Conference 7 – Complaint #4237 – Case 14-0017-PHR
The following individuals were present to discuss the complaint:
1. Lyle Brauner – Pharmacist - Respondent
2. Dr. Steven Perlmutter – Legal Counsel for Mr. Brauner
President Foy stated that Mr. Haiber had given a brief overview of the complaint concerning the compounding of hazard products without protective equipment, lack of pharmacist supervision of compounding technician activities, compounding recipes not maintained, and lack of compounding training for technicians.
President Foy asked Mr. Brauner to address the complaint.
Mr. Brauner stated that he was hired three years ago by Maxor to be the pharmacist in charge at the outpatient pharmacy at Phoenix Children’s hospital. Mr. Brauner stated that at the time he
was still employed at Safeway. Mr. Brauner stated that he did complete the online training for Maxor at this time. Mr. Brauner stated that he had 8 days to open the pharmacy.
Mr. Brauner stated that he attended an orientation at Phoenix Children’s Hospital concerning
Hospital policies.
Mr. Brauner stated that he was given three pharmacist applications and he was to select from those applications. Mr. Brauner stated that he selected a pharmacist that had compounding experience because his compounding experience was limited. Mr. Brauner stated that when he had worked at Fry’s he had compounded Miracle mouth wash and some Questran compounds.
Mr. Brauner stated that when he arrived at the pharmacy to start work there were no drug bays and no drugs ordered. Mr. Brauner stated that the computers were just being set up and there was a laminar flow hood in the compounding room.
Mr. Brauner stated that Maxor did not know what kind of compounds they would be making but did offer the service.
Mr. Brauner stated that they opened the pharmacy with two full time pharmacists and two fulltime technicians. Mr. Brauner stated that he asked if the pharmacy could open at a later date to get everything in order. Mr. Brauner stated that his request was denied.
Mr. Brauner stated that when they opened the pharmacy they used a spiral ring notebook to document their compounding. They did develop a compounding work sheet.
Mr. Brauner stated that because he did not have experience compounding he hired Ms. Cavanagh
when the first pharmacist quit. Mr. Brauner stated that Ms. Cavanagh indicated that they should
be documenting the lot number and expiration date , so that was added to the sheet.
Mr. Brauner stated that the pharmacy was making money for Maxor and most of the compounding was being done by pharmacy interns and pharmacy technicians.
Mr. Brauner stated that he was directed by Ms. Angela Serio-Harney to send the technicians to a pharmacy compounding course. Mr. Brauner stated that the technicians were sent to a program
certified by Sanford Brown college.
Mr. Brauner stated that the pharmacy was a busy pharmacy and they filled approximately 1,500
prescriptions a week. Mr. Brauner stated that they did not have enough staffing and the technicians usually went to the back room to do the compounding.
Mr. Brauner stated that after a technician came to him expressing her concerns about compounding hazardous substances he had a meeting with Phoenix Children’s Hospital (PCH) and Maxor. Mr. Brauner stated that he wanted to be transparent with both companies that they had been compounding hazardous medications.
Mr. Brauner stated that as a result the compounding recipe sheets were revamped and policies were put into place to insure the pharmacy was compliant.
Mr. Brauner stated that he would not have taken the job if he knew what he knows today.
Mr. Brauner stated that he was not given the proper time to open the pharmacy or the proper equipment.
Mr. Brauner stated that Ms. Serio-Harney stated that he was sent to training. Mr. Brauner stated that he did not go to any training since he could not leave the pharmacy for more than one day due to the pharmacy volume.
Dr. Foy asked Mr. Brauner if he had a good understanding of the pharmacy expectations when he opened the pharmacy. Mr. Brauner replied no.
Dr. Foy asked Mr. Brauner what occurred when they had a request to make a compound. Mr. Brauner stated that he referred the request to the other pharmacist.
Dr. Foy asked about the compound recipe worksheets. Mr. Brauner stated that they stopped pulling the recipe sheets and would make the products in bulk. Mr. Brauner stated that the
ingredients were on the compounding sheet and the recipe books were left on the shelf.
