Making Drug Delivery Safer

Needlestick safety legislation is spreading throughout Europe. On March 8, the European Union Employment and Social Affairs Ministers adopted a Directive to protect its 3.5 million healthcare workers from needlesticks and other sharps-related injuries. The new directive implements in law a framework agreement signed in July 2009 by the European Public Services Union and the European Hospital and Healthcare Employers' Association. Full compliance for all healthcare employers is unlikely to be imposed until mid to late 2012.

"Due to the new legislation in Europe, disposable auto injectors and safety shield devices are becoming extremely important now," says Sheila Dell, Ph.D., vice president of business development, Catalent Pharma Solutions (Somerset, NJ). "We've been finding that some of our customers are still not aware of the new legislation, which requires all prefilled syringes to have a safety shield device," she says.

Catalent recently partnered with a Manchester-based company, Innovate UK, to market a new safety shield device, as well as help its European customers comply faster with the new legislation. As a result of the joint marketing and distribution agreement between Catalent Pharma Solutions and Innovate UK, a new proprietary safety shield device will be brought to market, called "Click In." It is designed to be used with syringes that have luer lock, luer slip, or staked needles.

Catalent Pharma Solutions is currently showing it to pharmaceutical customers, and the device has been receiving an excellent response, according to Dell. The safety shield device is designed so that a syringe slides into it, where it clicks in place and is securely held.

According to Simon Cohen, managing director, Innovate UK, "Click In" offers a quick, turnkey solution for complying with new legislation. "Simplicity of action and ease of use are key advantages. There is no need to change or validate a syringe filling line," says Cohen.

To use the safety feature, the injection is performed normally. After injection, the shield moves forward and locks in place when a button is pressed. It can then be put into a sharps container for disposal. "Since the device is not surface activated, there is no chance of splash contamination," says Cohen.

During the development of this safety device, Cohen explains that the main challenge faced was to make sure its design allowed flexibility in packaging options. "We wanted a system that could be added after fill as part of the packaging line, for an automated pre-fitted option. In addition, we wanted it to be offered as a stand-alone system that could be sent out with the product to be manually added by the clinician at point of use," explains Cohen.

Catalent Pharma Solutions is taking a proactive role in helping its customers comply with the new legislation. "We're happy to be able to offer our customers an off-the-shelf product range of safety devices that represent a safe, simple, and secure solution to the problem of needle stick injury," says Dell. "We've been heavily promoting this device to our worldwide pharmaceutical customers, making sure their prefilled syringes start to incorporate this safety device sooner, rather than later. It's an inexpensive way to keep doctors, nurses, and caregivers safe."

Catalent Pharma Solutions will be exhibiting at Pharmapack 20111 in Stand 144 February 23-24, 2011.

This article was written by freelance writer Marie Redding.

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