E-pedigree
E-Pedigree , also ePedigree (electronic pedigree = electronic family tree), stands for the labeling of medicinal products with a unique number and their complete documentation over the entire life cycle of the preparation. This traceability ensures protection against counterfeiting and reduces the manufacturer's risk of loss.
Legal regulations
The US Food and Drug Administration (FDA) has been demanding for years that all pharmaceutical packaging be clearly labeled. So far this has usually been done by pallet or container, but neither the origin of the individual pack nor its authenticity can be proven beyond doubt.
The state of California was planning a law to serialize e-pedigree for 2009, but the date has since been postponed to 2015. This gives pharmaceutical companies and all downstream companies more time to adapt their operations to the increased requirements and to provide the necessary technical infrastructure. The delay also serves to develop binding standards for the entire industry.
Other US states are also currently formulating corresponding laws. The European Association of the Pharmaceutical Industry (EFPIA) is preparing an e-pedigree guideline for 2011. From this point onwards, the E-Pedigree should be mandatory for all pharmaceutical companies in Europe .
The procedure
E-Pedigree requires billions of unique serial numbers to be generated, printed on packs, and the résumés of all medicines to be saved.
With the help of a two-dimensional barcode, the so-called data matrix code , or the radio technology RFID (Radio Frequency Identification), companies can attach and read the key figures in coded form on the products. In contrast to RFID, the barcode does not work with radio and is therefore harmless even for biological substances such as bacterial strains. A combined procedure is also possible for particularly expensive drugs.
In order to record and compare the respective data, the companies need cameras to read out the data matrix code and / or RFID readers. All information on each individual product can then be called up in the company's own databases at any time and for up to 30 years.
The basic data of an electronic family tree contain the following information:
- Manufacturing batch
- Active ingredient content
- expiry date
- electronic product code and government drug code
- Manufacturer
- Sales organization, intermediaries and wholesalers, pharmacies
- unique identifier of the sales unit
While RFID is predominantly used for e-pedigree applications in the USA , the EFPIA recommends in Europe to label pharmaceuticals with the data matrix code , since RFID is not yet fully developed for this purpose and is too expensive. Since the EFPIA does not rule out that RFID could also be used at a later point in time, the corresponding IT systems must be able to record and compare data from both data matrix and RFID processes at the same time.
Product safety and minimized risk of loss
The ultimate goal of E-Pedigree is to protect consumers from counterfeit medicines . For manufacturers, transparent production processes and distribution channels are also crucial. E-Pedigree also offers advantages in the event of a drug recall: Up to 500,000 products are produced in one production run and packed over several days. If there is a faulty production - for example as a result of a system failure - the entire batch would have to be destroyed without serialization . However, a corresponding serial number makes it easy to find out which packs were being produced at the time of the failure. This significantly limits the company's losses.
In Europe , serialization is subject to stricter regulations than in the USA . Instead of consecutive serial numbers , the pharmaceutical industry relies on random numbers . In this way, the companies can prevent counterfeiters from extrapolating sequential sequences of numbers on the basis of determined production speeds.
Transparency for the end user
Some pharmaceutical manufacturers are planning to make the family tree understandable for end customers. To this end, the companies want to make all product information available on their website. The customer only has to enter the code from his packaging and will immediately receive its previous résumé. Another variant is the MMS method: the end user takes a picture of the data matrix code with his mobile phone and sends the picture message to a service number. The manufacturer responds with the information about the history of the drug in question.
Effects on the IT industry
E-Pedigree requires high-performance, fail-safe systems that meet the high requirements of the industry: All IT systems used must be validated according to Good Manufacturing Practice or FDA guidelines. In addition, they must be able to collect and compare data from both data matrix and RFID processes at the same time.
Various companies have developed corresponding complex IT systems that enable the implementation of e-pedigree. These include, for example, Siemens IT Solutions and Services , IBM and Axway . Start-up companies have also been founded just for this market, such as ePedigree Solutions in Florida .
See also
Individual evidence
- ↑ FDA on E-Pedigree ( Memento from May 13, 2009 in the Internet Archive )
- ↑ Article on FDAlegislative.com ( Memento from April 20, 2008 in the Internet Archive )
- ↑ EFPIA website on E-Pedigree ( Memento from May 3, 2009 in the Internet Archive ).
- ↑ Position paper of EFPIA ( page no longer available , search in web archives ) Info: The link was automatically marked as defective. Please check the link according to the instructions and then remove this notice. .
- ↑ Business case EFPIA ( page no longer available , search in web archives ) Info: The link was automatically marked as defective. Please check the link according to the instructions and then remove this notice. .
