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Board Meeting Minutes
July 27, 2006 Board Meting Minutes
THE ARIZONA STATE BOARD OF PHARMACY
HELD A REGULAR MEETING JULY 27, 2006
TUCSON, ARIZONA
The following Board Members and staff were present: President Chuck Dutcher, Vice-President
Tom Van Hassel, Zina Berry, Louanne Honeyestewa, Dennis McAllister, Linda McCoy, Ridge
Smidt, Paul Sypherd, and Bryan Tippett. Compliance Officers Rich Cieslinski, Larry Dick, Ed
Hunter, Sandra Sutcliffe, and Dean Wright, Deputy Director Cheryl Frush, Executive Director
Hal Wand, and Assistant Attorney General Dawn Lee.
President Dutcher convened the meeting at 8:00 A.M. and welcomed the audience to the
meeting.
Ms. Frush explained that law continuing education would be offered for attendance at the
meeting.
AGENDA ITEM 1 - Approval of Minutes
Following a review of the minutes and an opportunity for questions and on motion by Dr.
McCoy and Dr. Tippett, the minutes of the Regular Meeting held on May 24 and 25, 2006 were
unanimously approved by the Board Members.
AGENDA ITEM 2 - Introduction of New Assistant Attorney General - Dawn Lee
President Dutcher introduced Assistant Attorney General, Ms. Dawn Lee, who will serve as the
Board's new full-time attorney. Ms. Lee gave a brief overview of her work experience.
AGENDA ITEM 3 - Permits and Licenses
President Dutcher stated that all permits were in order for resident pharmacies and
representatives were present to answer questions from Board Members.
Allens Pharmacy
Owners Casey Allen and Roger Allen were present to answer questions from Board Members.
President Dutcher opened the discussion by asking Mr. Allen to describe the nature of their
business. Mr. Allen stated that they would be opening a general retail pharmacy with a small
over the counter section.
President Dutcher asked Mr. Allen if they would be compounding prescriptions for patients.
Mr. Allen stated that he does not initially plan to compound prescriptions, but may decide to
compound prescriptions later for his patients.
President Dutcher asked Mr. Allen if he understood the compounding regulations. Mr. Allen
asked if the Board could review the basic compounding regulations. Mr. Wand addressed the
compounding regulations. Mr. Wand stated that the pharmacy could not compound medications
that are commercially available. Mr. Wand stated that the prescriptions must be patient specific.
Mr. Wand stated that the pharmacy is able to compound up to 5% of their total sales for use in
physician's offices. Mr. Wand stated that the products sold to physician's offices are intended
for office administration and are not to be dispensed by the physician. Mr. Wand stated that the
products for office use must be labeled properly.
Mr. Wand reminded the applicants that they cannot fill prescriptions that result from an internet
questionnaire. Mr. Wand stated that there must be a valid patient-doctor relationship and the
patient cannot be diagnosed by an internet questionnaire.
Mr. Dutcher thanked the applicants for appearing and wished them luck with their business.
InTown Pharmacy
Owners Jyothsna Boyapaty and Halim Hasani were present to answer questions from Board
Members.
President Dutcher opened the discussion by asking the owners to discuss the nature of their
business. Mr. Hasani stated that they would be operating an independent retail pharmacy.
Mr. Dutcher asked where the pharmacy would be located. Mr. Hasani stated that the pharmacy
would be located in Quartzsite, Arizona.
Mr. Dutcher asked if the pharmacy would be located in a clinic. Mr. Hasani stated that the
pharmacy would be located in space in the clinic, but the pharmacy business is independent of
the clinic.
Mr. Dutcher asked the owners about the lease. Mr. Dutcher stated that there was some concern
that the pharmacy might not be paying the going rate for rent. Mr. Hasani stated that as far as he
knows that the rate on the lease is the going rate in Quartzsite. Mr. Dutcher stated that there is
some concern that it might appear to the public as a profit making deal. Mr. Hasani stated that
there would be no connection between them and the physician's and there would be no profit
made by the physicians.
Mr. Dutcher asked if the pharmacy would fill prescriptions from the clinic and from incoming
customers outside the clinic. Ms. Boyapaty replied yes.
Mr. Dutcher reminded the applicants about the compounding regulations and internet regulations.
Mr. Hasani stated that they do not plan on compounding medications.
Mr. Wand asked the applicants if they planned on being open year round since at certain times of
the year the population in Quartzsite diminishes. Ms. Boyapaty stated that they plan on being
open all year.
Mr. Dutcher thanked the applicants for appearing and wished them luck with their business.
Custom Medications
Owner Lee Ori was present to answer questions from Board Members.
President Dutcher opened the discussion by asking Mr. Ori to describe the nature of his business.
Mr. Ori stated that he would be opening a pharmacy specializing in compounding. Mr. Ori stated
that about 75% of his business would be compounding. Mr. Ori stated that he currently owns a
compounding only pharmacy in St. Louis, Missouri. Mr. Ori stated that he is a member of
PCAA and ICP. Mr. Ori stated that he is fully aware of the compounding regulations.
Mr. Dutcher asked Mr. Ori if he has hired a pharmacist for the pharmacy. Mr. Ori stated that he
has not hired a pharmacist yet. Mr. Ori stated that the pharmacist he hires will be trained in
compounding procedures. Mr. Ori stated that the pharmacist he hires will be sent to PCAA for
training courses in compounding.
Mr. Dutcher asked Mr. Ori if he would be compounding for retail and physicians. Mr. Ori stated
that he would be compounding only for retail patients pursuant to prescriptions.
Mr. Wand asked Mr. Ori if he would be shipping prescriptions out of state. Mr. Ori replied no.
Dr. Smidt asked if Mr. Ori would have an inventory of tablets and capsules on site. Mr. Ori
stated that he would have some limited inventory used for compounding. Mr. Ori stated that
eventually he would have a retail side. Mr. Ori stated that his store in St. Louis does have a retail
inventory. Mr. Ori stated that he carries stock for established patients.
Dr. Smidt asked if the legal name of the company is Custom Medications. Mr. Ori replied yes.
Dr. Smidt stated that the floor plans show Lipodissolve. Mr. Ori stated that he is subletting space
from Lipodissolve. Mr. Ori stated that Lipodissolve does not have any vested interest in his
company. Mr. Ori stated that he does compound an injectable that Lipodissolve recommends.
Mr. Ori stated that Lipodissolve is located in St. Louis and they have developed a business
relationship only. Mr. Ori stated that they have offered him the opportunity to expand his
business and he has signed a lease to rent the space at fair market value.
Dr. Smidt asked if Mr. Ori would be compounding medications in advance anticipating
prescriptions from Lipodissolve. Mr. Ori stated that initially a patient would walk into the
pharmacy with a prescription and the product would be compounded at that time. Mr. Ori stated
that if there is a demand for a certain product, he would then make the product in advance for a
justified prescription volume.
Mr. Dutcher asked Mr. Ori if he would be compounding controlled substances. Mr. Ori stated
that they would compound controlled substances if necessary.
Mr. Van Hassel asked Mr. Ori about his clean room. Mr. Ori stated that he would have a Class
10,000 Clean Room with a 100 Laminar Flow hood. Mr. Ori stated that he would be installing a
T-Mod which is a small clean room.
Mr. Van Hassel asked Mr. Ori if he is familiar with USP 797. Mr. Ori stated he is familiar with
the USP 797 regulations and has served as a consultant.
Mr. Wand asked Mr. Ori if the product he would be compounding is available commercially.
Mr. Ori stated that the product is not available in an injectable form commercially. Mr. Wand
asked if the raw material is USP approved. Mr. Ori replied yes and stated that he is hoping to
buy the materials directly from the manufacturer.
Mr. Dutcher thanked the applicant for appearing and wished him luck with his business.
At the conclusion of questions from the Board Members and on motion by Mr. Van Hassel and
Dr. McCoy, the Board unanimously approved the resident permits listed below. All approvals
are subject to final inspection by a Board Compliance Officer where appropriate.
RESIDENT (In Arizona)
- Food City United Drug #124
2600 W. 16th St.
Yuma, AZ 85364
Bashas' Inc.
- Bashas' United Drug #167
12100 N. Dove Mountain Blvd.,
Marana, AZ 85653
Bashas' Inc.
- Allens Pharmacy
1106 N. Gilbert Rd., Ste. #1,
Mesa, AZ 85213
Casey Allen
- Walgreens #09186
18600 S. Nogales Hwy.,
Sahuarita, AZ 85629
Walgreen Arizona Drug. Co.
- CLP Arizona Pharmacy, LLC
20612 N. Cave Creek Rd, Suite 150,
Phoenix, AZ 85024 (O)
CLP Arizona Pharmacy, LLC
- InTown Pharmacy
150 E. Tyson Rd.,
Quartzsite, AZ 85359
Jyothsna Boyapaty Halin Hasani
- Custom Medications
8841 E. Bell Rd.,
Scottsdale, AZ 85258
Lee Ori
(O) = Ownership Change
Non-Resident Permits
President Dutcher asked if all non-resident permits are in order. Mr. Wand stated that the
permits are in order and the Board Office has received copies of the permits issued by their home
state Board.
At the conclusion of questions from the Board Members and on motion by Dr. Smidt and Dr.
Berry, the Board unanimously approved the non-resident permits listed below.
NON-RESIDENT (Out of State)
- Oncology Rx Care Advantage
13501 Park Vista Blvd., #150,
Ft. Worth, TX 76177
US Oncology Dispensing Solutions
- GlobalNet Pharmacies, LLC
134 NW 16th St, #4,
Boca Raton, FL 33432
GlobalNet Pharmacies, LLC
- Home Medical Enhancement Services Pharmacy
7880 Foundation Dr. #1,
Florence, KY 41042
HME Services, Inc.
- Prime Therapeutics, LLC
2901 Kinwest Parkway, Bldg. B,
Irving, TX 75003 (O)
Prime Therapeutics, LLC
- Savon.com
2510 El Camino Real, Suite A,
Carlsbad, CA 92008 (O)
New Alberston's Inc.
- Central Express Pharmacy, Inc.
8301 Florida Dr. #216,
Pembroke Pines, FL 33025
Central Express Pharmacy, Inc.
- Pharmacy South
8258 Hwy 31, P.O. Box 1330,
Calera, AL 35040
Pharmacy South, Inc.
- Costco Pharmacy #581
802-134th St. SW, Bldg. C, #140,
Everett, WA 98204
Costco Wholesale Corp.
- Express Scripts
13736 Riverport Dr.,
Maryland Heights, MO 63043
ESI Mail Pharmacy Service, Inc.
- McKesson Specialty Pharmaceuticals, LLC
700 Waterfront Dr.,
Pittsburgh, PA 15222
McKesson Corporation
- USDRUGS.COM
9-3505 8th Street South,
Moorhead, MN 56560
USDRUGS.COM
- IV League, Inc.
6076 Bristol Parkway #104,
Culver City, CA 90230
IV League, Inc.
- Medicap Pharmacy #251
501 E. Lakeway Rd.,
Gillette, WY 82718
Above Par PC
- Native Pharmaceutical Direct
77 Main Street,
Salamanca, NY 14779
Ross L. John, Sr.
- Westchase Compounding Pharmacy
11669 Countryway Blvd.,
Tampa, FL 33626
RS Compounding, LLC
- Modern Health Pharmacy
110 E. Huntington Dr.,
Monrovia, CA 91016
Modern Healthcare, Inc.
- Caremark PCS Texas Mail Pharmacy, LLC
2105 Eagle Pkwy.,
Fort Worth, TX 76177
Caremark PCS Texas Mail Pharmacy, LLC
- Access Therapeutics. Inc.
200 Saw Mill River Rd., #128
Hawthorne, NY 10532
Access Therapeutics, Inc.