Dr. Foy asked why it took until 2014 for these concerns to be raised. Mr. Brauner stated that no concerns were brought to him by the staff.
Mr. Van Hassel asked if they checked every compound that was made by the technicians. Mr.
Brauner stated that they did not check every compound that was made Mr. Van Hassel asked Mr. Brauner why he did not put in a request for a biological safety cabinet
sooner. Mr. Brauner stated that he was not aware they needed a biological safety cabinet because the recipes were not pulled.
Mr. Van Hassel asked Mr. Brauner if the technicians and staff pharmacists were intimidated by him. Mr. Brauner stated that he has managed multiple pharmacies and thinks of the other employees as colleagues. Mr. Brauner stated that one of the employees had worked with him previously. Mr. Brauner stated that he worked hard and is demanding of his employees.
Dr. Foy stated that there is an e-mail from Mr. Brauner dated July 29, 2011 indicating that he had ordered all supplies and completed training. Mr. Brauner stated that he completed Maxor’s online training which included the following: fraud prevention, HIPAA, Rx entry, and use of the cash register. Mr. Brauner stated that this year Maxor added harassment training.
Dr. Foy asked Mr. Brauner if he was privy to PCH policies. Mr. Brauner stated that the only PCH policies that he was familiar with were the employee conduct policies.
Mr. Brauner stated that PCH did little to promote the pharmacy. Mr. Brauner stated that communication improved after Ms. Douthard arrived. Mr. Brauner stated that he did mention to Ms. Serio-Harney that it was difficult to communicate with the hospital. Mr. Brauner stated.
Mr. Brauner stated.that he reported the prescription volume and financials to PCH.
Dr. Musil asked who constructed the pharmacy. Mr. Brauner stated that he believed the pharmacy was designed by PCH. Mr. Brauner stated that at his initial interview with Ms.
Serio-Harley he addressed the issue of pharmacy storage. Mr. Brauner stated that the pharmacy was built to look pretty.
Dr. Musil asked about the size of the compounding room. Mr. Brauner stated that the pharmacy was built before he arrived and that was the size of the room that Eric Sinner the operations manager had approved.
Mr. Brauner stated that when he was looking in the file that he discovered on the back of the initial inspection report were items that needed to be purchased or completed. Mr. Brauner stated that he did order a compounding book and was developing a training manual after he found the reports.
Ms. Rosas asked Mr. Brauner if he had been given access to PCH’s computer system. Mr. Brauner stated that the pharmacy operates off the Maxor network. Mr. Brauner stated that he
can log on to PCH system to obtain third party information for insurance billing.
Dr. Foy asked Mr. Brauner about Maxor not knowing that they were making hazardous compounds. Mr. Brauner stated that they started making the products when the pharmacy opened. Mr. Brauner stated that the first pharmacist did not mention that these medications
special attention. Mr. Brauner stated that he did order masks, goggles, and gloves.
Dr. Foy asked Mr. Brauner about making the products in the inpatient pharmacy. Mr. Brauner stated that this was not an ideal solution because they had limited time to use the hospital hood.
Mr. Brauner stated that they were making bulk products in the hospital and partial filling prescriptions and mailing the remainder.
On motion by Dr. Musil and seconded by Mr. Francis, the Board agreed to offer Mr. Brauner a consent agreement with the following terms:
1. A fine of $5,000 dollars
2. Completion of an off-site compounding training course
3. Probation for one year. May appear in front of the Board in 6 months from the
effective date of the Consent to ask for the probation to be removed if the fine
and training course have been completed.
