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26 PHArMA Hospital Post <strong>Europe</strong> 04/08 Arid deserts and icy peaks – Geri Winkler loves extremes. The Vienna resident is the third Austrian and the first person with diabetes to conquer the Seven Summits – a group of mountains comprising the highest peaks on each of the seven continents. By successfully scaling Mount McKinley (Denali) in Alaska, which is nearly 6,200 meters high, the type 1 diabetic – whose pancreas can no longer produce the vital metabolic hormone insulin – has conquered the final mountain missing from his collection. “I’ve fulfilled a lifelong dream with this climb,” says the adventurer after his Overcoming Boundaries Geri Winkler becomes the first Diabetic to Conquer the Seven Summits return to Vienna. “The tour was physically demanding, but at the same time an unbelievable experience mentally.” Winkler made the decision to take up the Seven Summits challenge in the autumn of 2003. “What made the project so appealing was climbing the highest peaks in regions and climate zones that are completely different in terms of landscape,” explains the globetrotter. On the agenda were expeditions to Mount Elbrus in the Russian Caucasus, Aconcagua in South America, Mount Vinson in Antarctica, Kilimanjaro in Africa, and Carstensz Pyramid in Oceania. The biggest athletic and mental challenge of the project, however, was the ascent to the roof of the world – Mount Everest. In May 2006, Winkler became the first diabetic to reach the 8,848 meter-high summit of the world’s highest mountain. The success of his Seven Summits project was dependent not just on endurance and physical fitness, but also particularly on a functioning insulin therapy. This gives the diabetic athlete a high level of flexibility, as he can administer the hormone according to his body’s demand for it. To regularly monitor his glucose level, Winkler always has a blood glucose monitoring system from Bayer HealthCare with him on his journeys around the world. The system provides the avid outdoorsman with reliable and precise measurements and therefore gives him security. “I prefer a system that is easy to use and good for ten tests after I insert the sensor disc,” says Winkler. Of particular advantage is the fact that the system doesn’t need to be manually coded when a new test strip pack is opened – a frequent source of errors. After all, reliable test results are vital for the athlete. Whether it’s wild glacier ridges in the Andes or rocky deserts in Africa – despite breathtaking landscapes, Winkler has never underestimated the risks of his tours. The beauty of mountainous terrain is often deceptive, as the adventurer must expect avalanches at any time. Winkler knows that he has to carefully prepare himself for each mountain. He never gave up and lost sight of his main objective. Thanks to his strong willpower, the passionate mountaineer successfully completed his Seven Summits project. “You have to believe in yourself and keep setting new goals for yourself,” emphasizes Winkler, describing his phi- losophy of life. www.bayer.com About Geri Winkler Geri Winkler was born in vienna in 1956 and has suffered from type 1 diabetes for 24 years. His passion is the discovery of foreign countries, cultures, and communities. He prefers to explore these worlds on foot or by bicycle. on May 20, 2006, he reached the 8,850-meter summit of Mount Everest. It was the longest ascent of all time, as Geri Winkler began the climb at the lowest point in the world – on the banks of the dead sea in Jordan, 411 meters below sea level. traveling alone by bicycle and ultimately on foot, he reached the base of the world’s highest mountain in five months before ascending to the peak together with an American colleague. New Treatment Strategies for Women with Early-Stage Breast Cancer Until recently, a five-year period of endocrine treatment with tamoxifen was widely acknowledged as being the gold standard, adjuvant therapy for postmenopausal women with early breast cancer (EBC). Recent clinical data suggest that the new generation of endocrine agents – aromatase inhibitors (AIs) – provide more effective protection against breast cancer recurring than tamoxifen – while at the same time reducing the risk of complications such asthromboembolic/cerebrovascular events and endometrial cancer. A group of 15 internationally-renowned breast cancer specialists (oncologists, surgeons, and gynaecologists) is so concerned that some women with EBC are continuing to receive sub-optimal endocrine treatment that they have met to discuss the prevailing evidence on the use of AIs as adjuvant treatment. Meeting in the UK last spring, members of this forum first considered why postmenopausal hormone receptor-positive women with EBC should be treated with endocrine therapy in the first place: to prevent recurrence; to prolong survival; to minimize life-threatening side-effects; to maintain quality of life. The American Society of Clinical Oncology (ASCO) and the National Institute for Health and Clinical Excellence (NICE) in the UK both signal that AIs should be playing an essential part in treatment strategies in this vulnerable cohort of women. However, clear guidance as to the timing of AI initiation remains somewhat vague. While there is a steady take-up of AIs as the endocrine treatment of preference, there are some who are still reluctant to commit to AIs up-front. Data From Clinical Trials? 