Wednesday, September 24, 2014
Agenda for New Jersey State Board of Pharmacy September 24, 2014 Meeting
Board of Pharmacy - State of New Jersey 
www.nj.gov/lps/ca/pharm/agenda/pharage_092414.pdf
New Jersey
Safe Medications Why Do Patients Need Compounded Medicines
http://www.safemedication.com/safemed/PharmacistsJournal/Access-to-Compounded-Medicines
Notice to Florida Licensed Non-Resident Pharmacies
Notice to Florida Licensed Non-Resident Pharmacies
floridaspharmacy.gov/.../notice-to-florida-licensed-non-resident-pharma...5 hours ago - Effective October 1, 2014, s. 465.0158, Florida Statutes, requires all nonresident pharmacies to obtain a Nonresident Sterile Compounding Permit in order to ...
Tuesday, September 23, 2014
Question of the Day September 23, 2014 What are the chances that IACP's Plan to Fix DQSA backfire? The number in Congress who signed off on the letter the FDA was not that great. It is an election year. More and more problems with compounding pharmacies are being discovered. The DQSA has not been fully implemented. What if Congress ends up giving the FDA complete jurisdiction over all compounding--traditional and non, animal and human? What if states pass and adopted identical or similiar laws--making the DQSA--office use prohibited (for human and animal) like some states have already done.
IACP Town Hall September 25, 2014 to discuss Office Use, IACP's Kick-off of Fix DQSA Initiative and SaveRxAccess grest presenter Jay McEniry
IACP Members: Join us for a Town Hall on Thursday, September 25, 2014, at 3:00 pm EST – 2:00 pm CST – 1:00 pm MST – 12:00 pm PST!
We will discuss FDA's Statements on Office-Use; IACP's Kick-off of its "Fix DQSA" Initiative; and, SaveRxAccess - with guest presenter, Jay McEniry, Executive Director.
A blast fax and email have been sent to all members with specific call-in instructions. This information also can be found in the IACP Members-only site. Please email us your questions ahead of the call to iacpinfo@iacprx.org. Don't miss it!
We will discuss FDA's Statements on Office-Use; IACP's Kick-off of its "Fix DQSA" Initiative; and, SaveRxAccess - with guest presenter, Jay McEniry, Executive Director.
A blast fax and email have been sent to all members with specific call-in instructions. This information also can be found in the IACP Members-only site. Please email us your questions ahead of the call to iacpinfo@iacprx.org. Don't miss it!
9/23/14 - Bypassing pharmacies boosts workers' comp prescription costs in Pa. [The Philadelphia Inquirer]
Sept. 23Nearly half of what Pennsylvania's workers' compensation program pays for prescription drugs goes to physicians who dispense them directly to patients, bypassing pharmacies, a lucrative practice that is limited by many states and not reimbursed at all by private insurance, Medicare or Medicaid, according to a new report.
Although few doctors take advantage of the loophole, the cost differential can be enormous. A single Percocet cost an average 64 cents at a pharmacy last year, the Workers Compensation Research Institute reported Monday, vs. $3.55 when dispensed by a physician. Patients typically don't know the difference; there are no copays in workers' comp, which is funded by businesses.
continue to read here
Although few doctors take advantage of the loophole, the cost differential can be enormous. A single Percocet cost an average 64 cents at a pharmacy last year, the Workers Compensation Research Institute reported Monday, vs. $3.55 when dispensed by a physician. Patients typically don't know the difference; there are no copays in workers' comp, which is funded by businesses.
continue to read here
Pa. - WCRI Finds Physician Dispensing Makes Up almost Half of Drug Spending
by Tom Wanamaker
Physician dispensing of medication to workers’ compensation… Read more »
Issues with medictions from Wellness Store found
Issues with medictions from Wellness Store found: The Tennessee Department of Health has been warning people not to use certain medications made by a local compounding pharmacy. The Wellness Store Compounding Pharmacy and pharmacist Robin Terrero ...
Impetus for Change and Standards of Practice for Compounding: A New Era Sponsored by Medisca, Inc. --A positive outlook at the new infrastructure
Impetus for Change and Standards of Practice for Compounding: A New Era
Sponsored by Medisca, Inc.
Saturday, October 18, 2014, 10:30 am - 12:00 pm
Austin Convention Center
Location: 16A, Level 4
Continuing Education Credits: 1.5 (0.15 Contact Hours)
ACPE #: 207-000-14-236-L04-P
The Application-based activity explores the changes, current and forthcoming, to the practice of compounding. The implications surrounding H.R. 3204, Drug Quality and Security Act, and subsequent guidance documents for Pharmacy Compounding of Human Drug Products under Section 503A and Current Good Manufacturing Practice—Interim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B, of the Federal Food, Drug and Cosmetic Act are outlined. Subsequent changes to standards of practice as expressed in the United States Pharmacopeia and the National Institute for Occupational Safety and Health are revealed. Changes in legislation and standards of practice pave the way for new beginnings and opportunities. A positive outlook and newly realized philosophy and fundamental business practice infrastructure is presented. A unique framework for a comprehensive compounding-related quality management system now becomes a necessary framework for a compounding practice of the future. An overview of this framework is presented and rounds out this Application-based Activity.
Pharmacist Learning Objectives:
Categories:
Activity Type: Application-based
Audience: Pharmacists
Austin Convention Center
Location: 16A, Level 4
Continuing Education Credits: 1.5 (0.15 Contact Hours)
ACPE #: 207-000-14-236-L04-P
The Application-based activity explores the changes, current and forthcoming, to the practice of compounding. The implications surrounding H.R. 3204, Drug Quality and Security Act, and subsequent guidance documents for Pharmacy Compounding of Human Drug Products under Section 503A and Current Good Manufacturing Practice—Interim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B, of the Federal Food, Drug and Cosmetic Act are outlined. Subsequent changes to standards of practice as expressed in the United States Pharmacopeia and the National Institute for Occupational Safety and Health are revealed. Changes in legislation and standards of practice pave the way for new beginnings and opportunities. A positive outlook and newly realized philosophy and fundamental business practice infrastructure is presented. A unique framework for a comprehensive compounding-related quality management system now becomes a necessary framework for a compounding practice of the future. An overview of this framework is presented and rounds out this Application-based Activity.
Pharmacist Learning Objectives:
- Analyze the implications of H.R. 3204, Drug Quality and Security Act, and 503A and 503B of the FD&C Act.
- Contrast similarities and differences in standards of practice requirements under 503A and 503B of the FD&C Act.
- Summarize the health and safety requirements under NIOSH and the proposed USP Chapter <800>.
- Recognize a unique framework for a comprehensive compounding-related Quality First Management System.
- Illustrate new opportunities under a revised business practice infrastructure for pharmacy compounding.
- Construct the benefits of establishing a compounding practice infrastructure based on Quality, Risk and Validation Management.
- List new and innovative opportunities for the small and large compounding practice.
Categories:
Activity Type: Application-based
Audience: Pharmacists
Integrity Rx Specialty and Vasco Rx Deviation Request to Arizona Board of Pharmacy Regarding Compounded Medications
AGENDA ITEM 16 – Integrity Rx Specialty and Vasco Rx Deviation Request
Dr. Musil was recused due to a conflict of interest.
The following individuals were present to answers questions from Board Members concerning their deviation request.
1. Jeffrey Karp – Integrity Pharmacy
2. Paul Vasililauskas – Vasco Rx
3. Mark Boesen – Legal Counsel for the Pharmacies
President Foy asked the individuals to address their deviation request.
Mr. Boesen stated that Integrity is a new start up pharmacy helping patients with infertility issues. Mr. Boesen stated that many of the products to treat infertility issues are compounded products and Integrity does not have the resources to set up a compounding lab. Mr. Boesen stated that Integrity has asked Vasco to support their services by compounding medications in a shared service arrangement. Mr. Boesen stated that Vasco would like to place a remote
dispensing machine in Integrity,
Mr. Karp stated that compounding is essential with infertility treatments. Mr. Karp stated that compounding should be left to the experts and that is why he wants to enter into a shared service
agreement with Vasco.
Mr. Vasililauskas stated that they would enter into a shared service agreement and he would place a pyxis machine in an area at Integrity.
Dr. Foy asked the individuals to explain the process. Mr. Karp stated that the prescription would be entered by Integrity and electronically transferred to Vasco. Mr. Karp stated that the patient must agree to the transfer. Mr. Karp stated that Vasco will mix a three to five day batch and place in the Med-Dispense machine in Integrity. Mr. Karp stated that Vasco will track the lot numbers of the products dispensed. Mr. Karp stated that Vasco will be on site each day in
Integrity’s space. Mr. Karp stated that the compounded product would be labeled and
checked by the Vasco pharmacist.
