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THE ARIZONA STATE BOARD OF PHARMACY
HELD A REGULAR MEETING JANUARY 24, 2007
GLENDALE, ARIZONA
The following Board Members and staff were present: President Chuck Dutcher,
Vice President Tom Van Hassel, Zina Berry, Louanne Honeyestewa, Dennis McAllister, Linda
McCoy, Ridge Smidt, and Paul Sypherd, Compliance Officers Rich Cieslinski, Larry
Dick, Ed Hunter, Sandra Sutcliffe, and Dean Wright, Deputy Director Cheryl
Frush, Executive Director Hal Wand, and Assistant Attorney General Dawn Lee.
President Dutcher convened the meeting at 8:30 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 - Nomination and Election of Officers
President Dutcher opened the nominations for President. Mr. Van Hassel was
nominated for President. On motion by Mr. McAllister and Dr. Smidt
the Board unanimously approved the nomination of Mr. Van Hassel for
President of the Board for 2007.
President Dutcher opened the nominations for Vice President. Dr. Berry was
nominated for Vice President. On motion by Dr. Smidt and Dr. Sypherd
the Board unanimously approved the nomination of Dr. Berry for Vice
President of the Board for 2007.
President Dutcher turned the meeting over to newly elected President Van
Hassel.
AGENDA ITEM 2 - Approval of Minutes
Following a review of the minutes and an opportunity for questions and
on motion by Dr. McCoy and Mr. Dutcher, the minutes of the
Regular Meeting held on November 8 and 9, 2006 were unanimously approved by the
Board Members.
AGENDA ITEM 3 - Permits & Licenses
President Van Hassel stated that all permits were in order for resident
pharmacies and representatives were present to answer questions from Board
members.
University of Arizona College of Pharmacy Kevin Boesen,
Director of the Medication Management Center, and Roger Morris,
Legal Counsel for the University of Arizona College of Pharmacy, were present to
answer questions from Board Members.
President Van Hassel asked Mr. Wand to open the discussion concerning this
permit application.
Mr. Wand stated that the University of Arizona has been participating in a
Medication Management therapy pilot program in collaboration with an insurance
company. Mr. Wand stated that they have been using the existing University of
Arizona pharmacy permit. Mr. Wand stated that the program is seeking a separate
permit to apply for non-resident licenses in other states. Mr. Wand stated that
the Board needs to consider if there is adequate space for the pharmacy and if
all security requirements are met by the pharmacy.
Mr. Boesen stated that the Medication Management Program is currently working
with a national Medicare Part D plan to provide medication management therapy services.
Mr. Boesen stated that the services provided are in conjunction with local community
pharmacies. Mr. Boesen stated that they act as a safety net for the pharmacies.
Mr. Boesen stated that they feel pharmacists are the best suited individuals to
provide the medication management therapy. Mr. Boesen stated that if a patient
does not have access to a community pharmacy they would provide services to the
patients that are enrolled in the program. Mr. Boesen stated that they speak to
the patients over the telephone.
Mr. Boesen stated that the pharmacy would be located on the second floor of
the new Pharmacy School building. Mr. Boesen stated that it is a secure floor
and it requires a card swipe for entry to the floor. Mr. Boesen stated that
there are no medications, supplies, or data on site. Mr. Boesen stated that all
data is stored on a web based portal that they access by entering a secure
password. Mr. Boesen stated that notes that they generate would be kept in a
locked file cabinet in a locked office.
Mr. Morris stated that this is a non-dispensing pharmacy that would be
providing counseling services. Mr. Morris stated that the reason that they would
like to obtain a pharmacy permit is to allow them to apply for non-resident permits,
so that they would be able to counsel non-residents.
Mr. Dutcher asked if this would be a limited-service pharmacy permit.
Mr. Wand stated that this would be a limited-service permit and they would need to
develop policies and procedures that would be approved by the staff or the
Board.
Mr. Boesen stated that their goal is to provide services to other patients in
addition to patients enrolled in the Medicare Part D plans. Mr. Boesen stated
that currently patients are qualifying for the 2007 Medicare Part D
program.
Mr. Wand stated that the issue is that the Board would be issuing a permit
for a pharmacy with web based patient information. Mr. Wand stated that the
computer system is secure. Mr. Wand stated that a non-pharmacist in the area
could not access the web page.
Dr. McCoy asked if the patients are contacted by telephone or if the patient
could come to the pharmacy site to speak with the pharmacist. Mr. Boesen stated
that all contact is by telephone.
Mr. Boesen stated that the patients must meet certain criteria. Mr. Boesen
stated that the patients must be spending over $4,000 for medications, they must
have at least 4 disease states, and must be taking at minimum 10 different
medications. Mr. Boesen stated that many patients are taking up to 25 drugs. Mr.
Boesen stated that the chain stores have now signed up for the plan.
Dr. McCoy asked if there should be criteria established for such programs.
Mr. Wand stated in the past the Board Staff has approved the policies and
procedures for limited service pharmacies and felt that maybe the Board Members
would like to review the policies and procedures for limited service pharmacies
in the future. Mr. Wand stated that the staff could continue to review the
policies and procedures and bring any issues to the Board Members for review at
a Board Meeting.
Dr. McCoy stated that since this is the first pharmacy applying
for this type of permit that maybe the Board should review their policies and
procedures.
Mr. Wand stated that the policies could be reviewed, placed on an
agenda, and approved by a telephone meeting.
Mr. Van Hassel asked about the procedures and staffing of the Center.
Mr. Boesen stated that he would be the Pharmacist In Charge. Mr. Boesen stated that
there would be six trained pharmacists present. Mr. Boesen stated that students
would be involved in the program. Mr. Boesen stated that first and second year
students would call patients to see if they were interested in participating in
the service. Mr. Boesen stated that if the patient is interested in the services
then the patient would be contacted by a pharmacist or a third-year or
fourth-year intern under the supervision of a pharmacist.
Dr. Smidt stated that by becoming licensed they are agreeing to regulation by
the Board. Dr. Smidt stated that he has no issue in the Board Staff approving
the policies and procedures for this pharmacy.
Dr. McCoy stated that she does not have any issue in the Board Staff
approving the plans, but would like to see a copy of the policies and
procedures.
On motion by Dr. McCoy and Mr. Dutcher, the Board
unanimously agreed to approve the permit for the University of Arizona Pharmacy
School with the Board staff approving the policies and procedures, notifying the
University of Arizona that the permit would be issued upon acceptance of the
policies and procedures, and providing the Board Members with a copy of the
policies and procedures.
Arizona Medical Infusion
Owners Anthony Sammartino and Henry Konerko were present to answer questions
from Board Members. Mr. Sammartino is a pharmacist and Mr. Konerko is the
financial advisor.
President Van Hassel opened the discussion by asking Mr. Sammartino to
describe the nature of his business.
Mr. Sammartino stated that he plans to open a small home infusion pharmacy.
Mr. Sammartino stated that he does not have any
clients at this time, but does have contracts in the works to provide first
dosing.
Mr. Van Hassel asked Mr. Sammartino if he is familiar with the sterile
compounding rules.
Mr. Sammartino replied that he is familiar with the rules.
Mr. Van Hassel asked Mr. Sammartino if he is familiar with the USP 797
compounding rules.
Mr. Sammartino replied that he is familiar with the rules and
has been working in sterile compounding for the last three years.
The Compounding Center
Owner and Pharmacist In Charge Paul Vasiliauskas was present to answer
questions from Board Members.
President Van Hassel opened the discussion by asking Mr. Vasiliauskas to
describe the nature of his business.
Mr. Vasiliauskas stated that he is purchasing an existing compounding pharmacy.
Mr. Dutcher asked Mr. Vasiliauskas if he is familiar with Arizona Compounding
rules.
Mr. Vasiliauskas stated that he is familiar with the rules.
Mr. Dutcher asked Mr. Vasiliauskas if he has been working at the pharmacy.
Mr. Vasiliauskas stated that he has not been working at the pharmacy.
Dr. McCoy asked Mr. Vasiliauskas if he has any compounding experience.
Mr. Vasiliauskas stated that he has done compounding for about a year and half at
his prior job.
Dr. McCoy asked Mr. Vasiliauskas if he has taken any special compounding
classes.
Mr. Vasiliauskas replied no.
Mr. Dutcher asked Mr. Vasiliauskas if he is familiar with the laws that would
not allow him to compound a commercially available product.
Mr. Vasiliauskas stated that he is familiar with the laws.
Mr. Dutcher asked Mr. Vasiliauskas what type of products he would be compounding.
Mr. Vasiliauskas stated that he would be compounding oral
medications, topical medications, and subcutaneous medications. Mr. Vasiliauskas
stated that he would not be compounding IV medications.
Mr. Wand asked Mr. Vasiliauskas if his business would be separate from the
wholesale business.
Mr. Vasiliauskas stated that he is only purchasing the
pharmacy and the old owners would still maintain the wholesale business at the
location.
Synergy Rx
Owner and Pharmacist In Charge Mayur Dev was present to answer questions from
Board Members.
President Van Hassel opened the discussion by asking Mr. Dev to describe the
nature of his business.
Mr. Dev stated that he plans to open a pharmacy that
would cater to clients from the dental practice and urgent care practice located
in the retail plaza.
Mr. Van Hassel asked Mr . Dev if he plans to supply medications to the urgent
care clinic or the dental practice.
Mr. Dev stated that he does not plan to sell medications to either practice.
Mr. Dev stated that his primary focus is to fill prescriptions for the
patients of the dental practice. Mr. Dev stated that he does not intend to
advertise his pharmacy. Mr. Dev stated that he plans on carrying only 20
products.
Mr. McAllister asked Mr. Dev to describe the rest of his business that is
located at the site.
Mr. Dev stated that he is currently operating a sports
nutrition store at the site. Mr. Dev stated that he is taking the healthcare
approach and using that approach to educate individuals on the safe use of
nutritional and supplement products. Mr. Dev stated that they work with athletes
and are currently working with approximately 60 baseball players and the
selection of nutritional products for their use. Mr. Dev stated that they also
work with seniors requesting natural products to treat illnesses and ensure that
they do not interact with medications that they may be taking for other
conditions.
Mr. Van Hassel asked Mr. Dev if he would be compounding any of these
products.
Mr. Dev stated that he would not be doing any compounding.
Mr. Dutcher asked if the pharmacy is located in the same area as the sports
store.
Mr. Dev replied that the pharmacy is located in the site and the pharmacy
is secure and can be locked. Mr. Dev stated that he plans to cater to the dental
business.
Mr. Wand asked Mr. Dev if he performs any lab tests.
Mr. Dev stated that they do not perform any lab tests at this time. Mr. Dev stated that they may become
CLIO certified to perform cholesterol testing and liver enzyme testing.
Mr. Wand stated that the issue of stocking medications could be addressed by
the fact that Mr. Dev is meeting the demands of his trading area. Mr. Wand
stated that Mr. Dev would be stocking the products necessary to meet the demands
of the dental population.
Mr. Wright stated that he has been to the site and made recommendations. Mr.
Wright stated that Mr. Dev does have adequate space.
Dr. McCoy asked if this should be a limited service permit. Mr. Wand stated
that this should be a limited service permit.
At the conclusion of questions from the Board Members and on motion
by Mr. Dutcher and Dr. McCoy, the Board unanimously approved the
resident permits listed below. All approvals are subject to final inspection by
a Board Compliance Officer where appropriate.
RESIDENT (In Arizona)
- Target Pharmacy T-2227
24890 N. Lake Pleasant Pkwy.
Peoria, AZ 85383
Target Corporation
- West Kingman Pharmacy
3505 Western Ave.
Kingman, AZ 86401
(O) West Kingman Pharmacy, LLC
- Arizona Medical Infusion
20650 N. 29th Pl., Suite 105
Phoenix, AZ 85050 Arizona
Medical Infusion, LLC
- Wal-Mart Pharmacy #10-4325
8151 E. 32nd St.
Yuma, AZ 85365
Wal-Mart Stores, Inc.
- >CVS/pharmacy #5437
6030 N. 43rd. Ave.
Glendale, AZ 85301
German Dobson CVS, LLC
- Medical Arts Pharmacy
1946 S. Dobson Rd. #3-5
Mesa, AZ 85202
(O) T- Med Products
- The Compounding Center
4045 E. Bell Rd., Suite 163
Phoenix, AZ 85032
(O) Vitalab Pharmacy Inc.
