Bill Text: MI SB0860 | 2013-2014 | 97th Legislature | Engrossed
Bill Title: Health; pharmaceuticals; opioid antagonist including naloxone hydrochloride; allow prescribers to prescribe and pharmacists to dispense under certain circumstances to friends or family of individuals who may suffer overdose, and require department to publish a report. Amends secs. 1106, 17745, 17751, 17754 & 17757 of 1978 PA 368 (MCL 333.1106 et seq.) & adds secs. 7421 & 17744b. TIE BAR WITH: SB 0721'13, SB 0858'14, SB 0859'14
Spectrum: Partisan Bill (Republican 11-0)
Status: (Engrossed - Dead) 2014-06-04 - Referred To Committee On Judiciary [SB0860 Detail]
Download: Michigan-2013-SB0860-Engrossed.html
SB-0860, As Passed Senate, June 4, 2014
SUBSTITUTE FOR
SENATE BILL NO. 860
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending sections 1106, 17745, 17751, 17754, and 17757 (MCL
333.1106, 333.17745, 333.17751, 333.17754, and 333.17757), section
1106 as amended by 2000 PA 58, sections 17745, 17751, and 17757 as
amended by 2013 PA 186, and section 17754 as amended by 2013 PA
268, and by adding sections 7421 and 17744b.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 1106. (1) "Opioid antagonist" means naloxone
hydrochloride or any other similarly acting and equally safe drug
approved by the federal food and drug administration for the
treatment of drug overdose.
(2) "Opioid-related overdose" means a condition, including,
but not limited to, extreme physical illness, decreased level of
consciousness, respiratory depression, coma, or death, that results
from the consumption or use of an opioid or another substance with
which an opioid was combined or that a layperson would reasonably
believe to be an opioid-related overdose that requires medical
assistance.
(3)
(1) "Parentage registry" means the
department's
compilation of data concerning children's parentage, which data the
department receives from any source, including, but not limited to,
a copy of an order of filiation from the circuit court or an
acknowledgment of paternity or parentage under this act, under
section 2114 of the estates and protected individuals code, 1998 PA
386, MCL 700.2114, or under the acknowledgment of parentage act,
1996 PA 305, MCL 722.1001 to 722.1013.
(4) (2)
"Person" means an
individual, partnership,
cooperative, association, private corporation, personal
representative, receiver, trustee, assignee, or other legal entity.
Person does not include a governmental entity unless specifically
provided.
Sec. 7421. By February 1 each year, the department shall
ascertain, document, and publish a report on the number, trends,
patterns, and risk factors related to opioid-related overdose
fatalities that occurred in this state in the preceding calendar
year. The department shall include in the report information on
interventions that would be effective in reducing the rate of fatal
or nonfatal opioid-related overdoses in this state.
Sec. 17744b. (1) Notwithstanding any provision of this act to
the contrary, a prescriber may issue a prescription for and a
dispensing prescriber or pharmacist may dispense an opioid
antagonist to any of the following:
(a) An individual patient at risk of experiencing an opioid-
related overdose.
(b) A family member, friend, or other individual in a position
to assist an individual at risk of experiencing an opioid-related
overdose.
(c) A person other than an individual that meets all of the
following requirements:
(i) Acts at the direction of the prescriber or dispensing
prescriber.
(ii) Upon receipt of an opioid antagonist, stores the opioid
antagonist in compliance with this part.
(iii) Dispenses or administers an opioid antagonist under a
valid prescription issued to an individual or a patient.
(iv) Performs the requirements under this subsection without
charge or compensation.
(2) When issuing a prescription for or dispensing an opioid
antagonist as authorized under this section to a person other than
a patient, the prescriber, dispensing prescriber, or pharmacist, as
appropriate, shall insert the name of the person as the name of the
patient.
(3) Notwithstanding any provision of this act to the contrary,
a person that is acting in good faith and with reasonable care may
possess and dispense an opioid antagonist.
(4) A prescriber who issues a prescription for or a dispensing
prescriber or pharmacist who dispenses an opioid antagonist as
authorized under this section is not liable in a civil action for a
properly stored and dispensed opioid antagonist that was a
proximate cause of injury or death to an individual due to the
administration of or failure to administer the opioid antagonist.
