March 6 & 7, 2002 Board Meeting minutes

THE ARIZONA STATE BOARD OF PHARMACY

HELD A REGULAR MEETING MARCH 6 & 7, 2002

4425 WEST OLIVE AVENUE

GLENDALE, ARIZONA

The following Board Members and staff were present: President William E. Jones, Vice President Paul Draugalis, Dennis McAllister, Linda K. McCoy, Daniel Ketcherside, Eugene ‘Gene' Drake and Gerald Ritt. Also present were: Compliance Officers Ed Hunter, Cheryl Frush, Dennis Waggoner and Dean Wright, Deputy Director Hal Wand and Executive Director L.A. Lloyd; Assistant Attorney General Victoria Martin (March 6th only).

President Jones convened the meeting at 1:00 p.m., welcomed the audience, and asked Deputy Director Wand to advise the audience on the policy to obtain continuing education credit for attending. Executive Director Lloyd introduced Jill Mehrer, a University of Arizona College of Pharmacy student on rotation at the board office, Roger Morris, R.Ph., J.D.; introduced Lisa Pajestka, a Midwestern University College of Pharmacy intern on rotation with Mr. Morris.

President Jones introduces recently appointed and confirmed Board Member Linda McCoy to the audience and administered the Oath of Office to Ms. McCoy and welcomed her as a new member of the board. President Jones also acknowledged that Eugene ‘Gene’ Drake has been reappointed to serve a five year term on the board.

AGENDA ITEM I - APPROVAL OF MINUTES

On motion by Mr. Drake and Mr. Ritt, the Board unanimously approved the minutes of the January 9 & 10, 2002 and the telephone conference call of January 23, 2002 meeting as presented.

AGENDA ITEM II - PERMITS/LICENSES

Pharmacy Permits:

Deputy Director Wand indicated that applications for pharmacy permits were in order and that the fees have been paid. Following a final review of the applications and on motion by Mr. Draugalis and Mr. Ketcherside; applications 1-10 in the original agenda plus number 1 in the addendum and ‘non-resident pharmacy permits numbers 1-16, were unanimously approved pending final inspection by the staff where applicable.

Wholesale Drug Permits:

Mr. Wand indicated that the following applications were in order and all fees paid, he further indicated that the applicant had read and signed the wholesale drug dealer orientation provided by the office. Mr. Wand indicated Mr. Michael Blaire RPh representing Diamondback Drugs and David Przybyszewski representing Drug Valet Inc. were present and available to answer questions from the Board. Mr. Przybyszewski told the Board that his business plan was to distribute prescription drugs and controlled substances to medical doctors’ offices and non-acute care treatment facilities. Mr.Przybyszewski responded to questions about previous drug wholesale experience by indicating this was his initial venture in this area.

There being no questions from the Board, on motion by Mr. McAllister and Mr. Draugalis, the wholesale drug permits numbered 1 - 3 were approved subject to final inspection by the compliance staff:

Pharmacist Licenses and Pharmacy Intern Licenses:

On motion by Mr.Draugalis and Mr. Ketcherside, following a review of the applications and the assurance that all applications were in order; the Board unanimously approved pharmacist licenses # S13083 through S13115 and pharmacist intern licenses # I05581 through I05597, see attachment A and B for complete listing of full names.

AGENDA ITEM III - REPORTS

Executive Director Lloyd called the Board’s attention to the copy of his report and to the financial statement and FYI items passed out at the meeting. Mr. Lloyd addressed the staffing situation and the impact of the ‘general state employee hiring freeze’ that has been imposed by the Governor. Lloyd provided alternative approaches to carrying out the mission of the Board in compliance visits to pharmacies, drug wholesalers and drug manufacturers. Mr. Lloyd also reminded Board Members of the annual NABP meeting being held in Phoenix and our responsibilities as the host state. Mr. Lloyd advised the Board that the staff was developing a ‘disaster mobilization plan’ for pharmacists to assist in large-scale disasters. Members were encouraged to make hotel reservations for the Tucson and Flagstaff meetings scheduled for May and August. During the ensuing discussion, a suggestion was made to start the out-of-town meetings at 10 a.m.

