California Board of Pharmacy hears comments on unique IDs

The California Board of Pharmacy (CBP) held a public meeting on December 13 to discuss feedback on amendments to its electronic pedigree (ePedigree) requirements.

All told the CBP received six comments on the amendment which focused on the addition of a new article (5.5) on pedigree requirements, namely the use of unique identification numbers for medicine packs. The supporting materials for the meeting can be downloaded here.

Article 5.5 is the first of the proposed regulations that will be needed to allow implementation of the ePedigree system by the deadline of January 1, 2015, and is an attempt to bring California's ePedigree requirements into line with the US FDA's 2010 guidance on standardised numerical identifiers (SNIs).

The FDA guidance calls for the use of a National Drug Code (NDC) combined with a unique numeric or alphanumeric serial number.

The amendment also explains how to calculate the percentage of their product that is serialised - 50 per cent is the 2015 target with 100 per cent serialisation mandated a year later - and covers grandfathering - a process for dealing with the medicines still on pharmacy shelves that were shipped before the implementation deadlines.  

A comment from a Johnson & Johnson representative, asked for clarification that this should be placed on the "smallest unit of sale", in other words the pack rather than for example blisters contained within it, and suggested changes to the language to emphasise this.

Concerns were also raised about the potential for pharmacists to find themselves at risk of criminal charges in cases of human error according to the current wording, and also whether there would be an appeals process in the event of any failure to comply with the requirements.

One written comment on the proposals - from Optel Vision - suggested that previous CBP documents indicate that the identifier should be a GS1-compliant Global Trade Item Number (GTIN) plus a serial number, although this interpretation was questioned by the Board.

Optel added out that NDCs can be embedded within GTINs anyway and noted that that the NDC is not fully compatible with the GS1-standard 2D datamatrix codes employed by many drugmakers in their serialisation initiatives.

Other commentators called for a more thorough assessment to gauge the economic impact of the ePedigree amid concern that pedigree increases complexity and cost over rival medicine tracking and verification models, and warned against the potential for disparate state-level requirements that would further complicate matters.

A webcast of the meeting is can be viewed below: The section on pedigree can be viewed from around 27 minutes into the video.