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Board Meeting Minutes

April 6, 2005 Board Meeting minutes

THE ARIZONA STATE BOARD OF PHARMACY

HELD A REGULAR MEETING APRIL 6, 2005

GLENDALE, ARIZONA

The following Board Members and staff were present: President Linda McCoy, Vice President Chuck Dutcher, Dennis McAllister, Bryan Tippett and Tom Van Hassel. 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 Roberto Pulver.

President McCoy convened the meeting at 9:00 A.M. and welcomed the audience to the meeting. Ms. Frush explained that law continuing education would be offered for attendance at the meeting.

AGENDA ITEM 1 - Approval of Minutes

Following a review of the minutes and an opportunity for questions and on motion by Mr. Dutcher and Mr. Van Hassel, the minutes of the Strategic Planning Meeting held on March 16, 2005 were unanimously approved by the Board Members with one correction to be made on Page 12 of the minutes.

AGENDA ITEM 2 - Request for Continuance - Hearing No. 04-0032-PHR, Marjorie Daily

President McCoy stated that the respondent in this case had requested a continuance, but after obtaining legal advice has signed a Consent Agreement.

A roll call vote was taken. (Mr. McAllister - aye, Mr. Van Hassel - aye, Dr. Tippett - aye, Mr. Dutcher - aye, and President McCoy - aye). All Board Members present voted to unanimously accept the following Consent Agreement as presented at the meeting and signed by the respondent Marjorie Daily 04-0032-PHR

AGENDA ITEM 3 - Permits/ Licenses

President McCoy stated that all permits were in order for resident pharmacies and representatives from several pharmacies were present to answer questions from Board Members.

Pima Community College

Mary Ann Jordan, the Pharmacist In Charge, was present to answer questions from Board Members.

Mr. Wand opened the discussion. Mr. Wand stated that Pima Community College offers a pharmacy technician certification program. Mr. Wand stated in the past Pima College was able to use the compounding lab at the University of Arizona. Mr. Wand stated that the University has moved their lab to Reed's Compounding Pharmacy and Pima College was not included in the move. Mr. Wand stated Pima College is requesting a pharmacy permit in order to continue to teach the compounding portion of their course. Mr. Wand stated that Pima College would not have any controlled substances on site and therefore will not need a DEA permit. Mr. Wand stated that security measures would be the same as any other retail pharmacy. Mr. Wand stated that Ms. Jordan would be the only individual allowed to open and close the pharmacy. Mr. Wand stated that Ms. Jordan would be responsible for the security of the pharmacy at all times.

Mr. Wand stated that the Board has issued pharmacy permits to schools for training purposes.

Mr. McAllister asked Ms. Jordan of she intended to use legend products in the lab. Mr. McAllister stated that if the program did not use legend products and did not dispense medications to the public he felt that there would be no need for a pharmacy license. Ms. Jordan stated that there are no medications dispensed to the public. Ms. Jordan stated in the compounding lab they use medications to make various creams, ointments, and suppositories. Ms. Jordan stated in the sterile product lab they use antibiotic powders to prepare IV medications. Ms. Jordan stated that the ASHP certification committee recently reviewed her program. Ms. Jordan stated the review committee suggested that the program should also train the individuals to work in a retail environment. Ms. Jordan stated that she has asked retail pharmacies to donate out-dated drugs to her program so that the students would be able to see the various medications. Ms. Jordan stated that the College would be providing more security. Ms. Jordan stated that for the rest of the semester, she has ordered the fake drugs used for teaching purposes. Ms. Jordan stated that it is cheaper to order the actual medications or receive donations.

Mr. Van Hassel asked if the program was accredited by ASHP. Ms. Jordan replied yes.

Mr. Dutcher asked Ms. Jordan if ASHP required the College to have a Pharmacy license. Ms. Jordan replied that ASHP did not require a pharmacy license for accreditation. Ms. Jordan stated that the accreditation committee was not satisfied with the lab facilities and suggested to the Deans of the College that the program should have their own lab facilities.

Mr. Dutcher asked if the College needed a license. Mr. Wand stated as long as they have legend drugs that they must have a permit. Mr. Dutcher asked what type of license would be issued to the College. Mr. Wand replied that the College would be licensed as a limited service pharmacy.

Payson Apothecary Shop

Craig Mathews, the new owner was present to answer questions from Board Members.

Mr. Wand stated that Mr. Mathews is purchasing the Apothecary Shop where he currently works as the Pharmacist In Charge. Mr. Wand stated that this is a compounding pharmacy.

President McCoy opened the discussion. Ms. McCoy asked Mr. Mathews about his employment at this pharmacy. Mr. Mathews stated that he has been the Pharmacist In Charge at this pharmacy for the last three years.

President McCoy asked Mr. Mathews if he is familiar with the compounding regulations. Mr. Mathews stated that he is familiar with the compounding regulations.

Mr. Van Hassel asked Mr. Mathews if he would be compounding medications for physicians as well as for patients. Mr. Mathews stated that the pharmacy does a limited amount of compounding for physician's offices.

Mr. Van Hassel asked Mr. Mathews if he was familiar with the new USP 797 guidelines. Mr. Mathews stated he was not familiar with USP 797. Mr. Van Hassel explained that the guidelines involve the labeling and sterility requirements of sterile products.

Ms. McCoy asked Mr. Mathews if he would be preparing sterile products. Mr. Mathews replied that he does not currently prepare any sterile products. Mr. Mathews stated that he does have a hood in the pharmacy, but he has not prepared any sterile products for two years. Mr. Mathews stated that all sterile products were being prepared at the Scottsdale pharmacy. Mr. Mathews stated that he does not have any plans to prepare sterile products at this time.

President McCoy stated that representatives for two Non-resident pharmacies have been requested to appear to answer questions for Board Members.

Computerx Pharmacy IV

Michael Licamele, one of the owners, appeared to answer questions.

President McCoy stated that Mr. Licamele was present to answer questions concerning his past violations. Mr. Licamele stated that the violations occurred in 1978. Mr. Licamele stated that he was the owner of several pharmacies and one of the pharmacies was cited for improper documentation of Medicaid sales for OTC products.

Mr. Licamele stated that they were suspended from participating in Medicare programs and were reinstated in 1987. Mr. Licamele stated that it took 9 years to resolve the issues. Mr. Licamele stated that they made restitution. Mr. Van Hassel asked Mr. Licamele to describe his pharmacy business. Mr. Licamele stated that the pharmacy prepares compounded medications and dispenses respiratory products. Mr. Licamele stated that his facility meets all current standards. Mr. Licamele stated that he is a member of several compounding organizations. Mr. Van Hassel asked Mr. Licamele if the products compounded are patient specific. Mr. Licamele stated that all compounds are patient specific and are delivered to the patient. Mr. Licamele stated that they do not compound prescriptions for use in physician's offices or clinics. Mr. Dutcher asked Mr. Licamele if the pharmacy would be shipping products to Arizona residents. Mr. Licamele stated that as soon as they have patients requesting prescriptions be mailed to them, a member of his staff will verify if a pharmacy permit is required to mail prescriptions to that state. If a non-resident pharmacy permit is required, then the pharmacy applies for a permit. Mr. Dutcher asked Mr. Licamele how Arizona residents learn about his pharmacy in Connecticut. Mr. Licamele stated it is by word of mouth. Mr. Wand asked Mr. Licamele if his company has a policy concerning the compounding of commercially available products. Mr. Licamele stated that they would not compound any commercially available products and refuse to compound respiratory medications that are commercially available.

Dawn National Pharmacy

President McCoy asked if a representative from Dawn National Pharmacy was present to answer questions. No representative came forth to answer questions.

Ms. Frush stated that Mr. Ray had called the office and had asked about attending a future meeting after receiving his appearance letter. Mr. Ray was told that the next meeting was in June.

Mr. Ray stated to leave him on the April meeting agenda.

