Pharmaceutical Logistics: Shipping Pharmaceuticals Safely and Efficiently

August 7, 2023

Pharmaceutical Transport

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The pharmaceutical industry has seen massive growth over the last decade. The US earned $550 billion in annual revenue in 2021, up from $286 billion in 2013. This growth cannot happen in isolation; it necessitates greater capacity across the entire supply chain. With 4.73 billion prescriptions dispensed in the U.S. in 2022 alone, there has never been more pressure to get pharmaceutical products to consumers safely and effectively.

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Pharmaceutical logistics companies have had to adapt and grow with the increasing demand, which poses a risk to quality standards. This article looks at the stakeholders involved in shipping pharmaceuticals and how they can do it responsibly.

The responsibilities of each stakeholder

The transport of pharmaceuticals involves a wide range of stakeholders. Each stakeholder plays an important role in ensuring the safety and efficiency of the process. These stakeholders have to be able to collaborate effectively to maintain the integrity of pharmaceutical shipments. The following are the responsibilities of each stakeholder in the process:

Pharmaceutical companies

Manufacture and distribute pharmaceutical products. They are responsible for ensuring that the drugs are properly packaged, labeled, and stored, following the necessary guidelines. They must provide the necessary documentation and instructions for handling the products, including temperature requirements and expiration dates.

Pharmaceutical logistics providers

Handle the physical transportation of pharmaceuticals from the manufacturing facilities to the end destinations, ensuring that the shipments are handled with care and delivered on time. They must have expertise in handling sensitive and temperature-controlled shipments, utilizing specialized equipment and technologies.

Regulatory authorities

Government agencies such as the Food and Drug Administration (FDA) play a vital role in regulating and overseeing the transportation of pharmaceuticals. They set guidelines and standards for transportation and storage, conduct inspections, and ensure compliance with safety regulations to protect public health.

Customs and border protection

These agencies are responsible for inspecting pharmaceutical shipments at borders and entry points to ensure compliance with import/export regulations. They verify the authenticity, quality, and proper documentation of the products, preventing counterfeits and unauthorized substances from entering the supply chain.

Healthcare providers

Hospitals, clinics, and pharmacies are where pharmaceutical shipments get delivered. They play a critical role in ensuring the safe storage and handling of drugs upon delivery. They must adhere to storage conditions, monitor expiry dates, and follow proper dispensing practices to maintain product efficacy and patient safety.

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Each stakeholder contributes to the safety and efficiency of pharmaceutical shipping in various ways. When each one understands their role in the process and can trust the other roleplayers in the supply chain, pharmaceutical products are likely to be fit for consumers.

Pharmaceutical logistics guidelines for safely and efficiently

Following transportation best practices and managing the touchpoints within your operation will help maintain the viability of pharmaceutical products. These are some of the key touchpoints that you can manage to ensure that your pharmaceutical logistics can meet the needs of the pharmaceutical industry.

Temperature control

Pharmaceuticals are often sensitive to temperature fluctuations. Shippers must use temperature-controlled containers and packaging to maintain the required temperature range throughout the entire shipping process. Monitoring devices, such as Smart Tags, should be used to track temperature conditions and provide evidence of compliance.

Proper packaging

Pharmaceutical products should be securely packaged to prevent damage during transit. This includes using suitable cushioning materials, protective barriers, proper spacing practices, and tamper-evident seals. Packaging should also be designed to protect against light exposure and potential contamination.

Documentation and labeling

Accurate and detailed documentation is crucial for pharmaceutical shipments. Shippers must provide comprehensive labeling, including product information, lot numbers, expiration dates, and handling instructions. Additionally, all necessary regulatory and customs documents should be prepared and included to help with efficient customs clearance.

Security and tracking

Pharmaceutical shipments are susceptible to theft and tampering. Shippers should implement robust security measures, such as tamper-evident seals and tracking technologies like Smart Tags and Scanning. These measures enhance security and provide real-time visibility throughout the shipping process.

Training and communication

Effective communication among all stakeholders is crucial. Shippers and their staff need to be trained and retrained as needed to stay abreast with industry requirements and innovations. A culture of knowledge sharing and clear communication should be developed between pharmaceutical companies, logistics providers, regulatory authorities, and healthcare providers. Collaboration enables timely information sharing, and problem-solving, and ensures a smooth flow of pharmaceutical logistics.

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By following these guidelines, shippers can significantly enhance the safety and efficiency of pharmaceutical shipping.

Pharmaceutical transportation regulations you should know about

Pharmaceutical shippers need to be aware of the relevant regulations that apply to their operation to be able to comply with their standards. Non-compliance presents big safety and financial risks to all stakeholders in the supply chain. Here are some important regulations to consider:

Good Distribution Practices (GDP): GDP guidelines outline the standards for pharmaceutical transportation, storage, and distribution. They ensure that the integrity and quality of the pharmaceuticals are maintained throughout the supply chain. Compliance with GDP helps to prevent contamination, improper handling, and other risks that could compromise product safety.

Drug Supply Chain Security Act (DSCSA): Enforced by the FDA, the DSCSA focuses on making sure that pharmaceuticals are not counterfeit, stolen, or contaminated. These guidelines require serialization and traceability of prescription drugs, establishing a system to track and trace products through the supply chain.

Hazardous Materials Regulations (HMR): The HMR, issued by PHMSA, provides guidelines for the safe pharmaceutical transportation of hazardous materials, including certain pharmaceuticals like vaccines or insulin. It covers packaging, labeling, documentation, and handling procedures for hazardous substances, ensuring their safe transport.

Customs and Border Protection (CBP) Import/Export Regulations: CBP regulations govern the import and export of pharmaceuticals across borders. Shippers must comply with customs requirements, such as accurate documentation, proper classification, and import/export restrictions.

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Staying informed about these regulations and maintaining compliance ensure safe and lawful pharmaceutical transportation.

Start tracking your pharmaceuticals with Varcode

Varcode provides you with the cutting-edge technology you need to keep up with industry needs. Having Varcode’s Smart Data Solution at your fingertips gives you the power to make quick data-driven decisions that ensure that pharmaceutical products are shipped safely and efficiently. If you want to take control of your pharmaceutical shipment tracking and data analysis, contact Varcode today.