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Board Meeting Minutes
August 11 & 12, 2004 Board Meeting minutes
THE ARIZONA STATE BOARD OF PHARMACY
HELD A REGULAR MEETING AUGUST 11 & 12, 2004
PRESCOTT, ARIZONA
The following Board Members and staff were present: President Dennis
McAllister, Vice President Linda McCoy, Paul Draugalis, Chuck
Dutcher, and Bryan Tippett. Compliance Officers Rich Cieslinski, Larry
Dick, Ed Hunter, and Dean Wright, Deputy Director Cheryl Frush,
Executive Director Hal Wand, and Assistant Attorney General Roberto
Pulver.
President McAllister convened the meeting at 9:00 A.M. and welcomed
the audience to the meeting. Ms. Frush explained that law continuing
education would be offered for attendance at the meeting. President
McAllister introduced Dr. Anne Lin, the new Dean of the Pharmacy
School at Midwestern University.
AGENDA ITEM I - Approval of Minutes
Following a review of the minutes and an opportunity for questions and
on motion by Mr. Dutcher and Ms. McCoy, the minutes of the Regular
Meeting held on June 24, 2004 were unanimously approved by the
Board Members.
AGENDA ITEM II - Permits/Licenses
President McAllister stated that all permits were in order for resident
pharmacies and representatives from several pharmacies were
present to answer questions from Board Members.
Greentree Pharmacy
Norbert Laskowski, the Pharmacist-In-Charge, was present to answer
questions from Board Members.
President McAllister opened the discussion by asking Mr. Laskowski to
describe the business. Mr. Laskowski stated that the pharmacy would
be a closed-door pharmacy servicing patients enrolled in NARVA in
Yavapai County. Mr. Laskowski explained that NARVA is the mental
health portion of AHCCCS.
President McAllister asked if the patients would receive the
medications by mail since they were a closed-door pharmacy. Mr.
Laskowski stated that they would only service NARVA patients and
would not be dispensing any other prescriptions than prescriptions
written for mental health issues. Mr. Laskowski stated that there are
forty-one (41) beds at the clinic for patients that have been remanded
to the clinic or have been self-committed.
Mr. Dutcher asked Mr. Laskowski if the pharmacy would only be
servicing the institutionalized patients. Mr. Laskowski stated that the
pharmacy will service both the institutionalized and the walk-in
patients covered by the NARVA plan. Mr. Laskowski stated that there
would be no cash paying customers.
Mr. Wand stated that the members must be NARVA members to utilize
the services of this pharmacy and it is not a closed-door pharmacy. It
was determined that the pharmacy is a single payer pharmacy and not
a closed-door pharmacy.
Mr. Wand informed the audience that when a new pharmacy practice
opens that is different from a traditional pharmacy and has not been in
existence in Arizona, the pharmacy is asked to appear at the Board
Meeting so that the Board Members have an opportunity to ask
questions about the practice.
McKesson Specialty Arizona, Inc.
Steve Hoffman from McKesson Specialty was present to answer
questions from Board Members.
Roger Morris was present as legal counsel for McKesson Specialty.
President McAllister opened the discussion by asking Mr. Hoffman to
describe the pharmacy business and the waivers that are being
requested by the company.
Mr. Hoffman stated that the pharmacy would be a limited service
pharmacy. The pharmacy would be a non-dispensing pharmacy. Mr.
Hoffman stated that the pharmacy would operate in conjunction with a
patient assistant program for a large pharmaceutical manufacturer.
Mr. Hoffman stated under this program that they would receive
prescriptions, qualify the patients for the program, and help the patient
seek additional reimbursement options if they did not qualify for the
program. After the patient has been qualified, the prescription will be
transferred legally to another pharmacy to dispense the medication.
Mr. McAllister asked Mr. Hoffman to describe the personnel mix that
would be hired for the pharmacy. Mr. Hoffman stated that they would
be hiring Arizona licensed pharmacists and licensed pharmacy
technicians.
Mr. Wand stated that the reason that the pharmacy needs a permit is
that according to our statutes that a prescription cannot be left at a
place that is not licensed as a pharmacy. Mr. Wand stated that the
waivers being requested are equipment related.
Mr. Dutcher asked Mr. Hoffman how the prescriptions would be
transferred to other pharmacies.
Mr. Hoffman stated that the prescriptions would be scanned and
assigned a prescription number and then would be legally transferred
to another pharmacy. The receiving pharmacy would receive an
electronic image of the prescription. Mr. Hoffman stated that there
would be a file transfer of the images on a nightly basis.
Mr. Dutcher asked which pharmacies would be involved in the
receiving the transferred prescriptions. Mr. Hoffman stated that it
could be various pharmacies and that the first pharmacy involved
would be the Walgreens Mail Order Pharmacy located in Tempe, AZ.
Mr. Dutcher asked Mr. Hoffman how the patients are referred to the
program. Mr. Hoffman replied that it is a national program. Mr.
Hoffman stated that the physicians have enrollment forms that would
allow their patients to qualify for the program. Mr. Hoffman stated that
the first program would be for GlaxoSmithKline. Mr. Hoffman stated
that they would also search for alternate insurance plans to cover the
patient. If they are not able to find alternative payers, then the patient
assistance program is the payer of last resort.
Mr. Morris stated that the pharmacy would also be able to participate
in other non-dispensing functions. Mr. Morris stated that they envision
that in theory that they may be involved in some compliance issues
such as making phone calls to patients to see if they have received
their medications and if they have any questions concerning their
medication. Mr. Morris stated in order to contact the patient, a
pharmacist would need to call the patient to ask the questions and
that is why they are requesting a pharmacy permit.
Mr. Wand stated that another issue discussed was the substantive
policy concerning transferred prescriptions. Mr. Wand stated that the
policy states that a number must be assigned to the prescription prior
to transferring the prescription and the pharmacy wishes to comply
with this policy.
Ms. McCoy asked how the patient would be contacted. Mr. Hoffman
stated that they would be contacting the patient by telephone. Ms.
McCoy asked if Mr. Hoffman anticipated any walk-in patients. Mr.
Hoffman replied that they would not have any walk-in patients.
Ms. McCoy asked how many pharmacists they were planning on
employing. Mr. Hoffman stated that they anticipate starting with a
Pharmacist-In-Charge and two (2) additional pharmacists. They
anticipate hiring this number of pharmacists to cover the hours that
they will be open and to cover lunch hours.
Mr. Wand stated that a motion would be necessary to waive the
pharmacy requirements in R4-23-611 and R4-23-612. Mr. Morris
indicated that they will maintain copies of the Arizona pharmacy rules
and regulations, the Controlled Substance Act, a professional
reference library, a red C stamp, current antidote and drug interaction
information, and the regional number for the poison control center. Mr.
Wand stated that the proposal does meet the requirements for a
waiver. Mr. Wand stated in order to grant a waiver, the process must
be experimental or involve a technological change.
On motion by Ms. McCoy and Dr. Tippett, the Board unanimously
approved the request to waive the requirements of R4-23-611 and R4-23-612 that are listed
in the letter dated July 30, 2004 from Mr. Roger
Morris, legal counsel, for McKesson Specialty Arizona, Inc.
At the conclusion of questions from the Board Members and on motion
by Mr. Dutcher and
Dr. Tippett, the Board unanimously approved the resident permits
listed below. All approvals are subject to final inspection by a Board
Compliance Officer where appropriate.
RESIDENT PHARMACY PERMITS (in Arizona)
- Wal-Mart Pharmacy 10-5349
8335 Guadalupe Rd.
Mesa, AZ 85215
Wal-Mart Stores, Inc.
- Wal-Mart Pharmacy 10-5189
5250 W. Indian School Rd.
Phoenix, AZ 85031
Wal-Mart Stores, Inc.
- St. Luke's Behavioral Health Center
1800 E. Van Buren
Phoenix, AZ 85006
Iasis Healthcare
- Greentree Pharmacy
642 Dameron Dr.
Prescott, AZ 86301
West Yavapai Guidance Clinic, Inc.
- Target Pharmacy T-1905
2140 E. Baseline
Phoenix, AZ 85040
Target Corporation
- Northwest Medical Center Oro Valley
1551 E. Tangerine Drive
Oro Valley, AZ 85737
Oro Valley Hospital, LLC.
- Sam's Pharmacy 10-6205
1462 S. Pacific Avenue
Yuma, AZ 85365
Wal-Mart Stores, Inc.
- Wal-Mart Pharmacy 10-5342
2501 S. Avenue "B"
Yuma, AZ 85364
Wal-Mart Stores, Inc.
- Wal-Mart Pharmacy 10-5331
7575 W. Lower Buckeye Rd.
Phoenix, AZ 85043
Wal-Mart Stores, Inc.
- Arizona Senior Care Pharmacy (Tucson)
6150 E. Grant Road
Tucson, AZ 85712
Arizona Senior Care, Inc.
- McKesson Specialty Arizona, Inc.
4343 N. Scottsdale Rd, Ste. #150
Scottsdale, AZ 85251
McKesson Specialty Arizona, Inc.
- Walgreens Pharmacy #01076
333 Hunt Highway
Queen Creek, AZ 85242
Walgreen Arizona Drug Co.
- CVS Pharmacy #01716
1-10 Tuthill & Verrado Way,
Buckeye, AZ 85236
Buckeye AZ CVS, LLC.
- CVS Pharmacy #03967
3990 W. Ray Rd.
Chandler, AZ 85226
Ray McClintock CVS, LLC.
- CVS Pharmacy #05039
30 E. Williams Field Rd.
Gilbert, AZ 85296
Chandler Gilbert CVS, LLC.
- CVS Pharmacy #05791
Camelback & Litchfield Rd.
Litchfield Park, AZ 85340
Litchfield Park CVS, LLC
- CVS Pharmacy #05891
3170 S. Higley Rd.
Gilbert, AZ 85297
Pecos Gilbert CVS, LLC.
- CVS Pharmacy #06719
44274 W. Smith Erke Rd.
Pinal County, AZ 85239
Pinal County AZ CVS, LLC.
- CVS Pharmacy #07836
McKellips & Stapley
Mesa, AZ 85240
(O) CVS McKellips Mesa AZ, LLC.
- CVS Pharmacy # 07837
McDowell & Power Rd.
Mesa, AZ 85240
(O) CVS EGL McDowell Mesa AZ, LLC
- CVS Pharmacy #07852
Tatum & Dynamite
Phoenix, AZ 85028
CVS EGL Tatum Phoenix AZ, LLC.
- CVS Pharmacy #07859
Skyline & Campbell Ave.
Tucson, AZ 85739
CVS EGL Skyline Tucson AZ, LLC.
- CVS Pharmacy #07860
16thSt. & Baseline Rd.
Phoenix, AZ 85042
CVS EGL 16th Baseline AZ, LLC.
- CVS Pharmacy #07867
Grant Rd, & Rosemont
Tucson, AZ 85711
CVS EGL Rosemont Goodyear AZ, LLC.
On motion by Mr. Draugalis and Ms. McCoy, the Board unanimously
approved the Non-Resident permits listed below.
NON-RESIDENT PHARMACY PERMITS(out of state)
- Star Medical Rx
700 NW Argosy Parkway
Riverside, MO 64150
(O) Apria Health Care, Inc.
- Specialty Infusion Pharmacy Inc.
604 E. Huntington Drive
Monrovia, CA 91016
(O) Priority Healthcare Pharmcy, Inc.
- Save Now Discount Pharmacy
3333 184th St. SW
Lynnwood, WA 98037
Save Now Discount Pharmacy, Inc.
