March 24, 2005, Introduced by Senators HARDIMAN, PATTERSON, GARCIA, BIRKHOLZ, ALLEN, CROPSEY, HAMMERSTROM, SIKKEMA, KUIPERS, STAMAS and JELINEK and referred to the Committee on Health Policy.
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending sections 17708, 17751, 17752, and 17763 (MCL 333.17708,
333.17751, 333.17752, and 333.17763), sections 17708 and 17751 as
amended by 1997 PA 153 and section 17763 as amended by 2004 PA 536,
and by adding section 17753.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
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 for a drug or device written
and signed or transmitted by other means of communication by a
prescriber to be filled, compounded, or dispensed. Prescribing is
limited to a prescriber. An order transmitted in other than written
form shall be recorded 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), 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(g) 17763(e), written and
signed or transmitted by other means of communication by a
physician prescriber licensed to practice 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".
(c) A drug designated by the board as a drug that may only be
dispensed pursuant to a prescription.
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) A pharmacist may dispense a prescription written and
signed or transmitted by other means of communication by a
physician 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(g)
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 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.
Sec.
17752. (1) A prescription, or an equivalent record
thereof
of the prescription approved by the board, shall be
preserved by a licensee or dispensing prescriber for not less than
5 years.
(2) A prescription or equivalent record on file in a pharmacy
is not a public record. A person having custody of or access to
prescriptions shall not disclose their contents or provide copies
without the patient's authorization, to any person except to any of
the following:
(a) The patient for whom the prescription was issued, or
another pharmacist acting on behalf of the patient.
(b) The authorized prescriber who issued the prescription, or
a licensed health professional who is currently treating the
patient.
(c) An agency or agent of government responsible for the
enforcement of laws relating to drugs and devices.
(d) A person authorized by a court order.
(e) A person engaged in research projects or studies with
protocols approved by the board.
(3) A pharmacist may refill a copy of a prescription from
another pharmacy if the original prescription has remaining
authorized refills, and the copy is issued according to the
following procedure:
(a) The pharmacist issuing a written or oral copy of a
prescription shall cancel the original prescription and record the
cancellation. The record of cancellation shall include the date the
copy was issued, to whom issued, and the identification of the
pharmacist who issued the copy.
(b) The written or oral copy issued shall be a duplicate of
the original prescription except that it shall also include the
prescription number, the name of the pharmacy issuing the copy, the
date the copy was issued, and the number of authorized refills
remaining available to the patient.
(c) The pharmacist receiving a written or oral copy of the
prescription shall exercise reasonable diligence to determine
whether it is a valid copy, and having done so may treat the copy
as an original prescription.
(d) Except as described in this part, all other copies
furnished shall be used for information purposes only and clearly
marked "for informational or reference purposes only".
(4) Subsection (3) does not apply to pharmacies that share a
real-time, on-line database or transfer prescriptions pursuant to a
written contract for centralized prescription processing services
as provided under section 17753.
Sec. 17753. (1) A pharmacy may perform centralized
prescription processing services or outsource those services to
another pharmacy if each of the following conditions are satisfied:
(a) The pharmacies have the same owner or have A written
contract outlining the services to be provided and the
responsibilities and accountabilities of each pharmacy in
fulfilling the terms of the contract in compliance with federal and
state laws and regulations.
(b) The pharmacies share a common electronic file or have
appropriate technology to allow access to sufficient information
necessary or required to prepare a prescription drug order.
(2) A pharmacy that performs, or contracts for, centralized
prescription processing services shall maintain a policy and
procedures manual, along with documentation that implementation is
occurring, and each shall be made available to the board for
inspection and review upon request and the manual shall include,
but is not limited to, the following:
(a) A description of how the pharmacies will comply with
federal and state laws and regulations.
(b) The maintenance of appropriate records to identify the
responsible pharmacist, or pharmacists, in the various stages of
the drug product preparation, dispensing, and counseling process.
(c) The maintenance of a mechanism for tracking the
prescription drug order during each step in the drug product
preparation, dispensing, and counseling process.
(d) The maintenance of a mechanism to identify on the
prescription label each pharmacy involved in the preparation and
dispensing of the prescription drug order.
(e) The provision of adequate security to protect the
confidentiality and integrity of a patient's protected health
information.
(f) The maintenance of a quality improvement program for
pharmacy services designed to objectively and systematically
monitor and evaluate the quality and appropriateness of patient
care, pursue opportunities to improve patient care, and resolve
identified problems.
(3) In addition to the contents required under section 17756,
each prescription drug dispensed to a patient utilizing a
centralized prescription processing system shall bear a label
containing an identifiable code that provides a complete audit
trail of the preparation and dispensing of the drug and patient
care activities.
(4) As used in this section, "centralized prescription
processing" means the processing by a pharmacy of a request from
another pharmacy to prepare a prescription drug order or to perform
processing functions such as dispensing, performing drug
utilization review, completing claims adjudication, obtaining
refill authorizations, and initiating therapeutic interventions.
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)
Employing the mail to sell, distribute, or deliver a drug
that
requires a prescription when the prescription for the drug is
received
by mail.
(a) (b)
Permitting the dispensing of prescriptions by an
individual who is not a pharmacist, pharmacist intern, or
dispensing prescriber.
(b) (c)
Permitting the dispensing of prescriptions by a
pharmacist intern, except in the presence and under the personal
charge of a pharmacist.
(c) (d)
Selling at auction drugs in bulk or in open packages
unless the sale has been approved in accordance with rules of the
board.
(d) (e)
Promoting a prescription drug to the public in any
manner.
(e) (f)
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 or transmitted
by a physician prescriber in a state other than Michigan, unless
the prescription is issued by a physician prescriber who resides
adjacent to the land border between this state and an adjoining
state or resides in Illinois or Minnesota and who is authorized
under the laws of that state to practice medicine or osteopathic
medicine and surgery and to prescribe controlled substances and
whose practice may extend into this state, but who does not
maintain an office or designate a place to meet patients or receive
calls in this state.