FROM THE PUBLISHER
PHARMACOECONOMICS
The effective control of Diabetes Mellitus (DM) is an actual problem from optimal expenditures of health care system point of view. Glucagon-like peptide-1 receptor agonists (GLP-1 RA) are one of the modern options for glycemia control in DM Type 2 and included in all current guidelines for the treatment control. The economic comparative aspects of the use of these drugs in the local conditions are important for decision making.
Materials and methods. The comparative economic evaluation for injectable remedies such kind as fixed combination of insulin glargine + lixisenatide (iGlaLixi), exenatide (Exe), dulaglutide (Dula), liraglutide (Lira), semaglutide (Sema) and fixed combination of insulin degludec + liraglutide (iDegLira) has been performed base on published clinical data of efficacy in patients who did not reach target of HbA1c on oral antidiabetic drugs treatment. Number of patients with HbA1c <7 % was chosen as efficacy criterion. Non-direct comparison with Odds Ratio (OR) calculation was prepared. Direct and indirect costs (medications, treatment of CV-complications, GDP loses etc.) were indicated and calculated based on constructed model. Sensitivity analysis has been provided for validation of results.
Results. Pharmacoeconomic analysis for all drugs included into analysis has shown of economic advantages of effective DM2T control. iGlaLixi has demonstrated economic advantages as well usage aGLP-1 only (direct costs decreasing vs Exe on 37,8 %, vs Dula on 31,8 %, vs Lira on 63,5 %, vs Sema - on 41,9 %) as vs iDegLira - on 36,1 %. iGlaLixi decreased a total cost (direct and non-direct) better than Exe, Dula, Lira and Sema (on 30,7; 22,3; 52,1 and 30,4 % accordingly.
Conclusion. An effective control of DM2T with GLP-1 RA and medicines on their based has an economic value because lead to expenditures for complications decreasing from government position.
PHARMACOVILIGANCE
The group of non-steroidal anti-inflammatory drugs has occupied one of the leading positions in terms of demand by the population over the past decade. This fact is explained by non-prescription sale, a wide range of purposes and an affordable price range. The lack of proper control over the use of non-steroidal anti-inflammatory drugs (NSAIDs) greatly complicates the assessment of safety, timely detection and prevention of events associated with patient’ safety.
Target. Evaluation of data from the national pharmacovigilance database of the safety of non-steroidal anti-inflammatory drugs.
Materials and methods. This is a cross-sectional study covering the period from 2010 till 2020. The assessment of the safety profile of international non-proprietary names (INN) from the group of NSAIDs at the post-registration stage was carried out according to the data of uploading the national database (Automated Information System of Roszdravnadzor; AIS RZN), as well as PubMed, Medline, Google Scholar, Elibrary databases.
Conclusions. Over a ten-year period, the number of registered spontaneous messages was 8,334. With regard to the three international generic names, the number of adverse drug reactions prevails - this is metamizole (1875 (22.5 %)), acetylsalicylic acid (1716 (20.6 %)), diclofenac (979 (11.7 %)). The main system organ class with safety-related events are described for skin and subcutaneous structures. This fact is not consistent with the data of reference sources of information, which indicates the ineffectiveness of post-marketing observations by marketing authorization holders.
PHARMACOEPIDEMIOLOGY
Relevance. According to statistics of the World Health Organization, at least half of the world’s adult population experienced headaches at least once a year. Patients suffering from headaches do not always have the opportunity to visit a doctor, therefore, an important role in helping these patients is assigned to pharmacists.
Purpose. Based on the pharmacoepidemiological study to identify the features of providing pharmaceutical care to patients with headache in pharmacies in the issue of rationality of recommendations of pharmaceutical workers.
Materials and methods. A pharmacoepidemiological study was conducted based on a survey of 153 pharmaceutical workers (Saratov) using a specially developed questionnaire that includes free-form questions with a simulated situation. The data was processed using Microsoft Excel 2010 and STATISTIKA 6.0.
Results Of the groups recommended to visitors, INNs in the group «Nonsteroidal anti-inflammatory and antirheumatic drugs [M01A]» account for 45.0 % of all INNs, and the group «Analgesics [N02]» - 55.0 %. Ibuprofen (62.8 %) and the combination of drotaverine + caffeine + naproxen + paracetamol + phenylephrine (41.2 %) were noted as the most frequently recommended. A visit to a doctor was recommended by the majority of respondents (52.3 %, n=153) in the case of a patient with a headache accompanied by nausea and vomiting. Ibuprofen (90.8 %) or paracetamol (45.8 %), moreover in the form of suspension or suppositories, are the preferred recommendations for headache in children under 3 years of age (n=131). Paracetamol in combinations (69.2 %) prevails as the first recommendation for headache associated with acute respiratory viral infections (n??=146). Non-selective NSAIDs for a patient with gastrointestinal complications could be recommended by 43.4 % of specialists (n=113). The NSAID recommendation is the most frequent (51.8 %, n=110) in the case of an 80-year-old patient without concomitant diseases. Paracetamol (50.0 %) or ibuprofen (34.7 %) would be more often recommended by pharmaceutical workers for a pregnant woman with headache (n=98). In case of headache after trauma, 47.1 % recommend a visit to a doctor (n=153).
