Before a marketing authorisation is granted for a medicine, its benefits and risks are weighed carefully. Pharmaceutical companies and the authorities continue to monitor the safety, efficacy and quality of pharmaceutical products after they have been brought to market. Safety information is collected about suspected adverse events, inefficacy, medication errors, interactions, exposure during pregnancy and overdoses, for example.
It is important to monitor the safety of medicines after the marketing authorisations have been secured, particularly because before this, the medicine has usually been tested on only a few thousand or fewer people in controlled conditions. In reality, a medicine may have millions of users, and patients and their special circumstances can vary greatly. For this reason, it is not always possible to find all the data related to the adverse events or safety of the medicine when clinical trials – that is, studies on people – are being carried out.
The management and reporting of drug safety data is an essential part of pharmacovigilance. This is a binding obligation for marketing authorisation holders such as Orion.
Safety data is compiled over the entire life cycle of a medicine
In addition to their intended effects, all medicines have adverse effects – that is, unintended and harmful effects – on some users. Adverse effects range from mild to severe, and information about them is provided in the package leaflet, for example. The adverse effects that are more difficult to identify can be associated with other simultaneous conditions and medication, pregnancy, long-term use and extremely rare side effects.
Information about adverse events and other factors affecting patient safety is updated throughout the life cycle of products. The monitoring of these is global, and is carried out by the national authorities in different countries in collaboration with pharmaceutical companies. We receive information from all over the world about the adverse events and other safety issues of the medicines that we market, throughout their life cycles.
In the most serious cases, the use of a medicine can be limited or even prohibited if the risks related to the medicine outweigh its benefits. For patients and professionals, safety data management is an important way to convey information about adverse effects or other aspects. This also improves patient and medication safety and the accuracy of product information.
Continuous dialogue with the authorities
We engage in continuous interaction with the authorities. This interaction is guided by highly detailed legislation, which determines what should be reported and when. In addition to reporting individual cases, we prepare reports for the authorities on events and conclusions over the long term. All the events reported to us are also reported forward to a centralised European database where the information is available to all authorities in the European Economic Area (EEA) in real time.
For healthcare professionals and consumers, the reporting of adverse effects to pharmaceutical companies or the authorities is voluntary. It is carried out by doctors and healthcare and pharmacy staff, as well as patients and their families and carers. Orion’s employees have an obligation to report immediately if they become aware of any adverse effects related to our products. We encourage consumers and healthcare professionals to report any adverse effects, so that the overall picture of the safety of a medicine is as comprehensive as possible.