100-month data from the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial have revealed that the “carry over” benefits of managing hormone-sensitive EBC with an up-front AI (anastrozole) are maintained well beyond the conventional fiveyear course of treatment. Those taking part in the discussions at Crewe Hall acknowledge that the absolute benefit of an AI seen in ATAC might seem small. They also concede that the “carryover” effect may be a difficult concept to understand. The term “carry over” may even be confusing clinicians, and might be better described as a “cure” effect. Thus, if malignant cells are killed during endocrine therapy, future recurrences are prevented. Dr. Jack Cuzick (Wolfson Institute of Preventive Medicine, London, UK) says that the carry-over effect should not be so mystical. “If you eradicate micro-metastases in just a small proportion of patients, it’s an effect that lasts forever. In those patients, this is a cure – and it establishes the case for treating with an AI in the first few years to create a carry-over benefit later on.” Data from the Early Breast Cancer Trialists’ Collaborative Group show that while the carry-over benefit with tamoxifen only extends to ten years of follow-up, there is every expectation that the additional benefit of AI therapy will continue for 20 years and possibly longer. To date the, upfront trials ATAC (Arimidex, Tamoxifen, Alone or in Combination) and BIG1-98 have not demonstrated an overall survival (OS) benefit for the AI, and clinicians continue to be cautious about up-front AI therapy. However, the specialists who took part in the forum recognized that believe there are competing causes of mortality that increase with age which decrease the likelihood of being able to easily demonstrate a better survival outcome with AIs. “In a sense,” said Dr. Cuzick, “it means that these women are not dying from breast cancer, but from other causes. We must make sure that oncologists appreciate the significance of the difference in recurrence with an AI. It is totally unrealistic to expect a decrease in OS.” However, in the ATAC trial, fewer deaths after recurrence were seen on anastrozole compared to tamoxifen. Based on the outcome of studies comparing tamoxifen to placebo, Dr. Chlebowski suggested “Follow-up exceeding ten years may be needed before an OS benefit could be anticipated to emerge.” Even if clinicians accept the evidence for giving up-front AIs, cost may be an issue. Members of the forum argue, however, that the impact of recurrence is too great a price to pay for not choosing a therapy that has been shown to reduce that risk. They emphasize that the psychological impact of recurrence cannot be overestimated in terms of anxiety, stress, and a negative impact on overall quality of life. Impact of Non-Breast Cancer Deaths etc.? In the management of women with EBC, clinicians do not always think about the impact that their prescribed therapies are having on other aspects of their patients’ health and well-being, or on other potential causes of mortality. In terms of therapeutic intervention, their decisions tend to focus largely upon what can be done to minimize the risk of recurrence. Members of the forum are anxious; however, to stress that as adjuvant endocrine therapy does not offer most women a cure for breast cancer, it is vital that those women experience an optimal quality of life during the course of their remaining years. With this in mind, the risk-benefit profile of AIs is an important issue. Are clinicians being deterred from prescribing AIs because they perceive that the side-effects of therapy outweigh the proven advantages in extending time to recurrence? Prof. Rowan Chlebowski (University College of Medicine, Los Angeles, US) commented that the side-effects of endocrine treatment must be put into perspective. “The scarcity of adverse events is more striking than any potential safety differences between tamoxifen and AIs,” he said. “We can be too negative about side-effects. We must convince patients of the benefits of persisting with therapy through years 3, 4 and 5 – not just year 1.” It was pointed out that much has been made of the