The aim of this thesis is to examine the contributory factors in drug errors and their reporting so as to design an enhanced reporting scheme to improve the quality of reporting in an acute hospital trust. The related research questions are: 1. What are the contributory factors in drug errors? 2. How effective is the reporting of drug errors? 3. Can an enhanced reporting scheme, predicated on the analysis of local documentary and interview data, identify the contributory factors in drug errors and improve the quality of their reporting in an acute hospital trust? The study aim and research questions reflect a growing consensus, articulated by Boaden and Walshe (2006), that patient safety research should focus on understanding the causes of adverse events and developing interventions to improve safety. Although there are concerns about the value of incident reporting (Wald & Shojania 2003, Armitage & Chapman 2007), it would appear that error reporting systems remain a high priority in advancing patient safety (Kohn et al 2000, Department of Health 2000a, National Patient Safety Agency 2004, WHO & World Alliance for Patient Safety 2004), and consequently it is the area chosen for intervention in this study. Enhancement of the existing scheme is based on a greater understanding of drug errors, their causation, and their reporting.

The aim of this thesis is to examine the contributory factors in drug errors and their reporting so as to design an enhanced reporting scheme to improve the quality of reporting in an acute hospital trust. The related research questions are: 1. What are the contributory factors in drug errors? 2. How effective is the reporting of drug errors? 3. Can an enhanced reporting scheme, predicated on the analysis of local documentary and interview data, identify the contributory factors in drug errors and improve the quality of their reporting in an acute hospital trust? The study aim and research questions reflect a growing consensus, articulated by Boaden and Walshe (2006), that patient safety research should focus on understanding the causes of adverse events and developing interventions to improve safety. Although there are concerns about the value of incident reporting (Wald & Shojania 2003, Armitage & Chapman 2007), it would appear that error reporting systems remain a high priority in advancing patient safety (Kohn et al 2000, Department of Health 2000a, National Patient Safety Agency 2004, WHO & World Alliance for Patient Safety 2004), and consequently it is the area chosen for intervention in this study. Enhancement of the existing scheme is based on a greater understanding of drug errors, their causation, and their reporting.

No / Background: Drug errors are a common and persistent problem in health care and are also associated with serious adverse events. Reporting has become the cornerstone of learning from errors, but is not without its imperfections. Aim: The aim of this study is to improve reporting and learning from drug errors through investigating the contributory factors in drug errors and quality of reporting in an acute hospital. Methods: A retrospective, random sample of 991 drug error reports from 1999 to 2003 were subjected to quantitative and qualitative analysis. This was followed by 40 qualitative interviews with a volunteer, multi‐disciplinary sample of health professionals. The combined analysis has been used to develop a knowledge base for improved drug error reporting. Results: The quality of reports varied considerably, and 27% of reports lacked any contributory factors. Documentary analysis revealed a focus on individuals, sometimes culminating in blame without obvious justification. Doctors submitted few reports, and there were notable differences in reporting according to clinical location. Communication difficulties commonly featured in causation, and high workload and interruptions were predominant contributory factors in the interview data. Interviewees viewed causation as multifactorial, including cognitive and psychosocial factors. Organizational orientation to error was predominantly perceived by interviewees as individual rather than systems‐based. Staff felt obliged to report but rarely received feedback. Implications and conclusio: Drug errors are multifactorial in causation. Current reporting schemes lack a theoretical basis, and are unlikely to capture the information required to ensure learning about causation. Health professionals have reporting fatigue and some remain concerned that reporting promotes individual blame rather than an examination of systems factors. Reporting can be strengthened by human error theory, redesigned to capture a range of contributory factors, facilitate learning and foster supportive actions. It can also be feasible in routine practice. Such an approach should be examined through multi‐centred evaluation.

