and complete a review course such as Morris Cody.
There was one nay vote by Dr. Tippett.
#18 Mamta Praful Desai
Mamta Praful Desai appeared with Legal Counsel, Roger Morris, to request the Board waive the requirement that each candidate for FPGEC certification, graduating from a pharmacy program after January 1, 2003 must have completed a minimum five-year pharmacy curriculum.
President Dutcher opened the discussion by asking Ms. Desai to describe the nature of her request.Ms. Desai stated that she is present to ask the Board to waive the FPGEC certification.
Mr. Dutcher asked Ms. Desai why she needed that waiver.
Ms. Desai stated that she graduated from a four-year degree pharmacy program after 2003 and NABP stated that after January 1, 2003 that they have a minimum requirement of a five-year degree.
Mr. Dutcher asked Ms. Desai if it was possible for her to take that exam earlier.
Ms. Desai stated that due to visa issues she had to return to the United States and as a result did not graduate in
2002 as anticipated, but graduated in 2003.
Mr. Dutcher asked Ms. Desai if she left three weeks before school ended.
Ms. Desai stated that she left three weeks before school ended in 2001 to take care of visa issues before she turned 21 years of age.
Mr. Morris stated that the requirements changed in 2002 and Ms. Desai was not aware of the requirements at that time.
Mr. Dutcher asked Ms. Desai about her visa issues.
Ms. Desai stated that she had various visa issues because of September 11, 2001. Ms. Desai stated that NABP denied her request because she did not complete a five-year program.
Mr. Morris stated that Ms. Desai has been involved in the NABP process for the last year and a half. Mr. Morris stated that Ms. Desai has passed the TSE exam, TOEFL exam, Morris-Cody review exam, and has passed the certified technician
exam. Ms. Desai is currently working as a technician.
Mr. Dutcher asked Ms. Desai about the five-year program.
Ms. Desai stated that the country from which she obtained her degree does not offer a five-year program.
Mr. Dutcher asked if Ms. Desai could have completed a program in the states.
Ms. Desai stated that she would have had to go through the whole three year program and she would have needed additional courses. Ms. Desai stated that they would not transfer all of her credits.Mr. Morris stated that she is asking for a waiver to complete her intern hours and be able to take the exams. Mr. Morris stated that he cannot conceive of any other student in the same situation.
On motion by Dr. Smidt and Dr. McCoy, the Board unanimously approved Ms. Desai's request to waive the FPGEC certification and proceed with the licensing requirements.
AGENDA ITEM 4 - Reports
Executive Director
Executive Director Wand began his report by discussing the financial reports. Mr. Wand stated that the Board will have a carryover amount this year and can be used in the following year. Mr. Wand stated that Dr. Smidt has offered to assist in the Budget process. Mr. Wand stated that the Board Members can offer input into what they would like to see in the budget. Mr Wand stated that he would like to obtain additional funding for the PAPA program.
Mr. Wand introduced Tiffany Poetsch. Ms. Poetsch was hired as the new Records Supervisor. Ms. Poetsch will be responsible for the maintaining of the office records and the processing of the disciplinary records for NABP. Ms. Poetsch has a Masters Degree in Library Science.
Mr. Wand asked Board Members to submit to him any topics that they would like discussed in the upcoming newsletter.
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 fact that January was spent inspecting non-prescription outlets and educating the owners about the new pseudoephedrine regulations. Ms. Frush stated that the number of complaints and number of investigations for diversions are continuing to grow.
Ms. Frush stated during th months of March and April the Compliance Staff issued letters for the following violations:
Controlled Substance Violations
- 1. Controlled Substance Overage - 2
- 2. Controlled Substance Shortage - 6
- 3. Controlled Substance Inventory Not Complete - 1
- 4. Failure to Conduct Controlled Substance Inventory upon change of Pharmacist in Charge - 2
Documentation Violations
- 1. Failure to Document Medical Conditions - 6
- 2. Failure to Document Required Information on an oral prescription - 1
- 3. Failure to Document Agent's name authorizing refill - 1
- 4. Unable to produce a drug specific report - 1
- 5. Failure to have signed technician statements concerning job description, policies, and
procedures and board rules - 6
- 6. Failure to have a technician training manual - 2
- 7. Failure to have a technician Policies and Procedures manual - 3
- 8. Daily prescription log not signed - 2
Dispensing Violations
- 1. Dispensing a faxed CII prescription without obtaining the original prescription - 1
- 2. Failure to follow Current Good Compounding Rules - Calculations - 1
- 3. Drugs removed from Limited Service facility without proper documentation - 1
- 4. Failure to input the correct date written into the computer system - 1
- 5. Allowing a pharmacy technician trainee to compound - 1
- 6. Outdated Rx and OTC items in the pharmacy - 1
- 7. Failure by the pharmacist to sign off on prepackaged products - 1
Pharmacy Violations
- 1. Allowing technicians to work without a license - 2
- 2. Allowing a technician to work with an expired license - 2
- 3. Wall certificates not posted - 5
- 4. Pharmacy permit not available -1
The following areas were noted on the inspection reports for improvement:
- 1. Documentation of health conditions
- 2. Documentation of agent's name authorizing new prescription or refill via telephone
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. Change of address
- 2. Physicians assistants can write a CII for a 72 hour supply and if certified for a 14 day supply.
The Board adjourned for lunch recess.
The meeting reconvened at 1:15 P.M. President Dutcher called the meeting to order.
AGENDA ITEM 5 - Proposed Rules
Electronic Prescription Rules
Compliance Officer/Rules Writer Dean Wright opened the discussion by stating that he has made the changes the Board requested at the March meeting. Mr. Wright stated that he has added language to require offsite storage of backup files and a requirement for a quality assurance program.
Mr. Dutcher asked if it was necessary to ask for the address of the practitioner on a refill
authorization since most refill authorization requests are usually initiated by the pharmacy and
the pharmacy has the information on file.
Mr. Wright stated that he can remove that from the rule.
