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Bisphosphonate-Induced Osteonecrosis: OMS Perspective
Symposia
SYMPOSIUM ON THE PREVENTION OF MEDICAL ERRORS Presented on Friday, September 23, 2005, 10:30 am—12:30 pm Moderator: Lewis N. Estabrooks, DMD, MS, South Portland, ME
Common Errors in Oral and Maxillofacial Surgery Practice Lewis N. Estabrooks, DMD, MS, South Portland, ME It has been reported that medical errors add to the overall health care expenditures. When these errors are critical they often lead to indefensible litigation allegations, which add to the cost of professional liability. Closed claims will be presented to demonstrate examples of errors reported to OMSNIC. Techniques used by various offices will be discussed to try and have our oral surgery community minimize preventable errors and make the health care system safer for all.
Non-Punitive Approach to Prevention of Medical Errors Lucian Leape, MD, Boston, MA The problem of medical error and accidental injury came to public attention suddenly and dramatically in
November 1999 with the release of the Institute of Medicine report ‘To Err Is Human.’ Neither the shocking figures that 44,000-98,000 patients die annually in America as the result of medical errors nor its central message, that errors are caused by faulty systems not by faulty people, was new, but health care had failed to act. The IOM called on hospitals and health care systems to make error prevention a priority, to establish safety programs, and to implement known best practices for safety. Although governmental and private agencies, professional societies, and hospitals are implementing an impressive array of safe practices, a major culture change is needed if safety in health care is to approach that in aviation and other “high reliability” industries. The barriers to such a culture change are formidable: physician resistance, a pervasive culture of blame, and the complexity of modern healthcare, among others. Hospitals and physicians struggle and see little gain. We will consider the causes of their frustration and how they can be overcome.
SYMPOSIUM ON BISPHOSPHONATE-INDUCED BONE NECROSIS Presented on Friday, September 23, 2005, 1:00 pm—3:00 pm Moderator: Joseph I. Helman, DMD, Ann Arbor, MI
Pharmacology Donald B. Kimmel, DDS, PhD, West Point, PA No abstract provided.
Hematology/Oncology Paul Richardson, MD, Boston, MA No abstract provided.
Bisphosphonate-Induced Osteonecrosis: OMS Perspective Salvatore L. Ruggiero, DMD, MD, New Hyde Park, NY There has been a growing awareness throughout our community of interest and medical oncologists regarding the relationship between osteonecrosis of the jaws and bisphosphonate therapy. Bisphosphonates are non-metabolized analogues of pyrophosphate that are capable of localizing to bone and inhibiting osteoclastic function. Following infusion, bisphosphonates bind avidly to exposed bone mineral around resorbing osteoclasts resulting in very 16
high levels of bisphosphonate in the resorption lacunae. Since bisphosphonates are not metabolized, these high concentrations are maintained within bone for long periods of time. Bisphosphonates are then internalized by the osteoclast, causing disruption of osteoclast-mediated bone resorption. This results in markedly decreased osteoclast-mediated lysis of bone. The efficacy of these agents in reducing bone pain, hypercalcemia, and skeletal complications has been extensively documented in patients with advanced breast cancer and multiple myeloma. Thus bisphosphonates are frequently administered to patients with osteolytic metastases, especially if there is risk for significant morbidity. Over the past several years, however, there has been a growing incidence of osteonecrosis localized to the jaws in patients receiving bisphosphonate treatment. It is hypothesized that the profound inhibition of osteoclast function impairs bone remodeling and bone healing to the extent that simple bone wounds (extraction sites) do not heal. The typical clinical presentation is that of a “non-healing”extraction socket, or spontaneously exposed jawbone with proAAOMS • 2005
Symposia gression to sequestrum formation. These sites are often associated with localized swelling, pain, and purulent discharge. The management of these patients with bisphosphonate-related osteonecrosis is very challenging. Aggressive surgical debridement of the necrotic bone has not proved efficacious since most of these sites do not heal and continue to be focuses of infection. Management strategies should be focused on minimizing trauma to the alveolar bone and preventing the progression of secondary infections. Oral surgeons, general dentists, and medical oncologists need to be aware of the potential complications associated with the use of these agents.
