The purpose of this study is to explore professional drug addiction care workers’ attitudes towards harm reduction interventions. The data collection was conducted through digital survey mailed to mangers and staff. In total 73 individuals choose to answer the survey. The biopsychosocial perspective and stigmatization theory were used to theoretically reflect on the results. Most respondents reported positive attitudes towards maintenance treatment, needle exchange programs and overdose prevention with naloxone. The result also shows that the majority of respondents’ have a negative attitude towards injection rooms and decriminalization of drugs for personal use. Moreover, staff with higher education reported more positive attitudes towards maintenance treatment, needle exchange, injection rooms and decriminalization of drugs for personal use. In conclusion, it is important to recognize and spread new developments and evidence-based research regarding harm reduction and decriminalization of narcotics drugs. Based on the respondents’ negative attitudes towards implement injection rooms and decriminalize drugs for personal use, but also the improvement of staffs’ attitudes that present study found it is supposed that neglecting prohibition and showing zero tolerance towards personal use will probably disappear in the future even in Sweden.

Orientador: Silvia Cristina Mangini Bocchi / Resumo: Introdução. Verifica-se eficácia no uso da laserterapia transcutânea (Intravenous Laser Irradiation of Blood – ILIB) na saúde dos indivíduos, entretanto, existem escassas evidências científicas para tratamento dos efeitos colaterais de quimioterápicos citotóxicos. Objetivo. Avaliar a eficácia dos protocolos ILIB 30’ e 60’ com comprimento de onda de 660nm sobre os efeitos colaterais no trato gastrointestinal (náuseas, vômitos, diarreias e constipação) e no tecido hematopoiético (plaquetopenias, neutropenias e alterações da hemoglobina), em pacientes oncológicos recebendo tratamento quimioterápico endovenoso. Método. Ensaio clínico, randomizado, unicego e aprovado por Comitê de Ética em Pesquisa (CAE 82323318.90000.5411, Parecer 2.512.164) e pelo Registro Brasileiro de Ensaios Clínicos (RBR – 7y8rtz). Estudo realizado em serviço ambulatorial de quimioterapia de hospital público do estado de São Paulo, Brasil. A amostra constituiu de 55 pacientes ³ 18 anos, com tumores sólidos, a partir do segundo ciclo de tratamento quimioterápico com fármacos endovenosos citotóxicos para o trato gastrointestinal e tecido hematopoiético, assim alocados nos grupos de seguimentos: 21 no controle, 21 no ILIB 30’ e 13 no ILIB 60’. A aplicação deu-se por via transcutânea sobre a artéria radial, utilizando-se aparelho de laser de baixa intensidade com comprimento de onda de 660nm. Considerou-se eficácia a manutenção ou aumento dos parâmetros mínimos hematológicos (hemoglobina, plaquetas e neutrófilos... (Resumo completo, clicar acesso eletrônico abaixo) / Mestre

The overall aim of this thesis was to evaluate clinical pharmacist interventions with the focus on methods aiming to improve the quality of drug therapy and increase patient safety. Adverse drug events caused by medication errors, suboptimal dosages and inappropriate prescribing are common causes of drug-related morbidity and mortality. Clinical pharmacists integrated in multi-professional health-care teams are increasingly addressing these issues. A randomised controlled trial (RCT) was conducted to investigate the effectiveness of clinical pharmacists’ interventions in reducing morbidity and use of hospital care for patients 80 years or older. The results showed that the intervention group had fewer visits to hospital and that the intervention was cost-effective. In a subsequent study based on the population in the RCT, the appropriateness of prescribing was assessed using three validated tools. The results indicated improved appropriateness of prescribing for the intervention group as a result of the intervention. The tools and the number of drugs at discharge were then tested for validity in terms of causal links between the scores at discharge and hospitalisation. No clear correlations between high scores for the tools or a high number of drugs and increased risk of hospitalisation could be detected. During the inclusion period of the RCT a survey based study was conducted where the perceived value of ward-based clinical pharmacists, from the perspective of hospital-based physicians and nurses as well as from general practitioners (GPs) was evaluated. The respondents were positive to the new collaboration to a high degree and stated increased patient safety and improvements in patients’ drug therapy as the main advantages. In the last study the frequency and severity of prescription and transcription errors, when patients enrolled in the multidose-dispensed medications (MDD) system are discharged from hospital, was investigated. The results showed that errors frequently occur when MDD patients are hospitalised.

