International Journal of Risk & Safety in Medicine - Volume 27, issue s1

Authors: Kazaryan, I. | Vardanyan, L.

Article Type: Abstract

Abstract: BACKGROUND: Drug therapy plays a key role in pediatrics. Effective treatment in pediatric practice means that medicines should be both effective and safe for children. However, there is not enough data on effectiveness and safety of medicines for children due to small number of clinical trials [1 ]. Access to medicines for children remains a serious problem worldwide [2 ]. The World Health Organization (WHO) has significantly increased the efforts in the field of pediatric pharmaceuticals in order to improve the situation [4 ]. In 2007, the World Health Organization (WHO) Model List of Essential Medicines for Children (EMLc) was …firstly developed. Although WHO promotes access to essential medicines for children in countries by encouraging inclusion of these medicines in national essential medicines lists (EMLs) and treatment guidelines, many essential medicines are not covered by (EMLs) in some countries. The results of a study performed in 14 countries has shown that of 20 surveyed medicines the proportion included in national EMLs ranged from 50% to 90% and some medicines of the EML were not included in local standard treatment guidelines [3 ]. OBJECTIVE: To examine the current situation with access to essential medicines for children in the Republic of Armenia (RA). METHODS: The Armenian Essential Medicines Lists (AEML) of 2007 and 2013, as well as the Lists of medicines registered in Armenia have been analyzed (2011 – 2013). The following indicators have been calculated: the percentage of medicines from the WHO EMLc, which were included on the current AEML, the percentage of medicines from the WHO EMLc which were registered in Armenia and the percentage of medicines from the WHO EMLc which were included in approved clinical guidelines. Also, recommendations on prescribing of medicines for pneumonia, included in Armenian clinical guidelines, were analyzed. RESULTS: The analysis of the use of pharmaceuticals from the WHO Model List of Essential Medicine for Children (WHO EMLc) by medicines supply system in the Armenia has revealed that in 2013 only 57.7% of all the medicines from WHO EMLc were included on the National List of Essential Medicines of RA (AEML) and only 68.5% were registered. The results of studies carried out in 2011, 2012, 2013 showed that the situation in regard to the coverage of medicines from the WHO EMLc (without taking into account drug formulations and strengths) by AEML and clinical guidelines used in RA has not changed considerably during that period of time, while the percentage of essential medicines for children recommended by WHO, which were registered in Armenia and available in the pharmaceutical market, slightly increased. Analysis of recommendations on prescribing medicines for pneumonia treatment, included in clinical guidelines used in Armenia, has revealed that these recommendations slightly differ in terms of recommended medicines and other treatment details. Accordingly, approval and use of a single set of criteria for selecting medicines to be included into pediatric clinical guidelines should be considered as an effective approach for optimizing supply of medicines for children. CONCLUSIONS: Access to essential medicines for children in Armenia is unsatisfactory. Essential medicines for children recommended by the WHO are only partially covered by the medicines supply system for children in Armenia. Development of the List of Essential Medicines for children in Armenia is an approach to solve this problem. Currently actions are being taken in this direction. It is also considered appropriate to develop national clinical guidelines on the most common childhood diseases in Armenia. Show more

Keywords: Access to medicines, essential medicines, children, clinical guidelines, Armenia

DOI: 10.3233/JRS-150682

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S43-S44, 2015

Authors: Zurdinova, A.A.

