Senate File 484 - Introduced




                                 SENATE FILE       
                                 BY  COMMITTEE ON HUMAN
                                     RESOURCES

                                 (SUCCESSOR TO SSB
                                     1074)

                                      A BILL FOR

  1 An Act relating to pharmacy regulation, including alternate
  2    board of pharmacy members, drug disposal program funding, an
  3    impaired professionals program, and pharmacy internet sites.
  4 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
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PAG LIN



  1  1    Section 1.  NEW SECTION.  155A.2A  Board of pharmacy ==
  1  2 alternate members.
  1  3    1.  Notwithstanding sections 17A.11, 69.16, 69.16A, 147.12,
  1  4 147.14, and 147.19, the board may have a pool of up to seven
  1  5 alternate members, including members licensed to practice under
  1  6 this chapter and members not licensed to practice under this
  1  7 chapter, to substitute for board members who are disqualified
  1  8 or become unavailable for any reason for contested case
  1  9 hearings.
  1 10    a.  The board may recommend, subject to approval by the
  1 11 governor, up to seven people to serve in a pool of alternate
  1 12 members.
  1 13    b.  A person serves in the pool of alternate members at
  1 14 the discretion of the board; however, the length of time an
  1 15 alternate member may serve in the pool shall not exceed nine
  1 16 years. A person who serves as an alternate member may later be
  1 17 appointed to the board and may serve nine years, in accordance
  1 18 with sections 147.12 and 147.19. A former board member may
  1 19 serve in the pool of alternate members.
  1 20    c.  An alternate member licensed under this chapter shall
  1 21 hold an active license and shall have been actively engaged in
  1 22 the practice of pharmacy in the preceding three years, with the
  1 23 two most recent years of practice being in Iowa.
  1 24    d.  When a sufficient number of board members are unavailable
  1 25 to hear a contested case, the board may request alternate
  1 26 members to serve.
  1 27    e.  Notwithstanding section 17A.11, section 147.14,
  1 28 subsection 2, and section 272C.6, subsection 5:
  1 29    (1)  An alternate member is deemed a member of the board only
  1 30 for the hearing panel for which the alternate member serves.
  1 31    (2)  A hearing panel containing alternate members must
  1 32 include at least five people.
  1 33    (3)  The majority of a hearing panel containing alternate
  1 34 members shall be members of the board.
  1 35    (4)  The majority of a hearing panel containing alternate
  2  1 members shall be licensed to practice under this chapter.
  2  2    (5)  A decision of a hearing panel containing alternate
  2  3 members is considered a final decision of the board.
  2  4    f.  An alternate member shall not receive compensation in
  2  5 excess of that authorized by law for a board member.
  2  6    Sec. 2.  Section 155A.3, subsection 36, Code 2017, is amended
  2  7 to read as follows:
  2  8    36.  "Practitioner" means a physician, dentist, podiatric
  2  9 physician, prescribing psychologist, veterinarian, optometrist,
  2 10 physician assistant, advanced registered nurse practitioner, or
  2 11 other person licensed or registered to prescribe, distribute,
  2 12  or dispense a prescription drug or device in the course of
  2 13 professional practice in this state or a person licensed by
  2 14 another state in a health field in which, under Iowa law,
  2 15 licensees in this state may legally prescribe drugs.
  2 16    Sec. 3.  Section 155A.39, Code 2017, is amended to read as
  2 17 follows:
  2 18    155A.39  Programs Program to aid monitor impaired pharmacists,
  2 19 pharmacist=interns, or pharmacy technicians == reporting,
  2 20 confidentiality, immunity, and funding.
  2 21    1.  A person or pharmaceutical peer review committee may
  2 22 report relevant facts to the board relating to the acts of
  2 23 a pharmacist in this state, a pharmacist=intern as defined
  2 24 in section 155A.3, subsection 31, or a pharmacy technician
  2 25 in this state if the person or peer review committee has
  2 26 knowledge relating to the pharmacist, pharmacist=intern, or
  2 27 pharmacy technician which, in the opinion of the person or
  2 28 pharmaceutical peer review committee, might impair competency
  2 29 due to chemical abuse, chemical dependence, or mental or
  2 30 physical illness, or which might endanger the public health
  2 31 and safety, or which provide grounds for disciplinary action
  2 32 as specified in this chapter and in the rules of the board.
