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FLORIDA | Board of Pharmacy Draft Meeting Minutes October 1-3, 2018 Embassy Suites Ft. Lauderdale 1100 SE 17 th Street Ft. Lauderdale, FL 33316 Contact Hotel: 954-315-1326 Jeenu Phillip, BPharm Chair Jeffrey J. Mesaros, PharmD, JD Vice-Chair C. Erica White Executive Director

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Page 1: Draft Meeting Minutes - floridaspharmacy.gov › Meetings › Minutes › 2018 › ... · Draft Meeting Minutes October 1-3, 2018 Embassy Suites Ft. Lauderdale 1100 SE 17th Street

FLORIDA | Board of Pharmacy

Draft Meeting Minutes

October 1-3, 2018

Embassy Suites Ft. Lauderdale 1100 SE 17th Street

Ft. Lauderdale, FL 33316 Contact Hotel: 954-315-1326

Jeenu Phillip, BPharm Chair Jeffrey J. Mesaros, PharmD, JD Vice-Chair C. Erica White Executive Director

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Tuesday, October 2, 2018 Call to Order: The meeting was called to order by the Chair, Jeenu Phillip, at 3:30 p.m. Roll Call: Those present during the meeting included the following:

Board Members: Jeenu Philip, BPharm - Chair (Jacksonville) Jeffrey J. Mesaros, PharmD, JD, Vice- Chair (Orlando) David Wright, BPharm (Ft. Pierce) David Bisaillon, Consumer Member (Bradenton) Jonathan Hickman, PharmD (Tallahassee) Mark Mikhael, PharmD (Orlando) Gavin Meshad, Consumer Member (Sarasota) Richard Montgomery, BPharm, MBA (Orlando) Blanca R. Rivera, MPharm, MBA (Miami) Board Counsel: David Flynn, Assistant Attorney General Lawrence Harris, Assistant Attorney General Department of Health Counsel: Christopher Jurich, Assistant General Counsel Hannah Philips, Assistant General Counsel Board Staff: C. Erica White, Executive Director Shay Marcelus, JD, - Prog. Operations Admin.

TAB 1. Reports A. Chair’s Report - Jeenu Philip, BPharm, Chair

Discussion: Thank you to Ms. White and for their efforts in executing the Executive order during Hurricane Florence which allowed Florida to help dispense pharmaceuticals to those in need. Ms. White played an important part in relaying the information on various websites to inform the public. Mr. Philip gave an overview of the hot topic discussed at the FDA Conference and the difference processes used by each state to amend their rules. He discussed some of the key statistics discussed surrounding the Opioid Crisis and how all medical professions are affected by this new epidemic.

B. Executive Director's Report – C. Erica White, Executive Director

Discussion: Update – FDA Conference for September 2018 Ms. White gave an overview of the information of the topic she presented while sitting on multiple panels at the FDA Conference.

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Discussion: Proposed PCP Dates for 2019 Chair approved the proposed PCP dates for 2019.

Discussion: Budget Report The Board office has provided the Board with Budget Report for all Boards member to review.

Discussion: Universal Department Application The Department is developing a universal will be available for review for the Board at the December Board meeting.

Discussion: Revised Board Dates The Board Office has received an updated list of the 2019 Board meeting dates. The Board will send out the updated list to all Board members. Mrs. Rivera would like the Board to consider using Miami as a location for a meeting in 2020.

C. Attorney General's Report ‐ David Flynn, Assistant Attorney General

Discussion: Annual Regulatory Plan 2018 – 2019 Mr. Flynn gave an update on the Annual Regulatory Plan. Mr. Flynn and Mr. Phillip were able to complete, execute, and file the Annual Regulatory Plan. The project is comprised of two parts. Part one has been complete. The second portion of the project includes a roadmap for the Board of the rules in which the Board intends to work on this year. This is a great tool to use as a point of reference as the Board continues to work on the rule throughout the year. Motion to ratify the Annual Regulatory Plan 2018 – 2019 by Dr. Mesaros. Motion was seconded by Mr. Bisaillon. Motion passed unanimously.