- Senior Respiratory Solutions
3448 Summerhill Rd.,
Texarkana, TX 75501
Senior Respiratory Solutions, Inc
- Custom Scripts Pharmacy
4600 N. Habana Ave.,16-A,
Tampa, FL 33614
Tiberius, Inc.
- College Pharmacy Advanced Medical Therapeutics
4217 S. New Hope Rd.,
Gastonia, NC 28056
Tom Rader
(O) = Ownership Change
Manufacturer Permits
National Vitamin Company
Tom Rumolo, Technical Director, for the company was present to answer questions from Board
Members.
President Dutcher asked Mr. Rumolo about the nature of his request. Mr. Rumolo stated that the
company has a facility currently being upgraded in Casa Grande. The company is closing their
businesses in Nevada and California and moving this business to the Casa Grande facility.
President Dutcher asked Mr. Rumolo what the company anticipates manufacturing. Mr. Rumolo
stated that the company manufactures dietary supplements and over-the-counter products. Mr.
Rumolo stated that they manufacture tablets, two piece capsules, powders, liquids, and softgels.
Mr. Rumolo stated that the company also packages their own products.
Mr. Dutcher asked Mr. Rumolo if the company has hired a pharmacist. Mr. Rumolo stated that
they have not hired a pharmacist. Mr. Rumolo stated that is why he is appearing today to ask the
Board for an exception. Mr. Rumolo stated that in lieu of having a pharmacist he is asking if the
Board would accept his expertise and grant the company an exception. Mr. Rumolo stated that
as Technical Director he is in charge of writing the standard operating procedures for the
company.
Mr. Dutcher asked Mr. Rumolo if the company reviewed the regulations prior to moving to
Arizona. Mr. Rumolo stated that he believes that the owners did not look at the regulations.
Mr. Wand stated that regulations to review are A.R.S. § 32-1961 and R4-23-604 (H) (1) (d). The
regulations state that a drug manufacturer shall manufacture and distribute a drug only under the
supervision of an Arizona Board-licensed pharmacist. Mr. Wand stated that an exemption could
only be granted for experimentation or technological advances. Mr. Wand stated that he does not
believe there is a basis to grant the exemption. Ms. Lee advised the Board that the language does
not provide for an exemption. Ms. Lee read R4-23-604 (J)(2) that states a drug manufacturer
permittee shall ensure that an Arizona Board-licensed pharmacist is present at the facility
whenever a drug is manufactured, packaged, repackaged, labeled, or relabeled.
Mr. Rumolo asked if the pharmacist could be present part-time. Mr. Wand stated that the
pharmacist does not need to be present full-time, but must be present during the manufacturing
process. Mr. Rumolo stated that the softgel process would occur 24/7. Mr. Wand stated that the
pharmacist would not need to be present during the manufacturing of the dietary supplements,
but would need to be present during the manufacturing of the over-the-counter products.
Mr. Wand read R4-23-406 (H) (1) (d) that states that a drug manufacturer permittee shall
manufacture and distribute a drug only: under the supervision of an Arizona Board-licensed
pharmacist as required in A.R.S. § 32-1961. Manufacturing processes that require the supervision
of a pharmacist include weighing, mixing, compounding, tableting, packaging, and labeling.
Dr. McCoy asked when the regulations were last reviewed. Mr. Wand stated that it has probably
been about twenty years, since the regulations were changed. Mr. Wand stated that another issue
is that a repackager must apply for a manufacturer's permit in Arizona.
Mr. Van Hassel asked Mr. Rumolo if the company has an anticipated opening date. Mr. Rumolo
stated that the move from California should be completed in three to four weeks. Mr. Rumolo
stated that the Arizona facility is being renovated and new equipment is being installed. Mr.
Rumolo stated that it would then take another five to six weeks to train employees.
Mr. Dutcher asked Mr. Rumolo why the company wanted to leave California and Nevada. Mr.
Rumolo stated that they were able to purchase the 300,000 sq. ft. Arizona facility for a good
price. Mr. Rumolo stated that the facility could easily be retrofitted for their business and they
would be able to produce the product more efficiently. Mr. Rumolo stated that employee issues
in California caused the owners to want to leave the state. Mr. Rumolo stated that the company
plans to employ about 150 employees.
Dr. McCoy stated that her concern is the way that the regulation is worded that would require the
pharmacist to be present 24/7. Ms. McCoy asked if the Board could define what the Board's
expectations are of the Pharmacist In Charge. Mr. McAllister stated that he does not recall in the
past if the Board has required a pharmacist to be there 24 hours. Mr. Wand stated that the
Pharmacist In Charge could be there a certain number of hours a week as long as he signs off on
the processes. Mr. Wand stated that the number of hours would be dependent on the volume.
Mr. Rumolo stated that some processes would take two to three days to complete.
Mr. Wand asked Mr. Rumolo if they would be able to hire a pharmacist for 40 hours a week.
Mr. Rumolo stated that the owners have not budgeted for a pharmacist. Mr. Rumolo asked if the
pharmacist would need to be full-time. Mr. Wand stated that the precedence is 40 hours a week.
Mr. Wand stated that a pharmacist is required by the regulations.
Dr. McCoy asked if the Board could stipulate what the pharmacist's responsibilities are at the
facility. Ms. Lee stated that the Board could formulate a Substantive policy statement that would
define how the Board interprets its rules or statutes. Ms. Lee stated that the policy would set out
by definition how the Board has viewed the cases in the past and what the Board would consider
sufficient.
Mr. Wand stated that a substantive policy could be written that would set the precedence at 40
hours a week for the Pharmacist In Charge. Mr. Wand stated that the policy would need to be
approved by the Board and could probably be approved by the Board via a phone meeting.
Ms. Berry stated that the Pharmacist In Charge needs to appear at a Board Meeting.
Mr. Wand stated that the Board would set up an inspection of the facility by a Compliance
Officer, the Board would write a substantive policy, and the Board would have a telephone
meeting to approve the permit and interview the Pharmacist In Charge. Ms. Lee advised the
Board that they would need to table the application at this time.
On motion by Dr. McCoy and Mr. McAllister, the Board unanimously agreed to table the
application for National Vitamin Company, Inc.
Dr. McCoy asked if the Board could review the manufacturer's regulations. Mr. Wand stated
that the Board would need to do an Omnibus bill to change the statutes.
Pharmacist, Pharmacy Interns, and Pharmacy Technician Licenses
Following a review and discussion of the roster of applicants for licensure as pharmacists,
interns, and pharmacy technicians and assurance by the staff that all applications were in order
and all fees paid: On motion by Dr. McCoy and Mr. McAllister, the Board unanimously
approved the Pharmacists licenses 15397 through 15542. On motion by Dr. Tippett and Dr.
Berry, the Board unanimously approved the Intern licenses 7499 through 7610. On motion by
Dr. Tippett and Dr. Berry, the Board unanimously approved the Pharmacy Technician licenses
10499 through 10982. Also, approved were 246 licensee changes from Pharmacy technician
trainee to Pharmacy technician.
AGENDA ITEM 4 - Motion to Rescind Vote to Consent/Formal Hearing
President Dutcher asked Mr. Wand to address this issue. Mr. Wand stated that for two
complaints new evidence has been received that may substantially change the opinion of the
Board. Mr. Wand stated that Ms. Lee stated that she could make a motion to rescind the
previous motion to go to a Consent/Formal Hearing and the evidence could be reviewed at the
September meeting.
Ms. Lee stated that the motion is before the Board today based on the review of the new evidence
presented in both the cases. Ms. Lee stated that is the state's belief that it is in the Board's best
interest to reconsider their motion to vote to rescind their vote to formal hearing and place these
cases on a future agenda for disposition.
Rory Albert
On motion by Mr. McAllister and Dr. Tippett, the Board unanimously agreed to accept the
motion to rescind the vote to Consent/Formal Hearing in the case of Rory Albert and set the
matter for a future agenda item.
Sean Shaffer
On motion by Dr. Smidt and Dr. Tippett, the Board unanimously agreed to accept the motion
to rescind the vote to Consent/Formal Hearing in the case of Sean Shaffer and set the matter for a
future agenda item.
AGENDA ITEM 5 - Low Cost Pharmacy - Review of Board's Acceptance of
Administrative Law Judge's Decision
President Dutcher asked Mr. Wand to address this issue. Mr. Wand stated that after discussing
this issue with the Solicitor it has been decided that the discussion of this agenda item will be
postponed until September.
AGENDA ITEM 6 - Special Requests
#1 Douglas McDowell
Douglas McDowell appeared with Brad Barron from the PAPA program to request a reduction
in the number of required drug screens per Board Order 03-0019-PHR.
President Dutcher opened the discussion by asking Mr. McDowell to describe the nature of his request.
Mr. McDowell stated that he signed a PAPA contract in 2003 and one of the stipulations was that
he was to submit for a random drug screen once a week. Mr. McDowell stated that he has had no
problems with his recovery and is requesting a reduction in the drug screens from once a week to
once every two weeks.
Mr. Dutcher asked Mr. Barron if PAPA supports Mr. McDowell's request. Mr. Barron stated
that PAPA does support his request. Mr. Barron stated that the PAPA program does allow a
participant to request a decrease in drug screens after two years and PAPA can approve that
request. Mr. Barron stated that Mr. McDowell's consent order was written differently than most
contracts and did not allow the PAPA steering committee to approve his request for a reduction
in the number of screens.
On motion by Mr. Van Hassel and Ms. Honeyestewa, the Board unanimously agreed to
approve Mr. McDowell's request to decrease his random drug screens from one random drug
screen a week to one random drug screen every other week as recommended by PAPA.
#2 Roy Cohen
Roy Cohen appeared on his own behalf to request to proceed with reciprocity.
President Dutcher opened the discussion by asking Mr. Cohen to describe the nature of his
request. Mr. Cohen stated that he is requesting to proceed with reciprocity from his Oregon
license.
Mr. Dutcher asked if there was a problem with his pharmacist's license in another state. Mr.
Cohen stated that he was disciplined by the California Board for not calling the doctor for refill
authorization. Mr. Cohen stated that his probation ended in January.
Mr. Dutcher asked if Oregon took similar action against his Oregon license. Mr. Cohen replied
yes. Mr. Dutcher asked if Mr. Cohen's license is in good standing at this time. Mr. Cohen stated
that his license has been in good standing since January.
Dr. McCoy asked Mr. Cohen if he is currently working. Mr. Cohen stated that he is working for
the Department of Corrections in California.
On motion by Dr. McCoy and Dr. Tippett, the Board unanimously approved Mr. Cohen's
request to proceed with reciprocity.
#3 Ruben Quiroz
Ruben Quiroz appeared on his own behalf to request to proceed with pharmacy technician
trainee licensure.
President Dutcher asked Mr. Quiroz to address the nature of his request. Mr. Quiroz stated that
he is applying for a pharmacy technician trainee license. Mr. Dutcher stated that Mr. Quiroz had
a felony conviction in his past. Mr. Dutcher asked Mr. Quiroz if he has any problems with the
law since that time. Mr. Quiroz replied no.
Mr. Dutcher asked Mr. Quiroz if he has been working in pharmacy long. Mr. Quiroz replied that
he has been working in pharmacy for 2 years and 5 months as a technician.
Dr. McCoy asked Mr. Quiroz if he has been working as a technician for the last two years. Mr.
Quiroz stated yes. Mr. Wand stated that Mr. Quiroz should have been licensed as a technician at
that time. Mr. Quiroz stated that when he started working in the pharmacy in 2002 he did not
need to be licensed. Mr. Quiroz stated that he was laid off after working for the company for two
years. Mr. Quiroz stated that when he started his current job he signed an agreement that he
would obtain a license and his certification. Mr. Quiroz stated that the Compliance Officer noted
that he did not have a trainee license posted and issued a violation.
