2.10.4. Automatic identification and traceability technologies

 

Recent technological developments has made possible systems that using bar-codes or radio frequency identification (RFID) allow automatic identification and data capture of pharmaceutical products, medical devices, patients, caregivers, assets, equipment and locations in a faster, accurate, more efficient way and at a lower cost than manual identification alone.

 

Automatic identification systems have a very wide range of applications, including point-of-care scanning to match product data to patient data, verification of patient identity via a wristband, enabling the introduction of robotic dispensing systems, recording implant serial numbers in patient records and central registries, tracking and tracing of individual instruments through decontamination, stock control and supplies management, tracking assets throughout a network of facilities. These technologies make also feasible a unique identification for each and every pack of drugs or medical device, which in turn will enable authentication and traceability systems. All these applications and systems enable the realisation of associated health and economic benefits: reducing medication errors, preventing counterfeiting, saving costs and increasing the healthcare supply chain efficiency and transparency.

 

Medication errors

 

More than 30% of all adverse drug events are preventable and appear to be consequences of medication errors8. Several studies in different countries indicate the significance of medication errors. For example: in the UK, the NHS has calculated that approximately 60 patients die each day due to adverse drug errors9. Around 10% of admissions are likely to incur patient safety incidents, which may cost around £2 billion/year in hospital stay alone. About 400 people per year die, or are seriously injured, in adverse events involving medical devices. In Spain, an Adverse Event Study indicated that 9.3% of hospital stays incurred a serious adverse event, with medication errors being first (37.4% of such events). 10

 

Medication errors are rarely the fault of an individual Healthcare professional, but rather represent the failure of a complicated Healthcare system and can occur anywhere in the distribution system, although predominantly during prescription and administration. Prescription and administration are most often associated with medication errors, respectively standing at 39% and 38%. Dispensing and transcription account for 11% and 12%. While about half of the prescription errors are intercepted by nurses or pharmacists before they reach the patient, only 2% of administration errors are intercepted.

 

Automating the prescription and administration processes through bar-code verification at the point-of-care, electronic prescription systems and robotic dispensing systems will significantly reduce medication errors. Numerous studies have shown that automatic identification throughout the entire Healthcare supply chain, right to the point of delivery to the patient, is an extremely effective tool for preventing medication errors. For example, the introduction of bedside bar-code scanning at the Gerle Ziekenhuizen in Maastricht, the Netherlands, resulted in a reduction of 74% in administration errors (from 3.10% to 0.84%)11. Chelsea and Westminster Healthcare NHS Trust, UK, introduced a robotic dispensing system in May 2003. A study in the hospital pharmacy found that dispensing errors were reduced by 67% from 2.7% to 0.9% of prescriptions12.

 

Drug counterfeiting

 

In Europe, around 1% of pharmaceuticals are now counterfeit according to the WHO13. As counterfeiting becomes more sophisticated, these products are increasingly present even in developed markets, for example because of increased Internet-based sales through illegal Internet pharmacies. In 2006, 2.7 million items were seized by European Customs, a 384% growth versus 2005(14). It is likely that counterfeiting will continue to significantly increase over the next years. The US based Centre for Medicines in the Public Interest predicts that counterfeit drug sales will reach US$ 75 billion globally in 2010, an increase of more than 90% from 200515.

 

The introduction of a unique identification for drugs or medical device, where appropriate, will enable authentication and traceability systems that will make it much more difficult for counterfeiters to intrude into the Healthcare supply chain, or at least make it uneconomical. The first step is to assign a unique identity to a product at the point of manufacture, which then remains with it throughout the supply chain until its consumption. This unique identification can then be crosschecked against a remote database and so make it possible to verify and authenticate a product at any point of the supply chain, including dispensing or point of sale. Counterfeiters would then first of all need a legitimate identification number that is registered in the database and linked to the correct item to enable authentication. In the worst case, two packs of drugs with the same serial number would be present in the supply chain, in which case stakeholders would be alerted about this intrusion when the second pack is being crosschecked.

