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FDA Starting to Crack Down on Compounding Pharmacies Making Sterile Products

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  • #21
    I agree with Davistina. Multi-dose bottles of Ace, Adequan, Legend all pose the same problem. Ace especially because it likely isn't used very often.

    While economy is a reason most of us buy multi-dose, the signle dose of Pentosan (6ml) is not enough for a large horse. I give 8ml and I give it once a week (yes, you read right). So my big bottle only lasts 6 weeks.

    Comment


    • #22
      Asking again in hopes the OP can help . . . is there a similar review of "standard" or non-compounding pharmacies available to the public WRT safety violations? I daresay none of these operations passes an inspection like this (the fine-toothed comb variety) with zero findings. Just trying to compare apples to apples a bit.
      Click here before you buy.

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      • Original Poster

        #23
        I didn't find anything specific (although I didn't look too hard, to be honest) comparing compounding pharmacies to manufacturers, but FDA posts all enforcement actions (warning letters, 483's, etc) and there are plenty to go around for manufacturers. I wasn't really looking for the link I posted- I get a daily newsfeed related to goings-on in the pharma industry, and the article on compounding just caught my eye because of the discussions here onCOTH.

        Hospira and Ben Venue are two major suppliers who have had a host of problems over the past year or so. In fact, Hospira just failed yet another inspection at their Rocky Mount, NC facility. I did a quick search on FDA's website and came up with this list of inspection reports for Hospira, so that might be a good start for you to compare.

        Rockfordbuckeye, thank you for your extremely informative posts.
        ~Living the life I imagined~

        Comment


        • #24
          This is slightly off topic, but I just got a new multi use vial of Pentosan from Wedgewood.

          What if I put a needle in to draw the med and left the needle in there and put the cap back on it? Then for every dose I just put the syringe on the needle and draw it out.
          I'm not sure if my question is clear, but I'm trying to come up with a way to limit contamination.
          Kanoe Godby
          www.dyrkgodby.com
          See, I was raised by wolves and am really behind the 8-ball on diplomatic issue resolution.

          Comment


          • #25
            Any time you breach the rubber stopper you are letting germs in. Leaving a needle in gives the bacteria a nice, easy path alongside the needle--they don't need to go through the needle itself. So a cap would not help.

            Best is to allow the rubber stopper to "seal" as it's meant to do between uses, and to keep it scrupulously clean. Before I put a needle through a rubber stopper I wet it with alcohol and LET IT SIT until it dries, then again and let it dry and then once again before I draw up the drug. Then I wipe it down a last time. Each time I use a new alcohol swab. Between uses the bottle is kept in a baggie in a clean place. (my house, not a shelf in the tack room)

            I also prep the horse in a similar fashion before IM injections--clean the skin with multiple (large, kleenex-sized) alcohol wipes, letting the skin dry in between. I spend a good 10 minutes prepping. Call me a germ freak in this one particular scenario. I really am not, generally speaking, but this helps me sleep better at night.
            Click here before you buy.

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            • #26
              Originally posted by CDE Driver View Post
              This is slightly off topic, but I just got a new multi use vial of Pentosan from Wedgewood.

              What if I put a needle in to draw the med and left the needle in there and put the cap back on it? Then for every dose I just put the syringe on the needle and draw it out.
              I'm not sure if my question is clear, but I'm trying to come up with a way to limit contamination.
              So that would actually increase the risk of contamination because you would be creating what we call an "open system" meaning bacteria/small particles could enter the vial via the air through the opening with the needle.

              Really the best you can do is wipe the vial with a sterile alcohol swab before entering it each time and then inbetween uses - in the hospital we cover the vial tops with these: http://shop.gohcl.com/default.aspx?p...itemcode=18299 which are suppose to minimize contamination from the air getting into the micro holes that are left in the vial septum once it has been entered (right - if you look at that rubber top up close - once a needle has gone through it - the hole remains - the more times you enter into it - not only are you possibly bringing contamination in from the air with the needle but it also jeopardizes the integrity of that rubber top). And then of course being scrupulous about throwing away product after 28 days or whatever the expiration is. And like I said - when in doubt throw it out. In the hospital if I see a vial that has been "cored" - meaning the vial septum has lots of holes, I will chuck it. Better safe than sorry. Especially if it's a med for intravenous use.

              I also tend to be a ninny and I use a smaller needle for withdrawing the drug from the vial (higher gauge) and then swap out to a new needle before injecting the horse. This serves two purposes. One - some believe that using the needle through teh vial septum dulls it and therefore changing to a fresh one before injecting is less painful. I think this is an anecdotal thing but you can see a forum here with nurses discussing it. http://allnurses.com/general-nursing...ior-67769.html. The main reason I do it is so that the holes in the vial are smaller so less risk of contamination of a multiple dose vial. How much that *really* matters though? I have no idea. It makes me feel better

              Comment


              • #27
                Thanks so much for a the great information!

