Pulmonary Health Hub

Is it just me? I don’t think that I have visited with a single patient this week who’s not struggling with sleep. Our heavily caffeinated, media-obsessed, melatonin-killing, computer-screen-staring, tragic work-life imbalances explain away a lot of it. Knowing that, though, patients in front of me seek immediate relief.

A prescription takes substantially less effort than does training patients on sleep hygiene or sleep restriction. The problem with “z” drugs is, of course, that tolerance can develop within 4 weeks with daily use. These drugs have been associated with mood and cognitive changes and increased mortality. Many of my patients cannot use them sparingly, because relief of insomnia is something of which they cannot get enough. Then we are either back to square one or playing the dose-escalation game.

I have always wondered how much of this is the “placebo effect” and how we could use this to our clinical advantage. This is certainly what I hear from my cynical colleagues when I recommend melatonin – which, by the way, I personally believe is an extremely effective and underutilized intervention. We should remind ourselves to be cognizant of the “if I can’t prescribe it, it can’t work that well” mentality.

Alexander Winkler and Winfried Rief of the University of Marburg, Germany, conducted a brilliant systematic review examining the effect of placebo conditions in randomized trials including polysomnography addressing primary insomnia (Sleep. 2015 Jun 1;38[6]:925-31).

The investigators identified 32 studies with almost 4,000 patients in 82 treatment conditions: The studies were published between 1992 and 2012. Of those 82 treatment conditions, 17 included hypnotic drugs.

Results suggest that 64% of drug response to medications for primary insomnia is achieved in the placebo group.

So what does this mean clinically? I think the first thing it means is that we should consider (re)launching frank discourse about the ethics surrounding the use of placebo in clinical medicine. Are we all too horrified to think that patients may get better despite us rather than because of us to dig too deeply here?

The second thing it means is that patients should be instructed to use the medications only when needed. If a minority of the drug effect for insomnia is from the drug itself, we should minimize the buildup of tolerance by using it sparingly. Studies that have alternated a hypnotic with a placebo show that this works just as well as using a hypnotic every night.

Patients should be encouraged to alternate therapy, such as trying melatonin first and resorting to a “z” drug only if sleep remains elusive. Alternating drug therapy may also enhance the efficacy of the medication.

Always try to combine pharmacotherapy with good sleep hygiene to maximize benefits.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article. Follow him on Twitter @jonebbert.

Is it just me? I don’t think that I have visited with a single patient this week who’s not struggling with sleep. Our heavily caffeinated, media-obsessed, melatonin-killing, computer-screen-staring, tragic work-life imbalances explain away a lot of it. Knowing that, though, patients in front of me seek immediate relief.

A prescription takes substantially less effort than does training patients on sleep hygiene or sleep restriction. The problem with “z” drugs is, of course, that tolerance can develop within 4 weeks with daily use. These drugs have been associated with mood and cognitive changes and increased mortality. Many of my patients cannot use them sparingly, because relief of insomnia is something of which they cannot get enough. Then we are either back to square one or playing the dose-escalation game.

I have always wondered how much of this is the “placebo effect” and how we could use this to our clinical advantage. This is certainly what I hear from my cynical colleagues when I recommend melatonin – which, by the way, I personally believe is an extremely effective and underutilized intervention. We should remind ourselves to be cognizant of the “if I can’t prescribe it, it can’t work that well” mentality.

Alexander Winkler and Winfried Rief of the University of Marburg, Germany, conducted a brilliant systematic review examining the effect of placebo conditions in randomized trials including polysomnography addressing primary insomnia (Sleep. 2015 Jun 1;38[6]:925-31).

The investigators identified 32 studies with almost 4,000 patients in 82 treatment conditions: The studies were published between 1992 and 2012. Of those 82 treatment conditions, 17 included hypnotic drugs.

Results suggest that 64% of drug response to medications for primary insomnia is achieved in the placebo group.

So what does this mean clinically? I think the first thing it means is that we should consider (re)launching frank discourse about the ethics surrounding the use of placebo in clinical medicine. Are we all too horrified to think that patients may get better despite us rather than because of us to dig too deeply here?

The second thing it means is that patients should be instructed to use the medications only when needed. If a minority of the drug effect for insomnia is from the drug itself, we should minimize the buildup of tolerance by using it sparingly. Studies that have alternated a hypnotic with a placebo show that this works just as well as using a hypnotic every night.

Patients should be encouraged to alternate therapy, such as trying melatonin first and resorting to a “z” drug only if sleep remains elusive. Alternating drug therapy may also enhance the efficacy of the medication.

Always try to combine pharmacotherapy with good sleep hygiene to maximize benefits.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article. Follow him on Twitter @jonebbert.

Is it just me? I don’t think that I have visited with a single patient this week who’s not struggling with sleep. Our heavily caffeinated, media-obsessed, melatonin-killing, computer-screen-staring, tragic work-life imbalances explain away a lot of it. Knowing that, though, patients in front of me seek immediate relief.

A prescription takes substantially less effort than does training patients on sleep hygiene or sleep restriction. The problem with “z” drugs is, of course, that tolerance can develop within 4 weeks with daily use. These drugs have been associated with mood and cognitive changes and increased mortality. Many of my patients cannot use them sparingly, because relief of insomnia is something of which they cannot get enough. Then we are either back to square one or playing the dose-escalation game.

I have always wondered how much of this is the “placebo effect” and how we could use this to our clinical advantage. This is certainly what I hear from my cynical colleagues when I recommend melatonin – which, by the way, I personally believe is an extremely effective and underutilized intervention. We should remind ourselves to be cognizant of the “if I can’t prescribe it, it can’t work that well” mentality.

Alexander Winkler and Winfried Rief of the University of Marburg, Germany, conducted a brilliant systematic review examining the effect of placebo conditions in randomized trials including polysomnography addressing primary insomnia (Sleep. 2015 Jun 1;38[6]:925-31).