Mr. Wand stated that the information provided by the applicant states that he was charged with under reporting of taxes. The applicant stated that his pharmacist license was placed on probation in 1989. Mr. Wand stated that the policy of the Board has been to ask applicants with disciplinary actions to appear in front of the Board. Mr. Wand stated that the application could be tabled until June or the Board could approve the permit.

Mr. McAllister stated that the pharmacist's license has been reinstated and he feels that the Board could not deny this application.

At the conclusion of questions from the Board Members and on motion by Mr. McAllister and Mr. Van Hassel, the Board unanimously approved the resident and non-resident permits listed below. All approvals are subject to final inspection by a Board Compliance Officer where appropriate.

RESIDENT (In Arizona)

  • Wal-Mart Pharmacy #10-3357
    3925 E Grant Rd., Tucson, AZ 85712
    Wal-Mart Stores, Inc.
  • Sam's Club #10-4927
    1375 S. Arizona Ave., Chandler, AZ 85224
    Wal-Mart Stores, Inc.
  • Wal-Mart Pharmacy
    10-3314 7450 W. Glendale Ave., Glendale, AZ 85303
    Wal-Mart Stores, Inc.
  • Sierra Tucson
    39580 S. Lago del Oro, Tucson, AZ 85739 (O)
    CRC Merger Acquisition Corp.
  • Pima Community College District
    4905 E. Broadway Blvd., Tucson, AZ 85709
    Pima Community College District
  • Wal-Mart #10-5329
    4435 W. Anthem Way, Phoenix, AZ 85086
    Wal-Mart Stores, Inc.
  • Home Pharmacy
    Services 1110 E. McDowell, Phoenix, AZ 85006 (O)
    Home Pharmacy Services, Inc.
  • Paradise Pharmacy
    4232 E. Cactus Rd., Suite #103, Phoenix, AZ 85032 (O)
    Neeti, Inc.
  • Payson Apothecary
    201 W. Main St., Suite L, Payson, AZ 85541 (O)
    Craig Mathews

(O)= Change of Ownership

NON-RESIDENT (Out of State)

  • Armenia Pharmacy
    8338-B North Armenia Ave., Tampa, FL 33604
    Armenia Pharmacy, Inc.
  • Healthcare Options of Minnesota, Inc.
    2055 15th St. North, Ste. C, St. Cloud, MN 56303
    Option Care Enterprises, Inc.
  • Caremark One Great Valley Blvd., Wilkes Barre, PA 18706
    Caremark PCS Pennsylvania Mail Pharmacy, LLC.
  • Custom Compounding Pharmacy
    8301 Florida Dr., Suite 208,Pembroke Pines, FL 33025
    Nathan Moy
  • Centric Health Resources
    17877 Chesterfield Airport Rd., Chesterfield, MO 63005
    Centric Health Resources, LLC
  • I Care Pharmacy
    1562 Park Lane South, Ste 500, Jupiter, FL 33458
    Market Street Medical, Inc.
  • Caremark
    19102 N. Creek Pkwy., Suite 110 , Bothell, WA 98011
    Caremark Washington Specialty Pharmacy, LLC.
  • Computerx Pharmacy IV
    35 Ontario St., Stratford, CT 06615
    Computerx Pharmacy, Inc.
  • Dawn National Pharmacy Inc.
    4215 Commercial Way, Glenview, IL 60025
    Dawn National Pharmacy Inc.

Wholesale Permits

President McCoy indicated that there is one application for a resident wholesale permit.

On motion by Mr. Dutcher and Dr. Tippett, the Board unanimously approved the resident wholesaler permit listed below. All permits are subject to final inspection by a Board Compliance Officer where appropriate.

  • Sam's Club # 10-4927
    1375 S. Arizona Ave., Chandler, AZ 85224
    Wal-Mart Stores, Inc.

Pharmacist, Pharmacy Intern, and Pharmacy Technician Licenses

Following a review of the roster of applicants for licensure as pharmacists, pharmacy interns, and pharmacy technicians and on assurance by the staff that all applications are in order and all fees paid: on motion by Mr. Dutcher and Dr. Tippett, the Board unanimously approved the following licenses:

Pharmacists licenses 14659 through 14683, Pharmacy Intern licenses 6843 through 6871, and Pharmacy Technician licenses 6998 through 7178. Also, approved were 12 licensee changes from pharmacy technician trainee to pharmacy technician. For a complete list of names see attachments.

AGENDA ITEM 4 - REPORTS

Executive Director's Report

Executive Director Hal Wand began his report by discussing the financial statements.

Mr. Wand stated that the Board has spent roughly 60% of the appropriated budget with three months remaining for the current budget period. Mr. Wand stated that there is a large fund balance. Mr. Wand stated that if the Board receives a grant for the Prescriptions Drug Monitoring Program that the Board might be able to request additional funds for the program from the fund.

Mr. Wand stated that he would be attending a meeting to evaluate six providers for a new database for the Board. Mr. Wand stated that the new database would include electronic renewals. Mr. Wand stated that if the Board receives approval to purchase the new database then it would be purchased during next years budget. Mr. Wand stated that the Board might need to ask for a supplemental from the fund to cover the cost of the program.

Mr. Wand stated that with the extra money there would be improvements made in the office. Mr. Wand stated that he has ordered Tablet PCs for the Compliance Officers. Mr. Cieslinski stated that he has tried the Tablet PC out in the field and he was able to print the inspection report at the site. Mr. Wand added that the database is loaded on the tablet and the Compliance Officers would be able to verify license status. Mr. Wand stated that since the inspection report is printed, the report would be legible and readable several years later.

Mr. Dutcher asked if the Board was still proceeding to purchase laptops for the Board Members to use at the Board Meeting. Mr. Wand stated that at the present Mr. Dobrowski is submitting a proposal to the state. Mr. Wand stated that the laptops are being purchased through a state contract. Mr. Wand stated that the laptops should be received by the end of June and Mr. Dobrowski will need to develop procedures for preparing the Board Meeting CDs. Mr. Wand stated that he does not anticipate using the laptops until probably September or November.

President McCoy stated that included in the meeting book are copies of customer satisfaction surveys that are returned to the Board Office rating the service that they received from the office staff. Ms. McCoy stated that a rating of 8 indicates that the customer was totally satisfied with the service. Ms. McCoy noted that all the surveys rated the individuals with an 8 and had very positive comments about the service that they received.

Deputy Director Report

Deputy Director Frush introduced the newly hired drug inspector, Heather Lathim. Ms. Lathim will be inspecting the non-prescription outlets and wholesale operations.

Deputy Director Frush directed the Board Members attention to the activity reports for the Compliance Officers. Ms. Frush stated that the Compliance Staff is ahead of the number of pharmacy inspections that were completed at this time last year. Ms. Frush stated that the number of complaints is increasing. Ms. Frush stated that the compliance staff is performing more audits this year than in other years. Audits are performed when the office receives reports of theft, diversion, or forgeries. The Compliance staff must perform audits at the store level and often must visit various physician's offices to determine the legitimacy of the prescriptions.

