In 2022, the Paul-Ehrlich-Institut successfully implemented digital reporting of human vaccine supply shortages via PharmNet.Bund.
Human vaccine supply shortage reports are published on the Paul-Ehrlich-Institut's website. The reports contain data on the supply shortage as well as other relevant information, e.g. on alternative vaccines or vaccination options. Supply shortage reports are submitted by the pharmaceutical companies and are predicated on a voluntary commitment to report supply shortages for supply-relevant medicines.
A portal with a form-based reporting system for the submission of supply shortage reports to the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) was made available in 2016. In the next expansion stage of the PharmNet.Bund portal, BfArM and the Paul-Ehrlich-Institut developed an online reporting portal for supply shortages. This portal ensures that submissions meet quality standards, supported by an automated process linked to a regulatory database. The system was developed to significantly improve the flow of information in the event of impending supply shortages, to serve as support for decisions on countermeasures, and thus to contribute to increased safety for patients or persons to be vaccinated.
Reporting of human vaccine supply shortages was switched from the form-based reporting system to the online portal in April 2022. Since then, supply shortage reports have been transmitted electronically by the PharmNet.Bund portal to the Paul-Ehrlich-Institut. The reports are received using specially developed software and evaluated by Institute experts. As of December 2022, the reports are also automatically published on the Paul-Ehrlich-Institut's website.
Following those developments, it is also now possible to submit a digital report if a manufacturer has completely sold out of an influenza vaccine product in the course of a season and no doses of the seasonal vaccine product are available from the manufacturer as a result. This information will then be published on the Paul-Ehrlich-Institut's website in the section on influenza vaccines.
In addition, doctors, pharmacists or private individuals can submit a report if the desired vaccine product is not listed among the supply shortages on the Paul-Ehrlich-Institut’s website and is not available to the reporter. These reports should be submitted via web form on the Paul-Ehrlich-Institut's website.
The introduction of digital supply shortage reports for human vaccines represents the last step towards the digitalisation of drug supply shortage reports in Germany, thus paving the way for connection to the European Shortages Monitoring Platform (ESMP).
Human Vaccine Supply Shortage Reports
Influenza Vaccines
Reporting of Suspected Supply Shortages by the Consumer