ADR is an important public health problem which reduces quality of care patients receive and increases cost to healthcare system. Little is known about the incidence and economic burden of ADR-related ED visits and subsequent hospitalizations in Canada. This study estimated the incidence and cost of ADR-related ED visits and subsequent hospitalizations for patients (>65 years) in Ontario, and explored patient, drug and system factors associated with severe ADRs. In a population-based retrospective cohort of Ontario older adults, 7222 (0.75%) of all ED visits were ADR-related, and among these patients 21.56% were hospitalized in 2007; In 2007, the total measured cost of ADR-related visits and subsequent hospitalizations amounted to $13.6 million with the cost being $333.47 and $7528.64 per person for ED visits and subsequent hospitalizations, respectively. Severe ADRs were associated with sex, age, comorbidity, multiple drugs, multiple pharmacies, newly prescribed drugs, recent ED visit, recent hospitalization and LTC residents.

ADR is an important public health problem which reduces quality of care patients receive and increases cost to healthcare system. Little is known about the incidence and economic burden of ADR-related ED visits and subsequent hospitalizations in Canada. This study estimated the incidence and cost of ADR-related ED visits and subsequent hospitalizations for patients (>65 years) in Ontario, and explored patient, drug and system factors associated with severe ADRs. In a population-based retrospective cohort of Ontario older adults, 7222 (0.75%) of all ED visits were ADR-related, and among these patients 21.56% were hospitalized in 2007; In 2007, the total measured cost of ADR-related visits and subsequent hospitalizations amounted to $13.6 million with the cost being $333.47 and $7528.64 per person for ED visits and subsequent hospitalizations, respectively. Severe ADRs were associated with sex, age, comorbidity, multiple drugs, multiple pharmacies, newly prescribed drugs, recent ED visit, recent hospitalization and LTC residents.

Diss. (sammanfattning) Uppsala : Uppsala universitet, 2005. / Härtill 6 uppsatser.

Class of 2010 Abstract / OBJECTIVES: To comprehensively review medical literature and report angiotension converting enzyme inhibitors (ACE-­‐I) adverse drug reactions including, incidences, mechanism of action, predisposing conditions, and report prevention and treatments. METHODS: This was a descriptive retrospective study of data related to ACE-­‐I adverse drug reactions other than ACE-­‐I induced cough. It was to review the ADR that accompany with the use of ACE-­‐I. Literature obtained through search engines MEDLINE and OVID SP available through the Arizona Health and Science Library at the University of Arizona. RESULTS: This comprehensive literature review looked at angioneurotic edema, orthostatic hypotension, hyperkalemia, and increased risk of bleeding and anaphylaxis with tPA and to a minor extent Elevated serum creatinine, and Teratogenicity. Angioneurotic edema (angioedema) reports initially estimated an incidence of 0.1 to 0.7%. A comprehensive review suggested the incidence was even lower at 0.1 to 0.2%, but the OCTAVE trial that specifically looked at angioedema as an endpoint estimated an incidence of ~0.7% although the study only had a 24-­‐week follow up. Most patients that discontinued treatment due to angioedema experienced symptom relief within 72 hours. The incidence of orthostatic hypotension from a study that followed patients on lisinopril was only 0.25%;moreover, a meta-­‐analysis by Agusti et al included 51 RCT that reported a relative risk of developing OH on an ACE-­‐I alone was 1.95. Hyperkalemia incidence reporeted varied from 1.1% to 10%; the more recent literature suggests a value near the lower end of this range. Elevated serum creatinine appears to occur early in ACE-­‐I treatment with discontinuation resolving in resolution. ACE-­‐I have been shown to be teratogenic during any trimester and should generally be avoided in pregnancy. There appears to be an increased risk of bleeding and anaphylactoid typer reactions when alteplase and ACE-­‐I are used simultaneously. Muravyov et al reported the viscosity of whole blood and plasma to be decreased after only three weeks of ACE-­‐I administration. CONCLUSIONS: With the continued increasing use of ACE-­‐Is and the drug class' ability to achieve therapeutic outcomes in a wide array of patient populations, it is important to better understand the processes and mechanisms behind the ADRs associated with ACE-­‐I therapy. A basic understanding of incidence rates and physiologic mechanisms will allow clinicians to properly assess the probability of causation and better treat patients who have experienced an ACE-­‐I induced ADR. However, an in-­‐depth level of understanding can help guide clinicians in making decisions that will hopefully decrease the amount of ADRs their patients experience or prevent their patients from developing ACE-­‐I related ADR altogether. It is important to note that, in most of the aforementioned ADR situations, treatment consists of ACE-­‐I discontinuation and avoidance of future exposures.

