Nearly four years ago, Congress passed legislation called the Drug Supply Chain Security Act to counter the worldwide problem of fake drugs. About 10 percent of drugs worldwide are counterfeit, according to data from the World Health Organization. Several components of the law will be phased in over several years. By November this year, electronic reporting of transaction information, history and statements is required for all manufacturers, according to data from Pillsbury Winthrop Shaw Pittman.
Several technology companies have developed products to protect the pharmaceutical supply chain and support track and trace technology so counterfeit drugs can be easily spotted and identified.
The Forerunner Group worked with a healthcare system to develop the RxTransparent Compliance platform for pharmaceutical dispensers. The health IT startup, which was profiled in The Philadephia Inquirer last month, has put together a database of pharmaceuticals regulated by the U.S. Food and Drug Administration. The database is updated monthly from different online sources, according to the company’s website. The cloud-based platform validates input and makes corrections automatically. NDC numbers are validated as well.
The company’s customers include hospitals and health systems, the article noted. A contract with the company typically lasts three years at $5,000 a year. Forerunner expects to raise $10 million in a Series A round later this year and will use part of the funding to add 36 positions, the article said. Among other applications of interest for Forerunner are drug shortage notification and medical research.
The technology that supports Bitcoin is also being enlisted to address security of the drug supply chain. Blockchain Health is working with pharmaceutical companies to help meet the regulatory burden that the Drug Supply Chain Security Act will bring. The idea is to make it possible to track the source of all the components that go into a pharmaceutical product, not just the drug itself.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Other technology companies pursuing their own drug security software solutions are TraceLink and Kit Check, among others.
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