Mémoire numérisé par la Division de la gestion de documents et des archives de l'Université de Montréal

Siauro terapinio indekso vaistų vartojimas ir farmakokinetikos tyrimų interpretavimas reikalauja specialių farmakokinetikos žinių. Mokslinės literatūros šaltiniuose teigiama, jog gydymo procese dalyvaujant klinikiniams vaistininkams vaistų vartojimas yra optimizuojamas. Lietuvoje panašios vaistininkų veiklos nėra, todėl tyrimo tikslas buvo įvertinti siauro terapinio indekso vaistų vartojimo racionalumą ir nustatyti klinikinės farmacijos paslaugos poreikį stacionarinio gydymo įstaigoje. Darbo uždaviniai: nustatyti ir įvertinti farmakoterapinių problemų, siejamų su siauro terapinio indekso vaistų (vankomicino, ciklosporino, digoksino, gentamicino) vartojimu, paplitimą tretinio lygio ligoninėje; kiekybiškai ir kokybiškai įvertinti nustatytų farmakoterapinių problemų rizikos veiksnius; įvertinti vankomicino farmakokinetikos stebėsenos praktiką ligoninės skyriuose; įvertinti farmacininko konsultacijos įtaką vankomicino farmakokinetikos stebėsenai. Tyrimui pasirinktų siauro terapinio indekso vaistų farmakokinetikos tyrimų analizė atskleidė klinikinės farmacijos paslaugos poreikį optimizuojant tokių vaistų vartojimą Lietuvos ligoninėse. Nustatytų farmakoterapinių problemų rizikos veiksnių analizė identifikavo praktikoje dar visuotinai nepripažintą padidintą inkstų klirensą ir jo reikšmingą įtaką vaistų veiksmingumui. / The prescription of narrow therapeutic index drugs (NTID) and interpretation of pharmacokinetic measurements require special pharmacokinetic knowledge. Scientific publications report that active participation of clinical pharmacists in the treatment process results in optimization of the drugs use. In Lithuania, there are no similar services provided by pharmacists up till now. Aim of the study: to evaluate the rationality of the use of NTIDs and to determine the demand for clinical pharmacy services in hospitals. Objectives of the study: to identify and evaluate the prevalence of drug-related problems associated with the use of NTIDs (vancomycin, cyclosporine, digoxin, and gentamicin) in the tertiary-level hospital; to perform quantitative and qualitative analysis of risk factors for the identified drug-related problems; to evaluate the practice of pharmacokinetic vancomycin monitoring in hospital departments; to evaluate the influence of pharmacist intervention on pharma¬cokinetic vancomycin monitoring. The analysis of pharmacokinetic measurements of NTIDs selected for this study revealed the demand for clinical pharmacy services while optimizing NTIDs use in the Lithuanian hospitals. The analysis of risk factors associated with the identified drug-related problems identified augmented renal clearance, which is not widely acknowledged in practice, and its significant impact on the effectiveness of drugs.

