Este trabalho avaliou a qualidade dos medicamentos em comercialização no Brasil com base nos bancos de dados dos dois maiores laboratórios oficiais de controle da qualidade de produtos para a saúde: Instituto Nacional de controle de qualidade em saúde - INCQS/RJ e Instituto Adolfo Lutz IAL/SP. Os procedimentos metodológicos deste estudo orientaram-se pelos pressupostos da pesquisa qualitativa, avaliando: modalidades de análises - previstas e não previstas na legislação sanitária; ensaios analíticos executados nas amostras de medicamentos; análise documental; análises física, química e físico-química; análise microbiológica e análise toxicológica/farmacológica; amostras analisadas - quantitativamente em relação ao número de medicamentos em comercialização e qualitativamente em função da avaliação final satisfatória ou insatisfatória. Este estudo demonstrou que o percentual de medicamentos avaliados oficialmente foi insuficiente para definir a qualidade dos medicamentos comercializados no país, apontando para a necessidade de revisão do sistema nacional de controle oficial de medicamentos. / The purpose of this research was to assess the quality of medical drugs on sale in Brazil, using the data banks of the country\'s most important official health products quality control laboratories - the National Institute for Health Quality Control (INCQS/RJ) and the Adolfo Lutz Institute (IAL/SP). The methodological procedures of this research study are based on qualitative research presumptions and evaluate the following: modalities of analysis; laid down or not in health legislation; analytical screening of drug samples; documentary, physical, chemical and physical-chemical; microbiological and toxicological/pharmacological analysis; samples analysed quantitatively in relation to the number of drugs on sale and qualitatively on the basis of final satisfactory or unsatisfactory evaluation. This study demonstrated that the percentage of officially-evaluated drugs is not sufficient to assess the quality of the medicines on sale in the country, and that a requirement therefore exists for a review of the national system of official control of medical drugs.

Introdução: com o crescimento da população idosa no Brasil, observa-se aumento da incidência e prevalência de doenças associadas ao envelhecimento, em especial, das doenças crônicas não-transmissíveis. O aumento do número de diagnósticos, por sua vez, implica o aumento na quantidade de medicamentos utilizados e no gasto de famílias com idosos com estes insumos. Objetivo: analisar os gastos em medicamentos e fatores associados ao perfil dos gastos em famílias com idosos no Brasil. Método: realizou-se estudo transversal por meio da análise dos dados da versão 2008-9 da Pesquisa de Orçamentos Familiares do Instituto Brasileiro de Geografia e Estatística e elaborou-se estatística descritiva e modelo de duas partes utilizando-se o software Stata versão 2011. A coleta de dados da POF abrangeu 55.970 domicílios, onde residiam 56.091 famílias, e ocorreu entre maio/2008 e maio/2009. Famílias que continham idosos foram agrupadas em três arranjos: famílias com um idoso como pessoa de referência, famílias com um casal de idosos e famílias com um idoso não considerado pessoa de referência. A variável de desfecho do modelo foi o gasto mensal per capita com medicamentos. Resultados: os três arranjos com idosos apresentaram frequências semelhantes de despesas monetárias e não monetárias em medicamentos, porém famílias com um 1 idoso considerado pessoa de referência e com um 1 casal de idosos declararam gasto em medicamentos maiores que famílias com um 1 idoso não considerado pessoa de referência. A despesa mensal per capita com medicamentos mais elevada em famílias com idosos mostrou associação significativa com residir nas regiões Centro-Oeste, Sudeste e Sul, ter pelo menos um 1 idoso com plano de saúde, ter pelo menos um 1 idoso recebendo benefício da previdência social e ter renda mensal no segundo, terceiro e quarto quartos de renda mensal per capita. A presença de crianças com menos de 5 anos de idade e a realização de despesa não- monetária se mostraram associadas ao menor gasto mensal com medicamentos per capita. Conclusão: famílias com um idoso não considerado pessoa de referência tiveram despesas mais baixas com medicamentos em comparação aos outros dois arranjos. A política de previdência social e a política de assistência farmacêutica contribuíram na redução dos gastos em medicamentos por mecanismos diferentes / Introduction: there is an increase in the