By using 2D barcoding technology, a hospital pharmacy department in Sunderland has met the standards set out in the EU falsified medicines Directive to ensure packs are suitably labelled and identified
Rod Beard BPharm MSc MBA MProf MRPharmS
Karen Shield BPharm MSc MRPharmS
Pharmacy Department, Sunderland Royal Hospital,
Around 2005, concerns started to be raised about the volumes of counterfeit medicine entering the global supply chain, and the pharmaceutical industry started to look at means by which to identify how this could be addressed. In 2008,(1) there was the first public call from the hospital service for uniquely identified packs using two-dimensional (2D) barcodes. This chimed with the need of the pharmaceutical industry to identify individual packs. The hospital service was interested in tracking products easily using robotic dispensing systems, and on a larger scale, but for similar reasons, the industry also wanted to track in more detail where their products were going.
Counterfeiting of medicines is a global phenomenon, and operates on a massive scale. After a series of debates about the problem, the European Union (EU) acted. In June 2011, it issued Directive 2011/62/EU, known as the ‘falsified medicinal products directive’. This Directive has amended 2001/83/EC relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products. This tightening was necessary in the face of overwhelming evidence that the 2001 Directive was failing to stem the flow of counterfeit medicines into the EU, up from just over 560,000 articles in 2005 to over four million in 2007, with up to 90% of medicines bought online being fake in some areas.
Directive 2011/62/EU stipulates that from January 2013, medicinal products offered for sale should bear additional information to standard labelling. The additional information required is a barcode and a unique pack reference number. The Directive does not specify how this information needs to appear.
The pharmacy department at City Hospital Sunderland serves approximately 1000 beds, with a catchment area covering approximately 350,000 people. The pharmacy supplies medicines to a variety of clinics in the area under its Medicines and Healthcare products Regulatory Agency (MHRA) ‘specials’ licenses. The Directive was considered with regards to these products and of the options available. Barcode technology is an obvious approach to the problem. Barcodes come in a variety of sizes, from the six digit PZN (Pharma Zentral Nummer) used in Germany, through the more familiar 13-digit codes frequently seen on medicine packs, up to 126-digit codes. Obviously, the longer the barcode, the greater the amount of information that can be stored within it. However, 126 digits is a long string, and the barcodes can be too long to physically apply to a package within the defined label space. However, the amount of information on a 126-digit barcode can be retained, but the size reduced, if a two-dimensional (2D) barcode is used. Such barcodes compress the information to a manageable size for labels. In order to meet the requirement of the Directive over a range of pack sizes, from small to large, it was decided to use 2D barcode technology to provide all the additional information the Directive required.
Applying for barcodes
The first step was to register for barcodes with GS1, the national registry for all barcodes, and register all the products produced in the pharmacy. Registration is free for National Health Service organisations.(2) We received an initial quota of 10,000 unique codes, which is ample for the number of products we produce in our organisation. The first part of the barcode denotes the country of manufacture, the second string the place of manufacture of the medicine, and the third string of digits refers to the individual product. Once registered, these product codes must never be varied or changed. Considerable work is required to ensure there is no deviation from standard operating procedures to trigger an error when setting up labels for products. These procedures will be scrutinised by inspectors as part of the licensing renewal process. Access codes to the list of assigned barcodes is hierarchy- and password-restricted, to prevent unauthorised entry to the database of barcodes and potential mis-assignment. Any hospital unit considering similar arrangements must give serious thought to protecting the assigned barcodes because a wrongly assigned code could have devastating effects.
The next step was to look at potential labellers for the products. The pharmacy already used the Episys Ultimate™ Platinum labelling system. The Ultimate™ Platinum Labelling Solution is a validated system compliant with MHRA guidelines and we use it to prepare labels and worksheets for both our over-labelled and cytotoxic products. Episys was approached to explore the possibility of incorporating 2D bar codes.
The software was designed for both linear and 2D bar codes, and by using the 126 characters of a 2D barcode, the product barcode number, batch number, expiry date and unique pack number could be incorporated. The unique pack number is also printed on the pack label, making it readable without a scanning device. The system was flexible enough to fit all the packs Sunderland produces, and could print 13-character linear bar codes as well as 2D codes on the label, to suit customers’ scanner requirements. The unique pack number is a feature of interest to hospital pharmacists because it will, for the first time, be possible to easily log to which ward or department an individual packet was dispatched. This will be easier for those pharmacies that use dispensing robots. The significance of this is of particular interest for products that are prone to diversion (for example, benzodiazepines, and opiate analgesics, such as codeine). If a hospital has a full audit trail of where each specified pack went, it makes the process of product accountability easier, should it be necessary to do so. Audit trails might be further enhanced with electronic medicines cupboards on wards. As more and more manufacturers incorporate unique pack numbers on their products, there could be benefits in community pharmacy, particularly regarding controlled drugs.
One of the concerns that emerged from the Shipman Enquiry (where a General Practitioner, Harold Shipman, is thought to have killed around 300 patients using morphine and diamorphine injections) was the lack of traceability of controlled drug medicines once they had left the community pharmacy. For a number of different reasons, traceability of these products is difficult, and unique pack codes could be a means of pinpointing what happens to these products in the community.
Figure 1 shows boxes of azithromycin using the labelling system. Note the individual pack number highlighted in red. The standard 13-digit barcode carries information about the product. The 2D barcode carries the additional information of batch number, expiry and pack number.
By using this technology, the pharmacy department is able to meet the standards set out in the EU Directive, and ensure packs are suitably labelled and identified. However, most hospital pharmacies do not have 2D scanners. Whereas these are relatively inexpensive, capturing the additional information and interpreting it potentially adds to costs in upgrading pharmacy robots. In due course, all this will be resolved as more manufacturers use 2D bar codes on their products. The full benefit of this EU Directive will take time to appreciate, from the pharmaceutical companies, to addressing counterfeit drugs, to better audit of products within hospitals, and better accountability of products in the community.
- The Directive provides an opportunity for hospital manufacturing units to review labelling procedures in line with good practice guidance.
- Increasingly, packs will be supplied with a unique pack identifier from manufacturers.
- technology is available for hospital manufacturing units to comply with the Directive.
- Robotic dispensing machines will increasingly need 2D reading capabilities to fully utilise the benefits the Directive creates.
- Unique pack identification creates potential for better audited practices for stock.
- Beard RJ. 2008 Pharmacy Distribution Interest Group Award: Advances in IV fluid distribution. www.ghp.org.uk/groups/UAS@GK/JTHYST/RDIFNH (accessed 22 January 2013).
- Department of Health. Coding for success: Simple technology for safer patient care;2007. www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_066082 (accessed 22 January 2013).