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Pharmaceutical Manufacturing and Packing Sourcer

Keeping Track

Protecting the pharmaceutical supply chain is a continuous challenge. Recent tragic news – such as the deaths of over 500 children after ingesting paracetamol containing renal toxins – highlights the industry’s continued vulnerability to counterfeiting (1). Dispensing errors, reimbursement issues and increasing cases of counterfeits in the supply chain illustrate the need to establish an effective process for identifying each individual medication pack. Simply put, the industry has a moral and ethical responsibility to protect people from falsified products that can harm or kill them.

Stark Reality


Counterfeits that flood the pharma supply chain every day may typically contain products with incorrect ingredients, reduced levels or no active drug, or – in some cases – a completely different drug. The results pose serious threats to patient safety and can even be fatal. Unfortunately, there is a history of mortalities as a result of counterfeit drugs. In Canada, one fatality resulted from taking fake sleeping pills purchased on the internet, which were later determined to contain a lethal mix of dangerous metals, including uranium. Alarmingly, this is just one example of many cases over the last decade which have seen counterfeit products leading to death, with developing countries particularly vulnerable to such events.

The health risk of false products to already immune-compromised patients under treatment is obvious. The high-profile case in the US involving a counterfeit version of Avastin (bevacizumab) illustrates these dangers; Avastin is used to treat various forms of cancer, typically used by vulnerable individuals undergoing chemotherapy. Over the past few years, various incidents have been reported by the Food and Drug Administration (FDA) regarding counterfeit Avastin with little or no active ingredient. Nineteen medical practices in the US were affected, resulting in patients not receiving the required therapy. This is a stark warning to healthcare professionals and patients in the developed world, where there is a perception that counterfeit medicines are a ‘rest of the world’ issue.

The World Health Organization estimates that counterfeit drugs are present in approximately one per cent of the supply chain in developed countries, rising to 30-40 per cent in developing countries. While one per cent seems a small amount, it constitutes millions of prescriptions in the US alone – which has a market of 246 million prescriptions per year – further emphasising the threat to the wellbeing of patients on a global scale (2,3).

The pharma industry knows it must avoid becoming complacent about the continuous threat from counterfeiters. The worldwide strategy for this ongoing fight must be dynamic and adaptable to ensure anti-counterfeiting measures remain one step ahead of criminals. There is now a call for a united effort to clamp down on counterfeit products by developing methods that reliably track and trace prescription drugs (4). With millions of pharma products being transported and sold globally each year, the supply chain is becoming increasingly complex, with over 35 individual sets of regulations. As a result, there is an increasing lack of transparency and greater challenges in providing a full genealogy of medicines in the market. To improve traceability within the industry, there is now a call for a standardised identification solution to be established by regulatory bodies, wholesalers and retailers. Both pharma companies and worldwide governments believe that counterfeiting by organised crime can be significantly reduced by implementing anti-counterfeiting strategies, of which improved traceability is just one element (3). Only by utilising strategies incorporating a coordinated mix of anti-counterfeiting tactics can the industry hope to combat this worldwide menace.

Anti-Counterfeiting Tactics

In order to protect public health, including the relationship of trust between patients and pharma suppliers, the whole supply chain needs to be cohesive and united in its effort to combat counterfeiting. The international scale of the pharma industry means the progress of regulation has become complicated, with the fragmentation of regulatory compliance across multiple geographies evident in all areas. This in itself is not a problem, as long as variations within the industry can be coordinated to establish continuity in the existing supply chain, minimising opportunities for counterfeits to enter legitimate channels.

Some regulatory changes currently taking place will have an impact on manufacturing and quality control departments, with responsibility falling to businesses to ensure that they are fully compliant with industry processes. Information technology departments will play an increasing role in packaging operations with the adoption of serialisation methodologies.

Track and Trace


Track and trace is the system by which codes and transactions are systematically followed for drug products through the supply chain, from manufacturer to patient. Track and trace systems exist in various authentication methods, monitoring and controlling processes that effectively regulate medicines. The benefit of using serial numbers is that they can be tracked throughout the supply chain, successfully pinpointing a product’s point of entry. Track and trace solutions need to accommodate different manufacturing sites and technologies, regulatory regimes and product requirements. Within track and trace, there are two anti-counterfeiting subdivisions relating to the product pedigree system and packaging serialisation.

Currently, the pedigree or history of every product is captured and kept on file by supply chain participants, albeit inconsistently, across global markets and distribution channels with varying standards. At every transfer of ownership, the transaction is documented and added to the product’s file. This is currently carried out at a lot/batch level and includes manufacturer-towholesaler, wholesaler-to-pharmacy (or hospital) and pharmacy-to-patient transfers – plus any intermediate sales. However, individual pack supply chain history is not recorded as a standard regulatory procedure.