On motion by Dr. Berry and Ms. Honeyestewa, the Board unanimously approved the request
by Mr. Quiroz to proceed with licensure as a pharmacy technician trainee.
#4 Sandra Finn
Sandra Finn appeared on her own behalf to request to take the MPJE exam for the fourth time.
President Dutcher opened the discussion by asking Ms. Finn about the nature of her request. Ms.
Finn replied that she is requesting permission from the Board to take the MPJE exam for the
fourth time. Mr. Dutcher noted that Ms. Finn's scores are improving each time.
Mr. McAllister asked Ms. Finn if she is practicing in Massachusetts. Ms. Finn stated that she is
practicing in Massachusetts and has practiced in Massachusetts for twenty years. Ms. Finn stated
that she is also licensed in New Hampshire.
Mr. Wand stated that the MPJE is a combination of state and federal questions. Mr. Wand stated
that one of the Compliance Officers could review the law with her. Mr. Wand stated that there
are several links on the Board's website that may be helpful.
On motion by Mr. Van Hassel and Dr. McCoy, the Board unanimously approved Ms. Finn's
request to take the MPJE exam for the fourth time with the stipulation that if she is unsuccessful
that she must take a law review course prior to requesting to take the exam for the fifth time.
#5 Andries Erasmus
Andries Erasmus appeared on his own behalf to request to take the NAPLEX exam for the
fourth time.
President Dutcher opened the discussion by asking Mr. Erasmus to discuss the nature of his
request. Mr. Erasmus stated that he is requesting to take the NAPLEX exam for the fourth time.
Mr. Dutcher asked Mr. Erasmus if he resides in Arizona. Mr. Erasmus stated that he lives in
Arizona and is originally from South Africa.
Mr. McAllister asked Mr. Erasmus if he has taken a review course. Mr. Erasmus stated that he
checked about taking the Kaplan course but they are not offering the course until next year. Mr.
Wand stated that Morris Cody offers a review course for the NAPLEX exam. Mr. Erasmus
stated that he has joined a study group.
Mr. McAllister stated that the average score on the NAPLEX is 100 and 75 is the minimum score
for passing. Mr. McAllister suggested that if the Board moves forward with granting his request
he feels that Mr. Erasmus should complete a NAPLEX review course.
Dr. Smidt asked Mr. Erasmus if he is working. Mr. Erasmus stated that he is working as a
graduate intern.
Dr. Smidt asked Mr. Erasmus if he has trouble taking exams. Mr. Erasmus stated that he
becomes anxious and tries to rush through the exam to finish and misreads the questions. Mr.
Erasmus asked the Board if it would be possible to extend the time that he is allowed to take the
exam. Mr. Wand stated that Mr. Erasmus would need to contact NABP because the Board does
not have the authority to extend the amount of time that he requires to complete the exam.
On motion by Mr. McAllister and Dr. McCoy, the Board unanimously approved the request
by Mr. Erasmus to take the NAPLEX exam for the fourth time with the stipulation that he
provide documentation of completing the Kaplan or Morris Cody review course prior to taking
the exam.
#6 Mohamad Sobhi Hassanein-Elemababi
Mohamad Hassanein-Elemababi appeared on his behalf to request that the Board waive the
FPGEE exam. Mr. Hassanein-Elemababi has not passed the FPGEE exam.
President Dutcher opened the discussion by asking Mr. Hassanein-Elemababi about the nature of
his request. Mr. Hassanein-Elemababi stated that he would like the Board to waive the FPGEE
exam so that he could proceed with his licensure.
President Dutcher asked Mr. Hassanein-Elemababi if he has taken the FPGEE exam. Mr.
Hassanein-Elemababi replied yes.
Mr. Dutcher asked Mr. Hassanein-Elemababi if he worked as a pharmacist in California before
moving to Arizona. Mr. Hassanein-Elemababi stated that he worked as a technician.
Dr. McCoy asked Mr. Hassanein-Elemababi if he has taken and not passed the FPGEE exam.
Mr. Hassanein-Elemababi stated that he has taken the exam four times and not passed.
Mr. McAllister stated that the process for a foreign graduate is to submit their documents of
education and licensure to NABP. The foreign graduate may then be approved by NABP to take
the FPGEE exam if their documents are in order. Mr. McAllister stated that if allowed they may
start their intern hours during that time. Mr. McAllister stated after passing the exam, they are
certified to have an equivalent education to a United States pharmacist and then may proceed
with licensure. Mr. McAllister stated that by failing the exam four times it indicates that there
may be problems with his education.
Mr. Wand stated that for the Board's information the Board has in the past approved an alternate
equivalency exam for individuals that did not qualify to take the FPGEE exam. Mr. Wand stated
that in this case Mr. Hassanein-Elemababi has qualified to take the exam, but has not passed the
exam.
Ms. Lee advised the Board that the statutes do not allow the Board to waive the equivalency
exam.
Dr. Tippett asked if there are any alternatives to his degree. Mr. McAllister stated that he is not
aware of any add on programs and he would need to take a degree program in the United States.
Dr. Smidt asked if the applicant could take the exam for a fifth time. Mr. Wand stated that he is
allowed to take the exam for the fifth time. Dr. Smidt asked if has taken a review course. Mr.
Hassanein-Elemababi stated no. Mr. Hassanein-Elemababi stated that the company he is
working for as an intern is only giving him until the end of the year to complete the exam.
On motion by Mr. Van Hassel and Mr. McAllister, the Board unanimously agreed to deny the
request made by Mr. Hassanein-Elemababi to waive the FPGEE exam.
#7 Maha Makhail
Maha Makhail appeared on her own behalf to request the Board waive the requirement that each
candidate for FPGEC certification, graduating from a pharmacy program after January 1, 2003
must have completed a minimum five-year pharmacy curriculum.
President Dutcher opened the discussion by asking Ms. Makhail about the nature of her request.
Ms. Makhail stated that she is requesting a waiver of the FPGEE. Ms. Makhail stated that she is
a licensed pharmacist in New Zealand and Australia. Ms. Makhail stated that she applied to take
the FPGEE exam one year ago. Ms. Makhail stated that she has moved to Arizona because her
family has moved here. Ms. Makhail stated that her mother and sister are both pharmacists. Ms.
Makhail stated that the reason she is asking for the waiver is because the educational
requirements have changed and she did not complete a five-year pharmacy curriculum. Ms.
Makhail stated that she completed three years towards a pharmacology degree and then
completed a four year pharmacy degree. Ms. Makhail stated that the National Board is still
reviewing her degree requirements.
Mr. McAllister stated that this issue will continue to come before the Board. Mr. McAllister
stated that NABP met with the advisory committee on examinations, the foreign graduate exam
committee, and ACPE and decided that after the last BS degree is issued in the United States, the
acceptable entry level degree would be a five year professional degree. Mr. McAllister stated
that all foreign schools that offer a four year degree would not be equivalent to the United States
degree.
Dr. McCoy asked what recourse the individuals have in this situation. Mr. McAllister stated that
they would need to attend and graduate from an ACPE approved degree program.
Dr. Tippett asked if there is any equivalency in the program to a degree issued in the United
States. Mr. McAllister stated that there may be some equivalent classes and that is determined by
NABP. Mr. McAllister stated that NABP will not review the documents unless the applicant has
completed the required program.
Dr. Sypherd asked if there is another way to show competency. Mr. McAllister stated that if the
Board decides to accept another method to test competency it would set a precedence that would
go against NABP. Mr. McAllister stated that there are several countries where educational
standards are in question. Mr. McAllister stated that the process is a two step process. The first
step is to pass the foreign equivalency exam and then pass the NAPLEX exam.
Mr. Wand stated that the Board could approve another equivalency exam. Ms. Lee advised the
Board that they could approve another equivalency exam, but they could not waive the
requirement for the equivalency exam. Mr. Wand stated that the FPGEE exam is chosen
because it is a trusted exam. Mr. McAllister stated that these are psychometrically sound and he
does not feel that there is an equivalent exam.
Dr. Tippett asked how Ms. Makhail's sister was able to obtain a license. Ms. Makhail stated that
her sister graduated before 2003.
Mr. Dutcher stated if the Board were to approve a different process then it could potentially open
the floodgates. Mr. McAllister stated that the Board staff would then have to approve the
documentation and approve the requests. Mr. Wand stated at the beginning of each year the
Board approves the FPGEE, NAPLEX, and MPJE as the approved exam for applicants.
On motion by Mr. Van Hassel and Dr. Sypherd, the Board denied Ms. Makhail's
request to waive the FPGEE exam. There was one nay vote by Dr. Tippett.
#8 Catherine Barrameda
Catherine Barrameda appeared on her own behalf to request to take the NAPLEX exam for the
fourth time.
President Dutcher opened the discussion by asking Ms. Barrameda about the nature of her
request. Ms. Barrameda stated that she is requesting to take the NAPLEX exam for the fourth
time. Ms. Barrameda stated that she is a foreign graduate and has passed the equivalency exam
and the MPJE exam.
President Dutcher stated that Ms. Barrameda's scores are improving. Mr. Dutcher asked Ms.
Barrameda if she has taken any review courses. Ms. Barrameda stated that her scores are
improving but she decided that she needed help, so she took the review course at Midwestern
University at the end of May and has the material for the Kaplan review course.
On motion by Mr. Van Hassel and Dr. Smidt, the Board unanimously approved the request
by Ms. Barrameda to take the NAPLEX exam for the fourth time.
AGENDA ITEM 7 - Reports
Executive Director
Mr. Wand stated that he would like to talk about the budget process. Mr. Wand stated in the
book is a summary of last year's budget. Mr. Wand stated that there was $100,000 left over. Mr.
Wand stated that the Board can spend this money this year.
Mr. Wand stated that he is currently working on the budget that is due September 1, 2006. Mr.
Wand stated that he is asking for a new compliance officer. Mr. Wand stated that Mr. Wright
has been moved to the Compliance Policy Advisor position. Mr. Wand stated that all the
Compliance Officers are now uncovered. Mr. Wand stated that he has asked for a pay increase
for the compliance officers. Mr. Wand stated that he must also obtain a new car and budget for
expenses for the new compliance officer.
Mr. Wand stated that the Board had not budgeted for the new technician Board Member and he is
asking for an increase for expenses. Mr. Wand stated that he would like to budget for training
for Board Members and staff.
Mr. Wand stated that he is budgeting for aid to the University of Arizona School of Pharmacy
that was approved during the telephone meeting. Mr. Wand stated that this would be another
decision package. Mr. Wand stated that he spoke to the Office of Strategic Planning and was
told that if the expenses could be justified that the expenses would probably be approved.
Mr. Wand stated that the Board has never had a budget for the Attorney General position and that
totals about $100,000 and it has been absorbed within the budget. Mr. Wand stated that the
funding of the Attorney General position would be another decision package.
Mr. Wand stated that he is currently working with IBM to develop online applications with credit
card approvals. Mr. Wand stated that he will be meeting with IBM every other Tuesday until the
end of the year. Mr. Wand stated that the Board has not had to pay for the development of the
applications. Mr. Wand stated that the funds are coming from the Governor's Technology fund.
Mr. Wand stated that he is planning on asking for another decision package that would tie in the
scanned disciplinary records so that the disciplines would be available on line.
Mr. Wand stated that another decision package would be the budgeting for a new lease. Mr.
Wand stated that the lease is up at the end of June. Mr. Wand stated that the space is limited
and the Board cannot expand at the current space. Mr. Wand stated that he feels a two-year lease
would be sufficient in case the Board wants to move to a larger space at a later date. Mr. Wand
stated that if the Prescription Drug Monitoring program is approved then that program could be
moved to another space.