Mr. Karp stated that they are trying to eliminate drug misadventures. The patient will receive one order instead of two different orders from two different pharmacies.
Mr. Wand asked about the shared services. Mr. Boesen stated that they would have a written
agreement between the two pharmacies.
Mr. Van Hassel asked about the advantage of having the machine in the pharmacy. Mr. Karp
stated that there is an acuity in the patient needing their medication.
Dr. Foy asked if the products are patient specific. Mr. Karp stated that they are labeled for the patient.
Mr. Kennedy asked who the patient would call if there was an issue. Mr. Karp stated that they could call either pharmacy.
Dr. Foy stated that he is not sure that it satisfies the shared service regulations.
Ms. Rosas asked if the prescriptions in the machine are patient specific. Mr. Karp stated that they are compounded without the patient’s name. Mr. Karp stated that the technology would
coordinate the inventory.
Dr. Foy stated that if Mr. Vasililauskas is compounding medications that are not patient specific he is a manufacturer. Mr. Vasililauskas stated that he is compounding in anticipation of the prescriptions so he is not a manufacturer.
Dr. Foy stated that in order to grant a deviation there must be a rule that they want waived.
Mr. Lee stated that the Board could use R4-23- 614.
The Board agreed to grant Integrity Pharmacy and Vasco Pharmacy a deviation for R4-23-614. source
Read minutes
Dr. Musil was recused due to a conflict of interest.
The following individuals were present to answers questions from Board Members concerning their deviation request.
1. Jeffrey Karp – Integrity Pharmacy
2. Paul Vasililauskas – Vasco Rx
3. Mark Boesen – Legal Counsel for the Pharmacies
President Foy asked the individuals to address their deviation request.
Mr. Boesen stated that Integrity is a new start up pharmacy helping patients with infertility issues. Mr. Boesen stated that many of the products to treat infertility issues are compounded products and Integrity does not have the resources to set up a compounding lab. Mr. Boesen stated that Integrity has asked Vasco to support their services by compounding medications in a shared service arrangement. Mr. Boesen stated that Vasco would like to place a remote
dispensing machine in Integrity,
Mr. Karp stated that compounding is essential with infertility treatments. Mr. Karp stated that compounding should be left to the experts and that is why he wants to enter into a shared service
agreement with Vasco.
Mr. Vasililauskas stated that they would enter into a shared service agreement and he would place a pyxis machine in an area at Integrity.
Dr. Foy asked the individuals to explain the process. Mr. Karp stated that the prescription would be entered by Integrity and electronically transferred to Vasco. Mr. Karp stated that the patient must agree to the transfer. Mr. Karp stated that Vasco will mix a three to five day batch and place in the Med-Dispense machine in Integrity. Mr. Karp stated that Vasco will track the lot numbers of the products dispensed. Mr. Karp stated that Vasco will be on site each day in
Integrity’s space. Mr. Karp stated that the compounded product would be labeled and
checked by the Vasco pharmacist.
Mr. Karp stated that they are trying to eliminate drug misadventures. The patient will receive one order instead of two different orders from two different pharmacies.
Mr. Wand asked about the shared services. Mr. Boesen stated that they would have a written
agreement between the two pharmacies.
Mr. Van Hassel asked about the advantage of having the machine in the pharmacy. Mr. Karp
stated that there is an acuity in the patient needing their medication.
Dr. Foy asked if the products are patient specific. Mr. Karp stated that they are labeled for the patient.
Mr. Kennedy asked who the patient would call if there was an issue. Mr. Karp stated that they could call either pharmacy.
Dr. Foy stated that he is not sure that it satisfies the shared service regulations.
Ms. Rosas asked if the prescriptions in the machine are patient specific. Mr. Karp stated that they are compounded without the patient’s name. Mr. Karp stated that the technology would
coordinate the inventory.
Dr. Foy stated that if Mr. Vasililauskas is compounding medications that are not patient specific he is a manufacturer. Mr. Vasililauskas stated that he is compounding in anticipation of the prescriptions so he is not a manufacturer.
Dr. Foy stated that in order to grant a deviation there must be a rule that they want waived.
Mr. Lee stated that the Board could use R4-23- 614.
The Board agreed to grant Integrity Pharmacy and Vasco Pharmacy a deviation for R4-23-614. source
Read minutes
Arizonia Board of Pharmacy addresses contamination of Calcium Glucontate 10% injection made by Rx Formualtions. and gives one year suspension and $3000 fine.
Conference 8 – Complaint #4336
The following individuals were present to discuss the complaint:
1. Troy Albright – Pharmacist – Respondent
2. Ken Baker – Legal Counsel for Mr. Albright
President Foy opened the discussion by asking Mr. Waggoner to give a brief overview of the complaint.
Mr. Waggoner stated that the Board Office received a call from Banner Good Samaritan Regional Medical Center on 11/27/2013 concerning the discovery of a contaminated vial of
Calcium Glucontate 10% injection. It was determined that the contaminated vials were made by Rx Formualtions.
Mr. Waggoner stated that he visited Banner Good Samaritan and Rx Formulations. Mr. Waggoner stated that he noticed the black particles in the vial at Banner Good Samaritan.
Mr. Waggoner stated that he has made multiple visits to the site and accompanied an FDA inspector to Rx Formulations.
Mr. Waggoner stated that the Board Members have a copy of various visits and at the last Board Meeting the Board asked him to conduct a follow- up inspection. Mr. Waggoner stated that the
Board has received copies of that inspection.
Mr. Baker stated that he would like to clarify several points. Mr. Baker stated that the FDA referred to good manufacturing practices which are not the same as compounding regulations.
Mr. Baker stated that the products were not patient specific because they were being made for
hospital use. Mr. Baker stated that Mr. Albright made the medications for stat orders due to
shortages. Mr. Baker stated that the products Mr. Albright made were not commercially available at the time due to shortages. Mr. Albright would only compound commercially available products if they were not available.
Mr. Baker stated that Mr. Albright that did not solicit Banner’s business. Mr. Baker stated that Mr. Albright was going to discontinue making any products for Banner in September because they were building their own pharmacy. Mr. Baker stated that Mr. Albright was contacted by Banner to continue compounding medications for them on a month to month basis because their
pharmacy was not ready.
Mr. Baker stated that Mr. Albright has canceled the contract and only compounds patient specific
medications. Mr. Baker stated that Mr. Albright does no batch compounding.
Dr. Foy asked Mr. Albright if he had any prior issues with the FDA. Mr. Albright stated that he did not have any previous issues with the FDA.
Dr. Musil asked Mr. Albright about USP 71 testing. Mr. Albright stated that if it is greater than 25 units then it must be tested.
Dr. Musil asked Mr. Albright if he prepared 40 units of 100 cc each how many are sent for testing. Mr. Albright replied 10% for testing.
Dr. Musil asked Mr. Albright why he only sent 5 mls for testing. Mr. Albright stated that the technician sent 5 ml but they would normally send 10%.
Dr. Musil asked about the product testing. Mr. Albright stated that the product was identified as calcium gluconate.
Dr. Musil asked about the fine crystals that were present in the product. Mr. Albright stated that
the pharmacist saw crystals in the product. Mr. Albright stated that they reviewed their lot
and procedures. Mr. Albright stated that the product is temperature sensitive and it could have been handled incorrectly.
Dr. Musil asked Mr. Albright if he had documentation supporting a 30 day beyond use date.
Mr. Albright stated that his understanding is that the product could be used for 30 days.
Dr. Musil stated that the product is a high risk product and should have an expiration date of
3 days.
Dr. Musil asked about the environmental concerns that were found by the FDA and the Board.
Mr. Albright stated that he has purchased a new autoclave.
Dr. Musil asked about the ceiling tiles if they met USP 797 and certification standards. Mr.
Albright stated that a technician had gauged the tiles with a mop. Mr. Albright stated that the ceiling tiles and the electrical outlet had been replaced.
Dr. Musil asked about bubble point testing that was noted by the Board Compliance Officer.
Mr. Albright stated that for filters up to 25mm no bubble point test is required. Mr. Albright stated that he uses a double filter.
Dr. Musil indicated that USP 797 requires bubble point testing. Mr. Albright stated that the products were sent for testing and there was no bacterial growth found in the product.
Dr. Musil discussed the practice of bringing trash can liners into the room with Mr. Albright.
Dr. Musil asked Mr. Albright if he quarantined the product when he made a batch. Mr. Albright replied yes. Dr. Musil told Mr. Albright that he needs to add the quarantine to his policies.
Dr. Musil asked Mr. Albright if he is monitoring the contaminants in his clean room.
Mr. Albright stated that he used a different method than the FDA to monitor the contaminants.
