Developing drug administration devices for geriatric use

Abstract

Older patients, frequently suffering from multiple chronic diseases, tend to have difficulty in using injectables, patches, eye droppers, nebulizers, inhalers and more complex devices, since such administration devices often require challenging preparatory, administration and disposal steps. Preventing user error is important, especially in the case of critical errors affecting the outcome of the treatment. Prescribers can employ the therapeutic trinity tool to discuss and select the optimal administration option for their older patients; depending upon the choice, prescribers may need to test the older patients for cognitive and physical ability to properly handle the device. Knowledge of the impact of physical and cognitive limitations of elderly patients for drug self-administration is a prerequisite for companies designing administration devices to be used by an aging population. Strict adherence to regulatory requirements for the development of drug/device combination products, such as applying design control and risk management under a suitable quality management system, is essential for obtaining a finished administration device with acceptable safety and the desired performance in older patients. This includes usability and human factors studies of both prototype and finalized device designs, performed in environments simulating those of home and domiciliary care. Directly involving older patients in all phases of development of administration devices is highly recommended. Usability testing of administration devices should be performed with all relevant subsets of the older adult population, paying attention to the specific human factors of each subset, including their physical, sensory, emotional and intellectual capabilities. Here, companies must take into account that the manufacturers include adequate numbers of older population, even within a single age category, is very heterogeneous, and it is therefore recommended that elderly persons with different degrees of frailty in validating the safety and performance of administration devices.