Stopping the counterfeiters

With the World Health Organization reporting that up to ten percent of pharmaceuticals in Europe and the US may be counterfeit, Carol Houghton asks what the industry is doing to protect consumers

Sales in the global pharmaceutical market more than doubled between 2000 and 2009. The Latin American and Asian markets have seen the strongest growth, pushing Europe’s share in 2009 to third place at 31 percent. The American pharmaceutical industry remains the biggest in the world, with sales of around $250bn. It has a 37 percent share – the world’s biggest single market.

Some of the fastest growing Asian markets are China, Malaysia, South Korea and Indonesia, where a rise in disposable income has prompted intense competition amongst pharmaceutical companies and seen the emergence of health insurance schemes supporting sales of branded drugs.

China in particular has seen a huge growth in infrastructure and technology and is expected to contribute 21 percent of overall global growth through 2013. Meanwhile, Srikant Kumar Jena, India’s minister for chemicals and fertilizers, claims his country is the third largest producer of pharmaceuticals globally.

Choosing converters

A clinical label with added security and information features can account for as much as 30 percent of the total packaging cost for a pharmaceutical product, while the majority of labels account for between five to ten percent.

Pharmaceutical packaging buyers have to consider a wide range of factors apart from print quality when choosing a label supplier: experience in the sector, product quality and consistency, price, reliability, security, waste handling, financial stability and production and management strengths. Manufacturers tend to use two or three label suppliers to reduce the risk of supply failure and generally use local or regional businesses to ensure security and quicker supply. These may be independent converters, or regional arms of global converting groups. Converters need the capacity to react quickly and provide technical support. A long-term relationship is also desirable. Specifications are generally longstanding and the end users rarely desire change.

Manufacturers have many packaging requirements, including the outer box, leaflets and blister packaging. Blisters are made of aluminum and usually heat-sealed. The foil must be printed with the ingredients, expiry date and check code while the material is on the roll. A key trend is for converters, or converting groups, to offer all or most of these product components.

Converters in this sector need to be specialists in tamper-evidence and barcode-driven Track and Trace label systems. ‘From haematology samples through to biochemistry departments, the need for 100 percent verified barcoded labels in the pharma sector is paramount,’ says Dr Adrian Steele, MD, Mercian Labels Group, which recently acquired variable barcode pharmaceutical label specialist AC Labels.  Steele says the labels they produce are normally multi-part with multiple colored bands associated with different departments within each hospital. They are supplied to the end user’s specific requirements on rolls, sheets or fan folded sheets.

Glemser Technologies is a specialist in creating software which France leads the way automates the submission of label content to the appropriate regulatory authorities. The company is familiar with the range of hurdles faced by pharmaceutical and medical device companies – particularly the complexity involved in interacting with multiple health authorities. In addition, label content has to be printed in multiple languages and adjusted to meet local format and classification requirements. Other challenges include ensuring that changes to core data on all labeling documents and translations are implemented, erasing redundant product information.

Jan De Roeck, director of solutions management, EskoArtwork, says this means the packaging production workflow is no longer isolated from the rest of the pharma product lifecycle. ‘A strong integration of the packaging assets and production processes with existing product lifecycle management guarantees a consistent brand message and ultimately contributes positively to the business goals of the pharma industry. Tangible benefits are reaped when automating repetitive and mundane tasks of the pre-production workflow and when managing the digital approval online.’

A significant trend is late-stage customization – implementing coding and marking at the latest possible stage in the production process, including instructions product details, disclaimers and expiry dates, as well as machine readable data like 2D matrix codes and production data. This is an area where digital printing is having a major impact on the industry.

Anti-counterfeiting

Counterfeiters generally sell a low quality product masquerading as a known brand. Their products are distributed through networks of under-regulated wholesalers and re-packagers in the supply chain, internet pharmacies and illegal imports. The counterfeit market is particularly ferocious in the rapidly growing online sales of prescription products.

The counterfeit supply chain reacts quickly to opportunities and weaknesses in the legitimate production and supply of pharmaceutical products. The World Health Organization (WHO) estimates up to 25 percent of medicines in developing countries are counterfeit and that annual earnings from global sales of substandard medicines are more than $32 billion.

The situation may well be getting worse. A joint survey by the International Pharmaceutical Federation (FIP) and Pfizer revealed that 63 percent of 2,000 community, retail and hospital pharmacists in Europe, the US and Australia believe current policies and technology are insufficient in dealing with counterfeit medicines.

Serialization offers another way to protect against counterfeiters, but even here there are dangers. Unique serial numbers are traditionally sequential but this is predictable and easily copied. Even randomization presents the possibility of repeated numbers, compromising reliability.

Generating and managing serialization demands proper organization at the corporate level. Data must be strictly controlled and protected, and after high-speed printing and code verification, codes must be easily but securely retrievable. Traditionally, pharmaceutical companies viewed serialization as a packaging supplier responsibility, but it is now accepted that it needs to be driven by corporate IT systems.

A key trend is to produce multi-layered anti-counterfeit systems. Ian Lancaster, general secretary of the Institute of Healthcare Management (IHM) believes multi-layered holograms have a key role in protecting patients’ safety because of their ability to combine authentication with covert, forensic and track-and-track elements when used as seals, labels or as the foil on blister packs.

Also widely used are destructible films, fluorescent fibers and security inks. RFID is used, although there remain some performance issues and the need for a complex infrastructure. Inkjet specialist Atlantic Zeiser, for example, offers systems for direct package printing and as well as RFID label systems as anti-counterfeit measures. The company’s strategy involves incorporating these systems into late customization solutions.