                Would you reuse the smaller needle you use to withdraw the drug or use a new one every time?
                Kanoe Godby
                www.dyrkgodby.com
                See, I was raised by wolves and am really behind the 8-ball on diplomatic issue resolution.

                Comment


                • #28
                  Thanks so much for a the great information!

                  Would you reuse the smaller needle you use to withdraw the drug or use a new one every time?
                  Kanoe Godby
                  www.dyrkgodby.com
                  See, I was raised by wolves and am really behind the 8-ball on diplomatic issue resolution.

                  Comment


                  • #29
                    what about just when you get the vial, immediately draw it up into 6 individual syringes and cap those and store for when you are ready to use them? Would this prevent problems?

                    Comment


                    • #30
                      Originally posted by CDE Driver View Post
                      Thanks so much for a the great information!

                      Would you reuse the smaller needle you use to withdraw the drug or use a new one every time?
                      I throw away the smaller needle - it's no longer sterile so it should never be used again.

                      Regarding the drawing up 6 doses into individual syringes sand capping/storing - now that is an interesting question And the answer is that it depends. If you are drawing from a single use vial - then the answer is absolutely not because without preservatives and once the drug is removed from the original container - no matter what you do with it, it is already non-sterile now and subject to bacterial contamination. So it should go into the horse or get thrown away immediately after being removed from the vial. IF you are attempting to withdraw multiple syringes from a multidose vial, The FDA does comment on that. In a sterile enviroment - like a compounding pharmacy doing this in a special hood - yes this is allowable. But for us at a barn which is a dirty environment, no this is not considered any safer and probably less safe than just leaving the drug in the original vial.

                      I did find a specific comment on the CDC site regarding the earlier question about leaving the needle IN the vial. Here is the response from the CDC:

                      Is it acceptable to leave a needle or other device inserted in the septum of a medication vial for multiple medication draws?
                      No. A needle or other device should never be left inserted into a medication vial septum for multiple uses. This provides a direct route for microorganisms to enter the vial and contaminate the fluid.
                      Link: http://www.cdc.gov/injectionsafety/p..._med-prep.html

                      Comment


                      • #31
                        Originally posted by deltawave View Post
                        Best is to allow the rubber stopper to "seal" as it's meant to do between uses, and to keep it scrupulously clean. Before I put a needle through a rubber stopper I wet it with alcohol and LET IT SIT until it dries, then again and let it dry and then once again before I draw up the drug. Then I wipe it down a last time. Each time I use a new alcohol swab. Between uses the bottle is kept in a baggie in a clean place. (my house, not a shelf in the tack room)
                        I, too, keep mine in a baggie in the house and will be adopting your rubber stopper disinfection procedure (my process was nowhere near as thorough).

                        I also prep the horse in a similar fashion before IM injections--clean the skin with multiple (large, kleenex-sized) alcohol wipes, letting the skin dry in between. I spend a good 10 minutes prepping.
                        I think this is worthy of repeating, because most horse people I know just jam the needle in. That's what I used to do, but thinking back it does seem pretty stupid to spend so much effort keeping the needle and syringe sterile, only to jam it through who knows how many layers of dirt and dust and whatever the horse may have rolled in that day.

                        Since I started prepping the skin my horse has not had any needle reactions. He used to get a hard lump at the injection site that sometimes took a month to resolve.

                        I use a bottle or isopropyl alcohol and squeeze it over the area and wipe it off with a paper towel. I do this a few times and then I squeeze a bunch on and let it sit until it dries -- about five minutes.

                        Comment


                        • #32
                          I use isopropanol wipes that I get at the grocery store--in one of those cylindrical pop-up containers. They're nice and big and juicy! I will take one and wipe the stopper, then scrub the spot on the horse I'm going to inject with the same wipe, then chuck it. Same with wipe #2: vial first, then horse. Repeat with wipe #3, letting the skin dry thoroughly between wipes. It is the drying that kills the bugs, not a brief swim in alcohol.
                          Click here before you buy.

                          Comment


                          • #33
                            SIMKIE…I always get single dose vials of Pentosan from Wedgewood as per my vet's recommendations.

                            Comment


                            • #34
                              I keep my pentosan at the house but I just put it back into the plastic with the snap cap that it's delivered in. The main bottle doesn't go to the barn. I clean off the septum with alcohol prior to removing the dose.

                              It's also important to look at the solution carefully. It's a clear, very pale amber color when I pull the first dose. Check each dose. If the color changes or you notice any turbidity do not use it. It's hard to see in the amber bottle so make sure to examine it carefully and know what it is supposed to look like when you pull it into the syringe.
                              "Some people are born on third base and go through life thinking they hit a triple” – Barry Switzer

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