THE ARIZONA STATE BOARD OF PHARMACY

HELD A REGULAR MEETING SEPTEMBER 20 & 21, 2006

GLENDALE, ARIZONA

 

 

September 20, 2006

 

The following Board Members and staff were present: President Chuck Dutcher, Vice President Tom Van Hassel, Zina Berry, Louanne Honeyestewa, Dennis McAllister, Linda McCoy, Paul Sypherd, Ridge Smidt, and Bryan Tippett.  Compliance Officers Rich Cieslinski, Larry Dick, Ed Hunter, Sandra Sutcliffe, and Dean Wright, Drug Inspector Heather Lathim, Deputy Director Cheryl Frush, Executive Director Hal Wand, and Assistant Attorney General Dawn Lee.

 

President Dutcher convened the meeting at 8:00 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 the opportunity for questions and on motion by Dr. McCoy and Mr. Van Hassel, the minutes of the Regular Meeting held on July 27, 2006 were unanimously approved by the Board Members.

 

AGENDA ITEM 2 – Reconsideration of Final Disposition of Complaints

 

President Dutcher asked Assistant Attorney Dawn Lee to open the discussion concerning this agenda item. 

 

Assistant Attorney Dawn Lee opened the discussion by stating that she has submitted to the Board a memorandum of legal advice concerning the complaints listed on Agenda Item 2 for Rory Albert and Sean Shaffer.  Ms. Lee stated that she could answer any questions that the Board Members may have concerning the two complaints.

 

Reconsideration of Complaint Against Rory Albert

 

Mr. Dutcher asked Ms. Lee to explain why the Board was reconsidering their final disposition of the complaints.

 

Ms. Lee stated at the July meeting she requested that the Board rescind their vote for formal hearing to reconsider new information that was submitted to the Board.  Ms. Lee stated that Mr. Albert’s attorney submitted new information to the Board that consisted of a signed affidavit from the doctor stating that he authorized the prescriptions dispensed by Mr. Albert.  Ms. Lee stated that she felt that the Board should review this information

and decide how they would like to proceed with the complaint.  Ms. Lee stated that there is still the issue of failure to enter the prescription in the pharmacy database.  Ms. Lee stated that the Board could dismiss the case, issue a letter of concern, offer a consent order, or revoke the matter to formal hearing.  Ms. Lee stated that the Board voted the matter to Formal Hearing previously and now new information has been submitted.

Mr. Dutcher opened the discussion by asking for Board Members to discuss the new information and what action they would like to take concerning the complaint disposition.

 

Ms. Lee reviewed the options.  Ms. Lee stated that the Board could dismiss the case.  Ms. Lee stated that the Board could issue a letter of concern expressing the Board Member’s concerns.  Ms. Lee stated that a letter of concern would be a record of the action taken by the Board and placed in the respondent’s file.  Ms. Lee stated that the Board could offer a consent agreement to the respondent.  The Board could determine the terms of the consent agreement and a time frame by which the consent agreement must be signed.  Ms. Lee stated that the order should state that if the consent agreement is not signed by a certain time frame the complaint would be referred for a Formal Hearing.

 

President Dutcher asked if Mr. Albert was present.  Mr. Albert was present.  Mark Harrison was present as Legal Counsel for Mr. Albert.

 

Mr. Harrison stated that in his letter and affidavit to the Board the only issue is that Mr. Albert forgot to enter the prescription into his pharmacy database.   Mr. Harrison stated that based on the evidence it would seem that the Board should dismiss the case or issue a

letter of concern.  Mr. Harrison stated that he felt it did not warrant a consent agreement or a Formal Hearing.

 

Ms. Lee stated that the Board Members could ask questions or if additional investigation is warranted then the case could be postponed and placed on a future agenda.

 

Mr. Dutcher stated that he feels not entering the prescription into the database is not a minor infraction.  Mr. Dutcher stated that he could not understand how a pharmacist could take a prescription for a controlled substance for a family member and not enter the prescription into the computer.

 

Mr. Albert replied that he took the prescription and placed the prescription in the file and did not enter the prescription into the computer.  Mr. Albert stated that he took the bottle and gave it to his father-in-law.

 

Mr. Dutcher asked Mr. Albert if his father-in-law took the bottle out of the pharmacy without a label.  Mr. Albert replied that is correct.

 

Mr. Dutcher asked if this is standard practice.  Mr. Albert replied no.  Mr. Dutcher asked Mr. Albert if the prescription was ever entered into the computer.  Mr. Albert replied no.

 

Mr. Harrison stated that the prescription was probably not entered into the computer due to human error.

 

Dr. Sypherd asked Mr. Albert if he paid for the prescription.  Mr. Albert replied yes.  Dr. Sypherd asked Mr. Albert if the prescription was refilled three times, since the prescription had three refills.  Mr. Albert stated that he does not recall if all three refills were dispensed.

 

Dr. McCoy asked Mr. Albert if the three refills were also unlabeled.  Mr. Albert replied yes.  Dr. McCoy stated that it is not human error when a prescription is dispensed four times unlabeled.

 

Mr. Harrison stated that it was his understanding that there was not going to be a hearing today and if the Board was going to ask his client questions he would have liked to have had time to prepare his client to answer the questions.

 

Mr. Harrison stated that the previous Consent Agreement was based on the fact that he had dispensed a prescription without a valid prescription.  Mr. Harrison stated that they were able to prove that Mr. Albert did have a valid prescription and the doctor’s affidavit indicates that he did authorize the prescription.  Mr. Harrison stated that he and his client are not prepared to answer questions concerning the issue of not entering the prescription into the database.  Mr. Dutcher replied that not entering the prescription into the database is not standard practice.

 

Mr. McAllister stated that the Board has been presented new evidence that the prescription was valid, but has discovered that the prescription was not entered into the database and was dispensed four times.  Mr. McAllister stated that he feels that there was

some reason for not entering the prescription into the database.  Mr. McAllister stated that he feels that the Board should move forward with a hearing.

 

Mr. Wand stated that the Board could offer Mr. Albert a Consent Agreement to be signed within 10 days or move to a Formal Hearing in November instead of asking questions at this meeting.

 

Dr. McCoy asked about the Consent Agreement.  Dr. McCoy asked if the respondent does not agree to the Consent Agreement would the complaint move to a hearing.  Mr. Wand replied yes.

 

Ms. Lee stated that if the Board is not satisfied with disposing of the complaint today, then the Board could discuss the Consent Agreement and no disciplinary action would be taken at this meeting.  Ms. Lee stated that the respondent and his counsel could review the Consent Agreement and negotiate any terms with the Board Counsel and/or Board Staff.  Ms. Lee stated that in the motion the Board would state if the Consent Agreement

is not signed in a certain time frame then the complaint would proceed to Formal Hearing in November.

 

Dr. Sypherd stated that he feels a Consent Agreement would be premature since the Board does not have all the facts.

 

Mr. Wand suggested that the physician could appear or the Board could obtain a deposition from the doctor since he gave the Board conflicting information.  Ms. Lee stated that the Board does have investigative powers to interview individuals that they deem might be able to provide pertinent information to clarify the complaint.  Ms. Lee stated that the Board could set a conference for the November meeting and ask the physician to appear.

 

Mr. Van Hassel asked Mr. Albert if he knew any reason why the doctor would change his mind.  Mr. Van Hassel stated in the first letter the doctor stated that he did not write the prescriptions and the affidavit stated that he did not write the prescriptions. Mr. Van Hassel noted that the signature of the doctor is different on each document.  Mr. Harrison replied that he, nor his client, could predict what motivated the doctor to change his

mind.

 

On motion by Mr. Van Hassel and Dr. Sypherd, the Board unanimously agreed to move the complaint against Mr. Albert to a Formal Hearing at the November meeting.

 

Dr. Smidt asked if a consent agreement could be offered prior to the Hearing.  Ms. Lee stated that a consent agreement could be offered and then the Board would approve the agreement at the next meeting if signed by the respondent.  Ms. Lee stated that if the Board did not approve the signed consent agreement, then the complaint would proceed to a Formal Hearing.