Mr. Dutcher asked if it is necessary to obtain the full name of the medical practitioner's agent
authorizing the refill. Mr. Dutcher stated that he feels the last name is not necessary and the first
name is sufficient.
Mr. Wright stated that he can eliminate full name and insert name.
Mr. Dutcher asked about the retention of the original hard copy prescriptions if an electronic
imaging recordkeeping system is used.
Mr. Wright stated that the original hard copy must be maintained for at least 30 days.
The Board authorized Mr. Wright to proceed with the rulemaking process.
Policies and Procedures and Intern Rules
Mr. Wright stated that a Public Hearing was held on May 15, 2006. One individual, Janet Elliott, representing the Arizona Community Pharmacy Committee attended the hearing. Ms. Elliott spoke in favor of the proposed rulemaking.
Written comments were received from Ms. Elliott.
There were no comments requesting any changes to the rule.
Mr. Wright stated that he has 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 will be presented to GRRC for their August 1, 2006 meeting agenda for final approval with the rules. If approved by GRRC, the rules would become effective on September 30, 2006.
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 changes in the Policies and Procedures rules and the Intern rules,
Pharmacist's Initials to Document Counseling Rule
Mr. Wright stated that a Public Hearing was held on May 15, 2006. One individual, Janet Elliott, representing the Arizona Community Pharmacy Committee attended the hearing. Ms. Elliott spoke in opposition of the proposed rulemaking. Written comments were received from Ms. Elliott. The Arizona Community Pharmacy Committee (ACPC) requested that the Board
reconsider amending the proposed rules that would require the documentation of the name or initials of the pharmacist, graduate intern, or pharmacy intern who does or does not provide oral consultation on a new prescription. ACPC feels that this proposed requirement would unfairly place a pharmacist or intern in jeopardy by expecting them to remember facts of a conversation with a patient regarding counseling.
Mr. Wright stated that he has made changes recommended by the staff in Subsection 10 and Subsection 15 which he has handed out to the Board Members. Mr. Wright stated that Section 10 will require the pharmacist to check prescription order data entry to ensure the prescription is entered correctly. The change in Subsection 15 would require the pharmacist to verify or take responsibility to verify that the prescription medication is sold to the correct patient and if necessary the pharmacist should obtain positive identification of the person who picks up the completed prescription.
Several Board Members expressed concerns that individuals may not be able to produce an ID and felt it was not necessary to pick up a prescription. Mr. Dutcher stated that checking ID may prevent the wrong prescription from being given out to the wrong patient and may prevent fraud. The Board Members agreed to allow the proposed change if the requirement for ID was removed.
Mr. Wright stated that he would make the change.
Dr. Smidt stated that the rule change to document the pharmacist's initials that performed counseling does not require them to recall the conversation. Dr. Smidt stated that the documentation of the initials would protect the pharmacist.
Mr. Dutcher added by documenting the initials the Board would be able to identify who did or did not perform counseling instead of bringing the whole staff in front of the Board.
The Board Members agreed to keep the changes to subsection 4, subsection 10, and subsection 15 with the requested modifications. The Board granted approval to Mr. Wright to proceed with a Notice of Supplemental Proposed Rulemaking.
Automated Storage and Distribution System/ Mechanical Counting Devices.
Mr. Wright stated that a Public Hearing was held on May 15, 2006. One individual, Janet Elliott, representing the Arizona Community Pharmacy Committee attended the hearing. Ms. Elliott spoke in support of the proposed rulemaking. Written comments were received from Ms. Elliott. Mr. Wright stated that he received written comments from NACDS expressing their concerns. Mr. Wright stated that NACDS requested that the pharmacy can document electronically the policies and procedures. Mr. Wright stated the policies can be written or in a manner approved by the Board. Mr. Wright stated that the Board does approve the documentation of the policies electronically.
Mr. Wright stated that he has added a new section for mechanical counting devices that do nothing but count medications and do not store the medication. Mr. Wright stated that Section R4-23-615 deals with mechanical storage and counting devices for drugs in solid, oral dosage forms. This would include machines such as baker cells and ScriptPro. Mr. Wright stated that Section R4-23-616 would deal for mechanical counting devices such as scales and Kirby-Lester machines.
Mr. Wright stated that an issue has arisen concerning medications that have been returned to stock. Mr. Wright stated that he has added language to require the pharmacist to return the medication to the correct cell and document the return. Mr. Wright stated that the medication could be left on the shelf to be counted again.
Dr. Smidt stated that in either case the pharmacist would be responsible for checking the product.
Mr. Dutcher stated that often technicians are not as careful as pharmacists in returning the drugs.
Mr. Wright stated that the filling of the cell is checked after the fact.
Dr. Smidt asked if there is a difference between the stock bottle and the return to stock.
Mr. Wright stated that there is no way to bar code a return to stock bottle. Mr. Wright stated that there are no processes to cover return to stock medications. Mr. Wright stated that a stock bottle has a lot number and a return to stock bottle does not have a lot number. Mr. Wright stated that since there is not a lot number then the return to stock bottle medication should not be placed in the cassette.
Dr. McCoy stated that she agrees that the Return to Stock bottle should not be returned to the cell and the other Board Members agreed.
Mr. Wright stated that NACDS requested that R4-23-615 (B)(2) be amended to allow any prescriptions that do not require oral consultation be placed in the automated storage and distribution system. Mr. Wright stated that previously the section read that only refilled prescriptions could be placed in the storage system. Mr. Wright stated that he has made that
change.
Mr. Wright state that R4-23-616 was a result of the site visits. Mr. Wright stated that the rules have been added to ensure that the devices are calibrated and working properly.
Dr. McCoy asked if they would need to maintain a log.
Mr. Wright stated that would be part of their policy and procedures.
The Board authorized Mr. Wright to proceed with the rulemaking process.
