Has the anti-benzodiazepine backlash gone too far?

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When benzodiazepines were first introduced, they were greeted with enthusiasm. Librium came first, in 1960, followed by Valium in 1962, and they were seen as an improvement over barbiturates for the treatment of anxiety, insomnia, and seizures. From 1968 to 1982, Valium (diazepam) was the No. 1–selling U.S. pharmaceutical: 2.3 billion tablets of Valium were sold in 1978 alone. Valium was even the subject of a 1966 Rolling Stones hit, “Mother’s Little Helper.”

By the 1980s, it became apparent that there was a downside to these medications: patients became tolerant, dependent, and some became addicted to the medications. In older patients an association was noted with falls and cognitive impairment. And while safe in overdoses when they are the only agent, combined with alcohol or opioids, benzodiazepines can be lethal and have played a significant role in the current overdose crisis.

Dr. Dinah Miller

Because of the problems that are associated with their use, benzodiazepines and their relatives, the Z-drugs used for sleep, have become stigmatized, as have the patients who use them and perhaps even the doctors who prescribe them. Still, there are circumstances where patients find these medications to be helpful, where other medications don’t work, or don’t work quickly enough. They provide fast relief in conditions where there are not always good alternatives.

In the Facebook group, “Psychiatry for All Physicians,” it’s not uncommon for physicians to ask what to do with older patients who are transferred to them on therapeutic doses of benzodiazepines or zolpidem. These are outpatients coming for routine care, and they find the medications helpful and don’t want to discontinue them. They have tried other medications that were not helpful. I’ve been surprised at how often the respondents insist the patient should be told he must taper off the medication. “Just say no,” is often the advice, and perhaps it’s more about the doctor’s discomfort than it is about the individual patient. For sleep issues, cognitive-behavioral therapy is given as the gold-standard treatment, while in my practice I have found it difficult to motivate patients to engage in it, and of those who do, it is sometimes helpful, but not a panacea. Severe anxiety and sleepless nights, however, are not benign conditions.

This “just say no, hold the line” sentiment has me wondering if our pendulum has swung too far with respect to prescribing benzodiazepines. Is this just one more issue that has become strongly polarized? Certainly the literature would support that idea, with some physicians writing about how benzodiazepines are underused, and others urging avoidance.

I posted a poll on Twitter: Has the anti-benzo movement gone too far? In addition, I started a Twitter thread of my own thoughts about prescribing and deprescribing these medications and will give a synopsis of those ideas here.

Clearly, benzodiazepines are harmful to some patients, they have side effects, can be difficult to stop because of withdrawal symptoms, and they carry the risk of addiction. That’s not in question. Many medications, however, have the potential to do more harm than good, for example ibuprofen can cause bleeding or renal problems, and Fosamax, used to treat osteoporosis, can cause osteonecrosis of the jaw and femur, to name just two.

It would be so much easier if we could know in advance who benzodiazepines will harm, just as it would be good if we could know in advance who will get tardive dyskinesia or dyslipidemia from antipsychotic medications, or who will have life-threatening adverse reactions from cancer chemotherapy with no tumor response. There are risks to both starting and stopping sedatives, and if we insist a patient stop a medication because of potential risk, then we are cutting them off from being a partner in their own care. It also creates an adversarial relationship that can be draining for the doctor and upsetting for the patient.

By definition, if someone needs hospitalization for a psychiatric condition, their outpatient benzodiazepine is not keeping them stable and stopping it may be a good idea. If someone is seen in an ED for a fall, it’s common to blame the benzodiazepine, but older people who are not on these medications also fall and have memory problems. In his book, “Being Mortal: Illness, Medicine, and What Matters Most in the End” (New York: Picador, 2014), Atul Gawande, MD, makes the point that taking more than four prescriptions medications increases the risk for falls in the elderly. Still, no one is suggesting patients be taken off their antidepressants, antihypertensives, or blood thinners.

Finally, the question is not should we be giving benzodiazepines out without careful consideration – the answer is clearly no. Physicians don’t pass out benzodiazepines “like candy” for all the above reasons. They are initiated because the patient is suffering and sometimes desperate. Anxiety, panic, intractable insomnia, and severe agitation are all miserable, and alternative treatments may take weeks to work, or not work at all. Yet these subjective symptoms may be dismissed by physicians.

So what do I do in my own practice? I don’t encourage patients to take potentially addictive medications, but I do sometimes use them. I give ‘as needed’ benzodiazepines to people in distress who don’t have a history of misusing them. I never plan to start them as a permanent standing medication, though once in a while that ends up happening. As with other medications, it is best to use the minimally effective dose.

There is some controversy as to whether it is best to use anxiety medications on an “as-needed” basis or as a standing dosage. Psychiatrists who prescribe benzodiazepines more liberally often feel it’s better to give standing doses and prevent breakthrough anxiety. Patients may appear to be ‘medication seeking’ not because they are addicted, but because the doses used are too low to adequately treat their anxiety.

My hope is that there is less risk of tolerance, dependence, or addiction with less-frequent dosing, and I prescribe as-needed benzodiazepines for panic attacks, agitated major depression while we wait for the antidepressant to “kick in,” insomnia during manic episodes, and to people who get very anxious in specific situations such as flying or for medical procedures. I sometimes prescribe them for people with insomnia that does not respond to other treatments, or for disabling generalized anxiety.

For patients who have taken benzodiazepines for many years, I continue to discuss the risks, but often they are not looking to fix something that isn’t broken, or to live a risk-free life. A few of the patients who have come to me on low standing doses of sedatives are now in their 80’s, yet they remain active, live independently, drive, travel, and have busy social lives. One could argue either that the medications are working, or that the patient has become dependent on them and needs them to prevent withdrawal.

These medications present a quandary: by denying patients treatment with benzodiazepines, we are sparing some people addictions (this is good, we should be careful), but we are leaving some people to suffer. There is no perfect answer.

What I do know is that doctors should think carefully and consider the patient in front of them. “No Benzos Ever For Anyone” or “you must come off because there is risk and people will think I am a bad doctor for prescribing them to you” can be done by a robot.

So, yes, I think the pendulum has swung a bit too far; there is a place for these medications in acute treatment for those at low risk of addiction, and there are people who benefit from them over the long run. At times, they provide immense relief to someone who is really struggling.

So what was the result of my Twitter poll? Of the 219 voters, 34.2% voted: “No, the pendulum has not swung too far, and these medications are harmful”; 65.8% voted: “Yes, these medications are helpful.” There were many comments expressing a wide variety of sentiments. Of those who had taken prescription benzodiazepines, some felt they had been harmed and wished they had never been started on them, and others continue to find them helpful. Psychiatrists, it seems, see them from the vantage point of the populations they treat.

People who are uncomfortable search for answers, and those answers may come in the form of meditation or exercise, medicines, or illicit drugs. It’s interesting that these same patients can now easily obtain “medical” marijuana, and the Rolling Stones’ “Mother’s Little Helper” is often replaced by a gin and tonic.

Dr. Dinah Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore. Dr. Miller has no conflicts of interest.

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When benzodiazepines were first introduced, they were greeted with enthusiasm. Librium came first, in 1960, followed by Valium in 1962, and they were seen as an improvement over barbiturates for the treatment of anxiety, insomnia, and seizures. From 1968 to 1982, Valium (diazepam) was the No. 1–selling U.S. pharmaceutical: 2.3 billion tablets of Valium were sold in 1978 alone. Valium was even the subject of a 1966 Rolling Stones hit, “Mother’s Little Helper.”

By the 1980s, it became apparent that there was a downside to these medications: patients became tolerant, dependent, and some became addicted to the medications. In older patients an association was noted with falls and cognitive impairment. And while safe in overdoses when they are the only agent, combined with alcohol or opioids, benzodiazepines can be lethal and have played a significant role in the current overdose crisis.

Dr. Dinah Miller

Because of the problems that are associated with their use, benzodiazepines and their relatives, the Z-drugs used for sleep, have become stigmatized, as have the patients who use them and perhaps even the doctors who prescribe them. Still, there are circumstances where patients find these medications to be helpful, where other medications don’t work, or don’t work quickly enough. They provide fast relief in conditions where there are not always good alternatives.

In the Facebook group, “Psychiatry for All Physicians,” it’s not uncommon for physicians to ask what to do with older patients who are transferred to them on therapeutic doses of benzodiazepines or zolpidem. These are outpatients coming for routine care, and they find the medications helpful and don’t want to discontinue them. They have tried other medications that were not helpful. I’ve been surprised at how often the respondents insist the patient should be told he must taper off the medication. “Just say no,” is often the advice, and perhaps it’s more about the doctor’s discomfort than it is about the individual patient. For sleep issues, cognitive-behavioral therapy is given as the gold-standard treatment, while in my practice I have found it difficult to motivate patients to engage in it, and of those who do, it is sometimes helpful, but not a panacea. Severe anxiety and sleepless nights, however, are not benign conditions.

This “just say no, hold the line” sentiment has me wondering if our pendulum has swung too far with respect to prescribing benzodiazepines. Is this just one more issue that has become strongly polarized? Certainly the literature would support that idea, with some physicians writing about how benzodiazepines are underused, and others urging avoidance.

I posted a poll on Twitter: Has the anti-benzo movement gone too far? In addition, I started a Twitter thread of my own thoughts about prescribing and deprescribing these medications and will give a synopsis of those ideas here.

Clearly, benzodiazepines are harmful to some patients, they have side effects, can be difficult to stop because of withdrawal symptoms, and they carry the risk of addiction. That’s not in question. Many medications, however, have the potential to do more harm than good, for example ibuprofen can cause bleeding or renal problems, and Fosamax, used to treat osteoporosis, can cause osteonecrosis of the jaw and femur, to name just two.

It would be so much easier if we could know in advance who benzodiazepines will harm, just as it would be good if we could know in advance who will get tardive dyskinesia or dyslipidemia from antipsychotic medications, or who will have life-threatening adverse reactions from cancer chemotherapy with no tumor response. There are risks to both starting and stopping sedatives, and if we insist a patient stop a medication because of potential risk, then we are cutting them off from being a partner in their own care. It also creates an adversarial relationship that can be draining for the doctor and upsetting for the patient.

By definition, if someone needs hospitalization for a psychiatric condition, their outpatient benzodiazepine is not keeping them stable and stopping it may be a good idea. If someone is seen in an ED for a fall, it’s common to blame the benzodiazepine, but older people who are not on these medications also fall and have memory problems. In his book, “Being Mortal: Illness, Medicine, and What Matters Most in the End” (New York: Picador, 2014), Atul Gawande, MD, makes the point that taking more than four prescriptions medications increases the risk for falls in the elderly. Still, no one is suggesting patients be taken off their antidepressants, antihypertensives, or blood thinners.

Finally, the question is not should we be giving benzodiazepines out without careful consideration – the answer is clearly no. Physicians don’t pass out benzodiazepines “like candy” for all the above reasons. They are initiated because the patient is suffering and sometimes desperate. Anxiety, panic, intractable insomnia, and severe agitation are all miserable, and alternative treatments may take weeks to work, or not work at all. Yet these subjective symptoms may be dismissed by physicians.

So what do I do in my own practice? I don’t encourage patients to take potentially addictive medications, but I do sometimes use them. I give ‘as needed’ benzodiazepines to people in distress who don’t have a history of misusing them. I never plan to start them as a permanent standing medication, though once in a while that ends up happening. As with other medications, it is best to use the minimally effective dose.

There is some controversy as to whether it is best to use anxiety medications on an “as-needed” basis or as a standing dosage. Psychiatrists who prescribe benzodiazepines more liberally often feel it’s better to give standing doses and prevent breakthrough anxiety. Patients may appear to be ‘medication seeking’ not because they are addicted, but because the doses used are too low to adequately treat their anxiety.

My hope is that there is less risk of tolerance, dependence, or addiction with less-frequent dosing, and I prescribe as-needed benzodiazepines for panic attacks, agitated major depression while we wait for the antidepressant to “kick in,” insomnia during manic episodes, and to people who get very anxious in specific situations such as flying or for medical procedures. I sometimes prescribe them for people with insomnia that does not respond to other treatments, or for disabling generalized anxiety.

For patients who have taken benzodiazepines for many years, I continue to discuss the risks, but often they are not looking to fix something that isn’t broken, or to live a risk-free life. A few of the patients who have come to me on low standing doses of sedatives are now in their 80’s, yet they remain active, live independently, drive, travel, and have busy social lives. One could argue either that the medications are working, or that the patient has become dependent on them and needs them to prevent withdrawal.

These medications present a quandary: by denying patients treatment with benzodiazepines, we are sparing some people addictions (this is good, we should be careful), but we are leaving some people to suffer. There is no perfect answer.

What I do know is that doctors should think carefully and consider the patient in front of them. “No Benzos Ever For Anyone” or “you must come off because there is risk and people will think I am a bad doctor for prescribing them to you” can be done by a robot.

So, yes, I think the pendulum has swung a bit too far; there is a place for these medications in acute treatment for those at low risk of addiction, and there are people who benefit from them over the long run. At times, they provide immense relief to someone who is really struggling.

So what was the result of my Twitter poll? Of the 219 voters, 34.2% voted: “No, the pendulum has not swung too far, and these medications are harmful”; 65.8% voted: “Yes, these medications are helpful.” There were many comments expressing a wide variety of sentiments. Of those who had taken prescription benzodiazepines, some felt they had been harmed and wished they had never been started on them, and others continue to find them helpful. Psychiatrists, it seems, see them from the vantage point of the populations they treat.

People who are uncomfortable search for answers, and those answers may come in the form of meditation or exercise, medicines, or illicit drugs. It’s interesting that these same patients can now easily obtain “medical” marijuana, and the Rolling Stones’ “Mother’s Little Helper” is often replaced by a gin and tonic.

Dr. Dinah Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore. Dr. Miller has no conflicts of interest.

When benzodiazepines were first introduced, they were greeted with enthusiasm. Librium came first, in 1960, followed by Valium in 1962, and they were seen as an improvement over barbiturates for the treatment of anxiety, insomnia, and seizures. From 1968 to 1982, Valium (diazepam) was the No. 1–selling U.S. pharmaceutical: 2.3 billion tablets of Valium were sold in 1978 alone. Valium was even the subject of a 1966 Rolling Stones hit, “Mother’s Little Helper.”

By the 1980s, it became apparent that there was a downside to these medications: patients became tolerant, dependent, and some became addicted to the medications. In older patients an association was noted with falls and cognitive impairment. And while safe in overdoses when they are the only agent, combined with alcohol or opioids, benzodiazepines can be lethal and have played a significant role in the current overdose crisis.

Dr. Dinah Miller

Because of the problems that are associated with their use, benzodiazepines and their relatives, the Z-drugs used for sleep, have become stigmatized, as have the patients who use them and perhaps even the doctors who prescribe them. Still, there are circumstances where patients find these medications to be helpful, where other medications don’t work, or don’t work quickly enough. They provide fast relief in conditions where there are not always good alternatives.

In the Facebook group, “Psychiatry for All Physicians,” it’s not uncommon for physicians to ask what to do with older patients who are transferred to them on therapeutic doses of benzodiazepines or zolpidem. These are outpatients coming for routine care, and they find the medications helpful and don’t want to discontinue them. They have tried other medications that were not helpful. I’ve been surprised at how often the respondents insist the patient should be told he must taper off the medication. “Just say no,” is often the advice, and perhaps it’s more about the doctor’s discomfort than it is about the individual patient. For sleep issues, cognitive-behavioral therapy is given as the gold-standard treatment, while in my practice I have found it difficult to motivate patients to engage in it, and of those who do, it is sometimes helpful, but not a panacea. Severe anxiety and sleepless nights, however, are not benign conditions.

This “just say no, hold the line” sentiment has me wondering if our pendulum has swung too far with respect to prescribing benzodiazepines. Is this just one more issue that has become strongly polarized? Certainly the literature would support that idea, with some physicians writing about how benzodiazepines are underused, and others urging avoidance.

I posted a poll on Twitter: Has the anti-benzo movement gone too far? In addition, I started a Twitter thread of my own thoughts about prescribing and deprescribing these medications and will give a synopsis of those ideas here.

Clearly, benzodiazepines are harmful to some patients, they have side effects, can be difficult to stop because of withdrawal symptoms, and they carry the risk of addiction. That’s not in question. Many medications, however, have the potential to do more harm than good, for example ibuprofen can cause bleeding or renal problems, and Fosamax, used to treat osteoporosis, can cause osteonecrosis of the jaw and femur, to name just two.

It would be so much easier if we could know in advance who benzodiazepines will harm, just as it would be good if we could know in advance who will get tardive dyskinesia or dyslipidemia from antipsychotic medications, or who will have life-threatening adverse reactions from cancer chemotherapy with no tumor response. There are risks to both starting and stopping sedatives, and if we insist a patient stop a medication because of potential risk, then we are cutting them off from being a partner in their own care. It also creates an adversarial relationship that can be draining for the doctor and upsetting for the patient.