Article Type: Abstract

Abstract: BACKGROUND: Improving quality of care in many countries is one of the priorities of health systems. At the same time one of the most important methods of improving quality of care is the widespread use of methods and principles of evidence-based medicine (EBM) [1 ]. The implementation of EBM in public health practice provides for the optimization of quality of care in terms of safety, efficacy and cost, one way of which is the use of clinical guidelines. Clinical guidelines developed with the use of EBM, provide an opportunity to use the latest and accurate information to optimize or neutralize …impact on physician decision-making of subjective factors such as intuition, expertise, opinion of respected colleagues, recommendations of popular manuals and handbooks, etc. OBJECTIVE: To assess and analyze the developed clinical guidelines (CG) and protocols (CP) in the Kyrgyz Republic in the period from 2008 to 2014 and evaluate their implementation in practical healthcare. METHODS: Retrospective analysis of the developed clinical guidelines and protocols according to the approved methodology, interviewing leaders, questioning doctors and patients for their implementation. All participants gave informed consent for voluntary participation in the study. RESULTS: Within the framework of the National Program “Manas Taalimi” “Strategy for development of evidence-based medicine in the Kyrgyz Republic for 2006–2010” (MOH Order №490 from 09.04.06) was developed and approved for use. Its main purpose was to create a sustainable system of development, deployment and monitoring of the CG and CP and further promotion of EBM into practical health care, education and science. As a result, a number of documents (“Expert Council for assessing the quality of clinical guidelines/protocols”, “AGREE instrument to assess the methodological content of clinical guidelines” [2 ], “The methodology of development and adaptation of clinical guidelines based on evidence-based medicine”) were approved by the Order of the Ministry of Health from 31.12.2008 №704. This methodology was based on the international guideline SIGN-50 [3 ], as part of the strategy, it was decided to adapt clinical guidelines of the advanced countries of the world to the organizational characteristics of health care in the Kyrgyz Republic. According to the adopted methodology, the development of clinical guidelines should include the following steps: choose a theme, create a multidisciplinary group to conduct a search of existing clinical guidelines and assess their quality, if necessary, conduct an additional search of evidence, make recommendations and draw up the text of clinical guidelines, conduct peer review and consultations, approve clinical guidelines in the pilot, approve the clinical management of the Ministry of Health, publish and distribute, put into practice, monitor the effectiveness of implementation, provide for the revision and updating of clinical guidelines as new credible information appears. In the future, these CGs will be considered as a basis for the development of the CP in accordance with the possibilities of health care organizations of the country. Figuratively speaking, the CG answers the question - “What can be done in an ideal situation? ‘, And CP -” What should be done in a country?“. The Ministry of Health over the period 2008–2014 years approved 41 CGs and 118 CPs for common diseases. It should be noted that only 31.7% of them were represented by the corresponding CGs. Among the approved CPs only 15.3% were based on the corresponding CGs. All of the CGs and CPs (100%) identified experts who prepared the documents and to whom they are addressed. The search strategy information was available only in 24.3% of cases, and only 18.1% used the criteria for selection of international guidelines, which were found in the CGs. 100% of the CGs and CPs indicated no conflict of interest of their developers, but it should be noted that 89% of the CG and CP were developed with the financial assistance of donor organizations supporting the Kyrgyz health reform. The degree of evidence of the recommendations was presented in 100% of the documents, but grading scales were different: in one CG manual grading was used with 3 levels of evidence (A, B, C), in the other – 4 levels (A, B, C, D ), and in the third - tier 5-6 (I, II, III, IV, V), which is not the approved methodology, which was based on gradation - A, B, C, D. In the process of approval of CGs and CPs, 100% did not specify points of methodological quality evaluation. To assess the implementation of approved CG in the practice (training, availability of the CG and CP for each doctor, informing patients about the CG and CP, monitoring use) we interviewed the leaders of health care organizations (20), surveyed 200 doctors and 100 patients. Only 10% of leaders said that they participated in the training on the CG and CP. 5% of them confirmed that every doctor had the corresponding copies of CGs and CPs, 100% of the leaders conduct internal audits on the use of the CG and CP, in 95% of cases the developed CGs and CPs do not take into account local health systems conditions (drugs, equipments etc.). 100% of respondents followed the CGs and CPs, as penalties were introduces by the Ministry of Health, Health Insurance Fund for violation of these recommendations. 25% of respondents reported improved clinical outcomes. To the question “How to improve the practice of medicine with the use of CGs and CPs?” 100% of the managers answered that they needed trainings: trainings for physicians, trainings for the developers of these documents. The survey of doctors showed that only 5% of them were trained in the use of CGs and CPs, 100% of them had the copies of CGs and CPs, 100% of doctors answered that the CGs and CPs not always were suitable for their practice. Questioning patients revealed the following: 100% of them never heard of the CGs and CPs, 2% of patients noted some improvement in healthcare delivery, and 20% of patients were referred to private laboratories for diagnostic tests, and 100% of the patients-respondents bought their drugs for their own pocket money. CONCLUSIONS: It is very important to ensure equal opportunities in access to medical interventions designed accordingly to the CGs and CPs at all health facilities that will prevent discrimination, depending on territorial distribution, administrative subordination, and other factors in the provision of health care. Implementation of CG and CP recommendations depends not only on the level of health care, knowledge and judgment of a clinician, but also on affordability of a particular diagnostic or therapeutic technologies for a patient. Cases when effective services are not unaffordable for patients should be considered from ethical perspective. Show more

Keywords: Evidence-base guidelines, Kyrgyz Republic, clinical guidelines, clinical protocols, interviewing, survey

DOI: 10.3233/JRS-150683

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S45-S46, 2015

Authors: Mohanta, G.P. | Manna, P.K.