Shared Services Rules
Mr. Wright stated that a Public Hearing was held on April 3, 2006. Mr. Wright stated that Janet
Elliott of the Arizona Community Pharmacy Committee and Matt Cook and Dan Luce from Walgreens attended the Public Hearing. Ms. Elliott provided written comment requesting the Board to change the proposed rules.
Ms. Elliott is requesting that R4-23-621(E)(3)(f) be changed to read: ' ... operating a continuous quality improvement program for shared services designed to resolve identified problems."
Mr. Cook and Mr. Luce spoke in favor of the rule but agreed with the change proposed by Ms. Elliott.
The Board received written comment from NACDS concerning the language in R4-23-621 (D) (1) and (2) that requires a record of the name of each pharmacist, graduate intern, pharmacy intern, pharmacy technician, and pharmacy technician trainee who participates in the filling, dispensing, counseling, drug use review, refill authorization, or therapeutic intervention functions.
Mr. Wright stated that NACDS feels that most pharmacy computer systems may not have the capability to capture each of the names involved in the prescription filling process. Mr. Wright stated that the changes have been made and it now states that manual or electronic records must be maintained identifying the pharmacist or intern responsible for each order processing function.
Mr. Wand stated that recording the name may not prevent the mistake but may lead back to the root cause of the problem if an error occurs.
Dr. Smidt stated that most systems can document people who changed an order. The initials may not be upfront but may be in the background somewhere.
Mr. McAllister stated that the Board should be encouraging the pharmacies to upgrade their systems to record these processes and allow a time frame to implement the changes.
Dr. McCoy stated that she agrees and the Board needs to identify who is responsible for the errors.
Mr. Van Hassel stated that he feels that if a quality assurance monitoring program is in place then the initials are not needed.
The Board requested that Mr. Wright proceed with the rule as proposed.
Mr. Wright asked about the changes requested to the quality assurance program.
Dr. Smidt stated that the requested change was to have a quality assurance program in place to resolve identified problems. Dr. Smidt stated that the purpose of a quality assurance program is to identify problems.
Dr. McCoy stated that the purpose of a quality improvement program is to look at your system to prevent errors from occurring in the first place.
The Board authorized Mr. Wright to proceed with the rulemaking process and to proceed with the rule as proposed.
AGENDA ITEM 6 - Complaint Review
The Consumer Complaint Review committee met prior to the Board Meeting to review 56 complaints.
Dr. Berry, Dr. Sypherd and Ms. Honeyestewa served as the review committee.
Board Members were encouraged to discuss issues ane were encouraged to ask questions.
The following summary represents the final decisions of the Board in each complaint:
- Complaint #3067
No Further Action
- Complaint #3068
Advisory Letter
- Complaint #3069
No Further Action
- Complaint #3070
Advisory Letter
- Complaint #3071
No Further Action
- Complaint #3072
No Further Action
- Complaint #3075
Conference/Pharmacist
- Complaint #3077
Conference/Technician
- Complaint #3078
Conference/Pharmacist
- Complaint #3079
Conference/Pharmacist
- Complaint #3080
No Further Action
- Complaint #3085
No Further Action
- Complaint #3086
Advisory Letter
- Complaint #3087
No Further Action
- Complaint #3088
Advisory Letter
- Complaint #3089
No Further Action
- Complaint #3099
Advisory Letter
- Complaint #3100
Advisory Letter
- Complaint #3101
Conference/Pharmacist
- Complaint #3102
Conference/Pharmacists
- Complaint #3103
No Further Action
- Complaint #3104
No Further Action
- Complaint #3105
Conference/Technician
- Complaint #3106
No Further Action
- Complaint #3107
No Further Action
- Complaint #3108
Conference/Pharmacist
- Complaint #3109
Advisory Letter
- Complaint #3110
Conference/Pharmacist
- Complaint #3111
No Further Action
- Complaint #3112
No Further Action
- Complaint #3113
Advisory Letter to District Supervisor concerning Complaint Reply
- Complaint #3114
Conference/Pharmacist
- Complaint #3115
Advisory Letter
- Complaint #3116
Advisory Letter
- Complaint #3117
No Further Action
- Complaint #3118
No Further Action
- Complaint #3119
Advisory Letter
- Complaint #3121
Withdrawn
- Complaint #3122
Conference/Pharmacist and Technician
- Complaint #3123
Conference/Technician
- Complaint #3124
Conference Pharmacist
- Complaint #3125
Consent/Hearing (Revocation)
- Complaint #3126
No Further Action
- Complaint #3127
No Further Action
- Complaint #3128
No Further Action
- Complaint #3129
Withdrawn
- Complaint #3130
Conference/Pharmacist
- Complaint #3131
Conference/Pharmacist
- Complaint #3132
Conference/Pharmacist
- Complaint #3135
No Further Action
- Complaint #3138
Consent/Hearing (Revocation)
- Complaint #3145
Consent/Hearing (Revocation)
- Complaint #3146
Consent/Hearing (Revocation)
- Complaint #3147
Consent/Hearing (Revocation)
- Complaint #3148
Consent/Hearing (Revocation)
- Complaint #3149
No Further Action
AGENDA ITEM 7 - Conferences
Complaint #3026
Pharmacist In Charge Pamela Huntoon and Pharmacy Supervisor Holly Prievo were present in
response to a consumer complaint.
Compliance Officer Dean Wright gave a brief overview of the complaint.
Mr. Wright stated a three-year old patient received Strattera prescribed and labeled for a ten-year
old patient with the same first and last name. The only difference is the ten-year old has an "e" at
the end of her first name. The three-year old took four doses of Strattera before the error was
discovered. A cashier gave out the wrong drug.
President Dutcher asked Ms. Huntoon if this was a new or refill prescription.
Ms. Huntoon stated that they were all new prescriptions.
Mr. Dutcher asked if the pharmacist should have been handing out the prescriptions since they were new prescriptions
and the patient should be counseled.
Ms. Huntoon stated that the cashier rings up the prescription and then sends the patient to the pharmacist for counseling.
Mr. Dutcher asked if the patient was sent to the pharmacist for counseling.
