Pharmacovigilance

Dear colleagues and consumers of medicines!

In order to protect the health of patients and fulfill their obligations to our customers, the Pharmacovigilance System has been introduced in Business Center Pharmacia LLC. To do this, our company has developed standard operating procedures based on the legislation of Ukraine and international standards. Company employees regularly undergo training in pharmacovigilance issues.

Responsible employees of the pharmacovigilance system in our company are focused on the implementation of tasks:

  • organization of the collection, processing and evaluation of information about adverse reactions or lack of effectiveness of medicines, presented by our company

  • informing regulators and manufacturers of identified cases of adverse reaction or lack of effectiveness

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

Use the following forms to fill out:

  • For medical and pharmaceutical worker. Form No. 137 / Card - a message about an adverse reaction and / or lack of efficacy of a drug during its medical use.

  • For the patient. A message card for the patient and / or his representative, the organizations representing the interests of the patient, to provide information about the adverse reaction and / or lack of efficacy of the drug during its medical use. Download the document.

Information regarding adverse reactions or lack of efficacy of medicines is taken 24 hours a day / 7 days a week. All information that you provide to us is confidential and is not subject to disclosure, except in cases established by law.

Before you start filling out a message about a suspected adverse reaction or lack of effectiveness of a drug, we ask you to familiarize yourself with the basic concepts and terms in the field of pharmacovigilance: 

An adverse reaction is any undesirable negative reaction that occurs with the use of medicines in the usual doses recommended for the prevention, diagnosis and treatment of diseases.

The expected side reaction of a drug is a side reaction, the nature or severity of the manifestations of which corresponds to the available information about the drug (for example, with the Instruction / Insert sheet for medical use of the drug).

An unexpected drug side reaction is a side reaction, the nature or severity of which does not correspond to the available information about the drug (for example, with the Instructions / Insert Sheet for medical use of the drug).

A serious adverse drug reaction is any adverse reaction that has led to:

  • of death;
  • a condition requiring urgent hospitalization or extension of its terms;
  • life threatening condition;
  • disability or significant and permanent disability;
  • the development of congenital anomalies and malformations.

A non-serious adverse drug reaction is any adverse reaction that does not meet the criteria for a "serious adverse reaction."

The lack of effectiveness of the drug is the lack of therapeutic effect of the drug on the course and duration of the disease.

Reactions of interaction are the reactions arising against reception of several medicines which are a consequence of their mutual influence on pharmacodynamics and pharmacokinetics of each other. 

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

A suspected drug is a medicament, for administration to which there is a causal relationship between the clinical manifestations of any adverse reaction and its medical use. 

A series number is a characteristic combination of numbers that specifically identifies a series. Applied to all types of packaging.