Mr. Wand stated that on September 1, 2006 he will turn the budget into the Office of Strategic
Planning and Budget, the JLBC, and the Governor's Office. Mr. Wand stated that the budget
would be reviewed and the Board should receive an answer by December if it is approved. Mr.
Wand stated that the Legislature would vote on the budget in the next session.
Dr. Smidt asked if the Legislature has line item veto. Mr. Wand stated that they have line item
veto or they could reduce the budget by a certain percentage.
Dr. McCoy asked if there is sufficient help to write the rules. Mr. Wand stated that is why he has
asked for the Compliance Policy Advisor position. Mr. Wand stated that is why he is asking for
an additional inspector to replace Dean if he accepts the new position. Ms. McCoy asked if the
Board should hire two Compliance Officers with the growing number of pharmacies in the state.
Mr. Wand stated that he could budget for two inspectors. Ms. McCoy asked if Mr. Wand feels
there is sufficient monitoring of legislative issues. Mr. Wand stated that it is difficult to get a
lobbyist budgeted. Mr. Wand stated that the Board could hire a legislative facilitator and that
must be taken from operating expenses. Mr. Dutcher asked if the Compliance Policy Advisor
position could assist in legislative issues. Mr. Wand replied that the position could help with
legislative issues.
Mr. Van Hassel asked if money could be budgeted to have funds available to have Board
sponsored education programs. Mr. Wand stated that they requested this as a budget item
previously and they were denied. Mr. Wand stated that he would put in a decision package for
this request and see what happens.
Mr. Wand stated that he put in a decision package for the budgeting of the Prescription Drug
Monitoring Program. Mr. Dutcher stated that the practitioners he spoke with did not object to
paying a fee for the monitoring program. Mr. Wand stated that Dean is making the changes to
charge a fee for all practitioners and pharmacies.
Mr. Wand stated that the Board could save money by having licensees print their own licenses.
Dr. McCoy asked if the reason the Board went to the security paper was because of forgeries. Mr.
Wand stated that there was only one individual that attempted to forge a license. Mr. Wand stated
the Compliance Officers would be able to dial into the database and verify the license. Mr.
Wand stated that online verification would be available on the website for the employer.
Mr. Wand stated that the renewal license does not need to be posted and only the wall certificate
needs to be posted. Mr. Wand stated that the wall certificates would still be printed.
On motion by Dr. McCoy and Mr. Van Hassel, the Board unanimously agreed to accept the
Budget proposals as presented by Mr. Wand.
PAPA Budget
Mr. Wand stated that the PAPA budget is enclosed in the meeting book. Mr. Wand stated that he
is proposing increasing the contribution to PAPA to $100,000 annually. Mr. Wand stated that
some of the Board Members expressed the need for technicians to be able to participate in the
PAPA program. Mr. Barron stated if the financing was available that PAPA could look at
starting a second track for technicians. Mr. Barron stated that due to salary differences
technicians cannot afford to self-pay for their treatment.
Mr. Barron stated that the PAPA program is financed by fees from the pharmacist. Mr. Wand
stated that it is not possible to attach fees to the technician license at this time.
Dr. McCoy stated that she has concerns about pharmacists in rural areas. Mr. Barron stated that
there are programs in place for rural pharmacists. Mr. Barron stated that the pharmacists in rural
areas do private counseling instead of driving to Phoenix or Tucson for group sessions. Mr.
Barron stated that PAPA tailors the contract for the pharmacist without requiring the pharmacist
to relocate.
Ms. Lee advised the Board that they should consider the addition of technicians to the PAPA
program as item on a future agenda.
Dr. Tippett asked Mr. Barron to explain the Utah School. Mr. Barron stated that it in intense
program about drug and alcohol addiction. Mr. Barron explained that the participant learns that
addiction is a disease. Mr. Barron stated that it is a seven day course and is a life changing
experience.
On motion by Mr. Van Hassel and Dr. Berry, the Board unanimously agreed to approve the
budget request to increase the contribution to PAPA to $100,000 annually.
Deputy Director Report
Deputy Director Frush directed the Board Members attention to the activity reports for the
Compliance Staff. Ms. Frush noted that the Compliance Staff is slightly behind in the number of
inspections completed during the same period last year due to the fact that January was spent
inspecting non-prescription outlets and educating the owners about the new pseudoephedrine regulations. Ms. Frush stated that the number of complaints and number of investigations for
diversions are continuing to grow.
Ms. Frush stated during th months of May and June the Compliance Staff issued letters for the
following violations:
Controlled Substance Violations
- 1. Controlled Substance Overage - 8
- 2. Controlled Substance Shortage - 7
- 3. Controlled Substance Inventory Not Complete - 4
- 4. Failure to Conduct Controlled Substance Inventory upon change of Pharmacist in Charge - 2
- 5. No Annual Controlled Substance - 2
Documentation Violations
- 1. Failure to Document Medical Conditions - 8
- 2. Failure to Document Required Information on an oral prescription - 1
- 3. Failure to have signed technician statements concerning job description, policies, and procedures and board rules
- 5
- 4. Failure to have a technician training manual - 3
- 5. Daily prescription log not signed - 3
- 6. Filing of Controlled Invoices - 1
Dispensing Violations
- 1. Outdated Rx and OTC items in the pharmacy -5
- 2. Pharmacy not locked when Pharmacist not present - 2
- 3. Failure to counsel on new prescriptions - 2
- 4. Dispensing a CII past the 60 day limitation - 1
Pharmacy Violations
- 1. Allowing technicians to work without a license - 1
- 2. Allowing a technician to work with an expired license - 2
- 3. Wall certificates not posted - 2
- 4. Pharmacy permit not available -1
- 5. Hospital - No Rx Blank Security Policy -1
The following areas were noted on the inspection reports for improvement:
- 1. Documentation of health conditions
- 2. Filing of invoices
The following areas were noted on the inspection reports where pharmacists and
technicians are meeting or exceeding standards:
- 1. Pseudoephedrine regulations
Areas outside the inspection reports that may be of interest:
- 1. Change of address and employment - Pharmacist In Charge changes
- 2. CII corrections - Errors and Omissions
Arizona Pharmacy Alliance (APA) Report
Mindy Rasmussen, Executive Director of the Arizona Pharmacy Alliance was present to update
the Board on upcoming events.
Ms. Rasmussen welcomed the Board to the 2nd annual meeting of the Arizona Pharmacy
Alliance.
Ms. Rasmussen stated that the APA held nine regional rallies and 400 pharmacy personnel
attended the rallies.
Ms. Rasmussen stated that there are legislative packets available at the front desk. Ms.
Rasmussen stated that it is important to have a lobbying presence at the legislative sessions.
Ms. Rasmussen stated that all the programs at the annual meeting would be videotaped and a
pharmacist would be able to log on to the APA website and view the program online for CE
credit. Ms. Rasmussen stated that APA will be holding various meetings. In September, they
will sponsor a Ladies Spa and CE retreat. In November, there are plans for a technician
conference. Ms. Rasmussen stated that they would be back in the community doing programs on
the Pharmacy Quality Commitment program.
Ms. Rasmussen stated that other projects that APA is addressing include the following:
Continuity of Care, Medication Reconciliation, and Medication Therapy Management involving Medicare Part D.
Ms. Rasmussen stated that future legislative issues include: adding student pharmacists to the
immunization regulations allowing them to administer immunizations, supporting the
Prescription Drug Monitoring Program.
Ms. Rasmussen stated that she would be attending the stakeholder meeting concerning
therapeutic substitution. Ms. Rasmussen stated that she would like to see collaborative practice
extended to the retail setting. Ms. Rasmussen stated that APA would like to support a bill to
allow pharmacists to be paid for cognitive services.
ITEM 8 - Medco Home Verification Pilot
Mary Ryan and Nevin Okay appeared on behalf of Medco Health Solutions (Medco) to present
an overview of a program Medco is pursuing in Arizona.
Ms. Ryan stated the Medco is developing several work at home programs for the pharmacists.
Ms. Ryan stated that they focus on areas where the demographics support a pharmacist working
at home. Ms. Ryan stated that the pharmacists would work with doctors in the area explaining
the generic and therapeutic substitution programs. The pharmacists would also be able to remotely review prescriptions and provide patient counseling.
Mr. Okay described the security features of the system to the Board Members. Mr. Okay stated
that there would be a virtual private network using encryption technology. Mr. Okay stated that
the data resides on Medco's servers and data cannot be retrieved from the workstation.
Mr. Okay explained that each workstation has the capability of e-mail, instant messaging, voice
mail, and video streaming. Mr. Okay explained that each work station is equipped with a
biometric reader (fingerprint) and a camera.
Mr. Okay stated that each pharmacist receives a unique User ID . Mr. Okay stated that the
system has a lock-out process if no activity is detected and the pharmacist would need to
complete the sign-on process to re-establish connectivity.
Mr. Okay stated that the system is equipped with Quality Assurance Monitoring Software and
allows a supervisor to monitor the pharmacist in "real-time" and "retrospectively". Mr. Okay
stated that supervisors would make regular visits to the home sites.
Mr. Okay stated that the home workstation is dedicated only to the pharmacy operation. Mr.
Okay stated that there will be no printers, hard drives, or memory sticks that would allow for the
storage of data.
Mr. Wand asked Ms. Ryan how many pharmacists would be participating in the program. Ms.
Ryan stated that they anticipate hiring two to ten pharmacists.
Mr. Wand asked a Compliance Officer could inspect the home site. Ms. Ryan stated that a site
inspection would be fine.
Mr. McAllister asked about the company not being located in Arizona. Ms. Ryan stated that they
are licensed as a non-resident pharmacy. Ms. Ryan stated that the pharmacist would be an
employee of the Texas division of Medco and Texas is licensed as a non-resident pharmacy.
Dr. Smidt asked if an error was made by a pharmacist who would have jurisdiction. Mr. Wand
replied since the pharmacist is licensed in Arizona the Board would have jurisdiction.
Mr. Dutcher thanked Ms. Ryan and Mr. Okay for appearing and discussing their home
verification program with the Board.
AGENDA ITEM 9 - Arizona Community Pharmacy Committee - Proposed Therapeutic Interchange Legislation and Meeting
Janet Elliot was present on behalf of the Arizona Community Pharmacy Committee.
President Dutcher asked Mr. Elliot to address this issue for the Board Members. Ms. Elliott
stated that the Arizona Community Pharmacy Committee is pursuing legislation for therapeutic
interchange that would allow a pharmacist to dispense a therapeutic alternative drug in place of
the drug prescribed by the practitioner, to allow for formulary compliance.
Ms. Elliott stated that the Arizona Community Pharmacy Committee feels that by allowing
therapeutic interchanges there would be a cost savings to the patient and better patient care would
result.
Ms. Elliott stated that there will be an initial stakeholder meeting held on August 8, 2006. The
meeting will be held at the Arizona Medical Association's office at 810 W. Bethany Home Road, Phoenix from 10:00 A.M. to 11:30 A.M.
AGENDA ITEM 10 - Proposed Rules
Compounding and Sterile Pharmaceutical Products Rules
Compliance Officer/Rules Writer Dean Wright opened the discussion by stating that he has
prepared a Notice of Final Rulemaking and an Economic Impact Statement for Board approval
for the Compounding and Sterile Pharmaceutical Products Rules.
Mr. Wright stated that a Notice of Proposed Rulemaking was published in the Arizona
Administrative Register on April 14, 2006. A public hearing for comments on the proposed
rulemaking was held on May 23, 2006. Janet Elliott of the Arizona Community Pharmacy
Committee attended the hearing and provided written comment in favor of the rulemaking.