Ms. Huntoon stated that counseling was declined.
Mr. Dutcher asked Ms. Huntoon what has been done at the pharmacy to ensure that the correct patient receives the correct medication.
Ms. Huntoon stated that their policy is to verify the address on all prescriptions.
Ms. Huntoon stated that the policy was reinforced when the pharmacy was notified of the error. Ms. Huntoon stated a notice was posted and a verbal warning was given to everyone. Ms. Huntoon stated that they have a three strikes policy in their pharmacy and upon the third strike the individual is terminated.
Mr. Dutcher asked if there is a procedural problem at the pharmacy.
Ms. Huntoon stated that she is not sure if the clerk verified the address on both bags.
Dr. McCoy asked Ms. Huntoon if the pharmacy knows that there are two patients with the same name is there anything they do proactively to separate the bags.
Ms. Huntoon stated that if there are two patients that they know have the same name they will add a middle initial or add a note to the address indicating that there are two patients with the same name.
Dr. Smidt asked if either patient was new to the pharmacy.
Ms. Huntoon replied no.
Dr. Smidt asked Ms. Huntoon if the technician asked the patient if they wanted to speak to the pharmacist.
Ms. Huntoon stated that the technician would tell the patient that the pharmacist would like to speak to you about your medication and ask the patient to step over to the window. Ms. Huntoon stated at this point the patient refused counseling.
Dr. Smidt asked if the technician makes the judgment concerning counseling.
Ms. Huntoon states that the technician asks the patient to step to the counseling window.
Dr. Smidt asked if the patient pays for the medication and is given the medication and then asked to step to the counseling window.
Ms. Huntoon stated that before the patient pays for the prescription the technician will tell the patient that this is a new prescription and the pharmacist will want to review the prescription with you. Ms. Huntoon stated as this point the technician has the option to select accept or deny counseling. Ms. Huntoon stated that if the patient accepts counseling the prescription is passed to the pharmacist.
Dr. Smidt stated then the decision to counsel is left up to the technician's judgment.
Mr. Dutcher asked Ms. Huntoon if there are other patients at her store with the same name.
Ms. Huntoon stated that there are other patients.
Mr. Dutcher asked if there were any flags in the computer system for these two patients.
Ms. Huntoon stated no.
Mr. Dutcher asked if they havea policy in place.
Ms. Huntoon stated that when a patient drops off a prescription and the technician entering the prescription notices a duplicate name then they will add a middle initial or a message on the address line.
Mr. McAllister stated that he is concerned that the technicians are making decisions concerning counseling. Mr. McAllister stated that other pharmacies have been sanctioned for allowing technicians to make the decision on counseling. Mr. McAllister stated in this case the care-giver does bear some responsibility to question why a doctor would prescribe a capsule when her child takes liquid medications.
Mr. Van Hassel asked about the address on the label. On the label after the address it says add2. Mr. Van Hassel wanted to know if this was the designation used.
Ms. Huntoon stated that due to limited space that is all that appeared on the label. Ms. Huntoon stated that this note was added after the error.
Dr. McCoy stated that she thought when the counseling rules were changed that the technician could not accept the refusal of counseling.
Mr. Dutcher stated that all new prescriptions requiring consultation should go the consultation window. Mr. Dutcher stated that the patient should refuse counseling when they speak to the pharmacist.
Dr. Smidt stated that he knows from personal experience that the technician will document the refusal of counseling without any input from the pharmacist.
Ms. Frush read for the Board Members R4-23-402 (H) which states that a pharmacist, graduate intern, or pharmacy intern shall document or assume responsibility to document, that oral consultation is provided or: when a patient refuses oral consultation or a person other than the patient or patient's care giver picks up a prescription and oral consultation
is not provided, document or assume responsibility to document , that oral consultation is not provided....
Dr. Smidt stated that pharmacy technicians cannot accept the refusal.
Dr. McCoy stated that it is a pharmacist that determines if counseling is provided.
Mr. Wright stated that the issue is the documentation of counseling at the register. The technician enters yes or no into the register and then passes the prescription to the pharmacist. If the patient declines counseling then the register cannot be changed.
Mr. Dutcher asked Ms. Prievo to address the issue with their corporate office.
Mr. Wand stated that the Board could change the rule to remove the statement "assume the responsibility" to document and this would eliminate the technician from documenting counseling.
Dr. McCoy stated that the reason the statement was placed in the rules was to allow Walgreens to document the counseling on the register, but the intent was not to allow the technician to determine if counseling would take place.
Dr. Smidt asked Ms. Prievo what could be implemented to solve the problem tomorrow.
Ms.Prievo stated that signs have been added to the register to remind the person at the register to verify the patient's address. The sign reminds the person to ask for the address versus reading the address to the patient. Ms. Prievo stated that there are pilot programs in other parts of the country that offer a payment to the patient if the cashier does not ask for the patient's address. Ms. Prievo stated that documentation changes on the register would need to be changed by
corporate.
Dr. Smidt asked if the pharmacist would need to log onto the register to document counseling.
Ms. Prievo replied yes and that they are testing other systems in other areas but at this time there would be no easy fix.
Dr. Smidt asked if a hard copy log could be kept.
It was noted that Walgreens does not maintain any hard copy logs.
Mr. Dutcher asked if a key pad could be located near the pharmacist to document counseling.
Dr. Smidt stated that if he was a pharmacist he would want to document everything to ensure there were no problems.
Mr. Dutcher asked Ms. Huntoon what has changed in the pharmacy.
Ms. Huntoon stated that she is constantly aware if the technicians are asking for the address. Ms. Huntoon stated that she counsels the patient and really does not give them the option of refusing counseling.
Mr. Dutcher asked Ms. Prievo discuss the Board's recommendations with her corporate office.
Complaint #3051
Pharmacist John Markus and Pharmacy Supervisor Sean Duffy were present to answer questions concerning a consumer complaint.
