Av de läkemedel som förskrivs i Sverige, konsumerar de äldre över 65 år ca 40 %. Anledningen är att denna grupp drabbas av många sjukdomar och behandlas med fler läkemedel. Äldre får generellt sett annorlunda och fler biverkningar än yngre. Syftet med uppsatsen var att beskriva hur sjuksköterskan kan säkerställa en god farmakologisk omvårdnad hos äldre och uppmärksamma de konsekvenser som uppstår till följd av polyfarmaci. Studien utfördes som en litteraturstudie där 22 vetenskapliga artiklar granskades och analyserades varefter två teman framträdde. Dessa båda teman var förutsättningar för god farmakologisk omvårdnad och konsekvenser vid polyfarmaci. Läkemedelsrelaterade problem är en vanlig orsak till sjukhusinläggningar och fördröjer ofta utskrivningen. Läkemedelsbiverkningarna ökar med antalet konsumerade läkemedel. Den farmakologiska kunskapen upplevs som bristfällig bland sjuksköterskorna. Även kortare utbildningar ger ökad kunskap vilket leder till att fler läkemedelsrelaterade problem upptäcks och biverkningar rapporteras i högre grad.  Utbildning och användande av bedömningsmallar kan därför förbättra den farmakologiska omvårdnaden. / Elderly often have several diseases and treated with many drugs. They use about 40 percent of all prescribed medications in the country and get different and more adverse events than younger. The aim of the study was to describe how the nurse can ensure a good pharmacological nursing in the elderly and pay attention to the consequences that arise as a result of polypharmacy. The study was conducted as a litterature study there 22 scientific articles were reviewed and analyzed whereafter two themes were found. Those were conditions for pharmacological care and polypharmacy consequences. Drug related problems are a common cause of hospital admissions and delays often discharge. Adverse drug reactions increases with the number consumed medicines. The pharmacological knowledge is perceived as deficient among nurses. Shorter courses provide increased knowledge leading to more drug-related problems were discovered and side effects were reported more often. Education and use of assessment templates leads to improved pharmacological care.

Inom ramen för Världshälsoorganisationens (WHO:s) internationella biverkningsprogram rapporterar sjukvårdspersonal och patienter misstänkta läkemedelsbiverkningar i form av spontana biverkningsrapporter som via nationella myndigheter skickas till Uppsala Monitoring Centre (UMC). Hos UMC lagras rapporterna i VigiBase, WHO:s biverkningsdatabas. Rapporterna i VigiBase analyseras med hjälp av statistiska metoder för att hitta potentiella samband mellan läkemedel och biverkningar. Funna samband utvärderas i flera steg där ett tidigt steg i utvärderingen är att studera den medicinska litteraturen för att se om sambandet redan är känt sedan tidigare (tidigare kända samband filtreras bort från fortsatt analys). Att manuellt leta efter samband mellan ett visst läkemedel och en viss biverkan är tidskrävande. I den här studien har vi utvecklat ett verktyg för att automatiskt leta efter medicinska biverkningstermer i medicinsk litteratur och spara funna samband i ett strukturerat format. I verktyget har vi implementerat och integrerat funktionalitet för att söka efter medicinska biverkningar på olika sätt (utnyttja synonymer,ta bort ändelser på ord, ta bort ord som saknar betydelse, godtycklig ordföljd och stavfel). Verktygets prestanda har utvärderats på manuellt extraherade medicinska termer från SPC-texter (texter från läkemedels bipacksedlar) och på biverkningstexter från Martindale (medicinsk referenslitteratur för information om läkemedel och substanser) där WHO-ART- och MedDRA-terminologierna har använts som källa för biverkningstermer. Studien visar att sofistikerad textextraktion avsevärt kan förbättra identifieringen av biverkningstermer i biverkningstexter jämfört med en ordagrann extraktion. / Background: Initial review of potential safety issues related to the use of medicines involves reading and searching existing medical literature sources for known associations of drug and adverse drug reactions (ADRs), so that they can be excluded from further analysis. The task is labor demanding and time consuming. Objective: To develop a text extraction tool to automatically identify ADR information from medical adverse effects texts. Evaluate the performance of the tool’s underlying text extraction algorithm and identify what parts of the algorithm contributed to the performance. Method: A text extraction tool was implemented on the .NET platform with functionality for preprocessing text (removal of stop words, Porter