Discussion: Rules Report for September 2018

Mr. Flynn gave an overview of two key rules on the Rules Report. First, Mr. Flynn gave an update on the progress of amending Rule 64B527.797, F. A. C.- The Standards of Practice for

Compounding Sterile Products. This rule addresses sterile compounded products prepared utilizing a process that includes lyophilization. A rules hearing will be held at the December 2018 Board meeting about Rule 64B527.797, F. A. C.- The Standards of Practice for Compounding Sterile Products. Also, Mr. Flynn gave an overview of Rule 64B16-28.750, F. A. C.- Class III Institutional Pharmacies. He informed the Board that the permit and all the rules pertaining to the Class III Institutional permit will be in effect in mid- October. He is really impressed with the efforts of Ms. White and Mr. Harris in getting the forms completed before the July 1, 2019 deadline.

D. Investigative Services Report – Robert Difiore, Pharmaceutical Program Manager

Discussion: Mr. Robert Difiore gave an overview on the status of current fiscal year inspections. Within the current inspection year, 1,592 non- sterile inspection out of 6,713 have been completed, resulting in an 24% completion rate. Also, 144 sterile compounding inspections out of 508 have been completed, resulting in a 28% completion rate. Mr. Difiore informed the Board that the Bureau of Enforcement in conjunction with the Board of Pharmacy will be sponsoring its third Sterile Compounding Workshop on November 8, 2018 at the DoubleTree Orlando SeaWorld Hotel. The workshop will be held between the hours of 9 a.m. to 4 p.m. and will be worth 5 continuing education credits for attendees.

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TAB 2. Business A. Ratification of Issued Licenses/Certificates – A motion was made by Dr. Mikhael to ratify. Motion

was seconded by Mr. Bisaillon. Motion passed unanimously.

• Pharmacist (Licensure) • Pharmacist (Exam Eligibility) • Pharmacist Interns • Consultant Pharmacist • Pharmacy/Facilities • Registered Pharmacy Technicians • Registered Pharmacy Technician Training • Nonresident Sterile Compounding • Approved CE Providers • Approved CE Courses

B. Review and Approval of Minutes

Board Minutes – August 7-8, 2018 A motion was made to approve as amended. Motion was seconded by Mr. Meshad. Motion passed unanimously. Rules Committee – August 7, 2018 – A motion to approve was made by Mr. Bisaillon. Motion was seconded by Mrs. Rivera. Motion passed unanimously. Compounding Committee – August 7, 2018 – A motion to approve was made by Dr. Mikhael. Motion was seconded by Mr. Wright. Motion passed unanimously.

Motion to adjourn the Board Meeting was made by Mr. Bisaillon, and the Motion was seconded by Mr. Wright. Meeting adjourned at 4:14 p.m.

Wednesday, October 3, 2018 Call to Order: The meeting was called to order by the Chair, Jeenu Phillip, at 9:00 a.m. Roll Call: Those present during the meeting included the following:

Board Members: Jeenu Philip, BPharm - Chair (Jacksonville) Jeffrey J. Mesaros, PharmD, JD, Vice- Chair (Orlando) David Wright, BPharm (Ft. Pierce) David Bisaillon, Consumer Member (Bradenton) Jonathan Hickman, PharmD (Tallahassee) Mark Mikhael, PharmD (Orlando) Gavin Meshad, Consumer Member (Sarasota) Richard Montgomery, BPharm, MBA (Orlando)

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Blanca R. Rivera, MPharm, MBA (Miami) Board Counsel: David Flynn, Assistant Attorney General Lawrence Harris, Assistant Attorney General Department of Health Counsel: Christopher Jurich, Assistant General Counsel Hannah Philips, Assistant General Counsel

Board Staff: C. Erica White, Executive Director Shay Marcelus, JD, - Prog. Operations Admin.

TAB 3. Committee Reports A. Rules Committee – Jeffrey J. Mesaros, PharmD, JD, Chair:

Discussion: Dr. Mesaros gave an overview of the issues discussed around Rules Workshop: Automation. He discussed the language amended was surround by the Florida high school-based program. The Committee will conduct research to attempt to decrease the list of approved programs. Discussed the Board consider placing a required certification program in place for the Pharmacy Technician Programs. Mr. Harris will propose language for December placing a certification program in place. Motion by Mr. Philip. Motion was seconded by Mr. Bisaillon to move forward with the certification question. Motion passed unanimously.