Within serialisation, the absence of a standardised system in Europe has resulted in many countries developing their own individual processes. The concern here is that these systems all vary in terms of the content of each code, through to its physical placement; meaning that the lack of a coherent approach to verifying scanned barcodes on pharma packaging has undoubtedly contributed to the growing problem of counterfeiting and endangerment of patients.

In an ongoing serialisation system, at the time of packaging every pack should have a unique identifier applied, which may include human readable code, barcodes, radio frequency identification (RFID) tags, or a combination thereof. Currently, regulations within the industry on the recording of these codes within the product pedigree are yet to be defined.

The Move to Serialisation

A serialisation system where unique barcodes are included on product packaging – verified at the point of dispensing – would significantly improve the ability to track pharma products internationally. Ultimately, serialisation technology provides the ideal solution to enhancing efficiency in the supply chain, reducing theft and counterfeit products, and allowing manufacturers, distributors, retailers, pharmacies and end-users to ensure compliance with industry regulations. Flexible and customisable serialisation solutions can be provided to meet customers’ specific needs and can be easily integrated into existing manufacturing lines to ensure minimum disruption.

Following the successful trial of a point of dispensing verification system in Sweden, the European Union (EU) is currently implementing a coding system that will combat counterfeiting through unique identifiers on each product. In a July 2011 report on the Falsified Medicines Directive, it was noted that the introduction of anti-counterfeiting measures throughout the pharma supply chain should not be a preference, but a requirement. The report stated that by January 2013, EU members were required to adopt the specified measures, with pharma companies to be fully compliant with these requirements by 2017 in order to trade within the EU.

As it stands, serialisation regulations are in place in Turkey, India, China, Brazil, Argentina and South Korea, with regulations pending in Canada and the EU. Most recently, the US House of Representatives has approved legislation to establish a track and trace system throughout the pharma supply chain to provide a traceable pedigree for drug products (of which serialisation plays a key role). The challenge here is that each nation or state follows its own guidelines and motivations to prevent counterfeiting and safeguard patients – such as California’s e-pedigree law, or the differing serialisation guidelines of the FDA, Turkey and the Chinese State Food and Drug Administration. In spite of these varying laws, the pharma industry can take comfort in the fact that the majority of regulations are built around GS1 standards; this means that by using unique numbers, pharma companies can develop one program that sufficiently meets all global requirements, making the reliable identification of products and assets possible.

Successful Systems

One serialisation system already in place and proving successful in the fight against counterfeiting is an end-to-end, point-of-dispense identification solution which uses a unique code on each pack, generated and applied by the packer. The system uses data structures defined by GS1 in the Global Traceability Standard for Healthcare to create a ‘licence plate’, or serial, on each pack. This number, when combined with the Global Trade Item Number (GTIN), creates a globally unique number. Each serial contains a 2D data matrix code, together with the human readable data contained within – for example, GTIN, lot number and expiry date. Each pack can then be associated with its bundle, the shipping container and finally the pallet, with all of this aggregation information stored and moved around the supply chain. Most importantly, this provides confirmation that a product has not been previously marked as ‘dispensed’ and does not contain any warning or advisory notes.

Activation and aggregation data can then be sent securely to enable a customer’s system to prepare for the receipt of the serialised product, and then perform its onward distribution. In a future state, ultimately the patient receiving the medication or pharmacist dispensing would be able to personally verify the authenticity of the medication at the point of dispensing.

However, the track and trace system alone is insufficient to ensure governments and the pharma industry stay ahead of counterfeiters. These anti-counterfeiting efforts need to be complemented by both overt and covert packaging technologies to ensure a robust, agile and dynamic strategy in deterring counterfeiting.

Packaging Technologies

There are many anti-counterfeiting technologies available, ranging from simple through to highly sophisticated and extremely secure. They are usually specific to the drug, package and market. Layered anti-counterfeiting technologies enable the authentication of an item by government or industry regulators, but also allow the public to deter counterfeiters.

Overt Technologies
Overt security features are apparent and visible to the naked eye. Overt technologies on packaging are typically optical and contain variable coatings which change colour when the viewing angle is changed – for example, colour shifting inks or holographic foils. Optically variable devices do not normally include a 3D component and may include thermochronic inks and coatings, such as watermarks. In order to increase safety, these two technologies are increasingly being adopted alongside tamper-proof features, including blister foils or a tear band on the packaging.

Furthermore, these colour-shifting security inks and films are userverifiable, and can be a deterrent to the counterfeiters. However, many disadvantages exist; notably, they may be easily mimicked, and some will add significant cost. Overt technologies also rely on covert features for authentication.

