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Board Meeting Minutes
June 16, 2005 Board Meeting Minutes
THE ARIZONA STATE BOARD OF PHARMACY
HELD A REGULAR MEETING JUNE 16, 2005
CHANDLER, ARIZONA
The following Board Members and staff were present: President Linda
McCoy, Vice President Chuck Dutcher, Dennis McAllister, Ridge Smidt, and Tom Van
Hassel. Compliance Officers Rich Cieslinski, Ed Hunter, Sandra Sutcliffe and
Dean Wright, Deputy Director Cheryl Frush, Executive Director Hal Wand, and
Assistant Attorney General Roberto Pulver.
President McCoy convened the meeting at 8:30 A.M. and welcomed the audience
to the meeting.
Ms. Frush explained that law continuing education would be offered for
attendance at the meeting.
AGENDA ITEM 1 - Introduction of New
Board Members & Oath of Office
President McCoy introduced the newly appointed Board Member, Ridge Smidt.
President McCoy administered the Oath of Office to Dr. Smidt to allow Dr. Smidt
to assume the duties of a voting member of the Board.
AGENDA ITEM 2 - Approval of
Minutes
Following a review of the minutes and an opportunity for questions and
on motion by Mr. McAllister and Mr. Dutcher, the minutes of the
Regular Meeting held on April 6, 2005 were unanimously approved by the Board
Members.
AGENDA ITEM 3 -
Permits/Licenses
President McCoy stated that all permits were in order for resident pharmacies
and representatives were present to answer questions from Board Members.
- Cottonwood de Tucson
Jason Lashbrook, the Pharmacist In Charge, was
present to answer questions from Board Members.
President McCoy opened the
discussion by asking Mr. Lashbrook to describe his proposed business.
Mr.
Lashbrook stated that the pharmacy would be located in a Level 1 Behavioral
Health Facility.
Mr. Lashbrook stated that the facility is a 74-bed
facility that is a drug and alcohol rehab center.
Mr. Lashbrook stated
that the facility treats patients with behavioral health problems.
Ms.
McCoy asked if the facility was being served by an outside pharmacy.
Mr.
Lashbrook stated the facility was utilizing an outside pharmacy, but would
like to open its own pharmacy to optimize patient care.
- Melrose Pharmacy
Lidia Stickler, pharmacy owner, was
present to answer questions from Board Members.
President McCoy opened the
discussion by asking Ms. Stickler to describe her business.
Ms. Stickler
stated that she plans to open an independent retail pharmacy.
Ms. Stickler
stated that she plans to do some compounding.
Ms. Stickler stated that she
plans to consult with patients concerning diabetic management and the use of
bio-identical hormone therapy for hormone replacement.
Ms. Stickler stated
that she would be taking courses offered by PCCA for compounding.
Mr.
Dutcher asked Ms. Stickler if she understands the compounding rules.
Ms.
Stickler stated that she is aware of the rules and possible changes.
Mr.
Wand asked Ms. Stickler what her procedure would be if she received a
prescription for a commercially available product.
Ms. Stickler stated
that she would fill it with the commercially available product and not
compound the medication.
- The International Cosmetic and Compounding Pharmacy
Dr. Kenneth Proefrock, pharmacy owner, and Peter Orzech were present to
answer questions from Board Members.
President McCoy asked the individuals
to discuss the nature of their pharmacy business.
Dr. Proefrock stated
that the pharmacy would be a compounding pharmacy.
Dr. Proefrock stated
that they would be compounding cosmetic products pursuant to a physician's
order.
Mr. Dutcher asked about the type of products to be compounded by
the pharmacy.
Dr. Proefrock stated that they would be compounding products
for mesotherapies, prolotherapies, dermal fillers, and bio-identical hormone
replacement therapies.
Dr. Proefrock signed a statement that he will not
write any prescriptions that will be filled by the pharmacy.
Dr. Proefrock
is a naturopathic physician.
Mr. Wand stated that Mr. Pulver, the
Assistant Attorney General, has discovered that there is an injunction in
place from the FDA and the United States Government.
Mr. Pulver stated
that there is an injunction against the Cosmetic Pharmacy, Dr. Chad Livdahl,
Dr. Zahra Karim, and Toxin Research.
Mr. Pulver stated the injunction
states that if there is to be any change to the corporate structure, assets,
or sub-leasing that the FDA must be notified.
Mr. Pulver asked Dr.
Proefrock if he has anything from the defendants that they have notified the
FDA of this change.
Dr. Proefrock stated that he personally has contacted
the FDA to try and clear up any miscommunications.
Dr. Proefrock stated
that his understanding was that there were no issues.
Dr. Proefrock stated
that they purchased the clean room from the defendants.
Dr. Proefrock
stated that the easiest way for the new company was to keep the clean room at
the present location rather than dismantle the clean room and move it to a new
location. Dr. Proefrock stated that they do have a transfer of ownership
agreement signed by Dr. Livdahl.
Dr. Proefrock stated that they are a
separate entity from Dr. Livdahl's business.
Mr. Pulver asked Dr.
Proefrock if he has any documents from the FDA saying that the defendants
notified them of this ownership change.
Mr. Pulver stated that if Dr.
Proefrock does not have any documents from the FDA, then there is a violation
of the injunction.
Mr. Pulver stated that Dr. Livdahl must notify the FDA.
Mr. Pulver stated that the Board must have some documentation from the FDA
that the defendants have notified the FDA.
Dr. Proefrock stated that this
would be difficult for the defendants because they are incarcerated and the
defendant's ability to communicate with anybody is limited.
Mr. Pulver
stated that he is sure the FDA would speak with the defendants.
Dr.
Proefrock stated that when he contacted the FDA they stated that the
incarceration was a private matter and they would not discuss the issues with
him.
Mr. Pulver told Dr. Proefrock that the FDA must provide him with
documentation that they have spoken with the defendants or there could be a
violation of the injunction.
Mr. Pulver told Dr. Proefrock preferably the
documentation should come from the FDA.
Mr. Pulver told Dr. Proefrock that
the Board could only move forward after receiving this documentation.
Mr.
Pulver stated that he is not sure what the FDA will do concerning this
transaction.
Mr. Pulver stated that the injunction states that any
actions, such as sub-leasing or assignments, must be approved by the FDA to
ensure the defendants are complying with the order.
Mr. Wand gave the
defendants the necessary information to contact the local FDA office.
On motion by Mr. Dutcher and Mr. Van Hassel, the Board
unanimously agreed to table the application for The International Cosmetic and
Compounding Pharmacy until further documentation is received from the
applicants.
- Portable Medical Pharmacy of Arizona
Christopher
Smith, pharmacy owner, and Mike Donohue, Pharmacist In Charge, were present to
answer questions from Board Members.
President McCoy opened the discussion
by asking the applicants to describe their business.
Mr. Smith stated that
they would be opening an institutional pharmacy that provides services to
skilled nursing facilities in the Tucson area.
Mr. Wand asked Mr. Smith if
he operates a similar business in Nevada. Mr. Smith replied no. Mr. Smith
stated that they would have some strategic partners in Nevada.
Mr. Smith
stated that he owns some skilled nursing facilities. Mr. Smith has operated in
the Tucson area a radiology and cardiology business for skilled nursing
facilities.
Mr. Wand asked if his strategic partner in Nevada is a
licensed pharmacy.
Mr. Smith replied yes.
Mr. Wand asked if the Nevada
Board of Pharmacy has ever disciplined the pharmacy.
Mr. Smith replied no.
Mr. Wand asked if Mr. Donohue planned to remain as the Pharmacist In
Charge.
Mr. Donohue replied that this would be an interim position for
him.
Mr. Wand asked if they have been successful in recruiting a
pharmacist.
Mr. Smith stated that they are currently searching for a
pharmacist and are currently looking to relocate a pharmacist.
Mr. Wand
asked if they plan to sell drugs to doctors, clinics, or hospitals.
Mr.
Smith stated that they would only be selling to skilled nursing facilities.
Mr. Wand asked if the medications sent to the facility would be filled as
patient specific prescriptions.
Mr. Smith replied that the routine
medications would be dispensed from the pharmacy in Nevada and the stat
medicines and controlled substances would be filled at the Tucson site.
Mr. Wand asked if the strategic partner in Nevada is licensed as a
non-resident pharmacy in Arizona.
Mr. Smith replied no.
Mr. Wand asked
if the Nevada pharmacy was currently shipping drugs into Arizona.
Mr.
Smith replied that the pharmacy is not currently providing service to Arizona
residents.
Mr. Wand informed Mr. Smith that the Nevada pharmacy would have
to be licensed in Arizona prior to shipping products to Arizona.
Mr.
Dutcher asked if the pharmacy in Nevada would be labeling the product for the
facilities in Arizona. Mr. Smith replied yes.