References Ruggiero SL, Mehrotra B, Rosenberg TJ, et al: Osteonecrosis of the jaws associated with the use of bisphosphonates: A review of 63 cases. J Oral Maxillofac Surg 62:527, 2004 Marx RE: Pamidronate (Aredia) and zoledronate (Zometa) induced avascular necrosis of the jaws: A growing epidemic. J Oral Maxillofac Surg 61:1115, 2003 Durie BGM, Katz M, McCoy JMS, et al: Osteonecrosis of the jaws in myeloma: Analysis of risk factors including time dependency of AREDIA® and ZOMETA® use, steroid use and underlying dental problems. Estilo CL, Van Poznak CH, Williams T, et al: Osteneocrosis of the maxilla and mandible in patients treated with bisphosphonates: A retrospective study. Proc Am Soc Clin Oncol 22:750, 2004
CHALMERS J. LYONS MEMORIAL LECTURE Presented on Friday, September, 23, 2005, 1:00 pm—2:30 pm
The Birth of a New Form of Medicine— Gene Therapy Theodore Friedmann, MD, San Diego, CA The revolution in biological sciences and genetics in the past several decades has produced a completely new concept in therapy for genetic disease. All previous approaches to treatment of disease have focused on the effects of underlying genetic defects rather than directly at the root causes of disease—the defective genes themselves. With the recognition of the role of DNA as the repository of genetic information, the role of mutant genes in much or even most human disease and the birth of methods for DNA manipulation, a new therapeutic concept has emerged based on the correction of the genetic defect itself. The evolution of human gene therapy has been complicated not only by setbacks and reversals common to most areas of clinical research but also by an initial exaggerated set of expectations and undeliverable promises. Nevertheless, in the short period of three
decades, the field has evolved from its initial concept to an undeniable proof of concept that gene manipulation can successfully be used to treat serious human disease. In at least one disease category—inherited immunodeficiency diseases—very long-term correction has been achieved, although the methods have also produced lethal adverse consequences in some of the patients. Obviously, a great deal of work is still required to make gene transfer methods safer and more effective. Interestingly, the tools of gene transfer are also being applied to potentially new approaches to the treatment of dental and craniofacial disease, including oral malignancies, dental decay and bone regeneration. References Friedmann T: Overcoming the obstacles to gene therapy. Sci Am 276:95, 1997 Friedmann T: The road toward human gene therapy—a 25 year prospective. Ann Med 29:575, 1997 Friedmann T: Gene therapy, in Brenner S, Miller J (eds): Encyclopedia of Genetics. London, UK, Academic Press, 2001, pp 814-819 Friedmann T: Principles for human gene therapy studies. Science 287:2163, 2000
SYMPOSIUM ON IMMEDIATE RESTORATION OF SINGLE TEETH Presented on Saturday, September 24, 2005, 8:00 am—10:00 am Moderator: Robert S. Glickman, DMD, New York, NY
Immediate Restoration of Single Teeth Michael S. Block, DMD, New Orleans, LA David Garber, DMD, Atlanta, GA Maurice Salama, DMD, Atlanta, GA Diagnosis and Treatment Planning for single tooth restorations in an extraction site must follow a prescribed protocol that is established based on strict AAOMS • 2005
criteria. Preoperative planning should be practical but include assessment of the available bone, final pros thetic design concepts, local factors such as infection and dental health, and patient-related criteria such as smoking and systemic disease. Preoperative evaluation based on models will allow for proper placement of two stage or one stage implants, with immediate provisionalization of the implants. Data from our current 17
SYMPOSIUM ON THE PREVENTION OF MEDICAL ERRORS Presented on Friday, September 23, 2005, 10:30 am—12:30 pm Moderator: Lewis N. Estabrooks, DMD, MS, South Portland, ME
Common Errors in Oral and Maxillofacial Surgery Practice Lewis N. Estabrooks, DMD, MS, South Portland, ME It has been reported that medical errors add to the overall health care expenditures. When these errors are critical they often lead to indefensible litigation allegations, which add to the cost of professional liability. Closed claims will be presented to demonstrate examples of errors reported to OMSNIC. Techniques used by various offices will be discussed to try and have our oral surgery community minimize preventable errors and make the health care system safer for all.
Non-Punitive Approach to Prevention of Medical Errors Lucian Leape, MD, Boston, MA The problem of medical error and accidental injury came to public attention suddenly and dramatically in
November 1999 with the release of the Institute of Medicine report ‘To Err Is Human.’ Neither the shocking figures that 44,000-98,000 patients die annually in America as the result of medical errors nor its central message, that errors are caused by faulty systems not by faulty people, was new, but health care had failed to act. The IOM called on hospitals and health care systems to make error prevention a priority, to establish safety programs, and to implement known best practices for safety. Although governmental and private agencies, professional societies, and hospitals are implementing an impressive array of safe practices, a major culture change is needed if safety in health care is to approach that in aviation and other “high reliability” industries. The barriers to such a culture change are formidable: physician resistance, a pervasive culture of blame, and the complexity of modern healthcare, among others. Hospitals and physicians struggle and see little gain. We will consider the causes of their frustration and how they can be overcome.
SYMPOSIUM ON BISPHOSPHONATE-INDUCED BONE NECROSIS Presented on Friday, September 23, 2005, 1:00 pm—3:00 pm Moderator: Joseph I. Helman, DMD, Ann Arbor, MI
Pharmacology Donald B. Kimmel, DDS, PhD, West Point, PA No abstract provided.
Hematology/Oncology Paul Richardson, MD, Boston, MA No abstract provided.
