Drug Safety and Pharmacovigilance

The incredible scientific progress in the field of medicine and pharmacy is considered one of the greatest achievements of mankind. Today we can successfully treat many of those diseases even about which we knew almosth nothing 100 years ago. Life expectancy has increased, thanks in large part to the development of health care and new drugs. Drug safety and pharmacovigilance are essential part of this.

Every year, dozens of new medicines registered in the EU. But any drug that benefits its patients also carries certain risks. We should understand that there can be no completely safe drug (even if the advertisement or information on the package assures the opposite).

Ancient Paracelsus said, “All things are poison, and nothing is without poison, the dosage alone makes it so a thing is not a poison”. Similarly, drugs have both benefits and risks. Only those drugs in which benefits prevails over risks may be on the pharmaceutical market. Most of the drug risks can be estimated based on clinical results before registration and the drug market lauch. However, not all potential adverse drug reactions (ADRs) can be identified in this way.

Clinical trials and adverse reactions

Imagine 1,000 patients participated in the clinical trial of the drug. The adverse drug reaction is serious but rare and occurs at a frequency of 1 case per 10,000 (or 100,000) patients. In that case, most l it will not be detected during this clinical trial. That is why it is very important to monitor the drug safety after receiving the market approval. And pharmacovigilance is responsible for it. The owner of the drug authorization is fully responsible for the safety of its product. Detection, evaluation, analysis, and prevention of drug-related adverse reactions are main tasks of drug safety activities.

Pharmacovigilance in Ukraine

Pharmacovigilance in Ukraine is carried out both at the level of the state (State Expert Center of the Ministry of Health of Ukraine) and each company that produces drugs for the market.

The owner of the drug authorization is fully responsible for the safety of its product. The daily tasks of specialists in pharmacovigilance include continuous monitoring of drug safety data, taking measures to minimize risks; updating drug information. Proper communication of drug safety to patients, medical and pharmaceutical specialists is also a part of responsibility.

Thus, drug safety is very important and critical process. Realizing this, the DrugCard team developed the electronic pharmacovigilance platform. Our experience in drug safety allowed us to make a convenient, reliable and valid system. Leave the routine to us, the important tasks to your experts.