4. Can be a pharmacist in charge during the probation period
A roll call vote was taken. ( Ms. Locnikar – aye, Dr. Musil – aye, Mr. Francis – aye, Mr. Minkus-aye, Ms. Rosas – aye, Mr. Kennedy – nay, Mr. Van Hassel – nay, and Dr. Foy – aye)
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The following individuals were present to discuss the complaint:
1. Lyle Brauner – Pharmacist - Respondent
2. Dr. Steven Perlmutter – Legal Counsel for Mr. Brauner
President Foy stated that Mr. Haiber had given a brief overview of the complaint concerning the compounding of hazard products without protective equipment, lack of pharmacist supervision of compounding technician activities, compounding recipes not maintained, and lack of compounding training for technicians.
President Foy asked Mr. Brauner to address the complaint.
Mr. Brauner stated that he was hired three years ago by Maxor to be the pharmacist in charge at the outpatient pharmacy at Phoenix Children’s hospital. Mr. Brauner stated that at the time he
was still employed at Safeway. Mr. Brauner stated that he did complete the online training for Maxor at this time. Mr. Brauner stated that he had 8 days to open the pharmacy.
Mr. Brauner stated that he attended an orientation at Phoenix Children’s Hospital concerning
Hospital policies.
Mr. Brauner stated that he was given three pharmacist applications and he was to select from those applications. Mr. Brauner stated that he selected a pharmacist that had compounding experience because his compounding experience was limited. Mr. Brauner stated that when he had worked at Fry’s he had compounded Miracle mouth wash and some Questran compounds.
Mr. Brauner stated that when he arrived at the pharmacy to start work there were no drug bays and no drugs ordered. Mr. Brauner stated that the computers were just being set up and there was a laminar flow hood in the compounding room.
Mr. Brauner stated that Maxor did not know what kind of compounds they would be making but did offer the service.
Mr. Brauner stated that they opened the pharmacy with two full time pharmacists and two fulltime technicians. Mr. Brauner stated that he asked if the pharmacy could open at a later date to get everything in order. Mr. Brauner stated that his request was denied.
Mr. Brauner stated that when they opened the pharmacy they used a spiral ring notebook to document their compounding. They did develop a compounding work sheet.
Mr. Brauner stated that because he did not have experience compounding he hired Ms. Cavanagh
when the first pharmacist quit. Mr. Brauner stated that Ms. Cavanagh indicated that they should
be documenting the lot number and expiration date , so that was added to the sheet.
Mr. Brauner stated that the pharmacy was making money for Maxor and most of the compounding was being done by pharmacy interns and pharmacy technicians.
Mr. Brauner stated that he was directed by Ms. Angela Serio-Harney to send the technicians to a pharmacy compounding course. Mr. Brauner stated that the technicians were sent to a program
certified by Sanford Brown college.
Mr. Brauner stated that the pharmacy was a busy pharmacy and they filled approximately 1,500
prescriptions a week. Mr. Brauner stated that they did not have enough staffing and the technicians usually went to the back room to do the compounding.
Mr. Brauner stated that after a technician came to him expressing her concerns about compounding hazardous substances he had a meeting with Phoenix Children’s Hospital (PCH) and Maxor. Mr. Brauner stated that he wanted to be transparent with both companies that they had been compounding hazardous medications.
Mr. Brauner stated that as a result the compounding recipe sheets were revamped and policies were put into place to insure the pharmacy was compliant.
Mr. Brauner stated that he would not have taken the job if he knew what he knows today.
Mr. Brauner stated that he was not given the proper time to open the pharmacy or the proper equipment.
Mr. Brauner stated that Ms. Serio-Harney stated that he was sent to training. Mr. Brauner stated that he did not go to any training since he could not leave the pharmacy for more than one day due to the pharmacy volume.
Dr. Foy asked Mr. Brauner if he had a good understanding of the pharmacy expectations when he opened the pharmacy. Mr. Brauner replied no.
Dr. Foy asked Mr. Brauner what occurred when they had a request to make a compound. Mr. Brauner stated that he referred the request to the other pharmacist.
Dr. Foy asked about the compound recipe worksheets. Mr. Brauner stated that they stopped pulling the recipe sheets and would make the products in bulk. Mr. Brauner stated that the
ingredients were on the compounding sheet and the recipe books were left on the shelf.