- Option Care of Nevada
3900 W. Charleston Blvd. Ste. G
Las Vegas, NV 89102
Convention Center Drug, Inc.
- Carepharm Pharmacy
12 Chapel Lane
New Boston, TX 75570
Carepharm LTC
- Power Medica Inc.
600 W. Hillsboro Blvd. Suite 104
Deerfield Beach, FL 33441
Power Medica
- KABS Pharmacy
2812 E. Bears Ave.
Tampa, FL 33613
KABS of Tampa, Inc.
- Home Care Supply Pharmacy
2155 IH-10 East, Suite B
Beaumont, TX 77701
NuPharm, Inc.
- Kay Pharmacy #001
3500 E. Fletcher Ave. Suite 120
Tampa, FL 33613
Hepzibah, Inc.
- Specialty Scripts Pharmacy
315 Pleasant St., Bldg-1, 6th Floor
Fall River, MA 02721
Specialty Scripts, Inc.
- Express Pharmacy Services
620 Epsilon Drive
Pittsburgh, PA 15238
(O) Express Pharmacy Services of PA, Inc.
- Express Pharmacy Services
8275 Bryan Dairy Rd.
Largo, FL 33777
(O) Express Pharmacy Services of FL, Inc.
- Pacific Coast Pharmacy
1400 Grand Ave Ste. F
Grover Beach, CA 93433
Integrated Health Concepts, Inc.
- Sun Dance Pharmacy
538 North 1300 East
St. George, UT 84770
Sun Dance Pharmacy, LLC
- Quality Infusion Care
9555 W. Sam Houston Pwky #225
Houston, TX 77099
Quality Infusion Car, Inc.
- Immediate Pharmaceutical Services, Inc.
33381 Walker Rd.
Avon Lake, OH 44012
Immediate Pharmaceutical Services,Inc.
- Scrip Pharmacy, Inc.
2787 Charter St.
Columbus, OH 43228
Scrip Pharmacy, Inc.
- Specialty Pharmacy Services by Eckerd 8000
8275 Bryan Dairy Rd., Largo, FL 33777
(O) Largo Procare Pharmacy, Inc.
- Mt. States Regional Hemophilia Treatment Ctr.
13001 E. 17th Pl. Bldg. #500, Room EG 303
Aurora, CO 80010
Univ. of Colorado - Regents
Wholesale Permits
President McAllister indicated that there were five applicants for
resident wholesale permits.
Quik 'N Tasty Foods, Inc. Mr. Draugalis asked if the owner
would be selling to the QT gas stations and wanted to know if the QT stations
were franchised operations. The Board Office was contacted and the information
provided indicated that the QT stations were not franchised.
Physician Laboratories, Inc. Monroe Fazali was present to
answer questions from Board Members.
President McAllister asked Mr. Fazali if he had been a non-prescription
wholesaler previously. Mr. Fazali stated that he had not been a
wholesaler previously. Mr. Fazali stated that he has worked with an
internet company that did not concentrate on wholesale business. Mr.
Fazali stated that in the future that they may want to sell to
government agencies and schools.
Mr. McAllister asked Mr. Fazali if he had read the orientation and
understands the rules. Mr. Fazali replied that he had read the
orientation and understands the rules.
Mr. Wand asked Mr. Fazali if they were licensed as a non-prescription
retailer. Mr. Fazali replied that they were licensed as a non-prescription retailer.
Mr. Wand reminded Mr. Fazali that he must keep
a copy of the permit or license on file for each person to whom he sells
product.
Mr. Wand asked Mr. Fazali if he planned on selling pseudoephedrine
products. Mr. Fazali replied that he did not and was aware of the rules
for a single transaction purchase.
Pharmelle LLC Joe Ducharme was present to answer questions from Board Members.
President McAllister asked Mr. Ducharme if he had read the
orientation. Mr. Ducharme stated that he had read the orientation
information. Mr. McAllister reminded Mr. Ducharme that he must
maintain the appropriate records for all transactions. Mr. McAllister
asked Mr. Ducharme if he was aware of the precursor chemical
regulations. Mr. Ducharme stated that he is aware of the precursor
chemical regulations.
On motion by Dr. Tippett and Mr. Dutcher, the Board unanimously
approved the resident wholesaler permits listed below. All approvals
are subject to final inspection by a Board Compliance Officer where
appropriate.
- Physician Laboratories, Inc.
301 W. Deer Valley Rd.
Phoenix, AZ 85027
Monroe Fazeli
- Pharmelle L.L.C.
170 S. William Dillard Dr., Building 3, Suite 109
Gilbert, AZ 85233
Joe Ducharme
- Three Sisters Wholesale II
Hwy 163
Kayenta, AZ 86033
Cynthia Benedict
- Sam's Club 10-6205
1462 S. Pacific Ave.
Yuma, AZ 85365
Wal-Mart, Inc.
On motion by Mr. Draugalis and Ms. McCoy, the Board unanimously
approved the wholesaler listed below. The approval is subject to final
inspection by a Board Compliance Officer where appropriate.
- Quik 'N Tasty Foods, Inc.
8501 W. Latham St.
Tolleson, AZ 85353
Quik 'N Tasty Foods, Inc.
Manufacturer Permits
President McAllister noted that there was one manufacturer permit to
be approved. At the meeting in June, Mr. Eshima appeared on behalf
of Biotech Cyclotron. At that time, Mr. Eshima had not received the
FDA registration number for Biotech Cyclotron and the Board tabled
his request. Mr. McAllister informed the Board that Biotech Cyclotron
had now received their FDA registration and the Board may now
approve the application.
On motion by Mr. Draugalis and Dr. Tippettt, the Board unanimously
approved the manufacturer permit listed below. All approvals are
subject to final inspection by a Board Compliance Officer where
appropriate.
- Biotech Cyclotron of Arizona
4540 E. Cotton Gin Loop
Phoenix, AZ 85040
Biotech Cyclotron of Arizona, LLC.
Pharmacist, Pharmacy Intern, and Pharmacy Technician Licenses
Following a review of the roster of applicants for licensure as
pharmacists, pharmacy interns, and pharmacy technicians and on
assurance by the staff that all applications are in order and all fees
paid: on motion by Mr. Dutcher and Ms. McCoy, the Board
unanimously approved the following licenses:
Pharmacist licenses 14156 through 14271 (with 14226 being voided),
Pharmacy Intern licenses
6413 through 6461, and Pharmacy Technician licenses 1365 through
3409. For a complete list of names see attachments.
Mr. Dutcher asked if the Pharmacy Technician Trainee license
number would change upon certification. Mr. Wand stated that the
number would remain the same and the status would be changed in
the system.
AGENDA ITEM III - Reports
Executive Director Report
Executive Director Wand began his report by discussing personnel
issues. Mr. Wand stated that the person responsible for the database
administration in the Board Office has been reclassified from an
Administrative Assistant II to an Info Technology Specialist. This
personnel change resulted in a pay increase for the individual. Mr.
Wand stated in the future he hopes to be able to reclassify the officer
manager from an Administrative Assistant III to a more appropriate
classification.
Mr. Wand stated that we are currently recruiting for the Compliance
Officer and Non-Prescription Drug Inspector position due to the
resignation of personnel in these positions.
Mr. Wand stated that there are still issues with technician licensure
relating to felony convictions and the inability to provide a copy of
their high school diplomas. Mr. Wand stated that beginning on
September 1, 2004, the Compliance Officers would begin enforcing
the licensing rules. On inspection, if a technician is working who is
not licensed and has not applied for licensure, a violation letter
would be issued, and a response would be expected within 15 days.
If an unsatisfactory or no response is received, the matter would be
referred to the Complaint Review Committee. Mr. Wand stated that if
the technician provides documentation to the Board Office that they
are completing requirements necessary for their licensure, such as
PTCB certification, the technician would be given a waiver until the
requirements are completed.
Mr. Wand stated that he would like to thank Mr. Wright for the speed
with which he completed the statutory changes that the Board hopes
to present to the legislature next year. Mr. Wand stated that he and
Dean had meet with John Mangum to review the proposed statutory
changes. The statutory changes are necessary in order for us to
comply with the federal lists of Controlled Substances. Mr. Wand
stated that the statutes would be revised concerning the disciplinary
actions that the Board may take against licensees and permit
holders. Mr. Wand stated that Mr. Mangum hopes to drop our bill by
the end of August.
Mr. Wand stated that he provided the Board with a copy of the annual
report. Mr. Wand stated that he concentrated on positive outcomes.
Mr. Wand stated that he felt the report should indicate what the
Board accomplished in the past year. In the annual report, Mr. Wand
discussed the licensure of the pharmacy technicians and the
relationship to the protection of the public. Mr. Wand stated that he
discussed the fact that the Board has obtained the services of a half-time (50%)
Assistant Attorney General. The assignment of the
Assistant Attorney General to the Board has enabled the Board to
resolve issues in a timelier manner. The Board has also been able to
assist in the revocation of a non-prescription drug retailer permit
which shut off a significant source of precursor chemicals used in the
illegal manufacture of methamphetamine.
Mr. Wand discussed the Boards approval of the first group of
Pharmacy Drug Therapy Management Agreements, which allow
certain specially trained pharmacists to enter into collaborative
agreements with physicians to implement and modify drug treatment
protocols.
Mr. Wand discussed the Fund Balance and stated that it is basically
paper money that must be appropriated by the legislature. Mr. Wand
stated that he is attempting to have money appropriated to buy tablet
PCs for the Compliance staff. This will allow the handwritten
documents to be changed to a Word document and printed. Mr. Wand
stated that he would also try to obtain funding to redo the web page
to conform with the state government web pages. Mr. Dutcher asked
if the page could be done in house. Mr. Wand stated that it would be
difficult for the staff to redo the page. Mr. Wand asked if the Board
Members would be interested in receiving a CD instead of a paper
Board Book. Mr. Wand stated that if he could obtain funding that
each Board Member would be provided a laptop with the necessary
software. Board Members indicated that they would be interested in
this option. Mr. Wand stated that he would also ask for an increase
for the PAPA budget.
Ms. McCoy asked if we would be limited in holding Board Meetings
outside the Phoenix area. Mr. Wand stated that money is budgeted
for in-state and out-of-state travel. Ms. McCoy stated that she was
concerned that the Board would not be able to hold a meeting out-of-town.
Mr. Wand stated that the Board usually holds two meetings
out-of-town. Traditionally, the Board has one meeting in Tucson and
one out-of-town where a Board Member resides. Mr. Wand stated that
one concern with having a meeting out-of-town is that the Solicitor
General will not travel to out-of-town hearings. Mr. Wand stated that
even though we may have the money in the budget that state policy
would only allow two individuals to attend out-of-state meetings
unless the governor's office approves additional individuals to attend
the meeting. Mr. Wand stated that the schedule for next year's Board
Meetings would be discussed at the November meeting.
Deputy Director Report
Ms. Frush directed the Board Members attention to the activity
reports for the Compliance Officers and the Drug Inspector. Ms.
Frush stated the Compliance Staff is still ahead of the number of
inspections completed at this time last year. Ms. Frush stated that
the hiring process is continuing in an effort to hire a Compliance
Officer and Drug Inspector.
Ms. Frush presented the report showing issues that were discovered
by the Compliance Staff during the month of June.
Ms. Frush stated during the month of June the compliance staff
issued letters for the following violations:
- Non-Functional Class A Prescription Balances (2)
- Failure to inventory Soma products on Controlled Substances 2004 Inventory
- Annual Controlled Substance Inventory was unavailable
- Controlled Substance Audit - Overage
- Controlled Substance Audit - Shortage
- Failure to document and record patient's medical conditions (4)
- Failure to document and record patient's allergies
- Outdated prescription and over-the-counter products in the pharmacy area (2)
- Failure to properly prepackage medications for future dispensing
- Failure to maintain a hard-copy printout or log book of each day's original or refill data
indicating that the pharmacist has reviewed the data.
