Hospital Administration

      HOSPITAL ADMINISTRATION MANAGEMENT

Case Study 1 -- A New Approach to Managing GORD - ALTANA Pharma

COMPANY PROFILE

ALTANA Pharma is the pharmaceutical division of ALTANA AG. The company concentrates on innovative pharmaceutical products in therapeutics, imaging (contrast media) and OTC medication. Therapeutics, the most important business area, is based on prescription drugs for gastrointestinal and respiratory diseases.

INTRODUCTION

A new method has been developed for diagnosing gastro-oesophageal reflux disease and assessing treatment progress. Until now, assessing the progress of treatment for Gastro-Oesaphageal Reflux Disease (GORD) has relied primarily on an assessment of oesophageal healing. Documenting GORD therapy success is a difficult task, as mucosal damage does not always correspond with the severity of symptoms.1 In addition, 70% of all patients with

GORD symptoms have endoscopic-negative GORD. To further complicate the GORD picture, Endoscopy-Negative Reflux Disease (ENRD), Non-Erosive Reflux Disease (NERD), functional heartburn or reflux-like dyspepsia is often diagnosed, and most patients with

heartburn do not have mucosal breaks. Moreover, diagnostic approaches vary between primary and secondary care. In the absence of gold standard diagnostic testing for GORD, symptom assessment and understanding how symptoms impact on a patient’s quality of life is critical to the successful management of a patient. Recent research has suggested that the symptom complex experienced by GORD patients is much wider than previously appreciated. Besides heartburn, acid eructation, and pain on swallowing, a variety of other GORD-related symptoms are experienced, including nausea, diarrhoea or constipation and sleep disturbance, as well as other symptoms, such as respiratory complaints. GORD is a condition of diverse and variable symptoms, many of which significantly impair quality of life. The problem for gastroenterologists trying to build a complete picture of a patient’s symptoms is that patients may find it difficult to describe accurately all the symptoms they are experiencing. Consequently, they may not be treated effectively. Even after successful acute treatment, the majority of patients suffer a recurrence of symptoms within six months. And, if the non-classic signs of GORD are not seen, patients may be misdiagnosed. The broad spectrum of symptoms in GORD patients and the high prevalence of endoscopy-negative GORD highlight the need for a robust, validated approach to symptom assessment.

SIMPLE QUESTIONNAIRE

One such approach is ReQuest™, a simple and effective questionnaire, which patients use to assess themselves

daily for a wide range of GORD symptoms. It was created following discussions with patients and physicians to identify the spectrum of symptoms reported and establish how they were described by GORD patients. The questionnaire was also based on an evaluation of relevant medical literature and clinical trial data. ReQuest is divided into seven dimensions covering acid complaints, upper abdominal/stomach complaints, lower abdominal / digestive complaints, nausea, sleep disturbances, general well-being and other complaints. A short version of the questionnaire, which can be completed in less than five minutes, focuses solely on these seven dimensions, while the full version, which takes approximately 20 minutes, is more wide-ranging. Both tests have undergone extensive clinical trial evaluation and statistical analysis, which has confirmed their internal consistency, test-retest reliability, construct validity, and responsiveness to changes during treatment. ReQuest fulfils the criteria set by the regulatory authorities for a validated symptom-based system for use as the primary outcome measure in clinical trials of GORD therapy. It has now been validated in 26 languages and tested

in 20 countries.

REQUEST / LA CLASSIFICATION

The ReQuest / LA classification system is the first to effectively integrate a highly sensitive patient questionnaire (ReQuest) with an adaptation of the LA classification for esophagitis. The new index allows the combined assessment of symptom relief and the healing of oesophageal lesions in GORD. The adapted LA classification (N = lesions not present, grade A–D) was paired with a grading of patients’ symptom burdens from 0–4 (0 = no disease, 1 = minor, 2 = tolerable, 3 = troublesome, 4 = intense), as assessed by the rescaled subscale of the established GORD symptom evaluation instrument ReQuest. By comparing both scales in a matrix, clinicians are able to quantify both aspects of GORD and assign an index to each patient. An index of 0N indicates optimal treatment outcome, in other words complete remission (relief from symptoms and the healing of oesophageal lesions).

