On the front line

Criminal gangs are finding increasingly sophisticated ways to profit from pharmaceuticals, from stealing large shipments to counterfeiting blockbuster drugs.

The World Health Organisation (WHO) estimates that worldwide sales of counterfeit pharmaceuticals could be worth more than £45 billion annually. Leading manufacturers are taking action by helping to fund Interpol’s creation of the Pharmaceutical Crime Program.

But well-managed, tracked supply chains could be the best weapon pharmaceutical companies have against crime.

Governments worldwide are introducing regulations to make life sciences and healthcare (LSH) supply chains more secure. Turkey and France have introduced national track-and-trace systems that require pharmaceutical products to be marked with data matrix codes. In the USA, Congress approved the Drug Quality and Security Act in November 2013, which will implement a national track-and-trace system over the next ten years. This legislation was passed in response to a range of incidents, including a fatal meningitis outbreak caused by a contaminated batch of steroids. 

Thefts, fakes and freezing

According to Jonathan Blamey, Vice President of Product Development, Life Sciences and Healthcare at DHL Supply Chain, the risks to LSH supply chains can be split into three broad categories: theft, counterfeiting and environmental damage.

In Blamey’s experience, goods are usually stolen from vehicles that are docked or parked. Thefts from moving vehicles are rare in most parts of the world, with the exception of some high-risk areas for vehicle hijacking, notably Brazil, Mexico and southern Italy. Thefts from warehouses, such as the high-profile theft of £48 million worth of pharmaceuticals from an Eli Lilly warehouse in 2010, tend to be isolated incidents.

Counterfeit drugs fall into a variety of categories, ranging from medication containing harmful ingredients and medication containing the correct ingredients but in the wrong quantities, to medication in mislabeled packaging. Eli Lilly’s Cialis and Pfizer’s Viagra are amongst the most counterfeited drugs: in early 2014, French customs seized a record-breaking haul of 2.4 million tablets, which was made up predominately of these two drugs.

Finally, product damage (and therefore loss) caused by environmental factors is becoming more common. Blamey explains that the reason for this rise is two-fold. First, it’s now possible to measure environmental changes with greater accuracy. As a result, suppliers are more aware of when products have been exposed to damaging conditions. "Previously, I don’t think we really knew what proportion of products had gone out of their ideal temperature range because not all shipments – particularly ambient (2-30C) products – were tracked,” says Blamey. "Now we have much better data, so we at least have a baseline figure.” Secondly, with the growth of biotechnology and bio-similar products, there are now more products that need to be kept in controlled environments.  

Keeping stock secure

The easiest way to secure pharmaceutical stocks is to fit alarms to containers and vehicles. DHL has developed alarms that track not only movement but also changes in light, humidity and temperature. "The biggest issue is not knowing if something’s been opened,” Blamey says. "It may have been opened for a legitimate reason, such as a customs clearance. If something’s been opened, as long as there is reliable and accurate data, companies can assess the risk. If they don’t know if something’s been opened, then they don’t know what the risk is.” 

For those transporting stock through areas where road theft is a risk, Blamey suggests the use of geo-fencing – which uses Global Positioning Systems (GPS) – as part of a vehicle tracking solution. This will trigger an alarm at the control centre if the driver deviates from his designated route or into high-risk areas.  

Parallel trade, where medication is purchased in one country and then moved to another, also raises security issues. Because the practice can involve placing pharmaceuticals in new packaging, it is possible for the original product to be replaced with a counterfeit one. Although parallel trade is legal in most territories, including the EU, Blamey advises that companies wanting to keep their supply chains secure should be aware of parallel trade operations. He suggests looking for warning signs, such as unusually high medication orders that far exceed the number of patients in a particular region.

It is also vital to know if pharmaceuticals have been opened once they have been delivered to doctors and patients. Blamey stresses the importance of using security seals on products, so consumers can easily tell if a product has been tampered with. In 1982, seven people in Chicago, USA, died from taking Tylenol tablets that had been laced with cyanide. The contamination is believed to have happened once the product was in stores. The incident was so serious that it led to reform of the laws regulating packaging of over-the-counter medication.

A safer alternative to the traditional wholesaler model may be the direct-to-pharmacy model. In this setup, the manufacturer controls the supply chain right up to the end point of dispensing. Using manufacturer-branded webstores with direct fulfillment managed by the manufacturer through their 3PL partner is another way to control the end-to-end supply chain.

Planning for the worst

If stock is stolen or contaminated, companies must work quickly to limit the damage to both their profits and their reputation. "It’s important companies have a supply chain flexible enough to deal with a loss by moving stock to the affected area,” advises Blamey. "The market will know there’s a problem when product isn’t available.”

A quick and secure collection process is crucial in such situations but the issue of not knowing where medication has gone makes recalls challenging. Until recently, lack of suitable technology made it impractical to track each individual packet in a pallet. Even if pharmaceutical companies did track individual items to the wholesaler, medication was not monitored when it was administered to patients. Although a number of countries are implementing national schemes to track medication, many companies already use track-and-trace systems.

DHL Supply Chain uses 2D barcodes on products to support national regulations where required. Both 3M and IBM offer radio-frequency identification (RFID) chips that can be embedded into packaging. DHL has recently implemented Cool Green Cell, which uses RFID chips embedded into interlocking packaging that has been designed for shipments that need to be kept within a certain temperature range. Patients in Africa and South Asia have access to a service called mPedigree, which enables them to text a code on the packaging to a free number to confirm whether the drugs they have received are genuine or not.

LSH supply chains are more robust than ever before but criminals are finding new ways to outsmart the system. Blamey indicates similarities between current LSH supply chains and tobacco supply chains 10 years ago. Tobacco was traditionally the commodity of choice for criminals looking to make money quickly. As tighter controls and harsher repercussions have been introduced, thieves and counterfeiters have moved on to other products, including medicines. Companies and governments must work to secure supply chains to make pharmaceuticals less attractive to criminals.

You can read more at https://www.dhlsupplychainmatters.dhl.com