Pharmacovigilance is a scientific and practical activity related to identification, evaluation, understanding and prevention of adverse reactions or other possible drug-associated problems. Pharmacovigilance system works in strict adherence to international directives and Ukrainian legislation. For monitoring and further in-depth study of drugs safety in the market, a spontaneous reporting system for adverse reactions is used.
The system includes collection of information from all subjects of treatment with the medicinal product (patients, pharmacists, physicians, etc.) in conditions of real clinical practice. This approach:
– allows us to study the peculiarities of the impact of drugs on patients
– makes possible to reveal rare adverse effects,
– reveals previously unexplored facts of interaction with other drugs,
– allows to study the impact of drugs in vulnerable groups of people who were not involved in clinical studies.
What are the tasks of the pharmacovigilance service?
- Collection and evaluation of information on adverse reactions;
- Informing of the State Expert Center about adverse reactions occurring on the territory of Ukraine and abroad;
- Development of risk minimization plans;
- Personnel training for the principles of pharmacovigilance;
- Pharmacovigilance for commercial activities of the company;
- Security monitoring in international and local clinical trials conducted by the company.
How does pharmacovigilance work?
The functioning of the pharmacovigilance service at “Orisil-Pharm” Ltd. is strictly regulated by standard operating procedures (SOPs). The procedures describe in detail all the tasks and mechanisms for monitoring safety of drugs in accordance with the law.
Pharmacovigilance assistants are available 24 hours a day/7 days a week for consultation. If we become aware of changes in the company’s safety profile, we inform the State Expert Center and the national regulatory authorities as soon as possible.
The employees of the company “Orisil-Pharm” are trained in pharmacovigilance. Each employee is personally responsible for collecting information about unwanted reactions associated with drugs manufactured by the company and transferring it within 24 hours to the employees of the pharmacovigilance service.
The employees of the department inspect medical editions for the availability of information on adverse reactions associated with the drugs manufactured by the company.
If you have information about the adverse reactions to “Orisil-Pharm” product, you can report it to:
Tel .: (032) 297 04 06
Important! The message shall contain the following information:
1. Patient (initials, age, gender).
2. Name of drug
3. Description of the reaction.
4. Information about the attending physician.
5. Contact for feedback.