Monitoring the safety of antiretroviral medicines in Belarus
Antiretroviral (ARV) medicines for treatment of HIV/AIDS are associated with significant safety concerns, including serious adverse reactions that could affect patient adherence and complicate a national ARV programme. The failure of ARV therapy (ART) for safety or efficacy reasons increases the possibility of the development of drug-resistant viral strains and decreases the efficacy of medicinal programmes and epidemiological control.
The social significance of HIV and specificity of the local epidemiological and social situations increase the importance of a system to monitor ART safety. Evidence indicates that cohort monitoring is one of the most effective tools for ART monitoring and reporting in health care providers’ routine practice.
National monitoring programme
The first national programme for cohort adverse event monitoring (CEM) of antiretroviral medicines in Belarus began on 20 December 2012. The Ministry of Health and the centre for examinations and tests in the health service in Belarus – with support from WHO and the Uppsala Monitoring Centre, Sweden – carry out this intensive programme to monitor ART safety.
The CEM programme is conducted in five clinical sites with HIV centres: the Minsk City and Gomel regional infectious disease hospitals, and the Soligorsk, Svetlogorsk and Zhlobin central regional hospitals.
General goals of the CEM project include:
- improving patient care and ART safety/efficacy, taking account of co-morbidities and the social circumstances of every patient;
- increasing reporting among health care professionals providing ART;
- implementing an ART reporting system that collects information that can be used to improve patient safety;
- implementing an effective system for continuous monitoring of ART safety/efficacy and assurance of the safety of HIV-infected patients;
- implementing an effective system to give early warning of problems related to the use of ARV medicines;
- promoting the safe, rational and more effective use of ARV medicines;
- contributing to the assessment of benefit, harm, effectiveness and risk of medicines used in HIV-infected patients, to prevent harm and maximize benefit; and
- promoting understanding, education, training and pharmacovigilance, and effectively communicating the importance of pharmacovigilance to the public.
All scientific and practical results of the CEM programme will be presented to the pharmacovigilance and HIV research communities and the general public.