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Administrator
Posts: 578
Registered: ‎02-22-2010
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Outsourced Medications Webinar

[ Edited ]

Thanks for joining our webinar with Eric Kastango, "Outsourced Medications: How Can You Know They are Safe?"

Download the slides.

 

Have a question for Eric? Post it here for him to answer.

Administrator
Posts: 578
Registered: ‎02-22-2010
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Re: Outsourced Medications Webinar

Here are some questions from our live presentation:

 

Q: But have these on-site visits noted the issues recently made public?

Q: After fda inspects, it's my understanding they issue their report on form 483, and getting these reports requires a formal freedom of information request.  Is there a mechanism or website (clearing house) where all these 483’s are aggregated, where consumers can review the findings and compare apples to apples?

Q: Are we (hospital) required to be able track by lot number what compounded products are used in which patients?

Q: Do State Boards of Pharmacy also make warning letters or inspections publically available?

Q: Do lot numbers from bulk product pruchased from a company such as Pharmedium need to be tracked down to the patient level?

Q: How do you know your membrane filtration test will not be inhibited by the compounded medication? How do you validate your membrae or direct Inoculation test is valid?

Q: How much does a true stability indicating assy cost?  

Q: When reviewing vendor quality assurance reports should we expect employee media testing results?

Q: Will hospitals be able to compound CSPs for multiple sites within there own organization?

Expert
Posts: 1,168
Registered: ‎02-23-2010
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Re: Outsourced Medications Webinar

Q: But have these on-site visits noted the issues recently made public?

 

A: Sorry, but I don't understand the question.  If you are referring to NECC, there has been a lot of information released by the Mass Dept of Health.

Q: After fda inspects, it's my understanding they issue their report on form 483, and getting these reports requires a formal freedom of information request.  Is there a mechanism or website (clearing house) where all these 483’s are aggregated, where consumers can review the findings and compare apples to apples?

 

A: Great question.  I recently found out that if the FDA receives three FOIA for a specific 483 or warning letter, that they must make their findings public on the FDA website.  Start making those requests of vendors you want to know about.

Q: Are we (hospital) required to be able track by lot number what compounded products are used in which patients?

 

A: According to the FDA, they expect the outsourcer to be able to do this but if you check your contract, you will find that the outsourcer will typically make this responsibility your problem. 

Q: Do State Boards of Pharmacy also make warning letters or inspections publically available?

 

A: I don't know since each state will handle that information differently.  You should call your state's board of pharmacy and find out how to get that information.

Q: Do lot numbers from bulk product pruchased from a company such as Pharmedium need to be tracked down to the patient level?

 

A: Ideally, yes.  How would you identify patients who received a contaminated batch?  What mechanisms do you have in place to identifiy potentially affected patients?

Q: How do you know your membrane filtration test will not be inhibited by the compounded medication? How do you validate your membrae or direct Inoculation test is valid?

 

A: Great question.  That is a question to ask the lab is performing this test for you. They should have validated their procedures specifically with the drugs they are testing.

Q: How much does a true stability indicating assy cost? 

 

A: In the past, I did a study with Trissel for oxytocin and it cost $15,000 for one concentration in three solutions in 2003.

Q: When reviewing vendor quality assurance reports should we expect employee media testing results?

 

A: Absolutely.  Since almost all of the outsourcers use personnel to aseptically prepare these doses as you would in the hospital, the results of employee media fills should be a critical quality metric that you should ask for and know about.

Q: Will hospitals be able to compound CSPs for multiple sites within there own organization?

 

A: The FDA permits hospitals to centralize their compounding operations as long as you have access to the patient's health information.  You need to find out from your state board of pharmacy if they permit this practice.  It will depend on the state pharmacy rules and regulations where your organization is located.

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Administrator
Posts: 578
Registered: ‎02-22-2010
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Re: Outsourced Medications Webinar

Here are more questions from our live presentation:

 

Q: To obtain extended BUD, is batch sterility testing required on each lot?

Q: Do you know of a good resource to acquire contract templates for outside vendors?

Q: To build on the NDC question, should we be tying all sterile products back to each specific patient like the home health folks do... What is best practice?

Q: Opinion of being PCAB certification?  How about being certfied by an accreditation agency approved by CMS?

Q: How do you differentiate between an outsourced compounding vendor and an FDA-approved manufacturer (other than knowing the "big" companies)?

Q: Can you "trust" a stability study that is published in a peer review journal?

Q: How do we create experts in this? Can our GPO's or professional organizations vet these organizations for us?

Expert
Posts: 1,168
Registered: ‎02-23-2010
0

Re: Outsourced Medications Webinar

Q: To obtain extended BUD, is batch sterility testing required on each lot?

 

A: Yes

Q: Do you know of a good resource to acquire contract templates for outside vendors?

 

A: I have attached template agreement for your consideration along with an article on auditing

Q: To build on the NDC question, should we be tying all sterile products back to each specific patient like the home health folks do... What is best practice?

 

A: Best practice is to be able to have a system of traceability and recallability.  You need to have a mechanism to identify patients at risk in the event of a problem.

Q: Opinion of being PCAB certification?  How about being certified by an accreditation agency approved by CMS?

 

A: PCAB accreditation looks most closely at the actual practices associated with compounding.  We know that simply attaining a PCAB-accredited “seal” or any type of accreditation status from any organization means absolutely nothing if one does not continually put into practice the policies, procedures, and standards that are a part of such an accreditation. 


Q: How do you differentiate between an outsourced compounding vendor and an FDA-approved manufacturer (other than knowing the "big" companies)?

 

A: Ask them if their medications are FDA approved?  Ask what their licensure status is in their state?  Are they a pharmacy, registered establishment with the FDA or a DEA manufacturer?  Ask to see their licenses.


Q: Can you "trust" a stability study that is published in a peer review journal?

 

A: Great question and one that Larry Trissel was quite concerned about as he was retiring.  Who is going to fill his shoes?  The acceptance criteria for drug stability studies have been dumbed down.  See the attached article that Trissel penned.

Q: How do we create experts in this? Can our GPO's or professional organizations vet these organizations for us?

 

A: A passion for wanting to learn the principles and science of quality systems, sterilization, compounding, disinfection amongst other topics.  It takes time to study and require work to become good.  Malcolm Gladwell has said it takes 10,000 hours to become proficient/expert. The GPOs and professionals orgs would need to determine if they have the internal resources and expertise to properly assess these types of operations.   

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.