October 27, 2009, Introduced by Reps. Liss, Roy Schmidt, Ball and Byrum and referred to the Committee on Ethics and Elections.
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending sections 17703, 17704, 17706, and 17707 (MCL 333.17703,
333.17704, 333.17706, and 333.17707), section 17703 as amended by
2006 PA 672, section 17706 as amended by 1986 PA 304, and section
17707 as amended by 1990 PA 333, and by adding section 17746a.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
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 authorized
agent transmitted the prescription. Electronically transmitted
prescription does not include a prescription or refill
authorization transmitted by telephone or facsimile machine.
(7) "Emergency drugs" are those drugs that are required to
meet the immediate therapeutic need of a resident of a medical
institution and that are to be administered by authorized personnel
to the resident before the interpretation and review by a
pharmacist when waiting for interpretation and review would cause a
medically unacceptable delay.
Sec. 17704. (1) "Federal act" means the federal food, drug,
and
cosmetic act, of 1938, 21 U.S.C. USC 301
to 392 399a.
(2) "Generic name" means the established or official name of a
drug or drug product.
(3) "Harmful drug" means a drug intended for use by human
beings
which that is harmful because of its toxicity, habit-forming
nature, or other potential adverse effect, the method of its use,
or the collateral measures necessary to its safe and effective use,
and
which that is designated as harmful by the board according to
rule.
(4) "Institutional pharmacy" means a pharmacy licensed under
this part that is located in this state; that dispenses, compounds,
and distributes drugs, devices, and other materials; and that
engages in the practice of pharmacy for a medical institution.
(5) (4)
"Internship" means an
educational program of
professional and practical experience for an intern.
Sec. 17706. (1) "Manufacturer" means a person who prepares,
produces, derives, propagates, compounds, processes, packages, or
repackages a drug or device salable on prescription only, or
otherwise changes the container or the labeling of a drug or device
salable on prescription only, and who supplies, distributes, sells,
offers for sale, barters, or otherwise disposes of that drug or
device and any other drug or device salable on prescription only,
to another person for resale, compounding, or dispensing.
(2) "Medical institution" means a federally- or state-licensed
organization or facility the primary purpose of which is to provide
a physical environment at which on-site medical care is provided to
individuals and a permanent medical record documenting the
provision of medical care, including medications ordered and
administered, to that individual is maintained. Medical institution
includes, but is not limited to, a hospital, convalescent home,
home for the aged, nursing home, skilled nursing facility, county
medical care facility, extended care facility, adult foster care
facility, assisted living facility, mental health facility,
psychiatric center, developmental disability center, and any other
health facility or agency that is licensed under article 17 and
that directly or indirectly provides or includes pharmacy services
to residents.
(3) "Medication drug kits" are those drugs that may be
required to meet the therapeutic needs of a resident of a medical
institution when a pharmacist is not in personal charge of the
institutional pharmacy.
(4) "Medication order" means a lawful order entered on the
permanent medical record of a resident of a medical institution by
a prescriber and is considered a prescription drug order. If
written, the medication order shall include the signature of the
prescriber or personnel authorized by the medical institution or,
if electronically transmitted, the appropriate electronic
signature.
(5) (2)
"Official compendium"
means the United States
pharmacopoeia and national formulary, homeopathic pharmacopoeia of
the United States, or a supplement thereof existing on July 1,
1983.
Sec. 17707. (1) "Personal charge" means the immediate physical
presence of a pharmacist or dispensing prescriber.
(2) "Pharmacist" means an individual licensed under this
article to engage in the practice of pharmacy.
(3) "Pharmacist intern" or "intern" means an individual who
satisfactorily completes the requirements set forth in rules
promulgated by the board and is licensed by the board for the
purpose of obtaining instruction in the practice of pharmacy from a
preceptor approved by the board.
(4) "Pharmacy" means a building or part of a building in which
the practice of pharmacy is conducted.
(5) "Practice of pharmacy" means a health service, the
clinical application of which includes the encouragement of safety
and efficacy in the prescribing, dispensing, administering, and use
of drugs and related articles for the prevention of illness, and
the maintenance and management of health. Practice of pharmacy
includes the direct or indirect provision of patient care services
associated with the practice of pharmacy to medical institutions.
Professional functions associated with the practice of pharmacy
include:
(a) The interpretation and evaluation of the prescription.
(b) Drug product selection.
(c) The compounding, dispensing, safe storage, and
distribution of drugs and devices.
(d) The maintenance of legally required records.
(e) Advising the prescriber and the patient as required as to
contents, therapeutic action, utilization, and possible adverse
reactions or interactions of drugs.
Sec. 17746a. (1) A pharmacist in charge of an institutional
pharmacy shall make arrangement in advance for the period of time
during which a pharmacist is not in personal charge of the
institutional pharmacy. A pharmacist shall be on call and available
to the medical staff and other authorized personnel of the medical
institution for the period of time during which a pharmacist is not
in personal charge of the institutional pharmacy. A pharmacist in
charge shall include in the arrangement under this subsection a
method to provide drugs to the medical staff and other authorized
personnel of a medical institution by use of emergency drugs or
medication drug kits, or both. A pharmacist in charge may include
in emergency drugs or medication drug kits those drugs that may be
required to meet the immediate therapeutic needs of a resident of
the medical institution and that are not available from any other
authorized source in sufficient time to prevent risk of harm to the
resident because of delay resulting from obtaining the drugs from
other sources.
(2) When a pharmacist is not in personal charge of the
institutional pharmacy, emergency drugs and medication drug kits
shall be stored in secured areas of the medical institution to
prevent unauthorized access and in areas designed to ensure a
proper environment for preservation of the drugs. The pharmacist in
charge, in conjunction with the appropriate committee of the
medical institution, shall do all of the following:
(a) Develop inventory listings of the drugs contained in the
emergency drugs and medication drug kits, including name, strength,
quantity, and expiration date of the contents.
(b) Determine who is authorized access to the emergency drugs
and medication drugs kits and under what circumstances.
(c) Ensure that all of the emergency drugs and medication
drugs kits are properly labeled.
(d) Ensure that only a limited number of drugs in unit dose or
unit-of-use packaging are available in amounts sufficient for
immediate therapeutic requirements of residents.
(e) To prevent diversion of the emergency drugs and medication
drug kits, institute controls and record-keeping procedures to
adequately account for the drugs and to ensure that all of the
following occur:
(i) That emergency drugs and medication drug kits are removed
from the secure area only pursuant to a valid medication order.
(ii) That only authorized individuals are able to access the
emergency drugs and medication drug kits and that documentation of
that access is maintained.
(iii) That documentation of proof-of-use by residents or return
of the unused emergency drugs and medication drug kits to the
secure area is provided.
(iv) That any other record-keeping requirement determined
necessary under this section is met.
(f) Provide procedures for the inspection of the inventory of
the emergency drugs and medication drug kits to assure proper
utilization and replacement of the drug supply.
(g) Upon notification that an emergency drug or medication
drug kit is used, restock emergency drugs and medication drug kits
within a reasonable time so as to prevent risk of harm to
residents.
(h) Establish any other written policies and procedures
necessary to implement the requirements of this section.