On motion by Dr. Musil and seconded by Ms. Rosas, the Board unanimously agreed to offer
Rx Formulations a consent agreement with the following terms:
1. 1 year suspension with the suspension stayed for 2 years
2. $3,000 fine
3. 2 inspections at the cost of the permit holder. After the second inspection
the permit holder must appear before the Board and discuss the findings.
If the pharmacy fails either inspection, they must appear before the Board.
A roll call vote was taken. ( Ms. Locnikar – aye, Dr. Musil – aye, Mr. Francis – aye, Mr. Minkus-aye, Ms. Rosas – aye, Mr. Kennedy – aye, Mr. Van Hassel – aye, and Dr. Foy – aye)
source
Read minutes
The following individuals were present to discuss the complaint:
1. Troy Albright – Pharmacist – Respondent
2. Ken Baker – Legal Counsel for Mr. Albright
President Foy opened the discussion by asking Mr. Waggoner to give a brief overview of the complaint.
Mr. Waggoner stated that the Board Office received a call from Banner Good Samaritan Regional Medical Center on 11/27/2013 concerning the discovery of a contaminated vial of
Calcium Glucontate 10% injection. It was determined that the contaminated vials were made by Rx Formualtions.
Mr. Waggoner stated that he visited Banner Good Samaritan and Rx Formulations. Mr. Waggoner stated that he noticed the black particles in the vial at Banner Good Samaritan.
Mr. Waggoner stated that he has made multiple visits to the site and accompanied an FDA inspector to Rx Formulations.
Mr. Waggoner stated that the Board Members have a copy of various visits and at the last Board Meeting the Board asked him to conduct a follow- up inspection. Mr. Waggoner stated that the
Board has received copies of that inspection.
Mr. Baker stated that he would like to clarify several points. Mr. Baker stated that the FDA referred to good manufacturing practices which are not the same as compounding regulations.
Mr. Baker stated that the products were not patient specific because they were being made for
hospital use. Mr. Baker stated that Mr. Albright made the medications for stat orders due to
shortages. Mr. Baker stated that the products Mr. Albright made were not commercially available at the time due to shortages. Mr. Albright would only compound commercially available products if they were not available.
Mr. Baker stated that Mr. Albright that did not solicit Banner’s business. Mr. Baker stated that Mr. Albright was going to discontinue making any products for Banner in September because they were building their own pharmacy. Mr. Baker stated that Mr. Albright was contacted by Banner to continue compounding medications for them on a month to month basis because their
pharmacy was not ready.
Mr. Baker stated that Mr. Albright has canceled the contract and only compounds patient specific
medications. Mr. Baker stated that Mr. Albright does no batch compounding.
Dr. Foy asked Mr. Albright if he had any prior issues with the FDA. Mr. Albright stated that he did not have any previous issues with the FDA.
Dr. Musil asked Mr. Albright about USP 71 testing. Mr. Albright stated that if it is greater than 25 units then it must be tested.
Dr. Musil asked Mr. Albright if he prepared 40 units of 100 cc each how many are sent for testing. Mr. Albright replied 10% for testing.
Dr. Musil asked Mr. Albright why he only sent 5 mls for testing. Mr. Albright stated that the technician sent 5 ml but they would normally send 10%.
Dr. Musil asked about the product testing. Mr. Albright stated that the product was identified as calcium gluconate.
Dr. Musil asked about the fine crystals that were present in the product. Mr. Albright stated that
the pharmacist saw crystals in the product. Mr. Albright stated that they reviewed their lot
and procedures. Mr. Albright stated that the product is temperature sensitive and it could have been handled incorrectly.
Dr. Musil asked Mr. Albright if he had documentation supporting a 30 day beyond use date.
Mr. Albright stated that his understanding is that the product could be used for 30 days.
Dr. Musil stated that the product is a high risk product and should have an expiration date of
3 days.
Dr. Musil asked about the environmental concerns that were found by the FDA and the Board.
Mr. Albright stated that he has purchased a new autoclave.
Dr. Musil asked about the ceiling tiles if they met USP 797 and certification standards. Mr.
Albright stated that a technician had gauged the tiles with a mop. Mr. Albright stated that the ceiling tiles and the electrical outlet had been replaced.
Dr. Musil asked about bubble point testing that was noted by the Board Compliance Officer.
Mr. Albright stated that for filters up to 25mm no bubble point test is required. Mr. Albright stated that he uses a double filter.
Dr. Musil indicated that USP 797 requires bubble point testing. Mr. Albright stated that the products were sent for testing and there was no bacterial growth found in the product.
Dr. Musil discussed the practice of bringing trash can liners into the room with Mr. Albright.
Dr. Musil asked Mr. Albright if he quarantined the product when he made a batch. Mr. Albright replied yes. Dr. Musil told Mr. Albright that he needs to add the quarantine to his policies.
Dr. Musil asked Mr. Albright if he is monitoring the contaminants in his clean room.
Mr. Albright stated that he used a different method than the FDA to monitor the contaminants.
On motion by Dr. Musil and seconded by Ms. Rosas, the Board unanimously agreed to offer
Rx Formulations a consent agreement with the following terms:
1. 1 year suspension with the suspension stayed for 2 years
2. $3,000 fine
3. 2 inspections at the cost of the permit holder. After the second inspection
the permit holder must appear before the Board and discuss the findings.
If the pharmacy fails either inspection, they must appear before the Board.
A roll call vote was taken. ( Ms. Locnikar – aye, Dr. Musil – aye, Mr. Francis – aye, Mr. Minkus-aye, Ms. Rosas – aye, Mr. Kennedy – aye, Mr. Van Hassel – aye, and Dr. Foy – aye)
source
Read minutes
More on the issues Relating to Phoenix Children's Hospital and Compounding issues
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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Arizona Board of Pharmacy Case Involving Compounding--Phoenix Children't Hospital
Conference 6 – Complaint #4237 – Case 14-0021-PHR
The following individuals were present to discuss the complaint:
1. Jacqueline Cavanagh – Pharmacist – Respondent
2. Yolanda Douthard – Chief of Pharmacy Services for Phoenix Children’s Hospital –
Respondent
3. Angela Serio-Harney – Executive Vice President of Operations for Maxor
4. Tom Kirschling – Corporate Compliance for Maxor
5. Roger Morris and Christine Cassetta – Legal Counsel for Ms. Cavanagh and
Phoenix Children’s Hospital
President Foy opened the discussion by asking Mr. Haiber to give a brief overview of the complaint.
Mr. Haiber stated that during a complaint investigation by the Compliance Officers the following allegations were investigated:
1. Compounding of hazardous products was performed without protective equipment
2. Lack of compounding training for technicians
3. Compounding preparation recipes were not provided
4. Lack of pharmacist supervision of compounding technician activities
5. Compounding room sanitation
President Foy asked the respondents to address the complaint and allegations.
Mr. Morris stated that Phoenix Children’s Hospital contracts with Maxor Pharmacy Services to
operate the outpatient pharmacy at Phoenix Children’s Hospital (PCH). Mr. Morris stated that Ms. Serio-Harney would address the issues. Ms. Serio-Harney is the Executive Vice President of Operations at Maxor.
Ms. Serio-Haney stated that she hired Lyle Brauner to be the pharmacist in charge in July of
2011. Ms. Serio-Harney stated that Mr. Brauner was given the basic Maxor policies and asked for input on changing the policies. Ms. Serio-Harney stated that Mr. Brauner was tasked with
developing the technician training program and compounding program. Ms. Serio-Harney
stated that Mr. Brauner was given carte blanche for training programs. Ms. Serio-Harney
stated that it was assumed that Mr. Brauner had attended a training program.
Ms. Serio-Harney stated that the last three years the pharmacy operated smoothly. Ms. Serio-Harney stated that the prescription volume increased, wait times were acceptable, and there were only a few medication errors. Ms. Serio-Harney stated that quality reports were sent to Ms. Douthard.
Ms. Serio-Harney stated that nothing suggested that there egregious issues within the pharmacy.
Ms. Serio-Harney stated that it was never mentioned that they were compounding hazardous
medications in the pharmacy. Ms. Serio-Harney stated that she visited the pharmacy in J
and she had no idea hazardous compounds were being made in the pharmacy.
Ms. Serio-Harney stated that while she was on maternity leave Mr. Brauner met with Ms. Douthard on May 2, 2014 concerning hazardous materials that were being compounded.
Mr. Brauner revealed on May 5, 2014 the products that were being made and that enhanced protection was needed. Mr. Brauner indicated that they needed a hood. Ms. Serio-Harney
stated that Mr. Birdsong at Maxor told Mr. Brauner to quit compounding the medications
immediately.
Ms. Serio-Harney stated that two weeks later a complaint was filed by the technician with
OSHA. Ms. Serio-Harney stated that Mr. Brauner’s employment was then terminated.