Conclusion. The frequent recommendation of combined analgesics and their association with the development of drug-induced headaches indicates the need for careful recommendation of these drugs. Not always correct recommendations indicate the need to increase the level of professional knowledge, study clinical recommendations for the therapy and diagnosis of cephalgia, which can make it possible to make a rational choice of the drug, initially assume that the visitor has conditions that require a visit to a doctor, and ultimately improve the quality of pharmaceutical care.
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.
CLINICAL PHARMACOLOGY
The use of many drugs is associated with the risk of adverse drug reactions (ADRs), including those that increase mortality and / or morbidity and / or seek medical help or hospitalization, so called «drug-induced diseases» (DID). There is a number of factors that increase the risk of DID (risk factors) including comorbid diseases (for example, chronic kidney disease, hepatic impairment, obesity etc.). These pathologic conditions induce changes in pharmacokinetics (PK) and pharmacodynamics of drugs, thereby increasing the risk of ADRs. One of these diseases is heart failure (HF). Most studies of PK changes were conducted among patients with LVEF from 40 to 45 %, and excluded patients with concomitant diseases that could affect the PK of drugs (for example, serious liver and / or kidney diseases), therefore in polymorbid patients, trial findings may not be applicable. HF may be associated with a decrease in bioavailability, a decrease in volume of distribution, a change in the activity of cytochrome P450 isoenzymes, etc.
Individual dose and dosage regimen adjustment can significantly reduce risks, improve the quality of medical care and improve the prognosis in patients with heart failure.
Drug administration, can be potentially associated with adverse drug reactions (ARDs), including serious ones, contributing to an increase in the risk of death or the development of conditions that potentially increase mortality and / or morbidity and / or become the cause of clinical manifestations, requiring the patient to seek medical attention or hospitalization - so called drug-induced diseases (DID). Some pathological conditions, like chronic heart failure (CHF), are potential risk factors for DID due to changes in the pharmacokinetics and pharmacodynamics of drugs. For example, after oral administration of fosinopril, the average T1/2 value in patients with CHF II - III NYHA functional class was 14.2 (±7.3) hours, and in healthy individuals of the control group - 11.0 (±5.2) hours. Values of AUC per os and Cmax were also slightly higher in patients with heart failure (HF) than in healthy individuals, and Cl per os, on the contrary, were lower. After intravenous administration of fosinopril, similar results were observed. Another example is the altered absorption of furosemide in patients with decompensated heart failure. Thus, in patients with heart failure, as the edema syndrome is corrected, the time to the onset of the maximum drug concentration in the blood serum (Tmax ) decreases by 27 % and Cmax increases by 29 %, which may indicate a decrease in the slowdown in the absorption rate (by 57 %). Since furosemide is mainly excreted in the urine unchanged, the observed changes in Cmax and Tmax could be associated with delayed gastric emptying, decreased intestinal motility, or edema of the intestinal wall. Individual selection of the dose and dosing regimen, taking into account the characteristics of the pharmacokinetics of drugs in patients with CHF, will help improve the quality of life and prevent potential ADR.
AUDIT
The use of different methods for analyzing the procurement of drugs for state needs made it possible to reveal the excessive range of drugs included in state contracts, as well as the low efficiency of the use of funds.
REAL-WORLD DATA
Introduction. To date, 20 COVID-19 vaccines have been registered and used in the world, three of them have been developed in the Russian Federation. The results of clinical studies of the domestic vaccine «Sputnik V» were published in the international journal «The Lancet». However, there are not so many publications on the effectiveness of Russian vaccines in real practice, mainly from Argentina. At the beginning of August 2021, the Health Committee in St. Petersburg published data on the number of people who became ill with COVID-19 after vaccination in open sources.
Aim. To evaluate the effectiveness of vaccination against COVID-19 based on real world data.
Materials and methods. The data source was information on the number of persons, the number of persons vaccinated in St. Petersburg, as well as those who became ill after vaccination, as of 07/23/2021.
Results. The risk of developing a new coronavirus infection among patients who have passed the full course (2 injections) of vaccination is 6.0–7.0 times lower (95 % CI: 6.34–7.24) compared with the group of patients who have not passed the full course (2 injections) of vaccination against COVID-19.
Conclusions. Vaccination against COVID-19 is an effective way to reduce the risk of disease.
ISSN 2618-8473 (Online)