Article Type: Abstract

Abstract: BACKGROUND: India, the largest democracy in the world, is with a federal structure of 29 states and 7 union territories. With a population of more than 1.2 billion, resource is always a constraint and so is in the health system too. In the federal structure, providing healthcare is largely the responsibility of state governments. Medicines are important component of health care delivery system and quality care is dependent on the availability and proper use of quality medicines. In spite of being known as pharmacy of the third world, poor access to medicines in the country is always a serious concern. …Realizing the need of quality use of medicines, several initiatives have been initiated. RESULTS: As early as 1994, seeds of rational use of medicines were sown in the country with two initiatives: establishment of a civil society, Delhi Society for Promoting Rational Use of Drugs (DSPURD) and establishment of government agency in Tamil Nadu, a southern state, called Tamil Medical Services Corporation Limited (TNMSCL). DSPUD was in official association with World Health Organization Country Office for implementing essential medicine programme in the country for two biennia. In addition to organizing sensitising and training programme for healthcare professionals throughout the country, it looked after the procurement and appropriate use of medicines in Delhi government health facilities. TNMSCL has made innovations in medicine management including procurement directly from manufacturers as a part of pooled procurement, establishing warehouses with modern storage facilities and Information Technology enabled management of whole process. TNMSCL Model is now replicated in almost the entire country and even in some small other countries as it is successful in improving access to medicines. The National Government and the State Governments have developed strategies to promote rational use of medicines as a part of improving access and quality care in public health facilities. National Government developed policies and regulations for combating antimicrobial resistance, controlling the prices of medicines, establishing generic medicines stores and advocating for the need for improvement of medicine logistics at state level and prescription auditing system. There is wide variation in medicine procurement and management system among the states. Spending on medicines ranges from as small as 2% of health budget to as high as 17%. The procurement system varies from individual facilities to partial pooled procurement to complete centralised system. There are attempts of developing essential medicine lists, standard treatment guidelines and costing of treatment of common illnesses. Except for the few states, essential medicine list remains an ornamental showpiece. However, with apex court’s intervention, the prices are now controlled for all 348 medicines listed in national list. The pharmaceutical companies continue to violate price regulations either through making the medicines at different strengths or new fixed dose combinations (FDCs). Perhaps the largest number of FDCs and many of them with no valid justification are available in the country. Decisions on compulsory licensing have made the new anticancer medicines affordable. Other countries have also benefited from this decision. CONCLUSIONS: While some progress has been made for appropriate use of medicines in public health facilities, there are little efforts in private sectors and at community levels. Availability of prescription medicines without much control and free drug advertising are other concerns. Like all other countries irrational use of medicines continues to be of concern in India despite of several attempts of improving use of medicines both in the health system as well as in community. But efforts continue to be made for improving the use of medicines! Show more

Keywords: Rational use of medicines, health system, improving use of medicines, medicine list

DOI: 10.3233/JRS-150684

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S47-S48, 2015

Authors: Golikov, A.S. | Tikhomirova, A.V.

Article Type: Abstract

Abstract: BACKGROUND: In Russia, the incidence of melanoma is increasing steadily. The approved standard of specialized medical care for melanoma of the skin defined the range of drugs, recommended for the provision of quality health care. However, it appears that the most effective innovative and safe medicines are at the same time the most expensive drugs. The most important is the assessment of drug use, taking into account their relative efficacy, safety (risk/benefit) and cost (economic efficiency), which may help to create the conditions for controlling their use. Based on this analysis, it is necessary to introduce drugs on the lists …of drugs within the framework of the provision of state guarantees of free medical care to citizens (patients). OBJECTIVE: To analyze the drug use according to the standard of specialized medical care for melanoma of the skin, to perform information retrieval in specialized libraries and databases Cochrane, Pubmed, Medline, as well as in the database of the state register of medicines (GRLS) of Russian Ministry of Health. METHODS: The nomenclature of drugs was determined according to the standards of specialized medical care for 2006 and 2012, to the data of GRLS; information searches were performed in specialized libraries and databases Cochrane, Pubmed, Medline. RESULTS: Analysis of anticancer drugs for melanoma of the skin consisted of determining of nomenclature of drugs, included in the standard of specialized medicine care. The standard of specialized medicine care for patients with malignant melanoma of the skin (with specialized assistance) (Order dated December 6, 2006 № 828) includes the following anticancer drugs: dacarbazine (alkylating agents), vinblastine (antineoplastic agent - an alkaloid), cisplatin (platinum), lomustine (nitrosoureas), bleomycin (antitumor agent, an antibiotic) [1 ]. The standard of specialized medical care in melanoma skin generalization or recurrent disease (chemotherapy) (Order of November 7, 2012 № 604n) includes the following anticancer drugs: lomustine and fotemustine (nitrosoureas), dacarbazine and temozolomide (alkylating agents), cisplatin (platinum) [2 ]. So, the standard of specialized medical care for for melanoma of the skin by 2012 compared with the standard of care by 2006 includes temozolomide and fotomustin and excludes vinblastine and bleomycin. Based on the database GRLS of Russian Ministry of Health Care [3 ], as well as information retrieval in databases of Cochrane, Pubmed, Medline the efficacy and safety of melanoma of the skin have proven innovative products, in particular, such as vemurafenib (Zelboraf) dobrafenib (Tafinlar) and trametinib (Mekinist) that are already registered in Russia. At the stage of the clinical study are targeted drugs, such as GSK1120212, AMG 678, pembrolizumab, ipilimumab, tremilimumab, nivolumab and etc. The inclusion or exclusion of data from the restrictive drug lists, such as lists of “Vital and essential medicines”, “Drugs for certain categories of citizens”, the “Minimum range”, according to the Russian Government Decree №871 of 28.08.2014 [4 ] is carried out after the risk/benefit ratio and cost effectiveness assessment to increase their availability. The availability of high-quality, effective and safe drugs for medical use within the reduced budget, taking into account the formation of a rational and balanced system of health care is the main task of the strategy of the drug provision of the population of Russia for the period till 2025 [5 ]. CONCLUSIONS: The most rational use of limited resources and cost containment within the framework of state regulation refers to modern trends in the health care of the Russian Federation. There is a need to develop targets aimed at all subjects of the pharmaceutical market, to increase the availability of innovative drugs for melanoma of the skin treatment. This strategy should be based on evidence and assessments of the efficacy, safety and economic viability of anticancer drugs. Show more

Keywords: Anticancer drugs, standard, medical care, melanoma, benefit/risk ratio, cost effectiveness

DOI: 10.3233/JRS-150685

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S49-S50, 2015

Authors: Akhmadyar, N.S. | Khairulin, B.E. | Amangeldy-kyzy, S. | Ospanov, M.A.

