Bill Text: MI HB5407 | 2013-2014 | 97th Legislature | Chaptered
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.
Spectrum: Slight Partisan Bill (Republican 6-2)
Status: (Passed) 2014-10-22 - Assigned Pa 311'14 With Immediate Effect [HB5407 Detail]
Download: Michigan-2013-HB5407-Chaptered.html
Act No. 311
Public Acts of 2014
Approved by the Governor
October 13, 2014
Filed with the Secretary of State
October 14, 2014
EFFECTIVE DATE: October 14, 2014
STATE OF MICHIGAN
97TH LEGISLATURE
REGULAR SESSION OF 2014
Introduced by Reps. Forlini, Graves, Lane, Yanez, Zorn, Crawford, Lauwers and Kowall
ENROLLED HOUSE BILL No. 5407
AN ACT to amend 1978 PA 368, entitled “An act to protect and promote the public health; to codify, revise, consolidate, classify, and add to the laws relating to public health; to provide for the prevention and control of diseases and disabilities; to provide for the classification, administration, regulation, financing, and maintenance of personal, environmental, and other health services and activities; to create or continue, and prescribe the powers and duties of, departments, boards, commissions, councils, committees, task forces, and other agencies; to prescribe the powers and duties of governmental entities and officials; to regulate occupations, facilities, and agencies affecting the public health; to regulate health maintenance organizations and certain third party administrators and insurers; to provide for the imposition of a regulatory fee; to provide for the levy of taxes against certain health facilities or agencies; to promote the efficient and economical delivery of health care services, to provide for the appropriate utilization of health care facilities and services, and to provide for the closure of hospitals or consolidation of hospitals or services; to provide for the collection and use of data and information; to provide for the transfer of property; to provide certain immunity from liability; to regulate and prohibit the sale and offering for sale of drug paraphernalia under certain circumstances; to provide for the implementation of federal law; to provide for penalties and remedies; to provide for sanctions for violations of this act and local ordinances; to provide for an appropriation and supplements; to repeal certain acts and parts of acts; to repeal certain parts of this act; and to repeal certain parts of this act on specific dates,” 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) “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) “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 of community health 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) The department shall provide a copy of the notice required under subsection (2) to each licensee. 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.
(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.
This act is ordered to take immediate effect.
Clerk of the House of Representatives
Secretary of the Senate
Approved
Governor
