May 15, 2013, Introduced by Reps. Darany, Haines, Segal, McCann, Callton, Knezek, Schor, Dillon, Stallworth, Santana, Graves, Foster, Roberts, Brinks, Rutledge, Slavens, Irwin, Kosowski, Lipton, Cavanagh, Tlaib, Switalski, Durhal, Townsend, Faris and Smiley 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:
1 Sec. 5110. (1) To protect and promote the public health of
2 individuals in this state, expedited partner therapy is
3 authorized as provided in this section. Expedited partner therapy
4 is authorized to protect individuals in this state from the
5 spread of sexually transmitted infections, which can cause
6 infertility and ectopic pregnancies. The department may
7 promulgate rules under the administrative procedures act of 1969
8 that it determines necessary to implement and administer this
1 section. In addition to the requirements of section 5111, the
2 department shall include in the list of reportable diseases,
3 infections, and disabilities a separate list of sexually
4 transmitted infections for which expedited partner therapy as
5 authorized in this section is appropriate. In developing the
6 list, the department shall consult with the federal centers for
7 disease control and prevention and health professionals in this
8 state.
9 (2) In addition to treating his or her patient, a health
10 professional may provide expedited partner therapy if all of the
11 following requirements are met:
12 (a) The patient has a laboratory-confirmed or suspected
13 clinical diagnosis of a sexually transmitted infection.
14 (b) The patient indicates that he or she has a partner with
15 whom the patient has engaged in sexual activity within the 60-day
16 period immediately before the diagnosis of a sexually transmitted
17 infection.
18 (c) The patient indicates that his or her partner is unable
19 or is unlikely to seek clinical services in a timely manner.
20 (3) A health professional who provides expedited partner
21 therapy as authorized in this section shall do all of the
22 following:
23 (a) Dispense or prescribe the therapy in the name of the
24 partner, if known, without the physical examination of the
25 partner by the health professional. Notwithstanding any provision
26 of this act or rules to the contrary, if the name of the partner
27 is not known, the health professional shall dispense or prescribe
1 the therapy in the name of "expedited partner therapy".
2 (b) Convey to the patient that it is important to notify his
3 or her partner of his or her diagnosis and that it is important
4 for the partner to obtain medical care for a complete evaluation,
5 testing for sexually transmitted infections, counseling, and
6 treatment.
7 (c) Distribute to the patient the information sheet
8 developed under subsection (4).
9 (4) The department shall develop and distribute to local
10 health departments and, upon request, distribute to health
11 professionals subject to this section an information sheet that
12 includes all of the following information:
13 (a) A description of expedited partner therapy and its
14 purpose.
15 (b) A statement that a common therapy for certain sexually
16 transmitted infections is antibiotic therapy and that, if the
17 expedited partner therapy dispensed or prescribed for the reader
18 includes antibiotic therapy, the information sheet contains
19 important warnings and information of which the reader should be
20 aware.
21 (c) A warning about the dangers of administering certain
22 antibiotic therapies to a pregnant individual.
23 (d) Information about antibiotics dispensed or prescribed in
24 antibiotic therapy and dosages of those antibiotics dispensed or
25 prescribed.
26 (e) A warning about the risk of allergies to and drug
27 interactions with antibiotics described in subdivision (d).
1 (f) Information about sexually transmitted infections, the
2 treatment of diagnosed sexually transmitted infections, and the
3 prevention of sexually transmitted infections.
4 (g) A notice that the partner should be tested for sexually
5 transmitted infections.
6 (h) A notice of the risk to the patient, his or her partner,
7 and others, including the public health, if a sexually
8 transmitted infection is not completely treated.
9 (i) A notice of the responsibility of the patient to notify
10 his or her sexual partners of the risk of sexually transmitted
11 infections and the importance of examination and treatment for
12 sexually transmitted infections.
13 (j) A statement advising any individual who has any
14 questions regarding anything in the information sheet to contact
15 his or her health professional or local health department.