Bisphosphonate-Induced Osteonecrosis: OMS Perspective Salvatore L. Ruggiero, DMD, MD, New Hyde Park, NY There has been a growing awareness throughout our community of interest and medical oncologists regarding the relationship between osteonecrosis of the jaws and bisphosphonate therapy. Bisphosphonates are non-metabolized analogues of pyrophosphate that are capable of localizing to bone and inhibiting osteoclastic function. Following infusion, bisphosphonates bind avidly to exposed bone mineral around resorbing osteoclasts resulting in very 16
high levels of bisphosphonate in the resorption lacunae. Since bisphosphonates are not metabolized, these high concentrations are maintained within bone for long periods of time. Bisphosphonates are then internalized by the osteoclast, causing disruption of osteoclast-mediated bone resorption. This results in markedly decreased osteoclast-mediated lysis of bone. The efficacy of these agents in reducing bone pain, hypercalcemia, and skeletal complications has been extensively documented in patients with advanced breast cancer and multiple myeloma. Thus bisphosphonates are frequently administered to patients with osteolytic metastases, especially if there is risk for significant morbidity. Over the past several years, however, there has been a growing incidence of osteonecrosis localized to the jaws in patients receiving bisphosphonate treatment. It is hypothesized that the profound inhibition of osteoclast function impairs bone remodeling and bone healing to the extent that simple bone wounds (extraction sites) do not heal. The typical clinical presentation is that of a “non-healing”extraction socket, or spontaneously exposed jawbone with proAAOMS • 2005
Symposia gression to sequestrum formation. These sites are often associated with localized swelling, pain, and purulent discharge. The management of these patients with bisphosphonate-related osteonecrosis is very challenging. Aggressive surgical debridement of the necrotic bone has not proved efficacious since most of these sites do not heal and continue to be focuses of infection. Management strategies should be focused on minimizing trauma to the alveolar bone and preventing the progression of secondary infections. Oral surgeons, general dentists, and medical oncologists need to be aware of the potential complications associated with the use of these agents.
References Ruggiero SL, Mehrotra B, Rosenberg TJ, et al: Osteonecrosis of the jaws associated with the use of bisphosphonates: A review of 63 cases. J Oral Maxillofac Surg 62:527, 2004 Marx RE: Pamidronate (Aredia) and zoledronate (Zometa) induced avascular necrosis of the jaws: A growing epidemic. J Oral Maxillofac Surg 61:1115, 2003 Durie BGM, Katz M, McCoy JMS, et al: Osteonecrosis of the jaws in myeloma: Analysis of risk factors including time dependency of AREDIA® and ZOMETA® use, steroid use and underlying dental problems. Estilo CL, Van Poznak CH, Williams T, et al: Osteneocrosis of the maxilla and mandible in patients treated with bisphosphonates: A retrospective study. Proc Am Soc Clin Oncol 22:750, 2004
CHALMERS J. LYONS MEMORIAL LECTURE Presented on Friday, September, 23, 2005, 1:00 pm—2:30 pm
The Birth of a New Form of Medicine— Gene Therapy Theodore Friedmann, MD, San Diego, CA The revolution in biological sciences and genetics in the past several decades has produced a completely new concept in therapy for genetic disease. All previous approaches to treatment of disease have focused on the effects of underlying genetic defects rather than directly at the root causes of disease—the defective genes themselves. With the recognition of the role of DNA as the repository of genetic information, the role of mutant genes in much or even most human disease and the birth of methods for DNA manipulation, a new therapeutic concept has emerged based on the correction of the genetic defect itself. The evolution of human gene therapy has been complicated not only by setbacks and reversals common to most areas of clinical research but also by an initial exaggerated set of expectations and undeliverable promises. Nevertheless, in the short period of three
decades, the field has evolved from its initial concept to an undeniable proof of concept that gene manipulation can successfully be used to treat serious human disease. In at least one disease category—inherited immunodeficiency diseases—very long-term correction has been achieved, although the methods have also produced lethal adverse consequences in some of the patients. Obviously, a great deal of work is still required to make gene transfer methods safer and more effective. Interestingly, the tools of gene transfer are also being applied to potentially new approaches to the treatment of dental and craniofacial disease, including oral malignancies, dental decay and bone regeneration. References Friedmann T: Overcoming the obstacles to gene therapy. Sci Am 276:95, 1997 Friedmann T: The road toward human gene therapy—a 25 year prospective. Ann Med 29:575, 1997 Friedmann T: Gene therapy, in Brenner S, Miller J (eds): Encyclopedia of Genetics. London, UK, Academic Press, 2001, pp 814-819 Friedmann T: Principles for human gene therapy studies. Science 287:2163, 2000
SYMPOSIUM ON IMMEDIATE RESTORATION OF SINGLE TEETH Presented on Saturday, September 24, 2005, 8:00 am—10:00 am Moderator: Robert S. Glickman, DMD, New York, NY
Immediate Restoration of Single Teeth Michael S. Block, DMD, New Orleans, LA David Garber, DMD, Atlanta, GA Maurice Salama, DMD, Atlanta, GA Diagnosis and Treatment Planning for single tooth restorations in an extraction site must follow a prescribed protocol that is established based on strict AAOMS • 2005
criteria. Preoperative planning should be practical but include assessment of the available bone, final pros thetic design concepts, local factors such as infection and dental health, and patient-related criteria such as smoking and systemic disease. Preoperative evaluation based on models will allow for proper placement of two stage or one stage implants, with immediate provisionalization of the implants. Data from our current 17