A widespread use of β-lactam antibiotics such as penicillins in practical medicine, and its authorized use in special categories of patients (e.g. children, pregnant and lactating women, the elderly) requires a critical investigation of their safety as well as the obligatory risk assessment before conducting antibacterial pharmacotherapy.The aim of the work was the conduction of a retrospective study of adverse reactions cases, the identification and analysis of drug-related problems (DRP) associated with the use of penicillin family antibiotics.Materials and methods. The objects of the study were adverse drug reactions (ADR) associated with the use of penicillin family antibiotics in inpatient and outpatient facilities, as well as the cases of self-treatment, which were recorded in the official ADR reports and then inputted in the regional (Republic of Crimea) database of spontaneous reports called ARCADe (Adverse Reactions in Crimea, Autonomic Database). The covered period is 2009–2018. The analysis of DRP was carried out using the 9.0 version of the qualification system DRP PCNE (Pharmaceutical Care Network Europe Foundation).Results. The data analysis of ADR reporting forms has revealed that Amoxicillin clavulanate and Amoxicillin were the most frequent cause of ADR. A high incidence of penicillins ADR in pediatric patients (from 0 to 18 years) – 142 cases – has been found. The clinical manifestations of reactions included drug hypersensitivity reactions (309 cases), dyspeptic disorders (28 cases) and disorders of the central nervous system (5 cases). The incidence of serious ADR was 113 cases (33% of the total number of ADR in the study), which indicates a rather high risk of developing severe ADR for penicillins, resulted in a significant decrease in the quality of patients’ lives.Conclusion. The detection of DRP using the PCNE V9.0 approach is a useful and promising tool important to improve the quality of pharmacotherapy and their adherence to treatment. The highest DRP values which were observed for Amoxicillin clavulanate and Amoxicillin, may indicate a high frequency of irrational use of these drugs.List of abbreviations: DRP – drug related problems; ADR – adverse drug reactions; INN – international non-patented name
Iron deficiency is the most common micronutrient deficiency worldwide. Prevention and treatment of iron deficiency conditions are some of the most important health problems in many countries of the world. At the same time, the main problems for it remain the timely diagnosis, elimination of the cause, as well as the choice of replacement therapy with iron-containing drugs and correction of adverse reactions (ADR) that occur during their use.The aim. This research aims to study the peculiarities of the development of antianaemic drugs ADRs in patients living in the territory of the Republic of Crimea.Materials and methods. The objects of research were cases of ADR occurrence associated with the use of a group of antianaemic drugs and revealed during the 2009-2018 period in the territory of the Republic of Crimea. The main tasks in the analysis of notification forms were the study of the ADR severity, the causality assessment for suspected drugs and ADRs, as well as analysis of particular problems associated with the use of antianaemic drugs (Drug-related problems, DRP).Results. Iron supplements in combination with other drugs became the leaders in the incidence of ADR among antianaemic drugs (28 cases, 42.4% of all cases of ADR). The largest number of cases was registered in patients aged from 18 to 30 years, with female patients prevailing. Among the clinical manifestations of ADR, the most cases were drug hypersensitivity reactions of varying severity (40 cases) and disorders of the gastrointestinal tract (18 cases). The study of the problems associated with the use of antianaemic drugs made it possible to determine that the highest rates of DRP values were observed with the use of iron preparations for parenteral use and cyanocobalamine. The minimal DRP values were observed when prescribing iron protein succinylate preparations.Conclusion. The basis of pharmacotherapy for various types of anemias is the replenishment of iron and vitamin B12 (cyanocobalamin) depots. The effectiveness of the treatment in these cases largely depends on the patient's adherence to treatment, which is, in turn, depends on the frequency and severity of ADRs that occur during the use of antianaemic drugs.