- Synergy Rx
1473 N. Dysart Rd., Suite 104
Avondale, AZ 85323
Mayur Dev
- U of A College of Pharmacy
1295 N. Martin Ave.
Tucson, AZ 85721
The University of Arizona
(O) Ownership
Non-Resident Permits
At the conclusion of questions from the Board Members and on motion
by Dr. McCoy and Dr. Smidt, the Board unanimously approved the non-resident
permits listed below.
NON-RESIDENT (Out of State)
- Progressive Solutions Pharmacy
85 W. 9400 South
Sandy, UT 84070
Meds for Vets
- Sterling Medical Services
2 Twosome Dr.
Moorestown, NJ 08057
(O) Sterling Medical Services, LLC
- Focus Home Medical
1100 N. Mustang Rd., Ste. F
Mustang, OK 73064
Focus Home Medical, Inc.
- Pharmacy Solutions
2201 Waukegan Rd., Suite 200
Deerfield, IL 60015
TAP Pharmaceuticals Inc.
- Access Pharmaceutical Services
113 E. Sellers Ave.
Ridley Park, PA 19078
Access Pharmaceutical Services, LLC
- Patient Care Pharmacy
2318 East Pass Road
Gulfport, MS 39507
Patient Care Pharmacy, Inc.
- Diabetic Care Rx
1860 N. Pine Island Road, S#104
Plantation, FL 33322
Diabetic Care Rx
- Liberty Healthcare of Nevada
6225 Annie Oakley Dr., Suite 100
Las Vegas, NV 89120 Liberty
Healthcare Group, Inc.
- Westlab Pharmacy
4410 W. Newberry Rd., Ste. A-5
Gainesville, FL 32607
Westlab Pharmacy, Inc.
- Caremark
800 Biermann Ct., Suite B
Prospect, IL 60056
(O) Caremark Illinois Specialty Pharmacacy
- >Life Extension Pharmacy, Inc.
1100 W. Commercial Blvd, #130
Fort Lauderdale, FL 33309
Life Extension Pharmacy, Inc.
- A Plus Healthcare Pharmacy
100 Pear Orchard Dr., Suite A
Vicksburg, MS 39183
(O) Axium Healthcare Pharmacy, Inc.
- Axium Healthcare Pharmacy
550 Technology Park,
Lake Mary. FL 32746
(O) Axium Healthcare Pharmacy, Inc.
- IgG America
514 Progress Dr., Suite X-Z
Linthicum Heights, MD
Amerisource Bergen
- FCS Pharmacy II
2333 Courage Dr., Suite F
Fairfield, CA
Factor Health Management, LLC
- Women's International Pharmacy
2 Marsh Ct.
Madison, WI 53718
Women's International Pharmacy
(O) = Ownership
Wholesale Permits
President Van Hassel stated that there was one resident non-prescription wholesale permit to
approve.
On motion by Mr. Dutcher and Dr. Berry, the Board unanimously approved the
resident wholesale permit listed below. All permits are subject to final inspection by a Board
Compliance Officer where appropriate.
Value Wholesale Inc.
4733 N. 43 rd Ave., Suite 1
Phoenix, AZ 85031
Aziz Mallik
Non-Prescription Drug Manufacturer
National Vitamin Co., Inc
Pharmacist In Charge Oliver Waite was present to answer questions from Board Members.
President Van Hassel asked Mr. Wand to open the discussion.
Mr. Wand stated that the applicant appeared at a past board meeting and the application
was tabled until the company had hired a Pharmacist In Charge. Mr. Wand stated that a Bill
is currently in the legislature that would remove the requirement that a Pharmacist must be
present at a non-prescription manufacturer. Mr. Wand stated that until the Bill is passed a
Pharmacist must be present at the manufacturer's facility during production runs.
Mr. Van Hassel asked Mr. Waite if he is familiar with the rules and regulations.
Mr. Waite stated that he is familiar with the rules and began his employment with the
company on January 2, 2007. Mr. Waite stated that his past experience has been in clinical
research and development.
Mr. Dutcher asked Mr. Waite about his responsibilities as Pharmacist in Charge at the facility.
Mr. Waite stated that he has been learning the procedures. Mr. Waite stated that the company is a
large production company. Mr. Waite stated that they have chemistry labs, microbiology labs, and testing
labs on site.
Mr. Wand stated that most of the processes are automated and have testing labs on site.
Mr. Waite stated that the company manufactures nutritional supplements and one major non-prescription
product. The non-prescription product is Docusate.
Mr. Van Hassel asked Mr. Waite if he feels that a pharmacist is of value in the manufacturing process.
Mr. Waite stated that he feels that a pharmacist can contribute to the process.
Mr. Wand stated that only 7 states have a requirement that a pharmacist must be present at a manufacturing
facility. Mr. Wand stated that the requirement would remain for any company manufacturing prescription medications.
At the conclusion of questions from the Board Members and on motion by Mr. Dutcher and Dr. Smidt,
the Board unanimously approved the resident manufacturer permit listed below. All approvals are subject to final inspection
by a Board Compliance Officer where appropriate.
National Vitamin Co., Inc.
1145 W. Gila Bend Hwy.
Casa Grande, AZ 85222
National Vitamin Co, Inc.
Following a review and discussion of the roster of applicants for licensure as
pharmacists, interns, and pharmacy technicians and assurance by the staff that all
applications were in order and all fees paid: On motion by Dr. McCoy and Dr. Berry,
the Board unanimously approved the Pharmacists licenses 15820 through 15896.
On motion by Dr. Berry and Mr. Dutcher, the Board unanimously approved the
Intern licenses 7870 through 7894. On motion by Mr. Dutcher and Dr. Berry,
the Board unanimously approved the Pharmacy Technician licenses 11770 through 12333. Also, approved were 185 licensee changes from Pharmacy
Technician Trainee to Pharmacy Technician. For a complete list of names see attachments.
Mr. McAllister stated that he recently served on the PTCB credentialing committee. He stated that he reviewed
the test questions and the exam is a very well designed exam. Mr. McAllister stated that the next exam in February
will be computerized like the NAPLEX exam.
AGENDA ITEM 4 - Conferences
Complaint #3208
The following individuals were present to answer questions from Board Members concerning a consumer complaint:
Pharmacist Cindy Pawlicki, Pharmacy Technician Trainee Dustin Bellah, and Pharmacy Supervisor John Reitz.
Compliance Office Larry Dick gave a brief overview of the complaint. Mr. Dick stated that the
complainant's prescription for Levoquin 500 mg was filled correctly by the pharmacy. However, the
complainant presented the pharmacy with a list of medications he was currently taking and the pharmacy
failed to note this information and dispensed Levoquin 500 mg even though the complainant was taking
Pacerone which has a significant drug-drug interaction with Levoquin.
President Van Hassel opened the discussion and asked Ms. Pawlicki to discuss the complaint.
Ms. Pawlicki stated that she was at the consultation and verification window. Ms. Pawlicki stated
that Dustin was at the out window where the patients pick up their medications. Ms. Pawlicki stated the
patient handed Dustin a yellow sheet of paper with a list of medications. Ms. Pawlicki stated that Dustin
was entering the patient's health conditions and allergies. Ms. Pawlicki stated that Dustin gave the sheet
to the patient and told them to give the sheet to the pharmacist. Ms. Pawlicki stated that she counseled the
patient and she instructed the patient to call the pharmacy if they had any questions. Ms. Pawlicki stated
that the patient did not give her the sheet of paper with the drugs on the paper.
Mr. Van Hassel asked Mr. Bellah if he agreed with Ms. Pawlicki's summary of the situation.
Mr. Bellah replied yes.
Mr. Dutcher asked about the patient's comment in her letter stating that as the young man was entering the
information from the sheet of paper he was told by a woman that he was taking too long and he did not need all
that information. Ms. Pawlicki stated that she did not tell the technician that he was taking too long.
Mr. Dutcher asked where the breakdown was in the system.
Mr. Reitz stated that the breakdown was basically a training issue. Mr. Reitz stated that the pharmacy staff does have the
capability of entering additional medications into the computer system. Mr. Reitz stated that if the drugs were entered
into the system the computer would screen for drug interactions. Mr. Reitz stated since Mr. Bellah was new he was not
sure how to enter the drugs and told the patient to give the list to the pharmacist. Mr. Reitz stated that the breakdown was that the medications were
not entered into the system and the pharmacist did not have the information in front of her.
Mr. Dutcher asked Ms. Pawlicki how she has corrected the problem.
Ms. Pawlicki stated that she now asks the patients if they are taking any additional medications that were not filled at
Walgreens.
Mr. Reitz stated that more emphasis has been placed on the training of the technicians to enter other
medications into the patient's profile.
Dr. Smidt asked if consultation is documented.
Ms. Pawlicki stated that she documents refusal of counseling.
Dr. Smidt asked Ms. Pawlicki if the patient had given her verbally all the medications that the patient was
taking what would she have done with the information.
Ms. Pawlicki stated that if she had said that the patient was taking Amiodorone a red flag would have
been raised. Ms. Pawlicki stated that pharmacists are aware that there are many interactions with amiodorone.
Mr. Dutcher stated that the prescription was written by a cardiologist for a prostate problem.
Mr. Wand stated that there is no limit on prescribing authority for a practitioner.
Mr. Van Hassel stated that the patient feels she did not receive the service the level of service that she
should have been given by the pharmacist.
Dr. McCoy stated that documentation of counseling is required.
On motion by Mr. Dutcher and Dr. Smidt, the Board unanimously agreed to issue an advisory letter
to the Pharmacist and the Permit Holder concerning consultation requirements.
<
P>Complaint # 3216
Pharmacist Gary Sims and Regional Pharmacy Manager Kim Soricone were present in response to a consumer complaint.
Compliance Officer Larry Dick gave a brief overview.
Mr. Dick stated that the complainant stated that the pharmacy filled her prescription for Uniphyll 600 mg. and lost
the prescription. The patient was pursuing a lawsuit against the physician. The patient was suing the physician because
he issued a new rescription for Uniphyll and she was currently taking theophylline and she was not aware that they were
the same product and she took double the dose of theophylline and was hospitalized.
Mr. Dutcher asked Mr. Sims why he filled a theophylline and Uniphyll prescription on the same day. Mr. Sims stated
that the first prescription for theophylline was written by one doctor and the other prescription for Uniphyll was written
by another doctor.
Mr. Sims stated that the patient's insurance was down and a prior authorization was required for Uniphyll. Mr. Sims stated
that the patient called in for the theophylline.
Mr. Dutcher asked Mr. Sims if he filled the theophylline and if any questions were raised because this was a
duplication of therapy.
Mr. Sims stated the duplicate verification was overridden because the Uniphyll was to be ordered in place of the theophylline
because the spouse of the patient stated that the two tablets of theophylline at bedtime were not working.
Mr. Dutcher asked if the patient was given a months supply.
Ms. Soricone stated that the pharmacist never dealt with the patient but with the patient's spouse. Ms. Soricone stated that they
gave her a months supply because they did not know how long it would take to receive a prior authorization. Ms. Soricone stated that
the pharmacy always spoke with the husband instead of the wife.
Mr. Dutcher stated that the problem occurred when the patient's husband was not counseled on discontinuing the theophylline when
he picked up the Uniphyll.
Ms. Soricone stated that is correct.
Mr. Dutcher stated that should have been done.
Mr. Dutcher asked Mr. Sims if he ever spoke to the patient over the phone.
Mr. Sims stated that he has only spoken with the husband.
Dr. McCoy asked Mr. Sims during counseling if he indicated that this was a duplication of medication that the
patient was already taking.
Mr. Sims stated that the patient received printouts on both medications and if she read the printouts they both would have stated
that the medication was theophylline.
Dr. McCoy asked Mr. Sims if he identified the potential drug interaction during counseling. Dr. McCoy asked Mr.
Sims if he told the husband that taking both of the medications together could cause harm.
Mr. Sims stated that it was understood that the husband knew the reason the Uniphyll was ordered was to achieve a better therapeutic effect over
the theophylline.
Dr. McCoy asked Mr. Sims if that point came across to the caregiver during counseling.
Mr. Sims stated that it did not.
Mr. McAllister stated that there was an issue with counseling, but the issue for the patient was the lost
prescription.