 

Mr. Dutcher asked how the complaint originated.  Ms. Frush stated that the complaint was filed as a result of a routine inspection.  Ms. Frush stated that Ms. Sutcliffe conducted a controlled substance audit as part of her inspection.  Ms. Sutcliffe discovered the Ambien shortage.  Ms. Frush stated that Mr. Albert told Ms. Sutcliffe that he did not enter prescriptions into the computer for his wife and father-in-law.  Ms. Sutcliffe asked Mr. Albert to write a statement stating that he did not enter the prescriptions into the computer and Mr. Albert wrote the statement and signed the statement.  Ms. Frush stated that Ms. Sutcliffe sent letters to the doctors.  His wife’s doctor indicated that she authorized the prescriptions while his father-in-law’s doctor stated that he did not write the prescriptions.  Ms. Frush stated that in either case Mr. Albert failed to enter the prescriptions into the computer system resulting in the discrepancy found during the audit.

 

Dr. Smidt asked if there were other shortages of narcotics.  Ms. Frush explained that at each pharmacy during the routine inspection the Compliance Officers select controlled

substances to be audited.  In this case, the Ambien was selected and a shortage existed.  Ms. Frush stated that other controlled substances could be audited if necessary.

 

Dr. Tippett asked what would be the benefit of not entering the prescription into the database.

 

Mr. McAllister stated that is a standard of care to create a patient record and this was avoided four times.

 

Reconsideration of Complaint Against Sean Shaffer

 

President Dutcher asked if Mr. Shaffer was present.  Roger Morris, Legal Counsel, for Mr. Shaffer was present.  Mr. Shaffer was not present.

 

Mr. Wand addressed the original complaint.  Mr. Wand stated that it was reported to the Board that Mr. Shaffer had sold a prescription medication to a person that did not have a permit or license.  Mr. Wand stated that information received later indicated that the prescription product was sold to a representative of a permit holder.  Mr. Wand stated that the new information indicates that there were no violations and that is why the Board is being asked to reconsider their decision.

 

Mr. Wand stated that after reading the information the Board could dismiss the complaint, offer a consent agreement, or proceed to a conference or formal hearing at the November meeting if the Board would like any clarification of statements found in the transcript.

 

Both Mr. Wand and Mr. Morris stated that as far as they know the DEA has closed the case.

 

Mr. Wand stated that the Board has since revoked the permit of the permit holder that purchased the product.  Mr. Wand stated that there is no violation under the original consent agreement offered to the respondent because the permit holder was licensed at the time.

 

Mr. McAllister indicated that the violation for the current complaint is unfounded.  Mr. McAllister indicated that he would like to see an investigation of the wholesaler’s sales.

 

Ms. Lee stated that if the inspection of the sales records indicates any violations then a new complaint could be issued.

 

On motion by Mr. McAllister and Dr. Sypherd, the Board unanimously agreed to dismiss the current complaint and open an investigation of the sales records of the wholesaler.

 

AGENDA ITEM 3 – Low Cost – Consideration of Respondent’s Petition for Rehearing or Review

 

President Dutcher stated that this is the time and place for consideration of the Respondent’s motion for rehearing or review in the matter of Low Cost Pharmacy license

Number 3561.

 

President Dutcher asked if the Respondent was present or represented by Counsel.

 

Mr. John Rao, the permit holder was present.  Adam Palmer, Legal Counsel, for Mr. Rao was present.

 

President Dutcher told Mr. Rao that the Board has received and reviewed his Motion for Rehearing or Review, and the State’s Response to the Motion for Rehearing or Review.

 

President Dutcher asked Mr. Rao if he would like to make a brief statement at this time.  Mr. Rao stated that he would like to make a brief statement. President Dutcher asked Ms. Rao to limit his statements to less than five minutes.

 

Mr. Rao stated that the future is now for telemedicine. The definition of telemedicine, one in which this individual helped define on behalf of the American Telemedicine Association addresses Internet Prescribing in its language.  Mr. Rao stated that Tamiflu is prescribed yearly and requested by patients from many Internet doctors.  Mr. Rao stated that they wish to continue to make this flu vaccine available to Arizona patients much like the flu shot that can be received in retail establishments.  Also, any other medication that the Pharmacy Board decides meets this type of dispensing.

 

Mr. Rao stated that Low Cost would like to see the pharmacist’s role elevated to more than a clerk to one that the pharmacist can issue prescriptions for these lifestyle drugs based on a questionnaire.  Mr. Rao stated that pharmacists do this for a small number of other drugs currently.

 

Mr. Rao stated that Low Cost would like to know why they did not receive a fair hearing and why they were not allowed to enter testimony from one of the leading experts in the pharmacy industry.  Mr. Rao stated that Low Cost would like to know why they did not have the right to see the real judge presiding over the case, as many of the decisions by the presiding judge were not his.  Mr. Rao stated that the judge left the room several times to converse with the real decision maker in this case. 

 

Mr. Rao stated that he would like to know why their right to interstate commerce has been denied.  Mr. Rao stated that he has spent tens of thousands of dollars in various states obtaining licenses to fill prescriptions from doctors in their states with Board approval in their state for this type of prescribing.  Mr. Rao stated that Low Cost did not fill any prescriptions for Arizona patients derived from a questionnaire or phone call.

Mr. Rao stated that twenty percent of the prescriptions filled by Low Cost were from the Internet and the other eighty percent were from phone calls.  Mr. Rao stated that the prescriptions filled by Low Cost were prescribed by doctors that never rendered a diagnosis but were prescribed for a pre-existing condition.  Mr. Rao stated that based on pharmacy statutes a diagnosis was never rendered for any Internet prescriptions; therefore no pharmacy laws were broken.

 

Mr. Rao stated that Low Cost has never filled a prescription for a controlled substance.  Mr. Rao stated that Low Cost has only filled prescriptions for safe lifestyle drugs that are

safer than some of the drugs sold over the counter to young adults in Arizona.

 

Mr. Rao stated that Low Cost does not feel that the intent of the Board’s actions are directed to the safety of Low Cost’s patients because these issues have never been addressed by the Board in any of its testimony.  Mr. Rao stated that Low Cost finds this concerting and could only surmise that this is selective enforcement and the Board is abusing its regulatory authority.

 

Mr. Rao stated that they have filled over six hundred thousand lifestyle prescriptions the last few years with never a medical issue or lawsuit of any kind.

 

In closing, Mr. Rao stated that any damages resulting from any forced patient abandonment by this Board should be the responsibility of the Pharmacy Board, each of its Board Members, in making an assessment of its actions to have Low Cost discontinue refilling lifestyle prescriptions, especially since some of these prescriptions are for sexually transmitted diseases.

 

President Dutcher asked Ms. Lee, the Assistant Attorney General, if she had any comments to make in response.

 

Ms. Lee stated that she would like to make a few points.  Ms. Lee stated that the Board has not been presented with any new information today that would make the Board alter their decision that the statutes have been violated and that disciplinary action is warranted.

 

Ms. Lee stated that the Respondent had the opportunity to be heard at the time of the hearing and thoroughly litigated all issues before the Administrative Law Judge.  Ms. Lee stated that because the respondent is now unhappy with the results after they have litigated all issues it does not mean the Board is obligated to provide a new hearing or reconsideration of the entire matter.  Ms. Lee stated that the Board’s decision to accept the Administrative Law Judge’s decision was justified and supported by all the evidence.  Ms. Lee stated that the evidence supported the Findings of Fact and Conclusions of Law.  Ms. Lee stated that the Board accepted the decision with minor alterations and that decision was appropriate and at this time the State is requesting that the Board deny the Respondent’s motion for rehearing or review.

 

Mr. Palmer, Legal Counsel for the permit holder asked President Dutcher if he could respond to the comments made by the Board Counsel.

 

Mr. Munns, the Solicitor, advised Mr. Dutcher it was the Board’s decision if they wanted to allow Mr. Palmer to speak.  The Board granted Mr. Palmer five minutes to respond to the comments made by Counsel.

 

Mr. Palmer stated that one of the reasons for their request that the Board reject the Administrative Law Judge’s findings was that they believe that the Judge abused his discretion by precluding their pharmacy expert from testifying on issues.  Mr. Palmer stated that they were denied the right to have their expert testify.  Mr. Palmer stated that this case will be appealed to the higher level courts, such as the Court of Appeals and the Arizona Supreme Court.