Dr. Mesaros gave on overview Rule 64B16-30.001, F.A.C. - Disciplinary Guidelines; Range of Penalties; Aggravating and Mitigating Circumstances. Motion to amend language under the disciplinary guideline dealing with $10,000 fine for fraud. Mr. Harris request to amend the fine and notice for rule making and respond to the concerns of the issues present by the attorneys. Motion was made by Mr. Bisaillon, and the Motion was seconded by Ms. Rivera. Motion passed unanimously.

Mr. Mesaros gave overview on the discussion of Rule 64B16-27.410, F.A.C. - Registered Pharmacy Technician to Pharmacist Ratio. Dr. Mikhael voiced his concerns about implementing ratios into the profession and how such an action can take away from the professional discretion of the pharmacist. He is not in favor of the ratios. Mr. Philip clarified that the rule allows the PDM to set the ratios. Mr. Wright is concerned about the pharmacist being able to adequately supervise the technicians. The Committee amended the language. Motion to ratify the Committee amendments to the rules was by Dr. Mikhael, and the Motion was seconded by Bisaillon. Motion passed unanimously.

Dr. Mesaros gave an overview of the historical knowledge of Rule 64B16-28.110, F.A.C. – Outdated Pharmaceuticals. Mr. Harris informed the Board that there is certain area of quarantine, and under Chapter 499, F.S. a pharmacy shall not have any expired medication. The committee decided to modify the rule for the language to read as:

Subsection 1: Persons qualified to do so, shall examine the stock of the prescription department of each pharmacy, and shall remove all outdated, damaged, deteriorated, misbranded or adulterated prescription drugs including prescription drugs and pharmaceuticals which bare upon a container and expiration date which date has been reached.

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Subsection 2 will read as follows: Each pharmacy shall maintain a quarantine area which is physically separated apart from active stock of pharmacy, for the quarantining of outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs or pharmaceuticals.

Subsection 3: Existing language

The major change is the removal of the 4-month intervals, eliminating the 4-month minimum will cause a continuing duty for persons qualified that are to examine and remove outdated or damaged stock. Mrs. Rivera wanted to voice her concerns that having expired medication is harm to the health, safety, and welfare of public. The Board discussed referring rule back to the Rules Committee to allow Mr. Harris to develop proposed language and bring the finalized language to the full Board Meeting in December 2018.

The Committee discussed Rule 64B16-30.003, F.A.C. Citations, and the fact that citation rules were created for violation of rules that do not harm the health, safety, and welfare of public. Committee discussed possible fines under the fines Rule 64B16-30.003, F.A.C. The Committee discussed possible fine to place a $100 on the 64B16-30.003(3)(p), F.A.C. Committee also discussed to place $500 under Rule 64B16-30.003(3)(q), F.A.C. the Committee accepted the proposed fines and to have the language in Rule 64B16-30.003 (3) (q), F.A.C to mirror the language in the Rule 64B16.30.002 (1)(a), F.A.C., for a minor violation. Proposed changes to Subsection (1) 1 for new language, to remove pieces of language that refer to substantial threat. Delete subsection 2, with renumbering for existing subsections 3,4, and 5. Motion to accept the proposed language was made by Mr. Philip, and seconded by Dr. Mikhael. Motion passed unanimously.

The Committee discussed Rule 64B16-26.400, F.A.C. – Pharmacy Interns; Registration; Employment. The issue discussed is whether an intern license can be expired. The Committee discussed what happens when the interns have dropped out of school. The committee discussed the process that was previous used to expire intern license. Mr. Flynn has requested to continue this discussion to the December Board meeting to allow the board to have all relevant information before further discussion or a vote can take place.

Controlled Substances Committee - Mark Mikhael, PharmD, Chair Discussion:

Dr. Mikhael gave an overview of the presentation that was given about student compounding. The Board decided move further discussion on this topic to the December Board Meeting.

Legislative Committee - Jeenu Philip, BPharm - Chair Discussion: Mr. Philip discussed duty to consult the PDMP, and the recommendation from the committee for the language to be modified not making it mandatory for the checking of PDMP for facilities like Hospice, ICF/IID, long-term care facilities not limited to assisted living not required to check the PDMP for all cases.