Mr. Wand told Mr. Smith that
the next meeting would be held in August and the Nevada pharmacy might want to
have their permit approved at that meeting.
Mr. Van Hassel asked if the
records would be kept at the Tucson pharmacy.
Mr. Smith replied that
everything would originate in Tucson.
Mr. Wand stated that in order to
fill the prescriptions in Nevada the prescriptions would need to be
transferred by the Tucson facility.
Mr. Wand asked if they were planning
to use a central fill process.
Mr. Wand stated that they could either
transfer the prescriptions or have a central fill process approved.
Mr.
Wand explained that the central fill process would have one common database
and the prescriptions are filled with the same numbering system at both
facilities.
Mr. Smith stated that it would not be a central fill process.
Dr. Smidt reminded Mr. Smith that the process he selected would require a
pharmacist in Tucson to transfer all the prescriptions.
On motion by Mr. Dutcher and Mr. McAllister, the Board
unanimously approved the application for Portable Medical Pharmacy of Arizona
with the understanding that the strategic partner pharmacy in Nevada needs to
apply for a non-resident pharmacy permit in Arizona prior to shipping
medications to Arizona.
At the conclusion of questions from the Board Members and on motion
by Mr. Van Hassel and Mr. McAllister, the Board unanimously approved
the resident permits listed below. All approvals are subject to final
inspection by a Board Compliance Officer where appropriate.
- Cottonwood de Tucson
4110 W. Sweetwater Dr.
Tucson, AZ 85745
Cottonwood de Tucson, Inc.
- Bashas' United Drug #161
4940 S. Gilbert Rd.
Chandler, AZ 85249
Bashas' Inc.
- CVS/Pharmacy #7115
7530 W. Cactus Rd.
Peoria, AZ 85381
Peoria
AZ CVS LLC
- CVS/Pharmacy #7849
1015 E. Ray Rd.
Chandler, AZ 85225
CVS EGL
Ray McQueen AZ LLC
- CVS Pharmacy #5038
2010 S. Dobson Rd.
Chandler, AZ 85248
German Dobson CVS, LLC
- CVS/Pharmacy #7078
3303 S. Rural Rd.
Tempe, AZ 85281
Southern
Tempe AZ CVS
- Bashas' United Drug #160
2000 W. River Rd.
Tucson, AZ 85704
Bashas', Inc.
- Walgreens Drug #9057
18433 N. 19th Ave.
Phoenix, AZ
85009
Walgreen Arizona Drug Co.
- Wal-Mart Pharmacy #10-5428
1710 S. Greenfield Rd.
Mesa, AZ 85206
Wal-Mart Stores, Inc.
- Surgical Specialty Hospital of AZ
6501 N. 19th Ave.
Phoenix, AZ 85103
(O) Surgical Specialty Hospital of Arizona, LLC
- Wal-Mart Pharmacy #10-2671
1175 S. Arizona Ave.
Chandler, AZ 85248
Wal-Mart Stores, Inc.
- Melrose Pharmacy
709 W. Montecito Ave.
Phoenix, AZ 85013
Melrose Pharmacy, LLC
- Walgreens Drug #7933
15514 W. Waddell Rd.
Surprise, AZ 85379
Walgreen Arizona Drug Co.
- Graham Greenlee Pharmacy
620 Central Ave., Suite C,
Safford, AZ
85546
Morenci Healthcare Center, Inc.
- Safeway Pharmacy #1997
17049 W. Bell Rd.
Surprise, AZ 85374
Safeway, Inc.
- CVS/Pharmacy #07855
2601 S. Houghton Rd.
Tucson, AZ 85730
CVS
EGL Golf Links AZ, LLC
- Walton Drug of Morenci
408 Burro Alley
Morenci, AZ 85540
(O)
Debbie Walton
- Cornerstone Hospital of Southeast AZ
7220 E. Rosewood St.
Tucson,
AZ 85710
(O) Cornerstone Hospital of Tucson, LLC
- El Rio West Pharmacy
1701 West St. Mary's, Suite 150
Tucson, AZ
85745
El Rio Santa Cruz Neighborhood Health Center
- Walgreens Drug #09261
4710 E. Rose Garden Lane
Phoenix, AZ 85050
Walgreen Arizona Drug Co.
(O) = Ownership change
On motion by Mr. McAllister and Mr. Dutcher, the Board
unanimously approved the non-resident permits listed below.
- Atlas RX, Inc.
2208 S. Hickory St.
Foley, AL 36535
Atlas RX,
Inc.
- Encino Pharmacy
16500 Ventura Blvd. #110,
Encino, CA 91436
Ocean Drug, Inc.
- MSC- Medical Services Company
11764 Marco Beach Dr.
Jacksonville,
FL 32224
MSC- Medical Services Company
- Lifecare Solutions, Inc.
170 N. Daisy Ave.,
Pasadena, CA 91107
Lifecare Solutions, Inc.
- Advanced Pharmacy Services
744 Horizon Ct., Ste 110,
Grand
Junction, CO 81506
Advanced Pharmacy Services, LLC
- AmMed Homecare Pharmacy
1657 Murfreesboro Rd.
Nashville, TN 37217
American Health Centers, Inc.
- Galloway Pharmacy
2995 National Ave.
San Diego, CA 92113
Galloway, Inc.
- Accu-Care Services, Inc.
18812 S. Dixie Hwy.
Miami, FL 33157
Accu-Care Services, Inc.
- Prime Therapeutics LLC
2901 Kinwest Parkway, Bldg. B
Irving, TX
75063
Prime Therapeutics LLC
- Budget Drug Rx
1137B Bustleton Pike
Feasterville, PA 19053
Charlotte Lopacki
- Pro Med Pharmacies, Inc.
701 N. Taylor
Amarillo, TX 79107
Pro
Med Pharmacies, Inc.
- Kohll's/Rx MPSS Pharmacy
4230 L. Street
Omaha, NE 68107
Kohll's Pharmacy & Homecare, Inc.
- PBM Plus Mail Service Pharmacy
300 Technecenter Dr., Suite C
Milford, OH 45150
PBM Plus Mail Service Pharmacy, LLC
Wholesale Permits
- President McCoy stated that all permits were in order and representatives
from two resident wholesalers were present to answer questions from Board
Members.
Michael Jones, president and owner of Gallipot, appeared to
answer questions from Board Members.
Mr. Jones is a pharmacist.
President McCoy opened the discussion by asking Mr. Jones to describe the
nature of his wholesale business.
Mr. Jones stated that Gallipot is a
company that he and his wife, who is also a pharmacist, started 25 years ago.
Mr. Jones stated that they would like to open a distribution center in
Scottsdale.
Mr. Jones stated that they sell compounding supplies and
chemicals to pharmacies.
Mr. Jones did sign and return the wholesale
orientation form for wholesalers.
- Phoenix Long Term Care Pharmacy
Steven Hardman, the
managing partner, was present to answer questions from Board Members.
President McCoy opened the discussion by asking Mr. Hardman to describe
the nature of his wholesale business.
Mr. Hardman stated that the business
is a long term care pharmacy that has recently contracted with a county
correctional facility. The long term care pharmacy has been asked to supply
bulk medications to the clinic and that is why they are applying for the
wholesale permit.
President McCoy asked Mr. Hardman to discuss the housing
of his wholesale business in the same suite as his pharmacy business.
Mr.
Hardman stated that the wholesale permit is being requested because of the
correctional facility business.
Mr. Hardman stated that the facility would
be ordering from them once a week.
Mr. Hardman stated that they also
provide the unit dose for the facility.
Mr. Hardman stated that it would
be a minor part of their business, but it would be greater than 5% of their
total business.
Mr. Wand asked if an individual would need to pass through
the pharmacy to reach the wholesale area.
Mr. Hardman stated that the
pharmacy has an entrance in back and an individual would enter through the
front office to reach the wholesale area.
Mr. Wand asked if only a
pharmacist could enter the pharmacy area.
Mr. Hardman replied yes.
Mr.
Hardman replied that there is a locked door between the two areas.
Mr.
Dutcher asked if the wall that separates the two areas is presently there.
Mr. Hardman replied yes. Mr. Wand reminded Mr. Hardman that an inspection
would be conducted before the permit is issued and that the wall between the
two areas must go to the true ceiling for security procedures.
Dr. Smidt
asked if the pharmacy would be shipping more than 5% of its sales to the
correctional facility.
Mr. Hardman replied that is the reason he is
applying for the wholesale permit.
Mr. Wand asked to whom Mr. Hardman
would be issuing the invoice at the correctional facility for the bulk
products.
Mr. Hardman stated that the medications would be invoiced to the
Medical Director.
Mr. Wand reminded Mr. Hardman that he signed the
wholesale agreement, which states that he cannot repackage any products.