 

Mr. Palmer stated that the eyes of the court would be looking at the selective enforcement of issues by the Board.  Mr. Palmer stated that the Board’s Counsel responded that influenza and pneumonia vaccines that are provided to individuals on a regular basis are not dispensed but administered as a one-dose injection.  Mr. Palmer stated that Board’s Counsel indicated that the administration of the injections is not administered in an environment where there is a lack of contact with the patient.  Mr. Palmer stated that these statements are untrue.  Mr. Palmer stated that the medical expert for the Board stated during testimony that influenza, Tamiflu, and other flu vaccines are legend drugs and that they need to be dispensed by prescription only.  Mr. Palmer stated that in this case against Low Cost Pharmacy the Board has interpreted that since the doctor has not examined the patient at least one time, the prescription is deemed to be misbranded and has violated Arizona law.  Mr. Palmer stated in influenza cases that anyone could go to any retail establishment and get a flu shot without a pharmacist being present.  Mr. Palmer stated that the Board turns a blind eye to this type of medical practice and finds that this type of medical practice is appropriate.  Mr. Palmer stated that the Court of Appeals would agree with Low Cost that the Board selectively enforces pharmacy law in this state.

 

Mr. Palmer stated that another reason the Board should reject the Administrative Law Judge’s decision is that the Judge erroneously adopted word for word the findings by a collateral Medical Board.  Mr. Palmer stated that they cited numerous cases and that this type of adoption of another Board’s findings when different parties are involved in administrative hearings violates Arizona law.  

 

Mr. Palmer stated that Board Counsel stated that the Judge did not abuse his discretion.  Mr. Palmer stated that the Board’s Counsel did not cite one case that the Judge did not abuse his discretion and Low Cost cited several cases that show the Judge did abuse his discretion.

 

Mr. Palmer stated that that Board should refer this matter back to the Administrative Law Judge to have Low Cost’s expert witness testify.

 

President Dutcher stated that the Board Members would now proceed to deliberate on the request for rehearing or review.

 

Dr. Sypherd asked if the application of a vaccine being given without being examined by a physician is the basis of their appeal.

 

Mr. Dutcher replied that is correct, but that the issue was not addressed the last time they appeared in front of the Board.  Mr. Dutcher stated that the complaint before the Board is filling Internet prescriptions with a diagnosis by a questionnaire.  Mr. Dutcher stated that Low Cost Pharmacy violated the laws on the books for all pharmacies to read and follow.

 

Mr. McAllister stated that he would like to clarify the issue of administration of a vaccine by a nurse.  Mr. McAllister stated that the administration by a nurse is covered under the Department of Health Services.  The Board of Pharmacy deals with the dispensing of medications to the public.  Mr. McAllister noted that administration and dispensing are two separate and distinct issues.

 

Dr. Smidt stated that the Board has reviewed and discussed all the information presented to them by Low Cost.  Mr. Munns asked Dr. Smidt to clarify his statement concerning the discussion of the information. Dr. Smidt stated that the Board has discussed this information thoroughly at the Board Meetings with the Respondent. 

 

On motion by Mr. McAllister and Mr. Van Hassel, the Board unanimously denied the Respondent’s request for rehearing or review.  A roll call vote was taken.  ( Mr. McAllister – aye, Ms. Honeyestewa – aye, Dr. Tippett – aye, Dr. Smidt – aye,

Dr. Berry – aye, Dr. McCoy – aye, Dr. Sypherd – aye, Mr. Van Hassel – aye, and President Dutcher – aye.)

 

President Dutcher concluded the request for rehearing or review by Low Cost Pharmacy.

 

AGENDA ITEM 4 – Permits and Licenses

 

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

 

The Guidance Center

 

President Dutcher asked if anyone from The Guidance Center was present.  No one came forth.

 

Ms. Frush stated that they were sent a letter to appear.  Ms. Frush stated that the pharmacist is still negotiating with the owners.  Ms. Frush stated that the CFO was told that he should still appear and state that they are currently negotiating with the pharmacist.

 

Mr. Wand stated that applicants are asked to appear if they are non-pharmacist owners, first-time pharmacy owners, or their pharmacy business is different than the normal retail pharmacy.

 

Mr. Wand stated that the Board could approve their permit without talking to the owners.

Mr. Wand stated that they are invited to attend the meeting and describe their business, so that the Board has a record of their proposed business plans.

 

Mr. Wand stated that the permit is in order and the Board has received the floor plans and zoning information.  Mr. Wand stated that the Board could approve the permit.  Mr. Wand stated that the Compliance Officer could review the requirements with the pharmacy owners or the Board could wait to approve the permit at the next meeting.

 

Dr. McCoy asked if the pharmacy size was clarified. Ms. Frush stated that she received an e-mail from the CFO stating that the pharmacy will be roughly 900 square feet.

 

The Board decided that they would have the Compliance Officer review the pharmacy regulations with the Pharmacist In Charge and Pharmacy Owners.

 

WR Group

 

Owner and CEO Carey Williams and Pharmacist In Charge Cindy Vlosic were present to address question from the Board Members.

 

President Dutcher opened the discussion by asking the applicants to describe the nature of their business.  Mr. Williams sated that they would have an Internet pharmacy for pet medications.  Mr. Williams stated that the pharmacy would be in an enclosed space in a warehouse in Phoenix.

 

Mr. Dutcher asked Mr. Wand if the same regulations apply to veterinary Internet prescriptions.  Mr. Wand stated that the regulations are the same for dispensing human and veterinary prescriptions.  Mr. Wand stated that there must be a valid patient-doctor relationship.  Mr. Wand stated that there must be an examination of the animal and the doctor must have a history of the animal on file.  Mr. Wand stated that a prescription could not be issued for an animal as the result of an Internet questionnaire.  Mr. Williams explained that the animal would be examined and they would either have the prescription faxed or e-mailed to them.

 

Mr. Wand asked if they would be compounding any medications.  Ms. Vlosic stated that they would not be compounding.

 

Mr. Dutcher asked about the pharmacy being located in the warehouse.  Mr. Dutcher asked what products they sell in the warehouse.  Mr. Williams stated that the company sells health products for humans and pets.  Mr. Williams stated that they sell pet supplements, pet toys, and other pet supplies.

 

Mr. Dutcher asked where the prescription items are being stored.  Ms. Vlosic stated that they would be stored in a secure area.  Mr. Williams stated that the pharmacy is a contained area and the prescription items would be stored within the pharmacy.

 

Mr. Dutcher reminded the owner that the pharmacist is the only person that can open the pharmacy.

 

Dr. Smidt asked if they would fill a prescription for a human.  Ms. Vlosic stated that they did not have any plans to dispense human medications.  Mr. Williams stated that the products that they sell for humans are mainly supplements, herbs, and vitamins.  Mr. Williams stated that most of these customers are located in Europe.

 

Mr. Wand asked if they would be selling prescriptions items to doctors in addition to dispensing prescriptions.  Ms. Vlosic stated that they would only be filling prescriptions.

 

Dr. Smidt asked if all his businesses are located in Phoenix.  Mr. Williams stated that he bought this company last year and has a large customer base and decided to start the pharmacy to compliment his current businesses.

 

President Dutcher wished the applicants luck with their new business.

 

Holbrook Hospital

 

Andrew Maestasos appeared on behalf of Holbrook Hospital.

 

President Dutcher asked Mr. Maestasos about the business plan for the Holbrook Hospital.  Mr. Maestoeos stated that they would be reopening the hospital and would be operating both an inpatient and outpatient pharmacy.

 

Mr. Dutcher asked if they had hired a pharmacist.  Mr. Maestasos stated that they are in the process of hiring a pharmacist.

 

President Dutcher asked if the pharmacy met the square footage requirements.  Ms. Frush stated that they have adequate square footage.  Ms. Frush stated that the hospital would

need to have two pharmacists because the inpatient and outpatient pharmacies appear to have a dividing wall between the two pharmacies.  Mr. Wand further clarified that it would be difficult for one pharmacist to directly supervise the pharmacy staff in both areas if they could not see the employees because a dividing wall blocks their view.

