EMD Serono launches counterfeit-fighting app

EMD Serono, the US pharma division of German firm Merck KGaA, has launched a new smartphone app for patients and serialised its brands in the US to help counter fakes.

The company, which makes drugs for multiple sclerosis and cancer, has serialised all of its major brands in the US, which helps patients and doctors to authenticate the company's medicines at the unit level.

This new serialisation initiative will launch before new legislation for pharma companies to serialise their prescription drug products at the unit level comes into force in 2017.

In conjunction with its serialisation initiative, EMD Serono has also launched 'Check My Meds', a smartphone app that will put the ability to verify medicines in the hands of EMD Serono's patients. The app is now available for free download in English on Apple's iOS and Android mobile phones.

"EMD Serono has been a long-standing leader in product integrity and patient safety, and we believe that every biopharmaceutical company has a responsibility to work toward a counterfeit-free drug supply in the US," explains Paris Panayiotopoulos, president and MD of EMD Serono.

"I am proud that EMD Serono is well ahead of the FDA's upcoming requirement that drug companies include a unique serial number on each package of drugs dispensed by 2017."

Through the serialisation initiative all major EMD Serono brands, which include therapies for multiple sclerosis, infertility, growth disorders and HIV-associated wasting, will have unique and randomised serial numbers that are generated and printed on each package during the production process.

"Counterfeit and compromised drugs have breached the US drug supply numerous times over the past decade," says Allan Coukell, senior director for health programmes at The Pew Charitable Trusts.

"By serialising medicines three years in advance of statutory requirements to do so, EMD Serono has taken steps to increase security of the drug supply chain and protect patients."

The Check My Meds app allows patients to check this serial number to verify the authenticity of their medication, and also link to mobile sites for EMD Serono's patient support and access programmes, including: MS LifeLines, Fertility LifeLines, The Axis Center and Connections for Growth.

The new requirements, put forward by the new serialisation legislation, were set out in the Drug Supply Chain Security Act (DSCSA), which was enacted on 27 November, 2013. The requirements of the DSCSA are enforced by the FDA.