teaser
Traceability has long been perceived as a task for drug manufacturers. But with an increase in counterfeit products the healthcare community has been forced to consider track-and-trace management as a shared issue
Christian Lovis
MD MPH
Professor
Head, Unit of Clinical Informatics
University Hospitals of Geneva
Switzerland
Christian Hay
Partner GS1
Medinorma LLC
Since the beginning of barcode usage in the early 1970s, it has expanded in numerous fields around the world to be almost ubiquitous. When major stakeholders started to develop and implement a barcode, including both a symbology and a semantic standardisation, they were establishing a worldwide standard in supply chains – what is known today as GS1 standard. The initial purpose was to speed up processes at the point of sale, but, ten years later, several other purposes emerged, such as the need to standardise tools for traceability. This led to the adoption of an extended semantic, which had to
be carried over from another symbology (Code 128).
From the 1980s to the turn of the century, a new need appeared, demanding a thinner granularity in traceability processes that needed objects to be serialised. The “internet of the objects”, born at the Massachusetts Institute of Technology, became a new pillar in the GS1 standard.
The user community, in defining its needs in traceability by lot (from the 1980s) or by serialisation (from the early 2000s), was responding to regulatory demands. This addressed food and beverages,[1] veterinary products (because of the connection to food for human consumption), and many other market segments where the need to trace an object’s history has
become a vital need.
In healthcare, traceability has long been perceived as a task for the sole manufacturer of products, such as drugs or implants.[2,3] When new risks have appeared (such as AIDS, CJD and so on), regulatory and other incentives have led the healthcare community to consider traceability as a shared issue involving the supply chain. More recently, the increase in counterfeit products has forced users and regulators to consider
product serialisation and traceability at unit level.[4] To address this, a consensus about the use of a single standard across the geographical and branch markets has been raised.[5]
Barcode or radio-frequency identification?
Traceability – being the ability to retrieve information on the origin of a product and its destination – requires increasingly sophisticated tools as the granularity increases. By respecting an open semantic, all parties are able to participate in the traceability effort. Relevant information would include product identity, lot number and serial number – the last two being attributable to the first.
For large objects, a linear barcode and UHF RFID (ultra-high frequency radio-frequency identification) tags present the best option. For smaller objects, such as a drug retail pack, two-dimensional Datamatrix or HF RFID tags offer the best technical solution. When considering small items like a vial, a pre-filled syringe, a blister pack or a surgical instrument, two-dimensional Datamatrix is the only technical solution.[6]
Several studies and discussions have taken place to define which kind of data carrier presents the best solution. Table 1,
by an expert group from European Federation of Pharmaceutical
Industries and Associations (EFPIA)[7], illustrates why optical solutions are currently preferred.
The choice of technology impacts the possibility to deploy certain processes: RFID, for example, because the information can be collected without direct line of sight, allows data capture at a higher speed – such as might facilitate delivery preparation in a wholesale facility. In special applications, where temperature
control is important, or where the capacity to change or add information on the item itself is an asset, RFID tags offer the best solution.
The research by EFPIA demonstrates that RFID tags on retail packs are less reliable than Datamatrix, which can be damaged up to 60% and still be readable.[8] Reliability of RFID tags is influenced by constraints imposed by the antenna. On soft materials, antenna may be damaged, which disables data capture. When built into a more rigid base, however – such
as patient wristbands or when integrated into surgical instruments – users can expect RFID tags to meet reliability requirements.
[[HPE39.58]]
The place of traceability in hospital
There are many benefits to expect from track and trace
management in the healthcare sector. Among them, it is worth emphasising the following:
Improved supply chain efficiency
Care providers, patients and healthcare facilities are at the crossroads of many supply industries: pharmaceutical, medical devices, disposable products, implantable devices to name the most obvious. But there are also numerous other suppliers such as food and groceries, beds, clothes, computers, office equipment and so on. Many hospitals are comparable to small cities, with distributed stocks management and internal markets
embedded in the global market in a global world. Improving this management through greater visibility, accuracy and velocity is expected to produce the same improvement in economic efficiency as measured in other industries. Traceability is a crucial component of logistics, which is the optimal management of flows and resources. Logistics includes: physical flows, such as buildings, materials, objects and people; logical
flows, such as information or processes descriptions; and financial flows.
Prevention of errors
Errors in patient or drug identification are far from rare. Unique patient information can be encoded in data carriers, as can information on care providers, drug dosage, and package units of use. This enables automated verification, which enforces a last-minute check to prevent error.