link between AIs and an increased risk of musculo-skeletal problems – but that while these may be troublesome, they are not life-threatening, and can be treated. Indeed, when the risks associated with AIs (e.g. bone fractures and arthralgias) are compared with that of tamoxifen (e.g. life-threatening endometrial cancer, strokes, pulmonary embolism, urinary sarcomas) few oncologists would think twice about prescribing an AI. Meanwhile, the ATAC 100-month data also indicate that the excess fracture risk associated with active anastrozole therapy – a continuing concern for physicians considering AI therapy in this setting – completely disappears within a matter of months of stopping treatment (i). Promoting Adherence to Endocrine Treatment in EBC Even if clinicians are persuaded by the powerful arguments in favour of up-front AIs, there may be a problem of convincing women with EBC that they need to persist with these new agents Prof. Peyman Hadji (University of Marburg, Germany) highlighted the importance of adhering to endocrine therapy – at least for the 5-year period currently recommended. There is no question, he said, that AIs offer greater benefit than tamoxifen in terms of risk of recurrence – but how to keep patients on AIs when they perceive that the side-effects of therapy outweigh those benefits? Professor Hadji says that a significant proportion of patients do not perceive an improvement in their symptoms or the likelihood of a cure. Patients will not experience an immediate benefit since there are no acute symptoms from which AIs give relief – but AIs do reduce the risk of recurrence and distant metastases. Furthermore, a significant percentage of patients who say they are compliant, are not. As with clinicians, they may have difficulties in accepting that the side-effects associated with AIs pale into insignificance when compared to the potential benefits. “We must strike a balance,” he says, “between telling patients about the potential for side-effects from AI therapy – none of which are life-threatening and most of which can be treated successfully – and the need to warn women that recurrence and its consequences are a constant risk of non-adherence.” “It underlines,” says Prof. Hadji, “the importance of communicating with patients from the outset – involving women with EBC in the choice of endocrine therapy, and increasing the intensity of consultations in the first three to six months following diagnosis to ensure patients understand the importance and value of their treatment and the potential side effects.” Proceedings To Be Published The members of this international forum of breast cancer specialists are planning to publish a proceedings from their discussion later in 2008. Prof. Chlebowski concluded: “We have to convince clinicians that an upfront strategy with AIs will pay dividends – and we have to convince patients that they have to take their treatment for the duration of prescribed therapy. If cost were not an issue, there would be no argument against giving an AI up-front.” The UK forum was chaired by Professor Rowan Chlebowski (USA). The other participants were: Jack Cuzick (UK), Peyman Hadji (Germany), Shinzaburo Noguchi (Japan), Sunil Verma (Canada), Stephen Chia (Canada), Andre Robidoux (Canada), Nicholai Maass (Germany), Ingo Bauerfeind (Germany), Bruno Cutuli (France), Aman Buzdar (USA), Rick Linforth (UK.) This article has been supported by funding from AstraZeneca UK Ltd. Stephen Pinn
Hospital Post <strong>Europe</strong> 04/08 Through the implementation of the German Diagnosis Related Grouping (DRG) system and the resulting cost pressure, the need for optimized use and operation of the premises in hospitals is growing. The link between primary processes and facility management (FM) services, however, is missing. Therefore the Chair for Facility Management at the University of Karlsruhe (Germany) analyzed the interdependencies between facility management performance, costs, and primary processes in hospitals. This project is abbreviated, in German, OPIK – optimization and analysis of hospital processes. Process-Oriented Cost Model The treatment of patients in hospitals can be described by a clinical path that is interpreted in terms of space. Figure 1 illustrates this – the patient’s way through the hospital follows a certain path, symbolized by the black line. Along this, the patient requires specific functions from various entities. Depending on each function, differing infrastructure services are necessary – symbolized by the grey circles. At the level of space, primary and infrastructure processes are linked through the functional units. The focus is set on the patient and his/her presence in the functional unit. Any performance is related to this case. Fig. 1: Patient’s path through the hospital This relation