incidence and prevalence of diseases associated with aging especially non-transmissible diseases because of the growth of the elderly population in Brazil. The increase in the number of diagnoses implies an increase in the number of prescribed medicines and out-of-pocket expenditures on medicines by families with elderly people. Objective: to analyse out-of-pocket expenditures on medicines and associated factors of families with older people in Brazil. Method: a cross-sectional study was performed by analysing the data of the Family Budgets Survey (FBS) of the Brazilian Institute of Geography and Statistic. Descriptive statistics and two-part model were developed with Stata software. The data collection from FBS covered 55,970 households, 56,091 families, and occurred between May 2008 and May 2009. Families containing elderly were grouped into three arrangements: families with one elderly person as a reference person, families with an elderly couple and families with one elderly person not considered a reference person. The outcome variable was monthly per capita expenditure on medicines. Results: the three arrangements presented similar frequencies of monetary and non-monetary expenses in medicines, however families with one elderly person considered a reference person and one elderly couple reported larger spending on medicines than families with one elderly person not considered a reference person. The higher monthly per capita expenditure on medicines in families with elderly people showed a significant association with residing in the Midwest, Southeast and South regions, having at least one elderly person with a health plan, having at least one elderly person receiving social security benefits and higher income per capita. The presence of children under 5 years of age and the presence of non-monetary expenditure were shown to be associated with lower monthly expenditure per capita. Conclusion: families with an elderly person not considered a reference person spent lower out-of-pocket expenditures on medicines. Social security and pharmaceutical assistance policy contributed to reduce out-of-pocket expenditure on medicines by families with elderly by different mechanisms

Estados e municípios puderam definir seu próprio elenco de medicamentos a ser ofertados aos seus cidadãos com a Política Nacional de Medicamentos (1998), e a consequente descentralização da Assistência Farmacêutica. Percebeu-se a oportunidade de realizar um estudo para analisar peculiaridades de um conjunto de Relações Municipais de Medicamentos Essenciais (Remumes) de municípios paulistas, visando a racionalidade das listas como instrumento norteador da aquisição, distribuição, prescrição e planejamento da AF municipal. Considerou-se as possibilidades de diferentes cenários, dependente da qualidade da gestão, organização e do perfil dos recursos humanos locais e que uma equipe farmacêutica competente e qualificada prove uma melhor gestão da AF. Além disso, considerando os impactos da transição demográfica e epidemiológica da população brasileira em que os idosos utilizam mais medicamentos, gestores e profissionais da saúde precisam selecionar medicamentos criteriosamente para atender necessidades dessa faixa etária. O emprego de medicamentos potencialmente inapropriados (MPI) para idosos requer cuidado e estudos tem procurado lista-los e criar instrumentos de seleção. Aqueles inclusos nos critérios Beers definidos com apoio da Sociedade Americana de Geriatria encontram-se associados a desfechos desfavoráveis de saúde e mortalidade. OBJETIVOS: Analisar Remumes disponibilizadas para este estudo visando alertar profissionais de saúde e gestores sobre MPIs que podem comprometer a segurança dos pacientes no processo de utilização de medicamentos. MÉTODOS: Trata-se de um estudo transversal de análise das Remumes dos municípios sedes dos 17 Departamentos Regionais de Saúde (DRSs) e das Remumes dos 27 municípios do Departamento Regional de Saúde (DRS) XIII enfatizando aqueles MPIs contidos nelas. Obtiveram-se 100% das 17 Remumes dos municípios sedes dos DRSs e 92,3% das 27 Remumes dos municípios do DRS XIII, formando um banco de dados com 9063 medicamentos, discriminados pela classificação ATC e pelos diversos critérios de Beers. RESULTADOS E DISCUSSÃO: Os municípios sedes apresentaram Remumes contendo de 128 (Piracicaba) a 396 (Santos) medicamentos, com média de 272,3 (DP=71,1) medicamentos. As Remume dos municípios da DRS XIII apresentaram entre 32 (Luiz Antônio) e 403 (Cássia dos Coqueiros) medicamentos, com média de 198 (DP=111,4). Predominaram os medicamentos que atuavam no sistema nervoso seguidos pelos cardiovasculares e anti-infecciosos sistêmicos. Quando os medicamentos contidos nas Remumes foram submetidos à aplicação dos critérios de Beers, foram identificados 59,9% de MPIs, sendo que do total de 77 classes terapêuticas 39 (53,6%) classes tinham pelo menos um representante na lista dos Critérios de Beers. Os achados foram discutidos comparando dados dos municípios, outros critérios para medicamentos inapropriados para idosos, à luz de evidências clíncas mais recentes. CONCLUSÃO: As Remumes mostraram elevada variação no número de medicamentos e grupos farmacológicos e elenco considerável de medicamentos dos critérios de Beers. Apontou para necessidade de qualificação da assistência farmacêutica municipal e a elaboração de um guia norteador que contribuam para o fortalecimento da Atenção Básica e da Assistência Farmacêutica. Este aprimoramento da utilização de medicamentos em geral e para idosos, envolvendo a prescrição, dispensação, administração e uso pelo paciente, reduzem morbimortalidade relacionada aos medicamentos. / States and municipalities were able to define their own list of medicines to be offered to their citizens with the National Drug Policy (1998) and the consequent decentralization of Pharmaceutical Assistance (PA). It was noticed the opportunity to carry out a study to analyze the peculiarities of a set of Municipal Lists of Essential Medicines (Remumes) of São Paulo state municipalities, aiming at the rationality of lists as a guiding instrument for the acquisition, distribution, prescription and planning of the municipal PA. Consideration was given to the possibilities of different scenarios, depending on the quality of management, organization and the profile of local human resources, and that a competent and qualified pharmaceutical team provides a better management of PA. In addition, considering the impact of the demographic and epidemiological transition of the Brazilian population in which the elderly use more drugs, managers and health professionals need to select medicines carefully to meet the needs of this age group. The employment of potentially inappropriate medications (PIM) for the elderly require care and studies have sought to list them and develop screening tools . Those included in the Beers criteria, defined with support from the American Society of Geriatrics, are associated with unfavorable health and mortality outcomes. OBJECTIVES: To analyze Remumes made available for this study in order to alert health professionals and managers about MPIs that may compromise patients\' safety in the medication use process. METHODS: This is a cross-sectional study of the Remumes of the municipalities of the 17 Regional Health Departments (DRSs) and of the Remumes of the 27 municipalities of the Regional Health Department (DRS) XIII emphasizing those MPIs contained in them. 100% of the 17 Remumes of the municipalities of the DRSs and 92.3% of the 27 Remumes of the municipalities of the DRS XIII were formed, forming a database with 9063 medicines, discriminated by the ATC classification and by the diverse criteria of Beers. RESULTS AND DISCUSSION: The municipal districts presented Remumes containing from 128 (Piracicaba) to 396 (Santos) medications, with an average of 272.3 (SD = 71.1) medications. Remume of DRS XIII municipalities presented medications between 32 (Luiz Antônio) and 403 (Cássia dos Coqueiros), with a mean of 198 (SD = 111.4). Predominant drugs that worked in the nervous system followed by cardiovascular and systemic anti-infectious. When medicinal products contained in Remumes were submitted to the Beers criteria, 59.9% of PIMs were identified. Of the total of 77 therapeutic classes, 39 (53.6%) classes had at least one representative in the list of Criteria of Beers. The findings were discussed comparing data from the municipalities, other criteria for PIMs for the elderly, in light of more recent clinical evidence. CONCLUSION: Remumes showed high variation in the number of drugs and pharmacological groups and considerable list of drugs of the Beers criteria. He pointed to the need for qualification of municipal pharmaceutical assistance and the elaboration of a guiding guide that contribute to the strengthening of Primary Care and Pharmaceutical Assistance. This improvement in the utilization of medications in general and for the elderly, involving prescription, dispensing, administration and use by the patient, reduces drug-related morbidity and mortality.

