Sunday, May 5, 2013

Utah Board of Pharmacy Minutes from March 26, 2013--A lot of Compounding Issues


MINUTES
UTAH
BOARD OF PHARMACY
MEETING
March 26, 2013
Room 474 (fourth floor)– 8:30 A.M.
Heber Wells Building
Salt Lake City, UT 84111
CONVENED: 8:31 A.M. ADJOURNED: 4:40 P.M.
Bureau Manager: Richard J. Oborn
Board Secretary: Lee Avery
Board Members Present: David Young, Pharm D., Chair
Kelly Lundberg, Ph.D.
Jan Bird, CPhT, pharmacy technician
Derek Garn, R.Ph.
David Young, Pharm D
Andrea Kemper, Pharm D
Greg Jones, R.Ph.
Carl “Trip” Hoffman, Pharm D
DOPL Staff Present: Ray Walker, Division Enforcement Counsel
Connie Call, Compliance Specialist
Jared Memmott, Investigator
Jake Corsi, Investigator
There is a new bureau manager and board secretary
assigned to the pharmacy profession.
Guests: Matt Ence, USPA
Greg Jensen, Target
David Cheney, Assoc. Foods
Scott Mitchell, Assoc. Foods
Linda Sandberg, R.Ph
Betty Yamashita, IHC
Brittany Bryan, IHC
Ian Ford, University of Utah
Adam Jones, Utah Pharmacist Association
Jamie Peterson, Walgreens
Nick Estrada, University of Utah
Dave Davis, retired pharmacist
Erin Johanson, Roseman University Page 2 of 12
Minutes
Pharmacy Licensing Board
March 26, 2013
Paige Patterick, Smith’s
Blair S. Woolf, Smith’s
J. Anderson
TOPICS FOR DISCUSSION DECISIONS AND RECOMMENDATIONS
Minutes: Dr. Lundberg made a motion to approve the minutes
dated February 26, 2013, with corrections. Dr.
Kemper seconded the motion. All Board members
voted in favor of the motion.
DISCUSSION ITEMS:
1. 8:45 a.m. - Report from Compounding
Taskforce
Mr. Hoffman suggested the Division review standards
for compounding pharmacies established by other
states, such as Texas, North Carolina.
2. 9:00 a.m. - Rule changes prompted by bills
passed during 2013 Legislative Session
Mr. Walker reviewed several bills that were passed
during the 2013 Legislative Session. Dr. Young led
the Board in discussing rule amendments that need to
made due to action taken by the legislature.
3. 11:00 a.m. - Discussion regarding Kroger
distribution plan to assist with addressing
issues in rule
Mr. Paige Patterick, Mr. Blair Woolf, and Mr.
Brody White, representatives of Kroger Stores, met
with the Board. Kroger has a call center to help the
Kroger Pharmacies provide better customer service.
These representatives reviewed how call center
technicians take calls from customers with a variety of
questions such as is my prescription ready, how much
is my prescription, and can you refill my prescription?
When a customer contacts the call center and the
technician cannot help the customer, the customer is
transferred to the store pharmacist. These types of
calls would include drug interactions. The Board
indicated that they may recommend rule amendments
to be made to the Division in the future that would
impact what Kroger is hoping to set up in Utah. The
Board requested this topic be discussed at the June
or July Board meeting.
4. 11:20 a.m. - Division’s response to
Compounding Task Force Report

Taken out of order on the agenda.
Mr. Steinagel met with the Board and reviewed the
Division’s response to recommendations made by the
Compounding Task Force.
The task force recommends that the Division enforce Page 3 of 12
Minutes
Pharmacy Licensing Board
March 26, 2013
an inspection moratorium on compounding
pharmacies. The Division is uncomfortable with this
idea. The Division cannot cease issuing citations and
disciplining compounding pharmacies.
The task force recommends that DOPL investigators
and inspectors go through training on federal laws that
regulate the pharmacy profession. The Division
supports this idea and is willing to provide additional
training for investigators. Five investigators will go
through intensive NABP training in May that was
scheduled before the task force met to discuss
recommendations.
The task force encourages inspectors to educate
licensees when they investigate them and follow-up on
inspections. The Division supports this idea.