between FM services and the primary processes has been described in a mathematic process modelled by the University of Karlsruhe. The model’s quintessence is the description of the relation of all core infrastructure processes to a primary process profile. Thus, a value from the primary process has been assigned to each relevant main FM process. For the operation room (OR) – of key importance –, the cost dominant process “sterile goods supply” is discussed in the following as an example. The results are based on the analysis of empirical data of four German hospitals. Sterile Goods Supply in the OR Figure 2 shows the average cost shares of the FM processes for the OR: 39 % of the costs are related to the process “sterile goods supply”. Therefore, this process is paramount for the OR. Fig. 2: Average FM cost share for the functional unit operation of four hospitals FAcILItY MAnAGEMEnt 27 FM Cost in the OR Cost Driver The relation between primary and FM processes can be separated into fixed and variable costs. “Sterile goods supply” is part of the variable costs. When changing intervention activities in the OR from one shift to two shifts per day and assuming similar workload, it may be assumed that these costs will double in a linear manner. According to the standard of the German “Institut für das Entgeltsystem im Krankenhaus” (InEK), the basis of the allocation, and therefore abstract cost driver for the costs of the medical and non-medical infrastructure in the OR, is the time between first incision of the skin and last suture plus the setup time for each intervention. This approach is simplistic in assuming that all infrastructure costs are linear dependent on the length of the intervention. Time is the only cost driver. For a transparent analysis of costs and for the purpose of benchmarking and optimization of FM products, the relation between cost and cost driver has to be examined in detail. Does an intervention of double length really mean a doubled effort for sterilization and packing of the surgical kits? The cost driver for sterile goods supply is, rather, the number, and content of surgical kits – i.e. the type of intervention rather than the procedure time. A problem occurs when large surgical kits are opened just for the use of one or two elements: the unused content has to be sterilized and repacked. To avoid this needless effort, there has to be good communication between surgeons, medical staff, and the sterilization Texcare International – New Technologies Early in June, the international tradeshow for textile handling took place in Frankfurt/ Germany. Around 15,500 trade visitors from 80 countries came to discuss solutions and products from 258 exhibitors who included “big names” such as Kannegiesser, Jensen- Group, Lavatec, Pellerin Milnor, Alliance, Renzacci, Girbau, Multimatic ilsa, Miele, and Ecolab. More than half of the attendees travelled to Frankfurt from outside Germany. The portfolio of the show included laundry and dry-cleaning machines, logistics and transport, finishing and ironing equipment, as well as linen hire and research. “The Texcare Forum was also given a good reception by all visitors and well attended,” said Friedrich Eberhard, Vice President of the German Dry Cleaning Association. “The most important topics at this year’s Texcare were: energy efficiency, environmental conservation, and the linkage of mechanical units for greater efficiency and economy.” New technologies supporting logistics were also at the top of the agenda – in particular at the booths of Tagsys, Sokymat – where the Miniature Laundry Tag S-Tag10 was presented – and Datamars. The Swiss RFID specialist Datamars announced, in Frankfurt, a partnership with the Dutch logistics vendor ABS Laundry Business Solutions. A modular approach is the partners’ reply to increasing demand in handling industrial and rental textiles, speakers said at the press conference. “Our objective is to ensure that [RFID] technology is accessible to businesses of all sizes, by bundling hardware and software components to deliver total customized ID solutions that are affordable and truly meet the individual needs and budgets of our customers. Our alliance with the leading automation and logistics solutions provider for the textile rental business worldwide, ABS, reflects this objective,” underlined Ken Boyle, Chief Marketing Officer at Datamars. The next Texcare is to take place four years from now. Michael Reiter department. Standardized surgical kits should be used for routine interventions and the documentation should be made available for FM purposes. The average costs for sterile goods supply for the operation of a hip joint in 2005 – based on the information from four hospitals – is about € 190 with an average number of sterile goods entities of 5.5. The average cost