April 10, 2019

Distribution Methods for Pharmaceuticals, Pt. 2: Cold Chain Best Practices

Written by Garret Weigel | Pharmacy Safety, Supply Chain

Part 1 in our series on pharmaceutical distribution outlined a big picture overview of the current (but ever-changing) model of the pharma cold chain. In this post, we dive further into the Good Distribution Practices (GDPs) recommended to guarantee supply chain safety and security of medications as they move from manufacturer to patient. Because prescription drugs have become more expensive and specialized, the federal government has passed more stringent regulations and mandated increased FDA oversight. In this climate of public scrutiny, GDP is essential at every link in the pharmaceutical supply chain.

 

The Drug Supply Chain Security Act (DSCSA)

The Drug Supply Chain Security Act (DSCSA) was a major advance in improving safety and security in pharmaceutical distribution. Establishing a single, digital, national solution, it outlines steps to identify and trace prescription medications during nationwide distribution. The DSCSA also improves detection and elimination of unsafe drugs from the supply chain to protect consumers.

 

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The FDA plays the primary role in defining and enforcing the law’s regulations. The agency’s role is to:

  • Help protect patients from exposure to drugs that may be contaminated or otherwise harmful.
  • Develop standards, guidance documents, and pilot programs, as well as all other efforts necessary to support efficient and effective implementation.
  • Establish national licensure standards for wholesale distributors and third-party logistics providers.

 

Pharma Supply Chain Good Distribution Practices (GDP)

Along with the federal requirements of the DSCSA, the World Health Organization (WHO) has recommended detailed Good Distribution Practices of pharmaceutical products that can be adopted and adapted by any country, including the U.S.

 

The goal of the GDPs is to help ensure the quality and identity of pharmaceutical products during all aspects of the supply chain process: procurement, purchasing, storage, distribution, transportation, repackaging, relabeling, documentation and record-keeping. The following principles of the WHO GDP apply to pharmaceutical products moving forward in the supply chain from the manufacturer to the patient, as well as moving backward as the result of a recall.

 

Quality System

Each stakeholder in the supply chain should create and document a Quality System (QS) outlining the overall requirements of their role. The QS should include the procedures, resources and actions necessary to ensure adequate confidence that a product satisfies all given requirements for quality and safety. Inspection, auditing, risk assessments, and certification of compliance with the International Standardization Organization (ISO) by third parties is also recommended to maintain quality and to address new potential threats.

 

Traceability

To foster a safe and secure supply chain, transparency procedures must be put in place in ensure traceability of all drugs transported and received along the supply chain. These measures require detailed, recorded documentation that can be used throughout all distribution channels to locate the point of origin responsible for supplying an unsafe drug at risk of patient administration. By increasing traceability, the recall process becomes more efficient and effective.

 

Training & Management

At every level of the supply chain, employees should be fully informed and trained in clearly defined duties to ensure product safety. A designated manager should be appointed with the authority and responsibility for implementing and maintaining a Quality System.

 

Transportation Planning

Methods of transportation should be selected with care. Local conditions must be accommodated, including the climate and any seasonal variations. Delivery schedules should be established and routes planned, taking local needs and conditions into account. Care should be taken to ensure that the volume of pharmaceutical products ordered does not exceed the capacity of storage facilities at the destination. Finally, procedures should be put in place to ensure that:

  • The identity of the product is maintained.
  • Products are not cross-contaminated.
  • Adequate precautions are taken against spillage, breakage, and theft.
  • Appropriate environmental conditions, especially temperature, are maintained.

 

Components

  • Good Storage Practices (GSP): Storage areas should be clean and dry, maintained at proper temperature limits, and of sufficient capacity to allow the orderly storage of the various categories of pharmaceutical products to prevent mix-ups and cross-contamination.
  • Vehicles: Dedicated vehicles equipped to prevent exposure of products to stop contamination should be used, where possible, to distribute, store, or handle pharmaceutical products, with procedures in place for cleaning and maintenance.
  • Shipping Containers: Pharmaceutical products should be stored and distributed in shipping containers that offer adequate protection from contamination and should bear identification labels providing information on handling and storage conditions, as well as precautions to ensure that the products are safe and secure at all times.
  • Dispatch and Receipt: Under the cover of weather-protected facilities, incoming shipments should be examined to verify the integrity of the container and that labelling appears intact to enable traceability of the pharmaceutical product in the case of a recall.
  • Documentation: Readily retrievable and transferrable (i.e. digital) records of all activities relating to the distribution of pharmaceutical products should be stored and retained using facilities that are safeguarded against unauthorized modification, damage, deterioration or loss.

 

Next up in part 3: we’ll take a close look at vaccine distribution to understand the importance of temperature monitoring to drug safety along the pharma supply chain.

 

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