September 20, 2012, Introduced by Rep. Liss and referred to the Committee on Health Policy.
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending sections 17745, 17751, 17754, and 17757 (MCL 333.17745,
333.17751, 333.17754, and 333.17757), sections 17745 and 17757 as
amended by 2011 PA 210 and sections 17751 and 17754 as amended by
2012 PA 209, and by adding section 5110.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 5110. (1) To protect and promote the public health of
individuals in this state, expedited partner therapy is authorized
as provided in this section. Expedited partner therapy is
authorized to protect individuals in this state from the spread of
gonorrhea and chlamydia, each of which can cause infertility and
ectopic pregnancies. The department may promulgate rules under the
administrative procedures act of 1969 that it determines necessary
to implement and administer this section.
(2) In addition to treating his or her patient, a health
professional may provide expedited partner therapy if all of the
following requirements are met:
(a) The patient has a laboratory-confirmed or suspected
clinical diagnosis of a gonorrhea or chlamydia infection.
(b) The patient indicates that he or she has a partner with
whom the patient has engaged in sexual activity within the 60-day
period immediately before the diagnosis of a gonorrhea or chlamydia
infection.
(c) The patient indicates that his or her partner is unable or
is unlikely to seek clinical services in a timely manner.
(3) A health professional who provides expedited partner
therapy as authorized in this section shall do all of the
following:
(a) Dispense or prescribe single-dose antibiotic therapy in
the name of the partner, if known, without the physical examination
of the partner by the health professional. Notwithstanding any
provision of this act or rules to the contrary, if the name of the
partner is not known, the health professional shall dispense or
prescribe the single-dose antibiotic therapy in the name of
"expedited partner therapy".
(b) Convey to the patient that it is important to notify his
or her partner of his or her diagnosis and that it is important for
the partner to obtain medical care for a complete evaluation,
testing for sexually transmitted diseases, counseling, and
treatment.
(c) Distribute to the patient the information sheet developed
under subsection (4).
(4) The department shall develop and, upon request, distribute
to health professionals subject to this section an information
sheet that includes all of the following information:
(a) A description of expedited partner therapy and its
purpose.
(b) A notice that an individual who has been treated for a
gonorrhea or chlamydia infection should be retested 3 months after
treatment to detect possible persistent or recurrent gonorrhea or
chlamydia infection.
(c) A warning about the dangers of administering single-dose
antibiotic therapy to a pregnant individual.
(d) Information about antibiotics dispensed or prescribed in
single-dose antibiotic therapy and dosages of those antibiotics
dispensed or prescribed.
(e) A warning about the risk of allergies to and drug
interactions with the antibiotics described in subdivision (d).
(f) Information about sexually transmitted diseases, the
treatment of sexually transmitted diseases, and the prevention of
sexually transmitted diseases.
(g) A notice that the patient and his or her partner should
abstain from sexual activity for 7 days after the patient and his
or her partner have both completed the single-dose antibiotic
therapy.
(h) A notice that the partner should be tested for sexually
transmitted diseases.
(i) A notice of the risk to the patient, his or her partner,
and others, including the public health, if a sexually transmitted
disease is not completely treated.
(j) A notice of the responsibility of the patient to notify
his or her sexual partners of the risk of sexually transmitted
diseases and the importance of examination and treatment for
sexually transmitted diseases.
(k) A statement advising any individual who has any questions
regarding anything in the information sheet to contact his or her
health professional or local health department.
(5) Except as otherwise provided in this subsection, a health
care professional who provides expedited partner therapy as
authorized under this section is not subject to prosecution in a
criminal proceeding, liable for damages in a civil action, or
subject to administrative action under sections 16221 and 16226 for
personal injury, death, or other consequences arising from or
related in any way to the provision of expedited partner therapy by
the health care professional. This subsection does not apply if the
action of the health care professional in providing expedited
partner therapy is gross negligence.
(6) As used in this section:
(a) "Expedited partner therapy" is the indirect treatment of a
partner of a patient who has been diagnosed as having a gonorrhea
or chlamydia infection through the dispensing or prescribing of
single-dose antibiotic therapy for the treatment of the partner
without the physical examination of the partner by a health
professional.
(b) "Gross negligence" means conduct so reckless as to
demonstrate a substantial lack of concern for whether an injury
results.
(c) "Health professional" means any of the following:
(i) An individual licensed or otherwise authorized to engage in
a health profession under article 15 and whose scope of practice
includes the diagnosis and treatment of gonorrhea and chlamydia
infections.
(ii) For the purpose of dispensing single-dose antibiotic
therapy under this section, a pharmacist who is licensed or
otherwise authorized to engage in the practice of pharmacy under
article 15.
(d) "Sexual activity" includes sexual contact and sexual
penetration as those terms are defined in section 5129.
(e) "Sexually transmitted disease" includes gonorrhea,
chlamydia, human immunodeficiency virus, and other diseases or
infections generally acquired through sexual activity.
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)
A Except as otherwise authorized
for expedited partner
therapy in section 5110, 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 and including expedited partner therapy
provided as authorized under section 5110. 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, and prescription drugs prescribed for the
patient,
and prescription drugs dispensed or prescribed for expedited
partner therapy as authorized under section 5110. 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)
The Except as otherwise authorized
for expedited partner
therapy in section 5110, 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, shall list 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 required in this subsection, either by
dispensing the complimentary starter dose drug to the patient in a
container that bears a label containing the required information or
by
giving the patient a written document which that may
include,
but is not limited to, a preprinted insert that comes with the
complimentary
starter dose drug , and
that contains the required
information. The information required to be given to the patient
under this subsection includes all of the following:
(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)
That Except as otherwise
authorized for expedited partner
therapy in section 5110, 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
and the federal act, a prescription may be transmitted
electronically
as long as 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)
The Except as otherwise
authorized for expedited partner
therapy in section 5110, 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)
Prior to 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 shall not be 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 which 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 copy of the notice required under subsection (2) shall
be provided to each licensee by the department. Additional copies
shall be available if needed from the department. 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 whatsoever.
(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 that
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, shall list the name of the
delegatee.
(i)
The Except as otherwise authorized
for expedited partner
therapy in section 5110, the name of the patient for whom the drug
was prescribed.
(j) The price for which the drug was sold to the purchaser.
(7) Subsection (6)(a), (b), and (c) may be omitted from a
receipt by a pharmacist only if the omission is expressly required
by the prescriber. The pharmacist shall retain a copy of each
receipt furnished under subsection (6) for 90 days. The inclusion
of the information required under subsection (6) on the
prescription container label is a valid receipt to the purchaser.
Including the information 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.