  2 33  The board may establish a review committee and may implement a
  2 34 program to monitor impaired pharmacists, pharmacist=interns,
  2 35 and pharmacy technicians pursuant to section 272C.3, subsection
  3  1 1, paragraph "k".
  3  2    2.  A committee of a professional pharmaceutical
  3  3 organization, its staff, or a district or local intervenor
  3  4 participating in a program established to aid pharmacists,
  3  5 pharmacist=interns, or pharmacy technicians impaired by
  3  6 chemical abuse, chemical dependence, or mental or physical
  3  7 illness may report in writing to the board the name of the
  3  8 impaired pharmacist, pharmacist=intern, or pharmacy technician
  3  9 together with pertinent information relating to the impairment.
  3 10 The board may report to a committee of a professional
  3 11 pharmaceutical organization or the organization's designated
  3 12 staff information which the board receives with regard to a
  3 13 pharmacist, pharmacist=intern, or pharmacy technician who may
  3 14 be impaired by chemical abuse, chemical dependence, or mental
  3 15 or physical illness.
  3 16    3.  Upon determination by the board that a report submitted
  3 17 by a peer review committee or a professional pharmaceutical
  3 18 organization committee is without merit, the report shall
  3 19 be expunged from the pharmacist's, pharmacist=intern's, or
  3 20 pharmacy technician's individual record in the board's office.
  3 21 A pharmacist, pharmacist=intern, pharmacy technician, or an
  3 22 authorized representative of the pharmacist, pharmacist=intern,
  3 23 or pharmacy technician shall be entitled on request to examine
  3 24 the peer review committee report or the pharmaceutical
  3 25 organization committee report submitted to the board and to
  3 26 place into the record a statement of reasonable length of the
  3 27 pharmacist's, pharmacist=intern's, or pharmacy technician's
  3 28 view with respect to any information existing in the report.
  3 29    4.  Notwithstanding other provisions of the Code, the
  3 30 records and proceedings of the board, its authorized agents,
  3 31 a peer review committee, or a pharmaceutical organization
  3 32 committee as set out in subsections 1 and 2 shall be privileged
  3 33 and confidential and shall not be considered public records or
  3 34 open records unless the affected pharmacist, pharmacist=intern,
  3 35 or pharmacy technician so requests and shall not be subject
  4  1 to a subpoena or to a discovery proceeding. The board may
  4  2 disclose the records and proceedings only as follows:
  4  3    a.  In a criminal proceeding.
  4  4    b.  In a disciplinary hearing before the board or in a
  4  5 subsequent trial or appeal of a board action or order.
  4  6    c.  To the pharmacist licensing or disciplinary authorities
  4  7 of other jurisdictions.
  4  8    d.  To the pharmacy technician registering, licensing, or
  4  9 disciplinary authorities of other jurisdictions.
  4 10    e.  Pursuant to an order of a court of competent
  4 11 jurisdiction.
  4 12    f.  Pursuant to subsection 11.
  4 13    g.  As otherwise provided by law.
  4 14    5.  2.  An employee or a member of the board, a peer
  4 15  review committee member, a professional pharmaceutical
  4 16 organization committee member, a professional pharmaceutical
  4 17 organization district or local intervenor, or any other person
  4 18 who furnishes information, data, reports, or records in good
  4 19 faith for the purpose of aiding the an impaired pharmacist,
  4 20 pharmacist=intern, or pharmacy technician, shall be immune from
  4 21 civil liability. This immunity from civil liability shall be
  4 22 liberally construed to accomplish the purpose of this section
  4 23 and is in addition to other immunity provided by law.
  4 24    6.  3.  An employee or member of the board or a review
  4 25  committee or intervenor program member is presumed to have
  4 26 acted in good faith. A person alleging a lack of good faith has
  4 27 the burden of proof on that issue.
