USP Updates for Drug Storage and Distribution 
Advancements

When ensuring consumer drug safety, trust is the cornerstone in how medications, dietary supplements and food products are securely moved through the supply chain. 

US Pharmacopeia (USP) is integral in setting transparency standards for a stronger and safer drug supply chain. 

Establishing procedure is successfully achieved through essential compounding USP General Chapters.

Health practitioners such as Hancock Regional Hospital, Hendricks Regional Hospital and Indiana University Health utilize USB chapters to deliver personalized care for patients. 

Specifically, Sonicu supports hospital pharmacies by providing reliable storage and distribution temperature and environmental monitoring solutions within their organization’s system. 

Chapter updates help build standards and trust for patients relying on community hospitals, especially for emergency and immediate care during the pandemic.


Why USP Updates are Important

The USP’s chapter development is considered the “keystone standard today.” 

The 1079 chapter, in USP since 2004, specifically focuses on storage and distribution practices. The chapter continues to be updated, most recently in 2019.

Revisions to USP chapters, especially regarding storage and distribution practices, provide a portfolio of solutions for pharmacopeial transparency and quality control. 

This portfolio includes USP documentary standards that serve as benchmarks to strengthen manufacturing and regulatory consistency. 

According to USP, such public quality standards are vital to the consistent development, manufacture, distribution and administration of safe and effective medicines in the global supply chain.

“Documentary standards also enable manufacturers and regulators to determine the identity of a drug, control for harmful levels of impurities, and ensure the correct potency of the drug and its ability to be properly absorbed in the body,” reports the USP in the documentary standards summary. 

“This helps patients to trust that medicines with the same name identified in a USP documentary standard will be consistent in quality no matter who manufactures them,” adds the USP.

Management of Temperature Excursions

The USP chapter helps establish patient and consumer trust. It also recognizes compounding quality risks by addressing temperature variation types that drug products encounter as they navigate the supply chain.

The Centers for Disease Control and Prevention (CDC) identifies temperature excursion as “any temperature reading outside ranges recommended in the manufacturers’ package inserts.” 

In properly managing vaccine storage units, the CDC suggests quickly identifying temperature excursions and taking immediate action to correct them. 

“This can prevent vaccine waste and the potential need to revaccinate patients,” the CDC says in this resource page in the Vaccine Storage and Handling Toolkit.

The CDC resource says to follow these important steps in handling a temperature excursion in a vaccine storage unit:

Notify the primary or alternate vaccine coordinator immediately or report the problem to a supervisor.
Document details of the temperature excursion.
Contact your immunization program and/or vaccine manufacturer(s) for guidance per your standard operating procedures (SOPs).
Correct the situation if the temperature alarm goes off repeatedly by checking the basics, including: power supply, unit door(s), thermostat settings. Do not disconnect the alarm until the cause is determined and addressed.



Pharmacy in Transit Trends

Prior to the arrival of pharmacy products to their storage destinations, they must be shipped in some form or fashion.

To meet industry standards and ensure efficacy and safety, temperatures are controlled and monitored in shipping containers via different modes of transportation.

Moving products through the supply chain can be achieved by land, sea or air. 

As global shipping demands increase, new USP chapters are important as ever for temperature excursion management of pharmaceuticals. 

Inadequate storage and improper distribution should be identified early and often.

Desmond Hunt, PhD, senior principal scientist at USP, said in an interview with industry publication “Pharmacy Times” that the topic of pharmaceuticals in transit is trending. 

Extreme weather conditions, such as extreme heat and extreme cold, are presenting further challenges for temperature integrity along the supply chain. 

“Temperatures can be extremely high, as well as extremely low, both of which can have a significant impact on drug product quality,” he said.

Hunt said environmental factors are key in temperature excursion management for products highly sensitive to impacts such as light, shock, vibration, and compression.

Hunt says drug product packaging systems can be damaged and leak. 

In worst-case scenarios, packaging system leaks can cause “microbial ingress, and other potential patient safety risks.”

Safe Practices During a Pandemic

Mitigating safety risk by monitoring highly sensitive pharmaceutical products continues to be a global priority as the world navigates the full spectrum of pandemic impact.

Maintaining temperature control of single-batch vaccines through transport and storage have taken precedence in combating deadly and devastating viruses.  

Sonicu’s high-tech remote wireless temperature and environmental monitoring systems continue to provide real-time solutions in the administration of vaccines, especially on a local level.

