By Kevin E. Cancelliere
Director, Pharmaceutical Delivery Systems Marketing
West Pharmaceutical Services Inc.
When equipment fails during an emergency, not only is the patient at risk, but the nurse or caregiver may be injured as well. Issues with glass vials and syringes, including breakage, detached needles, jammed IV lines, or syringe tip cracking and breaking, have prompted the U.S. FDA to consider issuance of new recommendations and potential solutions to avoid delays in the administration of a medication.
The draft guidance, “Glass Syringes for Delivering Drug and Biological Products: Technical Recommendations to Supplement International Organization for Standardization (ISO) Standard 11040-4 (Draft),” relates to events related to connectivity problems with certain prefilled needleless glass syringes are used with some needleless IV access systems.
While the FDA guidance is focused on patient safety, it is the nurse or caregiver who often bears the pain of connectivity issues. In extreme situations, including medical emergencies, delays in receiving medication and injuries to caregivers may potentially result in harm to the patients. Because of this, FDA has recognized that compliance to ISO 11040-4 alone does not ensure that glass syringes can be connected effectively, and proposes supplemental tests to help ensure patient safety.
As potential design or redesign options, FDA proposes:
• The use of a bonded or staked needle with appropriate sharps protection for intramuscular or subcutaneous
injections.
• Glass syringes designed with specific internal dimensions to ensure connectivity.
• New designs for dedicated dual connections between the syringe and connecting devices.
Several solutions are available to help drug manufacturers mitigate risk to patients and caregivers, including syringes made from novel materials such as cyclic olefin polymers, and adapters that allow for needle-free connections to a vial and/or an IV bag. In addition, advanced delivery systems such as staked needle prefillable syringe systems or integrated safety needle systems can provide a measure of safety when used during any healthcare situation, including the homecare setting.
Plastic systems have long been recognized as having considerable advantages over glass in many applications. One key benefit is the ability to provide container systems with improved dimensional tolerances, and the ability to create customized containers. Dimensional tolerances on plastic or molded components are significantly tighter and more precise than glass. Break-resistant polymers, including the Daikyo Crystal Zenith cyclic olefin polymer, can reduce the risk of breakage and can be manufactured with increased dimensional precision, particularly at the front end of the syringe, which may help to optimize functionality. When a glass syringe breaks, it often does so at the tip, where the needle or other luer connection is attached. Increased forces required to deliver high-viscosity products, high breakloose forces, or excessive twisting or other movement may increase the risks of glass syringe breakage.
One solution for direct injection, where a needle may need to be attached to a syringe, is to move to a staked needle system with an integrated safety mechanism. This avoids the need for additional components since the needle and its safety system are already part of the delivery system.
In addition to reduced breakage, plastic syringes can be manufactured to high standards of cleanliness and tolerance and specifically designed to meet the packaging and delivery needs of today’s pharmaceutical and biopharmaceutical products. Adapters, including vial adapters or needle free transfer devices, offer the perfect solution for quick and safe transfer of drug product from vials while allowing convenient, optimal quantity aspiration.
Systems like the West Vial2Bag system connect to standard IV bags through the IV set port. The drug vial connects to the transfer system with a West vial adapter and diluent is transferred from the IV bag to the vial for drug reconstitution. The reconstituted drug is then transferred from the vial back to the bag. Standard syringes can also be connected to the Vial2Bag system.
West offers a variety of packaging and delivery solutions that can help to ensure effective delivery, including the Daikyo Crystal Zenith syringe systems, passive and active safety system technologies for staked and Luer lock syringes, needle-free administration systems, and collaborative development solutions for combination
products.
Partnering with packaging manufacturers early in the drug development process will help to ensure that challenges of packaging, delivery and administration can be overcome through the use of innovative design, high-quality materials and/or novel polymers that meet the proposed FDA recommendations for connectivity.
For more details, please link to the draft guidance:
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM346181.pdf