The task force recommends updating of the
compounding self-inspection report. The Division
agrees with this idea and will consult with Board
members and others in the field as necessary as
updates to the report are made. The Division will
make updates to the report and submit a revised selfinspection report to the Board for review at the May
meeting.
The task force recommends creation of selfinspection reports for Class B and C pharmacies. The
Division is working on this.
The task force recommends that the Pharmacy
Practice Act be revised. The Division is happy to
provide input to Board members, legislators, and
associations as they propose amendments to the Act.
The Board will be discussing possible amendments to
the Act during future Board meetings.
The task force recommends that standards regarding
transferring compounds within the same institutional
setting be clarified and that language in regard to
manufacturing vs. traditional vs. non-traditional
compounding be clarified. The Division is willing to
work with the Board on these items.
The task force recommends that DOPL send a letter to Page 4 of 12
Minutes
Pharmacy Licensing Board
March 26, 2013
compounding pharmacies. A letter was sent last year
and the Division is willing to consider sending a
second one this year.
The task force recommends that network-networknetwork become compliant with USP standards. This
is something the Division agrees that the industry can
work on.
Mr. Steinagel advised the Board that DOPL is
interested in inviting NABP to come to Utah to make
training available to representatives of pharmacies in
Utah that engage in compounding. This training is
three or four days and is very intensive. Mr. Steinagel
advised the Board that it would require legislation to
amend the laws upon which the inspection report is
based.
The Board expressed concern regarding sending
sterilized compounding out of state. Mr. Steinagel
noted that currently pharmacies are self reporting to
DOPL and encouraged the Board to consider the
following options: (1) Creation of licensure for
compounding pharmacy; (2) Require pharmacies to
declare whether they do sterile compounding; (3)
During renewal, have the pharmacy representative
affirm whether they are engaging in sterile
compounding. The Board will discuss this at a
future meeting.
5. 11:40 a.m. - Transferring refillable
controlled substances from one pharmacy to
another within a chain pharmacy system
Mr. Oborn stated that the Division received a question
regarding transferring refillable controlled substances
from one pharmacy to another within a chain
pharmacy system. The Board reviewed the rule noting
that a prescription for legend drugs having a
remaining authorization for refill may be transferred
by the pharmacist or pharmacy intern at the pharmacy
holding the prescription to a pharmacist or pharmacy
intern at another pharmacy upon the authorization of
the patient to whom the prescription was issued or
electronically. The transferring pharmacist or
pharmacy intern and receiving pharmacist or
pharmacy intern shall act diligently to ensure that the
total number of authorized refills is not exceeded.
The Board also noted that pharmacy technicians may Page 5 of 12
Minutes
Pharmacy Licensing Board
March 26, 2013
not transfer controlled substances.
APPOINTMENTS:
1:00 p.m. - Connie Call, compliance report 1. Jessica Keady 2012-530: BOARD REQUEST:
Board wanted to follow-up with her to see how she is
doing and if she understands her probation. She
failed to submit any of her paperwork that was due
February 1 or March 1, 2013. She activated her
Affinity account but has not been checked in since
February 5, 2013. Compliance tried to contact her
twice on February 20, 2013 to see what the problem is
but she has not returned the call. She sent a letter on
February 26, 2013 stating she was in jail. She was
incarcerated February 4 – 28, 2013 which allowed her
to turn her paperwork in due February prior to the
incarceration and she was released on the 28th so she
could have sent in her March paperwork. She missed
all three of her drug screens since she activated her
account. She did not fill any prescriptions this past
quarter. Non-Compliant due to failure to check-in
with Affinity and failure to submit required
paperwork.
2. 4 Care Pharmacy (Robert Pratt) 2013-40: He is
being seen because he was not compliant last month as
he failed to meet with compliance staff prior to that
meeting. Compliance met with Mr. Pratt on March 6,
2013 and reviewed his Order. He was informed the
Board wanted to meet with Randy Bushell, the PIC.
3. James Ammon 2012-394: BOARD REQUEST:
He is being seen because he was non-compliant. He
failed to notify the Division of his employment until
they received his employer report. He failed to submit
a practice plan prior to accepting employment and his
paperwork was late.