Article Type: Abstract

Abstract: BACKGROUND: One of the main problems of drug provision of multidisciplinary hospitals is the necessity to improve the efficiency of budget spending. Despite the efforts undertaken in Kazakhstan for improving the mechanism of drug distribution (creation of the Kazakhstan National Formulary, Unified National Health System, the handbook of medicines (drugs) costs in the electronic register of inpatients (ERI), having a single distributor), the number of unresolved issues still remain. “National Medical Holding” JSC (NMH) was established in 2008 and unites 6 innovational healthcare facilities with up to 1431 beds (700 children and 731 adults), located in the medical cluster – …which are “National Research Center for Maternal and Child Health” JSC (NRCMC), “Republic Children’s Rehabilitation Center” JSC (RCRC), “Republican Diagnostic Center” JSC (RDC), “National Centre for Neurosurgery” JSC (NCN), “National Research Center for Oncology and Transplantation” JSC (NRCOT) and “National Research Cardiac Surgery Center” JSC (NRCSC). The main purpose of NMH is to create an internationally competitive “Hospital of the Future”, which will provide the citizens of Kazakhstan and others with a wide range of medical services based on advanced medical technology, modern hospital management, international quality and safety standards. These services include emergency care, outpatient diagnostic services, obstetrics and gynecology, neonatal care, internal medicine, neurosurgery, cardiac surgery, transplantation, cancer care for children and adults, as well as rehabilitation treatment. OBJECTIVE: To create a program of development of a drug formulary of NMH and its subsidiaries. METHODS: In order to create drug formularies of NMH, analytical, software and statistical methods were used. AII subsidiary organizations of NMH (5 out of 6) except for the NRCOT have been accredited by Joint Commission International (JCI) standards, which ensure the safety of patients and clinical staff, by improving the technological infrastructure, management systems, production environments, and developing program for medications management and use (MMU), etc. MMU is the Chapter 7 of the 5th edition of the standard JCI [1 ] which is an up-to-date recognized international standard for hospital drug supply and includes 7 points of medication management lifecycle for inpatient hospitals: drug management and organization; selection and procurement; storage; prescription; preparation and distribution; administering medications; monitoring. Due to the developed MMU program of subsidiary organizations the drug provision system was rationalized, starting from defining the individual therapy of a patient and ending with the drug procurement strategy. The practical activity was introduced to the use of drugs committeees with reliable evidence-based performance with obligatory consideration of cost-benefit analysis for each diagnosis-related group. RESULTS: Pre-collected applications for drugs for the year 2015 were submitted in a uniform format in accordance with the structure of the Republican form of the drug [2 ]. In view of the evidence-base physicians-clinical pharmacologists performed discussions and review of 851 drugs included on the uniform format of the list. Totally 51 (6%) positions were excluded from the list; it was suggested that the format of the application for Paracetamol and Ibuprofen in injectable form be revised; the committee revised the sections on the list for “Antianaemia drugs”, iron preparations and methods of prevention of venous thromboembolism with oral anticoagulants. On the basis of this work, the new format, consisting of 449 international nonproprietary names was developed, representing 795 positions with pediatric formulations. In view of the exisitng data and the move to bring to the common standards and uniformity prices of drugs purchased for 2016, the NMH program of clinical pharmacology content with on-line and open access to physicians was created. Within 60 days the DSCHC work was carried out with consultations, selection, definition of requirements of generic and therapeutic substitution. CONCLUSIONS: Summing up, drug applications for 2016 with dosage forms include 802 positions and the total bid in monetary terms was by 4,7% lower than in 2015. For the establishment of NMH rational and balanced system of medicine provision to patients and in order to increase availability of quality, safe and effective drugs, we need to have an open and transparent program of the MMU, developed in accordance with the standards of JCI, with the NMH drug formulary, indicating the reference price values of the lower units (tablet, capsule, ampoule, vial, etc.), including the drug lists for a single distributor. To improve drug supply of the NMH DSCHC we have to further cooperation with clinical pharmacologists for the rational use of medicines, guided by the principles of evidence-based medicine. Show more

Keywords: drug formularies, drug safety, efficacy, availability, rational drug use, monitoring

DOI: 10.3233/JRS-150686

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S51-S52, 2015

Authors: Khafizianova, R.Kh. | Burykin, I.M.

