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

The risk of acute liver injury among users of antibiotic medications: a comparison of case-only studies.

PURPOSE: The aims of this study were two-fold: (i) to investigate the effect of exposure to antibiotic agents on the risk of acute liver injury using a self-controlled case series and case-crossover study and (ii) to compare the results between the case-only studies. METHODS: For the self-controlled case series study relative incidence ratios (IRR) were calculated by dividing the rate of acute liver injury experienced during patients' periods of exposure to antibiotics to patients' rate of events during non-exposed time using conditional Poisson regression. For the case-crossover analysis we calculated Odds Ratios (OR) using conditional logistic regression by comparing exposure during 14- and 30-day risk windows with exposure during control moments. RESULTS: Using the self-controlled case series approach, the IRR was highest during the first 7 days after receipt of a prescription (10.01, 95% CI 6.59-15.18). Omitting post-exposure washout periods lowered the IRR to 7.2. The highest estimate in the case-crossover analysis was found when two 30-day control periods 1 year prior to the 30-day ALI risk period were retained in the analysis: OR = 6.5 (95% CI, 3.95-10.71). The lowest estimate was found when exposure in the 14-day risk period was compared to exposure in four consecutive 14-day control periods immediately prior to the risk period (OR = 3.05, 95% CI, 2.06-4.53). CONCLUSION: An increased relative risk of acute liver injury was consistently observed using both self-controlled case series and case-crossover designs. Case-only designs can be used as a viable alternative study design to study the risk of acute liver injury, albeit with some limitations

Controversy and consensus on a clinical pharmacist in primary care in the Netherlands

Background Controversy about the introduction of a non-dispensing pharmacist in primary care practice hampers implementation. Objective The aim of this study is to systematically map the debate on this new role for pharmacists amongst all stakeholders to uncover and understand the controversy and consensus. Setting: Primary health care in the Netherlands. Method Q methodology. 163 participants rank-ordered statements on issues concerning the integration of a non-dispensing pharmacist in primary care practice. Main outcome measure: Stakeholder perspectives on the role of the non-dispensing pharmacist and pharmaceutical care in primary care. Results This study identified the consensus on various features of the non-dispensing pharmacist role as well as the financial, organisational and collaborative aspects of integrating a non-dispensing pharmacist in primary care practice. Q factor analysis revealed four perspectives: "the independent community pharmacist", "the independent clinical pharmacist", "the dependent clinical pharmacist" and "the medication therapy management specialist". These four perspectives show controversies to do with the level of professional independency of the non-dispensing pharmacist and the level of innovation of task performance. Conclusion Despite the fact that introducing new professional roles in healthcare can lead to controversy, the results of this Q study show the potential of a non-dispensing pharmacist as a pharmaceutical care provider and the willingness for interprofessional collaboration. The results from the POINT intervention study in the Netherlands will be an important next step in resolving current controversies

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

Health literacy among pharmacy visitors in the Netherlands

Purpose: Health literacy is defined as the ability to obtain, understand and apply information to make appropriate health decisions. Most health literacy research has been performed in the USA. Our objective was to study the prevalence of limited health literacy among adult pharmacy visitors in the Netherlands and to assess the association between health literacy and understanding of drug label information. Methods: A cross-sectional study was performed in community pharmacies belonging to the Utrecht Pharmacy Practice network for Education and Research. Adult pharmacy visitors (aged ≥18years) were approached in the pharmacy waiting area and invited for a brief interview including the newest vital sign, a validated health literacy assessment measure and questions about understanding of standard drug label instructions. Results: A total of 984 pharmacy visitors were included in the study: 63% were women, mean age was 56years and the majority was of native origin (84%). Based on newest vital sign scores, 52% had limited health literacy skills. Pharmacy visitors with limited health literacy skills had significantly lower understanding of drug label instructions (p<0.001). Conclusion: Approximately half of the pharmacy visitors in this study had limited health literacy skills. These individuals experienced more difficulties understanding drug label instructions. These findings emphasize the need to identify patients with limited health literacy skills, as these patients might be at increased risk for drug-related problems caused by misunderstanding of information

Marketing medicines through randomised controlled trials: the case of interferon

Randomised clinical trials are regarded as a most helpful tool to relieve medical practice of subjectivity. Interferon became a part of everyday clinical practice through randomised clinical trials. Despite initial disappointment with its clinical efficacy, interferon became legitimised as a part of medical practice. Randomised clinical trials had the side effect of widening interferon's therapeutic profile and were central to the marketing strategies of pharmaceutical companies. The use and interpretation of randomised clinical trials differ substantially for experimental drugs in serious illness and for research into less serious disease