Mr. Dutcher asked Mr. Sims what he believes happened to the prescription.
Mr. Sims stated that he believes that the prescription was thrown away with the prior authorization paperwork. Mr. Sims
stated that they have changed procedures in the pharmacy so that no prescription would be lost.
On motion by Mr. McAllister and Dr. Smidt,the Board unanimously agreed to issue an advisory letter to the Permit Holder and Pharmacist concerning counseling issues and prescription retention.
Complaint # 3225 - Incident 1
Pharmacist Emily Lawrence, Pharmacy Supervisor Hahn Nyguen, Director of Regulatory Compliance Susan DelMonico, and Legal Counsel Roger Morris were present in response to a consumer complaint. Compliance Officer Rich Cieslinski gave a brief overview of the complaint.
Mr. Cieslinski stated that the patient's prescription for Novolog 70/30 was incorrectly entered and filled as Novolin 100 units/ml.
Mr. Dutcher opened the discussion by asking Ms. Lawrence about her written statement in the complaint response that indicated that she was checking the scanned image of all refill and hold prescriptions.
Ms. Lawrence stated that she is checking the image. Ms. Lawrence stated that she is looking at the scanned image and then looking at the
label.
Mr. Morris stated that the company has made changes to the computer system that forces the pharmacist to look at the scanned image for all prescriptions before placing the label on the prescription.
Ms. Delmonico stated that the scanned image is brought up each time a prescription is filled. Ms. Delmonico stated there has been a quality assurance enhancement made to the process. Ms. Delmonico stated that the barcode must be scanned on both the stock bottle and label to ensure the correct product is dispensed. Ms. Delmonico stated that if the product is not scanned the pharmacist would be alerted at verification that the scanning did not occur.
State of Arizona 12 Board Meeting
On motion by Mr. McAllister and Dr. McCoy, the Board unanimously agreed to issue an advisory letter to the
pharmacist concerning the final verification of a completed medication.
Complaint #3225- Incident 2
Pharmacist Mohamed Hamade, Pharmacy Supervisor Hahn Nyguen, Director of Regulatory Compliance Susan DelMonico, and Legal Counsel Roger Morris were present in response to a consumer complaint. Compliance Officer Rich Cieslinski gave a brief overview of the complaint.
Mr. Cieslinski stated that the complainant received Gabapentin 300mg instead of Gabapentin 100mg. The pharmacist incorrectly filled the prescription with the incorrect product and did not catch the error on verification. The pharmacist had noted to tell the patient that the color of the product had changed because they changed manufacturers. The pharmacist counseled the patient on the change. After the patient left the pharmacy, the pharmacist recognized that he had made an error when returning the stock bottle to the shelf. The pharmacist called the patient and informed her of the error and had the incorrect medication delivered to the patient's home.
President Van Hassel asked Ms. Delmonico if this incident occurred before the scanning of the barcodes was implemented.
Ms. Delmonico replied yes.
Mr. Dutcher stated that on the complaint reply the pharmacist indicated that the image of the medication was hard to see. Mr. Dutcher asked Ms. Delmonico if the image has been changed with the recent computer update.
Ms. Delmonico stated that the image has been updated and it is clearer to see.
Mr. Wand stated that some of the images were difficult to see when they toured the pharmacy depending on the software and
hardware used.
Mr. Dutcher asked Mr. Hamade about the counseling process with the patient.
Mr. Hamade stated that he showed the medication to the patient and told her about the color change. Mr. Hamade stated that at that time he believed the medication was Gabapentin 100mg.
Mr. Dutcher asked Mr. Hamade if he checked the product in the stock bottle with the medication in the prescription vial.
Mr. Hamade stated that he checked the image with the image on the screen. Mr. Hamade stated that sometimes the image on the screen was distorted by the flash of the camera that took the picture. Mr. Hamade stated that the scanning process is now in place.
Mr. Morris stated that the pharmacist did tell the patient that they changed brands.
Dr. McCoy stated that Mr. Hamade did handle the error appropriately and his service recovery plan was excellent.
Dr. Smidt asked if the pharmacy documents counseling.
Ms. Delmonico stated that the company has just updated their counseling log to be in compliance with the law and th log would
be sent to the stores with a memo. Ms. Delmonico stated that there is a column that has been added to document the reason why counseling
was not performed.
Dr. Berry asked if the memo states who can offer counseling.
Ms. Delmonico stated that only a pharmacist or intern would be able to offer and accept a refusal for counseling.
Dr. Berry stated that several times the Board has heard that the technician offers counseling at this chain.
Ms. Delmonico stated that the memo states the only a pharmacist or intern can perform this function and the Pharmacist in Charge is responsible to
comply with the law.
On motion by Mr. Dutcher and Mr. McAllister, the Board unanimously agreed to take no further action on this complaint.
Complaint # 3226
Pharmacy Supervisor Jim Foy, Director of Regulatory Compliance Susan DelMonico, Director of Government Affairs Richard Mazzoni, and Legal Counsel Roger Morris were present in response to a consumer complaint. Compliance Officer Rich Cieslinski gave a brief review of the complaint.
Mr. Cieslinski stated that the complainant received an unmixed bottle of Amoxicillin suspension. The pharmacy was undergoing a conversion and the pharmacy was short staff. A member of store management was running the cash register and did not call the pharmacist to counsel the patient. The patient was asked if she had any questions for the pharmacist and she said no. The patient caught the error when she went to give the medication to her son and called the pharmacy and was told to bring the bottle back to the pharmacy for the medication to be mixed.
President Van Hassel stated that the reason the Board asked upper management to appear for a conference was that there appears to be staffing and training issues in the stores. Mr. Van Hassel asked the management personnel to address what changes have been made since this incident.
Mr. Foy addressed the issue of the conversion of the Osco stores to CVS stores. Mr. Foy stated that the incident occurred after post-system conversion. Mr. Foy stated that an individual that was not a member of the pharmacy staff was working in the pharmacy as a cashier during a peak time. Mr. Foy stated that it appears the prescription was filled and did not go through the normal process where a blue card is placed with the prescription alerting the pharmacist that the medication needs to be reconstituted.
Mr. Foy was asked to address the conversion process. Mr. Foy stated that they have a real time training and monitoring system. Mr. Foy stated that each employee is required to attend and complete certain training courses. Mr. Foy stated that every employee is expected to complete the training courses by a certain date. Mr. Foy stated that if the training is not completed then the person is removed from the training schedule.
Mr. Foy stated that for the conversion it was scheduled for one store for each supervisor per week. Mr. Foy stated that this allowed the supervisor to focus their attention on that particular store. Mr. Foy stated that all employees were required to go through the training process. Mr. Foy stated that the training included the following: CDs, online and workbook training, 2 hours of in-store observation at a model store, 6 hours of classroom system training, and 8 hours of follow-up training in the model store. After the conversion, there were CVS trainers present in the store for one to two weeks. After this point, there was a functional team of CVS pharmacists, technicians, and trainers that were involved with the store post-conversion for two to ten weeks depending on the need of the store. Mr. Foy stated that during the conversion period there was no regard to payroll and the necessary help was placed in the stores to help with the conversion. Mr. Foy stated that the staffing model is different than the Osco staffing model. Mr. Foy stated that the workflow is quite different. Mr. Foy stated that the prescriptions are scanned at CVS while Osco did not scan the prescriptions. Mr. Foy stated a store was not converted until the training was complete.
Mr. Van Hassel asked if management personnel completed the pharmacy training.
Mr. Foy stated that store personnel are trained to run the cash register and it is their expectation that the store personnel would only be used in that capacity if no existing staff was available in the pharmacy to run the cash register. Mr. Foy stated the store personnel that may work in the pharmacy receive minimal HIPAA training. Mr. Foy stated that if there is a need for ongoing help an additional technician would be added to the schedule.
Dr. Sypherd asked if the conversion process occurred while the store was open.
Mr. Foy stated that the conversion of the files and the installation of the hardware was completed overnight. Mr. Foy stated that when the store opened the next day the conversion has been completed.
Dr. Sypherd asked if the workflow is different is there additional pharmacist help.
Mr. Foy stated that there is more technician help in the stores than with the previous company.
Ms. Delmonico addressed the issue of the reconstitution of liquids. Ms. Delmonico stated that the computer now generates a label that states if the medication needs to be reconstituted or refrigerated. Ms. Delmonico stated that the label also has an indication that counseling is required. Ms. Delmonico stated that when the prescription is rung at the register a statement would appear on the register indicating that counseling needs to be done by the
pharmacist.
Mr. Van Hassel asked if all the stores have been converted.
Ms. Delmonico replied that the conversions are completed.
Mr. Van Hassel asked if the conversion caused this error.
Mr. Foy stated that he is not sure. Mr. Foy stated that it appears to be a process breakdown and this breakdown could have occurred
at any store where the process was not followed.
Mr. Wand asked Mr. Foy if he could describe the work schedule at CVS.
Mr. Foy stated that the staffing schedule is based on volume and hours of operation. Mr. Foy stated that it is up to the pharmacy team to establish the work schedule. Mr. Foy stated that the pharmacists cannot work more than 2 longs days in a row. Mr. Foy stated that there is no mandatory schedule. Mr. Foy stated as the volume in a store increases the staffing would be increased accordingly.
Dr. Sypherd asked how many hours a day would a pharmacist work.
Mr. Foy stated that the stores are open from 8:00 A.M. to 10 P.M. daily. The pharmacist could elect to work the whole day, but
they cannot work more than 2 long days in a row.
Mr. Wand noted that the Board does not have the authority to regulate work hours since there are no rules concerning working hours.
On motion by Dr. Berry and Mr. Dutcher, the Board unanimously agreed to take no further action on this complaint. The Board felt that the company has completed the conversion of all stores and have implemented new policies.
Complaint # 3229
Pharmacist Paul Shiechel and Pharmacy Supervisor June Piposar were present in response to a consumer complaint.
Compliance Officer Sandy Sutcliffe gave a brief overview. Ms. Sutcliffe stated that the patient ( five-month old child) received another patient's Amoxicillin 400mg/5ml with directions to take 2½ teaspoonfuls twice daily instead of Amoxicillin 250mg/5ml with directions to take 1 teaspoonful twice daily. The child received wo doses of the incorrect medication before the mother noticed the bottle had he wrong patient's name and doctor's name on the label.
President Van Hassel opened the discussion by asking Mr. Shiechel to address the complaint.
Mr. Shiechel stated that he filled two prescriptions for different strengths of Amoxicillin and both prescriptions were filled correctly. Mr. Shiechel stated that when a prescription needs reconstituted the medication is placed on a shelf near the sink and when the patient arrives to pick up the medication the medication is reconstituted at that point. Mr. Shiechel stated that he mixed the medication and thought that he had the correct patient. Mr. Shiechel stated that he walked to the register where the patient was waiting and said the child's name and proceeded to counsel the patient. Mr. Shiechel stated that he explained how to use the dosing syringe and the patient did not question the dose.
Mr. Van Hassel asked if the names were similar.
Mr. Shiechel stated that they were not similar.
Dr. Berry asked if he said the patient's whole name. Mr. Shiechel stated that he only said the first name.
Dr. Berry asked if the patient had the baby with her when she picked up the prescription.
Mr. Shiechel stated that she was alone.
Mr. Wand asked Mr. Shiechel if he asked the patient for their address as a check.
Mr. Shiechel stated that he did not ask for the address because the technician asks for the address and rings up the prescription. Mr. Shiechel stated that while the technician was ringing up the sale he mixed the prescription which unfortunately was the wrong prescription. Mr. Shiechel stated that when he counsels now and the patient is a young child he tells the patient the date of birth and asks if that is correct. Mr. Shiechel stated that the new prescription is now going to the register with the medication.
Ms. Piposar stated that as a result of the new regulations all new prescriptions are being sent to the consultation window. Ms. Piposar stated that the pharmacist can then document the acceptance or refusal of counseling on the prescription.
Dr. Smidt asked about the dosing syringe capacity.
Mr. Shiechel stated that the syringe goes up to two teaspoons and he explained to the patient that she would need to fill the syringe once and
then draw up another ½ teaspoon.
On motion by Dr. Sypherd and Ms. Honeyestewa, the Board unanimously agreed to issue an advisory letter to the pharmacist.