Article Type: Abstract

Abstract: BACKGROUND: Adequate and rational pharmacotherapy is an important element of rehabilitation of patients with myocardial infarction. Orders of the Ministry of Health of the Russian Federation, domestic and international guidelines, and scientific publications - all contain a complete algorithm for rational pharmacotherapy [1, 2 ]. These documents are based on the principles of evidence-based medicine (EBM) and help practicing physicians to carry out individualized and rational pharmacotherapy. However, clinical studies have shown low adherence of physicians to clinical guidelines. In the Russian Federation the death rate from cardiovascular diseases is higher than in developed countries. Thus, studies of the causes …of high cardiovascular mortality are needed. OBJECTIVE: To assess adherence of practicing physicians to principles of evidence-based medicine in treating patients after myocardial infarction at the stage of rehabilitation. METHODS: A retrospective analysis of 157 cases of patients in rehabilitation after myocardial infarction for the years 2006 and 2009 was undertaken. We analyzed the list of drugs, prescribed to patients during the period of rehabilitation, drug combinations, regimens and pharmacoepidemiological parameters. We used the following rehabilitation criteria: blood pressure control, smoking cessation, and weight control. Recommendations of controlled physical activities have also been studied. Patient care was compared with the guideline recommendations. Statistical analysis was performed using the OLAP system. RESULTS: 65 patients with myocardial infarction received rehabilitation therapy in 2006, and 92 - in 2009. It was found, that in 2006 physicians prescribed an average of 4.5 drugs per patient, and in 2009 - 4.6 drugs per patient. The average number of cardiovascular drugs (category C of ATC classification) per patient was 2.9 in 2006, and 2.6 – in 2009. Polypharmacy was found in half of the patients. In terms of evidence-based medicine, an important element in the rehabilitation of patients is smoking cessation and normalization of body weight. Nicotine replacement therapy and prescriptions of drugs for weight loss is one of the strategies to achieve goals. According to our study, drugs for smoking cessation and overweight were not prescribed at all. In terms of evidence-based medicine, the use of beta-blockers and ACE inhibitors for a long time by all patients is an important element of secondary prevention. The frequency of prescribing of beta-blockers was 86.1% and 91.1 %% in 2006 and 2009 respectively. The frequency of prescribing of subgroup C09 “Agents acting on the renin-angiotensin system (RAAS)” was 67.7% and 44.4% in 2006 and 2009 respectively. Beta-blockers had the highest frequency of use, while the subgroup RAAS drugs were second to them. We found that the following recommendations of clinical guidelines, based on the principles of evidence-based medicine, were not followed. We found low rates of ACE inhibitors prescribing. The structure of prescribed ACE inhibitors varied in 2006 and 2009. In 2006, 58.4% of all prescriptions were for enalapril. In 2009 enalapril use decreased to 30%, while prescribing of lisinopril increased from 0 in 2006 to 13.3%. Among angiotensin II antagonists (C09C) only losartan was used in 3.1% and 1.1% of cases in 2006 and 2009, respectively. Fixed drug combinations were not used at all. The proportion of patients who had hypertension was 73.9% and 61.9 %% in 2006 and 2009, respectively. The rate of Antihypertensive use (C02), namely Guanfacine and Moxonidine was less than 2% in both 2006 and 2009. In accordance with evidence-based principles the strategy for prevention of recurrent myocardial infarction with prescription of lipid-lowering drugs was used. Lipid-lowering drugs were prescribed to 13.8% of patients in 2006 and to 82.2% of patients in 2009. Doctors used atorvastatin and simvastatin only from the list of drugs of this group. We found that in clinical practice physicians used drugs, not supported by evidence, in particular trimetazidine was frequently used. Antiarrhythmic drugs were not prescribed at all, while part of the patients had arrhythmias. Standards of rehabilitation of patients with myocardial infarction do not contain a section on pharmacotherapy and could not be used for quality assessment. CONCLUSIONS: Pharmacotherapy of patients aimed at secondary prevention of myocardial infarction did not fully conform to the principles of evidence-based medicine. Standards for rehabilitation after myocardial infarction require revision based on existing clinical guidelines and evidence-based medicine. Show more

Keywords: Adhearance, guidelines, myocardial infarction, rehabilitation

DOI: 10.3233/JRS-150687

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S53-S54, 2015

Authors: Farnosova, M.E. | Zharikova, T.F. | Gamirova, R.G. | Sivkova, S.N.

