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Compounded drugs in syringes warning

According to the U.S. Food and Drug Administration (FDA), compounded or repackaged drugs stored in 3 milliliter (ml) and 5ml syringes manufactured by Becton-Dickinson (BD) should be avoided unless there is no there suitable alternative.

The reason for the warning is because medicines held in these types of syringes could lose potency over a period of time. Loss of potency means that the drug would no longer be as effective as intended. The reason for this is due to a possible reaction between the rubber stopper in the syringe and the formulated drug product. There are no risks of non-sterility or microbial contamination with the sterile plastic disposables.

Furthermore, other BD 10ml, 20ml and 30ml syringes may also contain the same rubber stopper. For this reason, BD has alerted customers to avoid using these syringes for holding medicines (what is referred to as a “closed container system”). This applies to any compounded and repackaged drugs.

The issue has come about because the FDA has only approved the syringes for the aspiration or injection of fluids, and not for the long-term holding of medicines. It has come to the health agency’s attention that syringes are being used to hold certain types of drugs, such as fentanyl, morphine, methadone and atropine. Reports indicate that prolonged storage has led to a loss of potency.

At present it is unknown how long medicines can be held in the syringes before degrading. This will vary according to different drug products and can only be assessed by a stability trial, where portions of the drug are removed from syringes at set time points and assessed for the required levels of chemicals. The fact that this has not been done for a number of drugs rests with the pharmaceutical compounders who prepared the medications. Running such studies, with sterile plastic disposable items, forms part of Good Manufacturing Practice (GMP) expectations.

Different plastics will react with different drugs over different periods of time. Other variations will occur at different temperature of storage. The risks are that plastic or rubber will degrade or that a reaction will occur where something is leached out of the material. In short, physical and chemical studies are required.

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