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

Authors: Kazaryan, I. | Sevikyan, A.

Article Type: Abstract

Abstract: BACKGROUND: Reliable medicine information is important not only for physicians and pharmacists, but also for patients [6 ]. However, the results of studies implemented in some countries show that patients may have slightly different needs and preferences in using sources of information [1, 4, 5, 7 ]. The main objective of patient medicines information is assisting consumers to achieve safe and effective use of pharmaceuticals [2, 3 ]. OBJECTIVE: To identify patients’ needs in medicine information and sources they use to receive it. METHODS: We interviewed 1059 people who had visited community pharmacies in 10 regions …of Armenia and Yerevan. Previously developed questionnaire was used for interviewing patients. Statistical analysis was conducted using SPSS program. RESULTS: We found that consumers need medicine information. 68.9% of respondents often use pharmaceuticals only if necessary medicines information is available. The majority of them believe that it is important to have information about therapeutic indications of pharmaceuticals to be used (91.8%), their dosage and method of administration (91.1%), contraindications (82.4%), adverse reactions (81.9%) and the simultaneous use of multiple medicines (76.5%). 58.9% of consumers value information about medicine’s price. More than 70% of patients often seek information from health professionals and use medicines package information leaflets (PIL), and more than 75% of respondents mainly trust the same sources. 71.5% of respondents read package leaflets, while 42.0% of consumers do this several times. Only 36.7% of respondents completely understand information in a leaflet. CONCLUSIONS: Patients in Armenia need medicine information. They prefer to receive information from sources they trust. Many patients do not understand the content of package information leaflets (PILs) due to barriers, which can be removed by introducing appropriate regulatory provisions for their content and readability. Show more

Keywords: Patient information leaflet, medicine, information, patient, consumer

DOI: 10.3233/JRS-150675

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S21-S22, 2015

Authors: Zastrozhin, M.S. | Smirnov, V.V. | Sychev, D.A. | Savchenko, L.M. | Bryun, E.A. | Matis, O.A.

