Spontaneous reporting systems (SRSs) for adverse drug reactions (ADRs) have been developed as a result of the thalidomide disaster, whereby thousands of children world-wide were born with birth defects. The Swedish Adverse Drug Reactions Advisory Committee was established in 1965. Since 1975, reporting has been compulsory for all suspected serious or new ADRs. International collaboration started in 1968 with countries contributing their ADR reports to an international database set up by the World Health Organization. ADRs represent the negative side of the benefit-to-risk balance that in theory needs to be counteracted by perceived or established positive drug effects. All drugs are subject to preclinical and clinical testing prior to marketing authorization. However, these studies are insufficient to detect rare ADRs, ADRs that occur after long-term administration or with latency, ADRs that occur in special patient groups such as children, the elderly, patients with renal or hepatic insufficiency or patients on concomitant drug treatment, and ADRs that represent a modest increase in the risk of diseases (including mortality) that are prevalent in the study population. Postmarketing surveillance of drugs is therefore essential, and regulatory action may be needed on the basis of new ADR information. SRSs are important sources of ADR information as exemplified here by the evaluation of peripheral sensory disturbances with fluoroquinolones, hyponatremia with antidepressants, blood dyscrasias with dipyrone, glucose intolerance with atypical antipsychotics, pulmonary embolism with combined oral contraceptives and extrapyramidal symptoms with selective serotonin reuptake inhibitors. SRSs can be used to study clinical manifestations of ADRs (that can give insights into potential ADR mechanisms), risk factors for the ADR or for specific outcomes of the ADR, and ADR reporting incidences when combined with sales data. Signals from SRSs may need to be studied further e.g., by use of large-scale epidemiologic studies based on record linkage between drug prescription databases and health databases. Owing to the rapid availability of information, however, SRSs are likely to remain of major importance for the post-marketing surveillance of drugs.

The importance and use of data and information to make sound programmatic decisions are receiving increased attention as state and federal funding for public health programs grows tighter and as demands for accountability continue. This dissertation provides insight into fundamental questions regarding the utilization of a Web-based reporting system on knowledge management practices for Tobacco Prevention Programs and examines what happened in Texas after the merger of the Tobacco Prevention Program into the Substance Abuse Prevention Program. A phenomenological qualitative approach was used to explore meaning of actions and to identify common themes as they relate to information sharing and utilization of Texas’ Program Management and Tracking System (PMATS). Twenty-four semi-structured interviews were conducted. First, core functions of PMATS are examined through the experiences of its end-users; and second, the impact of the merger on retention and use of PMATS within the Department of State Health Services is explored. Four themes were identified as they relate to core functions of PMATS, including its use as a codification system, its use to track performance measures, and its use for report generation and for programmatic decision-making. These four primary uses of PMATS remained the same pre- and post- merger, although how the systems were utilized during these periods differed. A central theme that permeated all interviews was the impact of the merger of the Tobacco Control Program into the Substance Abuse Program on individual beliefs and attitudes (i.e., job security, low morale, etc.), on systems characteristics (i.e. feedback, internal reporting structures, etc.), and on organizational culture (i.e., training, leadership, etc.). Since entering into PMATS was contractually required, individual attitudes and beliefs did not impact use of PMATS. However, competing IT systems, lack of a champion, lack of knowledge and support by upper management, and lack of communication were identified as key influences on systems characteristics and on organizational culture, which ultimately contributed to the termination of PMATS. Both applied research and practice recommendations are discussed, including IT due diligence, creating a knowledge culture, and network analysis of information sharing practices. / text

The user interface for a proposed alternative emergency service was conceived and designed for a standard touch-tone telephone. The service would allow a user to activate an automated, pre-recorded message containing information to aid emergency responders. The user must only press a few specified keys on the telephone key-pad, avoiding the need for verbal interaction with a dispatcher. The interface was designed in terms of providing the necessary instructions for activation and considering various input strategies and feedback. Icons, written instructions, and voice feedback were employed in the development of a successful and effective interface between the user and the system. Because the system is expected to attract elderly users and families with young children, the performance and attitudes of these two age groups in regard to a system prototype were examined to determine if the interface was suitable. A two and eight second initial system response time were imposed upon users to determine any effect these delays might have on user response time, error rate, and subjective attitudes. Additionally, a secondary task, designed to increase cognitive loading was employed to determine if the system is usable while the user is engaged in a dual-task environment. The dependent variables used to gauge the effects of the manipulated variables include the objective measures of user response time and error rate and subjective questionnaire responses. The results of the study indicate that the elderly adults and young children were able to activate the system successfully. System response time and cognitive loading had no significant effect on user performance or subjective attitudes. Distinct practice effects were observed. Attitude scales indicated satisfaction with the service and its interface. Finally, a significant effect of age was observed on average user response time, with the elderly activating the system quicker than the children. / Master of Science