 

Ms. Frush asked Mr. Maestasos how many inpatient beds were in the hospital.  Mr. Maestasos replied that there would be fifteen beds.

 

Mr. Wand asked Mr. Maestasos if both pharmacies would be open 40 hours a week.  Mr. Maestasos replied that the outpatient pharmacy would not be open 40 hours.

 

Mr. McAllister stated that he feels that a door could be placed between the two pharmacy areas to allow the pharmacist to view both areas.  Mr. Maestasos stated that the Department of Health Services requires that they have a separate inpatient and outpatient area.  Mr. Maestasos stated that originally the hospital was designed to have twenty-eight beds and the number of beds was reduced to fifteen beds.  Mr. Maestasos stated that the dividing wall is a firewall and a door could not be placed in the firewall.

 

Mr. McAllister stated that he feels that a pharmacist would not be needed full-time in the inpatient pharmacy for fifteen beds.  Mr. McAllister stated that the pharmacist could lock the inpatient pharmacy when he is not needed and supervise the outpatient staff.

 

Dr. McCoy asked Mr. Maestasos if they could use the same space for the inpatient and outpatient pharmacy since there is adequate space.  Mr. Maestasos stated that the Department of Health Services requires a separation of inpatient and outpatient areas.  Mr. Wand stated that he would check with the Department of Health Services for clarification if separate inpatient and outpatient pharmacy areas are required.

 

Mr. Wand asked Mr. Maestasos to fax a copy of the Department of Health Services permit to the Board Office.

 

Mr. Dutcher asked Mr. Maestasos if the outpatient pharmacy would be open to the public.  Mr. Maestasos replied yes.

 

Mr. Dutcher wished the applicant luck on opening the hospital.

 

Arizona Rx Solutions

 

Owner and Pharmacist In Charge Raymond Barone appeared to answer questions from Board Members.

 

President Dutcher opened the discussion by asking Mr. Barone what type of limited service pharmacy he would be operating. 

 

Mr. Barone stated that he would be opening a closed door retail pharmacy. Mr. Barone stated that he would not be doing any mail order prescriptions.  Mr. Barone stated that he plans on operating in the Phoenix area.  Mr. Barone stated that prescriptions would be faxed or phoned to the pharmacy and the prescriptions would then be delivered to the patients.

 

Mr. Dutcher asked if the pharmacy would be open to the public.  Mr. Barone replied no.

 

Mr. Dutcher asked if this would qualify as a limited service pharmacy.  Mr. Wand stated the reason for him to be licensed as a limited service pharmacy would be more structural in nature than the type of clientele that he would service.  Mr. Wand stated that by being licensed as a limited service pharmacy he would not need a sneeze barrier.  Mr. Wand stated that Mr. Barone would need to write policies and procedures for his business.

 

Mr. Wand asked Mr. Barone how the doctors would know about the pharmacy.  Mr. Barone stated that he plans to focus on assisted living homes.

 

Mr. Dutcher wished Mr. Barone good luck with his business.

 

Safescript Pharmacy

 

Owner Ghanshyam Patel appeared to answer questions from Board Members concerning the change of ownership of this pharmacy.

 

President Dutcher opened the discussion by asking Mr. Patel about his business.  Mr. Patel stated that he is buying an existing business. Mr. Patel stated that he is a licensed pharmacist.

 

Mr. Wand asked Mr. Patel to describe the pharmacy business.  Mr. Patel stated that he would be taking over the business next month.  Mr. Patel stated that twenty percent of the business is retail and the remainder of the business is filling prescriptions for assisted living homes.

 

Ms. Frush stated that they were asked to appear because the previous owner supplied physicians with PDA’s to prescribe pain management medications.  Mr. Patel stated that he would be evaluating that practice when he takes over the business.  Mr. Patel stated that currently there are only three doctors participating in the pain management program and he will evaluate the program.   Mr. Patel stated that the pain management program is only ten percent of the business and that is why the pharmacy has been switched to a retail pharmacy.  Mr. Wand indicated that originally the pain management portion was one hundred percent of the business.

 

President Dutcher wished the applicant luck in his new business.

 

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

 

RESIDENT PHARMACIES ( In State )

  • The Guidance Center
    2187 N. Vickey St.
    Flagstaff, AZ 86004
    The Guidance Center, Inc.
  • Walgreens Pharmacy #09179
    5075 W. Baseline Rd.
    Phoenix, AZ 85338
    Walgreen Arizona Drug Co
  • Wal-Mart #10-3807
    1106 N. Gilbert Rd., Suite #1
    Mesa, AZ 85213
    Wal-Mart Stores, Inc.
  • Wal-Mart #10-4264
    7951 N. Oracle Rd.
    Oro Valley, AZ 85704
    Wal-Mart Stores, Inc.
  • WR Group, Inc.
    518 W. Knudsen Dr., Suite 102,
    Phoenix, AZ 85024
    WR Group, Inc.
  • CVS/pharmacy #1743
    13870 Greenway Rd.
    Surprise, AZ 85374
    German Dobson CVS LLC
  • Holbrook Hospital, Inc.
    500 E. Iowa
    Holbrook, AZ 86025
    Holbrook Hospital Gov. Board
  • Havasu Regional Med. Center Rehab.
    101 Civic Center Ln.
    Lake Havasu City, AZ 86403 (O)
    Havasu Regional Med. Ctr. LLC
  • Havasu Regional Medical Center
    101 Civic Center Ln.
    Lake Havasu City, AZ 86403 (O)
    Havasu Regional Med. Ctr. LLC
  • Tucson Heart Hospital
    488 N. Stone Ave.
    Tucson, AZ 85705 (O)
    Medcath of Tucson, LLC
  • Arizona Cancer Center
    3838 N. Campbell Ave.
    Tucson, AZ 85743
    University Medical Center
  • Arizona Rx Solutions, LLC
    2431 W. Peoria Ave., #1005,
    Phoenix, AZ 85029
    Arizona Rx Solutions, LLC
  • Safescript Pharmacy
    310 N. Wilmot Rd., #310
    Tucson, AZ 85711
    Sayona Pharmacy, Inc.

NON-RESIDENT PHARMACIES ( Out of State )

  • US Bioservices
    359 Inverness Dr. South, Suite J
    Englewood, CO 80112
    IHS Acquisition
  • Emissary HMO Pharmacy
    2546 E. Second St., #100,
    Casper, WY 82609
    Emissary Professional Group,LLC
  • Mt. Laurel Veterinary Pharmacy
    17 Mt. Laurel Ave.
    Birmingham, AL 35242
    Mt. Laurel Veterinary Pharmacy
  • Fairview Specialty Services Pharmacy
    711 Kasota Ave. SE
    Minneapolis, MN 55414
    Fairview Pharmacy Services, LLC
  • PCM Venture I LLC
    5201 Green St., Suite 225
    Murray, UT 84123
    PCM Venture I LLC
  • Prescription Solutions
    6800 W. 115th St., Suite 150
    Overland Park, KS 66211
    UnitedHealth Group
  • Anazao Health Corporation
    5211-B W 9th
    Amarillo, TX 79106
    Anazao Health Corporation
  • SaveDirectRx, Inc.
    4243 Center Gate
    San Antonio, TX 78217
    SaveDirectRx Inc.
  • RX Depot, LLC
    317 SW Wilshire Blvd., Ste 100-B
    RX Depot, LLC
  • Pharmacy 101, LTD
    5620 Jefferson Hwy.
    Elmwood, LA 70123
    Elizabeth Prechter
  • Icore Healthcare, LLC
    855 SW 78th Ave., Suite 110
    Plantation, FL 33324 (O)
    Green Spring Health Services
  • Medfusion Pharmacy
    2211 5th St. N., Ste. B
    Columbus, MS 39705
    Medfusion RX, LLC
  • Borg Warner Family Pharmacy
    4005 W. Kilgore Ave.
    Muncie, IN 47304
    CHDM, LLC
(O) = Ownership Change

Wholesalers

 

President Dutcher stated that all wholesale permits were in order and one applicant was present to answer questions from Board Members

 

Maricopa County Department of Public Health Pharmacy

 

Shawn Tennant, Pharmacy Manager for the Maricopa County Department of Public Health Pharmacy and Diane Temporado, the designated Manager for the Wholesale business were present to answer questions. Ms. Tennant stated that the pharmacy is no longer processing pharmaceutical services for several grants that reduced the pharmacy revenue from six million dollars to two hundred thousand dollars.  Ms. Tennant stated that as a result of the decrease in revenue the medication that they distribute to other clinics now exceeds the 5% business limit.