Ms. Frush indicated that were was one area noted on inspection
reports that needed improvement. It was noted that a Controlled
Substance Inventory must be taken annually in Arizona.
Ms. Frush stated that the Compliance Officers have noted occasions
where the pharmacists and technicians are meeting or exceeding
standards:
- Pharmacy technicians are posting their new wall certificates and licenses are readily retrievable.
- The number of outdates in the OTC departments have decreased.
- Most pharmacies have complied with the regulation to maintain a hard-copy printout or log book of each day's
original and refill data indicating that the pharmacist has reviewed the data for accuracy.
PAPA Report
PAPA was represented by Lisa Yates. Ms. Yates stated that there are
a total of thirty-six (36) participants in the PAPA program. Ms. Yates
stated since May 12, 2004, there have been four (4) new participants
come into the program and one (1) termination of a PAPA contract.
APA Report
APA was represented by Kathy Boyle. Ms. Boyle stated that the 2004
Convention was a success.
and the 2005 Convention will be held from June 23-26, 2005 at the
Westin La Paloma in Tucson, Arizona.
Ms. Boyle stated that she has been facilitating meetings with Sure-Script and the Medical Association concerning electronic prescribing
practices.
Ms. Boyle stated that the association is waiting for GRCC to approve
the immunization regulations and she would like to request time on
the November agenda to present the APA certificate program for
approval by the Board as the immunization training program for
pharmacists.
Ms. Boyle stated that a meeting would be held to define the bylaws,
the financial structure, and the mission statement of the new
organization and the association would not be introducing any bills in
the upcoming legislative session.
Ms. Boyle stated that the association would be offering a 3-hour CE
law program on October 9, 2004 at Midwestern University. Ms. Boyle stated that
Roger Morris would be the speaker.
Ms. Boyle stated that the association has been contacted by the
Attorney General's Office for assistance in conducting the pricing
survey.
President McAllister called a brief recess and the meeting
reconvened.
AGENDA ITEMS IV - Special Requests
#1 Bradley Koonse
Bradley Koonse appeared with Lisa Yates from the PAPA program.
President McAllister asked Mr. Koonse to describe the nature of his
request. Mr. Koonse stated that he surrendered his license due to
drug dependency issues and would like to have his license
reinstated.
Mr. McAllister asked Mr. Koonse what has changed in his life since
the surrender of his license.
Mr. Koonse stated that through the PAPA program and support groups
that he has become better educated about drug dependency. Mr.
Koonse stated at first he felt the situation was hopeless and he feels
that he is now able to change his situation.
Mr. McAllister stated that the order was written on February 20, 2004.
Mr. McAllister asked Mr. Koonse when he signed a contract with
PAPA. Ms. Yates replied that Mr. Koonse's first contract was signed
on January 2, 2004 and he began inpatient treatment on January 21,
2004. He signed a new contract on February 18, 2004 after
completing the inpatient program. He ended his PAPA contract on
March 22, 2004 and surrendered his license. Ms. Yates stated that
Mr. Koonse signed a new contract on May 26, 2004. Ms. Yates
reported that he did attend meetings even though he did not a have
contract.
Mr. McAllister asked Ms. Yates about PAPA's recommendation. Ms.
Yates replied that he voluntarily surrendered his license and PAPA
supports his request to have his license reinstated.
Mr. McAllister asked Mr. Koonse if he was prepared for a more
stringent contract that would require more drug screenings and
meeting attendance once he returned to practice. Mr. Koonse replied
yes.
Mr. Wand stated that the normal suspension period for anyone who
signs a PAPA agreement is usually a minimum of six (6) months. Mr.
Wand stated that if the contract was signed on May 26, 2004 then the
suspension would end on November 26, 2004. Ms. Yates stated that
Mr. Koonse has not been practicing for six months. Ms. Yates stated
that she realizes that there was a lapse between the two contracts
signed by Mr. Koonse and the Board could decide when the
suspension period would end.
Mr. Wand asked Mr. Koonse if he was requesting that his license be
returned to him in a suspended status, on probated status, or if he
was willing to allow the Board to make that decision. Mr. Koonse
replied that the Board could decide the status and he would accept
the decision.
Mr. Wand stated that the statute the Board needs to consider is
A.R.S. § 32-1928 (D), which states the following:
With or without conditions the board may reinstate the license
of any pharmacist or pharmacy intern that it has placed on
probation or whose license it has suspended or revoked.
Mr. Pulver stated that the license was revoked. Mr. Pulver stated
that if the Board gives Mr. Koonse his license back that it sends out a
signal from a legal perspective that revocation is not considered a
serious issue. Mr. Pulver stated that he is also concerned about the
manner in which Mr. Koonse returned his license. Mr. Koonse
shredded and incinerated his license. Mr. Pulver stated that there
might be other issues involved because most licensees would not
return their license in that fashion.
Mr. McAllister asked Mr. Koonse to address Mr. Pulver's concern. Mr.
Koonse stated that he realized what he had done went against his
moral character and he was very depressed.
Mr. Wand stated that Mr. Koonse was offered a consent agreement
with the normal suspension and probation. Mr. Wand stated that Mr.
Koonse decided that he wanted his license revoked and did not want
the consent order offering the suspension and probation.
Ms. Yates stated that they when Mr. Koonse entered the PAPA
program that they noted anger and frustration issues. Ms. Yates
stated that these are issues that they have addressed with Mr.
Koonse and are ongoing issues that the program is addressing with
Mr. Koonse. Ms. Yates stated that Mr. Koonse is aware of these
issues.
Mr. McAllister stated that he realizes that when participants join the
PAPA program that they are at a low point in their life. Mr. McAllister stated that it is positive
that PAPA is supporting Mr. Koonse's request. Mr. McAllister asked Mr. Koonse if he felt that he
was on a road to steady recovery. Mr. Koonse replied that he is
making every effort on a daily basis to change. Mr. Koonse stated
that he is trying to change character issues that he has had in the
past.
Mr. Dutcher asked Mr. Wand about the terms of the consent order
that was offered to Mr. Koonse. Mr. Wand stated that it would be the
standard consent which is usually a six month suspension followed
by five years probation.
Ms. McCoy asked when the current contract was signed. Ms. Yates
replied that the contract was signed on May 26, 2004. Ms. McCoy asked when the previous
contract was signed. Ms. Yates replied that the previous contract
was signed on February 18, 2004 and was terminated in March.
Ms. Yates stated that he signed his first contract at the beginning of
January and that contract was terminated due to a relapse. Ms.
McCoy asked if he was in the program from March to May. Ms. Yates
replied that he was not in the program.
Ms. McCoy asked Mr. Koonse if he was being drug screened during
this period. Mr. Koonse stated he was not drug tested. Ms. McCoy
asked Mr. Koonse if he had any relapses during that period. Mr.
Koonse replied "NO".
Ms. McCoy stated that she has some concerns because an
established track record is missing. Ms. McCoy stated that she has
concerns about his commitment to the program. Mr. Wand stated
that the Board could reinstate his license in a suspended status. Ms.
McCoy asked Mr. Koonse if he had an employment opportunity. Mr.
Koonse replied that he did not have an employment offer at this time.
Mr. Draugalis stated that he respects the PAPA steering committee's
opinion and was wondering if Ms. Yates could state why the steering
committee is supporting the reinstatement of Mr. Koonse's license.
Ms. Yates stated that PAPA supports his request to return to work.
Ms. Yates stated that the steering committee will be meeting in October with
all the participants. Ms. Yates stated that everything Mr. Koonse has
done since his contract was terminated in May has been positive.
Ms. McCoy asked if the Board could suspend his license until October
when the steering committee meets and ask Mr. Koonse to appear at
the November Board meeting. Mr. Wand stated that A.R.S. § 32-1928
(D) states that the Board could reinstate his license with or without
restrictions.Mr. Pulver stated that the concern is that Mr. Koonse
does not have a track record of screenings and receiving counseling.
Mr. Pulver stated that if the Board reinstates the license in a
suspended state then the steering committee could provide the
Board with a track record indicating that Mr. Koonse has made a
commitment to the program.
Mr. McAllister stated that the issue that the Board is facing is that
during the period when Mr. Koonse surrendered his license and asked
for revocation it appears that there was turmoil in his life. Mr.
McAllister stated that other individuals in the same situation had
signed contracts and had their licenses suspended. Mr. McAllister
stated that the Board could start by suspending Mr. Koonse's license
and then the Board could determine when the suspension is removed.
Ms. McCoy asked if a license is suspended when could the licensee
appear at a Board meeting to have his license reinstated. Mr. Wand stated that the consent order
would state the terms of the suspension. Mr. Wand stated usually the
suspension is for six (6) months. Mr. Wand stated that some
contracts are for one year.
Mr. Dutcher asked if the licensee needed to be in the PAPA program
during that six month period. Mr. Wand stated that during the six
months the licensee must be in the PAPA program.
Mr. Dutcher stated that he felt that the Board should stay with the six
month suspension. Mr. Dutcher states that he feels the shredding of
the license indicated that there were conflicts in Mr. Koonse's life.
Mr. Dutcher stated that he feels that the Board should stay with the
standard suspension of six months.
Mr. McAllister stated that he agrees with Mr. Pulver that a pharmacist
should not feel that reinstatement from a revoked license is
something that the Board takes lightly. Mr. McAllister stated that the
Board did not revoke the license through a hearing but upon request
by the licensee. Mr. McAllister stated that the Board should treat Mr.
Koonse like all other new members in the PAPA program.
Mr. Wand stated that the PAPA steering committee meets in October
and the next Board meeting is in November. Mr. Wand stated that the
license could be suspended until the next Board meeting and the
Board could receive a report from the PAPA steering committee. Mr.
Wand stated at the November Board meeting the Board could then
decide if they wanted to impose probation.
Mr. Wand asked if a new consent order would be necessary or if the
present contract could be amended. Mr. Pulver stated that the
consent order could be amended and then a new order would be
required after the suspension.
On motion by Mr. Dutcher and Dr. Tippett, the Board unanimously
agreed to reinstate Mr. Koonse's license in the suspended state with
the opportunity for Mr. Koonse to appear at the November meeting at
which time the Board will decide what additional actions will be
taken. During this period, Mr. Koonse must be enrolled in the PAPA
program. A roll call vote was taken. The result of the roll call vote:
Mr. Dutcher - Yes Mr. Draugalis - Yes Dr. Tippett - Yes Ms. McCoy -
Yes Mr. McAllister - Yes
#2 John Cook
John Cook appeared with Lisa Yates from the PAPA program.
President McAllister asked Mr. Cook to describe the nature of his
request. Mr. Cook replied that
he has completed his five- year contract with the PAPA program and
is requesting that his probation be terminated. Mr. McAllister asked
Mr. Cook how he is today compared to 5 years ago. Mr. Cook replied
that he is much better. Mr. McAllister asked Mr. Cook if he was
working. Mr. Cook replied that he was working.
Mr. McAllister asked Ms. Yates about Mr. Cook's progress. Ms. Yates
replied that Mr. Cook is a different person today than when he
entered the program. Ms. Yates replied that Mr. Cook is more
outgoing. Mr. McAllister reminded Mr. Cook that recovery is a life
long process. Mr. Cook said he is aware that recovery is life long.
