Free Clinics of Michigan Annual Meeting November 11, 2011 Blue Cross Blue Shield Meadows Conference Center South Lyon, MI - PowerPoint PPT Presentation

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Free Clinics of Michigan Annual Meeting November 11, 2011 Blue Cross Blue Shield Meadows Conference Center South Lyon, MI

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Title: Free Clinics of Michigan Annual Meeting November 11, 2011 Blue Cross Blue Shield Meadows Conference Center South Lyon, MI


1
Free Clinics of MichiganAnnual MeetingNovember
11, 2011Blue Cross Blue Shield Meadows
Conference CenterSouth Lyon, MI
  • Jesse C. Vivian, BS, JD
  • Professor of Pharmacy Practice
  • Detroit, MI 48201
  • Office 313-577-5389
  • jessevivian_at_wayne.edu
  • http//jessevivian.org

2
Wayne State University
Cultural Center of Detroit Erroneous Images
Old Main
Promotional Marketing ANY UNIVERSITY CAN EXPAND
YOUR MIND. WE EXPAND YOUR LIFE. AIM HIGHER
3
(No Transcript)
4
Distribution of Drugs in Free Clinics
  • Laws and Regulations
  • Licensing
  • Security
  • Prescribers (MD, DO, NP, PA, others)
  • Pharmacists Voluntary Involvement
  • Nurses Voluntary Involvement

5
My Involvement
  • Pharmacists (RPh) wanting to get involved
  • Want to know laws, regulations, liability
  • Controversy
  • Some Rphs
  • Cant be done unless building is licensed as a
    pharmacy
  • May be allowed if certain conditions satisfied
  • Just do it

6
April/May, 2011, Vol. 49, Issue 2
7
http//viewer.zmags.com/publication/4e32abed/4e32
abed/7
8
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

9
Drug Control LicenseMCLA 333.17745(1)
http//www.michigan.gov/lara/0,4601,7-154-27417_27
648---S,00.html
10
PUBLIC HEALTH CODE (EXCERPT)Act 368 of
1978333.17745 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.

11
PUBLIC HEALTH CODE (EXCERPT)Act 368 of
1978333.17745 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 prescribers own patients?

12
PUBLIC HEALTH CODE (EXCERPT)Act 368 of
1978333.17745 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.

13
PUBLIC HEALTH CODE (EXCERPT)Act 368 of
1978333.17745 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.

14
PUBLIC HEALTH CODE (EXCERPT)Act 368 of
1978333.17745 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.

15
PUBLIC HEALTH CODE (EXCERPT)Act 368 of
1978333.17745 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.

16
PUBLIC HEALTH CODE (EXCERPT)Act 368 of
1978333.17745 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.

17
PUBLIC HEALTH CODE (EXCERPT)Act 368 of
1978333.17745 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.

18
PUBLIC HEALTH CODE (EXCERPT)Act 368 of
1978333.17745 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.

19
PUBLIC HEALTH CODE (EXCERPT)Act 368 of
1978333.16215
  • 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.

20
PUBLIC HEALTH CODE (EXCERPT)Act 368 of
1978333.16215
  • (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.

21
PUBLIC HEALTH CODE (EXCERPT)Act 368 of
1978333.16104
  • (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.

22
PUBLIC HEALTH CODE (EXCERPT)Act 368 of
1978333.16215
  • (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.

23
PUBLIC HEALTH CODE (EXCERPT)Act 368 of
1978333.16104
  • 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 cant see eye to eye,
    there aint good guys, there aint bad guys,
    theres only you and me and we just disagree

24
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.

25
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.

26
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.

27
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

28
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

29
Questions
30
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