Board discussed amending the language to only require the PDMP to be check for initial fills of controlled substance prescription. The Committee discussed the scope of the issues that are present when failing to check PDMP for a refill. They discussed the value in checking the PDMP for refills.

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The Committee recommended only mandate checking the PDMP for initial fills to Department of Health’s 2019 Legislative Package. Motion made by Dr. Mikhael to accept the Committee’s recommendations, and the Motion was seconded by Mr. Wright. Motion passed unanimously.

TAB 4. Applications Requiring Board Review A. Pharmacist

1. Timothy David; 2201/52044 – A motion to deny the application was made by Mr. Meshad. Motion was seconded by Mr. Bisaillon. Motion passed unanimously.

2. Jorge Lamas; 2201/52972 – Respondent was present, sworn in and was not represented

by counsel. Dr. Martha Brown, Associate Medical Director of Professional Resource Network, was present and supported the Board approving the application based on the applicant full compliance with his PRN contact. A motion was made by Mr. Philip to accept application. Motion was seconded by Mr. Bisaillon. Motion passed unanimously.

3. Karen Scriven; 2201/51439 – Respondent was present, sworn in and was represented by

Ed Bayo, Esq. A motion was made by Mr. Philip to deny the application due to fraudulent misrepresentation and the current disciplinary action on applicants Illinois license. Motion was seconded by Mr. Meshad. All motion was withdrawn. Applicant requested to withdraw her application. A motion was made by Mr. Philip to accept the applicant’s request to withdraw her application. Motion was seconded by Mr. Meshad. Motion passed unanimously.

4. Richard Trevisani; 2201/52934 – Respondent was present, sworn in and was not

represented by counsel. Dr. Brown, Associate Medical Director of Professional Resource Network, was present and supported the Board approving the application based on the applicant full compliance with his PRN contact. A motion was made by Mr. Philip to approving the application. Motion was seconded by Mr. Bisaillon. Motion passed unanimously.

5. Ronald Wood; 2201/49276 – Respondent was present, sworn in and was not represented

by counsel. A motion was made by Mr. Philip to accept application. Motion was seconded by Mr. Wright. Motion passed unanimously.

B. Registered Pharmacy Technician

1. Angela Steward; 2208/73030 – A motion was made by Dr. Mesaros to continue. Motion was seconded by Mr. Wright. Motion passed unanimously.

C. Pharmacy Permits

1. Downing Labs; 2210/289 – A motion was made by Dr. Mikhael to deny the application bases on the applicant not obtaining a passing inspection and the applicant prior disciplinary action. Motion was seconded by Bisaillon. Motion passed unanimously.

2. Medforte Inc. dba Forte Rx Pharmacy; 2205/25740 – Application for Non-Resident

Permit without a passing inspection in California. A motion was made by Mrs. Rivera to accept the application because the Board has no authority to require California to conduct

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an inspection. Motion was seconded by Bisaillon. Motion passed failed. motion was opposed by Mr. Wright, Mr. Philip, Dr. Mesaros, Mr. Meshad, and Dr. Mikhael. Motion made by Mr. Philip to require the applicants’ appearance at one of the next two Board meetings. Motion was seconded by Mr. Wright. Motion passed unanimously.

3. Optum Rx, Inc.; 2205/25710 – A motion was made by Mr. Philip to approve application.

Motion was seconded by Dr. Mesaros. Motion passed unanimously.

4. Tasaj Services, LLC; 2205/25671 – Respondents was present, sworn in and was not represented by counsel. A motion was made by Mrs. Rivera to grant application. Motion was seconded by Mr. Mikhael. Motion passed unanimously.

5. Bal Pharmacy; 2205/24490 – Both respondents, Beatrice Loussaint and Rops Pierre, were

present, sworn in and was not represented by counsel. A motion was made by Ms. Rivera to change the name of the pharmacy to Bal Pharmacy. Motion was seconded by Dr. Mikhael. Motion passed unanimously.