Mr. Morris asked Ms. Cavanagh to address the complaint and allegations. Mr. Morris stated that Ms. Cavanagh is now the current pharmacist in charge.
Ms. Cavanagh stated that she was hired in March of 2012. Ms. Cavanagh stated that she did have compounding experience. Ms. Cavanagh stated that she noticed deficiencies in the pharmacy and brought the issues up to Mr. Brauner and was told that they do not do that here.
Ms. Cavanagh stated that some of the issues related to good compounding guidelines. Ms.
Cavanagh stated that she backed down because she was afraid of losing her job.
Ms. Cavanagh stated that Mr. Brauner had a tendency to get angry and created an intimidating work environment. Ms. Cavanagh stated that she should have turned Mr. Brauner into the Board or reported the issues to Maxor. Ms. Cavanagh stated that she did not know what to do.
Ms. Cavanagh stated that the technicians were compounding the medications and the ingredients were not verified before they were made. Ms. Cavanagh stated that Mr. Brauner did not think it
was necessary to check the compounds. Ms. Cavanagh stated that she told the technician to come to her to check the compounds. Ms. Cavanagh stated that she could not guarantee that she
checked every compound that was made. Ms. Cavanagh stated that there were medications that she knew that they should not be making and she talked to Mr. Brauner about those medications.
Ms. Cavanagh stated that she did not know that other medications needed to made in a hood.
Ms. Cavanagh stated that it was her job to know which medications should have been made in
a hood. Ms. Cavanagh stated that she is making corrections going forward.
Ms. Cavanagh stated that she is now the pharmacist in charge and has changed functions in the pharmacy. Ms. Cavanagh stated that all compounds are checked before and after being compounded. Ms. Cavanagh stated that only a pharmacist is compounding in the pharmacy.
Ms. Cavanagh stated that she has developed new compounding sheets. Ms. Cavanagh stated that to ensure that the proper equipment is being used any products that need to compounded in a biological safety cabinet is on a bright red form indicating that it is a hazardous or chemo medication.
Ms. Cavanagh stated that everyone must sign a sheet indicating they understand that when certain medications are handled they must wear masks and gloves. Ms. Cavanagh stated that they have a chemo spill kit in the lab and every other Friday the hospital cleans the lab. anuary
Ms. Cavanagh indicated that she would attend an off-site compounding course when she finds the right course.
Mr. Morris asked Tom Kirschling from Maxor to address the audits he conducted at the site.
Mr. Kirschling stated that he was contacted on June 3, 2014 to conduct an inspection at the site.
Mr. Kirschling stated that he has pediatric and compounding experience. Mr. Kirschling stated
that he is familiar with USP 797 and compounding regulations.
Mr. Kirschling stated that he investigated the situation and for employee safety and the patient’s
safety immediate steps were taken to move the compounding to the inpatient system.
Mr. Kirschling stated that he recommended training, documentation, and facilities be updated to be 795 compliant. Mr. Kirschling stated that Ms. Cavanagh has made some changes and he is
assisting in the compliance.
Dr. Foy asked Mr. Kirschling if he conducted any prior audits of the facility. Mr. Kirschling stated that he did not conduct any previous audits. Mr. Kirschling stated that this was the first audit he conducted at the site.
Ms. Serio-Harney stated that visual inspections were conducted at the site. Ms. Serio-Harney stated that she reviewed dispensing records, purchase records, and medication errors.
Ms. Serio-Harney stated that no red flags were raised and there were no employee complaints.
Ms. Serio-Harney stated that she was not aware that they were compounding chemo drugs in January and had not been aware that they had been compounding the medications since 2011.
Dr. Foy asked Ms. Serio-Harney if she reviewed the purchase records. Ms. Serio-Harney
replied that she did review the purchase records but did not realize they were compounding
chemo medicatins.
Mr. Morris asked Ms. Douthard , Chief of Pharmacy Services at PCH, to address the issues in the complaint.
Ms. Douthard stated that she joined the staff at PHC on April 1, 2013. Ms. Douthard stated that she is in charge of all the Phoenix Children Hospital sites. Ms. Douthard stated that she was aware that there was a contracted pharmacy in the building.
stated that she met with Mr. Brauner and walked the space with him. Ms. Douthard stated that they were outgrowing their current space.
Ms. Douthard stated that she asked Mr. Brauner if he had SOPs and he replied that he did.
Ms. Douthard stated that she did not look at his SOPs.
Ms. Douthard stated that she met Ms. Serio-Harney via telephone.
Ms. Douthard stated that there was no evidence of hazardous compounding. Ms. Douthard stated that Mr. Brauner told her that less than 20% of their business is compounding. Ms. Douthard stated that Mr. Brauner did have prn help as his volume had increased.
Mr. Wright, Pharmacy Operations Manager at PCH, met with Mr. Brauner and indicated the business metrics were good.
Ms. Douthard stated that they had looked at the Board inspections and the inspections looked
good.
Ms. Douthard stated that Mr. Wright contacted her and stated that they needed to meet with Mr. Brauner concerning the compounding of hazardous compounds.
Ms. Douthard stated that they asked Mr. Brauner and Ms. Schweitzer to bring a list of the
compounds that they are currently compounding and the products they anticipate compounding.
Ms. Douthard stated that when she reviewed the list she also saw three products that were teratogenic. Ms. Douthard stated that she told them to stop compounding the medications at this point.
Ms. Douthard stated that she asked Mr. Wright to contact Ms. Frush at the Board of Pharmacy to see if the Board would allow the outpatient pharmacy to prepare the products in the
inpatient pharmacy. Ms. Frush told Mr. Wright that she would talk with Mr. Wand because she had some concerns and would call him back. Ms. Frush told Mr. Wright that she discussed the issues with Mr. Wand and they stated that the outpatient pharmacy could use the inpatient pharmacy but there were several issues that needed to be addressed. Ms. Frush told Mr. Wright that the individuals (pharmacists or technicians) need to be properly trained on the compounding of the products. Also, if a technician compounds the medications they must be properly supervised. Ms. Frush told Mr. Wright that the inpatient pharmacy could compound the medications for the outpatient pharmacy. Ms. Douthard stated that the issues raised by the Board were the same concerns that she had concerning the compounding of the medications.
Ms. Douthard stated that they decided that the outpatient pharmacy would schedule a time to use the hood in the inpatient pharmacy and the employees needed to be trained.
Ms. Douthard stated that their current options are to redesign the space for the outpatient pharmacy, continue to use the inpatient pharmacy hood, or outsource the preparation of the
hazardous compounds.
Dr. Musil asked Ms. Serio-Harney how many outpatient childrens hospital pharmacies they manage. Ms. Serio-Harney stated just this one. Ms. Serio-Harney stated that they manage a
specialty infusion pharmacy for children.
Dr. Musil asked Ms. Serio-Harney if they conducted any audits and reviewed compounding policies. Ms. Serio-Harney stated that they had not conducted any audits prior to this complaint.
Ms. Serio-Harney stated that they sent out three compounds for testing and two of the products were fine.
Dr. Musil asked Ms. Serio-Harney if they conducted any compounding audits in their contracted pharmacies. Ms. Serio-Harney replied no.
Mr. Van Hassel asked Ms. Cavanagh when she started at PCH and what position she held.
Ms. Cavanagh stated that she started as a staff pharmacist in March of 2012.
Mr. Van Hassel asked if there was any additional staffing. Ms. Cavanagh stated that Mr. Brauner was the only other full-time pharmacist. Ms. Cavanagh stated that there was additional prn help.
Mr. Van Hassel asked about the cleaning of the compounding room. Ms. Cavanagh stated that the room was cleaned daily.
Mr. Van Hassel asked Ms. Cavanagh what was used to clean the room. Ms. Cavanagh stated that the room was never cleaned that they used Lysol wipes to clean the counters.
Mr. Van Hassel asked Ms. Cavanagh about the supervision of the technicians. Ms. Cavanagh stated that she expressed her concerns to Mr. Brauner but she was afraid of going around him to check the compounds. Ms. Cavanagh stated that it was not an excuse but she was placed in a hard position. Ms. Cavanagh stated that she could not guarantee the workflow issues.
Mr. Van Hassel asked Ms. Cavanagh if she believed that the technician was adequately trained.
Ms. Cavanagh stated that there were some deficiencies that she noted. Ms. Cavanagh stated that she believes that there was not enough supervision of the technicians. Ms. Cavanagh stated that one of the technicians indicated that the training course was a joke.
Mr. Van Hassel asked Ms. Serio-Harney about the training course Mr. Brauner attended.
Ms. Serio-Harney stated that she signed the expense sheet authorizing Mr. Brauner to attend a
training class and assumed he attended a class.