On motion by Mr. Dutcher and Mr. Van Hassel, the Board
unanimously approved the resident wholesale permits listed below. All permits
are subject to final inspection by a Board Compliance Officer where
appropriate.
- Gallipot
7441 E. Butherus Dr.
Scotttsdale, AZ 85260
Gallipot,
Inc.
- Phoenix Long Term Care Pharmacy
4630 E. Elwood St. #15
Phoenix, AZ
85040
Korman, LLC
- Smilessence Teeth Whitening Systems
2222 S. Harper St.
Mesa, AZ
85212
Jonathan Marquand
- Butler Animal Health Supply LLC
4635 W. McDowell Rd., Suite 130
Phoenix, AZ 85035
(O) Butler Animal Health Holding Co., LLC
(O)= Change of ownership
Pharmacist, Pharmacy Interns, and Pharmacy Technician
Licenses
Following a review of the roster of applicants for licensure as pharmacists
and assurance by the staff that all applications were in order and all fees
paid: On motion by Mr. Dutcher and Mr. Van Hassel, the Board
unanimously approved the Pharmacists licenses 14684 through 14782.
Following a review of the roster of applicants for licensure as pharmacy
interns and assurance by the staff that all applications were in order and all
fees paid: On motion by Mr. Van Hassel and Dr. Smidt, the Board
unanimously approved the Pharmacy Intern licenses from 6872 through 6981.
Following a review and discussion of the roster of applicants for licensure
as pharmacy technicians and assurance by the staff that all applications were in
order, with the exception of #7342, and all fees were paid: On motion by
Mr. McAllister and Mr. Dutcher, the Board unanimously approved the
Pharmacy Technician licenses 7179 through 7797, with the exception of license
#7342 for applicant Jill Gerkin, which was denied by the Board. (For discussion
of #7342, see Agenda Item #13). Also, approved were 95 licensee changes from
Pharmacy technician trainee to Pharmacy technician. For a complete list of names
see attachments.
AGENDA ITEM 4 -
Reports
Executive Director
Executive Director Wand began his report by discussing the financial
statements. Mr. Wand stated that some of the excess funds have been spent to
remodel the office. Mr. Wand stated that new furniture has been purchased for
the office staff that is ergonomically correct. Mr. Wand stated that the back
conference is being enlarged. Mr. Wand stated that there would be a small
conference room built that the Board can use to conduct an executive session
instead of asking the audience to leave the room.
Mr. Wand stated that the electronic Board Meeting equipment has been
purchased. Mr. Wand stated that 13 laptops have been purchased. Mr. Wand stated
that a CD duplicator has been purchased. Mr. Wand stated that a CD would be sent
to all the Board Members prior to the Board Meeting.
Mr. Wand stated that GITA (Government Information Technology Agency) has
approved the Board of Pharmacy to be a pilot for electronic renewals. The Board
of Pharmacy was selected from the thirty health care boards to be the pilot. Mr.
Wand stated that he anticipates having electronic renewals this October or next
October. Mr. Wand stated that in the future an applicant might be able to apply
on line with a credit card.
Mr. Wand stated that he has submitted a grant application to the Department
of Justice for $50,000. The grant would be used to assess the possibility of
implementing a Prescription Drug Monitoring Program. Mr. Wand stated that the
Board should hear by August if the Board has been approved to receive the
grant.
Mr. Wand stated that the Board's new statutes would take effect on August 12,
2005. Mr. Wand stated that the Boards and Commissions Office is being deluged
with new applications for new Board Member positions. Mr. Wand stated that the
number of Board Members would go from seven (7) Board Members to nine (9) Board
Members. The Board will add one technician and one pharmacist as new Board
Members. Mr. Wand stated that the Board Meeting room is being remodeled. Mr.
Wand stated that most meetings would then be held at the Board Office in the
future. Mr. Wand stated that the Board Meeting room should be completed by
August 12, 2005.
Deputy Director Report
Deputy Director Frush directed the Board Members attention to the activity
reports for the Compliance Staff. Ms. Frush indicated that the Compliance Staff
is currently ahead of the number of inspections completed at this time last
year. Ms. Frush indicated that the numbers of complaints are consistently
increasing and the staff is spending time investigating complaints and cases of
drug diversion. Ms. Frush indicated that the Drug Inspector has issued 65
letters from March through May. The majority of the Drug Inspector's letters
have been for outdated non-prescription medications.
Ms. Frush stated during the months of March, April, and May, the Compliance
staff issued letters for the following violations:
- 1. Outdated RX and OTC products in the pharmacy - (13)
- 2. Allowing technicians that are not licensed to work -(11)
- 3. Technician statements not signed - (11)
- 4. Failure to document disease and medical conditions- (9)
- 5. Controlled Substance Overages - (7)
- 6. Controlled Substance Shortages - (5)
- 7. Failure to have pharmacist or technician license available for review -
(4)
- 8. Failure to post wall certificates (Technicians) - (3)
- 9. Failure to post pharmacy permit - (1)
- 10. Annual Controlled Substance Inventory not completed - (2)
- 11. Annual Controlled Substance Inventory counted incorrectly - Counted
bottles - (1)
- 12. Unable to locate Controlled Substance Inventory - (2)
- 13. Failure to complete a Controlled Substances Inventory upon PIC change
- (1)
- 14. Failure to inventory CIII-CV at change of Pharmacist-In-Charge - (2)
- 15. Dispensed a CII prescription past the 60 day limit - (2)
- 16. Dispensed a CII prescription with missing information and no call made
to provider - (1)
- 17. Failure to obtain approval for central record keeping of controlled
substances (DEA) - (2)
- 18. Inadequate CII record keeping - (filing and missing invoices) - (1)
- 19. Failure to receive an original hard copy of a CII Emergency
prescription - (1)
- 20. No daily prescription log - (1)
- 21. Failure to sign daily prescription logs - (3)
- 22. Oral Prescriptions not initialed by transcribing pharmacist - (2)
- 23. Failure to document required information on an oral prescription - (1)
- 24. Failure to enter date of issuance correctly - (1)
- 25. Pharmacy Computer not functioning and reverted to manual system - (1)
- 26. Failure to provide adequate security for prescription blanks in a
hospital - (1)
- 27. Failure to store IV Solutions in a locked storage area at a hospital -
(1)
- 28. Inadequate temperature control in the pharmacy - (1)
- The following areas were noted on inspection reports for improvements :
- 1. Wall licenses of pharmacists and technicians need to be posted.
Licenses must be available for review.
The following areas were noted on the inspection reports where pharmacists
and technicians are meeting or exceeding standards :
- 1. Counseling
Areas outside the inspection reports that may be of interest :
- 1. Changes of employment and addresses can be made online at the Board
Website
- 2. Be sure that an individual is licensed with the Board before allowing
them to work in the pharmacy.
Mr. Dutcher asked if the Board contacts the prescriber if a CII is not
received when an emergency prescription is issued. Ms. Frush stated that it is
the responsibility of the pharmacist to notify the prescriber and DEA if the
prescription is not received. Mr. Wand added that the pharmacist must notify
the Board and DEA, but it is their responsibility to obtain the prescription.
Mr. Dutcher asked about the pharmacy that reverted to a manual system. Ms.
Frush indicated that the pharmacy must notify the Board when these changes
occur and when the problems are resolved, so that the system can be verified
by a compliance officer that the system complies with the rules.
Ms. McCoy stated that while reviewing complaints she has noted that
prescriptions transcribed by some pharmacists are as bad as the prescriptions
written by some physicians. Ms. McCoy stated that some pharmacists are using
abbreviations that are confusing. Ms. McCoy stated that the drug name should be
clearly written and that the strength and directions should be clearly
readable.
Ms. Frush acknowledged a letter received from the Office of Environmental
Programs for the City of Phoenix thanking Mr. Wright for attending their recent
meeting. The meeting addressed the issues of the disposal of pharmaceuticals.
Mr. Wright stated that the Commission was researching the issues of medication
disposal. Mr. Wright stated that the Commission is in a fact- finding mode at
this time.
APA
Kathy Boyle was present to represent the Arizona Pharmacy Alliance. Ms. Boyle
welcomed the Board and the audience to the convention. Ms. Boyle discussed the
various bills that were considered during the legislative session that ended on
May 13, 2005.
AGENDA ITEM 5 - Special
Requests
AGENDA ITEM 6 - USP 797
Presentation
Board Member, Tom Van Hassel gave an overview of USP 797. Mr. Van Hassel
stated that USP 797 deals with the preparation of sterile products. In 2004, USP
developed a set of standards to be followed by institutions preparing sterile
products.
Mr. Van Hassel stated that USP 797 would require system changes, policy and
procedure changes, quality practice changes, physical area renovations at most
sites, training changes, and documentation changes. Mr. Van Hassel stated that
JCAHO is requiring facilities to do complete an analysis of their current
system.
