Analysis of Spontaneous Adverse Events Reports after Tick-Borne Encephalitis Vaccine Author: Tereza Brázdová Supervisor: PharmDr. Eva Zimčíková, Ph.D. Consultant: PharmDr. Kateřina Malá, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University Introduction and aim: Tick-borne meningoencephalitis is one of the most frequent causes of viral meningitis in Europe. In recent years, the number of cases of this infection in the Czech Republic has begun to rise. Vaccination is the only reliable protection against infection, but it also comes with some risks. Analysis of spontaneous adverse reaction reports is a key source of information for signal detection, which is used to identify drug risks. The aim of this thesis was to analyse the spontaneous reporting of suspected adverse drug reactions (ADRs), using the data from the Central Database of ADRs provided by the State Institute for Drug Control. Methodology: Descriptive statistics were performed from reporting data in the period from June 2004 to October 2017. For example, the total number of reports, the number of ADRs and the patient characteristics were analysed. We compared the adverse reactions with the Vigibase database and evaluated the expectability of reported reactions. Results: During the...

Analysis of Spontaneous Adverse Events Reports of Measles, Mumps, and Rubella Vaccine Author: Jana Kulhavá Supervisor: PharmDr. Eva Zimčíková, Ph.D. Charles University in Prague, Faculty of Pharmacy in Hradec Králové, Department of Social and Clinical Pharmacy Keywords: vaccination, measles, mumps, rubella, adverse events reports Introduction: The MMR vaccine is a combined vaccine used to vaccinate children against measles, mumps and rubella. Spontaneous reporting of adverse reactions is an important source of information to identify potential risks of medicinal products. Objective: The aim of this diploma thesis is the analytical evaluation of spontaneous reports of suspected adverse reactions after vaccination with MMR vaccine registered in the database of the State Institute for Drug Control during the period 2004 to 2017. Methods: The data were analyzed in Microsoft Excel spreadsheet software using descriptive statistics methods. The reported adverse reactions were classified into appropriate organ system classes according to the MedDRA Glossary of Medical Terminology. The expectability and severity of adverse reactions were assessed. Results: A total of 805 cases of suspected adverse reactions were reported between 2004 and 2007, which included 2,812 adverse reactions. Most suspected adverse...

Analysis of utilisation and spontaneous adverse events reports related to human papillomavirus vaccines Author: Tereza Schrommová Supervisor: PharmDr. Eva Zimčíková, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University INTRODUCTION: HPV vaccination is one of the most effective types of prevention against the human papillomavirus infection that can lower the probability of its incidence up to 80-90 %. Besides the benefits of vaccination, there can also occur among many individuals certain risks and adverse effects. Spontaneous adverse events reports are used to identify these serious and unexpected adverse effects, their monitoring leads to increasing safety of therapy. Drug consumption is monitored to uncover the ratio of population exposure to certain drug during specific time in specific socioeconomic group. OBJECTIVE: The objective of this diploma was analysis of spontaneous adverse events reports of vaccines against the human papillomavirus that are registered in database of State Institute for Drug Control in the period from May 2007 to October 2017. Another aim of this work was to evaluate consumption of HPV vaccines in the Czech Republic in the period from 2006 to 2019 using data from State Institute for Drug Control again. METHODS:...

Background: Periprocedural intravenous hydration is suggested to decrease the risk of post-ERCP pancreatitis (PEP). However, quality of evidence supporting this suggestion remains poor. Here we hypothesized that aggressive hydration(AH) could be an effective preventive measure. Methods: Pubmed, EMBASE, CINAHL, Google Scholar, Clinical Trials. gov, Clinical Key, International Standard Randomized Trial Number registry as well as secondary sources were searched through January 2019 to identify randomized controlled studies comparing AH to standard hydration (SH) for prevention of PEP. Pooled odds ratio (OR) and 95% confidence intervals (CIs) were calculated using the random-effects model. RevMan 5.3 was used for analysis. Results: A total of 9 RCTs, with 2094 patients, were included in the meta-analysis. AH reduced incidence of PEP by 56% compared to SH (OR = 0.44, CI:0.28–0.69; p = 0.0004). The incidence of post-ERCP hyperamylasemia also decreased with AH compared to SH (OR = 0.51; p = 0.001). Length of stay decreased by 1 day with AH (Mean Difference (MD): −0.89 d; p = 0.00002). There was no significant difference in adverse events related to fluid overload between two groups (OR:1.29; p = 0.81) and post-ERCP abdominal pain (OR:0.35; p = 0.17). Numbers of patient to be treated with AH to prevent one episode of PEP was 17. Final results of the meta-analysis were not affected by alternative effect measures or statistical models of heterogeneity. Conclusion: Aggressive hydration is associated with a significantly lower incidence of PEP and it appears to be an effective and safe strategy for the prevention of Post ERCP pancreatitis.