En 2003, un groupe de travail de la Société Française de Pharmacie Clinique (SFPC) a mis au point un outil codifiant les interventions relatives aux problèmes médicamenteux détectés au cours de l'analyse de prescription par les pharmaciens ainsi qu'une base de données (ACT-IP©) destinée à la collecte de ces interventions. Notre recherche a eu pour objectifs de préciser les conditions et le potentiel d'analyse du contenu d'ACT-IP© et de fixer les limites de cette analyse. Le travail se décline en quatre séquences : 1. quantifier le savoir nécessaire pour prescrire et dispenser des médicaments 2. déconstruire ce contenu afin de rapporter de quoi une intervention pharmaceutique est le résultat 3. rechercher ce qui normalement aurait dû y être présent et qui est absent 4. dessiner les sujets de recherche à venir. Notre travail démontre que le contenu d'ACT-IP© constitue avant tout une base solide d'analyse des pratiques des pharmaciens. / In 2003, a working group of the French Society of Clinical Pharmacy (SFPC) validated an instrument for documentation of pharmacist's interventions in French speaking hospitals. To extend the documentation of these interventions to every pharmacist, a Web site database (ACT-IP©) was created. The aim of our research was to explore the potential and conditions for analyzing the ACT-IP© content and define the limits of this analysis. The work is divided into four sequences: 1. quantifying the necessary knowledge to prescribe and dispense drugs 2. deconstruction of this content in order to capture the elements that lead to pharmacist interventions 3. identifying interventions types that are absent whereas they normally should be present 4. define areas for future research as a connection of ACT-IP content with a fully structured drug information database in order to extend the field of hospital pharmacist practice studies. Our work demonstrates that the content of ACT-IP© primarily constitutes a basis for the analysis pharmacist professional practices instead of a database of prescribing errors.

Candidate: Zuzana Očovská1 Supervisor: prof. RNDr. Jiří Vlček, CSc.1 Consultant: PharmDr. Martina Maříková2 1 Department Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University 2 University Hospital Hradec Králové, Hospital Pharmacy, Head of the Division of Clinical Pharmacy Title of the master thesis: The analysis of drug-related problems potentially leading to hospitalization among geriatric patients Hospital admissions due to drug-related problems (DRPs) represent a relevant clinical issue with significant economic consequences. Polypharmacy and age-related pharmacokinetic and pharmacodynamic changes make elderly patients particularly prone to develop DRP. The aim of the theoretical part of this thesis was to introduce the issue of drug-related problems and to outline the results of previous studies concerning drug-related hospitalizations among geriatric patients. The aim of the practical part was to determine the prevalence of DRP potentially leading to hospitalization and to identify the most common medication classes involved in these DRPs. Over the period of six months 200 admissions to geriatric ward of III. Internal Gerontometabolic Clinic of University Hospital Hradec Králové have been retrospectively evaluated in order to determine whether the...

Os sistemas de farmacovigilância fundamentam as decisões sobre segurança no uso de medicamentos regulamentados por autoridades de saúde. Estudá-los e propor estratégias de melhorias contribuem para fortalecer os sistemas de saúde, aperfeiçoando a qualidade da assistência à saúde e assegurando a segurança do paciente e coletividade. A Tese objetivou analisar a evolução e desempenho do sistema brasileiro de farmacovigilância, denominado de SINAF, e as notificações dos pacientes com suspeitas de reações adversas a medicamentos (RAMs) registradas no Notivisa-medicamento no período de 2008 a 2013 e propor uma lista-referência de códigos da CID-10 para vigilância de RAMs e intoxicações medicamentosas (IMs). A Tese compreende seis artigos científicos organizados para publicação. No primeiro, uma revisão de escopo apresentou uma perspectiva histórica para caracterizar a evolução do SINAF e lacunas identificadas no processo, como a ausência de comissão de farmacovigilância que atenda aos requisitos mínimos de um sistema de farmacovigilância propostos pela Organização Mundial da Saúde. Os artigos 2, 3 e 4 analisaram características relacionadas com o desempenho do SINAF. O artigo 2 revelou que não há preferência digital da idade na base de dados das notificações de eventos adversos a medicamentos (EAMs) do Notivisa-medicamento. Mediante uma análise comparativa, o artigo 3 mostrou diferenças entre o formulário para notificação de EAMs utilizado no SINAF e de outros doze países latinoamericanos (Argentina, Bolívia, Chile, Colômbia, Costa Rica, Cuba, Guatemala, México, Panamá, Peru, Uruguai e Venezuela), sobretudo na quantidade de variáveis para preenchimento, podendo contribuir com a subnotificação de casos. No artigo 4 – um estudo de avaliação de