Mr. Van Hassel stated that there would be changes in cleaning procedures. Mr.
Van Hassel stated that there would be monitoring changes. Mr. Van Hassel stated
that there would be documentation changes.
Mr. Van Hassel stated that employees must complete an annual training
program. The program would consist of both didactic and written training.
Mr. Van Hassel stated that the USP 797 would assess various risk levels in
preparation of sterile products.
Mr. Van Hassel stated that USP is conducting area meetings to gather
information concerning the implementation of USP 797.
AGENDA ITEM 7 - Selection of USP 797
Task Force
The following individuals have agreed to serve on the USP 797 task force
:
Joe Foo (Cardinal Health)
David Feldman (Maryvale Hospital)
Geoff Tatelbaum (Coram Health Care)
Christopher Stoffel (New University of Arizona graduate)
Rich Gaffin (Pet Health)
Wallace Simons (Women's International Pharmacy)
Hal Wand, Cheryl Frush, and Dean Wright (Board Staff)
Chaired by Tom Van Hassel and Ridge Smidt (Board Members)
AGENDA ITEM 8 - Presentation - Primary
Care Clinicians and Prescription Drug Abuse
President McCoy introduced Katie Shubin, a recent graduate of Midwestern
University's master degree program for physicians assistants and Dr. Jim Stoehr,
a professor with Midwestern University. Ms. Shubin appeared to present her paper
entitled, "Attitudes, Behaviors, and Knowledge of Arizona Primary Care
Clinicians Regarding Prescription Drug Abuse.
Ms. Shubin stated that for the last year she had conducted a study concerning
prescription drug
abuse. Ms. Shubin's study assessed the practices, knowledge, and attitudes of
Arizona primary care clinicians to determine the educational needs of these
primary care providers regarding prescription drug abuse. Ms. Shubin stated that
a needs assessment survey was distributed to 1,000 primary care clinicians
including MDs, DOs, and PA's currently practicing in Arizona.
Ms. Shubin stated that two hundred and forty-two surveys (242) were
returned.
Ms. Shubin stated that the respondents correctly identified terms related to
drug abuse overall 77% of the time. Ms. Shubin stated that 91% of Arizona
clinicians view prescription abuse as a significant problem in Arizona. Ms.
Shubin stated that 89% of the respondents supported the implementation of a
prescription drug monitoring program in Arizona.
Ms. Shubin stated that the results of the study indicated that there is a
need for increased education among primary care clinicians regarding
prescription drug abuse.
Mr. Dutcher asked Ms. Shubin how she planned to educate the prescribers. Ms.
Shubin stated that she hopes to publish the article. Ms. Shubin stated that the
topics could be addressed by offering CME courses. Dr. Stoehr stated that the
school would offer the CE courses because that would be above the level of a
student.
Mr. Dutcher asked Ms. Shubin and Dr. Stoehr how they planned to distribute
the information to the clinicians. Dr. Stoehr stated that they would like to
provide tip sheets to the clinicians. Dr. Stoehr stated that they plan on adding
this information to courses currently being taught at the University.
Mr. McAllister stated that it is important to note that 89% of the
respondents were in favor of implementing a prescription drug monitoring
program.
The Board recommended that Ms. Shubin and Dr. Stoehr share this information
with the Arizona Medical Board and the Arizona Medical Association.
President McCoy thanked Ms. Shubin and Dr. Stoehr for sharing this
information with the Board.
AGENDA ITEM 9 - Review and Response to
Letter from Dennis Kendall, Assistant
Director of Health Services, Arizona Department of
Corrections
(Duty of a Pharmacy Technician)
Paulette Boothby, Acting Pharmacy Program Manager, and Marilyn Wand, Pharmacy
Manager at the Lewis Prison Complex, were present to address Board Members
issues.
Mr. Wand opened the discussion by stating that he received a letter from
Dennis Kendall concerning technician duties at the prison. Mr. Wand stated that
there are two questions. The first question is that they want pharmacy
technicians to perform duties at a prison facility that no longer has a pharmacy
permit due to budgetary concerns. Mr. Wand stated the activities that the
individuals will perform are on pages 1 and 2 of the letter. Mr. Wand stated
that he feels that some of the duties are clerk duties. Mr. Wand stated that the
first question is are the listed activities technician duties. Mr. Wand stated
that the second question is to whom this person would report. Mr. Wand stated
that these individuals were pharmacy technicians when the pharmacy was present
at the prison. Mr. Wand stated that it is still a requirement that the
individual be a pharmacy technician to hold this position. Mr. Wand stated that
they want to call these individuals administrative assistants and should they
report to a pharmacist.
President McCoy asked the participants to address the issue of to whom the
technicians would report. Ms. Boothby stated that they are proposing that the
title be changed from pharmacy technician to administrative clerk and they would
report to the facility health administrator.
Ms. McCoy asked if the clerks would be required to be licensed pharmacy
technicians. Ms. Boothby replied no. Ms. Boothby stated that this job would be
administrative.
Ms. McCoy asked if any patient health information would be available to these
clerks. Ms. Boothby stated that the clerks would have access to a reader that
would enable the clerk to verify if the medication has been sent and it will
allow them to print an MAR for healthcare providers.
Mr. Wand asked about the Health Needs Request Form. Mr. Wand asked about the
procedure if a patient asked a health related question on this form. Ms. Boothby
stated that the form would be faxed to the pharmacy and a pharmacist would
answer the question.
Ms. Wand stated that duties that the clerks would be asked to perform do not
require that a pharmacy technician perform these duties. Ms. Wand stated that at
the Winslow pharmacy the nursing staff is performing these duties and there have
been no problems.
Ms. Wand stated that the HNR forms are triaged by nursing and they determine
if the form is faxed to the pharmacy. Ms. Wand stated that in most cases the
forms are faxed to the pharmacy by nursing, not by the administrative clerk.
Dr. Smidt asked if the administrative clerk could view the patient's profile.
Ms. Wand replied in a read only fashion, just like the nursing personnel. Ms.
Wand stated that they could not make a change to the profile. Ms. Wand stated
that the prison system is exempt from HIPAA.
Ms. McCoy stated that this position would be similar to a health unit
secretary in the hospital and that individual reports to nursing. Mr. McAllister
stated that the position is similar to a medical records clerk in a physician's
office.
Mr. Wand stated that a licensed pharmacist from one of the regional
pharmacies would do a quarterly inspection at the prisons that do not have a
pharmacy. Ms. Boothby stated that those inspections would continue.
Mr. Van Hassel asked if there would be storage of unlabeled medications at
these facilities. Ms. Boothby stated that there would be a remote drug storage
area. Ms. Boothby stated that when the patient is seen, the prescriber would
authorize a nurse to pull and label the prescription.
Ms. McCoy asked if the administrative clerk would refill the remote drug
storage area. Ms. Boothby stated that it is possible that they could restock the
remote drug space. Ms. Wand stated that the clerk would order the medication
from the regional pharmacy and place the item in the remote area. Ms. McCoy
asked about the checking process to insure that the drugs are placed in the
remote drug storage area. Ms. Boothby stated that the nursing staff inventories
the remote drug storage area daily. Ms. Boothby stated that quarterly the
pharmacist would check the remote drug storage area when performing their
quarterly inspection.
The Board agreed that the duties were not technician duties and the employees
could report to the health care administrator. The Board authorized Mr. Wand to
respond accordingly.
AGENDA ITEM 10 - Fry's Electronic
Prescribing - Arizona Pilot
Matthew Feldman and Terry Daane presented Fry's Electronic Prescribing
Pilot.
Mr. Feldman opened the discussion by reviewing the benefits of e-
Prescribing. Mr. Feldman stated that e-Prescribing reduces handwritten
prescription illegibility issues, enhances security, data integrity, and forgery
protection, reduces time consuming phone calls and faxes, increases ability to
obtain responses from both prescribers and pharmacies, increases the ability to
see and be able to interact with patients on the estimated 20% of new
prescriptions that are not otherwise presented to the pharmacist, and improves
patient service.
Mr. Feldman stated that the physician may send new prescription orders to the
pharmacy, the pharmacy may send refill requests to the physician, and the
physician may approve or deny refill requests from the pharmacy.
Mr. Feldman reviewed the system components and the security features. Mr.
Feldman stated that only authorized individuals that are trained and qualified
personnel with password protected access will have access to the software and
activity.
Mr. Feldman reviewed the electronic prescribing process. Mr. Feldman stated
that if any errors or omissions are detected, the electronic prescription
message is returned to the originating system with a reject status message. The
system will not detect formulary rejections.
