Genetic testing has entered a new era in the past few years. Our ability to perform DNA-based tests and identify an individual's susceptibility to cancer, heart disease, diabetes, and so many other conditions is beginning to have a major impact on our practice of medicine.

Experts predict – thanks to advances in technology we already have – that in a few years we will be able to screen during the newborn period and identify every mutation and polymorphism present. This screening will permit us to predict a child's “medical life” through identification of individual susceptibilities to disease likely to develop during his or her lifetime. Although still in its infancy, this technology would revolutionize pediatrics from a field in which we wait for the child to develop symptoms and signs of disease and then react with medication and other treatments, to one where we can predict disease. This will give us the opportunity to help our patients in a whole new way: to prevent the symptoms and signs from arising in the first place.

With the good comes the bad, as with any new technology. For example, interpretation of results with this advanced testing will require special expertise in genetics and genomics. Unfortunately, interpretation of genetic findings often is not as “black and white” as diagnosis of anemia based on serum hemoglobin and hematocrit levels. Genetic test results often include polymorphisms, and most of these variations of normal are benign and not associated with disease. Subspecialist consultation may be needed to make these important distinctions.

General pediatricians play an essential role in interpretation of newborn screening tests. Fortunately, results are normal for the majority of children and no further follow-up is indicated. However, if an abnormality is detected, referral to a specialist is warranted to facilitate an early intervention that, in some cases, can make a difference in the long-term health of the child. You also can refer families who request consultation with a geneticist to discuss recurrence risk in future progeny and for additional genetic testing, as indicated.

Beyond standard newborn genetic screening, the role of the pediatrician is somewhat limited regarding the screening and testing for specific genetic disorders. However, there are situations in which the pediatrician should feel comfortable in ordering and interpreting genetic tests.

For example, testing in children with intellectual disabilities and autism spectrum disorder has become standard. As tier 1 testing in such children, I usually order a microarray-based comparative genomic hybridization (array CGH), a test that has largely replaced high-resolution chromosome analysis in this population. I also perform DNA testing for fragile X syndrome, the most common inherited cause of intellectual disabilities. Because the results of this testing will be normal in 80%–90% of these children, I encourage pediatricians to order these tests themselves. I then make myself available if genetic evaluation reveals an abnormality.

Another factor to consider is the recent direct-to-consumer marketing of genetic testing that expands standard newborn screening or uses genetic markers to predict susceptibility to specific conditions. These tests often require the family, with or without the assistance of the pediatrician, to send a sample of DNA to a reference lab. The lab returns the results directly to the family. Again, the laboratory results are difficult to interpret, and you may be called on to provide guidance. Sometimes interpretation is straightforward, but in other cases it can be tricky, and if you are uncomfortable you might want to refer them to a medical geneticist or genetic counselor.

When you refer a child to a geneticist, include all results of your previous testing, those performed by other specialists, and newborn screening. Genetic tests performed on the mother during the pregnancy (for example, amniocentesis, chorionic villus sampling, sonograms, and/or biochemical screening tests) also are important. Provide any imaging findings, including MRIs or CT scans.

Proceed cautiously when counseling families regarding results of genetic testing. It can be trickier than you might think. For example, results of a test for a single gene disorder might uncover a previously unknown change in the child's DNA. The finding could be a benign polymorphism that has no clinical consequences or it could be a pathogenic mutation responsible for the child's signs and symptoms.

Simply informing the family about this finding is inadequate. To be certain, the parents need to be tested. If one or both of them has the same genetic change, the polymorphism might be benign. In contrast, if neither parent has the mutation, the child's test result might reflect a spontaneous genetic change and increase the likelihood you have discovered the cause of the clinical condition.

In general, there are three categories of children who may require genetic testing. First, there are those children who have multiple congenital anomalies or dysmorphic features. These findings could be caused by chromosome abnormalities, single gene mutations, or teratogenic agents. In these children, in order to ensure that the appropriate tests are ordered, a genetic consultation is important.

A second group of children who may require genetic testing are those in whom deviation from typical development or “normal” growth parameters occur during the first few years of life. Such children may have chromosome abnormalities, single gene mutations, and/or an underlying metabolic disorder. Keep in mind seizures, developmental regression, failure to thrive, and respiratory disturbances can bolster the likelihood of a genetic or metabolic etiology.

Before ordering any genetic testing, it is essential to take a complete patient and family history and to perform a complete physical exam. Children with a family history of a first- or second-degree family member with a genetic disorder also might benefit from genetic evaluation, comprising the third group. For example, even before symptoms are present, testing a child who has a brother with Duchenne muscular dystrophy or a relative with cystic fibrosis may prove life saving if it uncovers a similar diagnosis.

Genetic testing has entered a new era in the past few years. Our ability to perform DNA-based tests and identify an individual's susceptibility to cancer, heart disease, diabetes, and so many other conditions is beginning to have a major impact on our practice of medicine.

Experts predict – thanks to advances in technology we already have – that in a few years we will be able to screen during the newborn period and identify every mutation and polymorphism present. This screening will permit us to predict a child's “medical life” through identification of individual susceptibilities to disease likely to develop during his or her lifetime. Although still in its infancy, this technology would revolutionize pediatrics from a field in which we wait for the child to develop symptoms and signs of disease and then react with medication and other treatments, to one where we can predict disease. This will give us the opportunity to help our patients in a whole new way: to prevent the symptoms and signs from arising in the first place.

With the good comes the bad, as with any new technology. For example, interpretation of results with this advanced testing will require special expertise in genetics and genomics. Unfortunately, interpretation of genetic findings often is not as “black and white” as diagnosis of anemia based on serum hemoglobin and hematocrit levels. Genetic test results often include polymorphisms, and most of these variations of normal are benign and not associated with disease. Subspecialist consultation may be needed to make these important distinctions.

General pediatricians play an essential role in interpretation of newborn screening tests. Fortunately, results are normal for the majority of children and no further follow-up is indicated. However, if an abnormality is detected, referral to a specialist is warranted to facilitate an early intervention that, in some cases, can make a difference in the long-term health of the child. You also can refer families who request consultation with a geneticist to discuss recurrence risk in future progeny and for additional genetic testing, as indicated.

Beyond standard newborn genetic screening, the role of the pediatrician is somewhat limited regarding the screening and testing for specific genetic disorders. However, there are situations in which the pediatrician should feel comfortable in ordering and interpreting genetic tests.

For example, testing in children with intellectual disabilities and autism spectrum disorder has become standard. As tier 1 testing in such children, I usually order a microarray-based comparative genomic hybridization (array CGH), a test that has largely replaced high-resolution chromosome analysis in this population. I also perform DNA testing for fragile X syndrome, the most common inherited cause of intellectual disabilities. Because the results of this testing will be normal in 80%–90% of these children, I encourage pediatricians to order these tests themselves. I then make myself available if genetic evaluation reveals an abnormality.

Another factor to consider is the recent direct-to-consumer marketing of genetic testing that expands standard newborn screening or uses genetic markers to predict susceptibility to specific conditions. These tests often require the family, with or without the assistance of the pediatrician, to send a sample of DNA to a reference lab. The lab returns the results directly to the family. Again, the laboratory results are difficult to interpret, and you may be called on to provide guidance. Sometimes interpretation is straightforward, but in other cases it can be tricky, and if you are uncomfortable you might want to refer them to a medical geneticist or genetic counselor.

When you refer a child to a geneticist, include all results of your previous testing, those performed by other specialists, and newborn screening. Genetic tests performed on the mother during the pregnancy (for example, amniocentesis, chorionic villus sampling, sonograms, and/or biochemical screening tests) also are important. Provide any imaging findings, including MRIs or CT scans.

Proceed cautiously when counseling families regarding results of genetic testing. It can be trickier than you might think. For example, results of a test for a single gene disorder might uncover a previously unknown change in the child's DNA. The finding could be a benign polymorphism that has no clinical consequences or it could be a pathogenic mutation responsible for the child's signs and symptoms.

Simply informing the family about this finding is inadequate. To be certain, the parents need to be tested. If one or both of them has the same genetic change, the polymorphism might be benign. In contrast, if neither parent has the mutation, the child's test result might reflect a spontaneous genetic change and increase the likelihood you have discovered the cause of the clinical condition.

In general, there are three categories of children who may require genetic testing. First, there are those children who have multiple congenital anomalies or dysmorphic features. These findings could be caused by chromosome abnormalities, single gene mutations, or teratogenic agents. In these children, in order to ensure that the appropriate tests are ordered, a genetic consultation is important.

A second group of children who may require genetic testing are those in whom deviation from typical development or “normal” growth parameters occur during the first few years of life. Such children may have chromosome abnormalities, single gene mutations, and/or an underlying metabolic disorder. Keep in mind seizures, developmental regression, failure to thrive, and respiratory disturbances can bolster the likelihood of a genetic or metabolic etiology.

Before ordering any genetic testing, it is essential to take a complete patient and family history and to perform a complete physical exam. Children with a family history of a first- or second-degree family member with a genetic disorder also might benefit from genetic evaluation, comprising the third group. For example, even before symptoms are present, testing a child who has a brother with Duchenne muscular dystrophy or a relative with cystic fibrosis may prove life saving if it uncovers a similar diagnosis.