By definition, if someone needs hospitalization for a psychiatric condition, their outpatient benzodiazepine is not keeping them stable and stopping it may be a good idea. If someone is seen in an ED for a fall, it’s common to blame the benzodiazepine, but older people who are not on these medications also fall and have memory problems. In his book, “Being Mortal: Illness, Medicine, and What Matters Most in the End” (New York: Picador, 2014), Atul Gawande, MD, makes the point that taking more than four prescriptions medications increases the risk for falls in the elderly. Still, no one is suggesting patients be taken off their antidepressants, antihypertensives, or blood thinners.

Finally, the question is not should we be giving benzodiazepines out without careful consideration – the answer is clearly no. Physicians don’t pass out benzodiazepines “like candy” for all the above reasons. They are initiated because the patient is suffering and sometimes desperate. Anxiety, panic, intractable insomnia, and severe agitation are all miserable, and alternative treatments may take weeks to work, or not work at all. Yet these subjective symptoms may be dismissed by physicians.

So what do I do in my own practice? I don’t encourage patients to take potentially addictive medications, but I do sometimes use them. I give ‘as needed’ benzodiazepines to people in distress who don’t have a history of misusing them. I never plan to start them as a permanent standing medication, though once in a while that ends up happening. As with other medications, it is best to use the minimally effective dose.

There is some controversy as to whether it is best to use anxiety medications on an “as-needed” basis or as a standing dosage. Psychiatrists who prescribe benzodiazepines more liberally often feel it’s better to give standing doses and prevent breakthrough anxiety. Patients may appear to be ‘medication seeking’ not because they are addicted, but because the doses used are too low to adequately treat their anxiety.

My hope is that there is less risk of tolerance, dependence, or addiction with less-frequent dosing, and I prescribe as-needed benzodiazepines for panic attacks, agitated major depression while we wait for the antidepressant to “kick in,” insomnia during manic episodes, and to people who get very anxious in specific situations such as flying or for medical procedures. I sometimes prescribe them for people with insomnia that does not respond to other treatments, or for disabling generalized anxiety.

For patients who have taken benzodiazepines for many years, I continue to discuss the risks, but often they are not looking to fix something that isn’t broken, or to live a risk-free life. A few of the patients who have come to me on low standing doses of sedatives are now in their 80’s, yet they remain active, live independently, drive, travel, and have busy social lives. One could argue either that the medications are working, or that the patient has become dependent on them and needs them to prevent withdrawal.

These medications present a quandary: by denying patients treatment with benzodiazepines, we are sparing some people addictions (this is good, we should be careful), but we are leaving some people to suffer. There is no perfect answer.

What I do know is that doctors should think carefully and consider the patient in front of them. “No Benzos Ever For Anyone” or “you must come off because there is risk and people will think I am a bad doctor for prescribing them to you” can be done by a robot.

So, yes, I think the pendulum has swung a bit too far; there is a place for these medications in acute treatment for those at low risk of addiction, and there are people who benefit from them over the long run. At times, they provide immense relief to someone who is really struggling.

So what was the result of my Twitter poll? Of the 219 voters, 34.2% voted: “No, the pendulum has not swung too far, and these medications are harmful”; 65.8% voted: “Yes, these medications are helpful.” There were many comments expressing a wide variety of sentiments. Of those who had taken prescription benzodiazepines, some felt they had been harmed and wished they had never been started on them, and others continue to find them helpful. Psychiatrists, it seems, see them from the vantage point of the populations they treat.

People who are uncomfortable search for answers, and those answers may come in the form of meditation or exercise, medicines, or illicit drugs. It’s interesting that these same patients can now easily obtain “medical” marijuana, and the Rolling Stones’ “Mother’s Little Helper” is often replaced by a gin and tonic.

Dr. Dinah Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore. Dr. Miller has no conflicts of interest.

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Contraception for women taking enzyme-inducing antiepileptics

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Topiramate, introduced as an antiepileptic drug (AED), is currently most widely used for prevention of migraine headaches.

Because reproductive-aged women represent a population in which migraines are prevalent, clinicians need guidance to help women taking topiramate make sound contraceptive choices.

Several issues are relevant here. First, women who have migraines with aura should avoid estrogen-containing contraceptive pills, patches, and rings. Instead, progestin-only methods, including the contraceptive implant, may be recommended to patients with migraines.

Second, because topiramate, as with a number of other AEDs, is a teratogen, women using this medication need highly effective contraception. This consideration may also lead clinicians to recommend use of the implant in women with migraines.

Finally, topiramate, along with other AEDs (phenytoin, carbamazepine, barbiturates, primidone, and oxcarbazepine) induces hepatic enzymes, which results in reduced serum contraceptive steroid levels.

Because there is uncertainty regarding the degree to which the use of topiramate reduces serum levels of etonogestrel (the progestin released by the implant), investigators performed a prospective study to assess the pharmacokinetic impact of topiramate in women with the implant.

Ongoing users of contraceptive implants who agreed to use additional nonhormonal contraception were recruited to a 6-week study, during which they took topiramate and periodically had blood drawn.

Overall, use of topiramate was found to lower serum etonogestrel levels from baseline on a dose-related basis. At study completion, almost one-third of study participants were found to have serum progestin levels lower than the threshold associated with predictable ovulation suppression.

The results of this carefully conducted study support guidance from the Centers for Disease Control and Prevention that women seeking contraception and using topiramate or other enzyme-inducing AEDs should be encouraged to use intrauterine devices or injectable contraception. The contraceptive efficacy of these latter methods is not diminished by concomitant use of enzyme inducers.

I am Andrew Kaunitz. Please take care of yourself and each other.

Any views expressed above are the author’s own and do not necessarily reflect the views of WebMD or Medscape.

Andrew M. Kaunitz is a professor and Associate Chairman, department of obstetrics and gynecology, University of Florida, Jacksonville.

A version of this article first appeared on Medscape.com.

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Topiramate, introduced as an antiepileptic drug (AED), is currently most widely used for prevention of migraine headaches.

Because reproductive-aged women represent a population in which migraines are prevalent, clinicians need guidance to help women taking topiramate make sound contraceptive choices.

Several issues are relevant here. First, women who have migraines with aura should avoid estrogen-containing contraceptive pills, patches, and rings. Instead, progestin-only methods, including the contraceptive implant, may be recommended to patients with migraines.

Second, because topiramate, as with a number of other AEDs, is a teratogen, women using this medication need highly effective contraception. This consideration may also lead clinicians to recommend use of the implant in women with migraines.

Finally, topiramate, along with other AEDs (phenytoin, carbamazepine, barbiturates, primidone, and oxcarbazepine) induces hepatic enzymes, which results in reduced serum contraceptive steroid levels.

Because there is uncertainty regarding the degree to which the use of topiramate reduces serum levels of etonogestrel (the progestin released by the implant), investigators performed a prospective study to assess the pharmacokinetic impact of topiramate in women with the implant.

Ongoing users of contraceptive implants who agreed to use additional nonhormonal contraception were recruited to a 6-week study, during which they took topiramate and periodically had blood drawn.

Overall, use of topiramate was found to lower serum etonogestrel levels from baseline on a dose-related basis. At study completion, almost one-third of study participants were found to have serum progestin levels lower than the threshold associated with predictable ovulation suppression.

The results of this carefully conducted study support guidance from the Centers for Disease Control and Prevention that women seeking contraception and using topiramate or other enzyme-inducing AEDs should be encouraged to use intrauterine devices or injectable contraception. The contraceptive efficacy of these latter methods is not diminished by concomitant use of enzyme inducers.

I am Andrew Kaunitz. Please take care of yourself and each other.

Any views expressed above are the author’s own and do not necessarily reflect the views of WebMD or Medscape.

Andrew M. Kaunitz is a professor and Associate Chairman, department of obstetrics and gynecology, University of Florida, Jacksonville.

A version of this article first appeared on Medscape.com.

Topiramate, introduced as an antiepileptic drug (AED), is currently most widely used for prevention of migraine headaches.

Because reproductive-aged women represent a population in which migraines are prevalent, clinicians need guidance to help women taking topiramate make sound contraceptive choices.

Several issues are relevant here. First, women who have migraines with aura should avoid estrogen-containing contraceptive pills, patches, and rings. Instead, progestin-only methods, including the contraceptive implant, may be recommended to patients with migraines.

Second, because topiramate, as with a number of other AEDs, is a teratogen, women using this medication need highly effective contraception. This consideration may also lead clinicians to recommend use of the implant in women with migraines.

Finally, topiramate, along with other AEDs (phenytoin, carbamazepine, barbiturates, primidone, and oxcarbazepine) induces hepatic enzymes, which results in reduced serum contraceptive steroid levels.

Because there is uncertainty regarding the degree to which the use of topiramate reduces serum levels of etonogestrel (the progestin released by the implant), investigators performed a prospective study to assess the pharmacokinetic impact of topiramate in women with the implant.

Ongoing users of contraceptive implants who agreed to use additional nonhormonal contraception were recruited to a 6-week study, during which they took topiramate and periodically had blood drawn.

Overall, use of topiramate was found to lower serum etonogestrel levels from baseline on a dose-related basis. At study completion, almost one-third of study participants were found to have serum progestin levels lower than the threshold associated with predictable ovulation suppression.

The results of this carefully conducted study support guidance from the Centers for Disease Control and Prevention that women seeking contraception and using topiramate or other enzyme-inducing AEDs should be encouraged to use intrauterine devices or injectable contraception. The contraceptive efficacy of these latter methods is not diminished by concomitant use of enzyme inducers.

I am Andrew Kaunitz. Please take care of yourself and each other.

Any views expressed above are the author’s own and do not necessarily reflect the views of WebMD or Medscape.

Andrew M. Kaunitz is a professor and Associate Chairman, department of obstetrics and gynecology, University of Florida, Jacksonville.

A version of this article first appeared on Medscape.com.

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What can be new about developmental milestones?

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The American Academy of Pediatrics, with funding from the Centers for Disease Control and Prevention, studied the CDC’s “Learn the Signs. Act Early” developmental surveillance milestones for children 0-5 years to update the milestones based on published studies. The goal was to improve this tool for developmental surveillance and use by the public. Developmental surveillance is not just observing a child at a check-up but rather “is a longitudinal process that involves eliciting concerns, taking a developmental history based on milestone attainment, observing milestones and other behaviors, examining the child, and applying clinical judgment during health supervision visits (HSVs).”1

While the milestones we were trained on were a good start and highlighted the developmental progression central to pediatrics, they were not based on norms or cut scores indicating significant developmental risk unless taught from a validated tool. The CDC was concerned that their public handouts and apps were based on median ages (middle number of the entire range) of attainment not the mode (most common) or even average ages. That means that about half of all typically developing children would “not have attained” that skill at the age noted, potentially evoking unnecessary concern for parents and a “wait-and-see” message from a knowledgeable provider who realized the statistical meaning and the broad range of normal. Another potential problem with using milestones set at the median age is that parents, especially those with several children or experienced friends, may see the provider as an alarmist when they have seen great variation in children who later were normal. This reaction can dampen provider willingness to discuss development or even to screen with validated tools. We have learned the hard way from COVID-19 that it is difficult to convey concepts of risk effectively both balancing fear and stimulating action.

Dr. Barbara J. Howard

The AAP experts reviewed the English literature for data-based milestones, finding 34 articles, 10 of which had an opinion for at least one milestone. If this sounds like a very small number, you are correct. You may not realize that almost all screening and diagnostic tools have been based on data collected by Gesell in 1928!2 While most of health care has changed since then, which milestones are measured in infants has not.

The biggest change from this review was deciding to use as milestones skills reported for 75% of children at each age of typical HSVs, adding ones for 15 and 30 months. The implication is that children not attaining these milestones are all at risk and deserving of more careful history, examination, and administration of a validated screening tool; not true when based on median data. Of the 94 existing CDC milestones retained after the review, one-third were moved to a different age with 21 of 31 assigned to an older age. Domains of functioning for the milestones were consolidated into social emotional, cognitive, language/communication, and motor, to help parents learn to distinguish these areas, and, although many milestones reflect several domains, each was included only once to reduce confusion.

Psychosocial assessment is recommended by the AAP and Bright Futures at every HSV but the fewest milestones with normative data were identified for this domain, often self-help rather than social engagement or emotion regulation skills. The cross-cultural study cited for many of the new milestones was reassuring overall in that the median ages for 67%-88% of milestones in most domains were equivalent across the four countries sampled, but only 22% of self-help skills were equivalent.3 This should remind us that parenting has more influence over psychosocial skills than other domains. Psychosocial and behavioral functioning, especially emotional regulation, also deserve “surveillance” as they have enormous impact on life outcomes but need to be measured and supported differently. Routine use of validated tools such as the Early Childhood Screening Assessment or the Ages & Stages Questionnaires: Social-Emotional for these domains are also needed.

Normal variations in temperament and patterns of attachment can affect many milestones including courage for walking, exploration, social engagement, and prosocial behaviors or self-control for social situations, attention, range of affect, and cooperation. All of these skills are among the 42 total (14 new) social-emotional milestones for 0- to 5-year-olds. Variations in these functions are at the root of the most common “challenging behaviors” in our studies in primary care. They are also the most vulnerable to suboptimal parent-child relationships, adverse childhood experiences, and social determinants of health.

As primary care providers, we not only need to detect children at risk for developmental problems but also promote and celebrate developmental progress. I hope that changing the threshold for concern to 75% will allow for a more positive review with the family (as fewer will be flagged as at risk) and chance to congratulate parents on all that is going well. But I also hope the change will not make us overlook parenting challenges, often from the psychosocial milestones most amenable to our guidance and support.

Early identification is mainly important to obtain the early intervention shown to improve outcomes. However, less than 25% of children with delays or disabilities receive early intervention before age 3 and most with emotional, behavioral, and developmental conditions, other than autism spectrum disorder, not before age 5. Since early intervention services are freely available in all states, we also need to do better at getting children to this care.

Let’s reconsider the process of developmental surveillance in this light of delayed referral: “Eliciting concerns” is key as parents have been shown to be usually correct in their worries. Listening to how they express the concerns can help you connect their specific issues when discussing reasons for referral. While most parent “recall of past milestones” is not accurate, current milestones reported are; thus, the need to have the new more accurate norms for all ages for comparison. When we make observations of a child’s abilities and behaviors ourselves we may not only pick up on issues missed by the parent, but will be more convincing in conveying the need for referral when indicated. When we “examine” the child we can use our professional skills to determine the very important risk factor of the quality of how a skill is performed, not just that it is. The recommended “use of validated screening tools” when the new milestones are not met give us an objective tool to share with parents, more confidence in when referral is warranted, which we will convey to parents (and perhaps skeptical relatives), and baseline documentation from which we can “track” referrals, progress, and, hopefully, better outcomes.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. Email her at pdnews@mdedge.com.

References

1. Zubler JM et al. Pediatrics. 2022;149(3):e2021052138.

2. Gessell A et al. Macmillan: New York, 1928.

3. Ertem IO et al. Lancet Glob Health. 2018 Mar;6(3):e279-91.

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The American Academy of Pediatrics, with funding from the Centers for Disease Control and Prevention, studied the CDC’s “Learn the Signs. Act Early” developmental surveillance milestones for children 0-5 years to update the milestones based on published studies. The goal was to improve this tool for developmental surveillance and use by the public. Developmental surveillance is not just observing a child at a check-up but rather “is a longitudinal process that involves eliciting concerns, taking a developmental history based on milestone attainment, observing milestones and other behaviors, examining the child, and applying clinical judgment during health supervision visits (HSVs).”1

While the milestones we were trained on were a good start and highlighted the developmental progression central to pediatrics, they were not based on norms or cut scores indicating significant developmental risk unless taught from a validated tool. The CDC was concerned that their public handouts and apps were based on median ages (middle number of the entire range) of attainment not the mode (most common) or even average ages. That means that about half of all typically developing children would “not have attained” that skill at the age noted, potentially evoking unnecessary concern for parents and a “wait-and-see” message from a knowledgeable provider who realized the statistical meaning and the broad range of normal. Another potential problem with using milestones set at the median age is that parents, especially those with several children or experienced friends, may see the provider as an alarmist when they have seen great variation in children who later were normal. This reaction can dampen provider willingness to discuss development or even to screen with validated tools. We have learned the hard way from COVID-19 that it is difficult to convey concepts of risk effectively both balancing fear and stimulating action.

Dr. Barbara J. Howard

The AAP experts reviewed the English literature for data-based milestones, finding 34 articles, 10 of which had an opinion for at least one milestone. If this sounds like a very small number, you are correct. You may not realize that almost all screening and diagnostic tools have been based on data collected by Gesell in 1928!2 While most of health care has changed since then, which milestones are measured in infants has not.

The biggest change from this review was deciding to use as milestones skills reported for 75% of children at each age of typical HSVs, adding ones for 15 and 30 months. The implication is that children not attaining these milestones are all at risk and deserving of more careful history, examination, and administration of a validated screening tool; not true when based on median data. Of the 94 existing CDC milestones retained after the review, one-third were moved to a different age with 21 of 31 assigned to an older age. Domains of functioning for the milestones were consolidated into social emotional, cognitive, language/communication, and motor, to help parents learn to distinguish these areas, and, although many milestones reflect several domains, each was included only once to reduce confusion.

