Commentary

Despite all the hoopla about Ebola and measles this winter, the most common reason for admitting an infant or young child to the hospital continues to be bronchiolitis. Yet clinical practice guidelines for diagnosing and treating this common infection have not been incorporated into clinical practice.

The use of over-the-counter cold medications to treat upper respiratory infections in young children was shown by meta-analysis in the mid-1990’s to be ineffective, but that use continued until the Food and Drug Administration mandated revisions to packaging in 2008. Antibiotics have been commonly prescribed to treat the ear infections and sinusitis that frequently occur with bronchiolitis. But over the past 20 years, the use of antibiotics has become less prevalent. I date that trend to the work of Dr. Jack Paradise, professor emeritus of pediatrics at the University of Pittsburgh, and Dr. Ellen Wald, now chair of pediatrics at the University of Wisconsin, Madison, in the mid-1990’s. RespiGam was approved in 1996, then supplanted with palivizumab, as a medication to reduce the burden of respiratory syncytial virus disease. In the summer of 2014, an updated analysis of the costs, risks, and benefits of RSV prophylaxis led to new recommendations that curtailed the indications for that treatment (Pediatrics 2014:134;415-20). What do these trends have in common? The time frame.

It is often cited that it takes 17 years for new evidence to be assimilated into clinical practice (J.R. Soc. Med. 2011;104:510-20). An Institute of Medicine report in 2001, “Crossing the Quality Chasm,” emphasized the importance of becoming more efficient at making progress. Those recommendations themselves are now 14 years old, and I’m not expecting a revolution in human behavior within the next 3 years.

In the new clinical practice guideline issued by the American Academy of Pediatrics in November 2014 for the treatment of young children with bronchiolitis, Dr. Shawn L. Ralston and her colleagues assessed various treatment modalities, found many to be ineffective, and recommended discontinuing their routine use (Pediatrics 2014;134:e1474-e1502). Beta-agonists were at the forefront of this. Was the new guideline based on new data? For the most part, no. In my reading, itmostly reiterated the concerns about effectiveness that were expressed at the time of the prior guidelines from 2006, but removed the weasel words. I admire the dedication of this committee to evidence-based medicine. But will this revised clinical practice guideline actually change practice?

The saying is, “Build a better mousetrap and the world will beat a path to your door.” That quote has been attributed (without adequate documentation) to Ralph Waldo Emerson. He was a great poet, but not a scientist.

During the same month that the new bronchiolitis guidelinewas being released, America held some elections. In the post mortem, President Obama said, “There is a tendency sometimes for me to start thinking: As long as I get the policy right, then that’s what should matter.” He elaborated that “one thing that I do need to constantly remind myself and my team of is it’s not enough just to build the better mousetrap. People don’t automatically come beating to your door. We’ve got to sell it; we’ve got to reach out to the other side and where possible, persuade” (The Wall Street Journal, Nov. 10, 2014).

That isn’t poetry, but the President’s idea is probably more accurate than Emerson’s.

The bronchiolitis clinical practice guidelinewas written in a standardized fashion with 14 key action statements and 242 references. That makes for a good evidence-based medicine document, but is not the best sales pitch.

What will it take to translate these new guidelines into practice? One option is to teach new residents the new guidelines and expect dinosaurs such as myself to retire. If the average pediatrician works for about 34 years, then over a period of 17 years, we will have replaced half the miscreants simply by attrition.

A program of reaching out to the other side and persuading them to change is a better option.

In discussions about this topic on a listserv for pediatric hospitalists, I focused on my concerns. We need to clarify the harms associated with therapies such as beta-agonists, deep nasal suctioning, and continuous pulse oximetry. We need to clarify the goals of treatment, which might include a shorter length of stay, patient comfort, meeting parents’ expectations that we will do something, and/or explaining why we are contradicting any previous recommendations made to the parents. We need to mesh these bronchiolitis guidelines with the asthma action plans and medication lists advocated for wheezing children who are 24 months of age. My colleagues pointed out that all of that is just continuing to refine the policy.

Getting the policy right is necessary but insufficient. What we are really missing is a campaign strategy to sell it.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He is also listserv moderator for the American Academy of Pediatrics Section on Hospital Medicine.

Despite all the hoopla about Ebola and measles this winter, the most common reason for admitting an infant or young child to the hospital continues to be bronchiolitis. Yet clinical practice guidelines for diagnosing and treating this common infection have not been incorporated into clinical practice.

The use of over-the-counter cold medications to treat upper respiratory infections in young children was shown by meta-analysis in the mid-1990’s to be ineffective, but that use continued until the Food and Drug Administration mandated revisions to packaging in 2008. Antibiotics have been commonly prescribed to treat the ear infections and sinusitis that frequently occur with bronchiolitis. But over the past 20 years, the use of antibiotics has become less prevalent. I date that trend to the work of Dr. Jack Paradise, professor emeritus of pediatrics at the University of Pittsburgh, and Dr. Ellen Wald, now chair of pediatrics at the University of Wisconsin, Madison, in the mid-1990’s. RespiGam was approved in 1996, then supplanted with palivizumab, as a medication to reduce the burden of respiratory syncytial virus disease. In the summer of 2014, an updated analysis of the costs, risks, and benefits of RSV prophylaxis led to new recommendations that curtailed the indications for that treatment (Pediatrics 2014:134;415-20). What do these trends have in common? The time frame.

It is often cited that it takes 17 years for new evidence to be assimilated into clinical practice (J.R. Soc. Med. 2011;104:510-20). An Institute of Medicine report in 2001, “Crossing the Quality Chasm,” emphasized the importance of becoming more efficient at making progress. Those recommendations themselves are now 14 years old, and I’m not expecting a revolution in human behavior within the next 3 years.

In the new clinical practice guideline issued by the American Academy of Pediatrics in November 2014 for the treatment of young children with bronchiolitis, Dr. Shawn L. Ralston and her colleagues assessed various treatment modalities, found many to be ineffective, and recommended discontinuing their routine use (Pediatrics 2014;134:e1474-e1502). Beta-agonists were at the forefront of this. Was the new guideline based on new data? For the most part, no. In my reading, itmostly reiterated the concerns about effectiveness that were expressed at the time of the prior guidelines from 2006, but removed the weasel words. I admire the dedication of this committee to evidence-based medicine. But will this revised clinical practice guideline actually change practice?

The saying is, “Build a better mousetrap and the world will beat a path to your door.” That quote has been attributed (without adequate documentation) to Ralph Waldo Emerson. He was a great poet, but not a scientist.

During the same month that the new bronchiolitis guidelinewas being released, America held some elections. In the post mortem, President Obama said, “There is a tendency sometimes for me to start thinking: As long as I get the policy right, then that’s what should matter.” He elaborated that “one thing that I do need to constantly remind myself and my team of is it’s not enough just to build the better mousetrap. People don’t automatically come beating to your door. We’ve got to sell it; we’ve got to reach out to the other side and where possible, persuade” (The Wall Street Journal, Nov. 10, 2014).

That isn’t poetry, but the President’s idea is probably more accurate than Emerson’s.

The bronchiolitis clinical practice guidelinewas written in a standardized fashion with 14 key action statements and 242 references. That makes for a good evidence-based medicine document, but is not the best sales pitch.

What will it take to translate these new guidelines into practice? One option is to teach new residents the new guidelines and expect dinosaurs such as myself to retire. If the average pediatrician works for about 34 years, then over a period of 17 years, we will have replaced half the miscreants simply by attrition.

A program of reaching out to the other side and persuading them to change is a better option.

In discussions about this topic on a listserv for pediatric hospitalists, I focused on my concerns. We need to clarify the harms associated with therapies such as beta-agonists, deep nasal suctioning, and continuous pulse oximetry. We need to clarify the goals of treatment, which might include a shorter length of stay, patient comfort, meeting parents’ expectations that we will do something, and/or explaining why we are contradicting any previous recommendations made to the parents. We need to mesh these bronchiolitis guidelines with the asthma action plans and medication lists advocated for wheezing children who are 24 months of age. My colleagues pointed out that all of that is just continuing to refine the policy.