stemming and use of synonyms) and matching medical terms using permutations of words and spelling variations (Soundex, Levenshtein distance and Longest common subsequence distance). Its performance was evaluated on both manually extracted medical terms (semi-structuredtexts) from summary of product characteristics (SPC) texts and unstructured adverse effects texts from Martindale (i.e. a medical reference for information about drugs andmedicines) using the WHO-ART and MedDRA medical term dictionaries. Results: For the SPC data set, a verbatim match identified 72% of the SPC terms. The text extraction tool correctly matched 87% of the SPC terms while producing one false positive match using removal of stop words, Porter stemming, synonyms and permutations. The use of the full MedDRA hierarchy contributed the most to performance. Sophisticated text algorithms together contributed roughly equally to the performance. Phonetic codes (i.e. Soundex) is evidently inferior to string distance measures (i.e. Levenshtein distance and Longest common subsequence distance) for fuzzy matching in our implementation. The string distance measures increased the number of matched SPC terms, but at the expense of generating false positive matches. Results from Martindaleshow that 90% of the identified medical terms were correct. The majority of false positive matches were caused by extracting medical terms not describing ADRs. Conclusion: Sophisticated text extraction can considerably improve the identification of ADR information from adverse effects texts compared to a verbatim extraction.

Health care systems in Saudi Arabia and elsewhere play a significant role in the lives of individuals as well as society at large. Although healthcare aims at enhancing the quality of life it can sometimes happen that treatment itself can lead to a diminution of the quality of life due to unexpected adverse effects. These problems may cause therapeutic failures or even drug-related morbidity and mortality. Consequently there is a need to have in place a system, conventionally known as Pharmacovigilance. The aims of Pharmacovigilance are to identify, quantify and continuously monitor all drug use through a system which would enable all health care professionals such as physicians, pharmacists, dentists and nurses to contribute. This thesis investigated the present knowledge of and use of, the Pharmacovigilance system in Makkah, in the Kingdom of Saudi Arabia. A mixed method yielded data that provided depth and breadth to the findings of this study. A questionnaire was designed for 170 community pharmacists and 310 respondents drawn from different medical roles across the seven hospitals in Makkah yielded some useful results. Resistance to change was identified in some groups but it was of interest to discover that 72% of respondents who admitted that their knowledge was insufficient were, nevertheless, agreed about its importance. Key issues from the analysis of the questionnaire were used to design the second phase of the sequential mixed method which involved semi structured interviews with seven senior pharmacists, one from each of the seven hospitals. Analysis yielded three overarching categories: Technology, Internalisation and Motivation. A follow up feedback survey at the end of a lecture, of a group of pharmacy students enhanced the overall findings of the study and revealed a very high degree of interest and acceptance of Pharmacovigilance reporting systems and an expressed desire for its inclusion as a subject in its own right in their training programme. Conflicting epistemological positions inherent in a mixed method are candidly admitted and no attempt is made to circumvent this difficulty. Rather, the enhanced nature of the findings is highlighted despite the opposing knowledge claims of both approaches. A key finding was that 59% of the respondents were unaware of the Saudi National Pharmacovigilance centre (NPC) and reporting arrangements. The problems of lack of internet access and of suitable reporting forms were important contributory reasons for the under-usage of the system. There is a need to raise awareness of all pharmacists of the importance of the knowledge and practice of Pharmacovigilance. Technological solutions should be implemented to facilitate reporting at all levels. Continuing professional development should include Pharmacovigilance. Resistance to change can be addressed by identifying the motivational factors that can lead to a more wholehearted acceptance of the importance of Pharmacovigilance for patient care and well-being. Indeed, these could well be the focus of future studies.

