Schreiner MediPharm, a German developer and manufacturer of specialty labels of for the pharmaceutical and medical device industry, has released a new tamper detection NFC enabled label for medical autoinjectors.
The labels wrap around the primary packaging of the device including the cap. When the cap is opened, the NFC chip registers the action and is able to report this via an NFC tag scan. Using a smartphone, the patient is therefore able to quickly tell if the product is original and/or has been previously tampered with.
In addition, the tags can also be used to pass on information regarding the drug. For example, product information, demo videos or special apps to aid patients during self-medication.
Schreiner MediPharm have commented that while this means that patients can check the security of the device at any time, it can also help prevent counterfeits getting into the supply chain.
NFC.Today reported on NXP’s NTAG213 TT tamper tag earlier this year. It’s not know which chip is being used in this product.
The counterfeit medicine market
Counterfeit medicines are big business.
The WHO estimates that 1 in 10 of all drugs sold in developing countries are fake and can be linked to over 100,000 deaths a year in Africa alone. The global size of the multi-billion dollar counterfeit drugs market is difficult to estimate but there’s no doubt that it’s growing. The number of fake drugs seizures by authorities all over the world is increasing. A report by the Pharmaceutical Security Institute stated that between 2011 and 2015 there was a 51% increase in incidents of global counterfeiting.
And it’s not just developing countries. In 2015, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) seized 6.2 million doses of counterfeit and unlicensed medicines. These included diabetes and cancer medications.
Falsified Medicines Directive
In 2011, the European Commission (EC) started to develop measures to protect against counterfeit drugs under the Falsified Medicines Directive (FMD). The final phase of the FMD is due to start on the 9th February 2019. As part of the FMD, manufacturers will be required to protect each drug package with two features : a 2D barcode and an anti-tampering device or security seal.
There are a number of methods being used to prevent counterfeit already, including scratch off panels which reveal a unique code. The code can be sent by SMS to check the authenticity of the tags.
To date, there hasn’t been a large scale rollout of NFC enabled tamper labels or indeed NFC tag authentication labels, partly perhaps due to the costs. However, with drugs manufacturers increasingly losing revenue to counterfeits and global and industry bodies such as the EU bringing in regulations to tackle the problem, this might be about to change.