The economic model that has underpinned the development of drug products for decades is currently under siege. Faced on one side with mounting pressure from payers to address affordability issues, pharmaceutical companies are facing ever more stringent regulatory requirements alongside
What is Medication Adherence Packaging?
Medication adherence packaging for clinical trials is like medication packaging used in clinical practice, but it includes digital connectivity. Hidden sensors inside the packaging capture medication event data in preparation for analysis in centralized adherence software. AARDEX Group's adherence ecosystem includes solutions selected for their ease of use, accuracy, and reliability, creating a network of industry-leading solutions that synchronize with our adherence software, MEMS AS®. Together with our partners, we deliver an approach boasting unparalleled accuracy, helping researchers understand adherence and identify opportunities for risk stratification.
MEDICATION ADHERENCE PACKAGING
How Medication Adherence Packaging Works
Medication adherence packaging features small, hidden microprocessors or sensors that capture and store medication event data. For example, smart blister packs contain trackers in each cavity, activating and capturing the date and time a pill is removed. Smart pill bottles leverage sensors in the cap to track the data when the cap is removed from the medicine container. By capturing data this way, researchers can gather adherence data in a way that provides no interruption to trial participants' daily lives.
Data from the packaging is synchronized with AARDEX Group's real-time medication adherence software, MEMS AS. The software analyzes and processes the data using over seventy pre-defined proprietary algorithms. Adherence intelligence is displayed in sleek, user-friendly dashboard visualizations, highlighting participants and sites with problematic adherence patterns. With MEMS AS, researchers don't have to rely on manual, cumbersome pill counts, reading e-diaries, or urine and blood samples to understand adherence; the software does all the heavy lifting. The payoff? By utilizing this approach, researchers can get to the participants that need coaching, and identify and query adverse events, much sooner than with alternative methods.
Given that poor adherence is prevalent across therapeutic areas and administration routes, we have created an ecosystem of medication adherence packaging solutions covering oral, ophthalmic, topical, and injectable administration. The ecosystem approach delivers a comprehensive yet practical solution for capturing medication event data in clinical trials for all routes of drug administration.
OUR ADHERENCE PACKAGING ECOSYSTEM
Our Medication Adherence Packaging Solutions
MEMS® Cap
Brought to you by AARDEX Group, the MEMS Cap transforms pill bottles into smart pill bottles. With hidden sensors in the cap, dosing events can be captured effortlessly.
Pill Connect
Brought to you by Pill Connect, this smart pill dispenser dispenses the right dose at the right time for participants, reducing the risk of unnecessary medication errors.
CleverCap Lite®
Brought to you by CMT, the CleverCap digital pill dispenser harnesses light and sound alerts to remind trial participants to take their medications on time.
Dosepak®
Dosepak is an innovative medication compliance packaging solution developed by Westrock. It features a reusable electronic e-module to monitor and record each package opening and closing date and time.
Cerepak®
Cerepak is a patient adherence packaging equipped with hidden processors that accurately capture the date, time, and location when medication is removed from the package.
Smart Blister
brought to you by Schreiner Medipharm, the Smart Bliser features concealed trackers in every cavity that automatically captures the exact time and date when pills or Pre filled syringes are removed
MEMS® HH
Brought to you by AARDEX Group, the Helping Hand automatically captures dosing events when the blister pack is removed from the sleeve.
ID-CapTM
Brought to you by etecRx, the ID-Cap electronic pill system harnesses ingestible sensors to transmit medication event data to a wearable device.
Injectapak®
Brought to you by westrock, Injectapak provides a convenient, easy-to-use solution for measuring adherence to injectable medicines in clinical trials.
MEMS® Button
Brought to you by AARDEX Group, the MEMS Button provides a user-friendly way of understanding how participants engage with the dosing regimen in trials.
Adherence Knowledge Center
Immerse yourself in a wealth of knowledge featuring an abundance of FAQs, case studies, industry expert-led videos, and cutting-edge scientific papers to gain a deeper understanding of medication adherence and why it matters in clinical trials.
Need Help?
Schedule a complimentary adherence consultation with our resident medication adherence expert, Bernard Vrijens.