Monitoring adverse drug reactions (ADRs) through pharmacovigilance is vital to health consumer safety. Health Canada accepts ADR reports from physicians, health consumers, lawyers and manufacturer. This study uses a multi-methods approach to evaluate health consumers ADR reporting to pharmacovigilance programs. Methods: Guided by Risk Perception Theory, this study involved three phases. 1) A systematic review to identify factors influencing health consumer ADR reporting 2) An observational study to compare health consumer and physician ADR reports received by Health Canada from 2000-2014 to determine differences in seriousness, system organ class, and anatomical therapeutic class. 3) A qualitative study to explore health consumers’ experiences with ADR reporting and usability of the Canadian Vigilance ADR system. Results: 1) Of 1435 citations identified, 22 studies were eligible. Common barriers for health consumers to report ADRs were poor awareness and confusion on who should report. Common motives were preventing ADRs in others and wanting feedback. 2) Of 198,781 ADR reports, 57,078 (29.0 %) were from health consumers and 52,843 (27.0%) from physicians. Compared to physicians, health consumers reported significantly more ADRs (serious and non-serious) (p<0.0001) and reported differently for organ systems affected and by types of medication. 3) Interviews from 15 adult health consumers revealed barriers (e.g., poor awareness about the available reporting systems) and motives for reporting ADRs (e.g., intolerable side effect impacting daily activities). Few were aware of the Canadian Vigilance reporting system and usability was limited by the number and complexity of questions. Conclusion: Health consumer role in directly reporting ADRs is influenced by several factors. In Canada, most were unaware of the Canadian Vigilance System and unclear about their role in reporting ADRs. Quarters of Canadian ADRs are reported by health consumers and their ADRs had different characteristics from physicians. These findings are relevant to policymakers, public health officials, and regulatory agencies for improving medication safety in Canada and worldwide.

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&#61616; 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.

>Magister Scientiae - MSc / Healthcare professionals (HCPs) have a primary role to play in the detection, assessment and spontaneous reporting of adverse drug reactions (ADRs). An improvement of their related knowledge, attitude and practice concerning pharmacovigilance and ADR reporting is vital. The objective of the study was to determine whether or not pharmacovigilance training, provided by a Pharmaceutical Company, would improve HCP’s perceptions and adherence to pharmacovigilance and ADR reporting. A quasi-experimental research design was used. A total of 44 HCPs participated in the study. Participants were divided into two groups: an experimental group that received pharmaceutical training intervention; and a control group that did not receive any training. Using a self-administered questionnaire before and after the training intervention assessed the knowledge, attitudes, and practice of pharmacovigilance and ADR reporting displayed amongst the HCPs.

