Monday, May 6, 2013

Vermont Board of Pharmacy Unapproved Minutes for March 27, 2013-- Compounding Issues Discussed


BOARD OF PHARMACY – Unapproved Minutes
Secretary of State, Office of Professional Regulation
23 College Street, Schulmaier Hall, Montpelier, VT 05602
March 27, 2013 at 9:00 A.M.
1. The meeting was called to order at 9:00 a.m.
 Members Present: Mr. Jeffrey P. Firlik, RPh, Chair; Ms. Julie A. Eaton, RPh; Vice-Chair; Mr.
Steven M. Vincent, RPh; Mr. King Milne, RPh; Mr. Larry Labor RPh; Ms. Judith Wernecke,
Public Member, Secretary; and James Arisman, Esq., Public Member.
OPR Personnel Present: Larry S. Novins, Board Counsel; Dan Vincent, Inspector; and Ronald
Klein, RPh, Executive Officer
Others Present both in person and via the telephone: Chris Piehler, Anthony Otis, Joe
Wonderly, Cora Colvin, Rob Calia, Beth Thompson, Ritchie Berger, Joseph Rampi, Robert
Hamilton, Mike Duteau, Rebecca Dugal, Tammy Del Bianco, Grace Skylar (Rite Aid), Amanda
Glover (Rite Aid), Bill Cover (Walgreens), Heather Shouldice (VT Association of Chain Drug
Stores), Mark Foley (Hannaford) and Ann Fellows (National Association of Chain Drug Stores).
2. The Chair called for approval of the Minutes of the December 5th - this was tabled as the
afternoon discussion from the meeting was not included. Ms. Eaton will advise Mr. Klein on
what needs to be included.
 The Chair called for approval of the Minutes of the January 23, 2013 minutes. Ms. Wernecke
noted a typo error on page 3 number 8; Mr. Eaton should be Ms. Eaton. Mr. Vincent made a
motion seconded by Ms. Eaton to approve the Minutes with correction. Motion passed.
3. Hearings/Stipulations et al:
9:15 am – Stipulation and Consent Order Re.: Karen Rouse 2012-384. Ms. Eaton made motion
 seconded by Mr. Vincent to accept the Order as presented. The board went into deliberative
 session at 10:30 and out at 10:39. The Board rejected the Order.
 9:15 am – Stipulation and Consent Order Re.: Medline Industries, Inc. Docket #’s 2011-360
 (RX), 2011-361(RX), 2011-362(RX), and 2011-363(RX): Medline was represented by Joseph
 Wonderly. Ms. Eaton made a motion to reject the Order and issue unencumbered licenses for
 all of the applications submitted. The motion was seconded by Mr. Vincent. The Board went
 into deliberative session at 10:05 and out at 10:20. The Board rejected the Order and
 advised Medline to resubmit updated applications.
 1:00 pm – Motion for Supervision Re.: Glen Myer Docket # 2009-487 and Follow-Up Case #
 M2011-54. Mr. Myer’s attorney participated via telephone call. Mr. Vincent made a motion to
 accept the proposed motion for supervision. The motion was seconded by Ms. Eaton. Mr. Firlik
 abstained from voting. Motion passed.
4. Discussion:
Pharmacist Workload Issues Discussion – Mr. Firlik requested Ms. Eaton lead the discussion on
this matter. The Board wanted to address this issue as there have been a number of concerns
voiced to board members, inspection staff and the board office. Prior to today’s’ meeting, Mr.
Klein sent a notice to all interested parties soliciting comment regarding staffing issues at
pharmacies, length of shift issues, technician ratios, quality of education of technicians, Board of Pharmacy Page 2
standards of technician education, and immunization issues occurring in community pharmacies.
 Ms. Eaton wanted to point out an article published in Chain Drug Review Journal, February 4th,
2013 issue, regarding community pharmacies being besieged with vaccination requests. Ms.
Eaton explained while pharmacists’ having the ability to administer vaccinations is a wonderful
thing for the public, it has put an added pressure on the pharmacists working at these
community pharmacies.