Getting the policy right is necessary but insufficient. What we are really missing is a campaign strategy to sell it.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He is also listserv moderator for the American Academy of Pediatrics Section on Hospital Medicine.

Despite all the hoopla about Ebola and measles this winter, the most common reason for admitting an infant or young child to the hospital continues to be bronchiolitis. Yet clinical practice guidelines for diagnosing and treating this common infection have not been incorporated into clinical practice.

The use of over-the-counter cold medications to treat upper respiratory infections in young children was shown by meta-analysis in the mid-1990’s to be ineffective, but that use continued until the Food and Drug Administration mandated revisions to packaging in 2008. Antibiotics have been commonly prescribed to treat the ear infections and sinusitis that frequently occur with bronchiolitis. But over the past 20 years, the use of antibiotics has become less prevalent. I date that trend to the work of Dr. Jack Paradise, professor emeritus of pediatrics at the University of Pittsburgh, and Dr. Ellen Wald, now chair of pediatrics at the University of Wisconsin, Madison, in the mid-1990’s. RespiGam was approved in 1996, then supplanted with palivizumab, as a medication to reduce the burden of respiratory syncytial virus disease. In the summer of 2014, an updated analysis of the costs, risks, and benefits of RSV prophylaxis led to new recommendations that curtailed the indications for that treatment (Pediatrics 2014:134;415-20). What do these trends have in common? The time frame.

It is often cited that it takes 17 years for new evidence to be assimilated into clinical practice (J.R. Soc. Med. 2011;104:510-20). An Institute of Medicine report in 2001, “Crossing the Quality Chasm,” emphasized the importance of becoming more efficient at making progress. Those recommendations themselves are now 14 years old, and I’m not expecting a revolution in human behavior within the next 3 years.

In the new clinical practice guideline issued by the American Academy of Pediatrics in November 2014 for the treatment of young children with bronchiolitis, Dr. Shawn L. Ralston and her colleagues assessed various treatment modalities, found many to be ineffective, and recommended discontinuing their routine use (Pediatrics 2014;134:e1474-e1502). Beta-agonists were at the forefront of this. Was the new guideline based on new data? For the most part, no. In my reading, itmostly reiterated the concerns about effectiveness that were expressed at the time of the prior guidelines from 2006, but removed the weasel words. I admire the dedication of this committee to evidence-based medicine. But will this revised clinical practice guideline actually change practice?

The saying is, “Build a better mousetrap and the world will beat a path to your door.” That quote has been attributed (without adequate documentation) to Ralph Waldo Emerson. He was a great poet, but not a scientist.

During the same month that the new bronchiolitis guidelinewas being released, America held some elections. In the post mortem, President Obama said, “There is a tendency sometimes for me to start thinking: As long as I get the policy right, then that’s what should matter.” He elaborated that “one thing that I do need to constantly remind myself and my team of is it’s not enough just to build the better mousetrap. People don’t automatically come beating to your door. We’ve got to sell it; we’ve got to reach out to the other side and where possible, persuade” (The Wall Street Journal, Nov. 10, 2014).

That isn’t poetry, but the President’s idea is probably more accurate than Emerson’s.

The bronchiolitis clinical practice guidelinewas written in a standardized fashion with 14 key action statements and 242 references. That makes for a good evidence-based medicine document, but is not the best sales pitch.

What will it take to translate these new guidelines into practice? One option is to teach new residents the new guidelines and expect dinosaurs such as myself to retire. If the average pediatrician works for about 34 years, then over a period of 17 years, we will have replaced half the miscreants simply by attrition.

A program of reaching out to the other side and persuading them to change is a better option.

In discussions about this topic on a listserv for pediatric hospitalists, I focused on my concerns. We need to clarify the harms associated with therapies such as beta-agonists, deep nasal suctioning, and continuous pulse oximetry. We need to clarify the goals of treatment, which might include a shorter length of stay, patient comfort, meeting parents’ expectations that we will do something, and/or explaining why we are contradicting any previous recommendations made to the parents. We need to mesh these bronchiolitis guidelines with the asthma action plans and medication lists advocated for wheezing children who are 24 months of age. My colleagues pointed out that all of that is just continuing to refine the policy.

Getting the policy right is necessary but insufficient. What we are really missing is a campaign strategy to sell it.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He is also listserv moderator for the American Academy of Pediatrics Section on Hospital Medicine.

By yesterday at lunch time, you knew you were sick. The sniffly nose and scratchy throat of the previous 2 days were maturing into a full-blown cold or worse. You woke this morning feeling achy and a bit feverish. The only thermometer in the house is a scary looking thing in the cutlery drawer next to the kitchen stove. There have been no cases of influenza reported in the country or even the state.

It is Thursday, and it is your partner’s traditional day off. You think you remember him saying that he was planning on driving out of state to visit his daughter who was struggling in her freshman year in college. Your new associate is in St. Louis taking her boards. The questions that need to be answered by 7:30 this morning are: Do I see if I can reach my partner before he leaves town and ask him if can work for me? If he is already on the road, do I call the office and tell them to cancel the day’s schedule because I am too sick to work?

This is the kind of scenario that most have us have faced more than once in our working lives. Who will I be putting at risk by going to work when I am sick? Of course, there are my patients. Is my patient population particularly fragile because of their age or immunological vulnerabilities? And there are my coworkers. Last of all, will going to work make me even sicker so that I will miss more work?

Where do you go for help in answering the question of whether you are too sick to go to work? Should you try to find a thermometer at an all-night convenience store? If you find one, exactly what temperature is the threshold that will prompt you to call in sick? How many sneezes per hour will render you too contagious to work? How many coughs? If your illness is primarily gastrointestinal, are you still a threat to your patients if your trips to the bathroom are spaced far enough apart to allow you to spend 15 minutes trapped in an examining room?

Would wearing a mask be of any benefit? My sense is that it wouldn’t help and may make you more of a threat if you keeping fiddling with it to readjust it for comfort. And a mask will certainly alarm some parents.

There are situations in which you look or sound worse than you are. I seem to develop laryngitis several days after the worst of my cold has passed. Unfortunately, this scenario is not one of those situations. If you show up in the office, you are going to sound and maybe look like you are as sick as you feel.

What are you going to do? I am embarrassed to admit that I was one of those masochists who would have gone to work regardless of my state of health. You would have had to tether me to an IV bottle to keep me at home. As a recovering workaholic, I have had to accept the fact that I may have jeopardized the health of some of my patients by my pigheaded and at times selfish devotion to showing up in the office come hell or high fever. But, on days when I was the only show in town, it was easy to fall into the trap of believing that I was indispensable. Although full-time emergency room physicians and hospitalists hadn’t been invented yet, there were a few other primary care physicians. I guess it was pride that prevented me from admitting that I could have called on them for help, even though they weren’t board certified pediatricians.

On the other hand, I still wonder how much harm I did by dragging myself to work when I was sick. Because Brunswick is a small town, I know my overly intense devotion to work didn’t result in any deaths. But how great was the collateral damage in the form of lost days from school and work for my patients, their parents, and my coworkers? There is no way to know, but I am sure there was some.

It is unreasonable to say, “I won’t ever go to work if I am ill.” I may have set the bar too high, but I am interested to hear how you decide when you are too sick to go to work.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “Coping with a Picky Eater.” E-mail him at [email protected].

By yesterday at lunch time, you knew you were sick. The sniffly nose and scratchy throat of the previous 2 days were maturing into a full-blown cold or worse. You woke this morning feeling achy and a bit feverish. The only thermometer in the house is a scary looking thing in the cutlery drawer next to the kitchen stove. There have been no cases of influenza reported in the country or even the state.