Dr. Musil asked about the compounding sheets that were used in the past. Ms. Cavanagh stated that the compounding sheets used in the past indicated the drug and concentration and the number of tablets to be made. Ms. Cavanagh stated that there were no specific instructions.
Ms. Cavanagh stated that they listed the lot number and expiration date of the items used.
Ms. Cavanagh stated that there were no step by step procedures.
Dr. Musil asked if there was a master formula record. Ms. Cavanagh stated that no formulation sheet was used.
Dr. Musil asked what corrections Ms. Cavanagh has made. Ms. Cavanagh stated that the new sheet identifies the individual that prepared the compound and the verifying pharmacist. Ms. Cavanagh stated that the lot number, expiration date, and NDC number of the product used is
recorded. Ms. Cavanagh indicated that if it is a hazardous product it is made in a biological safety cabinet.
Mr. Minkus asked Ms. Serio-Harney if there is any follow up with the forms to see if people are doing what they are supposed to be doing. Ms. Serio-Harney stated that the processes were
driven by barcode technology and no red flags were raised.
Mr. Minkus asked Ms. Cavanagh why she did not come forth when these issues occurred.
Ms. Cavanagh stated that she could not change her actions that occurred in the past.
Mr. Van Hassel asked Mr. Kirschling about changes at the site. Mr. Kirschling stated that there
are still some issues that need to be addressed. Mr. Kirschling stated that they use USP 797 as
best practices for employee and patient safety. Mr. Kirschling stated that they would have an independent expert inspect the site when the remodel is finished.
Dr. Foy asked Ms. Serio-Harney what plans they have going forth to monitor the site. Ms.
Serio-Harney stated that they plan to use an outside consultant. Ms. Serio-Harney stated that
have plans to audit the compounding records.
Dr. Foy asked Ms. Douthard if there are internal departments providing audits. Ms. Douthard
stated that risk management and the legal department would be providing audits.
Mr. Francis asked Ms. Serio-Harney how they manage other compounding sites. Ms. Serio-Harney stated that she is not aware of any other sites doing this type of compounding.
Ms. Rosas asked who the pharmacist in charge was when this incident took place. Ms. Cavanagh replied that Mr. Brauner was the pharmacist in charge.
Ms. Rosas asked Ms. Cavanagh who was responsible for checking the technicians work.
Ms. Cavanagh stated that she and Mr. Brauner were responsible for checking the technician’s
work. Ms. Cavanagh stated that prn pharmacists were also responsible for checking the
technician’s work.
Dr. Foy asked Ms. Serio-Harney if Maxor has an ethics line that is confidential. Ms. Serio-Harney stated that they have a 1-800 compliance line. Ms. Serio-Harney stated that the employee should report the incident to the first line supervisor and move up the chain to the next position. Ms. Serio-Harney stated that the number is posted in the pharmacy and on the
ADP site (payroll site).
Dr. Foy asked Ms. Cavanagh if she was aware that she could report issues. Ms. Cavanagh stated that she was not aware that she could report issues in this manner.
Ms. Serio-Harney stated that each employee receives a handbook and the information is in the handbook.
Mr. Kirschling stated that the number is listed on the front page of the ADP site.
Ms. Douthard stated that she told Ms. Cavanagh that she can take issues to the hospital staff because the hospital is the permit holder.
replied no. Ms. Cavanagh stated that when she started she did not know anyone and all communication was with Mr. Brauner and no one else within the hospital.
Ms. Douthard stated that Mr. Brauner did not always have direct access to someone within the
hospital because there was a lot of transition occurring in the staffing. Ms. Douthard stated that her position was vacant for a long period of time.
Mr. Francis asked about the training programs that Maxor offers online. Ms. Serio-Harney stated that they offer abuse training, HIPAA training, harassment training, and prescription filling. Ms. Serio-Harney stated that the completion of these programs are tracked at the
corporate level.
Mr. Minkus asked Ms. Serio-Harney how often the complaint process has been used. Ms. Serio-Harney stated that she is not sure and would have to ask for the statistics.
Mr. Kennedy asked Ms. Cavanagh if they were preparing hazardous products when she started in 2012. Ms. Cavanagh replied that they were preparing hazardous products before she started and in the past year the business doubled.
Mr. Kennedy asked Ms. Cavanagh if she talked to Mr. Brauner about preparing hazardous
products without a hood. Ms. Cavanagh stated that she did not know that the products were
to be made in a hood. Ms. Cavanagh stated that she does not recall when she brought up other compounding issues with Mr. Brauner.
Mr. Kennedy asked Ms. Cavanagh when she became aware of the issues. Ms. Cavanagh stated
that the complaint became evident at the end of April
Mr. Kennedy asked what happened to the concerns that she and the technicians expressed to Mr. Brauner. Ms. Cavanagh stated that that as far as she knew the complaints stopped at Lyle.
Ms. Rosas asked if there were any complaints that involved these compounded medications.
Ms. Serio-Harney stated that there were no issues related to the compounds.
Mr. Wand asked if there were any mistakes found when they checked the technicians work.
Ms. Cavanagh stated that no wrong medications were used but she did have an issue with the way the technician qs’ed a medication.
Ms. Locnikar asked if Maxor provides CE education for the pharmacists and technicians.
Ms. Serio-Harney stated that they completed the employee training provided.
Ms. Locnikar asked if the training was internally through the hospital. Ms. Serio-Harney stated that Maxor has their own internal training program.
Dr. Foy stated that the hazardous drug policies were last updated in August of 2012.
Mr. Kirsching stated that they have updated those policies to include USP 800.
Dr. Foy asked if there were hazardous compounding policies in effect in 2012. Ms. Cassetta stated that they only had policies for oral medications that were not compounded.
Dr. Foy asked if these policies were provided to Mr. Brauner. Ms. Serio-Harney stated that
the new policies developed in 2014 were not provided to Mr. Brauner.
Dr. Musil asked about the compounding assessment. Mr. Kirschling stated that the employee reviews the ASHP online program on sterile products and must have a passing assessment score.
Dr. Musil asked what happens if the employee fails the quiz. Mr. Kirschling stated that the pharmacist in charge would not certify the individual to compound if they do not pass the test.
Mr. Kirschling stated that it would be up to the pharmacist to determine how many times the
employee can take the test.
Dr. Musil asked who supervises the technicians in the lab. Ms. Serio-Harney stated that no technicians are compounding at this time.
Dr. Foy asked Ms. Serio-Harney did she communicate to Mr. Brauner that this was a compounding pharmacy when his background was in retail pharmacy. Ms. Serio-Harney
stated that she told Mr. Brauner that there would be a fair amount of compounding.
Dr. Foy asked Ms. Serio-Harney why Mr. Brauner was hired if he had no compounding training.
Ms. Serio-Harney stated that Mr. Brauner was working fulltime prior to the pharmacy opening.
Ms. Serio-Harney stated that Mr. Brauner could have made up the gap by taking an outside compounding course prior to the opening of the pharmacy.
Dr. Foy noted that Mr. Brauner would not have had any experience in pediatric compounding.
Ms. Serio-Harney stated that they purchased a recipe book and paid for training. Ms. Serio-Harney stated that she had assumed Mr. Brauner attended a training course.
On motion by Dr. Musil and seconded by Mr. Francis, the Board unanimously agreed to
offer a consent agreement to Ms. Cavanagh with the following terms:
1. A fine of $3,000
2. Attend a 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 have been completed.
A roll call vote was taken. ( Ms. Locnikar – aye, Dr. Musil – aye, Mr. Francis – aye, Mr. Minkus-aye, Ms. Rosas – aye, Mr. Kennedy – aye, Mr. Van Hassel – aye, and Dr. Foy – aye)
On motion by Dr. Musil and seconded by Mr. Kennedy, the Board unanimously agreed to
offer a consent agreement to Phoenix Childrens Hospital Outpatient Pharmacy with the following terms:
1. The permit be placed on suspension for two years with the suspension stayed 2. A fine of $5,000
3. Two inspections within 12 months at the cost of the permit holder. After the second inspection, the pharmacy shall appear before the Board. If the pharmacy fails either inspection, the pharmacy shall appear before the Board.
A roll call vote was taken. ( Ms. Locnikar – aye, Dr. Musil – aye, Mr. Francis – aye, Mr. Minkus-aye, Ms. Rosas – aye, Mr. Kennedy – aye, Mr. Van Hassel – aye, and Dr. Foy – aye)
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The following individuals were present to discuss the complaint:
1. Jacqueline Cavanagh – Pharmacist – Respondent
2. Yolanda Douthard – Chief of Pharmacy Services for Phoenix Children’s Hospital –
Respondent
3. Angela Serio-Harney – Executive Vice President of Operations for Maxor
4. Tom Kirschling – Corporate Compliance for Maxor
5. Roger Morris and Christine Cassetta – Legal Counsel for Ms. Cavanagh and
Phoenix Children’s Hospital
President Foy opened the discussion by asking Mr. Haiber to give a brief overview of the complaint.