Psychosocial assessment is recommended by the AAP and Bright Futures at every HSV but the fewest milestones with normative data were identified for this domain, often self-help rather than social engagement or emotion regulation skills. The cross-cultural study cited for many of the new milestones was reassuring overall in that the median ages for 67%-88% of milestones in most domains were equivalent across the four countries sampled, but only 22% of self-help skills were equivalent.3 This should remind us that parenting has more influence over psychosocial skills than other domains. Psychosocial and behavioral functioning, especially emotional regulation, also deserve “surveillance” as they have enormous impact on life outcomes but need to be measured and supported differently. Routine use of validated tools such as the Early Childhood Screening Assessment or the Ages & Stages Questionnaires: Social-Emotional for these domains are also needed.

Normal variations in temperament and patterns of attachment can affect many milestones including courage for walking, exploration, social engagement, and prosocial behaviors or self-control for social situations, attention, range of affect, and cooperation. All of these skills are among the 42 total (14 new) social-emotional milestones for 0- to 5-year-olds. Variations in these functions are at the root of the most common “challenging behaviors” in our studies in primary care. They are also the most vulnerable to suboptimal parent-child relationships, adverse childhood experiences, and social determinants of health.

As primary care providers, we not only need to detect children at risk for developmental problems but also promote and celebrate developmental progress. I hope that changing the threshold for concern to 75% will allow for a more positive review with the family (as fewer will be flagged as at risk) and chance to congratulate parents on all that is going well. But I also hope the change will not make us overlook parenting challenges, often from the psychosocial milestones most amenable to our guidance and support.

Early identification is mainly important to obtain the early intervention shown to improve outcomes. However, less than 25% of children with delays or disabilities receive early intervention before age 3 and most with emotional, behavioral, and developmental conditions, other than autism spectrum disorder, not before age 5. Since early intervention services are freely available in all states, we also need to do better at getting children to this care.

Let’s reconsider the process of developmental surveillance in this light of delayed referral: “Eliciting concerns” is key as parents have been shown to be usually correct in their worries. Listening to how they express the concerns can help you connect their specific issues when discussing reasons for referral. While most parent “recall of past milestones” is not accurate, current milestones reported are; thus, the need to have the new more accurate norms for all ages for comparison. When we make observations of a child’s abilities and behaviors ourselves we may not only pick up on issues missed by the parent, but will be more convincing in conveying the need for referral when indicated. When we “examine” the child we can use our professional skills to determine the very important risk factor of the quality of how a skill is performed, not just that it is. The recommended “use of validated screening tools” when the new milestones are not met give us an objective tool to share with parents, more confidence in when referral is warranted, which we will convey to parents (and perhaps skeptical relatives), and baseline documentation from which we can “track” referrals, progress, and, hopefully, better outcomes.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. Email her at pdnews@mdedge.com.

References

1. Zubler JM et al. Pediatrics. 2022;149(3):e2021052138.

2. Gessell A et al. Macmillan: New York, 1928.

3. Ertem IO et al. Lancet Glob Health. 2018 Mar;6(3):e279-91.

The American Academy of Pediatrics, with funding from the Centers for Disease Control and Prevention, studied the CDC’s “Learn the Signs. Act Early” developmental surveillance milestones for children 0-5 years to update the milestones based on published studies. The goal was to improve this tool for developmental surveillance and use by the public. Developmental surveillance is not just observing a child at a check-up but rather “is a longitudinal process that involves eliciting concerns, taking a developmental history based on milestone attainment, observing milestones and other behaviors, examining the child, and applying clinical judgment during health supervision visits (HSVs).”1

While the milestones we were trained on were a good start and highlighted the developmental progression central to pediatrics, they were not based on norms or cut scores indicating significant developmental risk unless taught from a validated tool. The CDC was concerned that their public handouts and apps were based on median ages (middle number of the entire range) of attainment not the mode (most common) or even average ages. That means that about half of all typically developing children would “not have attained” that skill at the age noted, potentially evoking unnecessary concern for parents and a “wait-and-see” message from a knowledgeable provider who realized the statistical meaning and the broad range of normal. Another potential problem with using milestones set at the median age is that parents, especially those with several children or experienced friends, may see the provider as an alarmist when they have seen great variation in children who later were normal. This reaction can dampen provider willingness to discuss development or even to screen with validated tools. We have learned the hard way from COVID-19 that it is difficult to convey concepts of risk effectively both balancing fear and stimulating action.

Dr. Barbara J. Howard

The AAP experts reviewed the English literature for data-based milestones, finding 34 articles, 10 of which had an opinion for at least one milestone. If this sounds like a very small number, you are correct. You may not realize that almost all screening and diagnostic tools have been based on data collected by Gesell in 1928!2 While most of health care has changed since then, which milestones are measured in infants has not.

The biggest change from this review was deciding to use as milestones skills reported for 75% of children at each age of typical HSVs, adding ones for 15 and 30 months. The implication is that children not attaining these milestones are all at risk and deserving of more careful history, examination, and administration of a validated screening tool; not true when based on median data. Of the 94 existing CDC milestones retained after the review, one-third were moved to a different age with 21 of 31 assigned to an older age. Domains of functioning for the milestones were consolidated into social emotional, cognitive, language/communication, and motor, to help parents learn to distinguish these areas, and, although many milestones reflect several domains, each was included only once to reduce confusion.

Psychosocial assessment is recommended by the AAP and Bright Futures at every HSV but the fewest milestones with normative data were identified for this domain, often self-help rather than social engagement or emotion regulation skills. The cross-cultural study cited for many of the new milestones was reassuring overall in that the median ages for 67%-88% of milestones in most domains were equivalent across the four countries sampled, but only 22% of self-help skills were equivalent.3 This should remind us that parenting has more influence over psychosocial skills than other domains. Psychosocial and behavioral functioning, especially emotional regulation, also deserve “surveillance” as they have enormous impact on life outcomes but need to be measured and supported differently. Routine use of validated tools such as the Early Childhood Screening Assessment or the Ages & Stages Questionnaires: Social-Emotional for these domains are also needed.

Normal variations in temperament and patterns of attachment can affect many milestones including courage for walking, exploration, social engagement, and prosocial behaviors or self-control for social situations, attention, range of affect, and cooperation. All of these skills are among the 42 total (14 new) social-emotional milestones for 0- to 5-year-olds. Variations in these functions are at the root of the most common “challenging behaviors” in our studies in primary care. They are also the most vulnerable to suboptimal parent-child relationships, adverse childhood experiences, and social determinants of health.

As primary care providers, we not only need to detect children at risk for developmental problems but also promote and celebrate developmental progress. I hope that changing the threshold for concern to 75% will allow for a more positive review with the family (as fewer will be flagged as at risk) and chance to congratulate parents on all that is going well. But I also hope the change will not make us overlook parenting challenges, often from the psychosocial milestones most amenable to our guidance and support.

Early identification is mainly important to obtain the early intervention shown to improve outcomes. However, less than 25% of children with delays or disabilities receive early intervention before age 3 and most with emotional, behavioral, and developmental conditions, other than autism spectrum disorder, not before age 5. Since early intervention services are freely available in all states, we also need to do better at getting children to this care.

Let’s reconsider the process of developmental surveillance in this light of delayed referral: “Eliciting concerns” is key as parents have been shown to be usually correct in their worries. Listening to how they express the concerns can help you connect their specific issues when discussing reasons for referral. While most parent “recall of past milestones” is not accurate, current milestones reported are; thus, the need to have the new more accurate norms for all ages for comparison. When we make observations of a child’s abilities and behaviors ourselves we may not only pick up on issues missed by the parent, but will be more convincing in conveying the need for referral when indicated. When we “examine” the child we can use our professional skills to determine the very important risk factor of the quality of how a skill is performed, not just that it is. The recommended “use of validated screening tools” when the new milestones are not met give us an objective tool to share with parents, more confidence in when referral is warranted, which we will convey to parents (and perhaps skeptical relatives), and baseline documentation from which we can “track” referrals, progress, and, hopefully, better outcomes.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. Email her at pdnews@mdedge.com.

References

1. Zubler JM et al. Pediatrics. 2022;149(3):e2021052138.

2. Gessell A et al. Macmillan: New York, 1928.

3. Ertem IO et al. Lancet Glob Health. 2018 Mar;6(3):e279-91.

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The power of the pause to prevent diagnostic error

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None of us like being wrong, especially about a patient’s diagnosis. To help you avoid diagnostic errors for 4 difficult diagnoses, read and study the article in this issue of JFP by Rosen and colleagues.1 They discuss misdiagnosis of polymyalgia rheumatica, fibromyalgia, ovarian cancer, and Lewy body dementia to illustrate how we can go astray if we do not take care to pause and think through things carefully. They point out that, for quick and mostly accurate diagnoses, pattern recognition or type 1 thinking serves us well in a busy office practice. However, we must frequently pause and reflect, using type 2 thinking—especially when the puzzle pieces don’t quite fit together.

I still recall vividly a diagnostic error I made many years ago. One of my patients, whom I had diagnosed and was treating for hyperlipidemia, returned for follow-up while I was on vacation. My partner conducted the follow-up visit. To my chagrin, he noticed her puffy face and weight gain and ordered thyroid studies. Sure enough, my patient was severely hypothyroid, and her lipid levels normalized with thyroid replacement therapy.

I recall vividly a diagnostic error I made years ago. I was treating a patient for hyperlipidemia but my partner recognized it as a case of severe hypothyroid.

A happier tale for me was making the correct diagnosis for a woman with chronic cough. She had been evaluated by multiple specialists during the prior year and treated with a nasal steroid for allergies, a proton pump inhibitor for reflux, and a steroid inhaler for possible asthma. None of these relieved her cough. After reviewing her medication list and noting that it included amitriptyline, which has anticholinergic adverse effects, I recommended she stop taking that medication and the cough resolved.

 

John Ely, MD, MPH, a family physician who has spent his academic career investigating causes of and solutions to diagnostic errors, has outlined important steps we can take. These include: (1) obtaining your own complete medical history, (2) performing a “focused and purposeful” physical exam, (3) generating initial hypotheses and differentiating them through additional history taking, exams, and diagnostic tests, (4) pausing to reflect [my emphasis], and (5) embarking on a plan (while acknowledging uncertainty) and ensuring there is a pathway for follow-up.2

To help avoid diagnostic errors, Dr. Ely developed and uses a set of checklists that cover the differential diagnosis for 72 presenting complaints/conditions, including syncope, back pain, insomnia, and headache.2 When you are faced with diagnostic uncertainty, it takes just a few minutes to run through the checklist for the patient’s presenting complaint.

References

1. Rosen PD, Klenzak S, Baptista S. Diagnostic challenges in primary care: identifying and avoiding cognitive bias. J Fam Pract. 2022;71:124-132.

2. Ely JW, Graber ML, Croskerry P. Checklists to reduce diagnostic errors. Acad Med. 2011;86:307-313. doi: 10.1097/ACM.0b013e31820824cd

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None of us like being wrong, especially about a patient’s diagnosis. To help you avoid diagnostic errors for 4 difficult diagnoses, read and study the article in this issue of JFP by Rosen and colleagues.1 They discuss misdiagnosis of polymyalgia rheumatica, fibromyalgia, ovarian cancer, and Lewy body dementia to illustrate how we can go astray if we do not take care to pause and think through things carefully. They point out that, for quick and mostly accurate diagnoses, pattern recognition or type 1 thinking serves us well in a busy office practice. However, we must frequently pause and reflect, using type 2 thinking—especially when the puzzle pieces don’t quite fit together.

I still recall vividly a diagnostic error I made many years ago. One of my patients, whom I had diagnosed and was treating for hyperlipidemia, returned for follow-up while I was on vacation. My partner conducted the follow-up visit. To my chagrin, he noticed her puffy face and weight gain and ordered thyroid studies. Sure enough, my patient was severely hypothyroid, and her lipid levels normalized with thyroid replacement therapy.

I recall vividly a diagnostic error I made years ago. I was treating a patient for hyperlipidemia but my partner recognized it as a case of severe hypothyroid.

A happier tale for me was making the correct diagnosis for a woman with chronic cough. She had been evaluated by multiple specialists during the prior year and treated with a nasal steroid for allergies, a proton pump inhibitor for reflux, and a steroid inhaler for possible asthma. None of these relieved her cough. After reviewing her medication list and noting that it included amitriptyline, which has anticholinergic adverse effects, I recommended she stop taking that medication and the cough resolved.

 

John Ely, MD, MPH, a family physician who has spent his academic career investigating causes of and solutions to diagnostic errors, has outlined important steps we can take. These include: (1) obtaining your own complete medical history, (2) performing a “focused and purposeful” physical exam, (3) generating initial hypotheses and differentiating them through additional history taking, exams, and diagnostic tests, (4) pausing to reflect [my emphasis], and (5) embarking on a plan (while acknowledging uncertainty) and ensuring there is a pathway for follow-up.2

To help avoid diagnostic errors, Dr. Ely developed and uses a set of checklists that cover the differential diagnosis for 72 presenting complaints/conditions, including syncope, back pain, insomnia, and headache.2 When you are faced with diagnostic uncertainty, it takes just a few minutes to run through the checklist for the patient’s presenting complaint.

None of us like being wrong, especially about a patient’s diagnosis. To help you avoid diagnostic errors for 4 difficult diagnoses, read and study the article in this issue of JFP by Rosen and colleagues.1 They discuss misdiagnosis of polymyalgia rheumatica, fibromyalgia, ovarian cancer, and Lewy body dementia to illustrate how we can go astray if we do not take care to pause and think through things carefully. They point out that, for quick and mostly accurate diagnoses, pattern recognition or type 1 thinking serves us well in a busy office practice. However, we must frequently pause and reflect, using type 2 thinking—especially when the puzzle pieces don’t quite fit together.

I still recall vividly a diagnostic error I made many years ago. One of my patients, whom I had diagnosed and was treating for hyperlipidemia, returned for follow-up while I was on vacation. My partner conducted the follow-up visit. To my chagrin, he noticed her puffy face and weight gain and ordered thyroid studies. Sure enough, my patient was severely hypothyroid, and her lipid levels normalized with thyroid replacement therapy.

I recall vividly a diagnostic error I made years ago. I was treating a patient for hyperlipidemia but my partner recognized it as a case of severe hypothyroid.

A happier tale for me was making the correct diagnosis for a woman with chronic cough. She had been evaluated by multiple specialists during the prior year and treated with a nasal steroid for allergies, a proton pump inhibitor for reflux, and a steroid inhaler for possible asthma. None of these relieved her cough. After reviewing her medication list and noting that it included amitriptyline, which has anticholinergic adverse effects, I recommended she stop taking that medication and the cough resolved.

 

John Ely, MD, MPH, a family physician who has spent his academic career investigating causes of and solutions to diagnostic errors, has outlined important steps we can take. These include: (1) obtaining your own complete medical history, (2) performing a “focused and purposeful” physical exam, (3) generating initial hypotheses and differentiating them through additional history taking, exams, and diagnostic tests, (4) pausing to reflect [my emphasis], and (5) embarking on a plan (while acknowledging uncertainty) and ensuring there is a pathway for follow-up.2

To help avoid diagnostic errors, Dr. Ely developed and uses a set of checklists that cover the differential diagnosis for 72 presenting complaints/conditions, including syncope, back pain, insomnia, and headache.2 When you are faced with diagnostic uncertainty, it takes just a few minutes to run through the checklist for the patient’s presenting complaint.

References

1. Rosen PD, Klenzak S, Baptista S. Diagnostic challenges in primary care: identifying and avoiding cognitive bias. J Fam Pract. 2022;71:124-132.

2. Ely JW, Graber ML, Croskerry P. Checklists to reduce diagnostic errors. Acad Med. 2011;86:307-313. doi: 10.1097/ACM.0b013e31820824cd

References

1. Rosen PD, Klenzak S, Baptista S. Diagnostic challenges in primary care: identifying and avoiding cognitive bias. J Fam Pract. 2022;71:124-132.

2. Ely JW, Graber ML, Croskerry P. Checklists to reduce diagnostic errors. Acad Med. 2011;86:307-313. doi: 10.1097/ACM.0b013e31820824cd

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Transgender youth: Bringing evidence to the political debates

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In 2021, state lawmakers introduced a record number of bills that would affect transgender and gender-diverse people. The vast majority were focused on transgender and gender-diverse youth in particular. We’ve seen bills that would take away gender-affirming medical care for minors, ones that would force trans kids to play on sports teams that don’t match their gender identity, and others that would ban trans kids from public facilities like bathrooms that match their gender identities.

These bills aren’t particularly new, but state lawmakers are putting more energy into them than ever. In response, some public figures have started pushing back. Ariana Grande just pledged to match up to 1.5 million dollars in donations to combat anti–trans youth legislative initiatives. However, doctors have been underrepresented in the political discourse.