The investigators identified 32 studies with almost 4,000 patients in 82 treatment conditions: The studies were published between 1992 and 2012. Of those 82 treatment conditions, 17 included hypnotic drugs.

Results suggest that 64% of drug response to medications for primary insomnia is achieved in the placebo group.

So what does this mean clinically? I think the first thing it means is that we should consider (re)launching frank discourse about the ethics surrounding the use of placebo in clinical medicine. Are we all too horrified to think that patients may get better despite us rather than because of us to dig too deeply here?

The second thing it means is that patients should be instructed to use the medications only when needed. If a minority of the drug effect for insomnia is from the drug itself, we should minimize the buildup of tolerance by using it sparingly. Studies that have alternated a hypnotic with a placebo show that this works just as well as using a hypnotic every night.

Patients should be encouraged to alternate therapy, such as trying melatonin first and resorting to a “z” drug only if sleep remains elusive. Alternating drug therapy may also enhance the efficacy of the medication.

Always try to combine pharmacotherapy with good sleep hygiene to maximize benefits.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article. Follow him on Twitter @jonebbert.

September, October, and November are well known as the “coughing months” in any general pediatrician’s office. We all can relate to the frustration we feel when that handful of patients returns for the unrelenting cough after steroids and albuterol have failed. Codeine has been known to be a good cough suppressant, and when coupled with promethazine (antihistamine), you have a very effective cough syrup that been used as such for decades.

Unfortunately, over the last few decades, this cough syrup has gained notoriety for use other than cough, and now is under great scrutiny. This common syrup is now the main ingredient of a poplar drink among teens known as “Sizzurp” or the “Purple Drank.” Well known artists tweet about it, post pictures of it on Instagram, sing about it in their songs, and glamorize it in their videos.

The mixture is simple; promethazine with codeine, lemon-lime sodas, and hard candies has all the makings of a party drink. It is fizzy, colorful, and sweet, with no horrible aftertaste, so gulping is easy. Most teens don’t limit their drinking to just the purple drink, so now we have a mixture of codeine with alcohol and or marijuana. All of which result in respiratory depression and potentially death.

The abuse of this cough syrup has become so great that Actavis was reported to pull it from production. Already the pint-size bottle sells on the street for $800, and limited access will only skyrocket its value.

As clinicians, we must be aware of the misuse and abuse of common prescription medications because teens prey on busy practices with false or exaggerated symptoms to try to obtain a prescription. Despite the American Academy of Pediatrics’ warning against codeine’s use as an antitussive in children (Pediatrics. 1997 Jun;99[6]:918-20.), there has not been a significant decline in its use (Pediatrics 2014 May;133[5]:e1139-47). Pediatricians need to use extreme caution, and be vigilant to identify frequent flyers or teens known to be at risk for drug abuse. Prescribe nonnarcotic-containing products first, and only prescribe small amounts promethazine/codeine products to prevent leftovers from being kept around the house for unsupervised use.

Most importantly, educate parents and families about the danger of overdose with these products so they can monitor its use.

Dr. Pearce is a pediatrician in Frankfort, Ill.

September, October, and November are well known as the “coughing months” in any general pediatrician’s office. We all can relate to the frustration we feel when that handful of patients returns for the unrelenting cough after steroids and albuterol have failed. Codeine has been known to be a good cough suppressant, and when coupled with promethazine (antihistamine), you have a very effective cough syrup that been used as such for decades.

Unfortunately, over the last few decades, this cough syrup has gained notoriety for use other than cough, and now is under great scrutiny. This common syrup is now the main ingredient of a poplar drink among teens known as “Sizzurp” or the “Purple Drank.” Well known artists tweet about it, post pictures of it on Instagram, sing about it in their songs, and glamorize it in their videos.

The mixture is simple; promethazine with codeine, lemon-lime sodas, and hard candies has all the makings of a party drink. It is fizzy, colorful, and sweet, with no horrible aftertaste, so gulping is easy. Most teens don’t limit their drinking to just the purple drink, so now we have a mixture of codeine with alcohol and or marijuana. All of which result in respiratory depression and potentially death.

The abuse of this cough syrup has become so great that Actavis was reported to pull it from production. Already the pint-size bottle sells on the street for $800, and limited access will only skyrocket its value.

As clinicians, we must be aware of the misuse and abuse of common prescription medications because teens prey on busy practices with false or exaggerated symptoms to try to obtain a prescription. Despite the American Academy of Pediatrics’ warning against codeine’s use as an antitussive in children (Pediatrics. 1997 Jun;99[6]:918-20.), there has not been a significant decline in its use (Pediatrics 2014 May;133[5]:e1139-47). Pediatricians need to use extreme caution, and be vigilant to identify frequent flyers or teens known to be at risk for drug abuse. Prescribe nonnarcotic-containing products first, and only prescribe small amounts promethazine/codeine products to prevent leftovers from being kept around the house for unsupervised use.

Most importantly, educate parents and families about the danger of overdose with these products so they can monitor its use.

Dr. Pearce is a pediatrician in Frankfort, Ill.

September, October, and November are well known as the “coughing months” in any general pediatrician’s office. We all can relate to the frustration we feel when that handful of patients returns for the unrelenting cough after steroids and albuterol have failed. Codeine has been known to be a good cough suppressant, and when coupled with promethazine (antihistamine), you have a very effective cough syrup that been used as such for decades.

Unfortunately, over the last few decades, this cough syrup has gained notoriety for use other than cough, and now is under great scrutiny. This common syrup is now the main ingredient of a poplar drink among teens known as “Sizzurp” or the “Purple Drank.” Well known artists tweet about it, post pictures of it on Instagram, sing about it in their songs, and glamorize it in their videos.

The mixture is simple; promethazine with codeine, lemon-lime sodas, and hard candies has all the makings of a party drink. It is fizzy, colorful, and sweet, with no horrible aftertaste, so gulping is easy. Most teens don’t limit their drinking to just the purple drink, so now we have a mixture of codeine with alcohol and or marijuana. All of which result in respiratory depression and potentially death.