Mr. Wright stated that if the Board approves the Notice of Final Rulemaking and Economic
Impact Statement, the rulemaking will be presented to GRCC for their October 5, 2006 meeting
agenda for final approval. If approved by GRRC, the rules would become effective on December 5, 2006.
On motion by Mr. McAllister and Dr. Tippett, the Board unanimously agreed to approve the
Notice of Final Rulemaking and Economic Impact Statement for the Compounding and Sterile Pharmaceutical Products Rules.
Dr. McCoy asked if the proposed rules were in conflict with any of the proposed USP 797
changes. Mr. Van Hassel stated that the proposed rules are minimum standards. Mr. Van Hassel
stated that the task force had two options. The two options were to adopt the USP 797 standards
or develop our own standards. Mr. Van Hassel stated that the task force chose to adopt their own
standards. The proposed rules establish the minimum levels of competency, documentation and
processes. Dr. Smidt added that the USP 797 rules defer to the Stated Boards for inspection
purposes. Dr. Smidt stated that the intention of the rules is to give the Compliance Officers clear
cut guidelines when conducting an inspection.
AGENDA ITEM 11 - Complaint Review
The Consumer Complaint Review committee met prior to the Board Meeting to review 34
complaints. Dr. Berry, Dr. Sypherd and Ms. Honeyestewa served as the review committee.
Board Members were encouraged to discuss issues and were encouraged to ask questions.
The Board Members discussed the following complaints.
Complaint # 3165
Dr. McCoy asked if a letter could be sent to the Dentist concerning the term "Original Percocet
Strength. Ms. Lee advised the Board that they had no authority over the dentist and could not
issue a letter to the Dentist. Ms. Lee stated that the Board could express their concerns in the
letter to the Dentist concerning the outcome of her complaint.
Complaint #3177
The Board members discussed this Complaint to determine if they wanted to issue a Consent
Order similar to the Florida Order or take other action against the permit holder.
Dr. Smidt stated that the company is shipping medications with no safeguards present in the
compounding of the medications.
Mr. Wand stated that a consent order could be issued that would not allow the company to ship
to Arizona residents.
Dr. Smidt stated that patients do not need to go out of state to have this product compounded and
a pharmacy in Arizona could compound the medication.
Dr. McCoy asked if these were Arizona patients. Mr. Wand replied that there is no way to know
where the patients were located.
Mr. Wand stated that if the Board feels the pharmacy would put a patient at risk the Board can
offer the company a consent order not to ship to Arizona. Mr. Dutcher asked how the Board
would enforce the consent order. Mr. Wand stated that if the company accepted the consent
order then they would be expected to comply with the order.
After further discussion, it was decided that the Board would offer the non-resident pharmacy a
consent order to voluntarily surrender their Arizona license.
Complaint #3185
Mr. McAllister opened the discussion by stating that the Board is treating technicians differently
than the pharmacists. Mr. McAllister stated that the pharmacists are being offered recovery
while the technician licenses are being revoked. Dr. Berry stated that at the present time there is
no recovery program for technicians.
Mr. Dutcher stated that the Board has been flooded with technician complaints concerning drug
diversion or the use of drugs.
Dr. Tippett stated that the Board has two standards. Dr. Tippett stated that he would feel more
comfortable if the Board revoked both technicians and pharmacists for the same behavior.
Dr. Smidt stated that morally and ethically he agrees with Dr. Tippett and Mr. McAllister and
feels that this topic should be placed as an item on a future agenda.
Mr. McAllister stated that the funds the Board contributes to PAPA are used to run the
administrative portion of the program and individuals pay for their own treatment.
Mr. Wand stated that often the technicians do not respond to the consent order. Dr. Tippett
stated that the Board could offer the technicians a consent order and it would be up to the
individual to respond and accept the consent order.
Mr. McAllister stated that there are two different issues in the cases before the Board today.
Mr. McAllister stated that there are issues with drugs in the work place and issues with drugs on
pre-employment screenings. Mr. Wand noted that the pre-employment screens usually are
positive for marijuana and there is no legal way for an individual to possess or use marijuana.
Dr. McCoy stated that the Board decided to license technicians to protect the public. Dr. McCoy
stated that by licensing the technicians the Board can take action against the technicians. Dr.
McCoy stated that the Board is dealing with two levels of practitioners and her concerns are that
the Board wants to place them on the same level when disciplinary actions are taken.
Mr. Dutcher stated that the consent could be offered and the technician could accept the consent
or appear for a hearing.
Dr. Tippett stated that he believes that the technician and pharmacist should both be revoked for
the same action.
Ms. Lee advised the Board that this item should be placed on a future agenda for further
discussion.
Complaint #3142
Dr. McCoy asked if this complaint involved a chain pharmacy. The reply was yes. Dr. McCoy
requested that someone in a higher administrative position than the pharmacy supervisor be
asked to attend the conference.
The following summary represents the final decisions of the Board in each complaint:
- Complaint #3120 - Conference - Pharmacist
- Complaint #3133 - Conference - Pharmacist In Charge
- Complaint #3134 - No Further Action
- Complaint #3136 - Conference - Pharmacist
- Complaint #3137 - Conference - Pharmacist
- Complaint #3139 - Advisory Letter
- Complaint #3140 - Conference - Pharmacist and Technician
- Complaint #3141 - Conference - Pharmacist
- Complaint #3142 - Conference - Pharmacist and Upper Management Supervisor
- Complaint #3143 - No Further Action
- Complaint #3144 - Consent/Hearing - Revocation
- Complaint #3151 - Advisory Letter
- Complaint #3152 - Conference -All Pharmacists Involved in the Case
- Complaint #3153 - Advisory Letter
- Complaint #3159 - No Further Action
- Complaint #3160 - No Further Action
- Complaint #3162 - Advisory Letter to Pharmacist and Supervisor
- Complaint #3164 - Advisory Letter
- Complaint #3165 - No Further Action
- Complaint #3166 - No Further Action
- Complaint #3170 - Consent/Hearing - Voluntary Surrender
- Complaint #3171 - Consent/Hearing - Voluntary Surrender
- Complaint #3172 - Consent/Hearing - Voluntary Surrender
- Complaint #3173 - Consent/Hearing - Voluntary Surrender
- Complaint #3177 - Consent/Hearing - Voluntary Surrender
- Complaint #3178 - Consent/Hearing - Voluntary Surrender
- Complaint #3181 - Consent/Hearing - Voluntary Surrender
- Complaint #3182 - Consent/Hearing - Voluntary Surrender
- Complaint #3184 - Consent/Hearing - Voluntary Surrender
- Complaint #3185 - Consent/Hearing - PAPA Contract
- Complaint #3186 - Conference - Pharmacist
- Complaint #3156 - No Further Action
- Complaint #3174 - No Further Action
- Complaint #3187 - Consent/Hearing - Revocation
- Complaint #3188 - Consent/Hearing - Revocation
AGENDA ITEM 12 - Conferences
Complaint #3095
Pharmacist In Charge Raj Patel and Pharmacy Supervisor Jim Foy were present in response to a
consumer complaint. Susan DelMonico, Pharmacy Attorney and Director of Regulatory
Compliance for CVS was also present.
Compliance Officer Larry Dick gave a brief overview of the complaint. Mr. Dick stated that two
pharmacy technicians were charged with the diversion of controlled substances from the
pharmacy. The technicians diverted thousands of tablets of hydrocodone products. The
technicians were terminated and arrested.
President Dutcher opened the discussion by asking Mr. Patel if he knew why he was appearing in
front of the Board. Mr. Patel stated that he was the Pharmacist in Charge at the store where the
diversion occurred and he is responsible for what occurs in the pharmacy.
Mr. Dutcher asked Mr. Patel how the diversion occurred. Mr. Patel stated that one of the
technicians involved was responsible for maintaining the inventory and would enter the inventory
in the computer system. Mr. Patel stated that the technician adjusted the inventory to track the
diversion. Mr. Patel stated that it was very difficult to track the diversion. Mr. Patel stated that
when he realized that something was wrong he contacted his supervisor.
Mr. Dutcher asked Mr. Patel how the technician was taking the drugs out of the pharmacy. Mr.
Patel stated that the technician would bring his backpack into the pharmacy and believed he was
placing drugs in his backpack when he went to help a customer. Mr. Patel stated that he would
also pass drugs out through the drive-up window when he left the pharmacy to help a customer in
the OTC section.
Mr. Dutcher asked Mr. Patel what he has learned from this experience. Mr. Patel stated that he
has made several changes. Mr. Patel stated that he does not allow any personal belongings, such
as backpacks, into the pharmacy. Mr. Patel stated that he does a monthly inventory and
investigates any discrepancies.
Dr. Smidt asked Mr. Patel if he signs the CII forms. Mr. Patel stated he is the only one that can
sign the CII order forms. Mr. Patel stated that they did not divert any CII medications.
Dr. Sypherd stated that every pharmacist in the audience should think about how to prevent these
incidents from occurring and not react to the situation after the fact.
Complaint # 3056
Complainant and Pharmacist Marcella von Gortler and Pharmacy Technician John Lamont were
present to answer Board Member's questions as a result of a complaint filed by Ms. von Gortler.
Dan Cavett was present as legal counsel for Ms.von Gortler. Compliance Officer Larry Dick
gave a brief overview of the complaint.
Mr. Dick stated that the complainant, a pharmacist, states that a technician gave her a vial of
expired Oxycontin 75 mg SR capusles, number 65, at his home for her personal use.
President Dutcher opened the discussion by asking Ms. von Gortler if she knew why she was
asked to appear in front of the Board. Ms. von Gortler stated that she is present to answer
questions concerning how she received the medication. Mr. Dutcher stated that the complaint
was discussed with the owner at the last Board Meeting.
Mr. Dutcher asked Ms. von Gortler how she came to have the CII medication in her possession.
Ms. von Gortler stated that she ended up with the product when she stayed with her boyfriend.
Ms. von Gortler stated that she found the product in his home in a box at the foot of the bed. Ms.
von Gortler stated that it was a stock bottle from the store where her boyfriend worked.
Mr. Dutcher asked Mr. Lamont to address the issue. Mr. Lamont stated that he did not take the
bottle from the pharmacy. Mr. Lamont stated that he believes the bottle inadvertently ended up
in a box of his personal items that he brought home from the pharmacy when they were
remodeling the pharmacy.
Mr. Dutcher asked Ms. von Gortler for further clarification. Mr. Dutcher asked Ms. von Gortler
if she knew what it was when she took the bottle. Ms. von Gortler stated that she took the bottle
because she recognized the stock bottle and removed the bottle. Ms. von Gortler stated that she
called the Board and was told that she should report the incident. Ms. von Gortler stated that she
then filed a complaint and the medication was picked up by a Compliance Officer.
Mr. Dutcher asked Ms. von Gortler if she was practicing at this time. Ms. von Gortler replied
yes. Mr. Dutcher asked Mr. Lamont if he was practicing at this time. Mr. Lamont replied no.
Mr. Van Hassel asked if the events occurred in 2005. Ms. von Gortler stated that the events
occurred at the end of the year in 2005. Mr. Van Hassel asked about the comment in her later
where she stated that Mr. Lamont offered her other medications. Ms. von Gortler stated that Mr.
Lamont had given her a bottle of blue capsules and told her that they would help with her
migraines. Ms. von Gortler stated that she gave those to a nurse that she knew because she was
not sure what was in the capsules and the nurse flushed the capsules.. Ms. von Gortler stated that
she did not ask Mr. Lamont to take any medication for her. Mr. Van Hassel asked if she took any
of the medications. Ms. von Gortler stated no she did not take any medications.
Mr. Lamont stated that these statements are not true. Mr. Lamont stated that he has worked as a
technician since 1984 and he does not take drugs. Mr. Lamont stated that he now works as a
carpenter because he is not able to obtain a job as a technician.