Article Type: Abstract

Abstract: BACKGROUND: Haloperidol is one of the most commonly used typical antipsychotics [2 ]. It has a powerful antipsychotic activity blocking mesolimbic postsynaptic dopamine receptors. Unwanted adverse effects accompany the use of haloperidol. Therefore alcohol abusers’ attitudes towards haloperidol are ambiguous and often negative, which sometimes limits it’s use in patients with addictive disorders [3 ]. Cytosolic carbonyl reductase reduces haloperidol to reduced form, which has 10–20% of the activity of the parent molecule. It is further metabolized by CYP3A4 to a tetrahydropyridine and then conjugated by glucuronidation and sulphation. Reduced haloperidol is back-oxidized to haloperidol by CYP3A4 and CYP2D6. Haloperidol …is N-dealkylated by CYP3A4 and CYP2D6 to 4-chlorophenyl-4-hydroxypiperidine and p-fluorobenzoyl propionic acid. The correlation between CYP2D6 and CYP3A4 activity and the rate of biotransformation of haloperidol was demonstrated in a number of studies on patients with schizophrenia [1, 2, 5 ]. At the same time other studies deny or disaffirm this correlation [4 ]. OBJECTIVE: To estimate the correlation between CYP3A4 isoenzyme activity and the efficacy and safety of haloperidol in patients with alcohol abuse during the exacerbation of the addiction. METHODS: The study involved 15 men, alcohol abusers, in exacerbation of their addiction, who were hospitalized in Moscow Research and Practical Centre for Narcology of the Departament of Public Health. All 15 patients received haloperidol in tablets and injections. Determination of CYP3A4 activity was performed using high performance liquid chromatography with mass spectrometry (HPLC/ MS) by determination of endogenous substrate of this isoenzyme and its metabolite in urine - the ratio: cortisol/6-beta–hydroxycortisol. We used international psychometric scales to assess efficacy of haloperidol (the scale of determining the severity of addiction of The National Research Center on Addictions of the Ministry of Health Of Russia, Hamilton Anxiety Research Scale (HARS)). The safety of haloperidol was estimated by the UKU Side-Effect Rating Scale. Scales express the clinical picture of the abuse. The higher the score, the more pronounced the addiction is. Calculating the differences in scores of the scales allowed for clinical assessment of haloperidol effects. The larger the difference in scores was, the more pronounced were the changes in clinical picture of abuse, and the higher the efficacy of therapy was assumed. Statistical analysis of the results of the study was performed by non-parametric statistics by the program STATISTICA v10.0 («StatSoft Inc.», USA). The normality of sample distribution was estimated by Shapiro-Wilk’s W-test, and the homogeneity of dispersion, that was estimated by Fisher’s T-test (in case of comparison of two samples). The differences were evaluated as significant in case of p < 0,05 (statistic power >80%). To determine the correlation between the quantitative characteristics Spearman rank R coefficient was calculated. The value of correlation coefficient r from 0,3 to 0,7 (p < 0,05) indicated positive moderate, but significant correlation between the characteristics, r >0,7 (p < 0,05) – strong and significant correlation, negative value of r indicated inverse correlation. RESULTS: Data analysis demonstrated a correlation between the activity of isoenzyme CYP3A4 and the scores of pathological addiction (r 1 = –0,36), HARS (r 2 = –0,45), UKU Side-Effect Rating Scale (r 3 = –0.15) in the entire group (p < 0.05). In a group of patients, who received the higher doses of haloperidol (more than 7.5 mg per day in tablets or 5 mg per day in injections), the following results were received in the same groups of data: r 1 = –0.68, r 2 = –0.71, r 3 = –0.76 (p < 0.05). CONCLUSIONS: The results demonstrate the correlation between CYP3A4 activities and the efficacy and safety of haloperidol in alcohol abusers during the exacerbation of the addiction. The inverse correlation indicates that the higher the activity of CYP3A4 is, the lower the efficacy of haloperidol is. Also it can be assumed that the presence of strong correlation between the activity of CYP3A4 and the efficacy of haloperidol in group of patients, who received higher doses of haloperidol, may indicate that CYP3A4 is involved in haloperidol metabolism when it is used at higher doses. Limitations of the study: It should be noted that in this research the activity of CYP3A4 was determined using high performance liquid chromatography with mass spectrometry (HPLC/MS) by determination the ratio of cortisol/6-beta–hydroxycortisol for the fist time. To increase the level of our confidence in the results further studies with a larger number of people are necessary. Show more

Keywords: Haloperidol, biotransformation, CYP3A4, ABCB1, side effects, alcohol abuse

DOI: 10.3233/JRS-150676

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S23-S24, 2015

Authors: Barysheva, V.O. | Ketova, G.G.

Article Type: Abstract

Abstract: BACKGROUND: Drug resistance is a phenomenon that has received serious attention in recent years in everyday medical practice. This may also be described as responsiveness or non-responsiveness to drugs, as patients respond partially to medical treatment or have no response at all [1 ]. The non-responsiveness to clopidogrel in cardiac patients of different populations is due to genetic variations in the cytochrome P450 (CYP) gene [2 ]. Carriers of at least one ‘poor metabolizer allele’ of CYP2C19 (either *2 or *3) have lower levels of the active metabolite of clopidogrel and have reduced platelet inhibition [3 ]. Furthermore, the significant …inter-ethnic variability in the allelic frequencies of CYP2C19*2 has been associated with differential clopidogrel resistance [4 ]. Such mutations in this variant allele are responsible for the inability of the CYP enzyme to convert clopidogrel into its active metabolite, which may result in the increased risk of death, heart attack or stroke among patients who have undergone percutaneous coronary intervention (PCI) [5 ]. South Ural is a multinational region, a subject of the Russian Federation, where genetic variations have not been studied fully yet. OBJECTIVE: To examine prevalence of mutant alleles in population of South Ural. METHODS: We conducted pharmacogenetic testing for specific single nucleotide polymorphisms in 54 patients. The present research was conducted in the alleles CYP2C19*2 and CYP2C19*3. The data were processed using the program SPSS Statistics. RESULTS: The mean age of patients was 58, 4 years (from 26 to 79 years). Among all patients 59.3% were male, 40.7% of female patients. Among the studied patients in allele CYP2C19*2, the “wild” type GG was detected in 75,9% of patients, GA type in 22.2% and AA variant was detected in 1.9% of all patients. Allele CYP2C19*3 is often found among alleles with reduced function and also associated with resistance to clopidogrel. Functional drug response is observed in patients with type GG. All of the studied patients were carriers of this type. According to literature data the frequency of genotypes associated with resistance to clopidogrel in the Russian population is 11.4%, which is comparable with European ethnic groups [6 ]. CONCLUSIONS: It was revealed that 75,9% of patients were sensitive to clopidogrel, and for them this drug in its standard dosage will be effective, and 24,1% of patients were not sensitive, therefore, they would require replacement of clopidogrel with another drug. Show more

