Abstract

Hazardous Drug Enteral Device: A Closed System Device for Crushing and Dispersing Hazardous Drug Tablets for Enteral Administration

Author(s): Lopez C Vidal, Rios GL Quito

Issue: Sep/Oct 2022 - Volume 26, Number 5

Page(s): 358-362

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Abstract

In 2016, the National Institute for Occupational Safety and Health (NIOSH) published a list of hazardous drugs in healthcare. The handling of such drugs must be conducted using closed system devices according to United States Pharmacopeia General Chapter <800> and other regulations, such as Directive (EU) 2022/431 of the European Parliament and of the Council of 9 March 2022 amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work. There are approximately 90 enterally administered drugs on the NIOSH list. In this list, NIOSH established that crushing tablets or making solutions from them causes an unacceptable risk at hospitals. Furthermore, United States Pharmacopeia <800> and European regulations impose the use of closed system devices and plastic pouches to contain any dust or particles generated during these operations. While there are several marketed closed system drug-transfer devices for intravenous treatments, there is no single system to crush, disperse, and administer hazardous drugs safely via enteral. This poses a great risk for patients who cannot swallow properly or are fed by an enteral tube. To solve this problem, we developed a new medical device to protect caregivers from such risks. We patented a new device that allows a safe administration and reduces exposure risk and environmental pollution at pharmacy departments (cross-contamination in cabinets), nursery units, and even at patients’ homes to protect caregivers and relatives. This initiative by a hospital pharmacist aims to solve a daily problem and provide an example of our potential in healthcare innovation.

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