Dr. Smidt stated that his concerns of Ms. Von Gortler being able to practice safely have been
satisfied by the letter from her physician.
Mr. Van Hassel asked Ms. von Gortler why she wanted to rescind her complaint. Ms. von
Gortler stated that she felt she was destroying the pharmacy owner's business. Ms. von Gortler
stated that at that time she was not stabilized on any medications and she was confused about
what to do with the situation that she created by filing the complaint.
Mr. Cavett summarized the complaint for the Board Members. Mr. Cavett stated that it is true
that a bottle of missing medication from the pharmacy turned up with Ms. von Gortler. Ms. von
Gortler did not work at the pharmacy and some how she ended up with the bottle. Ms. von
Gortler stated that she found the bottle at Mr. Lamont's residence and took the bottle because of
relationship issues and the fact that Mr. Lamont had his son living at the house. Mr. Cavett
stated that Mr. Lamont stated that the bottle was inadvertently found in a box of his personal
items at his house and stated that he did not steal the medication from the pharmacy. Mr. Cavett
stated that Ms. von Gortler filed the complaint out of ire. Mr. Cavett stated that Ms. von
Gortler's medical records state that she was distraught about the situation and she decided to try
and take the blame for the whole situation. Mr. Cavett stated that the Board had concerns about
Ms. von Gortler's level of competency. Mr. Cavett stated that Ms. von Gortler's physician feels
that she is competent to practice. Mr. Cavett stated that Ms. von Gortler has had no complaints
filed against her with the Board.
The Board Members followed the scenario and still were unsure how the medication left the
pharmacy.
Ms. Lee advised the Board Members that in order to resolve the case they would need to dismiss
the complaint, file an advisory letter, or offer a consent order to the individuals involved in the
conference.
On motion by Mr. McAllister and Dr. Smidt, the Board unanimously agreed to issue an
advisory letter to Ms. von Gortler and Mr. Lamont and keep a copy of the advisory letter on file.
Complaint # 3075
Pharmacist Courtney Mason and Pharmacy Supervisor Fauzia Somani were present to answer
questions concerning a consumer complaint. Compliance Officer Larry Dick gave a brief
overview of the complaint.
Mr. Dick stated that the complainant had two prescriptions for Cipro and Flagyl dispensed to him
from the same pharmacy that fills his ongoing warfarin prescription. The prescriptions were
dispensed despite significant adverse drug interactions. Mr. Dick stated that the patient's INR
range was in the dangerous range and the patient had to be carefully monitored until his INR
returned to the normal range. Mr. Dick stated that the patient's prescription for Flagyl was also
filled for thirty tablets instead of the twenty tablets written for on the prescription.
President Dutcher asked Ms. Mason to explain how the interactions got past her review. Ms.
Mason stated that she honestly cannot explain how the interactions got past her. Ms. Mason
stated that the incidence occurred in January and they were overwhelmed with the cough and
cold season. Ms. Mason stated that she does not know how the DUR got by her.
Mr. Dutcher asked if the technicians enter the prescription. Ms. Mason replied that the
technicians enter the prescriptions. Mr. Dutcher asked if the technicians notify the pharmacist
when a DUR screen comes up on the computer. Ms. Mason replied that the technicians do not
see the DUR screens that the DUR screens only show up on the pharmacist's screen when they
verify the prescription. Mr. Dutcher asked Ms. Mason if she was the one that overlooked the
DUR. Ms. Mason replied that she is not sure how it happened that she overlooked the DUR.
Mr. Dutcher asked the Pharmacy Supervisor about a statement in the complainant's letter that
stated his records were not flagged for interactions. Ms. Somani stated that the interaction does
come up on the screen and shows as a major interaction. Ms. Somani stated that the pharmacist must manually override the interaction.
Dr. Smidt asked Ms. Mason if she counseled the patient. Ms. Mason replied that she did. Dr.
Smidt told Ms. Mason that the patient information has the warning about Coumadin and she
missed the opportunity again to review the interaction. Ms. Mason stated that she was not aware
that he was taking the Coumadin.
Mr. Dutcher asked Ms. Mason what she has changed since this incident. Ms. Mason stated that
she has resolved to slow down. Ms. Mason stated that she has completed a CE on how to
minimize risks.
Mr. Wand asked if the computer prints auxilary labels to place on the bottle. Ms. Somani stated
that the computer does print the labels and there should have been a label for Coumadin. Ms.
Somani stated that the information is also in the written information given to the patient.
Mr. Dutcher reminded Ms. Mason to work at a pace that is comfortable. Mr. Dutcher reminded
Ms. Mason when the an interaction is on the screen to read the screen very carefully. Ms.
Somani stated that major interactions show up in red and the pharmacist manually override the
interaction.
On motion by Mr. Van Hassel and Dr. Smidt, the Board unanimously agreed to issue an
advisory letter to Ms. Mason and keep a copy of the advisory letter on file.
Complaint #3079
Pharmacist Guru Boggarapu and Pharmacy Supervisor Joe Leyba were present to answer
questions concerning a consumer complaint. Compliance Officer Rich Cieslinski gave a brief
overview of the complaint.
Mr. Cieslinski stated that the complainant presented to the pharmacist a prescription for
Rocephin Injectable for 1 gram. When the patient arrived home, she noticed that she did not
receive any diluent and that the prescription was for 250mg. The complainant stated that she
called the pharmacist back and was told that she would not be receiving any diluent and that
when she received the diluent she should add 4 ml to the vial to make 1000mg. The patient
stated that she knew that was not correct and had the prescription filled at another pharmacy.
Mr. Dutcher asked Mr. Boggarapu about the mathematical error he made in calculating the
dosage for this prescription. Mr. Boggarapu stated that he read the box and he thought each ml
contained 250 mg. Mr. Boggarapu stated on the front of the box it read 6 ml. Mr. Boggarapu
stated that he thought by adding 4 ml of diluent that would make 1000 mg. Mr. Boggarapu
stated that he did not read the leaflet that stated that the whole vial contained 250 mg.
Mr. Dutcher asked Mr. Boggarapu if he understands the dosing now. Mr. Boggarapu replied yes.
Mr. Dutcher asked Mr. Boggarapu what he is doing differently when filling a prescription.
Mr. Boggarapu replied that he is reading the leaflet.
Dr. McCoy asked Mr. Boggarapu about dispensing the drug without dispensing the diluent. Mr.
Boggarapu stated that he thought the patient was taking the medication back to the doctor.
Mr. Boggarapu stated that the patient did not wait for consultation. Mr. Boggarapu stated that
he was on the phone and the technician stated that the patient took the prescription and would
call him back if she had any questions. Dr. McCoy asked what the process is in the store when a
medication requires a diluent. Mr. Boggarapu stated that at the consultation window they would
ask the patient if they needed the diluent and they would call the doctor and ask for a prescription
for the diluent and the syringes. Mr. Boggarapu stated that the technicians have been told not to
place the prescriptions where the patient can take the prescriptions without being counseled.
Mr. Dutcher asked Mr. Boggarapu if they have the diluent in stock. Mr. Boggarapu stated that he
is not sure. Mr. Boggarapu stated that if the diluent is needed that they could order the diluent
for the next day. Mr. Dutcher told Mr. Boggarapu if they order a medication that requires a
diluent that they should also order the diluent.
On motion by Mr. McAllister and Dr. Smidt, the Board unanimously agreed to issue an
advisory letter to Mr. Boggarapu and keep a copy of the advisory letter on file.
Complaint # 3101
Pharmacist Peter Gentile and Pharmacy Owner Debbie Walton were present to answer questions
concerning a consumer complaint. Complainant Mary Flores was also presemt. Compliance
Officer Ed Hunter gave a brief overview of the complaint.
Mr. Hunter stated that a refill prescription written for Zyrtec Syrup was filled with Zantac Syrup.
Mr. Hunter stated that counseling was not performed because the prescription was a refill.
President Dutcher asked Mr. Gentile to discuss the complaint. Mr. Gentile stated that he is not
sure who pulled the bottle and poured the medication. Mr. Dutcher asked if the technician pulls
the bottle does the stock bottle remain with the prescription vial. Mr. Gentile replied yes.
Mr. Dutcher asked Mr. Gentile what he has done differently. Mr. Gentile stated that they have
moved the bottles in the pharmacy. The bottles were next to each other on the same shelf. Mr.
Gentile stated that they are now on different shelves in different areas.
Dr. McCoy stated that this mixup with drug names has been published in the literature. Dr.
McCoy stated that there are proactive actions that pharmacies can take to prevent these errors.
Dr. McCoy stated that if an error occurs at one place it can certainly occur at another place.
Dr. McCoy reminded pharmacists to be proactive and not wait for a consumer complaint to make
the necessary changes.
On motion by Dr. Berry and Ms. Honeyestewa, the Board unanimously agreed to issue an
advisory letter to Mr. Gentile and keep a copy of the advisory letter on file.
Complaint #3102
Pharmacists Ron Kaz, Nicole Oliver, and Montra Ervin were present to answer questions
concerning a consumer complaint. Pharmacy Supervisors Hahn Nguyen and Sean Duffy were
present. Susan DelMonicao, Pharmacy Attorney for CVS, was also present. Compliance Officer
Ed Hunter gave a brief overview of the complaint.
Mr. Hunter stated that the complaint was filed by a physician who stated that her patient was
receiving Hydrocodone 7.5/500 #180 every 10 to 11 days as a refill instead of every 30 days as
she prescribed and noted on the refill authorization form. Mr. Hunter stated that three refills wre
filled early. The pharmacists were relying on third party for limitations. This particular patient
had a discount plan and no limitations were triggered by the insurance company that the
prescription was too soon to be filled. The patient was taking in excess of the dose prescribed and tests were performed and the patient did not suffer any harm.
President Dutcher opened the discussion by asking Mr. Kaz, the Pharmacist In Charge, why they
allowed the prescriptions to be filled early.
Mr. Kaz stated that the process they had in place at that time was flawed. Mr. Kaz stated that the
process at the time was to rely on the rejection by the insurance company to avoid releasing a
prescription early. Mr. Dutcher told Mr. Kaz that they were neglecting to use their professional
judgment by relying on this process. Mr. Dutcher asked if the computer flags early refills. Mr.
Kaz stated that the system does not flag early refills. Mr. Kaz stated that when the technician
enters the prescription a screen would show up for an overlap or an early fill and the technician
would then print that screen and give to the pharmacist. Mr. Kaz stated that there was no flag to
stop this prescription.
Mr. Dutcher asked about the system in place at this time. Mr. Kaz stated that they are not relying
on any third party reject to make their professional judgment. Mr. Kaz stated that on any
prescription that contains acetaminophen or a controlled substance the technician is printing out a
patient profile and giving it to the pharmacist. The pharmacist decides that if 90% of the
medication has been consumed then the prescription will be released to the patient. Mr. Dutcher
asked if there are any issues with customers. Mr. Kaz stated that for the most part the customers
are not upset.
Mr. Dutcehr asked Mr. Kaz about the checks and balances. Mr. Kaz stated under the old system
the only way he would know if it was an early fill was if the technician printed out the early fill
notice.
Mr. McAllister stated that he has concerns. Mr. McAllister stated that the reason there are
controls is to protect the patient. Mr. McAllister stated that he feels that there is a failure to
control and to protect the patient and he feels a consent order would be appropriate.
Mr. Dutcher stated that the doctor authorized refills and noted that the prescription should last 30
days. Mr. Dutcher asked Mr. Kaz where that is noted in the system. Mr. Kaz stated that the note
must be manually entered as a dispensing note. Mr. Kaz stated that the technician would need to
enter that note. Mr. Dutcher asked if it would be put on the label. Mr. Kaz stated that if it is not
part of the directions the technician would not enter that into the sig. for the label.