 

Mr. Wand stated that the medications could not be sold to clinics but must be sold to the doctors at the clinic because clinics do not have permits.  Ms. Tennant stated that the medications are sold to the doctors at the various clinics.

 

 President Dutcher thanked the applicants for appearing.

 

Western Research Laboratories

 

Ms. Frush explained that Western Research Laboratories was not asked to appear.  Ms. Frush stated that this is an ownership change.  Ms. Frush stated that one of the original three owners would now be the sole owner.  Ms. Frush stated that the facility has been inspected in the past and there have been no issues.

 

At the conclusion of questions from the Board Members and on motion by Dr. Smidt and Dr. Berry, the Board unanimously approved the resident wholesale permits listed below.  All approvals are subject to final inspection by a Board Compliance Officer where appropriate.

Resident Wholesalers

  • Maricopa County Dept. of Public Health
    1645 E. Roosevelt St.
    Phoenix, AZ 85006
    Maricopa County Pharmacy
  • KB Bargain Wholesale Corp.
    4480 N. 43rd Ave. A-4
    Phoenix, AZ 85031
    KB Bargain Wholesale Corp.
  • Western Research Laboratories
    2404 W. 12th St., Suite 4
    Tempe, AZ 85281 (O)
    RLC Labs, Inc.
(O) = Ownership Change

Manufacturers

 

President Dutcher stated that there was one manufacturers permit to be approved.

Ms. Frush stated that the applicants were not requested to appear because this is a change of ownership. Ms. Frush stated that one of the original three owners would now be the sole owner.  Ms. Frush stated that the facility has been inspected in the past and there have been no issues.

 

At the conclusion of questions from the Board Members and on motion by Dr. Berry and Dr. McCoy, the Board unanimously approved the resident manufacturer permit listed below.  All approvals are subject to final inspection by a Board Compliance Officer where appropriate.

  • Western Research Laboratories
    2404 W. 12th St., Suite 4
    Tempe, AZ 85281(O)
    RLC Labs, Inc.
(O) = Ownership Change (O) = Ownership Change

 

Pharmacist, Pharmacy Interns, and Pharmacy Technician Licenses

 

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 Mr. McAllister and Dr. McCoy, the Board unanimously approved the Pharmacists licenses 15543 through 15740.  On motion by Dr. McCoy and Dr. Berry, the Board unanimously approved the Intern licenses 7611 through 7780.  On motion by Dr. Tippett and Dr. McCoy, the Board unanimously approved the Pharmacy Technician licenses 10983 through 11355.  Also, approved were 186 licensee changes from Pharmacy technician trainee to Pharmacy Technician.

 

AGENDA ITEM 5 – License Applications Requiring Board Review

 

#1  Anthony Breeding

 

Anthony Breeding appeared on his own behalf to request to proceed with licensure as a Pharmacist.

 

President Dutcher opened the discussion by asking Mr. Breeding why he was appearing in front of the Board.

 

Mr. Breeding stated that he is here to explain why the Iowa Board of Pharmacy placed his license on probation.  Mr. Breeding stated that in May of 2004 he was charged with a DUI offense.  Mr. Breeding stated that he was required by the College of Pharmacy to report the DUI within five days, which he did.  Mr. Breeding stated his advisor had informed him at this time that she was notified by the Iowa Pharmacy Board that he had not applied for his Intern license.  Mr. Breeding stated that on the application there is a question that asked if the applicant had ever been convicted of or pled guilty to a drug or alcohol offense.  Mr. Breeding stated at that time he had not had his court date and his advisor told him that he did not have to include the charge because he was not convicted yet.

 

Mr. Breeding stated that the Iowa Pharmacy Board later told him that he withheld information and he would need to appear in front of the Board.  Mr. Breeding stated that his advisor and Dean called the Board to inform them that Mr. Breeding was advised by them to answer no to the question since he had not been convicted.  Mr. Breeding stated that the Board still asked him to appear.

 

Mr. Breeding stated that he signed a Consent Order that put his Intern license on probation.  Mr. Breeding stated that he was not to drink alcohol as a requirement of his Consent Order.  Mr. Breeding stated that for one and one-half years he did not drink alcohol.  Mr. Breeding stated earlier this year he attended a Valentine’s party and was not aware that the punch contained alcohol.  Mr. Breeding stated that he was called for a random screen and he tested positive.  Mr. Breeding stated that the next incident occurred

at Easter when he drank alcohol at a family dinner.  Mr. Breeding stated that he again was called for a random drug screen and tested positive.  Mr. Breeding stated that the probation was then extended to his Pharmacist license.

 

Mr. Dutcher asked Mr. Breeding if he is on probation for two years.  Mr. Breeding stated that is correct.

 

Mr. Dutcher asked Mr. Breeding if he is planning to move to Arizona.  Mr. Breeding stated that he moved to Arizona about a month ago and is working as a cashier at CVS.

 

Mr. Dutcher asked Mr. Wand what are the Board’s options in this case.  Mr. Wand stated that the Board could offer the applicant a similar Consent Agreement to Iowa’s Consent Order or the Board could deny the application because his license is on probation in Iowa.

 

Mr. Dutcher asked Mr. Breeding if he is in a recovery program.  Mr. Breeding stated that he is participating in the Iowa Pharmacists Recovery Program.  Mr. Breeding stated that it is his understanding that if he were licensed in Arizona then the Iowa Board would allow him to participate in the Arizona recovery program.

 

Mr. McAllister asked if there was a schedule for random screenings.  Mr. Breeding stated that he called in daily Monday through Friday to see if he had been selected for a screening that day.

 

Mr. McAllister asked if he tested positive twice in a two month time period while under a Board Consent Order.  Mr. Breeding replied yes.

 

Mr. Van Hassel asked Mr. Breeding if he has consumed any alcohol since moving to Arizona.   Mr. Breeding stated that he has not consumed any alcohol.  Mr. Breeding stated that the first time he did not know the alcohol was in the punch and the second time he chose to drink the alcohol.

 

Dr. McCoy asked Mr. Breeding if he has ever worked as a pharmacist.  Mr. Breeding replied no.

 

Mr. McAllister made a motion that the Board deny Mr. Breeding’s request to proceed with licensure.  There was no second.

 

On motion by Dr. Tippett and Dr. Sypherd, the Board approved Mr. Breeding’s request to proceed with licensure with the stipulation that he sign a Consent Agreement with similar stipulations as the Iowa Consent Order including the signing of a five-year PAPA contract. The consent agreement would be for the same time frame as the Iowa Consent Order.

 

A roll call vote was taken.  (Mr. McAllister – nay, Ms. Honeyestewa aye,Dr. Tippett – aye, Dr. Smidt – aye, Dr. Berry – aye, Dr. McCoy – nay, Dr. Sypherd – aye, Mr. Van Hassel – nay, President Dutcher –aye).

 

Dr. McCoy stated that the individual does not have a reliable track record.

 

Mr. McAllister asked Mr. Wand if the Consent Agreement would state that Mr. Breeding must show the Consent Agreement to all his employers.  Mr. Wand replied yes.  Mr. Breeding stated that the Iowa Consent Order has the same stipulation.

 

 

#2  Duane Asp

 

Duane Asp appeared on his own behalf to proceed with reciprocity.

 

President Dutcher asked Mr. Asp why he was appearing in front of the Board.  Mr. Asp stated that he applied for reciprocity and was told he needed to appear at the Board

meeting this morning.  Mr. Asp stated that he assumed it was to answer questions concerning his Wisconsin and Texas license.

 

Mr. Dutcher asked Mr. Asp about his Wisconsin incidences.  Mr. Asp stated that when he sold his pharmacy in Wisconsin the State Board sent an inspector to his pharmacy to see if the transfer of ownership was completed properly.

