Less time–higher accuracy: Schreiner MediPharm has published a new video illustrating the benefits of smart blister packs in clinical trials compared to conventional methods. But what does the smart solution offer in comparison to traditional ones?

In the pharmaceutical industry, time-to-market is crucial. Clinical trials are complex, time-consuming, and cost-intensive and only as good as the data quality they generate. Conventional methods such as patient notes, assessments by healthcare professionals, or pillcounting are often inaccurate and may produce distorted outcomes. The new video from Schreiner MediPharm shows how those challenges can be overcome.

High Accuracy
With smart packaging from Schreiner MediPharm, digitally generated adherence data achieve nearly 98-percent accuracy. These innovative packaging solutions enable electronic collection, storage, and analysis of real-time data to ensure precision and reliability. At the same time, user friendliness remains at a high level—and taking pills as easy as usual. Schreiner MediPharm’s medication adherence monitoring solutions enhance therapy compliance and can help revolutionize the entire clinical trial landscape.

Learn about the benefits of smart blister packs in the video:

With Schreiner MediPharm’s Smart Blister Wallets, medication adherence in clinical trials can be monitored digitally and in real time. Supported by its partner Keystone, a leading US designer and manufacturer of pharmaceutical paperboard packaging, Schreiner MediPharm is now extending its product portfolio by a particularly child-resistant blister pack that can be customized and digitized by means of integrated electronics.

Key-Pak® is a flexible and versatile blister pack solution from Keystone Folding Box Company that is suitable for a variety of tablet forms, dosing regimens, and blisters. It has a special feature for opening the cavities ensuring a high level of child resistance as well as senior friendly use. Since its introduction in 2003, Key-Pak® has established itself as the clinical packaging standard and has been used in thousands of studies.

Schreiner MediPharm extends the child-resistant Key-Pak® Blister Wallet by an electronic function for digital medication monitoring. The blister wallet can be customized according to the respective clinical trial and its dosing regimen such as number of cavities, arrangement of the blisters, and various forms of tablets. Schreiner MediPharm’s development process ensures that the design of the integrated conductive lines is optimally adapted to the cavities. This guarantees that real-time data are automatically generated when the patient pushes a tablet out of the blister pack.

To track medication intake, for example, the time of removal, dose, and respective cavity are stored in the pack and transmitted by means of NFC or Bluetooth.

The Smart Blister Wallet based on Key-Pak® combines child resistance with high user friendliness for the patient and enables great flexibility for use in clinical trials. Digital tracking of patient compliance and the data gained optimizes processes, shortens trial periods, and accelerates approval processes for new drugs.

Due to aging populations, the number of patients who are prescribed several drugs at the same time is increasing. In addition, the need for personal visits to doctor’s offices is declining as patients increasingly receive digital care and home deliveries of their medicines. However, the often complex medication plans do not always make it easy for patients to precisely adhere to them. To physicians, adherence monitoring poses an even greater challenge. The Smart Blister Card from Schreiner MediPharm can help resolve those issues.

In our aging societies, many people need to regularly take not just one but several medicines at different times of the day. That is the case in most industrial nations and the older people become the more drugs are added. Yet many patients and their families underestimate that polypharmacy, i.e. the permanent therapy involving several medications, may entail major risks. According to estimates, wrong parallel intake of different medicines causes up to 25,000 deaths in Germany alone. That risk increases especially when medication intake cannot be monitored by healthcare professionals—for instance when elderly patients take their medicines independently at home or receive in-home care by relatives.

In the case of polypharmaceutical applications, the medicines are frequently filled into standard blister packs according to the individual medication plan by hospital and large pharmacies. That eases the patients’ burden because the drugs are packaged in accordance with the dosage regimen. However, the attending physician or pharmacy have no way of tracking when the patient has taken the medications. That is possible with Schreiner MediPharm’s Smart Blister Card because it extends the standard blister pack by digital medication adherence monitoring of the patient. The conductive lines contained in the Smart Blister Card combined with an electronic unit enable automatic tracking as soon as the patient pushes tablets out of a cavity. That generates data in real time such as the time of removal, the dose, or the respective cavity. The data is stored in the Smart Blister Card and transmitted to a database via a smartphone app or a reader using NFC or Bluetooth technology.

