Right Time Pharmacy
1895 Airport Exchange Blvd, Ste 250,
PB5-Pharmacy Builders 5, LLC
Elonger, KY 41018
Medipharm Spclty Pharmacy
4607 N. Clark Ave., Tampa, FL 33614
Medipharm Specialty Pharmacy
North American Pharm. Group
4906 S.W. 72ND Ave., Miami, FL 33155
North American Pharmaceutical
Group, Inc.
AH Pharmacy Services
10077 S. 134th St., Omaha, NE 68138
AH Pharmacy, LLC
Veterinary Spclty. Pharmacy
940 Ellendale Dr., Medford, OR 97504
Community Compunding Centers, Inc.
Pet Express Pharmacy
956 N.W. Circle Blvd., Corvallis, OR 97330
Health Southwest Pharmacy, Inc.
RXUSAPBM, Inc.
81 Seaview Blvd. , Port Washington, NY 11050
RXUSAPBM, Inc.
LifeCare Solutions, Inc.
10119 Carroll Canyon Rd., San Diego, CA 92131
LifeCare Solutions, Inc.
Universal RX
14936 N. Florida Ave, Tampa, FL 33613
Universal RX, Corp.
Bet Pharm
1517 Nicholasville Rd. Ste. 404, Lexington, KY 40503
Bet Pharm
Dyna Care I.V. Supplies
4804 W. 129th St., Alsip, IL 60803
Dyna Care IV Supplies, Inc.
Axium Healthcare Pharmacy
100 Pear Orchard Dr., Ste. A, Vicksburg, MS 39183
Axium Healthcare Pharmacy, Inc.
Script-wise
543 McCorkle Blvd., Westerville, OH 43082
Script-wise LTD.
Midland Pharmacy
606 Midland Ave., Staten Island, NY 10306
Midland Pharmacy and HealthCare, Inc.
EZRX
909A Rahway Ave, Union, NJ 07083
EZRX, LLC
Concept RX
1747 N. University Dr., Plantation, FL 33322
Concept RX, Inc.
North Howard Pharmacy
3202 N. Howard Ave., Tampa, FL 33607
North Howard Pharmacy, Inc.
Accredo Health Group
9625-D Southern Pines Blvd., Charlotte, NC 28273
Accredo Health Group, Inc.
Injured Workers Pharmacy
9 Branch Street, Methuen, MA
Injured Workers Pharmacy, LLC
PromptCare Pharmacy
51 Terminal Avenue, Clark, NJ 07066
The PromptCare Companies, Inc.
Meditech Laboratories, Inc.
3200 Polaris Ave. Ste. #27, Las Vegas, NV 89102
Modular Properties, LTD.
Pharmacy Solutions, LLC
6904 N. Main St. Suite 103, Columbia, SC 29203
Pharmacy Solutions, LLC
Specialty Pharmacy St. Louis
623 N. New Ballas Rd., Creve Coeur, MO 63141
Specialty Pharmacy of St. Louis, LLC
Central Admixture Services
7935 Dunbrook Rd. Suite C, San Diego, CA 92126
Central Admixture Pharmacy Services, Inc.
PMSI, Inc.
175 Kelsey Lane, Tampa, FL 33619
PMSI, Inc.
Adv Care Pharmacy 1
24129 U.S. Hwy. 19 North, Clearwater, FL 33763
Adv Care, Inc.
(O) - Ownership Change
Wholesale Permits
President McAllister indicated that there were two applicants for resident
wholesale permits. There was one permit for a non-resident wholesaler.
The non-resident wholesaler was asked to appear before the Board because a corporate
officer pled guilty to two counts of selling and brokering the purchase of
adulterated and misbranded drugs. The corporate officer of the non-resident
wholesaler was not able to appear at this meeting and he asked to postpone his
appearance until the June Board meeting.
On motion by Mr. Draugalis and Ms. McCoy, the Board unanimously approved the
resident wholesalers listed below. The non-resident wholesale permit was tabled
until the corporate officer appears at a Board meeting to answer questions from
the Board Members. All approvals are subject to final inspection by a Board
Compliance officer where appropriate.
Reed's Compounding Pharmacy (Full Service)
2729 E. Speedway, Tucson, AZ 85716
Jones Drug Co, Inc.
Three Sisters Wholesale Pharmaceutical Products (Full Service)
State Rte. #160, Tuba City, AZ 86045
Cynthia Benedict
(NON- RESIDENT WHOLESALER) - TABLED
Top Rx
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. Draugalis and Dr.
Tippett, the Board unanimously approved the following licenses:
Pharmacist licenses 14068 through 14109, Pharmacy Intern licenses 6321 through
6363, and Pharmacy Technician licenses 1 through 365. For a complete list of
names see attachments.
AGENDA ITEMS IV - Reports
Executive Director Report
Executive Director Wand stated that over 300 technicians have been licensed.
There are several glitches that have been experienced in the process. Often the
applicants are not able to provide a copy of their GED or high school diploma. This
issue has arisen when the technician attended school in a foreign country that
does not issue a high school diploma. Mr. Wand stated that some of the applicants
that were not issued a high school diploma might need to appear at a future board
meeting to obtain approval to be licensed as a pharmacy technician trainee. There
were also applicants that have had some criminal charges and the Board may have
to review their applications for approval.
Mr. Wand provided the Board Members with a copy of the financial report. Mr.
Wand indicated that included in the recent expenditures is three thousand dollars
for paper to print the technician licenses. The paper to print the licenses must be
security paper and numerically numbered. Mr. Wand stated that another issue is
the cost of the postage. Mr. Wand stated that some applications are being mailed
back to the applicants for missing information and documentation. Mr. Wand
estimated that the postage might be as high as seven or eight thousand dollars.
Mr. Wand estimated that there will be approximately 10,000 pharmacy technicians
to license. Mr. Wand stated that many chains are helping out by batching their
applications and either having someone pick up the licenses or the Board will
deliver the licenses to their office.
Mr. Wand then discussed staff personnel changes. Mr. Wand introduced Mr.
DeShetler, who was hired as a new administrative assistant in the office. Mr.
DeShetler gave a brief overview of his background. Mr. Wand told the Board that
Compliance Officer, Mitzi Wilson, had resigned to pursue another career
opportunity. Mr. Wand told the Board Members that a new Compliance Officer will
not be hired until July when the new fiscal year begins.
Mr. Wand stated that Drug Inspector, Tammy McPherson, has been helping in the
office with the technician licensing. He stated that she will probably work in the
office for the next week and will then return to doing inspections and will then
again help with processing the technician licenses when the large companies
submit their applications.
Mr. Wand stated that he is currently working with the procurement office to obtain
authorization to approve expenditures above ten thousand dollars. While trying to
hire a lobbyist to help with the legislative process for future Board issues, for
example the immunization rules and drug monitoring programs, Mr. Wand learned
that the authorization was never changed upon Mr. Lloyd's retirement.
Deputy Director's Report
Deputy Director Frush called the Board's attention to the Compliance Officers
Activity Report in the meeting book for March. Currently, the number of
inspections completed by the Compliance Staff are ahead of the number of
inspections that were completed at this time last year. Also, the number of
complaints exceeds the number of complaints that were investigated at this time
last year. Ms. Frush indicated that the number of non-prescription inspections are
ahead of the number of inspections that were completed at this time last year.
President McAllister said that he looks at the reports every month and wanted to
know what the findings were in the field that may help in future rule writing. He
suggested that maybe a summary could be included with the activity reports. Ms.
Frush stated that violations are noted in the field, such as controlled substance
overages and shortages, reference books that are not current, illegal substitutions,
and out-dated non-prescription medications. Mr. Wand noted that violation letters
are sent to the Pharmacist-In-Charge of the stores where violations occur. The
Pharmacist- In-Charge responds to the letter and returns the letter to Ms. Frush. If
the response is satisfactory, the letter is stamped as being in compliance and
returned to the Pharmacist-In-Charge.
Mr. McAllister felt a summary might be helpful to determine the issues that are
discovered during the inspections. Mr. Wand stated that the Board Members used
to receive a copy of all violation letters and the Board Members felt that they did
not need that much information. Mr. McAllister felt that a summary would be
sufficient. Ms. Frush stated that in addition to the violations that it would be
beneficial to report when a pharmacy has a good inspection. Mr. Wand indicated
that sometimes the Compliance Officers do note on their inspections when a
pharmacy does a good job or does something that exceeds the standards or
something that they have not seen before during an inspection that might be
helpful for other practitioners to know.
PAPA Report
PAPA was represented by Lisa Yates. Ms. Yates stated currently there are thirty-three participants in the PAPA program. Since the last PAPA report on January 14,
2004, Ms. Yates stated that two new participants have started the program, two
participants have completed the program, and there have been four terminations of
PAPA contracts.