Complaint # 3237
Pharmacist Gary Kudela, Pharmacy Supervisor John Cerni, Director of Regulatory Compliance Susan DelMonico, and Legal Counsel Roger Morris were present in response to a consumer complaint.
Compliance Officer Larry Dick gave a brief overview of the complaint. Mr. Dick stated that the complainant stated that the wrong patient's medication was placed into the complainant's prescription bag. The complainant received Levothyroxine 150mcg instead of Levothyroxine 50mcg. The complainant took the wrong medication for 26 days. The patient did not realize that she had the wrong medication until she attempted to refill the prescription and the name on the bottle was not her name.
Mr. Van Hassel asked Mr. Kudela to address the error. Mr. Kudela stated that he filled three prescriptions and was called away from the counter. Mr. Kudela stated he had verified all the prescriptions and placed the Levothyroxine bottle in the wrong bag. Mr. Kudela stated that the products in the two bags were switched with the correct paperwork on the outside of the bag.
Mr. Van Hassel asked if this was a conversion store.
Mr. Cerni stated that this was not a conversion store.
Mr. Kudela stated since the incident he uses baskets to separate each patient's prescription order. Mr. Kudela stated that he no longer multi-tasks. Mr. Kudela stated that when he counsels the patient now the patient is asked their birth date and shown the prescription bottle. Mr. Kudela stated that when he
found out the prescription was wrong he phoned the complainant's doctor and spoke with the doctor informing him of the error. Mr. Kudela stated that he
phoned the other patient and also phoned her doctor informing him of the error.
Mr. Dutcher asked Mr. Kudela if the second patient also took the wrong medication.
Mr. Kudela stated that the second patient also took the wrong medication and did not notice the error.
Mr. Dutcher asked if either patient called questioning the medication because it was a different color. Mr.
Kudela stated that neither patient called and both patients took the wrong medication.
Dr. McCoy stated that the patient does have some responsibility in reading the labels on their prescription bottles, since the medication bottle had a different patient name on the bottle and the tablets were a different color than the previous prescription.
On motion by Mr. McAllister and Dr. McCoy,the Board agreed to take no further action on this complaint. There was one vote of opposition by Dr. Sypherd.
The Board recessed for lunch.
President Van Hassel called the meeting to order at 1:00 P.M.
AGENDA ITEM 5 - License Applications Requiring Board Review
#1 Gary Koesten
Gary Koesten appeared on his own behalf to request to proceed with reciprocity.
President Van Hassel opened the discussion by asking Mr. Koesten to describe the nature of his request.
Mr. Koesten stated that he is requesting to proceed with reciprocity. Mr. Koesten stated that he had a prior stipulation in Florida. Mr. Koesten stated that he was fined, had to pay court costs, and had to perform so many hours of community service.
Mr. Van Hassel asked Mr. Koesten if he planned to move to Arizona.
Mr. Koesten replied yes.
Mr. Dutcher asked Mr. Koesten what type of pharmacy did he work in when he signed the stipulation.
Mr. Koesten stated that it was a pharmacy that specialized in mail order prescriptions for veterinary products. Mr. Koesten stated that he has worked in various practice sites, including hospital and retail sites. Mr. Koesten stated that he is currently working at 1-800 Petmeds in Florida.
Mr. McAllister asked Mr. Koesten which license he was using to reciprocate to Arizona.
Mr. Koesten stated that he is reciprocating from his New York license.
Dr. Smidt asked Mr. Koesten if he felt that a valid patient-veterinarian relationship should exist before the veterinarian prescribes a medication. Mr. Koesten stated that is the only way he medications are dispensed today.
Mr. Van Hassel asked Mr. Koesten if he was familiar with the Arizona compounding regulations.
Mr. Koesten stated that he is familiar with the laws.
Mr. Dutcher asked if the pharmacy mails prescriptions all over the country.
Mr. Koesten stated that they do mail prescriptions all over the country. Mr. Koesten stated that he plans to move to Arizona eventually, but does know that Arizona is implementing regulations that would require the Pharmacist In Charge of a non-resident pharmacy to be licensed in Arizona. Mr. Koesten stated that he would then be licensed in Arizona as the Pharmacist In Charge at the Florida pharmacy.
On motion by Dr. Sypherd and Mr. Dutcher, the Board agreed to approve Mr. Koesten's request to proceed with reciprocity. There was one vote of opposition by Mr. Van Hassel.
#2 Wanda Jellison
Wanda Jellison appeared on her own behalf to request permission to proceed with technician licensure.
President Van Hassel opened the discussion by asking Ms. Jellison to describe the nature of her request.
Ms. Jellison stated that she would like to apply for licensure as a pharmacy technician trainee and was told that she would need to appear at the Board Meeting because she had a past felony conviction about ten years ago. Ms. Jellison stated that it was not a pharmacy or drug conviction.
Mr. Dutcher asked if she has a job lined up as a pharmacy technician trainee.
Ms. Jellison stated that she is currently working for K-Mart and they are willing to train her to become a pharmacy technician trainee at the Bullhead City store. Ms. Jellison stated that she has sent in letters of recommendation from individuals that she works for at K-Mart. Ms. Jellison stated that she has worked for K-Mart for about four months. Ms. Jellison stated that she is currently taking college business courses and is working towards an associates degree.
Dr. Berry asked if the Board approved Ms. Jellison's request would she be able to take the PTCB exam.
Mr. Wand stated that in the past the PTCB has approved individuals to take the exam if the Board has approved their requests and issued them a license.
On motion by Mr. McAllister and Dr. Sypherd, the Board unanimously agreed to approve Ms. Jellison's request to proceed with technician licensure.
#3 Sue Molina
Sue Molina, Gerry Ritt, Pharmacist in Charge Amy Delano, and Pharmacy Supervisor Darren Kennedy were present to address Board Members concerning Ms. Molina's request to proceed with technician licensure.
President Van Hassel asked Ms. Molina to explain the nature of her request.
Ms. Molina stated that she would like the Board to approve her request to take the certification test because she did not complete all the requirements for her high school diploma. Ms. Molina stated that she is a few credits short of receiving a high school diploma.
Mr. Van Hassel asked Ms. Molina the reason why she did not want to obtain a GED.
Ms. Molina stated that it is for financial reasons that she has not pursued obtaining her GED.
Mr. Van Hassel asked Ms. Molina if she has researched the costs and requirements for obtaining a GED.
Ms. Molina stated it costs about $250.00 to take the GED.
Mr. Dutcher asked Ms. Molina what is the time frame involved in obtaining a GED.
Ms. Molina stated that someone can take the test without any review classes or someone can take the review classes and then take the GED exam. Ms. Molina stated that there is a financial cost involved in taking the exam.
Mr. Wand stated that the issue is if the Board wants to accept Ms. Molina's work experience as equivalent to the two credits that she is lacking in completing her high school diploma. Mr. Wand stated that the statutes state an applicant for a pharmacy technician trainee license must have a high school diploma or the equivalent of a high school diploma and the Board must decide if Ms. Molina's education and work experience are equivalent to a high school diploma.
Mr. Van Hassel asked Mr. Wand if Ms. Molina would be able to sit for the PTCB exam if she were licensed as a trainee by the Board.
Mr. Wand stated that he is not sure if she would be able to take the exam.
Mr. Van Hassel explained to Ms. Molina that her request to the Board is to become licensed as a Pharmacy Technician trainee and not the approval to take the exam. Mr. Van Hassel explained if the Board approves her request then she would be a Pharmacy Technician Trainee until she becomes certified. Mr. Van Hassel stated that the license is active for two years and if the applicant is not certified by that time the applicant may ask the Board for an additional two years to complete the requirements.
Mr. Dutcher asked Ms. Molina if she has been working in a pharmacy.
Ms. Molina stated that she has been working in the pharmacy for about nine years.
Mr. Dutcher asked if she has been working in the store or in the pharmacy.
Ms. Molina replied that she has been working in the pharmacy.
Mr. Van Hassel asked Ms. Molina what she does at the pharmacy.
Ms. Molina replied that she is a technician.
Mr. Dutcher asked Ms. Molina if she has been working as a technician without a trainee license.
Ms. Molina replied yes.
Mr. Dutcher asked Mr. Wand if a license was required when the law was passed.
Mr. Wand stated that the law passed in May of 2004.
Mr. Dutcher asked if the Pharmacist In Charge where Ms. Molina works was not aware of the qualifications to be a technician.
Ms. Molina stated that she has been working on the problem since she received the copies of her transcripts. Ms. Molina stated that when
she left school she returned the next year and completed the requirements and received a paper stating that she had met the requirements for her high school diploma. Ms. Molina stated that when she received the transcripts it showed that she fell short of the requirements. Ms. Molina stated they have been working on trying to get her GED taken, but she was pregnant and took time off work.
Mr. Wand asked Ms. Molina if she had a copy of the letter.
Ms. Molina replied no.
Mr. Van Hassel asked why the other individuals are with her today.
Ms. Molina stated that Ms. Delano is the Pharmacist Manager at the pharmacy, Mr. Kennedy is the Pharmacy Supervisor, and Mr. Ritt is her past employer.
Mr. Van Hassel asked if Ms. Delano and Mr. Kennedy are accountable for Ms. Molina not having a license and working as technician.
Ms. Delano replied yes.
Mr. Ritt stated that Ms. Molina did work for him at the pharmacy prior to him selling the pharmacy. Mr. Ritt
stated that Ms. Molina works well with the patients and doctor's offices.
Mr. Ritt stated that Ms. Molina respects the pharmacists and patients that she works with each day.
Dr. McCoy stated that Ms. Molina should have asked three years ago for a license.
Dr. McCoy stated that she is not sure that the PTCB would allow her to take the test without a high school diploma or GED.
Ms. Molina stated that if she has to obtain a GED the granting of the license would give her the chance to work and obtain her GED.
Ms. Lee stated that the Board could issue the license and Ms. Molina would need to reapply in two years if she does not have a GED and ask for an extension from the Board at that time.
Ms. Lee stated that the Board could grant the license upon signing a consent order stating the terms for approval of the license and the requirement of obtaining her GED.
Dr. Smidt asked Ms. Molina why she finally came forth at this time to ask permission to be a pharmacy technician trainee.
Ms. Molina stated that she was told that she could appear before the Board and ask permission.
Dr. Smidt asked Ms. Molina if it would not be to her advantage to complete the GED.
Ms. Molina stated that she does not have the money to complete the GED and wants to continue working.
Mr. McAllister stated that the requirements for being a technician have been known for years.
Dr. Sypherd stated that he feels that her experience would qualify for obtaining the license. Dr. Sypherd stated that it is important for Ms. Molina to realize that if the license is granted that she may not have the chance to reapply if she does not obtain a high school diploma or GED. Dr. Sypherd told Ms. Molina, as an educator, he would recommend that she take a review course for the GED prior to taking the exam.
On motion by Dr. Sypherd and Mr. McAllister, the Board unanimously agreed to grant Ms. Molina a pharmacy technician trainee license with the understanding that if she does not complete her GED within the two year time period she would need to appear at that time asking the Board permission to reapply for her trainee licensee.
Mr. McAllister stated that he would like to open a complaint against the employer for allowing a technician to work without a license.
Mr. Kennedy stated that when the compounding pharmacies were purchased the pharmacies were under a new division of Walgreens called WHS. Mr. Kennedy stated that the store is scheduled to come into his district at the beginning of February. Mr. Kennedy stated that when the stores come into his district there are safeguards in place. Mr. Kennedy stated that they do have a program which requires the licensing information be in the computer system for any individual required to be licensed. Mr. Kennedy stated that the lack of licensing should have been caught.
Mr. Van Hassel asked Mr. Kennedy if they have a Pharmacist in Charge at each site that understands the rules and regulations of the state.
Mr. Kennedy replied yes.
On motion by Mr. McAllister and Mr. Dutcher, the Board unanimously agreed to open a complaint against the Permit Holder and the Pharmacist In Charge for allowing a non-licensed individual to work as a technician.
AGENDA ITEM 6 - Special Requests
#1 Sierra Tucson Hospital
Pharmacist Shelly Midkiff, Director of Nursing Carol Power, and Bob DePhillips with Spectrum Pharmacy were present on the behalf of Sierra Tucson Hospital to request a continuation of an agreement with the Board from 1990.
President Van Hassel opened the discussion by asking the participants to describe the nature of their request.
