Dissertations / Theses on the topic 'Hospital; drug'

Drug-Drug interactions (DDIs) are an important focus of patient safety because they account for a substantial number of adverse drug events and are preventable. Objective. To study DDIs in a Canadian hospital, a retrospective observational study was completed using the Ottawa Hospital Data Warehouse. Study cohort. Admissions to the Ottawa hospital between January 1, 1999 and September 30, 2005. Methods. Potential drug-drug interactions were identified by examining all co-administered medications for combinations of drugs previously reported to have potential interactions. Poisson regression was used to examine potential patient and hospital factors associated with drug-drug interactions. Results. Between 1999 and 2005, we found at least one DDI in 19.3% of all hospitalizations and 18.8% of hospitalization time. Category 1 (drug combinations to be avoided) and Category 2 (drug combinations usually avoided) interactions were rare, accounting for only 0.022% and 1.4% of hospitalization time, respectively. Category 3 interactions (drug combinations requiring alteration) occurred with 5.7% of all drug orders and were present for 17.4% of hospitalization time. Poisson regression analysis found that DDIs were significantly more likely to occur in patients who were: older; admitted to a surgical service; had a greater number of comorbidities; and were prescribed a greater number of drugs. Conclusion. Drug-Drug interactions occurred frequently during hospitalization. Future study is required to determine if the interactions identified are associated with important clinical outcomes.

Adverse drug reactions (ADRs) are a significant public health problem. This thesis examined the incidence and nature of adverse drug reactions following admission to hospital. An initial pilot study was conducted to develop methodology, which was then utilised in a study of 3695 patients. Approximately 15% of patients experienced an ADR following admission, of which one-third were serious Commonly used drugs such as opioids, diuretics and anticoagulants were the most frequent causes of ADRs. Bleeding, renal impairment and Clostridium difficile were the ADRs with the greatest impact on patient length of stay and thus should be key areas for intervention strategies. Adoption of methods used in the assessment of hospital patient safety incidents such as root-cause analysis may help in identifying underlying factors leading to ADRs as well highlighting the importance of ADRs to senior hospital managers.

Thesis (M. Eng. in Logistics)--Massachusetts Institute of Technology, Engineering Systems Division, 2007.
Includes bibliographical references (leaves 51-53).
It has been estimated that on average, every patient admitted to a hospital is subject to at least one medication error per day (IOM, 2006). Errors may occur during various stages of the Medication Use System; a system composed of various tasks performed from the point of prescribing medication to the point in which a patient is monitored for adverse effects. Studies have shown that a majority of the errors that occur during the Medication Use System have little if any adverse effect on patients. However, there are classes of medication errors known as Adverse Drug Events (ADE's) which can cause significant harm to a patient. ADE's are not only dangerous but they have been estimated to cost the health care industry and the public in excess of $3.5 billion dollars per year (IOM, 2007). While extensive, current literature that exists on preventable ADE's varies greatly in regards how prevalent the issue is. The lack of a nationwide information system for identifying and defining ADE's only exacerbates the problem. In addition, when significant errors do occur, the repercussions for clinicians and hospitals are far from proportional. Several studies suggest that over one quarter of all medication related injuries are preventable (IOM, 2007).
(cont.) Many industry observers have long touted computerized information systems as the Holy Grail for reducing medication errors. While there is little question that computerized systems can reduce ADE's, hospitals and clinicians frequently ignore other solutions that can offer greater impact in improving the level of care that is being provided. The health care industry has long been touted as fostering a culture that supports at risk behavior and shuns the use of standardized processes. The lack of transparency into the health care industry coupled with an unwillingness to embrace cultural change continues to be one of the largest barriers in reducing the number of preventable ADE's. This paper recommends 4 different solutions that will change the culture of the health care industry, incent hospitals to focus on reducing preventable ADE's, improve the processes already in place for providing patient care and provide clinicians with the most up to date health care information available.
by Gregg Ramos.
M.Eng.in Logistics

A self-administered, mail questionnaire was used to assess the current state of hospital drug-use evaluation (DUE) programs within short-term, general U.S. hospitals. During February-March 1992, two mailings were sent to pharmacy directors at 491 randomly selected institutions. A net response rate of 66.6% (327/491) was achieved. The level of pharmacist participation in DUE program activities was found to be very high and to have a significant, positive correlation with the rated effectiveness of current DUE programs and the rated importance of pharmacist participation in DUE program activities. Pharmacists were members on 97.9% of responders' DUE (sub)committees, while 65.5% of pharmacist members held voting privileges. Pharmacists devoted an average of 11.27 hours per week to DUE-related tasks. Wide variation was demonstrated in rationale used to select DUE study drugs, interventions employed, use of DUE study results, and methods selected to evaluate DUE program effectiveness.

Antibiotic resistance in clinical bacterial isolates remains an ongoing problem requiring continuous monitoring to effect some form of control. Comparative studies have not been previously reported for the Eastern Cape Region, South Africa and this study was undertaken to monitor resistance patterns in clinical isolates from Provincial Hospital, Port Elizabeth. Over the three year period 1989 to 1991, 9888 susceptibility results from isolates examined in the SAIMR pathology laboratory were analysed and collated using a stand-alone computer program. Resistance patterns for a range of nineteen antibiotics were collated for isolates from various sampling points within the hospital. Results were reported as resistance patterns in individually isolated species. Levels of resistance in each species were compared to those reported from South Africa and abroad, and changing patterns of resistance were noted within the three year period at the Provincial Hospital, Port Elizabeth.

BACKGROUND: Hospital formularies are usually the gatekeepers for pharmaceutical drugs. Typical majority members of hospital formularies are physicians, although most of the time the formulary is chaired by a pharmacist. As German hospitals are struggling with a difficult economic environment the question arises: what kind of decision-making criteria are applied when pharmaceutical drugs should be added to the formulary list? Information regarding this topic is scarce due to the sensitive topic of decision-making. OBJECTIVES: Build a single decision-making framework which will be created to explain hospital drug funding decision-making and identify underlying mechanisms which explain processes and structures. The results can be used by hospitals to initiate knowledge sharing and provide a basis to analyse local formulary committee decision-making practice. Additionally, they can be used by the pharmaceutical industry to better adapt to the specific needs of the hospital decision-makers. METHODS: In this study, a mixed-methods approach has been used to confirm and further detail a preliminary hospital formulary decision-making framework derived from literature. An online survey was used to get insights on the structure of German hospital formularies and the relative importance of different decision-criteria. Additional semi-structured expert interviews were used to get in-depth information on the underlying mechanisms which influence decision-making on drug funding. RESULTS: Decisions for or against a pharmaceutical drug are influenced by a variety of perceived objective and specifically subjective criteria. Despite a consistency in a dominant, high impact role of pharmacists and lead physicians every hospital formulary member has different relative weighting of decision criteria. Drug funding decision-making in German hospital formularies is highly individual but usually starts with a quasi-rational preference influenced by a mixture of analytic and intuitive criteria. The decision to use more analytic or more intuitive criteria is influenced by a variety of factors. The two most important ones are uncertainty and power. The resulting individual preference is then challenged and adapted in a group decision-making process.

