Analysis of changes in pharmacotherapy of stable angina over the five-year period at specialized out-patient level of medical care (pharmacoepidemiological study)

Investigate the dynamics of drug prescription rates in patients with stable angina over the five-year period on the example of routine clinical practice of outpatient cardiology institution of Moscow for the purpose of further eliminating the prescribing gap for guideline recommended pharmacological strategies. Our research work was performed as a retrospective pharmacoepidemiological study including two stages with five-year interval using cross-section metho

The role of pharmacist in early phase clinical research

This article discusses the role of pharmacist in early phase clinical trials. Authors emphasize that in Russian phase I units pharmacists are rarely involved in clinical research activities. Probably the lack of regulatory documentation in this field is one of the main reasons. The opposite situation occurs abroad where pharmacist is key member of investigational team. This problem is particularly relevant because number of phase I studies in Russia steadily increases over the last years. Based on their practical experience authors describe the range of pharmacist functions and responsibilities when working in early phase research. Qualification requirements and skills of such specialist are pointed out as well. Due to the fact that not only number of trials but also number of phase I units increases (including private departments) the value of pharmacist in clinical research will grow

Specific aspects of source medical documents in clinical studies on healthy volunteers

This article covers important aspect of methodology of clinical trials - source medical documents. Special attention is always paid to source medical records in phase 1 trials when the future of novel medicinal product is at stake. Authors discuss some issues of development and application of trial-specific forms as part of source medical documentation on the basis of practical experience in conducting phase 1 studies on healthy volunteers. Primary focus is on the structure and content of these forms with respect to specific procedures and study population in early phase research. Authors believe that implementation of trial-specific forms improves the quality of clinical trials

The problem of over-volunteering in early phase clinical trials

This article discusses important problem of early phase clinical trials – over-volunteering. The overlapping or dual enrollment of healthy volunteers is a potential high risk not only to study subjects, but also to commercial sponsors because it could cause the delay in advancement of promising drug candidates. The problem of over-volunteering is payed special attention by clinical research professionals in foreign countries. Guidelines for early phase clinical trials recommend implementation of different control and prevention measures of multiple enrollment. The most effective instrument to prevent over-volunteering is considered to be a central internet-based registry of healthy volunteers. Such registries operate in various countries and differ in structure, scope of information collected, types of funding and management. The general operating principles of such registries are described on the example of TOPS data base. TOPS is а special system to prevent over-volunteering that is used by UK phase 1 units. In conclusion, authors urge regulatory authorities and pharmaceutical companies to approach this problem closely because over-volunteering is already a burning issue in our country. It is essential to improve relevant regulatory framework and launch central registries of healthy subjects with regard to international experience

Multivariate analysis of medication adherence among outpatients with stable coronary artery disease

Introduction. The results of local studies indicated that medication adherence of coronary outpatients is low (not more than 60 %). The search for significant predictors of adherence to recommended treatment might allow tailoring specific strategies to control adherence for further optimization of the pharmacotherapy of coronary artery disease (CAD) in routine primary care practice. Aim. To determine the factors associated with medication adherence in outpatients with stable CAD. Methods. This paper describes the results of the fragment of randomized controlled study of the effects of Pharmacy Care Program on medication adherence of coronary outpatients, that was conducted in 2019-2020 in one of the primary care clinics of Moscow. 123 subjects with stable CAD were included in line with the pre-specified criteria. Demography, social status, medical history, pharmacotherapy, healthcare burden data were registered. Medication adherence was measured by validated questionnaire MMAS-8 (8-item Morisky Medication Adherence Scale). The analysis of predictors of adherence was performed by linear regression. Results. Simple regression analysis revealed the list of parameters, that showed statistically significant (or as statistical trend) association with medication adherence of coronary patients in univariate models. The level of medication adherence was associated with patient’s having a partner or caregiver (p=0,002), higher education (p=0,009), additional medicinal maintenance (p=0,006). Medication adherence did not depend on medical history and pharmacotherapy characteristics, but the association of high values of low-density lipoproteins cholesterol (LDL-C) (p=0,001) with suboptimal adherence was demonstrated. Good medication adherence was associated with more frequent visits to general practitioner (p=0,036) and (as statistical trend) to cardiologist (p=0,093). The multivariate regression analysis revealed two positive independent predictors of medication adherence - patient’s having a partner or caregiver (р=0,015) and regular visits to cardiologist (р=0,025). Also, the negative association was confirmed for high LDL-C (р=0,002). Conclusion. Patient’s having a partner or caregiver and regular visits to cardiologist were revealed as independent predictors of good medication adherence of coronary outpatients. Subjects with suboptimal adherence had higher LDL-C

Medication adherence in patients with cardiovascular disease: current view of the problem