Ms. Midkiff stated that they are requesting a continuation of the agreement from 1990 that Sierra Tucson is able to have house stock.
Mr. Van Hassel asked if the facility is JCAHO accredited.
Ms. Power replied yes.
Mr. Dutcher stated that he read that they were seeking approval to continue the agreement due to a change in providers.
Ms. Midkiff stated that Spectrum Pharmacy has started servicing Sierra Tucson in October of 2006 and prior to that time Omnicare serviced the
facility
Mr. McAllister asked Mr. Hunter if he noted any issues that would affect patient safety.
Mr. Hunter stated that if they have made the changes listed in the letter that they have sent to the Board then he sees no issues of patient safety. Mr. Hunter stated that all parties that agreed to the original agreement are no longer present. Mr. Hunter stated that there will be a full service in-house pharmacy by 2008.
Mr. Van Hassel asked how the drugs are stored.
Ms. Midkiff stated that the drugs are stored in a medication box and the nurse signs out the medications logging all the necessary information. Ms.
Midkiff stated that she reconciles the box and reviews the order.
On motion by Mr. McAllister and Dr. McCoy, the Board unanimously agreed to approve the request by Sierra Tucson to continue the agreement for pharmacist hours and stock until the new pharmacy is operational.
#2 Omnicare
Kevin Fearins, Pharmacist with the Standards of Practice Division for Omnicare Corporate Office, and Harvey Hill, Executive Director of the Phoenix Omnicare Division were present on behalf of Omnicare to request a waiver of R4-23- 402 (A) (11) that requires a pharmacist or intern to perform a final accuracy check of the completed product.
President Van Hassel asked the participants to discuss the nature of their request.
Mr. Fearins opened the discussion by stating that they were present today to ask the Board's approval to replace the pharmacist through a
semi-automated process for the final verification step with a pharmacy technician.
Mr. Van Hassel asked Mr. Fearins to describe the process.
Mr. Fearins stated that Omnicare services nursing homes and there is no walk-in retail traffic. Mr. Fearins stated that the products dispensed are in unit dose packaging. Mr. Fearins stated that the products are packaged in house or from an FDA approved repackager. Mr. Fearins stated that they are seeking this approval nationally. Mr. Fearins stated that the process has been approved by some states and is pending in other states. Mr. Fearins stated that the process is a semi-automatic process that identifies the correct drug, the correct patient, and the correct nursing home facility. Mr. Fearins stated that the workflow has checks and balances throughout the system. Mr. Fearins stated that a label is not approved until the pharmacist verifies that the data entry is correct. Mr. Fearins stated that everything is time stamped and it is also recorded who has had access to each prescription. Mr. Fearins stated that each prescription processed has a unique patient drug code that identifies the drug and package for matching purposes. Mr. Fearins reviewed the process with the Board Members. Mr. Fearins stated that the process change occurs at the end of the process where a pharmacist scans the label and packaging to ensure the prescription is filled correctly. Mr. Fearins stated that they are requesting that a technician be allowed to perform the final scan on the products. Mr. Fearins stated that the pharmacists would verify the data entry, and DUR interventions, and the packaging to ensure the information is entered correctly and the correct product is prepackaged. Mr. Fearins stated that if there is a mis-match at the end of the process the product would be sent to a pharmacist. Mr. Fearins stated that the process is in conflict with R4-23-402 which lists the pharmacists responsibilities and also in conflict with the duties of a technician prohibiting them from doing a final check. Mr. Fearins stated that the PV2 pharmacist would be responsible for everything that leaves the facility. Mr. Fearins stated that the scanning process is superior to a visual check by the pharmacist.
Dr. Smidt asked why a technician is needed to scan the product.
Mr. Fearins stated that someone needs to scan the final product as their final check. Mr. Fearins stated that the process uses a scanning gun to scan the product barcode and the prescription label to ensure the correct product is selected. Mr. Fearins stated that the pharmacist is better used clinically at the front end of the process instead of the back-end of the process matching a product to a label.
Dr. Smidt asked Mr. Fearins if the only thing stopping a prescription from leaving the facility wrong is the barcode.
Mr. Hill explained the pre-packaging process. Mr. Hill stated that if the product does not come from an FDA approved packager, the product is packaged
in-house and verified by a pharmacist.
Dr. Smidt asked who labels the product.
Mr. Fearins replied that technicians label the product.
Mr. Dutcher stated that he does not feel comfortable in waiving the final check by the pharmacist.
Mr. Fearins stated that he feels the true practice of pharmacy is at the front end of the process. Mr. Fearins stated that the matching of the product to the label is not where they want their pharmacists to be in the process. Mr. Fearins stated that the pharmacist should be talking to caregivers, and reviewing clinical interventions. Mr. Fearins stated that barcode technology improves the safety factor.
Mr. Dutcher stated that the retail pharmacies use barcode technology, but still have a pharmacist verify the final prescription.
Mr. Fearins stated that they are not removing the pharmacist from the process.
Mr. McAllister stated the Board has already approved this process in numerous facilities. Mr. McAllister stated that they are not eliminating the pharmacist check. Mr. McAllister stated that they are moving the process. Mr. McAllister stated that the mail order pharmacies are using this technology and that Mr. Van Hassel's hospital is using similar technology.
Mr. Van Hassel stated that he is a supporter of technology. Mr. Van Hassel stated that as long as the first two checks are performed by a pharmacist then a technician can use a scanner to match the product. Mr. Van Hassel stated that policies and procedures should indicate that if there is a rejection then a pharmacist must review the product.
Dr. McCoy stated that the critical step of the process is at the front-end of the process.
Dr. Sypherd stated that he feels that there is a safety problem with using barcode technology. Dr. Sypherd stated that there are articles that have been written concerning the information that is entered into the computer that the reader uses to verify the product. Dr. Sypherd stated that this could pose a safety risk if not entered correctly.
Mr. Fearins stated that the information is downloaded from a National Data Bank.
Mr. Wand stated that the Board is giving a waiver for an existing rule. Mr. Wand stated that the only justification for waiving the rule is for experimental reasons or new technology. Mr. Wand stated that if the Board makes a motion to waive the rule the motion should state the reason why it is being waived and if they need to return to a future Board meeting with an update.
Dr. McCoy asked Mr. Fearins about the list of drugs that stated that these products would be checked manually.
Dr. McCoy asked if the products would also be barcoded.
Mr. Hill stated that they are barcoded, but because the drugs have a narrow therapeutic index they are checked by a pharmacist.
Mr. Fearins stated that they can send any medication to a pharmacist to be checked.
Dr. Smidt asked why certain drugs are sent to a pharmacist.
Mr. Fearins stated that they have recognized that these drugs have a narrow therapeutic index and prefer a pharmacist check the product.
Dr. Smidt stated that he is concerned that if a drug is pre-packaged incorrectly that a large number of patients would receive the incorrect drug.
Dr. McCoy stated that the drugs on the list are high risk drugs. Dr. McCoy stated that this is a second check of the dosage and not so much the product match.
Mr. Van Hassel stated that this is a check of the front end process on these high risk drugs and not for product verification.
Mr. Fearins stated that a technician cannot scan the high risk products and the check includes more than scanning the label.
Dr. Berry stated that her concern is that at the final check a pharmacist might potentially catch an error whereas a technician would not catch the same error because of training.
Dr. McCoy asked if the Board has asked for reports in the past when waivers have been approved.
Mr. Wand stated that the Board has for new technologies and he feels that barcoding is old technology. Mr. Wand stated that the Board has asked for reports in order to extend the process. Mr. Wand stated that the Board can determine a time period in which they need to report back to the Board.
Mr. Dutcher stated that he feels a report should be sent to the Board to ensure that the process is beneficial to the patients that are being served.
Mr. McAllister stated that he feels that in the past that the reports have been asked for when the technology is new and this process is redundant to many other firms and he sees no need in asking for a report.
Mr. Wand stated that the Board does have the option to waive a rule based on new technology and experimentation. Mr. Wand stated that barcode technology is old technology and not new technology.
Dr. Smidt stated that he feels the majority of the pharmacists would say that the final check would occur when the product is labeled.
Mr. Wand stated that the Board should consider what a reasonable man would see as the final check.
Dr. Smidt stated that he does not believe that the pharmacy would save that much money by using a technician to scan the final product. Dr. Smidt stated that we do not know if the pharmacist would be placed at the front end.
Dr. McCoy stated that the critical check occurs at the front-end of the process and the pharmacist could be effectively used at this point.
Dr. Berry asked when the label is produced. Mr. Fearins stated that the label is produced after the pharmacist performs the first check.
Mr. Wand asked if the label is attached manually and who attaches the label.
Mr. Fearins stated that the label is attached manually by a technician.
Dr. Sypherd stated that he believes that pharmacists should be at the front and back end of the process.
On motion by Mr. McAllister and Dr. McCoy, the Board approved an open-ended waiver of R4-23-402 (A) (11) based on the
information presented and the checks in their system.
A roll call vote was taken ( Mr. McAllister - aye, Ms. Honeyestewa - aye, Dr. Berry - aye, Dr. McCoy - aye, Dr. Smidt - nay,
Dr. Sypherd - nay, Mr. Dutcher - nay, and President Van Hassel- aye)
#3 Brett Roberson
Brett Roberson
appeared with Lisa Yates from the PAPA program to request that the Board terminate the suspension of his pharmacist's license and impose probation
per Board Order 07-0009-PHR.
President Van Hassel opened the discussion by asking Mr. Roberson to discuss the nature of his request.
Mr. Roberson stated that he is asking that the Board reinstate his license to probation.
Mr. Van Hassel asked Mr. Roberson why his license was on probation.
Mr. Roberson stated that due to disciplinary actions he entered the PAPA program and his license has been suspended.
Mr. Dutcher asked Ms. Yates if Mr. Roberson has been compliant with his PAPA program.
Ms. Yates stated that Mr. Roberson has been compliant with his contract. Ms. Yates stated that the Board has received a copy of a letter from Mr. Roberson's counselor indicating that he has been compliant.
Mr. Van Hassel asked Mr. Roberson if he has a job lined up.
Mr. Roberson stated that he does not have a job.
On motion by Mr. Dutcher and Mr. McAllister, the Board unanimously approved Mr. Roberson's request to terminate suspension and impose probation per Board Order 07-0009-PHR.
#4 Michelle Mai
Michelle Mai appeared with Legal Counsel Roger Morris to request that the Board terminate the suspension of her pharmacist's license and impose probation per Board Order 05-33-PHR(B).
President Van Hassel opened the discussion by asking Ms. Mai to discuss the nature of her request.
Ms. Mai stated that she is asking the Board to remove her license from suspension and place her license on probation.
Mr. Van Hassel asked if she has completed the terms of her suspension.
Ms. Mai stated that she has completed her community service, passed the MPJE exam, and paid the fine.
Mr. Dutcher asked Ms. Mai how long she has been practicing as a pharmacist.
Ms. Mai stated that she has been practicing for six years.
Mr. Dutcher asked Ms. Mai if the temptation to do the same thing is gone.
Ms. Mai replied absolutely.
Mr. Dutcher asked how long is Ms. Mai's probationary period.
Mr. Morris stated that the probation period is for two years.
Mr. Dutcher asked Ms. Mai if she has a job lined up at this time.
Ms. Mai replied not at this point. Ms. Mai stated that she would like to return to retail part-time.
Mr. McAllister stated that a license to practice is not a guarantee of employment. Mr. McAllister stated that if there are other infractions in the future that there are other ways to make a living.
On motion by Mr. McAllister and Dr. McCoy, the Board unanimously approved Ms. Mai's request to terminate suspension and impose probation per Board Order 05-33-PHR(B).
#5 Charles Allen
Charles Allen appeared on his own behalf requesting Board approval to take the MPJE exam for the fourth time.
President Van Hassel opened the discussion by asking Mr. Allen to explain the nature of his request.
Mr. Allen stated that he requesting permission to take the MPJE exam for the fourth time.
Mr. Van Hassel asked Mr. Allen if he is practicing at this time.
Mr. Allen stated that he is currently working as an intern.
Mr. Dutcher asked Mr. Allen about his scores.
Mr. Allen stated that he has trouble answering multiple choice questions.
Mr. Dutcher asked Mr. Allen if he completes all the questions.
Mr. Allen stated that he answers all the questions. Mr. Allen stated that he has taken a CE law course and will be taking another
law CE review offered by the APA.
