Το mHealth, η χρήση δηλαδή φορητών τεχνολογιών για την βελτίωση των παρεχόμενων υπηρεσιών υγείας, είναι σήμερα ένα από τα πιο ταχέως αναπτυσσόμενα πεδία της ηλεκτρονικής υγείας (eHealth). Ο αριθμός των επαγγελματιών υγείας που υιοθετούν έξυπνα κινητά τηλέφωνα (smartphones) για την εκτέλεση πληθώρας λειτουργιών αυξάνεται συνεχώς, εξαιτίας των δυνατοτήτων και της φορητότητας που αυτά παρέχουν. Ταυτόχρονα, τα σφάλματα στη φαρμακευτική αγωγή είναι από τα πιο συνηθισμένα ιατρικά λάθη με επιπτώσεις τόσο στην υγεία του ασθενούς όσο και στις δαπάνες στην υγεία. Η χορήγηση φαρμάκων είναι μια πολύπλοκη διαδικασία, καθώς απαιτεί από τον ειδικό της υγείας την ανάλυση πληθώρας παραγόντων και την ανάκτηση, επεξεργασία και διαχείριση μεγάλου όγκου πληροφορίας. Σύμφωνα με τη βιβλιογραφία, η χρήση τεχνολογιών πληροφορικής για την υποβοήθηση των επαγγελματιών υγείας στη λήψη αποφάσεων κατά τη συνταγογράφηση, μπορεί να συμβάλει σημαντικά στη μείωση των σφαλμάτων φαρμακευτικής αγωγής. Στο πλαίσιο της παρούσας διπλωματικής εργασίας, προχωρήσαμε στη διερεύνηση και αξιολόγηση των σημαντικότερων εφαρμογών έξυπνων κινητών συσκευών για το φάρμακο, με στόχο την εξαγωγή χρήσιμων συμπερασμάτων για τα χαρακτηριστικά και τις λειτουργίες που ενσωματώνουν. Ένα από τα βασικά συμπεράσματα της έρευνας ήταν η απουσία αντίστοιχης εφαρμογής για τα φάρμακα που είναι εγκεκριμένα από τον Εθνικό Οργανισμό Φαρμάκων (ΕΟΦ). Ως εκ τούτου, προχωρήσαμε στο σχεδιασμό και την ανάπτυξη εφαρμογής για τον έλεγχο ασυμβασιών μεταξύ φαρμάκων, η οποία παρέχει επιπλέον τη δυνατότητα προβολής πληροφοριών συνταγολογίου για τα φάρμακα του ΕΟΦ. Ο σχεδιασμός της εφαρμογής έγινε λαμβάνοντας υπόψη τις ανάγκες και τις απαιτήσεις μελλοντικών χρηστών, όπως οι επαγγελματίες υγείας και οι ασθενείς, προκειμένου να διασφαλιστεί η λειτουργικότητα και η ευχρηστία της. Η εν λόγω εφαρμογή προορίζεται για έξυπνες κινητές συσκευές που διαθέτουν λειτουργικό σύστημα Android, ενώ η πληροφορία που ενσωματώνει βασίζεται αποκλειστικά στο εθνικό συνταγολόγιο του ΕΟΦ. / Mobile Health or mHealth, namely the use of mobile and wireless technologies in order to improve health services and achieve health goals, is today one of the most rapidly expanding fields of electronic health (eHealth). The number of health professionals that adopt smartphones to perform multiple tasks, during their everyday medical practice, is increasing constantly. This is due to the fact that smartphones provide advanced computing capabilities and high portability. Simultaneously, medication errors are among the most common medical errors which have negative impact both for the health of the patient and the expenditure on health sector. Drug prescribing is quite a complex procedure, considering the fact that requires the health expert to analyze multiple factors and retrieve, process, manage and digest large volume of information. According to the literature, the use of information technologies to assist health professionals in decision-making when prescribing drugs, can contribute significantly to the reduction of medication errors. In the context of our work, we explored and evaluated the major smartphone applications for drugs, aiming to the extraction of useful conclusions about the features and functions that they incorporate. One of the research key findings was the absence of a corresponding application for the drugs that are approved by the National Drug Organization of Greece. Therefore, we design and develop an application for checking drug-drug interactions which additionally provides the ability to view national formulary information about drugs. The analysis and design of the application was implemented in collaboration with future users, such as health professionals and patients, in order to ensure that will meet their needs and requirements and at the same time will remain user friendly. This application is intended for Android smart mobile devices (e.g. smartphones, tablet PCs) and the information that integrates is solely based on the national formulary of the National Drug Organization of Greece.