Genetic testing has entered a new era in the past few years. Our ability to perform DNA-based tests and identify an individual's susceptibility to cancer, heart disease, diabetes, and so many other conditions is beginning to have a major impact on our practice of medicine.

Experts predict – thanks to advances in technology we already have – that in a few years we will be able to screen during the newborn period and identify every mutation and polymorphism present. This screening will permit us to predict a child's “medical life” through identification of individual susceptibilities to disease likely to develop during his or her lifetime. Although still in its infancy, this technology would revolutionize pediatrics from a field in which we wait for the child to develop symptoms and signs of disease and then react with medication and other treatments, to one where we can predict disease. This will give us the opportunity to help our patients in a whole new way: to prevent the symptoms and signs from arising in the first place.

With the good comes the bad, as with any new technology. For example, interpretation of results with this advanced testing will require special expertise in genetics and genomics. Unfortunately, interpretation of genetic findings often is not as “black and white” as diagnosis of anemia based on serum hemoglobin and hematocrit levels. Genetic test results often include polymorphisms, and most of these variations of normal are benign and not associated with disease. Subspecialist consultation may be needed to make these important distinctions.

General pediatricians play an essential role in interpretation of newborn screening tests. Fortunately, results are normal for the majority of children and no further follow-up is indicated. However, if an abnormality is detected, referral to a specialist is warranted to facilitate an early intervention that, in some cases, can make a difference in the long-term health of the child. You also can refer families who request consultation with a geneticist to discuss recurrence risk in future progeny and for additional genetic testing, as indicated.

Beyond standard newborn genetic screening, the role of the pediatrician is somewhat limited regarding the screening and testing for specific genetic disorders. However, there are situations in which the pediatrician should feel comfortable in ordering and interpreting genetic tests.

For example, testing in children with intellectual disabilities and autism spectrum disorder has become standard. As tier 1 testing in such children, I usually order a microarray-based comparative genomic hybridization (array CGH), a test that has largely replaced high-resolution chromosome analysis in this population. I also perform DNA testing for fragile X syndrome, the most common inherited cause of intellectual disabilities. Because the results of this testing will be normal in 80%–90% of these children, I encourage pediatricians to order these tests themselves. I then make myself available if genetic evaluation reveals an abnormality.

Another factor to consider is the recent direct-to-consumer marketing of genetic testing that expands standard newborn screening or uses genetic markers to predict susceptibility to specific conditions. These tests often require the family, with or without the assistance of the pediatrician, to send a sample of DNA to a reference lab. The lab returns the results directly to the family. Again, the laboratory results are difficult to interpret, and you may be called on to provide guidance. Sometimes interpretation is straightforward, but in other cases it can be tricky, and if you are uncomfortable you might want to refer them to a medical geneticist or genetic counselor.

When you refer a child to a geneticist, include all results of your previous testing, those performed by other specialists, and newborn screening. Genetic tests performed on the mother during the pregnancy (for example, amniocentesis, chorionic villus sampling, sonograms, and/or biochemical screening tests) also are important. Provide any imaging findings, including MRIs or CT scans.

Proceed cautiously when counseling families regarding results of genetic testing. It can be trickier than you might think. For example, results of a test for a single gene disorder might uncover a previously unknown change in the child's DNA. The finding could be a benign polymorphism that has no clinical consequences or it could be a pathogenic mutation responsible for the child's signs and symptoms.

Simply informing the family about this finding is inadequate. To be certain, the parents need to be tested. If one or both of them has the same genetic change, the polymorphism might be benign. In contrast, if neither parent has the mutation, the child's test result might reflect a spontaneous genetic change and increase the likelihood you have discovered the cause of the clinical condition.

In general, there are three categories of children who may require genetic testing. First, there are those children who have multiple congenital anomalies or dysmorphic features. These findings could be caused by chromosome abnormalities, single gene mutations, or teratogenic agents. In these children, in order to ensure that the appropriate tests are ordered, a genetic consultation is important.

A second group of children who may require genetic testing are those in whom deviation from typical development or “normal” growth parameters occur during the first few years of life. Such children may have chromosome abnormalities, single gene mutations, and/or an underlying metabolic disorder. Keep in mind seizures, developmental regression, failure to thrive, and respiratory disturbances can bolster the likelihood of a genetic or metabolic etiology.

Before ordering any genetic testing, it is essential to take a complete patient and family history and to perform a complete physical exam. Children with a family history of a first- or second-degree family member with a genetic disorder also might benefit from genetic evaluation, comprising the third group. For example, even before symptoms are present, testing a child who has a brother with Duchenne muscular dystrophy or a relative with cystic fibrosis may prove life saving if it uncovers a similar diagnosis.

pdnews@elsevier.com

Different forms of trauma can cause posttraumatic stress disorder in children, whether from an objective event like a car crash or sports injury to trauma involving loved ones, such as domestic violence, abuse, or neglect.

Pediatricians can help by routinely screening for dysfunction and by asking questions at annual well-child visits. Overt symptoms include fear related to the trauma such as avoiding the traumatic setting or activity. Less specific symptoms include anxiety, avoidance, social isolation, depression, and low self-esteem.

If a standard screen such as the Pediatric Symptom Checklist or another instrument reveals psychosocial dysfunction, you have to determine the cause of dysfunction, and PTSD should certainly be considered.

Is there family discord leading to violence in the home? If you suspect PTSD, ask a child what happened and why he or she thinks it happened. Determine if the child is blaming himself or herself in any way. Is the child grieving following a permanent injury and/or loss of a loved one? How have the parents discussed any traumatic event with the child? Do the parents feel traumatized by the child's experience?

If PTSD is a possibility, ask if the child is experiencing flashbacks, intrusive thoughts, and/or any related anxiety.

Some symptoms are expected after a traumatic event or following cancer or critical care treatment experienced as traumatic. Most children and adolescents overcome the fear of riding in a car or playing the sport that resulted in the trauma.

However, symptoms that persist for a month or more, with avoidance and associated anxiety, are core to the diagnosis of PTSD. The anxiety can build and be self-reinforcing so as to interfere with daily functioning. At this point, consider referral to a mental health specialist, preferably one with some experience in PTSD treatment. A specialist can help the patient overcome his or her anxiety and return to functioning through cognitive and behavioral techniques such as reframing the events, dealing with any guilt, and staged exposure to the anxiety.

If one of your patients experienced a car crash or other major trauma, you will likely know about it, already be treating the child, and should be planning to monitor them for signs of PTSD. In contrast, detection of subtle PTSD is more challenging, particularly if the trauma is unknown or occurred years ago. Trauma related to domestic violence or sexual abuse first requires consideration of this possibility and then gentle, empathic, and persistent questioning.

Triggers for reliving/reexperiencing the trauma also can be straightforward. For example, a child who gets into a car with a similar interior design years after a crash can immediately experience and emotionally return to the trauma. Other triggers are less obvious, such as a teenage girl who was held down and forced to have sex against her will, who later feels constrained by tight clothing and immediately relives the fear and anguish.

Like many presentations in pediatrics, management of PTSD depends on the developmental stage of the child, including his or her cognitive abilities and emotional state. For example, infants or toddlers might not be able to make much sense of what is happening when they witness domestic violence. Terror, fear, and confusion are their most likely reactions.

School-age children aged 5–8 years would not fully understand either, but they will try to make some sense of the domestic violence. Assuming no one reassures them otherwise, they also may feel that something they did sparked or contributed to the violence. For example, if they overhear arguments around issues in the family and hear their name mentioned, they may quickly assume that they are the cause of the domestic violence. This can lead to feelings of guilt, self-criticism, and unworthiness.

Adolescents will experience some of the same reactions as younger children. They will still experience shock, even if they are better equipped to conceptualize the domestic violence. Some will feel powerless because they cannot end the strife, particularly at a time when they are supposed to have more control over the real world. Teens might feel they have not lived up to expectations and perceive some blame. Others may choose to flee, find support through friends, and/or may deal with their feelings using substances.

Act when you encounter a patient who feels very guilty about parental fighting or who justifies abuse because he feels worthless or was told repeatedly he was a bad child. Help him realize he was not responsible for the conflict and that no one deserves abuse. Discuss other, more realistic possibilities for the family paradigm.

These are not easy conversations. Some pediatricians will feel comfortable working at this depth, others will prefer to refer.

Healing from PTSD related to family violence, sexual abuse, or criminal activity is a several-step process. As one's sense of guilt diminishes, other emotions such as anger at not being better protected or valued need to be addressed. Finally, there needs to be some grieving for what was lacking and some acceptance of what was possible. This is not a simple process; however, it is worthwhile because if their PTSD remains untreated, there is a greater likelihood they will continue to relive traumatic memories as adults.

There is some controversy as to whether talking through the traumatic event over and over truly helps. Some clinicians feel that a certain amount of supportive discussion in a calm way makes sense, especially early. But solely repeating the details of the event may re-traumatize the child and intensify negative feelings, especially if the memories are very vivid.

Cognitive and behavioral approaches can help the child reframe their trauma. An example is exposure therapy, where the child is carefully reexposed to the trauma in stages while they learn to reframe and diminish the intensity of the experience. Often, ideas about the trauma come out that can be examined objectively to try to lessen some of those traumatic feelings.