Antimicrobials are unique drugs in that they target "infectious" or "transferable" diseases. There is considerable evidence linking increasing antimicrobial use withincreasing resistance. Resistant bacteria do not know the boundaries, either between countries or within a society between hospital and primary care. Inappropriate prescribing of antimicrobials in hospitals therefore has consequences for whole communities and problems may spread both nationally and internationally. The gathering of reliable measurements of antibiotic use in hospitals employing standardised methods is essential to building an evidence base and highlighting inconsistencies at national and international levels. In this study, after data processing, validating and record linkage, a method forelectronic conversion of drug supply data to the ATC/DDD classification and forlongitudinal analysis was established for Tayside and then for a set of Europeanhospitals. Time series analysis and interrupted time series analysis were described and used for longitudinal surveillance and interventional study of antimicrobial use. This thesis explores issues concerning the evolution and management of hospital antimicrobial use using a wide range of methods. A series of drug utilisation research studies were implemented as the basis of research methods that, in combination of previously described methods, provided novel studies. No single measure can currently capture all of the aspects of hospital antibiotic use. However, a combination of detailed, point prevalence data from individual patients with longitudinal analysis of total consumption can provide meaningful data for comparison between hospitals and for analysis of the relationship between use and outcome. Additionally, there is a need to apply standard processes and novel methods to produce more meaningful surveillances. Longitudinal and point prevalence surveillances together with an explanation ofvariations in hospital characteristics are used to produce a set of coherent measurements of hospital antimicrobial use. Administrative data for longitudinal surveys requires continuous quality control.Whereas drug utilisation researchers and clinicians should target a set of indicators for interventional studies, large studies at national or international level need central data processing by country to identify targets for evaluation and for interventional studies. Support from experts in other fields is needed to address any shortcomings that may be experienced during continuous antibiotic drug utilisation monitoring at national and international levels.

Objetivos: Descrever o uso e determinar a prevalência de medicamentos potencialmente perigosos e de uso off label e não aprovados em prescrições de unidades de pediatria geral de um hospital universitário no sul do Brasil. Método: Estudo transversal, realizado de novembro de 2007 a janeiro de 2008, envolvendo pacientes até 14 anos de idade, com período de internação superior a 24 horas. Pacientes de unidades de terapia intensiva e oncologia pediátrica foram excluídos. A classificação quanto aos critérios de aprovação da Food and Drug Administration foi realizada pela fonte terciária DrugDex-Micromedex e a classificação dos potencialmente perigosos, pelo Institute for Safe Medication Practices. Resultados e discussão: No período de estudo foram analisadas 342 prescrições de 342 pacientes. O sexo masculino foi o mais freqüente (57%) e mais da metade dos pacientes já apresentavam doenças crônicas à internação. Analgésicos foi a classe terapêutica mais prescrita (26,9%) e entre os off label, os antiespasmódicos (31,5%) foram os mais prevalentes. Das prescrições analisadas, aproximadamente 39% tiveram pelo menos um medicamento de uso off label prescrito, principalmente em relação à indicação terapêutica (38,4%) e à idade (21,9 %), e 11,8% dos pacientes fizeram uso de fármacos não aprovados. Do total de itens (2026), cerca de 6% foram classificados como potencialmente perigosos, destacando-se os analgésicos opióides (35%). Não houve relação de associação entre medicamentos de uso off label e os potencialmente perigosos. Conclusão: As frequências encontradas de medicamentos off label e não aprovados estão de acordo com a literatura e podem ser consideradas elevadas. Os potencialmente perigosos, apesar da baixa prevalência, oferecem risco pelos efeitos prejudiciais que possam vir a causar nos pacientes. Assim, os medicamentos em destaque neste estudo representam uma preocupação constante em hospitais.
Objectives: Describe the use and determine the prevalence of high-alert medications, off label use and unlicensed drugs in prescriptions of general pediatric units of a university hospital in southern Brazil. Method: Cross-sectional study, performed from November 2007 to January 2008, involving patients up to 14 years of age, with admission period over 24 hours. Patients of intensive care and pediatric oncology units were excluded. The classification regarding the Food and Drug Administration approval criteria was performed according to the DrugDex-Micromedex tertiary source and the classification of high-alert medications according to the Institute for Safe Medication Practices. Results e discussion: In the study period, 342 prescriptions were analyzed. Males were more frequent (57%) and over half of the patients already presented chronic diseases for admission. Analgesic drugs were the most frequently prescribed therapeutic class of drugs (26.9%) and among the off-label drugs, antispasmodic drugs (31.5%) were the most prevalent. Around 39% of the analyzed prescriptions had at least one off-label use drug, especially in relation to therapeutic indication (38.4%) and age (21.9%), and 11.8% of the patients received unlicensed drugs. About 6% of the total items (2026) were classified as high-alert medications, such as opioid analgesic drugs (35%). No relation of association was observed between off-label use and high-alert medications. Conclusion: The frequency analyses found of off-label and unlicensed drugs are according to the literature and can be considered as high. The high-alert medications, although of low prevalence, offer risks due to negative effects that can occur in patients. Then, the drugs highlighted in this study constitute a constant concern in hospitals.