Submitted by Renata Lopes (renatasil82@gmail.com) on 2016-06-27T14:17:10Z No. of bitstreams: 1 marcelosilvasilverio.pdf: 1069610 bytes, checksum: 43e73e568df0511e0f30985da5203e18 (MD5) / Approved for entry into archive by Adriana Oliveira (adriana.oliveira@ufjf.edu.br) on 2016-06-28T12:58:38Z (GMT) No. of bitstreams: 1 marcelosilvasilverio.pdf: 1069610 bytes, checksum: 43e73e568df0511e0f30985da5203e18 (MD5) / Made available in DSpace on 2016-06-28T12:58:38Z (GMT). No. of bitstreams: 1 marcelosilvasilverio.pdf: 1069610 bytes, checksum: 43e73e568df0511e0f30985da5203e18 (MD5) Previous issue date: 2012-11-20 / CAPES - Coordenação de Aperfeiçoamento de Pessoal de Nível Superior / A produção e difusão de conhecimento sobre padrões quantitativos de utilização de medicamentos, perfis de prescrição, qualidade do que se usa, automedicação, vendas e custos comparativos contribuem para a formação de uma consciência critica da sociedade no uso dos medicamentos. Os estudos de utilização de medicamentos, como um dos ramos da farmacoepidemiologia, tem como principal objetivo gerar informações que possam racionalizar o uso dos medicamentos. O trabalho avaliou o perfil farmacoepidemiológico do município de Muriaé, MG, através de um estudo de utilização de medicamentos em Farmácias comunitárias e hospitalares. Foi avaliado o consumo de medicamentos industrializados e manipulados, em farmácias comunitárias, através do registro de comercialização em 4 estabelecimentos sem e 3 com manipulação, durante 3 meses, além do recolhimento 800 prescrições médicas para avaliação da qualidade das mesmas. As prescrições foram avaliadas pelos indicadores de prescrições da OMS, pela legibilidade e presença das informações essenciais. Em 4 hospitais do município, foi avaliado o uso de medicamentos cardiovasculares, psicotrópicos e antimicrobianos, durante 3 meses, e os resultados foram expressos em dose diária definida (DDD) por 100 leitos-dia. O estudo demonstrou que foi prescrita uma média de 2,2 medicamentos por receituário comum, que porcentagem de antibióticos prescritos foi de 22,1%, que 33% das prescrições ocorreram pelo nome genérico e que 46,5% dos medicamentos prescritos constavam na RENAME. As prescrições estavam em 68% dos casos pouco legíveis ou ilegíveis e as informações essenciais estavam ausentes em grande parte das prescrições. Os medicamentos comercializados, em mais de 30%, não estão presentes na RENAME, ocorreu um alto consumo de combinações em doses fixas, de antimicrobianos, e elevado uso de medicamentos sem valor terapêutico alto. Além disso, os produtos mais comercializados são diferentes nas Farmácias com e sem manipulação. No estudo hospitalar as cefalosporinas (51,1%) foram os antimicrobianos mais utilizados e o uso em DDD/100 foi de 45,69, considerados os 10 antimicrobianos mais utilizados. Entre os cardiovasculares os antitrombóticos (23,12%) e os IECA/ARA-II (22,80%) foram os grupos mais utilizados. Os ansiolíticos (35%) foram a classe de psicoativos mais utilizada, com destaque para o Midazolam (38,15 DDD/100) e o Diazepam (29,10 DDD/100). Estes resultados mostram que o uso de medicamentos no município, o que pode se repetir em municípios de porte semelhante. Como no Brasil ainda existem lacunas neste tipo de informação farmacoepidemiológica, este trabalho pode contribuir com novos estudos e servir de modelo para execução dos mesmos, além de contribuir para a formulação de estratégias sanitárias na área do medicamento. / The production and dissemination of knowledge on quantitative standards of drug use, prescription profiles, quality of what you use, self-medication, sales and comparative costs contribute to the formation of a critical conscience of society in the use of drugs. The utilization studies of drug, as a arms of pharmacoepidemiology, has as a major objective is to generate information that can rationalize the use of drugs. The study evaluated the pharmacoepidemiological profile of the city of Muriaé, MG, through a study of utilization study of drug in community and hospital pharmacies. Was evaluated the use of manufactured and manipulated drugs by record sales in 4 pharmacies without manipulation and 3 with manipulation, for 3 months, furthermore collected 800 prescriptions for evaluating the quality of these same establishments. The prescriptions were assessed by the WHO prescribing indicators, the presence of essential information and legibility. In four hospitals in the city was evaluated the use of cardiovascular drugs, psychotropic and antibiotics for 3 months, and the results were expressed as defined daily dose (DDD) per 100 beddays. The study showed that was prescribed an average of 2.2 drugs per prescription common, what percentage of antibiotics prescribed was 22.1%, that 33% of prescriptions were for generic name and that 46.5% of prescription drugs contained in RENAME. The prescriptions were in 68% of cases little readable or unreadable and essential information were largely absent from the prescriptions. The drugs marketed in more than 30%, are not present in the RENAME, there was a high consumption of fixed-dose combinations and of antimicrobials, elevated use of drugs without therapeutic value high. Furthermore, most products marketed in manipulation pharmacies are different from without manipulation. In the hospital study cephalosporins (51.1%) were the most commonly used antimicrobials and use in DDD/100 was 45.69, considered the 10 most used antimicrobial agents. Among the cardiovascular antithrombotics (23.12%) and ACEI / ARB (22.80%) were the most commonly used groups. Anxiolytics (35%) were the most commonly used class of psychoactive drugs, especially the Midazolam (38.15 DDD/100) and Diazepam (29.10 DDD/100). These results show that the use of drugs in the city, which can be repeated in cities of similar size. As in Brazil there are still gaps in this information pharmacoepidemiological, this work may contribute to new studies and serve as a model for their implementation, and contribute to the formulation of health strategies in the field of drugs.