Public health
Public health has important needs related to the ability to track and trace population-based events to their causal roots. A complete track and trace mechanism, from the manufacturer to the patient, would be very helpful, especially when faulty products are detected. Patients who have received a specific drug or prosthesis could be traced, as could the affected lots. Unfortunately, for some types of items, such as pacemakers,
very good traceability is available; for others, such as drugs, it is almost non-existent. In addition, the legal framework enforcing traceability is very dependent on national or state-level policies. A global approach – as is already proposed for food – would be of the highest value.
Medico-legal investigations
The use of an interoperable framework of identification schemes, allowing the identification of actors, objects, locations and actions in a temporal net of events, is priceless for medico-legal investigations. Such facility enable the “reverse engineering” of the cascade of events leading to unwanted or unexpected incident, or allowing clarification on the use of patient records when privacy breaches are suspected.
Clinical research and epidemiological surveillance
The high cost of clinical research – for example, in the surveillance of side-effects – would benefit hugely by moving from the current situation, with surveys limited in time and populations, towards continuous monitoring. A robust track and trace management system would be of great help, leveraging the power of secondary usage of clinical data.
Flows and processes management
One of the biggest challenges faced by healthcare systems is improving global care management. This includes clinical pathways in hospitals, community networks, continuum of care between inpatients and outpatients, and care throughout the life of the patient. However, this challenge is tightly linked to the ability to build interoperability between all systems.
Billing
This is certainly the most developed domain of healthcare in terms of the use of information technologies. However, a lot of work is still done by hand. Availability of a robust actors and asset identification and management system is mandatory in this field.
Counterfeit measures
Counterfeit drugs are increasingly available globally. While such drugs were only available in specific market segments, they are extending rapidly into most markets, in part due to the use of the internet. Counterfeit drugs result in financial losses to pharmaceutical companies and are a direct cause of increased morbidity and mortality in the world. One of the best weapons
against this illegal trade is a complete track and trace management system able to authenticate drugs and their provenance. Several initiatives are ongoing to help reduce counterfeit drugs, such as the use of ePedigree and serialisation.[9]
[[HPE39.59]]
Five-year forecast
- Bridges between healthcare standards and supply chain standards, such as GS1 and HL7; in 2007, the two global standards organisations signed a memorandum of understanding to work together on this issue.
- Move towards serialisation of coding to identify unique items; in the US, this is a prerequisite for the fulfilment of regulatory requirements regarding pedigree; in Europe, EFPIA is preparing a largescale pilot to investigate and understand processes linked to serialisation. In Switzerland, during the first quarter of 2008, a pilot was run with a small number of products and parties.[10]
- Increased usage of high-density coding, such as Datamatrix and RFID; the French registration authority, AFSSAPS, is to migrate to GS1 DataMatrix from January 2009.
- Increased availability of multi-modality readers.
- Decrease costs of RFID tagging.
References
1. EFSA. General principles of food law. Regulation (EC) No 178/2002. [cited 2008 Aug 5]. Available from:
http://europa.eu/scadplus/leg/en/lvb/f80501.htm
2. EC Enterprise and Industry. Guidelines on Good Distribution Practice of Medicinal Products for Human Use. No 94/C 63/03 [cited 2008 Aug 5]. Available from: http://ec.europa.eu/enterprise/pharmaceuticals/
pharmacos/docs/doc2001/may/gdpguidelines1.pdf
3. AFSSAPS. http://www.gs1health.net/
downloads/oe200703160064010720704.pdf
4. EC Enterprise and Industry. Counterfeit medicines – Major developments. [cited 2008 Aug 5]. Available from: http://ec.europa.eu/enterprise/pharmaceuticals/
counterf_par_trade/counterfeit_key.htm
5. Mansell P. Commission sets out its stall on anticounterfeiting
measures. in-pharmatechnologist.com. 2008 Mar 19 [cited 2008 Aug 5]. Available from:
http://www.in-pharmatechnologist.com/news/
ng.asp?n=84078-european-commission-gmpcounterfeit-
supply-chain-gdp
6. Hartmann C. EAHP News 2007;13 [cited 2008 Aug 5]. Available from: http://www.eahponline.org/upload/
ejhp/EAHPNews10(1).pdf
7. efpia.org [homepage on the Internet]. Brussels: European Federation of Pharmaceutical Industries and Associations [cited 2008 Aug 5]. Available from: http://www.efpia.org/Content/Default.asp
8. Poon E. Using Barcode Technology to Improve Patient Safety. Boston, MA, 2006.
9. James JS. FDA, companies test RFID tracking to prevent drug counterfeiting. AIDS Treat News 2005;(417):5-8.
10. SmartLog Pilot. [cited 2008 Aug 5]. Available from: http://www.gs1health.net/smartlog