At the same time, the application of the Smart Blister Card is a convenient and flexible procedure for physicians and pharmacists. After filling and sealing the blister pack, the Smart Blister Card is simply attached to the back of the pack without impairing the filling process in the polypharmaceutical application. The technology can be inconspicuously integrated into the packaging design, precisely adapted to the respective application, and is suitable for nearly all existing multi-dose and single-dose blister packs. Thanks to the transparent film with the conductive lines, the marking of each individual cavity concerning the medication it contains remains clearly visible. In addition, a temperature monitoring feature for sensitive active ingredients is an available option. Patients themselves do not need to do anything else than take their tablets as usual: With the Smart Blister Card, the cavities can be pushed through as easily as before. Smartphone apps provide patients with digital self-monitoring support of intake times and even enable a reminder function to comply with their medication plan. Thus, the risks of polypharmacy can be reduced and therapeutic success be enhanced.

With their specialized expertise, Schreiner MediPharm and AARDEX Group complement each other perfectly, and with their smart solution for digital medication adherence monitoring, are pursuing the goal of enhancing patient compliance especially in clinical trials. Non-adherence to the prescribed dosage regimen by patients participating in a trial may have severe consequences—such as inadequately documented efficacy of the medication or underestimated frequency of side effects. Stefan Wiedemann from Schreiner MediPharm and Bernard Vrijens from AARDEX Group talk about the capabilities of the digital Medication Adherence Monitoring solution and why it meets current and future trends.

How does the smart digital adherence monitoring solution from Schreiner MediPharm and AARDEX Group work?

Stefan Wiedemann (SW): Simply put, this is a smart form of pharmaceutical packaging combined with matching software. Blister packs for tablets are equipped with integrated electronics and sensor technology. Patients push their tablets out of the cavities as usual. The electronics are used to generate real-time data, such as time of removal, cavity, and dose, automatically store the data in the pack, and transmit it to a database via a smartphone app or reader. Specialized software subsequently serves to analyze the data.

How can digital adherence monitoring tools enhance patient compliance? Bernard Vrijens (BV): Digital Adherence Monitoring Tools can have a tangible impact on patient adherence to medications. But before we dive into the specifics of that, let’s look at the ramifications of poor adherence for the research industry. The stakes are high, both for drug developers and patients. When patients don’t take their medicine as prescribed, it can have life-altering or even life-threatening consequences.

Traditional, non-digital methods for monitoring adherence, such as pill count and self-report, do not consider such intricacies. They are subjective, open to bias, and merely provide a snapshot of medicine-taking behavior. Analogue methods also place an additional burden on patients and site staff, detracting from their utility. Digital adherence monitoring is different. It offers a holistic framework that can inform individualized intervention, even in therapeutic areas with notoriously high poor adherence rates, Oncology, and Psychiatry for example. What’s more, this type of approach is frictionless for the patients—all it asks of them is to take their medication.

What are possible drawbacks/challenges when it comes to digital adherence monitoring solutions and how can they be overcome?

BV: Historically, medication adherence has been the elephant in the room. And there’s a myth that drives this. Many know that poor adherence is prevalent in practice, but believe that it’s good in trials. We know that not to be true. Adherence is poor across the board. What’s more, some sponsors may not even realize that they have a non-adherence issue in their trials, and this is simply because what isn’t measured can’t be managed. This is a challenge—one that we can address quite easily in fact. Our approach to managing adherence is evidence-backed. Another challenge for sponsors is the change management process and the perceived complexity of implementing such solutions. This challenge isn’t exclusive to adherence management technology. It’s typical in industries that are very highly regulated.