Mr. Feldman stated that the prescriptions at the pharmacy end would be
formatted for prescription filling. A hard copy would be printed and filed in
the pharmacy.
Mr. Dutcher asked if they are using a third party. Mr. Feldman stated that
the third party validates the prescriber and translates the data in a secure
fashion.P>
Ms. McCoy asked about the error messaging. Mr. Feldman replied that it only
searches that each field is filled with data. Ms. McCoy stated that just because
a prescription is readable that the pharmacist should still be aware that errors
could occur.
Mr. Wand stated that the Board does not need to take action on this agenda
item that it is for informational purposes only because the process will comply
with the electronic prescribing rules.
President McCoy recessed the meeting for lunch.
President McCoy reconvened the meeting at 1:15 P.M.
AGENDA ITEM 11 -Feasibility of
Attendance at CLEAR Conference - Board Members and Staff
Mr. Wand opened the discussion by stating that the 2005 CLEAR Conference will
be held in Phoenix this year. Mr. Wand stated that programs would be available
for both Board Members and Compliance Officers. Mr. Wand stated that funds would
be available if any Board Members or Staff would like to attend the
conference.
The Board Members decided to list this as an agenda item for the next Board
Meeting and to let Mr. Wand know if anyone was interested in attending the
conference.
AGENDA ITEM 12 - Review of Hearing to be
referred to Office of Administrative Hearings (OAH)
President McCoy opened the discussion by stating that Mr. Wand has prepared a
Notice of Hearing to refer this case to the Office of Administrative Hearings.
Ms. McCoy stated that the case involves drug-related allegations against a
technician. Ms. McCoy stated instead of the Board hearing the case, the Board
could refer the case to the Office of Administrative Hearings. The Office of
Administrative Hearings would hear the case and make a recommendation to the
Board. Mr. McAllister stated that he felt that this would be an excellent test
case to send to the Office of Administrative Hearings.
On motion by Mr. Van Hassel and Mr. Dutcher, the Board
unanimously agreed to send this case to the Office of Administrative Hearings.
AGENDA ITEM 13 - Review of Jill Gerkin's
Technician Application
President McCoy opened the discussion by stating that the Board has received
additional information concerning application #7342 submitted by Jill Gerkin.
Ms. McCoy asked if Ms. Gerkin was present.
Ms. Gerkin came forth to discuss the application.
Ms. McCoy stated that the Board has received information that addresses a
felony conviction that was not disclosed on the application by Ms. Gerkin. Ms.
McCoy stated that the applicant has provided false or misleading information on
her application.
Ms. Gerkin stated that this was the first application that she filled out
since her conviction and it was an honest mistake. She stated that she did not
try to hide anything.
Mr. Pulver stated that the Board should review the application and ask the
applicant why she answered NO to question 7, which asks about felony
convictions.
Ms. McCoy read Question 7, which states, "Has the applicant had any
convictions involving a misdemeanor, felony offense, or any drug-related
offenses? Note: Even though a conviction has been vacated, pardoned, expunged,
dismissed, or appealed or your civil rights restored, you are required to answer
"YES." Ms. McCoy told Ms. Gerkin that she clearly checked No on the application.
Mr. Pulver stated that Question 8 states that if an applicant has been
convicted that they must provide a copy of that conviction with the application.
Ms. Gerkin again stated that it was an honest mistake and she said that she was
not thinking because this was the first application that she filled out since
the felony conviction.
Ms. McCoy stated that many of the duties and responsibilities of a pharmacy
technician require that the technician be familiar with the rules and
regulations of the Board of Pharmacy. Ms. McCoy stated that Ms. Gerkin did not
take the application seriously and that bothered her. Ms. McCoy asked Mr. Pulver
if the Board denied the application does she have the opportunity to apply at a
later date. Mr. Pulver stated that the applicant could reapply and the Board
could say no. Mr. Pulver stated that the applicant could appeal the decision.
Mr. Pulver stated that the applicant did not come back to the Board and report
herself. Mr. Pulver stated that the applicant did not come back to the Board
with the information, but it through the diligence of this Board that the
information was obtained. Mr. Wand stated that it was reported to the Board by
someone who works at the pharmacy. Mr. Wand stated that background checks are
not performed when applications are submitted.
Mr. Van Hassel asked Ms. Gerkin about her pharmacy background. Ms. Gerkin
stated that she worked at Safeway and is now employed at Casa Grande Hospital.
Ms. Gerkin stated that the conviction occurred in 2003. Mr. Dutcher asked if she
was working as a pharmacy technician when the conviction occurred. Ms. Gerkin
replied yes.
A roll call vote was taken. (Mr. McAllister-nay, Mr. Dutcher
- aye, Mr. Van Hassel - aye, Dr. Smidt- aye, and President McCoy -aye). The
Board Members voted to deny the application of Jill Gerkin to be licensed as a
pharmacy technician.
Ms. McCoy stated that it is the duty of the Board to protect the public and
as a result the Board could not approve her request to become a pharmacy
technician.
AGENDA ITEM 14 - Proposed Rules and
Five-Year Review
Pharmacist-administered Immunizations Rule
Compliance Officer/Rules Writer Dean Wright stated that he is submitting for
the Board's approval the changes made to the Pharmacist-administered
Immunizations rule. Mr. Wright stated that the changes include the following:
change pneumonia to pneumococcal, tetanus toxoid to tetanus booster, and add
language to allow the administration of diphenhydramine during emergency
situations.
The Board gave Mr. Wright approval to proceed with the rulemaking
process.
Graduate Intern Rule
Mr. Wright stated that he is submitting for the Board's approval the Notice
of Final Rulemaking
and the Economic Impact Statement for the Graduate Intern Rules. Mr. Wright
stated that he published a Notice of Proposed Rulemaking in the Arizona
Administrative Register on April 8, 20205 for the Graduate Intern Rule. A
hearing was held on May 16, 2005. Janet Elliott representing the Arizona
Community Pharmacy Committee presented verbal and written comments supporting
the proposed rulemaking. Mr. Wright stated that if approved by the Board the
Notice of Final Rulemaking and the Economic Impact Statement would appear on
GRRC's August 2, 2005 hearing agenda for final approval and if approved by GRCC
the rule will become effective on October 8, 2005.
On motion by Mr. McAllister and Mr. Dutcher, the Board
unanimously agreed to approve the Notice of Final Rulemaking and Economic Impact
statement for the Graduate Intern Rules.
Five -Year Review
Mr. Wright stated that the 5-year review for Articles 7, 9, and 10 is due
June 30, 2005. The review states that the Board will be amending all the rules
in Article 7 and R4-23-1003. Mr. Wright indicated that there is a time frame for
amending the rules. Mr. Wright stated that R4-23-1003 (A) (1) (f) and (A) (4)
should be amended to require records be retained for seven years instead of
three years to conform to other rules and statutes.
President McCoy stated that she felt a task force would be necessary to
review the Long Term Care Rules. Ms. McCoy indicated that the Board could
discuss the establishment of a task force at the next Board meeting. Ms. McCoy
indicated if any one was interested in serving on the task force that they could
contact Mr. Wand at the office.
On motion by Dr. Smidt and Mr. McAllister, the Board
unanimously approved the Five-Year Review.
Mr. Wright stated that the Counseling Rules would become effective on August
6, 2005.
AGENDA ITEM 15- Complaint
Review
The Consumer Complaint Review committee met prior to the Board Meeting to
review 43 complaints. Mr. Dutcher and Dr. Tippett served as the review
committee. Board Members were encouraged to discuss issues and were encouraged
to ask questions. Board Members discussed Complaints #2909, #2913, #2919, #2926,
#2928, #2935, and #2955.
On motion by Mr. Van Hassel and Mr. McAllister, the Board
unanimously approved the recommendations of the Complaint Review Committee.
The following summary represents the final decisions of the Board in each
complaint.
- Complaint # 2906 - Letter
- Complaint # 2909 - Conference
- Complaint # 2911 - No FurtherAction
- Complaint # 2912 - No Further Action
- Complaint # 2913 - No Further Action
- Complaint # 2914 - Conference
- Complaint # 2915 - Conference (Pharmacist and Technician)
- Complaint # 2916 - Conference
- Complaint # 2917 - No Further Action
- Complaint # 2918 - Letter
- Complaint # 2919 - Letter
- Complaint # 2920 - No Further Action
- Complaint # 2921 - No Further Action
- Complaint # 2922 - No Further Action
- Complaint # 2923 - Conference (Pharmacist and Technician)
- Complaint # 2924 - No Further Action
- Complaint # 2925 - Conference (Pharmacist and Technician)
- Complaint # 2926 - Conference
- Complaint # 2927 - Withdrawn
- Complaint # 2928 - No Further Action
- Complaint # 2929 - Conference
- Complaint # 2930 - Conference
- Complaint #2932 - No Further Action
- Complaint # 2933 - No Further Action
- Complaint # 2934 - Consent/Hearing
On motion by Mr. Dutcher
and Mr. Van Hassel, the Board unanimously agreed to refer this case
to OAH if the technician does not sign the consent agreement.
