Bill Text: MI HB5643 | 2011-2012 | 96th Legislature | Introduced
Bill Title: Occupations; pharmacists; generic substitution of an opioid drug; regulate, and require use of a tamper-resistance technology. Amends sec. 17755 of 1978 PA 368 (MCL 333.17755) & adds sec. 17755a.
Spectrum: Moderate Partisan Bill (Republican 5-1)
Status: (Introduced - Dead) 2012-05-17 - Printed Bill Filed 05/17/2012 [HB5643 Detail]
Download: Michigan-2011-HB5643-Introduced.html
HOUSE BILL No. 5643
May 16, 2012, Introduced by Reps. Lori, Haines, Tyler, Graves, Wayne Schmidt and Hobbs and referred to the Committee on Health Policy.
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending section 17755 (MCL 333.17755) and by adding section
17755a.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec.
17755. (1) When If a pharmacist receives a prescription
for
a brand name drug product, the pharmacist may, or when if a
purchaser requests a lower cost generically equivalent drug
product, the pharmacist shall dispense a lower cost but not higher
cost generically equivalent drug product if available in the
pharmacy, except as provided in subsection (3) and section 17755a.
If
a drug is dispensed which that
is not the prescribed brand, the
pharmacist
shall notify the purchaser shall be
notified and
indicate
on the prescription label shall
indicate both the name of
the brand prescribed and the name of the brand dispensed and
designate each respectively. If the dispensed drug does not have a
brand name, the pharmacist shall indicate on the prescription label
shall
indicate the generic name of the
drug dispensed, except as
otherwise provided in section 17756.
(2) If a pharmacist dispenses a generically equivalent drug
product, the pharmacist shall pass on the savings in cost to the
purchaser or to the third party payment source if the prescription
purchase is covered by a third party pay contract. The savings in
cost is the difference between the wholesale cost to the pharmacist
of the 2 drug products.
(3)
The A pharmacist shall not dispense a generically
equivalent drug product under subsection (1) if any of the
following applies:
(a) The prescriber, in the case of a prescription in writing
signed by the prescriber, writes in his or her own handwriting
"dispense as written" or "d.a.w." on the prescription.
(b) The prescriber, having preprinted on his or her
prescription blanks the statement "another brand of a generically
equivalent product, identical in dosage, form, and content of
active ingredients, may be dispensed unless initialed d.a.w.",
writes in his or her own handwriting, the initials "d.a.w." in a
space, box, or square adjacent to the statement.
(c) The prescriber, in the case of a prescription other than
one in writing signed by the prescriber, expressly indicates the
prescription is to be dispensed as communicated.
(4) A pharmacist may not dispense a drug product with a total
charge that exceeds the total charge of the drug product originally
prescribed, unless agreed to by the purchaser.
Sec. 17755a. (1) The Michigan board of pharmacy shall create a
list of the opioid analgesic drugs for which it has received
evidence from the drug manufacturer or distributor that the drug
meets all of the following:
(a) It incorporates a tamper-resistance technology.
(b) It has been approved by the United States food and drug
administration pursuant to an application that included at least 1
human tampering or abuse potential study or a laboratory study
comparing the tamper-resistance or abuse-resistance properties of
the drug to 1 or more opioid analgesic drugs that have been
approved by the United States food and drug administration and that
serve as a positive control.
(2) The Michigan board of pharmacy may not exclude an opioid
analgesic drug from the list described in subsection (1) because
the drug does not bear a labeling claim with respect to reduction
of tampering, abuse, or abuse potential at the time the drug is
included in the list. The list shall also include a determination
by the board as to which opioid analgesic drugs incorporating
tamper-resistance technologies included on the list provide
substantially similar tamper-resistance properties, based solely on
studies submitted to the United States food and drug administration
by the drug manufacturer and described in subsection (1)(b)
(3) A pharmacist shall not interchange or substitute an opioid
analgesic drug, brand or generic, otherwise eligible for
interchange or substitution under section 17755 for an opioid
analgesic drug incorporating a tamper-resistance technology without
doing 1 of the following:
(a) Verifying that the Michigan board of pharmacy has
determined under subsection (2) that the opioid analgesic drug
provides tamper-resistance properties substantially similar to the
prescribed opioid analgesic drug incorporating a tamper-resistance
technology.
(b) Obtaining written, signed consent from the prescriber for
the interchange or substitution.
(4) As used in this section:
(a) "Interchange or substitution of an opioid analgesic drug"
means the substitution of any opioid analgesic drug, brand or
generic, for a prescribed opioid analgesic drug incorporating a
tamper-resistance technology, whether or not the substituted drug
is rated as pharmaceutically and therapeutically equivalent by the
United States food and drug administration or Michigan board of
pharmacy or whether the opioid analgesic drug with tamper-
resistance technology bears a labeling claim with respect to
reduction of tampering, abuse, or abuse potential.
(b) "Opioid analgesic drug" means a drug in the opioid drug
class prescribed to treat moderate to severe pain or other
conditions, including opioid dependence, whether in immediate
release or extended release form and whether or not combined with
other drug substances to form a single tablet or other dosage form.
(c) "Opioid analgesic drug incorporating a tamper-resistance
technology" means an opioid analgesic drug listed as such by the
Michigan board of pharmacy under subsection (1).