Mr. Haiber stated that during a complaint investigation by the Compliance Officers the following allegations were investigated:
1. Compounding of hazardous products was performed without protective equipment
2. Lack of compounding training for technicians
3. Compounding preparation recipes were not provided
4. Lack of pharmacist supervision of compounding technician activities
5. Compounding room sanitation
President Foy asked the respondents to address the complaint and allegations.
Mr. Morris stated that Phoenix Children’s Hospital contracts with Maxor Pharmacy Services to
operate the outpatient pharmacy at Phoenix Children’s Hospital (PCH). Mr. Morris stated that Ms. Serio-Harney would address the issues. Ms. Serio-Harney is the Executive Vice President of Operations at Maxor.
Ms. Serio-Haney stated that she hired Lyle Brauner to be the pharmacist in charge in July of
2011. Ms. Serio-Harney stated that Mr. Brauner was given the basic Maxor policies and asked for input on changing the policies. Ms. Serio-Harney stated that Mr. Brauner was tasked with
developing the technician training program and compounding program. Ms. Serio-Harney
stated that Mr. Brauner was given carte blanche for training programs. Ms. Serio-Harney
stated that it was assumed that Mr. Brauner had attended a training program.
Ms. Serio-Harney stated that the last three years the pharmacy operated smoothly. Ms. Serio-Harney stated that the prescription volume increased, wait times were acceptable, and there were only a few medication errors. Ms. Serio-Harney stated that quality reports were sent to Ms. Douthard.
Ms. Serio-Harney stated that nothing suggested that there egregious issues within the pharmacy.
Ms. Serio-Harney stated that it was never mentioned that they were compounding hazardous
medications in the pharmacy. Ms. Serio-Harney stated that she visited the pharmacy in J
and she had no idea hazardous compounds were being made in the pharmacy.
Ms. Serio-Harney stated that while she was on maternity leave Mr. Brauner met with Ms. Douthard on May 2, 2014 concerning hazardous materials that were being compounded.
Mr. Brauner revealed on May 5, 2014 the products that were being made and that enhanced protection was needed. Mr. Brauner indicated that they needed a hood. Ms. Serio-Harney
stated that Mr. Birdsong at Maxor told Mr. Brauner to quit compounding the medications
immediately.
Ms. Serio-Harney stated that two weeks later a complaint was filed by the technician with
OSHA. Ms. Serio-Harney stated that Mr. Brauner’s employment was then terminated.
Mr. Morris asked Ms. Cavanagh to address the complaint and allegations. Mr. Morris stated that Ms. Cavanagh is now the current pharmacist in charge.
Ms. Cavanagh stated that she was hired in March of 2012. Ms. Cavanagh stated that she did have compounding experience. Ms. Cavanagh stated that she noticed deficiencies in the pharmacy and brought the issues up to Mr. Brauner and was told that they do not do that here.
Ms. Cavanagh stated that some of the issues related to good compounding guidelines. Ms.
Cavanagh stated that she backed down because she was afraid of losing her job.
Ms. Cavanagh stated that Mr. Brauner had a tendency to get angry and created an intimidating work environment. Ms. Cavanagh stated that she should have turned Mr. Brauner into the Board or reported the issues to Maxor. Ms. Cavanagh stated that she did not know what to do.
Ms. Cavanagh stated that the technicians were compounding the medications and the ingredients were not verified before they were made. Ms. Cavanagh stated that Mr. Brauner did not think it
was necessary to check the compounds. Ms. Cavanagh stated that she told the technician to come to her to check the compounds. Ms. Cavanagh stated that she could not guarantee that she
checked every compound that was made. Ms. Cavanagh stated that there were medications that she knew that they should not be making and she talked to Mr. Brauner about those medications.
Ms. Cavanagh stated that she did not know that other medications needed to made in a hood.
Ms. Cavanagh stated that it was her job to know which medications should have been made in
a hood. Ms. Cavanagh stated that she is making corrections going forward.
Ms. Cavanagh stated that she is now the pharmacist in charge and has changed functions in the pharmacy. Ms. Cavanagh stated that all compounds are checked before and after being compounded. Ms. Cavanagh stated that only a pharmacist is compounding in the pharmacy.
Ms. Cavanagh stated that she has developed new compounding sheets. Ms. Cavanagh stated that to ensure that the proper equipment is being used any products that need to compounded in a biological safety cabinet is on a bright red form indicating that it is a hazardous or chemo medication.
Ms. Cavanagh stated that everyone must sign a sheet indicating they understand that when certain medications are handled they must wear masks and gloves. Ms. Cavanagh stated that they have a chemo spill kit in the lab and every other Friday the hospital cleans the lab. anuary
Ms. Cavanagh indicated that she would attend an off-site compounding course when she finds the right course.
Mr. Morris asked Tom Kirschling from Maxor to address the audits he conducted at the site.
Mr. Kirschling stated that he was contacted on June 3, 2014 to conduct an inspection at the site.
Mr. Kirschling stated that he has pediatric and compounding experience. Mr. Kirschling stated
that he is familiar with USP 797 and compounding regulations.
Mr. Kirschling stated that he investigated the situation and for employee safety and the patient’s
safety immediate steps were taken to move the compounding to the inpatient system.
Mr. Kirschling stated that he recommended training, documentation, and facilities be updated to be 795 compliant. Mr. Kirschling stated that Ms. Cavanagh has made some changes and he is
assisting in the compliance.
Dr. Foy asked Mr. Kirschling if he conducted any prior audits of the facility. Mr. Kirschling stated that he did not conduct any previous audits. Mr. Kirschling stated that this was the first audit he conducted at the site.
Ms. Serio-Harney stated that visual inspections were conducted at the site. Ms. Serio-Harney stated that she reviewed dispensing records, purchase records, and medication errors.
Ms. Serio-Harney stated that no red flags were raised and there were no employee complaints.
Ms. Serio-Harney stated that she was not aware that they were compounding chemo drugs in January and had not been aware that they had been compounding the medications since 2011.
Dr. Foy asked Ms. Serio-Harney if she reviewed the purchase records. Ms. Serio-Harney
replied that she did review the purchase records but did not realize they were compounding
chemo medicatins.
Mr. Morris asked Ms. Douthard , Chief of Pharmacy Services at PCH, to address the issues in the complaint.
Ms. Douthard stated that she joined the staff at PHC on April 1, 2013. Ms. Douthard stated that she is in charge of all the Phoenix Children Hospital sites. Ms. Douthard stated that she was aware that there was a contracted pharmacy in the building.
stated that she met with Mr. Brauner and walked the space with him. Ms. Douthard stated that they were outgrowing their current space.
Ms. Douthard stated that she asked Mr. Brauner if he had SOPs and he replied that he did.
Ms. Douthard stated that she did not look at his SOPs.
Ms. Douthard stated that she met Ms. Serio-Harney via telephone.
Ms. Douthard stated that there was no evidence of hazardous compounding. Ms. Douthard stated that Mr. Brauner told her that less than 20% of their business is compounding. Ms. Douthard stated that Mr. Brauner did have prn help as his volume had increased.
Mr. Wright, Pharmacy Operations Manager at PCH, met with Mr. Brauner and indicated the business metrics were good.
Ms. Douthard stated that they had looked at the Board inspections and the inspections looked
good.
Ms. Douthard stated that Mr. Wright contacted her and stated that they needed to meet with Mr. Brauner concerning the compounding of hazardous compounds.
Ms. Douthard stated that they asked Mr. Brauner and Ms. Schweitzer to bring a list of the
compounds that they are currently compounding and the products they anticipate compounding.
Ms. Douthard stated that when she reviewed the list she also saw three products that were teratogenic. Ms. Douthard stated that she told them to stop compounding the medications at this point.
Ms. Douthard stated that she asked Mr. Wright to contact Ms. Frush at the Board of Pharmacy to see if the Board would allow the outpatient pharmacy to prepare the products in the
inpatient pharmacy. Ms. Frush told Mr. Wright that she would talk with Mr. Wand because she had some concerns and would call him back. Ms. Frush told Mr. Wright that she discussed the issues with Mr. Wand and they stated that the outpatient pharmacy could use the inpatient pharmacy but there were several issues that needed to be addressed. Ms. Frush told Mr. Wright that the individuals (pharmacists or technicians) need to be properly trained on the compounding of the products. Also, if a technician compounds the medications they must be properly supervised. Ms. Frush told Mr. Wright that the inpatient pharmacy could compound the medications for the outpatient pharmacy. Ms. Douthard stated that the issues raised by the Board were the same concerns that she had concerning the compounding of the medications.