It is Thursday, and it is your partner’s traditional day off. You think you remember him saying that he was planning on driving out of state to visit his daughter who was struggling in her freshman year in college. Your new associate is in St. Louis taking her boards. The questions that need to be answered by 7:30 this morning are: Do I see if I can reach my partner before he leaves town and ask him if can work for me? If he is already on the road, do I call the office and tell them to cancel the day’s schedule because I am too sick to work?

This is the kind of scenario that most have us have faced more than once in our working lives. Who will I be putting at risk by going to work when I am sick? Of course, there are my patients. Is my patient population particularly fragile because of their age or immunological vulnerabilities? And there are my coworkers. Last of all, will going to work make me even sicker so that I will miss more work?

Where do you go for help in answering the question of whether you are too sick to go to work? Should you try to find a thermometer at an all-night convenience store? If you find one, exactly what temperature is the threshold that will prompt you to call in sick? How many sneezes per hour will render you too contagious to work? How many coughs? If your illness is primarily gastrointestinal, are you still a threat to your patients if your trips to the bathroom are spaced far enough apart to allow you to spend 15 minutes trapped in an examining room?

Would wearing a mask be of any benefit? My sense is that it wouldn’t help and may make you more of a threat if you keeping fiddling with it to readjust it for comfort. And a mask will certainly alarm some parents.

There are situations in which you look or sound worse than you are. I seem to develop laryngitis several days after the worst of my cold has passed. Unfortunately, this scenario is not one of those situations. If you show up in the office, you are going to sound and maybe look like you are as sick as you feel.

What are you going to do? I am embarrassed to admit that I was one of those masochists who would have gone to work regardless of my state of health. You would have had to tether me to an IV bottle to keep me at home. As a recovering workaholic, I have had to accept the fact that I may have jeopardized the health of some of my patients by my pigheaded and at times selfish devotion to showing up in the office come hell or high fever. But, on days when I was the only show in town, it was easy to fall into the trap of believing that I was indispensable. Although full-time emergency room physicians and hospitalists hadn’t been invented yet, there were a few other primary care physicians. I guess it was pride that prevented me from admitting that I could have called on them for help, even though they weren’t board certified pediatricians.

On the other hand, I still wonder how much harm I did by dragging myself to work when I was sick. Because Brunswick is a small town, I know my overly intense devotion to work didn’t result in any deaths. But how great was the collateral damage in the form of lost days from school and work for my patients, their parents, and my coworkers? There is no way to know, but I am sure there was some.

It is unreasonable to say, “I won’t ever go to work if I am ill.” I may have set the bar too high, but I am interested to hear how you decide when you are too sick to go to work.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “Coping with a Picky Eater.” E-mail him at [email protected].

By yesterday at lunch time, you knew you were sick. The sniffly nose and scratchy throat of the previous 2 days were maturing into a full-blown cold or worse. You woke this morning feeling achy and a bit feverish. The only thermometer in the house is a scary looking thing in the cutlery drawer next to the kitchen stove. There have been no cases of influenza reported in the country or even the state.

It is Thursday, and it is your partner’s traditional day off. You think you remember him saying that he was planning on driving out of state to visit his daughter who was struggling in her freshman year in college. Your new associate is in St. Louis taking her boards. The questions that need to be answered by 7:30 this morning are: Do I see if I can reach my partner before he leaves town and ask him if can work for me? If he is already on the road, do I call the office and tell them to cancel the day’s schedule because I am too sick to work?

This is the kind of scenario that most have us have faced more than once in our working lives. Who will I be putting at risk by going to work when I am sick? Of course, there are my patients. Is my patient population particularly fragile because of their age or immunological vulnerabilities? And there are my coworkers. Last of all, will going to work make me even sicker so that I will miss more work?

Where do you go for help in answering the question of whether you are too sick to go to work? Should you try to find a thermometer at an all-night convenience store? If you find one, exactly what temperature is the threshold that will prompt you to call in sick? How many sneezes per hour will render you too contagious to work? How many coughs? If your illness is primarily gastrointestinal, are you still a threat to your patients if your trips to the bathroom are spaced far enough apart to allow you to spend 15 minutes trapped in an examining room?

Would wearing a mask be of any benefit? My sense is that it wouldn’t help and may make you more of a threat if you keeping fiddling with it to readjust it for comfort. And a mask will certainly alarm some parents.

There are situations in which you look or sound worse than you are. I seem to develop laryngitis several days after the worst of my cold has passed. Unfortunately, this scenario is not one of those situations. If you show up in the office, you are going to sound and maybe look like you are as sick as you feel.

What are you going to do? I am embarrassed to admit that I was one of those masochists who would have gone to work regardless of my state of health. You would have had to tether me to an IV bottle to keep me at home. As a recovering workaholic, I have had to accept the fact that I may have jeopardized the health of some of my patients by my pigheaded and at times selfish devotion to showing up in the office come hell or high fever. But, on days when I was the only show in town, it was easy to fall into the trap of believing that I was indispensable. Although full-time emergency room physicians and hospitalists hadn’t been invented yet, there were a few other primary care physicians. I guess it was pride that prevented me from admitting that I could have called on them for help, even though they weren’t board certified pediatricians.

On the other hand, I still wonder how much harm I did by dragging myself to work when I was sick. Because Brunswick is a small town, I know my overly intense devotion to work didn’t result in any deaths. But how great was the collateral damage in the form of lost days from school and work for my patients, their parents, and my coworkers? There is no way to know, but I am sure there was some.

It is unreasonable to say, “I won’t ever go to work if I am ill.” I may have set the bar too high, but I am interested to hear how you decide when you are too sick to go to work.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “Coping with a Picky Eater.” E-mail him at [email protected].

The American Academy of Pediatrics Committee on Infectious Diseases released a 2014 policy statement (Pediatrics 2014:134;415-20) updating guidance on use of palivizumab in high-risk patients infected with respiratory syncytial virus (RSV). The policy statement was accompanied by a detailed technical report to explain the committee’s rationale for the changes made since the previous update in 2012.

Since 2012, several observational studies were published related to risk factors associated with the need for hospitalization for RSV infection. The Committee on Infectious Diseases (COID) referred to these observational studies, along with other historical studies, in its 2014 technical report.

Some aspects of the updated guidance have met with controversy because the new advice limits palivizumab use among premature infants. The 2014 COID policy asserts that preterm infants born at greater than 29 weeks’ gestational age (GA) do not benefit substantially from palivizumab dosing during RSV season. This assertion has met with controversy because the justification detailed in the technical report cites several observational studies that don’t appear to support that conclusion. What percentage of a cohort would need to be hospitalized for RSV infection to identify them as high risk? COID doesn’t draw that line for us. Because approximately 3% of the term birth cohort is hospitalized with RSV, should we use this as the “baseline” and predetermine a percentage of hospitalization beyond baseline to define “at increased risk”?

The 2014 technical report states that RSV hospitalization rates from Stevens et al. (Arch. Pediatr. Adolesc. Med. 2000;154:55-61) were 7.5% and 4.4% for infants 28-30 weeks’ gestational age (GA) and 30-32 weeks’ GA, respectively. However, the rates quoted by COID were not the generalizable rates reported by Dr. T. P. Stevens and his team in their study. The authors calculated community-wide hospitalization rates for these groups to be 10% and 6.4%, respectively. These author-reported community-wide rates closely mirror rates reported in several other large observational studies, and still likely underestimate the true burden of RSV hospitalization based on the lower sensitivity of RSV detection testing done 15 years ago when that study was performed.

Similarly, the COID states that Dr. A.G. Winterstein’s study (JAMA Pediatrics 2013;167:1118-24) shows hospitalization rates among 32-34 weeks’ GA infants of 3.1% and 4.5% in two states based on health care insurance claims. Because fewer than half of infants are ever tested for RSV as the possible cause of their lower respiratory tract infection, these claims data are most certainly an underestimate of true rates. When active testing for RSV is done among hospitalized infants in this same GA category, using sensitive and specific PCR-based technology, hospitalization rates are 9.1%. Dr. Winterstein and associates also reported that RSV hospitalization rates increase as gestational age decreases.

