Pharmacovigilance | Amicum Pharma

Pharmacovigilance

Dear partners, clients, and consumers of medicinal products!

Amicum Pharma LLC pays special attention to the safety of medicinal products use and cares about the health of every person. To achieve this goal, the company has established a pharmacovigilance system, which is aimed at the continuous monitoring of the efficacy, quality, and safety of products, as well as the timely detection, assessment, understanding, and prevention of possible adverse reactions.

If during the use of a medicinal product you notice the occurrence of an adverse reaction, lack of efficacy, record a medication error, overdose, or other problem related to the use of a medicinal product, please report it to our pharmacovigilance service. The information provided by you is important for ensuring patient safety and improving the quality of medicinal products.

What information is desirable to specify:

For a correct assessment of the report, it is desirable that it contains:

  • information about the patient (age or age group, sex);
  • a description of the adverse reaction or problem;
  • the name of the medicinal product, dosage;
  • contact details of the reporting person (to enable clarification of additional information).

How to report a problem with the quality or safety of a medicinal product?

You can transmit information to the pharmacovigilance service of Amicum Pharma LLC in one of the ways convenient for you:

  • By phone (around the clock, 24/7) 095-335-00-50.
  • By email: send a message with a description of the situation to the address: pvg@amicum.com.ua

All received information is processed confidentially and used exclusively for the purpose of monitoring the safety of medicinal products in accordance with the current legislation of Ukraine in the field of pharmacovigilance.

BASIC TERMS AND CONCEPTS

Pharmaceutical control (pharmacy control) includes research and activities aimed at identifying, evaluating, understanding adverse reactions and preventing them, as well as any other problems related to the use of medicine.

Adverse reaction means any undesirable adverse reaction that occurs with the use of medicine at the usual doses recommended for the prevention, diagnosis and treatment of diseases.

Lack of effectiveness of the medicine presupposes the lack of therapeutic effect of the medicine on the course and duration of the disease.

Series number  is a characteristic combination of numbers (five, six, or seven digits) specifically identifying the series. It can be applied to all types of packaging.

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AMICUM PHARMA

The international practice and the World Health Organization (WHO) define pharmacy control is understood as a set of measures to detect, control and prevent adverse reactions caused by the administration of medicine and other biologically active drugs, as well as the lack of efficacy of medicine and/or absence of therapeutic effect.

The process of pharmacy control accompanies pharmaceutical products all the time from the development of medicine in scientific laboratories until they reach the consumer – the patients. Pharmacy control in most countries of the world is performed by the state through appropriate control bodies and producers of products. Therefore, pharmacy control, in addition to controlling the quality and effectiveness of medicine, is also an effective mechanism for combating counterfeiting.

Amikum Pharma is responsible for the products we offer and the quality of our service. That is why we have introduced our own pharmacy control system to collect all of us and our clients’ medical emergencies.