6. Maitland Labs of Central Florida; 2205/25432 – Application was withdrawn from the

Board meeting. The applicant has obtained a passing inspection and are currently licensed. TAB 5. Disciplinary Cases A. Settlement Agreements (Appearance Required)

1. Erum Ghayas Uddin, R.Ph.; Lic # PS52781 • Case #: 2018-05034, File #42778 – • Alleged Violation(s): Section 465.016(1)(g), Fla. Stat. (2017) (772.71) • Recused Members: Glass & Mesaros

Case Summary: At all times material to this Administrative Complaint, patience H.K had a prescription for losartan potassium 100mg. On or about January 25,2018, Respondent dispensed allopurinol 100mg to patient H.K in a prescription container bearing a label for losartan potassium.

Terms of Settlement:

• Appearance • $500 fine payable within 30 days • Costs limited to $1,663.22 payable within 90 days • CE’S- 8 hours Prevention of Medication Errors

Respondent was present, sworn in and was represented by Pro Se. A motion was made by Dr. Mikhael. Motion was seconded by Bisaillon. Motion passed unanimously.

2. Physician Family Pharmacy; Lic # PH30761

• Case #: 2017-20431, File # 24599– ($2011.76) • Alleged Violation(s): Count 1: Section 456.072(1)(k), F.S (2017), by and though a

violation of Section 465.023(1)(C), F.S. (2017), by and through a violation of Rule 64B16-28.109(1), F.A.C., AND Rule 64B16-28.109(5), F.A.C.

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• Count 2: Section 456.072(1)(k), F.S(2017), by and though a violation of Rule 64B16-28.109, F.A.C.

• Recused Members: Weizer and Philip

Case Summary: A.N., the owner of Respondent, did not hold a license to practice pharmacy in Florida. On or about December 20,2017, Department investigator(s) did not observe any indication that Respondent was closed. Department investigator(s) observed that a licensed pharmacist was not present and on duty when A.N was behind the counter of the prescription department. Department investigators observed that A.N had access to the prescription department and the prescription medications which were in an open area and not securely locked away.

Terms of Settlement: • Appearance • $500 fine payable within 90 days • Costs not to exceed $3,482.84 payable within 1 year • PDM shall complete 12-hour Laws and Rules CE course • Shall correct and address all deficiencies listed in the Administrative Complaint

Respondent was not present. A Motion was made by Dr. Mikhael to accept settlement. Motion was seconded by Mr. Bisaillon. Motion passed unanimously.

3. Manuel Cortez, R.P.T.; Lic # 33706

• Case #: 2017-16865, File #34521 • Alleged Violation(s): Section 456.072(1)(dd), F.S (2016-2017), by and through a

violation of Section 456.036(1)(c), F.S. (2016-2017) • Recused Members: Glass & Mesaros

Case Summary: On or about August 29, 2017, a Department inspector conducted an inspection of Yvonne Enterprises, located in Winter Haven, Florida. The inspection revealed that Respondent had practiced as a registered pharmacy technician with an expired license at Yvonne Enterprises on one or more occasions between on or about December 31, 2016, and on or about August 29,2017.

Terms of Settlement: • Appearance • $1,000 fine payable within 90 days • Costs limited to $1,791.75 payable within 90 days Amended Terms of Settlement: • Appearance • $1,000 fine payable within one year • Costs limited to $1,791.75 payable within one year

Respondent was present, sworn in and was not represented by counsel. A motion was made by Mr. Phillip to accept the orally amended settlement agreement. Motion was seconded by Dr. Mikhael. Motion passed unanimously.

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4. Qualgen, LLC; Lic # PH 29229 • Case: #2017-01126, File # –22770 • Alleged Violation(s): Section 456.072(1)(f), F.S. (2015) • Recused Members: Mesaros & Bisaillon Case Summary: On or about June 15,2016, the Oklahoma Board of Pharmacy issued a Final Order whereby discipling Respondent’s Oklahoma pharmacy permit for one or more violations that would constitute a violation of Florida law. Terms of Settlement: • Appearance • $2,000 fine payable within 90 days • Costs limited to $1,698.55 payable within 90 days • PDM shall complete 12-hour Laws and Rules CE within 1 year • 1-year probation with the following term: • Respondent shall submit any/all documents associated with inspections by other

jurisdictions to the board. Respondent was present, sworn in and was represented by Ed Bayo, Esq. A motion was made by Dr. Mikhael to accept. Motion was seconded by Mr. Meshad. Motion passed unanimously.