Dr. Jack L. Turban

Sadly, much of the discussion in this area has been driven by wild speculation and emotional rhetoric. It’s rare that we see actual data brought to the table. As clinicians and scientists, we have a responsibility to highlight the data relevant to these legislative debates, and to share them with our representatives. I’m going to break down what we know quantitatively about each of these issues, so that you’ll feel empowered to bring that information to these debates. My hope is that we can move toward evidence-based public policy instead of rhetoric-based public policy, so that we can ensure the best health possible for young people around the country.
 

Bathroom bills

Though they’ve been less of a focus recently, politicians for years have argued that trans people should be forced to use bathrooms and other public facilities that match their sex assigned at birth, not their gender identity. Their central argument is that trans-inclusive public facility policies will result in higher rates of assault. Published peer-review data show this isn’t true. A 2019 study in Sexuality Research and Social Policy examined the impacts of trans-inclusive public facility policies and found they resulted in no increase in assaults among the general (mostly cisgender) population. Another 2019 study in Pediatrics found that trans-inclusive facility policies were associated with lower odds of sexual assault victimization against transgender youth. The myth that trans-inclusive public facilities increase assault risk is simply that: a myth. All existing data indicate that trans-inclusive policies will improve public safety.

Sports bills

One of the hottest debates recently involves whether transgender girls should be allowed to participate in girls’ sports teams. Those in favor of these bills argue that transgender girls have an innate biological sports advantage over cisgender girls, and if allowed to compete in girls’ sports leagues, they will dominate the events, and cisgender girls will no longer win sports titles. The bills feed into longstanding assumptions – those who were assigned male at birth are strong, and those who were assigned female at birth are weak.

But evidence doesn’t show that trans women dominate female sports leagues. It turns out, there are shockingly few transgender athletes competing in sports leagues around the United States, and even fewer winning major titles. When the Associated Press conducted an investigation asking lawmakers introducing such sports bills to name trans athletes in their states, most couldn’t point to a single one. After Utah state legislators passed a trans sports ban, Governor Spencer Cox vetoed it, pointing out that, of 75,000 high school kids participating in sports in Utah, there was only a single transgender girl (the state legislature overrode the veto anyway).

California has explicitly protected the rights of trans athletes to compete on sports teams that match their gender identity since 2013. There’s still an underrepresentation of trans athletes in sports participation and titles. This is likely because the deck is stacked against these young people in so many other ways that are unrelated to testosterone levels. Trans youth suffer from high rates of harassment, discrimination, and subsequent anxiety and depression that make it difficult to compete in and excel in sports.
 

Medical bills

State legislators have introduced bills around the country that would criminalize the provision of gender-affirming medical care for transgender youth. Though such bills are opposed by all major medical organizations (including the American Medical Association, the American Academy of Pediatrics, the American Academy of Child & Adolescent Psychiatry, and the American Psychiatric Association), misinformation continues to spread, and in some instances the bills have become law (though none are currently active due to legal challenges).

Clinicians should be aware that there have been sixteen studies to date, each with unique study designs, that have overall linked gender-affirming medical care for transgender youth to better mental health outcomes. While these interventions do (as with all medications) carry some risks (like delayed bone mineralization with pubertal suppression), the risks must be weighed against potential benefits. Unfortunately, these risks and benefits have not been accurately portrayed in state legislative debates. Politicians have spread a great deal of misinformation about gender-affirming medical care for transgender youth, including false assertions that puberty blockers cause infertility and that most transgender adolescents will grow up to identify as cisgender and regret gender-affirming medical interventions.
 

Minority stress

These bills have direct consequences for pediatric patients. For example, trans-inclusive bathroom policies are associated with lower rates of sexual assault. However, there are also important indirect effects to consider. The gender minority stress framework explains the ways in which stigmatizing national discourse drives higher rates of anxiety, depression, and suicidality among transgender youth. Under this model, so-called “distal factors” like the recent conversations at the national level that marginalize trans young people, are expected to drive higher rates of adverse mental health outcomes. As transgender youth hear high-profile politicians argue that they’re dangerous to their peers in bathrooms and on sports teams, it’s difficult to imagine their mental health would not worsen. Over time, such “distal factors” also lead to “proximal factors” like internalized transphobia in which youth begin to believe the negative things that are said about them. These dangerous processes can have dramatic negative impacts on self-esteem and emotional development. There is strong precedence that public policies have strong indirect mental health effects on LGBTQ youth.

We’ve entered a dangerous era in which politicians are legislating medical care and other aspects of public policy with the potential to hurt the mental health of our young patients. It’s imperative that clinicians and scientists contact their legislators to make sure they are voting for public policy based on data and fact, not misinformation and political rhetoric. The health of American children depends on it.

Dr. Turban (twitter.com/jack_turban) is a chief fellow in child and adolescent psychiatry at Stanford (Calif.) University.

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In 2021, state lawmakers introduced a record number of bills that would affect transgender and gender-diverse people. The vast majority were focused on transgender and gender-diverse youth in particular. We’ve seen bills that would take away gender-affirming medical care for minors, ones that would force trans kids to play on sports teams that don’t match their gender identity, and others that would ban trans kids from public facilities like bathrooms that match their gender identities.

These bills aren’t particularly new, but state lawmakers are putting more energy into them than ever. In response, some public figures have started pushing back. Ariana Grande just pledged to match up to 1.5 million dollars in donations to combat anti–trans youth legislative initiatives. However, doctors have been underrepresented in the political discourse.

Dr. Jack L. Turban

Sadly, much of the discussion in this area has been driven by wild speculation and emotional rhetoric. It’s rare that we see actual data brought to the table. As clinicians and scientists, we have a responsibility to highlight the data relevant to these legislative debates, and to share them with our representatives. I’m going to break down what we know quantitatively about each of these issues, so that you’ll feel empowered to bring that information to these debates. My hope is that we can move toward evidence-based public policy instead of rhetoric-based public policy, so that we can ensure the best health possible for young people around the country.
 

Bathroom bills

Though they’ve been less of a focus recently, politicians for years have argued that trans people should be forced to use bathrooms and other public facilities that match their sex assigned at birth, not their gender identity. Their central argument is that trans-inclusive public facility policies will result in higher rates of assault. Published peer-review data show this isn’t true. A 2019 study in Sexuality Research and Social Policy examined the impacts of trans-inclusive public facility policies and found they resulted in no increase in assaults among the general (mostly cisgender) population. Another 2019 study in Pediatrics found that trans-inclusive facility policies were associated with lower odds of sexual assault victimization against transgender youth. The myth that trans-inclusive public facilities increase assault risk is simply that: a myth. All existing data indicate that trans-inclusive policies will improve public safety.

Sports bills

One of the hottest debates recently involves whether transgender girls should be allowed to participate in girls’ sports teams. Those in favor of these bills argue that transgender girls have an innate biological sports advantage over cisgender girls, and if allowed to compete in girls’ sports leagues, they will dominate the events, and cisgender girls will no longer win sports titles. The bills feed into longstanding assumptions – those who were assigned male at birth are strong, and those who were assigned female at birth are weak.

But evidence doesn’t show that trans women dominate female sports leagues. It turns out, there are shockingly few transgender athletes competing in sports leagues around the United States, and even fewer winning major titles. When the Associated Press conducted an investigation asking lawmakers introducing such sports bills to name trans athletes in their states, most couldn’t point to a single one. After Utah state legislators passed a trans sports ban, Governor Spencer Cox vetoed it, pointing out that, of 75,000 high school kids participating in sports in Utah, there was only a single transgender girl (the state legislature overrode the veto anyway).

California has explicitly protected the rights of trans athletes to compete on sports teams that match their gender identity since 2013. There’s still an underrepresentation of trans athletes in sports participation and titles. This is likely because the deck is stacked against these young people in so many other ways that are unrelated to testosterone levels. Trans youth suffer from high rates of harassment, discrimination, and subsequent anxiety and depression that make it difficult to compete in and excel in sports.
 

Medical bills

State legislators have introduced bills around the country that would criminalize the provision of gender-affirming medical care for transgender youth. Though such bills are opposed by all major medical organizations (including the American Medical Association, the American Academy of Pediatrics, the American Academy of Child & Adolescent Psychiatry, and the American Psychiatric Association), misinformation continues to spread, and in some instances the bills have become law (though none are currently active due to legal challenges).

Clinicians should be aware that there have been sixteen studies to date, each with unique study designs, that have overall linked gender-affirming medical care for transgender youth to better mental health outcomes. While these interventions do (as with all medications) carry some risks (like delayed bone mineralization with pubertal suppression), the risks must be weighed against potential benefits. Unfortunately, these risks and benefits have not been accurately portrayed in state legislative debates. Politicians have spread a great deal of misinformation about gender-affirming medical care for transgender youth, including false assertions that puberty blockers cause infertility and that most transgender adolescents will grow up to identify as cisgender and regret gender-affirming medical interventions.
 

Minority stress

These bills have direct consequences for pediatric patients. For example, trans-inclusive bathroom policies are associated with lower rates of sexual assault. However, there are also important indirect effects to consider. The gender minority stress framework explains the ways in which stigmatizing national discourse drives higher rates of anxiety, depression, and suicidality among transgender youth. Under this model, so-called “distal factors” like the recent conversations at the national level that marginalize trans young people, are expected to drive higher rates of adverse mental health outcomes. As transgender youth hear high-profile politicians argue that they’re dangerous to their peers in bathrooms and on sports teams, it’s difficult to imagine their mental health would not worsen. Over time, such “distal factors” also lead to “proximal factors” like internalized transphobia in which youth begin to believe the negative things that are said about them. These dangerous processes can have dramatic negative impacts on self-esteem and emotional development. There is strong precedence that public policies have strong indirect mental health effects on LGBTQ youth.

We’ve entered a dangerous era in which politicians are legislating medical care and other aspects of public policy with the potential to hurt the mental health of our young patients. It’s imperative that clinicians and scientists contact their legislators to make sure they are voting for public policy based on data and fact, not misinformation and political rhetoric. The health of American children depends on it.

Dr. Turban (twitter.com/jack_turban) is a chief fellow in child and adolescent psychiatry at Stanford (Calif.) University.

 

In 2021, state lawmakers introduced a record number of bills that would affect transgender and gender-diverse people. The vast majority were focused on transgender and gender-diverse youth in particular. We’ve seen bills that would take away gender-affirming medical care for minors, ones that would force trans kids to play on sports teams that don’t match their gender identity, and others that would ban trans kids from public facilities like bathrooms that match their gender identities.

These bills aren’t particularly new, but state lawmakers are putting more energy into them than ever. In response, some public figures have started pushing back. Ariana Grande just pledged to match up to 1.5 million dollars in donations to combat anti–trans youth legislative initiatives. However, doctors have been underrepresented in the political discourse.

Dr. Jack L. Turban

Sadly, much of the discussion in this area has been driven by wild speculation and emotional rhetoric. It’s rare that we see actual data brought to the table. As clinicians and scientists, we have a responsibility to highlight the data relevant to these legislative debates, and to share them with our representatives. I’m going to break down what we know quantitatively about each of these issues, so that you’ll feel empowered to bring that information to these debates. My hope is that we can move toward evidence-based public policy instead of rhetoric-based public policy, so that we can ensure the best health possible for young people around the country.
 

Bathroom bills

Though they’ve been less of a focus recently, politicians for years have argued that trans people should be forced to use bathrooms and other public facilities that match their sex assigned at birth, not their gender identity. Their central argument is that trans-inclusive public facility policies will result in higher rates of assault. Published peer-review data show this isn’t true. A 2019 study in Sexuality Research and Social Policy examined the impacts of trans-inclusive public facility policies and found they resulted in no increase in assaults among the general (mostly cisgender) population. Another 2019 study in Pediatrics found that trans-inclusive facility policies were associated with lower odds of sexual assault victimization against transgender youth. The myth that trans-inclusive public facilities increase assault risk is simply that: a myth. All existing data indicate that trans-inclusive policies will improve public safety.

Sports bills

One of the hottest debates recently involves whether transgender girls should be allowed to participate in girls’ sports teams. Those in favor of these bills argue that transgender girls have an innate biological sports advantage over cisgender girls, and if allowed to compete in girls’ sports leagues, they will dominate the events, and cisgender girls will no longer win sports titles. The bills feed into longstanding assumptions – those who were assigned male at birth are strong, and those who were assigned female at birth are weak.

But evidence doesn’t show that trans women dominate female sports leagues. It turns out, there are shockingly few transgender athletes competing in sports leagues around the United States, and even fewer winning major titles. When the Associated Press conducted an investigation asking lawmakers introducing such sports bills to name trans athletes in their states, most couldn’t point to a single one. After Utah state legislators passed a trans sports ban, Governor Spencer Cox vetoed it, pointing out that, of 75,000 high school kids participating in sports in Utah, there was only a single transgender girl (the state legislature overrode the veto anyway).

California has explicitly protected the rights of trans athletes to compete on sports teams that match their gender identity since 2013. There’s still an underrepresentation of trans athletes in sports participation and titles. This is likely because the deck is stacked against these young people in so many other ways that are unrelated to testosterone levels. Trans youth suffer from high rates of harassment, discrimination, and subsequent anxiety and depression that make it difficult to compete in and excel in sports.
 

Medical bills

State legislators have introduced bills around the country that would criminalize the provision of gender-affirming medical care for transgender youth. Though such bills are opposed by all major medical organizations (including the American Medical Association, the American Academy of Pediatrics, the American Academy of Child & Adolescent Psychiatry, and the American Psychiatric Association), misinformation continues to spread, and in some instances the bills have become law (though none are currently active due to legal challenges).

Clinicians should be aware that there have been sixteen studies to date, each with unique study designs, that have overall linked gender-affirming medical care for transgender youth to better mental health outcomes. While these interventions do (as with all medications) carry some risks (like delayed bone mineralization with pubertal suppression), the risks must be weighed against potential benefits. Unfortunately, these risks and benefits have not been accurately portrayed in state legislative debates. Politicians have spread a great deal of misinformation about gender-affirming medical care for transgender youth, including false assertions that puberty blockers cause infertility and that most transgender adolescents will grow up to identify as cisgender and regret gender-affirming medical interventions.
 

Minority stress

These bills have direct consequences for pediatric patients. For example, trans-inclusive bathroom policies are associated with lower rates of sexual assault. However, there are also important indirect effects to consider. The gender minority stress framework explains the ways in which stigmatizing national discourse drives higher rates of anxiety, depression, and suicidality among transgender youth. Under this model, so-called “distal factors” like the recent conversations at the national level that marginalize trans young people, are expected to drive higher rates of adverse mental health outcomes. As transgender youth hear high-profile politicians argue that they’re dangerous to their peers in bathrooms and on sports teams, it’s difficult to imagine their mental health would not worsen. Over time, such “distal factors” also lead to “proximal factors” like internalized transphobia in which youth begin to believe the negative things that are said about them. These dangerous processes can have dramatic negative impacts on self-esteem and emotional development. There is strong precedence that public policies have strong indirect mental health effects on LGBTQ youth.

We’ve entered a dangerous era in which politicians are legislating medical care and other aspects of public policy with the potential to hurt the mental health of our young patients. It’s imperative that clinicians and scientists contact their legislators to make sure they are voting for public policy based on data and fact, not misinformation and political rhetoric. The health of American children depends on it.

Dr. Turban (twitter.com/jack_turban) is a chief fellow in child and adolescent psychiatry at Stanford (Calif.) University.

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The VA Goes Its Own Way on Aducanumab

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In the Veterans Health Administration (VHA), the current prevalence of veterans with dementia is estimated to be about 10%.1 A 2013 report from the VHA Office of Policy and Planning projected a 22% increase in patients with dementia between 2020 and 2033. That increase amounts to between 276,000 and 335,000 additional veterans enrolled in the US Department of Veterans Affairs (VA) health care.2 Of course, these alarming statistics can in no way begin to convey the devastating biopsychosocial impact of Alzheimer disease and other dementias on veterans and their families. In many cases, veterans’ service to their country resulted in injuries and illnesses that increased the risk that they would develop dementia, such as traumatic brain injuries and posttraumatic stress disorder.3

Confronted with these concerning statistics, why didn’t VA Pharmacy Benefits Management (PBM) follow the US Food and Drug Administration (FDA) approval of aduncanumab-avwa for patients with dementia? Instead, PBM issued a monograph in July 2021 that recommended against providing aduncanumab-avwa to patients with Alzheimer dementia (mild or otherwise) or mild cognitive impairment, “given the lack of evidence of a robust and meaningful clinical benefit and the known safety signal.”4

In this editorial, I examine the reasons for the PBM recommendation, explain how the VA denial of approval for this new drug for dementia contravened that of the FDA and the ethical implications of this decision for veterans with dementia and the health care professionals (HCPs) who treat them.