Ms. Yates stated that PAPA would be sponsoring a 1.5 hour CE program at the
AzSHP/APA 4th Annual Joint meeting on Saturday, June 26, 2004. Merrill Norton,
R.Ph., NCAC II, CCS, will be speaking on "The Hijacking of the Brain - The
Neurobiology and Pharmacology of Chemical Dependence."
Dr. Tippett stated that he thinks that the PAPA program is great and offers
pharmacists a second chance. Dr. Tippett said he had questions concerning how
the program is reviewed. He asked Ms. Yates how often the program is evaluated
in terms of effectiveness, how well it is working, if there are areas that need
improvement, and does the evaluations occur on a regular basis. Ms. Yates replied
that the Steering Committee meets twice a year and reviews the programs. Ms.
Yates stated that the statistics are not done on a regular basis. She stated that
she had recently sent a report to Mr. Wand indicating how many people had
participated in the program and the outcomes. Dr. Tippett asked if success means
that the participant does not return to the program. Ms. Yates replied that the
success rate is determined by the participant not returning to the program.
Ms. McCoy stated that she saw the report and the report did show the success
rate. She asked Mr. Wand if he could provide the members with a copy of the
report and Mr. Wand replied that he could provide the members with a copy of the
report.
President McAllister stated that the PAPA program has changed pharmacy in
Arizona and has helped many pharmacists with addictions. Ms. Yates stated that
they feel the program has helped many individuals.
APA Report
APA was represented by Kathy Boyle. Ms. Boyle stated that the HB2196
concerning the continuing education requirements for pharmacy technicians did
pass and was signed by the Governor on April 19, 2004.
Ms. Boyle reminded everyone about the upcoming convention in June to be held in
Scottsdale at the Westin-Kierland resort. She stated that the Pharmacy Board will
hold a meeting at the resort on June 24, 2004. The APA will also be offering an
Immunization training program that Thursday. There are currently 5 pharmacists
signed up to participate in the Immunization training program.
Ms. Boyle stated that the members voted for the unification of the AZSHP and the
APA. The new
organization will be called the Pharmacy Association of Arizona. The PAPA
program will not change and will have the same working relationship with the
Board of Pharmacy. The first officer of the new organization will be the new
president, Jerome Wohleb. He will take office at the convention. John Musil will
be the second president. After the first two years, a full voting election will be
held.
President McAllister called a brief recess. President McAllister reconvened the
meeting.
AGENDA ITEM V - Special Requests
#1 Evan Davis
Evan Davis appeared with Lisa Yates from the PAPA program. President McAllister
asked Mr. Davis to describe the nature of his request. Mr. Davis replied that he is
requesting that the suspension of his pharmacist license be removed and
probation imposed.
Mr. McAllister asked Mr.Davis what brings him to this point. Mr. Davis replied in
the last year he has completed two different rehab programs for drug addiction. He
has completed both inpatient and outpatient rehab programs. Mr. Davis stated that
he has been active in the PAPA program since June of last year. Mr. Davis stated
that he has a sponsor that he reports to weekly. Mr. Davis stated that he attends
three self- help meetings a week. Mr. Davis stated that he is working a very good
program in addiction recovery.
Mr. McAllister asked Mr. Davis to describe his life now. Mr. Davis stated that his
life is almost a complete 180. He stated that a year ago he had hit rock bottom.
Mr. Davis stated that thanks to rehab and the PAPA program he has been able to
pick up the pieces of his life and move forward in a positive direction. He said the
program has given him a new lease on life. Mr. Davis said he is grateful for the
second chance that has been offered to him.
Mr. McAllister asked Ms. Yates for PAPA's recommendation. Ms.Yates replied that
the PAPA Steering committee supports the removal of the suspension and the
imposing of probation for Mr. Davis. Mr. Wand stated that the counselor has also
written a letter supporting Mr. Davis and the letter is in the Board Book.
Mr. McAllister asked Mr. Davis if he was ready to go back and work in the
pharmacy environment. Mr. Davis replied that he was ready to return to work.
Ms. McCoy told Mr. Davis that she thinks it is great that he has arrived at this
point in his life. She reminded him that he has a great support group within the
PAPA program and to go to the support group for help if things get tough. Dr.
Tippett also wished the participant success in moving forward.
On motion by Ms. McCoy and Dr. Tippett, the Board unanimously approved the
request by Mr. Davis to terminate the suspension of his pharmacist's license and
impose probation with the standard PAPA contract changes.
#2 - Tewabech Rensing- Minelek
Tewabech Rensing-Minelek appeared with legal counsel Roger Morris to request a
waiver of A.R.S. § 32-1922 (D) and (E) involving the preliminary equivalence exam.
Ms. Rensing appeared at the March 17, 2004 meeting and the Board tabled the
request and asked Ms. Rensing and Mr. Morris to return at the next Board meeting
with a proposal for the Board to review.
President McAllister began the discussion by asking Ms. Rensing about her
proposal to become licensed as a pharmacist in this state.
Mr. Morris stated that they have submitted a packet to the Board. Mr. Morris
stated that the Board requested that the test cover such areas as English
proficiency and academic areas. Mr. Morris stated that Ms. Rensing has taken and
passed the TOEFL exam and that will satisfy the English proficiency requirement.
Mr. Morris stated that the second issue was to find some exam that will prepare
her to take the NAPLEX and to satisfy the requirement that will satisfy the Board's
academic requirement for basic understanding of the sciences to be able to take
the NAPLEX. Mr. Morris stated that they contacted the schools that the Board
Members recommended and the schools stated that Ms. Rensing would need to be
enrolled at the school and taking courses in order to take the exam. Mr. Morris
contacted Morris-Cody and found that they offer a comprehensive remedial
program that is equivalent to an 80- hour course and offers an exam at the end of
the course. Mr. Morris suggested that if Ms. Rensing passes the Morris-Cody exam
along with the TOEFL exam the Board will allow her to sit for the NAPLEX exam.
President McAllister reviewed the facts leading up the request by Ms. Rensing. He
stated that Ms. Rensing was not able to take the FPGEE because she was an
Ethiopian citizen who had attended pharmacy school in Germany. He stated that
because she was not a German citizen she was not issued a permanent
pharmacist license. NABP will not allow Ms. Rensing to take the FPGEE because
it is a requirement for the applicant to have been issued a permanent pharmacist
license from the country where they attended pharmacy school. Mr. McAllister
stated that what the Board was looking for in order to allow Ms. Rensing to move
on in the process was an equivalence exam that would show that she has the
basic education equivalency prior to the practice examination. Mr. McAllister said
the Board needs to consider her issues as a unique individual and the system that
has been set up by NABP to approve foreign graduates. Mr. McAllister stated that
NABP has stated that they have found fraudulent degrees being submitted by
applicants and the rules have to be this strict to prevent fraudulent practitioners
from obtaining licenses. Mr. Morris stated that her degree had been credentialed
and the only issue that NABP had was that Ms. Rensing was not issued a
permanent license in Germany.
Mr. Draugalis stated that the Morris-Cody exam is a difficult exam and he had
taken the exam in preparation for taking the California Board. He felt that the
exam would be a good alternative exam.
Dr. Tippett said he had issues with the equivalency of the exam. Dr. Tippett said
he has no problem with the exam being issued if it is an equivalent exam.
Mr. Wand asked Mr. Morris or Ms. Rensing if the exam is a take-home exam. Mr.
Morris stated that was his understanding and he has talked to Ms. Rensing about
taking the exam as a proctored exam with someone whose credentials will not be
questioned by anyone.
Ms. McCoy stated that due to citizenship issues that she is not able to take the
test and NABP has certified the educational issues. Ms. McCoy stated that it is her
understanding that this is a pre-test. Ms. McCoy is comfortable with accepting
this test as a pre-test and would not accept this test in place of NAPLEX. Ms.
McCoy stated that this is an individual case and wants to make sure that this does
not set precedence for other individuals that cannot pass another licensing exam.
President McAllister stated that the issue in front of the Board is precedence. Mr.
McAllister stated that we do have risk as we go forward that the staff may become
burdened with numerous requests that they do not have the resources or the
ability to verify. He thinks that the letter from NABP stated the quality of her
credentials with the only issue being her citizenship requirement.
Mr. McAllister stated that the Board must keep in mind with the ACPE
determination all United States schools will offer the PharmD as the entry level
degree. There is a potential in the next few years as the last Bachelor degree
pharmacists graduates in the United States there will be very few equivalent
educational programs world-wide that can allow transfer or re-licensure in this
country. Mr. McAllister stated with the change in degree requirements there may
be a flood of requests for licensure in this country.
