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FDA Starting to Crack Down on Compounding Pharmacies Making Sterile Products

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  • FDA Starting to Crack Down on Compounding Pharmacies Making Sterile Products

    I recently ran across this article discussing how FDA is beginning to focus attention on compounding pharmacies, especially ones manufacturing sterile products. I followed the link in the article to the list of recent pharmacy inspections and clicked into a few of them.

    The inspection report for Wedgewood was particularly terrible!!....I do use the compounded Pentosan from Wedgewood so this gave me significant pause and perhaps a good personal wake-up call.

    I also recently attended a conference in Feb and was able to catch up with one of the top sterile manufacturing experts in the industry (helpful that he also happens to be a good friend of mine ). Without going into specific detail on why I was asking (I do attempt to keep my horsey and professional life separate! ), I inquired about the compounding of a sterile IM injectible and repeated usage from a single vial that extends over a period of several months (which describes exactly how i've used Pentosan- I get the big vial and withdrawn a single injection every 4 weeks until it was gone). As expected, he said that is just about the riskiest use of a sterile injectible that one could practice. Every time a needle pierces the top of the vial, there is significant chance of introducing subsequent contamination through the compromised stopper.

    After thinking about everything, including the huge cost benefit of the Pentosan (believe me, I know what a factor cost is- it's one of the main reasons I've been using it too, in spite of myself- and I KNOW better ), I have decided my personal risk analysis is to stop getting the multi-use vial (unless I end up in a multiple-horse situation where I would use the vial up all in one administration) and go for the single-use vials. More expensive but still a big cost savings, and I feel this reduces the risk significantly in what I know to already be a risky practice (compounded sterile injectibles).

    (Of course, this is until FDA decides that Pentosan fits the definition of an adulterated drug because there is already an approved therapy on the US market, and shuts it down everywhere!)

    YMMV, but I hope this is useful information/ food-for-thought for everyone else on here using Pentosan or other similar therapies.
    ~Living the life I imagined~

  • #2
    Thanks for posting this information.

    I just bought another multi-dose vial of Pentosan from Wedgewood. I have wondered about contamination. I keep the bottle in a zip-lock bag (not sterile but clean) and in the past I have doused the top with antiseptic before drawing out a dose. I don't know how much that helps, but I figure it won't hurt.

    I might just go back to Adequan. Ugh.

    Comment


    • #3
      It would sure be nice to have the option to buy Pentosan in single-use vials.
      Click here before you buy.

      Comment


      • #4
        So what is the difference between Pentosan and any other multi use injectable bottle?

        Comment


        • #5
          This doesn't suprise me at all, several people died due to contaminated compounded drugs that were manufactured in my state.

          I have always used PentAussie, not the compunded Pentosan, because that's what my vet sells.

          Ya, I want to know what the difference is between Pentosan and any other multi dose injectable vial too.
          Unrepentant carb eater

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          • Original Poster

            #6
            Originally posted by davistina67 View Post
            So what is the difference between Pentosan and any other multi use injectable bottle?

            it's a good question- I'll ask my friend and find out. Maybe the length of time it's being withdrawn from? It is my understanding that multi-use vials are used up very quickly, ie within a few days or a week. Whereas the Pentosan vial I've been using has already been sitting on the shelf for 6 months.

            So it's not available in single-use vials from any vendor? That's a shame. I confess I have not looked into this as I assumed it would be. Who else is out there besides WEdgewood? The number and content of those observations indicates a serious lack of quality at that facility, which may have pushed me over my own personal risk threshold for using them as a supplier.
            ~Living the life I imagined~

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            • #7
              Originally posted by hey101 View Post
              it's a good question- I'll ask my friend and find out. Maybe the length of time it's being withdrawn from? It is my understanding that multi-use vials are used up very quickly, ie within a few days or a week. Whereas the Pentosan vial I've been using has already been sitting on the shelf for 6 months.

              So it's not available in single-use vials from any vendor? That's a shame. I confess I have not looked into this as I assumed it would be. Who else is out there besides WEdgewood? The number and content of those observations indicates a serious lack of quality at that facility, which may have pushed me over my own personal risk threshold for using them as a supplier.
              Maybe ask your vet if they can order PentAussie for you? It is the same thing as Pentosan as far as I know, and its made in Australia by real drug manufacturers.