5. Qualgen, LLC, R.Ph.; Lic # NSC 133 • Case #2017-05615 • File #220 • Recused Members: Glass & Mikhael Alleged Violation(s): Section 456.072(1)(f), F.S. (2015) Case Summary: On or about June 15, 2016, the Oklahoma Board of Pharmacy issued a Final Order whereby disciplining Respondent’s Oklahoma pharmacy permit for one or more violations that would constitute a violation of Florida law. ($721.72) Terms of Settlement: • Appearance • $2,000 fine payable within 90 days • Costs limited to $1,393.70 payable within 90 days • PDM shall complete following CEs within 1 year: • 12- hour Laws and Rules • 50- hour Essential Elements of Compounded Sterile Preparations • 5.1-year probation with the following terms: • Respondent shall submit any/all documents associated with inspections by other

jurisdictions to the Board. Respondent was present, sworn in and was represented by Ed Bayo, Esq. A motion was made by Dr. Mesaros to accept the settle agreement. Motion was seconded by Mr. Meshad. Motion passed unanimously.

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6. Donny R. John, R.Ph.; Lic # PS 25852 • Case #2017-23195, File # 14919 • Alleged Violation(s): Section 465.016(1)(g), F.S. (2016) • Recused Members: Glass & Mikhael

Case Summary: Patient M.I. had a prescription for imatinib mesylate 100mg. On or about May 17, 2017, Respondent dispensed imatinib mesylate 400mg to Patient M.I instead of the imatinib mesylate 100 mg prescribed to M.I. Terms of Settlement: • Appearance • $250 fine payable within 90 days • Costs limited to $2,494.17 payable within 90 days • 8- Hour Prevention of Medication Errors CE to be completed within 1 year Respondent was present, sworn in and was represented by Andrea L. Diederich, Esq. A motion was made by Mr. Mesaros to dismiss the case. Motion was seconded by Mr. Bisaillon. Motion passed unanimously.

7. Arthur Goldglantz, R.Ph.; Lic # PS15648

• Case #2017-18716 • File #5802 • Recused Members: Glass & Mikhael Alleged Violation(s): Count 1: Section 456.072(1)(k), FS (2017) by and through a violation of Section 465.022(11)(a), FS (2017), by failing to ensure compliance with Rules 64B16-27.820(1), 64B16-28.450(4), and 64B1628.140(4), FAC Count 2: Section 465.016(1)(e), FS (2017) by and through a violation of Section 499.005(22), FS (2017) Count 3: Section 465.016(1)(e), FS (2017) by and through a violation of Section 456.022(11)(a), FS (2017) by and through a violation of Section 893.04(1)(c)6., FS (2017) Count 4: Section 465.016(1)(e), FS (2017) by and through a violation of section 465.022(11)(a), FS (2017) by and through a violation of section 893.055(4), FS (2017) Case Summary: Respondent was the prescription department manager and owner of record for Arthur’s “Original” Pharmacy, a permitted community located in Tamarac, Florida. On or about October 9, 2017, the Department conducted a community pharmacy inspection of Arthur’s “Original” Pharmacy and found one or more deficiencies. Terms of Settlement: • Appearance • Costs limited to $2,139.23 payable within 90 days • 12- hour Laws and Rules CLE within 1 year Respondent was present, sworn in and was represented by Brian Kahn. A motion was made by Dr. Mesaros to accept the settlement agreement. Motion was seconded by Mrs. Rivera. Motion passed unanimously.

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8. Arthur’s “Original” Pharmacy Lic # PH15255 • Case #2017-18715 • File # 5778 • Recused Members: Glass & Mikhael