VALUABLE INSIGHTS

A randomised, double-blind study of 581 patients using ReQuest has established that pantoprazole is as effective as esomeprazole (both 40mg/day) over 12 weeks in achieving the complete remission of erosive GORD. With respect to endoscopically confirmed healing, pantoprazole was superior to esomeprazole. A second randomised, double-blind ReQuest study, this time of four weeks’ duration (561 patients), again comparing pantoprazole and esomeprazole (both 40mg/day), demonstrated parity between the two PPIs in terms of symptom relief scores, but it also showed that the beneficial effects of pantoprazole were sustained for longer, with significantly fewer symptomatic relapses in the seven-day post-treatment phase. Professor K D Bardhan, consultant physician and gastroenterologist at the District General Hospital, Rotherham, in the UK, who was instrumental in developing the ReQuest/ L A classification, says: ‘We need a device that enables an accurate assessment of treatment success in GORD patients that combines the main parameters of symptom relief and oesophageal healing. The new ReQuest / LA classification enables a detailed clinical and treatment outcome assessment of GORD patients at any stage of their disease using a single and reliable global measure. In my view, ReQuest / LA classification represents a helpful step in the right direction and provides a means of standardising the assessment and reporting of GORD clinical trials.’ An extensive ReQuest database, which provides information on patient demographics, symptom profiles and treatment outcomes, now exists for over 8,000 patients with GORD. Use of the combined endpoint ‘complete remission’, evaluated using the ReQuest™/LA classification, will permit even greater insights by helping to analyse patient populations and shed light on the factors that dictate whether a treatment works. Such a source of GORD treatment outcomes, during various stages of the disease, could be of major benefit to patients, physicians and the organisations that fund healthcare in the future.

ISSUES TO BE DISCUSSED

1. Discuss the salient features put up in the case.

2. Evaluate the new approach based on your understanding of the case.

3. The case indicates two research studies. Give your insights based on these two studies.

Case -2 --A New Concept in Annuloplasty for Valve Repair: the Biodegradable Ring –

BIORING COMPANY PROFILE

BIORING, founded in 2000, develops and commercializes biodegradable medical devices that lower surgical risk and reduce post-surgical complications. The first device in the series, The Kalangos® ring, received the CE Mark in March 2005. BIORING is currently working on obtaining the FDA approval for this device

INTRODUCTION

The Kalangos® ring was developed for pediatric annuloplasty to preserve the growth potential of the child's heart. It is also suitable for adult annuloplasty by extension. This now commercially available device made of biodegradable polydioxanone induces the growth of autologous fibrous tissue that reinforces the deficient annulus. The good functioning of the native, or repaired valve depends on coaptation capacity of its leaflets. Annuloplasty rings have been used since 1968 to remodel the shape, correct the dilatation, and consolidate the repair of heart valves by improving coaptation of the valve's leaflets during systole. The further understanding of the three-dimensional geometry of the native valve annulus during the normal cardiac cycle lead to the evolution of the rings from the first rigid, planar stainless steel-based Carpentier ring to the fexible Duran ring and to the more recent Cosgrove-Edwards bands. All these devices, which actually fulfil the requirements of the application on adults, do not allow the further growth of the native annulus if implanted in children.

Indeed, implantation in growing hearts could result in a stenotic effect which could worsen with time. For this reason, these current traditional rings do not exist in pediatric sizes (under 26).

