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Safety in numbers

The serialisation of medicines packaging is becoming a reality, but there are hurdles to be overcome

A random selection of numbersAdding individual serial numbers to medicine packs can be a powerful weapon against counterfeiting and illegal diversion and momentum behind the approach is building.

The EU, US, China, India, Turkey and Brazil are all developing coding systems for medicines, largely based on unique pack identifiers, which are designed to provide some level of traceability and patient protection by making it harder for counterfeiters to inveigle products into the legitimate supply chain.

Should those plans alone come to fruition, more than half the world's population could be receiving medicines in serialised packages in the coming years. Those six regions alone also account for more than three-quarters of the global pharmaceutical market by value, according to 2009 figures from IMS Health.

So rather than being a nebulous, distant concept, serialisation of pharmaceuticals has progressed well beyond the pilot phase and looks destined to be a reality in many parts of the world.

The headline news at the moment is the adoption of the Directive on Falsified Medicines by the European Parliament (EP) in February 2011. This puts in place a requirement to add safety features such as serial numbers and tamper-evident seals to drug packaging, among a number of other measures designed to combat the trade in counterfeit finished medicines and ingredients.

Official communications from the EP indicate that safety features 'could for example include a serialisation number which can be 'read' by the pharmacy to ascertain that the pack is authentic'. While the Directive specifically uses the word traceability, it has been suggested that, rather than tracing product through the supply chain, patient safety can be largely achieved by simply adding a code during manufacturing which is then validated by the pharmacist at the dispensing point.

The adoption of the Directive is only the start of a long process. The legislation needs to be ratified by the EU Council of Ministers, and the European Commission will have to develop concrete guidelines to fit the somewhat vague and top-level language of the Directive.

Meanwhile, momentum is also starting to build again in the US, after dying away in the wake of the California Board of Pharmacy's decision to postpone its own deadline for an electronic pedigree system from 2011 to 2015. Pedigree involves passing traceability data in a cumulative fashion between the various actors in the supply chain, for example from manufacturer to wholesaler to pharmacy, so that a complete history of a product's journey is created on the fly.

Serialisation is a prerequisite for this kind of system and the US Food and Drug Administration took a big step towards a federally-backed system in March 2010 when it published its final guidance on the use of a serial numbering system to allow individual packs of prescription drugs to be identified, validated and authenticated, as well as allowing track-and-trace through the supply chain. The agency held a public meeting on the topic earlier in 2011 and is taking comments from stakeholders until April 2011. Additional public statements on its plans for serialisation and pedigree are expected over the coming months.

Elsewhere in the world serialisation initiatives are also moving on. Since the start of 2010 it has been mandatory in Turkey for pharmaceutical products there to carry a 2D datamatrix code identifying each individual medicine pack, which is scanned at the point of dispensing at the pharmacy to identify counterfeits and reduce reimbursement fraud. The next step will be to develop a system for exchanging data along the supply chain to allow full traceability.

China recently announced a plan to add a 20-digit linear barcode to packs of traditional Chinese medicine products, with each pack linked and associated with the shipping case and pallet. While details of the scheme are hard to find, particularly with regard to timeframes, expectations are that the coding system will be extended first to antibiotics and injectable medicines on China's essential drugs list, then to all products on the list and finally to all Chinese-made products over the next two to three years.

Earlier in 2011, India announced an ambitious scheme to add serial numbers to all exported medicines by July 1, via the printing of GS1-compliant 2D barcodes on primary packaging and 1D or 2D codes on secondary packaging. The government followed that in February 2011 with a requirement for the addition of serial numbers to the unit-pack level on all medicines destined for the domestic market. The unique identifier (UID) number will also be printed on the pack in a user-readable format so that it can be sent via text message to a centralised phone number for authentication.

Brazil is establishing a process too, with recently-passed law 11.903 requiring serialisation for all pharmaceuticals sold in the country by January 15, 2012. The law calls for serialised codes in a 2D datamatrix format which will be printed on self-adhesive security labels supplied by the Brazilian mint. The labels will contain authentication features such as micro fibres and coloured beads visible only under ultraviolet light. The aim is to have a full track-and-trace system in place for medicines within three years, although lobbying by the pharmaceutical industry could see the adhesive labels replaced with other approaches, such as inline printing.

Aside from these projects, there are other national initiatives already in existence which show the benefits of serialisation as a tool for medicine verification. Belgium has had a point-of-dispensing verification system in place for several years, which has shown its worth in preventing expired, short expiry and recalled products from being dispensed. Similar systems are also in place in Italy and Greece, while Spain, Germany, Switzerland, Japan, Korea and Serbia are also testing the feasibility of the approach.

Industry support
Governments around the world may have the difficult task of enshrining traceability within the legislature, but it is telling that the bigger players in the pharmaceutical industry are supporting the principles behind serialisation, not just in words but also in actions.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) carried out a serialisation pilot in 2010 which involved the addition of 2D datamatrix codes to around 100,000 medicine packs dispensed through 25 pharmacies in Sweden. Codes were added to the packs at production and read at the point-of-dispensing, the so-called 'bookend' approach that is favoured by most of EFPIA's membership as a way to ensure patient safety, without the additional expense of a full track-and-trace system. The pilot included 750 test packs, indicating product that had expired, was under recall or did not exist on the system and so was likely to be a fake, and the system highlighted them all.

Even before the pilot was planned and executed, many top-tier pharmaceutical companies, including AstraZeneca, GlaxoSmithKline and Novartis, were starting to adapt their packaging lines to accommodate coding. One driver was to reach conformity with France's CIP13 batch-level coding system, which many saw as a staging post on the path towards developing full serialisation. Introduced on January 1, 2011, CIP13 is based on a 2D datamatrix coding system, without serialisation, to allow each medicine pack to be easily scanned for data on batch number, expiry date and product identification number.

Wait-and-see approach
However, there are still many tier two and three drugmakers, as well as contract manufacturing organisations, which have yet to start the process, largely for fear of backing the wrong technology or standard and wasting limited resources. There seems to be some convergence around the use of the GS1 standards, with Europe, the US, India, Brazil and Turkey all converging around the use of coding based on GS1's Global Trade Identification Number (GTIN). However, questions remain about the feasibility of accommodating pre-existing national coding systems within the GTIN standard.

Companies that start late may find it difficult to find technology suppliers with capacity to carry out the pilots and validation studies required to implement serialisation. There are relatively few groups with the expertise and capability to ready a drug producer for serialisation and, given that a pilot can take several months to carry out, some manufacturers could find themselves struggling to meet regulatory mandates.

However, the general consensus is that serialisation alone is not enough to protect patients from counterfeit medicines. The codes themselves may be duplicated by counterfeiters, causing havoc if they can be quicker to market than the brand owner. Codes will have to be generated in a highly secure fashion to prevent removal, re-use or tampering and ideally used alongside other overt, covert and forensic authentication features to allow suspect products to be easily checked.

Of course, serialisation can lead to another set of problems. Few would argue that it will be important to have a ubiquitous, interoperable standard for codes, but the diversity of regulatory requirements may make this hard to achieve. Questions remain over who should pay for implementing the technology, the capacity of IT systems to deal with the huge volumes of transactional data and also who should serve as the custodian of the data.

Finally, of paramount concern is the security of the pedigree data and the IT systems in which it is carried. The criminals behind counterfeiting of medicines may decide that their best strategy is not to try to penetrate the system, merely break it and, as a result, undermine confidence in the entire system.

The Author
Phil Taylor
is a freelance journalist specialising in the pharmaceutical industry

To comment on this article, email pme@pmlive.com

3rd May 2011

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