The VA PBM national drug monographs are scientific reviews of clinical data supporting the potential inclusion of new medications in the VHA formulary.Aducanumab-avwa is a human monoclonal antibody. Its mechanism of action is to stimulate clearance of β-amyloid plaques from the brains of patients with Alzheimer disease. β-amyloid is a protein byproduct of amyloid precursor protein. Abnormal levels of β-amyloid build up in the brain of a patient with Alzheimer disease, forming clumps that disrupt neuronal connections that enable information transmission and other functions contributing to the death of brain cells.5

The FDA approved aducanumab on June 7, 2021, through the accelerated approval pathway.6 Drugs approved through the regular pathway must show a clinical benefit. Because detecting and demonstrating clinical benefit through research can be a lengthy process, in 1992 the FDA initiated the accelerated approval pathway. This alternative regulatory option permits the agency to approve a drug that “filled an unmet medical need” for a serious or life-threatening condition based on a surrogate endpoint.7 Examples of such endpoints are laboratory values, imaging evidence, physical signs, or other objective findings that are believed to predict a clinical benefit. In 2012, the FDA Safety Innovations Act expanded the basis for approval to an intermediate clinical endpoint: a measure of a therapeutic effect that demonstrates a “reasonable likelihood” of predicting clinical benefit.7

The FDA, unlike the PBM, found that aducanumab “provided a meaningful therapeutic advantage over existing treatments.” The FDA underscored that unlike other medications currently available to treat Alzheimer dementias that target symptoms, aducanumab acts on the underlying neurophysiology and neuropathology of the disease based on the decrease in β-amyloid plaques in participants in 2 large clinical trials. The FDA approved the drug for the treatment of patients with either mild cognitive impairment or in the mild state of Alzheimer dementia.

From the time of its announcement, the FDA decision to approve the drug was controversial and criticized in both professional articles and the news media. A particular poignant charge by Largent and Lynch was that the FDA had exploited the desperation of vulnerable patients with dementia and their families willing to try medications with unclear value and uncertain risk precisely because they believed they had no other viable options.8 Critics charged that the FDA took the unusual step of overruling the recommendations of a council of its senior advisors, claiming that there was insufficient evidence for approval; that there was a potential conflict of interest between the agency and the pharmaceutical industry; and that the FDA inappropriately used the accelerated approval pathway.9 In August 2021, in response to these critiques, the Office of the Inspector General announced that it would review the process the agency used in approving the drug.10 Nor was the VA alone in its refusal: The Centers for Medicare and Medicaid (CMS) has proposed to cover the drug for its beneficiaries enrolled in CMS-endorsed clinical trials with the caveat that the drug’s manufacturer, Biogen, must continue to conduct studies on the safety and effectiveness of the drug.11

Why did VHA come to a different scientific conclusion than that of the FDA? In reviewing the data from the 2 major studies, PBM did not find that this surrogate endpoint of reduction in β-amyloid plaques was a valid measure of a meaningful clinical benefit. Further, this lack of valid therapeutic change could not outweigh the risks of the amyloid-related imaging abnormalities (ARIA) in research participants. ARIA include cerebral vasogenic edema, effusions in sulci, microhemorrhages in the brain, and/or localized superficial siderosis. These findings are thought to be the result of the antibody binding to β-amyloid deposits that in turn increase cerebrovascular permeability.5

 

 



Thus, in not approving aducanumab, PBM and VHA leadership acted on the core bioethical principles of beneficence and nonmaleficence to prevent harms that proportionally outweighed benefits. Another ethical consideration for the VHA was that of distributive justice given the expense of the medication and the VHA obligation to be responsible stewards of public resources. At the time of the VHA decision, a year’s worth of aducanumab cost about $56,000: In December 2021, the manufacturer announced a dramatic decrease in the drug’s price.12 Although it may seem that fairness requires the VHA to provide any possible treatment for veterans whose cognitive impairment is in part an adverse effect of their time in uniform, a stronger counter argument is that the same high safety and scientific standard should be used for the approval of medications for patients with dementia as for any other disorder.

Among VHA HCPs and their patients with new and early diagnosed mild cognitive impairment or mild dementia, what is lacking in PBM’s clinical ethics analysis is the important principle of autonomy. PBM did carve out a space for the use of the drug in “highly selected patients by experts and centers that have the necessary diagnostic and management expertise.”5 The series of safety standards that must be met along with monitoring for the drug to be prescribed is PBM’s effort to obtain an equilibrium between preventing harm while respecting professional judgment and patient choice. PBM and VHA will reconsider its criteria if research shows improved effectiveness and safety. As with most debated decisions, for some patients and HCPs that balancing act may not have gone far enough, yet many believe that VHA for now is on the right side of the controversy.
References

1. Williamson V, Stevelink SAM, Greenberg K, Greenberg N. Prevalence of mental health disorders in elderly U.S. military veterans: a metaanalysis and systematic review. Am J Geriatr Psychiatry. 2018;26:534-545. doi:10.1016/j.jagp.2017.11.001

2. US Department of Veterans Affairs, Veterans Health Administration, Office of the Assistant Deputy Under Secretary for Health for Policy and Planning. Projections of the prevalence and incidence of dementias. Updated November 5, 2021. Accessed March 20, 2022. www.va.gov/geriatrics/GEC_Data_Reports.asp

3. Zhu CW, Sano M. Demographic, health, and exposure risks associated with cognitive loss, Alzheimer’s disease and other dementias in US military veterans. Front Psychiatry. 2021;12:610334. doi:10.3389/fpsyt.2021.610334

4. VHA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives. Aducanumab-avwa (ADUHELM) National Drug Monograph. Published July 2021. Accessed March 20, 2022. https://www.pbm.va.gov/PBM/clinicalguidance/drugmonographs/Aducanumab_ADUHELM_monograph_508.pdf

5. National Institutes of Health, National Institute on Aging. What happens to the brain in Alzheimer’s disease? Updated May 16, 2017. Accessed March 20, 2022. https://www.nia.nih.gov/health/what-happens-brain-alzheimers-disease

6. US Food and Drug Administration. FDA grants accelerated approval for Alzheimer’s drug. News release. Published June 7, 2021. Accessed March 21, 2022. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug

7. US Food and Drug Administration. Accelerated approval. Updated January 4, 2018. Accessed March 21,2022.https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval

8. Largent EL, Peterson E, Lynch HF. FDA approval and the ethics of desperation. JAMA Intern Med. 2021;181(12):1555-1556. doi:10.1001/jamainternmed.2021.6045

9. Belluck P, Kaplan S, Robbins R. How an unproven Alzheimer’s drug got approved. New York Times, Updated October 21, 2021. Accessed March 21, 2022. https://www.nytimes.com/2021/07/19/health/alzheimers-drug-aduhelm-fda.html

10. US Department of Health and Human Services, Office of the Inspector General. Review of the FDA’s accelerated approval pathway. Accessed March 20, 2022. https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000608.asp

11. Centers for Medicare and Medicaid Services. Monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease decision summary. Published January 11, 2022. Accessed March 21, 2022. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=305

12. Gleckman H. What’s behind Biogen’s move to cut prices on its controversial Alzheimer’s drug alduhelm. Forbes. Published December 23, 2021. Accessed March 21,2022. https://www.forbes.com/sites/howardgleckman/2021/12/23/whats-behind-biogens-move-to-cut-prices-on-its-controversial-alzheimers-drug-aduhelm/?sh=498c6a235154

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In the Veterans Health Administration (VHA), the current prevalence of veterans with dementia is estimated to be about 10%.1 A 2013 report from the VHA Office of Policy and Planning projected a 22% increase in patients with dementia between 2020 and 2033. That increase amounts to between 276,000 and 335,000 additional veterans enrolled in the US Department of Veterans Affairs (VA) health care.2 Of course, these alarming statistics can in no way begin to convey the devastating biopsychosocial impact of Alzheimer disease and other dementias on veterans and their families. In many cases, veterans’ service to their country resulted in injuries and illnesses that increased the risk that they would develop dementia, such as traumatic brain injuries and posttraumatic stress disorder.3

Confronted with these concerning statistics, why didn’t VA Pharmacy Benefits Management (PBM) follow the US Food and Drug Administration (FDA) approval of aduncanumab-avwa for patients with dementia? Instead, PBM issued a monograph in July 2021 that recommended against providing aduncanumab-avwa to patients with Alzheimer dementia (mild or otherwise) or mild cognitive impairment, “given the lack of evidence of a robust and meaningful clinical benefit and the known safety signal.”4

In this editorial, I examine the reasons for the PBM recommendation, explain how the VA denial of approval for this new drug for dementia contravened that of the FDA and the ethical implications of this decision for veterans with dementia and the health care professionals (HCPs) who treat them.

The VA PBM national drug monographs are scientific reviews of clinical data supporting the potential inclusion of new medications in the VHA formulary.Aducanumab-avwa is a human monoclonal antibody. Its mechanism of action is to stimulate clearance of β-amyloid plaques from the brains of patients with Alzheimer disease. β-amyloid is a protein byproduct of amyloid precursor protein. Abnormal levels of β-amyloid build up in the brain of a patient with Alzheimer disease, forming clumps that disrupt neuronal connections that enable information transmission and other functions contributing to the death of brain cells.5

The FDA approved aducanumab on June 7, 2021, through the accelerated approval pathway.6 Drugs approved through the regular pathway must show a clinical benefit. Because detecting and demonstrating clinical benefit through research can be a lengthy process, in 1992 the FDA initiated the accelerated approval pathway. This alternative regulatory option permits the agency to approve a drug that “filled an unmet medical need” for a serious or life-threatening condition based on a surrogate endpoint.7 Examples of such endpoints are laboratory values, imaging evidence, physical signs, or other objective findings that are believed to predict a clinical benefit. In 2012, the FDA Safety Innovations Act expanded the basis for approval to an intermediate clinical endpoint: a measure of a therapeutic effect that demonstrates a “reasonable likelihood” of predicting clinical benefit.7

The FDA, unlike the PBM, found that aducanumab “provided a meaningful therapeutic advantage over existing treatments.” The FDA underscored that unlike other medications currently available to treat Alzheimer dementias that target symptoms, aducanumab acts on the underlying neurophysiology and neuropathology of the disease based on the decrease in β-amyloid plaques in participants in 2 large clinical trials. The FDA approved the drug for the treatment of patients with either mild cognitive impairment or in the mild state of Alzheimer dementia.

From the time of its announcement, the FDA decision to approve the drug was controversial and criticized in both professional articles and the news media. A particular poignant charge by Largent and Lynch was that the FDA had exploited the desperation of vulnerable patients with dementia and their families willing to try medications with unclear value and uncertain risk precisely because they believed they had no other viable options.8 Critics charged that the FDA took the unusual step of overruling the recommendations of a council of its senior advisors, claiming that there was insufficient evidence for approval; that there was a potential conflict of interest between the agency and the pharmaceutical industry; and that the FDA inappropriately used the accelerated approval pathway.9 In August 2021, in response to these critiques, the Office of the Inspector General announced that it would review the process the agency used in approving the drug.10 Nor was the VA alone in its refusal: The Centers for Medicare and Medicaid (CMS) has proposed to cover the drug for its beneficiaries enrolled in CMS-endorsed clinical trials with the caveat that the drug’s manufacturer, Biogen, must continue to conduct studies on the safety and effectiveness of the drug.11

Why did VHA come to a different scientific conclusion than that of the FDA? In reviewing the data from the 2 major studies, PBM did not find that this surrogate endpoint of reduction in β-amyloid plaques was a valid measure of a meaningful clinical benefit. Further, this lack of valid therapeutic change could not outweigh the risks of the amyloid-related imaging abnormalities (ARIA) in research participants. ARIA include cerebral vasogenic edema, effusions in sulci, microhemorrhages in the brain, and/or localized superficial siderosis. These findings are thought to be the result of the antibody binding to β-amyloid deposits that in turn increase cerebrovascular permeability.5

 

 



Thus, in not approving aducanumab, PBM and VHA leadership acted on the core bioethical principles of beneficence and nonmaleficence to prevent harms that proportionally outweighed benefits. Another ethical consideration for the VHA was that of distributive justice given the expense of the medication and the VHA obligation to be responsible stewards of public resources. At the time of the VHA decision, a year’s worth of aducanumab cost about $56,000: In December 2021, the manufacturer announced a dramatic decrease in the drug’s price.12 Although it may seem that fairness requires the VHA to provide any possible treatment for veterans whose cognitive impairment is in part an adverse effect of their time in uniform, a stronger counter argument is that the same high safety and scientific standard should be used for the approval of medications for patients with dementia as for any other disorder.

Among VHA HCPs and their patients with new and early diagnosed mild cognitive impairment or mild dementia, what is lacking in PBM’s clinical ethics analysis is the important principle of autonomy. PBM did carve out a space for the use of the drug in “highly selected patients by experts and centers that have the necessary diagnostic and management expertise.”5 The series of safety standards that must be met along with monitoring for the drug to be prescribed is PBM’s effort to obtain an equilibrium between preventing harm while respecting professional judgment and patient choice. PBM and VHA will reconsider its criteria if research shows improved effectiveness and safety. As with most debated decisions, for some patients and HCPs that balancing act may not have gone far enough, yet many believe that VHA for now is on the right side of the controversy.

In the Veterans Health Administration (VHA), the current prevalence of veterans with dementia is estimated to be about 10%.1 A 2013 report from the VHA Office of Policy and Planning projected a 22% increase in patients with dementia between 2020 and 2033. That increase amounts to between 276,000 and 335,000 additional veterans enrolled in the US Department of Veterans Affairs (VA) health care.2 Of course, these alarming statistics can in no way begin to convey the devastating biopsychosocial impact of Alzheimer disease and other dementias on veterans and their families. In many cases, veterans’ service to their country resulted in injuries and illnesses that increased the risk that they would develop dementia, such as traumatic brain injuries and posttraumatic stress disorder.3

Confronted with these concerning statistics, why didn’t VA Pharmacy Benefits Management (PBM) follow the US Food and Drug Administration (FDA) approval of aduncanumab-avwa for patients with dementia? Instead, PBM issued a monograph in July 2021 that recommended against providing aduncanumab-avwa to patients with Alzheimer dementia (mild or otherwise) or mild cognitive impairment, “given the lack of evidence of a robust and meaningful clinical benefit and the known safety signal.”4

In this editorial, I examine the reasons for the PBM recommendation, explain how the VA denial of approval for this new drug for dementia contravened that of the FDA and the ethical implications of this decision for veterans with dementia and the health care professionals (HCPs) who treat them.

The VA PBM national drug monographs are scientific reviews of clinical data supporting the potential inclusion of new medications in the VHA formulary.Aducanumab-avwa is a human monoclonal antibody. Its mechanism of action is to stimulate clearance of β-amyloid plaques from the brains of patients with Alzheimer disease. β-amyloid is a protein byproduct of amyloid precursor protein. Abnormal levels of β-amyloid build up in the brain of a patient with Alzheimer disease, forming clumps that disrupt neuronal connections that enable information transmission and other functions contributing to the death of brain cells.5

The FDA approved aducanumab on June 7, 2021, through the accelerated approval pathway.6 Drugs approved through the regular pathway must show a clinical benefit. Because detecting and demonstrating clinical benefit through research can be a lengthy process, in 1992 the FDA initiated the accelerated approval pathway. This alternative regulatory option permits the agency to approve a drug that “filled an unmet medical need” for a serious or life-threatening condition based on a surrogate endpoint.7 Examples of such endpoints are laboratory values, imaging evidence, physical signs, or other objective findings that are believed to predict a clinical benefit. In 2012, the FDA Safety Innovations Act expanded the basis for approval to an intermediate clinical endpoint: a measure of a therapeutic effect that demonstrates a “reasonable likelihood” of predicting clinical benefit.7

The FDA, unlike the PBM, found that aducanumab “provided a meaningful therapeutic advantage over existing treatments.” The FDA underscored that unlike other medications currently available to treat Alzheimer dementias that target symptoms, aducanumab acts on the underlying neurophysiology and neuropathology of the disease based on the decrease in β-amyloid plaques in participants in 2 large clinical trials. The FDA approved the drug for the treatment of patients with either mild cognitive impairment or in the mild state of Alzheimer dementia.

From the time of its announcement, the FDA decision to approve the drug was controversial and criticized in both professional articles and the news media. A particular poignant charge by Largent and Lynch was that the FDA had exploited the desperation of vulnerable patients with dementia and their families willing to try medications with unclear value and uncertain risk precisely because they believed they had no other viable options.8 Critics charged that the FDA took the unusual step of overruling the recommendations of a council of its senior advisors, claiming that there was insufficient evidence for approval; that there was a potential conflict of interest between the agency and the pharmaceutical industry; and that the FDA inappropriately used the accelerated approval pathway.9 In August 2021, in response to these critiques, the Office of the Inspector General announced that it would review the process the agency used in approving the drug.10 Nor was the VA alone in its refusal: The Centers for Medicare and Medicaid (CMS) has proposed to cover the drug for its beneficiaries enrolled in CMS-endorsed clinical trials with the caveat that the drug’s manufacturer, Biogen, must continue to conduct studies on the safety and effectiveness of the drug.11

Why did VHA come to a different scientific conclusion than that of the FDA? In reviewing the data from the 2 major studies, PBM did not find that this surrogate endpoint of reduction in β-amyloid plaques was a valid measure of a meaningful clinical benefit. Further, this lack of valid therapeutic change could not outweigh the risks of the amyloid-related imaging abnormalities (ARIA) in research participants. ARIA include cerebral vasogenic edema, effusions in sulci, microhemorrhages in the brain, and/or localized superficial siderosis. These findings are thought to be the result of the antibody binding to β-amyloid deposits that in turn increase cerebrovascular permeability.5

 

 



Thus, in not approving aducanumab, PBM and VHA leadership acted on the core bioethical principles of beneficence and nonmaleficence to prevent harms that proportionally outweighed benefits. Another ethical consideration for the VHA was that of distributive justice given the expense of the medication and the VHA obligation to be responsible stewards of public resources. At the time of the VHA decision, a year’s worth of aducanumab cost about $56,000: In December 2021, the manufacturer announced a dramatic decrease in the drug’s price.12 Although it may seem that fairness requires the VHA to provide any possible treatment for veterans whose cognitive impairment is in part an adverse effect of their time in uniform, a stronger counter argument is that the same high safety and scientific standard should be used for the approval of medications for patients with dementia as for any other disorder.

