Why is using a URAC compliant shipping solution important for specialty pharmacies and temperature-sensitive pharmaceuticals?
Packaging, shipping, and distributing specialty drugs and pharmaceuticals cannot be left to chance. The importance of cold chain and temperature management for drugs and pharmaceuticals is critical.
Unfortunately, with the shifts in how medications can be purchased and distributed, often eliminating a real-life pharmacist from the medication transaction and education, the mismanagement of specialty drugs and medications is on the rise.
Several factors can be blamed for the mismanagement of temperature-sensitive and cold chain pharmaceuticals:
- Supply chain challenges
- Evolving role of pharmacists
- Strains on the healthcare sector
- Changes in how and where people buy their medications
- Rising costs of drugs and pharmaceuticals for manufacturers, pharmacists, and customers
- Increasing demands for specialty drugs, including gene therapies and biologics
This blog is about URAC, specialty and mail-order pharmacies, patients, and the importance of using qualified packaging solutions to ship, store, and distribute specialty drugs and pharmaceuticals.
These topics matter to everyone involved in the manufacturing, packaging, distribution, and delivery of temperature-sensitive pharmaceuticals. Not utilizing qualified packaging solutions results in medication loss, increased operational costs, and compromising patients’ health.
The Quick Facts on URAC You Need to Know
- URAC stands for Utilization Review Accreditation Commission
- Founded in 1990 as an independent non-profit accreditation entity
- Establishes quality standards for the healthcare industry
- The largest independent healthcare accreditation organization in the United States
- Certifies and accredits healthcare organizations across six specialty areas:
- Patient care management
- Administrative management
- Digital health and telehealth
- Health plan programs
- Mental health and substance use disorder parity
- URAC has established guidelines, standards, certifications, and accreditations for specific domains within each of these specialty areas.
- Earning a URAC accreditation is a clear indicator that the healthcare organization is committed to quality, accountability, and integrity when delivering services.
To learn more about URAC and their accreditation and certification standards read and watch:
- URAC Accreditation Process 101 – What Does It Take to Get Accredited?
- Pharmacy Accreditations & Certifications
- Accreditation FAQs
URAC Accreditation, Pharmaceuticals, and Temperature Management
With the shifting landscape in how and where people are buying and receiving medications, it is difficult to unequivocally guarantee patient safety and drug efficacy.
Pharmacists may not know who is receiving medication purchased online or how these medications are stored in a patient’s home.
Patients do not understand the importance of temperature management and expiration dates for their medications.
Healthcare organizations are relying on a diverse network of partners and suppliers to package and distribute medications within a crowded and overwhelmed supply chain.
Shipping, packaging, storage, and temperature requirements vary across every medication, specialty drug, and pharmaceutical type.
Pharmacist roles are evolving, with expectations around vaccine administration, front-line support, online and virtual patient education, and as the primary knowledge provider for patients who have limited access to healthcare professionals.
Mail-order pharmacies, community pharmacies, and specialty pharmacies may be dealing with patients they never meet face-to-face, making it challenging to provide patient education and to guarantee the correct packaging, distribution, handling, and storage of medications.
Mistakes happen during the shipping, distribution, handling, and storage of medications and pharmaceuticals. From traffic delays through to dropped packages and port shutdowns, there is a lengthy list of mistakes and damages that can occur through-out the pharmaceutical supply chain.
The evolution of the URAC standards helps underscore the pressures pharmacies, drug companies, healthcare organizations, and logistics companies deal with daily.
In the recent Gold Star Talk: Raising the Bar with Standards on Temperature Management Medication (Cold Chain Medication Management), URAC’s Jennifer Richards, Product Development Principal, explained the evolution of URAC standards for cold chain and temperature management:
“We started off super general. We were really just talking about stability and integrity within the pharmacy and during shipping. No direct standards on temperature ranges or management. In version 3.0, released in 2015 we started to raise the bar and we put in specific validation requirements for cold chain medications during shipping.
We still had temperature integrity within the pharmacy, and we were asking for monitoring of fridges, freezers, humidity, and room temperature – but we really expanded into the cold chain shipping requirements.
