Monitoring the safety of medicinal products in their medical use is one of the main directions in the implementation of the national policy on medicines in all countries of the world. The international and national regulatory mechanism for monitoring the safety of medicinal products has been called pharmacovigilance. The main objects of observation of the pharmacovigilance system are adverse reactions of medicinal products and cases of lack of effectiveness of medicines in their medical use. It should be noted that the proper quality of medicinal products is not an absolute guarantee that pharmacotherapy will not have adverse consequences. The use of medicinal products implies that their therapeutic effect should occur, but at the same time adverse reactions may arise. The latter are caused by the pharmacological properties of the active substance of the medicinal product or by the specific features of the body's response to its administration. It is precisely these issues that pharmacovigilance addresses.
The main areas of work of the pharmacovigilance system are:
- collection, analysis and summarisation of information on the safety, adverse reactions and lack of effectiveness of medicinal products;
- preparation of proposals for the Ministry of Health of Ukraine on the full or partial prohibition of a medicinal product, and the introduction of additions or changes to the instructions for the medical use of a medicinal product;
- conducting specialized expert evaluation of re-registration materials on the safety of medicinal products and materials submitted for variations;
- exercising control over the functioning of pharmacovigilance in the healthcare system and at the applicant;
- information and methodological support of the healthcare system on the safety of medicinal products, and awareness-raising activities.
The main result of the activity of the state pharmacovigilance system is the withdrawal from the pharmaceutical market of products whose risk of use outweighs the benefit.
The pharmacovigilance system in Ukraine has been functioning since 1996. Pharmacovigilance in Ukraine is regulated by the order of the Ministry of Health of Ukraine dated 27.12.2006 No. 898 “On approval of the Procedure for monitoring adverse reactions of medicinal products authorized for medical use” (registered with the Ministry of Justice of Ukraine on 29.01.2007 under No. 73/13340). This document is harmonized with international approaches to pharmacovigilance (WHO) and European legislation (Directive of the European Parliament and of the Council of the EU dated 06.11.2001 No. 2001/83 EU).
Pursuant to the order of the Ministry of Health of Ukraine dated 27.12.2006 No. 898, the Ministry of Health of Ukraine assigned the responsibility for supervising the safety of medicines to the State Enterprise "State Expert Center of the MoH". The state pharmacovigilance system is represented by its central body – the Post-Registration Surveillance Department of the State Enterprise "State Expert Center of the MoH" – and by the Department's regional offices, which operate in all regions of Ukraine. In healthcare institutions, this process is coordinated by pharmacovigilance officers, who are mainly deputy chief physicians for medical work, as well as heads of departments. The Department carries out pharmacovigilance by involving employees with medical and/or pharmaceutical education from all healthcare institutions regardless of their form of ownership, applicants, patients and patient rights organizations.
Thanks to the information obtained through pharmacovigilance in Ukraine, the Ministry of Health of Ukraine adopted important regulatory decisions, in particular to ban the use of such products as haemodesis, euphylline, where the stabiliser was ethylenediamine, kava-kava, cimetidine, furacilin tablets for internal use, combined products of diclofenac and nimesulide with resorptive action, rimonabant, efalizumab, sibutramine, rosiglitazone, as well as calcitonin (in the nasal spray dosage form), ketoconazole, the risk of which outweighed the benefit. In addition, the medical use of the following products was significantly restricted: gentamicin, metamizole sodium (analgin), detoxification solutions containing low-molecular-weight polyvinylpyrrolidone, rofecoxib, thioridazine, nimesulide, oseltamivir, calcitonin, trimetazidine.
Information on the pharmacovigilance system of Ukraine, the regulatory decisions adopted, and medicines safety news is published on the official website of the Center (http://www.dec.gov.ua) on the "Pharmacovigilance" page. Since 2002 Ukraine has been a full member of the WHO International Programme for International Drug Monitoring, which is coordinated by the WHO Uppsala Monitoring Centre, which is evidence that the pharmacovigilance system of Ukraine complies with world standards of effectiveness.