              But if sitting on the shelf is the issue, what then about my bottles of Ace and Banamine? Neither of which get used often.
              Unrepentant carb eater

              Comment


              • #8
                Originally posted by Judysmom View Post

                But if sitting on the shelf is the issue, what then about my bottles of Ace and Banamine? Neither of which get used often.
                Exactly. Not sure that Pent would have any more risk then Legend or Adequan unless something with compounding it increases the risk.

                Comment

                • Original Poster

                  #9
                  PentAussie is not the same thing- it has glucosamine in it as well.

                  I can't speak to the Ace (I don't use it), but I hope you are utilizing the Banamine on the oral mucosae rather than IV injection, especially if it has been sitting around for awhile in your barn. It has long been proven that banamine is as effective when absorbed through the oral mucosae as IV. Much safer too.

                  re: Legend and Adequan, more good examples. Although when I used to use Adequan many years ago, IIRC, I did use single-use vials (plus it's not compounded).
                  ~Living the life I imagined~

                  Comment


                  • #10
                    But if sitting on the shelf is the issue, what then about my bottles of Ace and Banamine? Neither of which get used often.
                    Why do you think IM Banamine has such a terrible reputation? Yes, it's irritating to the tissues. But the article everyone trots out as evidence that Banamine is strongly linked to clostridial myonecrosis strongly states that it is STORAGE AND TECHNIQUE that is the most likely problem.

                    I am fastidious about skin prep when I give IM injections and can't believe the careless way that shots are given by a majority of people. Why *ask* for trouble? I am also kind of nutso about storing meds and doing careful prep of syringes, even with older bottles. But I sure would prefer single-use vials!

                    Hey101, were there any reports on "regular" non-compounding pharmacies to compare to the ones you posted?
                    Click here before you buy.

                    Comment


                    • #11
                      I am glad the FDA is cracking down on all these crack pot places - it's long overdue but it takes a lot of man power (aka: money) for the FDA to go to all these pharmacies on site to see what the heck is going on and then to follow up that things are being improved/changed.

                      I also think out there in consumerlandia that there is a general disregard for expiration dates and proper handling of medication (e.g. room temp vs. refrigerated, etc.). Those expiration dates and stipulations aren't on there for decoration - they are there for safety and quality assurance. If you are using things beyond expiration date, you might as well just draw up some fungus and inject it into your horses because that is what you are gambling with. If you are not storing the medications properly than you have a great chance you are injecting placebo b/c the drug has degraded under improper conditions. Why risk it? So I think it's great that it's drawing attention to these areas so that everyone can learn how important they really are to the safety and well being of the animals.

                      Oh and DW - I love a single use vial too but you also have to face that fact that many will not respect that they are SINGLE use and will try and reuse. That freaks me out because single use vials have no preservatives so you are just brewing nastiness in those vials if they are saved and reused and I do have many articles on that. Yet somehow I have this argument with certain physicians on a regular basis because they "feel bad wasting" any left over drug in a single use vial and I think - gee, I feel bad injecting bacillus into people too! It's just hard for some to conceptualize contamination they cannot see. Kind of like people not going to the doctor for hypertension because it doesn't hurt...

                      And don't even get me started on people that re-use needles and syringes and yes barn people I see you do it all the time and I think holy moly a syringe is like cheapo compared to the cost of treating a case of cellulitis or worse....even the worst IV drug users (human) have learned not to reuse needles! Eeeeeek!

                      Comment


                      • #12
                        Originally posted by hey101 View Post
                        Whereas the Pentosan vial I've been using has already been sitting on the shelf for 6 months.
                        Double check me on this... but for some reason I think it's supposed to be used up within 6 months. It's got a short shelf life.
                        Brothers and sisters, I bid you beware
                        Of giving your heart to a dog to tear.
                        -Rudyard Kipling

                        Comment


                        • #13
                          Originally posted by deltawave View Post
                          Why do you think IM Banamine has such a terrible reputation? Yes, it's irritating to the tissues. But the article everyone trots out as evidence that Banamine is strongly linked to clostridial myonecrosis strongly states that it is STORAGE AND TECHNIQUE that is the most likely problem.