Keywords: Clopidogrel, pharmacogenetic testing, CYP, single nucleotide polimorphism

DOI: 10.3233/JRS-150677

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S25-S26, 2015

Authors: Safiullina, G.I. | Safiullina, A.A.

Article Type: Abstract

Abstract: BACKGROUND: Tics are diverse in nature inappropriate movements or vocalizations. They significantly degrade patients’ quality of life, lead to social difficulties, and disturbance of learning especially during exacerbations. The prevalence of tics among children ranges from 4% to 24%, thus emphasizing the relevance of the problem. OBJECTIVE: To study clinical and electrophysiological features of tics in children with development of new treatment methods. METHODS: We conducted a comprehensive clinical and electrophysiological examination of 50 patients with tics, aged 5 to 15 years. The control group consisted of 20 healthy children. The research included a thorough study …of the history, neurological examination, manual testing of skeletal muscles, psychological testing. Electrophysiological examination included a review of the functional state of corticospinal tract (CST) by the method of magnetic stimulation (MS), study of polysynaptic reflex excitability (PRE) according to a late component of the blink reflex (BR). Statistical analysis included parametric and nonparametric methods of data processing. RESULTS: All children of the study group showed signs of minimal brain dysfunction (MBD), they had complicated antenatal and postnatal history (trauma, disease, occurring with intoxication). There was a trend towards the increase of MBD signs with worsening of tics. Manual diagnosis in patients identified functional blockade at different levels of the vertebral column, sacroiliac joints, we identified latent myofascial trigger points (MFTP) mainly in the cervical-collar zone, in the area of the paravertebral muscles, periosteal triggers in the area of the sacroiliac joints. The research allowed determining decrease in propagation velocity of excitation (PVE) throughout CST in patients with tics. Correlation analysis revealed a negative correlation between the severity of tics and PVE (r = –0.38; p < 0.001). When studying polysynaptic reflex excitability (PRE) a significant predominance of hyper-excited types of blink reflex (BR) (90% of cases) was revealed. However, in 10% of patients there was a moderate decrease in propagation velocity of excitation (PVE), which allowed us to identify two subgroups of patients with tics: I – low and moderate type of reflex responses; and II – high type of reflex responses. Collation of data of MS and BR revealed a significant decrease of PVE in patients of the subgroup I, which probably reflects a deeper disturbance of the neuro-motor apparatus. The presence of numerous myofascial trigger points (MFTP) in patients of the subgroup I with moderately low polysynaptic reflex excitability (p < 0.05) was characteristic. CONCLUSIONS: The data show extraordinary sensitivity of neuromuscular system of children to various physiological and pathological stimuli, occurring in the body in the ontogenesis or diseases, and multifactorial origin of the pain syndrome in tics. The results suggest that one of the main mechanisms of development of pathological process is dysfunction of descending inhibitory control. However, further clarification of the type of polysynaptic reflex excitability in a certain patient is needed, that will allow to develop individualized approach to the choice of therapeutic interventions. Show more

Keywords: Tics, children, excitability, reflex, blink reflex

DOI: 10.3233/JRS-150678

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S27-S28, 2015

Article Type: Other

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S29-S29, 2015

Authors: Pasternak, E. | Alyautdin, R. | Asetskaya, I. | Lepakhin, V. | Romanov, B. | Merculov, V.

