916 resultados para Unlicensed medicines
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Background and objective: Asthma is one of the most frequent chronic diseases affecting children and adolescents. Good compliance is indispensable for effective treatment since a suboptimal use of inhalation devices can result in decreased therapeutic efficacy and increased morbidity. The objective of this work was to evaluate the inhalation technique of paediatric patients visiting a specialized consultation clinic of a university hospital. Design: Observational prospective study during a 3-month period. Setting Specialized consultation clinic of a university hospital. Main outcome measures: This study involved 40 outpatient infants, children and adolescents visiting alone or with their parent(s). Patients' data (age, sex, weight, diagnostic, reason for consulting, previous consultations) and their medicines were compiled using an ad hoc form. Filmed sequences of the inhalation procedure used by each child were reviewed independently by members of an interdisciplinary team consisting in a physician, a pharmacist, a nurse and a physiotherapist. A score of 1 was assigned to each correct step in the procedure, and a score of 0 to an incorrect step. A perfect procedure implied 12 correct steps. Results: Thirty patients were treated with a metered-dose inhaler and an inhalation chamber (Babyhaler or AeroChamber Plus); ten other patients were treated with a dry powder inhaler (Diskus or Turbuhaler). The agreement between the members of the interdisciplinary team was considered satisfactory. Nine patients (22.5%) reached an average score lower than 7, 18 patients (45%) a score between 7 and 10 and 13 (32.5%) a score equal to or better than 10. No patient reached the maximum score of 12. Users of the metered-dose inhalers (average score = 9.2) showed a better technique than users of the dry powder inhalers (average score = 7.4). Disappointingly, the score was not improved during a second consultation or following regular consultations. Conclusions: Video recording is a simple method to evaluate the degree of mastery of an inhalation procedure in paediatric patients. The method allows a convenient and efficient identification of suboptimal procedure steps by the hospital staff, and opens the way to patient-specific teaching. In two-thirds of juvenile patients, their inhalation technique was suboptimal despite initial training. This study shows conclusively that the inhalation technique in paediatric patients must be monitored during each examination, and teaching measures taken to improve it when necessary.
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During the past decades, anticancer immunotherapy has evolved from a promising therapeutic option to a robust clinical reality. Many immunotherapeutic regimens are now approved by the US Food and Drug Administration and the European Medicines Agency for use in cancer patients, and many others are being investigated as standalone therapeutic interventions or combined with conventional treatments in clinical studies. Immunotherapies may be subdivided into "passive" and "active" based on their ability to engage the host immune system against cancer. Since the anticancer activity of most passive immunotherapeutics (including tumor-targeting monoclonal antibodies) also relies on the host immune system, this classification does not properly reflect the complexity of the drug-host-tumor interaction. Alternatively, anticancer immunotherapeutics can be classified according to their antigen specificity. While some immunotherapies specifically target one (or a few) defined tumor-associated antigen(s), others operate in a relatively non-specific manner and boost natural or therapy-elicited anticancer immune responses of unknown and often broad specificity. Here, we propose a critical, integrated classification of anticancer immunotherapies and discuss the clinical relevance of these approaches.
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The purpose of this work was to develop and optimize a simple and suitable method to detect the potential inhibitory effect of drugs and medicines on alcohol dehydrogenase (ADH) activity in order to evaluate the possible interactions between medicines and alcohol metabolism. Commonly used medicines that are often involved in court litigations related with driving under the influence of alcohol were selected. Alprazolam, flunitrazepam and tramadol were tested as drugs with no known effect on ADH activity. Cimetidine, reported previously as having inhibitory effect on ADH, and 4-methylpyrazole (4-MP), a well known ADH inhibitor, were tested as positive controls. Apart from 4-MP, tramadol was identified as having the higher inhibitory effect with an IC50 of 44.7×10(-3)mM, followed by cimetidine (IC50 of 122.9×10(-3)mM). Alprazolam and flunitrazepam also reduced liver ADH activity but to a smaller extent (inhibition of 11.8±5.0% for alprazolam 1.0mM and 34.5±7.1% for flunitrazepam 0.04mM). Apart from cimetidine, this is the first report describing the inhibitory effect of these drugs on ethanol metabolism. The results also show the suitability of the method to screen for inhibitory effect of drugs on ethanol metabolism helping to identify drugs for which further study is justified.