Deputy Director Hal Wand distributed the most recent Compliance Officer Report reflecting the year to date and prior year compliance activities. Considerable discussion followed; much of which focused on the obvious increase in inspections resulting from the increasing numbers of pharmacies. Mr. Wand introduced recently hired non-pharmacy inspector, Antonio ‘Tony’ Salcido, to the Board and the audience. Mr. Wand provided a brief summary of Tony’s background and work history. Mr. Wand reported that required compliance reports from Osco Drug have been received in a timely fashion. Mr. Wand indicated that he recently attended a C.E. meeting where he was asked by attendees to comment on a prescription flavoring process that has become controversial among pharmacists. Mr. Wand elaborated the issues raised by pharmacists and staff relevant to the propriety of altering a manufactured prescription product. Mr. Wand indicated that Mr. David Rosen, attorney, was present representing a company that provides concentrated flavoring ingredients used in customizing oral medications to improve palatability. A prolonged discussion between Board Members, staff and Mr. Rosen ensued. Mr. Rosen indicated that over 6,000 U.S. pharmacies are franchised to use the flavoring additives marketed by the company he represents and that statistics indicate that medication use compliance is dramatically improved when custom flavoring is added to oral meds. A myriad of comments and questions were directed to Mr. Rosen.

On completion of a lengthy and informative discussion, Mr. Wand directed the Board’s attention to a proposed Resolution included in the meeting material that is primarily intended for consideration by the National Association of Boards of Pharmacy. However the resolution may also serve as a reminder to Arizona pharmacists that state laws and rules addressing prescription compounding also apply to adding an ingredient to a pre-manufactured medication. Following their discussion; on motion by Mr. Drake and Mr. Draugalis, the Board unanimously agreed to adopt the resolution and to submit the resolution to NABP for consideration at their annual meeting.

Lisa Yates, program director for Pharmacists Assisting Pharmacists of Arizona(PAPA) presented a copy of the organization’s quarterly report and shared a concern involving a new confidential participant that is having a difficult transition. Lisa reviewed the new in-takes and indicated that the current participant roster is 35. Lisa advised the Board of a ‘Drug Abuse/Treatment’ C.E. program that is directed toward area chain pharmacy supervisors. Board Members reviewed the report and directed questions to Ms. Yates relevant to specific participants.

AGENDA ITEM IV - SPECIAL REQUESTS

John Kynyk appeared on his own behalf requesting that the Board eliminate the requirement for him to acquire intern hours, normally required for licensure in applicants that have not practiced pharmacy at least 400 hours in the previous calendar year, see R4-23-203.A.5. Mr. Kynyk argued that his most recent employment of nine years (05/92 to 06/01) as medical affairs manager for a major drug manufacturing firm met the qualifications of 400 hours of pharmacy practice required for reciprocity.

Following a lengthy discussion on the issue; on motion by Mr. McAllister and Mr. Drake, the Board voted four in favor and two opposed, to completely waive the intern experience hours and allow Mr. Kynyk to pursue reciprocity of his active Ohio license.

Dale Decker, CEO of Wickenberg Hospital appeared with Roger Wilder, Dir. of Nursing and Scott Russell, R.Ph. with Pharmerica to request the Board’s permission to reduce the number of hours of pharmacist coverage in the facility. Mr. Decker and others described the role and mission of the facility; the changing environment and the trend of residents leaving town when hospital care is needed. Following an in-depth discussion, with Board Members directing many questions to the individuals present and on motion by Mr. Ritt and Mr. Draugalis, the Board unanimously approved the request to operate the facility with a pharmacist present six hours per week and with daily drug delivery available from the contract pharmacy Monday thru Saturday; Mr. McAllister did not participate in this discussion or decision.

Jerry Gillick, R. Ph., withdrew his special request prior to the meeting and did not appear.

AGENDA ITEM V - PROPOSED ADMINISTRATIVE RULES

Compliance Officer/Rule Writer, Dean Wright reported that the proposed rules revisions to R4-23-501 and R4-23-502 are included the meeting book for discussion. Mr. Wright indicated that the article is a very limited length rule and the proposed revisions are likewise brief. Following a brief discussion with minor suggestions; the Board agreed to move ahead with the revision as discussed.

AGENDA ITEM VI - TABLET SPLITTING REQUIRED FOR REIMBURSEMENT

Executive Director Lloyd provided background relevant to this issue and called the Board’s attention to material relevant to the item that was included in the meeting book. Lloyd specifically cited an NABP resolution that was adopted by the national organization recently and briefly mentioned a few of the potential pitfalls related to pharmacists splitting tablets.