                          I am fastidious about skin prep when I give IM injections and can't believe the careless way that shots are given by a majority of people. Why *ask* for trouble? I am also kind of nutso about storing meds and doing careful prep of syringes, even with older bottles. But I sure would prefer single-use vials!

                          Hey101, were there any reports on "regular" non-compounding pharmacies to compare to the ones you posted?

                          Why would I ever give Banamine IM????????

                          I always give Banamine IV.

                          Anyway my point wasn't so much the drugs - I used ace and banamine as examples as they are common drugs in stables - drugs that may sit around for a period of time and not be used - NOT because I had any particular questions about those drugs.

                          Good to know Pentosan and Pent Aussie are different. I have only used the latter.

                          So is the real issue that its bad for all injectable drugs to sit on the shelf for a period of time after opening, regardless of compounded status? I am always careful to wipe the injection port/ top with alcohol and when dry stick the needle in. Is that not relevant? Or should drugs be tossed, regardless of expiry date, a certain time after they have been opened?
                          Unrepentant carb eater

                          Comment


                          • #14
                            Well, why would anyone EVER use an old, dusty bottle of ace? Similar risk, the way I see it. Injecting a contaminated drug IV isn't any safer. Especially into a filthy horse.
                            Click here before you buy.

                            Comment


                            • #15
                              So there are a few things to consider about injectable drugs and whether they are ok to use. These are the rules we use in hospital pharmacies:

                              Single Use IV/IM ("injectable") vial - these have no preservatives in them, meaning they are very susceptible to contamination by bacteria and fungus that are introduced into the vial upon entering with a needle. They are meant to be entered by a needle only once. If there is any remaining drug in the vial it must be discarded.

                              Multiple Use vials - these have preservatives in them. They tend to have a longer shelf life (expiration date on the vial). ONCE one of these has been punctured (a needle has gone into the vial) they are only good for 28 days unless the manufacturer has given extended dating (this can occur if the manufacturer makes the product in a very very sterile environment) or has studies to show sterility beyond 28 days.

                              http://www.cdc.gov/injectionsafety/p...nglevials.html
                              http://www.cdc.gov/injectionsafety/p...ultivials.html

                              Hope this helps! When it doubt, throw it out! Always alcohol swab the top of the vial before putting your needle into it.

                              Comment


                              • #16
                                Well...here I was, SO excited that I finally got a script from my vet for Pentosan, and had it faxed directly to Wedgewood...Now i'm not sure what to do

                                Comment


                                • #17
                                  So DW - this place shows single dose pentosan but I have no idea how reputable they are. Seriously all these compounding pharmacies give me the heebie jeebies and look sketchy. http://www.horsemedsonline.com/

                                  Comment


                                  • #18
                                    I wonder if a company like Wedgewood would give you several single dose vials instead of one large multidose? Has anyone asked? Might be worth a shot...

                                    (Although that doesn't help much if the solution is contaminated to start :-/ Reading through their FDA report and it certainly is worrisome.)

                                    Comment


                                    • #19
                                      Okok, for those trying to evaluate if the compounding pharmacy is "safe" here is a nice newsletter (intended for vets) that gives some questions to ask a potential pharmacy: http://www.aaep.org/images/files/Com...%2009%2010.pdf

                                      It's quite an extensive list of questions but very legit. I can only imagine the stroke the pharmacy will have when you being asking....all of them. Perhaps as a group - animal owners haven't asked enough questions and maybe this is why these creepo pharmacies have been able to run amok. They know most people don't even know enough to question them and that sucks.

                                      Comment


                                      • #20
                                        Originally posted by rockfordbuckeye View Post
                                        Multiple Use vials - these have preservatives in them. They tend to have a longer shelf life (expiration date on the vial). ONCE one of these has been punctured (a needle has gone into the vial) they are only good for 28 days unless the manufacturer has given extended dating (this can occur if the manufacturer makes the product in a very very sterile environment) or has studies to show sterility beyond 28 days.

                                        .


                                        Thank you! This answered my question.
                                        Unrepentant carb eater

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