Compliance Officer Sandy Sutcliffe gave a brief overview of the complaint. Ms. Sutcliffe stated that the patient received Lisinopril 40 mg instead of Trazadone 50mg in his prescription vial. The patient took two doses of the incorrect medication.
President Dutcher asked Mr. Markus how Lisinopril was placed in the Trazadone bottle.
Mr. Markus stated that he believes that he placed the wrong label on the wrong bottle.
Mr. Dutcher asked Mr. Markus if he had technician help that day.
Mr. Markus stated that there is usually one pharmacist and one technician working at the same time.
Mr. Dutcher asked Mr. Markus if the two products look the same.
Mr. Markus stated that the products do not look alike and he probably did not complete the final verification.
Mr. Dutcher reminded Mr. Markus to be careful and to fill one prescription at a time.
Complaint #3056
Pharmacy Owner Craig Mathews and Legal Counsel Roger Morris were present to respond to a consumer complaint.
Ms. Frush stated that the other pharmacist and technician involved were not able to attend the meeting and asked for a postponement until the July meeting. The technician sent a letter to the Board but the Board is requesting that he appear at the Julymeeting.Compliance Officer Larry Dick gave a brief overview of the complaint.
Mr. Dick stated that the complainant, a pharmacist, stated that a technician employed at the pharmacy gave her a vial of expired Oxycontin 75 mg SR capsules at his home for her use. The bottle contained 65 capsules. Mr. Dick stated that he spoke to the technician and was told by the technician that he did not take the capsules from the pharmacy.
President Dutcher asked Mr. Mathews about the changes he has made at his pharmacy to ensure that this does not occur again.
Mr. Mathews stated that he now keeps all outdated products in a locked container. Mr. Mathews stated that he keeps a perpetual inventory of all medications in the locked container. Mr. Mathews stated that he has placed a lock on the swinging door between the dispensing area and the lobby. Mr. Mathews stated that he is conducting a monthly audit of his controlled substances used for compounding. Mr. Mathews stated that he is not compounding in excess of the quantity indicated on the prescription. Mr. Mathews stated that this change will insure that no extra capsules are compounded which could result in expired product. Mr. Mathews stated that he is more closely monitoring the powders used for compounding.
Mr. Dutcher asked Mr. Mathews if he had procedures in place prior to the incident.
Mr. Mathews stated that these are new procedures.
Mr. Dutcher asked Mr. Mathews if he did audits between the annual inventory previously.
Mr. Mathews stated that he did not.
Mr. Dutcher asked Mr. Mathews if the technician is still working for him.
Mr. Mathews stated that he suspended the technician and the technician sent him a letter terminating his employment.
Mr. Mathews stated that as far as he knows the technician is working as a carpenter at this time.
Dr. Smidt asked if everyone was asked to appear.
Ms. Frush indicated that the pharmacist has asked for a postponement and the technician has sent a letter to the Board but was told that he would be sent a letter to appear at the July meeting.
Dr. Smidt asked if the pharmacist is practicing in Arizona. Dr. Smidt stated that he is concerned about the numerous letters that she wrote.Ms. Frush stated that the pharmacist asked to postpone her conference so that she is able to bring an evaluation from her physician to the Board.Mr. Wand stated that conferences are held for fact finding.
Mr. Wand stated that the Board could order a psychological exam.
Dr. Smidt stated that this may have been a bad cycle in her life and asked if the pharmacist could bring the evaluation with her.
Mr. McAllister stated that this involves a relationship that went wrong and feels that we do not have enough information to make a decision.
Dr. McCoy stated that she is concerned that an unsafe practitioner may be working.
Mr. Van Hassel asked Mr. Mathews if he thought Mr. Lamont took the medication from his pharmacy.
Mr. Mathews stated that he is not certain who took the medication.
Mr. Dutcher asked if the pharmacist every worked for him.
Mr. Mathews stated that the pharmacist never worked for him. Mr. Mathews stated that her story changes every time.
Mr. Wand stated that the Board could take action if the respondent refuses to appear for a conference, but in this case the respondent has asked for a postponement.
Mr. Wolf stated that at this time all the Board has is a suspicion. Mr. Wolf stated that would be sufficient grounds for
ordering an evaluation.
Mr. Dutcher stated that Mr. Mathews has changed his practice substantially and hopes this never occurs again.
Complaint #3058
Pharmacist Jane Douglas, Pharmacist Chung Ma, Pharmacy Supervisor Vincent Bona, and Director of Pharmacy Services Jason Reiser appeared to discuss a consumer complaint.
Compliance Officer Rich Cieslinski gave a brief overview of the complaint.
Mr. Cieslinski stated that the patient and doctor allege that a prescription for Synthroid 0.075 mg was phoned to the pharmacy and was transcribed as Synthroid 0.175 mg by the pharmacist. The doctor's office phoned to the same pharmacist a prescription for Synthroid 0.075 mg and Synthroid 0.05 mg to be dispensed as written. The pharmacist took the prescriptions as the generic being approved. The prescriptions were counseled by a different pharmacist and the complainant stated that she was not told that the medications were generic.
President Dutcher opened the discussion by asking Ms. Douglas if the patient was a regular patient at the pharmacy.
Ms. Douglas replied yes.
Mr. Dutcher asked if the patient had been on Synthroid.
Ms. Douglas replied yes.
Mr. Dutcher asked why the prescription was filled generically.
Ms. Douglas stated that when the patient picked up the original prescription she complained about the high copay because the product was brand name.
Ms. Douglas stated that when the doctor phoned in the prescription the second time the generic was dispensed because
the doctor did not state that the prescription should be Brand name. Ms. Douglas stated that if the patient is present she will ask if the patient wants the generic medication. Ms. Douglas stated that she was not present when the patient picked up the prescription.
Mr. Dutcher asked Ms. Douglas when the prescription is data entered will the computer show that the patient has had Synthroid in the past.
Ms. Douglas stated that the profile is for Synthroid. Ms. Douglas stated that she has to manually go to the patient profile.