On motion by Mr. Draugalis and Ms. McCoy, the Board unanimously approved the
request by Ms. Rensing to waive the FPGEE and take the Morris Cody exam as a
proctored exam. President McAllister stated that as clarification for staff the
Board still is in full support of the FPGEE process.
Ms. McCoy stated that this is an individual case and this is not setting
precedence. She stated that NABP is the initial screening process for applicants.
Mr. Wand asked about the score that must be obtained for passing the Morris-Cody
exam. Mr. Wand asked if the passing score was 75%. Mr. Morris replied that is his
understanding for passing Morris-Cody, but the Board could ask for any percentage
that they want. Mr. McAllister stated that she still has a year of internship prior to
taking the NAPLEX. Ms. McCoy asked what the passing level was for the other
exam. Mr. Wand explained that the other exams are not based on a percentage
score. Mr. McAllister asked if the Board is looking for a specific score on the
Morris-Cody exam. Mr. Pulver asked Mr. Morris if he had any statistics on the
Morris-Cody exam. Mr. Pulver asked if an individual took the Morris-Cody exam and
received a certain score is there data that states at what rate they will pass the
NAPLEX exam. Mr. Morris stated that he does not have that information and the
75% score comes from a letter from the President of the company indicating that
successful completion of the program comes from the candidate correctly
answering 75% of the questions.
Mr. McAllister asked if she had to buy the course in order to take the exam. Mr.
Morris replied yes. Mr. McAllister stated that since she will have the study
materials prior to the exam and read from the company's material that successful
completion of the course is obtaining 75% on the exam. Mr. McAllister felt that
this is the standard that the Board should accept.
#3 Holly Vietor
Holly Vietor appeared on her own behalf to request permission to pursue licensure
by reciprocity from her active Oregon license.
President McAllister opened the discussion by asking Ms. Vietor what was the
nature of her request. Ms. Vietor replied that her request was to obtain licensure
in Arizona. She stated that she became licensed as a pharmacist in Oregon in 1998
and had disciplinary action taken against her license in 1999. She explained that
she was not listening to a conversation going on between the technician and a
customer at the register. The customer was insisting that a prescription was for
her daughter and the medication was not for daughter. The patient's daughter had
a similar name to the name on the filled prescription. The technician brought the
medication to her and told her the medication was labeled for the wrong patient.
Ms. Vietor believed the technician and did not pull the hard copy and re-labeled the
medication. The mother did not give the medication to her child. The mother filed
a formal complaint with the Oregon Board and an investigation followed.
President McAllister asked if she has practiced continuously from that time. Ms.
Vietor replied that she has been practicing since that time and is licensed in
Oregon and California. Mr. McAllister reminded Ms. Vietor that the Board has
taken a b stance against counseling errors. Mr. McAllister reminded Ms.
Vietor that it would be a very serious infraction if counseling is not done correctly
and as per the rules. Mr. McAllister stated that the reason she was appearing was
due to the disciplinary action.
Ms. McCoy stated that it seems that Ms. Vietor has learned from her experience
and she needs to take that experience to heart. She reminded her that counseling
is an issue that the Board is addressing. She stated that counseling is part of your
duty as pharmacist in Arizona.
Dr. Tippett asked Ms. Vietor if she has had any other infractions since that time.
Ms. Vietor replied no, but California did put a note in her file. Dr. Tippett asked
what types of changes Ms. Vietor has made in her practice to insure that a similar
incident does not occur again. Ms. Vietor
replied that she has learned to listen to several things at once. Ms. Vietor stated
that she has worked in a pharmacy in California where they did consultation on
every new prescription. The technicians printed the patient profile and the
pharmacist looked at the profile to determine if the
prescription was a new prescription and marked on the form what they would talk
about with the patient. She stated that several errors were caught before the
prescriptions left the pharmacy. Ms. Vietor stated that she always checks the date
of birth to be sure she has the correct patient. Ms. Vietor stated that she wants to
be sure the patient gets the correct medication and knows how the medication is
to be used. Ms. Vietor stated that the she feels counseling is important.
On motion by Mr. Draugalis and Dr. Tippett, the Board unanimously agreed to
allow Ms. Vietor to proceed with reciprocity.
AGENDA ITEM VI - Proposed rules
Compounding and Sterile Products Pharmacy Rules
Compliance Officer/Rules Writer Dean Wright began by telling the Board Members
that a Notice of Proposed Rulemaking was published in the Arizona Administrative
Register on February 20, 2004. A public hearing was held on the proposed rules on
March 22, 2004. One person attended the hearing and was in support of the
proposed rules as noticed. Mr. Wright stated that he has prepared a Notice of
Final Rulemaking and an Economic Impact Statement for approval by the
Board.
Ms. McCoy stated that USP has just released USP 797 standards concerning
sterile products and wanted to know if those standards had been reviewed. Mr.
Wright said these guidelines are not specifically addressed in this rulemaking
package. Ms. McCoy stated that the Board should probably review the 797
standards. Mr. Wright indicated that we can always enforce the USP guidelines
and he stated that he feels that this does not preclude the passing of this
rulemaking package.
Ms. McCoy stated that she would like to see this rulemaking package proceed and
the Board could discuss the USP 797 standards later. Mr. Wright stated that the
current rules talk about a space for compounding and does not address a clean
room. Ms. McCoy stated that JCAHO is planning on enforcing 797 standards in
terms of their survey of compliance. Mr. Wright stated that this rulemaking
package can proceed as is and the Board can visit the issue of clean rooms at a
later date.
On motion by Mr. Draugalis and Ms. McCoy, the Board unanimously agreed to
approve the Notice of Final Rulemaking and the Economic Statement for the
Compounding Sterile Pharmaceutical Products Pharmacy Rules and authorized Mr.
Wright to proceed with the process.
Mr. Wright stated that he will take the rulemaking package to GRCC for final
approval and hopefully will be placed on their July agenda. Mr. McAllister asked
that a letter be sent to the members of the Compounding Task force thanking them
for their help in developing the rules.
Substantive Policy Statement - Prescription Transfer Policy Statement
Mr. Wright explained that last June in response to a consumer complaint
conference the Board suggested that a policy be written regarding the transferring
of a new verbal or faxed prescription from a pharmacy where the prescription was
never filled to another pharmacy for initial and subsequent filling. Mr. Wright
drafted a substantive policy statement (SPS08) for the Board's review.
Mr. Draugalis stated that the policy is worded perfectly and fits the parameters
that were discussed at that meeting.
Mr. Wand stated for the benefit of the audience that substantive policies are not
enforceable by hearings or consent agreements. Even though not enforceable by
hearings, the Board still expects
pharmacies to adhere to this policy. The policy will act as a bridge until an
enforceable statute or rule can be written.
Mr. Wright stated that the policy is a guide for the pharmacies to follow to comply
with what the Board expects when transferring a prescription. Mr. Wright stated
that the transfer rule would need to be updated to reflect this procedure. Mr.
Wright stated that the Board expects the pharmacist to transfer a prescription and
not act as a doctor's agent and phone the prescription to another pharmacy
because a pharmacist does not have that authority. Mr. Wright stated the policy
states that a number must be assigned to the prescription even though the
prescription will not be dispensed and then transferred to the other pharmacy by
existing transfer procedures.
On motion by Dr. Tippett and Mr. Draugalis, the Board unanimously agreed to
approve SPS08, the Board's Prescription Transfer Policy Statement.
AGENDA ITEM VII - Complaint Review
The Consumer Complaint Review committee met prior to the Board Meeting to
review 25 complaints in preparation for making recommendations to the Board for
final resolution. Dr. Tippett and Mr. Dutcher served as the review committee. Dr.
Tippett provided a summary of each complaint and provided the committee's
recommendations to the Board. Board members were encouraged to ask
questions.
Complaint Discussion
Complaint # 2758
President McAllister requested that a pharmacy supervisor be present during the
Conference. He felt that it is the corporate computer personnel that are
automatically linking products that are not AB rated products.
Complaint # 2765
President McAllister and Mr. Draugalis requested to change the committee's
recommendation of a conference to a consent order. Mr. McAllister stated that the
failure to counsel resulted in the error. The Board Members agreed and the
recommendation was changed to a consent agreement.
Complaint # 2767
Ms. McCoy stated that a letter should be sent to the nursing student advising her
that ipecac was not the proper response to this ingestion.
Complaint # 2772
President McAllister requested to change the committee's recommendation of a
conference to a consent order. Mr. McAllister stated that the pharmacist did not
counsel the patient. He also indicated that a retake of the MPJE exam might be
one of the stipulations in the consent agreement. The Board agreed and the
recommendation was changed to a consent agreement.
Complaint #2773
President McAllister requested to change the committee's recommendation of a
conference to a consent order. Mr. McAllister stated that the checking procedures
were missed and patient safety was compromised.