Among VHA HCPs and their patients with new and early diagnosed mild cognitive impairment or mild dementia, what is lacking in PBM’s clinical ethics analysis is the important principle of autonomy. PBM did carve out a space for the use of the drug in “highly selected patients by experts and centers that have the necessary diagnostic and management expertise.”5 The series of safety standards that must be met along with monitoring for the drug to be prescribed is PBM’s effort to obtain an equilibrium between preventing harm while respecting professional judgment and patient choice. PBM and VHA will reconsider its criteria if research shows improved effectiveness and safety. As with most debated decisions, for some patients and HCPs that balancing act may not have gone far enough, yet many believe that VHA for now is on the right side of the controversy.
References

1. Williamson V, Stevelink SAM, Greenberg K, Greenberg N. Prevalence of mental health disorders in elderly U.S. military veterans: a metaanalysis and systematic review. Am J Geriatr Psychiatry. 2018;26:534-545. doi:10.1016/j.jagp.2017.11.001

2. US Department of Veterans Affairs, Veterans Health Administration, Office of the Assistant Deputy Under Secretary for Health for Policy and Planning. Projections of the prevalence and incidence of dementias. Updated November 5, 2021. Accessed March 20, 2022. www.va.gov/geriatrics/GEC_Data_Reports.asp

3. Zhu CW, Sano M. Demographic, health, and exposure risks associated with cognitive loss, Alzheimer’s disease and other dementias in US military veterans. Front Psychiatry. 2021;12:610334. doi:10.3389/fpsyt.2021.610334

4. VHA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives. Aducanumab-avwa (ADUHELM) National Drug Monograph. Published July 2021. Accessed March 20, 2022. https://www.pbm.va.gov/PBM/clinicalguidance/drugmonographs/Aducanumab_ADUHELM_monograph_508.pdf

5. National Institutes of Health, National Institute on Aging. What happens to the brain in Alzheimer’s disease? Updated May 16, 2017. Accessed March 20, 2022. https://www.nia.nih.gov/health/what-happens-brain-alzheimers-disease

6. US Food and Drug Administration. FDA grants accelerated approval for Alzheimer’s drug. News release. Published June 7, 2021. Accessed March 21, 2022. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug

7. US Food and Drug Administration. Accelerated approval. Updated January 4, 2018. Accessed March 21,2022.https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval

8. Largent EL, Peterson E, Lynch HF. FDA approval and the ethics of desperation. JAMA Intern Med. 2021;181(12):1555-1556. doi:10.1001/jamainternmed.2021.6045

9. Belluck P, Kaplan S, Robbins R. How an unproven Alzheimer’s drug got approved. New York Times, Updated October 21, 2021. Accessed March 21, 2022. https://www.nytimes.com/2021/07/19/health/alzheimers-drug-aduhelm-fda.html

10. US Department of Health and Human Services, Office of the Inspector General. Review of the FDA’s accelerated approval pathway. Accessed March 20, 2022. https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000608.asp

11. Centers for Medicare and Medicaid Services. Monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease decision summary. Published January 11, 2022. Accessed March 21, 2022. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=305

12. Gleckman H. What’s behind Biogen’s move to cut prices on its controversial Alzheimer’s drug alduhelm. Forbes. Published December 23, 2021. Accessed March 21,2022. https://www.forbes.com/sites/howardgleckman/2021/12/23/whats-behind-biogens-move-to-cut-prices-on-its-controversial-alzheimers-drug-aduhelm/?sh=498c6a235154

References

1. Williamson V, Stevelink SAM, Greenberg K, Greenberg N. Prevalence of mental health disorders in elderly U.S. military veterans: a metaanalysis and systematic review. Am J Geriatr Psychiatry. 2018;26:534-545. doi:10.1016/j.jagp.2017.11.001

2. US Department of Veterans Affairs, Veterans Health Administration, Office of the Assistant Deputy Under Secretary for Health for Policy and Planning. Projections of the prevalence and incidence of dementias. Updated November 5, 2021. Accessed March 20, 2022. www.va.gov/geriatrics/GEC_Data_Reports.asp

3. Zhu CW, Sano M. Demographic, health, and exposure risks associated with cognitive loss, Alzheimer’s disease and other dementias in US military veterans. Front Psychiatry. 2021;12:610334. doi:10.3389/fpsyt.2021.610334

4. VHA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives. Aducanumab-avwa (ADUHELM) National Drug Monograph. Published July 2021. Accessed March 20, 2022. https://www.pbm.va.gov/PBM/clinicalguidance/drugmonographs/Aducanumab_ADUHELM_monograph_508.pdf

5. National Institutes of Health, National Institute on Aging. What happens to the brain in Alzheimer’s disease? Updated May 16, 2017. Accessed March 20, 2022. https://www.nia.nih.gov/health/what-happens-brain-alzheimers-disease

6. US Food and Drug Administration. FDA grants accelerated approval for Alzheimer’s drug. News release. Published June 7, 2021. Accessed March 21, 2022. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug

7. US Food and Drug Administration. Accelerated approval. Updated January 4, 2018. Accessed March 21,2022.https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval

8. Largent EL, Peterson E, Lynch HF. FDA approval and the ethics of desperation. JAMA Intern Med. 2021;181(12):1555-1556. doi:10.1001/jamainternmed.2021.6045

9. Belluck P, Kaplan S, Robbins R. How an unproven Alzheimer’s drug got approved. New York Times, Updated October 21, 2021. Accessed March 21, 2022. https://www.nytimes.com/2021/07/19/health/alzheimers-drug-aduhelm-fda.html

10. US Department of Health and Human Services, Office of the Inspector General. Review of the FDA’s accelerated approval pathway. Accessed March 20, 2022. https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000608.asp

11. Centers for Medicare and Medicaid Services. Monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease decision summary. Published January 11, 2022. Accessed March 21, 2022. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=305

12. Gleckman H. What’s behind Biogen’s move to cut prices on its controversial Alzheimer’s drug alduhelm. Forbes. Published December 23, 2021. Accessed March 21,2022. https://www.forbes.com/sites/howardgleckman/2021/12/23/whats-behind-biogens-move-to-cut-prices-on-its-controversial-alzheimers-drug-aduhelm/?sh=498c6a235154

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When Are Inpatient and Emergency Dermatologic Consultations Appropriate?

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When Are Inpatient and Emergency Dermatologic Consultations Appropriate?

There are limited clinical data concerning inpatient and emergency department (ED) dermatologic consultations. The indications for these consultations vary widely, but in one study (N=271), it was found that 21% of inpatient consultations were for contact dermatitis and 10% were for drug eruptions.1 In the same study, 77% of patients who required a dermatology consultation eventually were given a different diagnosis or change in treatment after consultation. For example, of all consultations for suspected cellulitis, only 10% were confirmed after dermatology evaluation.1

Hospitalists and emergency physicians continue to struggle with the assessment of dermatologic conditions, often consulting dermatology whenever a patient has a “rash” or skin concern. Dermatology is still not emphasized in medical education and often is taught to most medical students in an abbreviated fashion, which results in physicians feeling ill-equipped to deal with any dermatologic condition—either mundane or potentially life-threatening. A study in 2016 showed that a monthly lecture series given to hospitalists over the course of 5 years did not improve diagnostic accuracy in patients who were admitted with skin manifestations.2 This further shows that there is a need for dermatologic experts in the hospital.

We need to develop better guidelines for physicians in the ED and on inpatient units to guide them on appropriate use of dermatologic consultation outside the ambulatory office and the clinic. A 2013 study showed that patients often were discharged immediately after a dermatologic consultation, furthering our hypothesis that many inpatient consultations can be delayed until after discharge.3

In an era in which medical costs are soaring and there is constant surveillance for ways to reduce costs without impairing quality of care, limiting unnecessary specialty consultations should be embraced. In 2009, $1.8 billion in Medicare claims was paid for dermatology-related admissions.3 A substantial savings to Medicare consulting fees for certain diagnoses, such as cellulitis or contact dermatitis, could be realized if patients were referred for outpatient assessment and treatment. In a study of 271 consultations, 54 patients also had a skin biopsy, which further increases dollars spent on inpatient care and is (usually) something that can be performed in the outpatient setting.1 In another study, the more common recommended treatments were topical corticosteroids and supportive educational measures for patients and hospital staff,3 which further substantiates that most dermatology consultations are not truly emergent and can wait for outpatient consultation.

In addition, we are dealing with the COVID-19 pandemic in our hospitals and EDs. Many physicians, including dermatologists, would prefer to avoid unnecessary exposure to SARS-CoV-2 on inpatient units and in the ED. It certainly would be preferable to require consultants to come in to evaluate patients only when they truly need to be seen while in the hospital.

There also is limited dermatology training in other specialties, and the dermatology team can help fill this gap with educational programs and one-on-one teaching. Hospital teams have signaled this need, but there has been limited success with multiple teaching opportunities.4

We believe that this need for inpatient dermatology services can be filled with the newer subspecialty of hospital dermatology, which is not commonly present at most hospitals; a reason why the subspecialty has not been more popular is that there are few available data in the form of randomized clinical trials that can guide inpatient dermatologists with the care of rare hospital skin diseases.5 Having a dermatologic hospitalist available might allow for patients to be seen more readily, which ultimately will save lives and health care dollars and would increase real-time teaching and education for house staff, nursing, and attendings at the bedside.

 

 

In a 2018 article,6 it was postulated that quicker diagnosis of pseudocellulitis and initiation of antibiotics to treat this condition would save the US health care system $210 million annually. We believe that pseudocellulitis would be best evaluated by inpatient dermatology teams, thereby avoiding costly dermatologic consultations, at an average rate of $138.89.6

Morbilliform drug eruptions are among the most common skin conditions seen in the hospital; approximately 95% of cases are an uncomplicated reaction to a medication or virus. Data show that many of these consultations might be unnecessary.7

Our institution (Hackensack University Medical Center, New Jersey) is a tertiary hospital that also is connected with a major cancer center. Given this connection, skin eruptions due to chemotherapy and radiation are common. The treatment of drug eruptions, graft-vs-host disease, and other oncologic or drug-related eruptions should be within the scope of practice of our hospitalists, but these cases frequently involve dermatologic consultation.

We constructed a consultation flowchart (Figure) to help guide the triage of patients in need of dermatologic evaluation by inpatient teams and possibly to avoid unnecessary consultation fees. The manner in which this—or any flowchart or teaching aid—is conveyed to hospital personnel is critical so that these tools are not perceived as patronizing or confrontational. In our flowchart, we list emergent dermatologic conditions that we believe are appropriate for dermatology consultation including erythrodermic psoriasis, bullous pemphigoid flare, and Stevens-Johnson syndrome/toxic epidermal necrolysis.

Inpatient dermatology consultation flowchart
Inpatient dermatology consultation flowchart. HS indicates hidradenitis suppurativa; SJS, Stevens-Johnson syndrome; TEN, toxic edpidermal necrolysis.

We believe that the flowchart can educate inpatient medical teams about appropriate dermatology consultation. Use of the flowchart also may decrease unnecessary consultations, which ultimately will lower health care spending overall.

References
  1. Davila M, Christenson LJ, Sontheimer RD. Epidemiology and outcomes of dermatology in-patient consultations in a Midwestern U.S. university hospital. Dermatol Online J. 2010;16:12.
  2. Beshay A, Liu M, Fox L, et al. Inpatient dermatology consultative programs: a continued need, tools for needs assessment for curriculum development, and a call for new methods of teaching. J Am Acad Dermatol. 2016;74:769-771. doi:10.1016/j.jaad.2015.11.017
  3. Hu L, Haynes H, Ferrazza D, et al. Impact of specialist consultations on inpatient admissions for dermatology-specific and related DRGs. J Gen Intern Med. 2013;28:1477-1482. doi:10.1007/s11606-013-2440-2
  4. Faletsky A, Han JJ, Mostaghimi A. Inpatient dermatology best practice strategies for educating and relaying findings to colleagues. Curr Dermatol Rep. 2020;9:256-260. doi:10.1007/s13671-020-00317-y
  5. Fox LP. Hospital dermatology, introduction. Semin Cutan Med Surg. 2017;36:1-2. doi:10.12788/j.sder.2017.015
  6. Li D, Xia FD, Khosravi H, et al. Outcomes of early dermatology consultation for inpatients diagnosed with cellulitis. JAMA Dermatol. 2018;154:537-543. doi:10.1001/jamadermatol.2017.6197
  7. Biesbroeck LK, Shinohara MM. Inpatient consultative dermatology. Med Clin North Am. 2015;99:1349-1364. doi:10.1016/j.mcna.2015.06.004
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Drs. Dobkin and Ashinoff are from Hackensack University Medical Center, New Jersey. Mr. Blackwell is from the Rowan University School of Osteopathic Medicine, Stratford, New Jersey.

The authors report no conflict of interest.

Correspondence: Hershel Dobkin, MD, Hackensack University Medical Center, 30 Prospect Ave, Hackensack, NJ 07601 (hersheldobkin@gmail.com).

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Drs. Dobkin and Ashinoff are from Hackensack University Medical Center, New Jersey. Mr. Blackwell is from the Rowan University School of Osteopathic Medicine, Stratford, New Jersey.

The authors report no conflict of interest.

Correspondence: Hershel Dobkin, MD, Hackensack University Medical Center, 30 Prospect Ave, Hackensack, NJ 07601 (hersheldobkin@gmail.com).

Author and Disclosure Information

Drs. Dobkin and Ashinoff are from Hackensack University Medical Center, New Jersey. Mr. Blackwell is from the Rowan University School of Osteopathic Medicine, Stratford, New Jersey.

The authors report no conflict of interest.

Correspondence: Hershel Dobkin, MD, Hackensack University Medical Center, 30 Prospect Ave, Hackensack, NJ 07601 (hersheldobkin@gmail.com).

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There are limited clinical data concerning inpatient and emergency department (ED) dermatologic consultations. The indications for these consultations vary widely, but in one study (N=271), it was found that 21% of inpatient consultations were for contact dermatitis and 10% were for drug eruptions.1 In the same study, 77% of patients who required a dermatology consultation eventually were given a different diagnosis or change in treatment after consultation. For example, of all consultations for suspected cellulitis, only 10% were confirmed after dermatology evaluation.1

Hospitalists and emergency physicians continue to struggle with the assessment of dermatologic conditions, often consulting dermatology whenever a patient has a “rash” or skin concern. Dermatology is still not emphasized in medical education and often is taught to most medical students in an abbreviated fashion, which results in physicians feeling ill-equipped to deal with any dermatologic condition—either mundane or potentially life-threatening. A study in 2016 showed that a monthly lecture series given to hospitalists over the course of 5 years did not improve diagnostic accuracy in patients who were admitted with skin manifestations.2 This further shows that there is a need for dermatologic experts in the hospital.

We need to develop better guidelines for physicians in the ED and on inpatient units to guide them on appropriate use of dermatologic consultation outside the ambulatory office and the clinic. A 2013 study showed that patients often were discharged immediately after a dermatologic consultation, furthering our hypothesis that many inpatient consultations can be delayed until after discharge.3

In an era in which medical costs are soaring and there is constant surveillance for ways to reduce costs without impairing quality of care, limiting unnecessary specialty consultations should be embraced. In 2009, $1.8 billion in Medicare claims was paid for dermatology-related admissions.3 A substantial savings to Medicare consulting fees for certain diagnoses, such as cellulitis or contact dermatitis, could be realized if patients were referred for outpatient assessment and treatment. In a study of 271 consultations, 54 patients also had a skin biopsy, which further increases dollars spent on inpatient care and is (usually) something that can be performed in the outpatient setting.1 In another study, the more common recommended treatments were topical corticosteroids and supportive educational measures for patients and hospital staff,3 which further substantiates that most dermatology consultations are not truly emergent and can wait for outpatient consultation.

In addition, we are dealing with the COVID-19 pandemic in our hospitals and EDs. Many physicians, including dermatologists, would prefer to avoid unnecessary exposure to SARS-CoV-2 on inpatient units and in the ED. It certainly would be preferable to require consultants to come in to evaluate patients only when they truly need to be seen while in the hospital.