The self-adhesive labels sector has generated some ground-breaking innovations. Schreiner ProSecure, for example, has developed a system of magnetically encoded thin threads, which are inserted between the adhesive and backing paper of a pressure sensitive label. FluxSecure elements have a diameter of about 30 micrometers and are built from a metal alloy mixture surrounded by a glass coating. The magnetic properties of the authentication feature can be read without line of sight using a handheld reader or sensor that generates a magnetic field, so products can be verified through heavy and metallic packaging.

At the same time as anti-counterfeit technology develops, organizations such as GS1 and EPC Global are helping to define standards to create a globally coherent track and trace strategy. GS1 standards use a unique set of identification numbers for products, companies, locations, services, assets, logistics units or customers and will affect the supply chain from manufacture through to the pharmacy.

France leads the way

The European Parliament passed a directive in February compelling pharma companies to print security codes on every product’s packaging in the EU from 2013, making them traceable and, in theory, harder to counterfeit. This will require an investment of up to 10billion euro, primarily to modify production processes and invest in coding and Track and Trace systems. Digital printing and its integrated verification modules will also play a part.

The European Federation of Pharmaceutical Industries and Associations agrees that 2D coding is a technology that will help protect patients against counterfeit drugs. And Gallus CEO Klaus Bachstein, speaking at the recent Brazil Label Summit (see p.88), said this represents a major opportunity for label converters to add value to services offered to pharma end users.

France has been a pioneer in legislating for such systems. Since 1 January 2011 all production lines in France must contain the new CIP 13 standarized GS1 code, a batch number and expiry date. The rest of the world is expected to adopt similar measures, meaning all medical products will be labeled with a GS1 data matrix 2D barcode. France’s healthcare minister Valérie Marchand believes the cost of implementing 2D barcodes means most manufacturers will only begin using it if it is made law.

The main barrier is the lack of space to add new labeling equipment to production lines, posing problems such as multiplication of interfaces and system communication issues. Labeling systems manufacturers have produced solutions to meet these requirements, with Avery Dennison, for example, adding a dedicated data matrix module to its AVL labeler.

Frédéric Lemaire, Southern Europe manager for Avery Dennison’s major accounts, states, ‘Establishing an effective medicine traceability system is a major challenge for pharmaceutical companies. France is the first country to standardize the use of data matrix codes, but it is a regulation that will ultimately become the standard worldwide.’

Verification of these codes is emerging as a key area for technical development.  Auto ID solutions provider Fairfield Group, for example, recently launched a multi-scan system which identifies 1D, 2D and pharmacodes in one scan. Mark Lynch, Fairfield’s managing director says; ‘This solution enables clients to read any valid current code, without having to change scanners, saving masses of time and effort.’

Dr Adrian Steele, MD, Mercian Labels Group says that poorly printed barcodes which get through to the end user will cause delays in testing laboratories and in the worst case could have life threatening consequences. ‘All our materials go through on-site testing to ensure their suitability in the differing environments throughout different hospital’s departments,’ says Steele. ‘In our experience all barcodes printed for pharma labeling applications need to be 100 percent scanned for verification during the printing process and again batch tested to ASCI standards during the rewind and packing process.’

AVT’s marketing manager, Guy Yogev confirms a growing demand from pharmaceutical printers to decode and verify barcodes and variable codes as a direct demand from the pharma companies. ‘Our Helios II is able to verify and grade all of these codes (1D codes, 2D codes, running numbers), compare them to a known database and alert for any duplication, missing codes, corrupted codes, etc – all in parallel to the regular print inspection.’ Job verification is carried out against a PDF file.

The fight against counterfeiters as well as to reduce costs and achieve 100 percent labeling accuracy involves the label converter as a key component in the pharma production, logistics and distribution chain. As such, there remain great opportunities to sell added value services and move further away from selling on price. In this market it is value, expertise and integrity that is valued by end users above all else. 

Secure waste

A key GMP (Good Manufacturing Practice) requirement for pharma label converters is the ability to handle and dispose of waste securely. Every detail of the operation is tracked and labels must be stored securely. Printed labels are sent from press to inspection in a secure container, one per order. After inspection, the labels are packed into a secured, wire-bound cage system, cleared via a check-in, check-out system, signed and dated by two people. After job completion, all material is removed from the press area. Printing plates are stripped from the print cylinders and work orders are packed in a security box, with printed copy, to go to rewind and quality control check. 

Performance requirements

Labels need to adhere firmly to the wide range of container types used in the pharma industry. There are distinct requirements for blood bags and non-migration adhesives for thin-walled containers which might also require sterilization. UPM Raflatac, for example, recently launched RP 31 Purus non-migration adhesive for labels applied to liquid filled low density polyethylene (LDPE) containers used for squeezable nose and eye drop containers. 

Over the counter

Over-the-counter (OTC) is a fast-growing market for non-prescription pharma products. The sector increasingly utilizes the branding power of both PS and shrink sleeve labels, which have built-in security features and advanced graphics. Blister packaging is increasingly being used instead of labeled rigid containers.

Regulations introduced in 2002 required over-the-counter drug packages to display more information in a standard format and minimum font sizes to make it easier for consumers to read, leading to a trend for extended content labels and peel-able self-adhesive booklet labels.

Selling through large retailers presents new challenges for pharmaceutical companies. Brands need to attract the consumer’s attention and as image and price have the greatest impact on the buying decision, manufacturers are choosing more colorful and elaborate designs to stand out from competitors. The difficulty is in producing a label which displays the required information and promotes the brand cost-effectively. Packaging has to be tamper resistant but easy to open while innovative graphics have to support the brand’s identity.

Pictured: Blood bag with multiple variable barcode labels

This article was published in L&L issue 3, 2011