Ms. McCoy asked Mr. Cook where he was working. Mr. Cook replied
that he works for Osco in Tucson. Ms. McCoy commended Mr. Cook
for completing his PAPA program. Ms. McCoy reminded Mr. Cook that
PAPA offers a wonderful support system and to stay in contact with
the PAPA program. Ms. McCoy reminded Mr. Cook that he could serve
as a role model for people entering the program. Mr. Cook stated
that PAPA is a great program. Mr. Cook stated that the program saves
careers and lives. Mr. Cook stated that the program keeps a tight lid
on the participants and that the PAPA program is a good program
On motion by Ms. McCoy and Mr. Dutcher, the Board unanimously
approved the request by Mr. Cook to terminate his probation subject
to Amended Board Order Number 99-0008-PHR.
#3 John Bacovcin - Request withdrawn
#4 James Bataoel
James Bataoel appeared on his own behalf to request that the
probation of his pharmacist license be terminated.
President McAllister asked Mr. Bataoel to describe the nature of his
request. Mr. Bataoel stated that he completed his six- month
probationary period and would like to have the probation terminated.
Mr. McAllister asked Mr. Bataoel why he was placed on probation.
Mr. Bataoel stated that when he had just begun working for the
Apothecary Shop he mislabeled a medication and dispensed a
medication that was 25 times the dose and the patient used the
medication. Mr. Bataoel stated that he did fulfill the requirements of
the consent order. Mr. Bataoel stated that he attended a continuing
education program on compounding and at this time he is a much
better compounding pharmacist.
Mr. McAllister told Mr. Bataoel that he is glad that he received the
compounding training because a patient is at the most risk from a
compounded medication. Mr. McAllister asked Mr. Bataoel if
procedures have changed at the pharmacy. Mr. Bataoel stated that
they now have quality assurance programs in place and there have
been decreased medication errors.
On motion by Dr. Tippett and Ms. McCoy, the Board unanimously
approved the request by Mr. Bataoel to terminate his probation
subject to Board Order Number 03-0018-PHR.
#5 Walgreens Arizona Drug Company
Dan Luce appeared on behalf of Walgreens Arizona Drug Company to
present Walgreens VISION program. Mr. Luce explained that
Walgreens VISION program is a central processing function. The
central processing would allow for data entry or DUR (drug utilization
review) to be performed at another pharmacy. The prescription
would be filled at the home store and dispensed to the patient.
Mr. Luce explained the process would utilize imaging technology.
The process would be used to balance the workload between stores.
Mr. Luce explained the image of the prescription would be scanned
and then the image would be used through out the dispensing
process. Mr. Luce explained the image would be resident on the
central system, which is a real time online system and is viewable by
any pharmacy at any point. Mr. Luce explained that prescriptions
that were imaged by a busy store in Phoenix could be data entered
and/or a drug utilization review could be performed by a slower
volume pharmacy in Tucson that had access to the image. Mr. Luce
explained that this would help balance the workload.
President McAllister asked if there were any legal issues involving
the licenses of the pharmacies. Mr. McAllister asked if there were
any problems crossing between different licenses. Mr. Wand stated
that the only problem would be the identification of the verifying
pharmacist and the ability to track that pharmacist's identity
throughout the process. Mr. Luce stated that they would be able to
identify all technicians and pharmacists that were involved in the
processing of the prescription throughout the entire process. Mr.
Wand stated that if they can identify the different individuals involved
in the process it is very similar to the processes at a mail order
pharmacy. Mr. Luce stated that they are able to track the initials in
the computer and have an audit trail.
Mr. Dutcher asked if the dispensing pharmacist would be able to view
the image. Mr. Luce stated that the image is available for any
pharmacist to view. Mr. Luce stated that it would be a training issue
to trust that the other pharmacist verified the prescription correctly.
Mr. Draugalis asked if the image would always remain in the state of
Arizona. Mr. Luce stated that there are no plans for the image to go
out-of-state.
Mr. McAllister asked if the program is being conducted in any other
states. Mr. Luce replied that that they have pilot programs in
California and Florida. Mr. Luce explained that they are presenting
the programs to the Boards of Pharmacy to ensure that they are
operating within the regulations of that state.
Mr. McAllister stated that Walgreens is requesting permission from
the Board to move forward with their program. Mr. McAllister stated
that Arizona licensed pharmacists will take care of Arizona patients.
Mr. Luce states that the patient brings the prescription to their local
store and picks the prescription up at their local store.
Mr. Dutcher asked Mr. Luce how the remote pharmacy decides to
enter the prescription into the system. Mr. Luce explained that the
prescriptions will reside in a queue and another store can access the
prescriptions. Mr. Luce explained that they will work on internal
processes to determine what stores will access the prescriptions.
Mr. Wand asked if the queue would be available to all stores. Mr.
Luce stated that all stores could access the queue. Mr. Luce stated
that the high volume stores will probably never access the queue and
the low volume stores will be accessing the queue more often. Mr.
Luce stated that the pharmacists and technicians are looking
forward to having additional help during peak times.
Mr. McAllister stated that it is very similar to the process that is
occurring in the mail order pharmacy. Mr. Wand stated that there is
nothing in the rules or statutes that would prevent the process.
Ms. McCoy stated that she feels that Walgreens is thinking out of the
box and this process is similar to order processing in the hospitals
where a pharmacist will process orders from a queue.
Ms. McCoy asked if Mr. Luce had any data from Florida or California
concerning error rates. Mr. Luce stated that they do not have any
data because they are in the infancy of this program. Mr. Luce stated
that they have developed a new verification screen that ensures that
every pharmacist in the country that works for Walgreens will verify
the prescription in the same manner. Mr. Luce explained that the
states that they picked in which to conduct the program have
demonstrated that the Boards are progressive in their thinking
process. Mr. Luce stated that he would be happy to come back and
share the results and hopes to demonstrate that the program does
provide a higher level of patient safety. Ms. McCoy stated that this
would allow a pharmacist to look at the drug interactions and allow
the pharmacist at the store to concentrate on the counseling issues.
Mr. Luce stated that it would allow the pharmacist to talk to the
patients.
Mr. Wand asked about CII prescriptions. Mr. Luce stated that all
controlled substances would be outside of this mix at this time.
Dr. Tippett asked about the security of the computer system. Mr.
Luce stated that they have the online satellite system. Mr. Luce
stated that they have had zero breaches of their firewall system.
Mr. Dutcher asked what would occur if the technician did not gather
all the necessary information from the patient at the in window to
process the prescription. Mr. Luce stated that the image cannot be
entered into the queue without the patient's name, address, birth
date, and any other information being verified by the technician.
Ms. McCoy asked Mr. Luce if he could update the Board in six
months. Mr. Luce stated that the pilot will end in approximately six
to eight months and he would be glad to return to update the Board.
Dr. Tippett suggested that if the Board Members could be provided
with laptops these types of presentations could be given as demos.
Mr. McAllister thanked Mr. Luce for presenting the VISION program to
the Board.
#6 Patricia Love
Patricia Love appeared on her own behalf to request permission to
proceed with technician licensure. President McAllister asked Ms.
Love to describe the nature of her request. Ms. Love stated that she
would like to proceed with technician licensure but is unable to
provide a copy of her high school diploma. Mr. Wand explained that
Ms. Love went to school in England. Mr. Wand stated that Ms. Love
did attempt to obtain the records but was told the school did not
have the records. Ms. Love did contact individuals that attended
school with her and they did e-mail statements attesting that they did
go to school with Ms. Love. Ms. Love stated that the school system is
different in England.
Mr. Dutcher asked Ms. Love if she was given a certificate when she
graduated. Ms Love stated no. Ms. Love stated that she took final
exams. She stated that her mother received a letter and told her that
she passed her exams and she does not know what happened to that
letter.
Mr. McAllister stated that the Board needs to consider the
extenuating circumstances. Mr. McAllister feels that this is a self-limiting
issue and that the Board will need to consider each case.
On motion by Mr. Draugalis and Mr. Dutcher, the Board unanimously
approved Ms. Love's request to proceed with pharmacy technician
licensure.
#7 Yvonne Rodriguez
Yvonne Rodriguez appeared on her own behalf to request permission
to proceed with technician licensure. President McAllister stated
that Ms. Rodriguez had appeared in front of the Board at the June
meeting. Mr. McAllister asked Ms. Rodriguez to review the issue. Ms.
Rodriguez stated that she applied online to take the certification test
on September 11, 2001. Ms. Rodriguez stated prior to that date she
was arrested for aggravated assault. Ms. Rodriguez stated that she
was convicted and was sentenced to probation. Ms. Rodriguez
stated that this sentencing occurred one month prior to her
application to take the test. Ms. Rodriguez stated that she could not
get a copy of the application but she was told by PTCB that there is a
spot on the application that asks if you were convicted of a felony.
Ms. Rodriguez stated that if there was a spot on the application
asking about a felony that it was a mistake that she did not mark the
box. Ms. Rodriguez stated that it was not intentional. Ms. Rodriguez
stated that she renewed her certification on November 8, 2003. Ms.
Rodriguez stated that she signed the renewal. Ms. Rodriguez stated
in May of this year when she applied for her technician license she
replied that she had been convicted of a felony and provided the
necessary paperwork. Ms. Rodriguez stated after appearing at the
meeting in June, she looked at the copies of her recertification and
realized that she had signed that she had not been convicted of a
felony. Ms. Rodriguez stated that it was a mistake and it was not
done to be deceiving. Ms. Rodriguez stated that she has been a
technician for 10 years and have worked for Safeway for 20 years.
Mr. McAllister said that he missed the statement on the bottom of the
recertification paperwork.
Ms. Rodriguez stated that she studied for the certification test and
applied to take the certification test. Ms. Rodriguez stated that no
one mentioned that she could not take the test if she was convicted
of a felony. Ms. Rodriguez stated that it was a stupid mistake that
she made on the application.
Mr. Dutcher asked Mr. Pulver what our rules state in regards to
felonies. Mr. Pulver stated that
A.R.S.§ 32-1923.01 (A) (5) states that an individual for licensure as a
pharmacy technician must
pass a board approved pharmacy technician examination. Mr. Pulver
stated that from his understanding that an applicant cannot take the
exam if they have been convicted of a felony.
Mr. Wand stated that A.R.S. § 32-1927.01 (A) (2) states that the Board
may deny a license to an applicant convicted of a felony. Mr. Wand stated that there are two
statutes that impact the Board's decision. Mr. Wand stated that is
the problem when we tie our own requirements into an outside
agency's requirements. Mr. Pulver stated that the test that the Board
approved was the PTCB test and the problem is that the PTCB will
not allow anyone to take the test that has been convicted of a felony.
Ms. McCoy asked if PTCB has a review process that will allow
someone to take the exam. Ms. Boyle stated that if an applicant
states that they were convicted of a felony then they are not eligible
to take the exam. Ms. Boyle stated that Ms. Muir at PTCB informed
her that they are reviewing their procedures because they have found
applicants for recertification have been convicted of felonies.
Mr. Wand stated that he spoke with Ms. Muir at PTCB and her
response was that on the original application the applicant is
precluded from taking the exam if they are convicted of a felony. Mr.
Wand stated Ms. Muir told him on the renewal process a case-by-case
decision is made depending on the type of felony.
Mr. McAllister stated that the Board is barred by our own statute to
make any changes today. Mr
McAllister asked Ms. Rodriguez to contact PTCB and let them know
that it was an inadvertent error when she first applied for her
certification. Mr. McAllister stated that Ms. Rodriguez would need to
obtain formal notification from PTCB that they would honor her
certification. Mr. McAllister stated that if PTCB will honor her
certification then the Board would consider her request to proceed
with technician licensure. Mr. McAlliser told Ms. Rodriguez that the
Board would stay her request until the November meeting.