Ms. Frush stated that during the months of January and February, the Compliance staff issued letters for the following violations:

  • Outdated Rx and OTC products in the pharmacy - (8)
  • Unable to locate Annual Controlled Substance Inventory - (7)
  • Controlled Substance overages - (7)
  • Controlled Substance shortages - (3)
  • Failure to document disease and medical conditions - (6)
  • Allowing unlicensed technicians to work - (5)
  • Controlled Substance Inventory not completed by new Pharmacist In Charge - (2)
  • Incomplete Controlled Substance Inventory upon change of Pharmacist In Charge -(1)
  • Selling more than 5% of pharmacy stock to physicians - (1)
  • Invoices for CIII - CV not available - (2)
  • Incomplete transfer information - (1)
  • Incomplete information on new oral prescriptions - (1)
  • Failure to provide required reference books - (1)
  • Expired permit - (1)
  • Compounding commercially available products - (1)
  • Original copies of CII prescriptions were not on site - (1)
  • Prescriptions not filed in numerical order- (1)
  • No daily log maintained - (1)
  • Annual Inventory record keeping not complete - (1)
  • Misbranding - Repackaged medications not compliant with labeling requirements - (1)
  • Partial filling of CII prescriptions from two pharmacy sites - (1)
  • Prescription verification by Non-Arizona licensed pharmacists - (1)
  • Dispensed a CII prescription past the 60 day limit - (1)
  • Labeling does not include "generic equivalent for" when substitution occurred - (2)
  • Inadequate hospital policies and procedures to address pharmacist verification of orders, removal after hours, and emergency medications - (1)
  • Current wall certificates for technicians and pharmacists not displayed - (1)
  • Scale not functioning - (1)
  • Incomplete completion of DEA 222 forms as purchaser and supplier - (1)

    The following areas were noted on the inspection reports for improvements:

  • Pharmacists and technicians must have current license at site when working

    The following areas were noted on inspection reports where pharmacists and technicians are meeting or exceeding standards:

  • Cleanliness of pharmacies - Less reports of dusty shelves

    Areas outside the inspection reports that may be of interest:

  • Changes of the Pharmacist In Charge must be reported to the Board immediately
  • DEA 106 (Loss of Drugs) must be filed with the Board and DEA.
  • Canadian and Mexican prescriptions cannot be transferred.
  • Annual Controlled Substance Inventory Books can be printed from the website.

Ms. Frush indicated that violations 14 through 22 were issued to one pharmacy. Board Members had concerns about the operation of the pharmacy. Mr. Pulver stated that the Board could open a complaint against the pharmacy and send the complaint to the Review Committee for action On motion by Mr. McAllister and Mr. Dutcher , the Board unanimously agreed to open a complaint against the pharmacy and proceed with the complaint process.

PAPA Report

PAPA was represented by Lisa Yates. Ms. Yates stated that there are a total of thirty-two (32) participants in the PAPA program. Ms. Yates stated since January 11, 2005, there have been two participants that have completed the program and there has been one termination.

Ms. Yates stated that on March 29, 2005, PAPA sponsored a two hour CE program "Addiction in the Workplace". Ms. Yates stated that the program was for pharmacy supervisors and/or managers. Ms. Yates stated the information was sent to 106 supervisors/ managers and only 12 individuals attended the program.

Dr. Tippett asked Ms.Yates how pharmacists are madeaware of the PAPA program.Ms. Yates stated that thereare links to the PAPA program on the Board's website and on the Alliance website. Ms. Yates stated that there is an advertisement in the Arizona Pharmacist magazine.

Dr. Tippett asked about opportunities for technicians to attend the program. Ms. Yates stated that the program would be available to the technicians. Ms. Yates stated that in order to participate in the program the participant must complete an extensive inpatient or outpatient program. Ms. Yates stated that many insurance companies do not cover these types of programs and the pharmacist must pay for these costs out-of-pocket. Ms. Yates stated that the participant must also pay the costs of the urine screening and counseling sessions. Ms. Yates stated that she is not certain how a technician would be able to cover the costs of participating in the program.

Dr. Tippett stated that in the future the Board might want to consider as an agenda item a method to help technicians enter the PAPA program and not be excluded because of the cost of the program. Mr. Dutcher stated that maybe there are grants that could be obtained to help the technicians. Mr. Pulver stated that it might be possible at a later date to approach the legislature about funding.

APA Report

Kathy Boyle was present to represent the Arizona Pharmacy Alliance. Ms. Boyle stated that she is the Chief Operating Officer for the Alliance.

Ms. Boyle spoke about the Bills being followed by the Alliance.

Ms. Boyle stated that the Convention will be held from June 16th through June 19th at the Wild Horse Pass. Ms. Boyle stated that the notices would be sent out to members next week. Ms. Boyle stated that this years meeting would offer 43.5 credits of CE.

Ms. Boyle stated that she attended the APHA annual meeting. Ms. Boyle stated that she attended a session on Medicare Part D. She stated that she will be meeting with the Alliance concerning Medicare Part D and how the Alliance can be a resource for the pharmacies and pharmacists when Medicare Part D starts in January of 2006.

Ms. Boyle stated that a PBS station back east is presenting a program on the role of pharmacists. The program will air in October of 2005. Ms. Boyle stated that the Alliance will try to negotiate with the local PBS stations to carry the program.

Ms. Boyle stated that the alliance will be working with Pharmacist Mutual to share ownership of a medication error program for community pharmacies.

A short recess was taken and the meeting was reconvened.

AGENDA ITEM 5 - Special Requests

#1Sonora Behavioral Health Hospital

Sonora Behavioral Health Hospital sent a letter requesting to appear at the June meeting.

#2 St. Luke's Behavioral Health Hospital

The following individuals were present to answer questions from Board Members: Scott Bonhus, Pharmacist In Charge and Gregory Jahn- Hospital Administrator.

President McCoy opened the discussion by asking the respondents about their request for an exemption to the rule that states pharmacy services shall be provided for a minimum of 40 hours per week in a hospital, unless the Board grants an exemption.

Mr. Bonhus stated that St. Luke's Behavioral Health Center is connected to St Luke's Medical Center and is located on the same campus Mr. Bonhus stated that the licensing board for acute care hospitals required that they have a pharmacy on site. Mr. Bonhus stated currently the Behavioral Center has backup coverage from St. Luke's Medical Center from 6:00 A. M. to midnight. Mr. Bonhus stated in the future that they will have 24 hour coverage through Pyxis Connect with their sister hospital in Tempe. Mr. Bonhus stated that because backup coverage is available that they are requesting that the hours of available pharmacy services be reduced to twenty (20) hours a week.

Mr. McAllister stated that a Behavioral Health Center is not an acute care hospital. Mr. McAllister felt that the Pharmacist In Charge would still be held accountable for any problems or violations.

Mr. Wand stated that the rules state that Pharmacy services shall be provided for a minimum of 40 hours per week, unless an exception for less than the minimum hours is made upon written request by the hospital and with express permission of the Board or its designee.

Mr. McAllister stated that this topic should be placed on the agenda of a future Board Meeting.

Mr. McAllister stated that the Board should review cases that set precedence and then allow the staff to make decisions on other cases.

On motion by Mr. McAllister and Mr. Dutcher, the Board unanimously approved the request by St. Luke's Behavioral Health Center to decrease the hours of pharmacy service from 40 hours per week to 20 hours per week as requested.

#3Glenn Namura

Glenn Namura appeared on his own behalf to request to proceed with reciprocity.

President McCoy asked Mr. Namura about the nature of his request. Mr. Namura stated that he would like to proceed with reciprocity. Mr. Namura stated that when he last appeared in front of the Board in November he discovered that his license in Colorado was still on probation. Mr. Namura stated that he has taken care of the issues in Colorado and his license is no longer on probation.

President McCoy asked Mr. Namura if he will be working in Arizona or if he plans on opening a pharmacy in Arizona. Mr. Namura stated that he lives in Laughlin, Nevada and anticipates working in Bullhead City, Arizona.

On motion by Mr. Van Hassel and Dr. Tippett, the Board unanimously approved the request by Mr. Namura to proceed with reciprocity.

#4 Harold Resnick

Harold Resnick appeared on his own behalf to request to proceed with reciprocity.

President McCoy opened the discussion by asking Mr. Resnick to describe the nature of his request Mr. Resnick stated that he would like to proceed with reciprocity and become licensed in Arizona. Mr. Resnick stated in 1992 he was disciplined by the Ohio Board of Pharmacy.

Ms. McCoy asked Mr. Resnick to describe the penalty that he received from the Ohio Board of Pharmacy. Mr. Resnick stated that he was reported for giving the access code to the pharmacy to two non-licensed personnel.