In Dr. Caroline Breese Hall’s 2013 observational study (Pediatrics 2013;132:341-8) she and her associates recognized that hospitalization rates in children under 2 years of age were similar among term and preterm infants. The COID used these data in its 2014 technical report to suggest that preterm infants are no longer at high risk. The detail omitted from the report was that approximately 70% of eligible preterm infants in Dr. Hall’s study (according to the 2012 COID guidelines) had received palivizumab prophylaxis. This suggests that maintaining RSV prophylaxis according to the 2012 COID policy statement (and not the 2014 policy statement) can be successful in reducing the rate of RSV hospitalizations in preterm infants to that observed in term infants.

Finally, the technical report cites “overall declining incidence of hospitalizations for bronchiolitis in the United States” from the 2013 publication by Hasegawa et al. (Pediatrics 2013:132:28-36) without defining this observation for the AAP readers. While Hasegawa did report such a decline, the decline was specific to term infants, as no such decline was observed in the higher-risk preterm infants.

Based on careful review of several of the manuscripts referenced by COID, it’s difficult to determine why the committee’s recommendations changed so dramatically in the most recent iteration. It appears that the data need another look.

Dr. Domachowske is professor of pediatrics and professor of microbiology and immunology at the State University of New York Upstate Medical University in Syracuse. He serves on the New York State American Academy of Pediatrics Chapter 1 executive committee, volunteers as his district’s immunization champion, and is an appointed member of the New York State Immunization Advisory Council. He is a Pediatric News Editorial Advisory Board member. Dr. Domachowske disclosed he does consulting for the vaccine divisions of GlaxoSmithKline, Medimmune, Pfizer, Merck, Sanofi Pasteur, and Novartis; he performs clinical trials with GlaxoSmithKline, Medimmune, Merck, and Novartis; and he does basic and translational research with GlaxoSmithKline. E-mail him at [email protected].

The American Academy of Pediatrics Committee on Infectious Diseases released a 2014 policy statement (Pediatrics 2014:134;415-20) updating guidance on use of palivizumab in high-risk patients infected with respiratory syncytial virus (RSV). The policy statement was accompanied by a detailed technical report to explain the committee’s rationale for the changes made since the previous update in 2012.

Since 2012, several observational studies were published related to risk factors associated with the need for hospitalization for RSV infection. The Committee on Infectious Diseases (COID) referred to these observational studies, along with other historical studies, in its 2014 technical report.

Some aspects of the updated guidance have met with controversy because the new advice limits palivizumab use among premature infants. The 2014 COID policy asserts that preterm infants born at greater than 29 weeks’ gestational age (GA) do not benefit substantially from palivizumab dosing during RSV season. This assertion has met with controversy because the justification detailed in the technical report cites several observational studies that don’t appear to support that conclusion. What percentage of a cohort would need to be hospitalized for RSV infection to identify them as high risk? COID doesn’t draw that line for us. Because approximately 3% of the term birth cohort is hospitalized with RSV, should we use this as the “baseline” and predetermine a percentage of hospitalization beyond baseline to define “at increased risk”?

The 2014 technical report states that RSV hospitalization rates from Stevens et al. (Arch. Pediatr. Adolesc. Med. 2000;154:55-61) were 7.5% and 4.4% for infants 28-30 weeks’ gestational age (GA) and 30-32 weeks’ GA, respectively. However, the rates quoted by COID were not the generalizable rates reported by Dr. T. P. Stevens and his team in their study. The authors calculated community-wide hospitalization rates for these groups to be 10% and 6.4%, respectively. These author-reported community-wide rates closely mirror rates reported in several other large observational studies, and still likely underestimate the true burden of RSV hospitalization based on the lower sensitivity of RSV detection testing done 15 years ago when that study was performed.

Similarly, the COID states that Dr. A.G. Winterstein’s study (JAMA Pediatrics 2013;167:1118-24) shows hospitalization rates among 32-34 weeks’ GA infants of 3.1% and 4.5% in two states based on health care insurance claims. Because fewer than half of infants are ever tested for RSV as the possible cause of their lower respiratory tract infection, these claims data are most certainly an underestimate of true rates. When active testing for RSV is done among hospitalized infants in this same GA category, using sensitive and specific PCR-based technology, hospitalization rates are 9.1%. Dr. Winterstein and associates also reported that RSV hospitalization rates increase as gestational age decreases.

In Dr. Caroline Breese Hall’s 2013 observational study (Pediatrics 2013;132:341-8) she and her associates recognized that hospitalization rates in children under 2 years of age were similar among term and preterm infants. The COID used these data in its 2014 technical report to suggest that preterm infants are no longer at high risk. The detail omitted from the report was that approximately 70% of eligible preterm infants in Dr. Hall’s study (according to the 2012 COID guidelines) had received palivizumab prophylaxis. This suggests that maintaining RSV prophylaxis according to the 2012 COID policy statement (and not the 2014 policy statement) can be successful in reducing the rate of RSV hospitalizations in preterm infants to that observed in term infants.

Finally, the technical report cites “overall declining incidence of hospitalizations for bronchiolitis in the United States” from the 2013 publication by Hasegawa et al. (Pediatrics 2013:132:28-36) without defining this observation for the AAP readers. While Hasegawa did report such a decline, the decline was specific to term infants, as no such decline was observed in the higher-risk preterm infants.

Based on careful review of several of the manuscripts referenced by COID, it’s difficult to determine why the committee’s recommendations changed so dramatically in the most recent iteration. It appears that the data need another look.

Dr. Domachowske is professor of pediatrics and professor of microbiology and immunology at the State University of New York Upstate Medical University in Syracuse. He serves on the New York State American Academy of Pediatrics Chapter 1 executive committee, volunteers as his district’s immunization champion, and is an appointed member of the New York State Immunization Advisory Council. He is a Pediatric News Editorial Advisory Board member. Dr. Domachowske disclosed he does consulting for the vaccine divisions of GlaxoSmithKline, Medimmune, Pfizer, Merck, Sanofi Pasteur, and Novartis; he performs clinical trials with GlaxoSmithKline, Medimmune, Merck, and Novartis; and he does basic and translational research with GlaxoSmithKline. E-mail him at [email protected].

The American Academy of Pediatrics Committee on Infectious Diseases released a 2014 policy statement (Pediatrics 2014:134;415-20) updating guidance on use of palivizumab in high-risk patients infected with respiratory syncytial virus (RSV). The policy statement was accompanied by a detailed technical report to explain the committee’s rationale for the changes made since the previous update in 2012.

Since 2012, several observational studies were published related to risk factors associated with the need for hospitalization for RSV infection. The Committee on Infectious Diseases (COID) referred to these observational studies, along with other historical studies, in its 2014 technical report.

Some aspects of the updated guidance have met with controversy because the new advice limits palivizumab use among premature infants. The 2014 COID policy asserts that preterm infants born at greater than 29 weeks’ gestational age (GA) do not benefit substantially from palivizumab dosing during RSV season. This assertion has met with controversy because the justification detailed in the technical report cites several observational studies that don’t appear to support that conclusion. What percentage of a cohort would need to be hospitalized for RSV infection to identify them as high risk? COID doesn’t draw that line for us. Because approximately 3% of the term birth cohort is hospitalized with RSV, should we use this as the “baseline” and predetermine a percentage of hospitalization beyond baseline to define “at increased risk”?

The 2014 technical report states that RSV hospitalization rates from Stevens et al. (Arch. Pediatr. Adolesc. Med. 2000;154:55-61) were 7.5% and 4.4% for infants 28-30 weeks’ gestational age (GA) and 30-32 weeks’ GA, respectively. However, the rates quoted by COID were not the generalizable rates reported by Dr. T. P. Stevens and his team in their study. The authors calculated community-wide hospitalization rates for these groups to be 10% and 6.4%, respectively. These author-reported community-wide rates closely mirror rates reported in several other large observational studies, and still likely underestimate the true burden of RSV hospitalization based on the lower sensitivity of RSV detection testing done 15 years ago when that study was performed.