for sterile goods supply for any intervention is only € 58. This difference can be related to the average intervention time, including setup, for a hip joint: the reference time is about 190 minutes. The average time for the different intervention portfolios in the hospitals of the research sample varies between 72 and 165 minutes. Considering the possible time span of interventions and the cost differences for sterile goods supply for a relatively short but complex kind of intervention – as in the case of a hip joint surgery –, the need for transparent, realistic cost allocation becomes clear. For sure, the cost for sterile goods supply can not properly be set in relation with intervention time. The University of Karlsruhe is developing a model that allows a realistic cost allocation for FM processes. Thus, the researchers are linking FM processes and the primary process for the function areas in the hospital. This is an important step towards cost transparency, and gives a very important basis for strategic planning of resources in the hospital. Contact: Dipl.-Ing. Karin Diez Prof. Kunibert Lennerts University of Karlsruhe (TH) Facility Management D-Karlsruhe Tel.: +49 721/608 8225 Fax: +49 721/608 4351 karin.diez@uni-karlsruhe.de www.facility-management. uni-karlsruhe.de Significant Effect on Skin Flora Trevira Bioactive is kind to the skin – as confirmed by a study of the Hohenstein Institute, which specializes in the physiology of clothing. Can wearing antimicrobial clothing in Trevira Bioactive exercise a negative effect on the skin flora? Does Trevira Bioactive influence other parameters of a skin-physiological nature? Evaluation of a four-week wearer trial should supply answers to these questions. The testers came to the conclusion that the antimicrobial activity of the fibres had no harmful effect on the skin flora, even after being worn for some considerable time. They were unable to establish any negative impact by the textile fibres on the flora, either in the case of individual trial participants or taking the whole participant group into consideration. In the wearer trials where Trevira Bioactive was compared with conventional textiles, it was not possible to establish any noticeable dif- Renovation Work in Jordania Thanks to the funding of the United States Agency for International Development (US- AID), renovation and expansion work in the Maan hospital in Jordan is now complete. The upgraded facilities were inaugurated in the middle of May by the Minister of Health Salah Mawajdeh and USAID Mission Director Jay Knott. The new facilities include a renovated delivery ward, obstetrics and paediatric departments, and operating theatre. After the renovation, the hospital is equipped with state-of-the-art medical equipment and furniture which are crucial to the safety and quality of the services provided to the women and newborns in Maan, according to a statement released by USAID. The renovation work was designed to meet the functional, infrastructure, and infection control requirements in accordance with international standards (AIA- ference in the total number of germs on the skin. In addition, the most important indicator of the protective function of the skin, “transepidermal water loss” (TEWL), stays unchanged when wearing Trevira Bioactive. There is also no alteration in the pH value and surface temperature of the skin. In comparison: in contrast to wearing clothing made from permanently antimicrobial polyester fibres, alcoholic skin disinfection has a significant effect on skin flora. By virtue of a silver additive that is firmly anchored in the raw material, Trevira Bioactive fibres prevent the growth of bacteria on the fibre surface. The effect is permanent and is not affected by either washing or usage. Furthermore it prevents odours forming and textiles stay fresh for longer. The vital factor is that in all this the effect is limited to the textile. www.trevira.com American). Furthermore, the staff of the Maan Hospital was also provided with clinical guidelines and trained how to use and maintain the new equipment in the obstetrics and neonatal departments. The Maan hospital – built in 1950 – serves about 100,000 people. Before the renovation work, a lot of Maan residents had to travel to Aqaba because of the limited services provided by the hospital. Now, medical treatment improved considerably and the people no longer need to take a trip. After renovating Maan hospital, renewals and expansion work of other hospitals will follow. The primary objective of the USAID’s Health Systems Strengthening project is to improve the health status of all Jordanians. Coverage and access to needed services for all citizens should be improved to provide high-quality and client-oriented care. CK
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