Improving patient safety through reduction of medical errors is a national priority. One of the strategies widely utilized to address this issue is the use of incident reporting systems. The purpose of this study was to describe factors that predict the likelihood that Certified Registered Nurse Anesthetists (CRNAs) will use incident reporting systems, guided by the theory of planned behavior (Ajzen, 1991). A non-experimental, correlational research design was utilized to achieve the study aims. Following IRB approval, a cross-sectional survey was administered electronically to a random sample of practicing CRNAs. Correlational analyses and a standard logistic regression were utilized to determine the relationship between cognitive factors and CRNAs' use of incident reporting systems. Two hundred and eighty-three practicing CRNAs participated in this study. These CRNAs value incident reporting, perceive social pressure to report, and feel in control over reporting, yet had not consistently used existing incident reporting systems in the past 12 months. A CRNA’s attitude toward reporting and the degree to which he or she perceived social pressure to report, were determined to be significant predictors of the likelihood that a CRNA would use an incident reporting system. Social pressure to report was the most important factor in the prediction model. The results of this study revealed that there are missed opportunities for learning from patient safety incidents in anesthesia practice. The information gained in this study has the potential to assist organizations in the design of strategies to promote incident reporting by practicing CRNAs.

nÃo hà / A Anfotericina B Desoxicolato (ANB-D) à uma droga que possui a capacidade de produzir muitos efeitos adversos. à uma substÃncia fungicida de escolha no tratamento da maioria das micoses sistÃmicas e uma alternativa importante para o tratamento da leishmaniose visceral. O Instituto de DoenÃas Tropicais Natan Portela à o Ãnico hospital de referÃncia para o tratamento de doenÃas infecciosas e parasitÃrias no Estado do PiauÃ. Participa da Rede Sentinela da ANVISA, e atravÃs do Sistema de FarmacovigilÃncia, monitora o uso dos fÃrmacos notificando qualquer reaÃÃo adversa a medicamentos (RAM). Partindo desse pressuposto, realizou-se este estudo, observacional, retrospectivo e quantitativo, a partir do qual foram analisados os prontuÃrios de todos os pacientes que utilizaram o fÃrmaco no perÃodo de janeiro a marÃo de 2009, um total de 60 pacientes, considerando sempre as reaÃÃes adversas a medicamentos, as queixas tÃcnicas e as interaÃÃes medicamentosas do fÃrmaco com outros medicamentos presentes nas prescriÃÃes mÃdicas. A anÃlise estatÃstica for realizadapelo programa Stata/SE 10.0 for Windows (CollegeStation, Texas, USA). Entre os pacientes analisados no presente estudo, 63,3% eram do sexo masculino. A faixa etÃria com maior nÃmero de pacientes foi a de â41 ou mais anosâ com 36%. A patologia presente na grande parte dos pacientes em uso de ANB-D foi a Leishmaniose visceral com 75,0%. 93,3% dos pacientes analisados apresentaram RAMs e 11,7% dos pacientes foram a Ãbitos, os quais apresentaram uma mÃdia de 5,6 RAMs/paciente. Evidenciou-se o maior numero de RAMs no grupo etÃrio de â21 à 40 anosâ. 6,0 RAMs/paciente foi o nÃmero mÃdio observado nos pacientes que nÃo receberam a prÃ-medicaÃÃo. Dentre as RAMs com maior freqÃÃncia estiveram: febre (76,7%), calafrios (45,0%), vÃmitos (40,0%), tosse (27,0%) e cefalÃia (25,0%). Observou-se que em um total de 221 RAMs, houve predominÃncia de RAMs de gravidade moderada (57%). Visualizou-se que nÃo houve interaÃÃo medicamentosa dos medicamentos prescritos quando utilizados em associaÃÃo à ANB-D. A maior letalidade ocorreu em pacientes com idade de 21 a 40 anos. Pacientes com AIDS tinham idade entre 21 e 40 anos principalmente. Conclui-se, portanto, que sÃo muitas as RAMs provocadas pela ANB-D. InformaÃÃes incompletas/ou ausentes sobre RAMs registradas nos prontuÃrios mostrou que pode existir subnotificaÃÃo dessas reaÃÃes. Dentre os grupos etÃrios, os que mais sofrem com o aparecimento dessas reaÃÃes sÃo adultos jovens (entre 21 e 40 anos).Acredita-se que, a maior freqÃÃncia de RAMs nos pacientes que vieram a Ãbito pode ter contribuÃdo para o agravamento do quadro clÃnico dos mesmos. Pacientes com AIDS tinham idade entre 21 e 40 anos principalmente, esta doenÃa pode ter sido a razÃo da maior letalidade. / Amphotericin B Desoxicolate (AmB-D) is a drug that possesses the capacity to produce many adverse effects. It is a fungicide substance of choice in the treatment of the majority of the systemic mycosis and an important alternative for the treatment of visceral leishmaniosis. The institute of tropical diseases Natan Portela is the only hospital of reference for the treatment of parasite and infectious diseases in the state of PiauÃ. Participate of the sentinel web ANVISA, and through the farmacovigilance system, monitors the use of drugs notifying any adverse reaction to drugs. This observing, retrospective and quantitative study, was carried out in which the records of all the patients Who used the drug between january and march 2009, a total of 60 patients were analyzed, considering at all times adverse reactions to drugs, the technical complaints and the interactions of the drug with other drugs present in the medical prescription. The statistic analysis was carried out by the program Stata/SE 10.0 for Windows (College Station, Texas, USA). Among the patients analyzed in the present study, 63,3% were male. The age group with greater number of patients was â41 or overâ with 36%.The presnet pathology in most patients using AmB-D was visceral Leishmaniosis with 75,0%. 93,3% of the patients analyzed presented RAMs and 11,7% of the patients passed away. These patients presented an average of 5,6 RAMs/pacient. It was evident the greater number of RAMs in the age group from â21 to 40 yearsâ. 6,0 RAMs/pacient was the average number observed in the patients Who did not receive pre-medication. Among the RAMs with greater frequence were: fever (76,7%), chills (45,0%), vomit (40,0%), cough (27,0%) and headache (25,0%). It was observed that in a total of 221 RAMs, there was the predominance of RAMs of moderate seriousness (57%). It was observed that there was no drug interaction of the prescribed drugs when administered in association with AmB-D. Thegreater lethality happened in patients with age between 21 and 40 years. Patients with AIDS were aged between 21 and 40 years, mainly. It was concluded, therefore, that there are many RAMs caused by AmB-D. Incomplete or absent Information about RAMs registered in the records have shown that there may exist sub-notifications of these reactions. Among the age groups, the ones who suffers most with the appearing of these reactions are Young adults (between 21 and 40 years). It is believed that, the greater frequency of RAMs in the patients who passed away could have contributed for the worsening the clinical picture of these patients. Patients with AIDS were aged between 21 and 40 years mainly, this could have been the reason of greater lethality.