Background: The Alliance for Patient Medication Safety (APMS) helps community pharmacies comply with continuous quality improvement requirements of many states and third party payment contracts through use of their Pharmacy Quality Commitment (PQC) program. Aims: To assess changes in the incidence of prescription Quality Related Events (QREs) and adoption of patient safety culture attitudes after guided PQC implementation. Methods: Twenty-one pharmacies were randomized to standard PQC practices (control) or guided PQC implementation (treatment). Pharmacy staff completed retrospective pre and post safety culture questionnaires. Negative binomial mixed and linear regression analyses were employed to examine changes in QREs rates and attitudes, respectively. Rasch analysis was used to assess questionnaire validity and reliability. Results: During the 2-month study period 3,343 QREs were reported to the online PQC system. At baseline, no difference in the average QRE reporting rate was identified between groups. Treatment group QRE reporting rates differed in one category post treatment (more incorrect safety caps QREs reported in treatment group, p<0.034). Seventy-one employees completed the questionnaire (70% response). Attitude improvement in the treatment group was 36% greater than in control (p<0.0001). The questionnaire demonstrated acceptable reliability and validity evidence. Conclusions: Guided PQC implementation increased reporting of certain QREs and increased the adoption of patient safety culture attitudes among staff pharmacy.

Improving the effectiveness and efficiency of medication error reporting is key to enhancing patient safety. The aim of this research was to explore medication error reporting in the United Arab Emirates (UAE), examining the attitudes, beliefs, behaviors and experiences of health professionals. The first phase was a Joanna Briggs Institute registered systematic review of the beliefs, attitudes and experiences of health professionals relating to medication error reporting. Findings indicated the need for original research employing a mixed methods approach to quantify and generate in-depth information, grounded in theories of behaviour change. In the second phase, a cross-sectional survey of health professionals in the UAE was conducted to determine the behavioural determinants and facilitators and barriers of medication error reporting. Principal component analysis of responses from 294 health professionals identified six components: knowledge and skills related; feedback and support related; action and impact related; motivation related; effort related; and emotions. Responses were neutral for the motivation and effort related components, but negative for the emotions component. Comparison of component scores identified that, nurses, females, those with greater experience and being older were more likely to be positive in their responses (p<0.05). In terms of emotions, the component with the lowest scores, older respondents with greater experience gave more positive responses (p<0.05). In the final phase, face-to-face semi-structured interviews with 29 health professionals explored in-depth the behavioural determinants of medication errors reporting in the UAE. The theoretical domains framework was employed in constructing the interview schedule and interpreting the findings. ‘Goals’ and ‘intentions’ were determinants which acted as facilitators while ‘beliefs of the consequences’, ‘emotions’,’ ‘social influences and environmental context’ were barriers. This doctoral research has generated original findings which can support the development of interventions, based on behaviour change techniques, to enhance medication error reporting. These changes could impact at the levels of the organisation, health professional and patient.

