EU Drug Makers Tackle Traceability With Pharmacy Verification Pilot Project

The European Federation of Pharmaceutical Industries and Associations is spearheading a project to develop an end-to-end verification system for individual packages of medications.

EFPIA expects to begin a pilot test of the system by the end of 2008 in a region of one country. The specific location will be selected during a June 19-20 EFPIA meeting that will bring together industry executives, regulators, academics and consumer groups.

The trade group's initiative is taking place as the European Commission considers alternative approaches for protecting patients from counterfeit medicines. A number of stakeholders submitted comments in the past few months to the EC.

"There is essentially only one point where one really needs to know that the product is safe, that is ... when it is dispensed to the end user at the pharmacy or hospital," EFPIA says in its comments on the EC consultation on methods to combat fake or substandard pharmaceuticals (¹ (Also see "EC Considers API Regulation In Effort To Fight Counterfeit Drugs" - Pink Sheet, 28 Apr, 2008.), p. 24).

Verification by the pharmacist of each unit pack "provides the most adequate level of security" and avoids the need to develop a full-fledged tracing system, such as an electronic pedigree, which is "costly and difficult to implement."

Approach Relies on Mass Serialization

To enable end-to-end verification, EFPIA says individual drug packs should be coded with a unique, randomized serial number, plus a product code, expiration date and batch number. The randomized, serialized code would be generated by a highly secure algorithm.

By accessing a central database, EFPIA notes, pharmacists could verify that the data on each pack matches the manufacturer's record; the pack has not previously been recorded as dispensed; and there are no notices about recalls, expiration or other warnings, so it is safe to dispense the medicine.

This approach provides a "mechanism" for detecting the use of a duplicate code prior to proliferation of a potential problem, such as counterfeiting, the group contends. Counterfeiters would gain little benefit from "putting one copy of a unique code on one individual counterfeited pack, which would need to beat the original pack to the pharmacy counter."

To demonstrate the feasibility of end-to-end verification, EFPIA is working with GS1, a non-profit standards organization, to set up the pilot test. GS1 has formed GS1 Healthcare, which includes representatives from throughout the pharmaceutical supply chain, to assist with the project.

Currently, the pilot test plans call for participation by 200 pharmacy outlets, coding of up to one million packs, and use of a single, hosted server system.

Eventually, EFPIA hopes to extend the system throughout the country where the pilot is conducted and then phase it in nation by nation in Europe. The full phase-in would take an estimated five years.

According to GS1 Healthcare comments to the EC, mass serialization of medicines "should work in a similar way as the validity check for payments with credit cards."

The EFPIA coding system is based on the GS1 open standard and the Data Matrix code ECC200. The GS1 standard provides the architecture for mass serialization, the group says. This architecture includes identification keys, communications standards and standardized symbologies for automatic identification.

GS1 Healthcare reports that its members have agreed on a roadmap for developing automatic identification and data capture application standards for their industry. A team has been formed to develop tools to meet traceability requirements around the world, including US pedigree regulations and future EU requirements.

The European approach of industry players working together on a tracing model contrasts with the U.S., where there is more emphasis at the moment on government standard setting (see ² (Also see "RFID’s Possible Interaction With Biologics Queried By Biogen, Pfizer" - Pink Sheet, 16 Jun, 2008.)).

The European Association of Full-Line Wholesalers supports the pilot test in its comments on the EC consultation. This is a "realistic approach" that considers current technical feasibility and cost."

"Today, there is no technology on the market which allows the automatic scanning of every pack of medicine" at the wholesale level, the group explains. RFID holds promise for the future, but "it has presently proven not to be a technology mature enough to be embraced in the short run" because of inaccuracy in reading aluminum, glass and/or liquids, which could be altered.

Once traceability technology does become available, the wholesalers caution, it "will require significant investment and increase the costs of medicines distribution," and there will be a significant decrease in the speed of commissioning and delivery in warehouses.

Pharmacy authentication of individual medicine packets would be an effective means of finding counterfeits, the Pharmaceutical Group of the European Union agrees. Such a system already is being pilot tested in Greece and Belgium, separately from the EFPIA project, the group notes.

Several issues need to be resolved, including the practicalities for pharmacy workflow, the cost and who owns the sales data that would be generated, PGEU says. A full medicines pedigree "is desirable in theory, but on a Europe-wide scale, simply unrealizable in the near future given the very substantial costs involved."

On an individual company level, Bristol-Myers Squibb is hesitant about mass serialization because that technology "is still evolving for real-world practice." Johnson & Johnson suggests that use of serial numbers be phased in, first for widely counterfeited medicines, followed by life-saving drugs and then for all other medications.

EGA Says Know Your Partners

Neither unique numbers on individual medicine packs nor a pedigree will thwart counterfeiting, the European Generic medicines Association contends in its comments to the EC.

"Business between certified/licensed partners only is the answer to stopping counterfeiting," it states. While tracking and tracing a specific pack may be possible, EGA notes, such an approach "does not secure all the possible links in the supply chain or stop the counterfeited pack from reaching the patient." And the additional costs would be "damaging to the competitiveness and sustainability of generic medicines companies."

- Cathy Dombrowski ([email protected])