A call taker is the first point of contact in the emergency service system and thus the interface between the caller and ambulance dispatch. Misunderstandings in an emergency call have implications for the survival of patients. Using an applied conversation analytic approach this study examined participants’ use of conversational repair as an interactional strategy. Data included 101 calls from a South African emergency medical services call centre. The data set was comprised of two distinct subsets, namely: the 107 and public corpora. The 107 corpus (53 calls) contained calls from a general emergency call centre. The 107 caller thus served as a mediating party on behalf of the public caller. The public corpus (48 calls) comprised calls received directly from members of the public. The data subsets afforded a unique opportunity to analyse ways in which participants to an emergency call manage asymmetries of knowledge. Differential patterns of the type and purpose of repair were tracked across both data sets and similarities and differences were explored. Both data sets showed that participants’ choice of interactional strategies was customized based on an ongoing assessment of knowledge asymmetries. However, whilst knowledge asymmetries posed some constraints an overriding interactional constraint, inherent within the institutional nature of the emergency call, was a rigid adherence to routinized protocols. The call taker’s dilemma was thus identified as the management of these constraints through the frequent use of conversational repair. Although a level of responsiveness is required to glean quality information from callers, high volumes of emergency calls would not be possible without routinized protocols. However, increased orientation to routinized protocols led to a decreased orientation to responsiveness. This research therefore showed that knowledge symmetry is not necessarily more advantageous but that successful call trajectory is reliant on the call taker’s ability to maximize the collaborative nature of the interaction and effectively negotiate through the judicious use of repair and other relevant interactional strategies. This has important implications for call taker training.