Mr. Dutcher asked if the only action taken by the Board was a fine. Mr. Resnick stated that he paid a five hundred dollar fine.

On motion by Mr. McAllister and Mr. Dutcher, the Board unanimously approved the request by Mr. Resnick to proceed with reciprocity.

#5 Anibal Rolon

Anibal Rolonappeared on his own behalf to request that the probation imposed by his Consent Order be terminated. Darren Kennedy, his supervisor, was present to answer questions.

President McCoy asked Mr. Rolon to describe the nature of his request. Mr. Rolon stated that he is requesting that his probation be terminated.

Ms. McCoy stated that the Consent Order was issued as a result of a misfill. Ms. McCoy asked Mr.. Rolon what he has learned from this experience. Mr. Rolon stated that it was not a misfill but was a recommendation that was wrong. Mr. Wand clarified the situation. Mr. Wand stated that Mr. Rolon was presented with a prescription that he could not read and told the patient to buy OsCal over the counter without filling the prescription.

Mr. Rolon stated that if he has questions about a prescription he calls the doctor for clarification.

Mr. Rolon stated that he has completed CE units on quality assurance.

Mr. McAllister stated that he had the opportunity to talk to his patient about their health conditions and did not talk to his patient. Mr. McAllister asked Mr. Rolon if he has changed the way he talks with his patients. Mr. Rolon stated he has changed the way he talks with his patients.

Mr. McAllister asked Mr. Kennedy about Mr. Rolon's performance. Mr. Kennedy stated that Mr.Rolon contacted him asking him what to do when the error was brought to his attention. Mr. Kennedy stated that they have had no other issues with Mr. Rolon's performance.

On motion by Mr. McAllister and Dr. Tippet , the Board unanimously approved the request by Mr. Rolon to terminate the probation imposed by Consent Order 2004-03-PHR.

#6 David Clapp

David Clapp appeared on his own behalf to request to have his pharmacist license reinstated.

President McCoy asked Mr. Clapp about the nature of his request. Mr. Clapp stated his license was revoked in 1998 and he would like to have his license reinstated.

President McCoy asked Mr. Clapp to describe the nature of his revocation. Mr. Clapp stated that he was addicted to methamphetamine. Mr. Clapp stated that he diverted drugs from the pharmacy to trade for methamphetamine.

President McCoy asked Mr. Clapp what he has been doing since his revocation. Mr. Clapp stated that he went through an extensive outpatient program at Aspen Hill in Flagstaff. Mr. Clapp stated that he entered the PAPA program. Mr. Clapp stated that he began working at a Cabinet factory in Kingman and during a period of 5 years, he worked his way up to Lead Production Supervisor.

Mr. Clapp stated that in May of 2004, he began working as a Production Supervisor for Honeywell in Kingman. Mr. Clapp stated that he was unable to continue in the PAPA program due to the costs associated with the program. Mr. Clapp stated that he has had support from his family and friends. Mr. Clapp stated that he did not appear before this time because he was embarrassed and did not-have the self-confidence to appear before his peers. Mr. Clapp stated that he is appearing before the Board to see if the Board would consider his request for reinstatement.

Mr. Dutcher asked Mr. Clapp if he wants to work as a pharmacist again. Mr. Clapp replied that is correct. Mr. Dutcher stated that there would be restrictions on his license if the Board decides to reinstate his license. Mr. Clapp stated that he understands that the Board must trust him first and he does not expect an answer today. Mr. Dutcher asked Mr. Clapp if he feels he has the fortitude to stay away from the temptations. Mr. Clapp replied definitely.

President McCoy stated that her concern is that he has not completed any type of addiction program.

Ms. Yates, from the PAPA program, stated that Mr. Clapp did enroll in the PAPA program and did withdraw from the program due to financial issues.

Mr. McAllister stated that the Board could create a plan to allow Mr. Clapp to restart in the pharmacy profession and protect the public. Mr. McAllister recommended that there should be monitoring, such as the PAPA program. Mr. McAllister stated that Mr. Clapp has been out of practice for seven years and the Board might want to consider an internship and the retaking of exams.

Ms. McCoy asked if the Board has ever asked for certification from a counselor. Ms. Yates stated that if Mr. Clapp signs a release form that she would be able to release his file to the Board.

Mr. Dutcher asked Mr. Clapp if he would be able to reenter the PAPA program. Mr. Clapp stated that he would have no problems entering into the PAPA program.

Mr. Pulver stated that the Board could require Mr. Clapp to see an addictionologist. Mr. Pulver stated that the addictionologist would do an extensive study and provide the Board with a report.

Mr. Pulver stated that the Board could then tailor a program to meet the individual's needs.

Mr. Wand stated in the past if there has been a positive recommendation from the addictionologist, then the Board has issued a graduate intern license with the number of intern hours determined by the Board.

Mr. Pulver stated that after looking over the addictionologist's report, the Board could recommend that Mr. Clapp enroll in the PAPA program.

Mr. McAllister felt that a stepwise plan would be appropriate and the Board could lay out that plan today. Mr. McAllister stated that he felt that1,500 hours of internship would be appropriate. Mr. McAllister felt that before a final probated license be issued that 30 CE units be completed. Mr. McAllister stated that he felt that a 5-year PAPA contract would be warranted.

Mr. Wand stated that other individuals were required to take the MPJE exam.

Mr. Dutcher asked if the Board wants to start with all the suggested steps or does the Board wait for the addictionologist's report and discuss the steps at the next Board Meeting.

Mr. McAllister stated he feels that it will be a stepwise program. He stated that he feels that the

staff could review the report and if there were any red flags then the Board would be informed.

Mr. Dutcher asked if the PAPA contract would be a 5-year contract. Ms. Yates stated that the steering committee would make that decision. Ms. Yates stated that the contracts are 5 year contracts.

On motion by Mr. McAllister and Mr. Dutcher, the Board unanimously agreed to issue Mr. Clapp a graduate intern license based upon a positive report from a specialist in addiction medicine. The staff will review the report. Upon a positive report, Mr. Clapp will be issued a graduate intern license to earn 1,500 hours of internship, earn 30 CE units, take the MPJE exam, and with support by PAPA, Mr. Clapp will be offered a pharmacist license on probation. Mr. Clapp will also sign a 5- year PAPA contract.

Mr. Pulver stated that the addictionologist must be approved by the Board or staff and the report must be sent from the addictionologist to the Board. Mr. Pulver stated that the report should also be sent to PAPA.

Mr. Pulver stated that the Board should put a time limit in the motion. Mr. Pulver stated that Mr. Clapp should make an appointment in 30 days and have a report back to the Board in 90 days. Mr. McAllister asked Mr. Clapp if he was prepared to move in that time line. Mr. Clapp replied yes.

On motion by Mr. McAllister and Mr. Dutcher, the Board unanimously agreed to amend the motion to require that Mr. Clapp make the appointment with a Board or staff approved addictionologist within 30 days and have the reports sent to the Board and PAPA office within 90 days.

Mr. Van Hassel stated that he feels that in seven years significant changes have occurred in the field and he does not feel that 30 CE units is adequate. Mr. Van Hassel stated that he felt that 45 or 60 CE units would be more appropriate.

Mr. McAllister stated that Mr. Clapp could complete his 1,500 hours of internship and then take the NAPLEX exam instead of completing CE credits. Mr. McAllister stated that NAPLEX would satisfy the Board's assessment of entry- level competency. Mr. Van Hassel stated that he feels that would be better than CE units. Mr. Dutcher stated that he feels that he would prefer the additional CE hours. Mr. McAllister stated that another alternative would be for Mr. Clapp to complete the Morris-Cody review course.

President McCoy asked if the Board required other individuals to take NAPLEX in the past. Mr. McAllister stated that they have asked individuals to take NAPLEX and have required other individuals to take a review course.