IntroductionDepuis plusieurs décennies, la pratique et les soins pharmaceutiques sont soumis à plusieurs changements en partie en raison de l’évolution de la société, des progrès de la recherche et de la mise sur le marché de nouveaux médicaments. La pratique du pharmacien a passée d’une délivrance centrée sur le médicament vers la délivrance centrée sur le patient notamment par la détection, l’intervention et la résolution des Problèmes Liés aux Médicaments (PLM).Certains patients atteints d’une condition médicale particulière, tels que les patients cancéreux, peuvent être soumis à des traitements lourds qui leurs sont nécessaires mais qui peuvent les rendre plus vulnérable à l’apparition d’un PLMObjectifsL'objectif de cette thèse était de mettre en évidence la proportion des PLM dans les pharmacies d’officines ainsi qu’à l'hôpital et d’évaluer les potentielles conséquences en milieu hospitalier.La première partie était composée de deux projets ;1) Traduction et adaptation de la classification du PCNE V6.2 à la pratique et au cadre juridique pharmaceutique belge en intégrant la validation du contenu et la fiabilité inter-évaluateur de la classification adaptée. 2) Étude pilote visant à évaluer la proportion de PLM des antidouleurs les plus utilisés en Belgique.La deuxième partie de cette thèse était composée de trois projets. 1) Quantification et classification des réadmissions des PLM des patients cancéreux réadmis dans les 30 jours et mise en évidence des facteurs de risque liés à ces réadmissions ;2) Évaluation des coûts liés aux réadmissions dues aux PLM et les potentielles économies de PLM évitables ;3) Détection des interactions médicamenteuses à partir de différentes sources disponibles au sein de la population cancéreuse réadmise lors du premier projet et évaluation de l’impact de ces interactions sur la survie des patients.MéthodeLa classification du PCNE V6.2 a été adaptée et traduite pour le contexte belge. Afin d’évaluer la validité du contenu, les pharmaciens académiques et d’officines ont évalué six critères, deux qui ciblaient le mode d’emploi (compréhensibilité, utilité) et quatre le formulaire d’encodage (pertinence, logique d’agencement, exhaustivité et redondance). Lors de leur pratique quotidienne, les pharmaciens ont appliqué l'outil adapté du PCNE afin d’évaluer si les instructions avaient été respectées et de quantifier le temps nécessaire pour résoudre un PLM. Par la suite, l’analyse des encodages des pharmaciens a permis d’estimer la fiabilité inter-évaluateurs. Le second projet était une étude pilote qui a permis aux étudiants de Master 2 d’encoder avec l’outil adapté du PCNE V6.2 les PLM détectés en officine par leur maître de stage. Les PLM impliquant les antidouleurs ont été extraits de la base de données initiale et ont été analysés.La deuxième partie s’est basée sur une étude rétrospective observationnelle de six mois dans deux établissements de soins Bruxellois :un hôpital général universitaire et un centre de référence en oncologie. Afin d’évaluer les PLM, une revue de médication de type 2b a été appliquée pour chaque patient réadmis aux urgences ou suite à une consultation médicale. La probabilité d’implication d’un PLM dans la réadmission a été évaluée à l’aide du système du Centre de surveillance de l'organisation mondiale de la santé d'Uppsala (OMS-UMC). La réception de la base de données des différents coûts liés à ces réadmissions a permis une estimation des coûts de réadmission de ces PLM pour chacun des deux établissements impliqués. Le caractère évitable d’un PLM a pu être évalué par l’utilisation du questionnaire de Schumock et al. Le dernier projet à évaluer les potentielles interactions médicamenteuses à l'aide des bases de données en ligne Lexicomp® et Epocrates®. Une analyse de survie de Kaplan-Meier et une analyse de Cox ont été effectuées pour évaluer le lien entre les variables interaction et survenue du décès.RésultatsL'adaptation de l’outil a permis l'ajout de 16 items. Une bonne validation du contenue a été obtenue suite à l’évaluation des pharmaciens académiques et des pharmaciens d’officine. Un total de 109 PLM a été encodé, avec un temps de résolution moyen de 5 min. Concernant la fiabilité inter-évaluateur, 74 items sur un ensemble de 83 ont montré une fiabilité élevée. L’étude pilote a permis de recueillir 15 952 PLM, dont 1 832 pour les antidouleurs, 3 200 interventions ont été produites afin de résoudre les PLM. La majorité des PLM ont été totalement ou partiellement résolus (77,2%).Lors de la seconde partie de la thèse, l’analyse des dossiers de patients cancéreux réadmis dans les 30 jours a révélé que 123 patients avaient été réadmis pour un PLM certain (4,9%), probable (49,6%) ou possible (45,5%). Les facteurs de risque mis en évidence étaient un faible score de Charlson, la polymédication et certaines chimiothérapies (préparations à base de Platine, les anthracyclines ou les vinca-alcaloides). Un montant total de 495 869,10 € a été mis en évidence pour les réadmissions dues aux PLM, avec une durée médiane d’hospitalisation de 7 jours. Les cancers prédominants liés à ces réadmissions étaient le poumon (19,5%) et le sein (17,9%). En se basant sur les diagnostiques des médecins, une part importante (71,5%) des réadmissions du aux PLM était liée aux effets indésirables de la chimiothérapie.Le troisième projet de la seconde partie de ce travail a inclus une population finale de 299 patients réadmis 30 jours après la sortie de l'hôpital en raison d’un PLM. Selon les bases de données en ligne, entre 78,9% et 80,9% des patients étaient réadmis avec au moins une interaction. En moyenne entre 1,6 et 2,3 interactions par patient ont été détectés pour Lexicomp® et Epocrates®. Les opioïdes (29,9%) suivis des anxiolytiques (15,8%) étaient les médicaments les plus souvent impliqués. Les effets indésirables les plus prédominants étaient les dépressions du système nerveux central (SNC) et les dépressions respiratoires. Des analyses de Kaplan-Meier ont montré une différence statistiquement significative sur la survenue du décès, entre les patients avec et sans interactions. Néanmoins, le décès ne semble pas être directement lié à la présence d'une interaction.ConclusionLa première partie a pu montrer que l’adaptation de l’outil au contexte francophone belge était fiable et avait une validité suffisante pour une utilisation quotidienne. La participation de 6 facultés belges a permis une implication nationale permettant d’obtenir une grande proportion de PLM (15 952) ;parmi eux, plus de 10% concernaient les antidouleurs dont la quasi-totalité ont été complètement résolus.Concernant la deuxième partie, environ 10% des réadmissions de patients cancéreux dans les 30 jours suivant leur dernier soin étaient liées à un PLM, parmi ces réadmissions 71,5% étaient liées à un effet indésirable. Le coût médian par réadmission était de 2 406,10 €. Les PLM évitables représentaient 7,3% dont le coût s’élevait à un total 27 938,61 €. L’évaluation des interactions a pu mettre en évidence une forte proportion de potentielles interactions liées aux traitements de patients cancéreux, néanmoins cela ne semble pas être lié à la survenue du décès.Ce travail a pu mettre en évidence la présence importante de PLM en officine et la volonté des pharmaciens d’officines belges à améliorer leur pratique. Néanmoins l’intégration d’un outil plus spécifique à la pratique officinale sur le terrain permettrait une adhésion plus complète et potentiellement une meilleure détection. La deuxième partie de ce travail a montré quelques facteurs de risque intéressants et l’importante présence d'interactions, qui demandent une potentielle vigilance chez les patients cancéreux afin de réduire les risques de réadmission dues aux PLM et les coûts associés. Cependant, une meilleure communication entre les professionnels de santé au sein de l’hôpital mais également avec les prestataires extérieurs tels que les médecins de famille et les pharmaciens d’officine, pourrait permettre un meilleur suivi et une diminution de ces réadmissions avec pour objectif d'améliorer la qualité de vie des patients.
Doctorat en Sciences biomédicales et pharmaceutiques (Pharmacie)
info:eu-repo/semantics/nonPublished

Background: Tertiary hospitals have multiple specialist outpatient clinics attended by patients suffering from various comorbid diseases. This results in individuals attending more than one clinic per month, since dedicated clinic days are seldom on the same day. As patients attend discrete clinics, they have separate encounters with various prescribers, increasing the potential for irrational drug use. In addition, multiple clinic visits have a negative socio-economic impact on health care users from poorer communities where financial resources are limited due to transport expenses and days of work missed. The aim of this study was to determine the prescribing pattern of drugs to chronic disease outpatients, and find possible solutions to provide a system that would reduce overprescribing of chronic medication at Steve Biko Academic Hospital (SBAH) in one measure namely drug duplication. Methods: A retrospective descriptive cross-sectional study with the use of convenience sampling was employed to determine the medication prescribing practises to comorbid chronic disease patients attending multiple specialist clinics at SBAH from February 1, 2018-May 31, 2018. Participants were selected according to their appearance in the hospital records, with sample saturation reached when each participant had visited all the different clinics. Chronic disease outpatients attending the SBAH clinics had reviews every three months. The reviews were controlled by issuing patients with medication for a three-month period, where after a follow up visit was mandatory in order to ensure prescription and medication renewal. Therefore, each patient visited all the clinics rendering a service relating to a specific chronic condition within a four-month period that determined the study period chosen. Hospital records of patients attending the most frequently visited clinics as reported by the SBAH Pharmacy and Therapeutics committee (PTC) were evaluated. These clinics included outpatient departments of diabetes, haematology, internal medicine, neurology, oncology and psychiatry. Each drug prescription observed was evaluated using guidelines of World Health Organization (WHO) titled, “How to investigate drug use in health facilities: selected drug use indicators.” Prescribing indicators relevant to this study were used from the WHO guidelines. Results: One hundred and six patients were multiple clinic-attendees during the study period. Of the 106 patients retained, 103 (97.17%) patients attended two clinics and three (2.83%) patients attended three clinics. Regarding the WHO prescribing indicators, the average number of visits to SBAH by the comorbid chronic disease outpatients observed was 3.03 visits during the four-month study period. Prescription analysis included 80 (75.47%) patients out of 106 patients attending multiple clinics at the same time. The average number of drugs prescribed per encounter was 4.97. The results also showed that 45.45% of the 187 prescriptions observed contained five or more drugs. Most frequently prescribed drugs were tramadol 51 (5.49%), followed by simvastatin 48 (5.17%) and enalapril 45 (4.84%). Drug duplication occurred in 68 individual cases in the 80 patients observed. In total, drug duplication affected 39 patients (48.75%) [95% CI = 37.80%: 59.70%]. The most duplicated drug classes were analgesics 18 (26.47%), followed by anti-depressants 14 (20.59%) cases recorded. Conclusion: The results from this study support findings from similar studies at different institutions. The study confirmed multiple clinic visits are prevalent in the medical disciplines, often prescribing drugs from the same class. Clinical implications from these frequent and separate encounters may result in irrational prescribing, adverse drug events, drug-drug interactions and polypharmacy. The establishment of polypharmacy to comorbid chronic disease patients indicates the high risk of drug-drug interactions and adverse drug events. A prospective study would have provided more data for analysis to determine the level of polypharmacy and drug duplication. Thus, supplementation of this study with further studies could provide conclusions on whether the patients suffered from problematic or had appropriate polypharmacy. Physicians treating multiple clinicattendees should be equipped to monitor rationality of prescribing encounters. Installation of an advanced electronic Hospital Information System (HIS) could aid in improving drug prescribing in tertiary hospitals. Use of electronic prescribing tools as shown in previous studies is a requirement to improve tertiary hospitals in developing countries such as SBAH. The incidence of drug duplication at SBAH builds on existing evidence of unnecessary healthcare costs because of medication errors.
Dissertation (MSc)--University of Pretoria, 2020.
Pharmacology
MSc (Pharmacology)
Unrestricted