Mr. Pulver stated that this raises an interesting issue that the Board
is bound by another entities rules. Mr. Pulver stated that the Board
may want to consider at a future meeting if they want to be bound by
another set of rules of an outside agency. Mr. Wand stated that the
Board did discuss this issue when the Board approved the PTCB
exam. Mr. Wand stated that the Board could approve an alternative
exam and is not sure if the Board wants to approve an alternative
exam. Mr. Wand stated that the Board did not approve the Virginia
exam. Ms. McCoy asked if the other exams have the same
requirements concerning felonies. Mr. Wand stated that the
requirements could be researched prior to approving the exam. Mr.
McAllister stated that he would like to see how PTCB responds to
this request before the Board takes any other actions.
President McAllister recessed the meeting for Lunch.
The meeting reconvened at 1:00 p.m.
#8 Pravin Patel
Pravin Patel appeared on his own behalf to request permission to
proceed with technician licensure. President McAllister opened the
discussion by asking Mr. Patel to describe his request.
Mr. Patel stated that he is applying for a technician license and has
surrendered his medical license in Pennsylvania, had his license
revoked in New York, and had his license denied in Iowa. Mr. Patel
studied that he finished his neurology residency in 2002 and applied
for a fellowship in Iowa. Mr. Patel stated that when he applied for the
Iowa license he did not mention two residencies that he did not
complete. Mr. Patel stated that he did not get credit for either
residency and he stated that he was on academic probation at that
time. Mr. Patel stated that after being denied in Iowa, he applied to
New York for a license. He was granted a license by New York and
the Medical Board started an investigation. Mr. Patel stated that he
did not mention the residencies on his application for licensure for
New York and did not mention the incomplete residencies on an
application to provide services for an insurance carrier. Mr. Patel
stated that he did not complete the residencies because the
residencies were very hard and he was requested to work 12- hour
shifts and he was worn out. Mr. Patel stated that he accepted a
residency close to his family and was diagnosed as being depressed.
Mr. Patel was left go from the residency because he was told that he
did not have interest in the residency and it was not in his field. Mr.
Patel stated that he started on Prozac and the medication made him
very drowsy. Mr. Patel stated that at the next residency he was
caught sleeping in the on call room and the chief resident complained
and he resigned from the hospital. Mr. Patel stated that
he then went to Connecticut and one day he was supposed to start a
rotation and he did not show up for the rotation. The chairman
dismissed him from this pediatric rotation. Mr. Patel stated that he
then went to New York and completed his residency. He stated that
he applied for the fellowship and licensure in Iowa and then the
problems began.
Mr. Patel stated that he apologizes for not being honest and promises
that it will never happen again. Mr. Patel stated that basically he is
an honest person and this mistake happened. Mr. Patel stated that
his medical career is gone.
Mr. McAllister asked if the revocation in New York was due to not
listing the two residencies. Mr. Patel stated that the revocation was
due to not listing the residencies and the denial of the license in
Iowa. Mr. McAllister asked if during the proceedings if there was any
discussion of Mr. Patel's competency. Mr. Patel stated no that he did
not make any clinical mistakes. Mr. Patel stated that no one
complained. Mr. McAllister stated that in the New York proceedings
there is a comment that states that Mr. Patel was on academic
probation for unsatisfactory performance. Mr. Patel stated that it
was probably due to past residencies.
Mr. Draugalis asked Mr. Patel if that was his signature on the
documents. Mr. Patel replied yes. Mr. Draugalis stated that Mr. Patel
kept stating that there were two issues that caused his problems yet
in the order there are 20 specifications of professional misconduct.
Mr. Patel stated that each allegation on his application in
Connecticut, New York, Iowa, and Pennsylvania counted as an
incident. Mr. Patel stated that he might have applied for a New York
license before and forgot about applying and stated that he said no
on the application
Mr. McAllister asked about the Nevada stamp on the orders. The
papers were stamped received by the Nevada State Board of Medical
Examiners on September 9, 2002. Mr. Patel stated that he had
applied in Nevada but he did not have any correspondence with the
Nevada Board. Mr. Patel stated that it might have been a mistake
that he gave the Board papers with the Nevada stamp. Mr. Patel
stated that he applied to the Nevada Board and he said there had
been no actions against him in Nevada and he did not go to hearing in
Nevada.
Mr. McAllister stated that he finds it interesting that from Mr. Patel's
perspective that he neglected to mention these two residencies and
his world collapsed around him. Mr. McAllister stated that in the
order it states that the respondent repeatedly lied to state medical
boards, hospitals, and insurance plans, in order to hide his past, and
obtain residency training, licensure, employment, and insurance
reimbursement. Mr. Patel stated that it is the same thing that he only
omitted the fact that he did not complete the residencies. Mr.
McAllister informed Mr. Patel that the Board was not evaluating his
skills as a medical practitioner, but the fact that another regulatory
Board had revoked his license based on a number of allegations. Mr.
McAllister stated that since Mr. Patel is applying for a pharmacy
technician license and will be reporting to another health care
regulatory board these allegations raise many concerns in his mind.
Mr. Patel stated that is why he is mentioning these issues on the
application. Mr. Patel stated that being born in another country is
totally different. Mr. Patel stated that he was not straight forward
concerning the residencies.
Mr. Draugalis asked Mr. Pulver to define moral character. Mr. Pulver
stated the Board should define moral character. Mr. Pulver pointed
out several issues in the Board Order for the Board Members. Mr.
Pulver stated that Mr. Patel was represented by Counsel during the
proceedings.
Mr. Pulver stated that in the order it shows that Mr. Patel lied to an
insurance plan. Mr. Pulver stated that the state of New York has
determined that this individual does not have an ethical compass.
Mr. Pulver stated that a sister agency took the time and gave him the
due process rights, notified him of the complaints against him, and
then gave him the opportunity to respond, and the opportunity to
have counsel and the Board revoked his license. Mr. Pulver stated
that the New York Board has decided that this individual is not
ethical.
On motion by Mr. Draugalis and Mr. Dutcher, the Board unanimously
denied the request by Mr. Patel to proceed with technician licensure.
Mr. Patel asked if he could withdraw the application at this time. Mr.
McAllister informed Mr. Patel that it is now part of public record and
if he wished to withdraw the application that should have been done
prior to the meeting.
#9 James Van Zanen - Requested to appear at November meeting
#10 Rosemary Carrizoza
Rosemary Carrizoza appeared on her own behalf to request
permission to proceed with technician licensure. Darren Kennedy,
Pharmacy Supervisor for Walgreens, was also present.
President McAllister opened the discussion by asking Ms. Carrizoza
to describe her request. Ms. Carrizoza stated that she wanted to
proceed with technician licensure and she does not have any felony
convictions. Mr. McAllister asked if Ms. Carrizoza has a felony
conviction.
Mr. Wand stated that there is a felony charge in 1986. Mr. Wand
asked if she was arrested for a felony. Ms. Carrizoza stated that she
was arrested for a felony. Mr. Wand asked if she was convicted of a
felony. Ms. Carrizoza stated that she was not convicted of a felony.
Ms. Carrizoza stated that in 1986 she was arrested and was
convicted of a Class 6 Undesignated Felony and she completed 3
years probation. Ms. Carrizoza stated that upon completion of her
probation it was dropped to a misdemeanor and she does not have
any felonies on her record. Mr. Wand told Ms. Carrizoza that she just
admitted that she was convicted of a felony. Ms. Carrizoza stated
that it should not be on her record. Mr. Wand stated that question 7
asks if the applicant has been convicted of a felony.
Mr. Draugalis asked Mr. Pulver about the felony conviction. Mr.
Pulver stated that there is an issue if the felony conviction is dropped
to a misdemeanor if the individual was convicted of a felony or a
misdemeanor. Mr. Pulver stated that the findings of fact indicate that
Ms. Carrizoza was arrested and convicted several times for
shoplifting and larceny and these are crimes of moral turpitude. Mr.
Pulver stated that the application asks if the applicant has been
convicted of crimes of moral turpitude and in this case the answer
would be yes. Mr. Pulver stated that because she has these crimes
of moral turpitude that the Board would need to consider if she is a
person of good moral character. Mr. Pulver stated that in order to be
licensed as a pharmacy technician the statute states that the
applicant must be of good moral character.
Ms. McCoy asked Mr. Pulver if Ms. Carrizoza 's request to work in
another health care setting was denied. Mr. Pulver stated that under
Arizona law that there is a very strict statute for individuals that want
to be CNA and work at nursing homes or assisted living facilities. Mr.
Pulver stated that if the individual has a felony conviction or crimes
of moral turpitude it is an absolute ban for an individual to work in
those types of settings. Mr. Pulver stated that Ms. Carrizoza was
denied to work in those settings due to her crimes of moral turpitude.
Mr. McAllister asked Mr. Kennedy about Ms. Carrizoza. Mr. Kennedy
indicated that Ms. Carrizoza has worked for Walgreens for five years
and has been a good employee.
Mr. McAllister asked when the felony was reduced to a misdemeanor.
Ms. Carrizoza stated that her felony was dropped to a misdemeanor
in 1989 upon completion of her probation. Mr. McAllister asked Ms.
Carrizoza if she ever went through a drug rehab program. Ms.
Carrizoza stated she had and that was the last condition of her
probation. Mr. McAllister asked if she has been sober since that
time. Ms. Carrizoza stated that she has been off drugs since that
time.
On motion by Mr. Draugalis and Ms. McCoy, the Board unanimously
approved the request by Ms. Carrizoza to proceed with technician
licensure.
Ms. McCoy said she is concerned about the PTCB screening process.
Mr. Dutcher asked if we have any discretion in these matters. Mr.
Pulver replied that it is up to the Board to define good moral
character.
Mr. Draugalis stated that he agrees with Ms. McCoy that the PTCB is
taking the word of the applicant and not doing any screening or
background checks of the applicants. Mr. McAllister stated that the
dating on these two issues is prior to NABP being a partner in PTCB.
NABP is now a one-third partner in the exam. Mr. McAllister asked
Mr. Wand to send a letter to Carmen Catizone describing these issues
and ask NABP to provide some answers. Mr. McAllister stated that
NABP has stated that this is a good exam for licensing. Mr.
McAllister noted that it was originally a competency exam and is now
being used as a licensing exam.
Mr. Wand stated that if PTCB removed the requirement that an
applicant could take the exam if they had been convicted of a felony,
the Board would still need to review the applications because the
Board decides if an individual that has committed a felony should be
licensed. The only difference would be that the Board would not
need to decide if the applicant lied to receive their PTCB certificate.
#11 The Apothecary Shop
James Bataoel and Roger Morris (legal counsel) were present to
request termination of the probation for Apothecary Shop pf Phoenix.
President McAllister asked about the nature of their request. Mr.
Morris stated that the Apothecary Shop is requesting to terminate
probation. Mr. Morris stated that they have met all the requirements
of their probation. Mr. Morris stated that they have submitted a copy
of their quality assurance program and had four inspections of the
pharmacy.
Compliance Officer Larry Dick was questioned by the Board Members
concerning the violations.
Mr. Dick stated that they had minor violations and they were
corrected and each inspection improved.
Ms. McCoy asked if the Quality Assurance Program would continue
after the probation ends. Mr. Bataoel replied that the Quality
Assurance Program would continue.
Mr. McAllister stated that all the requirements to terminate probation
have been met.
On motion by Mr. Dutcher and Dr. Tippett, the Board unanimously
approved the request by the Apothecary Shop of Phoenix to terminate
their probation subject to Board Order Number
03-0015-PHR.