Similarly, the COID states that Dr. A.G. Winterstein’s study (JAMA Pediatrics 2013;167:1118-24) shows hospitalization rates among 32-34 weeks’ GA infants of 3.1% and 4.5% in two states based on health care insurance claims. Because fewer than half of infants are ever tested for RSV as the possible cause of their lower respiratory tract infection, these claims data are most certainly an underestimate of true rates. When active testing for RSV is done among hospitalized infants in this same GA category, using sensitive and specific PCR-based technology, hospitalization rates are 9.1%. Dr. Winterstein and associates also reported that RSV hospitalization rates increase as gestational age decreases.

In Dr. Caroline Breese Hall’s 2013 observational study (Pediatrics 2013;132:341-8) she and her associates recognized that hospitalization rates in children under 2 years of age were similar among term and preterm infants. The COID used these data in its 2014 technical report to suggest that preterm infants are no longer at high risk. The detail omitted from the report was that approximately 70% of eligible preterm infants in Dr. Hall’s study (according to the 2012 COID guidelines) had received palivizumab prophylaxis. This suggests that maintaining RSV prophylaxis according to the 2012 COID policy statement (and not the 2014 policy statement) can be successful in reducing the rate of RSV hospitalizations in preterm infants to that observed in term infants.

Finally, the technical report cites “overall declining incidence of hospitalizations for bronchiolitis in the United States” from the 2013 publication by Hasegawa et al. (Pediatrics 2013:132:28-36) without defining this observation for the AAP readers. While Hasegawa did report such a decline, the decline was specific to term infants, as no such decline was observed in the higher-risk preterm infants.

Based on careful review of several of the manuscripts referenced by COID, it’s difficult to determine why the committee’s recommendations changed so dramatically in the most recent iteration. It appears that the data need another look.

Dr. Domachowske is professor of pediatrics and professor of microbiology and immunology at the State University of New York Upstate Medical University in Syracuse. He serves on the New York State American Academy of Pediatrics Chapter 1 executive committee, volunteers as his district’s immunization champion, and is an appointed member of the New York State Immunization Advisory Council. He is a Pediatric News Editorial Advisory Board member. Dr. Domachowske disclosed he does consulting for the vaccine divisions of GlaxoSmithKline, Medimmune, Pfizer, Merck, Sanofi Pasteur, and Novartis; he performs clinical trials with GlaxoSmithKline, Medimmune, Merck, and Novartis; and he does basic and translational research with GlaxoSmithKline. E-mail him at [email protected].

The development of an electronic health care system has revolutionized the way in which patients receive medical treatment. Every physician in practice is familiar with how EHRs have changed the way we record and retrieve information and even interact with patients.

Many of us are just beginning to become aware of a new trend: telemedicine. Proponents of telemedicine believe that it will give patients increased ease of access to trained health care professionals at low cost and skeptics feel that the quality of care will be low without either a physical exam or an ongoing relationship to help guide care. One thing, unfortunately, is for certain, with the evolution of health care comes the evolution of health care litigation. Physicians who are considering seeing patients through a telemedicine service should be aware of liability issues that may arise when seeing patients without actually seeing patients.

In 2009, Congress enacted the Health Information Technology for Economic and Clinical Health (HITECH) Act to develop a national health care infrastructure fueled by modern technology. In addition to offering health care providers financial incentives to replace patient medical charts with EHRs, leading over 400,000 health care providers to participate in the Medicaid and Medicare incentive programs, the HITECH Act also has encouraged the advancement of telemedicine through the use of virtual visits and electronic doctor/patient communication.

Telemedicine allows physicians and patients to exchange health information through telecommunication technologies while in different geographic locations (Model policy for appropriate use of telemedicine technologies in the practice of medicine, Federation of State Medical Boards, April 2014). Telemedicine emerged in the 1960s after NASA funded early research to allow astronauts to communicate with physicians while traveling in space. In recent years, telemedical practice has evolved into a much more practical and convenient method of practicing medicine.

Virtual visits now allow a patient to use a computer or other videoconference device to have a virtual visit with a doctor in lieu of having an in-person physical examination. Jason Gorevic, CEO of Teladoc, a leading telemedicine company, expects Teladoc to conduct a half a million telemedicine visits in 2015 (“Video visits, telemedicine today are like retail clinics were in the 1990s,” mobihealthnews, Nov. 4, 2014). The increase in the use of virtual visits comes largely from the high use of telemedicine in rural areas, where long distances exists between a patient and his/her physician.

Telemedicine has expanded rapidly, and state licensure requirements and regulation of telemedicine have not caught up with its use, leading regulations to vary from state to state. In an attempt to eliminate the state regulation disparities, the Federation of State Medical Boards (FSMB) has provided a framework for standards of care in regulating the practice of telemedicine, but each state still has its own requirements for telemedical practice (50 State Telemedicine Gaps Analysis: Physician Practice Standards and Licensure, American Telemedicine Association, September 2014).

Only nine states offer a conditional or telemedicine license that allows out-of-state physicians to practice telemedicine, and Maryland, New York, and Virginia are the only states that offer reciprocity to licensed physicians in bordering states. In California, a Colorado doctor was criminally prosecuted for prescribing medication via the web to a patient in California (Hageseth v. Superior Court). The California Court of Appeals found that jurisdiction was proper in California because the doctor willfully practiced medicine in that state by agreeing to prescribe medication to a California resident online.

Physicians also should be aware of the need to obtain informed consent from the patient before conducting any telemedicine visit or examination. Most states require a physician to obtain written or verbal informed consent from a telehealth patient. Although research is slowly establishing the reliability of telemedicine, there are inherent risks associated with receiving a consultation via telecommunication of which a patient should be aware, such as the limits of the evaluation given that a complete physical exam cannot be performed. The physician should inform the patient when the visit is being recorded and receive his/her consent before proceeding.

The physician also should be very careful when selecting telemedical technology to ensure that the technology is HIPAA/HITECH certified and permitted under the state regulations in the state in which the doctor is practicing. In Oklahoma, a physician was sanctioned by the state’s medical board for conducting a virtual visit via Skype. (“Oklahoma state medical board adopts policy following Skype case,” The Oklahoman, Sept. 25, 2013). Although Oklahoma permits the use of virtual visits, the state prohibits a physician from conducting these visits via Skype. The Oklahoma doctor turned out to not be subject to a HIPAA violation because the Skype website is encrypted.

Given telemedicine’s rapid expansion, experience and litigation in this area are limited. The one thing that the current litigation trend shows is that physicians must be particularly careful when treating patients outside of the state in which they practice, both with regard to entering into a patient-physician relationship, making a diagnosis, and particularly when prescribing medication. As patients and physicians enjoy the benefits of this new method of providing medical care, they must be careful to follow the evolving telemedicine litigation and legislative landscape.

Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital and professor of family and community medicine at Temple University in Philadelphia. Mr. Jones and Ms. Dandy are both attorneys at Marks, O’Neill, O’Brien, Doherty & Kelly, P.C. in Philadelphia.

Note: An earlier version of this article incorrectly stated that the FSMB had recommended a national licensure and practice standard.

The development of an electronic health care system has revolutionized the way in which patients receive medical treatment. Every physician in practice is familiar with how EHRs have changed the way we record and retrieve information and even interact with patients.

Many of us are just beginning to become aware of a new trend: telemedicine. Proponents of telemedicine believe that it will give patients increased ease of access to trained health care professionals at low cost and skeptics feel that the quality of care will be low without either a physical exam or an ongoing relationship to help guide care. One thing, unfortunately, is for certain, with the evolution of health care comes the evolution of health care litigation. Physicians who are considering seeing patients through a telemedicine service should be aware of liability issues that may arise when seeing patients without actually seeing patients.

