Author: Aiden Corcoran CEng, MIEI, CEO and managing director, Horizon

Horizon provides manufacturing engineering solutions to pharmaceutical, life-science and medical device companies in Ireland and overseas. The company has been central to the implementation of serialisation (track and trace) systems for clients seeking to mitigate their risk of counterfeiting, and is advocates for the importance of this ‘passport’ system approach to pharmaceutical, and other, products.

In 2013, the company project-managed serialisation projects at various levels for over 50 packaging lines in several companies, a process which the organisation feels is absolutely critical in the fight against counterfeit drugs.

In recent years, both pharmaceutical companies and regulatory authorities have noted a significant increase in counterfeiting of prescription pharmaceutical drugs. The World Health Organization (WHO) has identified that 1% of drugs in the developed world are likely to be counterfeit, the percentage rising to 10% globally, with particular concerns in Asia, Africa and Latin America. Internet drug sales represent a particularly high risk with the WHO estimating that up to 50% of available drugs are counterfeit.

Dangerous aspects of counterfeit drugs include:

• No actual active ingredient;
• Wrong strength (too high/low) of active ingredient;
• Drugs contaminated with dangerous materials;
• Expired drugs that may also be dangerous;
• Drug reimbursement fraud;

There is a direct cost of product recall, where positive identification of counterfeit can be difficult, without the identification and data handling capabilities provided by serialisation.

The increasing incidence of direct injury to patients due to fraudulent drugs, or losses of money due to fraudulent claims, has prompted national Ministries of Health to both develop mechanisms to better identify genuine drugs, and also secure international drug distribution.

APPROACH TO SERIALISATION/TRACK & TRACE

Globally there are significant differences in the current requirements across countries. For example, Turkey was an early adopter of ‘track and trace’ technology, and has quite different current requirements from China, which has a specific serialisation coding mechanism. These examples differ from the European Union requirements, with serialisation at the packaging/manufacturing point and verification at point of dispense. A number of countries have their own national coding mechanism for drug products.

Also, there have been significant developments in the last quarter of 2013, with the agreement of regulations at the US federal level, and new laws in Brazil (reported as having the biggest pharmaceutical market in South America).

Given the range of requirements internationally, an effective approach is to define a manufacturing and distribution technical infrastructure that allows configuration to meet individual national requirements, but based on international standards from groups like GS1 for Item Physical Coding, GTIN (Global Trace Identification Numbers), GLN (Global Location Number) and Electronic Product Code Information Services (EPCIS).

Adoption of standards reduces the costs of implementation and ongoing operation/support, as equipment and systems suppliers can directly offer solutions for which they have direct experience.

There are multiple levels to be included when looking at the business requirements to meet national serialisation needs. At a manufacturing level, identification needs to be made of which products (SKU – stock keeping units) are produced at which packaging lines, supplying which countries. As part of this product analysis, plans for new product introduction will also have to be considered, for serialisation impacts on both new and existing packaging equipment.

At warehouse level, how are the various product levels currently handled (including shipping cases and pallets)? Also aspects like third-party suppliers and distributors may need to be included. At distribution level, cold chain and other specialised requirements for air freight may apply. The overall aim is to securely identify the product, thus addressing counterfeiting, product diversion concerns and support product recalls.

Allowing configuration at an equipment level will permit appropriate levels of labelling at carton, bundle, shipping case pand pallet level to meet national requirements. At higher level, enterprise resource planning systems need to consider aspects of Master Data (National Drug Codes NDC/GTIN/GLN) to mirror such configuration needs.

CHALLENGES AND RISKS

Typically, the packaging lines most critical for the implementation of serialisation, are also the lines that are most heavily in use. This gives issues both for planning of equipment shutdown to allow changes, and often an initial impact on operational equipment efficiency (OEE) as the equipment returns to production after modification. Also, it may not be feasible to modify some older equipment, so replacement may be required.

There are a number of solutions currently available from specialist companies that handle serial number provisioning, and the appropriate logging of serialisation event data. Some solutions use available modules from Enterprise Resource Planning systems like SAP’s Object Event Repository/Auto ID Infrastructure subsystems and some solutions have evolved from companies with experience with vision systems and industrial data handling.

However, the Ministry of Health data handling mechanisms are still under development, with groups like the European Union still running development trials.

A number of the major pharmaceutical companies have pilot implementations on their own manufacturing sites. It is reported that a recent survey in Europe showed that approximately 50% of companies had some level of serialisation project in place.

Since 2010, Horizon has been working on serialisation and the impacts it has seen on many organisations include:

• Significant compliance and validation challenges when modifying existing equipment;
• Potential disruption of OEE and impact to line performance and flexibility;
• Intercompany, stakeholder and department conflicts with regard to scope and goals;
• Limitations of equipment suppliers having sufficient experienced system specialists and integration challenges with operational systems; and
• Lack of clear financial justification/defined payback of some aspects of serialisation, and poor consideration of technical risks.

WHAT IS THE PATH FORWARD?

Having delivered solutions through program management and turnkey installation, the Horizon team have seen and experienced the challenges and pitfalls associated with implementation of serialisation systems. For companies specifying regional requirements and optimising the packaging line the greatest one, however, is to obtain the best return on investment and keep line flexibility.

Undoubtedly, for companies operating within the pharmaceutical and medical device sectors, as well as other manufacturing organisations – the extreme impacts of counterfeiting cannot be ignored. Therefore, consulting with internal teams and obtaining a fully-appraised organisational understanding of potential impacts – as well as management controls – is central to progressing a serialisation project.

There are other outcomes associated with serialisation, and it will be interesting to see in the future how technology will be used by companies to target specific markets and gather information as to geographical nuances in purchasing. Intelligence such as this, alongside implementation of serialisation systems, will severely restrict counterfeiting and will give producers the opportunity to understand their market more effectively.

Aiden Corcoran CEng, MIEI is CEO and managing director of Horizon, which provides manufacturing engineering solutions to pharmaceutical, life science and medical-device companies in Ireland and overseas. For more information on Horizon, visit http://www.teamhorizon.ie/ or contact its Dublin and Connaught offices at: 01 9060500 or 098 50600, respectively.