President Jones described his personal practice related experiences and solicited comments from Board Members and staff. Several Board Members offered comments and concerns related to this practice. Assistant Attorney General Victoria Martin was asked if she wished to add anything. Ms. Martin indicated she was not prepared at this time to comment. Board Member Linda McCoy suggested that the staff could contact Institute for Safe Medical Practice (ISMP) for further information. President Jones encourages the staff to follow-up on this suggestion and to revisit the topic in the future.

AGENDA ITEM VII - COMPLAINT REVIEW/RECOMMENDATIONS

Consumer Complaint Review Committee met March 6th prior to the Board Meeting. Member Paul Draugalis called the Board’s attention to the hand-out item Complaint Summary containing the committee recommendations. Mr. Draugalis then summarized each complaint and described the committee recommendation and solicited board member comment. Following a thorough discussion of the eleven complaints; on motion by Mr. Ritt and Mr. Drake, the Board voted unanimously to adopt the Review Committee recommendations detailed below:

• Complaint # 2506 - Letter of Warning (Computer Records)
• Complaint # 2509 - Dismissed
• Complaint # 2510 - Dismissed
• Complaint # 2511 - Conference
• Complaint # 2512 - Dismissed
• Complaint # 2514 - Conference (Review policy on pre-fills)
• Complaint # 2515 - Letter of Warning
• Complaint # 2519 - Letter of Warning (see #2506)
• Complaint # 2520 - Conference
• Complaint # 2523 - Letter of Warning (Verification of Rx & abbreviations)
• Complaint # 2525 - Letter of Warning (To PIC & computer personnel)

AGENDA ITEM VIII - CONSENT AGREEMENTS

President Jones announced that this was the time and the place in the matter of the following Notices of Hearing and Consent Agreements:

President Jones asked if there were any comments relevant to either of the Consent to Entry of Order issues before the Board. Pharmacist/Attorney Roger Morris speaking as counsel to Express Scripts Pharmacy, advised the Board that the company has committed approximately $300,000 to hiring additional pharmacists and to train Customer Service Representatives to better serve pharmacy clients that phone in for information relating to their medications. There being no additional comments, President Jones indicated that a motion would be in order.

On motion by Mr. Draugalis and Mr. Drake, the Board on a roll call vote unanimously agreed to adopt the Finding of Facts and the Conclusions of Law in the matter of Notice of Hearing: 02- 0001- PHR issued to Steven Genrich and Notice of Hearing 02 - 0002 - PHR issued to Express Scripts Pharmacy-Phoenix, AZ.

There being no additional discussion in either matter:

On motion by Mr. Draugalis and Mr. Ketcherside, the Board on a roll call vote unanimously agreed to adopt the Order in the matter of Notice of Hearing: 02- 0001- PHR issued to Steven Genrich and Notice of Hearing 02 - 0002 - PHR issued to Express Scripts Pharmacy-Phoenix, AZ.

At 4:20 p.m., President Jones, after announcing that the Board can not respond, invited comments from the audience prior to recessing the session for the day. At 4:30 p.m. the meeting was recessed until 8 a.m. 3/7/02.

President Jones called reconvened the meeting at 8:05 a.m.

AGENDA ITEM IX - CONFERENCES

COMPLAINT # 2484
Pharmacist John ‘David’ Hamilton and supervisor Nicole Littel were present pursuant to a consumer complaint. Compliance Officer Dean Wright provided the findings of his complaint investigation. President Jones asked Mr. Hamilton to tell the Board his recollection of the incident. Mr. Hamilton indicated that he was not certain but feels that the final pharmacist verification should have discovered the error...but didn’t. He admitted that proper patient counseling would have caught the error as well. Several questions from Board Members were directed to Mr. Hamilton focused on improving dispensing procedures in the pharmacy. Board members reminded Mr. Hamilton that the pharmacist is ultimately responsible for the prescription and must verify its accuracy before it leaves the pharmacy. Mr. Hamilton described a revised dispensing/verification process that should preclude recurrence of this error. Parties were dismissed and encouraged to be more careful.

COMPLAINT # 2485
Daisy Thomas and Supervisor Dan Almblade appeared pursuant to a consumer complaint alleging that a patient received the wrong strength of medication. Compliance Officer Cheryl Frush provided an overview of her investigation which included a comment that all the tablets in the bubble packaged LTCF prescription were positioned such that the tablet identification was facing down and impossible to read. President Jones asked Ms. Thomas to describe and comment on the pharmacy policy/procedure of filling and verifying the accuracy of bubble packed medications. Following her response, Supervisor Dan Amblade indicated that an revised procedure was recently initiated; he described the process and indicated the new method was an improvement. In concluding the conference President Jones encouraged both of the conferees to continue to look for opportunities to improve their dispensing/verification procedures and focus on patient safety.