In 2009, Congress enacted the Health Information Technology for Economic and Clinical Health (HITECH) Act to develop a national health care infrastructure fueled by modern technology. In addition to offering health care providers financial incentives to replace patient medical charts with EHRs, leading over 400,000 health care providers to participate in the Medicaid and Medicare incentive programs, the HITECH Act also has encouraged the advancement of telemedicine through the use of virtual visits and electronic doctor/patient communication.

Telemedicine allows physicians and patients to exchange health information through telecommunication technologies while in different geographic locations (Model policy for appropriate use of telemedicine technologies in the practice of medicine, Federation of State Medical Boards, April 2014). Telemedicine emerged in the 1960s after NASA funded early research to allow astronauts to communicate with physicians while traveling in space. In recent years, telemedical practice has evolved into a much more practical and convenient method of practicing medicine.

Virtual visits now allow a patient to use a computer or other videoconference device to have a virtual visit with a doctor in lieu of having an in-person physical examination. Jason Gorevic, CEO of Teladoc, a leading telemedicine company, expects Teladoc to conduct a half a million telemedicine visits in 2015 (“Video visits, telemedicine today are like retail clinics were in the 1990s,” mobihealthnews, Nov. 4, 2014). The increase in the use of virtual visits comes largely from the high use of telemedicine in rural areas, where long distances exists between a patient and his/her physician.

Telemedicine has expanded rapidly, and state licensure requirements and regulation of telemedicine have not caught up with its use, leading regulations to vary from state to state. In an attempt to eliminate the state regulation disparities, the Federation of State Medical Boards (FSMB) has provided a framework for standards of care in regulating the practice of telemedicine, but each state still has its own requirements for telemedical practice (50 State Telemedicine Gaps Analysis: Physician Practice Standards and Licensure, American Telemedicine Association, September 2014).

Only nine states offer a conditional or telemedicine license that allows out-of-state physicians to practice telemedicine, and Maryland, New York, and Virginia are the only states that offer reciprocity to licensed physicians in bordering states. In California, a Colorado doctor was criminally prosecuted for prescribing medication via the web to a patient in California (Hageseth v. Superior Court). The California Court of Appeals found that jurisdiction was proper in California because the doctor willfully practiced medicine in that state by agreeing to prescribe medication to a California resident online.

Physicians also should be aware of the need to obtain informed consent from the patient before conducting any telemedicine visit or examination. Most states require a physician to obtain written or verbal informed consent from a telehealth patient. Although research is slowly establishing the reliability of telemedicine, there are inherent risks associated with receiving a consultation via telecommunication of which a patient should be aware, such as the limits of the evaluation given that a complete physical exam cannot be performed. The physician should inform the patient when the visit is being recorded and receive his/her consent before proceeding.

The physician also should be very careful when selecting telemedical technology to ensure that the technology is HIPAA/HITECH certified and permitted under the state regulations in the state in which the doctor is practicing. In Oklahoma, a physician was sanctioned by the state’s medical board for conducting a virtual visit via Skype. (“Oklahoma state medical board adopts policy following Skype case,” The Oklahoman, Sept. 25, 2013). Although Oklahoma permits the use of virtual visits, the state prohibits a physician from conducting these visits via Skype. The Oklahoma doctor turned out to not be subject to a HIPAA violation because the Skype website is encrypted.

Given telemedicine’s rapid expansion, experience and litigation in this area are limited. The one thing that the current litigation trend shows is that physicians must be particularly careful when treating patients outside of the state in which they practice, both with regard to entering into a patient-physician relationship, making a diagnosis, and particularly when prescribing medication. As patients and physicians enjoy the benefits of this new method of providing medical care, they must be careful to follow the evolving telemedicine litigation and legislative landscape.

Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital and professor of family and community medicine at Temple University in Philadelphia. Mr. Jones and Ms. Dandy are both attorneys at Marks, O’Neill, O’Brien, Doherty & Kelly, P.C. in Philadelphia.

Note: An earlier version of this article incorrectly stated that the FSMB had recommended a national licensure and practice standard.

The development of an electronic health care system has revolutionized the way in which patients receive medical treatment. Every physician in practice is familiar with how EHRs have changed the way we record and retrieve information and even interact with patients.

Many of us are just beginning to become aware of a new trend: telemedicine. Proponents of telemedicine believe that it will give patients increased ease of access to trained health care professionals at low cost and skeptics feel that the quality of care will be low without either a physical exam or an ongoing relationship to help guide care. One thing, unfortunately, is for certain, with the evolution of health care comes the evolution of health care litigation. Physicians who are considering seeing patients through a telemedicine service should be aware of liability issues that may arise when seeing patients without actually seeing patients.

In 2009, Congress enacted the Health Information Technology for Economic and Clinical Health (HITECH) Act to develop a national health care infrastructure fueled by modern technology. In addition to offering health care providers financial incentives to replace patient medical charts with EHRs, leading over 400,000 health care providers to participate in the Medicaid and Medicare incentive programs, the HITECH Act also has encouraged the advancement of telemedicine through the use of virtual visits and electronic doctor/patient communication.

Telemedicine allows physicians and patients to exchange health information through telecommunication technologies while in different geographic locations (Model policy for appropriate use of telemedicine technologies in the practice of medicine, Federation of State Medical Boards, April 2014). Telemedicine emerged in the 1960s after NASA funded early research to allow astronauts to communicate with physicians while traveling in space. In recent years, telemedical practice has evolved into a much more practical and convenient method of practicing medicine.

Virtual visits now allow a patient to use a computer or other videoconference device to have a virtual visit with a doctor in lieu of having an in-person physical examination. Jason Gorevic, CEO of Teladoc, a leading telemedicine company, expects Teladoc to conduct a half a million telemedicine visits in 2015 (“Video visits, telemedicine today are like retail clinics were in the 1990s,” mobihealthnews, Nov. 4, 2014). The increase in the use of virtual visits comes largely from the high use of telemedicine in rural areas, where long distances exists between a patient and his/her physician.

Telemedicine has expanded rapidly, and state licensure requirements and regulation of telemedicine have not caught up with its use, leading regulations to vary from state to state. In an attempt to eliminate the state regulation disparities, the Federation of State Medical Boards (FSMB) has provided a framework for standards of care in regulating the practice of telemedicine, but each state still has its own requirements for telemedical practice (50 State Telemedicine Gaps Analysis: Physician Practice Standards and Licensure, American Telemedicine Association, September 2014).

Only nine states offer a conditional or telemedicine license that allows out-of-state physicians to practice telemedicine, and Maryland, New York, and Virginia are the only states that offer reciprocity to licensed physicians in bordering states. In California, a Colorado doctor was criminally prosecuted for prescribing medication via the web to a patient in California (Hageseth v. Superior Court). The California Court of Appeals found that jurisdiction was proper in California because the doctor willfully practiced medicine in that state by agreeing to prescribe medication to a California resident online.

Physicians also should be aware of the need to obtain informed consent from the patient before conducting any telemedicine visit or examination. Most states require a physician to obtain written or verbal informed consent from a telehealth patient. Although research is slowly establishing the reliability of telemedicine, there are inherent risks associated with receiving a consultation via telecommunication of which a patient should be aware, such as the limits of the evaluation given that a complete physical exam cannot be performed. The physician should inform the patient when the visit is being recorded and receive his/her consent before proceeding.

The physician also should be very careful when selecting telemedical technology to ensure that the technology is HIPAA/HITECH certified and permitted under the state regulations in the state in which the doctor is practicing. In Oklahoma, a physician was sanctioned by the state’s medical board for conducting a virtual visit via Skype. (“Oklahoma state medical board adopts policy following Skype case,” The Oklahoman, Sept. 25, 2013). Although Oklahoma permits the use of virtual visits, the state prohibits a physician from conducting these visits via Skype. The Oklahoma doctor turned out to not be subject to a HIPAA violation because the Skype website is encrypted.