Mr. McAllister stated that the Board might want to request progress reports from his preceptors.

On motion by Mr. McAllister and Mr. Van Hassel, the Board unanimously agreed to amend the motion to include letters of support from Mr. Clapp's employer during his internship.

Mr. Dutcher stated that he still prefers the additional CE hours. Mr. Van Hassel stated that he has concerns about the type of CE units that would be completed. Ms. McCoy stated that if Mr. Clapp is trying to re-enter practice she hopes that he would select CE units that would be beneficial. Mr. Pulver stated that the Board can qualify what types of CE can be used to obtain credit. Mr. Dutcher asked if the types of CE needs to be stipulated in the motion or could the types of CE be stipulated at a later date. Mr Pulver stated that it could be stipulated at any time.

On motion by Mr. McAllister and Mr. Dutcher, the Board unanimously agreed to amend the original motion. The Board agreed to remove the completion of 30 hours of CE and insert that Mr. Clapp provides documentation of completion of a NAPLEX review course, such as Morris Cody

The final amended motion approved unanimously by the Board requires Mr. Clapp to make an appointment with a Board or staff approved addictionologist within 30 days and have the reports sent to the Board and PAPA office within 90 days. Upon a positive report, Mr. Clapp will be issued a graduate intern license to earn 1,500 hours of internship. During his internship, Mr. Clapp should submit to the Board office letters of support from his employer. Mr. Clapp will be required to complete a NAPLEX review course, such as Morris-Cody and submit documentation of completion to the Board office. Mr. Clapp will be required to take the MPJE exam. After completion of the 1,500 hours of internship, the completion of the review course, and passing the MPJE exam, Mr. Clapp will be offered a pharmacist license that is on probation. Mr. Clapp will be required to sign a 5-year PAPA contract.

#7 Express Scripts

Express Scripts is appearing before the Board to submit its request for approval to implement a pilot program for Remote Pharmacist Verification to begin May 1, 2005.

The following individuals were present to answer questions from Board Members: Eric Anger - Pharmacist In Charge, Pete Miller - Director of Information Services, and Roger Morris - Legal Counsel.

President McCoy stated that the Board Members had read the proposal and precedence had been set by Walgreens Healthcare Plus in establishing a similar program.

Ms. McCoy asked if the staff had ny concerns after reading the proposal. Ms. Frush stated that there were some concerns about the equipment and Mr. Miller has brought with him the computer that Express Scripts will install at the home site. Ms. McCoy asked Mr. Miller if Express Scripts owns the equipment. Mr. Miller replied that Express Scripts would own the equipment.

Mr. Dutcher asked if the computer is for home use. Mr. Miller replied yes. Mr. Dutcher asked if encryption or encoding is used. Mr. Miller replied individuals must log on with their password and that the password is encrypted. Ms. McCoy asked if all the USB ports have been disabled. Mr. Miller replied that the ports have been disabled and there will be no printing allowed locally.

Mr. McAllister asked if the home site has been reviewed by a Compliance Officer. Mr. Morris stated that Express Scripts was waiting for Board approval prior to setting up their first home site.

Mr. Morris stated that Express Scripts would meet with a Compliance Officer at the first site to insure that it meets with Board approval.

Ms. McCoy asked if this is intended as a pilot program with a report back to the Board at the August meeting. Mr. Morris replied that Express Scripts would share results at the August meeting.

Mr. Van Hassel asked about the goals of the program. Mr. Morris stated that the pharmacists would be verifying that the information that the technician entered is correct. Mr. Van Hassel asked if the goal is 100% accuracy. Mr. Morris stated that the goal is 100% accuracy at both the home site and workplace. Mr. Morris states that they hope it would be more accurate at the home site. Mr. Van Hassel stated that he would like to see those statistics at the August Board meeting.

Mr. McAllister asked if Walgreens is still doing remote verification. Ms. Frush stated that Walgreens currently has 6 pharmacists that are participating in the remote verification program.

Ms. Frush stated that the pharmacists work one week a month at the home site. Mr. Anger stated during the pilot program, the pharmacists would work at home every day. Mr. Anger stated that might change after the pilot program.

Mr. Wand stated that the advantage of the home program is that there are fewer distractions. Mr. Anger stated that there are fewer distractions at home and the pharmacist is able to work a flex schedule. Mr. Anger stated that the pharmacist would be able to work any time from 6:00 AM to 10:00 PM. Mr. Anger stated that the program would not be a substitute for daycare.

Mr. Wand asked about the selection of candidates for the program. Mr. Anger stated that the selection would be based on metrics. Mr. Anger stated that they must have been employed by Express Scripts for at least one year.

Mr. Van Hassel asked if they had considered using finger print identification instead of a passwords for security reasons. Mr. Miller replied that they had not considered using fingerprints.

Mr. Wand asked if the computer shuts down after a certain time period. Mr. Miller replied that the computer shuts down after 5 minutes.

Mr. Van Hassel asked about the errors. Mr. Anger replied that the pharmacist will reject the prescription in the system and the error must be corrected before the prescription can be filled.

On motion by Dr. Tippett and Mr. Van Hassel, the Board unanimously approved the request by Express Script to implement a Remote - Pharmacist Verification Pilot Program.

#8 Gary Heyland

Gary Heyland appeared on his own behalf to request to proceed with reciprocity.

President McCoy asked Mr. Heyland to explain the nature of his request. Mr. Heyland stated that he would like to proceed with reciprocity. Mr. Heyland stated that he works for Caremark in San Antonio, Texas and he takes prescriptions over the telephone and most of the prescriptions that he will be receiving will be filled in Arizona and that is why he is reciprocating to Arizona.

Mr. Heyland stated that the Texas Board of Pharmacy disciplined him two years ago.

Mr. Heyland stated that he misread a prescription. The technician entered a prescription for Orapred with directions to use four times a day instead of daily. Mr. Heyland stated that when he verified the prescription he misread the label. Mr. Heyland stated that he verified about 250 prescriptions a day.

Mr. Van Hassel asked if the Orapred was for an adult or a child. Mr. Heyland replied the prescription was for a child.

Ms. McCoy asked Mr. Heyland if he has had any complaints since that error. Mr. Heyland stated that he has had no errors since that time or prior to that incident.

Ms. McCoy asked Mr. Heyland if he would be moving to Arizona or would he be processing Arizona prescriptions in Texas. Mr. Heyland stated that he would be remaining in Texas and processing Arizona prescriptions there.

On motion by Mr. Van Hassel and Dr. Tippett, the Board unanimously approved the request by Mr. Heyland to proceed with reciprocity.

AGENDA ITEM 6 - Arizona Community Pharmacy Committee

Janet Elliott, Director of Pharmacy Affairs, and Kent Taylor appeared on behalf of the Arizona Community Pharmacy Committee to present to the Board a mock-up of the patient counseling brochure developed by the committee.

Ms. Elliott stated that the brochure is a collaborative effort by Arizona Community Pharmacy Committee, Independent and Chain Pharmacies, Pharmacy Manufacturers and NACDS.

Ms. Elliott stated that the Committee feels that there is a need to educate the public about the benefits of counseling and that the law requires the pharmacist to counsel the patient.

Ms. Elliott stated that this is a preliminary mock-up of the brochure and they are seeking Board input on possible changes. Ms. Elliott stated that the committee hopes to have a final copy available for review at the June Board Meeting.

President McCoy asked how the brochure would be distributed. Ms. Elliott stated that the committee would like to have 1,000 copies of the brochure in 1,100 pharmacies in Arizona.

The Board Members made the following suggestions:

  • Arizona Community Pharmacy Committee should add their website to the brochure
  • Adding the term "working with your physician" in the drug management section
  • Have the brochures available in the future
  • Have the brochures available in Spanish
  • Have the picture on the front of the brochure changed from a counting tray to a Pharmacist counseling a patient
  • Have a picture of a female or minority pharmacist on the brochure
  • Have the brochure displayed at the convention

Dr. Tippett asked how the documents would be distributed in the pharmacy. Mr. Taylor stated that the distribution would be up to each individual pharmacy.