- Complaint # 2935 - Letter
- Complaint # 2936 - No Further Action
- Complaint # 2937 - Letter
- Complaint # 2938 - Consent/Hearing
- Complaint # 2939 - Letter
- Complaint # 2940 - Conference
- Complaint # 2941 - Consent/Hearing
On motion by Mr. Dutcher
and Mr. Van Hassel, the Board unanimously agreed to the Hearing being
heard by the Board if the technician does not sign the consent.
- Complaint # 2942 - No Further Action
- Complaint # 2943 - No Further Action
- Complaint # 2944 - Conference
- Complaint # 2945 - No Further Action
- Complaint # 2949 - Consent/Hearing
- Complaint # 2950 - Consent/Hearing for Pharmacist; Conference for the
Pharmacy Technician
- Complaint # 2951 - Consent/Hearing
- Complaint # 2952 - Table
- Complaint # 2953 - Conference
- Complaint # 2954 - Consent/Hearing
- Complaint # 2955 - Consent/Hearing
Ms. McCoy asked that technician education be placed on the agenda for the
next Board Meeting.
Ms. McCoy stated that the technicians do not realize the importance of being
licensed and the expectations of the Board.
AGENDA ITEM 16 -
Conferences
- Complaint #2875
Pharmacist Jay McCoy and Pharmacy Supervisor Fauzia Somani were present in
response to a consumer complaint. Compliance Officer Rich Cieslinski gave a
brief overview of the complaint.
Mr. Cieslinski stated that a prescription for Zantac Syrup was filled with
Zrytec syrup. The patient was a two- month -old infant and was given 120 doses
before it was determined that the wrong drug had been dispensed.
President McCoy asked Mr. McCoy to address the error. Mr. McCoy stated that
the doctor phoned in a new prescription for the Zantac Syrup. Mr. McCoy stated
that the prescription was entered correctly but was incorrectly dispensed and
verified. Mr. McCoy stated that the patient received Zyrtec Syrup instead of
Zantac Syrup.
Ms. McCoy asked Ms. Somani why sound alike and look alike drugs were stored
by each other on the shelf. Ms. Somani stated the company has addressed the
issue. Ms. Somani stated that every store must separate the two products. Ms.
Somani stated that Zyrtec is on the fast rack and the Zantac is either in the
alpha or liquid section. Ms. Somani stated that both products are tagged with
orange shelf screamers. Ms. Somani stated that every supervisor has had to
verify that each store has these two products separated in the pharmacy.
Ms. McCoy stated that this is a common error and information has been
published concerning this error, yet action is not taken until a catastrophic
event occurs.
Mr. Dutcher stated that the label is attached to the stock bottle and the
error is blatant because the bottle says Zyrtec and the pharmacy label says
Zantac. Mr. Dutcher stated that the product was not verified. Mr. Dutcher told
the pharmacist that he needs to slow down and verify the prescriptions.
Mr. Van Hassel asked about the information given to a patient during
counseling. Mr. McCoy stated that the patient is told the directions and the
use of the medication. Mr. McCoy stated that the product was labeled correctly
and the patient was counseled from the patient literature, which indicated
that the correct medication was given. Mr. Dutcher asked if the patient was
shown the medication. Mr. McCoy stated that they did not open the bag.
Mr. Dutcher asked about changes to prevent this error. Mr. McCoy stated
that in addition to the shelf stickers, the staff has been educated, and the
error was reported to the ISMP website.
Mr. McCoy stated that they have received the electronic scale, which
provides an NDC check.
Ms. McCoy asked if the pharmacists have access to the ISMP newsletter. Ms.
Somani stated that every store has access to the ISMP website. Ms. Somani
stated the company has a new error reporting system, which will alert all
stores about errors that have occurred.
- COMPLAINT # 2879
Pharmacist David Carrick and Pharmacy Supervisor Melanie Malee were present
to address a consumer complaint. Compliance Officer Sandy Sutcliffe gave a
brief overview of the complaint.
Ms. Sutcliffe stated a patient received Epivir and Epzicom instead of
Viramune and Epzicom. The patient took the incorrect medication combination
for 30 days.
Mr. Carrick stated on the 17th of November, a prescription for
Epivir was filled because it was on the autofill system. When the patient came
in on the 20th of November, the patient filled her Epzicom. The
patient did not request the Viramune. The patient was given the Epzicom that
was filled that day and the Epivir that was on filled on the
17th.
Ms. McCoy asked if Mr. Carrick has made any changes in his practice. Mr.
Carrick stated that when he refills prescriptions, he goes over the names of
the medications with the patient. He stated that if a prescription is already
filled he asks the patient if they still need that prescription.
Mr. Dutcher asked Mr. Carrick if he thought the autorefill was a case of
the confusion. Mr. Carrick stated that he is not sure if the patient would
have asked for the second medication.
Ms. Malee states that many physicians like that the medications are
autofilled for HIV patients to improve compliance.
Ms. McCoy indicated in the reply it was stated that the computer triggered
no drug-drug interaction. Ms. Malee stated that they are working with Medispan
to correct the problem.
- Complaint # 2880
Pharmacist Nhung Nguyen and Pharmacy Supervisor Jeff Ramsey were present to
address a consumer complaint. Compliance Officer Rich Cieslinski gave a brief
overview of the complaint.
Mr. Cieslinski stated that a patient at a Long Term Care facility was to
receive 3 IV bags of Levaquin 250mg/50ml, but received 3 IV bags of Levaquin
500mg/100ml labeled as Levaquin 250mg/50ml. The error was caught by a nurse
prior to administering the medication to the patient.
President McCoy asked Mr. Nguyen about the error. Mr. Nguyen stated that he
worked by himself. Mr. Nguyen stated that he did not have any technician help.
Mr. Nguyen stated that there were a lot of orders that evening and he was
working alone. He stated that he was notified of the error the next day. Mr.
Nguyen believes that he confused the labels on two prescriptions, but he could
not check the prescription again because the driver had already left.
Ms. McCoy asked Mr. Nguyen if he has changed anything in his practice to
avoid making this error again. Mr. Nguyen stated that the items have been
separated on the shelves.
Mr. Ramsey stated that this is the first error that Nhung has made. Mr.
Ramsey stated that the products have been separated. Mr. Ramsey stated that
they are working with their IT people to be able to scan barcodes on their IV
products to avoid errors.
Mr. Dutcher stated that the pharmacist needs to check the label against the
product. Mr. Ramsey stated that they are no longer short staffed and there is
adequate help during peak hours.
- Complaint # 2881
Pharmacists Thomas Harker and Bruce Celiz-Hagen were present to respond to
a consumer complaint. Sandy Sutcliffe gave an overview of the complaint.
Ms. Sutcliffe stated that the complaint was filed by a long term care
facility that sent information on five separate dispensings that they
documented as medication errors. One prescription had the wrong patient name,
three were wrong medications dispensed, and one was the wrong strength of
medication was dispensed.
President McCoy asked Mr. Harker to address the issues. Mr. Harker stated
that he reversed the labels on two medication cards. Ms. McCoy asked if these
were pre-packaged cards. Mr. Harker replied yes.
Ms. McCoy asked Mr. Harker if he has changed his practice. Mr. Harker
stated that it was too much for his business, so he terminated the contract
with the pharmacist, the technician, and the care facility.
Ms. McCoy asked Mr. Celiz-Hagen to address his errors. Mr. Celiz-Hagen
stated that one was a phone call with the wrong patient's name and he is not
sure if there was an error. Mr. Celiz-Hagen stated that the other prescription
was filled with the wrong medication. Ms. McCoy asked if Mr. Celiz- Hagen if
he was still filling prescriptions for the home. Mr. Celiz-Hagen stated that
he still fills prescriptions for the home and where he works now that barcode
scanning is used to ensure the right product is dispensed.
Mr. Dutcher stated that the pharmacist should work at a pace that is
comfortable for the pharmacist.
Ms. McCoy asked Mr. Harker if he has other employees. Ms. McCoy asked Mr.
Harker if technicians process prescriptions. Ms. McCoy asked if Mr. Harker has
a way to identify who enters the prescription. Mr. Harker stated when he
entered into the contract; he hired another technician and an additional
pharmacist to handle the business. Mr. Harker stated that the long term care
facility kept changing the orders all day long. Mr. Harker stated that each
pharmacist logs on with his own initials and is responsible for the work of
his technician. Mr. Harker stated that he does not plan to do this type of
business again. Mr. Harker stated that he was not aware of any issues until
the complaint was filed which occurred after the contract ended.
