Pharmacovigilance in Germany and Europe

Why are side effects recorded in Germany?

Side effects in Germany have been increasingly collected in a decentralized man in the past. This means that various players in the healthcare sector, i.e. patients, medical professionals and authorities, reported side effects in a variety of ways.

The trend is heading in a different direction these days — it is increasingly being centralized and reported across Europe, which is significantly more efficient. For this reason, the Federal Association of Pharmaceutical Industry e.V. (BPI) predicted an increase in notifiable side effect cases to 500,000 per year in 2016.^[1] Reports from all parties are collected and processed centrally by the European Medicines Agency (EMA) alone.

In fact, recording and monitoring side effects still makes an essential contribution to drug safety even after market approval.^[2] Some very rare side effects, for example, only become apparent through monitoring by the general public. In addition, a more efficient and accurate benefit-risk analysis can be carried out in this way.

What is the legal basis for monitoring medicinal products?

In Germany, pharmaceutical manufacturers with approved drugs are required in accordance with Section 63b of the German Medicines Act (AMG) to set up a pharmacovigilance system, i.e. a system for the systematic monitoring of their drugs.

Doctors and pharmacists are also required to report adverse side effects to the respective Medicines Commission when they become known. Although patients can also submit drug notifications, they are not required to do so, even in the event of unexpected serious side effects.

Patients are the most powerful source of information and are actually ideally suited to fill pharmaceutical manufacturers' pharmacovigilance systems with valuable data.

What ways to report side effects are there anyway?

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A look at the existing reporting system in Germany shows the variety of options, some of which can be very confusing for patients and notifiers: Doctors and pharmacists should, in accordance with the requirements of their respective Commission, first report drug side effects to their respective Medicines Commission. The Medicines Commission of the German Medical Association, AkdAE for short, is responsible for doctors, and the Medicines Commission of German Pharmacists, the so-called AMK, is responsible for pharmacists.

The two drug commissions then forward the reports collectively to the higher federal authorities, i.e. the Paul Ehrlich Institute, PEI for short, and the Federal Institute for Drugs and Medical Devices, BfArM for short. From there, complete reports are forwarded to the EMA's European pharmacovigilance system, known as EudraVigilance.

However, it has become established that doctors and pharmacists report side effects directly to pharmaceutical manufacturers from time to time. Because a report is often accompanied by medical questions or product complaints.

In addition to these reports, pharmaceutical manufacturers also receive reports from patients themselves and forward them to the EMA via their pharmacovigilance system. There, the reports are again entered into EudraVigilance.

As can be seen in the graph, patients can report themselves to all institutions, i.e. pharmaceutical manufacturers, doctors and pharmacists as well as to higher federal authorities. As is easy to assume, these diverse reporting chains, which are often confusing for the user, can result in double notifications or even the disappearance of individual messages.

In addition, the filing of a report is not necessarily clearly structured for the average person. For a notification to be considered complete, it must fully meet four criteria^[3]:

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1. One or more suspicious side effect (s)
2. One or more suspicious substance (s) or medical product (s)
3. One or more uniquely identifiable patient (s)
4. One or more uniquely identifiable reporting source (s)

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Why does XO Life collect patient data on side effects?

While digitization in the health sector increasingly requires multilateral communication on equal terms, comprehensive access to health information, as well as trust and security, we have set ourselves the task of supporting this development. To this end, we have set up a multi-directional communication platform, which allows patients to report adverse drug effects quickly, easily and in a structured manner.

The reports are passed on to the respective authorisation holder in pseudonymized form, i.e. without revealing the personal identity of the notifier. For their part, manufacturers can send digital queries, so-called follow-ups, to patients with just a few clicks, which can answer them directly on a smartphone or laptop.

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What are the benefits of the XO Life platform?

Our platform has been proven to result in a 10-fold higher response rate from patients. Entire messages can usually be closed after 72 hours, which represents a significant time improvement over the current system. A look at the latest figures^[4], nearly 30% were processed through XO Life's platform. of drug notifications shows that of over 60,000 notifications received in 2020, just under 30% were processed via the XO Life platform. However, the number of total drug notifications is declining; in 2018, for example, there were still around 80,000 notifications.^[5] This is certainly partly due to declining doctor visits due to the COVID-19 pandemic. Healthcare professionals recorded around 15% fewer reports during this period.

It is interesting, however, that direct patient reports have increased by 36% in the same period.^{[4; 5]} This clearly underlines the trend of so-called patient empowerment. Patients are increasingly taking their health concerns into their own hands. To do this, patients use precisely digital, user-centered tools for direct communication between patients and pharmaceutical manufacturers. XO Life's communication platform is a typical example of such a digital tool.

This is how we want to shape the pharmacovigilance of the future, through digitization and automation.

Our goal is to make clearly structured data sets available to enable pharmaceutical manufacturers to quickly and efficiently evaluate safety-critical data. Of course, it is our highest aim to do this work in compliance with all the rules of the GDPR.

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Conclusion

Almost 100 pharmaceutical manufacturers are already registered on XO Life's real-world evidence platform. 50% of these also use the digital feedback option for patients — and the trend is rising sharply. This shows very clearly that pharmaceutical manufacturers are very interested in a simple reporting and communication platform to get in touch with their customers.

This not only helps general drug safety but also makes work easier for pharmacovigilance departments of many pharmaceutical manufacturers. XO Life helps patients and pharmaceutical companies get in direct contact to create an all-encompassing reporting and communication platform with data from real care.

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sources:

^[1] Federal Association of the Pharmaceutical Industry e. V. & Thurisch, B. (2016). Collection of adverse reaction reports challenges for the pharmaceutical industry [lecture slides]. Bfarm.de. https://www.bfarm.de/SharedDocs/Downloads/DE/Service/Termine-und-Veranstaltungen/dialogveranstaltungen/dialog_2016/160226/03_Folien_Thurisch.pdf?__blob=publicationFile&v=2

^[2] Commas, E., Lex, D., Huber, M. & Paeschke, N. (2019). Report suspected cases. DAZ.online. https://www.deutsche-apotheker-zeitung.de/daz-az/2019/daz-37-2019/verdachtsfaelle-melden

^[3] European Medicines Agency. (2017). Guideline on good pharmacovigilance practices (GVP). ema.europa.eu. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-good-pharmacovigilance-practices-gvp-module-vi-collection-management-submission-reports_en.pdf Last accessed: 19.05.2021

^[4] Federal Institute for Drugs and Medical Devices. (2021). Side effect reports State of the BfArM. 88th routine session.

^[5] Federal Institute for Drugs and Medical Devices. (2019). Side effect reports State of the BfArM. 84th routine session.