Introdução - Os medicamentos contribuem de forma significativa para melhorar a qualidade de vida das pessoas, mas não são isentos de riscos. Os erros envolvendo medicamentos têm recebido atenção dos profissionais, das instituições e das autoridades sanitárias no mundo todo. Em hospitais, a farmácia é elo importante no complexo processo de utilização de medicamentos interligando várias ações desenvolvidas em diferentes setores. Sua estrutura física, recursos humanos e tecnológicos e sua organização são fundamentais na prevenção dos erros com medicamentos. Objetivo - Avaliar erros de dispensação de medicamentos em hospital e os fatores envolvidos. Métodos A pesquisa foi realizada em um hospital universitário no Paraná, utilizando-se de três estratégias. 1ª Foram conferidos, de acordo com a prescrição, os medicamentos dispensados pela farmácia para as clínicas médica e cirúrgica no período de 4 a 19 de janeiro de 2010. Os medicamentos analisados eram separados utilizando-se a cópia carbonada da prescrição e dispensados de forma individualizada por paciente ou coletiva, em embalagem plástica (caixas ou sacos), separados por horário de administração, para 24 horas de atendimento. 2 a - Foram entrevistados 19 funcionários da farmácia envolvidos no processo de dispensação sobre erros nesse processo. 3ª Foram avaliados dezenove relatos voluntários de erros de dispensação de medicamentos ocorridos no hospital, entre outubro de 2006 a janeiro de 2010. Resultados Foram analisadas 259 dispensações, 1.963 medicamentos e 4.099 doses. Durante a observação, houve 61 erros de dispensação em 48 prescrições. Os erros ocorreram em 3,2 por cento dos medicamentos e em 1,71 por cento das doses dispensadas. Os erros de dispensação mais freqüentes foram: omissão de medicamento prescrito (23 por cento ); dispensação de medicamento não prescrito (14,8 por cento ); medicamento dispensado na ausência de informação ou contendo informação duvidosa ou ilegível (14,8 por cento ); concentração incorreta (9,8 por cento ); horário incorreto (9,8 por cento ) e medicamento incorreto (6,6 por cento ). Os erros estiveram associados ao número de medicamentos por prescrição e 33 por cento dos erros envolveram medicamentos potencialmente perigosos. Nas entrevistas, foram relatados, como fatores contribuintes para a ocorrência de erros de dispensação, problemas relacionados à comunicação, como: legibilidade da grafia dos prescritores; prescrições ambíguas, incompletas ou confusas e similaridade dos nomes de medicamentos. Em relação às condições de trabalho destacaram-se: pouco tempo para dispensação, sobrecarga de trabalho, nível de ruído, interrupções e distrações. Quanto às questões pessoais, 50 por cento relataram falta de conhecimento sobre medicamentos, estresse e cansaço. Os tipos de erros e os fatores envolvidos foram similares aos de pesquisas semelhantes. Conclusões Os dados sugerem baixa frequencia de erros quando comparados a outros estudos nacionais, o que pode ter ocorrido pela organização do processo de dispensação, dividido em etapas (triagem da prescrição, fracionamento e reembalagem, separação e fechamento das embalagens). A conferência dos medicamentos pela enfermagem e a notificação voluntária mostraram-se importantes na identificação de erros de dispensação. A investigação das circunstâncias de ocorrência dos erros pode oferecer informações importantes para desenvolver estratégias de prevenção / Introduction - Drugs make a significant contribution to improving people\'s quality of life, but are not without risks. Errors involving medications have attracted attention of health professionals, institutions and authorities worldwide. In hospitals, the pharmacy is an important link in the complex drug use process, as it interconnects various actions carried out in different areas. Its physical structure, human and technological resources, and its organization are critical in drug error prevention. Objective - Evaluate drug dispensing errors in hospitals and the factors involved. Methods - The survey was conducted at a university hospital in the state of Paraná, using three strategies. 1 st - The drugs the pharmacies dispensed to the medical clinics and to surgery were compared to the prescriptions in the period ranging from January 4 to 19, 2010. The drugs under analysis were segregated using the carbon copy of the prescription and dispensed individually, per patient, or collectively, in plastic packaging (boxes or bags), separated by time of administration for 24 hours of care. 2 nd - Nineteen employees involved in the pharmacy dispensing process were interviewed concerning errors in this process. 