4. Paul Martz 2010-231: QUARTERLY MEETING:
Drug screens are all negative. Received his employer
report, self-assessment, and 12-Step attendance. The
Board said until the Division receives a therapy form
or letter from Jeff Vorhees stating Paul has completed
his therapy, he will be non-compliant. The Page 6 of 12
Minutes
Pharmacy Licensing Board
March 26, 2013
compliance specialist sent a request to Mr. Vorhees in
November and December 2012 requesting an exit
report. Ms. Call called and left him a message and the
Division has still not received an exit letter from him.
Compliance spoke with Mr. Martz and he will attempt
to obtain an exit evaluation from Mr. Vorhees. CSD is
okay as he has submitted all of his prescriptions.
Compliant
5. Lincare, Inc. (Jeanne Reese) 2012-369: They
paid the licensing fee. They have submitted the report
due January 1, 2013 and the next one is due June 1,
2013. They have supplied a representative to meet
with the Board which is Jeanne Maguire. The board
secretary was informed that Mr. Gabos is no longer
with Lincare, Inc. so we will speak with Ms. Reese.
Compliant
6. Diann Millikan 2009-74: Drug screens are either
negative or prescription positive. Received her
employer report, therapy report, and PIR/12-Step.
She submitted all copies of her prescriptions filled
over the past quarter. Compliant
7. Kevin Whipple 2013-53: This is his initial
interview. Met with compliance staff on March 25,
2013. He has a couple of concerns and a few
questions. His biggest concern is the financial cost of
being on probation which he will discuss with the
Board. His other question is regarding clarification of
“direct supervision” in a hospital setting.
8. Wesley Remund: He was previously on probation
but surrendered his license. He has tested since
October 2012 and all drug screens have been negative.
MONTHLY PROBATIONERS NOT MEETING
WITH THE BOARD
Kirtland Wray 2012-413: Drug screens are all
prescription positive. Received his self-assessment,
employer report, and verification of 12-Step Page 7 of 12
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Pharmacy Licensing Board
March 26, 2013
attendance. Received all prescriptions filled over the
past quarter. Compliant
Michael Wright 2012-375: All drug screens are
prescription positive. Received his employer report
and self-assessment. He submitted a copy of all
prescriptions filled over the past month. He
submitted six months of reports so he can now submit
his paperwork quarterly. Compliant
Colton Dale 2012-231: Drug screens are not
required. He submitted his self-assessment and
employer report. He did not have any prescriptions
this past month. Compliant
1:30 p.m. - Jessica Keady, quarterly interview Ms. Keady failed to keep her appointment with the
Board. Ms. Bird motioned to recommend that the
Division propose a surrender of license order be
issued. If she refuses to surrender her license, the
Division should move forward to revoke her license.
The motion was seconded by Mr. Jones. The motion
carried unanimously.
1:45 p.m.- 4 Care Pharmacy (Owner: Robert
Pratt, PIC: Randy Bushell), New Order
Mr. Pratt and Mr. Bushell met with the Board. Mr.
Jones conducted the interview. Mr. Pratt advised the
Board that 4 Care Pharmacy is a closed door
pharmacy, serving mainly assisted living and troubled
youth. In May 2008, Mr. Pratt signed a stipulation
and order to cease and desist dispensing numerous
schedule II controlled prescriptions without a written
prescription signed by the prescribing practitioner that
were transmitted to the pharmacy via fax. In June
2012, the DOPL investigator found approximately 70
schedule II substance prescriptions which were
dispensed based upon electric communications from
the prescribing practitioner but without having first
obtained the prescribing practitioner’s physical
signature. They stored pharmaceuticals in the front
office of the pharmacy where technicians had access
after regular business hours and while the pharmacist
was not present. He also accepted back bubble pack
medications, including controlled substances that were
already dispensed to nursing care facilities or other
patient representatives. He failed to comply with the
cease and desist order from May 2008. Mr. Bushell
stated he is the current PIC and read the stipulation
order carefully and has made several changes to
comply with the stipulation order. Mr. Bushell stated Page 8 of 12
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Pharmacy Licensing Board
March 26, 2013
that there is only one other employee in the pharmacy.