Article Type: Abstract

Abstract: BACKGROUND: Rising of the cost of drug therapy is one of the most notable negative tendencies of modern medicine. The main reasons for this trend are the increased costs for preclinical and clinical phases of drug development. Reproduction of drugs after cessation of patent protection is much less costly. Replacement of the original (reference) drug to generics would greatly reduce the cost of drug therapy. However, the use of generic drugs should provide maintaining quality of medication similar to achieved using the original drug. Thus, the original and generic medicines should be interchangeable and this factor largely determines the fate …of the generics. In the Russian Federation the concept of drug interchangeability is entered by the Federal law of Russian Federation № 429-FZ from 22.12.2014. According to this law interchangeable drug is a drug with proven therapeutic equivalence or bioequivalence against the reference drug, having equivalent qualitative and quantitative composition, composition of active ingredients, the composition of excipients, same dosage form and route of administration. Especially the problem of interchangeability is particularly relevant for the drugs with a narrow range of therapeutic action, which include some anticonvulsants [1–3 ]. OBJECTIVE: In this regard the comparative analysis of indicators efficiency/risk using the data from the Federal database of adverse drug reaction in group of the patients treated with preparations of valproic acid is of interest [4 ]. METHODS: Assessment of the degree of certainty of causality between the development of adverse reactions and the use of the drugs of valproic acid in our research was assessed with Naranjo scale [5 ]. This method involves the use of the questionnaire focused on the obtaining concrete answers that are measured quantitatively in points. A certain number of points correspond to a certain degree of reliability. The category of the degrees of reliability of the relationship “medicine - no” on a scale Naranjo as a result of answers to 10 questions are defined as:  the certain......9 and more points  the probable.....5–8 points  the possible.....1–4 points  the doubtful.....0 and less points After determining the degree of certainty of causality, spontaneous reports only having a high degree of reliability reports (definite, probable and possible) were exposed to the further analysis. RESULTS: The Federal database of adverse drug reaction contains 753 spontaneous reports on the development of adverse reactions after the use of valproic acid preparations during the study period. Among 753 reports, 216 (29%) contained information about replacing one drug with another. The analysis of the action of drugs have shown that on the replacement of different drug forms of the original brand, adverse reactions occurred in 23 cases (14.6%), but on the replacement of the original drug on generic – in 135 (85,4%) cases. On the basis of clinical picture and assessment of severity of adverse reactions it was found that in 127 (77%) cases adverse reactions were serious. The criteria for seriousness of adverse reaction most often were clinically significant event and hospitalization or its prolongation. Analysis of the distribution of adverse reactions on replacement of drug preparations showed that 122 (77%) of 158 spontaneous reports were due to the problems of replacing the original drug to generic. CONCLUSIONS: Thus, replacement of the original preparation of valproic acid with generics should be considered as an independent risk factor for development of complications of drug therapy. In clinical practice, in case of successful seizure control substitutions of different preparations of valproic acid should be avoided. Show more

Keywords: Antiepileptic drugs, valproic acid, safety, efficacy, interchangeability

DOI: 10.3233/JRS-150679

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S31-S32, 2015

Authors: Kirilochev, O.O. | Dorfman, I.P. | Umerova, A.R.