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Medicine counterfeiting is a crime that has increased in recent years and now involves the whole world. Health and economic repercussions have led pharmaceutical industries and agencies to develop many measures to protect genuine medicines and differentiate them from counterfeits. Detecting counterfeit is chemically relatively simple for the specialists, but much more information can be gained from the analyses in a forensic intelligence perspective. Analytical data can feed criminal investigation and law enforcement by detecting and understanding the criminal phenomenon. Profiling seizures using chemical and packaging data constitutes a strong way to detect organised production and industrialised forms of criminality, and is the focus of this paper. Thirty-three seizures of a commonly counterfeited type of capsule have been studied. The results of the packaging and chemical analyses were gathered within an organised database. Strong linkage was found between the seizures at the different production steps, indicating the presence of a main counterfeit network dominating the market. The interpretation of the links with circumstantial data provided information about the production and the distribution of counterfeits coming from this network. This forensic intelligence perspective has the potential to be generalised to other types of products. This may be the only reliable approach to help the understanding of the organised crime phenomenon behind counterfeiting and to enable efficient strategic and operational decision making in an attempt to dismantle counterfeit network.
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Raman spectroscopy combined with chemometrics has recently become a widespread technique for the analysis of pharmaceutical solid forms. The application presented in this paper is the investigation of counterfeit medicines. This increasingly serious issue involves networks that are an integral part of industrialized organized crime. Efficient analytical tools are consequently required to fight against it. Quick and reliable authentication means are needed to allow the deployment of measures from the company and the authorities. For this purpose a method in two steps has been implemented here. The first step enables the identification of pharmaceutical tablets and capsules and the detection of their counterfeits. A nonlinear classification method, the Support Vector Machines (SVM), is computed together with a correlation with the database and the detection of Active Pharmaceutical Ingredient (API) peaks in the suspect product. If a counterfeit is detected, the second step allows its chemical profiling among former counterfeits in a forensic intelligence perspective. For this second step a classification based on Principal Component Analysis (PCA) and correlation distance measurements is applied to the Raman spectra of the counterfeits.
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Spectrum is an essential resource for the provision of mobile services. In order to control and delimit its use, governmental agencies set up regulatory policies. Unfortunately, such policies have led to a deficiency of spectrum as only few frequency bands are left unlicensed, and these are used for the majority of new emerging wireless applications. One promising way to alleviate the spectrum shortage problem is adopting a spectrum sharing paradigm in which frequency bands are used opportunistically. Cognitive radio is the key technology to enable this shift of paradigm.Cognitive radio networks are self-organized systems in which devices cooperate to use those spectrum ranges that are not occupied by licensed users. They carry out spectrum sensing in order to detect vacant channels that can be used for communication. Even though spectrum sensing is an active area of research, an important issue remains unsolved: the secure authentication of sensing reports. Not providing security enables the input of false data in the system thus empowering false results. This paper presents a distributed protocol based on wireless physical layer security, symmetric cryptography and one-way functions that allows determining a final sensing decision from multiple sources in a quick and secure way, as well as it preserves users¿ privacy.
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BACKGROUND: There is limited safety information on most drugs used during pregnancy. This is especially true for medication against tropical diseases because pharmacovigilance systems are not much developed in these settings. The aim of the present study was to demonstrate feasibility of using Health and Demographic Surveillance System (HDSS) as a platform to monitor drug safety in pregnancy. METHODS: Pregnant women with gestational age below 20 weeks were recruited from Reproductive and Child Health (RCH) clinics or from monthly house visits carried out for the HDSS. A structured questionnaire was used to interview pregnant women. Participants were followed on monthly basis to record any new drug used as well as pregnancy outcome. RESULTS: 1089 pregnant women were recruited; 994 (91.3%) completed the follow-up until delivery. 98% women reported to have taken at least one medication during pregnancy, mainly those used in antenatal programmes. Other most reported drugs were analgesics (24%), antibiotics (17%), and antimalarial (15%), excluding IPTp. Artemether-lumefantrine (AL) was the most used antimalarial for treating illness by nearly 3/4 compared to other groups of malaria drugs. Overall, antimalarial and antibiotic exposures in pregnancy were not significantly associated with adverse pregnancy outcome. Iron and folic acid supplementation were associated with decreased risk of miscarriage/stillbirth (OR 0.1; 0.08 - 0.3). CONCLUSION: Almost all women were exposed to medication during pregnancy. Exposure to iron and folic acid had a beneficial effect on pregnancy outcome. HDSS proved to be a useful platform to establish a reliable pharmacovigilance system in resource-limited countries. Widening drug safety information is essential to facilitate evidence based risk-benefit decision for treatment during pregnancy, a major challenge with newly marketed medicines.
