The first signs of the significant role of medical errors emerged with the Harvard Medical Practice Study in 1991. The number of unnecessary deaths owing to iatrogenic injury in the United States was estimated to be equivalent to 3 jumbo jet crashes every 2 days. In the report â€śError in medicineâ€ť (1994) Lucian Leape; a pediatric surgeon and patient safety pioneer came to the conclusion that there are significant parallels between human error science and medical errors: medical errors were seldom caused by irresponsible or unprepared individuals; but rather intrinsic to the system we work in. He stated; â€śAll humans err frequently. Systems that rely on error-free performance are doomed to failâ€ť. In 1998 the Institute of Medicine (IOM) published its 1998 report; â€śTo Err is Human.â€ť which concluded that between 44;000 and 98;000 Americans die annually from medical mistakes. The report estimated the cost of injury to be between $17 and $29 billion annually; over half of which was the direct cost of treating injury. The response was the creation of both voluntary and mandatory error reporting systems. Hospitals started to form patient safety agendas. In 2001 the IOM published a second medical error analysis; â€śCrossing the Quality Chasm;â€ť thus the conclusion was that big improvements were not seen yet and it suggested that â€śenvironments have to be created that foster and reward improvement by (1) creating an infrastructure to support evidence-based practice; (2) facilitating the use of information technology; (3) aligning payment incentives; and (4) preparing the workforce to better serve patients in a world of expanding knowledge and rapid changeâ€ť.
In Sweden the National Board of Health and Welfare estimated a number 150 of such cases in 2003 and a number of preventable non-fatal adverse events of around 30.500 per year. Unintended and severe medical errors are common in the complex area of pharmaceutical treatment. The Swedish National Board of Health and Welfare estimates that about 10% of all treatment time for hospitalized patients in internal medicine clinics are due to wrong pharmaceutical treatment. These so called adverse drug events (ADE) are in many cases preventable and have the potential to be reduced significantly. Studies show that serious ADEs are likely to prevent with information technology in certain key processes i.e. ordering by checking known information about the patient (allergies; bidiagnosis; etc.) against known information about the drugs intended for treatment; which often is a very complex process and prone to errors. In order to reward improvement; it is necessary to focus further research on medical errors in interaction with human behavior; error reporting systems and how close they are to reality. Quality measurement of overall service is needed in order to discover the right relations between these three fields and to leave the grounds of assumptions. This study is a step towards that aim.
In order to reach measurable improvements in service; the Six Sigma initiative; which first launched by Motorola 20 years ago and is today used by companies such as ABB; Kodak; General Electric; Siemens; Toshiba; NEC; Motorola; Ericsson and Samsung; gives us the tools required. The main goal of Six Sigma is to optimize the performance of processes. Putting the focus on error reduction in medical treatment processes; Six Sigma delivers possibilities to eliminate defects in process outcome through identification and control of variation in processes. The aim is to identify factors and root causes of hazardous processes and to redesign the processes in to order to gain safe; stable and predictable results. Six Sigma defines ultra high-quality manufacturing systems; in which only 3.4 defects occur per 1 million opportunities; a nearly perfect production rate of 99.9997%. Today most of businesses reach the level of three or two Sigma; meaning a defect rate between 65;807 and 308;530 defects per 1 million opportunities. It has been estimated that healthcare is unlikely to become better than three Sigma. Six Sigma has two key methodologies: DMAIC and DMADV. DMAIC (Define - Measure - Analyze - Improve - Control) is used to improve an existing business process. DMADV(Define - Measure - Analyze - Design - Verify) is used to create new product designs or process designs in such a way that it results in a more predictable; mature and defect free performance.
Keywords: Medical Error; Adverse Drug Event; Six Sigma; health care; electronic prescription