FundaÃÃo Cearense de Apoio ao Desenvolvimento Cientifico e TecnolÃgico
INTRODUÃÃO: ReaÃÃes adversas a medicamentos - RAM constituem causa de morbi-mortalidade em pacientes hospitalizados, pÃem em risco a vida do paciente e representam aumento no tempo de internaÃÃo e nos custos hospitalares. OBJETIVOS: Determinar a incidÃncia de reaÃÃes adversas a medicamentos no Hospital UniversitÃrio Walter CantÃdio - HUWC, investigar quais os fatores que podem estar associados a esses eventos e propÃr medidas de prevenÃÃo ou reduÃÃo do impacto negativo dessas reaÃÃes. MÃTODOS: Estudo observacional, analÃtico, prospectivo, com monitorizaÃÃo intensiva de pacientes, determinaÃÃo da incidÃncia acumulada de RAM e avaliaÃÃo exploratÃria de seus determinantes. Eram incluÃdos no estudo, todos os pacientes internados nas clÃnicas mÃdicas do HUWC, de 01 de setembro de 2000 a 28 de fevereiro de 2001, os quais foram acompanhados desde o momento da internaÃÃo atà a alta hospitalar ou Ãbito, para a detecÃÃo e acompanhamento de reaÃÃes adversas. Foram realizadas visitas diÃrias Ãs clÃnicas mÃdicas do HUWC, registrando os medicamentos utilizados e investigaÃÃo sobre a ocorrÃncia de RAM. Os casos em que os pacientes apresentavam RAM eram avaliados seguindo a metodologia recomendada pela OrganizaÃÃo Mundial de SaÃde. As reaÃÃes eram classificadas conforme imputabilidade, gravidade e tipo. Os medicamentos foram classificados de acordo com o Anatomical-Therapeutical-Chemical â ATC, Classification Index e as reaÃÃes adversas atravÃs do WHO-ART tambÃm recomendado pela OrganizaÃÃo Mundial da SaÃde. RESULTADOS: Foram internados nas clÃnicas mÃdicas do HUWC um total de 970 pacientes destes, 54% eram mulheres e 46% homens, com idade variando de 9 meses a 97 anos. Todos os pacientes fizeram uso de medicamentos durante a internaÃÃo, variando de 1 a 20 medicamentos/paciente. Os grupos de medicamentos mais utilizados, (1 nÃvel ATC) foram medicamentos que atuam no sistema nervoso central (19,0%), medicamentos que atuam sobre o trato alimentar e metabolismo (17,0%), medicamentos que atuam no sistema cardiovascular (16,7%). Do total, oito (0,8%) tiveram como diagnÃstico de internaÃÃo alguma reaÃÃo adversa a medicamento. Durante o perÃodo do estudo foram verificadas 30 novas ocorrÃncias de RAM em pacientes hospitalizados. As manifestaÃÃes das reaÃÃes adversas compreendiam principalmente afecÃÃes da pele (65,0%) e distÃrbios do estado geral (25,0%). Quanto à gravidade, as reaÃÃes foram na sua maioria classificadas como moderadas (79,0%), seguidas das reaÃÃes leves (19,0%). A relaÃÃo de causalidade foi considerada provÃvel em 58,0% dos casos e definida em 24,5%. Os grupos farmacolÃgicos mais envolvidos foram antibiÃticos de uso sistÃmico (66,4%), seguido por medicamentos que atuam no sistema nervoso (7,7%), antineoplÃsicos e agentes imunomoduladores (7,7%). A incidÃncia de RAM entre os pacientes hospitalizados nÃo està associada ao sexo nem à idade. O nÃmero de dias de internaÃÃo interferiu na ocorrÃncia de RAM. CONCLUSÃO: Foram identificadas ocorrÃncias de reaÃÃes adversas como causa de internaÃÃo e durante a internaÃÃo hospitalar. Todos os pacientes admitidos com RAM apresentaram manifestaÃÃes dermatolÃgicas. Os antibiÃticos, principalmente a cefalotina, foram os medicamentos mais envolvidos com a ocorrÃncia de RAM em pacientes internados.
INTRODUCTION: Adverse drug reactions (ADR) constitute cause of morbidity in hospitalized patients, represent a risk for patients and an increase in the period patients stay in hospitals and the costs. OBJECTIVES: To determine the incidence of adverse drug reactions in the Walter CantÃdio University Hospital (WCUH), investigate what factors may be associated with these events and propose measures to prevent or reduce the negative impact of those reactions. METHODS: An observational, analytical, and prospective study, with intensive monitoring of patients, analysis of the cumulative incidence of ADR and an exploratory evaluation of its determinants. The study included all inpatients in the medical clinics of WCUH from September 1st, 2000 to February 28th 2001, which were assisted from admission until discharge or death, to detection and monitoring of adverse reaction. Daily calls were made to the clinics WCUH in order to register the use of drugs and the occurrence of ADR. Cases in which patients had ADRs were assessed according to the methodology proposed by the World Health Organization. The reactions were classified based on liability, severity and type. Drugs were classified according to the Anatomical-Therapeutical-Chemical (ATC), Classification Index and adverse reactions through the WHO-ART also recommended by the World Health Organization. RESULTS: 970 patients were admitted to the medical clinics of HUWC. Of those, 54% were women and 46% were men, ranging in age from 09 months to 97 years. All patients received medication during hospitalization, ranging from 1 to 20 drugs / patient. The most commonly used drug groups (1st level ATC) are drugs that act on central nervous system (19.0%), drugs that act on the digestive tract and metabolism (17.0%), and drugs that act on the cardiovascular system (16.7%). Of the total, in eight (8%) the diagnosis for admission was an adverse reaction to medication. During the study, 30 new cases of ADRs in inpatients were registered. The results of adverse reactions comprised mainly skin disorders (65.0%) and general disturbances (25.0%). About gravity, the reactions were mostly classified as moderate (79.0%), followed by mild reactions (19.0%). The relation of causality was considered probable in 58.0% of cases and set at 24.5%. Most involved pharmacological groups were antibiotics for systemic use (66.4%), followed by drugs that act on the nervous system (7.7%), antineoplastic and immunomodulating agents (7.7%). The incidence of ADR among inpatients is not associated with age or gender. The number of days of hospital admission interfered with the occurrence of RAM. CONCLUSION: Adverse reactions as cause of admission were identified. All inpatients with ADRs have skin manifestations. Antibiotics, especially cephalosporins, were drugs commonly involved with the occurrence of ADRs in inpatients.

