Bill Text: MI HB5131 | 2011-2012 | 96th Legislature | Chaptered

Michigan House Bill 5131 (Prior Session Legislation)

Bill Title: Health; pharmaceuticals; duties of prescribers and agents; clarify, and modify certain pharmacy practices regarding the electronic transmission of prescriptions. Amends secs. 7405, 17702, 17703, 17708, 17751, 17754 & 17763 of 1978 PA 368 (MCL 333.7405 et seq.) & adds sec. 17744.

Spectrum: Bipartisan Bill

Status: (Passed) 2012-07-18 - Assigned Pa 209'12 With Immediate Effect [HB5131 Detail]

Download: Michigan-2011-HB5131-Chaptered.html

Act No. 209

Public Acts of 2012

Approved by the Governor

June 26, 2012

Filed with the Secretary of State

June 27, 2012

EFFECTIVE DATE: June 27, 2012

STATE OF MICHIGAN

96TH LEGISLATURE

REGULAR SESSION OF 2012

Introduced by Reps. Liss and Haines

ENROLLED HOUSE BILL No. 5131

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 7405, 17702, 17703, 17708, 17751, 17754, and 17763 (MCL 333.7405, 333.17702, 333.17703, 333.17708, 333.17751, 333.17754, and 333.17763), sections 7405, 17708, 17751, and 17763 as amended by 2011 PA 155 and sections 17702 and 17703 as amended and section 17754 as added by 2006 PA 672, and by adding section 17744.

The People of the State of Michigan enact:

Sec. 7405. (1) A person:

(a) Who is licensed by the administrator under this article shall not distribute, prescribe, or dispense a controlled substance in violation of section 7333.

(b) Who is a licensee shall not manufacture a controlled substance not authorized by his or her license or distribute, prescribe, or dispense a controlled substance not authorized by his or her license to another licensee or other authorized person, except as authorized by rules promulgated by the administrator.

(d) Shall not knowingly keep or maintain a store, shop, warehouse, dwelling, building, vehicle, boat, aircraft, or other structure or place, that is frequented by persons using controlled substances in violation of this article for the purpose of using controlled substances, or that is used for keeping or selling controlled substances in violation of this article.

(e) Who is a practitioner shall not dispense a controlled substance under 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 licensed to practice in a state other than Michigan, unless the prescription is issued by a physician prescriber or dentist prescriber who is authorized under the laws of that state to practice dentistry, medicine, or osteopathic medicine and surgery and to prescribe controlled substances.

(2) A person who violates subsection (1) is subject to the penalties prescribed in section 7406.

Sec. 17702. (1) “Agent” means an individual designated by a prescriber to act on behalf of or at the discretion of that prescriber as provided in section 17744.

(2) “Brand name” means the registered trademark name given to a drug product by its manufacturer.

(3) “Current selling price” means the retail price for a prescription drug that is available for sale from a pharmacy.

Sec. 17703. (1) “Device” means an instrument, apparatus, or contrivance, including its components, parts, and accessories, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in human beings or other animals, or to affect the structure or function of the body of human beings or other animals.

(2) “Dispense” means to issue 1 or more doses of a drug for subsequent administration to, or use by, a patient.

(3) “Dispensing prescriber” means a prescriber, other than a veterinarian, who dispenses prescription drugs.

(4) “Drug” means any of the following:

(a) A substance recognized or for which the standards or specifications are prescribed in the official compendium.

(b) A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in human beings or other animals.

(c) A substance, other than food, intended to affect the structure or a function of the body of human beings or other animals.

(d) A substance intended for use as a component of a substance specified in subdivision (a), (b), or (c), but not including a device or its components, parts, or accessories.

(5) “Electronic signature” means an electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record.

(6) “Electronically transmitted prescription” means the communication of an original prescription or refill authorization by electronic means including computer to computer, computer to facsimile machine, or electronic mail transmission that contains the same information it contained when the prescriber or his or her agent transmitted the prescription. Electronically transmitted prescription does not include a prescription or refill authorization transmitted by telephone or facsimile machine.