Article Type: Abstract

Abstract: BACKGROUND: Infantile spasms (called the West’s Syndrome) represent a severe epileptic syndrome which is characterized by a peculiar type of epileptic seizures, spasms, and by electroencephalographic (EEG) abnormalities often called hypsarrhythmia [1 ]. Infantile spasms are usually resistant to conventional antiepileptic drugs (AEDs) and adrenocorticotrophic hormone (the synthetic analog - tetracosactide) has been the preferred treatment since 1958. The evidence for other antiepileptic drugs is extremely limited compared with vigabatrin. Most recent studies deal only with short-term drug effects and fail to use clinically meaningful outcome measures. Furthermore, attention needs to be given to dropout rates in the studies, because …some studies include a majority of patients with primarily favourable outcome [2 ]. Effective treatment is now defined as complete cessation of the spasms plus abolition of hypsarrhythmia (’all-or-none response’) [3 ]. So far there has been no consensus on dosage or duration of therapy, influence of early initiation of treatment on the outcomes of West syndrome therapy. OBJECTIVE: To assess if the timing of treatment initiation (early or late) influences the outcomes of West syndrome therapy. METHODS: We conducted a retrospective observational study at the Kazan Municipal children’s hospital № 8 among children with West syndrome. When treatment with tetracosactide (synacthen depot) or antiepileptic drugs was initiated within 1 month after the onset of seizures we defined it as “early treatment initiation”. If this therapy was started after 1 month of the onset of seizures, we defined it as “late treatment initiation”. We used was the number of seizure-free patients after 2 months, 6 months and 1 year from the start of the treatment as the favorable outcome measure. We calculated risk ratios (RR) for favorable outcomes and their confidence intervals (CI) using RevMan 5.3 Software, comparing outcomes of early and late treatments. RESULTS: We analyzed medical records of 150 children with infantile spasms. The diagnosis of West syndrome was confirmed by video-EEG-monitoring findings and by clinical examinations. Gender distribution of patients with West syndrome was with some predominance of boys: 93 boys (62%) and 57 girls (38%), which corresponded to the published literature data. The duration of follow-up was at least 3.5 years. The mean age of patients at the time of analysis was 6 years, from 4 years (min) to 14 years 5 months (max). We divided all of the children into four groups: Group IA - early treatment initiation – included children who were started on tetracosactide within 1 month from the onset of seizures (30 patients). Group IB - late treatment initiation – included children who were started on tetracosactide after 1 month of the onset of seizures (60 patients). Group IIA - early treatment initiation – included children who were started on antiepileptic drugs as mono- or polytherapy within 1 month from the onset of seizures (22 patients). Group IIB - late treatment initiation – included children who were started on antiepileptic drugs after 1 month of the onset of seizures (38 patients). Children in all groups were similar with respect to age, sex, severity of the disease. Effectiveness of tetracosactide in the group IA and in the group IB at 2 months, 6 months and 1 year of follow up (from the beginning of treatment) was comparable: RR = 1.00; 95% CI [0.79, 1.27]; P = 1,00; RR = 0.96; 95% CI [0.74, 1.24]; P = 0,74; RR = 1.00; 95% CI [0.75, 1.33]; P = 1,00; respectively Comparative analysis of the effectiveness of treatment with antiepileptic drugs (without tetracosactide) at 2 months, 6 months and 1 year of follow up (from the initiation of treatment) demonstrated that the number of patients achieving clinical remission was higher in the group IIA, in which the therapy was started within 1 month of the onset of the disease versus the “late treatment initiation” group IIB: RR = 2.76; 95% CI [1.03, 7.41]; P = 0,04; RR = 1.62; 95% CI [1.01, 2.59]; P = 0,04; RR = 1.37; 95% CI [1.02, 1.84]; P = 0,04; respectively. CONCLUSIONS: The timing of initiation of tetracosactide therapy did not influence the outcomes of West syndrome therapy. The early initiation of treatment with antiepileptic drugs (but without tetracosactide) resulted in a greater number of patients achieving remission, compared with late treatment initiation. Show more

Keywords: West’s syndrome, tetracosactide

DOI: 10.3233/JRS-150688

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S55-S56, 2015

Authors: Butranova, O.I. | Razdrogina, T.N.

Article Type: Abstract

Abstract: BACKGROUND: Type 2 diabetes mellitus is a chronic pathology characterized by high prevalence, high morbidity and mortality. According to the data of the Ministry of Health of Volgograd region the number of patients with type 2 diabetes was 68,227 people on 01.01.2014. Medical and social significance of type 2 diabetes mellitus is determined by its complications. Skin and soft tissue infections (SSTIs) in patients with type 2 diabetes are among the main factors of hospitalization and mortality [1 ]. Diabetic foot syndrome is found in 30–80% of patients [2 ]. OBJECTIVE: Pharmacoepidemiological analysis of the structure of skin …and soft tissues infections in patients with type 2 diabetes, taking into account data on pathogens, parameters of their sensitivity, analysis of prescribed medicines and evaluation of their compliance with current clinical guidelines and standards. METHODS: A retrospective descriptive cross-sectional pharmacoepidemiological study using randomization by random numbers. The sample consisted of 253 medical records of patients with SSTIs and type 2 diabetes. These were patients admitted to the surgical departments of hospitals of the city of Volgograd for the period from January 2011 to December 2014. Gender structure was the following: 51.4% - women, 48.6% - men. The average age of patients was 64.5 years. The average number of hospital days was 19,5 ± 14,9. RESULTS: Diabetic foot syndrome was found in 81.3% of cases (n -204). The most common forms of diabetic foot syndrome were the following: gangrene of the lower extremities - 28% (n -58), ulcers of the skin - 26% (n -53), mixed forms of SSTIs - 18% (n -37 ). Surgical manipulations were performed in 39.1% of cases (n -99), including amputations in 65.7% (n -65) of cases. The blood glucose level on admission was studied in 97.6% (n -247), at discharge – in 89% (n -225). Urine analysis on admission was performed in 66.4% of patients (n -168), at discharge – in 51% of patients (n -129). The glycemic profile was studied in 81.4% of patients (n-206). Bacteriological sowing was carried out in 19% (n -48) of cases: blood - 4,2% (n -2), urine - 6,2% (n -3) (the growth of microorganisms was not detected in 100%); bacteriological sowing from the wound - in 89.6% (n -43), the growth of microorganisms were identified in 95.7% (n -44). Most common pathogens were: St. aureus - 28%, E. coli - 19%, St. epidermidis - 14%. Antibacterial medications were prescribed in 86% (n -216). These were: cephalosporin of the III generation - ceftriaxone (49.4%), other synthetic antibacterials - metronidazole (21%), fluoroquinolone - ciprofloxacin (7.5%). The highest levels of bacterial resistance of SSTIs pathogens were found to beta-lactam antibiotics (amoxicillin/clavulanic acid, ceftriaxone, and ampicillin), rifampin, and gentamicin. The highest levels of sensitivity of SSTIs pathogens were observed to levofloxacin, to vancomycin and meropenem. CONCLUSIONS: There is a vicious circle in patients with type 2 diabetes: the infectious process leads to decompensation of carbohydrate metabolism parameters; in turn, hyperglycemia leads to increase of severity of SSTIs. Normalization of glucose levels promotes prompt relief of symptoms of infection and bacterial eradication, rational treatment of infection contributes to rapid correction of glucose level. Therefore, an essential element of comprehensive treatment of this group of patients should be rational antibiotic therapy; the choice of medication should be based on the severity of the disease and potential etiologic agents [3 ]. The analysis of the degree of conformity of the pharmacotherapy to existing standards is a way to optimize the treatment of the given group of patients [4 ]. Show more