 

Mr. Asp stated that when the Inspector checked his CV logbook it was noted that he sold a large number of bottles of an over-the-counter CV cough syrup in a short time frame.

 

Mr. Dutcher stated that Mr. Asp sold 150 bottles of cough syrup to nine individuals in a two to three month time frame.

 

Mr. Dutcher asked Mr. Asp about the misdemeanor charges.  Mr. Asp stated that he was cited twice for disorderly conduct when arguments got out of hand and the police were called.

 

Mr. Dutcher asked Mr. Asp if he has a Texas license.  Mr. Asp replied no.

 

Mr. Dutcher asked Mr. Asp if he has a job in Arizona.  Mr. Asp replied that he has just moved to Arizona and does not have a job yet.

 

Dr. McCoy asked Mr. Asp if he could sell over-the-counter CV drugs.  Mr. Asp stated that he could not sell over-the-counter CV cough syrups.

 

Mr. Wand stated that Federal Law states that four ounces of a CV cough syrup can be sold every forty-eight hours to one individual, unless the state law is stricter.

 

On motion by Mr. Van Hassel and Dr Smidt, the Board approved Mr. Asp’s request to proceed with reciprocity.  There were two nay votes by Dr. Tippett and Dr. Berry.

 

#3  John Hart

 

John Hart appeared on his own behalf to request to proceed with licensure as a Pharmacy Technician.

 

President Dutcher asked Mr. Hart why he was appearing in front of the Board.  Mr. Hart stated that he is applying for a technician license and was told that he needed to appear at a Board Meeting because he has had felony convictions in the past.

 

Mr. Dutcher asked Mr. Hart if he is licensed in Colorado.  Mr. Hart stated technicians are not licensed in Colorado.

 

Mr. Dutcher asked Mr. Hart if he has been working as a technician in Colorado. Mr. Hart

replied yes. 

 

Mr. Dutcher asked Mr. Hart if he is moving to Arizona.  Mr. Hart stated that he wishes to move to Arizona.

 

Mr. Dutcher asked if Mr. Hart answered the questions honestly on the application.  Ms. Frush stated that he answered the questions honestly and provided the proper paperwork.

 

Mr. Hart stated that the charges stem from paperwork that he submitted concerning unemployment claims in Colorado.

 

Mr. Dutcher asked about the charges of obtaining a controlled substance by fraud and deceit.

 

Mr. Hart stated that he had a friend that he was assisting when he fell and broke both his feet.  Mr. Hart stated that his friend was in pain and did not have any insurance, so he forged a prescription for painkillers for his friend.

 

Mr. Dutcher asked if Mr. Hart was working as a Pharmacy Technician at the time of the forged prescription.  Mr. Hart replied that he was working at a hospital as a mental health technician.  Mr. Hart stated that he took a prescription from a prescription pad and wrote the prescription.

 

Mr. Dutcher asked Mr. Hart what happened to the charges for the forged prescription.  Mr. Hart stated that charges were dropped after he completed the drug program.

 

Dr. Smidt asked if this was a one-time occurrence.  Mr. Hart stated that he only forged one prescription for his friend and was caught.  Mr. Hart stated that he really did not want to forge the prescription but was being pressured by his friend.

 

Dr. McCoy stated that there is a track record that shows a clean record since the infractions.

 

On motion by Dr. McCoy and Dr. Smidt, the Board approved the request by Mr. Hart to proceed with technician licensure.  There was nay vote by Mr. Van Hassel.

 

AGENDA ITEM 6 – Special Requests

 

#1  Daniel Osborn

 

Daniel Osborn appeared on his own behalf to request the termination of probation imposed by Board Order 05-0011-PHR.

 

President Dutcher asked Mr. Osborn about the nature of his request.  Mr. Osborn stated that he is requesting that his probation be terminated.  Mr. Osborn stated that he has completed all the requirements of his Consent Agreement.

 

Mr. Van Hassel asked if Mr. Osborn had completed and submitted the CE units to the Board.  Ms. Frush replied yes.

 

On motion by Mr. Van Hassel and Dr. Tippett, the Board unanimously agreed to terminate the probation of Mr. Osborn’s license subject to the terms of Board Order

05-0011-PHR.

 

#2  Craig Westley

 

Craig Westley appeared with Lisa Yates from the PAPA program to request the termination of probation imposed by Board Order 02-0016-PHR.

 

President Dutcher asked Mr. Westley about the nature of his request.  Mr. Westley stated that he is requesting that his probation be terminated and his Pharmacist license be returned to active status.

 

President Dutcher asked if Mr. Westley fulfilled all the requirements of his Consent Agreement.  Mr. Westley stated that he has completed all the requirements.

 

Mr. Westley stated that living the life of recovery has been a positive change in his life and he has tried to serve as a role model for others.

 

Ms. Yates stated that Mr. Westley has been a participant that has reached out to help others in their recovery.

 

On motion by Dr. McCoy and Dr. Tippett, the Board unanimously agreed to terminate

the probation of Mr. Westley’s license subject to the terms of Board Order 02-0016-PHR.

 

#3  Remon Abd El-Malak

 

Remon Abd El-Malak appeared on his own behalf to request that the Board accept his TSE score of 45.

 

Mr. El-Malak stated that he has taken the TSE exam many times and each time he receives a score of 45.

 

Mr. Wand stated that it is important to note that the Board is not waiving the exam but the Board is giving an alternative exam when the Board Members ask questions of the applicant to ascertain if they are able to understand the individual when he speaks with them.

 

Mr. Van Hassel asked Mr. El-Malak to counsel the Board on a drug of his choice.  Mr. El-Malak counseled the Board Member’s on the use and side effects of Coumadin.

 

On motion by Mr. McAllister and Dr. McCoy, the Board unanimously approved Mr.

El-Malak’s request to accept his TSE score and proceed with licensure.

 

 

#4  Undra Patrice Graves- Guyton

 

Undra Patrice Graves-Guyton appeared on her own behalf to request to take the NAPLEX exam for the fourth time.

 

President Dutcher asked Ms. Graves-Guyton about the nature of her request.  Ms. Graves-Guyton stated that she is requesting to take the NAPLEX exam for the fourth time.

 

Ms. Graves-Guyton stated that she has taken the exam three times and each time her score has improved.  Ms. Graves-Guyton stated that she suffers from test anxiety and is currently being treated for her anxiety.  Ms. Graves-Guyton stated that she has anxiety issues when taking tests.

 

Mr. Wand told Ms. Graves-Guyton that if her physician writes a letter to NABP she might be able to have extra time to take the exam.

 

On motion by Mr. Van Hassel and Dr. Smidt, the Board unanimously approved the request by Ms. Graves-Guyton to take the NAPLEX exam for the fourth time and if she is not successful she must take a review course before asking to take the exam for a fifth time.

 

AGENDA ITEM 7 – Reports

 

Executive Director Report

 

Mr. Wand opened the discussion by stating that online renewals with a credit card are available this year.  Mr. Wand stated that 200 pharmacists, 22 technicians, and 10 pharmacies have renewed online so far.

 

Mr. Wand stated that there is a carry over of seventy thousand dollars from last year.  Mr. Wand stated that some of the carry over would be used to pay the Assistant Attorney General since this was not a budgeted expense.  Mr. Wand stated that when the there is in an increase in salaries or retirement the legislature appropriates the necessary funds to cover the additional expenses.

 

Mr. Wand stated that the money is appropriated in allotments quarterly.  Mr. Wand stated that the Board must remember that current revenues are not available for spending.

 

Mr. Wand reviewed the expenses with the Board Members.

 

Mr. Wand stated that he has passed out a copy of the Proposed Budget to the Board Members.  Mr. Wand stated that Dr. Smidt reviewed the Proposed Budget.  Mr. Wand stated that the Board is requesting approximately one million dollars more than in the 2008-2009 Budget.  Mr. Wand stated that the Board is asking for additional funds for the

following: a one-time contribution to the University of Arizona Pharmacy School, an increase in the Compliance Officer’s salary, an increase in PAPA contributions, additional cars for the two new proposed Compliance Officers, and funds for the Prescription Monitoring Program.