COMPLAINT # 2492
Pharmacist Raymond Schmal accompanied by an attorney, appeared pursuant to a consumer complaint alleging a dispensing error on a prescription issued to the complainant’s 7 year old daughter. Compliance officer Sheryl Frush summarized the findings of her investigation. President Jones asked Mr. Schmal to provide his recollection of the incident and to describe what changes can be made to preclude a recurrence of this alleged dispensing error in the future. President Jones indicated that patients have the expectation that they can speak with a pharmacist when questions relating to a prescription surface. The consumer believed that the pharmacy knew/or should have known that an error occurred and should have contacted them immediately. President Jones encouraged Mr. Schmal to focus on the patient’s health, make the extra effort to communicate and initiate corrective action promptly in the event of a dispensing error.

COMPLAINT # 2493
Pharmacist Sharyn Flanagan and Supervisor Nicole Littel, were present pursuant to a consumer complaint alleging a mislabeled prescription that was dispensed several times with the wrong directions. Compliance Officer Dennis Waggoner was present and provided an overview of the board’s investigation in this matter. President Jones asked Ms. Flannagan to relate to the Board her recollection of this incident including measures that have been implemented at the pharmacy to preclude a recurrence of this event. Following an exchange of questions/answers from board members, President Jones dismissed Ms. Bittinger with the admonition to carefully review labels of refilled prescriptions as well as new ones and that careful attention be given to accuracy.

COMPLAINT # 2503
Pharmacist Kelly Seabloom and Technician Nicole Coker were present pursuant to a consumer complaint alleging a mislabeled prescription. Compliance Officer Dennis Waggoner provided a review of his complaint investigation. President Jones asked Ms. Seabourn to provide her recollection of the incident leading to the complaint. Board members then directed questions to pharmacist Seabloom relevant to the investigation. Ms. Seabloom agrees with the findings of Mr. Waggoner’s report and believes that Ms. Coker had simply made a typing error that was not caught in the pharmacist’s verification.

President Jones concluded the conference by asking Ms. Seabloom what she had learned from the conference and what she would do to avoid a recurrence of this event. Ms. Seabloom committed to being more focused when verifying a prescription.

COMPLAINT # 2505
Pharmacists Shane Berthelot and Chuck Sinn, appeared with supervisor Nicole Littel. Compliance Officer Dennis Waggoner was present to provide the findings of his investigation. Mr. Waggoner described the pertinent parts of the investigation of this consumer complaint and indicated that it is likely that a misfilled Baker cell contributed to this error. President Jones asked Mr. Berthelot to provide his recollection of the incidents leading to this consumer complaint. Mr.Berthelot felt that the because a third pharmacist (floater) became involved, communications with the patient were not ideal. Additionally, Mr. Berthelot recalls opening the prescription vial to verify the accuracy, however, the correct medication and the errant medication were of similar size, color and shape making a quick differentiation difficult. Following his presentation, Mr. Berthelot was asked to describe the policy/procedure for refilling the Baker cells, his response included an improved filling verification process. Board Members directed questions to Mr. Berthelot and offered suggestions to preclude similar situations in the future. President Jones encouraged Mr. Berthelot to periodically review critical patient safety procedures.

AGENDA ITEM X - PROPOSED LEGISLATION

Executive Director Lloyd stated that while reviewing a recent NABP news release acknowledging that NABP has signed an agreement to partner with the Pharmacy Technician Certification Board to develop, administer and score the certification examination for pharmacy technicians, he was struck by the fact that NABP’s test development reputation will dramatically improve the credibility of the pharmacy technician certification process. With the improved reliability, accessability and outcome measurement verification; resistence to technician registration will be decreased. The result may be that the profession and the industry in Arizona will support registration of pharmacy technicians by the board of pharmacy. One of the precursors to technician registration is legislative endorsement and statutory authority.

Kathy Boyle of the Arizona Pharmacy Association shared her experience in this process while seeking approval for the ‘collaborative practice role for pharmacists’.

The Board directed questions to both Mr. Lloyd and Ms. Boyle and concluded the discussion by encouraging the staff to proceed with the process of registering pharmacy technicians.

AGENDA ITEM XI - ARIZONA PHARMACY ASSOCIATION REPORT

Kathy Boyle, Executive Director of the Arizona Pharmacy Association(APA) presented a review and status report of the pharmacy related legislation before the legislature. Ms. Boyle concluded her remarks and invited questions from Board Members. Ms. Boyle reported that the state legislature has suspended action on new bills and instead is focused on resolving the state budget issue, therefore there is not much to report at this point.