#12 Justin Lake
Justin Lake appeared on his own behalf to request permission to
proceed with reciprocity.
President McAllister asked Mr. Lake to describe the nature of his
request. Mr. Lake stated that he would like to reciprocate his license
from Virginia to Arizona. Mr. Lake stated that he was disciplined by
the Virginia Board of Pharmacy. Mr. Lake stated that in 1998-1999 he
was the Pharmacist-In- Charge at a Rite Aid store. He was charged
with mismanaging the pharmacy. He stated that he received a
reprimand and was required to pay a five hundred dollar fine. He was
not allowed to be a Pharmacist-In-Charge for 3 years and that ended
in 2003. He stated that his license is now in good standing.
Mr. McAllister asked Mr. Lake to define mismanagement. Mr. Lake
stated that he was an inexperienced pharmacist and by default he
became the Pharmacist-In-Charge at a new 24- hour store. Mr. Lake
stated that in two instances he failed to submit a theft/loss report to
the Board of Pharmacy in 30 days. The first report he stated he sent
to his District Office and assumed that the office sent the report to
the Board. The second report he stated he sent in late because he
forgot to mail the report prior to going on vacation.
Mr. Lake stated that an audit conducted from May 1,1998 to May
1,1999 showed several discrepancies. Mr. Lake stated that he was
leaving as the Pharmacist-In-Charge at the end of April and was going
on vacation for one week and would not be working on May 1, 1999 to
take the annual inventory. Mr. Lake stated that his supervisor told
him that he could take the inventory on April 23, 1999. Mr. Lake took
the inventory on April 23, 1999 and dated the inventory May 1, 1999.
By labeling the inventory as of May 1, 1999, the audit conducted by
the Board showed several discrepancies.
Mr. Lake stated that he allowed store employees to enter the
pharmacy to use the microwave because there was not a microwave
in the lunchroom.
Mr. Lake stated that the Board received a complaint stating that the
patient received 22 tablets of Synthroid instead of 32 tablets. Mr.
Lake stated that the patient filed a complaint because this was the
second time that the patient was shorted medication. Mr. Lake
stated that he talked to the technicians about being careful when
counting prescriptions. Mr. Lake stated that the Inspector counted 10
filled prescriptions and found all prescriptions were counted
correctly.
Mr. Lake stated that he was learned from his experiences and does
not want to be a pharmacist-in-charge.
Mr. McAllister told Mr. Lake that the Board expects all pharmacists to
be responsible for the medications and not just the pharmacist-in-charge.
Mr. Lake stated that he was not experienced in dealing with
the managerial tasks.
Mr. Draugalis asked Mr. Lake how many weeks vacation he received
at Rite Aid. Mr. Lake replied two weeks each year. Mr. Draugalis
asked Mr. Lake how long he was gone from the store when he failed
to send in the second theft/loss report. Mr. Lake replied that he was
gone for one week but did not return to that store after vacation.
On motion by Dr. Tippett and Mr. Dutcher, the Board approved the
request by Mr. Lake to proceed with reciprocity. Mr. Draugalis
opposed the decision.
AGENDA ITEM V - Arizona Community Pharmacy Committee
Janet Elliott with the Arizona Community Pharmacy Committee was
present to update the Board on the organizations attendance at the
Meth Watch State Leadership Training Program in Washington, DC.
Ms. Elliott explained that the Meth Watch program is designed to help
control the suspicious sales and theft of pseudoephedrine and other
precursor products used in the illicit manufacturing of methamphetamine.
She stated that the program was started in Kansas and now operates in the states of Washington,
Oregon, and South Dakota.
Ms. Elliott states that it is a voluntary program, which involves mainly
retail establishments. The retailers place the precursor products where they can easily be
monitored and then Meth Watch signs are posted at the windows and
doors, at the cash registers, and on the shelves where the precursor
products are located. The employees at the retail store are trained
to recognize suspicious customers and to contact law enforcement.
Mr. Dutcher asked Ms. Elliott if the program would involve all retailers
in the state. Ms. Elliott replied that it is a national program. She
stated that the program alerts retailers and consumers about illegal
activities,
Mr. Wand asked how a store wants to participate is there a cost
associated with participation. Ms. Elliott replied that CPHA does have funding available for retail
establishments. The initial cost is usually for the printing of the
signs. In Oregon, the fee was $25 to $35 for each store.
Mr. McAllister asked what other states are participating in the
program and what is the success rate of the program. Ms. Hawks
with CPHA replied that the program has been effective in Kansas.
She stated that Kansas did not have any limit on the amount of
pseudoephedrine that one could purchase and as a result of the
program there has been a decrease in the number of labs being
busted for methamphetamine production.
Ms. Hawks stated that CPHA hopes to help states limit the sales of
precursors and increase the penalties for making methamphetamine
around children.
Mr. Dutcher asked if the program just targets pharmacies. Ms Hawks
said that the program targets all retailers.
President McAllister thanked Ms. Elliott and Ms. Hawks for their
presentation of the Meth Watch program to the Board.
AGENDA ITEM VI - Complaint Review
The Consumer Complaint Review committee met prior to the Board
Meeting to review 13 complaints in preparation for making
recommendations to the Board for final resolution. Mr. Dutcher and
Mr. Ketcherside served as the review committee. Mr. Dutcher
provided a summary of each complaint and provided the committee's
recommendations to the Board. Board members were encouraged to
ask questions.
Complaint Discussion
The Board met in Executive Session to consult with the Board's legal
counsel for assistance in resolving a complaint issue.
The following summary represents the final decision of the Board in
each complaint:
- Complaint # 2796 - Letter of Warning
- Complaint # 2797 - Conference - Pharmacist and Technician
- Complaint # 2801 - Conference - Pharmacist and Technician
- Complaint # 2802 - Letter of Commendation to Pharmacist
- Complaint # 2803 - Consent
- Complaint # 2804 - Conference - Pharmacist (PIC & Technician)
- Complaint # 2805 - Add to Stipulated Stay
- Complaint # 2806 - Add to Stipulated Stay
- Complaint # 2807 - No Further Action
- Complaint # 2808 - No Further Action
- Complaint # 2809 - No Further Action
- Complaint # 2810 - No Further Action - Letter to Nurse Practitioner clarifying the duties of a
pharmacist
- Complaint #2811 - No Further Action
AGENDA ITEM VII - Counseling Task Force Committee Report
President McAllister asked Ms. McCoy to update the Board Members
concerning the activities of the Counseling Task Force.
Ms. McCoy opened the discussion by introducing the members of the
Task Force and thanked them for their time in reviewing the
counseling regulations. The following individuals served on the
Counseling Task Force: Jeff Donnelly, Cheryl Frush, Edwina Lanham,
Steve LeMahieu, Mike Noel, Molly Placko, Sharon Richardson, Kent
Taylor, Dennis Waggoner, and Hal Wand.
Ms. McCoy stated that the task force met several times. The goal of
the task force was to review the current Arizona State Board of
Pharmacy Regulations relative to patient counseling and if necessary
make recommendations for changes. Ms. McCoy stated that another
goal was to evaluate the current regulations and compliance issues
relative to patient safety and professional responsibility for the
protection of the public.
Ms. McCoy stated that the task force stated out by comparing the
counseling regulations in Arizona to the counseling regulations in
other states. The task force then looked at proposed changes to the
Arizona counseling regulations. Ms. McCoy stated that the Board
staff conducted a survey of other State Boards to determine how
counseling is regulated in other states. The other Boards were asked
questions concerning counseling statistics, the promotion of
counseling, the ability to conduct sting operations, and the disciplinary actions
taken against pharmacists that neglect to counsel their patients.
Ms. McCoy stated that the task force then identified issues related to
counseling. One of the major issues was when is counseling
required. Ms. McCoy stated that many patients were angry when
they had to be counseled about their maintenance medications every
month. The task force also discussed if counseling should be
required when a cab driver picks up the patient's medications. The
next issue discussed by the task force was what information should
be included in counseling. Using the Public Health Service model for
counseling, the task force made several recommendations allowing
the pharmacist to customize counseling for each patient's needs. The
task force identified issues relating to the documentation of
counseling. The task force felt documentation was important and it
would be valuable to document both the acceptance and denial of
counseling. Ms. McCoy stated that if an error was made in
dispensing a prescription then the documentation would be available
to the Board indicating if there was an acceptance or refusal of
counseling by the patient. Ms. McCoy stated that the task force
reviewed the options of whether a technician or pharmacist should
initiate counseling. The task force determined that the pharmacist
should initiate counseling. Ms. McCoy stated that the task force
looked at the responsibility of the permit holder. Ms. McCoy stated
that if the permit holder contributes to counseling violations then
sanctions would be taken against the permit holder.
Ms. McCoy stated that the proposed changes involve the removal of
language that would require a pharmacist to counsel a patient on
maintenance medications every month and would also eliminate the
need to counsel a patient when a prescription is updated
Ms. McCoy stated that the proposed changes involve the removal of
the prescriptive language that states each item the pharmacist must
cover with the patient during counseling. The proposed language
changes would allow the pharmacist to discuss with the patient the
name and strength of the medication, the use of the medication, the
dosage changes, and the effects and side effects of the medication.
Ms. McCoy stated that the proposed changes allow the pharmacist to
provide written material to the patient if oral consultation is omitted
and the reason is documented.
Ms. McCoy stated that the proposed changes require the pharmacist
to document the acceptance or denial of counseling.
Ms. McCoy stated the Arizona retailers want to market counseling to
the public. Ms. McCoy stated that the pharmacies might want to post
signs stating that counseling is required. Ms. McCoy stated that
counseling is necessary to protect the public.
Mr. Draugalis thanked the members of the task force for their input
and stated that he is in favor of the new changes.
Mr. Dutcher stated that he is favor of the proposed changes. He
stated that the biggest change is the removal of counseling on
maintenance medications. Mr. Dutcher stated that by decreasing the
time spent on counseling on maintenance medications that the
pharmacist would be able to spend more time counseling patients on
medications that they had never taken before.
Ms. McCoy stated that the task force tried to remove barriers to
counseling.
Mr. McAllister stated that he also feels the task force has provided a
tool for the Board to work with an error occurs. He stated that if an
error occurs, documentation will exist to help the Board make their
decision in the matter.
Mr. McAllister and the Board Members authorized Mr. Wright to
proceed to rulemaking with the changes proposed by the task force.
Mr. Wright stated that he will proceed with the changes and will be
adding the definition for caregiver for clarification purposes.
AGENDA ITEM VIII- Conferences
Complaint #2764
Pharmacist Anna De La Huerta, Pharmacist Sandra Warren (intern at
time of incident), and Pharmacy Supervisor Sarju Patel were present
in response to a consumer complaint. Compliance Officer Rich
Cieslinski gave a brief overview of the complaint. Mr. Cieslinski
stated that the patient received a labeled bottle of Carafate
Suspension and the label was missing the quantity of medication the
patient should take for each dose.
President McAllister opened the discussion by asking Ms. De La
Huerta about the incident. Ms. De La Huerta stated that the intern
entered the prescription and upon verifying the prescription she told
the intern the directions were incorrect. The intern had typed the
following directions: Use one hour before meds. Ms. De La Huerta
told the intern the directions should read take before meals. Ms. De
La Huerta stated that the intern retyped the label to use one hour
before meals. Ms. De La Huerta replied that she was sure that the
patient was counseled and would have been told to take one gram.
Mr. McAllister asked who crossed off the end of the directions. Ms.
De La Huerta stated that the physician had crossed off the directions.