The abuse of this cough syrup has become so great that Actavis was reported to pull it from production. Already the pint-size bottle sells on the street for $800, and limited access will only skyrocket its value.

As clinicians, we must be aware of the misuse and abuse of common prescription medications because teens prey on busy practices with false or exaggerated symptoms to try to obtain a prescription. Despite the American Academy of Pediatrics’ warning against codeine’s use as an antitussive in children (Pediatrics. 1997 Jun;99[6]:918-20.), there has not been a significant decline in its use (Pediatrics 2014 May;133[5]:e1139-47). Pediatricians need to use extreme caution, and be vigilant to identify frequent flyers or teens known to be at risk for drug abuse. Prescribe nonnarcotic-containing products first, and only prescribe small amounts promethazine/codeine products to prevent leftovers from being kept around the house for unsupervised use.

Most importantly, educate parents and families about the danger of overdose with these products so they can monitor its use.

Dr. Pearce is a pediatrician in Frankfort, Ill.

I was recently asked to evaluate a young child with a urinary tract infection caused by an extended spectrum beta-lactamase (ESBL)–producing Escherichia coli.

I’d just broken the bad news to the mother: There was no oral medication available to treat the baby, so she’d have to stay in the hospital for a full intravenous course.

“Has your child been treated with antibiotics recently?” I asked the mother, wondering how the baby had come to have such a resistant infection.

“She had a couple days of runny nose and a low-grade fever a couple of weeks ago,” she told me. “Her doctor treated her for a sinus infection.”

In 2011, doctors in outpatient settings across the United States wrote 262.5 million prescriptions for antibiotics – 73.7 million for children – and according to the Centers for Disease Control and Prevention, about 50% of these were completely unnecessary because they were prescribed for viral respiratory tract infections (Clin Infect Dis. 2015 May 1;60[9]:1308-16).

Prescribing practices varied by region, with the highest rates in the South. Don’t think I’m judging. I live in Kentucky, the state with the highest rate of antibiotic prescribing at 1,281 prescriptions per 1,000 persons. Is it any wonder that we’re seeing kids with very resistant infections?

The CDC estimates that at least two million people in the United States are infected annually with antibiotic-resistant bacteria and at least 23,000 of them die as a result of these infections. It is estimated that prevention strategies that include better antibiotic prescribing could prevent as many as 619,000 infections and 37,000 deaths over 5 years. Fortunately, my little patient recovered fully, but it has made me think about antimicrobial stewardship, especially its role in the outpatient setting.

According the American Academy of Pediatrics, the goal of antimicrobial stewardship is “to optimize antimicrobial use, with the aim of decreasing inappropriate use that leads to unwarranted toxicity and to selection and spread of resistant organisms.”

Antimicrobial stewardship programs (ASPs) are increasingly common in inpatient settings and have been shown to reduce antibiotic use. These programs can take many forms. The hospital where I work relies primarily on clinical guidelines emphasizing appropriate empiric therapy for a variety of common conditions. Other hospitals employ prospective audit and feedback, as well as a restricted formulary. Medicare and Medicaid Conditions of Participation will soon require hospitals that receive funds from the Centers for Medicare and Medicaid Services have an ASP.

Comparatively little has been published about ASPs in the outpatient setting. The American Academy of Pediatrics suggests that effective strategies include patient education, provider education, provider audit and feedback, and clinical decision support. We have at least some data that these work, at least in a research setting.

From 2000 to 2003, a controlled, cluster-randomized trial in 16 Massachusetts communities demonstrated that a 3-year, multifaceted, community-level intervention was “modestly successful” in reducing antibiotic use (Pediatrics. 2008 Jan;121[1]:e15-23). As a part of this intervention, parents received education via direct mail and in primary care settings, pharmacies, and child care centers while physicians received small-group education, frequent updates and educational materials, and prescribing feedback. Antibiotic prescribing was measured via health insurance claims data from all children who were 6 years of age or younger and resided in study communities, and were insured by one of four participating health plans. Coincident with the intervention, there was 4.2% decrease in antibiotic prescribing among children aged 24 to <48 months and a 6.7% decrease among those aged 48-72 months. The effect was greatest among Medicaid-insured children.

More recently, 18 primary care practices in Pennsylvania and New Jersey were randomized to an intervention that consisted of a 1-hour, on-site education session followed by 1 year of personalized, quarterly audit and feedback of prescribing for bacterial and viral acute respiratory tract infections (ARTIs), or usual practice (JAMA. 2013 Jun 12;309[22]:2345-52). The prescribing practices of 162 clinicians were included in the analysis.

Broad spectrum–antibiotic prescribing decreased in intervention practices, compared with controls (26.8% to 14.3% among intervention practices vs. 28.4% to 22.6% in controls), as did “off-guideline” prescribing for pneumonia and acute sinusitis. Antibiotic prescribing for viral infections was relatively low at baseline and did not change. The authors concluded that “extending antimicrobial stewardship to the ambulatory setting, where such programs have generally not been implemented, may have important health benefits.” Unfortunately, the positive effect in these practices was not sustained after the audit and feedback stopped (JAMA. 2014 Dec 17;312[23]:2569-70).

Not all antimicrobial stewardship interventions need to be time- and resource-intensive. Investigators in California found that providers who publicly pledged to reducing inappropriate antibiotic use for ARTIs by signing and posting a commitment letter in exam rooms actually prescribed fewer inappropriate antibiotic courses for their adult patients (JAMA Intern Med. 2014 Mar;174[3]:425-31).

 

“When you have a cough, sore throat, or other illness, your doctor will help you select the best possible treatments. If an antibiotic would do more harm than good, your doctor will explain this to you, and may offer other treatments that are better for you,” the letter read in part. There was a 19.7 absolute percentage reduction in inappropriate antibiotic prescribing for ARTIs among clinicians randomized to the commitment letter invention relative to controls.