The following summary represents the final decision of the Board in each
complaint:
Complaint # 2756 - Conference
Complaint # 2758 - Conference
(Incident 1 & 2)
Complaint # 2759 - No further Action
Complaint # 2761 - Letter
Complaint # 2762 - No Further Action
Complaint # 2763 - Letter of Warning- Pharmacy Manager
Letter of Commendation - Staff Pharmacist
Complaint # 2764 - Conference - Intern and Pharmacist
Complaint # 2765 - Consent
Complaint # 2766 - No Further Action
Complaint # 2767 - Letter of Warning
Complaint # 2768 - Letter of Warning
Complaint # 2769 - Letter of Warning
Complaint # 2770 - Conference
Complaint # 2771 - No Further Action
Complaint # 2772 - Consent
Complaint # 2773 - Consent
Complaint # 2774 - Conference
Complaint # 2775 - Letter of Warning
Complaint # 2776 - No Further Action
Complaint # 2777 - Conference
Complaint # 2778 - Letter of Warning
Complaint # 2779 - No Further Action
Complaint # 2780 - No Further Action
Complaint # 2781 - No Further Action
Complaint # 2782 - No Further Action
The meeting was recessed for lunch at 12:00 P.M.
President McAllister reconvened the meeting at 1:00 P.M.
AGENDA ITEM VIII - Conferences
COMPLAINT # 2728
Pharmacist Denice Brelsford and Supervisor Tina Sotelo were present relevant to a
consumer complaint. Compliance Officer Ed Hunter gave a brief overview of the
complaint and investigation.
President McAllister asked Ms. Brelsford to describe the events leading to this
discussion. Ms. Brelsford said her statement was taken out of context concerning
the generic substitution. Ms. Brelsford stated that when she checked the
prescription she missed the "dispense as written" because it was not clear to her.
She stated that she read the prescription as " substitution permissible". Ms.
Brelsford stated that when she told the Compliance Officer that the patient usually
gets what they want that she was just making an observation. She stated that
they always call the doctor. Ms. Brelsford stated that since everyone has pointed
out to her that the prescription was " dispense as written" , she can now see that
it was written that way. She stated that she wished the doctor had called her and
she would have fixed the mistake. She again stated that she meant the patient
usually gets what they want when they call the physician.
President McAllister asked Ms. Brelsford to explain how someone in the pharmacy
took it upon themselves to counsel the patient on the equivalency and that there
was no need for the patient to purchase the second cream. Ms. Brelsford said that
they think the technician told the patient that they did not need the cream. Ms.
Brelsford stated that she did not tell the patient that they did not need the second
cream. Ms. Brelsford also stated that the other pharmacist did not speak to the
patient. Ms. Brelsford believes that the technician talked to the patient. Ms.
Brelsford said that she did not hear the technician talking to the patient or she
would have stepped in and answered the questions. Ms. Brelsford stated that is
what the patient told the doctor and then the doctor drafted the letter.
Mr. McAllister asked Ms. Brelsford if she was the dispensing pharmacist. Ms.
Brelsford replied yes. Ms. Brelsford said that she missed the error. Mr. McAllister
asked if the patient declined counseling and she documented the refusal. Ms.
Brelsford replied yes. Mr. McAllister stated that he has a problem with this
because Ms. Brelsford was given a prescription from a skin and cancer center for
two specialty creams and somehow in the pharmacy it gets changed to the patient
only needs one of the products, a generic is dispensed, and the physician is not
called, and no discussion occurs with the patient. Mr. McAllister stated that even
though the patient did not want to talk about the medications, he felt that the
pharmacist has a responsibility to talk to the patient. Mr. McAllister said that he
feels the pharmacist has a duty to clarify these issues. Ms. Brelsford asked Mr.
McAllister what she needed to clarify. Mr. McAllister stated that she should have
told the patient this is the medication your doctor ordered and this is the
medication that we are giving you. Ms. Brelsford stated that she thought the
prescription was labeled correctly and the other prescription was put on hold and
meant that she was coming back tomorrow to pick up the other prescription. Ms.
Brelsford stated that she had no idea that the technician said that she only needed
one medication. Ms. Brelsford stated that the patient may have had the medication
at home and did not want the second medication and that is why the medication
was on hold. Mr. McAllister said it is his opinion that patient's do not know what
they need to know and in a complex situation like this a pharmacist should have
talked to the patient. Mr. McAllister stated that he feels Ms. Brelsford made an
error in judgment.
Mr. Draugalis stated that the prescription is poorly written and a letter should be
sent to the doctor concerning the signing of the prescription. Mr. Draugalis asked
Ms. Brelsford if there was a generic for this product. Mr. Draugalis stated as far as
he knew there was not a generic product for this cream. Ms. Brelsford stated that
she missed the XM at the end of the Glyquin and dispensed the generic for Glyquin
cream and not Glyquin XM cream. Mr. Draugalis asked her if she knew there was
no generic available at that time or did she find that out after the fact. Ms.
Brelsford replied for what. Mr. Draugalis stated for the Glyquin XM. Ms. Brelsford
replied that she did not for sure if there was a generic for Glyquin XM since it was
a new product and she assumed there was a generic product. She stated that she
missed the fact the prescription was written for Glyquin XM and approved the
Glyquin and subsequently filled the prescription with the generic for Glyquin. Ms.
Brelsford stated the only thing missing was the moisturizers. The directions were
the same and the patient requested the Lustra be placed on hold. Mr. Draugalis
stated that he has some of the same concerns as President McAllister that Ms.
Brelsford assumed many things such as a generic product was available for
Glyquin XM and the reason the prescription was placed on hold. Mr. Draugalis
suggested that Ms. Brelsford slow down. Mr. Draugalis asked if this was a busy
pharmacy. Ms. Brelsford replied yes. Mr. Draugalis asked how many prescriptions
were filled that day. Ms. Brelsford replied 300 and some. Mr. Draugalis asked how
many pharmacists were working. Ms. Brelsford replied 2. Mr. Draugalis asked if
the workflow was good. Ms. Brelsford replied as good as possible. Mr. Draugalis
asked if theworkflow has changed to avoid this happening in the future. Ms.
Brelsford stated that they are being more careful about checking the prescription
and it was something that just got missed. Ms. Brelsford stated that they do not
make many errors and it is something that just happened. Ms. Brelsford stated that
they are busy just like everywhere else and this occurred during the busy part of
the day. Ms. Brelsford stated that there is a little stress and pressure to get things
done. Ms. Brelsford stated that she apologizes that she just missed the XM part of
the Glyquin. Ms. Brelsford stated that it is quite common to put prescriptions on
hold, especially creams that are expensive. Ms. Brelsford stated that the patient
has had another prescription for Glyquin XM filled and has never picked up the
Lustra.
Ms. McCoy asked about the technician placing the prescription on hold and talking
to the patient.
Ms. McCoy asked when a drug is on hold does the pharmacist actually have the
opportunity to speak with the patient. She wanted to know if was customary for
the pharmacist to speak with the patient when prescriptions are placed on hold.
Ms. Brelsford replied that if the patient had stayed around that she would have
spoken with the patient during the counseling part. Ms. Brelsford stated that she
would have told the patient that she needs to apply the cream in the a.m. and does
she have the cream to apply in the p.m.. Ms. Brelsford stated that often patients
have the creams at home. Ms. Brelsford stated that often the patient grabs the
bag and bolts out. Ms. Brelsford stated that she never got the opportunity to talk
to the patient.
Ms. McCoy noted that Ms. Brelsford stated that in her written response that the
technician is no longer working there. Ms. Brelsford stated that he is no longer
working at the store. Ms. McCoy asked if the technicians that are currently
working at the store are instructed about counseling and making sure information
is given to the patient. Ms. Brelsford stated that this was a unique situation with
this one technician. Ms. Brelsford stated that if they heard anything going on that
they would stop him in his tracks. Ms. Brelsford stated that the technician was
terminated. Ms. Brelsford stated that he never said anything around her except
the normal acceptable things that a technician could tell a patient.
President McAllister stated that he was concerned about a comment written by
Ms. Brelsford in her written reply to the complaint. The comment stated that the
they were getting an intern in the next two weeks to help with busy times for
counseling. Mr. McAllister asked Ms. Brelsford if she knows that she has a
responsibility to supervise an intern. Ms. Brelsford replied sure. Mr. McAllister
told Ms. Brelsford that she could not just send the intern off unsupervised to
counsel patients. Ms. Brelsford replied correct. Ms. Brelsford stated that the
pharmacy is a small pharmacy and they can pretty much hear what is going on at
the counter. Ms. Brelsford said that they would be guiding the intern and be sure
they are saying the appropriate things and if she heard them saying something that
was not correct she would intervene a little bit. Ms. Brelsford stated that most of
her interns have been graduate interns waiting to take the boards.
