Парадигма юридичного ризику в системі національної безпеки України (прикладний аспект)

Розглядається загальна модель системи національної безпеки. Визначаються місце та роль юридичного ризику в функціонуванні системи національної безпеки. Аналізується категорія «юридичний ризик» та його основні складові, умови виникнення та функціонування. Пропонуються умови протидії ризикам та подається модель зниження юридичних ризиків у системі національної безпеки . Ключові слова: національна безпека, юридичний ризик.Рассматривается общая модель системы национальной безопасности. Определяется место и роль юридического риска при функционировании системы национальной безопасности. Анализируется категория «юридический риск» и его основные составляющие, условия возникновения и функционирования. Предлагаются условия противодействия рискам и подается модель снижения юридических рисков в системе национальной безопасности Ключевые слова: национальная безопасность, юридический риск.The problems of forming and development of the system of national safety are examined in the article. The general model of the system of national safety is offered and the role of legal risk is determined in this system. The location and role of legal risk is determined at functioning of the system of national safety. A category is analysed «legal risk» and his basic component elements, terms of origin and functioning. The terms of counteraction risks are offered and the model of decline of legal risks is given in the system of national safety. Key words: national safety, legal risk

Case-only designs for studying the association of antidepressants and hip or femur fracture.

The purpose of this study is to evaluate the performance and validity of the case-crossover (CCO) and self-controlled case-series (SCCS) designs when studying the association between hip/femur fracture (HF) and antidepressant (AD) use in general practitioner databases. In addition, comparability with cohort and case-control designs is discussed. Adult patients with HF and who received an AD prescription during 2001-2009 were identified from UK's The Health Improvement Network (THIN) and the Dutch Mondriaan databases. AD exposure was classified into current, recent and past/non-use (reference). In the CCO, for each patient, a case moment (date of HF) and four prior control moments at -91, -182, -273 and -365 days were defined. In SCCS, incidence of HF was compared between exposure states. Conditional logistic regression was used in the CCO and Poisson regression in the SCCS to compute odds ratios and incidence rate ratios, respectively. In CCO, we adjusted for time-varying co-medication and in SCCS for age. Adjusted estimates for the effect of current AD exposure on HF were higher in the CCO (co-medication-adjusted odds ratio, THIN: 2.24, 95% confidence interval [CI]: 2.04-2.47; Mondriaan: 2.57, 95%CI [1.50, 4.43]) than in the SCCS (age-adjusted incidence rate ratio, THIN: 1.41, 95%CI [1.32, 1.49]; Mondriaan: 2.14, 95%CI [1.51, 3.03]). The latter were comparable with the traditional designs. Case-only designs confirmed the association between AD and HF. The CCO design violated assumptions in this study with regard to exchangeability and length of exposure, and transient effects on outcome. The SCCS seems to be an appropriate design for assessing AD-HF association. Copyright © 2016 John Wiley & Sons, Ltd

The context of medicines’ use in benefit-risk evaluation

In benefit-risk evaluations there is a trend towards a life cycle approach including continuous benefit-risk evaluation instead of a single benefit-risk assessment at a certain (fixed) point in time. The objective of this thesis is to unravel how the context in which a medicine is used adds to the assessment of the benefit-risk profile, and to gain more insight in the value of this information for both drug development and regulatory decision-making. One of the main findings was that it is important to select the appropriate patient population for randomised clinical trials (RCTs), especially if both the pharmacological working mechanism and the expected patient population outside the clinical trial setting indicate that safety issues will focus within a certain area. Otherwise, extrapolation of the results to the setting outside clinical trials will be difficult. In some studies (not well-controlled and/or progressive) diabetes has been associated with an increased risk of infections. It is therefore difficult to study the effect of antidiabetic medicines on the occurrence of infections. We performed two studies that both showed that infections were approximately two times more frequently reported for DPP-4 inhibitors compared to other antidiabetic drugs. These findings, in combination with the biologic plausibility may suggest a potential relation between DPP-4 inhibitors and infections. Several studies showed that psychiatric disease was almost twice as present among patients starting anti-obesity drugs (AODs) than patients not starting these drugs. In addition, differences in general health care utilisation between these groups increased gradually over the 3-year period before start of AODs but no specific point in time could be identified from where differences between began to appear. We found that the duration of anti-obesity drug use was limited. One study, for example, showed that patients with a history of psychiatric illness were at increased risk of early discontinuation of rimonabant therapy, most pronounced due to psychiatric events. This implies that patients discontinue treatment because of psychiatric events before the possible cardiovascular benefits could develop, thereby negatively affecting the benefit-risk profile of rimonabant. These findings urge us to be very careful in interpreting the benefits and risks of anti-obesity drugs, both in terms of preventing possible exposure of drugs associated with psychiatric events in susceptible patients and in the evaluation of causality when a possible drug induced problem occurs. Finally we showed that differences in health status exist between users of the two strengths of the anti-obesity drug orlistat which are available through different channels (available on prescription vs. available without prescription, only in pharmacies). This information illustrates that user information from observational studies is also valuable for benefit-risk evaluations of one active component that is being used in two different settings. We concluded that for an adequate benefit-risk evaluation of a medicinal product, information on the complete context in which medicines are being used is necessary. This consists of extensive information on the patient population in which medicines are being used, usage patterns including the duration of use, and the effect of the regulated availability of medicines

