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Brenda Hutson

Changes to Manufacturer's Inserts

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I brought this up many years ago to one of the Reagent Manufacturing Companies (cannot recall now which one it was....Immucor, Gamma or Ortho....or maybe one of the ones that is no longer around).  When changes are made to Manufacturer's Inserts (and they can be as minor as a change in 1 word, which we can spend a long time searching for), it would be really nice if the Manufacturer would indicate the changes on the inserts (i.e. maybe italicize what is changed; or underline it; or highlight it......just give us a clue)!  We want to catch the significant changes, but not spend an hour reading and re-reading the insert to find the    ever-so-subtle and non-significant changes.

Thanks for listening,

Brenda Hutson, MT(ASCP)SBB

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Immucor does that.  They underline anything that has changed and use a closed triangle for anything deleted.  I've attached a copy of one from 2010.  What bugs me we get a new insert in 2016, and it was changed in 2013!  Where has it been all this time??changes.pdf

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On 7/1/2016 at 4:53 PM, mollyredone said:

Immucor does that.  They underline anything that has changed and use a closed triangle for anything deleted.  I've attached a copy of one from 2010.  What bugs me we get a new insert in 2016, and it was changed in 2013!  Where has it been all this time??changes.pdf

The short answer: Money - throwing stuff out is expensive.

The long answer: To get a good price for printed materials (package inserts, labels, etc.), one must purchase tens of thousands of copies. If changes are required, but not especially critical, the regulating bodies (FDA) will allow manufacturers a fair amount of leeway to use up current stock. Throwing out anything has an associated cost and since the commercial manufacturers are in the for-profit arena, they will tend to shy away from such actions. I'm sure this contributed to Immucor's tardiness.

Another contributor to slow moving changes: In the US, any changes to a package insert (or label) must be approved by the FDA before that new document is distributed. This process can take 6 - 12 months depending upon the complexity of the changes and the number of times the document goes backwards and forwards between the two parties.

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On 7/5/2016 at 6:23 AM, Auntie-D said:

Just check the release date/version number of the insert - if that hasn't changed then nothing in it has.

Auntie-D, I'm pretty sure Brenda had already done that and knew it was a different version before she posted.  She didn't know what had changed.

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On ‎7‎/‎1‎/‎2016 at 4:53 PM, mollyredone said:

Immucor does that.  They underline anything that has changed and use a closed triangle for anything deleted.  I've attached a copy of one from 2010.  What bugs me we get a new insert in 2016, and it was changed in 2013!  Where has it been all this time??changes.pdf

On ‎7‎/‎5‎/‎2016 at 8:05 AM, exlimey said:

The short answer: Money - throwing stuff out is expensive.

The long answer: To get a good price for printed materials (package inserts, labels, etc.), one must purchase tens of thousands of copies. If changes are required, but not especially critical, the regulating bodies (FDA) will allow manufacturers a fair amount of leeway to use up current stock. Throwing out anything has an associated cost and since the commercial manufacturers are in the for-profit arena, they will tend to shy away from such actions. I'm sure this contributed to Immucor's tardiness.

Another contributor to slow moving changes: In the US, any changes to a package insert (or label) must be approved by the FDA before that new document is distributed. This process can take 6 - 12 months depending upon the complexity of the changes and the number of times the document goes backwards and forwards between the two parties.

So I guess I am not so much talking about them making changes but the Inserts don't reflect it. (because they are still sending out old inserts until they use them up....though that is not good either)....I am talking about Inserts that have a different Version Number/ Date so you know there are changes in there.....somewhere.....but you can spend a lot of time looking for a one word, insignificant change.  As long as they are changing the Insert and sending out those new Inserts, it would be "so" helpful if they would (like Immucor) just indicate in "some way," what changes they made (i.e. underline it;       highlight in gray; etc. etc.; don't really care what they do as long as they do something).  That is good customer service! ;)

Thanks

Brenda Hutson

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20 hours ago, mollyredone said:

Auntie-D, I'm pretty sure Brenda had already done that and knew it was a different version before she posted.  She didn't know what had changed.

Right you are...thanks for the clarification.  I just want the Manufacturer to "give us a clue" so we don't waste so much time.

Thanks

Brenda

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In case you use Ortho reagents, they include a Summery of Revisions section on the last page of their inserts.  This way it is clear what has changed per revisions.

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23 hours ago, Brenda Hutson said:

So I guess I am not so much talking about them making changes but the Inserts don't reflect it. (because they are still sending out old inserts until they use them up....though that is not good either)....I am talking about Inserts that have a different Version Number/ Date so you know there are changes in there.....somewhere.....but you can spend a lot of time looking for a one word, insignificant change.  As long as they are changing the Insert and sending out those new Inserts, it would be "so" helpful if they would (like Immucor) just indicate in "some way," what changes they made (i.e. underline it;       highlight in gray; etc. etc.; don't really care what they do as long as they do something).  That is good customer service! ;)

Thanks

Brenda Hutson

I agree, Brenda. Immucor does a relatively good job of indicating changes. It can get a little ugly when the same "new" insert (with highlighted changes) is still being issued many years after the change. Perhaps Immucor buys a minimum number of inserts with highlighted changes and at some point transitions to the "clean" version ?

