Problem of insufficient involvement of population into pharmacovigilance system

Self Cite

Good pharmacovigilance practices (GVP) of the Eurasian Economic Union (EAEU) were prepared based on the GVP of the European Medicines Agency that have been in force in the European Union (EU) since 2012. The EAEU GVP have been in force in the Russian Federation and the other EAEU member states since 2016. It is important to identify potential diﬀerences between the current regulations in order to harmonise requirements for the pharmacovigilance systems in the EU and EAEU. The aim of the study was to analyse and compare GVP requirements in the EU and EAEU. The analysis helped to identify diﬀerences in the structure and contents of GVP sections, the deﬁnitions of terms (EU GVP deﬁnitions are more detailed and supported by examples, subsections, and references to other documents). Moreover, supplements and annexes to the EU GVP contain ﬁgures, templates, examples, algorithms, and tables, which are missing in the EAEU GVP. Expert analysis of these diﬀerences as applied to assessment of the pharmacovigilance systems’ eﬀectiveness, and practical activities of marketing authorisation holders, medicine developers, and regulatory authorities, demonstrated that the two GVPs are suﬃciently harmonised and have very few diﬀerences. However, the number of diﬀerences between the documents increases, as changes are made to the EU GVP. A more comprehensive harmonisation of the EAEU GVP with the current version of the EU GVP will make it possible to develop and use uniform pharmacovigilance documents in the EU and EAEU, and will facilitate the introduction of EAEU medicines into the global pharmaceutical market.

unclassified

Differences between the European and Eurasian Good Pharmacovigilance Practices

Матвеев¹,

Крашенинников

Матвеева

et al. 2021

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Learning Needs as a Reflection of Professional Interests among Health Experts

Голоенко

Ягудина

Куликов

et al. 2019

Eurasian Economic Union claims single rules for pharmaceutical circulation it will the ground for organizing the single pharmaceutical market. Because of such changes all the specialist from pharmaceutical market have to know all the new legislations. For the purpose of raise the organization responsibilities for quality and safety pharmaceuticals. Market autorotation holder have to create pharmacovigilance system. In connection with it the framework of the social survey was to find out the educational needs in pharmacovigilance among the health experts. The results of polling showed that experts had diffi culties in preparing pharmacovigilance documents. Major of the pollees expressed a wish to complete educational training which will be dedicated to the system of pharmacovigilance. The social survey results shows: converts educational needs among the pollees from 23 to 65 %, it points that experts want to get more additional information and some practical cases for understanding some issues in pharmacovigilance system through workshops, educational programs.

Analysis of Data on Adverse Drug Reactions and Functional Flaws of the Pharmacovigilance System Associated with Self-Treatment with Antibiotics

Верлан

Moroz

Kochkina

et al. 2022

In the Russian Federation, a substantial proportion of the population (39.3–75.7%) opts for self-treatment. Self-administration of prescription medicinal products, particularly antibiotics, can lead to serious adverse drug reactions (ADRs). The safety of medicines in circulation relies upon the proper functioning of the pharmacovigilance system, both in general and in the case of self-medication ADRs.The aim of the study was to analyse data on the serious ADRs attributed to self-treatment with antibiotics and reported to the Regional Centre for Drug Safety Monitoring of the Irkutsk Region, as well as on the pharmacovigilance problems associated with self-treatment.Materials and methods: the study analysed the suspected ADR reporting forms from the database accumulated by the Regional Centre for Drug Safety Monitoring of the Irkutsk Region in 2011–2019. The inclusion criteria for the reporting forms were full completion and a Naranjo probability score categorising antibiotic–ADR causality at least as “possible”.Results: of the total 2325 reports in the database, 790 (34%) were on the ADRs associated with the use of antibiotics. Of these, 222 reported serious ADRs caused by self-medication. The largest number of ADRs (126) was recorded in patients aged 40–70 years; the proportion of women (60.32%) was significantly higher than the proportion of men (39.68%). Hospitalisation was required for 23 patients with serious adverse events. In 80% of the studied cases, patients justified the need for self-prescription of antibiotics with cough (which they regarded as acute bronchitis), but their presumptive diagnosis coincided with that established in the hospital only in 47.83% of the cases. The reports of ADRs during self-treatment with antibiotics were mainly received from hospitals (205 cases), and much less often from outpatient clinics and directly from patients (9 and 8 cases, respectively). There were no reports from pharmacy organisations; and it may be assumed that their employees did not take active part in reporting.Conclusions: the use of antibiotics for self-medication can lead to serious ADRs; therefore, the medicinal products of this class should be used only as directed by a doctor. To reduce the incidence of ADRs, it is necessary to raise awareness of the population and medical specialists conducting antibiotic therapy. The quality of medical care will benefit from proper performance of pharmacovigilance activities by all parties to the circulation of medicines, active involvement of patients in treatment safety monitoring, inclusion of specific sections on practical functioning of the pharmacovigilance system into the training curricula of pharmaceutical professionals, and creation of a feedback system connecting pharmacovigilance organisations to medical ones and other subjects of the circulation of medicines.