16 (k) A statement that the cost of a prescription issued in
17 the name of expedited partner therapy and not in the name of a
18 patient who has prescription coverage under a health benefit plan
19 or other third-party reimbursement arrangement will be paid for
20 by the individual filling the prescription.
21 (5) Except as otherwise provided in this subsection, a
22 health professional who provides expedited partner therapy as
23 authorized in this section is not subject to prosecution in a
24 criminal proceeding, liable for damages in a civil action, or
25 subject to administrative action under sections 16221 and 16226
26 for personal injury, death, or other consequences arising from or
27 related in any way to the provision of expedited partner therapy
1 by the health care professional. This subsection does not apply
2 if the action of the health care professional in providing
3 expedited partner therapy is gross negligence.
4 (6) As used in this section:
5 (a) "Expedited partner therapy" is the indirect treatment of
6 a partner of a patient who has been diagnosed as having a
7 sexually transmitted infection through the dispensing or
8 prescribing of therapy in accordance with guidelines established
9 by the federal centers for disease control and prevention for the
10 treatment of the partner without the physical examination of the
11 partner by a health professional.
12 (b) "Health professional" means any of the following:
13 (i) An individual licensed or otherwise authorized to engage
14 in a health profession under article 15 and whose scope of
15 practice includes the diagnosis and treatment of sexually
16 transmitted infections.
17 (ii) For the purpose of dispensing therapy under this
18 section, a pharmacist who is licensed or otherwise authorized to
19 engage in the practice of pharmacy under article 15.
20 (c) "Sexual activity" includes sexual contact and sexual
21 penetration as those terms are defined in section 5129.
22 (d) "Sexually transmitted infection" means 1 of the
23 following:
24 (i) Until the department establishes a separate list under
25 subsection (1), a sexually transmitted infection for which the
26 federal centers for disease control and prevention recommends the
27 use of expedited partner therapy.
1 (ii) On and after the date the department establishes a
2 separate list under subsection (1), a sexually transmitted
3 infection included in that list.
4 Sec. 17745. (1) Except as otherwise provided in this
5 subsection, a prescriber who wishes to dispense prescription
6 drugs shall obtain from the board a drug control license for each
7 location in which the storage and dispensing of prescription
8 drugs occur. A drug control license is not necessary if the
9 dispensing occurs in the emergency department, emergency room, or
10 trauma center of a hospital licensed under article 17 or if the
11 dispensing involves only the issuance of complimentary starter
12 dose drugs.
13 (2) A Except
as otherwise authorized for expedited partner
14 therapy in section 5110, a dispensing prescriber shall dispense
15 prescription drugs only to his or her own patients.
16 (3) A dispensing prescriber shall include in a patient's
17 chart or clinical record a complete record, including
18 prescription drug names, dosages, and quantities, of all
19 prescription drugs dispensed directly by the dispensing
20 prescriber or indirectly under his or her delegatory authority,
21 including expedited partner therapy provided as authorized in
22 section 5110. If prescription drugs are dispensed under the
23 prescriber's delegatory authority, the delegatee who dispenses
24 the prescription drugs shall initial the patient's chart,
25 clinical record, or log of prescription drugs dispensed. In a
26 patient's chart or clinical record, a dispensing prescriber shall
27 distinguish between prescription drugs dispensed to the patient,
1 and prescription drugs
prescribed for the patient, and
2 prescription drugs dispensed or prescribed for expedited partner
3 therapy as authorized in section 5110. A dispensing prescriber
4 shall retain information required under this subsection for not
5 less than 5 years after the information is entered in the
6 patient's chart or clinical record.
7 (4) A dispensing prescriber shall store prescription drugs
8 under conditions that will maintain their stability, integrity,
9 and effectiveness and will assure that the prescription drugs are
10 free of contamination, deterioration, and adulteration.
11 (5) A dispensing prescriber shall store prescription drugs
12 in a substantially constructed, securely lockable cabinet. Access
13 to the cabinet shall be limited to individuals authorized to
14 dispense prescription drugs in compliance with this part and
15 article 7.
