What is Pharmacovigilance?
Pharmacovigilance is a scientific and practical activity related to the detection, assessment, understanding and prevention of adverse reactions or other problems that may be associated with the use of a drug. The pharmacovigilance system operates in strict accordance with international guidelines and Ukrainian legislation.
A spontaneous adverse reaction reporting system is used to monitor and further in-depth study the safety of drugs on the market.
The system includes collecting information from all subjects of drug circulation (patients, pharmacists, doctors, etc.) in real clinical practice. This approach allows to study:
- Features of the effects of drugs on patients,
- Allows detection of rare adverse reactions,
- The behavior of drugs in vulnerable populations that were not involved in clinical trials.
What are the tasks of the pharmacovigilance service?
- Collection and evaluation of information on adverse reactions;
- Informing the State Expert Center about cases of adverse reactions that occurred in Ukraine and abroad;
- Development of risk minimization plans;
- Training company personnel in pharmacovigilance principles;
- Pharmacovigilance of the company's commercial activities;
- Safety monitoring in international and local clinical trials conducted by the company.
How does the pharmacovigilance service work?
The functioning of the pharmacovigilance service at Orisil-pharm LLC is strictly regulated by standard operating procedures (SOPs). The procedures describe in detail all tasks and mechanisms for implementing drug safety control in accordance with the legislation.
Pharmacovigilance staff are available for consultation 24 hours a day/7 days a week. If we become aware of changes in the safety profile of the company's drugs, we will inform the State Expert Center and the country's regulatory authorities as soon as possible.
Orisil-Pharm employees undergo pharmacovigilance training. Each employee is personally responsible for collecting information about adverse reactions to the company's drugs and transmitting it to the pharmacosafety service staff within 24 hours.
The department's employees check medical publications for information about adverse reactions to the company's drugs.