Article Type: Abstract

Abstract: BACKGROUND: The problem of drug safety will never disappear as new drugs are delivered in increasing numbers. They have high biological activity and adverse drug reactions (ADR) [1 ]. Currently, adverse drug reactions are the fourth leading cause of death for patients. There are databases of ADRs (Vigibase, Eudravigilance), but we know that ADR manifestations may vary in different countries and regions, due to the demographic, genetic characteristics of the population and the quality of manufactured drugs [2 ]. In this regard, the study of the ADR at the regional level is very relevant. We aimed to optimize the work …on monitoring drug safety in Astrakhan region through pharmacoepidemiological research and development of computer database for analysis of information coming to the center for drug safety monitoring (CDSM). OBJECTIVE: 1. To study the rates of ADR reporting and the structure in the Astrakhan region at the regional center for drug safety monitoring. 2. To analyze the outcomes of registered adverse drug reactions. 3. To determine the causality of adverse drug reactions. 4. To identify reports on the ineffectiveness of drugs. 5. To analyze the rates and structure of ADR reporting for drugs prescribed off-label. METHODS: We studied spontaneous adverse event reporting. The adverse event reports received by the regional CDSM for the period of 2010 to 2014 was analyzed. The groups of drugs were categorized according by Anatomical Therapeutic Chemical classification system. The data were analyzed using Microsoft Office Excel. The likelihood of whether an ADR was actually due to the drugs was assessed with the Naranjo algorithm. RESULTS: The analysis of the results showed that the establishment of the CDSM in September 2010, contributed to improvement of drug safety monitoring in health facilities of the region. Noteworthy was the increasing the number of adverse event reports in 2011 and 2012, compared with the beginning of the year 2010, when the CDSM was not yet functioning. The decrease of adverse event reporting in 2013 and 2014 was due to the fact that doctors in the region had access to better ADR drug information. Along with the increasing number of adverse event reporting we also noted the increase in the number of health facilities that monitored drug safety. The number of health facilities that reported, doubled from 2010 to 2014. We observed the increase in the number of adverse event reports submitted by pharmaceutical companies. General anti-infective drugs for systemic use (class J) were the most common cause of all registered ADRs (44%). Drugs for treatment of tuberculosis (group J04A) were the cause of adverse drug reactions in 34% of reports. ADRs associated with drugs used for treating diseases of cardiovascular system accounted for 16% of case-reports; drugs belonging to the group of Alimentary tract and metabolism (class A) and to the group of Nervous System (class A) were reported to cause ADRs in 10% of cases each. Type A adverse drug reactions, which are usually a consequence of a drug’s primary pharmacological effect, were detected in 45% of cases. These reactions were often registered for drugs affecting cardiovascular system (class C), nervous system (class N), dlood and blood forming organs (class B). Type B ADRs were reported in 54% of cases. These were “idiosyncratic” reactions, which could not be predicted on the basis of the drug’s main pharmacological action, were not dose-related and were severe [3 ]. The most frequent cause of type B adverse drug reactions was the General anti-infective medicines for systemic use (Class J). The fatality rate associated with ADRs was 0.3%. Type A adverse drug reactions resulted in death in 38% of cases. Type B ADR (anaphylactic shock) accounted for 62% of the patient’s deaths. The Naranjo scale determined the causality of ADRs. The “definite” ADRs were detected in 14% of reports, “probable” – in 47%, and “possible” - in 39% of cases. The rate of reporting associated with ineffectiveness of drugs amounted to 1%. Most often the lack of therapeutic effect was reported in patients receiving drugs of class C (Cardiovascular system, 31% of all cases of inefficiency of drugs). These drugs were used in accordance with their official instructions for use. The proportion of ADR reports for drugs prescribed off-label was 1.4%. CONCLUSIONS: The results substantiate the need to continue drug safety monitoring in the Astrakhan region. We plan to further improve the software for ADR analysis. Show more

Keywords: Drug safety, monitoring, adverse drug reaction, regional reporting system, centre for drug safety monitoring

DOI: 10.3233/JRS-150680

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S33-S34, 2015

Article Type: Other

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S35-S35, 2015

Authors: Fayzrakhmanov, N.F.

