Nonsteroidal anti-inflammatory drugs’ adverse drug reactions: 10 years of national database data

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

Assessment of the economic feasibility of gadoversetamida (OptiMARK) MRI with intravenous contrast

Gadolinium based contrast agents are widely used in MRI in a diagnostic of variety of pathologies. The quality of contrast enhancement depends on the total dose. The aim of the study is to conduct a health economic evaluation of gadoversetamide (OptiMARK, Malickrodt Pharmaceuticals) in contrast enhanced MRI. The cost-effectiveness analysis, costminimizing analysis and sensitivity analysis and budget impact analysis were used modeling contrast enhanced MRI. In results, we can say that OptiMARK is cost-effective comparing to gadopentetic acid and gadobutrol

Assessment of the economic evaluation of the contrast agent Iomeron in percutaneous coronary intervention

Percutaneous coronary intervention (PCI — angiography and stent placement) aren’t possible without X-ray contrast agents. Contrast enhancement depends on the iodine concentration, while the safety of particular contrast agents diff ers. Th e aim of the study is to conduct health economic evaluation of Iomeron (Bracco Imaging S.p.A., Italy) in patients with acute coronary artery disease treating with PCI. Th e cost-eff ectiveness analysis, cost-minimization analysis, sensitivity analysis and budget impact analysis were used. In results, we can say that Iomeron is cost-eff ective comparing to iodixanol, iohexol, iopromide and ioversol

Assessment of the economic evaluation of the contrast agent MultiHance

Gadolinium based contrast agents are widely used in MRI in a diagnostic of variety of pathologies. The quality of contrast enhancement depends on the total dose (mM per kg body weight) and its relaxivity. Gadobenic acid (MultiHance® , Bracco Imaging S.p.A, Italy) has the highest relaxivity comparing to others gadolinium based contrast agents approved in Russia. The aim of the study is to conduct a health economic evaluation of gadobenic acid in contrast enhanced MRI. The cost effectiveness analysis, sensitivity analysis and budget impact analysis were used to modeling MRI of CNS, MR-angiography and MRI of the liver. In results, we can say that Multihance® is cost-effective comparing to gadopentetic acid, gadobutrol and gadodiamid in CNS MRI

Pharmacoepidemiology of botulinum toxin in the complex therapy of post-stroke spasticity in the Russian Federation. The survey data of neurologists

A pharmacoepidemiology study was performed of the use of botulinum toxin type A drugs (BTA) in the combined therapy of post-stroke spasticity in Russian Federation. Experts survey was the major method used and followed by application of the Delphi method. Questionnaire consisted of 30 questions. 12 completed questionnaires from 12 cities of Russia were analyzed as a result. Practicing neurologist participated in the survey who had experience of BTA use in combined treatment of post-stroke spasticity. Several indicators were identifi ed that represent signifi cant interest for their subsequent use, in particular, during the pharmacoeconomic studies, scientifi c analysis of outcomes with Markov modelling use, development of mathematical models

Pharmacoeconomic analysis of dexamethasone intravitreal implant for the treatment of diabetic macular edema in Russia

A health economic study was conducted under the Russian economic conditions to evaluate the feasibility of the use of dexamethasone 0.7 mg as a sustained release intravitreal implant (hereinafter, DEX implant) in the treatment of diabetic macular edema. Cost-effectiveness analyses (CEA) were performed using a decision tree model with calculation of cost effectiveness ratios (CER), as well as incremental cost-effectiveness and cost-utility ratios (ICER and ICUR). Ranibizumab 10 mg/ml, solution for intravitreal administration (hereinafter, ranibizumab), and a­ibercept 40 mg/ml, solution for intravitreal administration (hereinafter, a­ibercept), were used as the comparator drugs; the modeling study covered a three-year period. A probabilistic sensitivity analysis (PSA) was carried out to evaluate the level of uncertainty of the obtained results. A budget impact analysis was also performed. Free scenarios were reviewed for each analysis: the main scenario for phakic and pseudophakic eyes with the weighted average effects of the study drugs; alternative scenario 1 for pseudophakic eyes with the weighted average effects; alternative scenario 2 for pseudophakic eyes with the maximum possible effects of the study drugs. A network meta-analysis of 10 randomized controlled studies (RCT) was performed to evaluate the weighted average effect. e maximum possible effects were determined based on specific studies, including observational studies. e results of the main scenario and alternative scenario 1 demonstrated that the comparator drugs were inferior to the DEX implant with regard to the economic feasibility, since they had higher CER; the ICER and ICUR for the comparator drugs exceeded the social willingness to pay threshold. e results of alternative scenario 2 demonstrated that the DEX implant was dominant with regard to ranibizumab, and it was superior to a­ibercept with regard to the CER, ICER, and ICUR. The budget impact analysis demonstrated that a 3-year use of the DEX implant will allow to save the funds equivalent to an additional treatment of 102–189 patients if it replaces ranibizumab (depending on the scenario) or 72–286 patients if it replaces a­ibercept (depending on the scenario). e sensitivity analysis demonstrated low level of uncertainty of study conclusions