Inter-individual variability in drug response is a significant clinical concern and may lead to the development of adverse drug reactions, which are currently a top-ten cause of death in the United States. Recently, the manifestation of disease, which may alter normal physiological function, has gained increased attention for its role as a contributing factor in the development of inter-individual responses to drugs. One such disease, known as nonalcoholic fatty liver disease (NAFLD), is the most common chronic liver disease in Western society and represents a spectrum of clinical morbidities that range from the usually benign simple fatty liver to the more advanced nonalcoholic steatohepatitis (NASH). Prior investigations have identified liver-specific alterations in xenobiotic transporter and metabolizing enzymes in NASH, which lead to the functional disruption of drug disposition. To identify a useful model(s) that is representative of hepatic transporter expression profiles in humans with NASH, gene and protein expression profiles of liver membrane transporters were assayed across several commonly used experimental rodent models of the disease. NASH models that were representative of the human condition developed global, adaptive changes in transporter regulation in the liver, which was not present in models that failed to recapitulate human profiles. Specifically, decreased expression of hepatic uptake transporters was coupled with an induction of efflux transporters, which may serve as a hepatoprotective response by limiting hepatic exposure to potentially harmful substances during times of tissue stress. To link a possible molecular mechanism for these hepatic adaptations in NASH, the role of the oxidative stress-activated transcription factor, Nrf2, was investigated. A functional Nrf2 regulatory element was identified within the eighth intron of the human ABCC3 transporter gene, implicating Nrf2 activation in NASH as a contributor to the coordinated induction of hepatic efflux transporters in the disease. To further clarify the effects of NASH on renal membrane transporter regulation, a thorough analysis of gene and protein expression was conducted with the validated rodent models used previously. Following the manifestation of disease, a global induction of renal efflux was observed, suggesting a compensatory, coordinated response of membrane transporters in the kidney upon disease induction. The functional consequences of liver and kidney xenobiotic transporter dysregulation was shown to disrupt the disposition of the environmental toxicant, arsenic. Specifically, NASH results in increased excretion of arsenic into urine as well as altered hepatic and renal exposure. These findings are associated with hepatic and renal transporter dysregulation and demonstrate for the first time that NASH alters the disposition of environmental toxicants. In summary, these studies contribute novel findings that identify liver and kidney-specific adaptations in disease that may contribute to global alterations in xenobiotic disposition thereby increasing the likelihood of developing adverse drug reactions in patients with NASH.

Os medicamentos antidepressivos, especialmente os tricíclicos são indicados no tratamento farmacológico da depressão ou manejo de mialgias. Estes medicamentos têm sido utilizados em larga escala na rede sanitária pública do município de Ribeirão Preto, SP, Brasil. Os objetivos desta tese foram determinar o consumo dos psicotrópicos na rede pública de saúde de Ribeirão Preto, identificar os problemas relacionados com o medicamento amitriptilina (AMT), elaborar estratégias específicas de educação continuada para os médicos e verificar a resposta desta intervenção farmacêutica. Os dados de consumo foram obtidos das planilhas mensais das unidades de farmácia, arquivados na Divisão de Farmácia da Secretaria Municipal de Saúde de Ribeirão Preto. Para atingir os outros objetivos, esta pesquisa obteve os dados por meio de anamnese farmacêutica com os pacientes de oito unidades de saúde. Resultou na verificação da impressão dos pacientes sobre a assistência à saúde, dos fatores determinantes da prescrição de AMT, dos conhecimentos médicos sobre os problemas relacionados com este medicamento, seu comportamento quanto à assistência ao paciente e na resposta à intervenção farmacêutica, que mostrou impacto positivo. Este trabalho ainda reafirma a atenção farmacêutica como prática profissional de grande utilidade e necessidade para a melhor assistência ao paciente e como agente no uso racional do medicamento e da farmacovigilância / The antidepressants, specially the tricyclic ones, are indicated for the pharmacological treatment of depression and pain. This drugs have been used extensively by the public heath care of Ribeirão Preto, SP, Brazil. The purposes of this thesis were: to determine the psychotropic consumption at the Heath System of Ribeirão Preto, to identify the amitriptyline (AMT) adverse reactions and other related problems, to elaborate specific strategies of pharmaceutical continuing education to the physicians and to verify the response of this pharmaceutical intervention. Consumption data were obtained from monthly charts of the pharmacy sets, archived at the Pharmacy Division. To achieve the other purposes of this research, data were obtained from pharmaceutical anamnesis with patients from the health unities chosen. It resulted in verification of patients impression about health care received, AMT prescription determinant factors, medical knowledge about problems related to this drug and their behavior and also resulted in the pharmaceutical intervention response, which showed positive impact. This research affirms the pharmaceutical care as professional practice of great utility and necessity for better patient assistance and as agent at the rational drug use and pharmacovigilance.