Antidepressant use in pregnancy: knowledge transfer and translation of research findings

Background: Knowledge Transfer and Translation(KT) has become an important component in health care systems worldwide. Antidepressant use in pregnancy has become a controversial subject for a number of reasons, including differing interpretations of study results. An important question then arises as to how knowledge derived from studies is effectively disseminated to the stakeholders who need this information to be able to use and apply in various situations. A relatively new field in science has been emerging, that addresses the issue of ensuring that information generated from research, reaches the right people in the right format. This has been coined knowledge transfer and exchange or knowledge translation (KT). Although KT is now accepted practice among many public health leaders internationally, its potential to advance the quality of health of women during the perinatal period has not been fully examined. Objectives: (1) to determine how knowledge regarding the safety/risk of antidepressant use in pregnancy is created, (2) to describe different research models and statistical analyses that have been used, so as to critically evaluate the results, and (3) to identify how this information is currently disseminated. Methods: Selected key articles were indentified and retrieved from the literature. Relevant information was extracted and synthesized into themes, addressing each of the stated objectives. Results: All of the methods used for examining the safety of antidepressants in pregnancy have some deficiencies in study design and analysis, thus reinforcing the need for accurate interpretations when discussing results. In addition, dissemination in both the scientific and lay press, has been selective and therefore potentially biased. Conclusions: It is unlikely that in the near future, pregnant women will be included in randomized controlled trials, so studying the safety/risk of antidepressants in pregnancy is observational research. All of the methods used have some deficiencies in study design and analysis, thus reinforcing the need for improved rigor.. However, this does not mean that the information provided from the results of these studies is not valuable, as long as the methodology and analysis are critically evaluated and understood by the reader. It is apparent from this research, that (KT) has become an important component in the health care system. Consequently, it is critical that the current gaps between the creation of knowledge and ultimately to translating and transferring information to the patient are closed. This includes improving the methodology of the studies and unambiguous, dissemination of the results, so clinicians are capable of evaluating whether the results have clinical significance or not. It is critical, starting with the creators of knowledge, through to the recipients, that discrepancies are resolved, as lack of clarity may impede the transfer of unambiguous evidence-based information from health care providers to patients, thus impacting decision-making. For example, by implementing improved (KT) strategies, a pregnant, depressed woman, will be empowered to make a rational evidence-based decision regarding whether or not she should take an antidepressant during pregnancy

Instructies voor monitoren van klinische parameters in de registratieteksten van psychofarmaca: Overzicht en toepasbaarheid voor de klinische praktijk

background The Summary of Product Characteristics (SmPC) for psychotropic drugs includes instructions for clinical and biomarker monitoring intended to optimise effectiveness and minimise harm. aim To evaluate which monitoring instructions are given in the SmPC and to assess the applicability in clinical practice. method The reasons and requirements for monitoring in Smpcs for psychotropic drugs were assessed and somatic parameters were distinguished from non-somatic parameters, thereby the applicability was assessed. results An average of 3.3 instructions per drug label was found. Monitoring was primarily for safety reasons (78%). Requirement was predominantly mandatory (71%). Somatic parameters were most often mentioned (80%). Only 34% of the instructions were determined applicable. conclusion Monitoring instructions for psychotropic drugs are aimed at improving safe use. However, most instructions on monitoring do not provide sufficient information to be applicable in clinical practice