Submitted by isabela.moljf@hotmail.com (isabela.moljf@hotmail.com) on 2017-07-04T10:50:02Z No. of bitstreams: 1 eduardosiqueiraferandes.pdf: 2252400 bytes, checksum: 56e960a38ee98a43aa5d60c466f2b6e8 (MD5) / Approved for entry into archive by Adriana Oliveira (adriana.oliveira@ufjf.edu.br) on 2017-08-08T14:07:24Z (GMT) No. of bitstreams: 1 eduardosiqueiraferandes.pdf: 2252400 bytes, checksum: 56e960a38ee98a43aa5d60c466f2b6e8 (MD5) / Made available in DSpace on 2017-08-08T14:07:24Z (GMT). No. of bitstreams: 1 eduardosiqueiraferandes.pdf: 2252400 bytes, checksum: 56e960a38ee98a43aa5d60c466f2b6e8 (MD5) Previous issue date: 2009-08-13 / CAPES - Coordenação de Aperfeiçoamento de Pessoal de Nível Superior / O extrato de Ginkgo biloba (EGb) é usado no tratamento e prevenção de doenças neurodegenerativas, como antiinflamatório, no tratamento da vertigem, na perda de memória relacionada a idade. Efeitos do extrato de ginkgo na reprodução demonstraram que ele inibia a fertilização por reduzir a viabilidade de espermatozóides e degenerar o oócito. Administrado a camundongos alterou o peso de órgãos como a próstata e alterou o perfil reprodutivo desses animais – levando a uma menor taxa de prenhez e aumento das mortes embrionárias. Em ratas, o EGb demonstrou causar crescimento intra-uterino restrito, aventando-se a possibilidade do efeito ter sido causado por sua atividade estrogênica. Outros trabalhos também demonstraram efeito estrogênico do Ginkgo biloba. Sabe-se que os níveis adequados de estrogênio, progesterona e de prostaglandinas são cruciais para o transporte do concepto pela tuba uterina e sua implantação uterina, portanto existe a possibilidade da administração do EGb no início da prenhez causar alterações no desenvolvimento embrionário, sendo esse o propósito do presente trabalho. Para o estudo foram usadas 68 ratas Wistar, adultas, nulíparas, prenhes, provenientes do Biotério do Centro de Biologia da Reprodução, Universidade Federal de Juiz de Fora. As ratas foram distribuídas aleatoriamente em quatro grupos experimentais (n=17): Controle e tratados Gb 3.5, Gb 7 e Gb 14, que receberam, respectivamente, 3,5, 7 e 14mg/Kg/dia do extrato de Ginkgo biloba em 1mL de suspensão aquosa, via intragástrica, uma vez ao dia, durante os oito primeiros dias de prenhez. As ratas do grupo controle receberam pelo mesmo esquema 1mL de água destilada. As ratas foram eutanasiadas, no 15o dia de prenhez, por exsanguinação total sob anestesia. Foram avaliados: sinais clínicos indicativos de toxicidade materna – entre outros, alteração do consumo de ração e de água, alteração do peso corporal, hiper ou hipoatividade, piloereção, estereotipia, perfil bioquímico e hematológico e morte –; número de corpos lúteos; peso de órgãos maternos (ovários, fígado e rins); perfil hematológico e bioquímico maternos; peso de fetos e de placentas; número de fetos viáveis, reabsorvidos e mortos; malformações fetais em membros superiores e inferiores, fechamento de tubo neural e morfologia de face. Com exceção do perfil bioquímico materno em que houve aumento do nível de colesterol e decréscimo dos níveis de ALT, uréia e creatinina, significativamente relevantes, nos animais tratados com 7 e 14mg/Kg/dia de EGb, nenhuma outra alteração significativa foi encontrada nos parâmetros maternos ou fetais avaliados. De forma geral, o tratamento com EGb em ratas Wistar, durante o período de trânsito tubário e implantação, não causou efeito tóxico no organismo materno, tampouco induziu mortes, crescimento intrauterino retardado ou malfomações fetais. Há ainda indícios de que o EGb poderia agir de forma hepatoprotetora e nefroprotetora quando administrado a ratas Wistar durante o período de prenhez quando usado nas doses 7 e 14 mg/Kg/dia. / The Ginkgo biloba extract (EGb) is mainly used in the treatment for and in the prevention of neurodegenerative diseases. It is also used in the treatment for dizziness, age-related memory loss and as an anti-inflammatory. Effects of EGb on reproduction include fertilization inhibition through the reduction of spermatozoa viability and oocyte degeneration. When administered to male mice, EGb led to alterations in the weight of organs such as the prostate, and in the reproductive behavior of these animals (leading to lower pregnancy rates and embryo death increase). In female rats, EGb was proved to cause intra-uterine growth retardation, this effect being thought to be related to its estrogenic activity. Other studies have also shown EGb estrogenic effects. Adequate levels of