Alleged Violation(s): Count 1: Section 465.023(1)(c), FS (2017), by and through a violation of Rules 64B16-27.820(1), 64B1628.450(4), and 64B16-28.140(4), FAC Count 2: Section 465.023(1)(c), FS (2017) by and through a violation of Section 499.005(22), FS (2017) Count 3: Section 456.072(1)(k), FS (2017), by and through a violation of Section 465.23(1)(c), FS (2017), by and through a violation of Section 893.04(1)(c)6., FS (2017) Count 4: Section 456.072(1)(k), FS (2017) by and through a violation of Section 465.023(1)(c), FS (2017), by and through a violation of Section 893.055(4), FS (2017) Case Summary: On or about October 9,2017, the Department conducted a community pharmacy inspection of Respondent and found one or more deficiencies. Terms of Settlement: • Appearance • $5,000 fine payable within 90 days • Costs limited to $2,681.37 payable within 90 days • PDM shall complete 12-hour Laws and Rules CLE within 1 year • Probation for 1 year with the following term: • Semi-annual inspections at Respondent’s cost Respondent was present, sworn in and was represented by Brian Kahn. A motion was made by Dr. Mesaros to accept the settlement agreement. Motion was seconded by Mrs. Rivera. Motion passed unanimously.

B. Determination of Waivers

The Board, as appropriate, accepted unanimously the following motions: 1). The Department asks that you accept the investigative report into evidence for the purpose of imposing a penalty. 2). The Department asks that you find that the Respondent was properly served and waived the right to a formal hearing (either by failing to respond at all or timely). 3). The Department asks that you adopt the findings of fact and conclusions of law as set forth in the Administrative Complaint and find that this constitutes a violation of the practice act.

1. US Highway 1 Pharmacy, Inc. Lic #28920

• Case # 2017-08552 • File # 22032 • Recused Members: Weizer & Philip Prosecution Services Unit withdrew the case from the agenda.

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2. Natia Lanee Moise, R.P.T.; Lic #55144 • Case # 2017-20182 • File #57870 • Recused Members: Mikhael & Glass

A motion was made by Mr. Bisaillon for revocation of licensure. Motion was seconded by Mr. Meshad. Motion passed unanimously. Department withdrew its Motion for Costs.

3. Tashima Cheree Kenny, R.P.T.; Lic #62519

• Case # 2016-17809 • File #52314 • Recused Members: Weizer & Bisaillon A motion was made by Dr. Mikhael for revocation of licensure. Motion was seconded by Mr. Meshad. Motion passed unanimously. Department withdrew its Motion for Costs.

4. Reinaldo Morey, R.P.T.; Lic #34632

• Case # 2016-17844 • File #35498 • Recused Members: Philip & Glass A motion was made by Mr. Bisaillon for revocation of licensure. Motion was seconded by Mrs. Rivera. Motion passed unanimously. Department withdrew its Motion for Costs.

5. Sandra L. West, R.Ph..; Lic #27917

• Case #2017-08731 • File #16951 • Recused Members: Weizer & Bisaillon A motion was made by Wright. Motion was seconded by Rivera. Motion passed unanimously. Motion to accept costs on the reinstatement of the license in the cost of $571. Motion made by Mr. Wright. Motion was seconded by Mr. Meshad. Motion passed unanimously.

6. Luis Y. Santa, R.P.T.; Lic #51510

• Case #2017-24357 • File # 53907 • Recused Members: Meshad & Glass A motion was made by Mr. Bisaillon for revocation of licensure. Motion was seconded by Ms. Rivera. Motion passed unanimously. Department withdrew its Motion for Costs.

7. Kathryn A. Burchette, R.P.T.; Lic #50395

• Case #2017-20181 • File # 52426 • Recused Members: Glass & Mikhael A motion was made by Mr. Bisaillon for revocation of licensure. Motion was seconded by Ms. Rivera. Motion passed unanimously. Department withdrew its Motion for Costs.

8. Megan McGill, R.Ph.; Lic #33537

• Case #2017-19385 • File # 22547 • Recused Members: Meshad & Glass A motion was made by Mr. Bisaillon for revocation of licensure. Motion was seconded by Mrs.

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Rivera. Motion passed unanimously. Department withdrew its Motion for Costs.

9. Zugielys Castillo, R.P.Y.; Lic #35026 • Case #2017-22317 • File # 35885 • Recused Members: Weizer & Rivera A motion was made by Mr. Bisaillon for revocation of licensure. Motion was seconded by Mrs. Mesaros. Motion passed unanimously. Department withdrew its Motion for Costs.

10. Brigitte G. Arnold, R.Ph.; Lic #21715

• Case #2017-03928 • File #10920 • Recused Members: Philip & Meshad A motion was made by Mr. Bisaillon. Motion was seconded by Wright. Motion passed unanimously. Department motion for cost in the amount of $2666.68. motion to accept was made by Mr. Bisaillon. Motion was seconded by Wright. Motion passed unanimously.

