Stephen Kemp is business development director at Brecon Pharmaceuticals.

Stephen Kemp

Counterfeiting continues to be a huge challenge affecting both branded and generic products, which, although a worldwide issue, is especially prominent in developing countries; some reports suggest that 80% of counterfeit products are now coming out of China. Regulatory authorities are already working hard to address these issues, and as soon as authorities find counterfeit medicines, they are destroyed. Some counterfeit packs may have packaging features that state "genuine product" or even have a hologram, regardless of whether or not this appears on the original product. Though the introduction of the Falsified Medicines Directive (FMD) in Europe aims to prevent falsified medicines from reaching patients, this won't help those who continue to self diagnose and source their own drugs via the internet, where there is currently little control. 

In terms of technology, although 2D data matrix and serialisation codes are both gaining momentum, it may be the case that we need a combination of approaches to fully safeguard the pharma supply chain in the future. This is a constantly evolving situation and one that we are monitoring closely. Brecon complies with what our clients wish to provide to their customers; we follow their guidelines and work in partnership with them to provide the most effective anti-counterfeiting solution. Common technologies employed are 2D data matrices, serialisation and covert or overt package features that are embedded into the graphic artwork, for example the use of micro text and micro characters that cannot be seen by the naked eye.  

Packaging can play an important role in the war against counterfeit medicines and it follows the old saying that "prevention is better than cure". So pharmaceutical packaging should offer features that both protect the product before it reaches the end user, as well as deterring counterfeiting. Unfortunately, forgers will always find a way to copy, which is the constant battle facing the industry. The Burgopak, for example, and our new AndersonBrecon compliance packs (IntuiDose) go a long way to deter counterfeiting because they are patented, so we know which products are packed in this format. Additionally, the equipment used is typically bespoke and not easy to replicate economically, which acts as another deterrent.  

Packaging design needs to be combined with ever-greater lines of traceability through the inclusion of effective coding and marking, whether that be the use of 2D data matrix codes, QR codes, or linear/numerical codes. In the US, for example, the approach to track and trace appears to favour a 'chain of provenance,' whereby drugs can be traced from manufacturer to distributor to retailer and patient. In Europe, under the new FMD, unique and random product coding will enable a drug to be authenticated by the manufacturer. 

The severity of the counterfeiting trade means that industry and regulatory bodies are investing constantly to introduce new ways to address counterfeiting. I'm sure that sometime in the future, there will be a more universal approach. However, in the meantime, with the introduction of the EU's Falsified Medicines Directive, which will need to be addressed by 2013, we are already seeing the foundations of a future unified approach across Europe. 

There is also one final question to consider. Has the decision by some pharmaceutical companies to take their production overseas helped to fuel the opportunity for counterfeiting? In my opinion, by retaining manufacturing in the UK, for example, and distributing products internationally, we can retain containment and traceability. If manufacturing is moved to China or other low-cost producing countries, it may open up other channels and access to techniques that allow counterfeiting to be used with little trace. Is it time to re-consider where manufacturing should be conducted? After all, a company's reputation and brand protection could be at stake. 

 is business development director at Brecon Pharmaceuticals.

Articles

Counterfeiting continues to be a huge challenge affecting both branded and generic products, which, although a worldwide issue, is especially prominent in developing countries.

What's on the Box?

Editor's Note: This article is part of a special feature on packaging that was published in the May issue of PTE Digital.

There are a number of points to consider where secondary packaging is concerned. In most cases, the secondary pack has to fulfil dual roles of product protection and product information; both of which are arguably more important in pharma compared with other industries because of the nature of the product. 

Product protection falls into two categories. The first is physical protection. Will the carton withstand physical shocks? Is it substantial enough to maintain integrity throughout the supply chain? The second category is brand protection, which has been at the top of the pharma industry's agenda for years. Anti-counterfeiting strategies, which may involve both covert and overt features, as well as item-level serialisation, can also influence many aspects of the packaging. 

On-pack product information strategies are often influenced by the category of the product (e.g., prescription only, OTC) and the relative importance of product branding. Needless to say, on-shelf appeal has a significant impact on the design of every aspect of OTC packaging! 

Common to all pharma products is the requirement for variable data, including batch/lot codes and expiry dates. Some countries also operate reimbursement schemes that require a specific label or vignette to be applied. Most legislation require variable data in human-readable format, but in future, as a result of the EU's Falsified Medicines Directive, data will also need to be incorporated in Data Matrix format for products to be sold within EU markets covered by the directive. 

Pharma manufacturers and their suppliers are used to complying with regulations, but this doesn't mean that regulations don't present challenges. One recent example is the need to incorporate Braille onto packaging, which became mandatory for new Marketing Authorisations in 2005. Since 30 October 2010, it has been mandatory for all packs to bear the product name and strength in Braille. Some manufacturers also use accessible media packaging that assists the visually impaired by speaking product information aloud. 

The Falsified Medicines Directive will also present challenges, with the industry potentially having to re-evaluate every stockkeeping unit to ensure that there is adequate space and an appropriate surface to apply the new information. 

Last but not least, child-resistant and senior-friendly strategies are increasingly in the spotlight. The ideal pack is one that, through a combination of cognitive and physical capabilities, allows ease of access for adults, but remains strictly off-limits for minors. 

A number of innovations can be seen in pharma packaging. Some boost brand profile or protect the brand by frustrating the counterfeiters. Others can boost product protection or enhance patient compliance. One example of a novel pack with multiple benefits is the walletstyle packs. In the competitive OTC arena, such packs are popular for their portability and branding opportunities. Many also offer high childresistant and seniorfriendly properties. Some innovations respond to more than one of these objectives. The Burgopak sliding blister pack, for example, was originally developed for its marketing appeal, but has subsequently proved to have substantial benefits in terms of improved patient compliance and child-resistant and senior-friendly properties. 

Environmental responsibility is also high on the list of pharma's priorities and often forms part of the supplier qualification process where new contracts are concerned. While regulations governing pharmaceutical packaging may seem to militate against radical changes, major steps have been taken in the area of greener packaging. For example, pharmaceuticals are required by law to accommodate certain patient information. Traditionally, this has been in the form of a leaflet that is folded and inserted into the carton. However, the use of leaflet labels means that for some presentations (notably bottles), the product information can actually be applied directly to the product, which makes the carton superfluous. This can radically reduce a product's carbon footprint. 

Another notable trend is the move away from recycled materials to virgin board. While this might seem counter-intuitive, virgin board has a significantly improved environmental impact compared with recycled materials because of improved handling and lower ink absorption. 

Pharmaceutical packaging is positive proof that regulation doesn't necessarily stifle innovation! 

There are a number of points to consider where secondary packaging is concerned.