Ms. Douthard stated that they decided that the outpatient pharmacy would schedule a time to use the hood in the inpatient pharmacy and the employees needed to be trained.
Ms. Douthard stated that their current options are to redesign the space for the outpatient pharmacy, continue to use the inpatient pharmacy hood, or outsource the preparation of the
hazardous compounds.
Dr. Musil asked Ms. Serio-Harney how many outpatient childrens hospital pharmacies they manage. Ms. Serio-Harney stated just this one. Ms. Serio-Harney stated that they manage a
specialty infusion pharmacy for children.
Dr. Musil asked Ms. Serio-Harney if they conducted any audits and reviewed compounding policies. Ms. Serio-Harney stated that they had not conducted any audits prior to this complaint.
Ms. Serio-Harney stated that they sent out three compounds for testing and two of the products were fine.
Dr. Musil asked Ms. Serio-Harney if they conducted any compounding audits in their contracted pharmacies. Ms. Serio-Harney replied no.
Mr. Van Hassel asked Ms. Cavanagh when she started at PCH and what position she held.
Ms. Cavanagh stated that she started as a staff pharmacist in March of 2012.
Mr. Van Hassel asked if there was any additional staffing. Ms. Cavanagh stated that Mr. Brauner was the only other full-time pharmacist. Ms. Cavanagh stated that there was additional prn help.
Mr. Van Hassel asked about the cleaning of the compounding room. Ms. Cavanagh stated that the room was cleaned daily.
Mr. Van Hassel asked Ms. Cavanagh what was used to clean the room. Ms. Cavanagh stated that the room was never cleaned that they used Lysol wipes to clean the counters.
Mr. Van Hassel asked Ms. Cavanagh about the supervision of the technicians. Ms. Cavanagh stated that she expressed her concerns to Mr. Brauner but she was afraid of going around him to check the compounds. Ms. Cavanagh stated that it was not an excuse but she was placed in a hard position. Ms. Cavanagh stated that she could not guarantee the workflow issues.
Mr. Van Hassel asked Ms. Cavanagh if she believed that the technician was adequately trained.
Ms. Cavanagh stated that there were some deficiencies that she noted. Ms. Cavanagh stated that she believes that there was not enough supervision of the technicians. Ms. Cavanagh stated that one of the technicians indicated that the training course was a joke.
Mr. Van Hassel asked Ms. Serio-Harney about the training course Mr. Brauner attended.
Ms. Serio-Harney stated that she signed the expense sheet authorizing Mr. Brauner to attend a
training class and assumed he attended a class.
Dr. Musil asked about the compounding sheets that were used in the past. Ms. Cavanagh stated that the compounding sheets used in the past indicated the drug and concentration and the number of tablets to be made. Ms. Cavanagh stated that there were no specific instructions.
Ms. Cavanagh stated that they listed the lot number and expiration date of the items used.
Ms. Cavanagh stated that there were no step by step procedures.
Dr. Musil asked if there was a master formula record. Ms. Cavanagh stated that no formulation sheet was used.
Dr. Musil asked what corrections Ms. Cavanagh has made. Ms. Cavanagh stated that the new sheet identifies the individual that prepared the compound and the verifying pharmacist. Ms. Cavanagh stated that the lot number, expiration date, and NDC number of the product used is
recorded. Ms. Cavanagh indicated that if it is a hazardous product it is made in a biological safety cabinet.
Mr. Minkus asked Ms. Serio-Harney if there is any follow up with the forms to see if people are doing what they are supposed to be doing. Ms. Serio-Harney stated that the processes were
driven by barcode technology and no red flags were raised.
Mr. Minkus asked Ms. Cavanagh why she did not come forth when these issues occurred.
Ms. Cavanagh stated that she could not change her actions that occurred in the past.
Mr. Van Hassel asked Mr. Kirschling about changes at the site. Mr. Kirschling stated that there
are still some issues that need to be addressed. Mr. Kirschling stated that they use USP 797 as
best practices for employee and patient safety. Mr. Kirschling stated that they would have an independent expert inspect the site when the remodel is finished.
Dr. Foy asked Ms. Serio-Harney what plans they have going forth to monitor the site. Ms.
Serio-Harney stated that they plan to use an outside consultant. Ms. Serio-Harney stated that
have plans to audit the compounding records.
Dr. Foy asked Ms. Douthard if there are internal departments providing audits. Ms. Douthard
stated that risk management and the legal department would be providing audits.
Mr. Francis asked Ms. Serio-Harney how they manage other compounding sites. Ms. Serio-Harney stated that she is not aware of any other sites doing this type of compounding.
Ms. Rosas asked who the pharmacist in charge was when this incident took place. Ms. Cavanagh replied that Mr. Brauner was the pharmacist in charge.
Ms. Rosas asked Ms. Cavanagh who was responsible for checking the technicians work.
Ms. Cavanagh stated that she and Mr. Brauner were responsible for checking the technician’s
work. Ms. Cavanagh stated that prn pharmacists were also responsible for checking the
technician’s work.
Dr. Foy asked Ms. Serio-Harney if Maxor has an ethics line that is confidential. Ms. Serio-Harney stated that they have a 1-800 compliance line. Ms. Serio-Harney stated that the employee should report the incident to the first line supervisor and move up the chain to the next position. Ms. Serio-Harney stated that the number is posted in the pharmacy and on the
ADP site (payroll site).
Dr. Foy asked Ms. Cavanagh if she was aware that she could report issues. Ms. Cavanagh stated that she was not aware that she could report issues in this manner.
Ms. Serio-Harney stated that each employee receives a handbook and the information is in the handbook.
Mr. Kirschling stated that the number is listed on the front page of the ADP site.
Ms. Douthard stated that she told Ms. Cavanagh that she can take issues to the hospital staff because the hospital is the permit holder.
replied no. Ms. Cavanagh stated that when she started she did not know anyone and all communication was with Mr. Brauner and no one else within the hospital.
Ms. Douthard stated that Mr. Brauner did not always have direct access to someone within the
hospital because there was a lot of transition occurring in the staffing. Ms. Douthard stated that her position was vacant for a long period of time.
Mr. Francis asked about the training programs that Maxor offers online. Ms. Serio-Harney stated that they offer abuse training, HIPAA training, harassment training, and prescription filling. Ms. Serio-Harney stated that the completion of these programs are tracked at the
corporate level.
Mr. Minkus asked Ms. Serio-Harney how often the complaint process has been used. Ms. Serio-Harney stated that she is not sure and would have to ask for the statistics.
Mr. Kennedy asked Ms. Cavanagh if they were preparing hazardous products when she started in 2012. Ms. Cavanagh replied that they were preparing hazardous products before she started and in the past year the business doubled.
Mr. Kennedy asked Ms. Cavanagh if she talked to Mr. Brauner about preparing hazardous
products without a hood. Ms. Cavanagh stated that she did not know that the products were
to be made in a hood. Ms. Cavanagh stated that she does not recall when she brought up other compounding issues with Mr. Brauner.
Mr. Kennedy asked Ms. Cavanagh when she became aware of the issues. Ms. Cavanagh stated
that the complaint became evident at the end of April
Mr. Kennedy asked what happened to the concerns that she and the technicians expressed to Mr. Brauner. Ms. Cavanagh stated that that as far as she knew the complaints stopped at Lyle.
Ms. Rosas asked if there were any complaints that involved these compounded medications.
Ms. Serio-Harney stated that there were no issues related to the compounds.
Mr. Wand asked if there were any mistakes found when they checked the technicians work.
Ms. Cavanagh stated that no wrong medications were used but she did have an issue with the way the technician qs’ed a medication.
Ms. Locnikar asked if Maxor provides CE education for the pharmacists and technicians.
Ms. Serio-Harney stated that they completed the employee training provided.
Ms. Locnikar asked if the training was internally through the hospital. Ms. Serio-Harney stated that Maxor has their own internal training program.
Dr. Foy stated that the hazardous drug policies were last updated in August of 2012.
Mr. Kirsching stated that they have updated those policies to include USP 800.
Dr. Foy asked if there were hazardous compounding policies in effect in 2012. Ms. Cassetta stated that they only had policies for oral medications that were not compounded.
Dr. Foy asked if these policies were provided to Mr. Brauner. Ms. Serio-Harney stated that
the new policies developed in 2014 were not provided to Mr. Brauner.
Dr. Musil asked about the compounding assessment. Mr. Kirschling stated that the employee reviews the ASHP online program on sterile products and must have a passing assessment score.
Dr. Musil asked what happens if the employee fails the quiz. Mr. Kirschling stated that the pharmacist in charge would not certify the individual to compound if they do not pass the test.