Ms. Brelsford stated that they do not have any first or second year students.
Mr. Wand asked about the documentation on the prescription. He asked Ms.
Brelsford if the technician had documented the on hold indication on the
prescription. Ms. Brelsford replied yes.
Mr. Wand asked if she had documented the refusal of counseling. Ms. Brelsford
replied that the cashier had documented the refusal on the back of the
prescription. Ms. Brelsford stated that the cashier tells the patient that a
pharmacist will come discuss your prescriptions with you and if the patient says
no that they do not want to talk to the pharmacist then the pharmacist will
address the patient and ask if they have any questions. The cashier will write on
the prescription that counseling was refused. Mr. Wand told Ms. Brelsford that the
regulation requires that the pharmacist document the refusal of counseling. Mr.
Wand asked Ms. Brelsford if the back of the prescription was already marked with
counseling and is that why she did not talk to the patient.
Ms. Brelsford stated that the cashier said that the patient denied counseling and
Ms. Brelsford said she asked the patient if she had any questions and the patient
said no. Ms. Brelsford stated that for documentation purposes the cashier then
writes that counseling was denied on the prescription. Ms. Brelsford stated that
they always address the patient. Mr. Wand asked when they counsel the patient if
they have the hard copy of the prescription available. Ms. Brelsford replied yes.
Ms. Sotelo stated that the refusal of counseling is documented on the signature
log at the out window and is initialed by the pharmacist. Ms. Brelsford stated that
it is initialed by the cashier that witnessed the patient's denial of counseling and
then the pharmacist initials the sheet. Mr. Wand also asked if this was the third
party signature log. Ms. Sotelo replied that it is used for both purposes.
President McAllister reminded Ms. Brelsford that the Board is focusing on taking
care of your patients. The primary duty of the pharmacist is to consult with the
patient on the proper use of their medication. Mr. McAllister told Ms. Brelsford
that everything broke down in this case. Mr. McAllister reminded Ms. Brelsford that
the next time she does not counsel appropriately and a complaint is filed that a
consent order would be issued which could result in probation. Mr. McAllister
urged Ms. Brelsford to change her practice.
COMPLAINT # 2739
President McAllister called Pharmacist Thomas Randall and Supervisor Don
Featherstone forward to address the Board about the Consumer Complaint.
Compliance Officer Ed Hunter was present to report the findings of his
investigation. President McAllister asked Mr. Randall to discuss the events
leading up to this complaint. Mr. Randall stated that on the one prescription, he is
not sure if the prescription was transferred incorrectly or transcribed incorrectly.
Mr. McAllister asked Mr. Randall if this patient had received medications from their
pharmacy prior to this prescription. Mr. Randall replied that this was a new
pharmacy and they were just opening at the time, so he had no patient histories
available. Mr. McAllister asked about the delivery of the prescriptions. Mr.
Randall stated that all the prescriptions are delivered to the patients who are
home bound and a nurse who works with the Cochise Health System sets up the
medications in the home. Mr. Randall stated that the patients did not ingest any of
the incorrect medication.
Mr. Wand stated that he believes all the prescriptions were transferred from
another pharmacy because the health system was changing pharmacies due to
service issues. Mr. Wand stated that the pharmacy where Mr. Russell worked had
to take all the transfers via phone.
Mr. McAllister stated that this was a system with many problems and the
pharmacist was placed in a tough spot.
Mr. Draugalis asked who filed the complaint. Mr. Russell replied the nurse at
Cochise Health systems filed the complaint.
Dr. Tippett asked if there was a way that the pharmacy and the home health
nurses could work together as a team to avoid these errors in the future. Mr.
Russell said it is a difficult process because he fills the prescriptions, a delivery
person takes the medications to the patient, and a nurse checks the medications
at the patient's home. Mr. Featherstone stated that the patients are located in
remote areas of Cochise county. He stated that the medications are filled at their
pharmacy and delivered. He stated that the nurses are sent out from a different
city with most of the nurses coming from Bisbee. Mr. Featherstone stated that
direct communication is a problem because of the distances between the
practitioners. Dr. Tippett suggested that they might want to consider using
electronic means of communication.
Mr. Wand asked Mr. Featherstone if there are any medication administration
records produced by the pharmacy for the nurses to use at the patient's home. Mr.
Featherstone said that the nurses have forms from the HMO that employs the
nurses. Mr. Featherstone stated that since the pharmacists never go to the
patient's home that they do not set up the records for the nurses.
President McAllister stated that he is glad that they are resolving the service
issues.
COMPLAINT # 2743
President McAllister called Pharmacist Stephen Veerkamp and Supervisor Terry
Daane forward to address the Board concerning the Consumer Complaint. Mr.
Draugalis excused himself from taking part in this conference due to a conflict of
interest. At this point, Mr. Pulver informed the Board Members that they no longer
had a quorum. It was decided that Mr. Veerkamp would need to return at the next
meeting.
COMPLAINT # 2746
Pharmacist Dwight Overturf and Supervisor Jim Foy were present relevant to a
consumer complaint. Compliance Officer Rich Cieslinski was requested to
describe the findings of his investigation.
President McAllister opened the discussion by asking Mr. Overturf if he had looked
at the patient's profile because the patient had numerous prescriptions filled for
Neurontin. Mr. Overturf replied that he was working at the pharmacy through the
temporary service. Mr. Overturf stated that he was assigned to check the refills at
the back counter of the pharmacy and did not have access to any patient files or
the computer. Mr. Overturf stated that the prescriptions were laid out on the
counter and his job was to check the prescriptions.
Mr. Foy stated that in this pharmacy the refills are separated from the new
prescriptions. He stated on the back counter, the technicians fill the prescriptions
and leave the prescriptions to be checked by the pharmacist. Mr. Foy stated that
in most of their pharmacies they use temporary pharmacists to fill in for vacations
and leaves. Mr. Foy stated that they ask the temporary pharmacists to check the
refills. Mr. Foy said the temporary pharmacists are not trained on the computer
because the temporary agency does not always send the same pharmacist. Mr.
Foy said the temporary pharmacist will check refills or take telephone calls.
President McAllister asked if a technician processed the prescription that was
presented to Mr. Overturf. Mr. Foy stated that the prescription was entered into
the computer by a technician and counted by a technician. The paperwork and
label were set on the counter for Mr. Overturf to check.
President McAllister asked if the bottle was labeled correctly. Mr. Overturf replied
the label was correct but the medication dispensed was the incorrect strength. Mr.
Overturf stated in order to save time he signed his initials to all the labels on the
counter. He said by signing off on the labels that invited someone else to put the
label on the bottle assuming that he had checked the prescription. Mr. Overturf
and Mr. Foy think that another pharmacist placed the label on the bottle when the
patient came in to pick up the prescription assuming Mr. Overturf checked the
prescription because the sticker that goes on the refill log was missing.
Dr. Tippett stated that in the complaint comments it was stated that the
environment could be overwhelming and he asked Mr. Overturf how he handles this
situation. Mr. Overturf replied that he has trained himself. Mr. Overturf stated that
he now paces himself so that he does his job properly.
Dr. Tippett asked Mr. Foy if this was an overall staffing pattern. Mr. Foy stated
that they had 3 pharmacists and 6 technicians working that day and filled 200 new
prescriptions. Mr. Foy stated that he felt there was adequate staffing but this
error might have occurred due to a workflow issue.
Mr. Wand asked Mr. Foy about the refilling of prescriptions at this center due to the
fact that the company has a central refill center. Mr. Foy replied that the refill
center does about 75% of the refills, but some of the patients who do not want to
use the refill center because the turnaround time is a couple of days and they will
walk into the centers or call the centers to pick up the prescription that day. Mr.
Wand asked how many refills were filled at the center that day.
Mr. Foy stated that the refill center filled 143 prescriptions for the center and the
center filled 123 prescriptions that day. Mr. Wand stated that he thought the refill
center was to help the centers by allowing them to only fill new prescriptions. Mr.
Foy replied that they have increased the number of refills being filled at the refill
center and have stopped using the back counter for refills at this center.
Ms. McCoy asked if anyone saw the incorrect capsules. Mr. Cieslinski replied that
the Pharmacist-In-Charge did see the incorrect capsules. Ms. McCoy asked if they
filled the prescription with the correct medication and why they did not get the
incorrect medication back. Mr. Cieslinski replied the Pharmacist-In-Charge did
correct the error but the patient would not give him the incorrect medication. Mr.
Foy stated that he spoke with the Pharmacist-In-Charge and he stated that the
patient would not give him the incorrect medication because she wanted to keep
the incorrect medication as evidence for a lawsuit.
President McAllister reminded the participants to be careful and noted that the
center has made system realignments and the pharmacist has changed the
methods that he uses to check a prescription.