Sec. 17745. (1) Except as otherwise provided in this
subsection, a prescriber who wishes to dispense prescription drugs
shall obtain from the board a drug control license for each
location in which the storage and dispensing of prescription drugs
occur. A drug control license is not necessary if the dispensing
occurs in the emergency department, emergency room, or trauma
center of a hospital licensed under article 17 or if the dispensing
involves only the issuance of complimentary starter dose drugs.
(2) Except as otherwise provided in section 17744a or 17744b,
a dispensing prescriber shall dispense prescription drugs only to
his or her own patients.
(3) A dispensing prescriber shall include in a patient's chart
or clinical record a complete record, including prescription drug
names, dosages, and quantities, of all prescription drugs dispensed
directly by the dispensing prescriber or indirectly under his or
her delegatory authority. If prescription drugs are dispensed under
the prescriber's delegatory authority, the delegatee who dispenses
the prescription drugs shall initial the patient's chart, clinical
record, or log of prescription drugs dispensed. In a patient's
chart or clinical record, a dispensing prescriber shall distinguish
between prescription drugs dispensed to the patient, prescription
drugs prescribed for the patient, and prescription drugs dispensed
or prescribed as authorized under section 17744a or 17744b. A
dispensing prescriber shall retain information required under this
subsection for not less than 5 years after the information is
entered in the patient's chart or clinical record.
(4) A dispensing prescriber shall store prescription drugs
under conditions that will maintain their stability, integrity, and
effectiveness and will assure that the prescription drugs are free
of contamination, deterioration, and adulteration.
(5) A dispensing prescriber shall store prescription drugs in
a substantially constructed, securely lockable cabinet. Access to
the cabinet shall be limited to individuals authorized to dispense
prescription drugs in compliance with this part and article 7.
(6) Unless otherwise requested by a patient, a dispensing
prescriber shall dispense a prescription drug in a safety closure
container that complies with the poison prevention packaging act of
1970, 15 USC 1471 to 1477.
(7) A dispensing prescriber shall dispense a drug in a
container that bears a label containing all of the following
information:
(a) The name and address of the location from which the
prescription drug is dispensed.
(b) Except as otherwise authorized under section 17744a or
17744b, the patient's name and record number.
(c) The date the prescription drug was dispensed.
(d) The prescriber's name or, if dispensed under the
prescriber's delegatory authority, the name of the delegatee.
(e) The directions for use.
(f) The name and strength of the prescription drug.
(g) The quantity dispensed.
(h) The expiration date of the prescription drug or the
statement required under section 17756.
(8) A dispensing prescriber who dispenses a complimentary
starter dose drug to a patient shall give the patient at least all
of the following information, either by dispensing the
complimentary starter dose drug to the patient in a container that
bears a label containing the information or by giving the patient a
written document that may include, but is not limited to, a
preprinted insert that comes with the complimentary starter dose
drug, that contains all of the following information:
(a) The name and strength of the complimentary starter dose
drug.
(b) Directions for the patient's use of the complimentary
starter dose drug.
(c) The expiration date of the complimentary starter dose drug
or the statement required under section 17756.
(9) The information required under subsection (8) is in
addition to, and does not supersede or modify, other state or
federal law regulating the labeling of prescription drugs.
(10) In addition to meeting the requirements of this part, a
dispensing prescriber who dispenses controlled substances shall
comply with section 7303a.
(11) The board may periodically inspect locations from which
prescription drugs are dispensed.
(12) The act, task, or function of dispensing prescription
drugs shall be delegated only as provided in this part and sections
16215, 17048, 17076, 17212, and 17548.
(13) A supervising physician may delegate in writing to a
pharmacist practicing in a hospital pharmacy within a hospital
licensed under article 17 the receipt of complimentary starter dose
drugs other than controlled substances as defined by article 7 or
federal law. When the delegated receipt of complimentary starter
dose drugs occurs, both the pharmacist's name and the supervising
physician's name shall be used, recorded, or otherwise indicated in
connection with each receipt. A pharmacist described in this
subsection may dispense a prescription for complimentary starter
dose drugs written or transmitted by facsimile, electronic
transmission, or other means of communication by a prescriber.
