108
violation of section 4729.37, division (C) of section 4729.51, 109
division (J) of section 4729.54, or section 4729.61 of the Revised 110
Code, if the violation involves the sale, offer to sell, or 111
possession of a schedule I or II controlled substance, with the 112
exception of marihuana, and if the court imposing sentence upon 113
the offender finds that the offender as a result of the violation 114
is a major drug offender, as defined in section 2929.01 of the 115
Revised Code, and is guilty of a specification of the type 116
described in section 2941.1410 of the Revised Code, the court, in 117
lieu of the prison term authorized or required by division (E)(1) 118
of this section and sections 2929.13 and 2929.14 of the Revised 119
Code and in addition to any other sanction imposed for the offense 120
under sections 2929.11 to 2929.18 of the Revised Code, shall 121
impose upon the offender, in accordance with division (D)(3)(a) of 122
section 2929.14 of the Revised Code, the mandatory prison term 123
specified in that division and may impose an additional prison 124
term under division (D)(3)(b) of that section. 125

       (3) Notwithstanding any contrary provision of section 3719.21 126
of the Revised Code, the clerk of court shall pay any fine imposed 127
for a violation of section 4729.37, division (C) of section 128
4729.51, division (J) of section 4729.54, or section 4729.61 of 129
the Revised Code pursuant to division (A) of section 2929.18 of 130
the Revised Code in accordance with and subject to the 131
requirements of division (F) of section 2925.03 of the Revised 132
Code. The agency that receives the fine shall use the fine as 133
specified in division (F) of section 2925.03 of the Revised Code. 134

       (F) Whoever violates section 4729.531 of the Revised Code or 135
any rule adopted thereunder or section 4729.532 of the Revised 136
Code is guilty of a misdemeanor of the first degree. 137

       (G) Whoever violates division (C)(1) of section 4729.51 of 138
the Revised Code is guilty of a felony of the fourth degree. If 139
the offender has previously been convicted of or pleaded guilty to 140
a violation of this chapter, or of a violation of Chapter 2925. or 141
3719. of the Revised Code, that person is guilty of a felony of 142
the third degree. 143

       (H) Whoever violates division (C)(3) of section 4729.51 of 144
the Revised Code is guilty of a misdemeanor of the first degree. 145
If the offender has previously been convicted of or pleaded guilty 146
to a violation of this chapter, or of a violation of Chapter 2925. 147
or 3719. of the Revised Code, that person is guilty of a felony of 148
the fifth degree. 149

       Section 2. That existing sections 4729.38 and 4729.99 of the 150
Revised Code are hereby repealed. 151

Section 1. That sections 4729.38 and 4729.99 be amended and	4
section 4729.382 of the Revised Code be enacted to read as	5
follows:	6

Sec. 4729.38. (A) Unless instructed otherwise by the person	7
receiving the drug pursuant to the prescription, a pharmacist	8
filling a prescription for a drug prescribed by its brand name may	9
select a generically equivalent drug, as defined in section	10
3715.01 of the Revised Code, subject to the following conditions:	11

(1) The pharmacist shall not select a generically equivalent	12
drug if the prescriber handwrites "dispense as written," or	13
"D.A.W.," on the written prescription, or, when ordering a	14
prescription electronically or orally, the prescriber specifies	15
that the prescribed drug is medically necessary. These	16
designations shall not be preprinted or stamped on the	17
prescription. Division (A)(1) of this section does not preclude a	18
reminder of the procedure required to prohibit the selection of a	19
generically equivalent drug from being preprinted on the	20
prescription.	21

(2) The pharmacist shall not select a generically equivalent	22
drug unless its price to the patient is less than or equal to the	23
price of the prescribed drug.	24

(3) The pharmacist, or the pharmacist's agent, assistant, or	25
employee shall inform the patient or the patient's agent if a	26
generically equivalent drug is available at a lower or equal cost,	27
and of the person's right to refuse the drug selected. Division	28
(A)(3) of this section does not apply to any:	29

(a) Prescription that is billed to any agency, division, or	30
department of this state which will reimburse the pharmacy;	31

(b) Prescriptions for patients of a hospital, nursing home,	32
or similar patient care facility.	33

(4) If the drug is prescribed to treat epilepsy, the	34
pharmacist receives the statement required by section 4729.382 of	35
the Revised Code.	36

(B) Unless the prescriber instructs otherwise, the label for	37
every drug dispensed shall include the drug's brand name, if any,	38
or its generic name and the name of the distributor, using	39
abbreviations if necessary. When dispensing at retail a	40
generically equivalent drug for the brand name drug prescribed,	41
the pharmacist shall indicate on the drug's label or container	42
that a generic substitution was made. The labeling requirements	43
established by this division are in addition to all other labeling	44
requirements of Chapter 3715. of the Revised Code.	45

(C) A pharmacist who selects a generically equivalent drug	46
pursuant to this section assumes no greater liability for	47
selecting the dispensed drug than would be incurred in filling a	48
prescription for a drug prescribed by its brand name.	49