A NEW CONCEPT IN ANNULOPLASTY VALVE REPAIR

The above considerations were the driving elements for the development of a new concept in annuloplasty valve repair: the future device had to allow growth of the native annulus. Based on some encouraging results reported in annoloplasty practices performed in the pediatric population with different biodegradable materials and especially polydioxanone1-3, Bioring (Lonay, Switzerland) has developed the Kalangos® mitral and tricuspid rings, which are biodegradable annuloplasty devices made of polydioxanone. These advanced devices, do not work like traditional rings. Indeed, the device does not provide a mechanical support, except in the first short period following implantation, but induces the creation of endogenous fibrous tissue which will take on this function subsequently. Moreover, it was designed to facilitate its implantation. The device is introduced within the native annulus and simply secured to the anterior and posterior trigones by knotting the integrated monofilament sutures equipped with crimped stainless steel atraumatic needles. This intra-annular implantation prevents the device from being in contact with blood. This avoids thromboembolic complications which require systemic anticoagulation therapies until the endocardium covers the traditional rings sutured on the native annulus. In addition, Bioring's device is solely composed of materials that can be used in presence of endocarditis. In order to preserve the native annulus growth potential in children, the non-resorbable suture that is incorporated in the polydioxanone segment, in order to prevent further degenerative dilatation of the annulus in adults, is cut in pediatric sizes of the ring under 26. Ultrasound imaging follow-up of the first implantations performed on animals demonstrated the preservation of the valve's functional efficacy and of the ventricular contractility while allowing the physiological growth of the orifice. This was revealed by measures of the valve orifices on the sacrificed pigs which had seen their body weight increased by an average of more than 500% over a year. Six months or more following implantation, a fibrous autologous tissue was developed in all dissected hearts, in replacement of the implanted polydioxanone device, resorbed by hydrolysis. Moreover, it was discovered that the fibrous tissue continues on growing for a few months after complete resorption of the device. The newly grown fibrous tissue remodells the annulus and prevents it against redilatative stretch without interfering with its dynamical physiological motion.

CLINICAL STUDIES AND TRIALS

The preliminary clinical study that focussed on pediatric population gave positive outcomes and confirmed the results obtained in the animal trials. This demonstrated the biodegradable device's main feature for pediatric applications: the preservation of the growth potential of the native annulus4. In the frame of a clinical trial performed between April 2004 and May 2006, 111 patients affected by valve insufficiency, mostly of congenital, degenerative or rheumatic origin, received a mitral and/or a tricuspid Kalangos® ring. The patients included in this investigation were comprised between one and 75 years of age; 51 were aged 16 or less and 60 were aged 17 or more on the implantation date. Among them, 57 (51.3%) patients were

female and 54 (48.7%) were male. This population was monitored with a mean follow-up of

approximately 10 months. The benefits of the valve repair with Bioring's biodegradable annuloplasty device were assessed in terms of NYHA Grade for the 105 patients in whom the follow-up was complete. They were immediately tested post-op and monitored at 6, and 12 months. This evaluation was utilized as it is one of the most commonly used scoring systems worldwide. It can be seen that all patients fully recovered and are presently scored Grade 0 or Grade 1. Moreover, in this study it is also demonstrated that the degradation of the polymeric segment of the device occurs without any observable consequences for the patient. In conclusion, the Kalangos® ring is a new biodegradable device that has proven to be safe and efficient. Moreover it is the only commercial device available in pediatric sizes for  orrecting, remodelling the shape, reinforcing, and restoring the function of the valves' annuli, that preserves the native annulus growth potential in children. The tissue-growth properties associated with the intra-tissular implantation of this device introduce a completely new concept in annuloplasty.

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ISSUES TO BE DISCUSSED

1. Bring out the facts as enumerated in the case.

2. Analyse the new concept at length in terms of Biodegradable principle.

Case -3 --Bone Substitutes to replace Transplantation?

INTRODUCTION

An osteoconductive and osteoinductive biphasic ceramic replacement for bone loss could be an alternative to grafts. The safety and efficacy of this material has been shown in preclinical and clinical trials, demonstrating its suitability. Tumours, bone cysts and traumas, as well as osteomyelitis and osteolysis, can cause massive bone loss. The primary method used today for filling such defects is autogenic or allogeneic bone transplantation. As both approaches are associated with considerable problems there is an ongoing critical debate as to whether these procedures should still be considered the treatments of choice. Autogenic bone transplantation, for instance, is always associated with another surgery. For the patient, the surgical removal of graft material means additional stress and a higher postoperative morbidity due to local complications. In addition, the amount of graft material that can be harvested from the patient’s own body is limited. Economic analyses provide additional arguments for challenging the use of autogenic bone material. Given the extended duration of surgery, the use of autogenic bone grafts involves higher costs. Although allogeneic bone transplantats have the advantage of higher availability,

their inherent antigenicity is a major disadvantage.

BENEFITS OF BONE SUBSTITUTES

Given the multitude of problems associated with autogenic and allogeneic bone transplantation, the search for bone substitutes similar to bone grafts in terms of biomechanical strength and biological properties has intensified over the past few years.

