Matveev A.V., Krasheninnikov A.E., Egorova E.A., Konyaeva E.I., Bekirova E.Yu.
National Scientific Center for Pharmacovigilance, S.I. Georgievsky Medical Academy of the Crimean Federal University named after V.I. Vernadsky, Moscow, Simferopol.
At the present stage of healthcare development, the study of gender peculiarities of the onset and course of various diseases, as well as the variability of pharmacological response of patients of different sexes during the use of certain groups of drugs (medications) is becoming increasingly important.
The aim of our study was to investigate gender peculiarities of adverse reactions on the basis of the data of drug adverse reactions (ADR) notification cards.
Materials and methods
The objects of the study were ADR notification cards, registered in the regional database (Republic of Crimea) ARCADe (Adverse Reactions in Crimea, Autonomic Database) for the period 2009-2018. Classification of drugs by individual pharmacological groups was performed using the World Health Organization’s Anatomic Therapeutic Chemistry Classification (ATC) codes.
Results of the study
During the corresponding period, 6,903 notification cards were registered in the ARCADe database. A total analysis of the number of cases of ADR in patients of different sexes revealed that 59.9% (4132 cases) of side effects were observed in female patients and 37.7% (2602 cases) in male patients. In 169 cards (2.4%), information about the patient’s sex was missing. Pharmacological groups (according to the ATC classification of drugs) with the highest number of registered cases of ADR were antimicrobials for systemic use (2864 cases, 41.5% of all registered cases of reactions), drugs affecting cardiovascular (811 cases, 11.7%), and nervous (734 cases, 10.6%) systems. In each of the groups presented, the incidence of ADR was higher in female patients than in male patients. Thus, in the group of antimicrobials for systemic action, the ratio of cases of ADR in female and male patients was 55.2% and 40.6%, respectively. In 4.2% of cases, there was no indication of gender in the notification cards. A similar distribution of ADR cases in the group of drugs affecting cardiovascular function was 66.8% and 32.7%. In 0.5% of the cases, the gender of the patients was not specified. In the group of drugs affecting the functions of the nervous system, the number of female patients was 54.4% and 44.7% of male patients. In the rest of the notification cards, there was no information about the gender identity of the patients. Significantly fewer cases of ADR were associated with the use of drugs used in diseases of the digestive tract (622 cases, 9.01% of the total number of cases of adverse reactions), drugs used to treat the musculoskeletal system (492 cases, 7.13%), and drugs that regulate hematogenesis and blood clotting (448 cases, 6.49%). The proportions of female and male patients in these groups were 69.9% and 27.5% (ATC group «A» — digestive tract and metabolism), 63% and 36.6% (ATC group «M» — musculoskeletal system), and 62.5% and 35% (ATC group «B» — hematopoiesis and blood) respectively.
Conclusions
The study of gender-specific safety features of pharmacotherapy, conducted on the basis of the data of ADR records of drugs registered in the Republic of Crimea, confirmed a higher probability of the development of undesirable effects of drugs in female patients. This may be due to the peculiarities of pharmacokinetics and pharmacodynamics of drugs in women, psychological factors, more frequent use of drugs by this category of patients. However, despite the obvious physical and physiological sex differences, the peculiarities of efficacy and safety of drugs are very rarely taken into account when administering pharmacotherapy to the female patients. Implementing gender-specific drug selection can lead not only to better treatment outcomes but also to improved patient compliance.