SE: Stakeholders
This chapter describes how different stakeholders use, and are dependant on, Vnrs in the handling of pharmaceuticals and reimbursed consumer products on the Swedish market.
In Sweden there is not a single identification code, which provides a unique identity for all pharmaceuticals, medical devices, and consumer products. However, the Vnr has, in combination with other identification codes, a very important function in the handling of pharmaceuticals on the Swedish market.
It is extremely important that manufacturers working with products on the Swedish market are aware that the Vnr is a critical attribute. It functions as an information carrier between a number of IT-systems involved in the prescription, dispensing, ordering, storage and information regarding medicines. The usage of the Vnr is therefore a matter of well-functioning management of articles as well as patient safety. In addition, electronic prescriptions as well as highly automated management systems in all parts of the distribution chain enhance the risk of fatal consequences if a Vnr is mixed or incorrect.
In order for the distribution chain to function safely, it is important to know when and how an article should change Vnrs.
An error in a Vnr may result in unexpected and serious consequences. The result of an incorrect Vnr can be that a pharmaceutical loses its identification or is identified as a completely different pharmaceutical. After the reregulation of the pharmacy market the systems of the stakeholders have became highly automated and integrated, which further increases the need for correct Vnrs in order for the management of pharmaceuticals to function efficiently and safely.
In Sweden, the handling of Vnrs is funded through the FASS-charge and therefore there is no direct cost associated with acquiring a Vnr.
The administration of the Vnr system is under responsibility of the Nordic Number Centre, (NNC) , vnr@vnr.fi, located at Pharmaceutical Information centre Ltd. (Lääketietokeskus Oy), Helsinki, Finland.
2.1 Medical Product Agency – Läkemedelsverket (regulatory control)
The Medical Product Agency (Läkemedelsverket) use NPL id and NPL pack id as identification codes. Vnrs are not used, but in NPL there is a field for Vnr, which the responsible company adds together with other information.
2.2 TLV (prices)
Please read TLV’s document Information om ändringar i NPL som kan beröra subvention av läkemedel. The document is available on the website of TLV: http://www.tlv.se/lakemedel/ansok-om-pris-eller-subvention/information-om-andringar-i-nationellt-produktregister-for-lakemedel-npl/
2.3 eHälsomyndigheten (VARA – a national product and article register)
eHälsomyndigheten has the national responsibility to compile and supply a national product and article register to the Swedish market. The purpose of the register, called VARA, is to supply the Swedish market with up to date and quality assured product and article information for the approved pharmaceuticals on the market in Sweden and consumer products within the reimbursement system.
It is the responsibility of the information owners, such as TLV, MPA (LV) and pharma companies to deliver quality assured information to VARA and quickly correct any deviations.
Since information in NPL is distributed via VARA to the various stakeholders in the market, which in turn uses the information in a variety of situations and systems, it is very important that the Vnrs saved in NPL are correct. Changes in NPL are transferred and updated automatically in subsequent systems. Please be very careful when entering the Vnr. Notify eHälsomyndigheten and correct immediately if an error occurs. When the flag “On the market” once has been set and saved to “yes” the article information will always be distributed from VARA.
If an incorrect Vnr has been saved in NPL, and it is discovered later, prescription on the Vnr may have occurred. In such a situation – always contact eHälsomyndigheten to discuss how the situation should be handled. It is very important not to delete, edit or otherwise modify the incorrect information without first consulting with eHälsomyndigheten, since it can have major consequences in subsequent systems.
When a pharma company is about to change a specific Vnr, it is important to make the change in NPL a couple of days before the new packages are available at the distributor. The reason for this is to synchronize the change of Vnr between the pharmacies and the distributor in order to maintain the whole distribution chain. If the change of Vnr is done too early or too late in NPL, there is a risk that the pharmacies purchase orders won’t be recognized by the distributor.
2.4 Wholesale distributors (distribute)
Currently the distribution systems of the two main distributors in the Swedish market, Oriola and Tamro, use Vnrs to identify articles.
Vnrs are used throughout the whole distribution chain from pharma companies to the patient, e.g. purchase orders, inventory management and traceability according to GDP. In addition, all pharmacies currently order on Vnrs.
When the same Vnr is used in several Nordic countries for an identical article where only the product information leaflet in the packages is different there are problems in the handling of the article, since it is not visible on the package for which country the package is intended. If an article is sent to the wrong country it results in withdrawals.
2.5 Health care (prescribe)
Currently the handling of pharmaceuticals in health care would not function without Vnrs.
Most health care systems currently use Vnrs to identify pharmaceuticals when medicines are prescribed. It is therefore important that the Vnrs are updated and correct.
To be able to follow the information about a pharmaceutical over time, it is important that the article history of Vnrs is complete and clear, and that as few changes as possible are made to the article.
2.6 Pharmacies (logistics and dispensing)
Vnrs are necessary for many of the processes in pharmacies. They play a central role in
- Ordering from different pharmaceutical distributors and all parts of stock management in all kinds of pharmacies
- Dispensing with the support of the IT-systems for prescription dispensing in retail pharmacies, dose dispensing pharmacies, hospital pharmacies and distance pharmacies
- Ordering and dispensing of e-prescriptions, customer service etc.
- Management of article information in article repositories and article information in intra- as well as internet information systems
- Ordering systems for hospitals
The Vnrs are the information carriers between different IT-systems. This can be exemplified by the situation when a doctor is prescribing electronically to the national e-prescription database. The doctor prescribes a certain product and the information sent from his computer to the e-prescription database is only the Vnr for this product.
When the pharmacist dispenses this product the prescription is picked up from the e-prescription database and again the information about the selected product is transferred between the two systems in the form of the Vnr for the product. Also in the work with dispensing, handling reimbursement and payment etc. it is the Vnr that is used for transferring information between different systems.
Due to the important role of Vnrs in the management of prescribed drugs it is crucial that the Vnr is correct, showing the article it belongs to and being transferred in a safe and correct way between systems.