The objective of this study was to determine the pharmacokinetics and tolerance of tulathromycin (Draxxin®; 2.5 mg/kg once) after intramuscular (IM), subcutaneous (SC), and slow intravenous (IV) administration to six adult horses. A three-phase design and 4-week washout period were used. Drug concentrations in blood and bronchoalveolar lavage (BAL) samples were determined by ultra-performance liquid chromatography tandem mass spectrometry and pharmacokinetic parameters calculated using noncompartmental analysis. Following SC and IM administration, all horses exhibited sweating, discomfort, and periods of recumbency. As signs were more severe after SC administration this route was only used in 3/6 horses. Intravenous administration of tulathromycin was well tolerated in all horses. Mean bioavailability was 99.4% IM and 115% SC. Mean maximum plasma concentration was 645 ng/ml IM and 373 ng/ ml SC. Mean half-life was 59.8 h, 54.8 h, and 57.9 h for IV, IM, and SC administration, respectively. Mean clearance was 3.25 ml/kg/min, and mean volume of distribution was 16.8 L/kg following IV administration. Drug was detectable in plasma and BAL samples for 120 h following all routes; however, adverse effects may prevent IM use and SC use is not recommended. Tulathromycin may be a practical and affordable antibacterial for use in adult equine patients. / Master of Science / In human and veterinary medicine, antibacterial drugs are a mainstay of treatment. Antibacterials have been used for almost 100 years to prevent microbial organism infection, and as a treatment once there is an established infection. Although there are multiple "classes" of antibacterials that have different spectrums of activity and mechanisms of action, antibacterial resistance has become increasingly prevalent over time. The increasing rate of antimicrobial resistance has led to recommendations that medical practitioners be more judicious in the use of these drugs and to prescribe antibacterials to patients only when necessary. In equine medicine, once an antibacterial is deemed necessary, there are additional considerations, including administration method, frequency of administration, and availability and cost of antibacterial drugs. Tulathromycin, a long-acting semi-synthetic macrolide, is an antibacterial that is approved for use in cattle and swine and may have utility for equine patients for a variety of conditions. This study in healthy adult horses demonstrated that tulathromycin was detectable in plasma and the respiratory tract for up to 5 days after single dose administration. Thus, tulathromycin may be a practical and affordable antibacterial for use in equine patients.