There also is limited dermatology training in other specialties, and the dermatology team can help fill this gap with educational programs and one-on-one teaching. Hospital teams have signaled this need, but there has been limited success with multiple teaching opportunities.4

We believe that this need for inpatient dermatology services can be filled with the newer subspecialty of hospital dermatology, which is not commonly present at most hospitals; a reason why the subspecialty has not been more popular is that there are few available data in the form of randomized clinical trials that can guide inpatient dermatologists with the care of rare hospital skin diseases.5 Having a dermatologic hospitalist available might allow for patients to be seen more readily, which ultimately will save lives and health care dollars and would increase real-time teaching and education for house staff, nursing, and attendings at the bedside.

 

 

In a 2018 article,6 it was postulated that quicker diagnosis of pseudocellulitis and initiation of antibiotics to treat this condition would save the US health care system $210 million annually. We believe that pseudocellulitis would be best evaluated by inpatient dermatology teams, thereby avoiding costly dermatologic consultations, at an average rate of $138.89.6

Morbilliform drug eruptions are among the most common skin conditions seen in the hospital; approximately 95% of cases are an uncomplicated reaction to a medication or virus. Data show that many of these consultations might be unnecessary.7

Our institution (Hackensack University Medical Center, New Jersey) is a tertiary hospital that also is connected with a major cancer center. Given this connection, skin eruptions due to chemotherapy and radiation are common. The treatment of drug eruptions, graft-vs-host disease, and other oncologic or drug-related eruptions should be within the scope of practice of our hospitalists, but these cases frequently involve dermatologic consultation.

We constructed a consultation flowchart (Figure) to help guide the triage of patients in need of dermatologic evaluation by inpatient teams and possibly to avoid unnecessary consultation fees. The manner in which this—or any flowchart or teaching aid—is conveyed to hospital personnel is critical so that these tools are not perceived as patronizing or confrontational. In our flowchart, we list emergent dermatologic conditions that we believe are appropriate for dermatology consultation including erythrodermic psoriasis, bullous pemphigoid flare, and Stevens-Johnson syndrome/toxic epidermal necrolysis.

Inpatient dermatology consultation flowchart
Inpatient dermatology consultation flowchart. HS indicates hidradenitis suppurativa; SJS, Stevens-Johnson syndrome; TEN, toxic edpidermal necrolysis.

We believe that the flowchart can educate inpatient medical teams about appropriate dermatology consultation. Use of the flowchart also may decrease unnecessary consultations, which ultimately will lower health care spending overall.

There are limited clinical data concerning inpatient and emergency department (ED) dermatologic consultations. The indications for these consultations vary widely, but in one study (N=271), it was found that 21% of inpatient consultations were for contact dermatitis and 10% were for drug eruptions.1 In the same study, 77% of patients who required a dermatology consultation eventually were given a different diagnosis or change in treatment after consultation. For example, of all consultations for suspected cellulitis, only 10% were confirmed after dermatology evaluation.1

Hospitalists and emergency physicians continue to struggle with the assessment of dermatologic conditions, often consulting dermatology whenever a patient has a “rash” or skin concern. Dermatology is still not emphasized in medical education and often is taught to most medical students in an abbreviated fashion, which results in physicians feeling ill-equipped to deal with any dermatologic condition—either mundane or potentially life-threatening. A study in 2016 showed that a monthly lecture series given to hospitalists over the course of 5 years did not improve diagnostic accuracy in patients who were admitted with skin manifestations.2 This further shows that there is a need for dermatologic experts in the hospital.

We need to develop better guidelines for physicians in the ED and on inpatient units to guide them on appropriate use of dermatologic consultation outside the ambulatory office and the clinic. A 2013 study showed that patients often were discharged immediately after a dermatologic consultation, furthering our hypothesis that many inpatient consultations can be delayed until after discharge.3

In an era in which medical costs are soaring and there is constant surveillance for ways to reduce costs without impairing quality of care, limiting unnecessary specialty consultations should be embraced. In 2009, $1.8 billion in Medicare claims was paid for dermatology-related admissions.3 A substantial savings to Medicare consulting fees for certain diagnoses, such as cellulitis or contact dermatitis, could be realized if patients were referred for outpatient assessment and treatment. In a study of 271 consultations, 54 patients also had a skin biopsy, which further increases dollars spent on inpatient care and is (usually) something that can be performed in the outpatient setting.1 In another study, the more common recommended treatments were topical corticosteroids and supportive educational measures for patients and hospital staff,3 which further substantiates that most dermatology consultations are not truly emergent and can wait for outpatient consultation.

In addition, we are dealing with the COVID-19 pandemic in our hospitals and EDs. Many physicians, including dermatologists, would prefer to avoid unnecessary exposure to SARS-CoV-2 on inpatient units and in the ED. It certainly would be preferable to require consultants to come in to evaluate patients only when they truly need to be seen while in the hospital.

There also is limited dermatology training in other specialties, and the dermatology team can help fill this gap with educational programs and one-on-one teaching. Hospital teams have signaled this need, but there has been limited success with multiple teaching opportunities.4

We believe that this need for inpatient dermatology services can be filled with the newer subspecialty of hospital dermatology, which is not commonly present at most hospitals; a reason why the subspecialty has not been more popular is that there are few available data in the form of randomized clinical trials that can guide inpatient dermatologists with the care of rare hospital skin diseases.5 Having a dermatologic hospitalist available might allow for patients to be seen more readily, which ultimately will save lives and health care dollars and would increase real-time teaching and education for house staff, nursing, and attendings at the bedside.

 

 

In a 2018 article,6 it was postulated that quicker diagnosis of pseudocellulitis and initiation of antibiotics to treat this condition would save the US health care system $210 million annually. We believe that pseudocellulitis would be best evaluated by inpatient dermatology teams, thereby avoiding costly dermatologic consultations, at an average rate of $138.89.6

Morbilliform drug eruptions are among the most common skin conditions seen in the hospital; approximately 95% of cases are an uncomplicated reaction to a medication or virus. Data show that many of these consultations might be unnecessary.7

Our institution (Hackensack University Medical Center, New Jersey) is a tertiary hospital that also is connected with a major cancer center. Given this connection, skin eruptions due to chemotherapy and radiation are common. The treatment of drug eruptions, graft-vs-host disease, and other oncologic or drug-related eruptions should be within the scope of practice of our hospitalists, but these cases frequently involve dermatologic consultation.

We constructed a consultation flowchart (Figure) to help guide the triage of patients in need of dermatologic evaluation by inpatient teams and possibly to avoid unnecessary consultation fees. The manner in which this—or any flowchart or teaching aid—is conveyed to hospital personnel is critical so that these tools are not perceived as patronizing or confrontational. In our flowchart, we list emergent dermatologic conditions that we believe are appropriate for dermatology consultation including erythrodermic psoriasis, bullous pemphigoid flare, and Stevens-Johnson syndrome/toxic epidermal necrolysis.

Inpatient dermatology consultation flowchart
Inpatient dermatology consultation flowchart. HS indicates hidradenitis suppurativa; SJS, Stevens-Johnson syndrome; TEN, toxic edpidermal necrolysis.

We believe that the flowchart can educate inpatient medical teams about appropriate dermatology consultation. Use of the flowchart also may decrease unnecessary consultations, which ultimately will lower health care spending overall.

References
  1. Davila M, Christenson LJ, Sontheimer RD. Epidemiology and outcomes of dermatology in-patient consultations in a Midwestern U.S. university hospital. Dermatol Online J. 2010;16:12.
  2. Beshay A, Liu M, Fox L, et al. Inpatient dermatology consultative programs: a continued need, tools for needs assessment for curriculum development, and a call for new methods of teaching. J Am Acad Dermatol. 2016;74:769-771. doi:10.1016/j.jaad.2015.11.017
  3. Hu L, Haynes H, Ferrazza D, et al. Impact of specialist consultations on inpatient admissions for dermatology-specific and related DRGs. J Gen Intern Med. 2013;28:1477-1482. doi:10.1007/s11606-013-2440-2
  4. Faletsky A, Han JJ, Mostaghimi A. Inpatient dermatology best practice strategies for educating and relaying findings to colleagues. Curr Dermatol Rep. 2020;9:256-260. doi:10.1007/s13671-020-00317-y
  5. Fox LP. Hospital dermatology, introduction. Semin Cutan Med Surg. 2017;36:1-2. doi:10.12788/j.sder.2017.015
  6. Li D, Xia FD, Khosravi H, et al. Outcomes of early dermatology consultation for inpatients diagnosed with cellulitis. JAMA Dermatol. 2018;154:537-543. doi:10.1001/jamadermatol.2017.6197
  7. Biesbroeck LK, Shinohara MM. Inpatient consultative dermatology. Med Clin North Am. 2015;99:1349-1364. doi:10.1016/j.mcna.2015.06.004
References
  1. Davila M, Christenson LJ, Sontheimer RD. Epidemiology and outcomes of dermatology in-patient consultations in a Midwestern U.S. university hospital. Dermatol Online J. 2010;16:12.
  2. Beshay A, Liu M, Fox L, et al. Inpatient dermatology consultative programs: a continued need, tools for needs assessment for curriculum development, and a call for new methods of teaching. J Am Acad Dermatol. 2016;74:769-771. doi:10.1016/j.jaad.2015.11.017
  3. Hu L, Haynes H, Ferrazza D, et al. Impact of specialist consultations on inpatient admissions for dermatology-specific and related DRGs. J Gen Intern Med. 2013;28:1477-1482. doi:10.1007/s11606-013-2440-2
  4. Faletsky A, Han JJ, Mostaghimi A. Inpatient dermatology best practice strategies for educating and relaying findings to colleagues. Curr Dermatol Rep. 2020;9:256-260. doi:10.1007/s13671-020-00317-y
  5. Fox LP. Hospital dermatology, introduction. Semin Cutan Med Surg. 2017;36:1-2. doi:10.12788/j.sder.2017.015
  6. Li D, Xia FD, Khosravi H, et al. Outcomes of early dermatology consultation for inpatients diagnosed with cellulitis. JAMA Dermatol. 2018;154:537-543. doi:10.1001/jamadermatol.2017.6197
  7. Biesbroeck LK, Shinohara MM. Inpatient consultative dermatology. Med Clin North Am. 2015;99:1349-1364. doi:10.1016/j.mcna.2015.06.004
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Practice Points

  • Primary inpatient teams should call patients’ insurance companies to verify in-network dermatologists for eventual outpatient follow-up.
  • Chronic skin problems (eg, psoriasis, hidradenitis suppurativa) are better cared for in an outpatient setting due to the necessity for follow-up reassessments.
  • There remains a need to fill knowledge gaps for common inpatient dermatologic problems that do not necessitate consultations, such as morbilliform drug rash and other chronic and unchanged dermatoses.
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Residency Roundup: Introducing a New Partnership Between Cutis and the APD-RPDS

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We are excited to announce a new partnership between Cutis and the Association of Professors of Dermatology Residency Program Directors Section (APD-RPDS). The new APD-RPDS column Residency Roundup will contain quarterly communications and submissions that we hope will facilitate greater dissemination of information that is useful to the dermatology teaching community.

The APD is a group of academic dermatologists whose membership comprises chairs, chiefs, residency and fellowship program directors, and teaching faculty. Each fall, the group convenes in Chicago, Illinois, for a 2-day meeting centered around departmental and program leadership with a focus on education. The APD-RPDS was formed in 2020 and is led by a steering committee of 9 members, including our current Chair, Ilana S. Rosman, MD (Washington University School of Medicine, St. Louis, Missouri), and Vice Chair, Jo-Ann M. Latkowski, MD (New York University, New York). Committee members are elected from and by the APD membership and must serve in program leadership at their home programs. The APD-RPDS helps plan and coordinate breakout sessions and lectures at the annual APD meeting, which typically relate to program director duties, changing policies within the American Board of Dermatology or Accreditation Council for Graduate Medical Education, ideas for future growth, and changes in our specialty and in resident education. Members of the APD-RPDS have access to the APD listserv, a valuable resource for discussing issues affecting residency training. We also have work groups led by our members, which include diversity, equity, and inclusion; resource development; communications; and the annual survey. To join the APD, the RPDS, and/or any of our workgroups, please reach out to us or visit the APD website (https://www.dermatologyprofessors.org).

We look forward to welcoming and expediently reviewing members’ submissions to the new Residency Roundup column falling into 2 principal categories within the scope of dermatologic recruitment, didactic education, and clinical training. The first category will feature novel tools, programs, and platforms to improve dermatology training through collaboration. This could entail a description of a new platform designed for sharing resources among programs and specialties to enhance learning for trainees and faculty alike. For example, if a database is created that contains prerecorded lectures pertaining to alopecia, a potential article submission might introduce the database and provide information on what topics are covered and how to access these lectures for readers worldwide. Likewise, if a new technology emerges that allows for easier collaboration among programs, a possible submission would introduce the technology and discuss its potential benefits to trainees, faculty, and practicing dermatologists.

Secondly and more commonly, we anticipate the Residency Roundup column will feature articles that delve into the critical issues and challenges currently impacting recruitment, training, and administration in dermatology residency programs. Specific topics may include but are not limited to recruitment of underrepresented in medicine applicants to dermatology, technological advances to improve teaching methods within training programs, surveys delving into the dermatology match process, and educational gaps or future directions in the specialty. The column occasionally may be used to disseminate information from our section of the APD, including consensus statements or editorials related to changes implemented in the dermatology residency application process. A prospective editorial on this subject could explore varying viewpoints of implemented and proposed changes as well as the reasons behind the changes.

Our group is collaborative, and our aim is to improve education, equity, management of program director responsibilities, and the dermatology application process for programs and applicants alike. With your input, experience, and varied perspectives, we look forward to moving the field of dermatology to a better future by working together. 

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Dr. Worswick is from the Department of Dermatology, Keck Medicine of USC, Los Angeles, California. Dr. Latkowski is from the Department of Dermatology, New York University School of Medicine, New York.

The authors report no conflict of interest.

Correspondence: Scott Worswick, MD, 1450 San Pablo St, Los Angeles, CA 90033 (scott.worswick@gmail.com).

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Dr. Worswick is from the Department of Dermatology, Keck Medicine of USC, Los Angeles, California. Dr. Latkowski is from the Department of Dermatology, New York University School of Medicine, New York.

The authors report no conflict of interest.

Correspondence: Scott Worswick, MD, 1450 San Pablo St, Los Angeles, CA 90033 (scott.worswick@gmail.com).

Author and Disclosure Information

Dr. Worswick is from the Department of Dermatology, Keck Medicine of USC, Los Angeles, California. Dr. Latkowski is from the Department of Dermatology, New York University School of Medicine, New York.

The authors report no conflict of interest.

Correspondence: Scott Worswick, MD, 1450 San Pablo St, Los Angeles, CA 90033 (scott.worswick@gmail.com).

Article PDF
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We are excited to announce a new partnership between Cutis and the Association of Professors of Dermatology Residency Program Directors Section (APD-RPDS). The new APD-RPDS column Residency Roundup will contain quarterly communications and submissions that we hope will facilitate greater dissemination of information that is useful to the dermatology teaching community.

The APD is a group of academic dermatologists whose membership comprises chairs, chiefs, residency and fellowship program directors, and teaching faculty. Each fall, the group convenes in Chicago, Illinois, for a 2-day meeting centered around departmental and program leadership with a focus on education. The APD-RPDS was formed in 2020 and is led by a steering committee of 9 members, including our current Chair, Ilana S. Rosman, MD (Washington University School of Medicine, St. Louis, Missouri), and Vice Chair, Jo-Ann M. Latkowski, MD (New York University, New York). Committee members are elected from and by the APD membership and must serve in program leadership at their home programs. The APD-RPDS helps plan and coordinate breakout sessions and lectures at the annual APD meeting, which typically relate to program director duties, changing policies within the American Board of Dermatology or Accreditation Council for Graduate Medical Education, ideas for future growth, and changes in our specialty and in resident education. Members of the APD-RPDS have access to the APD listserv, a valuable resource for discussing issues affecting residency training. We also have work groups led by our members, which include diversity, equity, and inclusion; resource development; communications; and the annual survey. To join the APD, the RPDS, and/or any of our workgroups, please reach out to us or visit the APD website (https://www.dermatologyprofessors.org).

We look forward to welcoming and expediently reviewing members’ submissions to the new Residency Roundup column falling into 2 principal categories within the scope of dermatologic recruitment, didactic education, and clinical training. The first category will feature novel tools, programs, and platforms to improve dermatology training through collaboration. This could entail a description of a new platform designed for sharing resources among programs and specialties to enhance learning for trainees and faculty alike. For example, if a database is created that contains prerecorded lectures pertaining to alopecia, a potential article submission might introduce the database and provide information on what topics are covered and how to access these lectures for readers worldwide. Likewise, if a new technology emerges that allows for easier collaboration among programs, a possible submission would introduce the technology and discuss its potential benefits to trainees, faculty, and practicing dermatologists.