  4 28    7.  The board may contract with professional pharmaceutical
  4 29 associations or societies to provide a program for pharmacists,
  4 30 pharmacist=interns, and pharmacy technicians who are impaired
  4 31 by chemical abuse, chemical dependence, or mental or physical
  4 32 illness. Such programs shall include, but not be limited to,
  4 33 education, intervention, and posttreatment monitoring. A
  4 34 contract with a professional pharmaceutical association or
  4 35 society shall include the following requirements:
  5  1    a.  Periodic reports to the board regarding education,
  5  2 intervention, and treatment activities.
  5  3    b.  Immediate notification to the board's executive secretary
  5  4 or director or the executive secretary's or director's designee
  5  5 of the identity of the pharmacist, pharmacist=intern, or
  5  6 pharmacy technician who is participating in a program to
  5  7 aid impaired pharmacists, pharmacist=interns, or pharmacy
  5  8 technicians.
  5  9    c.  Release to the board's executive secretary or director or
  5 10 the executive secretary's or director's designee upon written
  5 11 request of all treatment records of a participant.
  5 12    d.  Quarterly reports to the board, by case number, regarding
  5 13 each participant's diagnosis, prognosis, and recommendations
  5 14 for continuing care, treatment, and supervision which maintain
  5 15 the anonymity of the participant.
  5 16    e.  Immediate reporting to the board of the name of
  5 17 an impaired pharmacist, pharmacist=intern, or pharmacy
  5 18 technician who the treatment organization believes to be an
  5 19 imminent danger to either the public or to the pharmacist,
  5 20 pharmacist=intern, or pharmacy technician.
  5 21    f.  Reporting to the board, as soon as possible, the name
  5 22 of a participant who refuses to cooperate with the program,
  5 23 who refuses to submit to treatment, or whose impairment is not
  5 24 substantially alleviated through intervention and treatment.
  5 25    g.  Immediate reporting to the board of the name of a
  5 26 participant where additional information is evident that known
  5 27 distribution of controlled substances or legend drugs to other
  5 28 individuals has taken place.
  5 29    8.  4.  The board may add a surcharge of not more than ten
  5 30 percent of the applicable fee to a pharmacist license fee,
  5 31 pharmacist license renewal fee, pharmacist=intern registration
  5 32 fee, pharmacy technician registration fee, or pharmacy
  5 33 technician registration renewal fee authorized under this
  5 34 chapter to fund programs a program to aid monitor impaired
  5 35 pharmacists, pharmacist=interns, or pharmacy technicians.
  6  1    9.  5.  The board may accept, transfer, and expend funds
  6  2 made available by the federal or state government or by another
  6  3 public or private source to be used in programs a program
  6  4  authorized by this section. The board may contract to provide
  6  5 funding on an annual basis to a professional pharmaceutical
  6  6 association or society for expenses incurred in management
  6  7 and operation of a program to aid impaired pharmacists,
  6  8 pharmacist=interns, or pharmacy technicians. Documentation of
  6  9 the use of these funds shall be provided to the board not less
  6 10 than annually for review and comment.
  6 11    10.  6.  Funds and surcharges collected under this section
  6 12 shall be deposited in an account and may be used by the
  6 13 board to administer programs a program authorized by this
  6 14 section, including the provision of education, intervention,
  6 15 and posttreatment monitoring to an impaired pharmacist,
  6 16 pharmacist=intern, or pharmacy technician and to pay the
  6 17 administrative costs incurred by the board in connection with
  6 18 that funding and appropriate oversight, but shall not be used
  6 19  for costs incurred for a participant's initial evaluation,
  6 20 referral services, treatment, or rehabilitation subsequent to
  6 21 intervention.
  6 22    11.  7.  The board may disclose that the license of a
  6 23 pharmacist, the registration of a pharmacist=intern, or the
  6 24 registration of a pharmacy technician who is the subject of an
  6 25 order of the board that is confidential pursuant to subsection
  6 26 4 section 272C.6 is suspended, revoked, canceled, restricted,
  6 27 or retired; or that the pharmacist, pharmacist=intern, or
  6 28 pharmacy technician is in any manner otherwise limited in the
  6 29 practice of pharmacy; or other relevant information pertaining
  6 30 to the pharmacist, pharmacist=intern, or pharmacy technician
  6 31 which the board deems appropriate.