SW: The complete solution for digital therapy control in clinical trials that we’ve developed can overcome exactly these challenges. It enables precise compliance with the requirements and dosage regimens for drug development according to the proposed clinical trial protocols of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Likewise, our digital tool can reveal structural deficits and collect important data about patient behavior. Such data can subsequently be used for marketing strategies.

What is AARDEX Group’s core competency and what is special about AARDEX MEMS® adherence software?

BV: What is measured can be managed, and on this front, AARDEX Group delivers. We’ve purposely expanded our ecosystem of partners to ensure that we have a device that can capture adherence behaviors—regardless of the route of administration. But collecting the data is only one side of the coin. The true value in MEMS AS® software is the statistical algorithms and behavioral analysis that underpin the solution. The inherent data processing capabilities negate the need for additional statistical analyses as the tool does it all automatically. Patient adherence analytics are conveniently presented in meaningful dashboard visualizations that can be interpreted at the patient, site, and study levels. Having access to readily available dashboards like these gives investigators the information they need to drive risk stratification and prevention. What’s more, the product is platform-agnostic and can be integrated with Interactive Response Technology (IRT), Electronic Data Capture (EDC), and Decentralized Clinical Trials (DCT).

What is the key benefit for AARDEX Group in cooperating with Schreiner MediPharm?

BV: Partnering with Schreiner MediPharm has allowed us to further reinforce our ecosystem with a solid partner for smart blisters. Together, with our common goal of enhancing the efficiency of drug development, by offering data generating packages and end-to-end solutions to manage medication adherence digitally, we will continue to thrive as the industry continues the shift to digital. What’s more, Schreiner MediPharm is a key player in this space, with solutions proven to deliver quality and high standards.

In your view, what are the key trends in Clinical Trial Management?

BV: For decades, the research industry has relied on the traditional trial model, where the majority of the trials conducted was built around sites, necessitating the need for in-person visits and monitoring. This was largely due to the fact that many sponsors were still using paper-based systems. However, when the pandemic hit, imposing restrictions on movement to reduce infections, the industry was pushed into a state of flux. While some sponsors had to halt trials, others embraced technology to ensure trial continuity. During this time, the industry truly realized the benefits of remote monitoring, not just for those conducting research but also for the participants. As a result, the use of remote monitoring has skyrocketed, prompting the FDA to create and publish draft guidance for the use of digital health technology in clinical investigations. I believe that the advent of this draft guidance will further cement Source Data Verification (SDV) for what it is, antiquated, and that the use of digital health technology and remote monitoring technology trials will rise rapidly.

How can digital adherence monitoring tools enhance patient compliance and how can they meet current and future trends?

BV: The utilization of Digital Health Technologies (DHT) is rising rapidly in clinical research. When talking about the decentralization of trials, David Burrow, the director of the FDA Office of Scientific Investigations, was quoted stating that they were “here to stay”. This, combined with the recent FDA draft DHT guidance, will serve as catalysts for the industry’s ongoing shift to digital. However, with fewer or no site visits on the table, this model could present an issue for sponsors that rely on traditional methods of measuring adherence, blood sampling, etc., Digital Adherence Monitoring bridges the gap by continuously monitoring patient medication-taking behaviors remotely.

What are the tangible benefits of the partnership between Schreiner MediPharm and AARDEX Group for pharmaceutical manufacturers?

SW: In our cooperation, we combine Schreiner MediPharm’s in-depth expertise in printing and packaging technology with AARDEX Group’s IT intelligence. We provide pharmaceutical manufacturers or CMOs with a wallet including printed electronics and all they have to do is integrate the blister. Their production processes remain unchanged. The flexibility we’re able to offer them is a major benefit. Due to roll-to-roll processing, our technology can be scaled from small volumes all the way to mass manufacturing. As a result, pharmaceutical manufacturers can fully exploit the potential of the digital adherence monitoring solution in clinical trials as well as use it in the commercial context.