Sec. 17708. (1) “Preceptor” means a pharmacist approved by the board to direct the training of an intern in an approved pharmacy.

(2) “Prescriber” means a licensed dentist, a licensed doctor of medicine, a licensed doctor of osteopathic medicine and surgery, a licensed doctor of podiatric medicine and surgery, a licensed optometrist certified under part 174 to administer and prescribe therapeutic pharmaceutical agents, a licensed veterinarian, or another licensed health professional acting under the delegation and using, recording, or otherwise indicating the name of the delegating licensed doctor of medicine or licensed doctor of osteopathic medicine and surgery.

(3) “Prescription” means an order by a prescriber to fill, compound, or dispense a drug or device written and signed; written or created in an electronic format, signed, and transmitted by facsimile; or transmitted electronically or by other means of communication. An order transmitted in other than written or hard-copy form shall be electronically recorded, printed, or written and immediately dated by the pharmacist, and that record constitutes the original prescription. In a health facility or agency licensed under article 17 or other medical institution, an order for a drug or device in the patient’s chart constitutes for the purposes of this definition the original prescription. Subject to section 17751(2) and (5), prescription includes, but is not limited to, an order for a drug, not including a controlled substance as defined in section 7104 except under circumstances described in section 17763(e), 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 licensed to practice dentistry, medicine, or osteopathic medicine and surgery in a state other than Michigan.

(4) “Prescription drug” means 1 or more of the following:

(a) A drug dispensed pursuant to a prescription.

(b) A drug bearing the federal legend “CAUTION: federal law prohibits dispensing without prescription” or “Rx only”.

Sec. 17744. (1) A prescriber may designate an agent to act on behalf of or at the discretion of that prescriber. A designation of an agent by a prescriber under this section is not required to be in writing to be a valid designation. If a designation of an agent by a prescriber under this section is contained in a written document, the prescriber or the agent may transmit that document to a pharmacy that will dispense a prescription issued by that prescriber.

(2) Only a prescriber acting within the scope of his or her practice may issue a prescription. An agent may prepare and transmit a prescription that has been signed by the prescriber, including a signature that meets the requirements of section 17754. The prescriber issuing a prescription and the pharmacist dispensing a drug or device under a prescription is responsible for all of the requirements of state and federal law, rules, and regulations regarding the issuance of prescriptions and dispensing of drugs or devices under prescriptions.

(3) A prescriber or his or her agent may transmit to a pharmacy a prescription that is contained within a patient’s chart in a health facility or agency licensed under article 17 or other medical institution. 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 created in an electronic format may contain more than 6 prescriptions and may contain prescriptions for schedule 3 through 5 controlled substances and noncontrolled substances on the same form.

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 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 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 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 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. 17763. In addition to the grounds set forth in part 161, the disciplinary subcommittee may fine, reprimand, or place a pharmacist licensee on probation, or deny, limit, suspend, or revoke the license of a pharmacist or order restitution or community service for a violation or abetting in a violation of this part or rules promulgated under this part, or for 1 or more of the following grounds:

(a) Permitting the dispensing of prescriptions by an individual who is not a pharmacist, pharmacist intern, or dispensing prescriber.

(b) Permitting the dispensing of prescriptions by a pharmacist intern, except in the presence and under the personal charge of a pharmacist.

(c) Selling at auction drugs in bulk or in open packages unless the sale has been approved in accordance with rules of the board.

(d) Promoting a prescription drug to the public in any manner.

(e) In addition to the prohibition contained in section 7405(1)(e), dispensing a prescription for a controlled substance as defined in section 7104 that is 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, unless the prescription is issued by a physician prescriber or dentist prescriber who is authorized under the laws of that state to practice dentistry, medicine, or osteopathic medicine and surgery and to prescribe controlled substances.

This act is ordered to take immediate effect.

Clerk of the House of Representatives

Secretary of the Senate

Approved

Governor