Can antimicrobial strategies work in the “real” world, in a busy pediatrician’s office? According to Dr. Patricia Purcell, a physician with East Louisville Pediatrics in Louisville, Ky., the answer is “yes.”

“We actually start with education in the newborn period,” Dr. Purcell said. “We let parents know that we are not going to call in antibiotics over the phone, and we’re not going to prescribe them for an upper respiratory tract infection.”

Dr. Purcell and her partners have committed to following evidence-based guidelines for antibiotic practices, such as the AAP’s guidelines for otitis media and sinusitis. She also noted that at least one major insurance company is starting to provide the group feedback about their antibiotic-prescribing practices. “They want to make sure we are not prescribing antibiotics for viruses,” she said.

Still, the message that antibiotics are not always the answer can be a bitter pill for some parents to swallow. A pediatrician friend in Alabama notes: “I have these conversations every day, and a lot of parents are mad at me for not prescribing antibiotics for their child’s ‘terrible cold.’” Another friend notes that watchful waiting can be a burden for parents who have high copays or difficulties with transportation.

Still, many parents would welcome a frank discussion about the risks and benefits of antibiotics. After I shared some of the CDC information for parents with a nursing colleague, she told me that her daughter recently had a febrile illness and was diagnosed with otitis media. “I don’t like giving my kids meds they don’t need,” she told me. “However, if the doc says they need antibiotics and they prescribe them, I give them. I never say, ‘Do we really need antibiotics for that?’”

Now she is rethinking that approach. “Was 10 days of amoxicillin necessary for a ‘red’ eardrum?! I’m just a mom. ... I don’t know the answer to that! Was her ear red because she had been crying or because of her fever? Did she get ‘treatment’ she did not need? Did the doctor give me antibiotics without education because she assumed that is why I brought her in?”

This year’s “Get Smart About Antibiotics Week” was Nov. 16-22. This annual 1-week observance is intended to raise awareness of the threat of antibiotic resistance and the importance of appropriate prescribing and use. Kudos if you celebrated this in your office. If you missed it, it’s not too late to check out some of the activities suggested by the CDC, and try one or two in your own practice. Email me with your ideas about stewardship in the outpatient setting, and I’ll try to feature at least some of them in a future column.

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Kosair Children’s Hospital, also in Louisville. Dr. Bryant disclosed that she has been an investigator for clinical trials funded by Pfizer for the past 2 years. Email her at [email protected].

I was recently asked to evaluate a young child with a urinary tract infection caused by an extended spectrum beta-lactamase (ESBL)–producing Escherichia coli.

I’d just broken the bad news to the mother: There was no oral medication available to treat the baby, so she’d have to stay in the hospital for a full intravenous course.

“Has your child been treated with antibiotics recently?” I asked the mother, wondering how the baby had come to have such a resistant infection.

“She had a couple days of runny nose and a low-grade fever a couple of weeks ago,” she told me. “Her doctor treated her for a sinus infection.”

In 2011, doctors in outpatient settings across the United States wrote 262.5 million prescriptions for antibiotics – 73.7 million for children – and according to the Centers for Disease Control and Prevention, about 50% of these were completely unnecessary because they were prescribed for viral respiratory tract infections (Clin Infect Dis. 2015 May 1;60[9]:1308-16).

Prescribing practices varied by region, with the highest rates in the South. Don’t think I’m judging. I live in Kentucky, the state with the highest rate of antibiotic prescribing at 1,281 prescriptions per 1,000 persons. Is it any wonder that we’re seeing kids with very resistant infections?

The CDC estimates that at least two million people in the United States are infected annually with antibiotic-resistant bacteria and at least 23,000 of them die as a result of these infections. It is estimated that prevention strategies that include better antibiotic prescribing could prevent as many as 619,000 infections and 37,000 deaths over 5 years. Fortunately, my little patient recovered fully, but it has made me think about antimicrobial stewardship, especially its role in the outpatient setting.

According the American Academy of Pediatrics, the goal of antimicrobial stewardship is “to optimize antimicrobial use, with the aim of decreasing inappropriate use that leads to unwarranted toxicity and to selection and spread of resistant organisms.”

Antimicrobial stewardship programs (ASPs) are increasingly common in inpatient settings and have been shown to reduce antibiotic use. These programs can take many forms. The hospital where I work relies primarily on clinical guidelines emphasizing appropriate empiric therapy for a variety of common conditions. Other hospitals employ prospective audit and feedback, as well as a restricted formulary. Medicare and Medicaid Conditions of Participation will soon require hospitals that receive funds from the Centers for Medicare and Medicaid Services have an ASP.

Comparatively little has been published about ASPs in the outpatient setting. The American Academy of Pediatrics suggests that effective strategies include patient education, provider education, provider audit and feedback, and clinical decision support. We have at least some data that these work, at least in a research setting.

From 2000 to 2003, a controlled, cluster-randomized trial in 16 Massachusetts communities demonstrated that a 3-year, multifaceted, community-level intervention was “modestly successful” in reducing antibiotic use (Pediatrics. 2008 Jan;121[1]:e15-23). As a part of this intervention, parents received education via direct mail and in primary care settings, pharmacies, and child care centers while physicians received small-group education, frequent updates and educational materials, and prescribing feedback. Antibiotic prescribing was measured via health insurance claims data from all children who were 6 years of age or younger and resided in study communities, and were insured by one of four participating health plans. Coincident with the intervention, there was 4.2% decrease in antibiotic prescribing among children aged 24 to <48 months and a 6.7% decrease among those aged 48-72 months. The effect was greatest among Medicaid-insured children.

More recently, 18 primary care practices in Pennsylvania and New Jersey were randomized to an intervention that consisted of a 1-hour, on-site education session followed by 1 year of personalized, quarterly audit and feedback of prescribing for bacterial and viral acute respiratory tract infections (ARTIs), or usual practice (JAMA. 2013 Jun 12;309[22]:2345-52). The prescribing practices of 162 clinicians were included in the analysis.