Dr. Berry asked Mr. Allen if he has taken the NAPLEX exam.
Mr. Allen stated that he has taken the exam twice and has a tutor to help study for the exam again.
Mr. Dutcher asked Mr. Allen when he graduated from pharmacy school.
Mr. Allen stated that he graduated from pharmacy school 30 years ago.
Mr. McAllister asked Mr. Allen if he has taken a law review course.
Mr. Allen stated that he is taking the Morris Cody review course and has taken review courses offered by Midwestern. Mr. Allen
stated that he has obtained some CDs to help him practice answering questions on the computer.
On motion by Dr. Smidt and Mr. Dutcher, the Board unanimously approved Mr. Allen's request to take the MPJE exam for the fourth time.
#6 Rondell Huttmann
Rondell Huttmann appeared on her own behalf requesting Board approval to take the MPJE exam for the fourth time.
President Van Hassel opened the discussion by asking Ms. Huttmann to describe the nature of her request.
Ms. Huttmann stated that she is requesting to take the MPJE exam for the fourth time. Ms. Huttmann stated that her scores are close to passing and she is currently working as an intern in a hospital. Ms. Huttmann stated that she has been licensed as a pharmacist in another jurisdiction.
Mr. Wand recommended that Ms. Huttmann purchase a book that reviews Federal Law because many of the questions are based on federal law.
On motion by Mr. Dutcher and Dr. McCoy, the Board unanimously approved Ms. Huttman's request to take the MPJE exam for the fourth time.
Ms. Huttmann asked what would happen if she did not pass the exam a fourth time.
Mr. Van Hassel stated that it would be up to the Board at the time to decide if Ms. Huttmann would be granted an opportunity to take the exam again.
#7 Kristine Wells
Kristine Wells appeared with Lisa Yates from the PAPA program to request that the Board amend Board Order 2004-01-PHR to allow her to be the Pharmacist In Charge.
President Van Hassel opened the discussion by asking Ms. Wells to describe the nature of her request.
Ms. Wells stated that she is requesting to be a Pharmacist In Charge and her consent order states that she is not allowed to be the Pharmacist In Charge.
Mr. Van Hassel asked Ms. Yates to address the request.
Ms. Yates stated that the stipulation that Ms. Wells cannot be a Pharmacist In Charge is a stipulation of her Board order and not her PAPA
contract. Ms. Yates stated that Ms. Wells has been compliant with this contract.
Mr. Dutcher asked Ms. Wells if her license was placed on probation in November of 2005.
Ms. Wells replied yes.
Dr. Smidt asked Ms. Wells why she wanted to be a Manager.
Ms. Wells stated the Pharmacist In Charge at her store has left and she would like the position.
Dr. Smidt asked Ms. Wells if this would be the best thing for her at this point.
Ms. Wells stated that she would like to accept the responsibility and feels that it would be good for her at this point.
Dr. Smidt stated that being a Pharmacist In Charge can be stressful and asked Ms. Wells if she could handle the stress.
Ms. Wells stated that she has never been a Pharmacist In Charge. Ms. Wells stated that she is up for the challenge. Ms. Wells stated that if she felt
it would be a problem she would decide against being a Pharmacist In Charge.
Mr. Dutcher stated that he does have a concern that her consent order has only been in effect for one year.
Dr. Sypherd asked if there was a job opening for Ms. Wells to be a Pharmacist In Charge.
Mr. Wand stated that it is not the Board's issue if there is a job opening. Mr. Wand stated that Ms. Wells is asking to have a stipulation of her consent order lifted. Mr. Wand stated that one of the stipulations of her order is that Ms. Wells cannot be a Pharmacist In Charge.
Mr. Wand asked Ms. Wells if she asked to be the Pharmacist In Charge or did her employer ask her to make the request.
Ms. Wells stated that she asked her District Pharmacy Supervisor if she could be the Pharmacist In Charge if the Board allowed her to be the Pharmacist
In Charge.
Mr. Wand noted that her employer does support Ms. Well's request to become a Pharmacist In Charge.
Dr. Smidt asked Ms. Wells how long she has worked at K-Mart.
Ms. Wells replied that she has worked there since October.
Mr. Wand stated Mr. Hands would not have written a letter of support for Ms. Wells if he did not feel she was ready to accept the responsibility.
Dr. McCoy stated that in Mr. Hand's letter he stated that he would supervise the situation and handle any issues that may occur. Dr. McCoy stated that her hesitancy is that the contract has just began and she is not sure the added stress would not create a problem.
Ms. Lee stated that she would just like the Board to be aware that if the Board lifts this condition then Ms. Wells would be able to act as a Pharmacist In Charge at any location. Ms. Lee stated that the Board could lift the condition with the requirement that Ms. Wells only work as a Pharmacist In Charge under Mr. Hand's supervision.
Mr. Wand asked Ms. Wells how long she was out of work prior to signing the current contract.
Ms. Wells stated that she had been out of work for one year.
Mr. Wand asked Ms. Wells about her prior PAPA contract.
Ms. Wells stated that she started the PAPA program in 2002.
Mr. Wand stated that she failed the first time after completing one year of the contract.
On motion by Dr. McCoy and Dr. Berry, the Board unanimously agreed to deny the request by Ms. Wells to amend her consent order to allow her to be a Pharmacist In Charge.
Mr. McAllister told Ms. Wells that the Board is here for her success. Mr. McAllister told Ms. Wells to keep her recovery strong and then come back at a later date and make her request.
AGENDA ITEM 7 - Reports
Executive Director
Mr. Wand opened the discussion by discussing a proposed move of the Board Office to the Executive Tower in downtown Phoenix. Mr. Wand explained to the Board Members that the Board's lease is up at the current site in June. Mr. Wand stated that the Board Office is being encouraged to move downtown.
Mr. Wand presented the two proposed floor plans of the downtown space to the Board Members. Mr. Wand explained that one floor plan has all board offices and the Board Room on the second floor. Mr. Wand explained the other floor plan has the board offices on the second floor and the Board Room in a separate space in the basement. Mr. Wand discussed the costs of the remodel of the existing area downtown. Mr. Wand stated that the he and several staff members have visited the proposed site and prefer the plan where the Board offices and Board Room are all on the second floor.
The Board Members stated that they preferred the plan with the Board Room upstairs with the Board Offices.
Mr. Wand was told to proceed with the plans if the Board can obtain the necessary space at an affordable price.
Mr. Wand stated that the next issue he would like to discuss is the creation of a survey card for the Compliance Officers. Mr. Wand stated that the Office Staff hands out survey cards and the cards are returned rating the service that the applicant received. Mr. Wand stated that at this time he is not certain how the cards would be returned to the office. Mr. Wand stated that the cards could be given to the Pharmacy being inspected by the Compliance Officer and the Pharmacist could place the survey in a sealed envelope and the envelope could be given back to the Compliance Officer and returned to the office.
Dr. Smidt suggested that the survey could be placed online.
Mr. Wand stated that the Compliance Officer would not be identified. Mr. Wand stated that the information would be used for budgeting information and to take any corrective action that would be needed.
The Board Members told Mr. Wand to proceed with the development of the survey cards.
Mr. Wand stated that Ms. Lee would be leaving the Pharmacy Board to take a position with the Accountancy Board and the attorney from the Accountancy Board would be assuming her position at the Board of Pharmacy.
Mr. Wand stated that the Boards receiving legal services from the Attorney General's office have drafted a letter to send to Terry Goddard concerning the salaries being paid to the attorneys servicing the Boards. The Boards hope that by increasing the salaries the AG's office would be able to recruit enough qualified and experienced attorneys to fill their vacancies.
Mr. Wand addressed the proposed operating Budget for 2008 and 2009. Mr. Wand stated that the Budget has been reviewed by the Joint Legislative Budget Committee (JLBC) and the OSPB (Governor's Office of Strategic Planning). Mr. Wand stated that the JLBC has approved funding for the
New Compliance Officers and an increase for legal services provided by the Attorney General's office. Mr. Wand stated that the Governor's Office approved
the majority of the requests including the Compliance Officer's raise, the donation to the University of Arizona, the new Compliance Officers, and the
other requests. Mr. Wand stated that currently the Budget is on the Consent Agenda. Mr. Wand stated that the Budget on the Consent Agenda is the Budget approved by the JLBC. Mr. Wand stated that if the Board wants to argue for any of the funding not approved then the Budget needs to be pulled off the Consent Agenda. Mr. Wand stated that if the Budget is pulled off the Consent Agenda then the Board takes the risk of losing the increases that
were included in the JLBC budget.
Dr. Smidt asked if the budget needed to be pulled in order for the Legislature to consider certain funding issues.
Mr. Wand stated that it is all or none. Mr. Wand stated that if the Board does not pull the budget then the JLBC and the Governor's Office would decide the funding.
The Board agreed that Mr. Wand should let the Budget on the Consent Agenda at this point.
Mr. Wand stated that HB2438 is currently being rewritten to remove the fee for the drug monitoring program. Mr. Wand stated that the Bill is being rewritten to ask for funds to be appropriated for the drug monitoring program. Mr. Wand stated that the monitoring program would help prevent individuals from doctor shopping and the diversion of drugs.
Deputy Director Report
Ms. Frush gave a brief overview of the Compliance Officer's Report and the Inspector's Report.
Ms. Frush stated that she has passed out a sheet showing the proposed revisions to the Compliance Officer's Activity Report. Ms. Frush stated that the new report would remove the column "Office Hours" . Ms. Frush stated that the Office Hours would be broken down to categories that define how the office hours are spent. Ms. Frush stated that the categories would include hours spent on rulewriting, complaint writeup, hours spent issuing certificates, and CE audit hours.
Ms. Frush stated during the months of November and December 2006, the Compliance Staff issued letters for the following violations:
- Controlled Substance Violations
1. Controlled Substance Overage - 4
2. Controlled Substance Shortage-7
3. Failure to Conduct Annual Controlled Substance Inventory - 1
4. Failure to Conduct Controlled Substance Inventory upon change of Pharmacist In Charge - 1
5. Failure to have Controlled Substance Invoices readily retrievable - 1
- Documentation Violations
1. Failure to Document Medical Conditions - 7
2. Failure to Document Allergies - 1
3. Failure to Document Required Information on an Oral Prescription - 1
4. Failure to have signed technician statements concerning job descriptions, policies and procedures, and Board Rules -7
5. Failure to have a technician training manual - 21
6. Failure to maintain Compounding Documentation - 1
7. Failure to enter the correct RX write date in the computer - 1
Dispensing Violations
1. Outdated Prescription and OTC items in the pharmacy - 6
- Pharmacy Violations
1. Allowing technicians to work without a license - 3
2. Allowing a technician to work with an expired license - 11
3. Wall Certificates not posted - 2
- The following areas were noted on the inspection reports for improvement:
1. Documentation of medical conditions
- The following areas were noted on the inspection reports where pharmacists and technicians are meeting or exceeding standards:
1. Pharmacy areas are neat and clean
- Areas outside the inspection reports that may be of interest:
1. Change of Pharmacist In Charge- A Pharmacist shall give immediate notice if there is a change of Pharmacist In Charge. A Pharmacist in Charge shall conduct a controlled substance inventory within 10 days.
2. A Pharmacist In Charge should verify that all licenses are current.
PAPA Report
Lisa Yates was present to represent the PAPA program. Ms. Yates stated that there are a total of forty (40) pharmacists in the PAPA ogram. Since the last report on November 8, 2006, there has been two (2) new participants that entered the program and there has been one (1) particpant t has transferred his program to the Nebraska State Board program.
Ms. Yates discussed with the Board Members concerns with several participants. Ms. Yates stated that there is a concern with one confidential member and if the problems continue the individual will be told that the PAPA program is reporting her to the Board which would end her confidential status.
Ms. Yates stated that the PAPA program is having difficulty in obtaining payment from six participants. Ms. Yates stated that by ignoring their financial responsibility the participants are in violation of their contract.
Mr. Wand stated that if they violate their PAPA contract then they would be violating their consent order.
On motion by Dr. McCoy and Dr. Smidt, the Board unanimously agreed to have the attorney draft a letter for Mr. Wand to send to all non-paying PAPA members indicating that if they refuse to meet their PAPA financial obligations they are in violation of their consent agreement and further action could be taken against their license.