Ms. Elliott stated that their goal is to have the brochures available in every pharmacy.

AGENDA ITEM 7 - Walgreens Patient Counseling Trial Program Update

Kent Taylor, District Pharmacy Manager for the Tucson East District appeared on Walgreens behalf to update the Board concerning the pilot project conducted in his district. In August, Mr. Taylor appeared and requested approval to conduct a pilot project to record documentation of counseling electronically. Walgreens requested to conduct the trial program because the rules state that a "pharmacist, graduate intern, or pharmacy intern shall document, or assume the responsibility to document a refusal for consultation on the original prescription order or document by alternative methods approved by the Board or its designee". At the August meeting, the Board authorized Mr. Taylor to conduct the pilot program.

Mr. Taylor gave a brief overview of the process. Mr. Taylor stated that a bar code on the receipt is scanned and the technician is prompted for consultation. If the prescription is a new prescription, the technician will inform the patient that the pharmacist needs to speak to them concerning their prescription. The technician would then press "1" on the register indicating counseling occurred. If the patient does not wish counseling, the technician would inform the pharmacist and the pharmacist would acknowledge that the patient does not want counseling and the technician would then press "2" to indicate counseling was refused. Mr. Taylor stated on refills the technician would ask the patient if they had any questions for the patient. The result of the inquiry would be recorded at the register and in the prescription history.

Mr. Taylor stated that the technician could not bypass this step, since they would not be able to complete the transaction. Mr. Taylor stated that the pharmacist would be responsible for accepting the refusal.

Mr. Taylor stated that the prompt is displayed on all prescriptions including refills. Mr. Taylor stated that during the pilot the statistics showed that 78.6% of new prescriptions were counseled in the Tucson East District.

Mr. Dutcher asked if all prescriptions are paid for at the pharmacy counter. Mr. Taylor stated that the prescriptions are rung at the pharmacy, but could be rung up front if there are circumstances that would prevent the prescription from being rung up at the pharmacy. Mr. Taylor stated that the individual is taken to a register up front to complete the transaction.

Mr. Dutcher asked if the technician could just press 1 or 2 without the pharmacist being involved.

Mr. Taylor stated that the pharmacists and technicians are aware that the company policy is to counsel on every new prescription. Mr. Taylor stated that this method would document if counseling occurred.

Mr. Wand stated that the documentation provides statistics that were not available prior to the pilot. Mr. McAllister asked if the statistics showed that refusals were higher during one shift than any other shift would Mr. Taylor react to the situation. Mr. Taylor stated that he was able to look at data from each site and question the pharmacy manager and technicians about their counseling procedures if the statistics were low. Mr. Taylor stated in some stores it is the type of clientele that determines if counseling occurs. Mr. Taylor stated at the onset of the program some of the patients were resistant, but now most patients just step to the consulting window.

Mr. Dutcher asked who would be reviewing the data. Mr. Taylor stated that he has had the data reported to him monthly since August. Mr. Dutcher asked if the Compliance Officer would be able to review the data. Mr. Taylor stated that the Compliance Officer would be able to review the patient screen where it shows the documentation of counseling.

Mr. Wright stated that the counseling rules will be changed soon and that the pharmacist must document the reason why counseling was refused. Mr. Taylor was asked if this system could document the reason why counseling was refused. Mr. Taylor stated that there is a free-form field that could document the exceptions.

Mr. Wand stated that this is not a waiver but a request by Walgreeens to approve an alternative method of documentation of counseling.

On motion by Mr. Van Hassel and Mr. Dutcher, the Board unanimously approved the request by Walgreens to use an alternative method (electronically captured at the register) to document counseling.

AGENDA ITEM 8 - Proposed Rules

Counseling Rules

Compliance Officer/Rules Writer Dean Wright stated that he is submitting for the Board's approval the Notice of Final Rulemaking and the Economic Impact Statement for the Counseling rule. Mr. Wright stated a Public Hearing was held on February 22, 2005 at the Board Office. The Public Hearing was attended by one individual representing the Arizona Community Pharmacy Committee and spoke in favor of the rulemaking and filed a written comment in favor of the rulemaking as proposed. Mr. Wright stated that if approved by the Board the Notice of Final Rulemaking and the Economic Impact Statement will appear on GRRC's June 7, 2005 agenda for final approval and if approved by GRRC the rule will become effective August 6, 2005.

On motion by Mr. McAllister and Mr. Dutcher, the Board unanimously agreed to approve the Notice of Final Rulemaking and the Economic Impact statement for the Counseling Rules and authorized Mr. Wright to proceed.

Computer Records/Wholesaler

Mr. Wright stated that he has opened a docket to amend the computer requirements of R4-23-408.

Mr. Wright stated that the proposed rules amend R4-23-408 (D), (E), and (G) to require compliance with R4-23-408 (A), (B), and (F).

Mr. Wright stated that the proposed rules for wholesalers would amend R4-23-605 (D) (2) and (3) with language that requires that a wholesaler shall sell a drug only in the original container packaged and labeled by the manufacturer and not package, repackage, label, or relabel any drug.

The Board gave Mr. Wright approval to proceed with the rulemaking process.

Hospital Rules

Mr. Wright stated that he has opened a docket to implement a standard requiring a pharmacist to review medication orders during the hours an on-site hospital pharmacy is closed.

Mr. Dutcher asked if this covers the off-site verification. Mr. Wright stated that the review can be on-site or off-site. Mr. Wand stated that a contractor that is a pharmacist could perform the review. Mr. Wright stated that the pharmacist must have access to the patient's records. Mr. Wright stated that the pharmacist must be licensed in Arizona.

Mr. McAllister stated that this rule might have a tremendous economic impact on the small hospitals. Mr. McAllister stated that it might force the small rural hospitals to change to skilled nursing homes.

President McCoy stated that horrendous errors have occurred when nursing staff enter the pharmacy at night and select the wrong medication. Ms. McCoy stated that technology is now available that will allow a pharmacist to verify prescriptions off-site. Ms. McCoy stated that she feels that this is a patient safety issue. Ms. McCoy stated that a pharmacist must review an order before 7 at night, but after that time a nurse is allowed to select the drug. Ms. McCoy stated that not all drugs need to be given at night and could wait until the next day. Ms. McCoy stated that nursing personnel would rather not enter the pharmacy and make the drug selection. Ms. McCoy stated that hiring a pharmacist might be cheaper than a lawsuit.

Mr. Dutcher stated that the rural pharmacies often have difficulty hiring pharmacists and the off-site verification may help provide needed pharmacy coverage.

Mr. Wand stated that part of the reason for considering this proposed rule was because JCAHO was requiring hospitals to comply with a similar procedure. Ms. McCoy stated that JCAHO has not made a final decision. Mr. Van Hassel stated that he feels that the hospitals may find the financial impact too great.

Ms. McCoy stated that this rule will raise the standards and that hospitals do not run the hospitals without other key personnel at night.

Mr. McAllister stated that hearings would be held to hear the public's view on the impact of the rule. Mr. Wand stated that people would come if they are aware of the hearing. Mr. Wand asked if he should send out a mailing to individuals to notify them of the hearing.

Ms. McCoy stated that the hospital association could notify their members. The Board gave Mr. Wright approval to proceed with the rulemaking.

Automated Systems and Mechanical Counting Device Rules

Mr. Wright stated that he opened a docket to establish rules for automated systems and mechanical counting devices.

Mr. Dutcher asked Mr. Wright about the amount of drug placed in the cell or cassette. Mr. Wright stated that the log would include just the amount of drug placed in the cell. Mr. Dutcher asked what would happen if the whole bottle would not fit in the cell. Mr. Wright replied that the person filling the cell would then need to count the number of tablets being placed in the cell. Mr. Dutcher questioned if it is necessary to log the quantity.