Broad spectrum–antibiotic prescribing decreased in intervention practices, compared with controls (26.8% to 14.3% among intervention practices vs. 28.4% to 22.6% in controls), as did “off-guideline” prescribing for pneumonia and acute sinusitis. Antibiotic prescribing for viral infections was relatively low at baseline and did not change. The authors concluded that “extending antimicrobial stewardship to the ambulatory setting, where such programs have generally not been implemented, may have important health benefits.” Unfortunately, the positive effect in these practices was not sustained after the audit and feedback stopped (JAMA. 2014 Dec 17;312[23]:2569-70).

Not all antimicrobial stewardship interventions need to be time- and resource-intensive. Investigators in California found that providers who publicly pledged to reducing inappropriate antibiotic use for ARTIs by signing and posting a commitment letter in exam rooms actually prescribed fewer inappropriate antibiotic courses for their adult patients (JAMA Intern Med. 2014 Mar;174[3]:425-31).

 

“When you have a cough, sore throat, or other illness, your doctor will help you select the best possible treatments. If an antibiotic would do more harm than good, your doctor will explain this to you, and may offer other treatments that are better for you,” the letter read in part. There was a 19.7 absolute percentage reduction in inappropriate antibiotic prescribing for ARTIs among clinicians randomized to the commitment letter invention relative to controls.

Can antimicrobial strategies work in the “real” world, in a busy pediatrician’s office? According to Dr. Patricia Purcell, a physician with East Louisville Pediatrics in Louisville, Ky., the answer is “yes.”

“We actually start with education in the newborn period,” Dr. Purcell said. “We let parents know that we are not going to call in antibiotics over the phone, and we’re not going to prescribe them for an upper respiratory tract infection.”

Dr. Purcell and her partners have committed to following evidence-based guidelines for antibiotic practices, such as the AAP’s guidelines for otitis media and sinusitis. She also noted that at least one major insurance company is starting to provide the group feedback about their antibiotic-prescribing practices. “They want to make sure we are not prescribing antibiotics for viruses,” she said.

Still, the message that antibiotics are not always the answer can be a bitter pill for some parents to swallow. A pediatrician friend in Alabama notes: “I have these conversations every day, and a lot of parents are mad at me for not prescribing antibiotics for their child’s ‘terrible cold.’” Another friend notes that watchful waiting can be a burden for parents who have high copays or difficulties with transportation.

Still, many parents would welcome a frank discussion about the risks and benefits of antibiotics. After I shared some of the CDC information for parents with a nursing colleague, she told me that her daughter recently had a febrile illness and was diagnosed with otitis media. “I don’t like giving my kids meds they don’t need,” she told me. “However, if the doc says they need antibiotics and they prescribe them, I give them. I never say, ‘Do we really need antibiotics for that?’”

Now she is rethinking that approach. “Was 10 days of amoxicillin necessary for a ‘red’ eardrum?! I’m just a mom. ... I don’t know the answer to that! Was her ear red because she had been crying or because of her fever? Did she get ‘treatment’ she did not need? Did the doctor give me antibiotics without education because she assumed that is why I brought her in?”

This year’s “Get Smart About Antibiotics Week” was Nov. 16-22. This annual 1-week observance is intended to raise awareness of the threat of antibiotic resistance and the importance of appropriate prescribing and use. Kudos if you celebrated this in your office. If you missed it, it’s not too late to check out some of the activities suggested by the CDC, and try one or two in your own practice. Email me with your ideas about stewardship in the outpatient setting, and I’ll try to feature at least some of them in a future column.

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Kosair Children’s Hospital, also in Louisville. Dr. Bryant disclosed that she has been an investigator for clinical trials funded by Pfizer for the past 2 years. Email her at [email protected].

I was recently asked to evaluate a young child with a urinary tract infection caused by an extended spectrum beta-lactamase (ESBL)–producing Escherichia coli.

I’d just broken the bad news to the mother: There was no oral medication available to treat the baby, so she’d have to stay in the hospital for a full intravenous course.

“Has your child been treated with antibiotics recently?” I asked the mother, wondering how the baby had come to have such a resistant infection.

“She had a couple days of runny nose and a low-grade fever a couple of weeks ago,” she told me. “Her doctor treated her for a sinus infection.”

In 2011, doctors in outpatient settings across the United States wrote 262.5 million prescriptions for antibiotics – 73.7 million for children – and according to the Centers for Disease Control and Prevention, about 50% of these were completely unnecessary because they were prescribed for viral respiratory tract infections (Clin Infect Dis. 2015 May 1;60[9]:1308-16).

Prescribing practices varied by region, with the highest rates in the South. Don’t think I’m judging. I live in Kentucky, the state with the highest rate of antibiotic prescribing at 1,281 prescriptions per 1,000 persons. Is it any wonder that we’re seeing kids with very resistant infections?

The CDC estimates that at least two million people in the United States are infected annually with antibiotic-resistant bacteria and at least 23,000 of them die as a result of these infections. It is estimated that prevention strategies that include better antibiotic prescribing could prevent as many as 619,000 infections and 37,000 deaths over 5 years. Fortunately, my little patient recovered fully, but it has made me think about antimicrobial stewardship, especially its role in the outpatient setting.

According the American Academy of Pediatrics, the goal of antimicrobial stewardship is “to optimize antimicrobial use, with the aim of decreasing inappropriate use that leads to unwarranted toxicity and to selection and spread of resistant organisms.”

Antimicrobial stewardship programs (ASPs) are increasingly common in inpatient settings and have been shown to reduce antibiotic use. These programs can take many forms. The hospital where I work relies primarily on clinical guidelines emphasizing appropriate empiric therapy for a variety of common conditions. Other hospitals employ prospective audit and feedback, as well as a restricted formulary. Medicare and Medicaid Conditions of Participation will soon require hospitals that receive funds from the Centers for Medicare and Medicaid Services have an ASP.