Introdução: Os erros de medicação em hospitais têm origem multidisciplinar e multifatorial, podendo ocorrer em qualquer uma das etapas do processo de utilização dos medicamentos. A constatação de que os erros podem ocorrer implica no reconhecimento de que medidas devem ser tomadas. Os erros de medicação não devem ser banalizados, nem magnificados, devem ser adequadamente abordados em todas as suas repercussões pessoais, profissionais e institucionais. O Modelo de Bioética Complexa é um referencial adequado para abordar a temática dos erros de medicação, por refletir sobre situações de complexidade crescente, incluindo os múltiplos aspectos envolvidos. Objetivos: Avaliar o sistema de notificação de erros de medicação do HCPA segundo o referencial da Bioética Complexa. Analisar a percepção de colaboradores das áreas de Enfermagem, Farmácia e Medicina sobre a notificação e o monitoramento dos erros de medicação na Instituição. Identificar as barreiras para a notificação dos erros de medicação. Identificar os facilitadores para a notificação dos erros de medicação. Identificar os motivos para realizar a notificação de erros de medicação. Método: Trata-se de um estudo descritivo e exploratório. Foi realizada uma pesquisa online através da ferramenta Formulários Google®. O questionário, composto por 9 perguntas, foi elaborado tendo como referência perguntas de estudo prévio sobre o tema. O questionário era anônimo, não sendo possível identificar os participantes. Por e-mail institucional do HCPA, foi enviado convite com o endereço eletrônico para acessar o instrumento de coleta de dados. Não foram incluídos colaboradores vinculados ao Programa de Gestão da Qualidade e da Informação em Saúde (QUALIS) e à Gerência de Risco (GR), bem como coordenadores e assessores do HCPA. O envio dos e-mails foi realizado em um período de 60 dias. Foram realizados 2 a 4 envios, em diferentes dias da semana. Foi obtida uma amostra aleatória de 411 participantes, de um total de 3872 colaboradores (profissionais de nível superior das áreas de Medicina, Enfermagem e Farmácia, contratados ou residentes, e técnicos de Enfermagem e de Farmácia). O conteúdo das respostas às perguntas abertas do questionário foi submetido à técnica de análise de conteúdo de Bardin. Os dados foram armazenados e avaliados no software de análise qualitativo QSR NVivo® versão 10. Resultados: Foram identificadas três categorias principais de barreiras: Barreiras Individuais, Barreiras Organizacionais e Barreiras Culturais. Na categoria Barreiras Individuais, emergiram seis subcategorias: medo, desconhecimento, responsabilidade, falta de comprometimento, esquecimento e vergonha. Na categoria Barreiras Organizacionais, emergiram quatro subcategorias: demanda de trabalho, dificuldades com o sistema de notificação, falta de feedback e infraestrutura. Na categoria Barreiras Culturais, emergiram três subcategorias: cultura de segurança não priorizada, cultura de banalização dos erros e cultura de infalibilidade. O medo foi a barreira individual mais referida pelos participantes. A demanda de trabalho foi percebida como uma das principais barreiras organizacionais pelos colaboradores e foi relacionada à falta de tempo. A partir da análise das respostas dos participantes, emergiram 12 categorias de facilitadores para a notificação dos erros de medicação: Divulgação e informação, Condução adequada da análise, Sistema de notificação, Resposta não punitiva, Feedback, Clareza, Cultura, Treinamento, Anonimato, Trabalho em equipe, Demanda de trabalho e Comprometimento. Doze categorias foram identificadas como motivos para notificar os erros de medicação. As categorias foram agrupadas quanto à sua relação com os profissionais, com os processos e com os pacientes. Motivos relacionados ao profissional: a Educação, a Proteção do Profissional envolvido em um erro de medicação e a Responsabilidade. Motivos relacionados aos processos envolvidos: Prevenir novos erros, Revisão dos processos, Análise dos erros, Barreiras de segurança, Protocolo Institucional e Cultura de segurança. Motivos relacionados aos pacientes: Segurança do Paciente, Qualidade da assistência e Riscos. Considerações finais: Verifica-se o engajamento dos profissionais participantes que deram inúmeras contribuições para o entendimento e aprimoramento do processo de notificação de erros de medicação, com uma ênfase na segurança do paciente. / Background: Medication errors in hospitals have multidisciplinary and multifactorial origin and can occur at any stage of the process of use of medicines. The finding that errors may occur involves the recognition that measures should be taken. Medication errors should not be trivialized or magnified, they should be adequately addressed in all their personal, professional and institutional repercussions. The Complex Bioethics model is an appropriate framework to address the issue of medication errors, by reflecting on the increasing complexity of situations, including the many aspects involved. Objective: To evaluate the medication error reporting system of the HCPA under the framework of Complex Bioethics. To analyze the perception of employees in the areas of Nursing, Pharmacy and Medicine on the reporting and monitoring of medication errors in the institution. Identify barriers to the reporting of