Mr. Dutcher asked if it was necessary to record the time that the cell was filled. Mr. Dutcher stated that most pharmacies do not have a computer system that will record the time the prescription was filled. Mr. McAllister stated if the cell is filled multiple times during the day the time may be relevant.

Mr. Wand asked Mr. Wright if these rules are similar to rules in other states. Mr. Wright replied yes.

Ms. McCoy stated that the Board could continue the discussion at the next meeting and allow Mr. Wright to do more research on rules in other states.

Five -Year Review

The Board Members decided that they would review the rules and respond to Mr. Wand by April 15, 2005.

AGENDA ITEM 9- Complaint Review

The Consumer Complaint Review committee met prior to the Board Meeting to review 36 complaints. Mr. Dutcher and Dr. Tippett served as the review committee. Board Members were encouraged to discuss issues and were encouraged to ask questions. Board Members discussed Complaints #2876, #2882, #2885, #2893, #2893, #2900, #2903, and #2910.

Board Members expressed concerns about the number of complaints involving long- term care facilities because the patients in these settings are vulnerable. The Board decided to issue a Consent Order for one complaint made by a physician on behalf of a home infusion patient.

On motion by Mr. Van Hassel and Dr. Tippett, 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 # 2873 - No Further Action
  • Complaint # 2874 - No Further Action
  • Complaint # 2875 - Conference
  • Complaint # 2876 - Letter
  • Complaint # 2877 - No Further Action
  • Complaint # 2878 - Letter
  • Complaint # 2879 - Conference
  • Complaint # 2880 - Conference
  • Complaint # 2881 - Conference (Invite home administrator)
  • Complaint # 2882 - Conference
  • Complaint # 2883 - No Further Action
  • Complaint # 2884 - Letter
  • Complaint # 2885 - Letter
  • Complaint # 2886 - Conference
  • Complaint # 2887 - No Further Action
  • Complaint # 2888 - No Further Action
  • Complaint # 2889 - No Further Action
  • Complaint # 2890 - Conference
  • Complaint # 2891 - Conference
  • Complaint # 2892 - No Further Action
  • Complaint # 2893 - No Further Action
  • Complaint # 2894 - Letter
  • Complaint # 2895 - No Further Action
  • Complaint # 2896 - No Further Action
  • Complaint # 2897 - No Further Action
  • Complaint # 2898 - No Further Action
  • Complaint # 2899 - No Further Action
  • Complaint # 2900 - Conference
  • Complaint # 2901 - No Further Action
  • Complaint # 2902 - No Further Action
  • Complaint # 2903 - Consent
  • Complaint # 2904 - No Further Action
  • Complaint # 2905 - No Further Action
  • Complaint # 2907 - No Further Action
  • Complaint # 2908 - Conference
  • Complaint # 2910 - Letter

AGENDA ITEM 10- Conferences

Complaint # 2814

Pharmacist Angeles Ballester and Pharmacy Supervisor Fauzia Somani were present in response to a consumer complaint. Compliance Officer Rich Cieslinski gave a brief overview of the complaint.

Mr. Cieslinski stated that the patient received Purinethol 50 mg instead of Propylthiouracil 50 mg.

The doctor wrote the prescription as PTU and the pharmacist told the technician that the abbreviation stood for Purinethol. The patient stated that she was not counseled which was refuted by the pharmacy. The patient took the wrong medication for 5 to 6 days, experiencing some side effects as a result.

President McCoy opened the discussion by asking Ms. Ballester about the complaint. Ms. Ballester stated that she did not recall telling the technician to enter the drug as Purinethol. Ms. Ballester stated that an intern did counsel the patient.

Ms. McCoy stated that she noticed in the response that Ms. Ballester had requested shelf stickers to place by the products. Ms. McCoy asked Ms. Ballester if she had received the stickers. Ms. Ballester replied yes. Ms. Somani stated that the shelf stickers were done company wide.

Mr. Dutcher asked Ms. Ballester about her triple check. Ms. Ballester stated that if it is a sound alike drug that she will go back a third time and check the entire prescription.

Mr. McAllister stated that often the partially educated intern is thrown into the counseling role without adequate supervision. Mr. McAllister stated that the statutes and rules require supervision, so that the technician learns from the experience.

Ms. McCoy asked about the supervision of interns in the pharmacy. Ms. Somani stated that the issue has been addressed with the pharmacy managers since this incident. The Managers were reminded that the interns are their responsibility and the intern must be under their direct supervision. Ms. Somani stated that an intern should not be expected to do all the counseling without supervision and the pharmacist should use this as an educational tool.

Mr. Dutcher asked Ms. Ballester if she verified the label on the back of the prescription to the face of the prescription. Ms. Ballester replied yes. Mr. Dutcher stated that if the prescription was checked it would be noted that PTU and Purinethol are not the same.

Mr. Dutcher stated that Ms. Ballaster noted in her reply that she was busy. Mr. Dutcher asked Ms. Ballester if she was too busy. Ms. Ballester replied that she was no busier than usual.

Ms. McCoy stated that if a doctor uses an abbreviation it might be wise to call the doctor to verify the abbreviation with the doctor's office. Ms. McCoy asked that the Board office send a letter to the doctor's office suggesting that they write out the name of the drug instead of using abbreviations to avoid such errors.

Mr. McAllister asked the Compliance Officers while they are doing their inspections to observe the pharmacy staff for proper supervision of an intern.

Ms. McCoy reminded Ms. Ballester to be careful.

COMPLAINT # 2858

Pharmacist Tammy Bruno and Pharmacy Supervisor Melanie Malee were present in response to a consumer complaint. Compliance Officer Sandy Sutcliffe gave a brief overview of the complaint.

Ms. Sutcliffe stated that the complainant stated that her prescription for Wellbutrin SR 100mg was incorrectly filled with Wellbutrin SR 150mg. The patient was out-of-town when she discovered the error. The patient missed approximately one or two doses of her medication before she received the correct medication. The patient did not take any of the incorrect medication.

President McCoy asked Ms. Bruno about the complaint. Ms. Bruno stated that the two strengths of Wellbutrin were beside each other on the shelf. Ms. Bruno stated that the bottle was a sealed bottle and she did not catch the error when she verified the prescription. Ms. Bruno stated that when the patient called her that evening she should have been more aggressive in getting the correct medication to the patient.

Ms. McCoy asked Ms. Bruno what she has done to change her practice since this error occurred. Ms. Bruno stated that the two medications have been separated in the pharmacy. Ms. Bruno stated that the pharmacy has received the updated scales and the final verification cannot be completed if the filling verification has not been completed by using the scale. Ms. Bruno stated that they have the updated picture of the medication in their system.

Ms. McCoy thanked the respondents for appearing.

Complaint #2867

Pharmacist James Kloster, Pharmacy Technician Catalina Ramirez, and Pharmacy Supervisor Deborah Tholen appeared as a result of a consumer complaint. Compliance Officer Ed Hunter gave a brief overview of the complaint. Mr. Hunter stated that the complaint was filed by a nurse at a health plan. The patient received Glyburide 5 mg. instead of Glipizide 5mg. The nurse at the skilled nursing home administered nine doses of the medication before the error was caught.

President McCoy asked Mr. Kloster about the complaint. Mr. Kloster stated that when the error was reported to the pharmacy the correct medication was sent to the patient. Mr. Kloster stated since that time several changes have been made. Mr. Kloster stated that they now have more data entry technicians. Mr. Kloster stated in their facility the orders are faxed and the data entry technicians enter the order and the pharmacists verify the prescriptions from a queue. Mr. Kloster stated currently his only job is to verify that the prescriptions are entered correctly and he no longer needs to worry about refills or billing issues. Mr. Kloster stated that he now reads the hard copy before looking at the prescription that was entered into the computer. Mr. Kloster stated that this process has slowed him down but he is able to catch errors .