Exposure therapy also can incorporate gradual steps to help the child overcome their fear. If a person survived a plane crash, the first step might be to take him or her to the airport, then to board an airplane without taking off, and so forth. This approach reintroduces the trauma without eliciting a full response. You don't want the brain to go on “red alert” again. In a state of hyperarousal, reliving the trauma may do more harm than good.

The terrified moments that children experience during a traumatic sequence tend to get burned into their memories much more strongly than everyday events. A school-age child might remember nothing about an uneventful trip in the car, but if a traumatic accident happens, often she remembers almost every detail. She recalls descriptive elements of what happened as well as the emotional fright or anguish very vividly.

Sometimes vivid, traumatic memories will enter your patient's mind spontaneously without him knowing why. In other cases, there are triggers. Sometimes these flashbacks arise shortly following trauma and sometimes they take years.

Pediatricians can do their patients and families a service if they are aware of PTSD either after an overt event like a car accident or by considering trauma in an anxious or dysfunctional child.

pdnews@elsevier.com

Different forms of trauma can cause posttraumatic stress disorder in children, whether from an objective event like a car crash or sports injury to trauma involving loved ones, such as domestic violence, abuse, or neglect.

Pediatricians can help by routinely screening for dysfunction and by asking questions at annual well-child visits. Overt symptoms include fear related to the trauma such as avoiding the traumatic setting or activity. Less specific symptoms include anxiety, avoidance, social isolation, depression, and low self-esteem.

If a standard screen such as the Pediatric Symptom Checklist or another instrument reveals psychosocial dysfunction, you have to determine the cause of dysfunction, and PTSD should certainly be considered.

Is there family discord leading to violence in the home? If you suspect PTSD, ask a child what happened and why he or she thinks it happened. Determine if the child is blaming himself or herself in any way. Is the child grieving following a permanent injury and/or loss of a loved one? How have the parents discussed any traumatic event with the child? Do the parents feel traumatized by the child's experience?

If PTSD is a possibility, ask if the child is experiencing flashbacks, intrusive thoughts, and/or any related anxiety.

Some symptoms are expected after a traumatic event or following cancer or critical care treatment experienced as traumatic. Most children and adolescents overcome the fear of riding in a car or playing the sport that resulted in the trauma.

However, symptoms that persist for a month or more, with avoidance and associated anxiety, are core to the diagnosis of PTSD. The anxiety can build and be self-reinforcing so as to interfere with daily functioning. At this point, consider referral to a mental health specialist, preferably one with some experience in PTSD treatment. A specialist can help the patient overcome his or her anxiety and return to functioning through cognitive and behavioral techniques such as reframing the events, dealing with any guilt, and staged exposure to the anxiety.

If one of your patients experienced a car crash or other major trauma, you will likely know about it, already be treating the child, and should be planning to monitor them for signs of PTSD. In contrast, detection of subtle PTSD is more challenging, particularly if the trauma is unknown or occurred years ago. Trauma related to domestic violence or sexual abuse first requires consideration of this possibility and then gentle, empathic, and persistent questioning.

Triggers for reliving/reexperiencing the trauma also can be straightforward. For example, a child who gets into a car with a similar interior design years after a crash can immediately experience and emotionally return to the trauma. Other triggers are less obvious, such as a teenage girl who was held down and forced to have sex against her will, who later feels constrained by tight clothing and immediately relives the fear and anguish.

Like many presentations in pediatrics, management of PTSD depends on the developmental stage of the child, including his or her cognitive abilities and emotional state. For example, infants or toddlers might not be able to make much sense of what is happening when they witness domestic violence. Terror, fear, and confusion are their most likely reactions.

School-age children aged 5–8 years would not fully understand either, but they will try to make some sense of the domestic violence. Assuming no one reassures them otherwise, they also may feel that something they did sparked or contributed to the violence. For example, if they overhear arguments around issues in the family and hear their name mentioned, they may quickly assume that they are the cause of the domestic violence. This can lead to feelings of guilt, self-criticism, and unworthiness.

Adolescents will experience some of the same reactions as younger children. They will still experience shock, even if they are better equipped to conceptualize the domestic violence. Some will feel powerless because they cannot end the strife, particularly at a time when they are supposed to have more control over the real world. Teens might feel they have not lived up to expectations and perceive some blame. Others may choose to flee, find support through friends, and/or may deal with their feelings using substances.

Act when you encounter a patient who feels very guilty about parental fighting or who justifies abuse because he feels worthless or was told repeatedly he was a bad child. Help him realize he was not responsible for the conflict and that no one deserves abuse. Discuss other, more realistic possibilities for the family paradigm.

These are not easy conversations. Some pediatricians will feel comfortable working at this depth, others will prefer to refer.

Healing from PTSD related to family violence, sexual abuse, or criminal activity is a several-step process. As one's sense of guilt diminishes, other emotions such as anger at not being better protected or valued need to be addressed. Finally, there needs to be some grieving for what was lacking and some acceptance of what was possible. This is not a simple process; however, it is worthwhile because if their PTSD remains untreated, there is a greater likelihood they will continue to relive traumatic memories as adults.

There is some controversy as to whether talking through the traumatic event over and over truly helps. Some clinicians feel that a certain amount of supportive discussion in a calm way makes sense, especially early. But solely repeating the details of the event may re-traumatize the child and intensify negative feelings, especially if the memories are very vivid.

Cognitive and behavioral approaches can help the child reframe their trauma. An example is exposure therapy, where the child is carefully reexposed to the trauma in stages while they learn to reframe and diminish the intensity of the experience. Often, ideas about the trauma come out that can be examined objectively to try to lessen some of those traumatic feelings.

Exposure therapy also can incorporate gradual steps to help the child overcome their fear. If a person survived a plane crash, the first step might be to take him or her to the airport, then to board an airplane without taking off, and so forth. This approach reintroduces the trauma without eliciting a full response. You don't want the brain to go on “red alert” again. In a state of hyperarousal, reliving the trauma may do more harm than good.

The terrified moments that children experience during a traumatic sequence tend to get burned into their memories much more strongly than everyday events. A school-age child might remember nothing about an uneventful trip in the car, but if a traumatic accident happens, often she remembers almost every detail. She recalls descriptive elements of what happened as well as the emotional fright or anguish very vividly.

Sometimes vivid, traumatic memories will enter your patient's mind spontaneously without him knowing why. In other cases, there are triggers. Sometimes these flashbacks arise shortly following trauma and sometimes they take years.

Pediatricians can do their patients and families a service if they are aware of PTSD either after an overt event like a car accident or by considering trauma in an anxious or dysfunctional child.

pdnews@elsevier.com

Different forms of trauma can cause posttraumatic stress disorder in children, whether from an objective event like a car crash or sports injury to trauma involving loved ones, such as domestic violence, abuse, or neglect.

Pediatricians can help by routinely screening for dysfunction and by asking questions at annual well-child visits. Overt symptoms include fear related to the trauma such as avoiding the traumatic setting or activity. Less specific symptoms include anxiety, avoidance, social isolation, depression, and low self-esteem.

If a standard screen such as the Pediatric Symptom Checklist or another instrument reveals psychosocial dysfunction, you have to determine the cause of dysfunction, and PTSD should certainly be considered.

Is there family discord leading to violence in the home? If you suspect PTSD, ask a child what happened and why he or she thinks it happened. Determine if the child is blaming himself or herself in any way. Is the child grieving following a permanent injury and/or loss of a loved one? How have the parents discussed any traumatic event with the child? Do the parents feel traumatized by the child's experience?

If PTSD is a possibility, ask if the child is experiencing flashbacks, intrusive thoughts, and/or any related anxiety.

Some symptoms are expected after a traumatic event or following cancer or critical care treatment experienced as traumatic. Most children and adolescents overcome the fear of riding in a car or playing the sport that resulted in the trauma.

However, symptoms that persist for a month or more, with avoidance and associated anxiety, are core to the diagnosis of PTSD. The anxiety can build and be self-reinforcing so as to interfere with daily functioning. At this point, consider referral to a mental health specialist, preferably one with some experience in PTSD treatment. A specialist can help the patient overcome his or her anxiety and return to functioning through cognitive and behavioral techniques such as reframing the events, dealing with any guilt, and staged exposure to the anxiety.

If one of your patients experienced a car crash or other major trauma, you will likely know about it, already be treating the child, and should be planning to monitor them for signs of PTSD. In contrast, detection of subtle PTSD is more challenging, particularly if the trauma is unknown or occurred years ago. Trauma related to domestic violence or sexual abuse first requires consideration of this possibility and then gentle, empathic, and persistent questioning.

Triggers for reliving/reexperiencing the trauma also can be straightforward. For example, a child who gets into a car with a similar interior design years after a crash can immediately experience and emotionally return to the trauma. Other triggers are less obvious, such as a teenage girl who was held down and forced to have sex against her will, who later feels constrained by tight clothing and immediately relives the fear and anguish.

Like many presentations in pediatrics, management of PTSD depends on the developmental stage of the child, including his or her cognitive abilities and emotional state. For example, infants or toddlers might not be able to make much sense of what is happening when they witness domestic violence. Terror, fear, and confusion are their most likely reactions.

