RESEARCH OF INFORMATION ASYMMETRY OF REGULATORY DOCUMENTS REGARDING DRUGS FOR THE PHARMACOTHERAPY OF DEPRESSIVE DISORDERS IN PREGNANT WOMEN AND WOMEN IN CHILDBIRTH

Abstract

The aim of the work. Comparative analysis of the te content of formulary articles of state forms of medicines and IFU of antidepressants, antipsychotics and anxiolytics to protect against potential risks of pharmacotherapy of depressive disorders in the motherfetus - child / dyad.

Materials and methods. The research materials were the data of the Unified Clinical Protocol of Primary, Secondary and Tertiary Medical Care for the Depression Treatment, State Formular of Medicines (Eleventh Release), State Register of Medicines of Ukraine as of 10.08.2019, in particular, IFU brands of antidepressants, antipsychotics, and anxiolytics., Methods of contextual analysis, comparison, generalization were applied in the work our research.

Results and discussion. According to the study of the regulatory document for the pharmacotherapy of depression, the row of drugs is shown under the international nonproprietary name, namely 18 antidepressants, 19 antipsychotics, and 2 anxiolytics. At the same time, in Ukraine were registered 80 antipsychotics, 101 antidepressants, 9 anxiolytics brands. Bat only, 69 antipsychotics, 71 antidepressants, and 8 anxiolytics are included in State Formular of Medicines (Eleventh Release). However, in Ukraine, are not registered brand names of Oxazepam and Chlordiazepoxide, as well as 15 brands from 12 subgroups of chemicals, although they are present in State Formular of Medicines. In this case, the considered State Forms of Medicines do not include the brand name from the subgroup Tianeptine.

Further analysis of the text contents of the formulary articles and IFU included in State Formular of Medicines showed that there are 128 brands, namely: 65 brands from 18 subgroups of antipsychotics, 6 brands from 2 subgroups of anxiolytics and 57 brands from 16 subgroups of antidepressants. There is a discrepancy with the formal articles regarding IFU in women during pregnancy and breastfeeding. Among them, only for brand name Amisulpride are indicate contraindications for breastfeeding, but no warning is given regarding the period of pregnancy.

During the in-depth study of the application features, IFU of brands revealed 33 theses regarding the period of pregnancy and 21 theses on breastfeeding, containing stylistic and semantic differences in the interpretation of these postulates. For unification, the indicated sets of reservations were grouped into 5 groups, respectively: during pregnancy and lactation.

Also, significant discrepancies in the text content were found in most IFU of analog brands for use during pregnancy and lactation, except for the chemical subgroups Amisulpride, Zuclopentixol, Sulpiride, Flupentixol Chlorpromazine, Clopinoprom, Esopin, Esopinol, Fluvoxamine, Citalopram (both periods), Doxepin, Duloxetine (breast), Venlafaxine (during pregnancy).

Conclusion. Based on the text comparative analysis of the texts of formulary articles of State Formular of Medicines and IFU of antidepressants, antipsychotics and anxiolytics, their semantic and stylistic differences are established, and pharmacotherapy of depressive disorders in women during pregnancy and breastfeeding can pose a threat to the adverse effects on the course of pregnancy, as well as at risk of negative effects on the embryo/fetus of both the newborn and the infant. To minimize the asymmetric information (discrepancies in the interpretation of the peculiarities of use) in the formulary articles of State Formular of Medicines and IFU of brands analogues, the State Expert Center of the Ministry of Health of Ukraine should unify approaches to the style and semantics of textual filling of the relevant sections of these regulatory documents.