Barmer and AOK offer package inserts digitally in the app for e-patient records
Package inserts for medications will soon have to be available digitally. First health insurance companies are participating. A database is to be built by 2028.
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AOK and Barmer insured individuals can now access the digital package insert of many medications via the app for the electronic patient record – at least partially. Health insurance companies are participating in a pilot project. AOK customers can access the package insert, for example, via the app for the electronic patient record (“Mein Leben”). The function can be found in the electronic medication list. After adding a medication, if the drug is available in the database, there is an option to find the respective digital package insert.
(Image:Â AOK)
The project was initiated by various manufacturer associations, such as the Association of Research-Based Pharmaceutical Companies (vfa). A complete digital database for prescription and over-the-counter preparations is to be created by 2028.
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In an initial test, no package insert could be retrieved for a well-known headache medication. “The digital patient information was implemented as part of the joint pilot project diGItal in cooperation with several statutory health insurance companies and the company ACS PharmaProtect GmbH. A central database was connected, whose structured content is transferred to the app via the FHIR standard (Fast Healthcare Interoperability Resources),” says a spokesperson for the Federal Association of AOKs. “Currently, the digital package insert is not yet available for all medications. This is because not all manufacturers licensed in Germany are participating in the project,” explains the spokesperson. The database is to be continuously expanded, and its functional scope is also to be expanded in the future.
“It is important that we are not talking about a PDF collection here, but that the data is available in the FHIR standard to fully utilize the advantages of digital provision,” says Dennis Geisthardt from the vfa to heise online. “Digital patient information is coming and will be mandatory. This decision by the EU is a clear commitment to improving care and shows that regulatory progress is possible when one thinks in a practice-oriented way. We must now continue with the implementation – to ensure that patients always receive current and correct information, a central and reliable database should be available.”
Electronic Product Information Part of the EU Pharma Reform
As part of the European pharmaceutical package, product information must also be made available electronically on a mandatory basis. Each member state will decide whether to then abolish the paper package insert. If it is up to EU Member of Parliament Peter Liese, as quoted by Apothekenumschau, the paper insert could be abolished immediately, “as long as patients who insist on it can receive a paper printout”.
The European Medicines Agency (EMA) welcomes the reform, which revises the legal framework for medicines in the EU for the first time in more than two decades. It is intended to simplify regulation and accelerate procedures, including a revised EMA committee structure and shorter assessment periods. In addition, the reform is intended to counteract supply bottlenecks.
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Companies are to be more strongly obliged to ensure supply, must report bottlenecks and recalls early, and plan better, especially for prescription drugs. An EU-wide list of critical medicines is also intended to further increase supply security.
Further priorities include better environmental protection and combating antimicrobial resistance. Stricter environmental risk assessments, special methods for assessing risks associated with antibiotics, and stricter requirements and additional information obligations are planned.
After formal confirmation by the European Parliament and the European Council, the EMA will work with the EU Commission and the member states to develop guidelines. A new central website is planned for transparency in implementation, which will contain all information on the legislation – including technical details and guides for companies.
Studies by the Fraunhofer Institute for Material Flow and Logistics, the IGES Institute, and Rote Liste Service GmbH had previously shown that digital package inserts, in addition to better searchable patient information, also bring environmental benefits.
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