Concerns with falsified medicines extend to where drugs which are targeted at those who are seriously ill. These types of medicines may be contaminated or they can contain the wrong ingredient or no active ingredient at all. Alternatively, the drugs may have the right active ingredient but at the wrong dose. In other words, such medicines may harm the patient or exert no beneficial effect at all.
The rise in counterfeit medicines is linked to a general increase in the number of people using the Internet to purchase commodities and this includes those using the Internet to self-diagnose and self-prescribe. This practice can lead to people purchasing ineffective medicines; medicines that normally require a prescription; or purchasing what they think are legitimate medicines but which are in fact fake.
For many years regulators, such as the U.S. Food and Drug Administration (FDA), Health Canada and the European Medicines Agency have taken measures to prevent counterfeit medicines from entering the drug supply chain (see Digital Journal’s earlier coverage of such efforts “Europe acts against falsified medicines“). One such example of a practice designed to reduce counterfeiting is by implementing product serialization. Serialization requires a comprehensive system to track and trace the passage of prescription drugs through the entire supply chain.
An alternative, based on digital technology, could be blockchain. “Blocks” on the blockchain are made up of digital pieces of information, which store information about transactions, say the date, time, and transaction price. Blocks also store information about who is participating in transactions, and information that distinguishes the block from other blocks. The system is designed to provide transparency and security.
In theory, with a pharmaceutical blockchain it would be impossible to tamper with a medicine or to swap legitimate medicines with fake medicines. In addition, someone purchasing a medicine would be able to assess where the medicine came from (that is, did it come from a bona fide manufacturer?)
It is for this reason that the U.S. FDA is examining the potential for blockchain, as Engadget reports. The federal agency has as begun a pilot program that enables the drug supply chain explore ways to track prescription medicine.
According to the FDA, blockchain will enable the “use of innovative and emerging approaches for enhanced tracing and verification of prescription drugs in the U.S. to ensure suspect and illegitimate products do not enter the supply chain.”
Pharmaceutical companies have until March 11, 2019 to apply. The pilot will not produce actionable results until 2023. In the meantime, more conventional methods for seeking to eliminate counterfeit medicines will have to suffice.