3 rd - Nineteen voluntary reports of medication dispensing errors occurring in the hospital between October 2006 and January 2010 were evaluated. Results - 259 dispensations, 1,963 drugs and 4,099 doses were analyzed. During the observation period, there were 61 dispensing errors in 48 prescriptions. The errors occurred in 3.2 per cent of the drugs and in 1.71 per cent of doses dispensed. The most common dispensing errors were: omission of a prescribed drug (23 per cent ); dispensing of a drug that had not been prescribed (14.8 per cent ); drug dispensed in the absence of information or containing questionable or unreadable information (14.8 per cent ); improper concentration (9.8 per cent ); wrong time (9.8 per cent ); and wrong drug (6.6 per cent ). The errors were associated with the number of drugs per prescription, and 33 per cent of the errors involved potentially dangerous drugs. During the interviews, issues related to communications were reported as contributing factors to dispensing errors and included readability of the prescriber\'s spelling, ambiguous, incomplete, and confusing prescriptions, in addition to drug name similarity. Insofar as working conditions were concerned, the following matters stand out: little time for dispensing, work overload, noise levels, interruptions and distractions. As for personal issues, 50 per cent reported a lack of knowledge about drugs, stress and fatigue. The types of errors and the factors involved were similar to those of similar surveys. Conclusions - The data suggest a low frequency of errors when compared to other national studies, which may have occurred on account of the organization of the dispensing process, divided into steps (screening prescription, fractioning and repackaging, sorting and closing of packages). Drug checking by the nurses and voluntary reporting were important in identifying dispensing errors. The investigation of the circumstances under which errors occurred can provide important information to develop prevention strategies

Introdução - Os medicamentos contribuem de forma significativa para melhorar a qualidade de vida das pessoas, mas não são isentos de riscos. Os erros envolvendo medicamentos têm recebido atenção dos profissionais, das instituições e das autoridades sanitárias no mundo todo. Em hospitais, a farmácia é elo importante no complexo processo de utilização de medicamentos interligando várias ações desenvolvidas em diferentes setores. Sua estrutura física, recursos humanos e tecnológicos e sua organização são fundamentais na prevenção dos erros com medicamentos. Objetivo - Avaliar erros de dispensação de medicamentos em hospital e os fatores envolvidos. Métodos A pesquisa foi realizada em um hospital universitário no Paraná, utilizando-se de três estratégias. 1ª Foram conferidos, de acordo com a prescrição, os medicamentos dispensados pela farmácia para as clínicas médica e cirúrgica no período de 4 a 19 de janeiro de 2010. Os medicamentos analisados eram separados utilizando-se a cópia carbonada da prescrição e dispensados de forma individualizada por paciente ou coletiva, em embalagem plástica (caixas ou sacos), separados por horário de administração, para 24 horas de atendimento. 2 a - Foram entrevistados 19 funcionários da farmácia envolvidos no processo de dispensação sobre erros nesse processo. 3ª Foram avaliados dezenove relatos voluntários de erros de dispensação de medicamentos ocorridos no hospital, entre outubro de 2006 a janeiro de 2010. Resultados Foram analisadas 259 dispensações, 1.963 medicamentos e 4.099 doses. Durante a observação, houve 61 erros de dispensação em 48 prescrições. Os erros ocorreram em 3,2 por cento dos medicamentos e em 1,71 por cento das doses dispensadas. Os erros de dispensação mais freqüentes foram: omissão de medicamento prescrito (23 por cento ); dispensação de medicamento não prescrito (14,8 por cento ); medicamento dispensado na ausência de informação ou contendo informação duvidosa ou ilegível (14,8 por cento ); concentração incorreta (9,8 por cento ); horário incorreto (9,8 por cento ) e medicamento incorreto (6,6 por cento ). Os erros estiveram associados ao número de medicamentos por prescrição e 33 por cento dos erros envolveram medicamentos potencialmente