Diss. (sammanfattning) Stockholm : Karol. inst. / Härtill 7 uppsatser.

Univ., Fak. Wirtschafts- und Sozialwiss., Diss.--Hamburg, 2005.

Thesis (Ph.D. )--University of Tennessee Health Science Center, 2007. / Title from title page screen (viewed on June 20, 2008 ). Research advisor: Clinton Stewart, Pharm.D. Document formatted into pages (xvi, 129 p. : ill.). Vita. Abstract. Includes bibliographical references (p. 112-129).

Thesis (M. Com.)--University of Canterbury, 2009. / Typescript (photocopy). "March 2009." Includes bibliographical references (leaves 81-82). Also available via the World Wide Web.

Augsburg, Univ., Diss., 2008.

<b>Background:</b> The aim of this thesis was to develop an evidence-based approach to the post-marketing withdrawal of medicinal products when harms are attributed to their use. <b>Methods:</b> Electronic and non-electronic searches were conducted to identify medicinal products withdrawn from the market because of adverse reactions. Data relating to the time periods between launch, first adverse reaction reports and withdrawals, the mechanism through which the adverse reactions occurred, and the countries of withdrawal were extracted. Standard criteria were used to document the levels of evidence used by drug regulators to make the withdrawal decisions; scatter plots and two-by-two tables used to explore the trends over time. A previously published algorithm was used to examine the justification for withdrawals. To examine the benefits and harms of medicinal products before regulatory approval, searches were conducted on drug regulatory websites and scientific databases. The Cochrane criterion was used to examine the risk of bias, Review Manager Software for meta-analysis, and GRADE criterion to rate the quality of evidence. <b>Results:</b> Improvements in pharmacovigilance over the past six decades have resulted in quicker detection of harms caused by approved medicinal products; however, there have not been corresponding improvements in how quickly harmful products are withdrawn from the market following the reports of harms. Harmful drugs are significantly less likely to be withdrawn in low resource settings. The quality of evidence in drug trials for which regulatory approval decisions are based is on the whole, poor. There is a lack of consistency in the methods used by drug regulators to assess the harms of medicinal products before granting marketing licences. <b>Conclusions:</b> Universally accepted guidelines for deciding when to withdraw approved medicinal products from the market should be developed. Pharmacovigilance systems in low-resource settings should be strengthened. The methods used to assess harms in clinical trials require improvement.

BACKGROUND: Transport of patients is sometimes necessary and unavoidable. However, there are many risks related to it. For this reason, safety of intra-hospital transport has been thoroughly studied in critical care patients; however there is no literature on adverse events during transport of trauma patients. Due to the acute nature of injury, trauma patients are fundamentally different than other populations of patients and require special consideration during transport. Lack of data makes initiating new protocols for transport conditions difficult. METHODS/RESULTS: Data from all activated trauma response patients who required transport to and from the CT scanner from the period of January 01, 2010 to December 31st, 2013 (total of 1103 patients) were collected. From these patients, 17 adverse events were identified (2.0% excluding missing documentation). Vomiting was the most common adverse event followed by peripheral IV line dislodgment. There were no cardiac arrests or deaths resulting from transport related events. CONCLUSION: Defining adverse events is a key part of evaluating safety during transport. Fluctuations in vital signs and other objective measures may reflect patient disease rather than transport. Our study provides clear definitions of what an adverse event is using outcomes and objectively identifies measures necessary for safe transport as well as areas of improvement.

abstract: For more than twenty years, clinical researchers have been publishing data regarding incidence and risk of adverse events (AEs) incurred during hospitalizations. Hospitals have standard operating policies and procedures (SOPP) to protect patients from AE. The AE specifics (rates, SOPP failures, timing and risk factors) during heart failure (HF) hospitalizations are unknown. There were 1,722 patients discharged with a primary diagnosis of HF from an academic hospital between January 2005 and December 2007. Three hundred eighty-one patients experienced 566 AEs, classified into four categories: medication (43.9%), infection (18.9%), patient care (26.3%), or procedural (10.9%). Three distinct analyses were performed: 1) patient's perspective of SOPP reliability including cumulative distribution and hazard functions of time to AEs; 2) Cox proportional hazards model to determine independent patient-specific risk factors for AEs; and 3) hospital administration's perspective of SOPP reliability through three years of the study including cumulative distribution and hazard functions of time between AEs and moving range statistical process control (SPC) charts for days between failures of each type. This is the first study, to our knowledge, to consider reliability of SOPP from both the patient's and hospital administration's perspective. AE rates in hospitalized patients are similar to other recently published reports and did not improve during the study period. Operations research methodologies will be necessary to improve reliability of care delivered to hospitalized patients. / Dissertation/Thesis / M.S. Industrial Engineering 2012

