"The field of medication adherence monitoring is rapidly evolving"

 

Ensuring adherence to medication regimens is vital for the success of clinical trials and therapies. Smart adherence monitoring solutions utilise advanced sensor technology embedded in pharmaceutical packaging to accurately track medication intake in real-time. Uwe Braun, Senior Business Development Manager Medication Adherence Monitoring Solutions at Schreiner MediPharm, a business unit of Schreiner Group, Oberschleißheim, Germany, explains how smart adherence monitoring solutions operate.

What are the primary reasons patients struggle with medication adherence during clinical trials and how significant is this issue in the industry?
Uwe Braun: Medication adherence in clinical trials is a critical yet often underestimated challenge. Approximately 50% of patients fail to adhere to the prescribed dosage regimen, which can be attributed to various factors such as forgetfulness, lack of knowledge, fear of side effects and the complexity of the dosing schedule. This non-adherence significantly impacts clinical trials by distorting outcomes – potentially underestimating the efficacy of a drug or masking its side effects. This can lead to delayed time-to-market, increased trial costs and the need for larger patient samples to achieve statistical significance. The issue is profound, with studies indicating that even a 1% improvement in adherence can result in significant cost savings, around $335,700 in Phase III clinical trials alone.

Can you explain how the smart adherence monitoring solutions operate, including the key technologies involved and how they ensure accurate and real-time tracking of medication adherence?
Smart adherence monitoring solutions leverage advanced sensor technology embedded within pharmaceutical packaging to track medication intake. These technologies automatically track when a patient removes e.g. a pill or vial from the packaging, capturing real-time data such as the exact time of removal, the dose, and the specific cavity or compartment accessed. This data is stored within the smart packaging and transmitted via NFC or Bluetooth to a smartphone app or reader, which then uploads the information to a secure database for analysis.
The core technologies involved include electronics, which are embedded into the packaging, combined with advanced data transfer systems. The accuracy of these systems is exceptional. Studies have shown that digitally generated adherence data reaches nearly 98% accuracy compared to traditional methods like pill counting (60%), healthcare professional rating (50%) or self-reporting (27%). This high level of accuracy ensures that pharmaceutical companies can trust the data they receive, leading to better-informed decisions and more effective interventions.

What specific smart packaging solutions does Schreiner MediPharm provide for monitoring medication adherence?
Schreiner MediPharm offers a comprehensive range of smart packaging solutions specifically designed for the requirements of the respective clinical trial, the tested drugs and the dosing regimen. These include e.g. Smart Blister Wallets and Smart Kit Boxes, each tailored to different types of medication forms and packaging needs. Smart Blister Wallets can feature up to 64 individual cavities for tablets. Schreiner MediPharm’s smart version of the Key-Pak Blister Wallet combines for instance the highest level of child-resistance with elderly friendliness while being suitable for a variety of tablet forms, dosing regimens and blisters. The Smart Kit Box is intended for vials or other devices stored in a carton box. All solutions enable real-time tracking of the removal time, the specific cavity and the drug dose. Optionally, temperature monitoring can be included, which is especially critical for temperature-sensitive medications like biopharmaceuticals. Schreiner Medi-Pharm ensures that the design of the conductive lines is optimally adapted to the cavities and inconspicuously integrated into the smart packaging. Patients can use the packaging as usual.

How do medication adherence monitoring solutions optimise clinical trial processes?
Smart Blister Wallets, Smart Vial Kits and other smart solutions are decisive in optimising clinical trial processes. By enabling the monitoring of medication adherence, these solutions significantly improve the quality and reliability of the data collected. Traditional methods of tracking adherence, such as pill counting or self-reporting, are prone to errors and inconsistencies, which can compromise the integrity of the trial data. In contrast, smart packaging solutions provide precise real-time data on medication intake that can be easily tracked and analysed. This leads to more accurate trial outcomes, allowing for faster decision-making and potentially accelerating the approval process for new drugs. Moreover, by reducing the need for manual documentation and on-site monitoring, these solutions lower operational costs and streamline trial workflows. This efficiency translates into significant cost savings for pharmaceutical companies, as it reduces the time and resources required to conduct trials. Additionally, the automation of adherence monitoring minimises the risk of human error, ensuring that the data collected is consistent and reliable. This not only enhances the validity of the trial results but also facilitates a faster time-to-market for new drugs, which is crucial in the highly competitive pharmaceutical industry.

What future trends do you anticipate in the field of medication adherence monitoring?
The field of medication adherence monitoring is rapidly evolving due to the rise of Digital Health Technologies (DHT) and the shift towards remote and decentralised trials. Historically, clinical trials relied heavily on site-based monitoring and paper systems. Our smart packaging solutions are ideally suited for this new environment, as they allow for continuous, real-time monitoring of medication adherence without requiring patients to visit clinical sites frequently. With the FDA’s new guidance supporting digital health technologies, we expect a continued decline in traditional site-based methods like Source Data Verification (SDV).

In your experience, how receptive have pharmaceutical companies been to adapt these smart packaging solutions?
Pharmaceutical companies and CROs see the clear benefits of our smart packaging solutions in terms of improved data accuracy, enhanced trial efficiency and significant cost savings. Moreover, our smart packaging technologies are designed to be easily integrated into existing manufacturing processes which facilitates their adoption. We provide the pharma manufacturers or CMOs with a complete packaging solution while they only have to integrate e.g. the blister. Thanks to roll-to-roll processing, our high-tech production can be scaled from small to big volumes. The positive reception underscores the growing recognition within the industry of the importance of medication adherence monitoring and the role that digital health technologies can play in enhancing trial outcomes.

 

About Schreiner MediPharm

Schreiner MediPharm, a business unit of Schreiner Group GmbH & Co. KG based in Oberschleißheim near Munich, Germany, is a leading developer and manufacturer of innovative, multifunctional specialty labels and marking solutions with value-added benefits for the healthcare industry. Thanks to its strong solutions expertise and specialised know-how, Schreiner MediPharm is a highly capable development partner and reliable quality supplier to leading pharmaceutical and medical device techno-logy companies worldwide

 

Images: Schreiner MediPharm
Caption 1: The Smart Kit Box from Schreiner MediPharm is intended for vials or other devices stored in a carton box and enables real-time tracking when a container is removed.
Caption 2: Uwe Braun talks about the rapidly evolving field of medication adherence monitoring.
www.schreiner-medipharm.com