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Tutkielman tavoitteena oli tutkia itsehoitolääkkeiden jakelukanavaverkoston laajentumista Suomessa. Päätavoitteena oli löytää erilaisia tulevaisuuden toimintamalleja, ja tutkia, onko jakelun vapauttaminen uhka vai mahdollisuus lääketeollisuudelle. Lisäksi tutkielmassa oli tavoitteena selvittää millaisia erityisvaatimuksia itsehoitolääkkeiden jakeluunliittyy ja mitkä tekijät puoltavat ja mitkä jarruttavat itsehoitolääkkeiden kilpailun vapauttamista Suomessa. Tutkielma jakautuu teoreettiseen ja empiiriseen osaan. Teoreettinen osa keskittyy tarkastelemaan jakelukanaverkoston laajentumista lääketeollisuudessa. Empiirinen tutkimus toteutettiin laadullisena case-tutkimuksena ja tutkimusmenetelmänä käytettiin puoli-strukturoitua haastattelua. Tutkimustulokset osoittavat, että itsehoitolääkkeiden jakelun vapauttaminen on monitahoinen kysymys jamielipiteet sen tarpeellisuudesta ja hyödyllisyydestä vaihtelevat suuresti lääketeollisuuden jakelukanavan eri jäsenten välillä. Itsehoitolääkkeiden vähittäisjakelu voitaisiin tulevaisuudessa järjestää mahdollisesti joko vain apteekeista, tai apteekeista ja päivittäistavarakapoista. Mahdollisuutena olisi myös saada itsehoitolääkkeitä hotelleista ja ravintoloista, huoltamoista ja kioskeista. Lääkkeitä voisi ostaa myös erilaisista automaateista ja internetistä. Uudet kaupan muodot olisivat mahdollisia jos itsehoitolääkkeiden jakelu vapautuu tulevaisuudessa.
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Les plantes médicinales représentent la seule source de médicaments pour près de 90 % de la population de certains pays d?Afrique. Le savoir-faire des guérisseurs traditionnels, d?une valeur inestimable, représente un point de départ pour l?investigation pharmacologique et phytochimique de ces médicaments naturels. Dans le cadre de ce travail, nous nous sommes dans un premier temps intéressés à valider l?utilisation en médecine traditionnelle de deux plantes, Diuscorea sylvatica (Dioscoreaceae) et Urginea altissima (Liliaceae), qui produisent, lorsqu?elles sont frottées sur la peau, une inflammation et des démangeaisons. Ces réactions cutanées ont pu être expliquées, au moins en partie, par la présence d?aiguilles acérées d?oxalate de calcium dans les organes souterrains. Ces microtraumatismes répétés de l?épiderme risquent de provoquer, lors d?une utilisation prolongée, des lésions granulomateuses. L?histamine n?a pas été détectée, mais d?autres substances pourraient être impliquées dans le processus inflammatoire. La seconde partie de ce travail a consisté en la détection, l?isolement et la caractérisation de nouveaux composés naturels présentant un intérêt thérapeutique potentiel. 70 extraits provenant de 28 plantes supérieures du Zimbabwe ont été soumis à un criblage chimique et biologique. Les extraits méthanoliques des parties aériennes de Jamesbrittenia fodina et J. elegantissima (Scrophulariaceae) ont été sélectionnés sur la base de leurs nombreuses activités. Le fractionnement guidé par l?activité de J. fudina a permis l?isolement des saponines A et B, responsables des activités antifongique, antibactérienne et molluscicide de l?extrait. De plus, les deux saponines ont montré une activité équivalente en tant qu?inhibiteurs de l?acétylcholinestérase, propriété encore non décrite pour cette classe de composés. Une analyse LC/uv/MS de l?extrait a permis d?attribuer l?activité antiradicalaire au verbascoside, un dérivé du phenylpropane; cette analyse a de plus montré la présence d?une série de dérivés de l?acide cinnamique, dont l?isolement a été entrepris. Deux problèmes d?instabilité sont apparus, empêchant l?isolement des composés par des méthodes chromatographiques de pointe, en dépit de très bonnes conditions de séparations. Des analyses LC/?H-NMR combinées à des analyses RMN classiques des mélanges ont permis d?attribuer ces instabilités d?une part à une isomérisation cis/trans induite par la lumière, et d?autre part à une transacylation du groupe cinnamoyl sur une unité de sucre. Ceci a permis l?identification de 12 esters cinnamiques d?iridoïdes, dont 8 nouveaux produits naturels. Ces dérivés présentent un intérêt thérapeutique, car des composés similaires ont montré des propriétés anti-inflammatoires significatives dans différents modèles in vivo. Deux flavanones ont aussi été isolées de l?extrait. Cette classe de composés n?a jamais été rapportée chez un membre des Scrophulariaceae. Une analyse LC/UV/MS comparative des extraits polaires des deux espèces, J. fodina et J. elegantissima, a été effectuée pour détecter la présence éventuelle de compos.és communs. Les saponines A et B et le verbascoside ont été identifiés dans l?extrait de J. elegantissima. Trois flavonoïdes ont de plus été isolés de ce dernier par CPC et HPLC semi-préparative.