16 (6) Unless otherwise requested by a patient, a dispensing
17 prescriber shall dispense a prescription drug in a safety closure
18 container that complies with the poison prevention packaging act
19 of 1970, 15 USC 1471 to 1477.
20 (7) A dispensing prescriber shall dispense a drug in a
21 container that bears a label containing all of the following
22 information:
23 (a) The name and address of the location from which the
24 prescription drug is dispensed.
25 (b) The Except
as otherwise authorized for expedited partner
26 therapy in section 5110, the patient's name and record number.
27 (c) The date the prescription drug was dispensed.
1 (d) The prescriber's name or, if dispensed under the
2 prescriber's delegatory authority, shall list the name of the
3 delegatee.
4 (e) The directions for use.
5 (f) The name and strength of the prescription drug.
6 (g) The quantity dispensed.
7 (h) The expiration date of the prescription drug or the
8 statement required under section 17756.
9 (8) A dispensing prescriber who dispenses a complimentary
10 starter dose drug to a patient shall give the patient at least
11 all of the following information required in this subsection,
12 either by dispensing the
complimentary starter dose drug to the
13 patient in a container that bears a label containing the required
14 information or by giving the patient a written document which
15 that may include, but is not limited to, a preprinted insert that
16 comes with the complimentary starter dose drug , and that
17 contains the required information. The information required to be
18 given to the patient under this subsection includes all of the
19 following:
20 (a) The name and strength of the complimentary starter dose
21 drug.
22 (b) Directions for the patient's use of the complimentary
23 starter dose drug.
24 (c) The expiration date of the complimentary starter dose
25 drug or the statement required under section 17756.
26 (9) The information required under subsection (8) is in
27 addition to, and does not supersede or modify, other state or
1 federal law regulating the labeling of prescription drugs.
2 (10) In addition to meeting the requirements of this part, a
3 dispensing prescriber who dispenses controlled substances shall
4 comply with section 7303a.
5 (11) The board may periodically inspect locations from which
6 prescription drugs are dispensed.
7 (12) The act, task, or function of dispensing prescription
8 drugs shall be delegated only as provided in this part and
9 sections 16215, 17048, 17076, 17212, and 17548.
10 (13) A supervising physician may delegate in writing to a
11 pharmacist practicing in a hospital pharmacy within a hospital
12 licensed under article 17 the receipt of complimentary starter
13 dose drugs other than controlled substances as defined by article
14 7 or federal law. When the delegated receipt of complimentary
15 starter dose drugs occurs, both the pharmacist's name and the
16 supervising physician's name shall be used, recorded, or
17 otherwise indicated in connection with each receipt. A pharmacist
18 described in this subsection may dispense a prescription for
19 complimentary starter dose drugs written or transmitted by
20 facsimile, electronic transmission, or other means of
21 communication by a prescriber.
22 (14) As used in this section, "complimentary starter dose"
23 means a prescription drug packaged, dispensed, and distributed in
24 accordance with state and federal law that is provided to a
25 dispensing prescriber free of charge by a manufacturer or
26 distributor and dispensed free of charge by the dispensing
27 prescriber to his or her patients.
1 Sec. 17751. (1) A pharmacist shall not dispense a drug
2 requiring a prescription under the federal act or a law of this
3 state except under authority of an original prescription or an
4 equivalent record of an original prescription approved by the
5 board.
6 (2) Subject to subsection (5), a pharmacist may dispense a
7 prescription written and signed; written or created in an
8 electronic format, signed, and transmitted by facsimile; or
9 transmitted electronically or by other means of communication by
10 a physician prescriber or dentist prescriber in a state other
11 than Michigan, but not including a prescription for a controlled
12 substance as defined in section 7104 except under circumstances
13 described in section 17763(e), only if the pharmacist in the
14 exercise of his or her professional judgment determines all of
15 the following:
16 (a) That Except
as otherwise authorized for expedited
17 partner therapy in section 5110, that the prescription was issued
18 pursuant to an existing physician-patient or dentist-patient
19 relationship.