This person is a pharmacy technician. Mr. Bushell
stated they hired Med-Call On Call Services, a
professional service, to handle calls. The Board asked
to see the owner, Mr. Robert Pratt and PIC, Mr. Randy
Bushell, after the annual inspection. 4 Care
Pharmacy is in compliance with the stipulation.
2:15 p.m.- James Ammon, quarterly
interview, confirmed 3/14
Mr. Ammon met with the Board. Ms. Kemper
conducted the interview. The Board advised Mr.
Ammon that he failed to advise the Board within one
week of any change in his employer or employment
status. He failed to submit a practice plan prior to
accepting employment and his paperwork was late.
Mr. Ammon stated he knew he needed to obtain preapproval before accepting employment; however, he
felt that because they required his reply in 48 hours, he
did not believe he could get approval from the Board
within that time frame. Mr. Ammon was assured the
Division would have replied to his request in a timely
manner. The problem is Mr. Ammon never notified
the Division that he is working in the field. The
Division was notified when his first supervisor report
was received. Mr. Ammon was advised that he needs
to make a plan to ensure there are no further
misunderstandings regarding his employment
notifications to the Division in a timely manner.
Mr. Ammon was advised that he needs to give a copy
of the stipulation and order to his employer and have
them sign and return the paperwork. The Board
recommended amending Mr. Ammon’s stipulation
regarding his work hours. Mr. Oborn will review the
Board’s recommendation with the Division Director.
Mr. Ammon was cautioned to not make any changes
in his work schedule until he receives an amended
stipulation with Mr. Steinagel’s signature. The Board
advised Mr. Ammon he needs to complete a thinking
errors course. The Board wants him to attend one in
person, not online. The Board advised Mr. Ammon
that if the changes are approved, he will need to
submit a new practice plan. This will be due within 2
weeks of when he starts the new work schedule.
The Board noted that his reports are monthly until the
thinking errors course is completed. The Board asked
to see Mr. Ammon August 27, 2013. If he is in
compliance, the Board will do a telephone interview. Page 9 of 12
Minutes
Pharmacy Licensing Board
March 26, 2013
Mr. Ammon is in compliance with his stipulation.
2:30 p.m. - Paul Martz, quarterly telephone
interview
Mr. Martz met with the Board. This interview was
conducted via telephone. Ms. Kemper conducted the
interview. Introductions were made. Mr. Martz stated
that things are going well. The Board noted that his
employer and self assessment reports look good.
There is no change in sending in paperwork. The
Board asked to see Mr. Martz in September as long as
he stays in compliance. Mr. Martz is in compliance
with his stipulation.
2:45 p.m. - Lincare, Inc. (Jeanne Reese)
quarterly telephone interview
Ms. Reese was contacted via telephone. Ms. Kemper
conducted the interview. Ms. Reese stated that Paul
Gabos is no longer working with Lincare. The Board
noted that Lincare’s Utah probation will mirror
Missouri’s probation and the Division received all
required paperwork. Lincare’s Missouri probation
will end May 2013 and once Utah receives this
documentation, Mr. Oborn will submit the order
removing Lincare’s Utah probation. The Board
advised Ms. Reese that unless she has questions for
the Board or problems, she will not need to meet with
the Board again.
3:15 p.m.- Diann Millikan, quarterly
interview
Ms. Millikan met with the Board. Dr. Lundberg
conducted the interview. Ms. Millikan stated she is
doing well. She has worked since October at the State
Hospital. She is enjoying her job. The Board noted
that her supervisor report indicates they are very
pleased with her performance. She was allowed to
close the pharmacy for the first time and felt good
about it. The Board noted that her probation will end
April 20, 2013 and this will be the last time she meets
with the Board. Ms. Millikan stated this process has
taught her boundaries, self confidence and humility.
She appreciated the therapist feedback and likes where
she is right now. The Board noted that she had made
remarkable changes and encouraged her to keep doing
what she is doing. Ms. Call advised her to continue
submitting reports until she receives the new
amendment and a new license.
3:30 p.m.- Wesley Remund, reinstatement
application
Mr. Remund met with the Board. Mr. Oborn
conducted the interview. Mr. Remund is requesting
reinstatement of his pharmacist license. He provided Page 10 of 12
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Pharmacy Licensing Board
March 26, 2013
the Division with documentation to verify six months
of clean UAs. At 3:32 P.M. Dr. Lundberg motioned
to close the Board meeting to discuss the character,
professional competence, or physical or mental health
of an individual. The motion was seconded by Mr.
