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
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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
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