School-age children aged 5–8 years would not fully understand either, but they will try to make some sense of the domestic violence. Assuming no one reassures them otherwise, they also may feel that something they did sparked or contributed to the violence. For example, if they overhear arguments around issues in the family and hear their name mentioned, they may quickly assume that they are the cause of the domestic violence. This can lead to feelings of guilt, self-criticism, and unworthiness.

Adolescents will experience some of the same reactions as younger children. They will still experience shock, even if they are better equipped to conceptualize the domestic violence. Some will feel powerless because they cannot end the strife, particularly at a time when they are supposed to have more control over the real world. Teens might feel they have not lived up to expectations and perceive some blame. Others may choose to flee, find support through friends, and/or may deal with their feelings using substances.

Act when you encounter a patient who feels very guilty about parental fighting or who justifies abuse because he feels worthless or was told repeatedly he was a bad child. Help him realize he was not responsible for the conflict and that no one deserves abuse. Discuss other, more realistic possibilities for the family paradigm.

These are not easy conversations. Some pediatricians will feel comfortable working at this depth, others will prefer to refer.

Healing from PTSD related to family violence, sexual abuse, or criminal activity is a several-step process. As one's sense of guilt diminishes, other emotions such as anger at not being better protected or valued need to be addressed. Finally, there needs to be some grieving for what was lacking and some acceptance of what was possible. This is not a simple process; however, it is worthwhile because if their PTSD remains untreated, there is a greater likelihood they will continue to relive traumatic memories as adults.

There is some controversy as to whether talking through the traumatic event over and over truly helps. Some clinicians feel that a certain amount of supportive discussion in a calm way makes sense, especially early. But solely repeating the details of the event may re-traumatize the child and intensify negative feelings, especially if the memories are very vivid.

Cognitive and behavioral approaches can help the child reframe their trauma. An example is exposure therapy, where the child is carefully reexposed to the trauma in stages while they learn to reframe and diminish the intensity of the experience. Often, ideas about the trauma come out that can be examined objectively to try to lessen some of those traumatic feelings.

Exposure therapy also can incorporate gradual steps to help the child overcome their fear. If a person survived a plane crash, the first step might be to take him or her to the airport, then to board an airplane without taking off, and so forth. This approach reintroduces the trauma without eliciting a full response. You don't want the brain to go on “red alert” again. In a state of hyperarousal, reliving the trauma may do more harm than good.

The terrified moments that children experience during a traumatic sequence tend to get burned into their memories much more strongly than everyday events. A school-age child might remember nothing about an uneventful trip in the car, but if a traumatic accident happens, often she remembers almost every detail. She recalls descriptive elements of what happened as well as the emotional fright or anguish very vividly.

Sometimes vivid, traumatic memories will enter your patient's mind spontaneously without him knowing why. In other cases, there are triggers. Sometimes these flashbacks arise shortly following trauma and sometimes they take years.

Pediatricians can do their patients and families a service if they are aware of PTSD either after an overt event like a car accident or by considering trauma in an anxious or dysfunctional child.

The Food and Drug Administration (FDA), after a review of reported cases of anaplastic large-cell lymphoma (ALCL), warns that there may be a link between silicone and saline breast implants and the rare cancer.

People with breast implants “may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant,” according to the agency.

The FDA based its announcement on a review of literature published between January 1997 and May 2010 that identified 34 unique cases of ALCL in women with either type of breast implant.

William Maisel, MD, chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health, said, “We need more data and are asking that healthcare professionals tell us about any confirmed cases they identify.”

Of the 34 unique ALCL cases reviewed, 24 had silicone and 7 had saline implants; 3 implants did not have the type specified. The women ranged in age from 28 to 87 years, with a median age of 51 years.

ALCL occurred in 19 women who received implants for aesthetic augmentation, 11 for reconstruction, and 4 had no reason recorded for the implant.

The women developed ALCL in a median of 8 years from time of implant, ranging from 1 year to 23 years. Most of the patients were diagnosed because they had implant-related symptoms, such as seromas, capsular contractures, or peri-implant masses that needed implant revision surgery.

Physicians found lymphoma cells in the seroma surrounding the implant, in the fibrous capsule, or within a peri-implant mass in all of the ALCL cases.

According to the FDA report, CD30 status was positive in all 29 of the cases that included this information, which is consistent with an ALCL diagnosis. ALCL cases in the rest of the body can be either ALK-positive or ALK-negative. The 26 reports of ALCL in women with breast implants that included ALK status were all ALK-negative.

The FDA recommends that physicians consider an ALCL diagnosis if patients present with capsular contracture or masses adjacent to the breast implant. Physicians should report all confirmed cases of ALCL in people with breast implants to Medwatch.

The FDA does not recommend removing breast implants in patients without symptoms, which include pain, lumps, swelllng, or asymmetry that develop after the surgical site is fully healed. The agency plans to update its review of silicone breast implants in spring 2011.

ALCL occurs in about 1 in 500,000 women each year in the United States, according to the Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute. In the breast, ALCL occurs in approximately 3 in 100,000,000 women annually in the US.

The Food and Drug Administration (FDA), after a review of reported cases of anaplastic large-cell lymphoma (ALCL), warns that there may be a link between silicone and saline breast implants and the rare cancer.

People with breast implants “may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant,” according to the agency.

The FDA based its announcement on a review of literature published between January 1997 and May 2010 that identified 34 unique cases of ALCL in women with either type of breast implant.

William Maisel, MD, chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health, said, “We need more data and are asking that healthcare professionals tell us about any confirmed cases they identify.”

Of the 34 unique ALCL cases reviewed, 24 had silicone and 7 had saline implants; 3 implants did not have the type specified. The women ranged in age from 28 to 87 years, with a median age of 51 years.

ALCL occurred in 19 women who received implants for aesthetic augmentation, 11 for reconstruction, and 4 had no reason recorded for the implant.

The women developed ALCL in a median of 8 years from time of implant, ranging from 1 year to 23 years. Most of the patients were diagnosed because they had implant-related symptoms, such as seromas, capsular contractures, or peri-implant masses that needed implant revision surgery.

Physicians found lymphoma cells in the seroma surrounding the implant, in the fibrous capsule, or within a peri-implant mass in all of the ALCL cases.

According to the FDA report, CD30 status was positive in all 29 of the cases that included this information, which is consistent with an ALCL diagnosis. ALCL cases in the rest of the body can be either ALK-positive or ALK-negative. The 26 reports of ALCL in women with breast implants that included ALK status were all ALK-negative.

The FDA recommends that physicians consider an ALCL diagnosis if patients present with capsular contracture or masses adjacent to the breast implant. Physicians should report all confirmed cases of ALCL in people with breast implants to Medwatch.

The FDA does not recommend removing breast implants in patients without symptoms, which include pain, lumps, swelllng, or asymmetry that develop after the surgical site is fully healed. The agency plans to update its review of silicone breast implants in spring 2011.

ALCL occurs in about 1 in 500,000 women each year in the United States, according to the Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute. In the breast, ALCL occurs in approximately 3 in 100,000,000 women annually in the US.

The Food and Drug Administration (FDA), after a review of reported cases of anaplastic large-cell lymphoma (ALCL), warns that there may be a link between silicone and saline breast implants and the rare cancer.

People with breast implants “may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant,” according to the agency.

The FDA based its announcement on a review of literature published between January 1997 and May 2010 that identified 34 unique cases of ALCL in women with either type of breast implant.

William Maisel, MD, chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health, said, “We need more data and are asking that healthcare professionals tell us about any confirmed cases they identify.”

Of the 34 unique ALCL cases reviewed, 24 had silicone and 7 had saline implants; 3 implants did not have the type specified. The women ranged in age from 28 to 87 years, with a median age of 51 years.

ALCL occurred in 19 women who received implants for aesthetic augmentation, 11 for reconstruction, and 4 had no reason recorded for the implant.

The women developed ALCL in a median of 8 years from time of implant, ranging from 1 year to 23 years. Most of the patients were diagnosed because they had implant-related symptoms, such as seromas, capsular contractures, or peri-implant masses that needed implant revision surgery.

Physicians found lymphoma cells in the seroma surrounding the implant, in the fibrous capsule, or within a peri-implant mass in all of the ALCL cases.

According to the FDA report, CD30 status was positive in all 29 of the cases that included this information, which is consistent with an ALCL diagnosis. ALCL cases in the rest of the body can be either ALK-positive or ALK-negative. The 26 reports of ALCL in women with breast implants that included ALK status were all ALK-negative.

The FDA recommends that physicians consider an ALCL diagnosis if patients present with capsular contracture or masses adjacent to the breast implant. Physicians should report all confirmed cases of ALCL in people with breast implants to Medwatch.

The FDA does not recommend removing breast implants in patients without symptoms, which include pain, lumps, swelllng, or asymmetry that develop after the surgical site is fully healed. The agency plans to update its review of silicone breast implants in spring 2011.

ALCL occurs in about 1 in 500,000 women each year in the United States, according to the Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute. In the breast, ALCL occurs in approximately 3 in 100,000,000 women annually in the US.