estrogen, progesterone and prostaglandins are known to be very important to tubal transit and uterine implantation. Hence, there is the possibility of EGb causing embryonic development alterations when administered in the beginning of pregnancy. Investigating this possibility is the aim of this thesis. In order to achieve that, the following experimental protocol was carried out with 68 nulliparous pregnant Wistar rats. The rats were randomly distributed into four experimental groups (n=17): Control, Gb 3.5, Gb 7 and Gb 14, which were treated, respectively, with zero, 3.5, 7.0 and 14.0mg/Kg/Day of EGb diluted in 1mL of distilled water through gavage, once a day, during the first eight days of pregnancy. Rats were euthanized in the 15th day of pregnancy, through total exsanguination under anesthesia. The following parameters were assessed: clinical signs of maternal toxicity – such as feed and water intake alterations, body weight alterations, hyper or hypoactivity, piloerection, stereotypy, biochemical and hematological profile and death –; number of corpora lutea; maternal organs (ovaries, liver and kidneys) weight; maternal hematological and biochemical profiles; fetuses and placentas weight; number of viable, resorpted and dead fetuses; fetal malformations in both superior and inferior members, neural tube closure and facial morphology. Amongst the parameters evaluated, alterations were found only in the maternal hematological profile. There was significant raise in the cholesterol level and reduction in the levels of ALT, urea and creatinine for the animals treated with 7 and 14mg/Kg/day of EGb. No significant alteration was found for other maternal and fetal parameters evaluated. Hence, it seems that treatment with EGb during both tubal transit and implantation periods did not cause toxic effects to the maternal organism of Wistar rats. Neither did it induce deaths, intra-uterine growth retardation or fetal malformation. There is also evidence that EGb could present hepatoprotective and nephroprotective effects when administered to Wistar rats during pregnancy in the dosages of 7 and 14 mg/Kg/day.

Patients' use of medicines is widely recognised as sub-optimal with a high proportion of patients with a long-term condition not taking their medicines as prescribed. Research and policy guidance emphasise the importance of partnership within the patient-prescriber encounter in enhancing patients' use of medicines. There is however considerable evidence that this is not usually achieved by medical prescribers, limiting the extent to which shared decision-making occurs about prescribed medicines. There is a general assumption that nurse prescribers, who within the United Kingdom have comparable prescribing rights to medical doctors, demonstrate greater abilities in collaborative working with patients leading to an enhanced use of medicines. Research evidence is however limited, particularly in relation to the ways in which patients' use of medicines is discussed and negotiated within the patient-nurse prescriber encounter. This study focused on the management of patients' use of medicines within the patient-nurse prescriber encounter. Seven nurse prescribers, working within a number of clinical specialities in both primary and secondary care settings, were recruited to the study together with their patients who were living with one or more long-term conditions (n=21). Data collection involved the non-participant observation of out-patient consultations to examine the management of patients' use of medicines within the encounter and semi-structured interviews with both patients and prescribers. Discourse analysis was undertaken to examine underpinning assumptions, views and beliefs regarding the management of patients' use of medicines. Asymmetry was evident within the encounters with prescribers controlling the agenda for discussion and interrupting patients' attempts to demonstrate their knowledge. Patient accounts of the moral approach adopted in managing their condition in the context of their everyday lives were also ignored. Biomedical and contrasting moral discourses are examined. An interpretive framework derived from the work of Michel Foucault is used to explain the operation of disciplinary, pastoral and bio-political power within the encounter and the extent to which subjugation of patients' knowledge and resistance were evident. Foucault's concept of technologies of the self is examined to explore its potential application in enhancing patients' medicines use.

