Pharmacovigilance

Dear colleagues and drug consumers!

In order to protect the health of patients and fulfill the obligations undertaken to our clients, a pharmacovigilance system has been introduced in Business Center Pharmacy LLC.

For this, our company has developed standard operating procedures based on Ukrainian legislation and international standards. The company's employees regularly undergo pharmacovigilance trainings.

Responsible persons of the pharmacovigilance system in our company are aimed at fulfilling the tasks:
  • organization of collection, processing and evaluation of information on adverse reactions or lack of effectiveness of medicines provided by our company
  • informing regulatory authorities and manufacturers about identified cases of adverse reactions or lack of effectiveness

If you have information regarding adverse reactions or lack of effectiveness of drugs that are sold by Business Center Pharmacy LLC, we suggest that you fill out a message about a suspected adverse reaction or lack of effectiveness of a drug or provide such information in any way convenient for you.

Use the following forms to fill out:
  • For medical and pharmaceutical workers. Form No. 137 / o Card - a message about an adverse reaction and / or lack of efficacy of a medicinal product during its medical use (Download document).
  • For the patient. A message card to be provided by the patient and / or his representative, organizations representing the interests of patients, information about an adverse reaction and / or lack of efficacy of the drug during its medical use (Download document).
Information regarding adverse reactions or lack of effectiveness of drugs is taken 24 hours a day / 7 days a week.

All information that you provide to us is confidential and not subject to disclosure, except as otherwise provided by law.

Before starting to fill out a report on a suspected adverse reaction or lack of effectiveness of the drug, we ask you to familiarize yourself with the basic concepts and terms in the field of pharmacovigilance:

Adverse reaction – this is any unwanted adverse reaction that occurs when drugs are used in the usual doses recommended for the prevention, diagnosis and treatment of diseases.

Expected adverse drug reaction – This is an adverse reaction, the nature or severity of the manifestations of which corresponds to the available information about the medicinal product (for example, with the Instruction / Package leaflet for the medical use of the medicinal product).

Unexpected adverse drug reaction – This is an adverse reaction, the nature or severity of the manifestations of which does not correspond to the available information about the medicinal product (for example, with the Instruction / Package leaflet for the medical use of the medicinal product).

A serious adverse drug reaction is any adverse reaction that results in:
  • of death;
  • a condition requiring urgent hospitalization or extension of its terms;
  • a life-threatening condition;
  • disability or significant and permanent disability;
  • the development of congenital anomalies or defects.

Minor adverse drug reaction – it is any adverse reaction that does not meet the criteria for "serious adverse reaction".

Lack of drug efficacy – this is the absence of a therapeutic effect of the drug on the course and duration of the disease.

Interaction reactions – these are reactions that occur while taking several drugs, which are the result of their mutual influence on the pharmacodynamics and pharmacokinetics of each other.

Medicinal product manufacturer – this is a legal entity that carries out at least one of the stages of production of a medicinal product, including packaging.

Suspected drug – it is a medicinal product, in the appointment of which there is a causal relationship between the clinical manifestations of any adverse reaction and its medical use.

Series number – it is a characteristic combination of numbers that specifically identifies the series. Suitable for all types of packaging.