Jones. The motion was carried unanimously. There
were no written notes taken. There was no recording
made. The Board meeting opened at 3:43 P.M. Dr.
Lundberg motioned to reinstate Mr. Remund’s license
with the following conditions: 3 year probation, drug
testing, supervision, attend therapy as requested by the
Board, attend support group once a week, retake the
law exam, and submit a practice plan for Board
approval. The motion was seconded by Mr. Garn and
amended to include passing the MPJE exam. The
motion was carried unanimously. The Board noted
that because he has a track record of being clean, he
does not have to start drug screens until he gets his
license back. Mr. Remund stated his goal is to pass
the exam by September 26, 2013. Mr. Oborn advised
him that if he does not pass the exam by September
30, 2013, the Division will deny his application and he
will need to reapply for a license. Mr. Remund
submitted certificates documenting completion of
thirty-two credit hours of CE courses completed
online via webinars.
3:45 p.m.- Kevin Whipple, new probation
interview
Mr. Whipple met with the Board. Mr. Jones
conducted the interview. The Board advised Mr.
Whipple that the Board’s role is to help him through
the process and maintain a balance of protecting the
public. Mr. Whipple advised the Board that he was
involved in an auto accident. He was charged with
one count of possession or use of a controlled
substance (3rd Degree Felony), one count of DUI
(Class B) and one count of use or possession of drug
paraphernalia (Class B) He did not have a current
valid prescription for Oxycodone and told
investigators he diverted them from his employer. His
employer filed a report indicating that 2,500 tables of
Oxy HCL were missing from their stock. Mr.
Whipple advised the Board that he obtained an
evaluation at the Utah County Health Department and
entered into a treatment program where he attended
classes four nights a week for three years and three 12
step support groups a week. Then his attendance was Page 11 of 12
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Pharmacy Licensing Board
March 26, 2013
moved to three nights a week and then two nights a
week until he successfully completed the program. He
found the program very helpful. They had homework
and gave him good feedback. Mr. Whipple reviewed
the requirements he needs to complete with the Board.
The Board discussed the evaluation he received at the
Utah County Health Department and he requested that
Mr. Whipple send a copy of this to Ms. Call. The
Board will review it and then decide if this evaluation
meets the Board’s needs, or if he will need to obtain
another evaluation. The Board encouraged him to get
into a support group two times a week while he is
waiting to get into a treatment program and drug
testing. Mr. Whipple advised the Board that currently
he is on court probation for 12 months. He needs to
complete 120 hours of community service and pay a
fine. The charges will be enhanced if he gets into
trouble again. The Board strongly urged Mr. Whipple
to get his account activated and to call Affinity every
day. This demonstrates he is moving forward and
doing everything he can. Mr. Jones motioned to
amend Mr. Whipple’s stipulation to require the
thinking errors course to be completed within one
year, drug testing, attend support groups 2 times a
week, and submit the completed essay to Ms. Call
within 90 days. The motion was seconded by Dr.
Lundberg and carried unanimously. Mr. Oborn will
contact Mr. Memmott regarding Mr. Whipple’s
evaluation. The Board noted how well Mr. Whipple
knew the contents and requirements of his stipulation.
The Board asked to see Mr. Whipple at the May Board
meeting.
ADJOURN: The Board meeting adjourned 4:40 P.M.
NEXT SCHEDULED MEETING: April 23, 2013
2013 Board meetings tentatively scheduled
April 23, May 28, June 10, July 30, August 27, September 24,
October 22, November 26 December 17
Note: These minutes are not intended to be a verbatim transcript but are intended to record the
significant features of the business conducted in this meeting. Discussed items are not necessarily
shown in the chronological order they were discussed.
April 23, 2013 (ss)David Young
Date Approved Chairperson Page 12 of 12
Minutes
Pharmacy Licensing Board
March 26, 2013
Pharmacy Licensing Board
April 23, 2013 (ss) Richard J. Oborn
Date Approved Bureau Manager,
Division of Occupational & Professional Licensing

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