<br/><br/>In certain African countries, medicinal plants represent the unique source of to 90% of the population. The knowledge of traditional healers represents a basis for the pharmacological and phytochemical investigation of these natural medicines. This work first focused on the validation of use of two plants frequently employed in traditional medicine, Dioscorea sylvatica (Dioscoreaceae) and Urginea altissimu (Liliaceae), which produce mild inflammation and itching when rubbed on the skin. These cutaneous reactions were shown to be due, at least in part, to the presence of sharp needles of calcium oxalate, implying the risk of granulomatous lesions following a long term use. Histamine was not detected, but other compounds could be involved in the inflammatory process. The second part of this work consisted of the detection, isolation and characterisation of new natural compounds of potential therapeutic interest from African plants. Seventy extracts obtained from 28 higher plants of Zimbabwe were submitted to a chemical and biological screening. The methanol extracts of the whole plants of Jamesbrittenia fodina and J. elegantissima (Scrophulariaceae) were selected for their various activities. An activity-guided fractionation of J. fodina led to the isolation of the saponins A and B, responsible for the antifungal, antibacterial and molluscicidal properties. Both saponins were equally active as inhibitors of acetylcholinesterase, a property that has, to our knowledge, never been described for this class of compounds. A LC/UV/MS analysis of the extract allowed the identification of verbascoside as the product with radical scavenging activity, and indicated the presence of a series of potentially interesting cinnamic acid derivatives. Two types of instability problems occurred in the course of their isolation, as some compounds could not be separated despite very good chromatographic conditions. LC/'H-NMR analyses combined with in-mixture NMR analyses enabled the attribution of the cause of the instability in one case to a cidtrans light-induced isomerisation, and in the other case to a transacylation of the cinnamoyl moiety on a sugar residue. These problems of instability have not been the object of previous studies. 12 cinnamic iridoid esters could be characterised, 8 of these being new natural compounds. Several similar substances have displayed significant anti-inflammatory properties in different in vivo models, suggesting a therapeutic interest for these new derivatives. Two flavanones were isolated from the same extract. This class of compound has not been previously reported from species of the Scrophulariaceae family. A comparative LCAJVNS study of the polar extracts of the two species J. elegantissima and J. fodina was performed in order to detect possible common compounds. Saponins A and B and verbascoside were thus identified in .J. elegantissima. Moreover, three supplementary flavonoids were isolated from J. elegantissima..
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BACKGROUND: No previous studies have explored how closely women follow their psychotropic drug regimens during pregnancy. This study aimed to explore patterns of and factors associated with low adherence to psychotropic medication during pregnancy. METHODS: Multinational web-based study was performed in 18 countries in Europe, North America, and Australia. Uniform data collection was ensured via an electronic questionnaire. Pregnant women were eligible to participate. Adherence was measured via the 8-item Morisky Medication Adherence Scale (MMAS-8). The Beliefs about Prescribed Medicines Questionnaire (BMQ-specific), the Edinburgh Postnatal Depression Scale (EPDS), and a numeric rating scale were utilized to measure women's beliefs, depressive symptoms, and antidepressant risk perception, respectively. Participants reporting use of psychotropic medication during pregnancy (n = 160) were included in the analysis. RESULTS: On the basis of the MMAS-8, 78 of 160 women (48.8%, 95% CI: 41.1-56.4%) demonstrated low adherence during pregnancy. The rates of low adherence were 51.3% for medication for anxiety, 47.2% for depression, and 42.9% for other psychiatric disorders. Smoking during pregnancy, elevated antidepressant risk perception (risk≥6), and depressive symptoms were associated with a significant 3.9-, 2.3-, and 2.5-fold increased likelihood of low medication adherence, respectively. Women on psychotropic polytherapy were less likely to demonstrate low adherence. The belief that the benefit of pharmacotherapy outweighed the risks positively correlated (r = .282) with higher medication adherence. CONCLUSIONS: Approximately one of two pregnant women using psychotropic medication demonstrated low adherence in pregnancy. Life-style factors, risk perception, depressive symptoms, and individual beliefs are important factors related to adherence to psychotropic medication in pregnancy.