sistemas de vigilância de saúde pública –, revelou que o desempenho do Notivisa-medicamento foi considerado satisfatório para três atributos (flexibilidade, validade e erro preditivo positivo) e deficitário para a maioria deles (simplicidade, aceitabilidade, representatividade, completude, consistência, oportunidade e clareza metodológica). O artigo 5, mediante estudo descritivo e retrospectivo, encontrou uma taxa de notificação de RAMs de 22,8/ 1 milhão de habitantes/ano. Trata-se de taxa bastante inferior a países de alta renda como Nova Zelândia, Suécia, Austrália e Suíça que possuem mais de 300 notificações por milhão, como em relação a países de média renda, como a África do Sul, com taxa de 77 por milhão de habitantes. A população feminina (60,5%) prevaleceu no total de pacientes (26.554), assim como, a raça/cor branca (58,1%). A idade variou de 0 a 112 anos (mediana = 46 anos). Quase 1/3 (32,5%) das suspeitas de RAMs ocorreram em populações vulneráveis (idosos e crianças). Foram avaliados 54.288 pares de medicamento-reação adversa, onde prevaleceram as reações adversas graves (59,2%), com destaque para as que resultaram em efeito clinicamente importante (83,1%). O estudo 6 propôs uma lista-referência com 691 códigos da CID-10, sendo 360 (52,1%) relacionados com RAMs e 331 (47,9%) com IMs. Um total de 511 (73,9%) códigos estão relacionados com casos de admissão hospitalar e/ou óbito. Os achados da Tese evidenciam a necessidade de mudanças em diferentes aspectos estudados do SINAF, como forma de contribuir na produção de informações completas, fidedignas e mais representativas sobre danos ocasionados por medicamentos comercializados no país. / The pharmacovigilance systems support the decisions on safety when using medications regulated by health authorities. Analyzing them and proposing improvement strategies are ways to make healthcare systems stronger, improving the quality of healthcare assistance, making sure the patient is safe and that the population is ensured. The dissertation was aimed at analyzing the evolution and performance of the Brazilian pharmacovigilance system, SINAF, and the notification of patients with suspected adverse drug reactions (ADRs) registered with the notification system NOTIVISA/medication from 2008 through 2013, as well as proposing a reference list of ICD-10 codes for surveillance of ADRs and intoxication due to medication (IDM). The dissertation is comprised of six scientific articles ready to be published. The first one, a scoping review, presents a historical perspective to demonstrate the development process of SINAF and the gaps identified during the process, such as the absence of a pharmacovigilance commission that complies with the minimum requirements of a pharmacovigilance system as proposed by World Health Organization. Articles 2, 3 and 4 presents an analysis of the performance-related characteristics of SINAF. Article 2 reveals that there is no digital age preference in the adverse drug events (ADEs) database belonging to NOTIVISA/medication. Using a comparative analysis, article 3 shows differences between the form for ADEs notification using SINAF and in other twelve Latin-American countries (Bolivia, Chile, Colombia, Costa Rica, Cuba, Guatemala, Mexico, Panama, Peru, Uruguay and Venezuela), highlighting the number of variables to complete, and it may collaborate with the sub-notification of cases. Article 4 – a study on the evaluation of public health surveillance systems over time – reveal that the performance of NOTIVISA/medication was considered satisfactory regarding three attributes (flexibility, validity and positive predictive error) and deficient regarding most of the others (simplicity, acceptability, representability, integrality, consistency, opportunity and methodological clarity). Article 5, by means of a descriptive and retrospective study, found an ADR notification rate of 22.8/million inhabitants/year. This is a much lower rate than in high income countries, such as New Zealand, Sweden, Australia and Switzerland, which have over 300 notifications per million, when compared against average income, such as South Africa, with a rate of 77/million inhabitants. Female population (60.5%) prevailed in the total number of patients (26,554), as well as white race/color (58.1%). Age was between 0 - 112 years old (median = 46 years). Almost 1/3 (32.5%) of the suspected ADRs occurred in vulnerable populations (elderly and children). 54,288 pairs of medication/adverse reactions were assessed. Severe adverse reactions prevailed (59.2%), and attention is drawn to those resulting in clinically important effect (83.1%). Study 6 proposes a reference list with 691 ICD-10 codes; 360 (52.1%) out of them are ADRs-related and 331 (47.9%) out of them are IDM. A total of 511 (73.9%) codes are related to cases of hospital admission and/or death. The dissertation findings prove the need of changes across different aspects in SINAF as a way to contribute to production of complete, reliable and representative information on damages caused by commercially available drugs in Brazil.