medication errors. Identify facilitators for reporting of medication errors. Identify the reasons to perform medication error reporting. Method: This is a descriptive and exploratory study. It was done a search online through Google Forms tool. The questionnaire consists of 9 questions, it has been established as a previous study questions reference on the subject. The questionnaire was anonymous, it is not possible to identify participants. Email invitation has been sent to the email address of the participants to access the questionnaire. The sending of e-mails was conducted in a period of 60 days. A random sample of 411 participants was obtained, a total of 3872 employees. The content of the answers to open questions of the questionnaire was submitted to Bardin content analysis technique. The data were stored and evaluated by qualitative analysis software QSR NVivo version 10. Results: We identified three main categories: individual barriers, organizational barriers and cultural barriers. In the category individual barriers emerged six sub-categories: fear, ignorance, responsibility, lack of commitment, forgetfulness and shame. In the category organizational barriers, four subcategories emerged: workload, difficulties with the reporting system, lack of feedback and infrastructure. In the category cultural barriers revealed three subcategories: not prioritized safety culture, banalization of errors and infallibility culture. Fear was the individual barrier most reported by the participants. The workload was perceived as a major organizational barrier by employees and was related to lack of time. From the analysis of the responses of the participants emerged 12 categories of facilitators for the reporting of medication errors: shared information, proper conduct of the analysis, reporting system, non- punitive response, feedback, clarity, culture, training, anonymity, teamwork, workload and commitment. Twelve categories were identified as reasons for reporting medication errors. The categories were grouped as to its relationship with the professionals, with the procedures and with patients. Reasons related to Professional: education, professional protection and responsibility. Reasons related to the processes involved: To prevent new errors, review of processes, analysis of errors, safety barriers, institutional protocol and safety culture. Reasons related to patients: patient safety, quality of care and risks. Conclusion: There is the engagement of the professionals who gave numerous contributions to the understanding and improvement of medication errors notification process, with an emphasis on patient safety.

A solução de problemas é parte fundamental da manutenção da qualidade e da melhoria contínua. Ao longo dos anos diversos métodos foram desenvolvidos para solucionar problemas, todavia nem todos os métodos são aplicáveis em todos os problemas ou adequados para todos os setores. Caracterizado pelo ambiente em constante mudança, o setor hospitalar possui problemas complexos, cuja solução necessita de uma abordagem adequada e robusta. Dessa forma, o presente trabalho objetiva avaliar o desempenho de três métodos normalmente utilizados para solução de problemas: A3, RCA e FRAM, quando aplicados em ambiente hospitalar. Para esse fim, os três métodos foram aplicados no mesmo processo, de prescrição e medicação, de um hospital universitário. Os resultados das aplicações foram analisados de acordo com os critérios: número total de ações de melhoria propostas, dificuldade de implementação, a possibilidade de replicação das ações entre as unidades do hospital, o tempo necessário para aplicação dos métodos, o número de envolvidos, a necessidade de capacitação da equipe e um indicador de prioridade das ações propostas. Além disso, a percepção dos profissionais da saúde em relação aos métodos foi analisada. Os resultados demonstram que, no contexto avaliado, os métodos apresentaram um bom desempenho, por terem apresentado melhorias que, em média, foram consideradas adequadas pela instituição. / Problem solving is a fundamental part for quality maintenance and continuous improvement. Through the years many methods were developed to solve problems, though these methods do not apply to every problem, or are suitable to every type of activity. Kwon for its constant changing nature, hospitals have complex problems, which need a suitable and robust approach to solve. Thus, the present study has the objective of evaluating the performance of three methods usually used for problem solving: A3, RCA and FRAM, when applied on a hospital. For this, the three methods were applied in the same process, of prescription and medication, in an academic hospital. The results were analyzed accordingly to the following criteria: the total number of improvement actions proposed, implementation difficult, replication possibility along the departments of the hospital, the time needed to apply the methods, the number of people involved, the need of training for the team and an indicator for prioritization. Besides that, the health sector workers’ perception regards the methods was analyzed. The results evidence that, in the studied context, the methods had good performance, because introduced improvements that, on average, were considered suitable for the institution.