CoordenaÃÃo de AperfeiÃoamento de Pessoal de NÃvel Superior / Os medicamentos sÃo a principal ferramenta terapÃutica para a recuperaÃÃo ou manutenÃÃo das condiÃÃes de saÃde da populaÃÃo. Dentre os problemas mais comuns relacionados aos mesmos estÃo a ReaÃÃo Adversa a Medicamentos (RAM) e Queixas TÃcnicas (QT), sendo necessÃria sua vigilÃncia atravÃs do gerenciamento, direcionamento e desenvolvimento de atividades de farmacovigilÃncia mediante a formaÃÃo de centros colaboradores/notificadores. Avaliar as notificaÃÃes de RAM e QT enviadas e analisadas pelo Centro de FarmacovigilÃncia do Cearà (CEFACE) durante os seus nove anos de funcionamento voltados para o contexto da saÃde pÃblica e do uso racional de medicamentos. Foram coletadas todas as notificaÃÃes de RAM e QT do banco de dados do CEFACE, durante o perÃodo de janeiro/97 a dezembro/05, sendo as seguintes variÃveis analisadas: sexo e idade, origem da notificaÃÃo, notificador, medicamento envolvido, RAM referida, e classificaÃÃo desta quanto à causalidade e severidade e tipo de RAM segundo Rawlins e Thompson. Quanto à QT, as variÃveis foram: origem da notificaÃÃo, tipo de QT, notificador e medicamento ou material mÃdico envolvido. Foi tambÃm realizado um levantamento para identificaÃÃo na literatura da possibilidade dos excipientes farmacÃuticos serem fatores de risco para RAM, utilizando-se como base inicial os 11 medicamentos mais vendidos no mercado brasileiro, no perÃodo de novembro/02 a novembro/03 e suas respectivas formulaÃÃes. Posteriormente foi feita a retirada de casos com envolvimento desses excipientes em estudos de casos clÃnicos suspeitos. No perÃodo de janeiro/97 a dezembro/05, o CEFACE registrou 1.293 notificaÃÃes. Destas, 1.172 (90,6%) foram casos de RAM e 121 (9,4%) de QT. Houve uma reduÃÃo significante do envio dessas notificaÃÃes durante os anos. A maioria das RAM foi referente ao sexo feminino (62,7%) e a faixa etÃria de 21-30 anos (17,7%). A busca ativa foi o mÃtodo de notificaÃÃo com maior percentual (59,3%). 85,6% (RAM) foram de origem hospitalar com percentual de pÃblicos de 81,6%. O grupo terapÃutico com maior envolvimento foi o dos antiinfecciosos de uso sistÃmico (40%). O sistema da pele (48,5%) destacou-se dentro das RAM referidas. Quanto à causalidade, o maior nÃmero de RAM foi do tipo provÃvel (44,1%) e para a severidade destacaram-se as moderadas (52,2%). A maioria foi RAM do tipo A. As RAM graves e fatais tambÃm ocorreram. As QT foram de origem hospitalar (n=120), com Ãnfase para a mudanÃa de coloraÃÃo (47,1%) e falta de eficÃcia (22,3%). Foram identificados na literatura 10 excipientes farmacÃuticos de risco, sendo 03 responsÃveis por RAM coletadas no banco de dados do CEFACE. O estudo de RAM e QT, bem como o estabelecimento de seus fatores condicionantes por um centro de farmacovigilÃncia tÃm grande importÃncia no contexto da saÃde pÃblica e do uso racional de medicamentos. Tanto o profissional notificador, como a populaÃÃo em geral, deve ser incentivado a notificar toda suspeita de RAM e QT aos ÃrgÃos responsÃveis para que sejam estabelecidas medidas administrativas, dentre elas: a) Retirada de produtos inadequados do mercado; b) MudanÃas nas suas bulas e c) RestriÃÃo de uso na populaÃÃo. O levantamento na literatura cientÃfica demonstra de forma clara que, o envolvimento