Ms. McCoy asked Ms. De La Huerta who verified the dose. Ms. De La
Huerta replied that the pharmacist-in-charge verified the dosage after
the patient called to verify the amount she should take before each
meal.
Mr. McAllister told the two pharmacists that there were two sources
of the error and they had two chances to correct the error. The error
could have been caught at the final verification and
again during counseling. Ms. De La Huerta stated that she possibly
told the patient the dosage during counseling.
Ms. De La Huerta stated that the complaint makes her look like a bad
pharmacist and she would like the Board to know that she takes
patient care seriously.
Mr. McAllister reminded the pharmacists to be careful.
Complaint #2770
Mr. Draugalis and Mr. McAllister both asked to be recused due to
conflicts of interest. At this point, Mr. Pulver notified the Board that
they had lost their quorum and they could not conduct business. The
pharmacist was told that the conference would be rescheduled for
November.
Complaint #2777
President McAllister called Pharmacist Patrick McNerney and
Supervisor Terry Daane forward to address the Board concerning a
Consumer Complaint. Mr. Draugalis recused himself from taking part
in the conference due to a conflict of interest. Compliance Officer
Rich Cieslinski gave a brief overview of the complaint. The
complainant stated that his father received Glucovance labeled for
another patient.
Mr. McAllister asked Mr. McNerney to explain the details of this
complaint. Mr. McNerney stated that they were not able to determine
what medication the patient received. The pharmacy stated that the
description of the tablets that the patient requested did not match
the description of the Glucovance tablets. The pharmacist was not
sure how the patient received another patient's bottle.
Mr. McNerney stated that the pharmacy now uses clear plastic
ziplock bags and every prescription bottle is checked when the
prescription is rung up at the register.
Mr. Dutcher asked if it was possible that the patient received the
correct medication. Mr. McNerney stated that it was possible that he
received the correct medication and the bottle was labeled
incorrectly. Mr. McNerney stated that the patient asks for his
medications by color and never by name. When the patient came to
the pharmacy, he requested tablets that did not match the color of
the Glucovance. Mr. McNerney stated that the doctor discontinued
the Norvasc and started the patient on a new strength of Vaseretic.
Mr. McNerney stated that it was possible that the patient did not
understand the changes and then the bottle was mislabeled with the
Glucovance label.
Dr. Tippett asked Mr. McNerney about his interaction with the
complainant. Mr. McNerney stated that the complainant is the
patient's son. Mr. McNerney said he went to the store after hours and
researched the issue and called the complainant back and told him
that his father may have received the wrong medication. Mr.
McNerney told the complainant that he found the bottle in the recycle
bin. Mr. McNerney stated that no technician was fired as a result of
the incident as the complainant stated in his complaint.
Mr. McAllister told Mr. McNerney to be careful in performing his final
verification. Mr. McNerney stated that they are using the clear
ziplock bags and are able to check the name on every prescription
bottle before the prescription leaves the pharmacy.
Complaint # 2787
Pharmacist Ray Weinstein and Supervisor Terry Daane were present
to a consumer complaint.
Michael Milinavich was present. Mr. Milinavich is the supervisor for
Cameron & Company since Mr. Weinstein is an employee of Cameron
& Company, which is a company that provides temporary pharmacy
staffing. Compliance Officer Dean Wright gave an overview of the
complaint. The complainant states that her mother received two
bottles of Lisinopril and did not receive her Clonidine. Mr. Wright
stated that no ingestion occurred.
Mr. McAllister asked Mr. Weinstein to describe the events leading up
to this complaint. Mr. Weinstein stated that he was working a 4- hour
shift that day. He stated that there was a large backup of
prescriptions to be filled when he arrived at work. He stated that the
backup was due to the fact that the pharmacy forgot to place their
order the day before, so they received a very large order that day.
Mr. Weinstein stated that the technician counted the medication. Mr.
Weinstein stated that he uses the scanner for any medications that
he counts. He stated that the technician counted the medication and
handed him the bottle. He did not check the contents inside the vial.
He stated that the lisinopril was filled from the Baker Cell.
Ms. McCoy asked about the scanning process. Mr. Weinstein stated
that the bar code is scanned on the prescription label and the stock
bottle and if they match then you have the correct drug. Mr.
Weinstein stated that he could not scan the label because the
medication was in the Baker cassette. Mr. Daane stated that since
Mr. Weinstein is a floater that he might not be aware that the bar
code is on the cassette and can be scanned instead of the stock
bottle.
Mr. McAllister reminded Mr. Weinstein to use the equipment that is
provided to him to help prevent errors.
Complaint # 2789
Pharmacist Ernst Kruger, Pharmacist Jim Olson, and Supervisor
Bryan Bakke were present to answer questions concerning a
consumer complaint. Compliance Officer Dean Wright gave a brief
overview of the complaint. The pharmacy dispensed 30 tablets of
Trazadone 50 mg instead of 60 tablets on two separate occasions.
Two different pharmacists filled the prescriptions.
President McAllister asked the pharmacists how the patient received
30 tablets each time instead of 60 tablets. Mr. Kruger stated that it
was purely an error. Mr. Olson stated that the bottle will hold 60
tablets and is not sure how the patient received 30 tablets each time.
Mr. Bakke stated that they have reviewed every possible scenario
and cannot determine how the same patient was shorted 30 tablets
on two different occasions. Mr. Bakke stated that the patient has
had subsequent prescriptions filled at the pharmacy and there were
no problems prior to these two shortages and there have not been
any problems since that time.
Mr. Draugalis asked the pharmacists if the shortages could have been
due to the fact that they were out of stock of the medication and
could only fill a partial quantity. Mr. Bakke stated that this did not
seem to be the case.
Mr. Dutcher asked about the procedure if the pharmacy was out of
stock of a medication. Mr. Bakke replied that the pharmacy would fill
the prescription as a partial and record on a second label the
remaining quantity to be dispensed when the product was received at
the pharmacy.
Mr. McAllister reminded the pharmacists to be careful and to check
the prescriptions carefully.
Complaint # 2791
Pharmacist Shilpa Binstock and Supervisor Matt Cook were present
pursuant to a consumer complaint. Compliance Officer Larry Dick
provided a summary of the complaint. The original prescription was
filled incorrectly with Crestor 10mg instead of Crestor 20 mg tablets,
which resulted in the patient taking only half of the prescribed
medication dosage for 29 days. The error was caught when the
patient received her refill and noticed the difference in the size of the
tablets.
President McAllister asked Ms. Binstock about the error. Ms.
Binstock replied that the label was typed correctly and when she
verified the contents of the vial she did not notice that the tablets
were incorrect. She showed the Board Members a picture of the two
tablets. The tablets are fairly close in size and are the same color.
Ms. Binstock stated since that time she has changed her practice.
She stated that she now pours the tablets in the cap of the bottle and
looks at the tablet first and then compares the tablet with the on
screen description. She stated that she looks at the tablet first so
that she does not have any pre-conceived idea of what the tablet
should look like or the color of the tablet. She stated that all the
technicians are using the Baker scanning system.
Mr. Dutcher asked Ms. Binstock to describe the scanning technology.
Ms. Binstock stated that the label and bottle are scanned to ensure
the right product is counted and dispensed. Ms. Binstock believes
that the technician did not use the scanner and she failed to verify
the medication correctly.
Ms. McCoy commended Ms. Binstock on her response to the
complaint. She stated that she was glad that Ms. Binstock filed the
ISMP error report since both strengths of the tablets could be confused easily.
Ms. McCoy also commended Ms. Binstock on taking
the time to complete CE on medication errors. Ms. Binstock stated
that she was very concerned about the error and the patient's safety.
Mr. McAllister agreed with Ms. McCoy's statements and reminded Ms.
Binstock to be careful.
Complaint #2793
President McAllister called Pharmacist Jerry Mayo and Supervisor
Craig Yee forward to address a consumer complaint. Compliance
Officer Rich Cieslinski gave a brief overview of the complaint. The
complainant alleges that she received 90 tablets of Actos instead of
30 tablets. The complainant also alleges that her Synthroid
medication was filled with Actos and she took double doses of Actos
for 10 days.
President McAllister asked Mr. Mayo to describe the incidents that
occurred. Mr. Mayo stated that they carry Actos in two size bottles.
They carry bottles of 30 tablets and bottles of 90 tablets.
Mr. Mayo stated that they open the bottles and show the patient the
medications.
Mr. McAllister asked Mr. Mayo about his statement that the patient
mixed the medications up at home. Mr. Mayo stated that he thinks
the patient put the Actos in the Synthroid bottle.
Mr. Draugalis asked Mr. Mayo if he gave the patient 90 tablets. Mr.
Cieslinski stated that the patient stated that Mr. Yee came to her
house to retrieve the bottle of 90 tablets. Mr. Yee stated that the
patient did receive 90 tablets.
Mr. Draugalis asked Mr. Mayo if the patient had been on these
medications prior to this filling. Mr. Mayo replied yes. He stated that
the tablets are not the same color and the patient have previously
taken the Synthroid. He stated that is why he felt the patient mixed
up the tablets to receive gift certificates from the pharmacy.
Mr. McAllister stated that a note would be placed in his file indicating
that the Actos and Synthroid mix-up could possibly be a he-said she-said situation.
It will be noted in the file that the patient did receive
90 tablets instead of 30 tablets.
AGENDA ITEM IX - Consent Agreements
President McAllister asked Board Members if there were any
questions or discussions concerning the consent agreements.
Executive Director Wand indicated that the eight consents
have been reviewed and approved by the Attorney General's Office
and have been signed. Mr. Wand provided an overview of the Consent
Agreements for the benefit of the audience.
Mr. Wand stated the following:
Consent Agreement #1 - Involved a drug addiction and the pharmacist
entered a PAPA contract
Consent Agreement #2 - Involved a failure to counsel which resulted
in a censure and a $1,000 fine
Consent Agreement #3 - Involved a prescription error which resulted
in a censure, a $1,000 fine and additional CE units
Consent Agreement #4 - Involved a failure to counsel which resulted
in probation and CE units
Consent Agreement #5 - Involved outdated OTC medications which
resulted in probation and a $520 fine
Consent Agreement #6 - Involved a drug addiction which resulted in a
2 year suspension and a PAPA contract
Consent Agreement #7 - Involved a prescription error which resulted
in probation and additional CE units
Consent Agreement #8 - Involved a drug addiction and the pharmacist
entered a PAPA contract
President McAllister stated that due to a conflict of interest he
requested to be recused from approving Consent Agreement #6.
On motion by Mr. Draugalis and Dr. Tippett, the Board unanimously
agreed to accept the following Notices of Hearing/Consent
Agreements as presented in the meeting book and signed by the
respondents:
- Jonathan Corey Ray
04-0012-PHR
- Bereket Gebre-Egziabher
04-0014-PHR>
- Joel Gibson
04-0015-PHR
- Michael Biegun
04-0016-PHR
- K-Mart #7236
04-0017-PHR
- Kanu Patel
04-0019-PHR
- Kerry Karn
04-0020-PHR
On motion by Mr. Dutcher and Dr. Tippett, the Board agreed to accept
the following Notice of Hearing/Consent Agreement as presented in
the meeting book and signed by the respondent:
Mr. McAllister was recused in this case due to a conflict of interest.
AGENDA ITEM X - NABP Joint District Meeting
President McAllister asked Mr. Wand to address the issue of
attendance at the NABP Joint District 7 and 8 meeting to be held in
Las Vegas, Nevada at the end of October. Mr. Wand stated that due
to state guidelines the Board could approve two participants to
attend the meeting. The state guidelines will only allow for the
reimbursement of two individuals and if additional individuals would
like to attend the meeting then the Governor's office would need to
approve the spending of the additional monies. The Board decided
that Ms. McCoy and Mr. Dutcher would attend the meeting.