Introdução: Os erros de medicação em hospitais têm origem multidisciplinar e multifatorial, podendo ocorrer em qualquer uma das etapas do processo de utilização dos medicamentos. A constatação de que os erros podem ocorrer implica no reconhecimento de que medidas devem ser tomadas. Os erros de medicação não devem ser banalizados, nem magnificados, devem ser adequadamente abordados em todas as suas repercussões pessoais, profissionais e institucionais. O Modelo de Bioética Complexa é um referencial adequado para abordar a temática dos erros de medicação, por refletir sobre situações de complexidade crescente, incluindo os múltiplos aspectos envolvidos. Objetivos: Avaliar o sistema de notificação de erros de medicação do HCPA segundo o referencial da Bioética Complexa. Analisar a percepção de colaboradores das áreas de Enfermagem, Farmácia e Medicina sobre a notificação e o monitoramento dos erros de medicação na Instituição. Identificar as barreiras para a notificação dos erros de medicação. Identificar os facilitadores para a notificação dos erros de medicação. Identificar os motivos para realizar a notificação de erros de medicação. Método: Trata-se de um estudo descritivo e exploratório. Foi realizada uma pesquisa online através da ferramenta Formulários Google®. O questionário, composto por 9 perguntas, foi elaborado tendo como referência perguntas de estudo prévio sobre o tema. O questionário era anônimo, não sendo possível identificar os participantes. Por e-mail institucional do HCPA, foi enviado convite com o endereço eletrônico para acessar o instrumento de coleta de dados. Não foram incluídos colaboradores vinculados ao Programa de Gestão da Qualidade e da Informação em Saúde (QUALIS) e à Gerência de Risco (GR), bem como coordenadores e assessores do HCPA. O envio dos e-mails foi realizado em um período de 60 dias. Foram realizados 2 a 4 envios, em diferentes dias da semana. Foi obtida uma amostra aleatória de 411 participantes, de um total de 3872 colaboradores (profissionais de nível superior das áreas de Medicina, Enfermagem e Farmácia, contratados ou residentes, e técnicos de Enfermagem e de Farmácia). O conteúdo das respostas às perguntas abertas do questionário foi submetido à técnica de análise de conteúdo de Bardin. Os dados foram armazenados e avaliados no software de análise qualitativo QSR NVivo® versão 10. Resultados: Foram identificadas três categorias principais de barreiras: Barreiras Individuais, Barreiras Organizacionais e Barreiras Culturais. Na categoria Barreiras Individuais, emergiram seis subcategorias: medo, desconhecimento, responsabilidade, falta de comprometimento, esquecimento e vergonha. Na categoria Barreiras Organizacionais, emergiram quatro subcategorias: demanda de trabalho, dificuldades com o sistema de notificação, falta de feedback e infraestrutura. Na categoria Barreiras Culturais, emergiram três subcategorias: cultura de segurança não priorizada, cultura de banalização dos erros e cultura de infalibilidade. O medo foi a barreira individual mais referida pelos participantes. A demanda de trabalho foi percebida como uma das principais barreiras organizacionais pelos colaboradores e foi relacionada à falta de tempo. A partir da análise das respostas dos participantes, emergiram 12 categorias de facilitadores para a notificação dos erros de medicação: Divulgação e informação, Condução adequada da análise, Sistema de notificação, Resposta não punitiva, Feedback, Clareza, Cultura, Treinamento, Anonimato, Trabalho em equipe, Demanda de trabalho e Comprometimento. Doze categorias foram identificadas como motivos para notificar os erros de medicação. As categorias foram agrupadas quanto à sua relação com os profissionais, com os processos e com os pacientes. Motivos relacionados ao profissional: a Educação, a Proteção do Profissional envolvido em um erro de medicação e a Responsabilidade. Motivos relacionados aos processos envolvidos: Prevenir novos erros, Revisão dos processos, Análise dos erros, Barreiras de segurança, Protocolo Institucional e Cultura de segurança. Motivos relacionados aos pacientes: Segurança do Paciente, Qualidade da assistência e Riscos. Considerações finais: Verifica-se o engajamento dos profissionais participantes que deram inúmeras contribuições para o entendimento e aprimoramento do processo de notificação de erros de medicação, com uma ênfase na segurança do paciente. / Background: Medication errors in hospitals have multidisciplinary and multifactorial origin and can occur at any stage of the process of use of medicines. The finding that errors may occur involves the recognition that measures should be taken. Medication errors should not be trivialized or magnified, they should be adequately addressed in all their personal, professional and institutional repercussions. The Complex Bioethics model is an appropriate framework to address the issue of medication errors, by reflecting on the increasing complexity of situations, including the many aspects involved. Objective: To evaluate the medication error reporting system of the HCPA under the framework of Complex Bioethics. To analyze the perception of employees in the areas of Nursing, Pharmacy and Medicine on the reporting and monitoring of medication errors in the institution. Identify barriers to the reporting of