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DSCSA's Jan 1 deadline is the immediate worry, says HDMA
The noisy revolution in pharma distribution activities is about to get even noisier as the Jan. 1 deadline approaches for having manufacturers and trading partners exchange data on shipments in a manner regulated by the 2013 Drug Quality and Supply Chain Security Act (DSCSA). However, there’s a strong feeling that 100% of manufacturers won’t be ready, and this creates the possibility that their wholesalers and distributors won’t be able to put products into commercial circulation as a result.
By contrast, some manufacturers are already finalizing their internal systems for the next step in traceability: tracking individual packages, which have been uniquely serialized, through the supply chain. Case in point: EMD Serono, which announced last week that it is already doing individual serialization for all four of its major brands: Serostim and Saizen (both somatropins); Rebif (interferon beta-1a); and Gonal-f (follitropin alpha). For many of its products, EMD Serono already has a limited-pharmacy network that it interacts with directly to ensure safe and appropriate dispensing. Serialization is carried out with 2D barcodes (and linear codes on cases). Layered on top of this is a new smartphone app, brandnamed Check My Meds, that allows patients to record and then authenticate their dosages with a central database maintained by EMD Serono.
Although such traceability has significant implications for supply chain visibility, Kimberly Fleming, associate director of product security and outbound logistics, says that Check My Meds is “data push, not data pull”—the company will not be collecting patient data such as locations or lookup frequency. Once a patient does perform the smartphone verification, there is an option to link into the company’s patient support services, but that’s at the patient’s option.
Meanwhile, the wholesaler community, led by the Healthcare Distribution Management Assn. (HDMA), is signaling growing worries over the Jan. 1 deadline. “There is concern among HDMA member distributors that the supply chain will not be 100 percent compliant with the DSCSA requirements on January 1, due to some legitimate products entering the supply chain without adequate transaction data,” it wrote in a letter to FDA in late November. HDMA urges the agency either to use “enforcement discretion” to allow the continued flow of products into commerce, or to provide additional guidance for what its members should do with undocumented product deliveries. (DSCSA requires certain transaction information at the lot level for shipments received after Jan. 1; the item-level traceability comes years later.)
As might be expected, traceability vendors are touting their increased level of activity among pharma clients. RfXcel (San Ramon, CA) says that its rfXchange trading network is operational with each of the Big Three wholesalers (McKesson, AmerisourceBergen and Cardinal Health), and that it has set up a “host” of wholesalers and distributors with “many” pharma clients. TraceLink (Woburn, MA) has made a similar announcement about the Big Three; it also claims that 50,000 organizations have signed onto its global data-exchange network, a first step to transmitting or receiving transaction information.
Both TraceLink and RfXcel offer cloud-based data management and transmission; others, such as Optel Vision, Roc-IT, Systech International, Axway, Acsis and International Business Systems offer on-premises solutions as well. The business is rapidly internationalizing (and, one could argue, that the US is merely playing catchup with the rest of the world); Optel opened an office in Ireland in November to serve European clients; Antares-Xyntek, a collaboration between those two companies, is touting its hundreds of implementations in Europe as it builds a US client base; and Aegate Ltd., a UK company that provides authentication in several European countries, says that it is negotiating an “envisaged protocol agreement” with the Ministry of Health of Italy to access a national drug-tracking database. It also claims that 90% of Italy’s pharmacies are already employing Aegate authentication technology.
Some of these companies provide machine-vision systems as well as software solutions for recording and transmitting transaction information; some are software only. Hardware-software collaborations between these companies as well as packaging-line component suppliers are also occurring. The chatter at an HDMA meeting held in mid-November was that only two-thirds to three-quarters of manufacturers would be ready on Jan. 1 (thus the concern by HDMA for undocumented product)—but right after that, US dispensers (pharmacies) are supposed to have their own data exchange in place by July 1. It’s going to be a bumpy ride.