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The purpose of the research is to develop a go-to-market strategy with pharmacies. As it was agreed with the client of the study, Reckitt Benckiser, the focus is solely on non-prescription products. Therefore, prescription medicines are not considered in the study. The main objective of the research is to clarify consumer and pharmacy personnel behavior concerning non-prescription products. These issues are observed with surveys, which are provided to consumers and pharmacy personnel. The go-to-market strategy is based on the survey results and is comprised by utilizing the marketing-mix model. Legislation and the present state & trends are additional minor research problems of the study. The results of the research provide many descriptive insights about consumer and pharmacy personnel behavior. It is concluded that the consumers’ level of involvement with non-prescription products is low and the type of behavior is habitual. It is also demonstrated that several decision-making criteria are very different among different age groups and genders. Concerning pharmacy personnel, the factors that they base their product recommendations are revealed. In addition, the sources of medicine information for both consumers and pharmacy personnel are found out.
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Since its introduction to the market in 1985, mefloquine has been used for malaria chemoprophylaxis by more than 35 million travellers. In Europe, in 2014, the European Medicines Agency (EMA) issued recommendations on strengthened warnings, prescribing checklists and updates to the product information of mefloquine. Some malaria prevention advisors question the scientific basis for the restrictions and suggest that this cost-effective, anti-malarial drug will be displaced as a first-line anti-malaria medication with the result that vulnerable groups such as VFR and long-term travellers, pregnant travellers and young children are left without a suitable alternative chemoprophylaxis. This commentary looks at the current position of mefloquine prescribing and the rationale of the new EMA recommendations and restrictions. It also describes the new recommendations for malaria prophylaxis that have been adapted by Switzerland, Germany, Austria and Italy where chemoprophylaxis use is restricted to high-risk malaria-endemic areas.
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The objective of the thesis was to evaluate business potential of wireless local area networks (WLAN, Wireless LAN). At first, the scope of business potential evaluation of technology was introduced. Next, a general framework of business potential evaluation of technology based on literature was presented. In addition, convergence of cellular networks and data networks was studied in order to get an insight of current situation of mobile telecommunications industry. Finally, wireless local area networks business potential was evaluated. A wireless local area network is a data communication system, which combines data connectivity with mobility and is implemented in unlicensed frequency bands, allowing new business opportunities to emerge. The main markets of WLAN are corporate networks, public area networks and access networks. At the moment the penetration of WLAN terminals is low which derives to low demand of wireless LAN services. In addition, unlicensed spectrum forces the teleoperators to set the service price relatively low. The business potential is in integrating wireless LANs to cellular networks and in offering value added services to end users. The future of wireless LAN is to be complementary network to cellular networks. In this vision cellular networks provide voice and low data services and broadband wireless networks enable multimedia services.
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The contribution of biodiversity and ecosystem services to our health care needs is significant, both for the development of modern pharmaceuticals (Chivian and Bernstein 2008; Newmann and Cragg 2007; see also chapter on contribution of biodiversity to pharmaceuticals in this volume) and for their uses in traditional medicine (WHO 2013). Long before the rise of pharmaceutical development, societies have been drawing on their traditional knowledge, skills and customary practices, using various resources provided to them by nature to prevent, diagnose and treat health problems. Today, these practices continue to inform health-care delivery at the level of local communities in many places around the world (WHO 2013). In socioecological contexts such as these, several resources used for food, cultural and spiritual purposes are also used as medicines (Unnikrishnan and Suneetha 2012). Traditional medicine practices provide more than health care to these communities; they are considered a way of life and are founded on endogenous strengths, including knowledge, skills and capabilities.