Os sistemas de farmacovigilância fundamentam as decisões sobre segurança no uso de medicamentos regulamentados por autoridades de saúde. Estudá-los e propor estratégias de melhorias contribuem para fortalecer os sistemas de saúde, aperfeiçoando a qualidade da assistência à saúde e assegurando a segurança do paciente e coletividade. A Tese objetivou analisar a evolução e desempenho do sistema brasileiro de farmacovigilância, denominado de SINAF, e as notificações dos pacientes com suspeitas de reações adversas a medicamentos (RAMs) registradas no Notivisa-medicamento no período de 2008 a 2013 e propor uma lista-referência de códigos da CID-10 para vigilância de RAMs e intoxicações medicamentosas (IMs). A Tese compreende seis artigos científicos organizados para publicação. No primeiro, uma revisão de escopo apresentou uma perspectiva histórica para caracterizar a evolução do SINAF e lacunas identificadas no processo, como a ausência de comissão de farmacovigilância que atenda aos requisitos mínimos de um sistema de farmacovigilância propostos pela Organização Mundial da Saúde. Os artigos 2, 3 e 4 analisaram características relacionadas com o desempenho do SINAF. O artigo 2 revelou que não há preferência digital da idade na base de dados das notificações de eventos adversos a medicamentos (EAMs) do Notivisa-medicamento. Mediante uma análise comparativa, o artigo 3 mostrou diferenças entre o formulário para notificação de EAMs utilizado no SINAF e de outros doze países latinoamericanos (Argentina, Bolívia, Chile, Colômbia, Costa Rica, Cuba, Guatemala, México, Panamá, Peru, Uruguai e Venezuela), sobretudo na quantidade de variáveis para preenchimento, podendo contribuir com a subnotificação de casos. No artigo 4 – um estudo de avaliação de sistemas de vigilância de saúde pública –, revelou que o desempenho do Notivisa-medicamento foi considerado satisfatório para três atributos (flexibilidade, validade e erro preditivo positivo) e deficitário para a maioria deles (simplicidade, aceitabilidade, representatividade, completude, consistência, oportunidade e clareza metodológica). O artigo 5, mediante estudo descritivo e retrospectivo, encontrou uma taxa de notificação de RAMs de 22,8/ 1 milhão de habitantes/ano. Trata-se de taxa bastante inferior a países de alta renda como Nova Zelândia, Suécia, Austrália e Suíça que possuem mais de 300 notificações por milhão, como em relação a países de média renda, como a África do Sul, com taxa de 77 por milhão de habitantes. A população feminina (60,5%) prevaleceu no total de pacientes (26.554), assim como, a raça/cor branca (58,1%). A idade variou de 0 a 112 anos (mediana = 46 anos). Quase 1/3 (32,5%) das suspeitas de RAMs ocorreram em populações vulneráveis (idosos e crianças). Foram avaliados 54.288 pares de medicamento-reação adversa, onde prevaleceram as reações adversas graves (59,2%), com destaque para as que resultaram em efeito clinicamente importante (83,1%). O estudo 6 propôs uma lista-referência com 691 códigos da CID-10, sendo 360 (52,1%) relacionados com RAMs e 331 (47,9%) com IMs. Um total de 511 (73,9%) códigos estão relacionados com casos de admissão hospitalar e/ou óbito. Os achados da Tese evidenciam a necessidade de mudanças em diferentes aspectos estudados do SINAF, como forma de contribuir na produção de informações completas, fidedignas e mais representativas sobre danos ocasionados por medicamentos comercializados no país. / The pharmacovigilance systems support the decisions on safety when using medications regulated by health authorities. Analyzing them and proposing improvement strategies are ways to make healthcare systems stronger, improving the quality of healthcare assistance, making sure the patient is safe and that the population is ensured. The dissertation was aimed at analyzing the evolution and performance of the Brazilian pharmacovigilance system, SINAF, and the notification of patients with suspected adverse drug reactions (ADRs) registered with the notification system NOTIVISA/medication from 2008 through 2013, as well as proposing a reference list of