Considerations For Pre-Filled Syringes For 503(b) Compounding Facilities

By Keith Dodson

Most injectable drugs administered at hospitals are infused intravenously (IV) directly into a patient's bloodstream. The IV route of administration allows a fast onset of drug action, a high accuracy, and a nearly 100 percent bioavailability of the medication.  However, IV drugs also have some disadvantages. The preparation and administration process of these drugs is a complex and time-consuming process that needs to be carried out by trained personnel and is associated with a high risk of causing harm to patients.  Medication errors related to IV drugs, such as the wrong drug, dose, or intravenous rate, can lead to adverse drug events that can end up in serious and sometimes even life-threatening situations. Another critical issue that may occur with IV drugs is microbial contamination. This contamination can cause severe bloodstream infections in patients.

The global health issue of medication errors is gaining more attention, and agencies such as the FDA and the WHO are taking initiatives to prevent them. The newly developed infusion devices such as syringe pumps are getting smarter and often equipped with software that contains a drug library, dosing units and limits, or an automatic detection system of syringes. This automatic detection of the syringes could be achieved through different systems, for example, a barcode, RFID chip, or even the geometrical parameters of the syringe. In addition to improving safety in the hospital setting, this technology will also improve inventory management in hospitals and allow traceability of drugs along the whole supply chain.

The FDA supports two approaches to respond to those global trends and allow hospitals to gain efficiency, lower medical errors and minimize drug shortages. The first is the implementation of ready-to-use containers and pre-fillable syringes (PFSs) in particular. PFSs are easy to use, reduce the complexity of IV preparation and administration and increase patient safety by minimizing medication errors. The second approach focusses on minimizing drug shortage by using alternative producers such as 503(b) compounding centers. These facilities enjoy a more flexible regulatory pathway, but in order to be successful to anticipate the changing drug shortage landscape, require a highly efficient and flexible production set-up to drive timelines for drug launches to the absolute minimum.