Such materials should support the bone healing process and ideally should be associated with

osteoconductive and osteoinductive properties and biocompatibility. Apart from natural materials obtained from corals or algae, there are inorganic materials such as ceramics made of hydroxyapatite or tricalcium phosphate. Other materials include xenografts and glass ionomer cements.

BIPHASIC CERAMICS

The development of Tricos® represents real progress in the field of bone substitutes. The idea behind this bone substitute was to ensure structured, physiological formation of bone substance. The biphasic ceramic containing hydroxyapatite (HA, 60%) and beta-tricalcium phosphate (ß-TCP, 40%), fulfills these requirements in several ways. This is used in combination with a fibrin matrix made of human plasma. In the new material there is a balanced equilibrium between the quickly resorbable beta-tricalcium phosphate and the slowly resorbable hydroxyapatite. ß-TCP has a high osteogenetic potential and constitutes a source of P+ and Ca++ ions. Simultaneously, with the progressive biodegradation of ß-TCP, biological apatite crystals begin to form, gradually replacing the bone substitute analogously to natural remodelling. Hydroxyapatite guarantees the long-term stability of the material; it ensures that the bone substitute supports cell adhesion in the long run, acting as a carrier. In its chemical structure the substance resembles the bone’s biological apatite crystals, and it is only mildly osteogenic. The new bone substitute has an interconnective pore system consisting of micropores and macropores; the granules are 1–2mm in size . The micropores less than 10μm in size provide for a rapid exchange of fluid and ions by means of diffusion. With their size of 300μm–600μm, macropores permit the adhesion and proliferation of osteogenetic cells. This ensures that the bone substitute material is successively replaced, by cells spreading from the periphery to the middle of the ceramic material

FIBRIN MATRIX

In order to optimise physiological bone regeneration the biological two-component matrix of

Tissucol/Tisseel® is added to the inorganic material. The two-component matrix consists of fibrinogen, plasmafibronectin, factor XIII and plasminogen as well as the plasmin inhibitor aprotinin. The human thrombin contained as a second component triggers the final step of physiological blood clotting, the conversion of fibrinogen to fibrin. The completely resorbable fibrin is used in all surgical fields. The fibrin matrix penetrates both micropores and macropores, and provides high stability through adhesion to the walls of the bone defect. Simultaneously, the fibrin matrix serves as a binding agent for the granules. Its content of polymerised fibrin, fibronectin and growth factors helps trigger cell proliferation and angiogenesis, and enhances wound healing. On a cellular level the artificial bone induces signals similar to physiological material. Diffusion of biological fluids into the ceramic´s micropores and macropores triggers the release of calcium ions; macrophages, mesenchymal stem cells, osteoblasts and osteoclasts will then enter the ceramic´s macropores. Cell adhesion is followed by cell proliferation, and gradually, osteoclasts will resorb the so-called artificial bone in a process similar to physiological remodelling, while osteoblasts will build new bone material. Application of Tricos is simple and straightforward. The preparation is ready for application approximately two minutes after mixing the two components. Similar to a plastic glue, the mixture can be applied with a spatula and used for anatomical reconstruction.

PRECLINICAL AND CLINICAL DATA

The benefits of biphasic ceramics combined with a fibrin matrix have been shown in many preclinical and clinical trials over the past few years. The easy-to-use, pliable material allows successful anatomical reconstruction, proving both biocompatible and stable.

Histological examinations reveal the polymerised fibrin to have a stable structure on which ions crystallize, thus enhancing intrinsic osteogenic properties. Biopsis shows that the material is progressively replaced by new lamellar bone within two or three months. A retrospective long-term trial over 16 years supported the material´s long-term tolerability, good bioactivity and high osteointegration rate.