Dr. Tippett asked about the consent order. Dr. McAllister stated that there is a failure to control
and failure to follow a physician's directions. Dr. McAllister stated that he would suggest in a
consent order there would be a $1,000 fine and a 90 day probation period. Mr. Dutcher stated
that it is a lack of professionalism to rely on an insurance company. Mr. Dutcher stated that
the technician should question the pharmacist when the previous fill shows up and is recent.
Mr. Dutcher stated that there is a serious flaw in professional judgment when the pharmacist
allows someone else to make their professional judgments or how to practice.
Dr. Smidt stated that on the refill authorization the doctor noted twice that the prescription was
for a 30 day supply. Dr. Smidt asked if the pharmacist sees the refill authorization. Mr. Kaz
stated that the technician takes the prescription off the fax machine, processes the prescription,
and sends the prescription down the line. Dr. Smidt asked if the note was missed. Mr. Kaz
stated that he was not the pharmacist and it looks like the technician missed entering the note.
Mr. Kaz stated that he is not sure if the pharmacist checked to see if the note was entered.
Dr. Berry asked if counseling was performed and was the patient told the prescription must last
30 days. Ms. Ervin stated that the patient declined counseling.
Dr. Smidt asked who the Board would be sanction. Mr. McAllister replied all three pharmacists.
Mr. McAllister stated that he feels the insurance company and the technicians are running the
pharmacy and the pharmacists are not protecting the patient.
Dr. McCoy said that she had a concern that the physician would authorize a refill early.
Ms. DelMonico stated that she does not feel a consent order would be appropriate. Ms.
DelMonico stated that she would like the Board to consider an advisory letter because there was
no patient harm.
Mr. Van Hassel stated that an advisory letter could be issued to the pharmacists and the permit
holder fined. Mr. Dutcher asked Mr. Kaz if it was corporate policy. Mr. Kaz stated that it was
not corporate policy but was each pharmacist's judgment and the judgment was poor.
Mr. Dutcher asked Mr. Kaz about their new policies. Mr. Kaz stated that if the literature does
not come from the technician he will go to the patient profile and make a decision based off of
the patient's profile. Ms. Ervan stated that she has learned not to rely on any third party and she
calculates the release date based off of 90% of the medication being used by the patient. Ms.
Oliver stated that she checks the refills and also checks for duplicate items, such as Percocet.
Ms. Lee advised the Board that they could not take action against the permit holder at this time.
Ms. Lee advised the Board that they would need to open a complaint against the permit holder
prior to taking action against the permit holder.
On motion by Mr. Van Hassel and Dr. Tippett, the Board unanimously agreed to issue an
advisory letter to Mr. Kaz, Ms. Oliver, and Ms. Montra and keep a copy of the advisory letter on
file.
Complaint # 3105
Pharmacy Technician Trainee Tabitha Needham and Pharmacy Supervisor Matt Cook were
present to address a consumer complaint. Compliance Officer Larry Dick gave a brief overview of the complaint.
Mr. Dick stated the complainant was given the wrong prescription by the pharmacy technician.
The patient was to receive Plavix 75 mg and received another patient's prescription for Topamax
100mg. The complainant took five days of the wrong medication and developed fatigue and
headaches while walking. Both patients had the same last name but different first names.
President Dutcher opened the discusssion by asking Ms. Needham to address the complaint. Ms.
Needham stated that she does not remember the incident, but she should have double checked the
address and the birth date. Mr. Dutcher asked Ms. Needham what her process is now. Ms.
Needham stated that she reviews the name, the address, and birth date with each patient.
Mr. Cook stated that he feels that it is important to note that this incident occurred during her
first two weeks of training.
On motion by Mr. McAllister and Dr. Sypherd, the Board unanimously agreed to dismiss the
complaint and take no further action against Ms. Needham since she has changed her practices to
prevent this type of error from occurring in the future.
Complaint #3122
Pharmacist Rob Smith, Pharmacy Technician Trainee Jolene Watts, and Pharmacy Supervisor
Matt Cook were present to answer questions concerning a consumer complaint. Compliance
Officer Sandra Sutcliffe gave a brief overview.
Ms. Sutcliffe stated that the complainant had a prescription filled for Acetaminophen #3 for their
ten year old son. The patient received a bottle containing both Toprol XL 100mg and
Acetaminophen #3 in the same bottle. The patient took one dose of the medication and it is
unknown which drug was ingested. The Toprol XL100 mg was accidentally placed in the
cassette for Acetaminophen #3 by the technician and the mixed tablets in the bottle was not
caught by the verifying pharmacist.
President Dutcher asked the pharmacist to address this issue. Mr. Smith stated that it appears
the Toprol XL was placed in the cell with the Acetaminophen #3. Mr. Dutcher asked if the
tablets were close enough in size that they went through the cell. Mr. Smith replied that they are
about the same size and are the same color.
Mr. Dutcher asked who filled the cell. Ms. Watts stated previously the technician filled the cell.
Ms. Watts stated that they have a new policy now that only the pharmacist can fill the cell.
Ms. Watts stated that they are not certain who filled the cell.
Mr. Dutcher asked if there was a log. Ms. Watts stated that there is a log but they believe that the
Toprol XL was a return to stock item that was not picked up. Ms. Watts stated that the policy is
that only pharmacists can put the return to stocks in a cell. Ms. Watts stated that it cannot be
determined who returned the medication to the cell.
Mr. Dutcher asked if there are now procedures in place to prevent this from occurring. Mr. Cook
stated that it was a policy prior to this incident and the policy has been reviewed with this store
and throughout the company.
Dr. Sypherd asked how the mistake was discovered. Ms. Watts stated that another pharmacist
discovered the error when she was checking a Acetaminophen #3 prescription and she called all
the patients that had received Acetaminophen #3 in the last few days. Dr. Smidt asked how
many people were called. Ms. Watts stated that she does not know how many people were
called. Mr. Cook stated that their computer system will allow them to identify very quickly the
prescriptions that were filled for a particular product for the last seven days.
Dr. Smidt asked if the pharmacist showed the patient the medication during counseling. Mr.
Cook stated that it would be difficult to identify the Toprol XL tablets if they was only 1 or 2
tablets at the bottom of the vial because they are so close in size and color.
Mr. Van Hassel asked if there is a log available. Mr. Smith stated that a log is available. Ms.
Watts stated that the log would only be signed by the pharmacist because the pharmacist is the
only ones who are allowed to fill the cells.
On motion by Mr. Van Hassel and Dr. Tippett, the Board unanimously agreed to issue an
advisory letter to Mr. Smith and Ms. Watts and keep a copy of the advisory letter on file.
Complaint #3124
Pharmacist Kathleen Watson and Pharmacy Supervisor Fauzia Somani were present to answer
questions concerning a consumer complaint. Compliance Officer Sandra Sutcliffe gave a brief
overview of the complaint.
Ms. Sutcliffe stated that the patient received Tramadol 50 mg instead of Trazadone 50mg. The
patient took 59 doses of Tramadol before the error was discovered. The patient reported he
suffered three episodes of suicidal thoughts while taking the Tramadol. The technician entered
the prescription incorrectly and the error was missed by the pharmacist when she verified the
prescription.
President Dutcher opened the discussion by asking Ms. Watson to discuss the complaint. Ms.
Watson stated that the error the caused the problem has been corrected. Ms. Watson stated that
the technician used to be able to use a speed code when entering the prescription. The speed
code was tra50. The technician selected the wrong drug. Ms. Watson stated that the speed code
tra50 has been removed. Ms. Watson stated that with every prescription for Tramadol or
Trazadone, a screen pops up at the point of entry requiring the technician to type their initials into
the system that they have verified the drug and the same prompt appears for the reviewing
pharmacist and they must enter their initials indicating that they have checked the drug. Ms.
Somani stated that this is an extra step for tracking sound-alike drugs.
Mr. Dutcher asked how the prescription is verified. Ms. Watson stated that the data entry is on
one side of the screen and the image on the other side of the screen and she verifies that it is
entered correctly.
Dr. Smidt asked if they thought about going to four letters for a short code because this has been
shown to eliminate the problem. Ms. Somani replied no, but she could take the suggestion back
to her corporate office.
Dr. McCoy asked is this is true of all stores in the chain. Ms. Somani stated that the change is
nationwide.
Mr. Van Hassel asked if the wife was counseled. Ms. Watson stated that the wife was counseled.
On motion by Dr. Smidt and Dr. Berry, the Board unanimously agreed to issue an advisory
letter to Ms. Watson and keep a copy of the advisory letter on file.
Complaint #3130
Pharmacist Quang Truong and Pharmacy Supervisor Truce Phan were present to answer
questions concerning a consumer complaint. Compliance Officer Dean Wright gave a brief
overview of the complaint.
Mr. Wright stated that the pharmacist dispensed two vials with Rifampin 300mg in the vial to the
patient without any labels on the vial
President Dutcher opened the discussion by asking Mr. Truong to discuss the complaint. Mr.
Truong stated that he forgot to the label the vial and has changed his practice to ensure that all
vials leave the pharmacy labeled. Mr. Truong stated that he gave the prescriptions to the
technician to enter. Mr. Truong stated that they only had four capsules of the Rifampin, so he
placed two in each vial and asked the technician to order the drug. Mr. Truong stated that he
compared the labels with the prescription and placed the bottles in the bag. Mr.Truong stated
that he forgot to label the vials.
Mr. Dutcher asked Ms. Phan about the company's policy on filling partial prescriptions. Ms.
Phan stated that the pharmacy should print two labels for all partial fills. Ms. Phan stated one
label should go on the bottle being dispensed and the other label is for the balance and would be
placed on the bottle when the remaining quantity is dispensed. Ms. Phan stated that a memo was
sent to all her pharmacies reviewing the policy for balances owed.
Dr. Berry asked Mr. Quong how he counseled the patient. Mr. Quong stated that he had
counseled the patient from the labels that he was holding in his hand.
On motion by Dr. Smidt and Dr. McCoy, the Board agreed to dismiss the complaint and take
no further action against Mr. Quong. There was one vote of opposition by Dr. Berry.
Complaint # 3132
Pharmacist Neeta Gulati appeared to answer questions concerning a consumer complaint.
Compliance Officer Sandra Sutcliffe gave a brief overview of the complaint.
Ms. Sutcliffe stated that the complainant received 73 units of insulin in a TPN bag instead of 7.3
units. The patient stated that her blood sugar went to 34 and she was incoherent. The patient's
husband was instructed to give the patient orange juice and candy to counter the effects of the
insulin. The pharmacy label indicated the correct amount of units to add to the TPN bag, but the
amount to add in mls was not correct. The label read add 7.25 units (0.73) and should have read
(0.073mls). The amount to be added was questioned by the home infusion nurse, but no call was
placed to the pharmacy to verify the dosage.
President Dutcher opened the discussion by asking Ms. Gulati to address the complaint. Ms.
Gulati stated that the error was due to a typing error. She stated that in the home infusion setting
they put both mls and units on the label. Ms. Gulati stated that the units were correct on the
label, but the mls were incorrect. Ms. Gulati stated that she typed 0.73 ml instead of 0.073 ml.
Ms. Gulati stated that the nurse did not see the units she just saw the mls. Ms. Gulati stated that
it has always been the policy that the nurse must check the medication dispensed prior to
administering with the medication ordered by the physician. Ms. Gulati stated that the nurse did
not call the pharmacy but did question the patient if she was diabetic. Ms. Gulati stated that the
patient told the nurse that she was not and the nurse commented on the high dose. Ms. Gulati
stated that she was called the next morning.
