Improving Patient Compliance with Autoinjector Trainers

In a world where self- and caregiver-administered therapies are becoming the norm, we continue to explore these therapies and their packaging. Is there a stumbling block that stands between the advancement of autoinjector technology and patient safety and efficacy? The answer is yes, and it is the challenge of training the layperson to deliver the drug safely and accurately as intended with every dose. The heart of that challenge is not hard to see: could you give yourself a shot as often as needed and how would you learn it?

Enter Autoinjector Trainers

New autoinjector devices are coming fast—with about 80 autoinjectors currently on the market. Amid that trend, makers must find ways to distinguish their product and offer what patients want and need. The best way to add value and engage users is by providing a robust autoinjector trainer to coach patients through the experience and let them practice.

Needle aversion is understandable. Reducing fear of pain, error or medical complication by training with a simulator device helps patients and families gain confidence that they can do it. Practice pens must also deliver the physical experience of the injection—what does it feel like? Do I have to press hard? How long does it take? What if I make a mistake?

Additionally, the trainer pen must provide a parallel experience as closely as possible even though a trainer does not inject anything into the patient’s body. Finally, trainer pens must be designed for repeat use so that patients can practice to proficiency and ask questions before embarking on the real deal—no small order.

Key Factors In Training Pens

A 2014 study (University of Texas Medical Branch Newsroom) on correct autoinjector use showed that 84 percent of participants incorrectly used the autoinjector, with a high incidence of failure to receive the full dosage due to incorrect and multiple steps in the process being skipped. Another factor that remains credible is the challenges that exist with IFUs and print support materials associated with medications and autoinjectors. With medical device IFUs, an ongoing discussion both in patient-facing and clinical surgical settings, it is worth noting that the study noted patient-facing IFU challenges that “many patients do not read or fully understand the instructions that accompany their drug delivery device.” There is great opportunity for both packaging professionals and makers of the drug delivery device/trainers to improve preparation, steps, and support materials to eliminate information gaps and improve outcomes. Another factor to consider is negative transfer, which occurs when patients assume how a product works based on previous experiences. Having a quality IFU can help mitigate this risk.

Just Like The Real Thing

Industry is accustomed to providing samples and prototypes for various testing and validations. There can be valid compromises in testing scenarios. This is not so with autoinjector training simulators. It is important to make the practice pen as close as possible in appearance, feel, and operation to that of the final drug delivery system. That said, it must be abundantly clear when a pen is a trainer and when is an actual drug delivery device, particularly in drugs for emergency use. This is not easy. Additionally, the practice device must have built-in repeatability. But how much, and where do cost centers affect quality needs? What if the final device will be single-use? For these reasons and more, training patients will most likely require medical professional interaction with patients for in-person or virtual education in addition to the characteristics and labeling of both the trainer and actual product.

With the previously mentioned study that revealed a high failure rate of patients autoinjecting the full dosage of medication (wet injections), simulator pens should accurately mimic the rate of drug injection for effective patient onboarding. Viscosity and other drug characteristics must also be taken into consideration—all while knowing that nothing will be dispensed from the practice pen. 

Regulatory Guidance and What’s Ahead

As drug and device makers explore this new and multifaceted frontier, there are myriad details to apply. The FDA points to ISO 11608-1:2022 and non-binding draft guidance for “pen, jet and related injectors for drugs and biologics, addressing the actual drug delivery mechanisms without mention of any type of trainer pens. Non-binding guidance published in 2013 discusses pens and jets related to biologics, although much advancement has occurred that will likely require revisiting. In Europe, the EU MDA issued 2015 Current Status “European Commission final decision” guidance that discusses the need for better training and education for patients using “adrenaline autoinjectors,” but does not address trainer pens or autoinjectors for biologics. Industry stands to be at the forefront of emerging studies and solutions related to autoinjectors and their training “dummy” counterparts.

In conclusion, improving patient compliance with autoinjector trainers is an essential step in bridging the gap between innovative drug delivery systems and patient safety and efficacy. The rapid growth of the self-injection market underscores the importance of equipping patients with tools and training to confidently and correctly administer medication. As the industry evolves, collaborative efforts between medical device manufacturers, healthcare professionals, and regulators will play a pivotal role in shaping the future of self-administered therapies.

Sources

• https://drug-dev.com/special-feature-injection-devices-as-self-injection-grows-drug-delivery-gets-smarter/#:~:text=The%20market%20was%20valued%20at,reach%20%24640%20million%20by%202021.&text=This%20growth%20is%20being%20fueled,over%20%24250%20billion%20by%202020.
• https://en.wikipedia.org/wiki/Epinephrine_autoinjector#:~:text=The%20first%20modern%20epinephrine%20autoinjector,by%20the%20FDA%20in%201987.
• https://drug-dev.com/special-feature-injection-devices-from-pens-autoinjectors-to-pills-sprays-capsules-injections-become-more-efficient/
• https://www.npr.org/sections/shots-health-news/2024/08/23/nx-s1-5086219/needle-less-alternative-epipen-fda-approval
• https://www.ema.europa.eu/en/medicines/human/referrals/adrenaline-auto-injectors#key-facts