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Pharmacovigilance: Focus on the safety of veterinary medicines!
Find out how TiHo Hannover monitors adverse drug reactions in animals and offers reporting options.
Pharmacovigilance: Focus on the safety of veterinary medicines!
The safety of veterinary medicines is the focus of the newly established Pharmacovigilance Center at the Hannover University of Veterinary Medicine Foundation (TiHo). This center allows systematic monitoring of adverse events that may occur following the use of drugs in animals. Symptoms such as nausea, joint pain or skin rashes are among the possible side effects. Reports of such adverse events can be submitted by various stakeholders in veterinary medicine, such as veterinarians, veterinary technicians, animal owners and even veterinary students.
The TiHo Pharmacovigilance Center is part of the Institute of Pharmacology, Toxicology and Pharmacy. Reports can be made in different ways: by email to ue@tiho-hannover.de, by phone at +49 511 953 8721 or via an online form on the TiHo website. It is also possible to report undesirable events directly to the Federal Office of Consumer Protection and Food Safety (BVL).
Importance of pharmacovigilance
Pharmacovigilance refers to the systematic monitoring of the safety of medicines for humans and animals in order to detect and evaluate adverse reactions (ADRs). This monitoring helps minimize risk. The need for such monitoring is highlighted by the fact that clinical trials often only include a limited number of patients, thereby failing to identify rare ADRs. New safety information can emerge long after a drug has been approved for marketing. Therefore, the detection of ADRs is crucial to ensure the safety of medicines.
The thalidomide tragedy in the 1960s led to the establishment of pharmacovigilance systems in many countries to monitor the safety of medications. In Germany, the legal basis for the spontaneous reporting of ADRs has been established since 1978. However, the number of reports often falls short of expectations, compromising the effectiveness of these systems. The reporting rate in Germany is only 5-10 percent, which makes it difficult to precisely record the frequency of ADRs.
International developments
To improve the detection of ADRs, some countries are implementing intensified systems, such as Prescription Event Monitoring (PEM) in the UK and regional pharmacovigilance centers in France. In Germany, regional pharmacovigilance centers were set up as part of the 12th AMG amendment. The importance of large epidemiological studies to quantify ADRs is also emphasized.
At the European level, EudraVigilance coordinates the central recording and evaluation of ADRs. Medicines that are under additional monitoring are marked with a black triangle to highlight potential risks. The legal basis for pharmacovigilance in the European Union is Directive 2001/83/EC, which requires pharmaceutical companies to submit detailed pharmacovigilance systems and risk monitoring plans with marketing authorization applications.
Overall, it is clear that systematic monitoring of drug safety for humans and animals is of utmost importance in order to protect the health of both animals and humans and to identify potential risks at an early stage.