Dr. Smidt asked Ms. Gulati's who idea it was to give the patient candy and keep the patient at
home. Ms. Gulati stated that the patient's husband called the nurse and the nurse instructed him
to give her candy and orange juice. Ms. Gulati stated by the time she received the call her blood
sugar was up to 54.
Dr. Berry asked Ms. Gulati if she calls the patient or their family prior to sending the medication
to the patient. Ms. Gulati stated that they talk to the patient after 24 hours because the nurse is
teaching on their behalf. Ms. Gulati stated that they call the patient in 24 to 72 hours for a
follow-up. Ms. Gulati stated that most of the time the patient is in the hospital and the nurse is
instructed on the use of the medication. Dr. Berry stated that Ms. Gulati may want to call the
patient or family member and discuss the medications that they will be receiving and follow up
the next day after receiving the medication.
Dr. Smidt asked if the nurse worked for the home infusion company. Ms. Gulati stated that the
nurse works for a home health agency. Ms. Gulati stated that the company contracts with this
home health agency for nursing services.
Mr. Dutcher asked Ms. Gulati what changes she has made in her practice. Ms. Gulati stated that
she would not be using mls on prescriptions for insulin.
Dr. Berry asked Ms. Gulati what syringes were sent with the TPN. Ms. Gulati stated that
she sent Insulin syringes. Dr. Berry asked if a copy can be sent to the Nursing Board. Mr. Wand
stated that a copy of the complaint would be forwarded to the Nursing Board.
Dr. McCoy asked if the calculation for insulin is done manually. Ms. Gulati stated that the sig
needs to be typed because each patient is different. Dr. McCoy asked if the computer could do
the calculations. Ms. Gulati stated she does not believe the computer has that capability.
Dr. Berry asked Ms. Gulati if her company has changed any policies. Ms. Gulati stated that since
she is the only pharmacist she has a pharmacy technician check her work. Ms. Gulati stated that
she has stressed to each nursing agency that the nurse must check the order.
Dr. McCoy asked if the insulin could be drawn up in syringes for the patient. Ms. Gulati stated
that they send out a seven day supply and sometimes the insulin changes, so the syringes are not >pre-drawn.
On motion by Dr. Berry and Dr. Smidt, the Board unanimously agreed to issue an advisory
letter to Ms. Gulati and keep a copy of the advisory letter on file.
AGENDA ITEM 13 -Consent Agreements
President Dutcher asked Board Members if there were any questions or discussions concerning
the consent agreements. Executive Director Hal Wand indicated that the consent agreements
have been reviewed and approved by the Attorney General's Office and have been signed.
On motion by Dr. McCoy and Mr. McAllsiter, the Board voted unanimously to accept the
consent agreement 05-0027-PHR for Robin Perkins as presented in the meeting book and signed
by the respondent. A roll call vote was taken. ( Dr. Berry -aye, Mr. McAllister - aye, Dr. Tippett-aye, Ms. Honeyestewa -aye, Dr. Smidt - aye, Dr. McCoy - aye, Dr. Sypherd - aye, Mr. Van Hassel - aye, President Dutcher -aye)
Ms Honeyestewa recused herself concerning the consent order for James Green.
On motion by Dr. McCoy and Dr. Tippett, the Board voted unanimously to accept the consent
agreement 06-0028-PHR for James Green as presented in the meeting book and signed by the
respondent. A roll call vote was taken. ( Dr. Berry -aye, Mr. McAllister - aye, Dr. Tippett-aye,
Dr. Smidt - aye, Dr. McCoy - aye, Dr. Sypherd - aye, Mr. Van Hassel - aye, President Dutcher -aye)
On motion by Dr. Tippett and Dr. McCoy, the Board voted unanimously to accept the consent
agreement 06-0029-PHR for Dione Valazquez as presented in the meeting book and signed by
the respondent. A roll call vote was taken. ( Dr. Berry -aye, Mr. McAllister - aye, Dr. Tippett-aye, Ms. Honeyestewa -aye, Dr. Smidt - aye, Dr. McCoy - aye, Dr. Sypherd - aye,
Mr. Van Hassel - aye, President Dutcher -aye)
On motion by Mr. McAllister and Dr. Smidt, the Board voted unanimously to accept the
consent agreement 06-0032-PHR for Jeffrey Hannibal as presented in the meeting book and
signed by the respondent. A roll call vote was taken. ( Dr. Berry -aye, Mr. McAllister - aye, Dr.
Tippett-aye, Ms. Honeyestewa -aye, Dr. Smidt - aye, Dr. McCoy - aye, Dr. Sypherd - aye,
Mr. Van Hassel - aye, President Dutcher -aye)
AGENDA ITEM 14 - Pharmacy Technician Trainee Reapplication
President Dutcher asked Mr. Van Hassel to address this issue. Mr. Van Hassel stated that the
committee has reviewed the Pharmacy Technician Trainee requests to reapply for licensure. Mr.
Van Hassel stated that the pharmacy technician trainees have received a letter stating that they
may only reapply for licensure as a pharmacy technician trainee one time. Mr. Van Hassel stated
that during the next two years the pharmacy technician trainee must take the PTCB test and
become certified it they would like to continue to work as a pharmacy technician.
On motion by Dr. McCoy and Dr. Berry, the Board unanimously approved the requests of the
Pharmacy Technician Trainees listed below to proceed with the licensure reapplication process.
The Pharmacy Technician Trainee may reapply for an additional two years as a pharmacy
technician trainee one time.
Pharmacy Technician Trainees Approved to reapply for licensure as a Pharmacy
Technician Trainee for an additional two years.
1. Selina Montano 44. Monica Jiminez 87. Troy Martinez
2. Judith McPherson 45. Nancy O'Mella 88. Amira Huseinovic
3. Marilynn Barton 46. Kristina Filed 89. Sheri Martinez
4. Huong Nguyen 47. Stephanie Armijo 90. Parthiner Miles
5. Selene Castro 48. John Kizer 91. Maritza Becerra
6. Phillip Vanta 49. Jeffrey Nelson 92. Josh Ponsock
7. Frank Atherton 50. Armida Benitez 93. Shermain McNeal
8. Sylvia Carpio 51. Marjan Tehranian 94. Lurinda Hatahil
9. Paula Martinez 52. Jessica Francis 95. Lisa Nez
10. Yvette Schultz 53. Anthony Saliba 96. Judy Meredith
11. Sophia Ortega 54. Wendy Mitchell 97. Julianna Vizi
12. Arkiteta Charley 55. Kinjal Shah 98. Rebecca Harvey
13. Arlene Pratt 56. Sergio Pena 99. Elizabeth Reynolds
14. Cortney Cook 57. Kung-Sheng Chen 100. Nick Banda
15. James Posadas 58. Antonio Peregrina 101. Valarie Cooper
16. Marla Kessler 59. April Villa 102. Alicia Thompson
17. Veronica Gonzalez 60. Sabrina Ballard 103. Regina Agacinski
18 Andrew Gee 61. Sandra Coger 104. Veronica Linares
19. Julia Scotto 62. Quan Thach 105. Tracey Browning
20. Lauralynn Barnes 63. Mayra Teran 106. Susanna Cubberly
21. Othella Sosa 64. Shannon Bell 107. Laura Hall
22. Barbara Dawson 65. Dolores Gomez 108. Jillian Quandt
23. Sandra Keighley 66. Miriam Martinez 109. Samantha Gutting
24. Rhonda Gibson 67. Beverly Millard 110. Lindsay Genrich
25. Marlys Hurlbert 68. Claudia Pena 111. Csilla Szaloczi
26. Evelyn Hanley-Bacon 69. Adrianne Figueora 112. Lorena Alvarez-Mendez
27. Abel Alvarez 70. Heather Powell 113. Stephanie Barsdale
28. Phillip Flore 71. Kimberly Navarro 114. Marlene Ramirez
29. Stacey Williamson 72. Cecillo Valenzuela 115. Annette Thrasher
30. Alex Chischilly 73. Mary Blanco 116. Carol Henderson
31. Dan Taylor 74. Diana Thompson 117. Hasnat Huq
32. Laura Christians 75. Christopher Kulish 118. Huy Nguen
33. Michelle Rolls 76. DeAndra Rodriguez 119. Jessica Layman
34. Pamela Roggensee 77. Marisela Ramirez 120. David Banuelos
35. Jessica Smith 78. Judith Kucharski 121. Ryan Erickson
36. Peggy John 79. Matthew Plumb 122. Monica Bethancourt
37. Max Thao 80. Shauntae Barr 123. Kelli Cladella
38. Margaret Griffiths 81. Luz Ramirez 124. Christina Godfrey
39. Christine Kensinger 82. Nadine Enriquez 125. Paula Rabuck
40. Tineke Cuthbertson 83. Randi Robbs 126. Ninoska Patel
41. Brad Madill 84. Eileen Stauffer 127. Gumesinda Bucher
42. Alissa Nickels 85. Misha Lewis 128. Roshannie Anderson
43. Paula Faltz 86. Jackie Weinstein 129. Veronica Teran
130. RoseMarie Bocskovits
AGENDA ITEM 15 - Review of Non- Resident Pharmacies - Internet Dispensing
President Dutcher asked Mr. Wand to address this topic. Mr. Wand stated that Dr. Smidt had
asked at the last Board Meeting to have this item placed on the agenda for discussion. Mr. Wand
stated that in the Book is a copy of the North Carolina newsletter showing that Arizona is not the
only Board dealing with internet prescribing and dispensing. Mr. Wand stated that by licensing
non-resident pharmacies the Board could take action against the permit if they desired. Mr.
Wand stated that since we cannot inspect non-resident pharmacies the Board must rely on other
Boards to ensure that the public is being protected.
Dr. Smidt stated that he is concerned that some of the non-resident pharmacies are dispensing
prescriptions that resulted from an internet questionnaire which is not allowed in Arizona. Dr.
Smidt suggested that it might be possible to have a student intern contact non-resident
pharmacies to see if they are dispensing prescriptions pursuant to an internet questionnaire.
Dr. McCoy asked if the Board could place a question on the application asking if the pharmacy
fills prescriptions pursuant to an internet questionnaire. Mr. Wand stated that the question could
be added to the new online application forms.
AGENDA ITEM 16- University of Arizona - David Burks - Transfer of Reserve Funds
David Burks, Senior Director of Development for the University of Arizona Pharmacy School,
was present on behalf of the University of Arizona.
Mr. Burks stated that he was present to thank the Board on behalf of the college for their support
in the expansion of the pharmacy school. Mr. Burks stated that if the additional funding is
obtained the funding would allow the pharmacy school to expand the number of clerkships in the Phoenix metropolitan area.
Mr. Burks stated that this year the pharmacy school will be increasing its class size to 88
students. Mr. Burks stated that additional funding would enable the school to increase its
clerkships and provide additional rotations to the students in the Phoenix area. Mr. Burks stated
that in the future the school would develop a full program in the Phoenix area and in the interim
their goal is to increase the number of clerkships in the Phoenix area.
Mr. Dutcher thanked Mr. Burks for attending the meeting.
AGENDA ITEM 17 - Call to the Public
President Dutcher announced that interested parties have the opportunity at this time to address
issues of concern to the Board; however the Board may not discuss or resolve any issues because the issues were not posted on the meeting agenda.
A pharmacist came forth and thanked the Board for ensuring that people of Arizona are kept safe
and receive proper care.
Dr. Sypherd stated that Dr. Bootman, Dean of the University of Arizona School of Pharmacy,
participated in the Institute of Medicine study involving medication errors. Dr. Sypherd noted
that the study showed that 1.5 million Americans are injured each year as a result of medication
errors.
There being no further business to come before the Board, on motion by Dr. McCoy and Dr.
Sypherd , the Board unanimously agreed to adjourn the meeting at 4:55 P.M.
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