COMPLAINT # 2746
Pharmacist Robert Hall and Supervisor Darren Kennedy were present to address
the Board concerning a consumer complaint. Compliance Officer Larry Dick
provided an overview of the complaint investigation.
President McAllister asked Mr. Hall about the complaint. Mr. Hall stated that an
error was made on calculating the dosage on the Tamiflu prescription. Mr. Hall
stated that it was his error.
President McAllister asked if the child's age was in the computer. Mr. Hall states
that the child's age was in the computer and on the prescription. Mr. McAllister
asked if the computer would catch a pediatric overdose. Mr. Kennedy stated that
he could not state for certain if his particular drug would be caught in the system.
President McAllister commended Mr. Hall for sending a letter to the physician and
the statements that he listed in regards to the changes that he has made in his
practice.
President McAllister asked about the label. Mr. McAllister asked if the
teaspoonfuls are automatically entered or did the technician type the teaspoonfuls
into the dosage. Mr. Hall replied the technician typed the teaspoons into the
system. Mr. Hall replied the technician entered the prescription and he did not
catch the error.
Ms. McCoy asked if the technician did the dosage calculation or is the calculation
done by the computer. McCoy asked if the technician writes their calculations on
the prescription as a safety check. Mr. Kennedy stated that the technician
manually calculated the dose and they do not have a policy on recording the
calculations. Ms. McCoy stated that Mr. Kennedy might suggest to the corporate
computer staff that they might want to add a feature to calculate the dosage.
President McAllister reminded the pharmacist to be careful.
COMPLAINT # 2750
President McAllister called Pharmacist Christian Gable and Supervisor Matt Cook
forward to address the Board concerning a Consumer complaint. Compliance
Officer Larry Dick gave an overview of his findings.
President McAllister opened the discussion by asking Mr. Gable if he was familiar
with this patient. Mr. Gable stated that he was filling in at that particular store for
the day and was not familiar with the patient. He said he did recall the prescription
because of the unusual directions for Oxycontin.
President McAllister asked Mr. Gable how he grabbed the wrong bottle. Mr. Gable
stated that he probably grabbed the wrong bottle when he went to the narcotics
cabinet. Mr. Gable stated that he filled the entire prescription.
Ms. McCoy asked Mr. Gable if he has looked at the way the bottles are stored and
if he has made any changes to ensure that he does not pull the wrong bottle again.
Mr. Gable said that he is not sure if the store has made any changes because that
was the only day that he had worked at that store. He stated that he double
checks the bottle at the narcotic cabinet and again when he gets to the counter.
Ms. McCoy stated that the supervisor should let the other stores know that this
error occurred so that they may correct any problems. Mr. Cook stated that he did
inform the other stores as part of their quality assurance program.
President McAllister reminded the pharmacist to be careful.
AGENDA ITEM VIII- Consent Agreements
President McAllister asked Board Members if there were any questions or
discussions concerning the consent agreements. Executive Director Wand
indicated that the first four consents on the agenda have been resolved as
Consent Agreements or stipulated orders that have been reviewed and approved
by the Attorney General's Office. Mr. Wand provided a brief overview of the
Consent Agreements for the benefit of the audience.
Mr. Wand stated that the first consent involved a pharmacist that had signed a
PAPA contract and had not complied with his PAPA contract and his license has
been revoked.
Mr. Wand stated that the second consent was signed by the permit holder for
having expired non-prescription medications on their shelves at a grocery store.
The permit holder had been on probation previously for the same violation. The
permit holder has been fined.
Mr. Wand stated that the third consent was signed by the permit holder of a
grocery store for having expired non-prescription medications on their shelves.
The permit holder was fined.
Mr. Wand stated that the fourth consent was signed by a pharmacist who failed to
comply with his PAPA contract and his license has been revoked.
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:
Jeffrey Szubinski 04-0005PHR
Albertson's #983 04-0007PHR
Bashas' United Drug #19 04-0008PHR
Alan Clendenin 04-0009PHR
Express Scripts Mail Order
President McAllister stated that he would open the floor for discussion by the
Board Members before opening the floor for discussion by the attorneys.
Mr. Draugalis asked about the error rate expressed in the work plan. Mr. Draugalis
stated in the order it states that the stay of the investigation or scheduling of a
hearing shall be removed if the Board receives and substantiates complaints of
prescription discrepancies at a rate of more than 1 per 100,000 prescriptions filled
which is one-tenth of the national average which is 1 per 10,000 prescriptions. Mr.
Wand stated that the firm is trying to say that they have put into place a culture of
safety by training their people and implementing a plan. Mr. Wand stated that Mr.
Morris should present the case for the firm.
Dr. Tippett asked President McAllister if we are able to address subsequent
complaints against this firm in terms of the order. The question was turned over
to the Solicitor General and she suggested that the attorneys present their
discussions and then the Board Members could ask questions.
Mr. Pulver opened the discussion by stating that he represents the State of
Arizona. He stated that the state requests that the Board accept this stipulated
stay because the state believes that it is more effective in attacking the root of
the problem. He stated currently the Board has sent forth the complaints regarding
Express Scripts to an administrative hearing.
Mr. Pulver then explained what options the Board has if they reject the stipulated
stay. Mr. Pulver stated that an administrative hearing is pending and it would go
forward. In the hearing, evidence would be provided from the investigation done
by the Board. Mr. Pulver stated that the State of Arizona believes that there is
sufficient and substantial evidence that Express Scripts has committed a violation
of the pharmacy act. Mr. Pulver stated that if the Board finds the facts to be true
then they have three options. Those three options are: probation, suspension, and
revocation. Mr. Pulver stated that if the Board decides that there is a violation,
and they chose to exercise one of those disciplines upon Express Scripts then that
is the end of the Board's duty. Mr. Pulver stated by disciplining Express Scripts,
the Board tells Express Scripts that they have violated the pharmacy practice acts
and they need to change their behavior.
Mr. Pulver stated that the state feels the stipulated agreement allows the Board to
look into the pharmacy practices, the methodology, and the training of the
employees and pharmacists of this firm and determine how to best help this entity
correct their problems. Mr. Pulver stated from the state's point of view there are
at least three problems on which the Board should focus. The first problem is
when the prescriptions are sent to Express Scripts via fax, telephone, or mail is
what being sent to Express Scripts being entered into their system. The Board
needs to determine what checks and balances are being used. The second
problem is during the process what checks and balances are being used to insure
that there are no drug interactions and that the prescriptions are entered on the
correct profile. The third problem is to determine if the correct prescription is
being shipped to the correct patient. Mr. Pulver states that the state feels that
this stay will allow the Board to look into the dealings of this corporation, find out
what steps they are taking in training their employees, and what methodology and
equipment they are using to remove these problems.
Mr. Pulver stated that if the Board disciplines Express Scripts through an
administrative hearing then the Board will not have the ability to look at the
company's practices. Mr. Pulver stated that the work plan that Express Scripts is
presenting to the Board indicates that they are serious about changing their
practices. Mr. Pulver stated that the agreement is not perfect. Mr. Pulver stated
that the Board could reject the stay, change or amend the stay, or accept the stay.
Mr. Pulver stated from the state's point of view this gives the Board more power to
control and understand what is going on with this corporation and to regulate their
behavior and make systemic changes that will protect the public. Mr. Pulver
stated that if the Board simply disciplines them in an administrative hearing, the
Board has no assurances that they will not be back in a couple of weeks. Mr.
Pulver stated that by accepting the stay, the Board has a greater assurance that
they have a hand in reviewing and seeing their processes and methods and
ensuring that they will not be making the same mistakes. Mr. Pulver states that
no matter what decision the Board makes the State of Arizona will support their
decision.
President McAllister then opened the floor to Mr. Roger Morris serving as counsel
for Express Scripts. Pharmacist-In-Charge Thomas Hinckley and Vice President
and Director of Pharmacy Practice Gary Sobocinski were present to represent
Express Scripts. Thomas Hinckley is the Pharmacist- in Charge at the Express
Scripts facility in Tempe. Mr. Sobocinski is in charge of supervising the
Pharmacists-In-Charge across the country for Express Scripts. Mr. Morris stated
that Mr. Sobocinski is present because the highest levels of the company are
supportive of this stay and will ensure each action occurs.
Mr. Morris stated that the reason they are here is because there are three
complaints that the Board has suggested to be carried over for hearing. Mr. Morris
stated that each of those complaints deal with problems that have occurred at
Express Scripts over the past several months. Mr. Morris stated that each of these
complaints dealt with human issues from the call center representatives that are
not helpful and have given out incorrect information and to the shippers who have
policies in place as to how they are supposed to ship a package and did not follow
the procedures.
