Driven by the growing prevalence of chronic diseases, the need for convenient and cost-effective drug delivery solutions, and the strong preference for tablets and capsules among both patients and healthcare providers, the global oral solid dosage (OSD) market is projected to reach $1.21 trillion by 2035, growing at a compound annual rate of 6.4% over the next decade¹.

This represents a clear opportunity for sponsors bringing the next generation of OSD drugs to market. However, to safeguard clinical trial supplies, promote patient-centricity, and secure successful trial outcomes – the right drugs must reach the right patients at the right time and in the right condition. This means adopting a best practice drug distribution strategy, underpinned by robust processes and innovative solutions, that identifies and overcomes key risk areas to effectively balance quality, compliance, and patient centricity.

Implementing a Right First-Time Culture

When patients are waiting for supplies that have the potential to transform health outcomes, every second counts. There’s no room for trial and error. It must be right first time. Distribution of OSD products therefore must drive quality and optimize operations to deliver timely, compliant supply. Starting right is key to staying right. This means ensuring the correct strategy is planned, developed, and implemented during the distribution set-up phase. Collaborating with distribution partners to examine the type of product, the product’s stability, the country profile, packaging design, and product value, in addition to other variables, will facilitate a customized and effective distribution strategy.

Once strategy is established, sponsors will need to adopt a risk-based approach to identify key risk hot spots and implement stringent checks to reduce opportunity for error. In-process checks built into the distribution process ensure efficient workflows by targeting higher risk stages such as temperature monitor verifications. This ensures two outcomes. Firstly, it supports the maintenance of high-quality standards, as the riskiest parts of the process are verified by independent checks. Secondly, it enhances efficiency, as checks target the riskiest parts of the process without creating unnecessary bottlenecks elsewhere.

By developing robust strategies and verifying that all critical steps are performed appropriately, the right drug can be delivered to the right patients, at the right time, and within the correct temperature range.

Keeping Regulatory Compliance at the Core

Robust adherence to regulatory requirements and continuous compliance improvement is also fundamental to OSD distribution best practice. Astute regulatory oversight supports product quality, trial performance, and patient safety. Key processes (i.e. change controls, standard operating procedures, and continuous improvement projects) must therefore be built on and reviewed against global regulation to ensure ongoing alignment. This involves routine reviews of process vs. regulation, whether that’s with GDP guidelines or region-specific legislation, such as US FDA 21 CFR Part 312 Investigational New Drug regulations, which include requirements for storage, accountability, and distribution.

Access to state-of-the-art, purpose built GMP/GDP compliant facilities is also essential for keeping regulatory compliance at the core of drug distribution strategy. When facilities are designed with processes and regulatory requirements built in, compliance and general efficiencies are optimized.

Prioritizing Innovation

Challenges that stand in the way of timely and compliant patient access never stop evolving, so it’s crucial that distribution solutions keep pace. Continuously refining procedures will help drive leaner operations. Use of technology, such as systems that permit real-time temperature and location tracking and enable preventative routing of shipments and interventions can also help avoid delays, disruptions, and temperature excursions that could negatively impact patients. Similarly, technologies like ERP, scanners, and barcode systems also have a role to play in reducing human error and streamlining processes by facilitating electronic real-time checks.

Innovative shipper solutions are also playing a more prominent role in delivering best practice in OSD drug distribution. Modern shipper solutions incorporating phase change materials and vacuum insulation panels offer enhanced temperature control over water-based refrigerants. These innovative solutions protect drugs in transit, ensuring product integrity, lowering the risk of temperature excursions and reducing waste. They do this in two core ways. By changing phase very slowly to maintain a midpoint of a selected temperature range for long periods of time (up to 96 hours) and by effectively hibernating when stored in an appropriate external environment/temperature range. This also allows the shipper to be reused multiple times and has key environmental benefits, especially when effectively managed as part of an end-to-end solution.

Harnessing the Right Expertise

Having the right expertise in place is critical for ensuring quality, compliance, and patient-centric distribution of OSD products. For instance, when dedicated packaging design and qualified engineer resource is available, kits and cartons can be designed to not only meet patients’ needs in terms of ease of use but to minimize environmental impact and distribution costs by reducing packaging size, for example.

Partnering with vendors that have extensive experience of shipping to over 110 countries with a control tower knowledge of global regulation and a significant network of risk-assessed transit routes that optimize timelines and limit risk facilitates best practice. As does operating with holistic oversight, as this encourages the proactive development of distribution strategies that consider the bigger picture. This means understanding how each element of drug distribution – from shippers, and temperature monitors to couriers and transit routes – connect to each other so that distribution strategies can be established that optimize how drugs move from A to B.

Best Practice by Design

Best practice in OSD drug distribution doesn’t happen by accident. It must be intentional, with distribution requirements considered at the earliest opportunity during a clinical trial’s planning stages. A right first-time culture must exist, one that is upheld by people who recognize the important role they play in supporting patients to access drugs that have the potential to improve health outcomes and/or quality of life. Building a robust strategy, taking a risk-based approach to identifying high-risk areas within distribution processes, and applying strict oversite will help avoid errors and keep timelines on track.

The same is true with compliance. When astute regulatory oversight is made a priority, product quality, trial performance, and patient safety is protected. As distribution challenges evolve, so too must the solutions sponsors choose to overcome them. This requires embracing technology, including real-time centralized temperature management, location tracking, and phase change shippers, along with a commitment to continuously refine procedures to drive leaner operations. Finally, best practice depends on expertise. When sponsors partner with the right vendors with extensive global drug distribution knowledge and experience, optimized, compliant and cost-effective strategies can be developed that place patient access at the heart of the operation.

Reference:

^1. https://www.factmr.com/report/oral-solid-dosage-pharmaceutical-market

Barry Kay has been with Almac Clinical Services since 2009, currently serving as Director, Logistics. With over 15 years of experience in clinical supply chain operations, Barry plays a pivotal role in overseeing logistics operations, ensuring the timely and compliant delivery of clinical trial materials across diverse markets. 

His leadership spans strategic planning, vendor management, and continuous process improvement, contributing to Almac’s reputation for excellence in clinical trial support. Barry’s leadership is marked by operational excellence, cross-functional collaboration, and a passion for improving patient outcomes through logistics innovation.