Comparatively little has been published about ASPs in the outpatient setting. The American Academy of Pediatrics suggests that effective strategies include patient education, provider education, provider audit and feedback, and clinical decision support. We have at least some data that these work, at least in a research setting.

From 2000 to 2003, a controlled, cluster-randomized trial in 16 Massachusetts communities demonstrated that a 3-year, multifaceted, community-level intervention was “modestly successful” in reducing antibiotic use (Pediatrics. 2008 Jan;121[1]:e15-23). As a part of this intervention, parents received education via direct mail and in primary care settings, pharmacies, and child care centers while physicians received small-group education, frequent updates and educational materials, and prescribing feedback. Antibiotic prescribing was measured via health insurance claims data from all children who were 6 years of age or younger and resided in study communities, and were insured by one of four participating health plans. Coincident with the intervention, there was 4.2% decrease in antibiotic prescribing among children aged 24 to <48 months and a 6.7% decrease among those aged 48-72 months. The effect was greatest among Medicaid-insured children.

More recently, 18 primary care practices in Pennsylvania and New Jersey were randomized to an intervention that consisted of a 1-hour, on-site education session followed by 1 year of personalized, quarterly audit and feedback of prescribing for bacterial and viral acute respiratory tract infections (ARTIs), or usual practice (JAMA. 2013 Jun 12;309[22]:2345-52). The prescribing practices of 162 clinicians were included in the analysis.

Broad spectrum–antibiotic prescribing decreased in intervention practices, compared with controls (26.8% to 14.3% among intervention practices vs. 28.4% to 22.6% in controls), as did “off-guideline” prescribing for pneumonia and acute sinusitis. Antibiotic prescribing for viral infections was relatively low at baseline and did not change. The authors concluded that “extending antimicrobial stewardship to the ambulatory setting, where such programs have generally not been implemented, may have important health benefits.” Unfortunately, the positive effect in these practices was not sustained after the audit and feedback stopped (JAMA. 2014 Dec 17;312[23]:2569-70).

Not all antimicrobial stewardship interventions need to be time- and resource-intensive. Investigators in California found that providers who publicly pledged to reducing inappropriate antibiotic use for ARTIs by signing and posting a commitment letter in exam rooms actually prescribed fewer inappropriate antibiotic courses for their adult patients (JAMA Intern Med. 2014 Mar;174[3]:425-31).

 

“When you have a cough, sore throat, or other illness, your doctor will help you select the best possible treatments. If an antibiotic would do more harm than good, your doctor will explain this to you, and may offer other treatments that are better for you,” the letter read in part. There was a 19.7 absolute percentage reduction in inappropriate antibiotic prescribing for ARTIs among clinicians randomized to the commitment letter invention relative to controls.

Can antimicrobial strategies work in the “real” world, in a busy pediatrician’s office? According to Dr. Patricia Purcell, a physician with East Louisville Pediatrics in Louisville, Ky., the answer is “yes.”

“We actually start with education in the newborn period,” Dr. Purcell said. “We let parents know that we are not going to call in antibiotics over the phone, and we’re not going to prescribe them for an upper respiratory tract infection.”

Dr. Purcell and her partners have committed to following evidence-based guidelines for antibiotic practices, such as the AAP’s guidelines for otitis media and sinusitis. She also noted that at least one major insurance company is starting to provide the group feedback about their antibiotic-prescribing practices. “They want to make sure we are not prescribing antibiotics for viruses,” she said.

Still, the message that antibiotics are not always the answer can be a bitter pill for some parents to swallow. A pediatrician friend in Alabama notes: “I have these conversations every day, and a lot of parents are mad at me for not prescribing antibiotics for their child’s ‘terrible cold.’” Another friend notes that watchful waiting can be a burden for parents who have high copays or difficulties with transportation.

Still, many parents would welcome a frank discussion about the risks and benefits of antibiotics. After I shared some of the CDC information for parents with a nursing colleague, she told me that her daughter recently had a febrile illness and was diagnosed with otitis media. “I don’t like giving my kids meds they don’t need,” she told me. “However, if the doc says they need antibiotics and they prescribe them, I give them. I never say, ‘Do we really need antibiotics for that?’”

Now she is rethinking that approach. “Was 10 days of amoxicillin necessary for a ‘red’ eardrum?! I’m just a mom. ... I don’t know the answer to that! Was her ear red because she had been crying or because of her fever? Did she get ‘treatment’ she did not need? Did the doctor give me antibiotics without education because she assumed that is why I brought her in?”

This year’s “Get Smart About Antibiotics Week” was Nov. 16-22. This annual 1-week observance is intended to raise awareness of the threat of antibiotic resistance and the importance of appropriate prescribing and use. Kudos if you celebrated this in your office. If you missed it, it’s not too late to check out some of the activities suggested by the CDC, and try one or two in your own practice. Email me with your ideas about stewardship in the outpatient setting, and I’ll try to feature at least some of them in a future column.

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Kosair Children’s Hospital, also in Louisville. Dr. Bryant disclosed that she has been an investigator for clinical trials funded by Pfizer for the past 2 years. Email her at [email protected].

ORLANDO – Starting varenicline in smokers while hospitalized for an acute coronary syndrome resulted in substantially higher smoking abstinence rates than with placebo at all time points through 6 months of follow-up in the double-blind, randomized EVITA trial.

“The ACS population is typically older, they’re long-term smokers, and they come into the hospital with a life-threatening condition. Their family is all around them. They’ve had angioplasty or CABG [coronary artery bypass graft] surgery. So they have pressure on them to stop smoking. This is a teachable moment, a window of opportunity. The public health benefit for smoking cessation in this population is huge. You can cut their risk of death and significant morbidity in half if you can get them to stop,” Dr. Mark J. Eisenberg said in presenting the EVITA results at the American Heart Association scientific sessions.