Quantitative and qualitative evaluation of the use of nonsteroidal anti-inflammatory drugs in the Russian Federation over 10 years

Relevance. Studies devoted to the assessment of consumption, as well as to the issues of pharmacosafety of nonsteroidal anti-inflammatory drugs, are limited at the national level in the Russian Federation. The study of these issues will determine the general trends of consumption and prescription of this group of drugs.Aim. To assess the consumption pattern of NSAIDs in the Russian Federation in the period from 2010 to 2020.Methods. Information was searched using data from the state register of drugs (GRLS) as well as national database downloads (automated information system of Roszdravnadzor; AIS RZN). To estimate the consumption of the main INN from the group of NSAIDs for the period 2010–2020 the information on the sales volume of all trade names, sold for sale in the Russian Federation was unloaded from the database of IQVIA Solutions Ltd. and analyzed.Results. The analysis showed that the first place by total amount of consumption was occupied by acetylsalicylic acid (5 953 058 854); second place — paracetamol (4 635 122 085); third place — ibuprofen (3 230 415 088); fourth place — metamizole (4 172 344 008); fifth place — ketorolac (91 617 809,04); sixth — nimesulide (69 761 7481,8). The claimed INNs showed a slightly different distribution when calculating the DDDs/P (patient-year) totals, namely, in descending order, nimesulide, ketorolac, ibuprofen, acetylsalicylic acid, paracetamol, and methamisole.Conclusion. The indicated levels of consumption do not correlate with the data of the national database “Pharmacovigilance”, which indicates insufficient post-marketing monitoring of the safety profiles of the indicated medicines

Pharmacovigilance system in Eurasian Economic Union

The article deals with the main provisions of the basic document — «Rules of good practice of pharmacovigilance of the Eurasian economic Union», which regulates the study and prevention of adverse reactions and other problems associated with drugs in the member States of the Union, including the Russian Federation. Also, the Rules establish requirements for the organization of pharmacovigilance system in pharmaceutical companies, detail the work of manufacturers in the field of risk management, as well as determine the procedure for informing employees of the pharmaceutical industry and specialists of medical institutions of the authorized bodies about the identified safety problems in the use of medicines

Principles of clinical and economic analysis of antimicrobial drugs

In light of rising costs in the health care system and the introduction of innovative but expensive technologies, decision makers are looking for reliable methods to assess their cost-effectiveness. To this end, a comprehensive assessment of medical technology is carried out, including the analysis of information on its comparative clinical efficacy and safety, as well as an assessment of the economic consequences of its implementation. One of the most important features of clinical and economic studies of antimicrobials is the ability of infectious agents to acquire resistance to therapy, which fundamentally changes their effectiveness, and, consequently, the clinical and economic feasibility of use over time. Taking into account the risks of resistance as a criterion of effectiveness in pharmacoeconomical studies of antimicrobial drugs is an important factor affecting the feasibility of inclusion of drugs in the restrictive lists. At the same time, this criterion remains underutilized

Pharmacoeconomic evaluation of mirabegron: results of the healthcare budget impact analysis

Overactive bladder (OAB) is a chronic disease that correlates with the age of the patient, and occurs in almost one in seven women and men. Pharmacotherapy is one of the main methods for correction of this nosology. Taking into account the absence of additional therapeutic option on the Vital and Essential Drugs List for patients with contraindications for the prescription of solifenacin and BTX-A, patients with intolerance to these drugs conduct, an analysis of the economic consequences of the use of mirabegron under the State Guarantees for Providing Free Medical Care for the OAB treatment. Approved recommendations on carrying out the budget impact analysis were used. Results of the study show, that the expansion of the mirabegron use in the treatment of patients with OAB in the target population leads to the reduction in the cost of medical therapy for this group of patients: with an increase in the share of mirabegron up to 5 %, costs will decrease by 7.8 %; with an increase in the mirabegron share up to 10 % costs will decrease by 12.5 %; when using in 15 % of the target population – by 22.3 %. Trend analysis of changes in the average weighted costs shows the following: an increase in the use of mirabegron leads to a significant reduction in total costs, the total benefit can reach 6 250 002 576 rubles per 3 years of the drug presence in the VED List, which allows attributing the OAB treatment with mirabegron to economically feasible and resource-saving medical technologies