Survey sets scene for serialisation roll-out in US

A survey of stakeholders has found that costs, data standards and aggregation are the main concerns for stakeholders facing the Drug Quality and Security Act (DQSA).

The system, which will be phased in over 10 years, requires pharmaceutical manufacturers to place a unique serial number on individual packages of prescription drugs, allowing each to be authenticated and electronically traced as it moves from the manufacturer to the wholesaler to the pharmacy.

Unsurprisingly, a uniform approach to storing and transmitting transaction data - which was not defined in the DQSA but has been left to the FDA to develop - is causing some anxieties among the respondents to the survey, which was carried out by Booz Allen Hamilton and the Pew Charitable Trusts.

A recent blog post by FDA's Ilisa Bernstein, Deputy Director of the Office of Compliance in the agency's Center for Drug Evaluation and Research (CDER) recognises that concern.

"We are working now to develop standards for this new system and we can’t do it alone," she notes. "Stakeholders - including drug manufacturers, wholesaler distributors, repackagers, and many dispensers (mainly retail and hospital pharmacies) - will be working with us.

The ultimate goal is to identify each individual prescription drug package in a way that will enable rapid and accurate verification of the legitimacy of a product, including a history of the transactions involving it. The FDA s holding an open meeting later this week to discuss the standards.

Time is of the essence because the law requires FDA to issue a draft guidance document with initial standards by November 27, 2014, and for many stakeholders to establish systems and processes that will enable them to comply by January 1, 2015, notes Bernstein.

Another key concern voiced by respondents to the survey (which was actually conducted before the legislation was passed) was the technology required aggregation and inference - the ability to infer the contents of a shipping crate without opening it. The DQSA says this should be the subject of "pilot programmes and public meetings to inform the interoperable, electronic unit-level system launching in 2023."

Meanwhile, among the positive findings of the survey was that manufacturers have already started making large technology investments in anticipation of the new system, with many already implementing serialisation programmes.

"Many stakeholders perceived that the cost of implementation might be a challenge; however, estimates for implementing a system ranged widely across and within supply chain sectors," says the report, which notes that there is a lot of variation among wholesalers' estimates suggesting "their costs are not as well understood as manufacturers' costs."

Meanwhile, almost two thirds of pharmacies responding to the questionnaire indicated they do not currently have implementation plans in place, although the report notes this likely reflects the staggered roll-out of the DQSA traceability requirements and the fact that the FDA still has to commission an independent study to assess costs borne by pharmacies.