(14) As used in this section, "complimentary starter dose"
means a prescription drug packaged, dispensed, and distributed in
accordance with state and federal law that is provided to a
dispensing prescriber free of charge by a manufacturer or
distributor and dispensed free of charge by the dispensing
prescriber to his or her patients.
Sec. 17751. (1) A pharmacist shall not dispense a drug
requiring a prescription under the federal act or a law of this
state except under authority of an original prescription or an
equivalent record of an original prescription approved by the
board.
(2) Subject to subsection (5), a pharmacist may dispense a
prescription written and signed; written or created in an
electronic format, signed, and transmitted by facsimile; or
transmitted electronically or by other means of communication by a
physician prescriber or dentist prescriber in a state other than
Michigan, but not including a prescription for a controlled
substance as defined in section 7104 except under circumstances
described in section 17763(e), only if the pharmacist in the
exercise of his or her professional judgment determines all of the
following:
(a) Except as otherwise authorized under section 17744a or
17744b, that the prescription was issued pursuant to an existing
physician-patient or dentist-patient relationship.
(b) That the prescription is authentic.
(c) That the prescribed drug is appropriate and necessary for
the treatment of an acute, chronic, or recurrent condition.
(3) A pharmacist or a prescriber shall dispense a prescription
only if the prescription falls within the scope of practice of the
prescriber.
(4) A pharmacist shall not knowingly dispense a prescription
after the death of the prescriber or patient.
(5) A pharmacist shall not dispense a drug or device under a
prescription transmitted by facsimile or created in electronic
format and printed out for use by the patient unless the document
is manually signed by the prescriber. This subsection does not
apply to a prescription that is transmitted by a computer to a
facsimile machine if that prescription complies with section 17754.
(6) After consultation with and agreement from the prescriber,
a pharmacist may add or change a patient's address, dosage form,
drug strength, drug quantity, directions for use, or issue date
with regard to a prescription. A pharmacist shall note the details
of the consultation and agreement required under this subsection on
the prescription and shall maintain that documentation with the
prescription as required in section 17752. A pharmacist shall not
change the patient's name, controlled substance prescribed unless
authorized to dispense a lower cost generically equivalent drug
product under section 17755, or the prescriber's signature with
regard to a prescription.
(7) A prescription that is contained within a patient's chart
in a health facility or agency licensed under article 17 or other
medical institution and that is transmitted to a pharmacy under
section 17744 is the original prescription. If all other
requirements of this part are met, a pharmacist shall dispense a
drug or device under a prescription described in this subsection. A
pharmacist may dispense a drug or device under a prescription
described in this subsection even if the prescription does not
contain the quantity ordered. If a prescription described in this
subsection does not contain the quantity ordered, the pharmacist
shall consult with the prescriber to determine an agreed-upon
quantity. The pharmacist shall record the quantity dispensed on the
prescription and shall maintain that documentation with the
prescription as required in section 17752.
Sec. 17754. (1) Except as otherwise provided under article 7,
article 8, and the federal act, a prescription may be transmitted
electronically if the prescription is transmitted in compliance
with the health insurance portability and accountability act of
1996, Public Law 104-191, or regulations promulgated under that
act, 45 CFR parts 160 and 164, by a prescriber or his or her agent
and the data are not altered or modified in the transmission
process. The electronically transmitted prescription shall include
all of the following information:
(a) The name, address, and telephone number of the prescriber.
(b) Except as otherwise authorized under section 17744a or
17744b, the full name of the patient for whom the prescription is
issued.
(c) An electronic signature or other identifier that
specifically identifies and authenticates the prescriber or his or
her agent.
(d) The time and date of the transmission.
(e) The identity of the pharmacy intended to receive the
transmission.
(f) Any other information required by the federal act or state
law.
