No abstract

More than 50 years after Propranolol was introduced to the pharmaceutical market as a drug that can lower the heart rate, beta-blockers (BAB) are still widely used in the pharmacotherapy of cardiovascular diseases. However, the use of BAB has a number of limitations, first of all, due to adverse drug events (AE) that develop during their use. The purpose of our review was to study the features of the BAB AE manifested by injuries of the skin and its appendages. The clinical manifestations of them are the development or exacerbation of psoriasis, lichen planus, contact dermatitis, acrocyanosis, Raynaud's disease, alopecia, hyperhidrosis, vitiligo, anaphylaxis, and allergic skin reactions. True medicinal psoriasis occurs in patients taking BAB with no family or previous history and most often mimics erythrodermic psoriasis and palmar-plantar pustular psoriasis. Systemic use of BAB can also be accompanied by exacerbation of vitiligo. In patients with segmental vitiligo, the results of Doppler flowmetry and iontophoresis showed increased blood flow in vitiligo foci compared with normal skin. The development of anaphylactic reactions against the background of BAB therapy may be due to the modulation of adenylate cyclase, which can affect the release of anaphylactogenic mediators, as well as a decrease in the severity of cardiovascular compensatory changes. The peculiarities of the development of such reactions may be the resistance of patients to traditional treatment, which is due to the development of paradoxical reflex vagotonic effects when using adrenaline. Some of the mentioned AE may pose a potential threat to the life and health of the patient and therefore require additional discussion.

Современная фармакоэкономика и фармакоэпидемиология FARMAKOEKONOMIKA Modern Pharmacoeconomics and Pharmacoepidemiology 2021 Vol. 14 No. 3 www.pharmacoeconomics.ru Данная интернет-версия статьи была скачана с сайта http://www.pharmacoeconomics.ru. Не предназначено для использования в коммерческих целях. Информацию о репринтах можно получить в редакции. Тел.:

High rates of adverse drug reactions (ADRs) associated with nonsteroidal anti-inflammatory drugs (NSAIDs), as well as their irrational and uncontrolled use for self-medication require continuous updating of information on safety profiles of these products.The aim of the study was to assess the reporting rate, frequency, and severity of ADRs to NSAIDs and paracetamol products, based on data from periodic safety update reports (PSURs) submitted to the autonomous non-profit organisation “National Pharmacovigilance Research Centre”.Materials and methods: the study covered 104 PSURs for NSAIDs and paracetamol products. Consumption levels were calculated in patient days (PTDs) and patient years (PTYs) for each international nonproprietary name (INN). The authors also analysed clinical manifestations and severity of ADRs.Results: the total number of PTDs and PTYs for all NSAIDs and paracetamol products, including combination medicines, was 1 963 750 485 PTDs or 5 380 138.3 PTYs, respectively. The PSURs reported 459 ADRs, of which 304 (66.2%) were serious ADRs (SADRs). The comparative analysis of ADR frequencies, expressed as the “ADR/PTY” ratio, for individual products, helped to identify INNs with the highest reporting rates.Conclusions: high ADR/PTY and SADR/PTY values indicating better ADR reporting for some INNs, were observed for piroxicam, paracetamol, dexketoprofen, and ketoprofen, while the lowest values were observed for the “acetyl salicylic acid+caffeine+paracetamol” combination, acetylsalicylic acid, and phenylbutazone. Thus, the comparison of ADR/PTY and SADR/PTY ratios can be recommended as an inclusive approach both for analysis of reporting trends for individual products and for comparison of reporting rates of different medicinal products.

The aim of the article is the gender characteristics study of the adverse drug reactions (ADRs) development based on the data of the notification forms registered in the regional database ARCADe (Adverse Reactions in Crimea, Autonomic Database), for the period from 2009 to 2018.Materials and methods. The objects of the study were 6903 notification forms about adverse drug reactions recorded in the regional database called ARCADe (Adverse Reactions in Crimea, Autonomic Database) for the period from 2009 to 2018. The classification of drugs for separate pharmacological groups was carried out using the codes of the Anatomical Therapeutic Chemical (ATC) classification system of the World Health Organization (WHO) medicinal products, the instructions data of the State Registers of medicinal preparations used in the Russian Federation and Ukraine (for the cases registered before the entry of the Republic of Crimea into the Russian Federation).Results. A general analysis of the number of cases of the adverse drug reactions (ADRs) development in patients of different genders made it possible to determine that 59.9% (4132 notification forms) of ADRs cases were observed in female patients; 37.7% (2602 cases) – in male patients. In 169 cards (2.4%), information about a patient’s gender was missing. The groups with the largest number of the registered cases of ADRs were antimicrobial agents for a systemic use (2864 cases, 41.5% of the total number of the ADRs registered cases), the drugs affecting the cardiovascular (811 cases, 11.7%) and nervous (734 cases, 10.6%) systems. In each of the presented groups, the incidence rate of ADRs in female patients exceeded that in men.Conclusion. The study of the gender characteristics of the pharmacotherapy safety, carried out on the basis of the notification forms of the ADRs data registered in the Republic of Crimea, confirmed a higher likelihood of developing ADRs in female patients. This may be due to the peculiarities of the pharmacokinetics and pharmacodynamics of drugs in the female body, psychological factors, a more frequent use of drugs by this category of people. The implementation of the drug, taking into account specific features of each gender, can lead not only to better treatment outcomes, but also to increased patients’ compliance.