Ms. Eaton pointed out that it’s really a public safety issue to not have a well staffed pharmacy,
with sufficient licensed pharmacists. Mr. Vincent read an anonymous letter submitted to the
Board office regarding the issues this individual is facing with lack of licensed professionals
working with them. Mr. Vincent acknowledged that the Board is having this open discussion to
get ideas on what would work best for the licensees in Vermont as well as the pharmacies
involved. Mr. Robert Hamilton, Dean of the Vermont campus of the Albany College of
Pharmacy, addressed the Board and guests about the type of training they are currently giving
their students. Ms. Eaton stressed the point that pharmacists need better trained support staff to
alleviate some of the pressure. One way this could be addressed is through the use of certified
technicians. Mike Duteau, VP of Pharmacy Operations for Kinney Drugs and Chairman of the
New York Board of Pharmacy, informed the group that the New York State Board of Pharmacy is
presently considering an increase to the pharmacist /pharmacy technician ratio. Mr. Duteau also
informed the Board that the New York State Board of Pharmacy has deemed “quotas”
mandating the number of prescriptions to be filled daily to be unprofessional conduct. There
were several pharmacists who spoke regarding the difficulties they have with providing
immunizations as well as completing their normal requirements for filling prescriptions.
Mr. Vincent informed the group about the new immunization bill currently in legislature, S.142,
will potentially allow pharmacists to administer vaccinations to children 7 years of age or older.
This will inevitably add to the pharmacist work load. Mark Foley spoke to the Board regarding
the policies and procedures currently enforced in Maine and made suggestions to the Board
about developing central processing (through the use of a machine) for prescription filling.
Compounding Pharmacy Rules – Inspector Vincent spoke to the Board about the issues he sees
when inspecting. He feels our Rules do not adequately address sterile compounding and
suggested the Board consider making USP 797 the standard for all compounding pharmacies to
follow. Ms. Eaton suggested making a small committee, possibly two Board members with
counsel and Mr. Klein, to discuss the adoption of USP 797 and refining the institutional
pharmacy regulations.
5. Case Manager’s Report:
 There are 46 cases pending, 8 are pending Investigative Team meetings, 2 are in intake for
screening, 1 is awaiting a response from the Respondent, 7 are under investigation, 4 are
pending charges, 14 cases ready for closing, 4 cases have had charges filed and 6 are pending
hearings.
 Mr. Vincent asked Mr. Klein about the status of discipline moving to being completely under Mr.
Klein. Mr. Klein informed the Board that everything that was previously under Ms. Preston will
be finished up by her. Any new cases are coming to Mr. Klein and he is working with Ms.
Morrison to keep up to date on this.
6. COMPLAINTS, review of Reports of Concluded Investigation:
 Report of Concluded Investigation Re.: 2011-850. Mr. Vincent made a motion to accept the
report, seconded by Ms. Eaton. Mr. Labor did not participate in the vote as he was the
investigative team member. Motion passed. Board of Pharmacy Page 3
 Report of Concluded Investigation Re.: 2011-851. Mr. Arisman made a motion to accept the
report, seconded by Mr. Milne. Mr. Labor did not participate in the vote as he was the
investigative team member. Motion passed.
 Report of Concluded Investigation Re.: 2012-100 and 2012-101. Mr. Vincent made a motion to
accept the report, seconded by Mr. Arisman.
 Ms. Eaton did not participate in the vote as she was the investigative team member. Motion
passed.
 Report of Concluded Investigation Re.: 2012-96 and 2012-97. Mr. Vincent made a motion to
accept the report, seconded by Mr. Arisman. Ms. Eaton did not participate in the vote as she was
the investigative team member. Motion passed.
 Report of Concluded Investigation Re.: 2012-94 and 2012-95. Mr. Vincent made a motion to
accept the report, seconded by Mr. Arisman. Ms. Eaton did not participate in the vote as she
was the investigative team member. Motion passed.
 Report of Concluded Investigation Re.: 2012-88 and 2012-89. Mr. Vincent made a motion to