News that domestic spending on healthcare grew at the lowest rate in recorded history could be viewed as trouble for HM leaders negotiating new contracts—or it could be the chance for a new generation of hospitalists to prove their worth.

"This is an opportunity for people who can do good clinical integration. … You can have gainsharing and actually still make physicians win financially but still deliver the right care for patients," says Steven Deitelzweig, MD, MMM, SFHM, chair of SHM's Practice Management Committee and chair of hospital medicine for Ochsner Health System in New Orleans.

According to the report "Recession Contributes To Slowest Annual Rate Of Increase In Health Spending In Five Decades" (doi:10.1377/hlthaff.2010.1032), healthcare spending in 2009 grew just 4%, to $2.5 trillion, the lowest growth rate since the federal government began tracking the data 50 years ago.

The impact of a record slowing in healthcare spending is particularly germane to HM group negotiators, considering they find themselves in talks at a unique time, according to an article in this month’s issue of The Hospitalist. Industry participants say that between stimulus money for quality reforms, the worst economic downturn since the Great Depression, and healthcare reform, hospitals have to do the proverbial more with less.

Dr. Deitelzweig urges hospitalists to promote their quality initiatives and take charge of processes that can save their institutions money. A hospital administration that saves money by eliminating unnecessary procedures and smoothing transitions of care, for example, can argue it deserves a piece of those savings, he says.

"The pie will be shrinking," he adds. "But that doesn't mean you can't figure a way to provide the right care in a less expensive way."

News that domestic spending on healthcare grew at the lowest rate in recorded history could be viewed as trouble for HM leaders negotiating new contracts—or it could be the chance for a new generation of hospitalists to prove their worth.

"This is an opportunity for people who can do good clinical integration. … You can have gainsharing and actually still make physicians win financially but still deliver the right care for patients," says Steven Deitelzweig, MD, MMM, SFHM, chair of SHM's Practice Management Committee and chair of hospital medicine for Ochsner Health System in New Orleans.

According to the report "Recession Contributes To Slowest Annual Rate Of Increase In Health Spending In Five Decades" (doi:10.1377/hlthaff.2010.1032), healthcare spending in 2009 grew just 4%, to $2.5 trillion, the lowest growth rate since the federal government began tracking the data 50 years ago.

The impact of a record slowing in healthcare spending is particularly germane to HM group negotiators, considering they find themselves in talks at a unique time, according to an article in this month’s issue of The Hospitalist. Industry participants say that between stimulus money for quality reforms, the worst economic downturn since the Great Depression, and healthcare reform, hospitals have to do the proverbial more with less.

Dr. Deitelzweig urges hospitalists to promote their quality initiatives and take charge of processes that can save their institutions money. A hospital administration that saves money by eliminating unnecessary procedures and smoothing transitions of care, for example, can argue it deserves a piece of those savings, he says.

"The pie will be shrinking," he adds. "But that doesn't mean you can't figure a way to provide the right care in a less expensive way."

News that domestic spending on healthcare grew at the lowest rate in recorded history could be viewed as trouble for HM leaders negotiating new contracts—or it could be the chance for a new generation of hospitalists to prove their worth.

"This is an opportunity for people who can do good clinical integration. … You can have gainsharing and actually still make physicians win financially but still deliver the right care for patients," says Steven Deitelzweig, MD, MMM, SFHM, chair of SHM's Practice Management Committee and chair of hospital medicine for Ochsner Health System in New Orleans.

According to the report "Recession Contributes To Slowest Annual Rate Of Increase In Health Spending In Five Decades" (doi:10.1377/hlthaff.2010.1032), healthcare spending in 2009 grew just 4%, to $2.5 trillion, the lowest growth rate since the federal government began tracking the data 50 years ago.

The impact of a record slowing in healthcare spending is particularly germane to HM group negotiators, considering they find themselves in talks at a unique time, according to an article in this month’s issue of The Hospitalist. Industry participants say that between stimulus money for quality reforms, the worst economic downturn since the Great Depression, and healthcare reform, hospitals have to do the proverbial more with less.

Dr. Deitelzweig urges hospitalists to promote their quality initiatives and take charge of processes that can save their institutions money. A hospital administration that saves money by eliminating unnecessary procedures and smoothing transitions of care, for example, can argue it deserves a piece of those savings, he says.

"The pie will be shrinking," he adds. "But that doesn't mean you can't figure a way to provide the right care in a less expensive way."

Sally Bullock, MD, medical director of the hospitalist program at Middle Tennessee Medical Center (MTMC) in Murfreesboro, Tenn., received the hospital’s 2011 Physician of the Year award at its annual Physician Christmas Reception in December. The award is voted on by hospital staff, and this is the first time it was given to a hospitalist.

“I’ve been here on staff for 26 years, mostly in private practice as an internist,” Dr. Bullock says. “Visiting the hospital was always a favorite part of my practice. In fact, I did not use hospitalists to care for my patients.”

However, family demands and time pressures of the practice led her to leave it for the flexibility of multiple part-time medical jobs, including HM shifts. In November of 2007, after repeated requests from Andy Brown, MD, MTMC's vice president of medical affairs, she accepted the hospitalist leadership position.

"I encouraged Dr. Bullock to take on this role because she genuinely cares about her patients. Sally is an excellent clinician and communicator who also leads by example," Dr. Brown says. "I knew that physicians would recognize these qualities and want to be part of the program."

The hospitalist program at MTMC started in 1999 with six physicians but experienced contraction in 2006. Under Dr. Bullock's leadership, it has grown to 22 physicians, with more expansion expected this year.

"I just jumped on it, and we got busy recruiting," Dr. Bullock says, adding that the award from her peers at MTMC reflects both her longevity in the medical community and appreciation for "taking the hospitalist program where it needs to be."

Currently, her position includes hospitalist shifts, both scheduled and fill-in, squeezing in administrative duties, and mentoring other physicians. "I'm sort of the program's surge protector," she says.

Sally Bullock, MD, medical director of the hospitalist program at Middle Tennessee Medical Center (MTMC) in Murfreesboro, Tenn., received the hospital’s 2011 Physician of the Year award at its annual Physician Christmas Reception in December. The award is voted on by hospital staff, and this is the first time it was given to a hospitalist.

“I’ve been here on staff for 26 years, mostly in private practice as an internist,” Dr. Bullock says. “Visiting the hospital was always a favorite part of my practice. In fact, I did not use hospitalists to care for my patients.”

However, family demands and time pressures of the practice led her to leave it for the flexibility of multiple part-time medical jobs, including HM shifts. In November of 2007, after repeated requests from Andy Brown, MD, MTMC's vice president of medical affairs, she accepted the hospitalist leadership position.

"I encouraged Dr. Bullock to take on this role because she genuinely cares about her patients. Sally is an excellent clinician and communicator who also leads by example," Dr. Brown says. "I knew that physicians would recognize these qualities and want to be part of the program."

The hospitalist program at MTMC started in 1999 with six physicians but experienced contraction in 2006. Under Dr. Bullock's leadership, it has grown to 22 physicians, with more expansion expected this year.

"I just jumped on it, and we got busy recruiting," Dr. Bullock says, adding that the award from her peers at MTMC reflects both her longevity in the medical community and appreciation for "taking the hospitalist program where it needs to be."

Currently, her position includes hospitalist shifts, both scheduled and fill-in, squeezing in administrative duties, and mentoring other physicians. "I'm sort of the program's surge protector," she says.

Sally Bullock, MD, medical director of the hospitalist program at Middle Tennessee Medical Center (MTMC) in Murfreesboro, Tenn., received the hospital’s 2011 Physician of the Year award at its annual Physician Christmas Reception in December. The award is voted on by hospital staff, and this is the first time it was given to a hospitalist.

“I’ve been here on staff for 26 years, mostly in private practice as an internist,” Dr. Bullock says. “Visiting the hospital was always a favorite part of my practice. In fact, I did not use hospitalists to care for my patients.”

However, family demands and time pressures of the practice led her to leave it for the flexibility of multiple part-time medical jobs, including HM shifts. In November of 2007, after repeated requests from Andy Brown, MD, MTMC's vice president of medical affairs, she accepted the hospitalist leadership position.

"I encouraged Dr. Bullock to take on this role because she genuinely cares about her patients. Sally is an excellent clinician and communicator who also leads by example," Dr. Brown says. "I knew that physicians would recognize these qualities and want to be part of the program."

The hospitalist program at MTMC started in 1999 with six physicians but experienced contraction in 2006. Under Dr. Bullock's leadership, it has grown to 22 physicians, with more expansion expected this year.

"I just jumped on it, and we got busy recruiting," Dr. Bullock says, adding that the award from her peers at MTMC reflects both her longevity in the medical community and appreciation for "taking the hospitalist program where it needs to be."

Currently, her position includes hospitalist shifts, both scheduled and fill-in, squeezing in administrative duties, and mentoring other physicians. "I'm sort of the program's surge protector," she says.

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Sometime early this year, after two years of controversy, the FDA might finally release its revised proposal for more stringent regulations on opioid pain relievers. The following are the key questions—and answers—surrounding new regulations, as well as a look at other recent FDA actions, including increased scrutiny of diabetes and obesity drugs due to heart concerns.

