Pharmaceutical central number

from Wikipedia, the free encyclopedia
Pharmaceutical registration number on the bottom of a pack

The Pharmazentralnummer ( PZN ) is a nationwide identification key for drugs , medical devices and other common pharmacy products. It is an eight-digit number (7 digits + check digit ) preceded by a minus sign, which clearly identifies the drug according to name, dosage form , active ingredient strength and package size. It is printed in plain text ( numbers ) preceded by “PZN” and as a barcode ( Code39 ) on every drug pack, whereby the character string “PZN” is not included in the barcode.

The PZN was originally developed for the rapid and error-free transmission of orders from pharmacies to pharmaceutical wholesalers. In the logistics chain (order, goods issue, goods receipt, invoicing) it is common in the pharmaceutical sector.

In addition, the PZN is used when billing the pharmacies with the health insurance companies. For this purpose, the pharmaceutical central numbers are scanned in the pharmacies when the pharmaceuticals are dispensed and printed on the prescriptions in a machine-readable manner . The data of those with statutory health insurance are recorded by IT and forwarded to the statutory health insurance companies as data and graphics files (images). In the case of prescriptions for persons insured with private health insurance, the pharmaceutical central numbers are either handwritten on the prescriptions or printed on them, but the indication of the pharmaceutical central number is not absolutely necessary for billing.

Mail order pharmacies usually allow the PZN to be entered directly in their order form. With the introduction of the electronic prescription , the pharmaceutical registration number will continue to gain in importance.

The PZN is not only limited to Germany, it also exists in Austria. There, the first 6 digits of the 7-digit PZN (6 digits + check digit) are integrated into the EAN number for medicinal specialties (format 908888zzzzzzP). The packs have an EAN 13 barcode. In Germany, on the other hand, this integration has not yet been implemented, with the result that many over-the-counter drugs have their own EAN and PZN. In this case, however, only the EAN barcode is given on the packaging and the PZN is only given in plain text.

In Germany the PZN is assigned by the Information Center for Medicinal Specialties (IFA).

Special pharmaceutical central numbers

In addition to the centrally assigned pharmaceutical central numbers, there is an area for in-house use by pharmacies. These numbers start with 080, 081, 082 or 083. Pharmaceutical wholesalers can assign numbers starting with 050 for products that do not have a central pharmaceutical number. For some products that do not have a pharmaceutical central number, but are still billed on a prescription (e.g. products manufactured in the pharmacy or individual imports), pharmaceutical central numbers are used that start with 09999, 02566 or 02567.

Expansion to 8 digits

In November 2010 the Information Center for Medicinal Specialties (IFA) announced the expansion of the PZN. As of January 1, 2013, the PZN was expanded to 8 positions. The previous 7-digit PZN will be retained and expanded to 8 digits with a leading zero. New PZN are assigned with a leading zero until the old number range is exhausted. The last digit is still the check digit.

Structure of the barcode

In addition to the seven or eight digits, a leading minus sign is encoded in the barcode . This is used to identify the PZN; it is reserved in ISO / IEC 15418 / ANSI MH10.8.2 as an identifier for the PZN code. A PZN is coded in a barcode type Code 39 (ISO / IEC 16388). The eight-digit PZN must be differentiated from the eight-digit EAN-8 code, which is a different code type and is specified in ISO / IEC 15420. The distinction between the two code types (and indirectly the coded data content) is made using the identifier in accordance with ISO / IEC 15424.

The integration of the PZN in an EAN code became difficult due to the extension to 8 digits, as the EAN only has a very limited number range with 13 digits (GTIN: " Global Trade Item Number " in the EAN-13 code). A frequent constellation of the GTIN is a 5-digit article number, which is preceded by the manufacturer ID and the number of the GS1 issuing point for the manufacturer number . There is therefore a space problem in the EAN-13 code for an 8-digit article number. With the introduction of the securPharm system (see below), the GTIN number range 04150xxxxxxxxP was reserved for coding German PZNs in the form of a GTIN (04150 = registration code for NTIN- coded PZNs in a GTIN-14, with GTIN-13 without a leading 0) .

Adaptation to EU Directive 2011/62 / EU

With the securPharm project, the national (German) PZN is converted into an internationally unique and unmistakable article number. The need for this arises from Directive 2011/62 / EU (“Falsified Medicines Directive ”). This guideline generally requires the possibility of recognizing counterfeit drugs and the possibility of recognizing whether the original packaging has been tampered with. securPharm implements the EU directive by inserting the PZN into a data frame in accordance with international ISO standards ( ISO / IEC 15459-2 , ISO / IEC 15418 , ISO / IEC 15434 ). The ISO 22742 uses these standards and shows the general rules. securPharm uses the principle of ISO 22742 and calls the result PPN Pharmacy Product Number . In order to comply with the EU directive, the PPN (with unchanged integrated PZN) is supplemented with a serial number that is manufacturer-specific and not deterministic. There is also a batch number and an expiry date. A classic Code39 barcode like the previous PZN would become much too large with the amount of information. For this reason, the complete PPN is encoded in a data matrix code ( ISO / IEC 16022 ). Since the EU directive has to be implemented in national law, nationwide use can be expected by 2016 or 2017.

On February 9, 2016, Regulation (EU) 2016/161 was published in the Official Journal of the European Union . The regulation does not need to be transposed into national law. It is valid and the requirements for all prescription drugs must be implemented within a three-year period (by February 9, 2019).

With the article number length of up to 18 alphanumeric characters, the PPN is very flexible and can easily integrate other article number systems by defining a PraCode. The advantage here is the unchanged further use of the databases, tables and so on of the article number systems integrated in the PPN. Translation tables between different article number systems are completely eliminated.

See also

Web links

Individual evidence

  1. ↑ see rules for coding medicinal products that are subject to verification in the German market. Cape. 4.3.
  2. ↑ Directive 2011/62 / EU of the European Parliament and of the Council of June 8, 2011 amending Directive 2001/83 / EC on the creation of a Community code for human medicinal products with regard to the prevention of counterfeit medicinal products from entering the legal supply chain , accessed on 8 June 2011 . June 2014 .
  3. ↑ Delegated Regulation (EU) 2016/161 of the Commission of October 2nd, 2015 supplementing Directive 2001/83 / EC of the European Parliament and of the Council by laying down precise provisions on the safety features on the packaging of medicinal products for human use