The need to improve transparency for pharmaceutical supply chains has been the subject of ongoing debate in the U.S., but little action. That could be changing if California and Florida are any indication of where the wind is blowing.
Florida has passed legislation to deal with counterfeit risk posed by secondary wholesalers in the state, which has a big retiree demographic. It tracks drugs by lot number. California has also passed legislation set to go into effect in 2015.
GHX, a healthcare supply chain specialist in Louisville, Colorado recently tested its track-and-trace technology in a pilot with Abbot Laboratories, McKesson and the Veterans Health Administration. Margot Drees is executive director of global strategy with GHX. She told MedCity News that the pilot would evaluate two things: how onerous would it be to implement a track-and-trace system industry-wide and is it doable? The pilot is testing the ability to scan serial numbers to identify a product that was recalled midshipment. The first part used one product line and was deemed successful, but the next phase will add another layer of complexity by using a mixed batch of products.
The U.S. Department of Veterans Affairs’ mail-order pharmaceutical division, CMOP, agreed to participate in the trial because of its experience with pharmaceutical supply chain, data capture capabilities and the high volumes it is accustomed to working with. The division uses RFID scanning along with bar code scanning as quality assurance mechanisms, according to documents from the VA.
The California legislation for prescription drug pedigrees requires “an electronic interoperable system”. It specifies that individual units must be identified and tracked from the manufacturer through to the point at which the product enters the dispensary (track and trace), said Drees.
The electronic record would contain information for each transaction, each change of ownership in the supply chain from the manufacturer to the wholesaler to the pharmacies.
The proposed federal law calls for a system that can do lot-level tracking in which serial numbers are published by the manufacturer and checked at the point they’re dispensed, referred to as the authentication model, said Drees. The language is still being hammered out, though. Although it gives guidance on the data carriers, it doesn’t call for a system like GHX.
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.
Various companies have developed technology that allows consumers to key in a number and send a text message with a mobile phone to determine an over-the-counter product’s legitimacy. There has been resistance against implementing an industry-wide system because of its perceived high cost and the complexities of establishing an industry standard.