AGENDA ITEM XVI - Call to the Public
President McAllister 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.
Comments were made concerning the following issues:
A member of the Arizona retailers association expressed her
concerns about the proposed regulations concerning the sale of
pseudoephedrine and precursor products.
A representative from NACDS shared her views on the sale of
pseudoephedrine.
A representative from CPHA shared her views on the sale of
pseudoephedrine and the Meth
Watch program.
There being no further business to come before the Board on motion
by Ms. McCoy and Mr. Draugalis, the Board unanimously agreed to
adjourn the meeting at 4:20 P.M.
August 12, 2004
President McAllister reconvened the meeting at 8:00 A.M. The
following Board Members and staff were present: President Dennis
McAllister, Vice President Linda McCoy, Paul Draugalis, Chuck
Dutcher, and Bryan Tippett. Compliance Officers Rich Cieslinski,
Larry Dick, Ed Hunter, and Dean Wright, Deputy Director Cheryl Frush,
Executive Director Hal Wand, and Assistant Attorney General Roberto
Pulver.
AGENDA ITEM XI - Proposed Rules and Statutes
Pharmacist and Intern Licensure Rules
Compliance Officer/Rules Writer Dean Wright began by telling the
Board Members that he has prepared the Notice of Final Rulemaking
and the Economic Impact Statement for the Pharmacist and Intern
Licensure Rules.
Mr. Wright stated that the term AZPLEX will be replaced with MPJE.
Mr. Wright stated that the term delinquent license will be amended to
include the terms pharmacy intern, graduate intern, and pharmacy
technician.
Mr. Wright stated that a public hearing was held on June 28, 2004.
No one attended the hearing and no written or oral comments were
received. Mr. Wright stated if the Board approves the changes, the
Notice of Final Rulemaking would go to GRRC for final approval at
their October 5, 2004 meeting. If approved by GRRC, the rules would
become effective approximately December 5, 2004.
On motion by Mr. Dutcher and Mr. Draugalis, the Board unanimously
agreed to approve the Notice of Final Rulemaking and the Economic
Impact Statement for the Pharmacist and Intern Licensure Rules and
authorized Mr. Wright to proceed with the process.
Pharmacy Personnel /Correctional and Mail-Order Pharmacy Rules
Mr. Wright stated that the rules are being amended to make correct
citations to other rules that have been recently amended. The rule
change will replace the term "certified pharmacy technician" with
the term "pharmacy technician trainee".
Mr. Wright stated that a public hearing was held on June 28, 2004.
No one attended the hearing and no written or oral comments were
received. Mr. Wright stated if the Board approves the changes, the
Notice of Final Rulemaking would go to GRRC for final approval at
their October 5, 2004 meeting. If approved by GRRC, the rules would
become effective approximately December 5, 2004.
On motion by Mr. Draugalis and Ms. McCoy, the Board unanimously
agreed to approve the Notice of Final Rulemaking and the Economic
Impact Statement for the Pharmacy Personnel/Correctional and Mail-Order Pharmacy Rules
and authorized Mr. Wright to proceed with the
process.
Manufacturer, Wholesaler, Discontinued Pharmacy, and Technician
CE Rules :
Mr. Wright stated that the manufacturer and wholesaler regulations
would be amended to specify the requirements for change of
ownership or relocation.
Mr. Wright stated that the regulations for discontinuing a pharmacy
would be amended. The rules would be amended to change the
number of days that a pharmacy has to notify the Board before
discontinuing the pharmacy from 10 days to 14 days as required by
the DEA. The rules would be amended to state that a discontinued
pharmacy's records must be retained for seven years instead of three
years.
Mr. Wright stated that the technician rules state that the technician
must obtain 20 contact hours of CE prior to renewal of their license
and 2 hours of CE must be law.
The Board Members gave Mr. Wright approval to proceed with the
rulemaking process.
Non-Prescription Drug Retail Permit Rules :
Mr. Wright stated that due to the continued diversion of precursor
chemicals this rule was an attempt to develop a precursor threshold
and reporting mechanism. Mr. Wright stated that it would be difficult
to track the sale of precursor products and he decided not to proceed
with the rule if the Board approves.
The Board Members gave Mr. Wright approval to terminate the
rulemaking process.
PROPOSED STATUTE CHANGES :
Mr. Wright opened the discussion by describing the major changes
that would be made to the statutes.
The first major change will add new definitions including unethical
conduct and unprofessional conduct.
Mr. Wright stated that the Board could add a technician to the Board
if they desired. The Board Members discussed the issue and decided
that the Board needed to stay at an odd number. The Board Members
opted to add one pharmacy technician and a community pharmacist.
Mr. Wright explained that changes would be made to the disciplinary
process and described the various disciplinary actions that could
occur. The new statute changes would allow the Board Members to
issue a consent at the conclusion of a conference.
Mr. Wright stated that the statutes would be changed so that
licensees will be required to report to the Board instances where
another licensee is incompetent or is involved in illegal activities. Mr.
Wright stated that this must be done in good faith or the person
reporting the violation could be disciplined if the report is found to be
untrue.
Mr. Wright stated that requirements will be added for electronic
prescription transmissions and
statutes will be changed to clarify prescription order requirements.
The Board Members discussed the maximum fine that could be
assessed for each occurrence. The Board Members agreed that the
maximum fine should be $1,000 across the board.
Mr. Wright stated that the changes to Title 36 would add Meperidine
to Schedule II, would add specific requirements for the filing of CII
prescriptions, and would include language specifying what can be
changed on a CII prescription with authorization from the prescriber,
and would add language to indicate when a CII prescription can be
faxed to the pharmacy.
Mr. Wright stated that the changes to Title 13 (Criminal Code) would
involve adding drugs or precursors that are listed in the Schedules in
Title 36 to the criminal code and changing the allowable quantity of
ephedrine, pseudoephedrine, norephedrine, or phenylpropanolamine
from 24 grams to 9 grams.
The Board gave Mr. Wright approval to proceed with the statutory
changes.
AGENDA ITEM XII - Review of Pseudoephedrine Sales.
Mr. Richard Rosky with the Tri-State Precursor Committee associated
with the DEA Group II gave the Board Members an overview of the
sale of pseudoephedrine and the illegal use of pseudoephedrine to
manufacture methamphetamine. Mr. Rosky explained the issues in
Arizona. Mr. Rosky explained that it is necessary to regulate the
sales of pseudoephedrine to help reduce the number of meth labs.
Mr. Rosky stated that law enforcement agencies are working to
increase penalties in cases where children are found in a household
where methamphetamine is being manufactured. Board Members
addressed questions to Mr. Rosky concerning the Meth Watch
program. Mr. Rosky stated that data is not available to show if the
Meth Watch program actually decreases the number of meth labs.
Mr. Rosky stated that legislation and education for the public would
help decrease the sale of pseudoephedrine for illegal purposes.
AGENDA ITEM XIII - Planning for the Future- Focus on Board Issues
President McAllister asked Executive Director Hal Wand to open the
discussion concerning the
planning for the Board's future. Mr. Wand asked the Board Members if
there were any issues that they would like to discuss at this time in
relation to the Board's future direction.
Ms. McCoy stated that she would like to see more training offered to
new Board Members. She stated that it is difficult to be a new Board
Member and not know what to expect at your first Board Meeting. Ms.
McCoy stated that if all new Board Members received the same
training then everyone would be operating off the same page. She
also stated that if new Board Members received training on their role
as a Board Member then the transition would be smoother when a
new Board Member starts their term.
Mr. Draugalis stated that he agreed with Ms. McCoy concerning the
training. Mr. Draugalis stated that it takes about two to three years
before a new Board Member feels comfortable in their position as a
Board Member. Mr. Draugalis stated that since the Governor may not
reappoint individuals there will be a constant influx of new Board
Members and he recommended that maybe the term should be
extended to seven years. He suggested that the appointee would
serve one seven- year term and not be eligible for reappointment.
The Board Members felt that it might be difficult for an individual to
make a seven year commitment.
Mr. Wand stated that Mr. Pulver may be able to offer a training course
on Board procedures. Mr. Pulver stated that he could provide training
for the Board Members concerning the due processes and what to
expect during hearings and other legal proceedings.
Mr. McAllister stated that he feels that new Board Member
orientation would be valuable and he feels that the Board should
develop some time of training program.
Ms. McCoy stated that maybe the Board could develop some
guidelines concerning questions to be asked during the Board
Meeting of applicants and individuals requested to appear before the
Board.
Mr. Dutcher stated that he felt that the Board should schedule a
retreat consistent with the public meeting notice requirements. Mr.
Dutcher stated that perhaps the Board could meet with the
pharmacists to see what issues are relevant to the pharmacists. Mr.
Dutcher suggested that the Board might want to look at developing a
Pharmacist-only classification of medications. He felt that by
developing this classification of medications that it would enhance
the pharmacist's visibility to the public.
Mr. McAllister stated that the Board might be able to have a meeting
at the office for one-half a day and allow pharmacists to bring issues
to the attention of the Board.
AGENDA ITEM XIV - PMC Quality Commitment - Medication Errors.
President McAllister asked Mr. Wand to address the issue of PMC
Quality Commitment. Mr. Wand stated that this is a quality
management tool to help pharmacies to reduce medication errors. A
division of the Pharmacists Mutual Company sells the program.
Mr. Wand stated that program allows for an online reporting system
that allows pharmacies to track errors and near misses according to
the day of the week, type of error, name of drug, and where the errors
are most often caught. Mr. Wand stated that various reports could be
generated by the system. Mr. Wand stated that the company's goal is
to help reduce pharmacy errors by learning from the past and
constantly improving for the future. Mr. Wand stated that this could
be required as part of a consent order for a permit holder.
Ms. McCoy stated that she liked the concept of tracking errors. Ms.
McCoy stated that ISMP has a similar program in tracking reported
errors. Ms. McCoy stated that she felt this program could be adapted
to monitor a specific practice site and would provide the pharmacy
with an analysis of errors that occur at their particular site.
Dr. Tippett stated that the program would allow the pharmacy to
address errors and provide continuing education programs on errors
that have occurred at the site.
AGENDA ITEM XV - Motion to Release Treatment Records for
Substance Abuse Treatment Program
President McAllister asked Executive Director Wand to address this
issue. Mr. Wand stated that A.R.S. § 32-1932.01 (B) (2) states that
the following:
B. The board may contract with other organizations to operate the
program established pursuant to subsection A of this section. A
contract with a private organization shall include the following
requirements:
1. Periodic reports to the board regarding treatment program activity.
2. Release to the board on motion and written request of all
treatment records.
Mr. Wand stated that he is requesting that the Board make a motion
to allow PAPA to release to the Board the treatment records for Kevin
Strychalski and Thomas Togno. The records are being requested due
to issues with the participants consent orders.
On motion by Mr. Duther and Mr. Draugalis, the Board unanimously
approved the request for PAPA to release the treatment records for
Kevin Strychalski and Thomas Togno.
The Board also discussed the changing of the statute to allow the
Executive Director to request the treatment records instead of
waiting for a Board Motion. Mr. Pulver stated that he would work
with Mr. Wright in implementing that change.
AGENDA ITEM XVI - Call to the Public
President McAllister 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 expressed his concerns involving a counseling violation
that resulted in a consent order
There being no further business to come before the Board on motion
by Ms. McCoy and Dr. Tippett, the Board unanimously agreed to
adjourn the meeting at 11:30 A.M.
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