 

Mr. Wand stated that the Budget was turned in on September 1, 2006.  Mr. Wand stated that the JLBC (Joint Legislative Budget Committee) and the OSBP (Office of Strategic Planning and Budgeting) analysts would review the Budget.  Mr. Wand stated that the analysts testify before the Joint Legislative Budget Committee and state whether or not they support the Budget.  Mr. Wand stated if they do not support the Budget then he would need to appear and state why the item should be supported.  Mr. Wand stated that this would occur in January and any Board Member could accompany him to testify.

 

Mr. Wand stated that if the JLBC and OSBP analysts support the Budget then the Budget would be placed on the Consent Agenda and he would not need to testify.  Mr. Wand

 

stated that the Board might need to testify this year due to the increased amount of funds requested.

 

Deputy Director Report

 

Deputy Director Frush directed the Board Members attention to the activity reports for the Compliance Staff.  Ms. Frush noted that the Compliance Staff is slightly behind in the number of inspections completed during the same period last year due to the increased

number of non-prescriptions inspections earlier in the year and the increased number of complaint investigations being conducted.  Ms. Frush stated that the number of inspections by the Drug Inspector is ahead of the number of inspections completed last year at this time.

 

Ms. Frush stated during the months of July and August the Compliance Staff issued letters for the following violations.

 

Controlled Substance Violations

1.  Controlled Substance Overage – 4

2.  Controlled Substance Shortage – 7

3.  Controlled Substance Inventory Not Complete – 3

4.  Failure to Conduct Controlled Substance Inventory upon change of Pharmacist in      

     Charge – 1

5.  Failure to Conduct Controlled Substance Inventory upon change of Ownership - 1

6.  Annual Controlled Substance not available - 2

Documentation Violations

1.  Failure to Document Medical Conditions – 15

2.  Failure to Document Required Information on an Oral Prescription – 2

3.  Failure to Document Correct Date Prescription was Written -1

4.  Failure to have signed technician statements concerning job description, policies & 

     procedures and Board rules - 12

5.  Failure to have a technician training manual – 2

6.  Failure to have a technician policy and procedure manual - 1

7.  Daily prescription log not signed – 1

8.  Failure to document allergies – 1

9.  Failure to maintain Compounding Documentation – 1

10. Failure to obtain the name of a the agent authorizing a refill – 1

11. Failure to maintain counseling documentation –1

 

Dispensing Violations

1.  Outdated Rx and OTC items in the pharmacy – 5

2.  Failure to obtain a signed CII Emergency prescription -1

 

 

 

 

Pharmacy Violations

1.  Allowing technicians to work without a license – 1

2.  Allowing a technician to work with an expired license - 3

3.  Wall certificates not posted – 11

4.  Failure to notify the Board of a Pharmacist in Charge change – 2

5.  Failure to maintain sanitary restroom conditions – 1

6.  Failure to have a working prescription balance - 1

 

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

1.  Documentation of medical conditions

2.  Name Badges – Lack of title

 

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

1.  Cleanliness of pharmacy

 

Areas outside the inspection reports that may be of interest:

1.   CII – Quantity to be dispensed – Not limited to 30 days

2.   Change of Pharmacist In Charge – Immediate Notification to Board – 10 days must   

      complete the Controlled Substance Inventory

 

PAPA Report

 

Lisa Yates was present to represent the PAPA program.  Ms. Yates stated that there are a total of forty-one (41) participants in the PAPA program.  Ms. Yates stated that since the last report on May 25, 2006 six participants have entered the program and there have been two terminations.  Ms. Yates discussed with the Board Members issues with several participants.

 

 

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 500 people attended the annual meeting and the Alliance offered 24.5 hours of CE.

 

Ms. Rasmussen stated that the Alliance is establishing a list of pharmacists that would like to participate as members of the Medical Therapy Management Task Force.  Ms. Rasmussen stated that the goal of the task force would be to obtain funding to pay for cognitive services.

 

Ms. Rasmussen stated that future legislative action would include obtaining prescriptive authority for pharmacists to give immunizations and extending the Collaborative Practice

Agreements to the community pharmacist.

 

Ms. Rasmussen stated that there are a few pharmacy employers that are interested in purchasing the Pharmacy Quality Management Program.

 

Ms. Rasmussen updated the Board on upcoming CE events that the Alliance would be sponsoring.

 

AGENDA ITEM 8 – Caremark

 

Richard Chin, Pharmacy Supervisor, and Vicky Long, Pharmacist In Charge, were present on behalf of Caremark’s Remote Verification Program.

 

Mr. Dutcher opened the discussion by asking the representatives about their program.

 

Mr. Chin stated that Caremark would like to offer their pharmacists the chance to work remotely and verify prescriptions that are entered by the technicians on site.

 

Ms. Sutcliffe stated that she has visited the initial two home sites.   She stated that the e-mail function has been discontinued.  Ms. Sutcliffe stated that the logout period was changed from fifteen minutes to five minutes.

 

Ms. Long stated that they have provided the Board with copies of their policies and procedures for remote verification.

 

Mr. Wand stated that the Board has set precedence by the Board approving previous requests for remote verification. Mr. Wand stated that the standards were set when Walgreens established the first home verification sites.   Mr. Wand stated that the companies seeking to do remote verification ask to appear before the Board so that the Board is aware that their company is doing remote verification.

 

Mr. Dutcher asked how many pharmacists would be doing remote verification.  Mr. Chin stated that they are starting with two pharmacists and anticipate up to ten pharmacists would participate in the program.

 

Mr. Dutcher thanked the representatives for appearing and presenting their remote verification program to the Board.

 

AGENDA ITEM 9 – Proposed Rules and Substantive Policy

 

Counseling – Pharmacist Initials Rule

 

Compliance Officer /Rules Writer Dean Wright opened the discussion by stating that he has added the changes requiring the initials of the pharmacist or intern that did or did not provide counseling.

 

Mr. Wright stated that a Public Hearing was held on July 24, 2006.  Mr. Wright stated that there were two attendees and written comment was submitted.  Mr. Wright stated

that the Board Members have received copies of the written comments.

 

Mr. Wright stated that he prepared the Notice of Final Rulemaking and the Economic Impact Statement for the Board’s approval.  Mr. Wright stated that if the Board approves the Notice of Final Rulemaking and the Economic Impact Statement, the rulemaking would be placed on GRCC’s December agenda and would become effective in February.

 

Dr. McCoy stated that the letter from the Arizona Community Pharmacy Committee stated that it would require the pharmacist to remember facts about the conversation with the patient about counseling.  Dr. McCoy stated that the intent of this rule just documents the initials of the pharmacist counseling the patient and does not require the pharmacist to recall the conversation.

 

On motion by Mr. McAllister and Dr. McCoy, the Board unanimously agreed to approve the Notice of Final Rulemaking and Economic Impact Statement for the change in counseling rules.

 

Drug Wholesaler Rules

 

Mr. Wright stated that the Forty- Seventh Legislature in 2005 added five new sections to the statutes, which are A.R.S.§ 32-1981 through A.R.S. § 32-1985.  These statutes deal with the wholesaling of prescription drugs.  Mr. Wright stated that the statutes require such items as bonds, pedigrees, and designated representatives.

 

Mr. Wright stated that this is the first draft of rules to implement the statutes.

Mr. Wand stated that the rules are written to clarify the statutes.

 

Mr. Wright stated that the statutes are very specific and spell out the requirements, so he has incorporated parts of the statutes into the rules.

 

Mr. Wright stated that the statutes give the Board the authority to fingerprint the designated representatives and if they are fingerprinted then DPS must run a background check.  Mr. Wright stated that the rule would reflect the fingerprinting process.  Mr. Wright stated that the applicant would be charged by DPS.

 

Mr. Wand asked Mr. Wright if there is any wording in the proposed rules that would prevent a wholesaler from selling a package that is repackaged from a legitimate manufacturer.  Mr. Wright replied no.

 

Mr. Wand asked if the statute states that the Board may request the fingerprints.  Mr. Wright stated that it does say, “may”. Mr. Wright stated that he added it as a source of verification.  Mr. Wand asked if it could be left in the rules as “may”.  Mr. Wright stated then the Board would need to decide who would be fingerprinted.