APA Report Mindy Rasmussen, Executive Director of the Arizona Pharmacy Alliance (APA), was present to update the Board
concerning the activities of the Alliance.Ms. Rasmussen stated that the Alliance is busy following the Alliance's bills through the Legislature. Ms.
Rasmussen stated that the Medication Therapy Management Bill passed through the Health Committee. Ms. Rasmussen stated that the Quality Assurance Bill was placed on Hold to address concerns and would be heard next Wednesday by the Health Council. Ms. Rasmussen stated that the Alliance is supporting the Prescription Monitoring Bill and the Emergency Prescription Bill. Ms. Rasmussen stated that the Alliance will be hosting their midyear meeting during the FBR open. Ms. Rasmussen stated that it would be a fundraising event for scholarships for students, CE will be offered, and legislators have been asked to join in the meeting and fundraising. Ms. Rasmussen stated that participants can also elect to attend the FBR open on Saturday. Ms. Rasmussen stated that preceptors can attend for a reduced rate.
Ms. Rasmussen stated that the Alliance is developing an online review of state and Federal Law. Ms. Rasmussen stated that they hope to offer the course beginning in March.
Dr. Smidt asked Ms. Rasmussen how many programs have been sold for the Quality Assurance Management Program.
Ms. Rasmussen stated that they have sold 19 programs with Cigna purchasing the majority of the programs.
Dr. Smidt asked if she has received any feedback concerning the Quality Assurance Program.
Ms. Rasmussen stated that they are still in the process of implementing the program and it has been chaotic.
AGENDA ITEM 8 - Introduction of New Assistant Attorney General
President Van Hassel asked Mr. Wand to introduce the new Assistant Attorney General to the Board.
Mr. Wand introduced Seth Hargraves to the Board Members. Mr. Wand stated that Mr. Hargraves graduated from the Roger Williams University School of Law in Rhode Island. Mr. Wand stated that Mr. Hargaves has served as Assistant Attorney General for the Board of Nursing and the Board of Accountancy. Mr. Wand stated that Mr. Hargraves would replace Ms. Lee. Mr. Wand stated that Ms. Lee would be representing the Board of Accountancy.
Mr. Hargraves stated that he is looking forward to working with the Board.
AGENDA ITEM 9 - Proposed Rules
Drug Wholesale Rules.
Compliance Officer/Rules Writer Dean Wright opened the discussion by stating at the November Board Meeting the Board decided to proceed with the fingerprinting of the wholesaler's designated representatives. Mr. Wright stated that he has added language to clarify the fingerprinting process. Mr. Wright stated that he has also added language to detail the requirements for "prescription-only drug returns and exchanges" and "returned, outdated, damaged, deteriorated,adulterated, misbranded, counterfeited, and contraband drugs".
Mr. Wand stated that Ms. Lathim, the Drug Inspector, attended the fingerprinting class.
The Board authorized Mr. Wright to proceed with the Notice of Proposed Rulemaking.
Prescription Donation Program
Compliance Officer/Rules Writer Dean Wright opened the discussion by stating that he has worked with the Department of Health Services Rulewriter in drafting these rules. Mr. Wright stated that the proposed rules have been approved by the Department of Health Services representatives. Mr. Wright stated that the draft has increased by about five pages. Mr. Wright stated that the new language deals with recipient eligibility and the donor and recipient forms.
Dr. Smidt asked what happens to the medication if it is not donated.
Mr. Wright stated that the medication is destroyed. Mr. Wright stated that the medication would be donated to a facility that volunteers to accept the donated medications. Mr. Wright stated that there would be a small fee charged to cover the processing.
Dr. Sypherd asked if a cost-benefit analysis has ever been conducted concerning donated medications.
Mr. Wright stated that he is not aware of any study. Mr. Wright stated that it depends on the willingness of individuals to donate medications to the
program.
The Board authorized Mr. Wright to proceed with the Notice of Proposed Rulemaking
Pharmacy Personnel & Security Procedure Rules
Mr. Wright stated that the automated storage and distribution rules that were to go into effect on March 10, 2007 would not go into effect on that date. Mr. Wright stated that due to a problem at GRCC , the January meeting was canceled. Mr. Wright stated that the meeting would be held on February 6, 2007 and the rules would become effective in April.
Mr. Wright stated that he has added language to allow prescriptions to be left in an automated distribution system that is within 20 feet of the pharmacy and does not require pharmacist consultation. Mr. Wright stated that he is proposing two additional changes to be consistent with language changes made in similar sections concerning the Automated Storage and Distribution System sections and the Mechanical Storage and Counting Device Sections.
The Board authorized Mr. Wright to proceed with the Notice of Proposed Rulemaking
Five-Year Rule Review
Mr. Wright stated that he is asking the Board Members to review Articles1,2,3, and 4 for the Board's Five-Year Rule Review. Mr. Wright stated that comments can be emailed to him or sent to the Board Office. Mr. Wright stated that he would like to receive comments by the next Board Meeting because the report is due in July. Mr. Wright stated that if he has the comments from the Board Members he can prepare a presentation for a future Board Meeting.
Agenda Item 10 - Complaint Review
- The Consumer Complaint Review Committee met prior to the Board Meeting to review 57 complaints. Dr. Berry, Dr. Sypherd, and Ms. Honeyestewa served as the review committee.
- Board Members were encouraged to discuss issues and were encouraged to ask questions.
- The Board Members discussed Complaint #3242. The Board decided to issue an advisory letter to the Pharmacist for giving a tablet from her prescription to a co-worker.
- The Board Members discussed Complaint #3245. After discussing the issue, the Board decided to take no further action on the complaint because the pharmacist did call the patient after she clarified the refills with the physician.
- The Board Members discussed Complaint #3249. After discussing the issue, the Board decided to offer the Pharmacist a Consent Order for Voluntary Surrender. The feeling was that the Pharmacist was using illegal drugs prior to employment.
- The Board Members discussed Complaint #3253. After discussing the issue, the Board decided that Upper anagement should appear for a conference to determine why there were not any DUR stops alerting the pharmacists.
- The Board Members discussed Complaint #3259. Dr. McCoy stated that sometimes customer service issues result in the lack of patient care. Mr. McAllister stated that this is a customer service issue and the complaint must show that the patient suffered harm for the Board to take action. Mr. Wand stated that there is no law stating how fast a prescription is filled. After discussing the issue, the Board decided to take No Further Action since this was a customer service issue.
- The Board Members discussed Complaint #3262. After discussing the issues, the Board decided the Pharmacist does have the right to refuse a prescription and decided to take No Further Action.
- The Board Members discussed Complaint #3263. After discussing the issues, the Board decided that this was a customer service issue and decided to take No Further Action.
- The Board Members discussed Complaint #3283. Afer discussing the issues, the Board decided that the Pharmacist In Charge should appear for a conference.
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 # 3232 - Conference - Pharmacist and Technician
- Complaint # 3233 - Advisory Letter to Pharmacist
- Complaint # 3234 - No Further Action
- Complaint # 3235 - No Further Action
- Complaint # 3238 - No Further Action
- Complaint # 3240 - No Further Action
- Complaint # 3242 - Advisory Letter to Pharmacist
- Complaint # 3243 - No Further Action
- Complaint # 3244 - No Further Action
- Complaint # 3245 - No Further Action
- Complaint # 3246 - No Further Action
- Complaint # 3247 - No Further Action
- Complaint # 3248 - Consent/Hearing for Technician - Revocation or enter Substance Abuse program at own expense, Conference for the PIC and the Permit
- Complaint # 3249 - Consent/Hearing - Voluntary Surrender
- Complaint # 3250 - No Further Action
- Complaint # 3251 - Conference - Pharmacist
- Complaint # 3252 - No Further Action
- Complaint # 3253 - Conference - Upper Management
- Complaint # 3254 - No Further Action
- Complaint # 3255 - No Further Action
- Complaint # 3256 - Letter - Not able to apply for licensure in Arizona
- Complaint # 3257 - No Further Action
- Complaint # 3258 - Conference - Pharmacist and Technician
- Complaint # 3259 - No Further Action
- Complaint # 3260 - No Further Action
- Complaint # 3261 - Advisory Letter to Pharmacist
- Complaint # 3262 - No Further Action
- Complaint # 3263 - No Further Action
- Complaint # 3264 - Conference - Pharmacist and Technician
- Complaint # 3265 - No Further Action
- Complaint # 3266 - Consent/Hearing for Technician - Revocation
- Complaint # 3267A - No Further Action
- Complaint # 3267B - Advisory Letter to Pharmacist and Technician
- Complaint # 3268 - Conference - Technician
- Complaint # 3269 - No Further Action
- Complaint # 3270 - Consent/Hearing - PAPA contract
- Complaint # 3271 - Consent/Hearing for Technician - Revocation or option to enter Substance Abuse program at own expense
- Complaint # 3272 - Consent/Hearing for Technician - Revocation or option to enter Substance Abuse program at own expense
- Complaint # 3273 - No Further Action
- Complaint # 3274 - No Further Action
- Complaint # 3275 - Advisory Letter to the Pharmacist and Permit Holder
- Complaint # 3276 - Conference - Pharmacist In Charge and the Technician
- Complaint # 3277 - Conference - Pharmacist and Upper Management
- Complaint # 3278 - No Further Action
- Complaint # 3279 - Advisory Letter to Pharmacist
- Complaint # 3280 - No Further Action
- Complaint # 3281 - No Further Action
- Complaint # 3282 - No Further ction
- Complaint # 3283 - Conference - Pharmacist In Charge
- Complaint # 3287 - Conference - Pharmacist
- Complaint # 3288 - Consent/Hearing for Technician - Revocation
- Complaint # 3289 - Consent/Hearing for Technician - Revocation or option to enter Substance Abuse program at own expense
- Complaint # 3290 - Consent/Hearing for Technician - Revocation or option to enter Substance Abuse program at own expense
- Complaint # 3291 - Consent/Hearing for Pharmacist - PAPA contract
- Complaint # 3292 - No Further Action
- Complaint # 3293 - Conference for Technician
- Complaint # 3294 - Conference for Pharmacist
AGENDA ITEM 11 - Consent Agreements
President Van Hassel asked Board Members if there were any questions or discussions concerning the consent agreements. Executive Director Hal Wand indicated that the consent agreements have been reviewed and approved by the Attorney General's Office and have been signed.
On motion by Mr. McAllister and Dr. Sypherd, the Board unanimously agreed to accept the consent agreements as presented in the meeting book and signed by the espondents. The consent agreements are listed below. A roll call vote was taken. Mr. McAllister - aye, Dr. Berry - aye, Ms. Honeyestewa -aye, Dr. Smidt - aye, Dr. McCoy - aye, Dr. Sypherd - aye, Mr. Dutcher- aye, President Van Hassel - aye
- Michele Norman - 05-0025-PHR
- Anthony Breeding - 07-0013A-PHR
- Paul Sanchez - 07-0014-PHR
- Bhavesh Soni - 07-0021-PHR
- Keith Likes - 07-0022-PHR
- Van Lieu - 07- 0023-PHR
- Caroline Begay - 07-0024-PHR
- Paul Okamoto - 07-0025-PHR
- Peter Massrock - 07-0027-PHR
- Angelica Cortes - 07-0029-PHR
- Kevin Denick - 07-0030-PHR
- Karen Lieb - 07-0031-PHR
- Consuelo Pipitan - 05-0013- PHR
AGENDA ITEM 12- Pharmacy Technician Trainee Reapplication
President Van Hassel addressed this issue. Mr. Van Hassel stated that the committee has reviewed the Pharmacy Technician Trainee requests to reapply for licensure. Mr. Van Hassel stated that the pharmacy technician trainees have received a letter stating that they may only reapply for licensure as a pharmacy technician trainee one time. Mr. Van Hassel stated that during the next two years the pharmacy technician trainee must take the PTCB test and become certified if they would like to continue to work as a pharmacy technician.
On motion by Dr. Sypherd and Mr. Dutcher, the Board unanimously approved the requests of the Pharmacy Technician Trainees listed below to proceed with the reapplication process. The pharmacy technician trainee may reapply for an additional two years as a pharmacy technician trainee one time.
Pharmacy Technician Trainees Approved to reapply for licensure as a Pharmacy Technician Trainee for an additional two years.