Mr. Kirschling stated that it would be up to the pharmacist to determine how many times the
employee can take the test.
Dr. Musil asked who supervises the technicians in the lab. Ms. Serio-Harney stated that no technicians are compounding at this time.
Dr. Foy asked Ms. Serio-Harney did she communicate to Mr. Brauner that this was a compounding pharmacy when his background was in retail pharmacy. Ms. Serio-Harney
stated that she told Mr. Brauner that there would be a fair amount of compounding.
Dr. Foy asked Ms. Serio-Harney why Mr. Brauner was hired if he had no compounding training.
Ms. Serio-Harney stated that Mr. Brauner was working fulltime prior to the pharmacy opening.
Ms. Serio-Harney stated that Mr. Brauner could have made up the gap by taking an outside compounding course prior to the opening of the pharmacy.
Dr. Foy noted that Mr. Brauner would not have had any experience in pediatric compounding.
Ms. Serio-Harney stated that they purchased a recipe book and paid for training. Ms. Serio-Harney stated that she had assumed Mr. Brauner attended a training course.
On motion by Dr. Musil and seconded by Mr. Francis, the Board unanimously agreed to
offer a consent agreement to Ms. Cavanagh with the following terms:
1. A fine of $3,000
2. Attend a 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 have been completed.
A roll call vote was taken. ( Ms. Locnikar – aye, Dr. Musil – aye, Mr. Francis – aye, Mr. Minkus-aye, Ms. Rosas – aye, Mr. Kennedy – aye, Mr. Van Hassel – aye, and Dr. Foy – aye)
On motion by Dr. Musil and seconded by Mr. Kennedy, the Board unanimously agreed to
offer a consent agreement to Phoenix Childrens Hospital Outpatient Pharmacy with the following terms:
1. The permit be placed on suspension for two years with the suspension stayed 2. A fine of $5,000
3. Two inspections within 12 months at the cost of the permit holder. After the second inspection, the pharmacy shall appear before the Board. If the pharmacy fails either inspection, the pharmacy shall appear before the Board.
A roll call vote was taken. ( Ms. Locnikar – aye, Dr. Musil – aye, Mr. Francis – aye, Mr. Minkus-aye, Ms. Rosas – aye, Mr. Kennedy – aye, Mr. Van Hassel – aye, and Dr. Foy – aye)
quoted from
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Feds link former Ventura doctor to kickbacks, unnecessary surgeries; "I always scoff at someone I'm sitting with that says well it's really not about the money, ah b**sh**, it is all about the money. We make a lot of money," Pike is recorded saying at the meeting, according to the federal complaint.
For years, a small group of Southern California doctors performed unnecessary or overly extensive spinal surgeries, which were then fraudulently billed to Medicare, according to a complaint recently filed by the U.S. Attorney's office.
The Justice Department is suing former Ventura surgeon Dr. Aria Sabit and three investors in a spinal implant distribution company, attempting to recover money Medicare paid for what government lawyers say were unnecessary or excessive surgeries encouraged by the defendants.The civil complaint (PDF), filed Sept. 8, claims Adam Pike and Bret Berry are the founders of Reliance Medical Systems, an implant company, and subsequently at least 12 physician-owned distributorships (PODs}. John Hoffman was an investor in one of the Reliance PODs.
continue to read here
Arizonia Board of Pharmacy to Inspecct Wells Pharmacy Network in Florida
AGENDA ITEM 15 – Wells Pharmacy Network – Case 14-0019-PHR
President Foy stated that the Board has received a letter from Wells Pharmacy Network concerning the Consent Agreement that was offered to them in response to an FDA warning letter. President Foy stated that Wells Pharmacy Network is declining to sign the Consent Agreement and is requesting a formal hearing.
On motion by Mr. Kennedy and seconded by Ms. Rosas, the Board unanimously agreed to
rescind their action offering a consent agreement to Wells Pharmacy Network.
The Board members discussed various options and decided to send a Compliance Officer to
Florida to conduct an inspection.
On motion by Ms. Locnikar and seconded by Mr. Minkus, the Board unanimously agreed to table the complaint until a Compliance Officer conducts an inspection at the pharmacy and the Board can review the outcome.
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President Foy stated that the Board has received a letter from Wells Pharmacy Network concerning the Consent Agreement that was offered to them in response to an FDA warning letter. President Foy stated that Wells Pharmacy Network is declining to sign the Consent Agreement and is requesting a formal hearing.
On motion by Mr. Kennedy and seconded by Ms. Rosas, the Board unanimously agreed to
rescind their action offering a consent agreement to Wells Pharmacy Network.
The Board members discussed various options and decided to send a Compliance Officer to
Florida to conduct an inspection.
On motion by Ms. Locnikar and seconded by Mr. Minkus, the Board unanimously agreed to table the complaint until a Compliance Officer conducts an inspection at the pharmacy and the Board can review the outcome.
source found at
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Minutes and Video of Arizona Board of Pharmacy August 27 & 28, 2014 Meeting
The minutes and video from the August 27 & 28, 2014 board meeting are now available:
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Watch video archive
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Watch video archive
Main Street Family Pharmacy has Volunarily and Permanently Surrendered License to Alabama Board of Pharmacy ; Assessed $5000.00 fine
MAIN STREET FAMILY PHARMACY, Permit #s 113413/201825
Voluntarily and permanently SURRENDER of permit(s) and not to seek any
permit(s) in the State of Alabama in the future; assessed $5,000.00
monetary fine.
source found here
So far this year, the California Board of Pharmacy has revoked licenses of five pharmacies, 21 pharmacists and 158 pharmacy technicians--DEA searching for evidence in NorCal pain pill thefts
KCRA Sacramento - 13 hours ago
So far this year, the California Board of Pharmacy has revoked the licenses of five pharmacies, 21 pharmacists and 158 pharmacy technicians.
California Board of Pharmacy Continues to File cases against compounding pharmacies; all cases filed in August 2014
A&O Specialty Pharmacy, PHY 47448, and LSC 99382, Administrative Case AC 5077
Salinas, CA
Accusation filed 8/8/2014; Case Pending.
View the accusation
Pacific Pharmacy, PHY 50504 Administrative Case AC 4971
Westminster, CA
Accusation filed 8/16/2014; Case Pending.
View the accusation
Pico Union Pharmacy, PHY 45340, Administrative Case AC 5059
Los Angeles, CA
Accusation filed 8/16/2014; Case Pending.
View the accusation
Southern California Compounding, PHY 49147 and LSC 99510, Administrative Case AC 4671
San Diego, CA
Accusation Filed 8/27/2014; Case Pending.
View the accusation
Supercare Health, Applicant, Statement of Issues Case SI 5232
City of Industry, CA
Statement of Issues filed 8/12/2014; Case Pending.
View the accusation
Salinas, CA
Accusation filed 8/8/2014; Case Pending.
View the accusation
Pacific Pharmacy, PHY 50504 Administrative Case AC 4971
Westminster, CA
Accusation filed 8/16/2014; Case Pending.
View the accusation
Pico Union Pharmacy, PHY 45340, Administrative Case AC 5059
Los Angeles, CA
Accusation filed 8/16/2014; Case Pending.
View the accusation
Southern California Compounding, PHY 49147 and LSC 99510, Administrative Case AC 4671
San Diego, CA
Accusation Filed 8/27/2014; Case Pending.
View the accusation
Supercare Health, Applicant, Statement of Issues Case SI 5232
City of Industry, CA
Statement of Issues filed 8/12/2014; Case Pending.
View the accusation
Article--Pharmacies banned from compounding for docs without prescription--shows mixing of terms (first sentence says compounding pharmacies must not manufacture medicine for hospital and doctors' offices, except for named patient)--Fails to state no compounding pharmacy should be manufacturing period!!!
The US Food and Drug Administration (FDA) says compounding pharmacies must not manufacture medicines for hospitals and doctors’ offices, except for named patients.
Michigan Health and Hospital Association to Host Session on Federal and State Compounding Laws
Oct. 2 - Michigan Health & Hospital Association
www.mha.org/mha/weeklymailing/.../ealert_compounding_pharm.pdf
Pharmacy's compounded meds may not be safe
- 7 hours ago - An investigation by the Tennessee Board of Pharmacy found safety issues at Wellness Store Compounding Pharmacy, 3555 Keith St. NW in
Compounding Pharmacy Recalls Potentially Contaminated ...
Compounding Pharmacy Recalls Potentially Contaminated ...
www.lawblogs.net/.../compounding-pharmacy-recalls-potentially-contam...
16 hours ago - Compounding Pharmacy Recalls Potentially Contaminated Drug Products Pharmacy Creations has voluntarily recalled four product lots (see below) following ...
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