Question: What’s the latest on the FDA release of new regulations for prescription opioids?

Answer: First, the back story: The controversy concerns the creation of a Risk Evaluation and Mitigation Strategy (REMS) for opioid analgesics amid a troubling boom in prescription drug abuse, addiction, and overdose, and an accompanying spike in deaths from opioid overdoses. Under a 2007 law, the FDA can require drug and medical device manufacturers to adopt a REMS to ensure that the benefits outweigh the risks of continued use and that patients are adequately informed. In this case, the strategy could impact how nearly 4 million patients receive long-acting and extended-release opioids annually, according to FDA statistics.

In February 2009, the FDA sent a letter to manufacturers of opioid pain relievers, proposing a classwide REMS that would require certification by a physician or pharmacist and restrict distribution of the drugs, among other provisions. In response, many healthcare providers and medical organizations warned of an increased regulatory burden that would negatively impact patients. Among the concerns: fewer primary-care physicians (PCPs) willing to manage patients with chronic pain, reduced access to medically necessary drugs in underserved communities, undermedicated cancer patients, and increased use of other drugs with less stringent oversight.

In response, the FDA dropped its proposal for a prescriber accreditation program and another for a patient registry. But an FDA advisory panel soundly rejected a revised REMS proposal in July, by a vote of 25-10. The panel criticized the new plans as being too lax, lacking a formal requirement f

Q: What will the new REMS likely include?

A: Based on the criticisms of FDA panelists in July, the revised REMS could mandate a training requirement for all prescribers. The program would likely be created by the FDA and not by the drug industry, as had first been proposed (many doctors have agreed that a centralized, standardized program would be far preferable to dealing with programs set up independently by drug manufacturers). The strategy also might govern immediate-release opioids, in addition to extended-release and long-acting formulations. The FDA could propose linking doctor education to an existing Drug Enforcement Administration registration, but that would require congressional approval.

Q: What was the outcome of safety deliberations over the diabetes drug rosiglitazone (Avandia)?

A: After several years of concern over a heightened risk of heart attacks and other heart problems among patients taking rosiglitazone for type 2 diabetes mellitus, the FDA sharply restricted its availability in September and required the manufacturer, GlaxoSmithKline, to submit a REMS. When implemented, the REMS will limit new prescriptions to patients who cannot achieve glycemic control with other medications and decide not to take the alternative (pioglitazone) for medical reasons.1 Other diabetes drugs have faced similar scrutiny: In October, the FDA rejected an extended-release form of the diabetes drug exenatide (Bydureon) due to safety concerns, citing the need for more studies from manufacturer Eli Lilly about its effect on heart rate.

Q: What’s the upshot of recent FDA actions on weight-loss drugs and supplements?

A: The FDA also cracked down on weight-loss formulations in 2010, declining to approve several new drugs, overseeing the withdrawal of Abbott Laboratory’s Meridia in October, and announcing a December recall of capsules marketed online as Fruta Planta. Safety concerns over the latter two were linked to sibutramine, a drug that is “known to increase blood pressure and/or pulse rate in some patients and may present a serious risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke,” according to the FDA. Additionally, the drug can interact “in life-threatening ways” with other medications, reinforcing the idea that hospitalists and other doctors should delve into patients’ recent history of weight-loss drug or supplement use.

Q: What should we expect from the FDA in the next year?

A: Analysts will be keeping an eye on the number of new drugs approved in 2011 to discern any new trends. As reported by The Wall Street Journal and other publications, the FDA gave 21 drugs the go-ahead in 2010, down from 26 cleared in 2009 and 25 approved in 2008. The dip has concerned some drug industry representatives, who warn that an overly cautious approach could lead to more delays in new drugs reaching patients. Of course, the lower number also could reflect a continued dry spell in the pipelines of many pharmaceutical companies. On the flipside, consumer watchdogs have expressed optimism that the FDA might be devoting more attention to safety. In November, for example, the FDA oversaw the pulling of popular painkiller propoxyphene (marketed as Darvon and Darvocet) after evidence accumulated that the medication can cause potentially fatal heart damage and rhythm abnormalities.

Bryn Nelson is a freelance medical writer based in Seattle.

References

1. Woodcock J, Sharfstein JM, Hamburg M. Regulatory action on rosiglitazone by the U.S. Food and Drug Administration. N Engl J Med. 2010;363(16):1489-1491.

Sometime early this year, after two years of controversy, the FDA might finally release its revised proposal for more stringent regulations on opioid pain relievers. The following are the key questions—and answers—surrounding new regulations, as well as a look at other recent FDA actions, including increased scrutiny of diabetes and obesity drugs due to heart concerns.

Question: What’s the latest on the FDA release of new regulations for prescription opioids?

Answer: First, the back story: The controversy concerns the creation of a Risk Evaluation and Mitigation Strategy (REMS) for opioid analgesics amid a troubling boom in prescription drug abuse, addiction, and overdose, and an accompanying spike in deaths from opioid overdoses. Under a 2007 law, the FDA can require drug and medical device manufacturers to adopt a REMS to ensure that the benefits outweigh the risks of continued use and that patients are adequately informed. In this case, the strategy could impact how nearly 4 million patients receive long-acting and extended-release opioids annually, according to FDA statistics.

In February 2009, the FDA sent a letter to manufacturers of opioid pain relievers, proposing a classwide REMS that would require certification by a physician or pharmacist and restrict distribution of the drugs, among other provisions. In response, many healthcare providers and medical organizations warned of an increased regulatory burden that would negatively impact patients. Among the concerns: fewer primary-care physicians (PCPs) willing to manage patients with chronic pain, reduced access to medically necessary drugs in underserved communities, undermedicated cancer patients, and increased use of other drugs with less stringent oversight.

In response, the FDA dropped its proposal for a prescriber accreditation program and another for a patient registry. But an FDA advisory panel soundly rejected a revised REMS proposal in July, by a vote of 25-10. The panel criticized the new plans as being too lax, lacking a formal requirement f

Q: What will the new REMS likely include?

A: Based on the criticisms of FDA panelists in July, the revised REMS could mandate a training requirement for all prescribers. The program would likely be created by the FDA and not by the drug industry, as had first been proposed (many doctors have agreed that a centralized, standardized program would be far preferable to dealing with programs set up independently by drug manufacturers). The strategy also might govern immediate-release opioids, in addition to extended-release and long-acting formulations. The FDA could propose linking doctor education to an existing Drug Enforcement Administration registration, but that would require congressional approval.

Q: What was the outcome of safety deliberations over the diabetes drug rosiglitazone (Avandia)?

A: After several years of concern over a heightened risk of heart attacks and other heart problems among patients taking rosiglitazone for type 2 diabetes mellitus, the FDA sharply restricted its availability in September and required the manufacturer, GlaxoSmithKline, to submit a REMS. When implemented, the REMS will limit new prescriptions to patients who cannot achieve glycemic control with other medications and decide not to take the alternative (pioglitazone) for medical reasons.1 Other diabetes drugs have faced similar scrutiny: In October, the FDA rejected an extended-release form of the diabetes drug exenatide (Bydureon) due to safety concerns, citing the need for more studies from manufacturer Eli Lilly about its effect on heart rate.

Q: What’s the upshot of recent FDA actions on weight-loss drugs and supplements?

A: The FDA also cracked down on weight-loss formulations in 2010, declining to approve several new drugs, overseeing the withdrawal of Abbott Laboratory’s Meridia in October, and announcing a December recall of capsules marketed online as Fruta Planta. Safety concerns over the latter two were linked to sibutramine, a drug that is “known to increase blood pressure and/or pulse rate in some patients and may present a serious risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke,” according to the FDA. Additionally, the drug can interact “in life-threatening ways” with other medications, reinforcing the idea that hospitalists and other doctors should delve into patients’ recent history of weight-loss drug or supplement use.

Q: What should we expect from the FDA in the next year?

A: Analysts will be keeping an eye on the number of new drugs approved in 2011 to discern any new trends. As reported by The Wall Street Journal and other publications, the FDA gave 21 drugs the go-ahead in 2010, down from 26 cleared in 2009 and 25 approved in 2008. The dip has concerned some drug industry representatives, who warn that an overly cautious approach could lead to more delays in new drugs reaching patients. Of course, the lower number also could reflect a continued dry spell in the pipelines of many pharmaceutical companies. On the flipside, consumer watchdogs have expressed optimism that the FDA might be devoting more attention to safety. In November, for example, the FDA oversaw the pulling of popular painkiller propoxyphene (marketed as Darvon and Darvocet) after evidence accumulated that the medication can cause potentially fatal heart damage and rhythm abnormalities.

Bryn Nelson is a freelance medical writer based in Seattle.

References

1. Woodcock J, Sharfstein JM, Hamburg M. Regulatory action on rosiglitazone by the U.S. Food and Drug Administration. N Engl J Med. 2010;363(16):1489-1491.

Sometime early this year, after two years of controversy, the FDA might finally release its revised proposal for more stringent regulations on opioid pain relievers. The following are the key questions—and answers—surrounding new regulations, as well as a look at other recent FDA actions, including increased scrutiny of diabetes and obesity drugs due to heart concerns.