dos excipientes à um fator de risco para a ocorrÃncia de RAM, possibilitando sua inserÃÃo no estudo de causalidade de casos suspeitos. / Drugs are the mainly therapeutical tool to the recoverying or maintenance of the population health condiction. Among the most common problems related for it are Adverse Drug Reactions (ADR) and Technical Complains (TC), being need this survey through the management, and development of activities of pharmacovigillance with the creation of helperâs and notifiers centers. Evaluate the ADR and TC sended to and analized by the pharmacovigillance center of ceara during its nine years of function toward to public health and rational use of drugs. Were collected All the ADR and TC notifications in the database of CEFACE, during the period of January 1997 to December 2005, being analized the following variables: gender and age, origin of the notification, notifier, drug involved, ADR, causality and severity classification of these ones and the kind of ADR according to Rawlins and Thompson. About the TC, the variables being: origin of notification, kind of TC, notifier, and drug or medical material involved. Also A research was made to identify in literature the possibility of pharmaceutical excipients being risks factors to cause ADR, using as initial data the 11 drugs most sold in the brazilian market in the period of November/02 to November/03 and their respective compositions. Lately was made the retrieve of cases with the involvement of these excipients in studies of suspects clinical cases. In the analized period, January 1997 to December 2005, the CEFACE registered 1.293 notifications. Of these ones, 1.172 (90,6%) ADR cases and 121 (9,4%) TC. There was a significant reduction of the number of notification during the years. Most of the ADR were registered in females (62,7%) and age of 21-30 anos (17,7%). Active search was the greatest notification method (59,3%). 85,6% (ADR) came from in hospitals with a percentual of publics in 81,6%. The therapeutical group with greatest involvement most was antibiotics for systemic use (40,0%). %). The skin system (48,5%) to be detached inside of the reported ADR. For causality, the higher number of ADR were classified as probably (44,1%) and for severity the highest percentual were considered as moderate (52,2%). Most were ADR A type. The severe and fatal ADR also occurred. The TC came from in hospitals (n=120), with emphasis to changing of color (47,1%) and lack of effectiveness (22,3%). In the literature were identified 10 risk pharmaceutical excipients, being 03 responsible for ADR collected in CEFACE database. The study of ADR and TC, as well as the establishment of their conditioners factors by a pharmacovigillance center, has large importance in public health and rational use of drugs context. Both the professional notifier and the population must be encouraged to notify all the suspects of ADR and TC to the responsable groups to be taken administrative measures among them: a) retrieve of inapropriated products from market; b) change in the labels and c) restriction in the use by population. The research in scientific literature shows in a clear way that, the involvment of excipients is a risk factor to ADR occurrence, enabling your insertion in the causality study of suspects cases.