 

EVITA (Evaluation of Varenicline in Smoking Cessation for Patients Post–Acute Coronary Syndrome) was an investigator-initiated, 40-center study involving 302 smokers hospitalized for ACS. They’d smoked for an average of 36 years and were puffing 22 cigarettes per day at enrollment. More than 90% of them had an acute MI just several days before starting on varenicline (Chantix) at 1 mg twice daily or placebo for 12 weeks.

“To our knowledge, this is the highest-risk population that’s been exposed to varenicline,” said Dr. Eisenberg, professor of medicine at McGill University and director of the cardiovascular health services research program at Jewish General Hospital in Montreal.

The primary study endpoint was continuous self-reported abstinence since baseline backed by biochemical confirmation in the form of an exhaled carbon monoxide level of 10 ppm or less at week 24 as well as at all the earlier follow-up visits. The rate was 47.3% in the varenicline group, compared with 32.5% in placebo-treated controls. That placebo response rate is in line with numerous prior studies that have shown that less than one-third of smokers with ACS remain abstinent after leaving the hospital.

“Most cardiologists would say, ‘All my patients stop smoking.’ But in the clinic if you look in the patients’ pockets, you find a pack of cigarettes. They stop smoking while in hospital, but as soon as they’re discharged, the relapse rate is almost immediate. Most patients are smoking the day they get out of hospital,” according to Dr. Eisenberg.

In EVITA, the number-needed-to-treat with varenicline for 12 weeks in order to produce 1 extra nonsmoker at 6 months was 6.8 patients.

The secondary endpoint of at least a 50% reduction in the number of cigarettes per day from baseline to 6 months was met by 67.4% of the varenicline group and 55.6% of controls, with a number-needed-to-treat of 8.5, he continued.

No safety issues emerged in the study, although as Dr. Eisenberg noted, EVITA wasn’t sufficiently powered to look at safety. The only side effect more common in varenicline-treated patients was abnormal dreams, with a 12-week incidence of 15%, threefold higher than in controls, a phenomenon seen in other, larger varenicline studies as well.

The EVITA investigators plan to follow participants out to 12 months. “If we see someone who at 1 year post MI is still smoking, maybe it’s time to go after them again, perhaps with another medication or behavioral therapy,” he said.

There are no randomized clinical trials demonstrating that starting nicotine patches or bupropion in the hospital is effective for smoking cessation in the ACS population, according to the cardiologist.

Dr. Eisenberg predicted this study will change clinical practice. In much the same way physicians now routinely start ACS patients on a statin, beta-blocker, and aspirin before they leave the hospital, physicians will capitalize on this opportunity to help ACS patients quit smoking as well, he said.

 

In an interview, Dr. David C. Goff, who wasn’t involved in EVITA, called the trial “a game changer” in preventive cardiology.

“The use of varenicline in ACS patients before they leave the hospital is a very important step forward. Cardiologists are increasingly comfortable with the idea of starting secondary prevention medications in the hospital, and there’s very little more important for a person with heart disease who smokes cigarettes than to help them quit smoking. It’s probably the No. 1 priority. So evidence that we can start a medication in the hospital and get more people who smoke cigarettes to quit smoking is definitely game changing, I think,” said Dr. Goff, professor of epidemiology and dean of the Colorado School of Public Health in Aurora.

 

Dr. Eisenberg reported receiving funding from Pfizer to perform the EVITA trial. He has also gotten honoraria from the company for providing continuing medical education talks on smoking cessation.

 

[email protected]

ORLANDO – Starting varenicline in smokers while hospitalized for an acute coronary syndrome resulted in substantially higher smoking abstinence rates than with placebo at all time points through 6 months of follow-up in the double-blind, randomized EVITA trial.

“The ACS population is typically older, they’re long-term smokers, and they come into the hospital with a life-threatening condition. Their family is all around them. They’ve had angioplasty or CABG [coronary artery bypass graft] surgery. So they have pressure on them to stop smoking. This is a teachable moment, a window of opportunity. The public health benefit for smoking cessation in this population is huge. You can cut their risk of death and significant morbidity in half if you can get them to stop,” Dr. Mark J. Eisenberg said in presenting the EVITA results at the American Heart Association scientific sessions.

 

EVITA (Evaluation of Varenicline in Smoking Cessation for Patients Post–Acute Coronary Syndrome) was an investigator-initiated, 40-center study involving 302 smokers hospitalized for ACS. They’d smoked for an average of 36 years and were puffing 22 cigarettes per day at enrollment. More than 90% of them had an acute MI just several days before starting on varenicline (Chantix) at 1 mg twice daily or placebo for 12 weeks.

“To our knowledge, this is the highest-risk population that’s been exposed to varenicline,” said Dr. Eisenberg, professor of medicine at McGill University and director of the cardiovascular health services research program at Jewish General Hospital in Montreal.

The primary study endpoint was continuous self-reported abstinence since baseline backed by biochemical confirmation in the form of an exhaled carbon monoxide level of 10 ppm or less at week 24 as well as at all the earlier follow-up visits. The rate was 47.3% in the varenicline group, compared with 32.5% in placebo-treated controls. That placebo response rate is in line with numerous prior studies that have shown that less than one-third of smokers with ACS remain abstinent after leaving the hospital.

“Most cardiologists would say, ‘All my patients stop smoking.’ But in the clinic if you look in the patients’ pockets, you find a pack of cigarettes. They stop smoking while in hospital, but as soon as they’re discharged, the relapse rate is almost immediate. Most patients are smoking the day they get out of hospital,” according to Dr. Eisenberg.

In EVITA, the number-needed-to-treat with varenicline for 12 weeks in order to produce 1 extra nonsmoker at 6 months was 6.8 patients.

The secondary endpoint of at least a 50% reduction in the number of cigarettes per day from baseline to 6 months was met by 67.4% of the varenicline group and 55.6% of controls, with a number-needed-to-treat of 8.5, he continued.