Article Type: Abstract

Abstract: BACKGROUND: The trafficking of falsified and substandard medicinal products is a global socio-economic problem, which poses a serious threat to economy and health of populations of most countries, including the Russian Federation. OBJECTIVE: To identify the main achievements and challenges in the fight against trafficking of falsified and substandard medicinal products in the Russian Federation, to formulate possible solutions to these problems. METHODS: The study of criminal cases and statistical information about the level of crime in the Russian Federation; legal analysis of regulatory legal acts in the sphere of criminal law and turnover of medicinal …products; review of scientific and practical publications. RESULTS: The problem of trafficking of falsified and substandard medicinal products in the Russian Federation was publicly discussed in the late 1990s – early 2000-ies, first in the media and special editions, later this phenomenon was the subject of extensive discussions at international conferences, in public authorities and public circles. However, the most significant results in tackling this problem were achieved only in the last 5 years. Thus, in 2010, the Russian Federation first joined the annual international police operation under the code name Pangaea, held since 2008 on the initiative of Interpol and the Medicines and Healthcare products Regulatory Agency of the World Health Organization (MHRA WHO). From year to year, the special operation Pangea unites the efforts of many countries from different continents and aims to eliminate transnational criminal groups operating through a global network the Internet. In 2010, as a result of large-scale international inspections 1 200 Internet sites were revealed, through which the fake medicines were spread and 10,000 boxes of medicines were seized, making more than a million falsified tablets in the amount of 2.6 million USA dollars. In 2011, in a special operation Pangea IV was attended by 165 different organizations from 81 countries, including 72 customs, 30 regulators, 26 police and representatives of Interpol from 37 countries. Closed 13 495 illegal websites, seized about 8,000 packages of fake medicines, containing about 2.5 million doses. In 2015, the special operation Pangea VIII was held on the territory of 115 member States of Interpol. In the Russian Federation this operation was carried out jointly by the Ministry of internal Affairs, Federal customs service, the Federal Service on Surveillance in Healthcare of Russian Federation, the Federal Drug Control Service of the Russian Federation and their regional subdivisions. As a result of this operation 34 criminal cases were initiated in our country in connection with hard drugs, falsified and substandard medicinal products and biologically active additives under the guise of high-performance drugs. Special attention during the operation was given to uncontrolled Internet sale of medicinal products and biologically active additives at a price, which was significantly higher than the actual costs, under the guise of highly effective means of treatment for various diseases. In General, in the Russian Federation 448 administrative offences were identified, which resulted in withdrawal of more than 268 thousand units of medicines from illegal circulation, worth over 9 million rubles; 40 thousand falsified and substandard preparations Contex and Durex for personal contraception were withdrawn. The mobile laboratory has conducted screening program of quality in respect of 294 samples of medicines. It identified 20 parties of dubious authenticity. A message about 264 Internet sites which sell medicines in violation of applicable Russian legislation was sent to the coordinating headquarters of the General Secretariat of Interpol. An official statement with Internet service providers on cessation of activities at these sites was issued [1 ]. On 26–28 October 2011, Moscow hosted an international high-level conference on counterfeiting of medicinal products, which was attended by more than 750 professionals in the field of law and pharmacy from different countries, including USA, China, countries of the European Council and the Commonwealth of Independent States. At the end of the conference the Convention on the counterfeiting of medicinal products and similar crimes involving threats to public health, was signed, which was called Medicrime [2 ]. The Convention was signed by representatives of Austria, Germany, Israel, Iceland, Italy, Cyprus, Portugal, Russian Federation, Finland, France, Ukraine, Switzerland. The Medicrime Convention is the first legal agreement in the field of criminal law aimed at criminalizing the trafficking of falsified and substandard medicinal products, as well as aimed at providing legal support for the investigation of these crimes at the international level. The positive side of the Convention of the Council of Europe Medicrime is that it is open for signature not only by member States of the Council of Europe and the European Union, but also by States that are not members of the Council of Europe, but participated in the elaboration of a Convention or have observer status with the Council of Europe. In addition, the Convention is open for signature by any other state at the invitation of the Committee of Ministers of the Council of Europe. The Convention introduces the responsibility for the production, storage and distribution of falsified medicinal products, active substances, excipients, components, materials and supplies; the use of falsified documents related to the trafficking of medicinal products (Articles 5, 6, 7). This legal act regulates the cooperation between the health authorities, customs, police and other competent authorities at international and national level (Articles 17, 21, 22). One of the results of the legal implementation of the rules of the Convention Medicrime in the Russian legislation was the adoption of the Federal law of the Russian Federation dated 31.12.2014 No. 532-FZ On amendments to certain legislative acts of the Russian Federation on countering the trafficking of falsified, counterfeit, substandard and unregistered medicines, medicinal