 

Mr. Dutcher stated that he would like to see it as shall fingerprint.  Mr. Wand stated that if fingerprinting is required then staffing would be needed to process the requests.

 

Dr. Sypherd asked what is the goal of fingerprinting the designated representatives.  Mr. Wright stated that the Board does not know if the person had any problems with drug distribution in the past.

 

Mr. Wand asked what would happen if it shows the person had a record.  Mr. Wright stated that the wholesaler would then need to appoint a new representative.

 

Gary Cacciatore, Director of Regulatory Affairs for Cardinal Health, was called forth to address Board Member’s concerns.

 

Mr. Van Hassel asked Mr. Cacciatore if he fingerprints his employees.  Mr. Cacciatore stated that the designated representatives are fingerprinted because some state regulations

require the fingerprints. Mr. Cacciatore stated that other employees are not fingerprinted.

Mr. Cacciatore stated that they do criminal background checks.  Mr. Cacciatore stated that fingerprinting is not a hardship.

 

Mr. Van Hassel stated that he would like to leave the fingerprint check as “shall” in the rules.

 

Mr. Wand stated that if the background check comes back positive then the individual could not be the designated representative, but could still work at the company.  Mr. Wand stated that he is not sure this is an advantage.

 

Dr. Sypherd stated that due to the inaccuracies with fingerprinting he is not sure what the advantage would be of fingerprinting the designated representative.

 

Dr. Tippett asked Mr. Wright to define failure to pass.  Mr. Wright stated that DPS would determine who passed by whether they had a criminal record or not.

 

Dr. Tippett asked who would establish the criteria for passing the background check.  Mr. Wright stated that the Board would establish the criteria.  Mr. Wright stated that if the background check comes back that the representative has a record then it would come

before the Board to determine if the individual could be the designated representative.  Mr. Wright stated that the Board would make the determination.

 

Mr. Wand read the statement on page 409 that stated if the person fails to pass the wholesaler shall select another person.  Mr. Wand stated that the Board could not make

the determination that the individual who failed the background check could be the designated representative.

 

Mr. Wright stated that he would modify the statement to say the individual would need to appear in front of the Board.

 

Dr. Tippett asked if the Board would have guidelines in determining if an individual could be the designated representative.  Dr. Tippett stated that guidelines would be useful to insure that the Board takes similar action in each case.

 

Ms. Lee asked if the criminal background check states that the individual passed or failed.  Mr. Wright stated that he does not know.  Ms. Lee suggested that the rule could be written stating that the agency that conducts the investigation would determine if an individual passed or failed and this would remove the burden from the Board.

 

Mr. Dutcher asked if the Board could receive comments from the wholesaler and DPS concerning these issues.

 

Mr. Wand stated that he would like to request that DPS make a presentation to the Board concerning background checks.

 

At this time, the Board decided to continue to review the rules and talk about the rules at a future meeting.

 

Pharmacist Licensing by Examination Rule

 

Mr. Wright stated that there is an incorrect citation in the rules and this change would correct the citation.

 

Mr. Wright stated that a Public Hearing was held on September 18, 2006. No one attended the hearing and no written comments were received.

 

Mr. Wright stated that if the Board approves the Notice of Final Rulemaking and the Economic Impact Statement, the rule change would be on GRCC’s December agenda and become effective in February.

 

On motion by Dr. McCoy and Mr. McAllister, the Board unanimously agreed to approve the Notice of Final Rulemaking and Economic Impact Statement for the change in Pharmacist Licensing by Examination Rule.

 

Substantive Policy – SPS09- Pharmacist In Charge of a Drug Manufacturer

 

Mr. Wright stated that at the July meeting he was asked to draft a substantive policy statement addressing the Pharmacist In Charge at a manufacturer and how many hours the Pharmacist In Charge must be present a week when the manufacturing process occurs 24/7.

 

Mr. Wright stated that the Pharmacist must be there a minimum of 40 hours a week and no drug can leave the facility until checked by the pharmacist.

 

Mr. Wand stated that policies are stopgaps.  Mr. Wand stated that there is a proposed statute change for next year.

 

Mr. Wright stated that the statute change would allow a non-prescription manufacturer to operate without a pharmacist.

 

Dr. Smidt asked why a pharmacist is required at a manufacturing plant.  Mr. Wand stated that Arizona is one of seven states that has this requirement. Mr. Wand asked if the Board would like to remove this requirement.

 

Dr. McCoy asked if the pharmacist adds any degree of safety. Mr. Wand stated that many manufacturing plants are automated.

 

Mr. Wright stated that a Bill would need to be introduced to remove manufacturer from

A.R.S. § 32-1961.

 

Mr. Wand stated that the policy should be put in place as a stopgap until the statute could be changed.  Mr. Wand stated that the policy would allow a manufacturer to open with a Pharmacist for only forty hours a week when operating 24/7.

 

On motion by Dr. Smidt and Dr. McCoy, the Board unanimously approved the acceptance of Substantive Policy SPS09 setting guidelines for the hours a Pharmacist In Charge must be present at a drug manufacturer.

 

AGENDA ITEM 10 – Complaint Review

 

The Consumer Complaint Review committee met prior to the Board Meeting to review 35 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 # 3201.  The Board Members decided that they would like Mr. Wand to order a psychological test.

 

Ms. Lee stated that the Board could have the examiner ask specific questions during the psychological exam.

 

Dr. Smidt asked about the psychological exam.  Ms. Lee stated that the Board could ask that the exam be completed in a certain time frame.  Mr. Wand stated that the results of the exam would stay in the respondent’s file and would be a permanent record. 

 

The Board decided that Mr. Wand would request the individual to submit to a psychological test and the complaint review committee prior to the November meeting would review the results and then the Board could act upon the committee’s recommendations at the November meeting.

 

The Board asked why the committee recommended revocation on Complaint 3223.  Mr. Wand stated that the individual has had three PAPA contracts in the past.

 

The following summary represents the final decisions of the Board in each complaint:

 

Complaint # 3150         -           Conference (Both Pharmacists)

 

Complaint # 3154         -           Advisory Letter

 

Complaint # 3155         -           Conference (Both Incidents)

 

Complaint # 3157         -           No Further Action

 

Complaint # 3158         -           No Further Action

 

Complaint # 3161         -           No Further Action

 

Complaint # 3163         -           No Further Action

 

Complaint # 3167         -           No Further Action

 

Complaint # 3169         -           Conference (Incident 1)   No Further Action (Incident 2)

 

Complaint # 3172         -           Conference (Pharmacist In Charge and Supervisor)

 

Complaint # 3175         -           Advisory Letter

 

Complaint # 3176         -           Advisory Letter

 

Complaint # 3179         -           No Further Action

 

Complaint # 3180         -           Conference (Verifying and Customer Service Pharmacist)

 

Complaint # 3183         -           Conference

 

Complaint # 3189         -           No Further Action

 

Complaint # 3191         -           Consent – Voluntary Surrender

 

Complaint # 3192         -           No Further Action

 

Complaint # 3193         -           No Further Action

 

Complaint # 3194         -           Conference

 

Complaint # 3195         -           No Further Action

 

Complaint # 3196         -           No Further Action

 

Complaint # 3197         -           No Further Action

 

Complaint # 3199         -           Advisory Letter

 

Complaint # 3200         -           Consent (PAPA)

 

Complaint # 3201         -           Order Psychological Test

 

Complaint # 3202         -           No Further Action

 

Complaint # 3203         -           Conference (Pharmacist and Technician)

 

Complaint # 3205         -           Conference (Both Pharmacists)

 

Complaint # 3206         -           Refer to Executive Director

 

Complaint # 3209         -           Consent – Voluntary Surrender

 

Complaint # 3210         -           No Further Action

 

Complaint # 3221         -           No Further Action

 

Complaint # 3222         -           Consent – Revocation

 

Complaint # 3223         -           Consent – Revocation

 

 

AGENDA ITEM 11 – Conferences

 

Complaint #3142

 

Pharmacist Doan Phuong, Pharmacy Supervisor Joe Leyba, Divisional Pharmacy Director Robbie Jacobs, and National Director of Pharmacy Affairs Phil Burgess were present