Post-marketing surveillance refers to any non-experimental or observational study, method, or monitoring strategy that is applied to obtain information on drug experience (primarily adverse) after a drug has been approved for clinical use. One of the major problems in post-marketing surveillance studies is the lack or under-reporting of drug experiences by health care professionals. This study was developed to describe the impact of three different prescription event monitoring programmes on the reporting of adverse drug reactions (ADR's) in the hospital situation. The intensive ADR monitoring programme and two voluntary ADR monitoring programmes which followed were conducted in the medical wards of an urban teaching and referral hospital. All patients admitted to the designated wards were monitored by a dedicated pharmacist in the intensive programme, ward pharmacists in the first voluntary programme and by medical and nursing staff in the second voluntary programme. The pharmacist monitored a cohort of patients prospectively in two medical wards for a period of three months. The patient's record was linked with any suspected ADR. All details, i.e. patient drug orders, characteristics and ADR description, were recorded and then reported. From 228 patients monitored, 25 cases have been reported. The impact of the intensive ADR monitoring programme was a reporting rate of 11 percent. Reports were received on ADR's of a particularly mild, common and pharmacologically predictable (type A) nature. The first voluntary ADR monitoring programme comprised the reporting of suspected AD R's and the recording of drug orders for the patients and the patient characteristics. The ward pharmacists monitored for suspected AD R's in all patients during their regular ward rounds. Six cases were reported in a population of 1506 patients monitored during the three months. The reports were mainly on moderate to severe suspected AD R's of pharmacologically unpredictable (type B) nature. The rate of reports received by the surveillance unit in this study was 4 reports per ward pharmacist per annum. The second voluntary ADR monitoring programme comprised the prospective monitoring of 1555 patients by medical and nursing staff during their stay at the designated medical wards during the three month period. Patients were monitored for any ADR and when an ADR was suspected, the patient characteristics and drug orders were recorded and reported to the surveillance unit. Ten cases were reported represented by six reports from doctors and four by sisters. The reporting rate was 2 reports per doctor in four years and 3 reports for each member of the nursing team in 5 years. Reports were mainly received on moderate to severe suspected ADR's of a pharmacologically unpredictable (type B) nature.

Magister Pharmaceuticae - MPharm
The objectives of the present study were to describe the type and frequency of prescribing errors and error frequency, to determine the error frequency for different drug classes, to identify potential drug interactions and drug-disease interactions to point out off-label prescribing and to evaluate risk factors of prescribing errors. Methods: This prospective cross sectional study was conducted over a period of 6 months from July 2012 to December 2012 in 2 specialist wards and 2 general medical wards at Red Cross War Memorial Children’s Hospital in Cape Town in South Africa. Only prescriptions generated by doctors in the above mentioned wards were assessed. Convenience sampling was used to select 200 prescription charts for analysis. Information relating to prescribing error, potential drug interaction, potential drug-disease interactions, off-label prescribing and potential risk factors of prescribing error were entered into excel spreadsheet and analysed using STATA versions 11&12. The mass of the patients was converted into weight-for-age z-score (WAZ) using WHO 2006 child growth standards. Univariate analysis and multiple logistic regression were used to identify risk factors of prescribing errors. Results: Of the 200 children on whom prescribing information was analysed, 40 (20%) were severely underweight and a further 25(12.5%) were moderately underweight. A total of 1402 prescribing errors were documented in 1282 drug items prescribed, a rate of 1.09 errors per drug item prescribed. Incomplete prescription information was the most common type of prescribing error, present in 65.6% of all drug items prescribed. The error frequency was high for all drug classes ranging from 57.9% of all respiratory drug items prescribed to 86.4% of all gastro intestinal system drug items prescribed. The number of potential drug-drug interactions was low i.e. 20 potential pharmacodynamics and 49 potential pharmacokinetic drug interactions were identified. The number of potential drug-disease interactions was also low i.e. 39 or 0.03% per drug item prescribed. Furthermore 57 off-label prescribing incidences were recorded. Senior doctors posed a significant risk factor for prescribing errors, an OR 1.95, 95% CI 1.46 – 2.61. Conversely, prescriptions written up in the general wards compared to the specialty wards (an OR 0.65. 95% CI 0.47-0.90) and prescribing during weekends compared to weekdays (an OR 0.71, 95% CI 0.53-0.96) were associated with lower prescribing error risk. Conclusion: This study provided valuable information about prescribing practices in children at RCWMCH. There is a need to improve prescribers’ practice at RCWMCH considering the type of errors observed viz. missing information, use of wrong drug name, abbreviations, legibility concerns and lack of clarity of the prescriptions, among others. Based on this study results further intervention studies are recommended to investigate the level of medical student’s training w.r.t prescribing practice.

The problem of the study was to determine the status of bloodborne pathogen education for injection drug users in Indiana hospital emergency departments. The study was designed to answer the following research questions: (a) Do Indiana hospital emergency departments have written policies on bloodborne pathogen education for injection drug users? (b) To what extent do Indiana hospital emergency departments provide bloodborne pathogen education for injection drug users? and (c) What are the major barriers for Indiana hospital emergency departments in providing bloodborne pathogen education for injection drug users?A valid instrument was developed and sent to 110 Indiana hospital emergency department nurse managers. Forty-six instruments were returned for a response rate of 43.8%.The results indicated only three (7.1 %) responding hospital emergency departments had written bloodborne pathogen educational policies. Ten (20.8%) emergency departments provided some form of bloodborne pathogen education for injection drug users. Major barriers indicated for not providing patient education consisted of insufficient monetary resources, injection drug users denying a drug history, and emergency department nurses being unable to identify injection drug usage.
Department of Physiology and Health Science