Secondly and more commonly, we anticipate the Residency Roundup column will feature articles that delve into the critical issues and challenges currently impacting recruitment, training, and administration in dermatology residency programs. Specific topics may include but are not limited to recruitment of underrepresented in medicine applicants to dermatology, technological advances to improve teaching methods within training programs, surveys delving into the dermatology match process, and educational gaps or future directions in the specialty. The column occasionally may be used to disseminate information from our section of the APD, including consensus statements or editorials related to changes implemented in the dermatology residency application process. A prospective editorial on this subject could explore varying viewpoints of implemented and proposed changes as well as the reasons behind the changes.

Our group is collaborative, and our aim is to improve education, equity, management of program director responsibilities, and the dermatology application process for programs and applicants alike. With your input, experience, and varied perspectives, we look forward to moving the field of dermatology to a better future by working together. 

We are excited to announce a new partnership between Cutis and the Association of Professors of Dermatology Residency Program Directors Section (APD-RPDS). The new APD-RPDS column Residency Roundup will contain quarterly communications and submissions that we hope will facilitate greater dissemination of information that is useful to the dermatology teaching community.

The APD is a group of academic dermatologists whose membership comprises chairs, chiefs, residency and fellowship program directors, and teaching faculty. Each fall, the group convenes in Chicago, Illinois, for a 2-day meeting centered around departmental and program leadership with a focus on education. The APD-RPDS was formed in 2020 and is led by a steering committee of 9 members, including our current Chair, Ilana S. Rosman, MD (Washington University School of Medicine, St. Louis, Missouri), and Vice Chair, Jo-Ann M. Latkowski, MD (New York University, New York). Committee members are elected from and by the APD membership and must serve in program leadership at their home programs. The APD-RPDS helps plan and coordinate breakout sessions and lectures at the annual APD meeting, which typically relate to program director duties, changing policies within the American Board of Dermatology or Accreditation Council for Graduate Medical Education, ideas for future growth, and changes in our specialty and in resident education. Members of the APD-RPDS have access to the APD listserv, a valuable resource for discussing issues affecting residency training. We also have work groups led by our members, which include diversity, equity, and inclusion; resource development; communications; and the annual survey. To join the APD, the RPDS, and/or any of our workgroups, please reach out to us or visit the APD website (https://www.dermatologyprofessors.org).

We look forward to welcoming and expediently reviewing members’ submissions to the new Residency Roundup column falling into 2 principal categories within the scope of dermatologic recruitment, didactic education, and clinical training. The first category will feature novel tools, programs, and platforms to improve dermatology training through collaboration. This could entail a description of a new platform designed for sharing resources among programs and specialties to enhance learning for trainees and faculty alike. For example, if a database is created that contains prerecorded lectures pertaining to alopecia, a potential article submission might introduce the database and provide information on what topics are covered and how to access these lectures for readers worldwide. Likewise, if a new technology emerges that allows for easier collaboration among programs, a possible submission would introduce the technology and discuss its potential benefits to trainees, faculty, and practicing dermatologists.

Secondly and more commonly, we anticipate the Residency Roundup column will feature articles that delve into the critical issues and challenges currently impacting recruitment, training, and administration in dermatology residency programs. Specific topics may include but are not limited to recruitment of underrepresented in medicine applicants to dermatology, technological advances to improve teaching methods within training programs, surveys delving into the dermatology match process, and educational gaps or future directions in the specialty. The column occasionally may be used to disseminate information from our section of the APD, including consensus statements or editorials related to changes implemented in the dermatology residency application process. A prospective editorial on this subject could explore varying viewpoints of implemented and proposed changes as well as the reasons behind the changes.

Our group is collaborative, and our aim is to improve education, equity, management of program director responsibilities, and the dermatology application process for programs and applicants alike. With your input, experience, and varied perspectives, we look forward to moving the field of dermatology to a better future by working together. 

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We all struggle with the unwritten rules of medical culture

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There is a two-lane bridge in my town. It is quaint and picturesque, and when we first moved here, I would gaze out at the water as I drove, letting my mind wander along with the seagulls drifting alongside the car. Until one day, crossing back over, I passed a school bus stopped in the other lane, and instead of waving back, the driver gave me such a fierce look of disapproval I felt like I’d been to the principal’s office. What had I done?

I started paying more attention to the pattern of the other cars on the bridge. Although it appeared to be a standard two-lane width, the lanes weren’t quite wide enough if a school bus or large truck needed to cross at the same time as a car coming from the opposite direction. They had to wait until the other lane was clear. It was an unwritten rule of the town that if you saw a school bus on the other side, you stopped your car and yielded the bridge to the bus. It took me weeks to figure this out. When I did, I felt like I finally belonged in the community. Before, I’d been an outsider.

This got me thinking about culture. Every place has its unwritten rules, whether a community or a workplace. But how do we know the culture of a place? It’s pretty much impossible until we experience it for ourselves.

When I did figure out the bridge, I had a little bit of anger, to be honest. How was I supposed to know about the lanes? There weren’t any signs. Geez.

Now, when I approach the bridge, I don’t even think about it. I know what to do if I see a bus coming.

But sometimes I remember that time of confusion before I deciphered the unwritten rule. I still have a twinge of guilt for having done something wrong, even though it hadn’t been my fault.

It reminded me of a memory from medical training. I was an MS4, and my ER rotation was in a busy county hospital with a level I trauma center. To say that the place was chaotic would be an understatement.

On the first morning, I was shown the chart rack (yes, this was back in the day of paper charts). Charts were placed in the order that patients arrived. Med students and residents were to take a chart in chronological order, go triage and assess the patient, and then find an attending. Once finished, you put the chart back on the rack and picked up the next one. This was the extent of my orientation to the ER.

The days and weeks of the rotation flew by. It was a busy and exciting time. By the end of the month, I’d come to feel a part of the team.

Until one day, after finishing discharging a patient, an attending asked me, “Where’s the billing sheet?”

I had no idea what she was talking about. No one had ever shown me a billing sheet. But by this point, as an MS4, I knew well that if an attending asked you something you didn’t know the answer to, you shouldn’t just say that you didn’t know. You should try to figure out if you could at least approximate an answer first.

As I scrambled in my mind to figure out what she was asking me, she took one look at the apprehension in my eyes and asked again, raising her voice, “You haven’t been doing the billing sheets?”

I thought back to the first day of the rotation. The cursory 30-second orientation. Chart rack. Take one. See the patient. Put it back. See the next patient. Nothing about billing sheets.

“No,” I said. “No one ever told me about – ”

But the attending didn’t care that I hadn’t been instructed on the billing sheets. She ripped into me, yelling about how she couldn’t believe I’d been working there the entire month and was not doing the billing sheets. She showed me what they were and where they were supposed to be going and, in front of the whole staff, treated me like not only the biggest idiot she’d ever worked with but that the hospital had ever seen.

As she berated me, I thought about all the patients I’d seen that month. All the billing sheets I hadn’t placed in the pile. All the attendings who hadn’t gotten credit for the patients they’d staffed with me.

But how could I have known? I wanted to ask. How could I have known if nobody showed me or told me?

It was like the bridge. I was in a new environment and somehow expected to know the rules without anyone telling me; and when I didn’t know, people treated me like I’d done it the wrong way on purpose.

I didn’t end up saying anything more to that attending. What could I have said? She had already unleashed a mountain of her pent-up anger at me.

What I did decide in that moment was that I would never be an attending like that.

Like the bridge, this memory years later can still make me feel guilt and shame for doing something wrong. Even though it wasn’t my fault.

I was thinking about this recently with the Match. Thousands of freshly graduated medical students embarking on their new positions as interns in teaching hospitals across the country.

For anyone who, like me, struggled with the unwritten rules of the medical culture with each new rotation, remember to be kind to yourself. If someone treats you poorly for not knowing something, you are not an idiot. You’ve worked incredibly hard to get where you are, and you deserve to be there.

For attendings and more senior trainees, remember what it was like to be starting in a new place. We all make mistakes, and often it’s simply because of a lack of information.

Trainees shouldn’t have to suffer and be made to feel like outsiders until they figure out the unwritten rules of the place. They belong.
 

Dr. Lycette is medical director of Providence Oncology and Hematology Care Clinic, Seaside, Ore. She disclosed no relevant conflicts of interest. A version of this article first appeared on Medscape.com.

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There is a two-lane bridge in my town. It is quaint and picturesque, and when we first moved here, I would gaze out at the water as I drove, letting my mind wander along with the seagulls drifting alongside the car. Until one day, crossing back over, I passed a school bus stopped in the other lane, and instead of waving back, the driver gave me such a fierce look of disapproval I felt like I’d been to the principal’s office. What had I done?

I started paying more attention to the pattern of the other cars on the bridge. Although it appeared to be a standard two-lane width, the lanes weren’t quite wide enough if a school bus or large truck needed to cross at the same time as a car coming from the opposite direction. They had to wait until the other lane was clear. It was an unwritten rule of the town that if you saw a school bus on the other side, you stopped your car and yielded the bridge to the bus. It took me weeks to figure this out. When I did, I felt like I finally belonged in the community. Before, I’d been an outsider.

This got me thinking about culture. Every place has its unwritten rules, whether a community or a workplace. But how do we know the culture of a place? It’s pretty much impossible until we experience it for ourselves.

When I did figure out the bridge, I had a little bit of anger, to be honest. How was I supposed to know about the lanes? There weren’t any signs. Geez.

Now, when I approach the bridge, I don’t even think about it. I know what to do if I see a bus coming.

But sometimes I remember that time of confusion before I deciphered the unwritten rule. I still have a twinge of guilt for having done something wrong, even though it hadn’t been my fault.

It reminded me of a memory from medical training. I was an MS4, and my ER rotation was in a busy county hospital with a level I trauma center. To say that the place was chaotic would be an understatement.

On the first morning, I was shown the chart rack (yes, this was back in the day of paper charts). Charts were placed in the order that patients arrived. Med students and residents were to take a chart in chronological order, go triage and assess the patient, and then find an attending. Once finished, you put the chart back on the rack and picked up the next one. This was the extent of my orientation to the ER.

The days and weeks of the rotation flew by. It was a busy and exciting time. By the end of the month, I’d come to feel a part of the team.

Until one day, after finishing discharging a patient, an attending asked me, “Where’s the billing sheet?”

I had no idea what she was talking about. No one had ever shown me a billing sheet. But by this point, as an MS4, I knew well that if an attending asked you something you didn’t know the answer to, you shouldn’t just say that you didn’t know. You should try to figure out if you could at least approximate an answer first.

As I scrambled in my mind to figure out what she was asking me, she took one look at the apprehension in my eyes and asked again, raising her voice, “You haven’t been doing the billing sheets?”

I thought back to the first day of the rotation. The cursory 30-second orientation. Chart rack. Take one. See the patient. Put it back. See the next patient. Nothing about billing sheets.

“No,” I said. “No one ever told me about – ”

But the attending didn’t care that I hadn’t been instructed on the billing sheets. She ripped into me, yelling about how she couldn’t believe I’d been working there the entire month and was not doing the billing sheets. She showed me what they were and where they were supposed to be going and, in front of the whole staff, treated me like not only the biggest idiot she’d ever worked with but that the hospital had ever seen.

As she berated me, I thought about all the patients I’d seen that month. All the billing sheets I hadn’t placed in the pile. All the attendings who hadn’t gotten credit for the patients they’d staffed with me.

But how could I have known? I wanted to ask. How could I have known if nobody showed me or told me?

It was like the bridge. I was in a new environment and somehow expected to know the rules without anyone telling me; and when I didn’t know, people treated me like I’d done it the wrong way on purpose.

I didn’t end up saying anything more to that attending. What could I have said? She had already unleashed a mountain of her pent-up anger at me.

What I did decide in that moment was that I would never be an attending like that.

Like the bridge, this memory years later can still make me feel guilt and shame for doing something wrong. Even though it wasn’t my fault.

I was thinking about this recently with the Match. Thousands of freshly graduated medical students embarking on their new positions as interns in teaching hospitals across the country.

For anyone who, like me, struggled with the unwritten rules of the medical culture with each new rotation, remember to be kind to yourself. If someone treats you poorly for not knowing something, you are not an idiot. You’ve worked incredibly hard to get where you are, and you deserve to be there.

For attendings and more senior trainees, remember what it was like to be starting in a new place. We all make mistakes, and often it’s simply because of a lack of information.

Trainees shouldn’t have to suffer and be made to feel like outsiders until they figure out the unwritten rules of the place. They belong.
 

Dr. Lycette is medical director of Providence Oncology and Hematology Care Clinic, Seaside, Ore. She disclosed no relevant conflicts of interest. A version of this article first appeared on Medscape.com.

There is a two-lane bridge in my town. It is quaint and picturesque, and when we first moved here, I would gaze out at the water as I drove, letting my mind wander along with the seagulls drifting alongside the car. Until one day, crossing back over, I passed a school bus stopped in the other lane, and instead of waving back, the driver gave me such a fierce look of disapproval I felt like I’d been to the principal’s office. What had I done?

I started paying more attention to the pattern of the other cars on the bridge. Although it appeared to be a standard two-lane width, the lanes weren’t quite wide enough if a school bus or large truck needed to cross at the same time as a car coming from the opposite direction. They had to wait until the other lane was clear. It was an unwritten rule of the town that if you saw a school bus on the other side, you stopped your car and yielded the bridge to the bus. It took me weeks to figure this out. When I did, I felt like I finally belonged in the community. Before, I’d been an outsider.

This got me thinking about culture. Every place has its unwritten rules, whether a community or a workplace. But how do we know the culture of a place? It’s pretty much impossible until we experience it for ourselves.

When I did figure out the bridge, I had a little bit of anger, to be honest. How was I supposed to know about the lanes? There weren’t any signs. Geez.

Now, when I approach the bridge, I don’t even think about it. I know what to do if I see a bus coming.

But sometimes I remember that time of confusion before I deciphered the unwritten rule. I still have a twinge of guilt for having done something wrong, even though it hadn’t been my fault.

It reminded me of a memory from medical training. I was an MS4, and my ER rotation was in a busy county hospital with a level I trauma center. To say that the place was chaotic would be an understatement.

On the first morning, I was shown the chart rack (yes, this was back in the day of paper charts). Charts were placed in the order that patients arrived. Med students and residents were to take a chart in chronological order, go triage and assess the patient, and then find an attending. Once finished, you put the chart back on the rack and picked up the next one. This was the extent of my orientation to the ER.

The days and weeks of the rotation flew by. It was a busy and exciting time. By the end of the month, I’d come to feel a part of the team.

Until one day, after finishing discharging a patient, an attending asked me, “Where’s the billing sheet?”

I had no idea what she was talking about. No one had ever shown me a billing sheet. But by this point, as an MS4, I knew well that if an attending asked you something you didn’t know the answer to, you shouldn’t just say that you didn’t know. You should try to figure out if you could at least approximate an answer first.

As I scrambled in my mind to figure out what she was asking me, she took one look at the apprehension in my eyes and asked again, raising her voice, “You haven’t been doing the billing sheets?”

I thought back to the first day of the rotation. The cursory 30-second orientation. Chart rack. Take one. See the patient. Put it back. See the next patient. Nothing about billing sheets.

“No,” I said. “No one ever told me about – ”

But the attending didn’t care that I hadn’t been instructed on the billing sheets. She ripped into me, yelling about how she couldn’t believe I’d been working there the entire month and was not doing the billing sheets. She showed me what they were and where they were supposed to be going and, in front of the whole staff, treated me like not only the biggest idiot she’d ever worked with but that the hospital had ever seen.

As she berated me, I thought about all the patients I’d seen that month. All the billing sheets I hadn’t placed in the pile. All the attendings who hadn’t gotten credit for the patients they’d staffed with me.

But how could I have known? I wanted to ask. How could I have known if nobody showed me or told me?

It was like the bridge. I was in a new environment and somehow expected to know the rules without anyone telling me; and when I didn’t know, people treated me like I’d done it the wrong way on purpose.

I didn’t end up saying anything more to that attending. What could I have said? She had already unleashed a mountain of her pent-up anger at me.

What I did decide in that moment was that I would never be an attending like that.

Like the bridge, this memory years later can still make me feel guilt and shame for doing something wrong. Even though it wasn’t my fault.

I was thinking about this recently with the Match. Thousands of freshly graduated medical students embarking on their new positions as interns in teaching hospitals across the country.

For anyone who, like me, struggled with the unwritten rules of the medical culture with each new rotation, remember to be kind to yourself. If someone treats you poorly for not knowing something, you are not an idiot. You’ve worked incredibly hard to get where you are, and you deserve to be there.

For attendings and more senior trainees, remember what it was like to be starting in a new place. We all make mistakes, and often it’s simply because of a lack of information.

Trainees shouldn’t have to suffer and be made to feel like outsiders until they figure out the unwritten rules of the place. They belong.
 

Dr. Lycette is medical director of Providence Oncology and Hematology Care Clinic, Seaside, Ore. She disclosed no relevant conflicts of interest. A version of this article first appeared on Medscape.com.

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