- Complaint #2882
Pharmacist Roger Parker and Pharmacy Supervisor Bryan Bakke were present to
respond to a consumer complaint. Rich Cieslinski gave a brief overview of the
complaint.
Mr. Cieslinski stated that the patient received Augmentin, but had told the
pharmacy personnel that she was allergic to Penicillin. The patient stated
that she was not counseled.
President McCoy asked Mr. Parker about the error. Mr. Parker stated that
the technicians handed out the prescription and the patient was not counseled.
Mr. Parker stated that he believes that he was not called to the window to
counsel the patient.
Mr. Bakke stated that the pharmacy was not aware of the allergy. Mr. Bakke
stated that the patient had two previous fills of Keflex and no allergy
interaction was noted. Mr. Bakke stated that the technician overrode the
interaction that was the Keflex therapy. Mr. Bakke stated that the allergy
information was entered after the prescription was filled. Mr. Bakke stated
that the doctor was notified and they were not aware of any allergy and that
is why the prescription was written for Augmentin.
Dr. Smidt asked where the allergy information was collected. Mr. Bakke
stated that the input technician gathers the allergy information. Mr. Bakke
stated that the Compliance Officer has noted that allergies were documented on
the last three inspections. Ms. Cieslinski stated that even though allergies
are documented, there is no way to verify that they are correct. It is just
noted that information has been entered in the field, which may be No Known
Allergies.
Mr. Dutcher asked if a warning flashes on the screen what is the process.
Mr. Parker stated that the allergy is printed and the patient is asked about
the allergy at the time of counseling. Mr. Dutcher asked if the prescription
is filled. Mr. Parker stated the prescription is processed and not filled
until the patient is questioned about the allergy.
Mr. Wand asked about the MD override. Mr. Parker stated that the
technicians were advised not to override an interaction with the statement MD
aware.
Ms. McCoy stated that the handwriting and abbreviations on the prescription
were difficult to read. Ms. McCoy told Mr. Parker that when he transcribes a
prescription it should be legible and he should not use abbreviations for the
drug name.
Ms. McCoy asked about the counseling. Mr. Parker stated that the problem
has been rectified.
Mr. Parker stated that one prescription got away. Ms. McCoy cautioned Mr.
Parker to change his practices to prevent this from occurring again.
- Complaint # 2890
Pharmacist Stephen Gulley and Pharmacy Supervisor Fauzia Somani were
present to answer questions in response to a consumer complaint. Compliance
Officer Rich Cieslinski gave a brief overview of the complaint.
Mr. Cieslinski stated that the complainant received
Butalbital/APAP/Caffeine instead of Carisoprodol. The patient received the
wrong medication because the Baker Cell was filled incorrectly.
President McCoy asked Mr. Gulley about the error. Mr. Gulley stated that a
prescription was filled for the patient for 90 tablets of Carisoprodol. The
patient's insurance would not cover the prescription and the patient requested
5 tablets and he would pay cash for them. Mr. Gulley stated that he was not
aware that the tablets were mixed in the bottle. Mr. Gulley stated that when
he was notified , he checked the cells and the tablets were mixed in the cell.
Mr Gulley stated that he was truly sorry for the error. Mr. Gulley stated that
in order to correct the problem he has moved the two cells. Mr. Gulley said
that both products are made by the same company and look alike. Mr. Gulley
stated that a technician fills the cells and a pharmacist double checks the
cell.
Ms. McCoy asked Ms. Somani if there are policies in place for filling Baker
Cells. Ms. Somani stated that the pharmacist should verify the product and the
cell prior to the cell being filled. Ms. Somani stated that the technician
filled the cell before the pharmacist verified the medication was correct. Ms.
McCoy asked if this policy is in place in all the stores that are using Baker
cells. Ms. Somani replied yes.
Ms. McCoy reminded Mr. Gulley to be sure the technicians adhere to the
policy because if a Baker Cell is filled incorrectly there could be multiple
errors.
- Complaint # 2891
Pharmacist Abimbola Johnson and Pharmacy Supervisor Joe Klimpel were
present to answer questions in response to a consumer complaint. Compliance
Officer Dean Wright gave an overview of the complaint.
Mr. Wright stated that the pharmacist dispensed Tramadol 50 mg instead of
Demerol 50 mg on a new prescription. The patient took eight doses over the
two- day period before calling his doctor because he was feeling woozy and
sick to his stomach. The patient claims he was not counseled.
President McCoy asked Ms. Johnson about the error. Ms. Johnson stated that
she did counsel the patient. Ms. Johnson stated that her District Manager
called her because the patient had called him. The District Manager asked what
medication the doctor had prescribed. Ms. Johnson stated that the prescription
was for Tramadol. Ms. Johnson stated that her District Manager asked her to
pull the prescription and check to see if the medication was not Demerol.
Mr. Dutcher stated that looking at the prescription he did not see the drug
as Tramadol and it is clearly Demerol. Mr. Dutcher asked if she was working
too fast or was overloaded. Ms. Johnson stated that the prescription looked
like Tramadol to her. Ms. Dutcher asked if Ms. Johnson worked with a
technician. Ms. Johnson replied not at that time. Ms. Johnson stated that she
has a clerk.
Mr. Dutcher asked if counseling was performed. Ms. Johnson stated that she
counseled the patient.
Mr. McAllister asked if this patient had previous prescriptions for
Demerol. Ms. Johnson stated no.
Ms. McCoy asked Ms. Johnson if she has made any changes in her practice.
Ms. Johnson stated that she completed a CE on preventing errors. Ms. Johnson
stated that she has changed the way she verifies the prescriptions.
- Complaint # 2900
Pharmacist James Haislet and Pharmacy Supervisor Holly Prievo were present
to address a consumer complaint. Compliance Officer Dean Wright gave an
overview of the complaint.
Mr. Wright stated that the pharmacist dispensed Pacerone 200mg instead of
Pancrease on a new prescription. The patient did not take any of the incorrect
medication. The patient's wife stated that the pharmacist did not counsel her
husband. The pharmacist stated that the patient refused counseling, but the
pharmacist did not document the refusal.
President McCoy asked Mr. Haislet to address the complaint. Mr. Haislet
stated that the patient's wife dropped off the prescription and returned later
to pick up the prescription. Mr. Haislet stated that he and the technician
read the prescription as Pacerone. Mr. Haislet stated that he believes that he
left a note for someone to check the prescription the next morning. Mr.
Haislet stated that the technician asked the patient's wife if she had any
questions for the pharmacist and the wife replied no that the doctor had went
over the medication with them. Mr. Haislet stated that the wife read the
literature and called the pharmacy. Her husband did not take any of the
medication.
Ms. McCoy asked if there was an offer to do counseling from the technician.
Ms. McCoy asked if it is the policy of the store that the pharmacist counsels
the patient on all new prescriptions or are patients given an option. Mr.
Haislet stated that they offer counseling on all new prescriptions.
Mr. Dutcher stated that if the pharmacist had counseled the patient this
error would not have left the pharmacy. Mr. Haislet stated that he knows that
now. Mr. Dutcher stated that there are three points that should have alerted
Mr. Haislet to the fact that he had the wrong medication. The first point was
that the prescription was written for 270 tablets and most Pacerone
prescriptions are not written for that quantity. The second point was that
most patients do not take nine (9) Pacerone tablets daily. The third point was
that the prescription was written by a gastroenterologist.
Mr. Haislet stated that he did not realize that the prescription was
written by a gastroenterologist.
Ms. McCoy asked Ms. Prievo if they have addressed the staffing issues. Ms.
Prievo stated that they are currently recruiting and training technicians.
Ms. McCoy stated that the outcome could have been catastrophic if the
patient had not read the literature provided. Ms. McCoy asked Mr. Haislet what
he has changed in his practice. Mr. Haislet stated that he is looking for CE
on cardiology drugs. Mr. Haislet stated that he has completed a CE program on
errors.
- Complaint # 2908
Dawn Hoang was present to answer questions in response to a consumer
complaint. Compliance Officer Rich Cieslinski gave a brief overview of the
complaint.
Mr. Cieslinski stated that Ms. Hoang dispensed Azathioprine 50 mg instead
of 6- Mercaptopurine. The mother questioned the medication and was told that
the mediation was correct. The two-year- old child took the wrong medication
for 5 days before the medication was discontinued.
President McCoy asked Ms, Hoang about the error. Ms. Hoang stated that
prior to this prescription she had compounded Dexamethasone and Protonix in
liquid form for the patient.
Ms. Hoang stated a week later the patient had a prescription written for
6-Mercaptopurine. Ms.
Hoang stated that the first thing that came to her mind was Imuran. Ms.