OUR CLIENTS
The Go-To Solution for Pharma Companies
Some of the world's leading pharmaceutical companies have embraced our medication adherence packaging. From global giants to niche players, these organizations have recognized the value of our innovative solutions for enhancing medication adherence, reducing costs, and improving patient outcomes. It's an honor to partner with these remarkable brands, and we're proud to contribute to their efforts in advancing healthcare.
Medication Adherence Software →
Learn about our industry-leading adherence software for trials.
Discover our range of medication adherence devices.
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Medication Adherence Packaging FAQs
Medication adherence is a vital yet often overlooked aspect of successful research. That's why we've gone the extra mile to gather and organize the most frequently asked questions about this critical topic. Our goal is to empower researchers and patients alike with the knowledge they need to ensure medication adherence is never a hurdle to progress. So, without further ado, here are the answers you've been looking for!
Medication adherence packaging brings many benefits. Here are examples:
Real-time monitoring and feedback: can provide real-time monitoring of medication-taking behavior, which can allow healthcare providers to intervene quickly if participants are not taking their medications as prescribed. This can help to prevent adverse events and improve participant outcomes.
Improved adherence: can provide participants with reminders and alerts to take their medications on time, which can improve medication adherence and reduce the risk of medication errors.
Personalized care: can collect data on medication-taking behavior and use this data to personalize participant care, such as adjusting medication regimens based on participant response or providing targeted interventions for participants who are at high risk for non-adherence.
Looking for solutions that cater to inhalable medications? Check out our adherence device solutions here.
There are several types of medication packaging available in clinical trials, each with their own benefits. Here are some examples:
For Oral Dose Drugs
- Smart Blister Packs: Cavities in the blister pack come equipped with trackers that activate when pills are removed from the cavity and track the date and time. Cerepak® by Westrock, and Smart Blister Wallet from Schreiner MediPharm are stellar examples of this type of packaging.
- Smart Pill Bottles: The caps in the bottles have hidden sensors that intelligently detect when the bottle cap is removed. The sensor stores the date and time of the medication event. MEMS® Cap by AARDEX Group, Pill Connect’s smart pill dispenser, and AdhereTech’s aidia, are all examples of bottles that work in this way.
- Medication Compliance Packaging: This type of solution is typically an open and close wallet style packaging that includes an electronic module that activates when the wallet is opened, automatically tracking the date and time. An example of this type of solution is AARDEX Group and Westrock’s Electronic Dosepak® (EDP)
- Reusable plastic sleeves: These solutions, like the MEMS® Helping Hand, features technology to collect and store the time and date when the blister pack is removed from the reusable sleeve.
- Digital Pills: This type of solution features a capture that contains and ingestible sensor. When the stomach acid breaks down the capsule, a low beam frequency is sent to a wearable device, in some cases a lanyard or a smartwatch, where the medication event data is recorded. etectRx’s ID-Cap system works in this way.
For Injectables:
- Pre-Filled Syringe Packaging: Much like solutions for oral dose drugs, pre-filled syringes can be packaged in calendarized blisters that include processors to track when syringes are removed from the packaging. Injectapak® by Westrock is a prime example of this type of solution.
For Topical Medications:
- Adherence packaging for topical solutions work in the same way as a smart pill bottle does. The cap of the medication tube contains sensors that collect and store the date and time of application. An example of this type of solution is the MEMS® Cream Tube (CT)
The benefits of each type of medication packaging may vary depending on the specific requirements of the trial and the participant population being studied. Ultimately, the choice of medication packaging should be based on the goals of the trial, the medication being studied, and the participant population.
Yes – it has been proven to foster better adherence in clinical trials. Digital packaging options have the advantage of being able to passively capture medication event data, which can provide objective and real-time data on medication adherence.
Several studies have evaluated the effectiveness of digital adherence packaging in clinical trials. For example, a randomized controlled trial published in JAMA Internal Medicine in 2016 found that patients using MEMS packaging were more likely to achieve viral suppression in HIV treatment compared to those using standard packaging [1]. Another randomized controlled trial published in the New England Journal of Medicine in 2013 found that patients using MEMS packaging were more likely to adhere to their medication regimen and achieve viral suppression in HIV treatment compared to those using pill counting [2].
