Introduction: One of the most significant new risk-minimization measure established in 2012 was the development of the concept of additional
monitoring of medicinal products. More than 5 years after its implementation it remains unclear what benefits it brings to the pharmacovigilance system
and knowledge. The conducted study aims to evaluate patients’ level of knowledge on pharmacovigilance with a focus on the additional monitoring
component.
Methods: For the purpose of the study a closed-ended questionnaire has been developed and validated. For the current study 316 question sheet were
analyzed. Statistical methods used include quadratic analysis (Table 2*2 was applied to a Fisher Exam), non-Particular Tests by Man-Whitney and
Kruskal-Wallis and Kolmogorov-Smirnov test.
Results: 31,3% of the participants in the survey claimed they were informed about the possibility of direct ADR reporting to the national competent
authority (NCA) with most of them not taking medicinal products on a daily basis. Only one out of five respondents (21,5%) declared themselves familiar
with the meaning of the black triangle symbol. People without chronic diseases answered the question positively more frequently compared to everyday
medicines users.
Conclusion: Based on the obtained results it cannot be concluded that the black triangle symbol for additional monitoring has served its purpose due
to the fact that majority of the participants in the survey are not familiar with its meaning. In order to ameliorate the post-marketing surveillance of new
drugs innovative approaches should be reconsidered. Multidisciplinary methods for additional monitoring must be implemented in order to reflect the
complex nature of pharmaceutical system.
Author(s): Violeta Getova, MSc Pharm, PhD, Stanislav Gueorgiev, PhD, and Prof. Ilko Getov, PhD