Introduction Oral Non-steroidal anti-inflammatory drugs (NSAID) is an analgesia and is commonly used by people with osteoarthritis (OA). Oral NSAID is currently recommended as the second level of treatment for OA, and could be considered if physical activity, topical NSAID or paracetamol do not supply sufficient pain relief.   Aim To investigate how frequently oral NSAID is used in a sample of New Zealanders with OA and also to investigate the exposure to heightened risk of adverse events while using oral NSAID.   Method A cross-sectional survey was conducted to collect information about the use of oral NSAID by people with self-reported OA. The survey included 75 participants who were over the age of 45 with an average age of 70.6 years.   Results While having OA, 57,3% of the sample reported oral NSAID use. The results also show that 52% of the participants with cardiovascular (CV), gastrointestinal (GI) or renal comorbidities used oral NSAID, and 17,3% of them also combined that NSAID with medication for their comorbidity. Concerning the heightened risks of adverse events, 21% of the participants did acquire the analgesia over the counter (OTC), and 76,6% stated that they were over the age of 65.    Conclusion A majority of the participants in the study with self-reported OA take NSAID as an analgesia. Also, the study shows that NSAID is commonly used among participants with co-morbidity, which is similar to figures presented in previous studies in the area. However, the small sample size limits its generalizability to a larger population. / Introduktion Orala icke-steroida antiinflammatoriska läkemedel (NSAID) är en grupp smärtstillande mediciner som är vanligt använt av personer mer artros. Orala NSAID-preparat rekommenderas idag som en andrahandsbehandling och kan övervägas om fysisk aktivitet, topikala NSAID-preparat eller paracetamol inte ger tillräcklig smärtlindrande effekt.   Syfte Att undersöka hur vanligt användandet av orala NSAID-preparat är i ett stickprov av personer med artros i Nya Zeeland samt att undersöka exponering av orala NSAID-preparat i subgrupper med ökad risk för biverkningar vid användande av orala NSAID-preparat.   Metod En tvärsnittsstudie genomfördes för att samla in information kring användning av orala NSAID-preparat av personer med självrapporterad artros. Studiepopulationen bestod av 75 personer över 45 års ålder med en medelålder på 70,6 år.   Resultat 57,3% av deltagarna använder orala NSAID-preparat som behandling för sin självrapporterad artros. Gällande subgrupper med ökad risk för biverkning av NSAID användning visar studien att 52% av deltagare med kardiovaskulära, gastrointestinala eller njurpåverkade sjukdomar använder orala NSAID-preparat och av dessa kombinerar 17,3% NSAID-preparaten med medicin för sin samsjuklighet. Av deltagarna som uppgav att de använder orala NSAID-preparat erhåller 21% av dessa NSAID-preparaten receptfritt över disk. Av deltagare som var 65 år eller äldre uppgav 76,6% att de använder orala NSAID-preparat för behandling av artros.   Slutsats En majoritet av deltagarna med självrapporterad artros tar orala NSAID-preparat i smärtstillande syfte för sin artros. Studien visar också att NSAID ofta används bland deltagare med samsjuklighet, vilket motsvarar presenterade siffror från tidigare studier inom området. Den lilla stickprovsstorleken begränsar emellertid studiens generaliserbahet gentemot en större population.

Indiana University-Purdue University Indianapolis (IUPUI) / Intraoperative adverse events (IAEs) due to interprofessional miscommunication continue to occur despite implementation of surgical checklists and focused communication trainings. Much of the previous intraoperative communication research has focused on the content and quantity of interprofessional communication instead of its context and quality, and current communication interventions seem to have varying levels of engagement, effectiveness, and persistence. The purpose of this dissertation study was to explore the psychosocial processes involved during the establishment and maintenance of interprofessional communication surrounding IAEs or potential IAEs in the intraoperative environment and to identify the perceived facilitators and barriers to communication. Twenty surgical team members participated in semi-structured interviews and described their experiences with interprofessional communication during IAEs. Grounded theory methodology was used to identify the central process, Testing the Water, and two subprocesses, Reading the Room and Navigating Hierarchy. Testing the Water describes the situational nature of interprofessional communication as surgical team members navigate factors influencing the context and probable trajectories of surgical cases and the perceptions of professional rights and responsibilities within surgical teams. Participants in this study experienced Testing the Water differently based on their professional roles and tenure; findings were organized around three emerging groups identified as inexperienced nurses, experienced nurses, and surgeons. Interprofessional communication surrounding IAEs occurred for study participants in fluid, iterative phases identified as 1) Recognition, 2) Reconnaissance, 3) Rallying, 4) Reaction, and 5) Resolution. Participants recognized IAEs or potential IAEs, gathered information through reconnaissance, rallied other team members, reacted to stabilize patients, and resolved IAEs through individual or surgical team reflection. Study participants reported using strategies during communication to accomplish two psychosocial goals, preserving the flow of surgical cases, and protecting the ‘face’ of themselves and other surgical team members. Supporting these psychosocial goals through increased psychological safety for all surgical team members potentially leads to more effective, timely surgical team communication. More effective interprofessional communication facilitates the improved situational awareness, collective sensemaking, and integrated team mental models that are critical to coordinated responses to IAEs. The findings of this study suggest practical implications to increase the effectiveness of interprofessional communication in the intraoperative environment.