CoordenaÃÃo de AperfeiÃoamento de Pessoal de NÃvel Superior
Allergic drug reactions account for 6.5% of hospital admissions, prolonged hospitalization 15.1% of patients and are severe in 6.7% of patients. There are difficulties in understanding the immune mechanisms, diagnosis and treatment of patients. Therefore, such reactions are considered a Public Health problem. The objective of this study was to describe the cases of patients with suspected allergic hypersensitivity to drugs and to evaluate the response of individuals to skin tests. A total of 63 patients were included in the study. The experimental design was a cross-sectional observational study from June 2008 to October 2011. We applied a questionnaire to investigate the clinical and laboratory informations. Eight patients received other diagnosis and three died due to other reasons, so that 52 patients completed the study. Most patients were men (56.36%), non atopic, with a median age of 52 year. The drugs most commonly implicated were NSAIDs and the oral administration was the most commonly route used. It was documented 69 suspected reactions; most of them were considered as delayed hipersensitivity. Maculopapular rash and erythema multiforme were the most frequent manifestations. According to the severity of the reactions, most was considered moderate (72.46%). The patch test was performed in 22 patients for investigation of delayed reaction. Seven cases were positive (31.81%), DRESS (rash with eosinophilia and systemic symptoms) caused by captopril (+), contact eczema by rifamycin (+ +), lichenoid eruption by captopril (+), maculopapular rash + ampicillin and cephalexin to angioedema (+), two cases of fotoeczema one by captopril and another by AAS, both with positive results (+) and one case of Stevens-Johnson syndrome caused by phenytoin (++). For immediate hypersensitivity, 3 in 10 patients have shown positive results for prick test with AAS diluted to 1/1000. It was possible to confirm the liability of the drug reactions in 19 (27.53%), which demonstrated the importance of application of skin tests in the clinical investigation of allergic drug reactions. As for causality, 26 reactions were considered possible, 20 defined, 13 probable, 9 and a conditional reaction was considered not related to drugs. Given its importance, the performance of skin tests with these patients has opened perspectives on the possibility to incorporate this service in routine outpatient Dermatology HUWC.
As reaÃÃes alÃrgicas medicamentosas sÃo responsÃveis por 6,5% das admissÃes hospitalares, prolongam a hospitalizaÃÃo de 15,1% dos pacientes e sÃo graves em 6,7% dos pacientes. Hà dificuldades quanto à compreensÃo dos mecanismos imunolÃgicos, diagnÃstico e tratamento dos pacientes. Portanto, tais reaÃÃes sÃo consideradas um problema de saÃde pÃblica. O objetivo deste trabalho foi descrever os casos de pacientes com suspeita de hipersensibilidade alÃrgica a fÃrmacos e avaliar a resposta desses indivÃduos aos testes cutÃneos. Um total de 63 pacientes foram incluÃdos no trabalho, cujo delineamento experimental foi de um estudo observacional descritivo transversal realizado entre junho de 2008 e outubro de 2011. Utilizou-se um questionÃrio para investigaÃÃo das informaÃÃes clÃnico-laboratoriais. Oito pacientes receberam outro diagnÃstico e trÃs foram a Ãbito por outros motivos, de forma que 52 pacientes completaram o estudo. A maioria dos pacientes era homem (56,36%), nÃo atÃpicos, com mediana de idade de 52 anos. Os fÃrmacos mais implicados foram os AINES (anti-inflamatÃrios nÃo esteroidais) e a via oral foi a mais utilizada. Foram documentadas 69 reaÃÃes suspeitas, a maioria do tipo tardia. Exantema maculopapuloso e eritema multiforme foram as manifestaÃÃes mais freqÃentes entre as reaÃÃes tardias. Quanto à gravidade, a maioria foi considerada moderada (72,46%). O teste de contato foi realizado em 22 pacientes para investigaÃÃo de reaÃÃo tardia. Em sete casos, houve resultado positivo (31,81%), ou seja, DRESS (Rash com eosinofilia e sintomas sistÃmicos) causado por captopril (+), eczema de contato por rifamicina (++), erupÃÃo liquenÃide por captopril (+), exantema maculopapuloso + angiodema para cefalexina e ampicilina (+), dois casos de fotoeczema, um por captopril e outro por Ãcido acetilsalicÃlico (AAS), ambos com resultado (+) e um caso de sÃndrome de Steven-Johnson por fenitoÃna (++). Foram realizados dez testes de puntura e em trÃs pacientes houve positividade para AAS diluÃdo a 1/1000. Foi possÃvel confirmar a imputabilidade do fÃrmaco em 19 reaÃÃes (27,53%), o que demonstra a importÃncia da aplicaÃÃo dos testes cutÃneos na investigaÃÃo clÃnica das reaÃÃes alÃrgicas a medicamentos. Quando à causalidade, 26 reaÃÃes foram consideradas possÃveis, 20 definidas, 13 provÃveis, 9 condicionais e uma reaÃÃo foi considerada nÃo relacionada com fÃrmacos. Dada a sua importÃncia, a realizaÃÃo dos testes cutÃneos com esses pacientes abriu perspectivas sobre a possibilidade incorporar esse serviÃo na rotina do ambulatÃrio de Dermatologia do HUWC.

Magister Public Health - MPH
Background: South Africa has one of the most severe HIV epidemics globally, with an estimated 737,000 AIDS related deaths annually and over a million children rendered orphans due to AIDS in 2006. However in 2007, the South African government made a giant commitment to dealing effectively with the AIDS epidemic by implementing a National Strategic Plan (NSP), which had as one of its principal objectives the provision of antiretroviral medications to 80% of all people in need of the treatment by 2011. By the end of June 2011, the rollout of antiretroviral therapy continued to be successful with 1.4 million persons started on antiretroviral therapy and treatment initiation rates reaching 30, 000 per month. Patients have to subject to an uncompromising adherence of taking at least 95% of antiretroviral medication as prescribed, because poor adherence to ART leads to treatment failure, viral mutations and the development of drug resistance. Of major concern to ART programmes are the current obstacles that patients’ face in lieu of treatment. Aim: The aim of this study was to explore the barriers to adherence to antiretroviral treatment among patients in a public ART programme in Vredenburg, Western Cape. Methodology: An explorative qualitative study was conducted where data was collected through interviews with 18 patients receiving treatment from the Vredenburg hospital. Data was audio-tape recorded, transcribed in full and thematic content analysis done. Results: The study identified awareness of HIV status, disclosure, unemployment, lack of transport,insufficient feeding, disability grants, alcohol and alternative forms of therapy as well as stigma as major barriers to adherence. Whereas inadequate follow ups, recklessness in the way patients’ HIV results were handled, long waiting times and the fear of picking up other types of infections from other patients in the OPD also came under major criticisms from patients. Finally, the sharing of experiences at clinic visits, good healthcare provider’s patient relationships, believing in the treatment, good treatment literacy, being a parent and having children to take care of, the use of pill boxes, social and spiritual support from family members and friends were identified as factors that positively influenced adherence. Conclusion: HIV/AIDS has been a stigmatized illness since its onset in the early 1980s and, these results highlight that such stigma has yet to dissipate in Vredenburg. Therefore, stigma and disclosure must remain at the forefront of the ART programme implementation in Vredenburg; while long term projects that can support ART users economically should be created through partnerships with non-governmental organizations and the government of South Africa to optimize adherence in the community.

Orientadores: Mariangela Ribeiro Resende, Maria Luiza Moretti
Dissertação (mestrado) - Universidade Estadual de Campinas, Faculdade de Ciencias Medicas
Made available in DSpace on 2018-08-14T14:58:52Z (GMT). No. of bitstreams: 1 Ferrari_MichelaDeLuca_M.pdf: 2800534 bytes, checksum: 6c0f0dc17633a5c05f98eaf42e330cb7 (MD5) Previous issue date: 2009
Resumo: Os objetivos do presente estudo foram estimar a prevalência de resistência do M. tuberculosis aos fármacos de primeira linha entre pacientes com tuberculose diagnosticados no Hospital de Clínicas da Unicamp e avaliar o desempenho do método de microdiluição em placa com [3-(4,5-dimethylthiazol-2-yl)- 2,5diphenyl-tetrazolium bromide] (MTT) comparado ao Bactec MGIT 960®. No período foram notificados 360 casos de tuberculose. Destes 211 casos apresentaram cultura positiva para Mycobacterium sp, sendo incluídos 105 casos, nos quais foi identificado o M. tuberculosis. Dentre estes pacientes a apresentação pulmonar da TB ocorreu em 64,8% e co-infecção pelo HIV em 37,1%. A prevalência de resistência a qualquer fármaco foi de 6,7%; multidrogarresistência (RMP e INH) e resistência a INH e SM foram detectadas em 1%, em 3,8% e em 3,8% dos casos, respectivamente. Todos os isolados foram susceptíveis ao EMB. A resistência primária foi encontrada em quatro casos e resistência adquirida em três. Houve associação entre tratamento prévio e resistência (p=0,0181), as demais variáveis estudadas não foram associadas. Dentre os 119 isolados de M. tuberculosis incluídos para a avaliação do desempenho do MTT, ocorreu concordância de 100% para INH e EMB entre os métodos MTT e Bactec MGIT960®, de 99% para RMP (sensibilidade: 90%), enquanto que para SM houve concordância inferior aquela apresentada pelos outros fármacos (95,2%; sensibilidade: 90,9%). A prevalência de resistência entre os casos novos atendidos no Hospital de Clínicas da Unicamp no período de estudo foi de 3,8% para isoniazida, 1% para rifampicina, 3,8% para etambutol e 1% multidrogarresistente. Resistência a qualquer fármaco foi observada em 6,7% dos casos. O método colorimétrico com MTT apresentou bom desempenho e representa uma alternativa acurada, simples e de reduzidos custos, viável e sustentável para locais e países com limitados recursos.
Abstract: This cross-sectional, hospital-based study conducted between January 2006 and March 2008 sought to estimate the resistance of M. tuberculosis to first-line drugs among patients with tuberculosis confirmed by culture at a Brazilian hospital and evaluate the performance of the [3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl-tetrazolium bromide] (MTT) microplate assay in comparison to the Bactec MGIT 960. During the study period were reported to the surveillance system 360 tuberculosis cases, 211 out of these were confirmed by positive culture for Mycobacterium sp and 105 out of these had M. tuberculosis isolated on culture and were included to the prevalence study. Pulmonary involvement was present in 64.8% of cases and HIV co-infection was found in 37.1%. The prevalence of M. tuberculosis resistance was 6.7%; multidrug-resistance [rifampin (RMP) and isoniazid (INH)] and resistance to INH and streptomycin (SM) were detected in 1%, in 3.8% and in 3.8% of cases, respectively. All isolates were susceptible to ethambutol (EMB). The resistance was primary in four cases and acquired in three cases. Previous treatment was associated with resistance (p=0.0181). Among 119 isolates of M. tuberculosis included to the MMTT performance evaluation, there was 100% observed agreement for INH and EMB between the MTT and Bactec MGIT 960¿ methods. For RMP, the observed agreement was 99% (sensitivity: 90%), and for SM, the level of agreement was lower (95.2%; sensibility 90.9%) than those of the other drugs. The prevalence of M. tuberculosis resistance among the new cases during the study period was 6.7%; multidrug-resistance and resistance to INH and streptomycin (SM) were detected in 1%, in 3.8% and in 3.8% of cases, respectively. The colorimetric method with tetrazolium (MTT) represents an accurate, simple and low cost alternative that is both viable and sustainable for settings with limited resources.
Mestrado
Ciencias Basicas
Mestre em Clinica Medica

