The first national programme of “Cohort adverse event monitoring (CEM) of antiretroviral medicines in Belarus” starts

ARV medicines are associated with significant safety concerns including serious adverse reactions that could affect patient adherence and complicate national ARV programme. Failure of ARV therapy related to safety or efficacy reasons increases the possibility of development of drug–resistant viral strains, decreases the efficacy of medicinal programme and epidemiological control.

ARV medicines are associated with significant safety concerns including serious adverse reactions that could affect patient adherence and complicate national ARV programme. Failure of ARV therapy related to safety or efficacy reasons increases the possibility of development of drug–resistant viral strains, decreases the efficacy of medicinal programme and epidemiological control. Social significance of the HIV infection and specificity of the local epidemiological and sociological situation makes the implementation of the ARVT safety monitoring system very important. There are enough evidence that cohort monitoring is one of the most effective tools for implementation of the ADR monitoring and reporting activity in the health care providers’ routine practice.

On 20th of December the first national programme of “Cohort adverse event monitoring (CEM) of antiretroviral medicines in the Republic of Belarus” starts. This intensive ARVT safety monitoring project is performed by the Ministry of Health of the Republic of Belarus, Center for Examinations and Tests in Health Service with the support from the World Health Organization and Uppsala Monitoring Centre. CEM Programme will be conducted in five clinical sites with operating HIV centers: Minsk City Infectious Disease Hospital, Gomel Regional Infectious Disease Hospital, Svetlogorsk Central Regional Hospital, Soligorsk Central Regional Hospital and Zhlobin central regional hospital.

General goals of the CEM project include:

1.             Improving of patients care and ART safety/efficacy taking into account comorbidity and social specificity of every patient.

2.             Increasing of reporting activity among ART HCP, implementation of ART reporting system that receives information that can be used to improve patient safety.

3.             Implementation of the effective system of continuous safety/efficacy ART monitoring and assurance of safety of HIV–infected patients.

4.             Implementation of the effective system of early warning of problems related to the use of ARV medicines.

5.             Encouraging the safe, rational and more effective use of ARV drugs.

6.             Contributing to the assessment of benefit, harm, effectiveness and risk of medicines used in HIV–infected patients, leading to the prevention of harm and maximization of benefit.

7.             Promote understanding, education and training and pharmacovigilance and its effective communication to the public.

All scientific and practical results of the CEM Programme will be presented to pharmacovigilance community, HIV research community and general public.

Please see poster in Russian (pdf).