SUCCESSFUL TREATMENT TRAIL

At Würzburg Orthopaedic University Clinic further comprehensive clinical data on Tricos was collected between 10/2004–08/2005. During a one-year clinical trial, bone defects in a total of 17 patients aged between ten and 69 were treated using the new bone substitute. The material was used for filling various bone defects caused by benign tumours or tumour-like lesions. There were five patients with benign bone tumours (enchondrome, chondromyxoid fibroma, chondroblastoma, osteoma, osteoblastoma, osteoclastoma) and 12 with tumour-like lesions (juvenile bone cyst, non-ossifying fibroma, eosinophilic granuloma, intraosseous ganglion, fibrous dysplasia). The cysts were surgically removed and each bone defect then filled with two to ten syringes containing 3.5cm3 of Tricos, i.e. 7–35cm3 in total. During this one-year trial the bone substitute proved both easy to use and safe. There were no

complications. The long-term data after nine months showed that the biomaterial had successfully integrated into the bone; resorption was not yet complete.

Points to be addressed

1. Outline the salient facts of the case.

2. Discuss at length on the line of the salient features.

Case -4--Eliminating Latent TB

INTRODUCTION

Latent TB in healthcare workers is a major threat to patients. Traditional tests have too often been unable to detect the condition reliably. A new blood test looks set to change this, which is good news for patients - and healthcare workers. In December 2005 the New York Times reported that a nurse with active TB from a New York City hospital had exposed 1,500 patients and infected four infants, after 11 years of latency. As this case shows, the successful detection, monitoring and treatment of Latent Tuberculosis Infection (LTBI) after risk-assessment are crucial to reducing the number of active cases in patient healthcare settings. The detection of latently infected persons has been the objective of healthcare workers in patient-care settings in hospitals for decades, but has often yielded unsatisfactory results. The blame for this has been placed largely on the lack of a truly effective test for LTBI.

REPLACING THE TST

The Tuberculin Skin Test (TST), developed more than 100 years ago, has been the only tool available for detecting LTBI, and the limitations of that procedure are well documented. Although the TST may be a useful epidemiological tool, its poor specificity, vulnerability to false positives and subjective interpretation mean that it does not meet the standards required for today's medical decisions. As a consequence of this poor medical return, programmes to detect LTBI, which could include prophylactic treatment of the infection, have often been poorly established, and control programmes themselves neglected. In May 2005 the US Food and Drug Administration (FDA) approved the use of a whole blood test to aid the diagnosis of LTBI. The new test, QuantiFERON(r)-TB Gold (QFT-G), also eliminates the logistical

challenges of skin testing: a simple venipuncture procedure followed by a standard, batchable laboratory procedure is all that is required to obtain a definitive yes or no response to the question of LTBI. New guidelines from the US Center for Disease Control, published in December 2005, affirm that QFT-G can be used in all situations in which a skin test is used, thereby recognising its potential as a replacement for the TST.Unlike the TST, QFT-G is not confounded by BCG vaccination or infection by non-TB mycobacteria. Furthermore, it eliminates the logistical challenges of skin testing because of its simple application and laboratory procedure.

A NEW STANDARD

Hospitals around the world have started to use QFT-G as their standard for LTBI testing. Those that have implemented QFT-G programmes have recognised significant cost savings over TST. These come mainly from significantly lower rates of positivity, leading to reduced caseloads and elimination of working time losses for follow-up visits to the occupational health office.

Case Example: HOW A FALSE POSITIVE WAS ALMOST A REAL NEGATIVE

Keiko, a 19-year-old Japanese exchange student in the USA, took a routine Tuberculin Skin Test (TST) before beginning training to become a nurse. Although she showed no symptoms of TB, the test gave a positive result of 15mm. Her doctor insisted that nine months of preventive treatment with isoniazid was the standard of care recommended by the Centers for Disease Control. However, Keiko argued that her test was positive because of two BCG vaccinations she received as a child, and denied exposure to active disease. A chest X-ray confirmed that she did not have TB, but she was worried that her refusal of treatment might jeopardise her entry into the nursing programme. Her doctor then found out that the local TB programme used QFT-G and obtained a test for her. The result: no TB infection. Treatment was determined to be unnecessary. Issues to be Addressed

1. List out the facts of the case.

2. Project your perception on the new standard brought out in the testing.

3. Analyse the case example provided.

 SUBJECT: Hospital Administration

1. What is hospital and define Hospital Administration?

2. What do you mean by personnel administration in hospital?

3. What is the difference between hospital management and hospital administration?

4. What is the scope of hospital administration for MBA students?

5. What is medical negligence ?

6. Explain the need for man power planning in hospital.

7. Classify hospitals with examples

8. What is TQM ?