CoordenaÃÃo de AperfeiÃoamento de Pessoal de NÃvel Superior / Study of adverse events in an accredited secondary hospital of CearÃ: an approach to risk management. Author: Milena Pontes Portela Beserra. Supervisor: ProfÂ. Dr Marta Maria de FranÃa Fonteles. [Master degreeâs dissertation. Post Graduation in Pharmaceutical Science. Department of Pharmacy â Federal University of CearÃ]. BACKGROUND: Hospital Risk Management acts in the prevention, detection, control or eliminate risks that could cause harm to patients, in Brazil this concept was implemented in 2001 by the National Agency for Sanitary Surveillance (Anvisa), Ministry of Health with the project Sentinel Hospitals, and currently brings together nearly two hundred institutions. It consists basically of three pillars: pharmacovigilance, haemovigilance and technical surveillance. Indicators of results and adverse events are fundamental tools of quality by pointing out aspects of care that can be improved by making patient care without risks and failures, and therefore safer. In order to improve the quality of healthcare services in recent decades had the strength of the Hospital Accreditation Program consisting of external evaluation system that verifies the compliance of the structure and care processes with the adopted set of standards previously established. OBJECTIVES: To study adverse events suffered by hospitalized patients or that were related to drugs and related in a public secondary hospital accredited by National Accreditation Organization (ONA), in 2010, contextualizing the risk management approach in the hospital. METHODS: We conducted a retrospective documentary base at the Hospital General Dr. Waldemar Alcantara (HGWA) a survey of all reports of adverse drug reactions (ADRs), reactions to blood products and technical defects of materials, equipment and drugs, studying, and the risk management with a focus on pharmacovigilance, haemovigilance and technical surveillance, respectively. RESULTS AND DISCUSSION: There have been 271 events, with 166 (61.3%) RAM, 64 (23.6%) technical defects, 41 (15.1%) transfusion reactions. We found a higher number of RAM in patients with extreme age and use of antimicrobials, as well as previously reported. The main reported ADRs were dermatological and medical groups were more involved antimicrobials for systemic use. The main blood component was transfused red blood cells, is also a major cause of anemia, transfusion reactions and the main indication. The most transfusion reactions reported were fever (55.6%), dyspnea (8.9%) and urticaria (8.9%), these reactions were immediate in 92.7% of cases, they occurred in up to 24 hours after transfusion. Techniques have been reported 64 complaints of 40 different products, the main products cited were: saline 100 mL closed system (14.1%) and micropore tape (7.8%). Had the potential to cause direct harm to patients 81.3% the complaints and the nursing staff was the main notifier. CONCLUSION: The HGWA presents a program of effective risk management, maintaining and working on positive indicators for the safety of the patient. Even more important is to note that you can perform a quality service in terms of risk management, even when it comes to a public hospital in northeastern Brazil with financial constraints. / Estudo dos eventos adversos em um hospital secundÃrio acreditado do CearÃ: uma abordagem no gerenciamento de riscos. Autora: Milena Pontes Portela Beserra. Orientadora: ProfÂ. DrÂ. Marta Maria de FranÃa Fonteles. [DissertaÃÃo de Mestrado â PÃs-graduaÃÃo em CiÃncias FarmacÃuticasâ Departamento de FarmÃcia da Universidade Federal do CearÃ]. INTRODUÃÃO: O Gerenciamento de Riscos Hospitalares atua na prevenÃÃo, detecÃÃo, controle ou eliminaÃÃo de riscos capazes de causar danos aos pacientes. No Brasil este conceito foi implantado em 2001 pela AgÃncia Nacional de VigilÃncia SanitÃria (Anvisa), do MinistÃrio da SaÃde, com o projeto Hospitais Sentinela, e, atualmente, congrega quase duas centenas de instituiÃÃes. à constituÃdo basicamente por trÃs pilares: farmacovigilÃncia, hemovigilÃncia e tecnovigilÃncia. Indicadores de resultados como os eventos adversos sÃo ferramentas fundamentais da qualidade por apontarem aspectos do cuidado que podem ser melhorados tornando a assistÃncia aos pacientes livre de riscos e falhas e, portanto, mais segura. Com o objetivo de melhorar a qualidade assistencial dos serviÃos, nas Ãltimas dÃcadas, tiveram forÃa os Programas de AcreditaÃÃo Hospitalar que consistem em sistema de avaliaÃÃo externa que verifica a concordÃncia da estrutura e dos processos assistenciais adotados com o conjunto de padrÃes previamente estabelecidos. OBJETIVOS: Estudar eventos adversos que acometeram os pacientes internados ou que se relacionaram a medicamentos e correlatos, em um hospital pÃblico secundÃrio acreditado pela OrganizaÃÃo Nacional de AcreditaÃÃo (ONA), no ano de 2010, contextualizando a abordagem no gerenciamento de risco hospitalar. MÃTODOS: Foi realizado um estudo retrospectivo de base documental no Hospital Geral Dr Waldemar AlcÃntara (HGWA) com levantamento de todas as notificaÃÃes de reaÃÃes adversas a medicamentos (RAM), reaÃÃes aos hemocomponentes e queixas tÃcnicas de materiais, equipamentos e medicamentos, estudando, assim, o gerenciamento de riscos com foco na farmacovigilÃncia, hemovigilÃncia e tecnovigilÃncia, respectivamente. RESULTADOS E DISCUSSÃO: Foram notificados 271 eventos, sendo 166 (61,3%) RAM, 64 (23,6%) queixas tÃcnicas e 41 (15,1%) reaÃÃes transfusionais. Foi encontrado maior nÃmero de RAM nos pacientes pertencentes aos extremos etÃrios e em uso de antimicrobianos, conforme jà bem descrito na literatura. As principais RAM notificadas foram as dermatolÃgicas e o grupo medicamentoso mais envolvido foram os antimicrobianos de uso sistÃmico. O principal hemocomponente transfundido foi o concentrado de hemÃcias, sendo tambÃm o maior causador de reaÃÃes transfusionais e a anemia a principal indicaÃÃo. As reaÃÃes transfusionais mais notificadas foram: febre (55,6%), dispnÃia (8,9%) e urticÃria (8,9%), essas reaÃÃes foram imediatas em 92,7% dos casos, pois ocorreram em atà 24h apÃs a transfusÃo. Foram notificadas 64 queixas tÃcnicas de 40 produtos diferentes, os principais produtos citados foram: o soro fisiolÃgico 100mL sistema fechado (14,1%) e fita microporosa (7,8%). PossuÃam potencial para causar dano direto aos pacientes 81,3% das queixas e a equipe de enfermagem foi a principal notificadora. CONCLUSÃO: O HGWA apresenta um programa de gerenciamento de riscos eficiente, com manutenÃÃo de indicadores positivos e trabalhando em prol da seguranÃa do paciente. Ainda mais importante à ressaltar que à possÃvel realizar um serviÃo de qualidade, em termos de gerenciamento de riscos, mesmo quando se trata de um hospital pÃblico do nordeste brasileiro com limitaÃÃes financeiras.

Diss. (sammanfattning) Umeå : Univ., 2005. / Härtill 5 uppsatser.