Building a Cold Chain Compliance Toolkit for the Pharmaceutical Cold Chain

Learn the 10 questions every risk mitigation checklist should include

A truly compliant cold chain goes beyond simply moving medication from point A to point B. It requires a comprehensive toolkit of packaging, processes, technologies, and expertise to mitigate the risks that can compromise medication efficacy and patient safety. We will provide you with practical information that you need to succeed.

Be confident that your pharmaceutical cold chain is not keeping you up at night with concerns over the following:

1. Regulatory Compliance
   Know your pharmacy adheres to strict ACHC and URAC standards for product quality, safety, and efficacy.
2. Risk Mitigation
   Know that your employees are trained, and you have the contingency plans and procedures in place in the event of a cold chain disruption such as a temperature excursion, packing error, equipment failure, or communication break down.
3. Patient Safety and Satisfaction
   Know that patient safety, health, and satisfaction is protected.

What is a Compliant Cold Chain?

A compliant cold chain protects and secures temperature-sensitive medication against temperature excursions, tampering, and human error, ensuring these products move through the cold chain with zero risk to their integrity, quality, and safety.

Building and maintaining a compliant cold chain is critical for mail order and specialty pharmacies, life sciences manufacturers and distributors, and logistics providers.

A compliant cold chain ensures you have the tools, people, and processes to mitigate three core risks:

1. Risk to patient safety: Protect and guarantee against risks to medication efficacy, quality, and safety.
2. Risk to total cost of ownership: Protect and guarantee against the dollar and reputational costs of damaged medications, product recalls, patient health risks, and client loss.
3. Risk to accreditation status: Protect and guarantee against repeating or failing URAC, ACHC and other regulatory and accreditation audits.

Pharmaceutical Cold Chain Risk Mitigation Checklist

Since there are many contributing factors to a compliant cold chain, you need to know what the risk potential is within your pharmaceutical cold chain.

We recommend starting with these 10 risk mitigation questions:

1. Are your employees and partners trained about URAC and ACHC compliance and standards?
2. Are your employees trained to pack-out your medication shipments to the supplier’s guidelines?
3. How often do you review your processes?
4. How are you using technology to measure, monitor, test, and communicate medication status as it moves through the cold chain?
5. What types of cold chain packaging and temperature monitoring capabilities are you using?
6. How has the cold chain packaging been qualified to ensure it can maintain the required temperature range?
7. Where are the blind spots in your processes? What are you doing to prevent them?
8. Have your patients received the correct information about medication storage, expiration dates, and handling?
9. When were your freezer and refrigerators last serviced and verified for correct temperature and humidity levels?
10. Do your employees understand the protocols around the refrigeration and handling of medications and how these impact stability and efficacy timelines?

Along with identifying your risks, this risk mitigation checklist underscores the three core challenges of every pharmaceutical cold chain:

1. Providing compliance documentation for regulatory and accreditation audits
   Detailed records, reports, and forms documenting adherence to strict regulatory requirements are essential to passing the rigorous audits.
2. Completing performance qualification studies
   The pressure to complete PQ (performance qualification) studies combined with a lack of in-house expertise on PQ places deep demands and pressure on your people, processes, and operations.
3. Learning about thermal packaging
   Lacking a deep understanding of packaging options, product capabilities, and how to use them properly is a common challenge for mail-order and specialty pharmacies.

How To Build Your Cold Chain Compliance Toolkit

Building a cold chain compliance toolkit rests on the strength and provenance of your SOP compliance manual. This manual is your blueprint, back-up, and go-to support document – it is your user manual for pharmaceutical cold chain success.

Your compliance manual:

• Ensures consistency in knowledge and processes to fill gaps or questions due to staffing changes, turnover, or shortages.
• Is the gold standard source of all SOPs in the event of an accreditation audit.
• Maintains a paper trail for all employee audits on product packing procedures.
• Gives you a foundation and historical knowledge for accreditation and performance qualification standards.

We recommend your compliance manual be available on-site in a binder and easily accessible in a digital cloud-based format as well.

Ensure your SOP compliance manual contains:

• Historical testing data: Temperature monitoring and control testing of refrigerators and freezers, PQ shipments, and real-time product visibility.
  
  
• Pack-out diagrams: Clear and actionable diagrams for seasonal pack-out options, proper packaging configurations and materials, correct placement of insulation, gel packs, data loggers, and other packaging components.
  
  
• Test summaries: Proof of PQ tests conducted in your actual shipping lanes, end-to-end tests of real-time monitoring, visibility, temperature consistency and regulation.
  
  
• Training audits: Summaries of training programs and tests to educate staff on cold chain protocols and pack-outs, plans for scheduled training and evaluation, audits of employee packing and handling procedures.
  
  
• Performance qualifications: PQ testing data and test summaries, PQ protocols and reports submitted to URAC and ACHC, comprehensive PQ report.
  
  
• SOPs: Regulatory compliance, facility and equipment maintenance, inventory management and prescription processing, patient consultation and education, procedures for detecting and responding to temperature excursions, personnel training, roles and responsibilities of designated personnel.

Pharmacies can struggle with URAC and ACHC performance qualification standards. A successful PQ should include these key components:

• Qualified shipping solution
• Written protocol
• Data loggers
• Tests in your shipping lanes
• Performance qualification reporting
• Submission to accrediting agencies

We know and appreciate that cold chain compliance, logistics, and management can be overwhelming and complicated. It is important to work with your cold chain packaging supplier to build a compliant cold chain for your pharmacy. Find a partner that you trust who has a deep understanding of global industry regulations, guidance, and best practices to provide technical and quality assessment of every component in your cold chain process. In our next issue we will address what questions you should be asking when looking for a trusted cold chain partner.