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TECHNOLOGIE kan leveren farmaceutische industrie DOELMATIGHEIDSCONTROLE en het fundament CONSUMENTENVERTROUWEN

Radiofrequentie-identificatie

Radio frequency identification (RFID) provides access to transparent and accurate information to help pharmaceutical companies tackle a number of key business issues. They include ensuring patient safety and product security at all times; an increasing globalised market; the need to improve production and process efficiencies to cut costs, as well as addressing the overall effectiveness of the industry supply chain – from a drug’s development through production and distribution to point of sale.

Dean Chespy – Life Sciences Development Manager for Siemens Industry Automation, highlights the business benefits RFID can deliver for the pharmaceutical industry, touching on the growth of concepts such as Serialisation and ‘ePedigree’ as the latest technology to help improve operational processes and market traceability. He says that companies employing RFID will see improved operational efficiencies; have a better understanding of their processes and businesses and can develop a base to start to tackle cost concerns. As an associated benefit it can also protect companies as they work under a legislative spotlight designed to guarantee drug product safety and underpin consumer confidence globally.

Ever-changing competitive, legislative and economic pressures on pharmaceutical manufacturers mean businesses are confronting two key market drivers. These are the need to improve production and process efficiencies to reduce costs and encourage competitive advantage, as well as dealing with the industry effects of market globalisation. Proven technology developments such as RFID, and the growth of unique product identification concepts through the complementary approaches of Serialisation and ‘ePedigree’, can offer real solutions for an industry that is seeking answers to satisfy these twin challenges.

Businesses are having to increase operational efficiencies and create manufacturing flexibility with a keen eye on costs to ensure they can deliver quick, problem-free production changeovers to respond to altering market influences and trends. They also need to protect themselves against the increasing level of Government and legislator scrutiny that in the global marketplace is heavily focussed on patient and product safety. This is in the context of a continuing worldwide trade in counterfeit drugs that currently accounts for 5% of all drugs sold(1).

RFID is in many ways not a new technology. It employs ‘smart tags’ to track, trace and identify every type of item and has been in some form of use for a number of decades, predominately in the automotive and electronic sectors. However, over the past 10 to 15 years a renewed interest in the advantages of calling up complete product profiles has had great appeal for many other manufacturing sectors – with some parts of the pharmaceutical manufacturing industry seeing its clear potential.

In essence, RFID allows a physical entity such as a component or a container to be automatically identified as it moves along the supply chain. The technology consists of three vital elements. First, a tag (chip + antenna) which is attached to the physical entity in question. Secondly, a reader which can ‘read and write’ data from and to the associated tag. The third element is a system’s ability to communicate with a ‘real time’ communications platform.

One of the flexible characteristics offered by RFID is that information on the tags is read by sensors, which unlike barcode equivalents, can communicate with many tags at the same time, and do not need the tags to be in their direct ‘line-of-sight’. This enables physical items with attached tags to be identified automatically, removing manual intervention, improving processing accuracy and speeding up overall operation. It can act like a mobile database – as opposed to bar-coding solutions which have to link back to a central database.

RFID tags can be used in a number of formats, for example in repeat manufacturing operations, as well as in disposable packaging formats with information available over the life-time of the package. Tags in such use are becoming more prevalent and are increasingly cost effective as they offer the opportunity to track and trace items over the entire end-to-end supply chain.

Such technology enables the tracking of goods from their point of origin to help create a proven and high quality level of supply chain transparency. With RFID, each individual product possesses an electronic ‘pedigree’ containing all relevant information on the product, such as the raw materials used, production data, shipping dates, storage conditions and times, and the sale and application of the product. This essential information can be used to improve many operational elements for pharma companies, ranging from product availability at the point of sale to stock management, lead times, investment planning and, ultimately, customer satisfaction.

It can also play a pivotal role in enhancing productivity and product security which are important factors for pharmaceutical companies. In the healthcare sector, the ability to use such information can be utilised as a key tool for product authentification – which is a weapon to combat grey market, theft and drug counterfeiting activity.

Serialisation

The drive to increase the standards of product security for pharma companies has lead to the growth and adoption of the concept of Serialisation as the next stage, building upon the benefits clearly seen and derived from RFID technology. As globalisation across the pharmaceutical industry increases, so too does the complexity of its supply chain, posing new challenges and, potentially, bringing new levels of vulnerability to companies that, develop, manufacture, distribute and dispense drugs. Because of notorious episodes concerning tainted or counterfeited products, Governments have led the way in making supply chain security a top priority, and as a means of enacting and implementing traceability, politicians and legislators have encouraged moves behind the introduction of item-level Serialisation.

Serialisation is a process of identifying an object with a unique serial number which can be exchanged universally. Within pharmaceutical it can be applied to each item, case and pallet of a drug to authenticate the individual product and enable tracking and tracing (and building a pedigree) within the supply chains of manufacturers, distributors and wholesalers.