Instructies voor monitoren van klinische parameters in de registratieteksten van psychofarmaca: Overzicht en toepasbaarheid voor de klinische praktijk

background The Summary of Product Characteristics (SmPC) for psychotropic drugs includes instructions for clinical and biomarker monitoring intended to optimise effectiveness and minimise harm. aim To evaluate which monitoring instructions are given in the SmPC and to assess the applicability in clinical practice. method The reasons and requirements for monitoring in Smpcs for psychotropic drugs were assessed and somatic parameters were distinguished from non-somatic parameters, thereby the applicability was assessed. results An average of 3.3 instructions per drug label was found. Monitoring was primarily for safety reasons (78%). Requirement was predominantly mandatory (71%). Somatic parameters were most often mentioned (80%). Only 34% of the instructions were determined applicable. conclusion Monitoring instructions for psychotropic drugs are aimed at improving safe use. However, most instructions on monitoring do not provide sufficient information to be applicable in clinical practice

Instructions for clinical and biomarker monitoring in the Summary of Product Characteristics (SmPC) for psychotropic drugs: Overview and applicability in clinical practice

The Summary of Product Characteristics (SmPC) for psychotropic drugs includes instructions for clinical and biomarker monitoring intended to optimise effectiveness and minimise harm. The present study evaluated which monitoring instructions are given in the SmPCs, and assessed whether instructions are informative enough to be applicable in clinical practice. Monitoring instructions were collected from complete SmPCs for psychotropic drugs (n=70). Reasons and requirements for monitoring were assessed and somatic parameters were distinguished from non-somatic parameters. Instructions were evaluated using the Systematic Information for Monitoring (SIM) score and considered applicable when a SIM score of ⩾3 was found. An average of 3.3 (range 0-13) instructions per drug label was found. Monitoring was primarily for safety reasons (78%). Requirement was predominantly mandatory (71%). Somatic parameters were most often mentioned (80%). Only 34% of the instructions were determined applicable. Overall, an average SIM score of 2.0 (SD=1.7) was found (out of a maximum possible score of 6). In conclusion, prescribing of psychotropic drugs is accompanied by diverse instructions aimed at improving safe use. However, most instructions on monitoring do not provide sufficient information to be applicable in clinical practice

Antidepressant use in pregnancy: knowledge transfer and translation of research findings

RATIONALE: Knowledge transfer and translation (KT) has become an important component in health care systems worldwide. Antidepressant use in pregnancy has become a controversial subject for a number of reasons, including differing interpretations of study results. METHODS: Selected key articles were indentified and retrieved from the literature. Relevant information was extracted and synthesized into themes, addressing each of the stated objectives. OBJECTIVES: (1) To determine how knowledge regarding the safety/risk of antidepressant use in pregnancy is created; (2) to describe different research models and statistical analyses that have been used, so as to critically evaluate the results; and (3) to identify how this information is currently disseminated. RESULTS: All of the methods used for examining the safety of antidepressants in pregnancy have some deficiencies in study design and analysis, thus reinforcing the need for accurate interpretations when discussing results. In addition, dissemination in both the scientific and lay press has been selective and therefore potentially biased. CONCLUSION: It is critical, starting with the creators of knowledge, through to the recipients that discrepancies are resolved, as lack of clarity may impede the transfer of unambiguous evidence-based information from health care providers to patients, thus impacting decision making. For example, by implementing improved (KT) strategies, a pregnant, depressed woman, will be empowered to make a rational evidence-based decision regarding whether or not she should take an antidepressant during pregnancy

Discontinuation of somatic medication during psychiatric hospitalization

BACKGROUND: Psychiatric hospitalization can increase the risk of discontinuation of pharmacotherapy, which may negatively influence patients' health. OBJECTIVE: To investigate the association between psychiatric hospitalization and discontinuation of somatic medication. METHODS: A retrospective crossover study was performed in patients admitted to a psychiatric hospital (index date), who had got somatic medication dispensed during the 3 months prior to hospitalization. Discontinuation of somatic medication was investigated at the following time points: index date and 3, 6, and 9 months before the index date. Relative risks (RR) with 95% confidence intervals (95% CIs) of discontinuing somatic medication at the index date versus the time points before the index date were estimated using Cox regression. RESULTS: In all, 471 hospitalized patients were included in the study; 38.9% of the patients were discontinuers on the index date. RR for discontinuation of ≥1 somatic medication was 1.88 (95% CI=1.55-2.27) at the index date compared with the other time points and highest for patients<45 years (RR=2.83; 95% CI=1.92-4.18). CONCLUSIONS: Psychiatric hospitalization was associated with an almost doubled risk of discontinuation of somatic medication. Future studies should address the influence of discontinuation of care on patients' health