Mr. Reiser stated that it is part of the DUR check to review the patient profile.
Mr. Dutcher stated that if the patient has been on Synthroid for the last five years there would be no need to change to the generic unless the patient asked for the generic.
Mr. Reiser stated that he has spoke with Ms. Douglas about checking with the doctor or the patient when the patient has been on the Brand name product.
Mr. Dutcher asked about the counseling.
Mr. Cieslinski stated that the patient does not believe she was counseled properly. Mr. Cieslinski stated that Ms. Douglas stated that she did counsel the patient.
Mr. Dutcher stated that the doctor's office stated that the prescription was not transcribed correctly by the pharmacist. Mr. Dutcher asked Ms. Douglas if she took the prescriptions over the phone.
Ms. Douglas replied yes.
Mr. Dutcher asked Ms. Douglas if they are her check marks on the prescription.
Ms. Douglas replied yes. Ms. Douglas stated that when a prescription is phoned to the pharmacy she repeats all the information back to the doctor.
Mr. Dutcher stated that he believes that this is a communication problem and the doctor can always fax the
prescription to the pharmacy.
Ms. Douglas stated that she has given the doctor the fax number to fax the prescription to the pharmacy.
Mr. Dutcher asked about the patient profile and the voided prescriptions.
Mr. Reiser stated that voided prescriptions remain in the system, but do not show on the patient's profile to prevent any confusion about the medications that a patient is currently taking at this time.
Complaint # 3063
Pharmacist Edward Tsao appeared to answer questions concerning a consumer complaint. Mr. Tsao no longer works for the company where the error occurred and the Pharmacy Supervisor was unable to attend the meeting.
Compliance Officer Larry Dick gave a brief overview of the complaint.
Mr. Dick stated that the patient's prescription for Tramadol 50 mg was incorrectly filled with Trazadone 50 mg and the patient took thirty tablets of the wrong medication before noticing the error. The prescription was entered correctly but was dispensed incorrectly.
President Dutcher asked Mr. Tsao how Trazadone got in the bottle labeled Tramadol.
Mr. Tsao stated that he believes the incorrect drug was placed in the Baker Cell that he used to count the
prescription. Mr. Tsao stated that as a second check the medication is placed on the scale. Mr. Tsao stated that since the Baker Cell bar codes are loaded into the machine the pharmacist or technician does not scan the stock bottle as a second check. Mr. Tsao stated that the scale weight is the same for both tablets. Mr. Tsao stated that he did not look at the contents of the bottle that the technician filled. Mr. Tsao stated that he verified the label and did not verify the imprint code on the tablet to ensure he had the correct medication. Mr. Tsao stated that the tablets are the same size and shape and he should have checked the imprint code.
Mr. Dutcher asked Mr. Tsao what he has learned from this incident.
Mr. Tsao stated that he checks the NDC code and the imprint numbers on all the tablets that he checks.
Mr. Dutcher asked Mr. Tsao if the pharmacy where he is currently working uses Baker Cells to count medication.
Mr. Tsao stated that he must pull the bottles off the shelf and everything is counted manually.
Mr. Dutcher asked if the Tramadol and Trazadone are close.
Mr. Tsao stated that they are separated.
Dr. McCoy asked about the filling of the Baker Cell.
Mr. Tsao stated that a pharmacist is supposed to check the work of the technician that filled the Baker cell.
Mr. Dutcher asked Mr. Tsao if he has learned anything from this incident.
Mr. Tsao stated that he has left the retail environment and is in the process of returning to work in a hospital.
Mr. Dutcher reminded Mr. Tsao to be careful.
Complaint # 3084
Pharmacist Sameer Boshi, Pharmacy Supervisor Chad Schuster, and Pharmacy Supervisor Stephanie Wernsman were present at the request of the Board to address an issue of diversion that occurred at the pharmacy.
Compliance Officer Rich Cieslinski gave a brief overview of the complaint. Mr. Cieslinski stated that a pharmacist that worked at the store diverted controlled substances by creating a fictitious program which he used as a cover to create fake prescriptions using various patient names and prescribers. Sometimes the pharmacist paid for the prescriptions and other
times he would not pay for the prescriptions.
President Dutcher opened the discussion by telling Mr. Boshi that the Board takes seriously the job of a Pharmacist In Charge. President Dutcher asked Mr. Boshi how this could occur under his supervision.
Mr. Boshi replied that he never worked with the other pharmacist. Mr. Boshi stated that there is no overlap. Mr. Boshi stated that when he was off the other pharmacist worked and vice versa.
Mr. Dutcher asked if all the prescriptions were forged.
Mr. Boshi replied that all the prescriptions were forged.
Mr. Dutcher asked who filed the CII prescriptions.
Mr. Boshi stated that they both filed the CII prescriptions.
Mr. Dutcher asked Ms. Wernsman if it was a good company policy for the pharmacists to work two days on and two days off.
Mr. Dutcher asked Ms. Wernsman if overlap is needed.
Ms. Wernsman stated that the company does like overlap, but the scheduling is done by each store and not the supervisors.
Mr. Dutcher asked who has power of attorney to sign the DEA 222 forms.
Mr. Boshi stated that they both had power of attorney.
Mr. Dutcher asked Mr. Boshi if there was any overlap at anytime.
Mr. Boshi replied occasionally.
Mr. Dutcher asked Mr. Boshi if the pharmacist came to work impaired.
Mr. Boshi replied that the other pharmacist did come to work impaired the last week.
Mr. Dutcher asked about the perpetual inventory. Mr. Dutcher asked Mr. Boshi if he noticed any large quantities of drugs being dispensed.
Mr. Boshi stated that the last week he noticed 600 tablets of Adderall and began questioning the prescriptions. Mr. Boshi stated that he called the doctor two days later and found out that the prescriptions were fake and he contacted his
supervisor.
Mr. Dutcher asked how this could be prevented in the future.
