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Pharmacy & Pharmacology

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Vol 12, No 4 (2024)
View or download the full issue PDF (Russian) | PDF
https://doi.org/10.19163/2307-9266-2024-12-4

RESEARCH ARTICLE

266-280 29
Abstract

The aim of the study was to investigate the awareness of pharmacists’ knowledge of the pharmacovigilance basics in pharmacy organisations (PhOs) of the Russian Federation and to identify the factors influencing their participation in the drug safety monitoring system.

Materials and methods. A single-point survey study was conducted in the form of a single solid group online questionnaire survey of 513 pharmaceutical specialists from different regions of Russia. A specially designed 14-item questionnaire aimed was used to assess their knowledge of the pharmacovigilance system. Retrospective, comparative, statistical, and logical analysis methods were applied.

Results. A comprehensive assessment of the level of pharmaceutical specialists’ pharmacovigilance knowledge in Russia was carried out. The factors influencing the specialists’ awareness were determined. The necessity of educational activities to increase the involvement of PhOs employees in the drug safety monitoring system was justified. The insufficient level of pharmaceutical specialists’ knowledge about the basic concepts and procedures of pharmacovigilance was revealed. Specialists with secondary specialized education and less work experience demonstrated a lower level of awareness. Only 13% of the participants had received training on pharmacovigilance, while the majority (about 80%) considered it necessary to increase the number of training programmes. The influence of education, work experience and job position on the awareness of professionals was established. Most respondents recognize the need to report adverse drug reactions (ADRs) occurring when taking a medicine, but in practice the level of reporting remains low.

Conclusion. Insufficient knowledge of the pharmacovigilance basics among pharmacy workers causes a low level of ADRs reporting by them. A comprehensive approach, including educational initiatives and the development of targeted interventions, is required to improve specialists’ engagement in the drug safety monitoring system. Further research is necessary to develop and evaluate the effectiveness of educational programmes and motivational models to increase pharmaceutical specialists’ pharmacovigilance activities.

281-294 27
Abstract

The antioxidant activity of 10 synthetic dibenzylideneacetone (DBA) derivatives has been studied. Except for the base compound, all other derivatives contain electron-bearing substituents, such as OH and OCH3, on aromatic fragments. Formally, DBA can be considered a system containing a cinnamoyl moiety linked to a substituted styrene residue.

The aim of the study was to investigate antioxidant properties of the synthesized DBA derivatives and to analyze their quantum chemical parameters revealing the regularities of the «structure–activity» relationship.

Materials and methods. For the carbon atoms of the analyzed compounds, Mulliken charges (AUs), bond numbers (Nms), an unsaturation index (IUA), a free valence index (Fr), a theoretical valence (TV) and the electron density were determined. All calculations were performed on a workstation with an Intel Xeon E5-1620 3.5GHz processor and 20GB RAM using a semi-empirical RM7 method and the WinMopac 2016 software. Ionization energies were calculated using the WinMopac 7.21 software for the studied compounds. The Way2Drug PASS Online predictive program was used to evaluate their possible pharmacological activity. The antioxidant activity was evaluated both in vitro (using DPPH and ABTS assays) and in vivo (by measuring a superoxide dismutase (SOD) activity and the concentration of products reacting with 2-thiobarbituric acid (TBA-AP) in Wistar rats without pathology).

Results. A preliminary analysis of the possible types of the biological activity of the synthesized DBA derivatives was performed using the Way2Drug PASS Online program. This analysis showed that all the structures have an antitumor activity, which is apparently due to their antioxidant properties. This type of activity was experimentally confirmed by four tests: by DPPH and ABTS in vitro and the effect on SOD and by the TBA-AP in animals. The analysis of the data allowed us to determine that the most active antioxidants are compounds 5, 6, and 8, which contain phenolic hydroxyl groups. In these compounds, the 8-hydroxy group is surrounded by OCH3 radicals on both sides, making it spatially blocked and, therefore, the phenoxyl radical it forms is the most stable. A comparison of the values of the quantum chemical parameters found shows that the most informative for studying the structure–activity relationship are the Mulliken charges (AUs), electron density on carbon atoms, and also their IUA and Fr.

Conclusion. The structural features of the 1,5-diphenylpent-1,4-diene-3-one derivatives and the nature of free radicals formed during biological tests indicate that this class of compounds can be considered promising as antioxidants.

295-308 43
Abstract

The aim of the work was the synthesis of bromantane - N-(camphan-2-yl)anilines new structural analogues and the study of their psychotropic properties.

Materials and methods. The synthesized compounds were identified using the NMR spectroscopy. The purity of the compounds was confirmed by a GC-MS analysis. Psychotropic properties of N-(camphan-2-yl)anilines were studied in the experiments on the Wistar rats aged 18-20 weeks, the mice (12 weeks old) obtained from the “Stolbovaya” nursery using the following tests: the “Open Field”, the “Elevated Plus Maze”, the “Novel Object Recognition”, the “Vogel Conflict”, the “Tail Suspension”, the “Tightrope suspension”, the “Extrapolation” test.

Results. A series of new camphor aromatic amines, structural analogues of bromantane, were obtained and their psychotropic effects were evaluated by in vivo biological studies. Based on the results, it was possible to identify a leader compound, i.e. (1R,2R,4R)-1,7,7-trimethyl-N-(4-ethylphenyl)bicyclo[2.2.1.1]heptan-2-amine (4e), which had a pronounced anxiolytic effect. Substance 4f showed cognitive properties in the “Novel Object Recognition” and the “Extrapolation” tests. The fact was established by the indices of the time of learning a novel object and the time of diving.

Conclusion. The obtained data testify to the prospect of searching for substances with a psychotropic action in the range of aromatic camphor amines. Substance 4f, which deserves an in-depth study of the spectrum and mechanism of its psychotropic action, should be singled out separately.

REVIEW

309-320 42
Abstract

The revival of production pharmacies in Russia began in 2022. To effectively use the capabilities of compounding pharmacies, it is necessary to take into account the importance of eliminating the risk of infringement of intellectual property rights.

The aim. The study of the foreign practice of compounding pharmacies in terms of infringement of exclusive rights, as well as the position of foreign patent offices and the World Intellectual Property Organization (WIPO).

Materials and methods. A key aspect of the research was the study of the foreign practice of violating the exclusive rights to original medicines. An information search was conducted for publications related to the activities of compounding pharmacies in the world, as well as issues related to the regulation of the relationship between their activities and legislation in the field of intellectual property.

Results. The article analyzes foreign judicial practices and positions of patent offices, summarized by WIPO, on this issue. The results and discussion are based on the consideration of foreign court cases and legislative norms related to the production of patented drugs in compounding pharmacies. The examples of court cases that raise issues of violations of exclusive rights are given.

Conclusion. In Russia, the possibility of one-time compounding of drugs using the invention in pharmacies according to doctors’ prescriptions is fixed at the legislative level. However, this permission only applies to a “specific recipe”. One possible way to reduce the severity of the problem may be to directly allow pharmacies to use contractors to fulfill a specific request. The concept of “one-time compounding” also requires disclosure, which may expand the capabilities of pharmacies. The results obtained can be used in the framework of legislative regulation of the compounding of medicines in a pharmacy.



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ISSN 2307-9266 (Print)
ISSN 2413-2241 (Online)