京都大学 / 0048 / 新制・論文博士 / 博士(医学) / 乙第13192号 / 論医博第2156号 / 新制||医||1030(附属図書館) / (主査)教授 中山 健夫, 教授 松村 由美, 教授 川村 孝 / 学位規則第4条第2項該当 / Doctor of Medical Science / Kyoto University / DFAM

Introduction: Research show that patients frequently display abnormal vital signs as much as 48h before a serious adverse event occur, such as cardiac arrest or unplanned intensive care unit admission. Therefore, early recognition of these changes trough vital sign examination is essential in the prevention of deterioration. However, deterioration is often missed.Aim: The aim was to investigate to what extent nurses in the general ward are documenting vital signs prior to patient deterioration. Methods: A systematic literature review was done usingthe databases PubMed and CINAHL. Inclusion criteria: general ward and publication 2010-2020, exclusion criteria:emergency department, acute admission ward, paediatric ward, psychiatric ward, interventions and continuousmonitoring. Critical appraisalusingtools from Joanna Briggs Institute. PRISMA statement for reporting of systematic reviews.Results: Nine studies were included. It was seen that the fraction of cases who had vital signs documented prior to deterioration was diverse, although never complete. Some studies showed an acceptable fraction of patients who weremonitoredin the hours prior to deterioration, but it was seen that the monitoring did not always escalate as the patient got worse. The vital signs most frequently documentedwereheart rate and pulse, thoughstill missing in a large fraction of charts. Respiratory rate was documented less than the other vital signs.Conclusions: This study suggests that documentation of vital signs prior to deterioration is diverse but often incomplete. Further research is needed to understand what can be done to improve vital sign documentation on general wards.

Analysis of spontaneous adverse events reports of Infanrix hexa vaccine Author: Klára Kovaříková Supervisor: PharmDr. Eva Zimčíková, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University Introduction: Infanrix hexa vaccine is used for vaccination of infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b. Analysis of spontaneous adverse drug reactions (ADRs) reports is one of the most important sources of information to evaluate drug-related risks. Objective: The aim of this study was to analyse spontaneous ADRs reports of Infanrix hexa vaccine, which were sent to the State Institute for Drug Control (SÚKL) database in the period from 2004 to 2017. Methods: The data was analysed using descriptive statistic in MS Excel. ADRs were classified according to the MedDRA. Seriousness and expectedness of ADRs were evaluated. Results: Overall 1288 reports were obtained containing 4334 ADRs, approximately 3.4 ADRs per report. Infanrix hexa vaccine was the only suspected drug in most of the reports (75.9%). Physicians were the most frequent reporters (70.2%). Serious ADRs were found in 84.3% of reports. The most frequent ADRs were general disorders and administration site...

Department of Defense (DoD) implemented Human Social Cultural and Behavior (HSCB) program to meet the need to develop capability to understand, predict and shape human behavior among different cultures by developing a knowledge base, building models, and creating training capacity. This capability will allow decision makers to subordinate kinetic operations and promote non-kinetic operations to govern economic programs better in order to initiate efforts and development to address the grievances among the displeased by adverse events. These non-kinetic operations include rebuilding indigenous institutions’ bottom-up economic activity and constructing necessary infrastructure since the success in non-kinetic operations depends on understanding and using social and cultural landscape. This study aims to support decision makers by building a computational model to understand economic factors and their effect on adverse events. In this dissertation, the analysis demonstrates that the use of cellular automata has several significant contributions to support decision makers allocating development funds to stabilize regions with higher adverse event risks, and to better understand the complex socio-economic interactions with adverse events. Thus, this analysis was performed on a set of spatial data representing factors from social and economic data. In studying behavior using cellular automata, cells in the same neighborhood synchronously interact with each other to determine their next states, and small changes in iteration may yield to complex formations of adverse event risk after several iterations of time. The modeling methodology of cellular automata for social and economic analysis in this research was designed in two major implementation levels as follows: macro and micro-level. In the macro-level, the modeling framework integrates iv population, social, and economic sub-systems. The macro-level allows the model to use regionalized representations, while the micro-level analyses help to understand why the events have occurred. Macro-level subsystems support cellular automata rules to generate accurate predictions. Prediction capability of cellular automata is used to model the micro-level interactions between individual actors, which are represented by adverse events. The results of this dissertation demonstrate that cellular automata model is capable of evaluating socio-economic influences that result in changes in adverse events and identify location, time and impact of these events. Secondly, this research indicates that the socioeconomic influences have different levels of impact on adverse events, defined by the number of people killed, wounded or hijacked. Thirdly, this research shows that the socio-economic, influences and adverse events that occurred in a given district have impacts on adverse events that occur in neighboring districts. The cellular automata modeling approach can be used to enhance the capability to understand and use human, social and behavioral factors by generating what-if scenarios to determine the impact of different infrastructure development projects to predict adverse events. Lastly, adverse events that could occur in upcoming years can be predicted to allow decision makers to deter these events or plan accordingly if these events do occur.