Successful pharmaceutical supply chain management is fundamental to patient safety and product quality, when it comes to orphan drugs. We explore the key processes involved.
Supply chain management is an essential aspect of pharmaceutical operations, ensuring that drugs are delivered in good time and optimum conditions. According to GlobalData, pharmaceutical sales in Europe exceeded $93bn in 2023. Each product sold will have faced a multi-stage logistical process between manufacturer and patient.
Manufacturing is a critical field in pharma and can involve multiple complexities that must be carefully managed. International pharmaceutical companies dominate the manufacturing field and may address their needs in-house or outsource their work.
However, the sheer quantity of components required – in areas such as raw ingredients – means that a single company is unlikely to produce everything alone. Europe is the largest manufacturer of drugs globally, according to figures from GlobalData, followed by North America. There are more than 650 Phase III or pre-registration pipeline drugs in Europe, based on GlobalData figures from July 2024.
Primary and secondary packaging of pharma products
One of the earliest considerations is how the drug will be packaged. Primary and secondary packaging can play a key role in the marketing of a product. First and foremost, however, packaging is a way of maintaining the quality, integrity and stability of the medicine by containing the drug, preventing physical damage, and protecting ingredients from external influences such as light and moisture. To ensure safety, packages should be secure, tamperproof, and child-resistant, yet they should also be designed in such a way as to increase the ease of use for the end patient. Balancing this multitude of requirements is a complex yet necessary aspect of a successful drug launch.
Drug labelling is also an essential way of identifying the product, providing important information to handlers, pharmacists and end users in compliance with the EU Directive 2001/83/EC. In the EU, the Falsified Medicines Directive (FMD) mandates the serialisation and tamper-proofing of each product to prevent distribution of falsified medicines. Drugs are then registered at every stage in the supply chain.
Should there be a need for a recall, any errors can be easily tracked. At the point of delivery, prescription drugs are decommissioned using their unique identifier to confirm their authenticity and ensure that no future counterfeits can use the same details.
Distribution of pharma products to wholesalers and delivery to patients
The supply chains of certain drugs are often complex and need temperature-controlled environments or time-constrained deliveries. Any variations in the required conditions can mean that products are unusable and therefore unsellable. Wholesalers must meet these demands on a large scale and act as a point of contact between pharmaceutical companies and retailers. Wholesale businesses may buy a company’s entire stock or focus on a specific field.
Generic drugs are commonly available at supermarkets or pharmacy chains. However, GlobalData’s Global Pharmaceuticals Market: Supply Chain Analysis report reveals that most recipients access their drugs through healthcare providers. Private and state-funded organisations are usually able to purchase large quantities of a given medication. Yet in the case of orphan drugs, demand and stock may be significantly lower.
The various steps involved in pharmaceutical supply chains can cause delays. Widely used, highly stocked drugs may be unaffected by this model, but the risk posed for patients reliant on rare drugs is far greater. Any sudden delays or changes in demand may compromise patient safety.
Simplifying pharmaceutical supply chains
Outsourcing partnerships are common in this space, allowing pharmaceutical companies to focus on their core activities while specialist partners tackle the many technical and regulatory requirements of drug packaging and supply chain management. Frequently, products are sent to contract packaging organisations (CPOs) before further distribution to wholesalers. Partners and affiliates may then be brought in to assist with other aspects of the drug launch, including market access, pharmacovigilance, and medical affairs.
Another approach is to work with a company that can guide you through every aspect of the product’s launch, taking care of the hands-on activities surrounding packaging, labelling, warehousing, and distribution while also advising on the more strategic programme planning and launch execution considerations that are essential to a product’s commercial success. With a focus on delivering bespoke solutions for rare disease drugs, Abacus Medicine Pharma Services (AMPS) is one such full-service partner ready to deliver.
By managing the stages in pharmaceutical supply chain as a single body, Abacus Medicine Pharma Services maximises clients’ flexibility when it comes to changes in stock size and distribution location. This is a particularly important capability within the orphan drug market, because the supply chain must be able to adapt swiftly to ensure patient safety. Taking advantage of this service helps to guarantee continuity of supply. For example, sending unpackaged products to a commercialisation partner like AMPS means that when one market sees an unexpected increase in demand, AMPS can quickly adjust its packaging process accordingly. When it comes to rare disease products, it can be very difficult to give an exact prediction of demand in each given sales territory, making strategies like this very important in minimising wastage of high-value products and lowering the risk of supply shortages, ensuring treatments reach patients in need promptly.
“Our GMP packaging and supply chain management services are essentially one, but important, piece to the greater puzzle that makes us a full commercial launch partner,” says Alexander Franc Iversen, Vice President, Sales & Operations at Abacus Medicine Pharma Services.
“These services offer our clients greater flexibility. They don’t have to adjust their production scheme to a set of different markets. Our partners can simply send the products to our central European warehouse in the Netherlands in their primary packaging, and then we would prepare the packages for the end destination. This enables shorter lead times and risk mitigation in terms of more efficient stock management.”
Drugs are stored and transported in the specific conditions that they require. The company then uses its network of wholesalers and pharmacies to complete the delivery cycle across the European market, and can also send products directly.
“We provide a white glove treatment in the way that we hold rare medicines, both from a warehousing, distribution and packaging point of view to make sure that products get to the patient in good condition and with the upmost speed,” says Iversen.
