Counterfeiting pharmaceuticals is unforgivable and causes untold damage. To pharmaceutical manufacturers, to healthcare professionals and organisations, to consumer trust, to the ability of governments to encourage uptake of vaccines and, of course, to patients. It’s illegal, potentially life-threatening and we must all play our part in stopping it.
Yet the World Health Organisation (WHO) says an estimated 10 per cent of medical products in some regions are substandard or falsified[i]. For example, fake COVID-19 vaccines were identified in Mexico in February 2021[ii] and counterfeit leukaemia drugs have been found globally[iii]. Since the outbreak of COVID-19, the challenge of cracking down has become even more important.
This is because the pandemic has created what some see as a perfect storm where worldwide supply chain disruptions, regulatory confusion and an urgent public need for medical products provide a breeding ground for criminals to attempt distribution of their illegal goods[iv].
Reassuringly, there are a wide range of measures taken by pharmaceutical companies to minimise the likelihood of fake drugs reaching patients. Furthermore, the problem of counterfeits is most pronounced outside of the regulated supply chain[v]. But there is always room for improvement, innovation and the review of procedures.
What can be done?
There is no single solution. No silver bullet that will stop counterfeiters in their tracks. The whole industry needs to consider a multi-layered approach. While not an exhaustive list, there are some key steps that can be taken.
The first step is ensuring an individual is dedicated to monitoring the security of the supply chain from manufacturing sites, through to storage, forwarding, shipping, receipt of goods and even their use in a healthcare setting. There need to be assurances from the moment of production to the second a patient receives it. This should involve regular contact with suppliers and an ongoing review of every step.
Once in place, that person needs to be closely aligned to regulatory bodies, and agencies in their own country and globally. For example, the US Food and Drug Administration (FDA), WHO and Interpol. They have developed strategies to tackle counterfeit drugs that need to be followed or will have a role in bringing perpetrators to justice.
But it’s important not to make prevention someone else’s job. Organisations also need to ensure packaging is designed to make copying it harder than ever – down to the individual pack or dose. This can include bar codes, RFID tracking, holograms and unique identifiers – the last of which have been required by law in the EU since 2019[vi].
There are even solutions that allow manufacturers to embed traditional holographic effects directly into packaging during the injection moulding process[vii]. DNA markers have also come onto the market, which are deemed to be impossible to counterfeit[viii]. These must be checked throughout the supply chain to ensure no tampering at any point.
Active and passive cold chain
With this in mind, there’s another factor to consider: the integrity of bulk shipments in transit. They need to be protected from tampering as best they can. This can be achieved with what’s known as an active container.
To explain a little further, many modern pharmaceuticals require a cold-chain for transportation. This calls for specialist packing to maintain a constant temperature as the shipment is transported. There are two main choices for achieving this: passive packaging or active containers.
The former is called so because it doesn’t have moving parts or anything that proactively works to maintain the temperature in the shipment. It’s like a giant beer cooler or carboard box with insulation and cool packs.
Active containers are different. They’re reusable, battery powered and insulated metal units that can accommodate pallets of pharmaceuticals. Importantly, active containers often have doors that can be closed, latched and sealed.
Once this has taken place, the contents remain safe from tampering – as well as temperature deviations. What’s more, there are built-in monitoring tools in many containers. These record everything from position, temperature, battery level and humidity, to door openings.
This provides assurances about safety. If someone opens the unit, it will be recorded, leading to quicker investigations and risk assessments related to counterfeit, security concerns or shipment processes. Passive packaging, with its cardboard, removable insulation and wrapping, has none of this.
The difference between these methods of transportation is important to consider, because since 2013, the EU’s Good Distribution Practice of Medicinal Products for Human Use says, “Medicinal products should be transported in containers that have no adverse effect on the quality of the products, and that offer adequate protection from external influences, including contamination.”[ix]
Why take the risk?
This isn’t to say that we shouldn’t trust forwarders to protect drugs when in transit, whether in active containers or not. We should, and the US Drug Supply Chain Security Act of 2013 aimed to assure this, with national licensure standards for wholesale distributors and third-party logistics providers[x]. But forwarders themselves suggest global pharma supply chains are not immune from, “Bad actors seeking to pass off counterfeit pharmaceuticals.”[xi]
As a result, if there’s a measure that can be taken to cut risk even further, why not take it? Furthermore, when Total Landed Cost (TLC) is accounted for, active containers cost less to use overall. Given they’re safer and cheaper, it’s vital that more pharmaceutical companies consider active containers as part of a layered approach to reduce the likelihood of counterfeiting.
This industry, therefore, must always look for new innovations to secure itself from the growing threat of counterfeit pharmaceuticals. Active containers can cost-effectively play a role when used in conjunction with other measures, cutting out a potentially weak link in the supply chain.
[i] WHO, Substandard and falsified medical products, January 2018
[ii] WHO, Medical Product Alert N°2/2021: Falsified COVID-19 Vaccine BNT162b2, March 2021
[iii] WHO, Medical Product Alert N° 3/2019: Falsified ICLUSIG (Asia and globally), February 2019
[iv] Pharma Times, COVID and the growing threat of counterfeit medicines, April 2021
[v] UPS, The fight against counterfeit drugs, June 2021
[vi] European Commission, SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE, April 2021
[viii] L&NW, Schreiner-MediPharm offering counterfeit-proof feature for pharma labels, August 2019
[ix] Official Journal of the European Union, Guidelines on Good Distribution Practice of Medicinal Products for Human Use, March 2013