devices and falsified biologically active additives [3 ]. The law came into force on 23 January 2015. In accordance with the Federal Law of the Russian Federation Criminal Code is supplemented by three new articles: Article 235.1. Illegal manufacture of medicines and medicinal devices; article 238.1. Circulation of falsified, substandard and unregistered medicines, medicinal devices and trafficking in falsified biologically active additives; article 327.2. Forgery of documents on medicines or medicinal devices or the packaging of medicines or medicinal devices [4 ]. Although there are some deficiencies in the wording of these penal regulations, we believe their introduction in the Criminal Code is a serious step forward by the state to neutralize the trafficking of falsified and substandard medicinal products, and consequently to ensure the safety of the nation’s health and economic security of the country. The inclusion of these special articles in the Criminal Code will allow to analyze statistical information on their practical application by the authorities, to investigate crimes, to fully implement the monitoring, prediction and prevention of these socially dangerous acts. It will contribute to the development and implementation of effective management decisions on the identification and investigation of crimes of this type. In recent years, in the framework of the joint preventive measures to combat the circulation of falsified and substandard medicinal products there has been some constructive interaction between law enforcement and regulatory authorities, primarily by the bodies of internal Affairs and units of the Federal Service on Surveillance in Healthcare of Russian Federation. During 2010–2013 researches in the field of Economics, International and Criminal Law, Criminology, Criminalistics, Operatively-search activity, devoted to the development of measures to neutralize trafficking of falsified and substandard medicinal products, were developed as reserved dissertations. The legislation in the sphere of protection of public health and the turnover of medicines was updated. Thus, trafficking of falsified and substandard medicinal products in the Russian Federation at present is not an appeal and not a theory, but there is a real activity of specialists in the field of law and pharmacy, with a certain legal framework, scientific and methodological support. However, this problem is not yet solved. The Indicator of withdrawn from circulation of falsified and substandard drugs remains high. In Russia by the end of 2014, 1 109 batches of substandard, falsified and counterfeit medicines were detected and withdrawn from circulation. The volume of state quality control of medicines coming into circulation accounted for 16,3% [5 ]. A serious danger is the increased level of falsification of pharmaceutical substances, 80% of which is imported to the Russian Federation on indirect contracts from China and India without proper control at customs posts. The study of criminal cases and statistics about the trafficking of falsified and substandard medicinal products in the Russian Federation leads to the conclusion that this crime is of a latent character. Every year about 50 crimes are detected, for only 30–35 of them criminal cases are initiated, and only 15–20 of the investigated criminal cases are submitted to court. This indicates serious problems in proving the guilt of the perpetrators of these crimes and bringing them to justice. The fight against this crime requires long and reliable operational development of criminal groups, qualified investigation and trial. The special knowledge in the field of circulation of medicinal products is required at all stages, however, relevant educational programs to date have not been developed [6 ]. Trafficking of dangerous medicines over the Internet and the media remains widespread in the Russian Federation. Biologically active additives are sold uncontrollably outside of pharmacies. The scale and danger of these crimes is erroneously determined on the basis of market value of the seized medicines, and not on the basis of their type of action and dosage, the presence of direct threat of harm to life and health due to the content of harmful substances. Obviously, a spread of just a few packages of falsified or substandard medicines, which contain dangerous ingredients, or contain no active substances, can have irreversible impact for health of people. CONCLUSIONS: Detection, suppression, investigation and prevention of trafficking of falsified and substandard medicinal products should be systematic and not periodic in nature. It is necessary to organize training, close cooperation and continuous exchange of experience between specialists in the field of criminal law and pharmacy in the fight against this criminal phenomenon. Law enforcement and regulatory agencies need to adopt joint normative legal acts, regulating their functions and powers in joint fight against trafficking of falsified and substandard medicinal products. The use of an official position in the crimes related to trafficking of counterfeit and substandard medicinal products should be considered as an aggravating circumstance when considering qualification of those socially dangerous acts. It is necessary to develop a set of measures to prosecute Internet service providers, hosting and serving web sites, through which they operate the illicit trade of medicinal products on the Internet. We should develop a mechanism of accountability of media for advertising and distribution of obviously false information about medicinal products. It is advisable to tighten control over the circulation of biologically active additives, prohibit their sale outside pharmacies. It is necessary to revise the legal framework and to tighten control over the conduct of clinical trials of medicines and the legality of their registration. Show more

Keywords: Trafficking, falsified, substandard, medicinal products, enforcement, legal framework, international law, convention

DOI: 10.3233/JRS-150681

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S37-S40, 2015

Article Type: Other

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S41-S41, 2015