According to the data of the World Health Organization (WHO), human immunodeficiency virus (HIV) remains a major global public health problem.The mainmethod of treating HIV is using highly active antiretroviral therapy (HAART), which is the use of multiple medicines acting on different viral targets. The timely onset of HAART can suppress the replication of the virus in the human body and helps to strengthen its immune system and restore its ability to fight infections. At the same time, the choice of medicines to improve the quality of life and patients’ compliance during antiretroviral therapy should be based on their effectiveness and safety. The aim of this research was to analyze and study the adverse reactions that occur in patients with HIV living in the territory of the Republic of Crimea, when using HAART.Materials and methods.The objects of research were 274 report cards about the adverse reactions, registered in the regional base (registry) of spontaneous messages called ARCADe (Adverse Reactions in Crimea, Autonomic Database) for the period from 2011 to 2016.Results.The results of the study showed that the most often adverse reactions were observed when using medicines of the group of Nucleoside Reverse Transcriptase Inhibitors (NRTI). This is explained by the inclusion of NRTI medicines as the main medicine in the method of HAART. Efavirenz (EFV) and Nevirapine (NVP) were absolute leaders among these groups of antiretroviral medicines. Among the combined antiviral medicines active against HIV, the most frequently adverse reactions were associated with the use of a combination of Lamivudine (3TC) and Zidovudine (ZDV). The main clinical manifestations of adverse reactions in the use of combination medicines for treating HIV were a decrease in the level of hemoglobin and the development of anemia. At the same time, in 85% of cases, the patients needed medication in order to correct the resulting adverse drug reaction (ADR). The combination of antiretroviral therapy has often been associated with the development of serious ADR. In case of monotherapy, the main clinical manifestations of adverse reactions were disorders of the central nervous system (dizziness, hallucinations, sleep disorders) and allergic reactions of varying severity (including 1 case of angioedema to “Eferven” (Efavirenz (EFV)),600 mg). Hereby, in almost half of the cases, the usage of antiretroviral medicines of the NRTI group and protease inhibitors caused the development of serious side effects. This confirms the necessity to study and analyze adverse reactions in order to increase the safety of patients’ pharmacotherapy and improve their quality of life.Conclusion.The study of adverse reactions to the medicines used for treatment of HIV is of a paramount importance in improving the safety and compliance of HIV patients to lifelong pharmacotherapy.
A Drug-Related Problem is an event or circumstance involving drug therapy that actually or potentially interferes with desired health outcomes.The aim of the study was the analysis of the adverse drug reactions (ADR) associated with prescription of the non-steroidal anti-inflammatory drugs (NSAIDs) using the DRP PCNE V5.01 qualification system.Materials and methods. The objects of the study were 415 notification forms about adverse drug reactions of NSAIDs recorded in the regional database of spontaneous reports and called ARCADe (Adverse Reactions in Crimea, Autonomic Database) for the period from 1 January 2009 to 31 December of 2018. The study and analysis of the problems associated with drugs were carried out using the qualification system DRP PCNE V5.01 (Pharmaceutical Care Network Europe) 2006 in the modification of Prof. Zimenkovsky.Results. Among other representatives of the NSAID group, Ibuprofen and Diclofenac became the “leaders” in the incidence of ADR. The frequency of ADR cases for Ibuprofen was 142 reports (34.22% of the total number of ADR for NSAIDs), and for Diclofenac it was 90 cases (21.69%). The calculation of DRP values for each of the presented cases made it possible to determine that in 81 (19.51%) and 91 (21.9%) cases, the DRP value was 6 and 7, respectively. DRP values in the range of 8–10 were found in 92 reports. The highest DRPs value was observed after the administration of Parecoxib (13 problems but only one case was found in the database), the DRPs value of Dexketoprofen was 12.5 (95% CI: 7–17) and the DRPs value of Diclofenac combinations was 10 DRPs; 95% CI: 5–17 DRP). The minimum DRPs values were associated with Naproxen, Rofecoxib, and Etoricoxib prescriptions.Conclusion. Using the DRP system in the analysis of NSAIDs, ADRs allow to identify the medicines which have a high risk of causing safety problems, such as Parecoxib, Dexketoprofen and Diclofenac combinations. The prescription of these drugs should be carried out with special cautions and control to the indications and contraindications, the dose and duration of treatment, as well as to a possible interaction of them with concomitant drugs.
Background. Nonsteroidal anti-inflammatory drugs safety profile (NSAIDs) is well-studied in clinical trials. Meanwhile, the monitoring of adverse effects (AEs) of this drug class and analysis of AEs structure in pediatrics is essential. Our aim was to study AEs related to NSAIDs in children. Methods. Retrospective analysis of doctor reports about AEs associated with drugs from N02B and M01A groups (according to Anatomical Therapeutic Chemical Classification System) administration in patients under 18 years old in healthcare facilities or outpatiently (self-medication included) was carried out. Data source — regional database (Republic of Crimea) of spontaneous reports about AEs. Recall period — January 2010–December 2018. Results. 201 AEs cases were registered during research period. Most commonly AEs on NSAIDs were reported in infants — 87 (43.3%) cases, and in children at 1–3 years old — 65 (32.3%). Development of 126 (62.7%) AEs cases were associated with administration of Ibuprofen drugs, and 53 (26,4%) cases — with Paracetamol drugs. Significance level of cause-effect relationship was estimated in compliance with WHO Collaborating Centre method. For most cases AEs have started with such hypersensitivity reactions (193 cases, 96%) as hives, hyperemia, skin itching. Much less often AEs have presented with respiratory and gastrointestinal disorders. AEs were slight and posed no threat to children in 57% of all cases. Conclusion. AEs development on NSAIDs administration was associated with Ibuprofen and Paracetamol drugs in most cases. Immediate hypersensitivity reactions were the main clinical manifestations of AEs on NSAIDs.
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