Dès l'Antiquité, les oculistes, médecins spécialisés dans le soin des yeux, utilisaient des médicaments solides sophistiqués appelés collyres. Ils étaient composés de substances minérales, végétales et animales. Ce travail résulte d'une collaboration interdisciplinaire destinée à préciser la composition chimique et les structures des phases inorganiques ainsi que les procédés de fabrication de ces collyres. Les techniques analytiques mises en œuvre sont la spectroscopie Raman, la spectrométrie de fluorescence des rayons X (XRF) et la diffraction des rayons X (XRD). L'étude de la stabilité de réplicas à base de sels métalliques (plomb, zinc, cuivre, fer), fréquemment mentionnés dans les textes antiques, a permis de préciser les phases initialement présentes dans ces médicaments. Quatre collections de collyres archéologiques (Musée Gallo-Romain de Lyon, Musée d'Archéologie Nationale, Cabinet des Médailles de la BnF, Musée Atestino d'Este) ont été étudiées sur site au moyen d'instruments portables. Une méthodologie, combinant les résultats obtenus par XRF et par XRD, a été développée afin d'obtenir les proportions entre les phases inorganiques présentes. Les compositions obtenues par analyses physico-chimiques ont ainsi été comparées aux compositions décrites dans les textes anciens et, pour la première fois, des liens entre les deux ont été établis. / In the Antiquity, oculists (eye care specialised physicians) mixed mineral, vegetal and animal substances to prepare elaborate solid medicines termed collyria. In an interdisciplinary work, we investigated the chemical composition, the inorganic phases structure and the manufacturing process of such collyria. The implemented analytical techniques were Raman spectroscopy, X-ray fluorescence (XRF) and X-ray diffraction (XRD). The stability of metallic salts based replicas prepared according to ancient texts recipes was studied in order to identify the pristine phases. Four collections of archaeological collyria (Musée Gallo-Romain de Lyon, Musée d’Archéologie Nationale, Cabinet des Médailles de la BnF, Musée Atestino d’Este) were studied on site, using portable devices. A methodology combining XRF and XRD results was developed to quantify the inorganic phases distribution. For the first time, a straight relationship was established between compositions obtained by physico-chemical analysis and ancient recipes.

智慧財產權保護的利益包括道德利益，社會利益與經濟利益，然而三種利益彼此可能互相衝突，醫藥品專利便是其中一種常見案例，若醫藥品在專利權的保護下，價格與可得性皆容易成為取得必需醫藥品的高門檻。關於如何使病人取得所需的專利藥物，「強制授權」制度被認為是一種可使用的彈性手段。 本篇論文旨在分析專利強制授權制度對藥物可近性可能造成之影響。第二章從國際公約中對於強制授權的規範切入，說明目前國際上強制授權的運作條件；第三章說明強制授權的功能，其在專利權制度中可達到之經濟與公共利益的調和與平衡，對於反對者所認為「強制授權造成的經濟傷害」論點予以駁斥，並說明強制授權造成專利權人的經濟損失並不如反對者宣稱的巨大，反而因強制授權制度的存在，能有效減少濫用權利的誘因；第四章則著重分析強制授權對公共衛生政策的影響，對於開發中國家而言，建立起穩定的強制授權制度，有助於他們跨過初始的專利障礙，開始扶植本國藥廠並建立本國的藥物供應鏈，以達到獲取藥物的自主性；第五章以美國、加拿大、印度等國實施強制授權的案例，闡述強制授權在已開發國家與開發中國家的實施和效果，強調無論是以強制授權或是其他更為強勢的手段，在專利的壟斷性下，為社會利益保留一項具有彈性與最後手段的措施之必要性；第六章則就我國的專利法修法沿革分析，提出關於現行專利法中強制授權的彈性不足會造成的影響及修改的方向。 / The protection of intellectual property rights includes moral interests, social interests and economic interests, but the three interests may conflict with each other. Patents of pharmaceutical product are the common cases. If the products are under the protection of patents, the price and accessibility will become the obstacles for obtaining essential medicines. The "compulsory license" system is considered to be a flexible instrument that can be used when patented drugs are required by patients. This research aims to analyze the possible impact of patent compulsory license system on accessibility of medicines. In the second chapter, I points out the rule of operation of compulsory license from international conventions, introducing the current international conditions. Chapter 3 describes the function of compulsory license, that the reconciliation and balance between the economic and public interests can be achieved in the patent system. The opponents consider that economic harm would be caused by compulsory license. However, the actual economic loss of the patent owner is not as great as the opponents describe. In contrast, the incentive for the abuse of the right can be effectively reduced through the existence of the compulsory license system. Chapter 4 focuses on how compulsory license system affects public health policies. For developing countries, the establishment of a stable compulsory license system helps them to cross the initial barriers and start to foster their own pharmaceuticals industry. Building their own medicines supply chain helps them to achieve the accessibility of medicines. Chapter 5 illustrates the attitude toward compulsory license in developed and developing countries. The chapters introduce means of compulsory license in the United States, Canada, India and other countries. It emphasizes that, whether compulsory license or other more powerful means, to retain a flexible method for social interests is important in the patent law system. Chapter 6 analyzes the history of Taiwan's patent law. This chapter emphasizes the impact on lack of flexibility about compulsory license, and it mentions the direction of the amendment to Taiwan Patent Law.