20 (b) That the prescription is authentic.
21 (c) That the prescribed drug is appropriate and necessary
22 for the treatment of an acute, chronic, or recurrent condition.
23 (3) A pharmacist or a prescriber shall dispense a
24 prescription only if the prescription falls within the scope of
25 practice of the prescriber.
26 (4) A pharmacist shall not knowingly dispense a prescription
27 after the death of the prescriber or patient.
1 (5) A pharmacist shall not dispense a drug or device under a
2 prescription transmitted by facsimile or created in electronic
3 format and printed out for use by the patient unless the document
4 is manually signed by the prescriber. This subsection does not
5 apply to a prescription that is transmitted by a computer to a
6 facsimile machine if that prescription complies with section
7 17754.
8 (6) After consultation with and agreement from the
9 prescriber, a pharmacist may add or change a patient's address,
10 dosage form, drug strength, drug quantity, directions for use, or
11 issue date with regard to a prescription. A pharmacist shall note
12 the details of the consultation and agreement required under this
13 subsection on the prescription and shall maintain that
14 documentation with the prescription as required in section 17752.
15 A pharmacist shall not change the patient's name, controlled
16 substance prescribed unless authorized to dispense a lower cost
17 generically equivalent drug product under section 17755, or the
18 prescriber's signature with regard to a prescription.
19 (7) A prescription that is contained within a patient's
20 chart in a health facility or agency licensed under article 17 or
21 other medical institution and that is transmitted to a pharmacy
22 under section 17744 is the original prescription. If all other
23 requirements of this part are met, a pharmacist shall dispense a
24 drug or device under a prescription described in this subsection.
25 A pharmacist may dispense a drug or device under a prescription
26 described in this subsection even if the prescription does not
27 contain the quantity ordered. If a prescription described in this
1 subsection does not contain the quantity ordered, the pharmacist
2 shall consult with the prescriber to determine an agreed-upon
3 quantity. The pharmacist shall record the quantity dispensed on
4 the prescription and shall maintain that documentation with the
5 prescription as required in section 17752.
6 Sec. 17754. (1) Except as otherwise provided under article 7
7 and the federal act, a prescription may be transmitted
8 electronically as long as if the prescription is
transmitted in
9 compliance with the health insurance portability and
10 accountability act of 1996, Public Law 104-191, or regulations
11 promulgated under that act, 45 CFR parts 160 and 164, by a
12 prescriber or his or her agent and the data are not altered or
13 modified in the transmission process. The electronically
14 transmitted prescription shall include all of the following
15 information:
16 (a) The name, address, and telephone number of the
17 prescriber.
18 (b) The Except
as otherwise authorized for expedited partner
19 therapy in section 5110, the full name of the patient for whom
20 the prescription is issued.
21 (c) An electronic signature or other identifier that
22 specifically identifies and authenticates the prescriber or his
23 or her agent.
24 (d) The time and date of the transmission.
25 (e) The identity of the pharmacy intended to receive the
26 transmission.
27 (f) Any other information required by the federal act or
1 state law.
2 (2) The electronic equipment or system utilized in the
3 transmission and communication of prescriptions shall provide
4 adequate confidentiality safeguards and be maintained to protect
5 patient confidentiality as required under any applicable federal
6 and state law and to ensure against unauthorized access. The
7 electronic transmission of a prescription shall be communicated
8 in a retrievable, recognizable form acceptable to the intended
9 recipient. The electronic form utilized in the transmission of a
10 prescription shall not include "dispense as written" or "d.a.w."
11 as the default setting.
12 (3) Prior to Before
dispensing a prescription that is
13 electronically transmitted, the pharmacist shall exercise
14 professional judgment regarding the accuracy, validity, and
15 authenticity of the transmitted prescription.
16 (4) An electronically transmitted prescription that meets
17 the requirements of this section is the original prescription.