  6 32    12.  8.  The board may adopt rules necessary for the
  6 33 implementation of this section.
  6 34    Sec. 4.  Section 155A.43, Code 2017, is amended to read as
  6 35 follows:
  7  1    155A.43  Pharmaceutical collection and disposal program ==
  7  2 annual allocation.
  7  3    Of the fees collected by the board pursuant to sections
  7  4 124.301 and 147.80 and this chapter 155A by the board of
  7  5 pharmacy, and retained by the board pursuant to section 147.82,
  7  6 not more than one hundred seventy=five thousand dollars may
  7  7 be allocated the board may annually allocate a sum deemed by
  7  8 the board to be adequate for administering the pharmaceutical
  7  9 collection and disposal program originally established
  7 10 pursuant to 2009 Iowa Acts, ch. 175, {9. The program shall
  7 11 provide for the management and disposal of unused, excess,
  7 12 and expired pharmaceuticals, including the management and
  7 13 disposal of controlled substances pursuant to state and federal
  7 14 regulations. The board of pharmacy may cooperate contract
  7 15  with the Iowa pharmacy association and may consult with the
  7 16 department and sanitary landfill operators in administering one
  7 17 or more vendors for the provision of supplies and services to
  7 18 manage and maintain the program and to safely and appropriately
  7 19 dispose of pharmaceuticals collected through the program.
  7 20    Sec. 5.  REPEAL.  Section 155A.13B, Code 2017, is repealed.
  7 21                           EXPLANATION
  7 22 The inclusion of this explanation does not constitute agreement with
  7 23 the explanation's substance by the members of the general assembly.
  7 24    This bill permits the board of pharmacy ("board") to
  7 25 recommend, subject to approval by the governor, a pool of up to
  7 26 seven qualified individuals to serve as alternate board members
  7 27 to ensure the availability of a quorum of board members to
  7 28 hear a contested case. The bill identifies the maximum term
  7 29 for an alternate board member, provides that an individual
  7 30 who previously served on the board may serve as an alternate
  7 31 board member, provides for compensation when the alternate
  7 32 member serves on a hearing panel, establishes requirements
  7 33 for the composition of a hearing panel containing alternate
  7 34 board members, and provides that the decision of a hearing
  7 35 panel containing alternate board members is considered a final
  8  1 decision of the board.
  8  2    The bill amends the definition of "practitioner" to
  8  3 identify the licensed health care practitioners that are
  8  4 authorized under Iowa law to prescribe, distribute, or dispense
  8  5 prescription drugs and devices to patients in the course of
  8  6 professional practice in this state.
  8  7    The bill amends provisions regarding the program to
  8  8 aid impaired pharmacists, pharmacist=interns, or pharmacy
  8  9 technicians by eliminating specific provisions relating to
  8 10 reporting and establishment of the program and directing
  8 11 that the program be implemented pursuant to Code section
  8 12 272C.3(1)(k), relating generally to the authority of licensing
  8 13 boards to establish licensee review committees. The bill
  8 14 identifies the limited information that may be disclosed
  8 15 regarding the license or registration of any individual subject
  8 16 to monitoring under the program and authorizes the board to
  8 17 adopt rules to implement the Code section.
  8 18    The bill amends provisions relating to the pharmaceutical
  8 19 collection and disposal program to authorize the board to
  8 20 allocate a sum from fees retained by the board to support
  8 21 board activities that the board has determined to be adequate
  8 22 for administering the pharmaceutical collection and disposal
  8 23 program. The bill authorizes the board to contract with one or
  8 24 more vendors to manage and maintain the program in compliance
  8 25 with federal and state regulations.
  8 26    The bill repeals all provisions regarding the registration
  8 27 and regulation of internet pharmacy sites and pharmacies
  8 28 associated or aligned with internet pharmacy sites.
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