The purpose of this study was to describe the lived experience of nurses who care for hospitalized women outside of an addiction treatment setting who have a problem with drugs and / or alcohol. The relational experiences of ten registered nurses who had cared for women with drug and alcohol problems were elicited. Heideggerian hermeneutic phenomenology was the method used to interpret the nurse participants’ meaning of their experience. The theoretical framework that was used to explore the nurses’ experience of caring for women who abuse or are dependent on alcohol was Boykin and Schoenhofer’s Nursing as Caring (1993). The relational themes that emerged were: Caring in the dark; Intentionally knowing the woman with AOD as a unique person; and Experiencing sisterhood.

Magister Public Health - MPH
Background: Healthcare providers are critical to collecting information on drug safety and successful adverse drug reaction (ADR) reporting. The roles of doctors and pharmacists have been recognized as important to voluntary ADR reporting and their roles are consistently being investigated. However, despite the strategic role of nurses in medicine administration, their role in ADR reporting has not been widely explored, particularly in sub-Saharan African countries. Aim: To assess the knowledge, attitudes and practice of ADR reporting amongst nurses in Lagos University Teaching Hospital (LUTH), a tertiary hospital located in Lagos; the economic centre of Nigeria, as well as the most populous city in the country. Methodology: A cross-sectional descriptive survey with analytical components was conducted among nurses in a tertiary institution. All nurses working in major specialties - out-patients’ clinics, theatre and clinical wards in the facility, were eligible to participate in the study. Student nurses undergoing training or postings in the facility were excluded from the study. A sample size of 124 nurses was calculated using OpenEpi sample size calculator based on an estimated study population of 400 with a 95% confidence interval and an assumed 5% of nurses reporting an ADR based on National Pharmacovigilance Centre database. A sample of 140 nurses was selected in an attempt to realize sample. Cluster sampling was used to randomly select clinics and wards and all nurses in the selected clusters were included in the study. A structured questionnaire consisting of close-ended questions was used. It comprised sections on nurses’ characteristics, knowledge of pharmacovigilance concepts, attitudes towards ADR reporting, and barriers to and practice of ADR reporting. Data collected were entered into an Excel spreadsheet and imported to the SPSS version 20 software for analysis. Descriptive analyses were conducted on all the variables and cross-tabulation between selected variables was explored to test for statistical significance using chi-squared test.

During the years of apartheid, South Africa developed two health care systems, public and private, that were fragmented and segregated by race. The private health care system (almost exclusively white patients) was on the same level as the tertiary care in industrialised countries, while the public health care system (almost exclusively black and coloured) was similar to the primary health care systems in many developing countries. Even so, South Africa in 1996 was spending much more than any other African country on health care, 8.5% of the GDP per year (McIntyre 1995). The political tide turned in 1996 and with new governments came a new focus on equity of health care, access and services. Equity in health care and access are the main foci of health initiatives in South Africa. This research evaluated the impact of the National Drug Policy (1996), and the National Drug Programme (NDP). The NDP's key component is the Standard Treatment Guidelines/Essential Drugs List (STG/EDL) to be used in South Africa's public hospitals' outpatient clinics at all levels (primary, secondary, and tertiary). This study is a cross-sectional case study that evaluates the effectiveness of the implementation of this policy through strategies to encourage prescribers to use the STGIEDL as a regular part of their prescribing repertoire. The research techniques included a combination of quantitative analyses with a drug utilisation survey (DUS) that measured adherence to rational prescribing measures, and qualitative analyses in depth interviews with nurses, pharmacists, physicians and administrators. The results of both the drug utilisation survey of 1,204 prescriptions from eleven clinics and 20 interviews showed that there was little evidence of rational prescribing in public hospital clinics. Overall the prescribers at the clinic level did not adhere to the NDP and rational prescribing. The one major change observed was that the hospital clinic pharmacy would substitute most brand medicines for generic ones, unless the physician formally requests the brand drug. The one clinic that was the most adherent to the rational prescribing standard had a pharmacist who was enrolled in a rational prescribing and monitoring course. In addition, the manager pharmacist developed an EDP bulletin for all the staff and encouraged the use of the Standard Treatment Guidelines Essential Drugs list for all staff in the hospital clinic. In summary, this study shows that the major goals of the National Drug Policy (NDP), the rational prescribing of drugs and equity of access to health care and services, have note been reached. Even though there is some progress towards attaining these goals will require an effort of all stakeholders through enforceable legislation, allocated budgets, patient and prescriber education, and a bottom-up approach to policy implementation.

Includes bibliographical references.
Aims : 1. To determine the proportion of patients who present with TB treatment and or ART-associated drug-induced liver injury (DILI) amongst all patients presenting with significant liver injury to GF Jooste Hospital during the study period. 2. To describe base line clinical characteristics and management of TB treatment and or ART-associated DILI patients. 3. To describe the in-patient and 3-month mortality of TB treatment and or ART-associated DILI patients. Background and Rationale : GF Jooste Hospital is a public sector referral hospital and serves a densely populated area with a high burden of HIV and tuberculosis (TB). ART rollout in the Western Cape started in 2001/2002 at two pilot clinics and is now well established (1). Many patients are on concomitant TB treatment and ART. At ART clinics in the referral area 25 - 40% of patients are on TB treatment when they start ART (2, 3) . At GF Jooste hospital many HIV positive patients are seen who are on TB treatment and or ART, and present with symptomatic liver dysfunction. Patients are on multiple hepatotoxic drugs, may have multiple opportunistic infections, systemic sepsis and hepatic TB immune reconstitution disease also plays a role. Anecdotally, these patients are complex to manage, require frequent specialist input, spend a long time in hospital and have high mortality. Management guidelines are based on expert opinion and is not evidence based. In practice management relies heavily on the attending clinicians’ experience and clinical judgment and management often differ widely between clinicians. Mortality could be due to progression of TB and or HIV because of interruption of effective therapy, other opportunistic infections or hospital acquired infections. Few early liver biopsies are done and it is not known if early liver biopsies would aid by guiding management of these patients. Prospective studies are urgently needed to guide management in these patients. The burden of TB treatment and or ART-associated drug induced liver injury in this setting has not been described to our knowledge, neither has management, outcome or mortality. This study was performed to aid planning of prospective studies in this field.

