Moldova. Pharmacovigilance System

Low implementation of drug monitoring poses a considerable risk for patients, as pre-marketing studies cover only a very small and highly selective proportion of all the patients who will use the drug in real life and are therefore not large enough to capture all possible side effects. Despite pharmacovigilance being part of the medical curriculum and the availability of reporting forms on the MMDA website, reporting is very low. This seems to be due to a lack of understanding of the importance of reporting, poor collaboration between medical institutions, a culture of fear of making contact with authorities, lack of pharmacovigilance responsibilities for manufacturers (though a new act is under development), lack, until recently, of SOPs on pharmacovigilance activities and unclear use of the data collected. Another issue is understaffing within the MMDA which is responsible for pharmacovigiliance.

Positive developments

After being stable for several years, between 2004 and 2011 the number of reports to the pharmacovigilance department at the MMDA has increased from 72 in 2011 to 180 in 2012 (of which 171 were reported to the Ferrario et al. Journal of Pharmaceutical Policy and Practice 2014, 7:4 Page 7 of 11 http://www.joppp.org/content/7/1/4 international monitoring centre in Uppsala). While these levels are very low even for a country of the size of Moldova, this is still an encouraging signal.

In 2012, 30% of all adverse drug reactions (ADR) reports were for TB medicines, 25% for antiretroviral drugs (ARV), 11% for antibiotics, 7% for medicines to induce labour and reduce post-partum haemorrhage, 4% contraceptives, 4% antihypertensives and the remaining percentage for other therapeutic groups.

While it is not possible to compare the increase in reporting by therapeutic group due to lack of disaggregated data for previous years, most of the ADR reports in 2012 were for TB and ARV drugs (55% combined), which is likely to be linked with the trainings organised by the Global Fund to fight AIDS, tuberculosis and malaria (GF) and WHO in these two therapeutic areas. Capacity building of health staff including management of side effects and reporting is part of the GF support to the country in the area of TB and ARV treatment. In addition to that, in 2011, WHO organised a training course on pharmacovigilance for ARV drugs in Kiev and participants (doctors involved in ARV treatment and two specialists from the MMDA) became enthusiastic and started sending reports. Although the increase in reporting is a positive result, more efforts are needed to improve reporting across all disease areas.

Other positive developments include the recent adoption by the MMDA of the Vigi Flow system and the introduction of a fee for pharmacovigilance activities, which were previously funded from the general budget of the MMDA.

Source: Journal of Pharmaceutical Policy and Practice