C. Voluntary Relinquishments

1. Brian Keith Angus, R.P.T.; Lic #,24335 • Case # 2018-07042 • File #25449 • No Recused Members A motion was made by Dr. Mesaros by to accept voluntary relinquishment #1. Motion was seconded by Mr. Mikhael. Motion passed unanimously.

2. Eylem Gonzalez, R.P.T.; Lic #,41896

• Case # 2017-11373 • File #43496 • Recused Members: Weizer & Bisaillon A motion was made by Dr. Mesaros to accept voluntary relinquishment #2. Motion seconded by Mr. Mikhael Motion passed unanimously.

3. Douglas A. Stewart, R. Ph..; Lic #23538

• Case # 2017-24212 • File #12645 • Recused Members: Glass & Mesaros A motion was made by Mr. Wright to accept voluntary relinquishment #3. Motion seconded by Mr. Bisaillon. Motion passed unanimously.

4. Donna Marie Licata, R.P.T.; Lic #34801

• Case # 2018-12458 • File #35230. • Recused Members: Meshad & Rivera A motion was made by Mr. Wright to accept voluntary relinquishment #4. Motion seconded by Mr. Bisaillon. Motion passed unanimously.

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D. Informals

The Board, as appropriate, accepted unanimously the following motions: 1). The Department asks that you accept the investigative report into evidence for the purpose of imposing a penalty. 2). The Department asks that you find that the Respondent was properly served and waived the right to a formal hearing (either by failing to respond at all or timely). 3). The Department asks that you adopt the findings of fact and conclusions of law as set forth in the Administrative Complaint and find that this constitutes a violation of the practice act.

1. Darshana Patel, RPT.; Lic #32959

• Case # 2017-08509 • File #33697 • Alleged Violation(s): Section 456.072(1)(m), F.S. (2016) • Recused Members: Glass & Wright

While employed as a registered pharmacy technician at Tri-Coast Pharmacy, Respondent made deceptive, untrue, or fraudulent representations in or related to the practice of her profession, or employed a trick or scheme in or related to the practice of her profession, by altering or forging one or more certificates of analysis for sterility testing of one or more lots of compounded sterile preparations compounded by Tri-Coast between October 19, 2016 through December 19, 2016.

A motion was made by Mr. Bisaillon for revocation of licensure. Motion was seconded by Mr. Meshad. Motion passed unanimously.

E. Prosecution Services Report – Christopher Jurich, Assistant General Counsel

Discussion: Mr. Jurich gave a brief update on the current caseload for the Prosecution Services Unit. Current caseload of 368 cases. Prosecution Services Unit(PSU) has hired additional attorneys for the Board of Pharmacy and is now fully staffed. A motion was made by Dr. Mikhael to allow PSU to continue to prosecute cases older than 1 year. Motion seconded by Mr. Bisaillon. Motion passed unanimously.

TAB 6. Licensure Issues

A. Petition for Extension

James Whitt, R.PH.; Lic #23825 • Case # 2016-27094 • File # 12920

A motion was made by Dr. Mikhael to extend the deadline for all required Continuing Education by an additional 180 days. Motion was seconded by Mr. Meshad. Motion passed unanimously.

B. Petition to Withdraw Sterile Compounding Permit

DNA Pharmacy.; Lic #20850 • Case # 2012-18237

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• File # 13154 Respondent was present, sworn in and was not represented by counsel. A motion was made by Dr. Mikhael to withdraw the application. Motion was seconded by Mr. Bisaillon. Motion passed unanimously.

Victor Okwute, Lic# 37354 • Case #2009-19412 • File# 28113

Respondent was present, not sworn in and was not represented by counsel. A motion was made by Dr. Mesaros to lift suspension, also imposed a date of 1 year for payment for fines and costs. Motion seconded by Ms. Rivera. Motion passed unanimously.

TAB 7. Public Comment No Discussion TAB 8. Adjournment Motion to adjourn made by Mr. Bisaillon. Motion Seconded by Mr. Meshad. Meeting adjourned at 2:53 p.m.