Delivering quality therapy since 1901

Pharmacovigilance

Our Company attaches great importance to drug safety, viewing it as a service whose goal is to ensure the conditions for the safe use of drugs for both physicians and patients and to comply with regulations and guidelines.

 

The Richter Group is constantly providing patients and physicians with up-to-date information to ensure the safe use of drugs, and it strives to answer all questions as soon as they arise and solve all issues raised by patients and physicians. In order to do so, Richter operates round-the-clock communication channels and information interfaces.

If you want to report a side effect, please click on the following link: report a side effect

What is pharmacovigilance?

Pharmacovigilance is a compound word derived from pharmakon (Greek for drug) and vigilare (Latin for to keep watch) that means guarding against the adverse effects of pharmaceutical products. Guarding means ensuring the safe use of drugs, assessing their efficacy and monitoring new and known side effects.

The term pharmacovigilance includes any activity carried out in order to ensure the safe use of drugs. According to the WHO definition published in 2002, pharmacovigilance “is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.”

According to the European Commission, “pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines. It is a key public health function.”

The tasks of pharmacovigilance:

  • identifying adverse effects caused by previously unknown drugs;
  • assessing the risks/benefits of drugs, estimating risks/rewards;
  • providing consumers with information on the safe use and efficacy of products;
  • facilitating and supporting measures in connection with using drugs more safely;
  • monitoring the effectiveness of these measures.

Pharmacovigilance also includes all the clinical aspects of drug safety, which include the following areas:

  • managing the safety of drugs in the clinical phase;
  • reporting side effects in healthy and ill populations;
  • studying, assessing and summarising drugs that are already on the market.

What is the significance of pharmacovigilance?

  • Diseases caused by the side effects of drugs are among the most frequent illnesses.
  • The side effects of drugs are one of the leading causes of death (in Europe they are the fifth most frequent cause of death).
  • A significant percentage of hospitalisations are due the adverse effects of drugs (one-fifth of admissions are due to drug side effects).