AGENDA ITEM XII - HEARINGS

This item appeared on the agenda in the event that a ‘consent order’ failed to be accepted and a hearing was required....both ‘consent orders’ were signed, as a result no hearings were held.

AGENDA ITEM XIII - NABP ANNUAL MEETING

Executive Director Lloyd reviewed the dates and registration procedure for the annual NABP meeting being held in Phoenix. Lloyd encouraged all board members and compliance staff to plan on attending. On the opening day of the meeting there is a ‘hospitality suite’ traditionally staffed by the ‘host state’ board of pharmacy. All available parties were encouraged to participate. The issue of everybody buying and wearing a ‘board of pharmacy logo’ shirt was discussed and agreed on.

Lloyd discussed the selection of an official delegate and an alternate for the meeting. It was suggested that the Board President be the official delegate and the Vice President be the alternate. Both Mr. Jones and Mr. Draugalis are planning on attending and agreed to accept the responsibility of these positions.

AGENDA ITEM XIV - FOREIGN PHARMACY GRADUATES (LICENSURE REQURIEMENTS)

Board Member Dennis McAllister spoke to this issue indicating that it his perception that historically the board decisions have lacked consistency in determining how many ‘graduate-intern’ hours a particular foreign graduate may require prior to licensure as a pharmacist.

An extensive open discussion among board members and staff followed. An issue that seemed to be agreed on by all present was that ‘competency’ to practice is a very difficult define and measure. Setting a hard and fast rule appears to be impossible, however developing ‘guidelines’ that address various aspects of: education, English language skills and pharmacy practice experience may be of value. Staff will begin the process by seeking legal advice as to granting graduate intern hour reductions pursuant to applicable ‘guidelines’.

AGENDA ITEM XV - FIVE YEAR RULES REVIEW

Compliance Officer/Administrative Rules Expert, Dean Wright advised the Board of the need to complete a 5-year rules review of a portion of the Board’s Administrative Rules. Mr. Wright indicated that because of revision activity within the last year on various rules, there are just twelve sections in Articles I-V requiring review by July 2002.

Mr. Wright also reported that recently revised rules R4-23-406, 407, 408 and 409 have received GRRC approval and are now in place. Mr. Wright provided a summary on the status of the ‘Collaborative Practice’ rule, indicating that a courtesy review by GRRC had revealed numerous reformatting suggestions. Dean will make the suggested changes and submit a copy to the Board at the May meeting with the expectation that final approval will be January 2003.

Executive Director Lloyd commended Mr. Wright on his efforts in the area of Administrative Rules writing and revision.

AGENDA ITEM XVI - ELECTRONIC PRESCRIPTION MONITORING

Deputy Director Hal Wand initiated the discussion on this topic. Mr. Wand indicated that Arizona was the only state in the southwest not having some form of controlled substance prescription monitoring program. Mr. Wand further stated that there are public and private funding sources available to assist states with start-up costs and that subsequent program costs are generally off-set by fees from a state controlled substance registration. Most state programs are considered to be ‘cost-neutral’. Benefits of having a monitoring program include: identifying ‘drug-seeking’ individuals and directing them to treatment programs, reducing ER visits resulting from drug over-doses, freeing up practitioners time to better treat legitimate patients, improve the quality of life in the state and assist law enforcement in their role of reducing illicit controlled substance use. Mr. Wand also suggested that other state agencies may be interested in assisting in the development and initiation of such a program.

Following a hearty discussion, President Jones asked for an informal indication of Board Member support or opposition. The Board unanimously support the concept and encouraged staff to pursue the issue and report back.

AGENDA ITEM XVII - CALL TO THE PUBLIC

As he had done on Wednesday, President Jones announced a call to the public as this session draws to a close. In doing so, he commented that the Board may only hear the comments, they may not discuss or act on them at this meeting. Pharmacist/attorney, Roger Morris offered an item for the Board’s future consideration: legally there is a difference between a pharmacist having an ‘active license’ and a pharmacist ‘actively practicing’.

AGENDA ITEM XVIII - ADJOURNMENT

There being no further business to come before the Board, President Jones entertained a motion to adjourn. On motion by Mr. Ketcherside and Mr. Draugalis, and unanimously approved, the meeting was adjourned by President Jones at 11:05 a.m.