Nesta pesquisa foram avaliados 186 idosos hospitalizados quanto ao aparecimento de reações adversas a medicamentos (RAM). Encontrou-se 199 RAM (1,07 por paciente). Para 11,3% dos idosos a RAM constituiu a causa da internação, para 17,2% estava presente à internação mas não como causa e 46,2% apresentaram RAM durante a hospitalização. As RAM sérias mais comuns foram a insuficiência renal aguda, a hipercalemia e a hipotensão postural. Concluiu-se que houve uma prevalência importante de RAM nesses pacientes, encontrando-se como fatores de risco significativos o número de diagnósticos, o número de medicamentos e o uso de medicamento inapropriado para idosos / The present study evaluated the prevalence of adverse drug reactions (ADR) among 186 hospitalized elderly. A total of 199 ADR were founded (1.07 per patient). For 11.3% of the patients the ADR was the cause of hospitalization, for 17.2% the ADR was present at hospitalization but not as the cause and for 46.2% it was presented during hospitalization. The most common serious ADR were acute renal insufficiency, hyperkalemia and postural hypotension. We concluded that a significant prevalence of ADR was found among that patients, with the number of diagnosis, the number of drugs and the use of a drug considered to be inappropriate as risk factors

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

Submitted by Luanna Matias (lua_matias@yahoo.com.br) on 2015-02-09T16:23:35Z No. of bitstreams: 2 Dissertação - Ana Carolina Figueiredo Modesto - 2014.pdf: 6541862 bytes, checksum: e3323351d0b19ca89de7c95a670ee23b (MD5) license_rdf: 23148 bytes, checksum: 9da0b6dfac957114c6a7714714b86306 (MD5) / Approved for entry into archive by Erika Demachki (erikademachki@gmail.com) on 2015-02-12T17:42:48Z (GMT) No. of bitstreams: 2 Dissertação - Ana Carolina Figueiredo Modesto - 2014.pdf: 6541862 bytes, checksum: e3323351d0b19ca89de7c95a670ee23b (MD5) license_rdf: 23148 bytes, checksum: 9da0b6dfac957114c6a7714714b86306 (MD5) / Made available in DSpace on 2015-02-12T17:42:48Z (GMT). No. of bitstreams: 2 Dissertação - Ana Carolina Figueiredo Modesto - 2014.pdf: 6541862 bytes, checksum: e3323351d0b19ca89de7c95a670ee23b (MD5) license_rdf: 23148 bytes, checksum: 9da0b6dfac957114c6a7714714b86306 (MD5) Previous issue date: 2014-07-09 / Fundação de Amparo à Pesquisa do Estado de Goiás - FAPEG / Background: The use of drugs isn’t harmless, and require greater attention by health professionals to assist in identifying and preventing adverse drug reactions. These, and other problems related to drug use are the subject of study of pharmacovigilance. It becomes necessary knowledge by health professionals to improve patient safety. Objective: To measure the knowledge and attitudes among healthcare professionals in a teaching hospital towards adverse drugs reactions and a pharmacovigilance program. Methodology: Cross-sectional study conducted from October 2013 to January 2014 with 54 health professionals in a medical unit and in the pharmacy of a sentinel hospital. Data were collected through a questionnaire divided into three sessions: the first is the profissiographic and demographic characteristics of health professionals, and the subsequent identification of knowledge on adverse drug reactions and Pharmacovigilance hospital program. Results: There was a predominance of technical professionals in nursing (35.2%), female (79.6%), aged between 26 and 30 years (33.4%). Almost half of the participants (46.2%) had knowledge about adverse drug reactions, likewise 35.8% did towards pharmacovigilance. The probability of having knowledge about adverse drug reactions increases with longer professional training and activities at the institution, and the same does not occur with the knowledge of pharmacovigilance. Regarding the institutional knowledge, only 11.1% of participants stated that they know the site that has operations across the suspected adverse drug reactions and 38.9% reported the knowledge about the inclusion of the institution on a pharmacovigilance program. Conclusion: There was a predominance of female professionals, the technical area in nursing and training time and work at less than or equal to five years institution. It was observed that doctors have more knowledge about the concept of adverse drug reaction, and nurse technician, the lowest. Health professionals had little knowledge about the location of the institution that has operations across the adverse drug reactions and inserting the same in any program pharmacovigilance. / Introdução: A utilização de medicamentos não está isenta de riscos, maior atenção por parte dos profissionais de saúde pode auxiliar na identificação e prevenção das Reações Adversas a Medicamentos (RAM). Estas, e demais problemas relacionados ao seu uso são objeto de estudo da Farmacovigilância (FV). Faz-se necessário seu conhecimento, por parte dos profissionais de saúde, como forma de contribuir para a segurança do paciente. Objetivo: Identificar os conhecimentos e condutas de profissionais de saúde de um hospital de ensino frente às Reações Adversas a Medicamentos e ao programa de Farmacovigilância hospitalar. Metodologia: Estudo transversal, com coleta de dados realizada no período de outubro de 2013 a janeiro de 2014 com 54 profissionais de saúde em uma unidade de clínica médica e no serviço de farmácia de um hospital da rede sentinela. Os dados foram coletados por meio de um questionário dividido em três sessões: a primeira consiste na caracterização demográfica e profissiográfica dos participantes, e as subsequentes, na identificação dos conhecimentos e condutas sobre as Reações Adversas a Medicamentos e ao programa de Farmacovigilância hospitalar. Resultados: Quase metade dos participantes (46,2%) mostraram conhecimentos sobre RAM, destes, os médicos foram os que detém maior conhecimento em relação aos demais profissionais (p=0,00). Em contrapartida, os técnicos em enfermagem mostraram menos conhecimento (p=0,00). Um total de 35,8% dos participantes do estudo mostraram conhecimentos em relação à FV, destes, os farmacêuticos demonstraram maior conhecimento em relação aos demais profissionais (p=0,00), em oposição, os médicos apresentaram menores conhecimentos sobre este conceito (p=0,01). A probabilidade de apresentar conhecimentos sobre as RAM aumenta em profissionais com maior tempo de formação e atuação na instituição, e o mesmo não ocorre com os conhecimentos sobre a farmacovigilância. Somente 11,1% dos participantes declararam conhecer o local que tenha atuação frente às suspeitas de RAM e 38,9% mencionaram o conhecimento acerca da inserção da instituição em um programa de FV. Conclusão: Houve predominância de profissionais do sexo feminino, da área técnica em enfermagem e tempo de formação e de trabalho na instituição inferior ou igual à cinco anos. Observou-se, dentre os profissionais participantes do estudo, que os médicos possuem maior conhecimento sobre o conceito de RAM, e o técnico em enfermagem, o menor. Os profissionais de saúde apresentaram poucos conhecimentos quanto ao local da instituição que tenha atuação frente às RAM, bem como a inserção da mesma em algum programa de FV.