accept the report, seconded by Mr. Arisman. Ms. Eaton did not participate in the vote as she
was the investigative team member. Motion passed.
 Report of Concluded Investigation Re.: 2012-143. Mr. Vincent made a motion to accept the
report, seconded by Ms. Eaton. Mr. Firlik did not participate in the vote as he was the
investigative team member. Motion passed.
8. Legislation/Rulemaking:
 Legislation in other states – Mr. Klein will provide an update at the next board meeting.
 Bill H.522 – Opioids – Mr. Klein provided the board with information on this bill.
 Bill S.142 – Immunizations – This bill was described during the course of the workload
discussion. Ms. Eaton was interested in attending Senate hearings and possibly giving
testimony regarding the immunization of children seven (7) years of age and older. The Board
stated that the only immunizations to be done on children, by a pharmacist, should be in an
emergency situation. If Mr. Klein should be called to testify regarding this bill the Board would
like him convey that they are against this Bill.
9. Review Applications for licensure:
The Board reviewed the following applications and voted to preliminarily deny them. These
applications will be reviewed in more detail at the April 24, 2013 meeting.
• Hotbar, LLC d/b/a Monroe Clinic Drugs – Monroe, LA
• Vicksburg Special Care Pharmacy & Compounding, LLC – Vicksburg, MS
• Abraxis Bioscience, LLC – Melrose Park, IL
• Advantage Pharmacy, LLC – Hattiesburg, MS
• Drug Depot, Inc. d/b/a APS Pharmacy – Palm Harbor, FL Board of Pharmacy Page 4
Mr. Firlik made a motion to approve Diabetic Care Rx, LLC d/b/a DCRX Infusion for licensure.
Mr. Vincent seconded the motion. Motion passed.
Mr. Firlik made a motion to approve Carepoint Healthcare, LLC d/b/a Carepoint Pharmacy for
licensure. Ms. Eaton seconded the motion. Motion passed.
Mr. Klein brought the Non-Resident Pharmacy application for FVS Holdings, Inc. d/b/a Green
Valley Drugs located in Henderson, Nevada for Board review and approval. Ms. Eaton made a
motion to approve the application for licensure. The motion was seconded by Mr. Vincent.
Motion passed.
Porter Hospital requesting for Renee Mosier to be the Pharmacist Manager for both the hospital
pharmacy and the institutional long term care pharmacy. Mr. Firlik made a motion to approved
Ms. Mosier’s request. The motion was seconded by Mr. Vincent. Mr. Arisman recused from
discussion and voting. Motion passed.
10. Executive Officer Report:
 Mr. Klein informed the Board that New York has moved Hydrocodone to a schedule II drug. Mr.
Klein informed the people that contacted him that a pharmacist filling a prescription for a
Vermont resident or shipping to Vermont residents they must abide by Vermont Law. Vermont
laws states that Hydrocodone is a schedule III drug.
Mr. Klein spoke to the Board regarding the numerous categories of licensure OPR has to try to
reduce the list. The Board would like to leave the licensing options as they are. Mr. Novins
spoke to the Board regarding license status changes that was previously in this years OPR bill
but was pulled. He hopes to add this to next years OPR bill.
Mr. Klein informed the Board that he went to NABP headquarters and wrote 43 questions for the
MPJE examination.
11. Correspondence:
 David Herlihy E-mail re.: Physician Dispensing. This was a topic of discussion for the Board.
 All-American Allergy Alternatives – letter regarding prescription pick-up and delivery. Mr. Klein
will respond to them and let them know that they must supply to the end user and therefore can
not distribute directly to the physician’s office.
 Express Scripts – Tour of Technology & Innovation Center during NABP meeting in St. Louis.
Ms. Eaton, Mr. Firlik and Mr. Klein will be attending the tour.
10. Pharmacy Technicians: Total number of Active Registered Technicians is 1,574 (1,458
Resident, 116 Non-Resident).
11. The next meeting is scheduled for Wednesday, April 24, 2013, at 9:00 A.M.
12. Mr. Vincent made a motion, seconded by Mr. Arisman, to adjourn at 3:43 p.m. Motion Passed.
Respectfully Submitted: Board of Pharmacy Page 5
_______________________________
Judith Wernecke, Secretary
Vermont Board of Pharmacy
_______________________________
Ronald J. Klein, RPh
Executive Officer
Vermont Board of Pharmacy


source found here

No comments: