Pharmacists respond favourably to EFPIA's serialisation pilot

Additional results from EFPIA's serialisation and point-of-dispensing verification pilot study in Sweden were unveiled at IQPC's Pharmaceutical Anticounterfeiting Conference in the Netherlands this week, including feedback from pharmacists who had used the system.

The end-to-end system - which involved adding a randomised, serialised 2D datamatrix code to more than 11,000 medicinal packs - ran for four months at 25 pharmacies in Sweden and ended a few weeks ago.

The codes were read in the pharmacy as the product was dispensed to the patient, allowing the pharmacist to check that a pack with that serial number has not been dispensed before. If it is already marked in the database as dispensed, the pharmacist is made aware of the possibility that the pack may be counterfeit and an alert is triggered. Scanning also provides an opportunity to check the product is still in shelf-life and has not been recalled.

230 pharmacists took part in the pilot, and 123 of them submitted feedback on the system. Of these 94 per cent said they found the verification system easy or very easy to use. 96 per cent felt that the additional effort required to make use of the system whilst dispensing products was acceptable or better.

Earlier reports had already revealed that the pilot was pretty robust in terms of read and response rates, with a 94 per cent successful read rate in less than 0.5 seconds, rising to 99.9 per cent in less than 2.0 seconds.

In the post-pilot survey, 85 per cent of pharmacists said they felt that the system was already fast enough, and it is likely that read times would improve in a full implementation.

Presenting the results at the Amsterdam meeting, Grant Courtney of GlaxoSmithKline, one of the participants in the pilot, stressed that the objective was not to prove the technology.

Rather, "we wanted to show that the approach was aligned to the EU pharmaceutical package, can be integrated into stakeholder operations and is a credible alternative to national governments adopting their own scheme," he told delegates.

As currently drafted, the EU's pharma package of proposals unveiled in December 2008 will require individual packs of prescription medicines to have covert, overt and forensic security features, tamper-evident seals and an individual identifier such as a serial number.

There were some exceptions recorded in the system, including 180 cases where the verification process picked up an incorrect serial number, 373 cases where packs were verified after having been marked as previously dispensed and 283 packs sold although already marked as dispensed.

One reason identified for the duplicates was occasions where a pharmacist took two packs of a product and scanned them, but the patient elected not to purchase or collect both of them. In these cases, the procedure would be for one pack to be checked back into the pharmacy's inventory system.

However, if the wrong pack was scanned back and subsequently dispensed it would fail verification because it would be marked already dispensed.

This sort of information is invaluable, according to Courtney.

"Understanding all the processes undertaken within the pharmacy is critical to ensure the system operates correctly," he said.

Other findings from the pilot and survey included that there were some instances in which the reader would scan the linear barcode, rather than the 2D datamatrix code, and get an error report.

The requirement to rescan was an irritation but could be solved easily by making sure there is only one barcode on the pack, according to Courtney. 

The pharmacists' feedback also revealed some interesting future requirements for such as system, for example they would have liked to see some more information provided by the system -  a description of the tablet colour and shape for example, or a photograph of the pack, blister or tablet.

The next steps for EFPIA in the wake of the pilot are to continue to push for a harmonised product coding system for Europe, promote the adoption of 2D datamatrix coding among the industry and encourage companies to commit to mass serialisation over an agreed period of time.

"Mass serialisation in Europe should be a reality over the next three to five years," said Courtney.


Related articles:

EFPIA updates on Swedish serialisation project at Pharmapack 

Public health sector weighs in on EU proposals 

EU Health Commissioner takes over pharma portfolio 

PGEU wants robust debate on safety features 

EFPIA updates on Swedish coding pilot