perigosos. Nas entrevistas, foram relatados, como fatores contribuintes para a ocorrência de erros de dispensação, problemas relacionados à comunicação, como: legibilidade da grafia dos prescritores; prescrições ambíguas, incompletas ou confusas e similaridade dos nomes de medicamentos. Em relação às condições de trabalho destacaram-se: pouco tempo para dispensação, sobrecarga de trabalho, nível de ruído, interrupções e distrações. Quanto às questões pessoais, 50 por cento relataram falta de conhecimento sobre medicamentos, estresse e cansaço. Os tipos de erros e os fatores envolvidos foram similares aos de pesquisas semelhantes. Conclusões Os dados sugerem baixa frequencia de erros quando comparados a outros estudos nacionais, o que pode ter ocorrido pela organização do processo de dispensação, dividido em etapas (triagem da prescrição, fracionamento e reembalagem, separação e fechamento das embalagens). A conferência dos medicamentos pela enfermagem e a notificação voluntária mostraram-se importantes na identificação de erros de dispensação. A investigação das circunstâncias de ocorrência dos erros pode oferecer informações importantes para desenvolver estratégias de prevenção / Introduction - Drugs make a significant contribution to improving people\'s quality of life, but are not without risks. Errors involving medications have attracted attention of health professionals, institutions and authorities worldwide. In hospitals, the pharmacy is an important link in the complex drug use process, as it interconnects various actions carried out in different areas. Its physical structure, human and technological resources, and its organization are critical in drug error prevention. Objective - Evaluate drug dispensing errors in hospitals and the factors involved. Methods - The survey was conducted at a university hospital in the state of Paraná, using three strategies. 1 st - The drugs the pharmacies dispensed to the medical clinics and to surgery were compared to the prescriptions in the period ranging from January 4 to 19, 2010. The drugs under analysis were segregated using the carbon copy of the prescription and dispensed individually, per patient, or collectively, in plastic packaging (boxes or bags), separated by time of administration for 24 hours of care. 2 nd - Nineteen employees involved in the pharmacy dispensing process were interviewed concerning errors in this process. 3 rd - Nineteen voluntary reports of medication dispensing errors occurring in the hospital between October 2006 and January 2010 were evaluated. Results - 259 dispensations, 1,963 drugs and 4,099 doses were analyzed. During the observation period, there were 61 dispensing errors in 48 prescriptions. The errors occurred in 3.2 per cent of the drugs and in 1.71 per cent of doses dispensed. The most common dispensing errors were: omission of a prescribed drug (23 per cent ); dispensing of a drug that had not been prescribed (14.8 per cent ); drug dispensed in the absence of information or containing questionable or unreadable information (14.8 per cent ); improper concentration (9.8 per cent ); wrong time (9.8 per cent ); and wrong drug (6.6 per cent ). The errors were associated with the number of drugs per prescription, and 33 per cent of the errors involved potentially dangerous drugs. During the interviews, issues related to communications were reported as contributing factors to dispensing errors and included readability of the prescriber\'s spelling, ambiguous, incomplete, and confusing prescriptions, in addition to drug name similarity. Insofar as working conditions were concerned, the following matters stand out: little time for dispensing, work overload, noise levels, interruptions and distractions. As for personal issues, 50 per cent reported a lack of knowledge about drugs, stress and fatigue. The types of errors and the factors involved were similar to those of similar surveys. Conclusions - The data suggest a low frequency of errors when compared to other national studies, which may have occurred on account of the organization of the dispensing process, divided into steps (screening prescription, fractioning and repackaging, sorting and closing of packages). Drug checking by the nurses and voluntary reporting were important in identifying dispensing errors. The investigation of the circumstances under which errors occurred can provide important information to develop prevention strategies