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.

 

     <<

 

Senate Bill No. 860 as amended June 4, 2014

 

 

 

 

 

 

 

 

 

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