Covert Technologies
Covert features are not immediately apparent and require instrumentation to identify them. The rationale of a covert feature is to aid the brand owner to recognise a counterfeited product. The general public will not be aware of its presence, nor will they have the resources to confirm it (5). Covert authentication technologies contain hidden features which can only be detected with commercially available microscopes or specialised readers. These technologies can either be incorporated into overt solutions or can function on a stand-alone basis to protect against counterfeiting or adulterants. Currently, there are various covert authentication options available, varying from machinereadable technology, micro-text, nano-text and imbedded images in holograms (6).

Forensic Technologies

Forensic methods essentially involve chemical or biological tags built into a medicine’s packaging, which are integrated into the product and therefore well concealed. Like covert technologies, these features cannot be detected without specialised equipment; yet they have the additional benefit of being variable and can be customised according to specific requirements (7). Existing forensic anti-counterfeiting technologies include RFID devices, digital mass serialisation and digital mass encryption (8). These techniques are considered to be the most secure against counterfeiting, but subsequently cost more and provide no visible reassurance to customers. They are primarily intended for extremely expensive pharmaceuticals and highend products, with markers such as micro taggants made of microscopic particles, or threads which contain encoded information requiring a greater speciality and effort to detect (7).

Global Strategy

The ever-increasing threat of counterfeit and falsified medicines entering the pharma supply chain is undoubtedly a global issue, and therefore requires a worldwide coordinated strategy where anticounterfeiting tactics are deployed at every level from policing and supply chain management, through to individual packaging and product design. The objective is to establish continuity in existing procedures and to discourage counterfeits from entering the legitimate supply chain, motivated by a single concern: patient safety.

The creation of a cohesive supply chain through a track and trace system is a crucial component in combatting this illegal trade in the most effective manner. In order to adequately protect public health interests and the relationship of trust between patients and pharma suppliers, the entire production and supply chain needs to be closely integrated. Packaging serialisation is one of the key development areas for countries and pharma leaders in the fight against counterfeiting.

Defeating the counterfeiter’s threat demands a multi-level approach – an element of which is secure packaging. In order to truly ensure optimal security of pharmaceuticals, a combination of different anticounterfeiting tactics, including overt and covert technologies, needs to be used (9). For serialisation, the formation of a unified, single-source, pan-European or even global database, where scanned barcodes can be verified at the point of dispensing, is the crucial next step in the creation of true serialisation and supply chain security. That is not to say that achieving a harmonised identification solution on a global scale will not represent a challenge, but once it has been effectively established, the benefits will be hugely significant in protecting patient safety.

References

1. Newton PN et al, Impact of poor-quality medicines in the ‘developing’ world, Trends in Pharmacological Sciences 31(3-3): p99, 2010
2. IMS health study identifies $200+ billion annual opportunity from using medicines more responsibly, Imshealth. com, 2013. Visit: www.imshealth.com/ portal/site/imshealth/menuitem.c76283 e8bf81e98f53c753c71ad8c22a/?vgnexto id=12531cf4cc75f310VgnVCM100000761 92ca2RCRD
3. Mass serialisation in the European pharmaceutical industry – working together on mass serialisation: whose responsibility is ensuring patient safety? Frost.com, 2013. Visit: www. frost.com/prod/servlet/cio/140658996
4. Schilpp G, A guide to pharmaceutical serialization, Life Science Leader, 2013. Visit: www.lifescienceleader.com/ doc/a-guide-to-pharmaceuticalserialization- 0004
5. Shah RY et al, Anticounterfeit packaging technologies, J Adv Pharm Technol Res 1(4): p368, 2010. Visit: www.ncbi.nlm.nih.gov/pmc/articles/ pmc3255398
6. Covert technology, Jdsu.com, 2014. Visit: www.jdsu.com/en-us/ authentication-solutions/technology/ covert/pages/default.aspx#.us_gibqqti1
7. The counterfeiting of healthcare products, GSK. Visit: www.gsk.com/ content/dam/gsk/globals/documents/ pdf/GSK-on-counterfeiting-ofhealthcare- products.pdf
8. Use of anti-counterfeiting technologies need government support, Express Pharma, Pharma.financialexpress. com, 2014. Visit: http://pharma. financialexpress.com/20100831/ pharmaally06.shtml
9. Burhouse R et al, How new packaging technologies are helping in the struggle against counterfeit drugs, Pharmaceutical Manufacturing, 2014. Visit: www.pharmamanufacturing.com/ articles/2010/119

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Ian Parsonage joined Packaging Coordinators in June 2009 as Head of Information Systems and was responsible for the introduction of a new enterprise resource planning system, coupled with significant process redesign. In March 2012, he took over the planning team and revised the planning systems and processes. Ian transferred to the role of Director, Global Serialization Systems, in June 2013 and has responsibility for all serialisation activity in the US and UK.
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