Drug Distributor Accreditation, previously known as Verified-Accredited Wholesale Distributors Program (VAWD), from the National Association of Boards of Pharmacy (NABP) is a crucial certification program that ensures pharmaceutical wholesalers and national retailers are following best practices for warehouse holding conditions, protocols for excursions, and corrective action paths. Legacy tools that rely on outdated data loggers, delayed visibility, and spotty Wi-Fi connectivity may help warehousing operations technically meet minimum compliance requirements. However, real-time visibility into different areas of a warehouse’s ambient condition and corresponding alerting is attainable with technology available on the market today that helps operators exceed regulatory compliance requirements and ensure patient safety, inventory freshness, and proactive actions.
With specialty medications now accounting for over half of all drug spending in the U.S., it is especially important for wholesalers and retailers to ensure the safe and effective delivery of critical, hard-to-get medications to patients who rely on safe, efficient supply chains for their health and wellbeing.
Recent Developments with OTC Regulation
Distribution centers that store and transport Over-the-Counter Medicines (OTCs) have always been FDA regulated at some level. However, lately, regulatory bodies have been paying much more attention to OTCs and biosimilars than ever before. State Boards of Pharmacy have significantly increased their vigilance in inspections over the past 2 years because of recent uncoverings that have surfaced from taking a deeper dive into storage conditions. Because OTCs are not refrigerated, their governance has been considered less important compared to refrigerated drugs. Monitoring temperature and humidity of storage conditions has always been a CDC suggestion, but not firmly regulated or enforced.
Family Dollar’s recent Advil recall is an illustration of the need for real-time intelligence into the state of pharmaceutical inventories. OTCs becoming too cold or too hot can cause the drugs to become unstable and even degrade, posing a risk of negative side effects and decreasing their effectiveness.
Warehouses feature shelving and cages that can be segmented into different “zones” within the footprint of the building. Ambient temperature varies between the zones of a warehouse, especially large warehouses that operate with a spoke–hub distribution paradigm. Similar to refrigeration assets, these zones have a certain temperature profile that can be optimized for inventory safety and product quality.
Conducting a thermal heat mapping study is a critical step in ensuring that a pharmaceutical warehouse meets FDA and NABP regulatory requirements. The study involves placement of numerous temporary sensors throughout the warehouse zones to gather temperature and humidity data that reveals the coldest and warmest areas of the warehouse. The data is analyzed, and a report is produced revealing the Mean Kinetic Temperature (MKT) for each zone, informing the placement of permanent sensing capabilities throughout the facility. Studies must be completed in both summer and winter of the same calendar year to account for differences in temperature throughout seasons. Regulations require these studies to be done once every three years for accreditation to remain current.
Mean Kinetic Temperature
MKT measures temperatures fluctuations in a way that provides a more useful picture of asset conditions over time. MKT smoothes out the outlier extremes and provides a sophisticated average that gives operators a clearer idea of product safety during storage. Let's say the temperature threshold is 77 degrees Fahrenheit, and the product temperature rises to 82 degrees Fahrenheit for five minutes but then comes back down to the acceptable range. The product doesn’t necessarily need to be disposed of or destroyed because operators who have access to the MKT have the context of the products’ stability and the effects of any degradation during excursion are factored in. Use of MKT is critical for monitoring ambient temperature and relative humidity.
The contextual nature of MKT helps operators optimize their warehouse with insights and actions concerning where to store different types of inventories. Based on zone behavior, dry foods, medications, vaccines, and other pharmaceuticals should be placed in different shelving units or cages throughout the warehouse to ensure maximum product quality and safety. Adjustments to the HVAC system and energy consumption can be informed with intelligence gathered from the sensing capabilities, optimizing storage and creating ease and confidence for operators and facilities management. The MKT process also accurately generates an output of the locations to place NIST compliance sensors to check the extreme temperatures in the warehouse and preserve quality and compliance.
In a cross-docking operation, products are transferred directly from incoming shipping vehicles to outbound vehicles with minimal storage time during transfer. Certain facilities or warehouses are designed specifically for the practice of cross docking. As a logistics strategy, the intent of cross docking is to speed up delivery times while minimizing warehousing and handling costs. Goods arriving at a cross-dock have a pre-assigned destination and are un-packaged, re-packaged, and organized accordingly, allowing seamless movement through the supply chain. Successful cross-dock operations build efficiency and cost-savings into the delivery process.
For cross-docking applications, storage conditions are not the main concern since storage is not the intended activity. However, heat mapping and MKT tracking are still essential functions to optimize the path of products in transit. Especially warm or cold areas of a cross-docking facility need to be accounted for to avoid the damage of crucial inventory, especially in the case of pharmaceutical transfer when specialty medications and critical vaccines are involved.
Internet of Things (IoT) Opportunities
When maintaining the quality of inventory is critically important, the data that operators use to base their decisions and adjustments upon must be accurate. Traditional sensing capabilities used in pharmaceutical warehouses typically have a manual component to their data transfer process, causing delays in visibility into conditions that may be actively changing. The sensing capabilities of modern IoT infrastructure alleviates the issues associated with conventional processes, providing real-time visibility into ambient conditions, increased accuracy and reliability in data collection, and even prescriptive insights that highlight opportunities for warehousing optimization. For pharmaceutical manufacturers, logistics providers, and retailers alike the opportunities to mitigate unnecessary risk and reduce product loss with modern sensing capabilities are extensive and cost-effective, all while easing the compliance process and building increased patient safety measures into operations.