Pharmacy group taps rfXcel to meet DSCSA compliance

Serialisation specialist rfXcel has won a contract to help pharmacies across the northern Nevada healthcare network comply with upcoming US regulations on medicines traceability.

The Antares Vision Group company will work with Renown Health Foundation to implement the IT platforms needed so that pharmacies in the network can track and trace pharmaceuticals in compliance with the Drug Supply Chain Security Act (DSCSA), which is due to come into full force in November.

For November 27, trading partners in the medicines supply chain will have to add serialised pharma product data to the transactional information already being provided when medicine within the scope of the legislation changes ownership.

Once it is fully implemented, the DSCSA should help to ensure that US patients are protected from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.

With the DSCSA less than nine months away, there are already warning signs that all the actors in the supply chain – from manufacturers to dispensers – may not be ready in time, which could raise the prospect of supply chain disruptions and potentially even product shortages.

A lot of smaller medicine producers have yet to reach the stage when they can send serialisation data as needed to distributors, for example, according to comments filed with the FDA last month by the Healthcare Distribution Alliance (HDA), which said it is expecting stakeholders to request enforcement discretion beyond the November 27 deadline.

For dispensers, the item-level traceability requirements that will come into play are a leap forward on their current lot-level requirements, that have been in effect since 2015. They will have to store and exchange serialised transaction data, carry out product verification and tracing, whilst ensuring all their trading partners are authorised and credentialed.

“Ensuring our patient’s medications are safe and legitimate is of the upmost importance to us,” said Renown’s head of pharmacy services Adam Porath.

“When members of our community get involved in our work, it brings us all closer together. We are thankful that Antares Vision Group and rfxcel are partnering with us on our healing mission. They are making it possible for us to keep our patients safe, comply with the demanding DSCSA requirements, and respond quickly to changing supply chain requirements.”