Magister Public Health - MPH / Malaria is a health, social and economic burden in Nigeria and consistently ranks amongst the four most common causes of childhood deaths. Treatment of malaria is usually started at home; care is only sought from the health facility when the treatment is ineffective (McCombie, 1996). Patent medicine vendors (PMVs) have been identified as a widely patronized source for drugs used in the home treatment of malaria (Breiger et al, 2001; Goodman, et al, 2007; Salako et al, 2001). Inadequate or poor knowledge and practices in the use of anti-malaria drugs (AMDs) increases morbidity and mortality, undermines therapeutic efficacy, and promotes the emergence and spread of drugresistant malaria. Aim: The aim of the study was to describe and quantify the knowledge and self-reported practices of PMVs in the use of antimalarials, particularly artemisinin-based combination therapies (ACTs), in a poor urban community in Lagos state, Nigeria. / South Africa

>Magister Scientiae - MSc / Herbal medicines have been an important part of health and wellness for hundreds of years. Recently the World Health Organization estimated that 80% of people worldwide rely on herbal medicines. Herbs contain many substances that are good for protecting the body and are therefore used in the treatment of various illnesses. Along with traditional medicines, herbs are often used in the treatment of chronic diseases such as rheumatism, migraine, chronic fatigue, asthma, eczema, and irritable bowel syndrome, among others. Herbal medicines are also applied in certain traditional communities as treatment against infectious diseases such as flu, malaria, measles, and even human immunodeficiency virus HIV-infection. Approximately 34 million people are currently infected with the human immunodeficiency virus (HIV) and 2.5 million newly infected. Therefore, HIV has become one of the major public health problems worldwide. It is important to understand the impact of herbal medicines used on HIV/AIDS. Mathematical models enable us to make predictions about the qualitative behaviour of disease outbreaks and evaluation of the impact of prevention or intervention strategies. In this dissertation we explore mathematical models for studying the effect of usage of herbal medicines on HIV. In particular we analyze a mathematical model for population dynamics of HIV/AIDS. The latter will include the impact of herbal medicines and traditional healing methods. The HIV model exhibits two steady states; a trivial steady state (HIV-infection free population) and a non-trivial steady state (persistence of HIV infection). We investigate the local asymptotic stability of the deterministic epidemic model and similar properties in terms of the basic reproduction number. Furthermore, we investigate for optimal control strategies. We study a stochastic version of the deterministic model by introducing white noise and show that this model has a unique global positive solution. We also study computationally the stochastic stability of the white noise perturbation model. Finally, qualitative results are illustrated by means of numerical simulations. Some articles from the literature that feature prominently in this dissertation are [14] of Cai et al, [10] of Bhunu et al., [86] of Van den Driessche and Watmough, [64] of Naresh et al., Through the study in this dissertation, we have prepared a research paper [1], jointly with the supervisors to be submitted for publication in an accredited journal. The author of this dissertation also contributed to the research paper [2], which close to completion. 1. Abdulaziz Y.A. Mukhtar, Peter J. Witbooi and Gail D. Hughes. A mathematical model for population dynamics of HIV with ARV and herbal medicine. 2. P.J. Witbooi, T. Seatlhodi, A.Y.A. Mukhtar, E. Mwambene. Mathematical modeling of HIV/AIDS with recruitment of infecteds.