(2) The electronic equipment or system utilized in the
transmission and communication of prescriptions shall provide
adequate confidentiality safeguards and be maintained to protect
patient confidentiality as required under any applicable federal
and state law and to ensure against unauthorized access. The
electronic transmission of a prescription shall be communicated in
a retrievable, recognizable form acceptable to the intended
recipient. The electronic form utilized in the transmission of a
prescription shall not include "dispense as written" or "d.a.w." as
the default setting.
(3) Before dispensing a prescription that is electronically
transmitted, the pharmacist shall exercise professional judgment
regarding the accuracy, validity, and authenticity of the
transmitted prescription.
(4) An electronically transmitted prescription that meets the
requirements of this section is the original prescription.
Sec. 17757. (1) Upon a request made in person or by telephone,
a pharmacist engaged in the business of selling drugs at retail
shall provide the current selling price of a drug dispensed by that
pharmacy or comparative current selling prices of generic and brand
name drugs dispensed by that pharmacy. The information shall be
provided to the person making the request before a drug is
dispensed to the person. A person who makes a request for price
information under this subsection is not obligated to purchase the
drug for which the price or comparative prices are requested.
(2) A pharmacist engaged in the business of selling drugs at
retail shall conspicuously display the notice described in
subsection (3) at each counter over which prescription drugs are
dispensed.
(3) The notice required under subsection (2) shall be in
substantially the following form:
NOTICE TO CONSUMERS
ABOUT PRESCRIPTION DRUGS
Under Michigan law, you have the right to find out the price
of a prescription drug before the pharmacist fills the
prescription. You are under no obligation to have the prescription
filled here and may use this price information to shop around at
other pharmacies. You may request price information in person or by
telephone.
Every pharmacy has the current selling prices of both generic
and brand name drugs dispensed by the pharmacy.
Ask your pharmacist if a lower-cost generic drug is available
to fill your prescription. A generic drug contains the same
medicine as a brand name drug and is a suitable substitute in most
instances.
A generic drug may not be dispensed by your pharmacist if your
doctor has written "dispense as written" or the initials "d.a.w."
on the prescription.
If you have questions about the drugs that have been
prescribed for you, ask your doctor or pharmacist for more
information.
To avoid dangerous drug interactions, let your doctor and
pharmacist know about any other medications you are taking. This is
especially important if you have more than 1 doctor or have
prescriptions filled at more than 1 pharmacy.
(4) The notice required under subsection (2) shall also
contain the address and phone number of the board and the
department. The text of the notice shall be in at least 32-point
bold type and shall be printed on paper at least 11 inches by 17
inches in size. The notice may be printed on multiple pages.
(5)
A The department shall
provide a copy of the notice
required
under subsection (2) shall be provided to each licensee.
by
the department. The department
shall provide additional copies
if needed. A person may duplicate or reproduce the notice if the
duplication or reproduction is a true copy of the notice as
produced by the department, without any additions or deletions.
Senate Bill No. 860 as amended June 4, 2014
(6) The pharmacist shall furnish to the purchaser of a
prescription drug at the time the drug is delivered to the
purchaser a receipt evidencing the transactions, which contains all
of the following:
(a) The brand name of the drug, if applicable.
(b) The name of the manufacturer or the supplier of the drug,
if the drug does not have a brand name.
(c) The strength of the drug, if significant.
(d) The quantity dispensed, if applicable.
(e) The name and address of the pharmacy.
(f) The serial number of the prescription.
(g) The date the prescription was originally dispensed.
(h) The name of the prescriber or, if prescribed under the
prescriber's delegatory authority, the name of the delegatee.
(i) Except as otherwise authorized under section 17744a or
17744b, the name of the patient for whom the drug was prescribed.
(j) The price for which the drug was sold to the purchaser.
(7) The items required under subsection (6)(a), (b), and (c)
may be omitted by a pharmacist only if the omission is expressly
required by the prescriber. The pharmacist shall retain a copy of
each receipt for 90 days. The inclusion of the items required under
subsection (6) on the prescription container label is a valid
receipt to the purchaser. Including the items required under
subsection (6) on the written prescription form and retaining the
form constitutes retention of a copy of the receipt.
(8) The board may promulgate rules to implement this section.
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