If something seems to good to be true, it generally is. It should therefore come as no surprise that vials purporting to be the cancer drug Avastin sold to 19 US medical practices by an unauthorised, foreign supplier at 25% below the list price turned out to contain no active ingredient at all.
With a supreme irony of timing, this latest counterfeiting scandal hit the headlines in the US just as visitors to Informex were attending an excellent Breakfast Briefing on supply chain security.
One of the main messages to emerge from this was that the pharma industry should not underestimate the criminal fraternity. Criminals are qualified professionals at what they do and are always looking for an opportunity to exploit.
The proceeds from counterfeit medicines are just as lucrative as those from the illegal narcotics trade, but the penalties are much lighter, so even the most rudimentary risk assessment will show which is the softer target.
The organisation Rx-360 has made enormous progress in the last three years when it comes to improving supply chain transparency by sharing audit information about upstream suppliers, but so far there has been less focus on monitoring downstream activities.
The manufacturers’ responsibility does not end when the finished pharmaceuticals leave the factory. They have a duty to ensure that the goods end up where they should: reaching the patient through a secure, transparent and authorised route at the right time and in the right dosage.
Although the systems put in place to control the upstream supply chain are aimed at quality management, they can also be very effective when applied to the prevention of theft, counterfeiting and diversion of product.
And while dialogue with external suppliers is crucial, conversations held internally within the company can also highlight clues that something is going awry – pointers that might be missed by individual departments in isolation.
Only by involving everybody in supply chain monitoring will it be possible to guarantee security from end to end.