Health care systems in Saudi Arabia and elsewhere play a significant role in the lives of individuals as well as society at large. Although healthcare aims at enhancing the quality of life it can sometimes happen that treatment itself can lead to a diminution of the quality of life due to unexpected adverse effects. These problems may cause therapeutic failures or even drug-related morbidity and mortality. Consequently there is a need to have in place a system, conventionally known as Pharmacovigilance. The aims of Pharmacovigilance are to identify, quantify and continuously monitor all drug use through a system which would enable all health care professionals such as physicians, pharmacists, dentists and nurses to contribute. This thesis investigated the present knowledge of and use of, the Pharmacovigilance system in Makkah, in the Kingdom of Saudi Arabia. A mixed method yielded data that provided depth and breadth to the findings of this study. A questionnaire was designed for 170 community pharmacists and 310 respondents drawn from different medical roles across the seven hospitals in Makkah yielded some useful results. Resistance to change was identified in some groups but it was of interest to discover that 72% of respondents who admitted that their knowledge was insufficient were, nevertheless, agreed about its importance. Key issues from the analysis of the questionnaire were used to design the second phase of the sequential mixed method which involved semi structured interviews with seven senior pharmacists, one from each of the seven hospitals. Analysis yielded three overarching categories: Technology, Internalisation and Motivation. A follow up feedback survey at the end of a lecture, of a group of pharmacy students enhanced the overall findings of the study and revealed a very high degree of interest and acceptance of Pharmacovigilance reporting systems and an expressed desire for its inclusion as a subject in its own right in their training programme. Conflicting epistemological positions inherent in a mixed method are candidly admitted and no attempt is made to circumvent this difficulty. Rather, the enhanced nature of the findings is highlighted despite the opposing knowledge claims of both approaches. A key finding was that 59% of the respondents were unaware of the Saudi National Pharmacovigilance centre (NPC) and reporting arrangements. The problems of lack of internet access and of suitable reporting forms were important contributory reasons for the under-usage of the system. There is a need to raise awareness of all pharmacists of the importance of the knowledge and practice of Pharmacovigilance. Technological solutions should be implemented to facilitate reporting at all levels. Continuing professional development should include Pharmacovigilance. Resistance to change can be addressed by identifying the motivational factors that can lead to a more wholehearted acceptance of the importance of Pharmacovigilance for patient care and well-being. Indeed, these could well be the focus of future studies. / Ministry of Interior, KSA

Yes / Proactive deprescribing - identifying and discontinuing medicines where harms outweigh benefits - can minimise problematic polypharmacy, but has yet to be implemented into routine practice. Normalisation process theory (NPT) can provide a theory-informed understanding of the evidence base on what impedes or facilitates the normalisation of routine and safe deprescribing in primary care. This study systematically reviews the literature to identify barriers and facilitators to implementing routine safe deprescribing in primary care and their effect on normalisation potential using NPT.PubMed, MEDLINE, Embase, Web of Science, International Pharmaceutical Abstracts, CINAHL, PsycINFO and The Cochrane Library were searched (1996-2022). Studies of any design investigating the implementation of deprescribing in primary care were included. The Mixed Methods Appraisal Tool and the Quality Improvement Minimum Quality Criteria Set were used to appraise quality. Barriers and facilitators from included studies were extracted and mapped to the constructs of NPT. A total of 12,027 articles were identified, 56 articles included. In total, 178 barriers and 178 facilitators were extracted and condensed into 14 barriers and 16 facilitators. Common barriers were negative deprescribing perceptions and suboptimal deprescribing environments, while common facilitators were structured education and training on proactive deprescribing and utilising patient-centred approaches. Very few barriers and facilitators were associated with reflexive monitoring, highlighting a paucity of evidence on how deprescribing interventions are appraised. Through NPT, multiple barriers and facilitators were identified that impede or facilitate the implementation and normalisation of deprescribing in primary care. However, more research is needed into the appraisal of deprescribing post-implementation. / This research was funded by the National Institute for Health and Care Research (NIHR) Yorkshire and Humber Patient Safety Translational Research Centre (NIHR Yorkshire and Humber PSTRC).

