The biopharmaceutical division of Merck KGaA, (EMD Serono in the US and Canada) has created a smartphone application which reads QR codes printed on the packaging of all Merck Serono drugs.
Users can validate the authenticity of their medicines against Merck’s database, verifying the product’s serial number, lot number and expiration date.
Federal laws
Merck Serono’s move pre-empts the FDA’s requirement, as part of the 2013 Drug Quality and Security Act, that all drug packaging must be labelled with serial numbers by November 2017.
The same Act requires that, from next January, US pharma manufacturers record the transaction history and lot-level movement of products throughout the supply chain, and store this information for at least six years. Electronic data storage will be necessary by 2017.
When in-Pharmatechnologist.com asked if tasking patients with checking their meds means the company is placing responsibility for safety too late in the supply chain, the company told us the app can be freely downloaded by anyone. “Wholesalers and pharmacies can also do it, so it can be leveraged by everyone in the distribution channel.”
Shift to biologics
EMD Serono’s Associate Director, Product Security and Outbound Logistics, told in-Pharmatechnologist.com the app is in part a response to “a shift” in pharmaceutical counterfeiting towards more biologic fakes – a crime that involves lower-volume, higher-value products.
“We do see an increase in the specialty areas,” said Kimberly Fleming, “particularly the Avastin case that recently happened.”
In June, Italian authorities were on alert after Roche’s large molecule oncology drug was among biologic vials – including Herceptin (Roche), Remicade (J&J) and Alimta (Lilly) – found to have been stolen. Batches of some drugs were tampered with and placed on the market.
Biologics are a lucrative target, said Fleming. “I personally think it’s because of the value of the products – they don’t have to produce the same volume to get the same dollar impact.”
Counterfeit biologics are a particular risk for patients who look for cheap deals online, she said.
“The biggest issue in the US is the internet. When patients decide to search the internet for products, they may not be getting the right products.”
The app aims to pre-empt sophisticated counterfeiting methods which could target a wide range of biopharmaceuticals, not just the biggest-selling oncology drugs.
“Because fertility products aren’t covered by insurance in all the states here in the US, there’s a tendency for patients to start searching on the internet,” said Fleming.
The Check My Meds app can is currently only available to US consumers but Merck Serono is considering rolling out a wider scheme using text messages, it told us.