In this article the authors address the problem of poor medication adherence in patients with cardiovascular disease. Poor medication adherence significantly reduces efficacy of pharmacotherapy thus increasing risk of cardiovascular complications and higher treatment costs in routine clinical practice. This problem was first raised by a few foreign scientists in the 90s and then officially recognized by the World Health Organization in 2003. The article presents review on the prevalence of low medication adherence in patients with cardiovascular disease and describes key factors associated with decreased adherence. An overview of widely used indirect methods to measure medication adherence is presented as well. On the way to solve this problem, the development and implementation of various measures and interventions to improve medication adherence is actively carried out in recent years. The results of the most significant studies on the effectiveness of such interventions are also presented in the article. Positive influence on patient adherence was demonstrated, however, only a number of studies reported reduction of the risk of unfavorable clinical outcomes of cardiovascular diseases. This confirms the need to further study the problem of medication adherence focusing on routine clinical practice in Russia

Potential barriers towards optimal medication adherence in out-patients with stable coronary artery disease

Introduction. The results from foreign and local studies demonstrate that more than a half of patients with cardiovascular diseases do not take medication in compliance with doctors’ recommendations. The search for significant barriers to optimal medication adherence might improve the development of adherence control measures in patients with stable coronary artery disease (SCAD) in routine clinical practice of primary care.Aim. To study the nature and incidence of potential barriers to optimal medication adherence and their association with social and demographic parameters in patients with SCAD.Methods. This publication describes the fragment of the study “PHARMCARE” in which 123 coronary patients were included. Data on demography, social status, medical history and pharmacotherapy were registered. The barriers to medication adherence were identified by means of validated scale (questionnaire) SEAMS (Self-Efficacy for Appropriate Medication Use Scale). Data analysis was conducted by descriptive statistics and regression modeling.Results. The analysis of incidence of barriers to medication adherence allowed to identify the list of most significant ones: “fear of side effects”, “intake of several different medicines each day”, “intake of medicines more than once a day”, “medicines look different than usual”, “normal routine gets messed up”, “busy day planned”, “no one reminds to take medicines” and “staying away from home”. More than a third of all the respondents reported at least one of barriers (37%), that was in major cases “fear of side effects” (22%). Linear one-factor modeling revealed association of number of significant barriers in patients with level of their education (р=0,009) and presence of partner or caregiver (р=0,001), that was also confirmed by the multivariate model. Less barriers were identified in coronary patients that had partner or caregiver (р=0,009) and higher education (р=0,045).Conclusion. The study results revealed that the significant barriers to optimal medication adherence in out-patients with SCAD were related either to patients’ behavior or to pharmacotherapy profile. Uncertainty in overcoming barriers was most typical for single patients without higher education. The obtained results should be taken into consideration when develop strategies for improvement of medication adherence in patients with SCAD in primary care practice

Non-pharmacological secondary prevention of cardiovascular diseases in patients with stable angina at specialized ambulatory institution

The article describes the results of retrospective epidemiology (non-interventional study) two-stage study. This study was initiated to reveal and analyze changes occurred in the field of detection and modification of cardiovascular risk factors in patients with stable angina over the five-year period. The study identified some positive shifts in how doctors of outpatient cardiology clinic captured information about risk factors in medical records and how they implemented measures of non-pharmacological modification. However, in general degree of physicians’ attention to cardiovascular risk factors remains low

The role of reference intervals of laboratory tests in early phase clinical research in healthy volunteers

This article discusses one of the most disputable issues in national clinical research practice in healthy volunteers. Regulatory requirements forbid to assess even minor deviations of laboratory parameters from reference intervals as not clinically significant. Authors made analysis of such requirements from positions of foreign and national guidelines of early phase clinical research and with regard to their own experience in the field. As an important part of this work, retrospective analysis of the laboratory test results data of healthy volunteers taken from several clinical trials was conducted. The aim of this analysis was to establish the rate of not clinically significant deviations from reference intervals. The results of the analysis revealed rather high rate of not clinically significant deviations of some laboratory parameters from reference intervals in volunteers with confirmed status “healthy”. Authors noted that developers of clinical trial protocols have no unified approach to generate list of necessary laboratory tests and methods of assessment of the results. Ethical and financial aspects of the problem under discussion are also touched in this article. In conclusion, authors suggest the scale of clinical significance assessment of deviations of basic laboratory parameters from reference intervals as one of the possible options of optimizing current regulatory requirements

Critical aspects of the management of stable coronary artery disease in primary care practice or how to increase the efficacy of evidence-based pharmacological therapy?

The publication describes a fragment of the pharmacoepidemiologic study conducted to review the quality of management of patients with stable coronary artery disease (SCAD) in primary care over a 12-year period. The aim of the study was to justify the application of standard operating procedures (SOPs). Such determinants of pharmacotherapy as non-pharmacological modification of cardiovascular risk factors (RFs) and medication adherence were analyze