The requirements for Serialisation are growing in the USA and Europe, and have included the FDA developing a standardised numerical identifier in the United States. Nearer to home, the European Federation of Pharmaceutical Industries and Associations (EFPIA) – through its 31 national pharmaceutical industry associations and 44 leading pharmaceutical companies – are adopting a pilot coding solution for Europe(2). This is to perform product authentification at the point of dispensing with a serialised Data Matrix Code on secondary packaging of all products sold in Europe. EFPIA’s clear objective is to improve patient safety at a European-wide level. It will be interesting to witness how the legislative enforcement evolves as the global market implications are tackled very much with a regional approach.

However, the benefits of Serialisation go beyond just supply chain security. Through Serialisation it is not only possible to uniquely identify an object and to track the movement of the object within the supply chain. It is also feasible to assign attributes to the object, such as location and timestamps (for track and trace), temperature, humidity and all quality attributes such as production and process data, which would not be available on any counterfeit medicine. Once this data is collected and assigned to the object, companies can respond to and manage the associated product information.

The specific objectives of Serialisation depend on the application, and in the pharmaceutical industry such goals may be to check the authenticity of a product, prevent counterfeit products from entering the supply chain, improve product recall management, or even aid a complex investigation in a case of an adverse event or incident. As an example, counterfeit medicines, already widespread in the developing world are now being found increasingly in the European Union. While internet-based sales are the main source of counterfeit medicines such products are also appearing in the traditional supply chain. Indeed, urgent measures are required to protect European patients, including a ban on medicine repackaging(3).

In an attempt to deal with the increasing problem of counterfeit drugs and its clear implications for patient safety, the FDA in America cites RFID as a key technology to enhance consumer medication safety. Together with the development of the Serialisation concept and the growth of an ‘ePedigree’ solution (where a product has an electronic record of information that is authenticated and updated electronically as it moves through the supply chain), RFID is central in the ongoing battle for product transparency and product security. For those companies who have started to utilise such an approach, it appears they are leading the way in terms of early adoption of item-level RFID and Serialisation solutions. However, global adoption generally across the industry still remains at relatively low levels as companies have been slow to pick up on the business benefits already experienced by automotive and electronic giants.

Going forward it is clear that legislative requirements on drug producing companies will become even more stringent. It is believed that there is a real potential for mandatory measures such as drug authenticity (relating to its original certified manufacturing data) and electronic pedigree (a record documenting that the drug was manufactured and distributed under secure conditions) being implemented either in the US or on a global scale. It is certain that pharmaceutical companies will have to comply with such rules if they are to continue developing, manufacturing and selling their products in large parts of the worldwide market.

Compliance with such requirements requires serious effort and investment. With the pharmaceutical industry facing increased pressures regarding time-to-market, market responsiveness, cost reduction and manufacturing flexibility, the technology solutions to hand help satisfy the need for transparent information, business process improvements, product safety criteria and overall supply chain efficiencies.

Whilst RFID can offer real benefit it is not just limited to pharma supply chain optimisation or pure track and trace applications. It offers great potential across the entire pharmaceutical value chain, as the table below illustrates:

Potential applications of RFID in life sciences include:

• Product Development – tracking of lab samples/tracking of patients and usage of preclinical trials to support R&D functions
• Asset Management – identification & tracking of containers in the lab or production/ container movement and history
• Agile & flexible manufacture and production – inventory management/material tracking/production line management/process efficiencies
• Supply Chain – grey market tracking/protection against counterfeiting/product recall management/expiration date management/drug validation issues at point-of-sale/drug pedigree

For drug manufacturers, distributors, pharmacies and hospitals, RFID, Serialisation and ‘ePedigree’ can fully underpin the desire for improved operational efficiencies in their businesses by eliminating human failures, increasing product throughput and cutting costs. Transparent, accurate and timely information on all facets of drug manufacture and use is now readily available through technology that can link together the various elements of drug design, production, storage, transportation and dispensing. Not only does RFID and Serialisation help in the task of continuous operational efficiency improvements so that competitive pressures can be overcome, they also aid the authorities in the ongoing global drug counterfeiting war.

It needs to be acknowledged that adoption of RFID technology has been limited to date in the pharmaceutical industry. Companies that haven’t embraced it should, in my view, see the technology as a clear stepping stone to proven process improvements and a pathway to a valuable understanding of their own business processes and how it operates, so that strategic and operational decisions can be made based on accurate information.

In addition, it will also lay a solid business foundation and provide product security across an industry which is seeing greater globalised regulatory control. It could be argued that the use of the type of technology outlined here lies at the very heart of the pharmaceutical industry’s ability to secure patient safety and satisfy consumer expectations for the future.
Referenties

1. Siemens UK Life Science Event, Warwick – October 2010
2. Siemens Newsletter – ‘Serialisation for ePedigree’ – March 2010
3. Siemens UK Life Science Event, Warwick – October 2010

Siemens Automation Industry – Manchester
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Tel: 0161 446 6400 or Web: www.siemens/automation.com

Siemens Industry

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