Aptar Pharma Prescription Division, a global solutions provider of innovative and proven aerosol, injection and spray delivery systems for prescription drugs, will present and discuss the latest data from a number of user studies carried out with its Pro-Ject® auto-injector at the Pharmapack Europe conference, to be held in Paris, France on February 12-13, 2014.
Integrating the human factor in the Pro-Ject® development cycle
Aptar Pharma's Pro-Ject® is a novel auto-injector that has been designed and developed with input from patients and healthcare professionals to provide optimal patient convenience and compliance.
It is now generally accepted that Human Factor Engineering is an integral part of developing any new drug delivery device. Human Factor studies address many different 'human elements' such as perceptual, cognitive, ergonomic, emotional, social and even cultural. The outcome of Human Factor studies should provide a clear understanding of how to avoid errors, identify safety risks, improve patient education/training and competence, and eventually patient compliance.
In addition, clear regulatory guidance has emerged from various government authorities, including the United States, Europe and others, over the last few years. This guidance outlines how to integrate Human Factor studies into drug delivery devices during their development in order to optimize their design and gain successful regulatory approval.
Aptar Pharma applied Human Factor guidelines to the Pro-Ject® development cycle. During the initial Pro-Ject® concept phase, Aptar Pharma carried out several investigations and market studies with patients and healthcare professionals. The main objective of these studies was to better understand users' and healthcare professionals' experiences, expectations and preferences for auto-injectors.
Once a prototype of Pro-Ject® had been developed, additional user acceptance studies and investigations were performed to deepen the understanding of how rheumatoid arthritis patients interacted with Pro-Ject®. During the studies, patients provided invaluable insights on these topics:
First impressions
Key preferences and suggestions for improvement
Perception of how the device handles, including ease of use, intuitiveness and user feedback
General interest in using the device
Results demonstrated that both training nurses and rheumatoid arthritis patients confirmed the benefits of Pro-Ject® in terms of ease of use, ergonomics and design. It was clearly demonstrated that Pro-Ject® met expectations, and had the support of both prescribers and patients.
Self-injection and the auto-injector market
Current estimates value the global market for injectable drugs at US $240 billion, giving injectables a 28% share of the overall drug market worldwide. The growth rate for the injectable drug market was 4% in 2012. The main driver for this growth is the category of drugs known as biologics which are large molecules manufactured by biotechnology processes. Biologics need to be administered by injection given their size and profile.
Auto-injectors are used in the treatment of chronic diseases such as rheumatoid arthritis, lupus, psoriasis, spondilarthritis, multiple sclerosis, hepatitis C, anemia, and for emergency/crisis treatments such as anaphylactic shock and migraine attacks by self-injection in a non-medical environment. The use of auto-injectors by properly trained patients does not require healthcare professionals to be present.
Key benefits of the Pro-Ject® auto-injector for users
Pro-Ject® integrates all of the user-preferred features that were identified during user studies. These features include:
Push-on-skin activation - some users with diseases such as rheumatoid arthritis cannot use their thumbs to push a button to activate the device
Slow injection - auto-injectors that deliver drugs too fast are perceived as being painful
Hidden needle - some patients become anxious when they see needles and anxiety can make injections more painful
Large and highly visible indicator window - coupled with an end-of-injection color indicator
Audible feedback - patients appreciate hearing audible clicks at the beginning and the end of the injection process
"Patient-centric development of drug delivery devices is now the accepted norm. Applying Human Factor principles means that the outcomes should benefit all the stake-holders involved", said Dr. Gerallt Williams, Director Scientific Affairs, Aptar Pharma Prescription Division. "Aligning Pro-Ject® with patient needs during its development process is a major step forward in delivering this benefit."
