Free Clinics of Michigan
Annual Meeting
November 11, 2011
Blue Cross Blue Shield Meadows Conference Center
South Lyon, MI
Jesse C. Vivian, BS, JD
Professor of Pharmacy Practice
Detroit, MI 48201
Office: 313-577-5389
jessevivian@wayne.edu
http://jessevivian.org
Wayne State University
Cultural Center of Detroit
Old Main
Erroneous Images
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Distribution of Drugs in Free Clinics
1.
2.
3.
4.
Laws and Regulations
Licensing
Security
Prescribers (MD, DO, NP, PA,
others)
5. Pharmacists Voluntary Involvement
6. Nurses Voluntary Involvement
My Involvement
• Pharmacists (RPh) wanting to get involved
• Want to know laws, regulations, liability
• Controversy
– Some Rphs
• Can’t be done unless building is licensed as a
pharmacy
• May be allowed if certain conditions satisfied
• Just do it
April/May, 2011, Vol. 49, Issue 2
http://viewer.zmags.com/publication/4e32abed#/4e32abed/7
Laws of Free Clinic Drugs
• Clinic Must Have Physician (MD, DO)
designated as the “Medical Director”
• Medical Director must obtain a “Drug Control
License from the MI Board of Pharmacy
• Medical Director must develop Policies and
Procedures Manual
– Must Include policy on who, when, where and
why others MAY be delegated to distribute drugs
– Do not confuse “dispense” with” distribute”
Drug Control License
MCLA § 333.17745(1)
http://www.michiga
n.gov/lara/0,4601,7
-154-27417_27648--S,00.html
PUBLIC HEALTH CODE (EXCERPT)
Act 368 of 1978
333.17745 Drug control license
(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.
PUBLIC HEALTH CODE (EXCERPT)
Act 368 of 1978
333.17745 Drug control license
(2) A dispensing prescriber shall dispense
prescription drugs only to his or her own
patients.
• Begs question of physician-patient relationship
– What are the factors to be included?
– Can a telephonetic/ computer image connection apply?
– Are “own patients” those of the clinic of just the prescriber who
sees the patient once and another physician sees that patient
on another visit to the clinic
– How to document prescriber’s “own” patients?
PUBLIC HEALTH CODE (EXCERPT)
Act 368 of 1978
333.17745 Drug control license
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 and prescription drugs prescribed for
the patient. 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.
PUBLIC HEALTH CODE (EXCERPT)
Act 368 of 1978
333.17745 Drug control license
(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, Public Law 91-601, 84 Stat. 1670.
PUBLIC HEALTH CODE (EXCERPT)
Act 368 of 1978
333.17745 Drug control license
(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) The patient's name and record number.
(c) The date the prescription drug was dispensed.
(d) The prescriber's name.
(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.
PUBLIC HEALTH CODE (EXCERPT)
Act 368 of 1978
333.17745 Drug control license
(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 which may include, but is not
limited to, a preprinted insert that comes with the complimentary starter
dose drug, that contains the 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.
(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.
PUBLIC HEALTH CODE (EXCERPT)
Act 368 of 1978
333.17745 Drug control license
(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.
PUBLIC HEALTH CODE (EXCERPT)
Act 368 of 1978
333.17745 Drug control license
(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.
PUBLIC HEALTH CODE (EXCERPT)
Act 368 of 1978
333.17745 Drug control license
(12) The act, task, or
function of dispensing
prescription drugs shall be
delegated only as provided
in section 16215 and this
part.
PUBLIC HEALTH CODE (EXCERPT)
Act 368 of 1978
333.16215
• Title of Section:
• Delegation of acts, tasks, or functions to licensed or
unlicensed individual; supervision; rules; immunity; third
party reimbursement or worker's compensation benefits.
PUBLIC HEALTH CODE (EXCERPT)
Act 368 of 1978
333.16215
(1) Subject to subsections (2) to (6), a licensee who
holds a license other than a health profession
subfield license may “delegate” to a licensed or
unlicensed individual who is otherwise qualified by
education, training, or experience the performance
of selected acts, tasks, or functions where the acts,
tasks, or functions fall within the scope of practice of
the licensee's profession and will be performed
under the licensee's supervision. A licensee shall not
delegate an act, task, or function under this section
if the act, task, or function, under standards of
acceptable and prevailing practice, requires the level
of education, skill, and judgment required of the
licensee under this article.
PUBLIC HEALTH CODE (EXCERPT)
Act 368 of 1978
333.16104
(1) “Delegation” means an authorization granted
by a licensee to a licensed or unlicensed
individual to perform selected acts, tasks, or
functions that fall within the scope of practice
of the delegator and that are not within the
scope of practice of the delegatee and that,
in the absence of the authorization, would
constitute illegal practice of a licensed
profession.
PUBLIC HEALTH CODE (EXCERPT)
Act 368 of 1978
333.16215
(5) A board may promulgate rules to further prohibit or otherwise
restrict delegation of specific acts, tasks, or functions to a
licensed or unlicensed individual if the board determines that
the delegation constitutes or may constitute a danger to the
health, safety, or welfare of the patient or public.
(6) To promote safe and competent practice, a board may
promulgate rules to specify conditions under which, and
categories and types of licensed and unlicensed individuals
for whom, closer supervision may be required for acts, tasks,
and functions delegated under this section.
(7) An individual who performs acts, tasks, or functions
delegated pursuant to this section does not violate the part
that regulates the scope of practice of that health profession.
PUBLIC HEALTH CODE (EXCERPT)
Act 368 of 1978
333.16104
• and that are not within the scope of
practice of the delegatee
– What does this mean?
– Why is this limitation included here?
– Does this really limit the delegation of distributing
drugs to a pharmacist in a Free Clinic?
– Reasonable Minds disagree
Dave Mason Song: “cause we can’t see eye to eye,
there ain’t good guys, there ain’t bad guys, there’s only
you and me and we just disagree”
Disagreements
• “and that are not within the scope of practice of
the delegatee” means that pharmacists and or
any other licensee that are permitted to dispense
drugs under the scope of the applicable statute
cannot be delegated this task from a delegating
prescriber. See Definition of Practice of
Pharmacy, MCL § 333.17707(4) expressly
including the act of “dispensing”
• This is nothing more than a definitional statute
and the operational statute, § 16215 does not
contain this limitation and therefore does not
prohibit the delegation.
Solutions?
• Remember § 333.17745 “Drug control license” (13
slides ago) the language:
“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
and prescription drugs prescribed for the patient.”
Reality
• To best of my knowledge, no pharmacist,
nurse or other licensed healthcare
professional has ever been disciplined by a
Healthcare Board for dispensing drugs in a
clinic setting, Free or not.
Liability
• Prior discussion limited to state imposed
sanctions available to “punish” non-compliant
clinics.
• Other issue to be concerned about is civil
liability: what if you are sued as a result of a
drug mishap?
– Does clinic have malpractice insurance?
– Are you a “covered person” under the terms of the
policy; remember you are not an employee
• More like an independent contractor
– Is the policy valid and kept up with paid premiums
Free Advise
• Buy your own personal malpractice insurance
policy
– For non-physicians, cost relatively low
• May be able to get “umbrella” rider
– Pays legal fees, not just judgments
– You have Choice of Representation by your own
attorney independent of the Clinics attorney
– Peace of Mind
Questions