medication errors. Identify facilitators for reporting of medication errors. Identify the reasons to perform medication error reporting. Method: This is a descriptive and exploratory study. It was done a search online through Google Forms tool. The questionnaire consists of 9 questions, it has been established as a previous study questions reference on the subject. The questionnaire was anonymous, it is not possible to identify participants. Email invitation has been sent to the email address of the participants to access the questionnaire. The sending of e-mails was conducted in a period of 60 days. A random sample of 411 participants was obtained, a total of 3872 employees. The content of the answers to open questions of the questionnaire was submitted to Bardin content analysis technique. The data were stored and evaluated by qualitative analysis software QSR NVivo version 10. Results: We identified three main categories: individual barriers, organizational barriers and cultural barriers. In the category individual barriers emerged six sub-categories: fear, ignorance, responsibility, lack of commitment, forgetfulness and shame. In the category organizational barriers, four subcategories emerged: workload, difficulties with the reporting system, lack of feedback and infrastructure. In the category cultural barriers revealed three subcategories: not prioritized safety culture, banalization of errors and infallibility culture. Fear was the individual barrier most reported by the participants. The workload was perceived as a major organizational barrier by employees and was related to lack of time. From the analysis of the responses of the participants emerged 12 categories of facilitators for the reporting of medication errors: shared information, proper conduct of the analysis, reporting system, non- punitive response, feedback, clarity, culture, training, anonymity, teamwork, workload and commitment. Twelve categories were identified as reasons for reporting medication errors. The categories were grouped as to its relationship with the professionals, with the procedures and with patients. Reasons related to Professional: education, professional protection and responsibility. Reasons related to the processes involved: To prevent new errors, review of processes, analysis of errors, safety barriers, institutional protocol and safety culture. Reasons related to patients: patient safety, quality of care and risks. Conclusion: There is the engagement of the professionals who gave numerous contributions to the understanding and improvement of medication errors notification process, with an emphasis on patient safety.

A solução de problemas é parte fundamental da manutenção da qualidade e da melhoria contínua. Ao longo dos anos diversos métodos foram desenvolvidos para solucionar problemas, todavia nem todos os métodos são aplicáveis em todos os problemas ou adequados para todos os setores. Caracterizado pelo ambiente em constante mudança, o setor hospitalar possui problemas complexos, cuja solução necessita de uma abordagem adequada e robusta. Dessa forma, o presente trabalho objetiva avaliar o desempenho de três métodos normalmente utilizados para solução de problemas: A3, RCA e FRAM, quando aplicados em ambiente hospitalar. Para esse fim, os três métodos foram aplicados no mesmo processo, de prescrição e medicação, de um hospital universitário. Os resultados das aplicações foram analisados de acordo com os critérios: número total de ações de melhoria propostas, dificuldade de implementação, a possibilidade de replicação das ações entre as unidades do hospital, o tempo necessário para aplicação dos métodos, o número de envolvidos, a necessidade de capacitação da equipe e um indicador de prioridade das ações propostas. Além disso, a percepção dos profissionais da saúde em relação aos métodos foi analisada. Os resultados demonstram que, no contexto avaliado, os métodos apresentaram um bom desempenho, por terem apresentado melhorias que, em média, foram consideradas adequadas pela instituição. / Problem solving is a fundamental part for quality maintenance and continuous improvement. Through the years many methods were developed to solve problems, though these methods do not apply to every problem, or are suitable to every type of activity. Kwon for its constant changing nature, hospitals have complex problems, which need a suitable and robust approach to solve. Thus, the present study has the objective of evaluating the performance of three methods usually used for problem solving: A3, RCA and FRAM, when applied on a hospital. For this, the three methods were applied in the same process, of prescription and medication, in an academic hospital. The results were analyzed accordingly to the following criteria: the total number of improvement actions proposed, implementation difficult, replication possibility along the departments of the hospital, the time needed to apply the methods, the number of people involved, the need of training for the team and an indicator for prioritization. Besides that, the health sector workers’ perception regards the methods was analyzed. The results evidence that, in the studied context, the methods had good performance, because introduced improvements that, on average, were considered suitable for the institution.