Philosophiae Doctor - PhD / The aim of the study was to detect the prevalence of AV and its associated bacteria with preterm delivery in the Western Cape, South Africa. Furthermore, it sought particularly to examine and investigate the predictive value of GBS and E. faecalis for preterm delivery (PTD). It also aimed to establish other factors which may predict adverse pregnancy outcomes. Three hundred and one pregnant women were recruited from four different antenatal in the Western Cape, South Africa. The study conformed with the Declaration of Helsinki (2013). Maternal data was collected from a questionnaire and maternal medical records. Vaginal and rectal swabs were collected and microscopically examined for AV, followed by culture characterization of GBS and E. faecalis. Antimicrobial susceptibility testing was also performed. In this study, AV was detected in 79 (26.2%) of the 301 pregnant women, and GBS and E. faecalis isolated from 50 (16.6%) and 21 (7.0%) respectively. GBS serotype V was the predominant serotype, followed by serotype III. Pulse field gel electrophoresis (PFGE) profile analysis for both GBS and E. faecalis yielded a total of 24 restrictions profiles for GBS and 16 for E. faecalis. Multivariable analysis revealed that parity, gravidity, vaginal discharge, urinary tract infection, and smoking were significantly associated with PTD. The results from the study provides improved guidelines maternal screening of pregnant women. The early detection of AV-related bacteria may significantly reduce maternal and neonatal morbidity.

Objetivo: A segurança no uso de medicamentos tem constituído importante indicador na assistência prestada em nível hospitalar. Para tanto, este estudo propõe avaliar o impacto clínico e econômico da implantação de um programa de farmacovigilância (PFV) intensiva em um hospital geral, através do monitoramento de reações adversas à vancomicina. Delineamento: Coorte. Amostra: 689 pacientes constituíram a amostra, sendo 151 acompanhados antes do PFV e 538 depois PFV. Principais Medidas: Ocorrência de reação adversa a medicamento (RAM) baseado no algoritmo de Naranjo e estimativa de custos hospitalares. Resultados: Houve redução na ocorrência de RAM após a implementação do PFV (19,9% vs. 13,4%; P < 0,05). O PFV foi um fator independente relacionado a uma diminuição da RAM, especialmente naqueles pacientes em uso de vancomicina inferior a 12 dias e em pacientes pediátricos, com um NNT de 15. Não houve diferença nos custos antes e após o programa, entretanto aqueles pacientes com RAM apresentaram um custo adicional de R$ 12.676,47, sendo que a atividade de vigilância representou um custo estimado de R$ 19,23 por caso acompanhado. Conclusão: Um PFV implementado ativamente, com busca e monitoramento de RAM, e com estratégias pró-ativas para minimizá-las, tem impacto positivo nos resultados clínicos e econômicos hospitalares. / Proper drug safety monitoring is a central aspect and an important quality indicator of hospital care. This study was carried to evaluate the clinical and economic impact of the implementation of an Intensive Phamacovigilance Program (IPP) in a general hospital. We selected the occurrence of Adverse Drug Reactions (ADR) related to the antimicrobial drug vancomycin to evaluate the program. Study design: Cohort. Methods: 689 patients were included, 151 of them were followed before the implementation of the IPP and 538 patients were followed after this. Main determinants: The occurrence of ADR was measured and classified based in the ‘Naranjo’ algorithm. All the hospital costs were estimated using the register of the financial department of the hospital. Results: There was a significant reduction in the ADR rates after the implementation of the IPP (19.9% versus 13.4%; P-value<0.05). The IPP was an independent factor for the reduction of the ADR rates; it was more important in those that used vancomycin for a period of time ≤ 12 days, and in pediatric patients, in this case the number needed to treat (NNT) estimated was 15. There was no difference between the costs comparing the period before and after the IPP implementation, but those patients that has ADR represented an additional cost of R$ 12,676.47. The cost of the IPP program was R$ 19.23 per individual case followed. Conclusion: The implementation of an IPP that monitored ADR and the strategies that were simultaneously developed to minimize them, had a positive impact in the clinical and economic aspects analized.