Syftet med denna studie är att undersöka vilka förändringar börsnoterade företag upplever efter konvertering till IFRS 15. Studiens vetenskapliga metod är kvalitativ forskning där datainsamlingen sker genom intervjuer. Studiens urval består av åtta respondenter från åtta olika börsnoterade företag. De utvalda respondenterna valdes på grund av sina kunskaper om IFRS 15 samt erfarenhet av FRS både före och efter implementeringen av IFRS 15. Vidare består den teoretiska referensramen av fyra organisatoriska förändringar i form av system och rapporteringssystem, interna kontroller, upplysningskrav samt kontraktsutformning. Uppsatsen har även institutionell teori som bas då den förklarar hur institutionella krafter influerar företag till att utföra förändringar. I studiens teori nämndes arbetsuppgifter som en indirekt påverkan på företag. I studien togs därmed med arbetsuppgifter som en femte förändring i den empiriska datainsamlingen. Resultat och slutsatser påvisar att majoriteten av respondenterna upplever förändring och merarbete gällande nya upplysningskrav enligt IFRS 15. Dessutom visar studien att en minoritet av respondenterna infört nya system samt interna kontroller efter konverteringen till IFRS 15. Med anledning av att samtliga företags nuvarande system och policys överensstämmer med IFRS 15, har majoriteten av respondenter upplevt att kontraktsutformning samt arbetsuppgifter förblivit oförändrade i samband med övergången till IFRS 15. / The purpose of this study is to investigate what changes listed companies experience after a transition to IFRS 15. The study's scientific method is of qualitative research where the data collection is made through interviews. The study's selection consists of eight respondents from eight different listed companies. The selected respondents were chosen because of their knowledge of IFRS 15 and experience with IFRS both before and after the implementation of IFRS 15. Furthermore, the theoretical reference framework consists of four organizational changes as in systems and reporting systems, internal controls, disclosure requirements and contract design. The study has also chosen institutional theory as the basis because it explains how institutional forces influence companies to make changes. In the theory of the study, work tasks were mentioned as an indirect impact on companies. The study therefore chose to include work tasks as a fifth change in the empirical data collection. Results and conclusions show that the majority of respondent’s experience change and additional work regarding new disclosure requirements according to IFRS 15. In addition, the study shows that a minority of respondents introduced new systems and internal controls after the transition to IFRS 15. Due to that all the companies' current systems and policies are consistent with IFRS 15, the majority of respondents’ have experienced that contract design and work tasks have remained unchanged after the transition to IFRS 15.