An overview on how the pharmacy product number (PPN) can protect against counterfeit medicines by harmonizing various coding systems in Europe’s pharmaceutical market
Product codes in the European health care sector were developed on a national level based on local factors and realities. Often, depending on the product category (e.g. medicinal products, medical devices or blood products), various coding systems can be in use in one single country. These coding systems are firmly rooted in various processes like material logistics, accounting/invoicing, registration procedures, etc. The directive 2011/62/EU requires measures to increase protection of medicinal products against counterfeits. One result is the need of product codes being unique on an international level.
Additionally, clear product codes do simplify logistics for internationally traded pharmaceuticals. In relation to this, the IFA has developed a system embedding existing coding systems (based on international standards – ISO/IEC) and therefore meeting the requirements resulting from the EU’s directive on a cross-national level. The EU directive contains further measures to increase the protection against falsified medicines. In addition to requirements relating to the production and sale of medicines, pharmaceutical active ingredients, excipients etc., the fundamental responsibility that all medicines, prescribed or otherwise, which have a potential risk of fraud should be equipped with a security feature which allows wholesalers, pharmacists and others involved to verify the authenticity of the medicinal product and to identify individual packages.
Further details are to be set out by the European Commission in delegated acts. In the next phase, the Union member states have to implement these regulations in their respective pharmaceutical law. The verification concept is based on a data match of a randomized serial number which is assigned uniquely per package. The package serial number will, at the point of dispensing, be verified against the manufacturer‘s data (End-to-end verification). The very generally expressed EU requirement for a “safety feature” has to be translated into a practical solution. The stakeholders decided on an authenticity verification system using a randomized serial number encoded in an ISO/IEC 16022 Data Matrix Code data carrier. The prerequisite for verification is the marking of each package with a globally unique product number and it‘s associated serial number. In order to automate the verification process, the data must be applied to the packaging in a standard, machine readable form. The Data Matrix Code contains the Pharmacy-Product- Number (PPN), which incorporates the German reimbursement number PZN and the safety feature required in the human medicine law in the form of a randomized serial number applied to an individual package, which can be verified against the original data of the medicine manufacturer. The code also includes the expiry date and production batch number. The upgrading of the PZN to PPN is necessary in order to guarantee a system for product identification for Germany and beyond.
Symbology
For the above reason, the stakeholders commissioned IFA (Informationsstelle für Arzneispezialitäten ) to establish itself as an ISO registered Issuing Agency (IA) with its own number range. The IFA, for many years, an acknowledged service provider for medicinal data and health care products safeguards the uniqueness of the PPN and provides the stakeholders with appropriate information and services. All definitions in regard to symbology, data descriptors and structures are based on ISO/IEC standards. The application of international standards ensures that other data structures such as e.g. HIBC and GS1, which are based on the same standards, can be used unambiguously and without conflict. To ensure readability and correct interpretation of the data on medicinal packages for all processes, adherence to this specification is mandatory for all involved parties. This specification describes the data container on medicinal product packages, which holds the necessary data elements for automatic identification. It contains a detailed description of the encoding and associated marking of medicinal product packages, the data structures and the form of the data elements as well as the coding with code size and print quality. In addition, this specification describes the Pharmacy- Product-Number, a worldwide unique product number created from national and other proprietary medicinal number systems. The underlying ISO standards of this specification allow the operator to integrate the data and the Pharmacy-Product- Number system into higher-level standard logistic and aggregation systems (ISO 15394). In addition, the stakeholders in the German pharmaceutical market agreed to add the following data elements to the machine-readable identification of medicinal product package:• product number • batch number • expiry date • serial number (optional).
The symbology used is Data Matrix Code according to ISO/IEC 16022 with data structure and syntax as per ISO/IEC 15418 as well as ISO/IEC 15434. In this way, the machine readability of the data elements is assured and the technical prerequisite for the implementation of the EU directive for protection against counterfeit medicines and also the anticipated additional requirements for verification of medicinal product packages. This code is referred to in its totality as PPN-Code.
Data identifier
The product-number (PPN) – use in Germany as part of the Health Reform Act is the Pharmazentralnummer (PZNfor the identification of medicinal products. Many processes e.g. reimbursement system and medicinal product identification are dependent on the PZN product number. However to provide verification in terms of the EU directive it is necessary to use a unique pan-European product number. To fulfil this requirement the Pharmacy- Product-Number (PPN) has been created. The Data Identifier ‘9N’ was assigned uniquely to the PPN. The PZN is converted into the globally unique PPN The IFA issues the PPN with PPN check digits. As the embedded PZN with the use of the PPN Data Identifier ‘9N’ and the PRA-Code ‘11’ are unambiguously identifiable. The usual prefixed hyphen identifier is no longer required. The check digits are calculated over the complete PPN data element.
Existing data base and software systems can use an algorithm to create the PPN from the PZN and vice versa. Databases can thus continue to work with the PZN. Alternatively translation tables can easily be created. The interoperability, with other number systems e.g. GTIN (GS1 as responsible IA) or HIBC (EHIBCC as responsible IA), is safeguarded by the common use of international standards. With the provisions of the PPN other healthcare participants can uniquely map their national or proprietary number systems to a globally unique numbering system e.g. the Eurocode IBLS of Blood banks, Belgian system (ABP-number), Greece (EOF-number), Italy system (AIM-number) etc. The IFA as Issuing Agency ensures with the assignment and registration of the PRA-Code the conflict-free correlation of the PPN.
PPN-code applications
Depending on the type of product, the PPN-Code is made up of different elements either the PPN alone or in combination with additional data elements. In the table the principle variants are shown: 1) In accordance with § 131 Para. 5 Health Reform Act (GRG) from 20 Dec 1998, the continued use of the PZN in the PZN-Code is, until further notice, mandatory. 2) The PPN-Code is optional for medicinal products which do not require verification and other common pharmacy products, however it is recommended for use where in addition to the PZN other coded data elements are needed. 3) May be used optionally for internal purposes.
Interoperability
For manufacturers, wholesalers, pharmacies, clinics and care centers, the interoperability of codes is a prerequisite for reliable reading and unequivocal identification of data elements. Integrated interoperability helps to ensure cost-effective processes for the involved parties. The common basis for this is the standard ISO/IEC 15459 Unique identifiers, the System and Data-standard ISO/IEC 15418 (ANSI MH10.8.2) and the syntax standard ISO/IEC 15434. With due regard to the standards, data from various data sources, different symbologies and identification systems are transferred without conflict. The following lists the main additional data identification systems used in health care, which can be used concurrently without conflict with the PPN.
GS1 / GTIN
The GS1 system is based on the product item identification using GTIN. Important features are the use of the header format control code “FNC1” and the use of Application Identifiers (AI) as Data Identifiers. The interoperability of the Data Identifiers is ensured by the reference tables of ISO/IEC 15418 (ANSI MH10.8.2). The envelope format of ISO/IEC 15434 is not used in the GS1 System.
HIBC
The Health Care Industry Bar Code HIBC is administered by the organization EHIBCC. EHIBCC is an Issuing Agency following ISO/IEC 15459. The classic HIBC is prefixed by the registered System Identifier “+” (plus) and thus can be clearly identified without risk of confusion from all other systems. The defining characteristic of the HIBC is the compact design and the capacity for alphanumeric product codes from 2 to 18 characters. The HIBC Standard has been extended to the alternative use of Data Identifiers on all logistical levels (DI 25P).
XML Standards
A standard based on XML standards and which provides a neutral description of the Data Identifiers allows for the open exchange of data, regardless of symbology and data structures.
By Paul Rupp, IPA