1 ABSTRACT Background The annual drug overdose rates have been increasing exponentially since the 90's worldwide. Toxicological information centre (TIC) represents a valuable source of information for evaluating the trends in the drug poisonings in Czech Republic. Aim of the study The purpose was to analyze the number and trends in the calls concerning poisonings due to central nervous system (CNS) affecting drugs, identify the reasons of medication errors caused by laymen, frequency and consequences of these errors across all age groups and also to analyze the numbers, causes, symptoms and severity of the paracetamol intoxications. Methods During the reference period the data from the enquiries were extracted from the TIC electronic database, discharge reports from the hospital were studied or phone call follow-ups with the patients were carried out to be able to evaluate the outcome of the poisonings. Results In the years 1997-2002 the number of calls caused by poisoning with tricyclic antidepressants and barbiturates decreased (by 366.7 % and 340,0 %, respectively) whereas the calls due to selective serotonin reuptake inhibitors and benzodiazepines overdose increased (by 1347.4 % and 359.8 %). The 0-5 years old children are at the highest risk of experiencing medication errors or accidental poisonings...

O processo de administração de medicamentos é considerado um processo complexo, crítico e de alto risco para os pacientes e tem apresentado altas taxas de ocorrência de eventos adversos que poderiam ser evitados. Este estudo teve o objetivo de analisar os riscos potenciais do processo de administração de medicamentos antiinfecciosos por via intravenosa de uma unidade de internação, visando a prevenir e a reduzir eventos adversos com medicamentos. A investigação, de natureza exploratória, foi realizada na unidade de Clínica Médica de um Hospital do Estado de Goiás, utilizando o Método de Análise do Modo e Efeito da Falha. Participaram do estudo, além da pesquisadora, seis profissionais envolvidos na terapêutica medicamentosa: médico, enfermeiro, técnico de enfermagem, farmacêutico e os gerentes de Enfermagem e de risco. Foram realizadas 24 reuniões, no período de 19 de fevereiro a 3 de julho de 2008, totalizando 56 horas. Todas os dados foram transcritos e armazenados em um banco eletrônico no programa Microsoft Excel® e analisados no software XFMEA 4. Os resultados indicaram que o processo de administração de medicamentos possui quatro microprocessos, dez atividades e 22 funções. No processo foram identificados 52 modos potenciais da falha (MPF), sendo que as maiores freqüências estiveram nas atividades de administração de medicamentos (16; 30,8%), preparo de medicamentos (12; 23,1%), aprazamento de medicamentos (5; 9,6%) e transcrição de medicamentos para etiquetas (5; 9,6%). Também foram identificados 79 efeitos potencias da falha (EPF), com as maiores freqüências nas atividades: administração de medicamentos (24; 30,4%), preparo de medicamentos (15; 19%) e transcrição de medicamentos para etiquetas (12; 15,2%). Dos EPF, 36,2% foram considerados de gravidade média; 28,7% de moderada, e 27,5% de alta. Em 80% das atividades, foram identificados efeitos de alta gravidade. A classificação dos efeitos apontou que os tipos mais freqüentes foram os erros de: técnica (21; 26,6%), omissão (20; 25,3%) e horário (15; 19%). Foram identificadas 285 causas potenciais da falha (CPF) com as seguintes freqüências quanto aos índices de ocorrência: 91 (31,9%) média, 78 (27,4%), baixa ou relativamente baixa; 40 (14,0%), alta; e 30 (10,5%), extremamente alta. As CPF foram classificadas dentro de três categorias: gestão dos processos organizacionais (125; 43,9%); recursos humanos (124; 41,4%); estrutura física e material (36; 12,6%). Em relação aos tipos de controles, os resultados mostraram que 211 (92,9%) eram de detecção e 12 (5,3%) de prevenção. O cálculo do número de prioridade de risco (NPR) das CPF identificou que 59 (20,7%) eram de alta prioridade de risco, 156 (54,7%) de média e 70 (24, 6%) de baixa. Foram recomendadas 293 ações de melhorias para as 215 CPF de alta e média prioridade, sendo 240 (81,9%) de curto prazo, 39 (13,3%) de médio prazo e 14 (4,8%) de longo prazo. A simulação do impacto das ações propostas possibilitou identificar uma redução de 79,7% dos MPF de alta prioridade de risco e de 59,6% dos MPF de alta criticidade, assim como uma redução do NPR total das atividades entre 90 e 31,8%, com medidas simples e de rápida aplicação, aumentando a confiabilidade e segurança do processo de administração de medicamentos / Intravenous drug administration is a high-risk process due to its complexity and high rates of adverse events. The aim of this study was to analyse potential risks associated to intravenous anti-infectious drug administration process in