Compounded Sterile Preparations: Important Considerations

Drug compounding is very different from drug manufacture. Drug manufacture is the mass production of an FDA approved formulation. Drug compounding on the other hand is the science of creating a patient specific formulation for individual needs according to direction from a practitioner. Compounding can be non-sterile, which is a practice that does not require absolute sterility. It can also be sterile. Compounded Sterile Preparations are meant for the eyes or for the intravenous route. Drug compounding can be done in-house at the hospital. It can also be outsourced to a facility. In fact, about three quarters of hospitals and ambulatory facilities elect to outsource. According to the law, a compounding outsourcing facility is a geographical location that is engaged in the science and has elected to register as that. The facility must comply with all requirements of section 503B of the 2013 Drug Quality and Security Act. 

  1. Extension on BUD

Extended beyond use dating is a practice meant to increase the stability and longevity of drugs. It lowers wastage. Usually drugs have a date after which it cannot be administered, stored, or transported. An extension pushes the boundaries defined by the US Pharmacopoeia. There is a lot of testing required like stability indicating testing for example. These tests require a lot of machinery and technology. Resources that hospitals will not have at hand. However, an outsourcing facility will have invested in these and will therefore be able to provide the extended beyond use dating. On the other hand, in-house compounding will produce formulations with a short shelf life. 

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  1. Absolute Sterility

61% of the hospitals that went for outsourcing did so for the sole reason of sterility testing. Sterility is a major and volatile aspect of this practice. Even the slightest presence of microbial can render a formulation useless and possibly toxic. In-house compounding is not subject to rigorous oversight and control. They can deviate from the standard protocols. Outsourcing facilities on the other hand are held to very high standards. They are required to report adverse events and are inspected according to FDA risk based schedule. In addition to his, these FDA preferred facilities must comply with CGMP requirements. A higher quality is expected from compounded sterile preparations. 

  1. Resource Allocation

In-house compounding will mean that hospital’s time and staff will be directed to the activity. This takes resources away from patient care. It also leaves room for errors by preparers in the chaos of daily hospital operation. Research has revealed that use of outsourcing facilities can reduce medication errors by 50% when the physicians use pre-filled pre-labeled syringes. 68% of practitioners said that they saved about 3-6 minutes on each case of their time by using the same. 

  1. Drug Availability

Admixing takes some time. Often the hospital might find itself in a bad position lacking one component of the formulation. This means that the patient will be required to wait a little longer for their medication. 68% of the hospitals that took up outsourcing revealed that this was their motivation for taking that path. The outsourcing facilities are fully equipped and schedules do not have to be interrupted. The hospital stays stocked up on prefilled pre-labeled syringes. At the end of the day, the patient wins. 

  1. Re-evaluate the In-House Decision

One may think in-house compounding is better as the chain of handling seems shorter. Aside for room to deviate from standard protocol there is a very high capital investment. The hospital will also have to observe regulations. Regulatory compliance is not cheap. Compounded sterile preparations will further dip into the hospital coffers. Something else to think about, the risk of adverse incidents. For example, if the drug has an adverse effect on the patient and it is realized that it was due to a mishap or issue in preparation then the hospital is left vulnerable to prosecution. 

Even FDA Approves of Outsourcing

The FDA highly advises and encourages outsourcing. Compounded sterile preparations are extremely volatile and delicate. A hospital or ambulatory service is not the best place to handle the processes. There are simply too many things that could go wrong. Too many chances for breach of sterility. Too much leeway for bending of regulation. Outsourcing is more fiscally sensible that in-house compounding. The whole admixing process is subject to federal regulation. That is of course if the facility outsourced to is reputable and in compliance with the entirety of section 503B. One thing remains true though, an entity must look at the full dimension of facts before making a decision. They must also take their time choosing a facility to trust with their CSPs.

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