 Success stories including Hancock Regional Hospital, Hendricks Regional Health and Indiana University Health 

“Having Sonicu in place was one of the elements that allowed us to play a central role in our community to distribute the vaccine,” said Hancock’s Pharmacy Director, Tim Livesay.

To maintain viable air filtration and optimal temperature control, Sonicu’s wireless remote monitoring technology and cloud-based management platform provide reliability to virtually any pharmacy. 

State-of-the-art technology includes fully automated, 24/7 monitoring, alarming, and reporting for virtually any monitoring application required.

Customers rely on Sonicu to automate regulatory compliance for agencies like the Food and Drug Administration, State Boards of Pharmacies and The Joint Commission. 

When coupled with our alerts and alarms, the remote wireless temperature monitoring solution from Sonicu delivers a powerful return on investment. 

Any changes to temperature, humidity, air pressure and sound are tracked with wireless sensors, allowing pharmacists and techs to control environmental impact on products.



Proper Pharmacy Storage: Powered by Affordable Monitoring 

Monitoring storage and distribution of finished drug products require next-level expertise, and USP chapter updates keep industry standards current at pharmacies.

Such high industry standards help Sonicu offer:

• NIST Calibrated Certificates: showing that the sensors meet the standards of the National Institute of Standards and Technology.
• Plug 'n' Play installation: the ability for nearby devices can be configured to a computer and used almost at once.
• Onboard battery & data backup - so you do not lose everything even if there is a power or network outage.

According to the USP, Reference Standards are “intended for test and assay use only; they are not for use in humans or animals as drugs or medical devices.”

View USP's policy statement on USP Reference Standard’s Uses and Applications.



How Pharmacies Reduce Risks and Protect Patients 

Sonicu helps Hancock Regional Hospital pharmacy ensure safe and efficient business practices as COVID still affects supply chain issues and medicine availability.

Livesay said many drugs aren’t as readily available as they were pre-COVID.
                                                    
“We simply can’t assume we can restock like we did. It’s scary to think about, but that’s the world we live in now,” he said.

Along with drug availability, environmental impacts continue to be a factor for Livesay and his team as they continually monitor and maintain temperature levels. 

Elevated humidity levels put patients at risk by harboring bacteria and mold. Drug efficacy is also affected.

Livesay cited this high-profile case at a facility in New England that allowed humidity levels to climb too high, contaminating the drugs and killing dozens.

“That case and all the legal action after it woke a lot of people up to how serious a threat humidity and other foreign agents really can be. We all realized this is something we can’t afford to not monitor diligently.”

Livesay knows the importance of monitoring and controlling climate in real-time. Recently, he noticed humidity levels rising to unsatisfactory levels in Hancock’s new oncology wing.  

Thanks to monitoring and alerts with Sonicu, Livesay took corrective action in working with the climate control contractor who recently installed the new air handling unit.

“We called the contractor back in and learned they had installed the wrong size air handling units during the new construction. The units were simply too small and could not keep up with the demand during the high humidity seasons,” he explained.

“They had to take them out and install the right size units so we could meet our requirements.”

Tools of the Trade

Sonicu has helped Hancock Regional, as well as other hospitals, by: 

• Automating measuring/logging to reduce staff burden on the freezer monitoring circuit and deliver peace of mind that human error won’t be the culprit behind a critical asset loss.
• Eliminating thousands of Full Time Equivalent Employees (FTE) hours previously dedicated to manual monitoring and data logging.
• Continuous (24/7/365) tiered alarming that drive action.
• Data and alarming platform accessible from any desktop, email or smartphone.
• User-defined parameters tailored to urgency levels that can be automatically escalated to the next level.
• Total monitoring and data accessibility via the AWS Cloud

Sonicu’s Smart Management Tools allow Hancock’s pharmacy techs to input comment and context for alarm events and automatically organize reports by folder in user-defined formats to streamline reporting and documentation.

Sonicu’s SNAP recalibration eliminates downtime associated with annual temperature probe recalibration requirements by pre scheduling a NIST traceable recalibrated probe that simply snaps back into service.

Such solutions help Sonicu’s health practitioners reduce costs and risks when drugs fail to meet temperature storage consistency.

By consolidating individual monitoring plans into one comprehensive system-wide enterprise license, Hancock Regional Hospital now identifies manual measuring and monitoring processes and automates them at one fixed price, as needs arise.

Such platforms allow for continuous temperature monitoring and protection for healthcare facilities, patients and reputations.

Along with USP’s commitment to provide “innovative solutions, advances in analytical methods, manufacturing processes and digital innovations“ Sonicu helps assure quality control and industry transparency.