Dr. Foy asked why it took until 2014 for these concerns to be raised. Mr. Brauner stated that no concerns were brought to him by the staff.
Mr. Van Hassel asked if they checked every compound that was made by the technicians. Mr.
Brauner stated that they did not check every compound that was made Mr. Van Hassel asked Mr. Brauner why he did not put in a request for a biological safety cabinet
sooner. Mr. Brauner stated that he was not aware they needed a biological safety cabinet because the recipes were not pulled.
Mr. Van Hassel asked Mr. Brauner if the technicians and staff pharmacists were intimidated by him. Mr. Brauner stated that he has managed multiple pharmacies and thinks of the other employees as colleagues. Mr. Brauner stated that one of the employees had worked with him previously. Mr. Brauner stated that he worked hard and is demanding of his employees.
Dr. Foy stated that there is an e-mail from Mr. Brauner dated July 29, 2011 indicating that he had ordered all supplies and completed training. Mr. Brauner stated that he completed Maxor’s online training which included the following: fraud prevention, HIPAA, Rx entry, and use of the cash register. Mr. Brauner stated that this year Maxor added harassment training.
Dr. Foy asked Mr. Brauner if he was privy to PCH policies. Mr. Brauner stated that the only PCH policies that he was familiar with were the employee conduct policies.
Mr. Brauner stated that PCH did little to promote the pharmacy. Mr. Brauner stated that communication improved after Ms. Douthard arrived. Mr. Brauner stated that he did mention to Ms. Serio-Harney that it was difficult to communicate with the hospital. Mr. Brauner stated.
Mr. Brauner stated.that he reported the prescription volume and financials to PCH.
Dr. Musil asked who constructed the pharmacy. Mr. Brauner stated that he believed the pharmacy was designed by PCH. Mr. Brauner stated that at his initial interview with Ms.
Serio-Harley he addressed the issue of pharmacy storage. Mr. Brauner stated that the pharmacy was built to look pretty.
Dr. Musil asked about the size of the compounding room. Mr. Brauner stated that the pharmacy was built before he arrived and that was the size of the room that Eric Sinner the operations manager had approved.
Mr. Brauner stated that when he was looking in the file that he discovered on the back of the initial inspection report were items that needed to be purchased or completed. Mr. Brauner stated that he did order a compounding book and was developing a training manual after he found the reports.
Ms. Rosas asked Mr. Brauner if he had been given access to PCH’s computer system. Mr. Brauner stated that the pharmacy operates off the Maxor network. Mr. Brauner stated that he
can log on to PCH system to obtain third party information for insurance billing.
Dr. Foy asked Mr. Brauner about Maxor not knowing that they were making hazardous compounds. Mr. Brauner stated that they started making the products when the pharmacy opened. Mr. Brauner stated that the first pharmacist did not mention that these medications
special attention. Mr. Brauner stated that he did order masks, goggles, and gloves.
Dr. Foy asked Mr. Brauner about making the products in the inpatient pharmacy. Mr. Brauner stated that this was not an ideal solution because they had limited time to use the hospital hood.
Mr. Brauner stated that they were making bulk products in the hospital and partial filling prescriptions and mailing the remainder.
On motion by Dr. Musil and seconded by Mr. Francis, the Board agreed to offer Mr. Brauner a consent agreement with the following terms:
1. A fine of $5,000 dollars
2. Completion of an off-site compounding training course
3. Probation for one year. May appear in front of the Board in 6 months from the
effective date of the Consent to ask for the probation to be removed if the fine
and training course have been completed.
4. Can be a pharmacist in charge during the probation period
A roll call vote was taken. ( Ms. Locnikar – aye, Dr. Musil – aye, Mr. Francis – aye, Mr. Minkus-aye, Ms. Rosas – aye, Mr. Kennedy – nay, Mr. Van Hassel – nay, and Dr. Foy – aye)
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