18 Sec. 17757. (1) Upon a request made in person or by
19 telephone, a pharmacist engaged in the business of selling drugs
20 at retail shall provide the current selling price of a drug
21 dispensed by that pharmacy or comparative current selling prices
22 of generic and brand name drugs dispensed by that pharmacy. The
23 information shall be provided to the person making the request
24 before a drug is dispensed to the person. A person who makes a
25 request for price information under this subsection shall is not
26 be obligated to purchase
the drug for which the price or
27 comparative prices are requested.
1 (2) A pharmacist engaged in the business of selling drugs at
2 retail shall conspicuously display the notice described in
3 subsection (3) at each counter over which prescription drugs are
4 dispensed.
5 (3) The notice required under subsection (2) shall be in
6 substantially the following form:
7 NOTICE TO CONSUMERS
8 ABOUT PRESCRIPTION DRUGS
9 Under Michigan law, you have the right to find out the price
10 of a prescription drug before the pharmacist fills the
11 prescription. You are under no obligation to have the
12 prescription filled here and may use this price information to
13 shop around at other pharmacies. You may request price
14 information in person or by telephone.
15 Every pharmacy has the current selling prices of both
16 generic and brand name drugs dispensed by the pharmacy.
17 Ask your pharmacist if a lower-cost generic drug is
18 available to fill your prescription. A generic drug contains the
19 same medicine as a brand name drug and is a suitable substitute
20 in most instances.
21 A generic drug may not be dispensed by your pharmacist if
22 your doctor has written "dispense as written" or the initials
23 "d.a.w." on the prescription.
24 If you have questions about the drugs which that have
been
25 prescribed for you, ask your doctor or pharmacist for more
1 information.
2 To avoid dangerous drug interactions, let your doctor and
3 pharmacist know about any other medications you are taking. This
4 is especially important if you have more than 1 doctor or have
5 prescriptions filled at more than 1 pharmacy.
6 (4) The notice required under subsection (2) shall also
7 contain the address and phone number of the board and the
8 department. The text of the notice shall be in at least 32-point
9 bold type and shall be printed on paper at least 11 inches by 17
10 inches in size. The notice may be printed on multiple pages.
11 (5) A copy of the notice required under subsection (2) shall
12 be provided to each licensee by the department. Additional The
13
department shall provide additional copies
shall be available if
14 needed. from the department. A person may duplicate
or reproduce
15 the notice if the duplication or reproduction is a true copy of
16 the notice as produced by the department, without any additions
17 or deletions. whatsoever.
18 (6) The pharmacist shall furnish to the purchaser of a
19 prescription drug at the time the drug is delivered to the
20 purchaser a receipt evidencing the transactions ,
which that
21 contains all of the following:
22 (a) The brand name of the drug, if applicable.
23 (b) The name of the manufacturer or the supplier of the
24 drug, if the drug does not have a brand name.
25 (c) The strength of the drug, if significant.
26 (d) The quantity dispensed, if applicable.
27 (e) The name and address of the pharmacy.
1 (f) The serial number of the prescription.
2 (g) The date the prescription was originally dispensed.
3 (h) The name of the prescriber or, if prescribed under the
4 prescriber's delegatory authority, shall list the name of the
5 delegatee.
6 (i) The Except
as otherwise authorized for expedited partner
7 therapy in section 5110, the name of the patient for whom the
8 drug was prescribed.
9 (j) The price for which the drug was sold to the purchaser.
10 (7) Subsection The
items required under subsection (6)(a),
11 (b), and (c) may be omitted from a receipt by a pharmacist only
12 if the omission is expressly required by the prescriber. The
13 pharmacist shall retain a copy of each receipt furnished under
14 subsection (6) for 90 days. The inclusion of the items required
15 under subsection (6) on the prescription container label is a
16 valid receipt to the purchaser. Including the items required
17 under subsection (6) on the written prescription form and
18 retaining the form constitutes retention of a copy of the
19 receipt.
20 (8) The board may promulgate rules to implement this
21 section.