Question: What’s the latest on the FDA release of new regulations for prescription opioids?

Answer: First, the back story: The controversy concerns the creation of a Risk Evaluation and Mitigation Strategy (REMS) for opioid analgesics amid a troubling boom in prescription drug abuse, addiction, and overdose, and an accompanying spike in deaths from opioid overdoses. Under a 2007 law, the FDA can require drug and medical device manufacturers to adopt a REMS to ensure that the benefits outweigh the risks of continued use and that patients are adequately informed. In this case, the strategy could impact how nearly 4 million patients receive long-acting and extended-release opioids annually, according to FDA statistics.

In February 2009, the FDA sent a letter to manufacturers of opioid pain relievers, proposing a classwide REMS that would require certification by a physician or pharmacist and restrict distribution of the drugs, among other provisions. In response, many healthcare providers and medical organizations warned of an increased regulatory burden that would negatively impact patients. Among the concerns: fewer primary-care physicians (PCPs) willing to manage patients with chronic pain, reduced access to medically necessary drugs in underserved communities, undermedicated cancer patients, and increased use of other drugs with less stringent oversight.

In response, the FDA dropped its proposal for a prescriber accreditation program and another for a patient registry. But an FDA advisory panel soundly rejected a revised REMS proposal in July, by a vote of 25-10. The panel criticized the new plans as being too lax, lacking a formal requirement f

Q: What will the new REMS likely include?

A: Based on the criticisms of FDA panelists in July, the revised REMS could mandate a training requirement for all prescribers. The program would likely be created by the FDA and not by the drug industry, as had first been proposed (many doctors have agreed that a centralized, standardized program would be far preferable to dealing with programs set up independently by drug manufacturers). The strategy also might govern immediate-release opioids, in addition to extended-release and long-acting formulations. The FDA could propose linking doctor education to an existing Drug Enforcement Administration registration, but that would require congressional approval.

Q: What was the outcome of safety deliberations over the diabetes drug rosiglitazone (Avandia)?

A: After several years of concern over a heightened risk of heart attacks and other heart problems among patients taking rosiglitazone for type 2 diabetes mellitus, the FDA sharply restricted its availability in September and required the manufacturer, GlaxoSmithKline, to submit a REMS. When implemented, the REMS will limit new prescriptions to patients who cannot achieve glycemic control with other medications and decide not to take the alternative (pioglitazone) for medical reasons.1 Other diabetes drugs have faced similar scrutiny: In October, the FDA rejected an extended-release form of the diabetes drug exenatide (Bydureon) due to safety concerns, citing the need for more studies from manufacturer Eli Lilly about its effect on heart rate.

Q: What’s the upshot of recent FDA actions on weight-loss drugs and supplements?

A: The FDA also cracked down on weight-loss formulations in 2010, declining to approve several new drugs, overseeing the withdrawal of Abbott Laboratory’s Meridia in October, and announcing a December recall of capsules marketed online as Fruta Planta. Safety concerns over the latter two were linked to sibutramine, a drug that is “known to increase blood pressure and/or pulse rate in some patients and may present a serious risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke,” according to the FDA. Additionally, the drug can interact “in life-threatening ways” with other medications, reinforcing the idea that hospitalists and other doctors should delve into patients’ recent history of weight-loss drug or supplement use.

Q: What should we expect from the FDA in the next year?

A: Analysts will be keeping an eye on the number of new drugs approved in 2011 to discern any new trends. As reported by The Wall Street Journal and other publications, the FDA gave 21 drugs the go-ahead in 2010, down from 26 cleared in 2009 and 25 approved in 2008. The dip has concerned some drug industry representatives, who warn that an overly cautious approach could lead to more delays in new drugs reaching patients. Of course, the lower number also could reflect a continued dry spell in the pipelines of many pharmaceutical companies. On the flipside, consumer watchdogs have expressed optimism that the FDA might be devoting more attention to safety. In November, for example, the FDA oversaw the pulling of popular painkiller propoxyphene (marketed as Darvon and Darvocet) after evidence accumulated that the medication can cause potentially fatal heart damage and rhythm abnormalities.

Bryn Nelson is a freelance medical writer based in Seattle.

References

1. Woodcock J, Sharfstein JM, Hamburg M. Regulatory action on rosiglitazone by the U.S. Food and Drug Administration. N Engl J Med. 2010;363(16):1489-1491.

Academic HM group leaders are concerned about the lack of mentorship their physicians receive and often feel viewed as a clinical service, not a pedagogical program, according to a report in this month's Journal of Hospital Medicine.

The cross-sectional e-mail survey of 57 leaders found that respondents agree a lack of mentorship is a worry for both clinician-educator faculty (75%) and research faculty (58%). Six in 10 of those surveyed say their departments of medicine view them through more of a clinical lens, with that number rising to nearly 8 in 10 when the perceived views of other departments are taken into account.

"The division chiefs, the section chiefs have to pay attention to mentoring; they have to pay attention to faculty development, they have to really understand the needs of their people," says study coauthor Rebecca Harrison, MD, FACP, a hospitalist at Oregon Health & Science University in Portland, Ore.

The report is based on a 2007 survey. Dr. Harrison says that as budgets became "more dire" during the economic downturn, academic HM leaders likely grew more frustrated by a perceived lack of resources committed to them.

She suggests that academic leaders look more to the negotiating tactics of their private-physician counterparts, who seek to leverage their involvement in quality programs and their return on investment when pushing for more support, respect, or resources.

Dr. Harrison adds that given that recruitment costs can range up to $400,000 for clinician-educator faculty, hospital executives "need to see the big picture. Hospital medicine is here to say. It's to their advantage; it behooves them not to avoid investing in sustainability."

Academic HM group leaders are concerned about the lack of mentorship their physicians receive and often feel viewed as a clinical service, not a pedagogical program, according to a report in this month's Journal of Hospital Medicine.

The cross-sectional e-mail survey of 57 leaders found that respondents agree a lack of mentorship is a worry for both clinician-educator faculty (75%) and research faculty (58%). Six in 10 of those surveyed say their departments of medicine view them through more of a clinical lens, with that number rising to nearly 8 in 10 when the perceived views of other departments are taken into account.

"The division chiefs, the section chiefs have to pay attention to mentoring; they have to pay attention to faculty development, they have to really understand the needs of their people," says study coauthor Rebecca Harrison, MD, FACP, a hospitalist at Oregon Health & Science University in Portland, Ore.

The report is based on a 2007 survey. Dr. Harrison says that as budgets became "more dire" during the economic downturn, academic HM leaders likely grew more frustrated by a perceived lack of resources committed to them.

She suggests that academic leaders look more to the negotiating tactics of their private-physician counterparts, who seek to leverage their involvement in quality programs and their return on investment when pushing for more support, respect, or resources.

Dr. Harrison adds that given that recruitment costs can range up to $400,000 for clinician-educator faculty, hospital executives "need to see the big picture. Hospital medicine is here to say. It's to their advantage; it behooves them not to avoid investing in sustainability."

Academic HM group leaders are concerned about the lack of mentorship their physicians receive and often feel viewed as a clinical service, not a pedagogical program, according to a report in this month's Journal of Hospital Medicine.

The cross-sectional e-mail survey of 57 leaders found that respondents agree a lack of mentorship is a worry for both clinician-educator faculty (75%) and research faculty (58%). Six in 10 of those surveyed say their departments of medicine view them through more of a clinical lens, with that number rising to nearly 8 in 10 when the perceived views of other departments are taken into account.

"The division chiefs, the section chiefs have to pay attention to mentoring; they have to pay attention to faculty development, they have to really understand the needs of their people," says study coauthor Rebecca Harrison, MD, FACP, a hospitalist at Oregon Health & Science University in Portland, Ore.

The report is based on a 2007 survey. Dr. Harrison says that as budgets became "more dire" during the economic downturn, academic HM leaders likely grew more frustrated by a perceived lack of resources committed to them.

She suggests that academic leaders look more to the negotiating tactics of their private-physician counterparts, who seek to leverage their involvement in quality programs and their return on investment when pushing for more support, respect, or resources.

Dr. Harrison adds that given that recruitment costs can range up to $400,000 for clinician-educator faculty, hospital executives "need to see the big picture. Hospital medicine is here to say. It's to their advantage; it behooves them not to avoid investing in sustainability."

Clinical question: Does full disclosure of medical errors increase or decrease liability and claims?

Background: The University of Michigan Health System (UMHS) actively seeks out medical errors, fully discloses these errors to patients, and offers compensation when at fault. Full disclosure is consistent with patient safety and ethical principles, but whether such programs exacerbate total liability costs remains controversial amongst physicians and malpractice professionals.

Study design: Retrospective before-and-after analysis from 1995 to 2007.

Setting: Public academic medical center and health system.

Synopsis: After the full implementation of a disclosure to offer program in 2001 at UMHS, the average monthly rate of new claims decreased to 4.52 per 100,000 patient encounters from 7.03 per 100,000 patient encounters. Median time to resolution of each claim also decreased to 0.95 years from 1.36 years. Average total liability monthly costs per month for every $1,000 of operating revenue dropped to $4.00 from $8.48 (p<.001), mostly driven by decreased costs for patient compensation and legal costs.