a hospital unit. It was an exploratory search at a University Hospital Medical Clinic unit in Goiás, by means of failure modes and effects analysis method. For data collection, it was formed a six members multidisciplinary staff: risk and nurse manager, medical, nurse, and pharmacist, in addition to the searcher. A number of 24 meetings was done, from February 19 and July 3, 2008, in an amount of 56 hours. One has collected data, copied and saved them in a Microsoft Excel® electronic data bank. Afterwards, they were analyzed by means of XFMEA 4 software. Results showed that administration process involves 4 micro process, 10 activities, 22 functions. The search identified 52 failure potential modes (FPM) whose most significant frequencies happened in the following activities: drug administration (16; 30.8%); drug preparation (12; 23.1%); drug delay (5; 9,6%) and drug names transcription to tags (5; 9.6%). The study identified also 79 failure potential effects (FPE), whose higher frequencies were: drug administration (24; 30.4%), drug preparation (15; 19%) and transcription to tags (12; 15.2%). Among FPE, 36.2% were considered as of medium severity ones; 28.7% moderate severity, and 27.5% of high severity ones. High severity effects were identified in 80% of the activities. Effect classification pointed that the most frequent types were the following ones: technical (21; 26.6%), omission (20; 25.3%) and schedule (15; 19%). A number of 285 failure potential causes (FPC) were identified with the following occurrence rates: 91 (31.9%) medium, 78 (27.4%), low or extremely low; 40 (14.0%), high; and 30 (10.5%), extremely high. FPC were classified in three categories: organizational process management (125; 43.9%); human resources (124; 41.4%); physical and material structure (36; 12.6%). Concerning to control types, results showed 211 (92.9%) derived from detection and 12 (5.3%) were prevention ones. FPC Risk priority number (RPN) calculation showed that 59 (20.7%) had high-risk priority; 156 (54.7%) medium and 70 (24.6%) low-risk priority. A number of 293 recommendations were done to high and medium priority FPC: 240 (81.9%) short term, 39 (13.3%) de medium term and 14 (4.8%) de long-term ones. Action impact simulation on failure modes allowed to identify a 79.7% reduction in high priority FPM as well a 59.6% one in high criticality FPM ones by means of simple and quick application measures that can improve reliability and safety in drug administration process

Medical devices are used to diagnose, treat, or prevent a disease or abnormal physical condition without any chemical action in the body. They can also result in unintended incidents and other errors. This thesis was divided into three chapters: i) a systematic review on the recognition, reporting and resolution of incidents related to medical devices and other health technologies; ii) telephone interviews with physicians and registered nurses (RNs) to solicit information on the resolution, reporting and resolution of medical device-related incidents based on their professional experience; and iii) a case study to review the continuous quality improvement (CQI) data retrieved from the wireless smart infusion pump system at The Ottawa Hospital (TOH) and to propose a CQI data analysis process. The systematic review included 30 studies on factors that influence the recognition, reporting and resolution of incidents in hospitals and interventions to improve patient safety. Central themes that emerged for incident reporting were personal attitudes, awareness and perception of incident reporting systems, organizational culture, and feedback to healthcare professionals. In our telephone interviews, physicians and RNs attributed incident recognition to devices not operating based on the manufacturer’s instructions, and to the hospital staff’s knowledge of and professional experience with the use of the medical device, and clinical manifestations of patients. Suggestions to improve medical device safety surveillance centered on education and training to ensure that the staff is able to use the medical device properly and know what would be considered an error, and how to report these errors. The results of the systematic review and interviews helped to inform the design of a medical device surveillance framework in a hospital setting. Our case study assessed the Dose Error Reduction Software compliance and frequency of soft and hard limit alerts with wireless smart infusion pump systems over a one year period. A CQI data analysis process to monitor the performance of wireless smart infusion pumps is proposed. The findings of this doctoral thesis can contribute to the development of a medical device surveillance system that would help to improve health care delivery and patient safety in a health care institution.