(D) The failure of a prescriber to restrict a prescription by	50
specifying "dispense as written," or "D.A.W.," pursuant to	51
division (A)(1) of this section shall not constitute evidence of	52
the prescriber's negligence unless the prescriber had reasonable	53
cause to believe that the health condition of the patient for whom	54
the drug was intended warranted the prescription of a specific	55
brand name drug and no other. No prescriber shall be liable for	56
civil damages or in any criminal prosecution arising from the	57
interchange of a generically equivalent drug for a prescribed	58
brand name drug by a pharmacist, unless the prescribed brand name	59
drug would have reasonably caused the same loss, damage, injury,	60
or death.	61

(1) "Epilepsy drug" means a drug prescribed for the treatment	63
of epilepsy or a drug prescribed to treat or prevent seizures.	64

(2) "Epilepsy" means a neurological condition characterized	65
by recurrent seizures.	66

(3) "Seizure" means a brief disturbance in the electrical	67
activity of the brain.	68

(4) "Interchange" means the substitution of a generically	69
equivalent drug for the prescribed drug, or substitution of a	70
different drug for the drug prescribed, including any of the	71
following:	72

(a) The substitution of a generic brand of the drug for the	73
brand prescribed;	74

(b) The substitution of one generic brand of the drug for	75
another generic brand;	76

(c) The substitution of one formulation of the drug for	77
another;	78

(d) The substitution of one therapeutic drug treatment for	79
another.	80

(B) A pharmacist shall not knowingly interchange a prescribed	81
epilepsy drug without notifying the prescriber and receiving a	82
signed statement consenting to the interchange from the prescriber	83
and either the patient or the patient's parent, legal guardian, or	84
spouse.	85

Sec. 4729.99. (A) Whoever violates section 4729.16, division	86
(A) or (B) of section 4729.38, or section 4729.382 or 4729.57 of	87
the Revised Code is guilty of a minor misdemeanor. Each day's	88
violation constitutes a separate offense.	89

(B) Whoever violates section 4729.27, 4729.28, or 4729.36 of	90
the Revised Code is guilty of a misdemeanor of the third degree.	91
Each day's violation constitutes a separate offense. If the	92
offender previously has been convicted of or pleaded guilty to a	93
violation of this chapter, that person is guilty of a misdemeanor	94
of the second degree.	95

(C) Whoever violates section 4729.32, 4729.33, or 4729.34 of	96
the Revised Code is guilty of a misdemeanor.	97

(D) Whoever violates division (A), (B), (D), or (E) of	98
section 4729.51 of the Revised Code is guilty of a misdemeanor of	99
the first degree.	100

(E)(1) Whoever violates section 4729.37, division (C)(2) of	101
section 4729.51, division (J) of section 4729.54, or section	102
4729.61 of the Revised Code is guilty of a felony of the fifth	103
degree. If the offender previously has been convicted of or	104
pleaded guilty to a violation of this chapter or a violation of	105
Chapter 2925. or 3719. of the Revised Code, that person is guilty	106
of a felony of the fourth degree.	107

(2) If an offender is convicted of or pleads guilty to a	108
violation of section 4729.37, division (C) of section 4729.51,	109
division (J) of section 4729.54, or section 4729.61 of the Revised	110
Code, if the violation involves the sale, offer to sell, or	111
possession of a schedule I or II controlled substance, with the	112
exception of marihuana, and if the court imposing sentence upon	113
the offender finds that the offender as a result of the violation	114
is a major drug offender, as defined in section 2929.01 of the	115
Revised Code, and is guilty of a specification of the type	116
described in section 2941.1410 of the Revised Code, the court, in	117
lieu of the prison term authorized or required by division (E)(1)	118
of this section and sections 2929.13 and 2929.14 of the Revised	119
Code and in addition to any other sanction imposed for the offense	120
under sections 2929.11 to 2929.18 of the Revised Code, shall	121
impose upon the offender, in accordance with division (D)(3)(a) of	122
section 2929.14 of the Revised Code, the mandatory prison term	123
specified in that division and may impose an additional prison	124
term under division (D)(3)(b) of that section.	125

(3) Notwithstanding any contrary provision of section 3719.21	126
of the Revised Code, the clerk of court shall pay any fine imposed	127
for a violation of section 4729.37, division (C) of section	128
4729.51, division (J) of section 4729.54, or section 4729.61 of	129
the Revised Code pursuant to division (A) of section 2929.18 of	130
the Revised Code in accordance with and subject to the	131
requirements of division (F) of section 2925.03 of the Revised	132
Code. The agency that receives the fine shall use the fine as	133
specified in division (F) of section 2925.03 of the Revised Code.	134

(F) Whoever violates section 4729.531 of the Revised Code or	135
any rule adopted thereunder or section 4729.532 of the Revised	136
Code is guilty of a misdemeanor of the first degree.	137

(G) Whoever violates division (C)(1) of section 4729.51 of	138
the Revised Code is guilty of a felony of the fourth degree. If	139
the offender has previously been convicted of or pleaded guilty to	140
a violation of this chapter, or of a violation of Chapter 2925. or	141
3719. of the Revised Code, that person is guilty of a felony of	142
the third degree.	143

(H) Whoever violates division (C)(3) of section 4729.51 of	144
the Revised Code is guilty of a misdemeanor of the first degree.	145
If the offender has previously been convicted of or pleaded guilty	146
to a violation of this chapter, or of a violation of Chapter 2925.	147
or 3719. of the Revised Code, that person is guilty of a felony of	148
the fifth degree.	149