ICD-10 codes for surveillance of ADRs and intoxication due to medication (IDM). The dissertation is comprised of six scientific articles ready to be published. The first one, a scoping review, presents a historical perspective to demonstrate the development process of SINAF and the gaps identified during the process, such as the absence of a pharmacovigilance commission that complies with the minimum requirements of a pharmacovigilance system as proposed by World Health Organization. Articles 2, 3 and 4 presents an analysis of the performance-related characteristics of SINAF. Article 2 reveals that there is no digital age preference in the adverse drug events (ADEs) database belonging to NOTIVISA/medication. Using a comparative analysis, article 3 shows differences between the form for ADEs notification using SINAF and in other twelve Latin-American countries (Bolivia, Chile, Colombia, Costa Rica, Cuba, Guatemala, Mexico, Panama, Peru, Uruguay and Venezuela), highlighting the number of variables to complete, and it may collaborate with the sub-notification of cases. Article 4 – a study on the evaluation of public health surveillance systems over time – reveal that the performance of NOTIVISA/medication was considered satisfactory regarding three attributes (flexibility, validity and positive predictive error) and deficient regarding most of the others (simplicity, acceptability, representability, integrality, consistency, opportunity and methodological clarity). Article 5, by means of a descriptive and retrospective study, found an ADR notification rate of 22.8/million inhabitants/year. This is a much lower rate than in high income countries, such as New Zealand, Sweden, Australia and Switzerland, which have over 300 notifications per million, when compared against average income, such as South Africa, with a rate of 77/million inhabitants. Female population (60.5%) prevailed in the total number of patients (26,554), as well as white race/color (58.1%). Age was between 0 - 112 years old (median = 46 years). Almost 1/3 (32.5%) of the suspected ADRs occurred in vulnerable populations (elderly and children). 54,288 pairs of medication/adverse reactions were assessed. Severe adverse reactions prevailed (59.2%), and attention is drawn to those resulting in clinically important effect (83.1%). Study 6 proposes a reference list with 691 ICD-10 codes; 360 (52.1%) out of them are ADRs-related and 331 (47.9%) out of them are IDM. A total of 511 (73.9%) codes are related to cases of hospital admission and/or death. The dissertation findings prove the need of changes across different aspects in SINAF as a way to contribute to production of complete, reliable and representative information on damages caused by commercially available drugs in Brazil.

Basis: Statistical data of the Police of the Czech Republic show that secondary drug crime is widespread among abusers of addictive substances in the entire Czech Republic. The crime is mainly due to the need for financial resources for buying the addictive substance. As a result, every addictive substance abuser is perceived as a potential perpetrator of a crime. Aim: The aim of this diploma thesis was to find out the incidence of secondary drug criminality in the clients of the contact center DRUG - OUT Klub, z. s. in Ústí nad Labem, and to study the effect of selected influential demographic factors (gender, age, type of addictive substance, duration of addictive substance abuse). Methods and Research Sample: The research was conducted in the drug addiction treatment center DRUG - OUT Klub, s. z. in Ústí nad Labem using a questionnaire. The research respondents were problem abusers of opioids and stimulants. The research sample was selected with help of the institution. Every client of the contact center, who was a problem opioid or stimulant abuser, was over 18 years old, and agreed to be part of the research could participate. The research sample consisted of 362 problem abusers of opioids and stimulants. Among those were 201 men (60 opioid abusers, 141 stimulant abusers) and 161 women (55...