Mr. Shuster stated that the company did have a requirement to do a perpetual audit once a month and that had been changed to once a quarter. Mr. Shuster stated that they could go back to the once a month audit.Mr. Boshi stated that he does a monthly audit.
Mr. Dutcher asked if Mr. Boshi did not notice the loss.
Ms. Wernsman stated that it may have been hard to detect since most of the medications went out under fake prescriptions.
Mr. Dutcher stated that there needs to be some double checks in the pharmacy.
Mr. McAllister stated that when the problem was discovered Mr. Boshi did report the problem to his supervisor.
Mr. Wand asked about the prescriptions being written by the same doctor.
Ms. Wernsman stated that the doctors were all real but the patients were fictitious.
Mr. Dutcher asked if the store staff knew that the pharmacist was delivering the prescriptions.
Mr. Boshi stated that he would stay and fill the prescriptions after hours and then deliver the prescriptions.
Mr. Cieslinski stated that Mr. Boshi filled six forged prescriptions that the pharmacist brought in at 7:30 on a Friday night.
Mr. Boshi stated that he trusted him as a pharmacist. Mr. Boshi stated that the prescriptions were very good forgeries but he questioned the doctor on Monday and found out the prescriptions were forged.
Mr. Dutcher stated that the corporate office may want to look at pharmacists staying after hours and the delivery of prescriptions.
Ms. Wernsman stated that if they were aware of the issues they would have taken action sooner. Ms. Wernsman stated that their company policy states that if an employee is not clocked in then they should not be in the pharmacy.
Mr. Shuster stated that the store management did not notify anyone that the pharmacist was staying after hours.
Dr. Smidt asked if any of the technicians are still working for the company.
Mr. Boshi replied that all the technicians are still working for the company.
Dr. Smidt asked about the technician knowing about the theft.
Mr. Boshi stated that the technician stated that she knew that the pharmacist had taken prescription pads home but she did not know that he was taking the medications. Mr. Boshi stated that the pharmacist had computer generated prescriptions and forged the signature.
Mr. Van Hassel asked over what time frame this occurred.
Ms. Wernsman stated that there was evidence back to September of 2005.
Mr. Van Hassel asked if he paid for the prescriptions.
Mr. Boshi stated that he paid for some prescriptions and did not pay for others.
Mr. Van Hassel asked if the corporation has a way to track prescriptions.
Ms. Wernsman stated that when the prescription is entered into the computer there is no tie in with the register. Ms. Wernsman stated that they do inventories. Ms. Wernsman stated that there were no red flags because the prescriptions were filled under fake prescriptions and the counts would be correct. Ms. Wernsman stated that they only way that they would know what prescriptions were paid for is by pulling the register records.
Mr. Dutcher stated that he believes that Dr. Smidt has concerns that the technician was aware of what was going on and is still employed.
Ms. Wernsman stated that she was involved with Loss Prevention in conducting the investigation and it was determined that no one in the pharmacy department was involved in any illegal activity other than the person arrested.
Mr. Dutcher asked if there are any policies against dispensing their own prescriptions.
Mr. Boshi stated that the pharmacist filled his own prescriptions because there were no other pharmacists present.
Mr. Dutcher stated that if the Pharmacist In Charge is responsible for the pharmacy then he needs to have oversight and in this case there was not oversight. Mr. Dutcher asked the District Managers to see if corporate could find ways to help the Pharmacist In Charge to prevent what happened in this store.
Ms. Wernsman stated that the policies that they have in place allowed them to remove the pharmacist quickly.
Mr. Dutcher stated that they should have policies to prevent the incident from occurring.
Complaint #3092
Pharmacy Director Lalit Mansukhani was present at the request of the Board to address an issue of diversion that occurred at the pharmacy.
Compliance Officer Rich Cieslinski gave a brief overview of the complaint. Mr. Cieslinski stated that a pharmacist diverted CII medications from the hospital for his personal use. The Board was notified and an investigation was conducted by the Compliance Officer.
President Dutcher asked Mr. Mansukhani how this occurred.
Mr. Mansukhani stated that he had some concerns earlier but his questions were answered by the pharmacist and he stated in retrospect that he should have been more suspicious. Mr. Mansukhani stated that he was called into the pharmacy one weekend in December after the pharmacist in question had worked. He stated that there were several discrepancies and the
afternoon pharmacist was concerned and did not want to be involved with the discrepancies. Mr. Mansukhani stated that he and the Pharmacy supervisor began an audit and found several discrepancies. Mr. Mansukhani stated that the pharmacist was not scheduled during the investigation and upon returning to work the pharmacist admitted his problem and was termintated.
Mr. Dutcher asked how long the pharmacist worked at the hospital.
Mr. Mansukhani stated that the individual started working for them in September of 2005 and his employment was
terminated in December of 2005.
Mr. Dutcher asked if he was stealing the whole time.
Mr. Mansukhani stated that in retrospect he believes that he was stealing the whole time. Mr. Mansukhani stated that he believes that he was stealing in lieu of wasting drugs. Mr. Mansukhani stated that he would make a PCA and since it was not the correct strength it would need to be wasted. Mr. Mansukhani stated that he believes the drug was not wasted. Mr. Mansukhani stated that one of the process changes that they have made is that two individuals must observe the wasteage. Mr. Mansukhani stated that any breakage or returns must be seen by two individuals. Mr. Mansukhani stated that they now have changed the documentation for exchanges that occur with the paramedics. Mr. Mansukhani stated that there are three pharmacists, including himself, evaluating discrepancies on a daily basis.
Mr. Dutcher asked about the narcotic inventory.
Mr. Mansukhani stated that the inventory is perpetual.
Complaint # 3093
Pharmacy Director Scott Waldrop was present at the request of the Board to address an issue of diversion that occurred at the pharmacy.