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

Multiple sclerosis and fracture risk: traditional meta-analysis versus mega-analysis of individual patient data

Introduction The aim of this systematic review was to evaluate the difference between a traditional meta-analysis and a mega-analysis of individual patient data when combining observational studies. Materials and methods We used data from two studies that evaluated the risk of fracture in patients with multiple sclerosis using the British General Practice Research Database and the Danish National Health Registries. The published results were pooled together in an inverse-variance fixed effect meta-analysis. Using patient level data, we made the study populations as comparable as possible regarding the index date, calendar time, selection of incident/prevalent patient and follow-up. The individual patient data of these populations were combined in a mega-analysis. Cox proportional hazards models were used to estimate hazard ratios of fracture, adjusted for shared confounders. Results A traditional meta-analysis of the original studies resulted in pooled adjusted hazard ratios of 1.13 [95%CI 1.03–1.23] for any fracture, hazard ratio 1.22 [95%CI 1.07–1.41] for osteoporotic fracture, and hazard ratio 2.47 [95%CI 1.72–3.53] for hip fracture. The mega-analysis of individual patient data showed an adjusted hazard ratio of 1.20 [95%CI 1.12−1.28] for any fracture, hazard ratio 1.36 [95%CI 1.24–1.50] for osteoporotic fracture, and hazard ratio 3.27 [95%CI 2.65–4.04] for hip fracture. The traditional meta-analysis of the original studies showed significant heterogeneity, which disappeared in a meta-analysis that pooled the two more comparable studies together. This meta-analysis yielded similar results as the mega-analysis with individual patient data. Conclusion A crucial step in performing a multi-country study is to reduce the level of heterogeneity between studies as much as possible before combining the data

Nonmedical Use of Attention-Deficit/Hyperactivity Disorder Medication Among Secondary School Students in The Netherlands

OBJECTIVE: No studies in Europe have assessed the extent of nonmedical attention-deficit/hyperactivitiy disorder (ADHD) medication use among adolescents, while also, in Europe, prescribing of these medicines has increased. Our objective was to study the prevalence and motives for nonmedical ADHD medication use among secondary school students in the Netherlands. METHODS: Adolescent students 10-19 years of age from six secondary schools were invited to complete an online survey on use of ADHD medication, tobacco, alcohol, and drugs. Nonmedical ADHD medication use was defined as self-reported use without a prescription during the previous 12 months. RESULTS: Survey data were available for 777 students (15% response rate). The overall proportion of students self-reporting nonmedical ADHD medication use was 1.2% (n = 9), which represented almost 20% of the adolescents who reported ADHD medication use (n = 49). Most adolescents reported self-medication or enhancing study performance as motives for ADHD medication use. CONCLUSIONS: The proportion of the study sample reporting nonmedical ADHD medication use in our study is lower compared with that in previous research conducted in the United States and Canada; however, on a population-based level, there might be a considerable proportion of recreational users

Optimaliseren geneesmiddelengebruik door ouderen

Kwint H-F, Faber A, Gussekloo J, Bouvy ML. Optimizing medication use for elderly patients. Huisarts Wet 2015;58(3):134-8. In conclusion, the studies presented in the thesis show the importance of the different steps of the medication review process when prescribing for elderly patients and the outcomes achieved. Studies of older users of multidose drug dispensing systems provide insight into the quality of medication use in these individuals. Further research is needed, for example, to determine which older patients will benefit the most from medication review or use of multidose drug dispensing systems. The thesis Improving appropriate medication use for older people in primary care investigated how the medication use of elderly patients on polypharmacy in primary care can be optimized, with emphasis on the effects of medication review and multidose dispensing systems. In this article, we present a series of studies from this thesis. We describe the effect of medication review on drug-related problems, disease-specific outcomes, and health-related quality of life. Thereafter we focus on the different steps of the medication review process, such as the medication history and the possible role of explicit STOPP-START criteria in the identification of drug-related problems. We investigated the extent of inappropriate prescribing to older patients receiving their drugs via multidose drug dispensers and compared the self-reported medication adherence and knowledge of these patients with those of patients receiving manually dispensed drugs