Hoang stated that because the patient was on Dexamethasone that is an
immunosuppressive, she chose Imuran because it was another immunosuppressive
agent. Ms. Hoang stated that she did not have reason to call the doctor. Ms.
Hoang stated that the parents never called her to question the drug. Ms. Hoang
stated that the nurse called her and asked her to pull the hard copy and check
the drug. Ms. Hoang stated that the nurse asked her why she dispensed Imuran.
Ms. Hoang stated that she told the nurse that Imuran metabolizes to 6-MP and
that is why she chose that drug. The nurse told her that was the wrong drug.
Ms. Hoang told the nurse that she would
give the patient the correct medication. The patient declined and had the
prescription filled at another pharmacy and filed the complaint with the
Board.
Ms. McCoy stated that the complaint report indicates that the mother
questioned the medication and was assured the medication was correct. Ms.
Hoang stated that the mother did not call and question this medication. Ms.
Hoang stated that she counseled the father.
Ms. McCoy asked if this was a compounded prescription. Ms. Hoang replied
that she dispensed the tablets.
Mr. Dutcher stated that he has issues with the fact that Ms. Hoang kept
stating "I chose"
and did not dispense the medication as the doctor had written the
prescription. Mr. Dutcher stated that Ms. Hoang stated that she saw 6-
Mercaptopurine and immediately thought of Imuran.
Ms. McCoy asked Ms. Hoang what her process is for the final check of a
prescription. Ms. McCoy stated that the label says azathioprine and the
prescription says 6-Mercaptopurine.
Ms. Hoang stated that it is her fault that she did not call the doctor, but
she thought the doctor wrote for the metabolite 6 - mercaptopurine. Ms. McCoy
stated that is beyond the scope of practice of a pharmacist. Ms. McCoy stated
that Ms. Hoang is second guessing what the doctor has written based on her
limited knowledge about the patient. Ms. McCoy stated that the prescription is
clearly written for 6-Mercaptopurine and Ms. McCoy stated that there would be
no reason to call the physician to clarify the prescription. Ms. McCoy stated
that the prescription was filled with the wrong product. Ms. McCoy stated that
the mother stated that she questioned the medication. Ms. McCoy stated that
when a parent questions a medication for a child that the pharmacist should
recheck the prescription.
Ms. McCoy asked Ms. Hoang if her pharmacy is a compounding pharmacy. Ms.
McCoy stated that if a product is compounded then the patient is at the mercy
of the pharmacist to compound the product correctly.
Mr. Dutcher stated that doctors do not write for metabolites, but write for
the product that they want dispensed,
Mr. McAllister stated that this is a serious error and she could have been
offered a consent order that would have resulted in suspension or revocation
of her license.
Ms. McCoy stated that this might be more serious than a conference since it
involves a child. Mr. Dutcher stated that the Board is thinking of more
serious actions. Mr. Pulver stated that the Board could take this to a higher
level, such as a consent or hearing.
Ms. McCoy stated that the patient did not get proper treatment for 5 days.
Ms. Hoang stated that the child is stable and Ms. Hoang stated that she
apologized to the parents.
Mr. Pulver stated that a consent could be offered to offset a hearing. Mr.
Wand stated that he believes Mr. Dutcher is asking if they can specify the
terms of the consent agreement. Mr. Pulver replied yes. Mr. Pulver stated that
a motion should be made for a consent order prior to specifying terms.
Dr. Smidt asked Ms. Hoang how long she has been a pharmacist. Ms. Hoang
stated that she graduated in 2001. Ms. Hoang stated that this is the first
mistake that she ever made.
Ms. McCoy stated that she feels that Ms. Hoang made a judgment based on
presumptions. Ms. Hoang stated that she would verify prescriptions if the name
is not written carefully. Ms. McCoy stated that the patient is not able to
search for compounded products on the Internet to ensure that they received
the correct medication.
Mr. Dutcher made a motion to offer Ms. Hoang a consent order. The motion
was not seconded.
Ms. McCoy told Ms. Hoang to review the scope of practice of a pharmacist.
Ms. McCoy reminded Ms. Hoang to keep her patients foremost in her practice.
Ms. McCoy asked that a letter be sent to the practitioner discouraging the
use of the writing the prescription as 6-Mercaptopurine.
AGENDA ITEM 17 - Consent
Agreements
President McCoy asked Board Members if there were any questions or
discussions concerning the consent agreements. Executive Director Hal Wand
indicated that the consent agreements have been reviewed and approved by the
Attorney General's Office and have been signed. Mr. Wand provided an overview
of the Consent Agreements for the benefit of the audience.
Mr. Wand stated that the first consent involved the removal of antibiotic
capsules from the pharmacy by a technician. The technician did not have a
valid prescription. Mr. Wand stated that the technician admitted to removing
other merchandise from the store. Mr. Wand stated that the technician's
license will be suspended for thirty days and he must pay a fine.
Mr. Wand stated that the second consent involved the changing of a
controlled substance prescription by the pharmacist and the addition of
refills to the prescription without authorization from the physician. The
prescription was for the pharmacist. The consent order requires the pharmacist
to sign a PAPA contract.
Mr. Wand stated that the third consent was issued due to violations
discovered at a recent inspection. Mr. Wand stated that the pharmacy will be
required to pay for two additional inspections within the next year ..
A roll call vote was taken. (Mr. McAllister - aye, Mr. Van
Hassel - aye, Dr. Smidt - aye, Mr. Dutcher - aye, President McCoy - aye). All
Board Members present voted to unanimously accept the following Notice of
Hearing/Consent Agreement as presented in the meeting book and signed by the
respondent:
- James Edwards
04-0031-PHR
- Lori Wickenhauser
05-0005-PHR
- excelleRx
05-0007-PHR
AGENDA ITEM 18 - Drug Therapy
Management Agreements
President McCoy asked Ms. Frush to open the discussion. Ms. Frush stated
that the Board had received four drug therapy management renewal agreements.
The Drug Therapy Management Committee reviewed the agreements and recommended
that the agreements be approved. Ms. Frush stated that the committee felt that
the Board might want to review the rules to require the pharmacist to submit
documentation showing quality assurance programs are in place and the
pharmacists have met with the physicians on a routine basis. The rules do not
require that the pharmacist submit this documentation when renewing their
contract. The committee felt that the applicant should be required to submit
outcome data and the data should cover the entire period of the contract.
Ms Frush stated that copies of the outcome data submitted are attached to
the report for review by the Board Members. Ms. Frush stated that the time
periods vary for each agreement and that is why the committee is recommending
that the outcome data cover the entire period of the contract.
On motion by Mr. Van Hassel and Mr. Dutcher, the Board
unanimously approved the following drug therapy agreements:
- Sandra Leal
El Rio Hospital
Diabetes Type 1 and 2, Hypertension,
and Hypercholestrolemia
- Marissa Soto
El Rio Hospital
Diabetes Type 1 and 2, Hypertension,
and Hypercholestrolemia
- Heather Yeager
Cigna Healthcare of Arizona
Anticoagulation Clinic
- Kenton Brown
Cigna Healthcare of Arizona
Anticoagulation Clinic
President McCoy asked how the applicants would be notified. Ms. Frush stated
that the applicants would be issued a new certificate with a new expiration
date.
Ms. McCoy stated that the pharmacists are providing a service to their
patients and hopes more pharmacists submit agreements to provide drug therapy
management to their patients.
AGENDA ITEM 19 - Review of letter from
PAPA concerning a contract violation by a confidential
member
President McCoy asked Mr. Wand to address this issue. Mr. Wand stated that he
received a letter from PAPA indicating that a confidential member has violated
his contract. PAPA has requested that the Board recommend the action that should
be taken against this individual. Mr. Wand stated that the Board could offer the
pharmacist a consent order that would change his status from a confidential
member to a known member.
President McCoy stated that she feels that the Board should act upon this
violation. She stated that the member has violated his contract twice.
Mr. Dutcher asked what the differences were in being a confidential member
versus a known member. Mr. Wand stated that a known member could not be a
preceptor or Pharmacist In Charge during their probation period. Mr. Wand stated
that if the pharmacist violates the consent order then he would be subject to a
hearing.
On motion by Mr. McAllister and Mr. Dutcher, the Board
unanimously agreed to issue the pharmacist a Consent order changing his status
from a confidential PAPA member to a known PAPA member.
AGENDA ITEM 20- Call to the
Public
President McCoy 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 :
1. A pharmacist noted that during the complaint review that it was mentioned
that a patient had a choice to have his prescription at any pharmacy. The
pharmacist stated that some patients only have the mail order option.
2. Bob Lipsy stated that the Board is helping improve the quality of patient
care in the state of Arizona.
There being no further business to come before the Board, on motion
by Mr. Dutcher and Dr. Smidt, the Board unanimously agreed to adjourn
the meeting at 3:45 PM.
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