No safety issues emerged in the study, although as Dr. Eisenberg noted, EVITA wasn’t sufficiently powered to look at safety. The only side effect more common in varenicline-treated patients was abnormal dreams, with a 12-week incidence of 15%, threefold higher than in controls, a phenomenon seen in other, larger varenicline studies as well.

The EVITA investigators plan to follow participants out to 12 months. “If we see someone who at 1 year post MI is still smoking, maybe it’s time to go after them again, perhaps with another medication or behavioral therapy,” he said.

There are no randomized clinical trials demonstrating that starting nicotine patches or bupropion in the hospital is effective for smoking cessation in the ACS population, according to the cardiologist.

Dr. Eisenberg predicted this study will change clinical practice. In much the same way physicians now routinely start ACS patients on a statin, beta-blocker, and aspirin before they leave the hospital, physicians will capitalize on this opportunity to help ACS patients quit smoking as well, he said.

 

In an interview, Dr. David C. Goff, who wasn’t involved in EVITA, called the trial “a game changer” in preventive cardiology.

“The use of varenicline in ACS patients before they leave the hospital is a very important step forward. Cardiologists are increasingly comfortable with the idea of starting secondary prevention medications in the hospital, and there’s very little more important for a person with heart disease who smokes cigarettes than to help them quit smoking. It’s probably the No. 1 priority. So evidence that we can start a medication in the hospital and get more people who smoke cigarettes to quit smoking is definitely game changing, I think,” said Dr. Goff, professor of epidemiology and dean of the Colorado School of Public Health in Aurora.

 

Dr. Eisenberg reported receiving funding from Pfizer to perform the EVITA trial. He has also gotten honoraria from the company for providing continuing medical education talks on smoking cessation.

 

[email protected]

ORLANDO – Starting varenicline in smokers while hospitalized for an acute coronary syndrome resulted in substantially higher smoking abstinence rates than with placebo at all time points through 6 months of follow-up in the double-blind, randomized EVITA trial.

“The ACS population is typically older, they’re long-term smokers, and they come into the hospital with a life-threatening condition. Their family is all around them. They’ve had angioplasty or CABG [coronary artery bypass graft] surgery. So they have pressure on them to stop smoking. This is a teachable moment, a window of opportunity. The public health benefit for smoking cessation in this population is huge. You can cut their risk of death and significant morbidity in half if you can get them to stop,” Dr. Mark J. Eisenberg said in presenting the EVITA results at the American Heart Association scientific sessions.

 

EVITA (Evaluation of Varenicline in Smoking Cessation for Patients Post–Acute Coronary Syndrome) was an investigator-initiated, 40-center study involving 302 smokers hospitalized for ACS. They’d smoked for an average of 36 years and were puffing 22 cigarettes per day at enrollment. More than 90% of them had an acute MI just several days before starting on varenicline (Chantix) at 1 mg twice daily or placebo for 12 weeks.

“To our knowledge, this is the highest-risk population that’s been exposed to varenicline,” said Dr. Eisenberg, professor of medicine at McGill University and director of the cardiovascular health services research program at Jewish General Hospital in Montreal.

The primary study endpoint was continuous self-reported abstinence since baseline backed by biochemical confirmation in the form of an exhaled carbon monoxide level of 10 ppm or less at week 24 as well as at all the earlier follow-up visits. The rate was 47.3% in the varenicline group, compared with 32.5% in placebo-treated controls. That placebo response rate is in line with numerous prior studies that have shown that less than one-third of smokers with ACS remain abstinent after leaving the hospital.

“Most cardiologists would say, ‘All my patients stop smoking.’ But in the clinic if you look in the patients’ pockets, you find a pack of cigarettes. They stop smoking while in hospital, but as soon as they’re discharged, the relapse rate is almost immediate. Most patients are smoking the day they get out of hospital,” according to Dr. Eisenberg.

In EVITA, the number-needed-to-treat with varenicline for 12 weeks in order to produce 1 extra nonsmoker at 6 months was 6.8 patients.

The secondary endpoint of at least a 50% reduction in the number of cigarettes per day from baseline to 6 months was met by 67.4% of the varenicline group and 55.6% of controls, with a number-needed-to-treat of 8.5, he continued.

No safety issues emerged in the study, although as Dr. Eisenberg noted, EVITA wasn’t sufficiently powered to look at safety. The only side effect more common in varenicline-treated patients was abnormal dreams, with a 12-week incidence of 15%, threefold higher than in controls, a phenomenon seen in other, larger varenicline studies as well.

The EVITA investigators plan to follow participants out to 12 months. “If we see someone who at 1 year post MI is still smoking, maybe it’s time to go after them again, perhaps with another medication or behavioral therapy,” he said.

There are no randomized clinical trials demonstrating that starting nicotine patches or bupropion in the hospital is effective for smoking cessation in the ACS population, according to the cardiologist.

Dr. Eisenberg predicted this study will change clinical practice. In much the same way physicians now routinely start ACS patients on a statin, beta-blocker, and aspirin before they leave the hospital, physicians will capitalize on this opportunity to help ACS patients quit smoking as well, he said.

 

In an interview, Dr. David C. Goff, who wasn’t involved in EVITA, called the trial “a game changer” in preventive cardiology.

“The use of varenicline in ACS patients before they leave the hospital is a very important step forward. Cardiologists are increasingly comfortable with the idea of starting secondary prevention medications in the hospital, and there’s very little more important for a person with heart disease who smokes cigarettes than to help them quit smoking. It’s probably the No. 1 priority. So evidence that we can start a medication in the hospital and get more people who smoke cigarettes to quit smoking is definitely game changing, I think,” said Dr. Goff, professor of epidemiology and dean of the Colorado School of Public Health in Aurora.

 

Dr. Eisenberg reported receiving funding from Pfizer to perform the EVITA trial. He has also gotten honoraria from the company for providing continuing medical education talks on smoking cessation.

 

[email protected]