The use of digital adherence packaging in clinical trials can also improve the accuracy and reliability of adherence data, which can enhance the validity and generalizability of the study results. Digital packaging can provide researchers with detailed information about medication-taking behavior, including dosing patterns, timing of medication administration, and potential adherence-related issues.
References:
- Haberer, J. E., Musinguzi, N., Boum, Y., Siedner, M. J., Mocello, A. R., Hunt, P. W., … & Bangsberg, D. R. (2016). Duration of antiretroviral therapy adherence interruption is associated with risk of virologic rebound as determined by real-time monitoring in rural Uganda. Journal of Acquired Immune Deficiency Syndromes (1999), 73(2), 174.
- Bangsberg, D. R., Ragland, K., Monk, A., Deeks, S. G., & Artz, A. S. (2013). A single tablet regimen is associated with higher adherence and viral suppression than multiple tablet regimens in HIV+ homeless and marginally housed people. AIDS (London, England), 27(4), 617-624.
Yes – it has been proven to foster better adherence in clinical trials. Digital packaging options have the advantage of being able to passively capture medication event data, which can provide objective and real-time data on medication adherence.
Several studies have evaluated the effectiveness of digital adherence packaging in clinical trials. For example, a randomized controlled trial published in JAMA Internal Medicine in 2016 found that patients using MEMS packaging were more likely to achieve viral suppression in HIV treatment compared to those using standard packaging [1]. Another randomized controlled trial published in the New England Journal of Medicine in 2013 found that patients using MEMS packaging were more likely to adhere to their medication regimen and achieve viral suppression in HIV treatment compared to those using pill counting [2].
The use of digital adherence packaging in clinical trials can also improve the accuracy and reliability of adherence data, which can enhance the validity and generalizability of the study results. Digital packaging can provide researchers with detailed information about medication-taking behavior, including dosing patterns, timing of medication administration, and potential adherence-related issues.
References:
- Haberer, J. E., Musinguzi, N., Boum, Y., Siedner, M. J., Mocello, A. R., Hunt, P. W., … & Bangsberg, D. R. (2016). Duration of antiretroviral therapy adherence interruption is associated with risk of virologic rebound as determined by real-time monitoring in rural Uganda. Journal of Acquired Immune Deficiency Syndromes (1999), 73(2), 174.
- Bangsberg, D. R., Ragland, K., Monk, A., Deeks, S. G., & Artz, A. S. (2013). A single tablet regimen is associated with higher adherence and viral suppression than multiple tablet regimens in HIV+ homeless and marginally housed people. AIDS (London, England), 27(4), 617-624.
Yes – it is generally welcomed by trial participants, although acceptance may vary depending on the study population and the specific type of packing play a part. From an acceptability standpoint, selected packaging should be easy to use and not place burden on participants.
One of the reasons why digital packaging is generally well-accepted is that it can provide patients with additional support and tools to help them adhere to their medication regimen. For example, regardless of the packaging or device the participant is using, AARDEX Group’s mobile app, MEMS® Mobile can provide participants with reminders to take their medication, which can be particularly helpful for patients who have difficulty remembering to take their medication on time.
Digital packaging can also provide patients with real-time feedback on their medication-taking behaviors, which can help them stay on track with their medication regimen. This can be particularly helpful for patients who are struggling with adherence-related issues or who are taking complex medication regimens.
In addition, digital packaging can provide patients with a sense of control over their medication regimen. By being able to track their medication-taking behavior and receive feedback on their adherence, patients may feel more empowered and engaged in their healthcare.
WEBINAR WITH MERCK & BIOGEN
Mitigating the Risk of Poor Adherence in Trials
Watch this live recording with adherence experts from Merck & Biogen to learn about their approach to mitigating the risk of poor adherence in trials.
FROM THE AARDEX GROUP BLOG
Featured Adherence Content
We are excited to showcase the expertise of Bernard Vrijens, a globally recognized authority on medication adherence. Non-adherence to medication regimens is a significant challenge that can hinder optimal health outcomes. Leveraging his extensive research and experience, Bernard Vrijens provides invaluable insights into the root causes of medication non-adherence and actionable strategies to address them. Our medication adherence blog features his expert contributions, offering evidence-based recommendations to improve medication adherence and ultimately enhance patient outcomes.
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