Keywords: Pharmacoepidemiology, antibiotic, infection, skin and soft tissues, diabetes mellitus, type 2 diabetes

DOI: 10.3233/JRS-150689

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S57-S58, 2015

Authors: Yevstigneev, S.V. | Titarenko, A.F. | Abakumova, T.R. | Alexandrova, E.G. | Khaziakhmetova, V.N. | Ziganshina, L.E.

Article Type: Abstract

Abstract: BACKGROUND: Rational use of medicines remains to be one of the most challenging problems in health systems worldwide [1, 2 ]. ABC/VEN-analysis has been recommended for use by the World Health Organization (WHO) and has been used in health care practice globally since 1981. It represents the simple and effective method of analysis of medicine expenditures, identifying priority groups of medicines, the use of which, when improved, may provide the greatest clinical and economic impact. ABC analysis provides an accurate and objective picture of budget expenditures on medicines. VEN-analysis helps to prioritize between various medicines in their selection for procurement …and use within a drug supply system [3–5 ]. OBJECTIVE: To assess the impact of introduction of evidence-based principles in the practice of medicine procurement and use on budget expenditures on medicines of a multidisciplinary health facility for the period of four years (2011–2014). METHODS: ABC/VEN analysis was carried out in a multidisciplinary health facility with over 1000 beds (an average number of beds for three years), which is responsible for provision of care to the population of about 1.4 million people. The analysis was carried out on the basis of information on medicine expenditures for 4 years: 2011 (1st year), 2012 (2nd year), 2013 (3rd year) and 2014 (4th year). When assigning VEN categories of medicines we used expert method: assignment of categories was carried out by clinical pharmacologists after reviewing all available evidence on effectiveness, safety and cost-effectiveness compared to other drugs in this group. In 2013, we implemented educational intervention, including detailed discussion of the results of the ABC/VEN-analysis for the years 2011-2012 from the standpoint of evidence-based pharmacology and recommendations for medicine procurement. In 2014, we delivered training workshop for the heads of clinical departments on evidence-based principles in clinical pharmacology and rational use of medicines. RESULTS: Medicines expenditures of the studied health facility for the year 2014 were less than for the year 2013, which was the important decrease reversing the trend of increasing medicines expenditures of the last three years: 2011 - 59,868,963 roubles; 2012 - 85,324,084 roubles, 2013 - 107 303 390 roubles, and 2014 - 74,416,692 roubles. The number of International Non-proprietary Names (INN) of medicines used in 2014 was 519, which was the highest number for the four years of the study: 2011 – 429 INN, 2012 – 432 INN, 2013 – 513 INN, and 2014 – 519 INN. Nearly 40% of the funds spent in 2014 on medicines have been used for Vital medicines: 2011 - 26%, 2012 - 39%, 2013 - 25%. Expenditures on Non-essential medicines in 2014 were about the same as in previous years - 14% of total medicine expenditures: 2011 - 16%, 2012 - 13%, 2013 - 15%. However in absolute numbers (roubles) expenditures on non-essential medicines decreased compared to the years 2013 and 2012: 2011 – 9,428,135 roubles, 2012 – 11,129,388 roubles, 2013 – 15,578,325 roubles, 2014 – 10,616,023 roubles. Expenditures on solutions for infusion (sodium chloride, Ringer’s solution, dextran, glucose, hydroxyethyl starch) decreased as compared to the year 2013, but still remained high, thus indicating on the abuse of parenteral methods of drug administration. The portion of expenditures on isotonic sodium chloride solution and hydroxyethyl starch in 2014 decreased compared to the year 2013. We found a positive trend in the structure of expenditures on antibacterial agents: in 2014 expenditures on fluoroquinolones decreased nearly fivefold compared to 2013, expenditures on cephalosporins also decreased, but not so dramatically. However, there was a significant increase in expenditures on carbapenems, more than twofold compared with the year 2013. In 2014 we noted a twofold decrease in expenditures on medicines affecting blood, including antithrombotic agents, hemostatics and antianemic medicines, as compared to the values of the year 2013. In 2014 there was also a decrease in expenditures of cardio-vascular medicines, medicines affecting nervous system, alimentary tract and metabolism. CONCLUSIONS: Introduction of evidence-based principles through educational interventions at a multidisciplinary health facility resulted in a number of changes towards more rational medicine use. Regular educational interventions for practicing physicians and heads of clinical departments of health facilities that promote rational prescribing are needed. Show more

Keywords: Rational use of medicines, ABC VEN analysis, multidisciplinary, health facility

DOI: 10.3233/JRS-150690

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S59-S60, 2015

Authors: Baturin, V.A. | Shchetinin, E.V. | Malykhin, F.T.