 

Increasing efficiency

 

Manual systems and processes in hospitals are unable to efficiently handle the constant change that occurs with supplies (inventory control, product recall, etc.). For example, administrative costs along supply chains in healthcare constitute roughly 30 to 40% of healthcare costs but only 6-8% in the retail industry and 3-6% in the grocery industry – both areas in which computer-based technologies routinely streamline how products are traced and distributed. An EHMA16 study indicated that 30-50% of all stock-on-hand in most hospitals is waste of working capital, with inventory for example being obsolete, expired or in excess17. Considering that inventory management accounts for between 17% and 35% of a hospital’s total budget, it is evident that reductions in inventory management costs can significantly improve hospital budgets18.

 

Automatic identification and traceability systems allow automating and hence simplifying and improving accuracy in a number of supply chain processes, including order processing, receiving/shipping management (simplification of product identity control and quantity checks of incoming goods) and inventory management (e.g. monitoring shelf life and automatic re-stocking).

 

For example, one UK trust, deploying a robotic dispensing system, saw a reduction in time spent in the dispensary by 34% for pharmacists and 51% for technicians, enabling far more time to be spent on the wards, working directly with patients and ward staff19. The implementation of an electronic prescription process and automatic product identification in the San Raffaele Scientific Institute in Italy resulted in a 30% cost reduction in the drug supply chain20.

 

Current situation

 

The availability of automatic identification systems in hospitals today is very low: it is estimated that less than 10% of hospitals currently use bar-codes for medication administration. The penetration of automatic identification technologies is higher with other healthcare supply chain stakeholders. Most pharmaceutical and medical device manufacturers and distributors already provide and use bar-codes or RFID tags for internal logistics purposes (often at logistic unit level). Retail pharmacies have also embraced bar-coding to a much larger extent than hospitals and use it at the point of sale.

 

Hospitals have delayed investment in the hardware and software necessary for automatic identification until manufacturers routinely bar-code or tag at the unit-dose level as this is necessary for a hospital to reap all possible benefits.

 

Some EU Member States have regulated national numbers to be labelled on the unit-of-use packages to enable reimbursement and to check product registration. These diverging national requirements require  manufacturers to adapt production and packaging lines per market, which increases the costs of production and supply chain management and hampers the development of a truly internal market, i.e. one of the primary objectives of the EU.

A few EU Member States are also investigating possibilities to implement national traceability systems for pharmaceuticals. Again, EU-wide or global standardisation would increase the efficiency throughout the supply chain and reduce the possibility of medication errors and counterfeiting.

 

Standards harmonisation

 

Only global and open standards enable the realisation of all Healthcare and economic benefits related to automatic identification and traceability systems. Open, technology-independent standards permit full interoperability and compatibility. End users are not locked into proprietary solutions and R&D resources can be created and used for other added value developments, once standards have been adopted. It also strengthens the competitiveness of companies by aligning national solutions and thus removing barriers impeding access to other markets.

 

Healthcare is by nature a global sector, with supply chains that often cross borders. A global standardised system for traceability, from product manufacture to patient treatment, is imperative to comply with the increasing legal requirements for product traceability around the world. In cases of cross border trading, a global identification number can be used to identify that product in any country without any restrictions or errors.

 

Local needs are incorporated into global standards, but local standards will jeopardise the realisation of the related benefits. Country-specific regulations may satisfy the needs of those countries, but when products move across borders throughout the global supply chain, this causes problems. It will be more difficult to achieve implementation on a national level due to the complexity of the myriad of systems required for various local requirements. Identification numbering schemes developed for one tracking system will not necessarily be recognised by another and the cost burden to the stakeholders in the healthcare supply chain will increase significantly. Identification numbering should be as ubiquitous as bar-coding of grocery items, whilst taking into account the specific needs of healthcare.

 

The Expert Group on Safe Medication Practices of the Council of Europe strongly recommends the related stakeholders “to update the National and European legislative framework to require complete and unambiguous labelling of every single unit of use of all licensed medicines products” using the GS1 System of global standards21. The Department of Health in the UK already called for the use of standardised information in healthcare: “The case for coding is compelling, but all stakeholders need to work to commonly agreed standards if the benefits are to be realised fully. The Department of Health is recommending that the GS1 System should be adopted throughout the Healthcare system in England, both for manufactured products and for coding systems used within healthcare settings, such as patient identification codes on wristbands.” 22