Ms. McCoy asked if they have any statistics that this process has decreased errors. Ms. Tholen replied that their business has doubled in the last two months, but their error rate has decreased.

President McCoy asked Ms. Ramirez if she has changed anything in her practice. Ms. Ramirez stated that she has slowed down. Ms. Ramirez stated that she pays more attention to what she is doing instead of paying attention to what is going on around her. Ms. Ramirez stated that she highlights the drug when she sees these two products so that she selects the correct product.

Mr. McAllister stated that the patients in the nursing homes are vulnerable and usually a nurse will not catch an error. Mr. McAllister stated that it is better that they slow down and be sure that the patient gets the correct medication.

Mr. Dutcher asked Ms. Ramirez if she double checks the prescription before she passes the prescription on to the pharmacist. Ms. Ramirez states that she enters the prescription and then checks each item on the screen against the prescription.

Ms. McCoy asked Ms. Tholen if their computer is capable of using the Tall Man lettering. Ms. Tholen stated that at this time their computer is not capable of changing the lettering.

Ms. McCoy thanked the respondents for appearing.

Complaint #2868

Pharmacist Debbie Walton and Pharmacy Technician LaTanya Calamity appeared in response to a consumer complaint. Compliance Officer Ed Hunter gave a brief overview of the complaint. Mr. Hunter stated that a prescription was filled correctly by the pharmacist, but was given to the wrong patient by the pharmacy technician. The technician gave the patient a prescription belonging to another individual with a similar name. The technician's employment was terminated.

President McCoy asked Ms. Walton about the complaint. Ms. Walton stated that when they were made aware of the error they contacted the patient. Ms. Walton stated that the patient told them he would check with his doctor and then come to the pharmacy to pick up the correct medication.

Mr. Dutcher asked Ms. Walton about her new procedure to insure that the correct medication is given to the correct patient. Ms. Walton stated that when the patient signs the log when they pick up their prescription, the technician is to verify that the name matches the name on the prescription.

Ms. McCoy asked Ms. Calamity if she was the technician involved in this incident. Ms. Calamity replied yes. Ms. Calamity stated that she now works at a different pharmacy. Ms. McCoy asked Ms. Calamity if she has changed the way that she verifies that the correct patient is getting the correct medication. Ms. Calamity states that at the pharmacy that she works at now that they must verify the patient's address and she also verifies the patient's first and last name. Ms. Calamity stated that at the pharmacy she works at now there are steps and training provided. Ms. Calamity stated at the other pharmacy she asked the patient their name and gave them their medicine.

Complaint #2871

Mr. Wand stated that the next conference was to be with David Cote. Mr. Cote stated that he did not want to appear for the conference and sent a letter and his license to the Board indicating that he was surrendering his license. Mr. Wand stated that he talked with Mr. Pulver and it was decided to send Mr. Cote a consent order indicating that he surrendered his license and will not ask for his license to be returned to him.

Mr. McAllister stated that he has concerns about the nursing home population. Mr. McAllister stated that he would like to have the Compliance Officers concentrate on the long-term care providers. Ms. McCoy asked if Mr. McAllister was suggesting that they check the quality assurance procedures. Mr. McAllister stated that they might want to visit with the homes to see if there are problems with the provider. Mr. Van Hassel stated that maybe the homes could provide an accurate account of the errors. Ms. McCoy stated that just because the prescription is going to another health care facility is not a safety net because the turnover in nursing staff is constant.

AGENDA ITEM 11- Consent Agreements

President McCoy asked Board Members if there were any questions or discussions concerning the consent agreements. Executive Director Hal Wand indicated that the consent agreements have been reviewed and approved by the Attorney General's Office and have been signed. Mr. Wand provided an overview of the Consent Agreement for the benefit of the audience.

Mr. Wand stated that the first consent agreement involved the filling of prescriptions for the pharmacist's son under his wife's name for insurance coverage.

Mr. Wand stated that the second consent agreement involved the dispensing of prescriptions by the pharmacist to himself without a valid prescription authorized by a physician.

Mr. Wand stated that the third consent agreement was signed by the owner of a pharmacy for allowing an unlicensed technician to enter the pharmacy without a pharmacist present and the unlicensed technician sold prescriptions while in the pharmacy.

A roll call vote was taken. (Mr. McAllister - aye, Mr. Van Hassel - aye, Dr. Tippett - aye, Mr. Dutcher - aye, President McCoy - aye). All Board Members present voted to unanimously accept the following Notice of Hearing/Consent Agreement as presented in the meeting book and signed by the respondent:

  • David Garden 04-0033-PHR
  • Mustafa Maher 05-0002-PHR
  • Willo Pharmacy 05-0004-PHR

AGENDA ITEM 12 - Approval of Attendance and Reimbursement for Attendance at APA Convention

President McCoy asked Mr. Wand to address this issue. Mr. Wand stated that the Board has enough money to reimburse Compliance staff, Board Members,and the Assistant Attorney for attendance at the APA Convention and he would need approval by the Board to spend the funds. Mr. Wand stated that the reimbursements would be made at the member's early registration fee.

On motion by Mr. Dutcher and Dr. Tippett, the Board unanimously agreed to approve the attendance and reimbursement for attendance at the APA convention in June for the Compliance Staff, Board Members, and the Assistant Attorney. All reimbursements will be made at the early members registration rate.

AGENDA ITEM 13 - Remodel of Board Meeting Room

President McCoy asked Mr. Wand to address this issue. Mr. Wand stated that there is money available to remodel the Board meeting room. Mr. Wand passed out several different table configurations to the Board Members for their review. The Board Members decided that they liked the U-shaped configuration, so that they could see each other

Mr. Wand stated that the new configuration would allow for some additional seating in the audience.

Mr. Wand stated that he is exploring the option of installing TV screens to allow the Board Members and audience to view presentations.

Ms. McCoy stated that she felt that the Board should remain audience friendly. Mr. Wand stated that many Boards do not encourage attendance at their Board Meetings.

AGENDA ITEM 14- NAPLEX Revisions

President McCoy asked Mr. Wand to address this issue. Mr. Wand stated that he received this memo from NABP concerning the new modern look of the NAPLEX exam.

Mr. Wand stated that the NAPLEX will be suspended for a short time period and all candidates will be scheduled within 30 days of the date requested.

AGENDA ITEM 15-Hearing

The Hearing for Pharmacist Marjorie Daily was cancelled. Ms. Daily signed a Consent Agreement that was accepted in lieu of the Hearing.

AGENDA ITEM 16- Mission Statement

President McCoy stated that several Board Members submitted proposed Mission Statements to Mr. Wand. She asked the Board Members for comments.

The Board Members liked the shorter version and made the following recommendations:

  • Change the word drugs to medications
  • Change compliance visits to compliance inspections
  • Delete established by the Legislature
  • Maintain the bullet points

President McCoy stated that Board Members could submit changes to Mr. Wand.

Mr. Wand stated that he would make the changes and list the Mission Statement Approval as an Agenda Item at the June Meeting.

AGENDA ITEM 17 - Call to the Public

President McCoy announced that interested parties have the opportunity at this time to address issues of concern to the Board, however the Board may not discuss or resolve any issues because the issues were not posted on the meeting agenda.

Comments were made concerning the following issues:

  • The Board should continue to keep the meetings open to the public and offer CE.
  • Mechanical Counting Device Proposed rules - The time is not necessary when filling the cassettes if the time of filling the prescription cannot be documented.
  • Mechanical Counting Device Proposed rules - The quantity placed in the cell is not necessary.

There being no further business to come before the Board, on motion by Dr. Tippett and Mr. Dutcher, the Board unanimously agreed to adjourn the meeting at 3:50 PM.

The Board did not meet on April 7, 2005 because all Board business was concluded on April 6, 2005.

 

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