Article Type: Abstract

Abstract: BACKGROUND: The last years have witnessed progressive growth of antimicrobial resistance (AMR) both in hospital-acquired and community-acquired respiratory infections. Regional guidelines (2006) presented standard approaches to pharmacotherapy and provided an important contribution to improvement of antimicrobial therapy at healthcare facilities of both the City of Stavropol and the Stavropol Region. At the same time, recent years have witnessed substantial changes in sensitivity to antimicrobials; besides, newer antibiotics have become available now. This substantiates the need for update of the regional guidelines [1 ]. OBJECTIVE: To determine the issues related to standardization of antibiotic therapy of lower respiratory tract …(LRT) infections at an outpatient setting; to assess regional changes (2007–2012) in the spectrum of pathogens causing LRT diseases in patients of the regional healthcare facilities in view of their age and the diagnosis as compared with the years of 2003–2006. METHODS: In 2007–2012, we examined sputum microbiology of patients with LRT infections at the bacteriological laboratory of the Centre for Clinical Pharmacology and Pharmacotherapy (Stavropol, Russia), following the methodology guidelines [2 ]. The comparison was carried out with the results of the microbiological examination of 7051 sputum samples (held in 2003–2006). Statistical analysis was carried out using arithmetic means, standard errors, and Student’s t test involving a software package STATISTICA 6.0. RESULTS: In the outpatient practice, half of the patients with LRT infections were identified to have Str. Pneumoniae. The sputum of every fifth examined patient allowed isolating Enterobacteriaceae family members such as Klebsiella spp . (Klebsiella pneumoniae in most cases), Serratia spp. , E. coli , and Enterobacter spp. It is essential to note that almost a quarter of the patients were found to have M. pneumoniae. C. Pneumonia was detected quite often as well (19%). Str. pneumoniae, M. pneumoniae, and C. pneumoniae were found in virtually 80% of all the cases of community-acquired pneumonia in adults. H. influenzae and M. pneumoniae were 2-3 times more often isolated from the sputum of patients with chronic obstructive pulmonary disease (COPD) and chronic non-obstructive bronchitis. Along with an increase in the patients’ age, regardless of the diagnosis, the proportion of pneumococci, Haemophilus influenzae and various members of the Enterobacteriaceae family went up, while the share of mycoplasmas went down. However, even in patients over 60 years of age M. pneumoniae accounted for a significant share in the overall spectrum of pathogens, which indicates the need for microbiological monitoring, especially as far as COPD is concerned. In contrast to the previous years, only 35% of the patients (previously 60%) underwent bacteriological examination (p<0.05) while receiving antibiotic therapy. Significant prevalence of mycoplasmas in the structure of the isolated microorganisms was found in patients who had been previously treated with β-lactam antibiotics. Associations of pathogens were detected in 14% of cases, which is half the rate found 2-3 years ago. The associations were found to reveal more frequent presence of H. influenzae in patients with acute exacerbation of chronic non-obstructive bronchitis, and Enterobacteriaceae – in patients with COPD and pneumonia. The recent years have shown that, combined with other microorganisms, there can be detected pneumococci (p<0.05), H. influenzae , as well M. pneumoniae, while there have been fewer cases of enterococci and enterobacteria; as for non-filterable bacteria, they have been never detected again (p<0.05). Strains of H. influenzae maintained high sensitivity to aminopenicillins, including the protected ones. The antibiotic resistance possessed by Str. pneumoniae to aminopenicillins doubled (12.4% strains vs. 6.4% 3 years ago, p<0.05). The resistance to Co-trimoxazole and Ofloxacin was 27.9% and to macrolides it was 17.9%. Various representatives of the Enterobacteriaceae family maintained high sensitivity to aminopenicillins, second and third generation cephalosporins, fluoroquinolones. Of the 20 M. pneumoniae strains that were tested, 8 (40%) displayed resistance to one or more antimicrobials. The highest numbers of cases with resistance were detected to Ciprofloxacin (25%) and Erythromycin (20%). 10% strains of mycoplasma showed resistance to Doxycycline and Ofloxacin, while only 5% of mycoplasmas were identified as having non-sensitivity to Clarithromycin and Azithromycin. CONCLUSIONS: The results of the research carried out in the recent years in comparison with the data of the previous years, call for reviewing of the standard approaches to the choice of antimicrobial agents in respiratory tract infections. In order to improve the standard of care, the choice of medicines should be based on a number of factors, namely the age, the severity of the respective pathological condition, previous antimicrobial use, and the level of care. Show more

Keywords: Antimicrobial resistance, respiratory tract infections, antimicrobial agents

DOI: 10.3233/JRS-150691

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S61-S62, 2015