Those who store and distribute medicinal products have a duty to ensure processes are in place to identify and remove unauthorised products from the supply chain. This white paper will explore some of the practical ways vendors achieve this.

We’ve previously written about the Drug Supply Chain Security Act (DSCSA) and the Falsified Medicines Directive (FMD), and the role that they now play in helping to ensure the integrity of pharmaceutical supply chains.

These ‘track and trace’ systems are very effective where they are applied, but they are not a “one-size-fits-all” solution. They were not designed specifically for international clinical trial supply chains, which often span multiple countries and involve many different products.

Which products are at risk?

Perhaps the most obvious examples are high-value products.

Oncology and rare disease treatments can cost thousands of dollars per dose, making them attractive targets for counterfeiters. Similarly, products with large black-market demand, such as opioids, anabolic agents and psychoactive drugs are also frequently targeted.

Uncommon products or those on shortage can also be a popular choice, as criminals see opportunities in products that are in high demand but have low availability in the market.

Even if cutting edge drug products are complex and difficult to replicate, their external presentation might not be. A “clear liquid in a vial” is easy to mimic. Those that falsify products are not concerned with therapeutic effect; they simply want to pass off something that looks legitimate.

Prevention

Understanding why some products are more prone to falsification is useful, but the truth is that no product is completely safe. Vendors that maintain a wide awareness of the market and that actively seek out regulatory updates are better positioned to avoid contact with bad product.

Regulatory authorities, e.g. The MHRA in the UK, The FDA in the US and The EMA in Europe, publish regular shortage, recall, and theft-of-medicines notifications. Subscribing to these notifications allows access to the most up-to-date market information.

If something sounds too good to be true, it probably is. Buyers should be able to recognise a suspicious product offer. If a supplier is offering large quantities of a product which others cannot, or at unusually low prices, it could be a red flag.

The shortest supply chains are the most secure. Extra care should be taken when sourcing a product from outside its licensed territory. While this can be a perfectly legitimate supply route, it requires a longer supply chain with more companies handling and transporting the goods, therefore, greater potential for vulnerability.

Before engaging with a new supplier, proper due diligence must be completed. Supply chains should be vetted, and purchase orders only placed on licensed and reputable companies. Existing suppliers should be regularly audited to ensure standards are maintained.

Real-time market awareness and intelligence, proactive supplier vetting, and regular audits are powerful tools that vendor can use to better scrutinise their supply chain and greatly reduce the risk of handling compromised products. Still, despite all precautions, bad product may still slip through.

Detection

Goods-in is a critical checkpoint in the clinical trial supply chain. Whether at a lab, pharmacy, hospital, wholesaler or CDMO, it represents a chance for human inspection to detect anomalies and raise any concerns.

Product packaging is the first and most visible indicator that a product may not be genuine. Inconsistencies in print quality, such as colour mismatches, poor quality type, irregular spacing, spelling mistakes and irregularities with fonts is a common indication that something is awry. You may expect that falsified products are poorly manufactured, but they can sometimes look better than the real thing.

Tamper evident seals are widely applied to medicinal products, so a broken, missing or re-sealed seal should prompt further investigation. Issues of this nature could indicate broader issues with the consignment.

A robust goods-in process includes photographs of the products and measurements of weight and dimensions, with information kept on file for future reference. Unexpected or unverified changes to product artwork, size or weight should trigger an internal investigation.

Detecting falsified products relies heavily on vigilance and timely reporting, but staff are far less likely to raise concerns if they are afraid to do so. When teams are encouraged and empowered to speak up, issues are identified earlier, and investigations are more thorough. Reinforcing this approach through training, leadership messaging, Standard Operating Procedures and Work Instructions helps embed it into daily operations.

Resolution

If any suspicions of a product are raised, it officially becomes “suspect falsified” and should be isolated and further distribution halted. Initiation of a quarantine procedure ensures the product is segregated while observations are properly documented and the correct quality personnel are notified.

Internal processes will define who is allowed to authorise the release of product from quarantine, and if required, when and how to notify regulators/competent authorities. A comprehensive investigation will be required, using the information obtained at goods-in.

Manufacturers can often provide useful supporting information, such as details of artwork changes and packaging updates. A comprehensive report from goods-in will greatly assist with the investigations into whether a suspect product is genuine or not.

Only after being signed off by a competent person, i.e. a Responsible Person, should goods be released to saleable stock. All evidence and details of the investigations should be retained by the vendor in case it is required by the regulatory authority or customer.

Summary

Falsified medicines present a significant risk to clinical trial supply chains, particularly where products are high value, in short supply, or sourced thought indirect channels. Identifying and managing of falsified products is not straightforward and there is no simple set of rules, but maintaining strict quality assurance processes gives a vendor the best chance of success.

Certain products, like oncology drugs and rare disease therapies, are especially vulnerable. The importance of being informed through regulatory alerts and performing supplier due diligence cannot be understated. Vendors that actively seek out intelligence will be better equipped.

At the point of receipt, visual inspection remains one of the most effective tools available. Red flags like print misalignment, broken seals, or missing documents should trigger an investigation. Maintaining visual records and comparing incoming goods to approved references strengthens this process. Given their unique position, training and empowering goods-in and quality assurance personnel is an effective way to improve security.

Finally, when a suspicious product is identified, prompt isolation, documentation, and escalation is essential. Suspicious products should never be released for further distribution without first fully verifying their legitimacy.

Patients deserve safe and legitimate medications, so Sponsors need to utilise high-quality and vigilant vendors to support their clinical trials.

To download a copy of this white paper, please click here.