Mr. Morris stated that Express Scripts has had a number of complaints filed with
the Board over the last two years. Mr. Morris stated that the number is not a
materialistic number compared to the volume of prescriptions dispensed. Mr.
Morris stated that Express Scripts does not want to have any errors and want to
change their practices. Mr. Morris stated that if the case goes to a hearing and
the company violated pharmacy statutes and acts then the Board would have the
opportunity to enforce discipline. Mr. Morris stated that it would only enforce
discipline and he asked the company to develop a plan that is better than
discipline. Mr. Morris stated that the stipulated stay is a way to give better
patient care from this pharmacy.
Mr. Morris wanted to walk through the key issues of the work plan. Mr. Morris
stated that the first key issue is to enhance their compliance program. Mr. Morris
stated that the senior members of the Board of Directors of the company have put
in a compliance program with the General Counsel of the company to review the
pharmacy policies. Mr. Morris stated that the company has hired special pharmacy
legal counsel and have a pharmacy law compliance officer that is an attorney and
pharmacist working for the company. Mr. Morris stated that the company would
hold a meeting every two weeks to review pharmacy compliance around the
country. Mr. Morris stated that the committee would report back to the Board of
the company.
Mr. Morris stated that Express Scripts would have a quality improvement program.
Mr. Morris stated that they will survey their members who are the patients that get
their prescriptions on a monthly basis. The survey will be sent to the Board for
approval and ask if there are other questions that the Board would like added to
the survey. Mr. Morris stated that the statistics will be submitted quarterly on the
member satisfaction.
Mr. Morris stated that there was an entire review of their policies and procedures
at this pharmacy. Mr. Morris stated that there is an enhanced training program for
the pharmacists, the technicians, and the call center. Pharmacists are
supervising the training program. Mr. Morris stated that there are numerous
quality meetings between the various groups. Mr. Morris stated that quality audits
would be performed. Mr. Morris stated that they have enhanced the number or
reviews for the shippers and call center representatives.
Mr. Morris stated that the company wants their pharmacists to be more involved in
the community and the profession and have agreed to reimburse the pharmacists
for participation in state pharmacy organizations. Mr. Morris stated that they have
purchased numerous continuing education programs for their pharmacists.
Mr. Morris stated that Express Scripts wants to have a quality dispensing program.
Mr. Morris stated that the agreed upon error rate by most experts is one error in
ten thousand prescriptions. Mr. Morris stated that Express Scripts is setting their
standard higher. Mr. Morris stated that they would use an error rate of one error in
one hundred thousand prescriptions. Mr. Morris stated that if they can not meet
that standard, then the stipulated stay fails and the Board is free to set an
administrative hearing and execute the three complaints and any other complaints
that get rolled into this consent. Mr. Morris stated that an error would include the
following: incorrect drug, incorrect dosage strength, incorrect directions for drug
use, incorrect patient name, incorrect prescriber name, lack of access to a
pharmacist, and inadequate product storage.
Mr. Morris stated that if the company complies with it's work plan the Board
should have fewer complaints. Mr. Morris stated that the company has six months
to prove to the Board that they can comply with this work plan and if they do not
the Board can lift the stay. Mr. Morris stated that if they do comply then the
complaints would be dismissed. Mr. Morris stated that the complaints that were
discussed at this Board meeting would be rolled into the consent order.
Mr. Wand stated that the Board will conduct two additional inspections at the
company's expense. Mr. Wand stated that they are trying to develop a culture of
safety. Mr. Wand stated that they are trying to change their culture from the top
down and that is why they are asking for six months.
President McAllister asked Mr. Morris to explain if an egregious complaint occurs
what will happen. He stated that he does not want the complaint to be rolled into
this ratio of errors and be ignored. Mr. Morris stated that the way the stay is
written up in terms of ratios and issues is that it must be a complaint of similar
nature to what the complaints are in the stay, such as shipping and patient
communication.
Dr. Tippett stated that as far as community involvement is concerned he feels the
company does not go far enough. Dr. Tippett stated that it might be beneficial to
have members of the community, such as clients who are on the receiving end be
included in the feedback loop.
Mr. Morris stated that the survey would be both by telephone and a written survey
asking for both positive and negative feedback. The feedback will be supplied to
the Director of the Board. Dr. Tippett suggested focus groups for face-to-face
contact with their clients.
Mr. Wand asked if Express Scripts was reporting the mistakes to the Board or if
the complainant must mail the complaint to the Board. Mr. Morris stated that the
Complainant would have to make an independent report. Mr. Morris stated that
the company does not track internal versus external errors. Mr. Morris stated that
the metrics in the stay is based off of complaints filed with the Board.
Mr. Wand asked about the time frame to fill 100,000 prescriptions. Mr. Morris
stated that it takes about 6 to 7 days to fill that number of prescriptions. Mr. Wand
stated that if you make more than one mistake in seven days then the company
would be in violation of this order. Mr. Morris stated that it would be looked at on a
six-month basis. Mr. Morris stated that if there are too many complaints the Board
could pull the agreement and could start the hearing process.
President McAllister asked Mr. Pulver, who was representing the state, if the
Board has oversight in this process. Mr. Pulver replied yes. Mr. Pulver stated that
the Board could wait for better ideas. Mr. Pulver stated that the Board has the
power to attack the roots of the problem. Mr. Pulver stated that the Board could
discipline the company. Mr. Pulver stated that the Board does not have to sign off
on this agreement today and could review the agreement at the next Board
meeting.
Dr. Tippett asked what the next step would be if at the end of six months there
were no violations. Dr. Tippett asked what guarantees do we have that changes
will remain in place and what actions would the Board take after this six- month
period. Solicitor General, Victoria Mangiapane, stated that the six month stay is in
place. She stated that if any similar consumer complaints are turned into the
Board, it is up to the discretion of the Board to determine if it is a
similar matter. Ms. Mangiapane stated that once the stay is concluded, the Board
has authority to investigate other future investigations. Ms. Mangiapane stated
that the Board must look at when that conduct occurred. If the conduct occurred
prior to November 12, 2004, the complaint may be wrapped up into the stipulated
stay because they are taking action to correct the problems. Ms. Mangiapane
asked if the work plan was in place. Mr. Morris replied that the vast majority of the
policies have been authored and they are instituting the policies and training. Mr.
Morris stated that the company has put the policies in place so that they could
demonstrate to the Board that they were not just talking but also actually working
on the work plan. Ms. Mangaipane asked if it is the intent of Express Scripts to
maintain this work plan after the six months. Mr. Morris stated that Express
Scripts intent is to do much better than the work plan during the six month stay
and afterwards.
Mr. Draugalis asked how many complaints Express Scripts had in the last six
months. Mr. Wand replied that they had ten complaints in the last six months. Mr.
Draugalis asked how many complaints would Express Scripts be allowed in this
time period. President McAllister stated that most of the complaints had a b
component of customer service and not breaking practice necessarily. Mr.
McAllister stated that we still have the opportunity to act on egregious errors.
Mr. McAllister stated that he feels that Express Scripts has heard the Board's
concerns and wants a chance to fix their systems. Mr. Wand stated that he only
gave the number of complaints and not the outcomes. Mr. Wand stated that some
of the complaints had no further action and others were dismissed with a letter.
Mr. Wand stated that not all the complaints were customer safety issues but
customer service issues.
Mr. Wand stated that he has read articles by Mr. Brushwood and the articles would
state that Boards were backwards and old-fashioned. Mr. Wand stated that this is
an outside of the box type settlement. Mr. Wand stated that it would be easy to
fine the company and impose probation. Mr. Wand stated that this agreement
would cause the company to change their practices.
Ms. McCoy stated that this agreement forces the company to look at the systems.
Ms. McCoy stated that some of the practices seem time limited. Ms. McCoy
suggested that Express Scripts should review the ISMP Self-Medication Self-Assessment which would allow the organization to score themselves against
proven safety practices. Ms. McCoy asked if the company involved any quality
change consultants in the process. Ms. McCoy stated that a culture change might
be needed. Ms. McCoy states that with this agreement the Board has the
opportunity to help improve health care delivery. Ms. McCoy stated that the items
mentioned in the work plan are not time limited but are ongoing processes. Ms.
McCoy stated that the metrics and outcomes should be constant and would like to
see Express Scripts make the commitment that this is not a six- month process
only. Ms. McCoy stated that if Express Scripts is going to change the company
culture that the process will take longer than six months.
Mr. Sobocinski stated that his role was created in early March. Mr. Sobocinski
stated that it is a commitment by the company to look at four things. Mr.
Sobocinski stated that patient contact is one of the areas. Mr. Sobocinski stated
that they would look at the software and automation to prevent system driven
errors. Mr. Sobocinski stated that they would look at regulatory compliance. Mr.