In the recent years, in the wake of mergers and consolidations, I've noted that the changes are often just name, logo, address or telephone numbers - of no real impact to the average user (unless you need to call Customer Service, of course).

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I keep all of our inserts on line instead of a notebook.  I have an Excel  listing with date revised and link to insert also on line.  Every so often I go on line and check my list against the inserts on line and download the revision if needed.  A few times we have gotten a new insert in the reagent, but the company still has the old one still on line.  I'll contact them asking them to e-mail me one and correct on line.

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Just to clarify a few misconceptions:

1. Once a package insert change has been approved and new stock is in, IT IS SOP-driven that all old versions are destroyed and not used in new packages. If you ever get 2 packages of the same product with different version inserts - report it immediately to the company. Major labeling booboo!

2. Changes in inserts are marked as changed until the next revision when those changes become what is marked and the previous set become repeated text. You never know how long it can be between product orders so a customer may not get a revised insert until they order the same product 2yrs later. The changes are tied to the revision number and at any point can be identified for lookbacks. 

3. Any change in insert must be approved by the FDA as this is a labeling issue and part of the license. This is not a free process. Any company makes sure the change is necessary and cost-effective within their Regulatory budget before making it. So small word change requests to "clarify" in the users' opinion are not likely to happen until the cost, changes and patient testing impacted make sense. 

4. The 6 - 12 month timeline is usually correct. as is the large amount printed for cost containment. It really hurts when branding or reagent changes happen and the Materials Management group just ordered a huge number of inserts which must now be destroyed.

 

Hope this helps :)

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3 hours ago, macarton said:

A few times we have gotten a new insert in the reagent, but the company still has the old one still on line.  I'll contact them asking them to e-mail me one and correct on line.

A word of caution: The "old" insert may still be relevant to in-date reagents on your or others shelves.

But saying that, it doesn't excuse the absence of the new insert.

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1 hour ago, Pony said:

Just to clarify a few misconceptions:

1. Once a package insert change has been approved and new stock is in, IT IS SOP-driven that all old versions are destroyed and not used in new packages. If you ever get 2 packages of the same product with different version inserts - report it immediately to the company. Major labeling booboo!

Pony,

I don't think anyone suggested that they get a shipment of reagents (with the same lot number) with varying inserts.

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On ‎7‎/‎7‎/‎2016 at 9:56 AM, mollyredone said:

Brenda,  didn't you see the attachment I put in my first response to this?  I'll attach it again.  Immucor does underline additions or significant changes.

changes.pdf

Yes, just responding to other Posts people had written.  I did see it and appreciate it.  Would like to see something then from other Manufacturer's as well.

Thanks

Brenda

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On ‎7‎/‎8‎/‎2016 at 7:52 AM, macarton said:

I keep all of our inserts on line instead of a notebook.  I have an Excel  listing with date revised and link to insert also on line.  Every so often I go on line and check my list against the inserts on line and download the revision if needed.  A few times we have gotten a new insert in the reagent, but the company still has the old one still on line.  I'll contact them asking them to e-mail me one and correct on line.

Regardless of where you keep them, it would still be "helpful" for them to somehow designate (as apparently Immucor does), what the changes are that they made (which apparently they did because there is a new Version Number/ Revision Date).

Thanks

Brenda

 

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On ‎7‎/‎7‎/‎2016 at 10:37 AM, kethaa said:

In case you use Ortho reagents, they include a Summery of Revisions section on the last page of their inserts.  This way it is clear what has changed per revisions.

Never noticed that before!  Thanks. ;)

Boy, so glad I posted this....learned all kinds of things!

Brenda

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I am wondering how do you handle the old/ expired package inserts? Do you keep them for period of time then discard it? Any regulatory requirement for this? Thanks.

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Yes, there are regulations for managing controlled documents for all manufacturers. Like Transfusion SOPs, they have to be put in a permanent archive so there is always a record of the instructions given to customers during a specific time period.

In the actual packaging area, there is an SOP-guided process for removing and destroying excess old inserts, once the new insert is approved for use. These usually have a "go live" date like other controlled processes.

 

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For hospital users...yes, you need to keep your old package inserts just as you would old SOPs. My old paper records are in boxes that have BIG messages on all sides - DON"T THROW THIS AWAY! We now use an electronic document control system. Once you retire or replace a document with a new version, the old version is maintained by the system. Pretty sweet!

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Ortho is good at adding revison summary.

 

Immucor---says they will underline and tringle....many times there is a change in their address and which is not underline so original poster's frustration is right.

I went through same and at the end noticed that the immucor address was chagned which was nor underline...

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