Compliance Officer Rich Cieslinski gave a brief overview of the complaint. Mr. Cieslinski stated that Mr. Waldrop reported to the Board that a pharmacist confessed to the taking of controlled substances for his personal use from January 20, 2005 through January 18, 2006. Mr. Cieslinski stated that the pharmacy began an investigation when an empty Dilaudid
box, blood-soaked paper towels, and syringe wrappers were found in the men's restroom. The pharmacist admitted to taking the Dilaudid and Fentanyl to treat his Crohn's disease.
President Dutcher asked Mr. Waldrop to address the issues.
Mr. Waldrop stated that he believes that the pharmacist diverted the drugs for his personal use for approximately one year. Mr. Waldrop stated that the pharmacist would enter prescriptions for PCA and narcotic drips for admitted patients. The pharmacist would indicate that he delivered the medication to the patient and then would state that the patient did not need the medication and credit the patient. Mr. Waldrop stated that the pharmacist would then take the medication. Mr. Waldrop stated that the pharmacist worked the night shift.
Mr. Dutcher asked if he deleted the medication from the profile would it not be entered back into the inventory.
Mr. Waldrop stated that the prescription profiles and the narcotic cabinet are two different systems. Mr. Waldrop stated that he could delete it off the profile without affecting the narcotic count.
Mr. Dutcher asked Mr. Waldrop if they have new checks and balances in place.
Mr. Waldrop stated that the same person cannot enter the prescription, compound the prescription, or deliver
the prescription. Each one of these steps must be performed by a different person.
Mr. McAllister stated that PCA compounding does provide a real challenge for hospitals.
Mr. Waldrop stated that they are trying to eliminate some of the problems by buying pre-filled syringes.
Mr. Van Hassel asked Mr. Waldrop about the quantity of Fentanyl used at the hospital.
Mr. Waldrop stated that they are a Level I trauma center and this amount of Fentanyl is not unusual.
Mr. Van Hassel stated that he just wanted the Board Members and audience to know that it would be difficult to track losses due to the amount of Fentanyl used by the hospital.
Complaint #3095 - Postponed until July meeting
AGENDA ITEM 8 -Consent Agreements
President Dutcher asked Board Members if there were any questions or discussions concerning
the consent agreements.
Executive Director Hal Wand indicated that the consent agreements have been reviewed and approved by the Attorney General's Office and have been signed.
On motion by Dr. Smidt and Mr. McAllsiter, the Board voted unanimously to accept the consent agreement 06-0012-PHR for Gary Sorensen as presented in the meeting book and signed by the respondent. A roll call vote was taken. (Ms. Honeyestewa - aye, Dr. Sypherd -aye,
Dr. Smidt - aye, Dr. Tippett - aye, Dr. McCoy - aye, Mr. McAllister - aye, Mr. Van Hassel -aye, President Dutcher - aye)
On motion by Dr. McCoy and Ms. Honeyestewa, the Board voted unanimously to accept the consent agreement 06-0015-PHR for Michael Yoha as presented in the meeting book and signed by the respondent. A roll call vote was taken. (Ms. Honeyestewa - aye, Dr. Sypherd -aye, Dr. Smidt - aye, Dr. Tippett - aye, Dr. McCoy - aye, Mr. McAllister - aye, Mr. Van Hassel -aye, President Dutcher - aye)
On motion by Mr. McAllister and Dr. McCoy, the Board voted unanimously to accept the consent agreement 06-0017-PHR for Alana Zinkie as presented in the meeting book and signed by the respondent. A roll call vote was taken. (Ms. Honeyestewa - aye, Dr. Sypherd -aye, Dr. Smidt - aye, Dr. Tippett - aye, Dr. McCoy - aye, Mr. McAllister - aye, Mr. Van Hassel -aye, President Dutcher - aye)
On motion by Dr. McCoy and Ms. Honeyestewa, the Board voted unanimously to accept the consent agreement 06-0019-PHR for David Hall as presented in the meeting book and signed by the respondent. A roll call vote was taken. (Ms. Honeyestewa - aye, Dr. Sypherd -aye, Dr. Smidt - aye, Dr. Tippett - aye, Dr. McCoy - aye, Mr. McAllister - aye, Mr. Van Hassel -aye, President Dutcher - aye)
On motion by Mr. McAllister and Dr. McCoy, the Board voted unanimously to accept the consent agreement 06-0020-PHR for Yvonne Trujillo as presented in the meeting book and signed by the respondent. A roll call vote was taken. (Ms. Honeyestewa - aye, Dr. Sypherd -aye, Dr. Smidt - aye, Dr. Tippett - aye, Dr. McCoy - aye, Mr. McAllister - aye, Mr. Van Hassel -aye, President Dutcher - aye)
On motion by Dr. McCoy and Mr Van Hassel, the Board voted unanimously to accept the consent agreement 06-0023-PHR for Richard Pillon as presented in the meeting book and signed by the respondent. A roll call vote was taken. (Ms. Honeyestewa - aye, Dr. Sypherd -aye, Dr. Smidt - aye, Dr. Tippett - aye, Dr. McCoy - aye, Mr. McAllister - aye, Mr. Van Hassel -aye, President Dutcher - aye)
AGENDA ITEM 9 - Pharmacy Technician Trainee Reapplication
President Dutcher asked Mr. Van Hassel to address this issue.
Mr. Van Hassel stated that the committee has reviewed the Pharmacy Technician Trainee requests to reapply for licensure. Mr. Van Hassel stated that the pharmacy technician trainees have received a letter stating that they may only reapply for licensure as a pharmacy technician trainee one time. Mr. Van Hassel stated that during the next two years the pharmacy technician trainee must take the PTCB test and become certified it they would like to continue to work as a pharmacy technician.
On motion by Dr. Sypherd and Ms. Honeyestewa,the Board unanimously approved the requests of the Pharmacy Technician Trainees listed below to proceed with the licensure reapplication process. The Pharmacy Technician Trainee may reapply for an additional two years as a pharmacy technician trainee one time.
Pharmacy Technician Trainees Approved to reapply for licensure as a Pharmacy Technician Trainee for an additional two years.
- Gloria Williams
- Maria Garcia