L’objectif principal de l’étude était d’identifier les principaux médicaments associés aux hépatites aiguës (HA) associé aux médicaments (HAM) en France. Trois approches méthodologiques ont été définies. L’approche méthodologique principale est l’analyse cas-population. Les autres approches sont cas-propre témoin et cas témoins.Les cas ont été identifiés parmi les patients adultes présents dans le SNIIRAM, ayant une première hospitalisation entre 01/01/2010-31/12/2014 dont le diagnostic principal est une atteinte hépatique toxique (Classification Internationale des Maladies (CIM-10) K71.1, K71.2, K71.6, K71.9) ou une insuffisance hépatique(CIM-10 K72.0). La population de référence a été définie à partir de l’EGB. La date index (DI) considérée est la date de première hospitalisation pour HA. Les délivrances de l’ensemble des traitements précédant la DI ont été étudiées en considérant une exposition variant de 7 à 60 jours avant la DI. Les produits les plus fréquemment retrouvés sont classiques: antalgiques et en premier lieu le paracétamol, puis les produits à visée digestive symptomatique (inhibiteur de la pompe à protons, prokinétique, antispasmodique). Les suivants sont l’amoxicilline seule ou associée à l’acide clavulanique, l’ibuprofène, la codéine associée et le furosémide. L’ensemble de ces résultats pourra informer les autorités sanitaires, les praticiens et les patients sur le risque associé à chacune de ces molécules tant au plan individuel (risque absolu, risque attribuable), qu’au sein d’une famille de produits(risque relatif) ainsi que plus globalement pour la population et le système de santé(nombre absolu de cas attribuables)
The main objective of EPIHAM study is to identify the main drugs associated with drug induced liver injury leading to hospital admission (DILIH) in France and the event rates associated with DILIH. Three methodological approaches were defined. Principal approach is case-population. The others are case-crossover and case control analyses. Cases were identified among adult patients present in SNIIRAM database having a first hospitalization between 01/01/2010-2010/31/12/1204, the main diagnosis of which is toxic liver disease (diagnostic codes according to the International Classification of Diseases (ICD-10) K71.1, K71.2, K71.6, K71.9) orK72.0. Reference population was defined from the EGB. Index date (ID) was considered as the date of hospital admission for DILI. The dispensations of all treatments preceding the ID were studied by considering an exposure windowvarying from 7 to 60 days before ID. The most frequently found are classical: analgesics and firstly paracetamol, followed by drugs acting on digestive system (proton pump inhibitors, prokinetics, antispasmodics). The following were amoxicillinalone or combined with clavulanic acid, ibuprofen, codeine combinations, and furosemide. These results can inform health authorities, practitioners and patients about the acute hepatitis risk leading to hospitalisation associated with each of these molecules, both individually (absolute risk, attributable risk) and within a therapeutic drug family (relative risk) as well as more generally for the population and the health system (absolute number of attributable cases)

Thesis (MPH)--University of Limpopo, 2011.
Abstract Background: Prevention, monitoring and reporting of adverse drug reactions is still a challenge among healthcare professionals. Even though some adverse drug reactions are minor and can be resolved quickly some can cause permanent disability or death. A recent South African study in a secondary hospital found that 6.3% of medical admissions were due to adverse drug reactions, which is similar to proportions found in developed countries. It is the responsibility of the healthcare professionals to detect, investigate, manage and report adverse drug reactions. Aim of the study: This study aimed to determine knowledge, attitudes and practices of healthcare professionals (doctors, nurses and pharmacists) regarding the reporting of patients‟ adverse drug reaction at Mafikeng Provincial Hospital. Methods: This was a descriptive quantitative study. A questionnaire was used to collect data from 29 doctors, 88 nurses and 5 pharmacists. Data was collected on demographic characteristics of the healthcare professionals, their knowledge, attitudes and practices towards ADR reporting. Data analysis was conducted using STATA (version 11) and Epi info (version 6). A test of association of selected variables was done using Pearson chi–square and logistic analysis to measure the association. Results: More than half of the participants were male (56.3%) and 53.8% percent of them were younger than 40 years. Majority of the respondents (72.27%) indicated that they do not know how to report ADRs. There was no significant difference in terms of knowledge by age category. None of the healthcare professionals have ever sent their ADR forms to the pharmacovigilance centre. Ninety-one percent (91.53%) felt that reporting of ADR can benefit the public health, 78.63% felt that filling of the ADR yellow form is useful and 98.29% felt that ADR should be compulsory. There was no significant association between knowledge of how to report and attitude towards reporting (X²=1.0, p= 0.317), no association between knowledge and practice (X²=0.974, p= 0.324). iv Conclusions: This study revealed that more than a third of the respondents (72.29%) did not have the knowledge of the procedure for reporting ADRs. Healthcare professionals had a positive attitude towards ADR; 98.29% of them said that ADR reporting should be compulsory. There was no significant association between knowledge, attitude and practice toward ADR reporting. Healthcare professionals' knowledge can be improved through educational interventions and trainings.

Pseudomonas aeruginosa é um dos principais agentes de infecção hospitalar que tem adquirido um caráter endêmico decorrente a sua resistência intrínseca e/ou adquirida aos antibacterianos comercialmente disponíveis. O objetivo do estudo foi avaliar, in vitro, opções terapêuticas baseadas na atividade sinérgica. Dez cepas de P. aeruginosa clonalmente não relacionadas, previamente caracterizadas como produtoras de metalo-beta-lactamase (MbL) do tipo SPM-1, VIM-1 e PA GIM-1, foram avaliadas. O efeito sinérgico foi investigado por Checkerboard e Time-Kill. As combinações [Piperacilina/Tazobactam x Aztreonam] e [Tigeciclina x nanofragmentos de bicamada de brometo de dioctadecildimetilamônio (DDA)] mostraram atividade sinérgica para 90 e 100% das cepas, respectivamente. Os resultados respaldam o uso terapêutico combinado de [Piperacilina/Tazobactam x Aztreonam], contra infecções produzidas por cepas de P. aeruginosa multirresistentes produtoras de MbLs, além disso, [DDA/Tigeciclina] pode constituir a base para consolidar uma nova forma farmacêutica de uso clínico.
Pseudomonas aeruginosa is a leading cause of nosocomial infections, which it has acquired an endemic status due to their intrinsic or acquired resistance to antibacterial agents commercially available. The aim of the study was to evaluate in vitro therapeutic options based on the synergistic activity. Ten clonally unrelated strains of P. aeruginosa, previously characterized as metallo-beta-lactamase (MbL) producers (i.e., SPM-1, VIM-1 and PA GIM-1) were evaluated. The synergistic effect was investigated by checkerboard and Time-Kill assays. The combinations [Piperacillin/Tazobactam x Aztreonam] and [Tigecycline x bilayer fragments of dioctadecyldimethylammonium bromide (DDA)] showed synergistic activity for 90 and 100% of the strains, respectively. The results support the use of combined therapy by using [Piperacillin/Tazobactam x Aztreonam] against infections produced by strains of P. aeruginosa producing MbLs, moreover, [DDA / Tigecycline] may be the basis for build a new pharmaceutical form for clinical use.