Given telemedicine’s rapid expansion, experience and litigation in this area are limited. The one thing that the current litigation trend shows is that physicians must be particularly careful when treating patients outside of the state in which they practice, both with regard to entering into a patient-physician relationship, making a diagnosis, and particularly when prescribing medication. As patients and physicians enjoy the benefits of this new method of providing medical care, they must be careful to follow the evolving telemedicine litigation and legislative landscape.

Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital and professor of family and community medicine at Temple University in Philadelphia. Mr. Jones and Ms. Dandy are both attorneys at Marks, O’Neill, O’Brien, Doherty & Kelly, P.C. in Philadelphia.

Note: An earlier version of this article incorrectly stated that the FSMB had recommended a national licensure and practice standard.

Note from NP Editor-in-Chief Marie-Eileen Onieal, PhD, CPNP, FAANP: Recently, the authors of this column and I started discussing the decision by the Drug Enforcement Administration (DEA) to reschedule hydrocodone and the resulting barriers to care. By the end of the conversation, it was evident that my colleagues needed to “get the word out” to our readers—so I afforded them this opportunity to do so.

On October 6, 2014, hydrocodone combination products were reclassified from Schedule III to Schedule II of the Controlled Substances Act, per a final ruling issued by the DEA’s Office of Diversion Control. The DEA’s ruling was the result of an evaluation of scientific and medical evidence supplied by multiple agencies, as well as considerations related to the FDA Safety and Innovation Act of 2012.¹ The rationale for rescheduling hydrocodone preparations was based on evidence of high potential for abuse, high rates of dependency, and epidemic levels of drug diversion related to these products.

Our purpose in this editorial is not to debate the DEA’s decision to reschedule hydrocodone preparations but rather to demonstrate that all policy changes have consequences. In this case, these include substantial limitations on the ability of NPs in several states to adequately manage acute and chronic pain for their patients. As a result, NPs may be prevented from delivering comprehensive care to patients with certain conditions. (We are aware that our PA colleagues may be similarly affected by this ruling but will restrict our commentary to NPs, as we are most familiar with our profession’s circumstances.)

Each state grants specific prescriptive privileges to advanced practice registered nurses (APRNs), resulting in wide variation across the country. Therefore, the effect of this ruling on patients’ access to care and providers’ ability to treat certain conditions differs by state. The states in which APRNs have prescriptive privileges for Schedule III but not Schedule II medications—those most impacted by this rule change—include Arkansas, Georgia, Missouri, Nebraska, Oklahoma, South Carolina, Texas, and West Virginia.² Prior to the effective date of this ruling, NPs in these states had hydrocodone and codeine preparations, as well as the nonnarcotic tramadol, in their armamentaria to treat pain.

The DEA ruling—coupled with restrictive state regulations—reduces the options for pain management in these states. The only other Schedule III narcotic treatment options are codeine preparations; for patients with codeine sensitivities or allergies, NPs are now unable to adequately manage acute or chronic pain. Besides inconvenience, this change results in additional costs, since patients will also need to be assessed by a provider with Schedule II prescriptive privileges if they hope to achieve adequate pain management. This is particularly burdensome in underserved or rural populations, which many of the affected states have.

In response to this (presumably) unintended consequence, legislatures need to consider the impact this ruling will have on patient care and move to modernize prescriptive authority for APRNs, especially in the most affected states. The Future of Nursing report³ from the Institute of Medicine (IOM) recommends that APRNs’ scope of practice be reformed to conform with the model rules and regulations established by the National Council of State Boards of Nursing (NCSBN). The NCSBN’s consensus model report supports full scope of practice for all APRNs, as well as collaboration among all health care disciplines as a professional norm, instead of the current restrictive practices.⁴

Continued on next page >>

Historically, APRNs have struggled to gain total support from state legislators in the quest for full practice authority, including prescriptive privileges. Our professional organizations, with support from the IOM, the National Governors Association, and the Federal Trade Commission, must be ready to provide accurate data on safety and outcomes to state and federal legislators. This evidence would support efforts to modernize NP scope of practice acts, including prescribing regulations, that are currently outdated and prevent APRNs from providing optimal care.⁵

This year (2015) marks the 50th anniversary of the NP role. Thus, it is the proper time for state legislatures to recognize and support the role of the NP in the delivery of comprehensive, cost-effective health care in the United States. With millions of previously uninsured Americans seeking primary care and the increasing shortage of primary care physicians, NPs are part of the answer to the problem of access to acute and chronic care in both urban and rural communities. With NPs available to close this gap, it is imperative that both state and federal legislatures support initiatives that will eliminate barriers to care and promote legislation that offers full scope of practice to NPs.

We welcome your feedback on this topic. Please send your comments to NPEditor@frontline medcom.com.

REFERENCES
1. Drug Enforcement Administration. Schedules of controlled substances: rescheduling of hydrocodone combination products from schedule III to schedule II (document no: 2014-19922). Federal Register. https://federalregister.gov/a/2014-19922. Accessed February 13, 2015.
2. Drug Enforcement Administration Office of Diversion. Mid-level practitioners authorization by state. www.deadiversion.usdoj.gov/drugreg/practioners. Accessed February 13, 2015.
3. Institute of Medicine. The Future of Nursing: Leading Change, Advancing Health. Washington, DC: The National Academies Press; 2011.
4. National Council of State Boards of Nursing. The Consensus Model for APRN Regulation, Licensure, Accreditation, Certification and Education (2008). www.ncsbn.org/Consen sus_Model_for_APRN_Regulation_July_2008.pdf. Accessed February 13, 2015.
5. National Council of State Boards of Nursing. Changes In Healthcare Professions’ Scope of Practice: Legislative Considerations (2009). www.ncsbn.org/ScopeofPractice_09.pdf. Accessed February 13, 2015.

Note from NP Editor-in-Chief Marie-Eileen Onieal, PhD, CPNP, FAANP: Recently, the authors of this column and I started discussing the decision by the Drug Enforcement Administration (DEA) to reschedule hydrocodone and the resulting barriers to care. By the end of the conversation, it was evident that my colleagues needed to “get the word out” to our readers—so I afforded them this opportunity to do so.

On October 6, 2014, hydrocodone combination products were reclassified from Schedule III to Schedule II of the Controlled Substances Act, per a final ruling issued by the DEA’s Office of Diversion Control. The DEA’s ruling was the result of an evaluation of scientific and medical evidence supplied by multiple agencies, as well as considerations related to the FDA Safety and Innovation Act of 2012.¹ The rationale for rescheduling hydrocodone preparations was based on evidence of high potential for abuse, high rates of dependency, and epidemic levels of drug diversion related to these products.

Our purpose in this editorial is not to debate the DEA’s decision to reschedule hydrocodone preparations but rather to demonstrate that all policy changes have consequences. In this case, these include substantial limitations on the ability of NPs in several states to adequately manage acute and chronic pain for their patients. As a result, NPs may be prevented from delivering comprehensive care to patients with certain conditions. (We are aware that our PA colleagues may be similarly affected by this ruling but will restrict our commentary to NPs, as we are most familiar with our profession’s circumstances.)

Each state grants specific prescriptive privileges to advanced practice registered nurses (APRNs), resulting in wide variation across the country. Therefore, the effect of this ruling on patients’ access to care and providers’ ability to treat certain conditions differs by state. The states in which APRNs have prescriptive privileges for Schedule III but not Schedule II medications—those most impacted by this rule change—include Arkansas, Georgia, Missouri, Nebraska, Oklahoma, South Carolina, Texas, and West Virginia.² Prior to the effective date of this ruling, NPs in these states had hydrocodone and codeine preparations, as well as the nonnarcotic tramadol, in their armamentaria to treat pain.