The observation that total liability costs decrease with full disclosure does not prove causality, as the number of reported claims throughout Michigan decreased from 2001 to 2007, and state wide malpractice reform was initiated in 1994. A comparison with 20 physician insurers, however, suggests quicker resolution times and decreasing legal and compensation costs of UMHS compared with its peers. Moreover, the Veterans Affairs Medical Center in Lexington, Ky., also had success after initiation of a similar disclosure-with-offer program, suggesting that the experience of such programs might be generalized to other settings.

Bottom line: Full disclosure of medical errors with offers of compensation is associated with decreased total claims and liability costs.

Citation: Kachalia A, Kaufman SR, Boothman R, et al. Liability claims and costs before and after implementation of a medical error disclosure program. Ann Intern Med. 2010:153(4):213-221.

Reviewed for TH eWire by Jill Goldenberg, MD, Alan Briones, MD, Chad Craig, MD, Ramiro Jervis, MD, FHM, Brian Markoff, MD, FHM, Andrew Dunn, MD, FACP, FHM, Division of Hospital Medicine, Mount Sinai School of Medicine, New York City

For more physician reviews of HM-related research, visit our website.

Clinical question: Does full disclosure of medical errors increase or decrease liability and claims?

Background: The University of Michigan Health System (UMHS) actively seeks out medical errors, fully discloses these errors to patients, and offers compensation when at fault. Full disclosure is consistent with patient safety and ethical principles, but whether such programs exacerbate total liability costs remains controversial amongst physicians and malpractice professionals.

Study design: Retrospective before-and-after analysis from 1995 to 2007.

Setting: Public academic medical center and health system.

Synopsis: After the full implementation of a disclosure to offer program in 2001 at UMHS, the average monthly rate of new claims decreased to 4.52 per 100,000 patient encounters from 7.03 per 100,000 patient encounters. Median time to resolution of each claim also decreased to 0.95 years from 1.36 years. Average total liability monthly costs per month for every $1,000 of operating revenue dropped to $4.00 from $8.48 (p<.001), mostly driven by decreased costs for patient compensation and legal costs.

The observation that total liability costs decrease with full disclosure does not prove causality, as the number of reported claims throughout Michigan decreased from 2001 to 2007, and state wide malpractice reform was initiated in 1994. A comparison with 20 physician insurers, however, suggests quicker resolution times and decreasing legal and compensation costs of UMHS compared with its peers. Moreover, the Veterans Affairs Medical Center in Lexington, Ky., also had success after initiation of a similar disclosure-with-offer program, suggesting that the experience of such programs might be generalized to other settings.

Bottom line: Full disclosure of medical errors with offers of compensation is associated with decreased total claims and liability costs.

Citation: Kachalia A, Kaufman SR, Boothman R, et al. Liability claims and costs before and after implementation of a medical error disclosure program. Ann Intern Med. 2010:153(4):213-221.

Reviewed for TH eWire by Jill Goldenberg, MD, Alan Briones, MD, Chad Craig, MD, Ramiro Jervis, MD, FHM, Brian Markoff, MD, FHM, Andrew Dunn, MD, FACP, FHM, Division of Hospital Medicine, Mount Sinai School of Medicine, New York City

For more physician reviews of HM-related research, visit our website.

Clinical question: Does full disclosure of medical errors increase or decrease liability and claims?

Background: The University of Michigan Health System (UMHS) actively seeks out medical errors, fully discloses these errors to patients, and offers compensation when at fault. Full disclosure is consistent with patient safety and ethical principles, but whether such programs exacerbate total liability costs remains controversial amongst physicians and malpractice professionals.

Study design: Retrospective before-and-after analysis from 1995 to 2007.

Setting: Public academic medical center and health system.

Synopsis: After the full implementation of a disclosure to offer program in 2001 at UMHS, the average monthly rate of new claims decreased to 4.52 per 100,000 patient encounters from 7.03 per 100,000 patient encounters. Median time to resolution of each claim also decreased to 0.95 years from 1.36 years. Average total liability monthly costs per month for every $1,000 of operating revenue dropped to $4.00 from $8.48 (p<.001), mostly driven by decreased costs for patient compensation and legal costs.

The observation that total liability costs decrease with full disclosure does not prove causality, as the number of reported claims throughout Michigan decreased from 2001 to 2007, and state wide malpractice reform was initiated in 1994. A comparison with 20 physician insurers, however, suggests quicker resolution times and decreasing legal and compensation costs of UMHS compared with its peers. Moreover, the Veterans Affairs Medical Center in Lexington, Ky., also had success after initiation of a similar disclosure-with-offer program, suggesting that the experience of such programs might be generalized to other settings.

Bottom line: Full disclosure of medical errors with offers of compensation is associated with decreased total claims and liability costs.

Citation: Kachalia A, Kaufman SR, Boothman R, et al. Liability claims and costs before and after implementation of a medical error disclosure program. Ann Intern Med. 2010:153(4):213-221.

Reviewed for TH eWire by Jill Goldenberg, MD, Alan Briones, MD, Chad Craig, MD, Ramiro Jervis, MD, FHM, Brian Markoff, MD, FHM, Andrew Dunn, MD, FACP, FHM, Division of Hospital Medicine, Mount Sinai School of Medicine, New York City

For more physician reviews of HM-related research, visit our website.

Determining Efficacy of Antibacterial Hand Wash Products

This promotional supplement was supported by American Cleaning Institute® and the Personal Care Products Council.

•Topics
•Faculty/Faculty Disclosures

To view the supplement, click the image above.

TOPIC HIGHLIGHTS

• 1994 FDA-Proposed Antiseptic Hand Wash Efficacy Criteria
• Need for Link Between Bacterial Log Reduction and Disease
• New Model for Efficacy Evaluation of Antibacterial Hand Washes
• New Scientific Model Links Bacterial Reduction with Reduction in Disease
• Expert Panel Review of the New Model for Efficacy Evaluation
• Expert Panel Consensus Statement
• Expanding the Scope of the New Scientific Model to Other Health Care Settings
• Moving Forward

FACULTY/FACULTY DISCLOSURE

Francis H. Kruszewski, PhD, DABT
Director, Human Health and Safety
American Cleaning Institute® (formerly the Soap and Detergent Association)
Washington, DC

Francis H. Kruszewski, PhD, DABT is employed by American Cleaning Institute® (formerly the Soap and Detergent Association)

John F. Krowka, PhD
Senior Environmental Scientist
The Personal Care Products Council
Washington, DC

John F. Krowka, PhD is employed by The Personal Care Products Council

Copyright © 2011 Elsevier Inc.

Determining Efficacy of Antibacterial Hand Wash Products

This promotional supplement was supported by American Cleaning Institute® and the Personal Care Products Council.

•Topics
•Faculty/Faculty Disclosures

To view the supplement, click the image above.

TOPIC HIGHLIGHTS

• 1994 FDA-Proposed Antiseptic Hand Wash Efficacy Criteria
• Need for Link Between Bacterial Log Reduction and Disease
• New Model for Efficacy Evaluation of Antibacterial Hand Washes
• New Scientific Model Links Bacterial Reduction with Reduction in Disease
• Expert Panel Review of the New Model for Efficacy Evaluation
• Expert Panel Consensus Statement
• Expanding the Scope of the New Scientific Model to Other Health Care Settings
• Moving Forward

FACULTY/FACULTY DISCLOSURE

Francis H. Kruszewski, PhD, DABT
Director, Human Health and Safety
American Cleaning Institute® (formerly the Soap and Detergent Association)
Washington, DC

Francis H. Kruszewski, PhD, DABT is employed by American Cleaning Institute® (formerly the Soap and Detergent Association)

John F. Krowka, PhD
Senior Environmental Scientist
The Personal Care Products Council
Washington, DC

John F. Krowka, PhD is employed by The Personal Care Products Council

Copyright © 2011 Elsevier Inc.

Determining Efficacy of Antibacterial Hand Wash Products

This promotional supplement was supported by American Cleaning Institute® and the Personal Care Products Council.

•Topics
•Faculty/Faculty Disclosures

To view the supplement, click the image above.

TOPIC HIGHLIGHTS

• 1994 FDA-Proposed Antiseptic Hand Wash Efficacy Criteria
• Need for Link Between Bacterial Log Reduction and Disease
• New Model for Efficacy Evaluation of Antibacterial Hand Washes
• New Scientific Model Links Bacterial Reduction with Reduction in Disease
• Expert Panel Review of the New Model for Efficacy Evaluation
• Expert Panel Consensus Statement
• Expanding the Scope of the New Scientific Model to Other Health Care Settings
• Moving Forward

FACULTY/FACULTY DISCLOSURE

Francis H. Kruszewski, PhD, DABT
Director, Human Health and Safety
American Cleaning Institute® (formerly the Soap and Detergent Association)
Washington, DC

Francis H. Kruszewski, PhD, DABT is employed by American Cleaning Institute® (formerly the Soap and Detergent Association)

John F. Krowka, PhD
Senior Environmental Scientist
The Personal Care Products Council
Washington, DC

John F. Krowka, PhD is employed by The Personal Care Products Council

Copyright © 2011 Elsevier Inc.