Introdução: Reação Adversa a Medicamento (RAM) é qualquer resposta prejudicial ou indesejável e não intencional que ocorre com medicamentos em doses normalmente utilizadas no homem para profilaxia, diagnóstico, tratamento de doença ou para modificação de funções fisiológicas. Atualmente, representa uma das principais causas de morbidade e mortalidade na área da saúde. Objetivo: Analisar as reações adversas a medicamentos e fatores associados em pacientes ortopédicos tratados com antibióticos. Método: Coorte prospectiva conduzida com 273 pacientes ortopédicos internados no Instituto Nacional de Traumatologia e Ortopedia, Rio de Janeiro, Brasil. A coleta de dados ocorreu nos anos de 2012 e 2013, por meio de instrumento composto por variáveis demográficas-clínicas e terapia medicamentosa. Para identificação das RAMs realizou-se o monitoramento ativo, composto de: entrevista, análise de prontuários e exames laboratoriais. As RAMs consideradas graves foram analisadas por meio do formulário do Instituto Catalão de Farmacologia, Espanha. Na análise dos dados utilizaram-se os testes Mann-Whitney, Qui-Quadrado, exato de Fisher e regressão logística, com significância de p 0,05. Resultados: A incidência de RAM foi de 41%. O grupo com RAM apresentou maior média de idade (43,3; DP 10,9), tempo de internação (72,7; DP 40,9) e número de medicamentos concomitantes (13,2; DP 4,1). Os fatores associados foram número de medicamentos, uso de antimicobacteriano (OR 2,44; IC 1,3944,270) e carbapenêmicos (OR 2,38; IC 1,167 4,872). Identificaram-se 466 RAM, cuja maioria (67,1%) foi classificada como leve. No grupo de pacientes com RAMs graves identificaram-se leucopenia (46,6%), insuficiência renal aguda (40%) e hepatite medicamentosa (26,6%). Os antibióticos foram os principais medicamentos suspeitos de causar as RAMs graves (76,4%), sendo os mais frequentes (23,5%) formados pela tríade: amicacina + vancomicina + piperacilina com tazobactam. Conclusão: A incidência de RAM é maior quando se incorpora ao serviço de farmacovigilância a técnica de monitoramento contínuo dos pacientes hospitalizados e se utiliza a analise de exames laboratoriais como preditores para suspeitas de RAMs potencialmente graves / Introduction: Adverse Drug Reaction (ADR) is any noxious, undesired or unintended response which occurs in the use of normal dosages of drugs for prophylaxis, diagnosis, treatments or for modifying physiologic functions. Nowadays, ADR represents one of the main causes of morbidity and mortality in the health service area. Objective: To analyze the occurrence of adverse reaction to drugs and factors related to orthopedic patients treated with antibiotics. Method: The prospective cohort study was conducted in 273 orthopedic patients hospitalized at the Brazilian Institute of Traumatology and Orthopedics in Rio de Janeiro. The data collection was made during the years 2012 and 2013, using instruments composed by demographic-clinical variables and drug therapies. With the purpose of identifying occurrences of ADRs, during active monitoring, interviews were conducted, medical charts and exams were analyzed. In addition, the occurrence of ADRs considered harmful was analyzed by using a form provided by the Catalan Institute of Pharmacology, Spain. In the study of the data collected, was made use of Mann-Whitney tests, Chi-Squared test, Fishers exact test and logist regression, with p-value 0,05. Results: The occurrence of ADRs was of 41%. This group was composed by individuals with major age rage (43,3, SD 10,9), major time spent hospitalized (72,7; SD 40,9), and quantity of concurrent drugs used (13,2; SD 4,1). Also, the related factors were the number of drugs, the usage of Antimicobacterial agents (OR 2,44, CI 1,394-4,270) and Carbapenemases (OR 2,38; CI 1,167 4,872). During the study, there were identified 466 ADRs, and the majority (67,1%) was classified as low-grade. Additionally, in the group of patients with harm adverse reactions, it was possible to identify leukopenia (46,6%), acute kidney failure (40%) and drug-induced hepatitis (26,6%). The antibiotics were the main drugs suspected to be the cause of potentially harmful ADRs (76,4%), being the most frequent (23,5%) formed by the triad: amikacin + vancomycin + piperacillin-tazobactam. Conclusion: The occurrence of ADRs is higher when the practice of continuous monitoring of hospitalized patients is incorporated to the pharmacovigilance service, and the analyzes of lab exams are used as predictors for the suspicion of potentially harmful ADRs