Sobocinski stated that there are many conflicting regulations for their company
because they operate on a nationwide basis. Mr. Sobocinski stated that the
company would be looking at the culture. Mr. Sobocinski stated that people must
be organized around a culture that does what is best for the patient.
Mr. Pulver stated that the Findings of Fact would go into the investigative file in
case Express Scripts is not able to fulfill the agreements of the stipulated stay.
Mr. Pulver stated that the Findings of Fact have been agreed upon. Mr. Pulver
stated that if the Board decides to accept the stay and Express Scripts fails, there
is no argument that they were not given the opportunity to change. Mr. Pulver
asked Mr. Morris to review the work flow charts for the Board Members.
Mr. Morris stated that in order for breakdowns to occur it requires multiple people
and multiple system errors and Express Scripts is refining their processes.
Mr. Wand indicated that since several Board Members were absent it might be nice
to have all the Board Members weigh in on this decision. Mr. Wand asked about the
three complaints that have come in after this process began. Mr. Wand asked if
these complaints would be rolled into this consent. Mr. Wand indicated that they
occurred after December and are shipping errors. Mr. Morris stated that the way
the stipulated stay is worded that the complaints would automatically roll into the
stay since they occurred before this Board Meeting. Mr. Wand stated that the
Finding of Fact have been agreed to by Express Scripts and would not need to be
proven to proceed with disciplinary action.
President McAllister asked the Board Members if this proposal meets the intent of
the Board in terms of the Board's mission and if there would be a benefit in waiting
a month for the other Board Members to weigh in on the issues or should the Board
move ahead.
Mr. Draugalis stated that he thought it would be beneficial for all Board Members
to review the proposal. Dr. Tippett stated that he feels that the proposal is a good
proposal and feels that the proposal meets the Board's goals. Dr. Tippett feels that
the other Board Members should review the proposal. Ms. McCoy stated that she
would like to have the other Board Members present to look at the process. Ms.
McCoy stated that even if the Board does not make a decision today, Express
Scripts should move forward with the work plan. President McAllister stated that
he disagreed. He felt that the other Board Members had a choice and he stated
that the firm has made an effort to meet the needs of the Board and he feels that
we should move on with the decision today.
Mr. Wand stated that the three new complaints should be added to the Findings of
Fact. Mr. Pulver stated that it would be important to include them in the Findings
of Fact if an administrative hearing were to be held. Mr. Morris stated that he
would review the complaints with the company. Mr. Morris stated that the
company would like to move forward with this agreement.
On motion by Mr. Draugalis and Ms. McCoy, a roll call vote was taken and the
Board unanimously accepted the stipulated stay.
Mr. Pulver asked if the Board wanted the additional Findings of Fact to be added to
the stay. Mr. Morris stated that he would not want to delay this motion.
On motion by Ms. McCoy and Dr. Tippett, a roll call vote was taken and the Board
unanimously agreed to add the three current complaints to the Findings of Fact if
agreed upon by counsel and the company.
Dr. Tippett stated that the company could hammer on the people and the
processes and unless they have buy in by the participants the changes are not
going to occur. Dr. Tippett said that he hopes there are some incentives built into
the plan for the employees and the employees can see why they are performing
these activities.
AGENDA ITEM X - Compounded Veterinary Drug Products
President McAllister asked Mr. Wand to address this issue. Mr. Wand stated that
in the packet is a copy of the letter from the FDA signed by Gloria Dunnavan
concerning veterinary compounding. Mr. Wand stated that the letter states the
compounding veterinary products is illegal since they are new drugs. Mr. Wand
stated that this is a policy that they may have not enforced in the past and may be
enforcing at this time due to complaints from veterinary practitioners. Mr. Wand
felt that this might impact numerous compounding pharmacies in Arizona.
Mr. Wand stated that he has been contacted by the FDA to participate in
inspections of pharmacies in Arizona on a collaborative inspection with the FDA
inspector. Mr. Wand feels that we should participate in the inspections so that we
can see what statutes and rules they want to enforce. By participating in the
inspections, the Board would be able to give their perspective on how the Board
interprets the rules. Mr. Wand stated that he looked at the compounding definition
in our rules and it does distinguish between compounding for humans and animals.
Mr. Wand stated that the definition would allow for compounding of medications
for animals. Mr. Wand stated that the statutes also require all practitioners and
permit owners to comply with Federal laws as while as state laws. Mr. Wand
stated that a permit holder could be disciplined for not following Federal laws that
are not a violation of state laws. Mr. Wand stated that he would have a least one
inspector participate in the inspections. Mr. Wand stated that he feels the
inspections are mainly for fact finding. President McAllister stated that he
believes it would be good for fact finding.
AGENDA ITEM XI - Task Force on Counseling
President McAllister asked Ms. McCoy to address the task force. Ms. McCoy
stated that at the last Board meeting it was decided that a task force would be
formed to look at the counseling issues. Ms. McCoy stated that several
practitioners have contacted Mr. Wand requesting to serve on the committee. Ms.
McCoy stated that the committee would probably meet at the Board office in the
early part of June. Ms. McCoy stated that the meeting would be held in the
evening. Ms. McCoy asked any practitioner that is interested in participating to
please contact Mr. Wand. Ms. McCoy stated that the committee is interested in
having pharmacists participate on the committee that counsel patients each day
in the field. Ms. McCoy stated that there would be a limited number of meetings.
Ms. McCoy stated that the committee would focus on quality improvement
techniques to make counseling more effective.
Mr. Wand stated that the following individuals have agreed to serve on the
committee:
Mike Noel - Cardinal Health
Sharon Richardson - Safeway
Dennis Waggoner - Caremark
Kent Taylor - Walgreens
P. Sean Duffy - Osco
President McAllister concluded that the task force was formed because the Board
is receiving Consumer complaints, which claim that the patient was not counseled
on new prescription. Mr. McAllister stated often the technician is accepting the
denial of counseling and the pharmacist is not aware that the patient was not
counseled. Mr. McAllister discussed a recent article he read about an automated
system that documents whether a patient wants counseled or not by the
pharmacist. The patient makes the choice and enters the information into the
system.
AGENDA ITEM XII - National Association of Attorneys General Letter -
Importation of Canadian Drugs
President McAllister asked Mr. Wand to address this issue. Mr. Wand stated that
the National Association of Attorneys General sent a letter to the Attorney
Generals requesting Secretary Thompson of HHS to allow the safe importation of
prescription drugs from Canada. Mr. Goddard, the Attorney General in Arizona, did
sign the letter along with eighteen other Attorney Generals. Mr. Wand stated that
Mr. Thompson stated that this might be a topic to be discussed at the next
Congress. Mr. Thompson stated that it is probably inevitable. Mr. Wand stated
that nobody from the Attorney General's Office contacted the Board to obtain the
Board's opinion before signing the letter. Mr. Wand stated that this is only a short-term solution.
Ms. McCoy stated that the importation will create problems in Canada's health
care system and is a challenge. Ms. McCoy stated that safety is thrown out the
window. Ms. McCoy stated at the NABP Convention is was pointed out to the
participants that there are many counterfeit drugs out there and importation is
another avenue for an individual to transport counterfeit drugs into this country.
Ms. McCoy stated that they were told it took one cow with Mad Cow disease to
shut down the beef importation and yet we have reports of counterfeit drugs daily
and there is no concern about the safety of the drugs coming into our country. Ms.
McCoy said that people are looking at economic factors and not safety factors.
Ms. McCoy stated that as pharmacists we failed the public because now they are
bypassing talking to any pharmacist in obtaining their medication from Canada.
Mr. Wand stated that when the Canadian drugs were in short supply the Director of
the Internet Canadian Pharmacy Association was contacted and he stated that " I
and my organization will scour the world for drugs that are safe". Mr. Wand stated
that this individual had just appointed himself as Health Canada and the FDA to
determine safety. Mr. Wand stated that the individual is motivated by profit.
AGENDA ITEM XIII- 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 pharmacist commented on the handling of the conferences and consents by the
Board. He stated in the state where he was originally licensed that most of the
cases would have resulted in reprimands or fines.
A pharmacist commented that he hopes the Board will not participate in the joint
inspections with the FDA at compounding pharmacies that compound veterinary
medications. He expressed concerns that the FDA has no regulatory jurisdiction
over compounding pharmacies.
Another individual stated that the APhA has asked that the letter be rescinded
concerning the compounding of veterinary medications because the FDA does not
have authority. It was noted that the FDA has not replied.
It was noted that the Arizona Pharmacy Association is against the importation of
medications and would like to meet with seniors and help them find alternative
ways to obtain their medications instead of purchasing medications from other
countries.
A pharmacist asked if the Board would consider posting on the website the
following items:
1. The PAPA statistical report
2. The letter from the National Attorneys General concerning importation from
Canada
3. The copy of the complaint grid
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
3:50 P.M.