The DEA ruling—coupled with restrictive state regulations—reduces the options for pain management in these states. The only other Schedule III narcotic treatment options are codeine preparations; for patients with codeine sensitivities or allergies, NPs are now unable to adequately manage acute or chronic pain. Besides inconvenience, this change results in additional costs, since patients will also need to be assessed by a provider with Schedule II prescriptive privileges if they hope to achieve adequate pain management. This is particularly burdensome in underserved or rural populations, which many of the affected states have.

In response to this (presumably) unintended consequence, legislatures need to consider the impact this ruling will have on patient care and move to modernize prescriptive authority for APRNs, especially in the most affected states. The Future of Nursing report³ from the Institute of Medicine (IOM) recommends that APRNs’ scope of practice be reformed to conform with the model rules and regulations established by the National Council of State Boards of Nursing (NCSBN). The NCSBN’s consensus model report supports full scope of practice for all APRNs, as well as collaboration among all health care disciplines as a professional norm, instead of the current restrictive practices.⁴

Continued on next page >>

Historically, APRNs have struggled to gain total support from state legislators in the quest for full practice authority, including prescriptive privileges. Our professional organizations, with support from the IOM, the National Governors Association, and the Federal Trade Commission, must be ready to provide accurate data on safety and outcomes to state and federal legislators. This evidence would support efforts to modernize NP scope of practice acts, including prescribing regulations, that are currently outdated and prevent APRNs from providing optimal care.⁵

This year (2015) marks the 50th anniversary of the NP role. Thus, it is the proper time for state legislatures to recognize and support the role of the NP in the delivery of comprehensive, cost-effective health care in the United States. With millions of previously uninsured Americans seeking primary care and the increasing shortage of primary care physicians, NPs are part of the answer to the problem of access to acute and chronic care in both urban and rural communities. With NPs available to close this gap, it is imperative that both state and federal legislatures support initiatives that will eliminate barriers to care and promote legislation that offers full scope of practice to NPs.

We welcome your feedback on this topic. Please send your comments to NPEditor@frontline medcom.com.

REFERENCES
1. Drug Enforcement Administration. Schedules of controlled substances: rescheduling of hydrocodone combination products from schedule III to schedule II (document no: 2014-19922). Federal Register. https://federalregister.gov/a/2014-19922. Accessed February 13, 2015.
2. Drug Enforcement Administration Office of Diversion. Mid-level practitioners authorization by state. www.deadiversion.usdoj.gov/drugreg/practioners. Accessed February 13, 2015.
3. Institute of Medicine. The Future of Nursing: Leading Change, Advancing Health. Washington, DC: The National Academies Press; 2011.
4. National Council of State Boards of Nursing. The Consensus Model for APRN Regulation, Licensure, Accreditation, Certification and Education (2008). www.ncsbn.org/Consen sus_Model_for_APRN_Regulation_July_2008.pdf. Accessed February 13, 2015.
5. National Council of State Boards of Nursing. Changes In Healthcare Professions’ Scope of Practice: Legislative Considerations (2009). www.ncsbn.org/ScopeofPractice_09.pdf. Accessed February 13, 2015.

Note from NP Editor-in-Chief Marie-Eileen Onieal, PhD, CPNP, FAANP: Recently, the authors of this column and I started discussing the decision by the Drug Enforcement Administration (DEA) to reschedule hydrocodone and the resulting barriers to care. By the end of the conversation, it was evident that my colleagues needed to “get the word out” to our readers—so I afforded them this opportunity to do so.

On October 6, 2014, hydrocodone combination products were reclassified from Schedule III to Schedule II of the Controlled Substances Act, per a final ruling issued by the DEA’s Office of Diversion Control. The DEA’s ruling was the result of an evaluation of scientific and medical evidence supplied by multiple agencies, as well as considerations related to the FDA Safety and Innovation Act of 2012.¹ The rationale for rescheduling hydrocodone preparations was based on evidence of high potential for abuse, high rates of dependency, and epidemic levels of drug diversion related to these products.

Our purpose in this editorial is not to debate the DEA’s decision to reschedule hydrocodone preparations but rather to demonstrate that all policy changes have consequences. In this case, these include substantial limitations on the ability of NPs in several states to adequately manage acute and chronic pain for their patients. As a result, NPs may be prevented from delivering comprehensive care to patients with certain conditions. (We are aware that our PA colleagues may be similarly affected by this ruling but will restrict our commentary to NPs, as we are most familiar with our profession’s circumstances.)

Each state grants specific prescriptive privileges to advanced practice registered nurses (APRNs), resulting in wide variation across the country. Therefore, the effect of this ruling on patients’ access to care and providers’ ability to treat certain conditions differs by state. The states in which APRNs have prescriptive privileges for Schedule III but not Schedule II medications—those most impacted by this rule change—include Arkansas, Georgia, Missouri, Nebraska, Oklahoma, South Carolina, Texas, and West Virginia.² Prior to the effective date of this ruling, NPs in these states had hydrocodone and codeine preparations, as well as the nonnarcotic tramadol, in their armamentaria to treat pain.

The DEA ruling—coupled with restrictive state regulations—reduces the options for pain management in these states. The only other Schedule III narcotic treatment options are codeine preparations; for patients with codeine sensitivities or allergies, NPs are now unable to adequately manage acute or chronic pain. Besides inconvenience, this change results in additional costs, since patients will also need to be assessed by a provider with Schedule II prescriptive privileges if they hope to achieve adequate pain management. This is particularly burdensome in underserved or rural populations, which many of the affected states have.

In response to this (presumably) unintended consequence, legislatures need to consider the impact this ruling will have on patient care and move to modernize prescriptive authority for APRNs, especially in the most affected states. The Future of Nursing report³ from the Institute of Medicine (IOM) recommends that APRNs’ scope of practice be reformed to conform with the model rules and regulations established by the National Council of State Boards of Nursing (NCSBN). The NCSBN’s consensus model report supports full scope of practice for all APRNs, as well as collaboration among all health care disciplines as a professional norm, instead of the current restrictive practices.⁴

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Historically, APRNs have struggled to gain total support from state legislators in the quest for full practice authority, including prescriptive privileges. Our professional organizations, with support from the IOM, the National Governors Association, and the Federal Trade Commission, must be ready to provide accurate data on safety and outcomes to state and federal legislators. This evidence would support efforts to modernize NP scope of practice acts, including prescribing regulations, that are currently outdated and prevent APRNs from providing optimal care.⁵

This year (2015) marks the 50th anniversary of the NP role. Thus, it is the proper time for state legislatures to recognize and support the role of the NP in the delivery of comprehensive, cost-effective health care in the United States. With millions of previously uninsured Americans seeking primary care and the increasing shortage of primary care physicians, NPs are part of the answer to the problem of access to acute and chronic care in both urban and rural communities. With NPs available to close this gap, it is imperative that both state and federal legislatures support initiatives that will eliminate barriers to care and promote legislation that offers full scope of practice to NPs.

We welcome your feedback on this topic. Please send your comments to NPEditor@frontline medcom.com.

REFERENCES
1. Drug Enforcement Administration. Schedules of controlled substances: rescheduling of hydrocodone combination products from schedule III to schedule II (document no: 2014-19922). Federal Register. https://federalregister.gov/a/2014-19922. Accessed February 13, 2015.
2. Drug Enforcement Administration Office of Diversion. Mid-level practitioners authorization by state. www.deadiversion.usdoj.gov/drugreg/practioners. Accessed February 13, 2015.
3. Institute of Medicine. The Future of Nursing: Leading Change, Advancing Health. Washington, DC: The National Academies Press; 2011.
4. National Council of State Boards of Nursing. The Consensus Model for APRN Regulation, Licensure, Accreditation, Certification and Education (2008). www.ncsbn.org/Consen sus_Model_for_APRN_Regulation_July_2008.pdf. Accessed February 13, 2015.
5. National Council of State Boards of Nursing. Changes In Healthcare Professions’ Scope of Practice: Legislative Considerations (2009). www.ncsbn.org/ScopeofPractice_09.pdf. Accessed February 13, 2015.