Blockchain For Pharma Supply Chain
Drug counterfeiting is a well-recognized and documented problem that affects human lives, but also the reputation and ROI of the pharma industry. In the US, the FDA stepped in and enforced the Drug Supply Chain Security Act to protect consumers from counterfeit drugs. Internationally, there is the Global Traceability Standard for Healthcare (GTSH) that defines the process standard, explaining and establishing the minimum requirements for all stakeholders involved in the healthcare supply chain internationally. Yet, the full implementation of global traceability standards as a cohesive solution is still a work in progress.
Blockchain can prove to be an all-encompassing, world-wide solution that will seamlessly save lives and dollars in the future. The World Health Organization (WHO) estimates that 10% of medicines in low- and middle-income countries are counterfeit. Developing countries suffer the brunt of this and the most tragic casualties are children. For example, WHO reports that in Africa more than 100,000 lives are lost annually due to counterfeit drugs.
Preparing To Meet the November 2019 FDA's DSCSA Deadline
The pharmaceutical industry is making big strides when it comes to traceability, as the deadline to comply with the DSCSA inches closer. The Act requires pharmaceutical industry stakeholders including packagers, distributors, manufacturers and logistics providers to be able to track and trace a drug's progress along the supply chain, thereby reducing quality control errors and the prevalence of counterfeit drugs.
The DSCSA deadline is one of the most important milestones the pharmaceutical industry needs to meet. The Drug Quality and Security Act (DQSA) was enacted by Congress on November 27, 2013, in doing so amending the Federal Food, Drug, and Cosmetic Act to grant the Food and Drug Administration more authority to regulate and monitor the manufacturing of compounded drugs.
Title II of the bill, the Drug Supply Chain Security Act (DSCSA) is designed to establish requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain. It outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed. This will enhance the FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect consumers.
On November 27th 2019, the DSCSA VRS deadline is enacted. The wholesale industries must be compliant and only accept products that contain a serial number or product identifier, and they must verify this product identifier before they can go on to resell these goods. They must also be able to complete a validatable returns process.