- Glenda Eason
- Sandi Barlow
- Joanne Campo
- Gabriella Alvarez
- Elaine Smith
- Vera Riedel
- Jason Ong
- LaTanya CalamityCarolyn Kellam
- Jessica Fenex
- Bridget cNamee
- Elbert de La Cruz
- Midori Maybin
- Randy Reed
- Rick Schader
- Kellie Attakai
- Brandi Funk
- Jose Galvan
- Elma Cortez
- Carrie McConkey
- Martha Montenegro
- Carolyn Petri
- Murray Lawrence
- Nichole Carroll
- Kevin Jaus
- Darshana Mistri
- Linda Skinner
- Jay Milne
- Jessica Booth
- Ashley Swigart
- Diana Park
- Shelley Bernal
- Angelica Dolezai
- Matthew Villalobos
- Shari Bohn
- Stephanie Galaviz
- David Surges
- Grace Munoz
- Mark Engelhard
- Lolita Mitchell
- Jose Martinez
- Shazia Rehman
AGENDA ITEM 13- Attendance at NABP Annual Meeting
President Van Hassel asked Mr. Wand to address this issue.
Mr. Wand stated that the NABP Annual Meeting would be held from May 19-22, 2007 in Portland, Oregon. Mr. Wand stated that the Board
could approve the reimbursement of travel and expenses for two participants. Mr. Wand stated that the Board could only reimburse two participants because of the state travel policy. Mr. Wand stated that the Board must also select a delegate and an alternate delegate.
On motion by Dr. McCoy and Dr. Sypherd, the Board unanimously selected the Board President, Mr. Van Hassel, and District 8 Chairman, Mr. Dutcher to attend the Annual NABP meeting. The Board unanimously agreed to reimburse their expenses.
On motion by Dr. McCoy and Dr. Sypherd, the Board selected Mr. Dutcher as the voting delegate and Dr. Berry as the alternate delegate.
Mr. Wand stated that the Board could apply for the grant from NABP for another participant. The Board decided that if the Board received the grant that Ms. Honeyestewa could use the grant to attend the meeting.
Agenda Item 14 - Potential Legislation Impacting the Board of Pharmacy
President Van Hassel asked Mr. Wand to address this topic. Mr. Wand stated that HB2438 concerns the Controlled Substances Monitoring Program. Mr. Wand stated that the Bill is currently being rewritten to remove the fee. The Board would ask for an appropriation to cover the costs of managing the program.
Mr. Wand stated that HB2136 removes the requirements that a Pharmacist In Charge be present at a Non-Prescription Manufacturer.
Mr. Wand stated that HB2155 would allow pharmacists to fill prescriptions during disasters, such as fires, floods, or tornadoes.
AGENDA ITEM 15 - Approval of Exams
President Van Hassel asked Mr. Wand to address this topic.
Mr. Wand stated that the statutes require that the Board periodically approve the licensing exams. Mr. Wand stated that the exams are given by NABP or the PTCB.
On motion by Dr. Smidt and Dr. McCoy, the Board unanimously approved the NAPLEX, MPJE, FPGEEC, and PTCB exams as the licensing exams for the state of Arizona.
AGENDA ITEM 16 - Approval of Colleges of Pharmacy
President Van Hassel asked Mr. Wand to address this topic.
Mr. Wand stated that the statutes require that the Board periodically review and approve the Colleges of Pharmacy.
On motion by Dr. Smidt and Mr. Dutcher, the Board unanimously approved the Colleges of Pharmacy listed in the Board Book.
AGENDA ITEM 17 - Approval of Delegation to Executive Director
President Van Hassel asked Mr. Wand to address this topic. Mr. Wand stated that Board can delegate authority to the Executive Director to order tests and exams listed in A.R.S.§ 32-1927 (F), A.R.S.§ 32-1927.01 (F), and A.R.S.§ 32-1927.02 (E).
On motion by Mr. Dutcher and Dr. Berry, the Board unanimously agreed to select Mr. Wand as the Executive Director and delegate the authority to the Executive Director to order tests and exams listed in A.R.S.§ 32-1927 (F), A.R.S.§ 32-1927.01 (F), and A.R.S.§ 32-1927.02 (E).
Dr. Smidt stated that he would like to compliment Mr. Wand and his staff on all the hard work that they do for the Board.
AGENDA ITEM 18 - Review of Investigation Concerning Pharmacist Jon Bach
Jon Bach was present to answer questions from Board Members concerning a recent investigation.
President Van Hassel asked Compliance Officer Rich Cieslinski to give a brief overview of the complaint.
Mr. Cieslinski stated that Mr. Wand requested that he meet him at the pharmacy where Mr. Bach was employed and interview the technicians that observed the working habits of Mr. Bach that morning.
Mr. Van Hassel asked Mr. Wand to address the issue.
Mr. Wand stated that he was called by the owner of the Pharmacy stating that he felt Mr. Bach had a medical problem. Mr. Wand stated
that when he arrived at the pharmacy Mr. Bach's behavior indicated that he was having medical issues or had a drug related problem. Mr. Bach was removed from the pharmacy because Mr. Wand stated that he felt he could not function as a pharmacist. Mr. Wand stated that he felt that this was a danger to the
public.
Mr. Dutcher asked if there was a complaint filed.
Mr. Wand stated that he was contacted by a technician and the owner indicating that there was a problem and the paramedics had been
called.
Mr. Wand stated that since this is a complaint the Board could take action against the Pharmacist.
Mr. Wand stated that previously the Board had ordered an evaluation by Dr. Pickens. The evaluation was non-committal that Mr. Bach had an addiction problem. Mr. Wand stated that the Board reviewed the evaluation at the last meeting and then this event occurred.
Mr. Van Hassel asked Mr. Bach to address the issue.
Mr. Bach stated that he was diagnosed with depression about a year ago. Mr. Bach stated that he was suffering from severe depression and
anxiety.
Mr. Sypherd asked Mr. Bach why he entered the PAPA program.
Mr. Bach stated that he needs stability in his life and entered the program again.
Mr. Wand stated that Mr. Bach agreed to enter the PAPA program.
Mr. Dutcher asked Mr. Bach if he is still working.
Mr. Bach stated that he works for RPH on the Go. Mr. Bach stated that he is currently doing his outpatient treatment on Monday, Wednesday,
and Friday. Mr. Bach stated that he still has his license and can work on Tuesday and Thursday.
Dr. Sypherd asked Mr. Bach if he feels that he is capable of continuing to practice.
Mr. Bach replied that he feels that he is capable of practicing.
Mr. Dutcher asked Mr. Bach what occurred that day.
Mr. Bach stated that he was seen by the Emergency Personnel and there were no issues.
Mr. Wand stated that Mr. Bach submitted to a urine screen and the test was positive for Phentermine. Mr. Wand
stated that Mr. Bach could not explain the positive screen.
Mr. Dutcher asked if the Board was looking for a consent agreement.
Mr. Wand stated that the Board could require that Mr. Bach undergo a psychological evaluation by Dr. Lett.
Mr. Bach told the Board that he has signed a five-year PAPA agreement.
Mr. McAllister asked Mr. Bach to give him a summary of his employers over the last two years.
Mr. Bach stated that he worked for K-Mart and resigned. Mr. Bach stated that he worked at various sites through RPH
on the Go. Mr. Bach stated that he worked at Maryvale Hospital.
Mr. Bach stated that he worked at Willo Pharmacy.
Mr. McAllister asked Mr. Bach if he was terminated from any of the positions.
Mr. Bach stated that he was left go from Maryvale hospital due to errors he made due to the lack of training. Mr.
Bach stated that Mr. Wand requested that he be removed from Willo pharmacy when this incident occurred.
Dr. McCoy stated that she has concerns about his competency and his continuation to practice until his petency is evaluated.
Mr. Van Hassel stated that he feels Mr. Bach should voluntarily surrender his license until he is evaluated.
Dr. Sypherd stated that he feels that there should be a temporary suspension.
Mr. Wand stated that the Board could issue a consent order or impose a summary suspension.
Ms. Lee stated that the Board could issue a consent order with all the requirements that they feel are necessary and if not signed by a certain time then the license could be summarily suspended.
Mr. Bach stated that he would voluntarily surrender his license.
On motion by Dr. McCoy and Mr. McAllister, the Board unanimously agreed to issue a consent agreement to Mr. Bach for temporary suspension until the psychological exam is completed and upon completion is reviewed at the next Board Meeting. During this period, Mr. Bach must comply with all requirements of the PAPA program. A roll call vote was taken. (Mr. McAllister - aye, Ms. Honeyestewa -aye, Dr. Berry - aye, Dr. Smidt - aye, Dr. McCoy - aye, Dr. Sypherd - aye, Mr. Dutcher- aye, President Van Hassel - aye)
AGENDA ITEM 19 - Review of Psychological Exam Ordered as a result of Complaint #3201 - Venkateswara Malladi
Mr. Malladi was not present.
President Van Hassel asked Mr. Wand to address this issue.
Mr. Wand stated that the Board had decided at the last meeting to authorize Mr. Wand to order a psychological exam for Mr. Malladi. Mr. Wand stated that Mr. Malladi was interviewed by him and Ms. Frush at the office and he was sent to Dr. Lett for a psychological evaluation. Mr. Wand stated that the Board Members have a copy of the evaluation and the decision is now what action to take against Mr. Malladi. Mr. Wand stated that a video is available of the assault on a customer. Mr. Wand stated that Mr. Malladi stated that he pushed the customer, but the video shows Mr. Malladi having the customer
in a headlock and punching the customer. Mr. Malladi was arrested for assualt.
Mr. Dutcher asked if his license is in good standing. Mr. Wand replied yes at this time.
Mr. Dutcher stated that he feels the Board should take some action against Mr. Malladi's license.
Dr. Smidt noted that the evaluation indicated that Mr. Malladi would only be safe to work as a pharmacist if he was involved in ongoing counseling.
Mr. Wand stated that the Board could issue a consent order mirroring Dr. Lett's recommendations or they could add or subtract recommendations.
Mr. Wand stated that Mr. Malladi stated that he would rather go to jail then admit to the charges.
Mr. McAllister stated that he feels Mr. Malladi has a problem with alcohol abuse and probably should be involved in the PAPA program or be involved in a urine monitoring program.
On motion by Mr. McAllister and Dr. Sypherd, the Board agreed to issue a Consent Agreement to Mr. Malladi mirroring Dr. Lett's recommendations with the addition of a drug recovery or monitoring program approved by the Board. A roll call vote was taken. (Mr. McAllister - aye, Ms. Honeyestewa -aye, Dr. Berry - aye, Dr. Smidt - aye, Dr. McCoy - nay, Dr. Sypherd - aye, Mr. Dutcher- aye, President Van Hassel - aye)
AGENDA ITEM 20 - Review of Board Meeting Schedule
President Van Hassel opened the discussion by stating that some Board Members had conflicts with the meeting scheduled for May 16th and May 17th , 2007. It was also noted that this is close to the NABP Annual Meeting.
The Board agreed to move the meeting to May 9th and May 10th, 2007.
Agenda Item 21- Approval of Building Sign for a Non-Prescription Retail Outlet
(OTC Drugs and More)
President Van Hassel asked Mr. Wand to address this issue.
Mr. Wand stated that when Ms. Lathim was inspecting non-prescription retail outlets at the Airport, she discovered an outlet that had a sign posted out front that said "Drugs and More". Mr. Wand stated that the company was notified that they could not use the word Drugs on their sign because it would confuse people and make them believe that a pharmacist was present to dispense medications. The Company asked if it would be alright to change their signage to "OTC Drugs and More" in an effort to not confuse the public.
Ms. Lee stated that they are trying to comply with the intent of the law not to confuse the public.
On motion by Dr. Smidt and Dr. Berry, the Board agreed to accept the signage as "OTC Drugs and More". There was one nay vote from Dr. Sypherd.
AGENDA ITEM 22 - Call to the Public/STRONG>
President Van Hassel 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.
Mr. Morris came forth and stated that he knows that the Board does not have control over a move downtown, but would like the Board to know that the Building is locked at 5:00 P.M. and the Public must leave the Building. Mr. Morris stated that the Board Meeting would need to end at that time and the Board could not continue the meeting.
There being no further business to come before the Board, on motion by Mr. Dutcher and Dr. Berry, the Board unanimously agreed to adjourn the meeting at 5:20 P.M. |