Then in 2019 we took it to the next level in our 4.0 standards – mail service 4.0 and specialty pharmacy 4.0. We expanded the validation requirements for shipping medications to require more frequent testing and it applies to all temperature ranges – all of cold chain but also room temperature and freezer stored medications.
Version 4.0 also focuses more on internal storage temperature management. We started to require continuous monitoring for all of those drug storage areas. Similar to what we were hearing about vaccines, it’s so key to make sure that all medications are even stored at the appropriate and proper temperature ranges to make sure there is integrity behind those drugs.”
We highlight this section of the URAC webinar to emphasize how important it is for every company and person involved in the pharmaceutical supply chain and cold chain to understand the importance of temperature management and continuous monitoring in ensuring drug efficacy and integrity.
Is Your Shipping Solution URAC-Compliant?
How do you know if your pharmaceutical shipping solution is URAC-compliant? Ask these questions as you establish or review your pharmaceutical supply chain:
What types of training do your employees and partners have in URAC-compliance and standards? Do the people handling pharmaceutical products understand the relationship between temperature, continuous monitoring, and drug efficacy?
How is technology being used to measure, monitor, test, and communicate the status of pharmaceutical products as they move through the supply chain? How can you deliver end-to-end visibility, regulatory compliance, and real-time updates?
Where are the blind spots in your processes and what are you doing to ensure there are no communication black holes or information lags?
What is your disaster recovery plan in the event of natural disaster, pandemic, or port or border closure? Do you have a backup network of trusted and verified partners who can support you in the event of a critical failure?
What types of cold chain packaging and temperature monitoring capabilities are you using? Can you receive real-time updates on temperature, location, humidity, package condition, and estimated time of arrival? How has the cold chain packaging been qualified to ensure it can maintain the required temperature range?
What types of patient education are you delivering? How do you know if your patients have received the correct information about drug storage, expiration dates, and handling?
When were your freezers and refrigerators last serviced and verified for correct temperature and humidity levels? Do your employees understand the protocols around the refrigeration and handling of medications and how these impact stability and efficacy timelines?
How capable is our team in the handling, delivery, and logistics of specialty drugs including autologous and allogeneic therapies, biologics, vaccines, and other temperature-sensitive pharmaceuticals?
As a URAC accredited pharmacy you cannot make any assumptions. There can be no doubt about the integrity, quality, and standards in each step of your pharmaceutical supply chain.
When evaluating the strength of your pharmaceutical supply chain, consider these industry statistics:
- 75% is the estimated percent of the approximately 7,000 prescription drugs in development that are specialty medications.
- 60% of the 600 drugs expected to receive FDA approval in 2022 are specialty drugs.
- $310 billion is the estimated specialty drug spend expected by 2030. (A Look at Specialty Pharmacy Dynamics)
- $35 billion US: biopharma industry annual loss due to temperature excursions and logistics.
- 99% of survey respondents in the pharmaceutical industry say they are using manual processes to achieve supply chain visibility. (The State of Supply Chain Visibility Report)
- 87% of survey respondents in the pharmaceutical industry say they do not have 100% visibility into the condition of their products in the last mile of delivery. (The State of Supply Chain Visibility Report)
- 20% is the spoilage rates for non-COVID-19 vaccines due to temperature failures in transport. (The Pharmaceutical Supply Chain: Closing the Visibility Gap)
It is important to keep conversations going about the challenges within the pharmaceutical supply chain and the importance of adhering to standards and accreditations like URAC. Raising awareness of challenges and problems is the first step in developing solutions and strategies to overcome these challenges. It is critical to maintain the standards for the packaging, distribution, and storage of specialty drugs and pharmaceuticals.
At Cold Chain Technology we have the people, technology, and experience to guide you through the URAC qualification process and our ISO 9001:2015, ISTA-certified, cGMP-compliant lab can do the testing for you.
Request a sample of our specialty drug shipping systems designed specifically for last mile distribution. Sign up for Cold Chain Tech blog updates to learn how our team helps you overcome your pharmaceutical supply chain challenges.