A despeito de suas limitações, os dados do SIHSUS são os mais sistemáticos e abrangentes sobre as Reações Adversas e Intoxicações a medicamentos que provocam hospitalização. Eles demonstram a importância das ações de educação e investigação de casos do Programa Nacional de Farmacovigilância para possibilitar o diagnóstico mais acurado e superação do quadro atual de ocorrência desses agravos, além da possibilidade de o SIH/SUS ser utilizado sistematicamente como fonte de dados na detecção e análise dos problemas relacionados a medicamentos. No período de 1999 a 2007, foram emitidas 6.670.609 AIH (tipo 1), entre as quais 3.611 foram classificadas como internações devidas a RAM e 4.675 como Intoxicações, correspondendo, respectivamente, às taxas médias de 5,41 casos por 104 AIH e 7,2 casos por 104 AIH. Ocorreram 137 óbitos (3,79% das AIH) por RAM e 207 (4,43% das AIH) por Intoxicações na população internada. Tanto as RAM como as Intoxicações tiveram menor chance de levar ao óbito quando comparados às outras causas. Uma característica da distribuição dos RAM foi concentrar 62% das AIH nas faixas etárias de 20 a 59 anos de idade (grupo adulto). Nas Intoxicações merece destaque a elevada proporção de AIH na faixa etária de 0-4 anos (14,29%). As AIH registradas com causas básicas relacionados a RAM foram principalmente de pacientes do sexo masculino, já as Intoxicações foram principalmente de pacientes do sexo feminino. Em ambos tipos de agravos estes pacientes foram internados em hospitais que não faziam parte da Rede de Hospitais Sentinelas do Programa Nacional de Farmacovigilância. No entanto, a probabilidade destes hospitais registrarem as AIH com códigos CID-10 referentes às RAM é maior, o que ocorre provavelmente por estarem mais capacitados em diagnosticar este tipo de agravo. Porém este fato não foi observado para as Intoxicações. Os fármacos que causaram os agravos estudados são psicoativos. Este estudo apresentou algumas evidências sobre a distribuição da morbi-mortalidade provocada por medicamentos entre pacientes internados em hospitais conveniados ao SUS no período de 1999-2007, baseadas nas informações das AIH, que podem ser úteis ao Programa de Farmacovigilância no Estado do Rio de Janeiro. / Despite its limitations, the data SIHSUS are the most systematic and comprehensive on Adverse Reactions and Drug Poisonings causing hospitalization. They demonstrate the importance of these actions and investigation of cases of National Pharmacovigilance Programme to enable the most accurate and overcoming the current frame of event occurrences diagnosis, beyond the possibility of SIH / SUS be systematically used as a data source in the detection and analysis of drug-related problems. In the period 1999-2007, were issued 6,670,609 AIH (type 1), among which 3,611 were classified as hospitalizations due to poisoning as RAM and 4675, corresponding, respectively, at average rates of 5.41 cases per 104 AIH and 7.2 cases per 104 AIH. There were 137 deaths (3.79% of AIH) by RAM and 207 (4.43% of AIH) by poisoning in hospitalized population. Both the RAM as poisoning were less likely to cause death when compared to other causes. A characteristic distribution of RAM was concentrating 62% of AIH in the age groups 20-59 years of age (adult group). In Poisoning deserves the high proportion of AIH aged 0-4 years (14.29%). The AIH registered root causes related ADRs were mostly male patients, since the poisoning were mainly female patients. In both types of injuries these patients were admitted to hospitals that were not part of the Network of Sentinel Hospitals of the National Pharmacovigilance Programme. However, the likelihood of these hospitals register the AIH with ICD-10 codes related to RAM is higher, which is probably because they are better able to diagnose this type of offense. However this was not observed for the poisoning. The drugs that caused the diseases studied are psychoactive. This study presented some evidence on the distribution of morbidity and mortality caused by drugs among patients admitted to the SUS hospitals during the period 1999-2007, based on the information of AIH, which may be useful to Pharmacovigilance Programme in the State of Rio de Janeiro .