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Breastfeeding in residency
I had my first child during my third year of medical school, and I remember being embarrassed to tell my attending and residents that I needed to pump. I was at the bottom of the training hierarchy and I didn’t want to ask for “special accommodations.” I remember racing to a separate wing of the hospital to pump during my lunch break (if not taken up by lectures), while devouring a sandwich. It quickly became overwhelming, and by the time my daughter was 3 months old, I started supplementing.
I am currently breastfeeding my second child now as a third year pediatric resident. The experience has been much better. My son is 6 months old and is still breastfed! As a resident, I felt more comfortable making everyone aware of my need to pump periodically during work hours. My coresidents and faculty have been very supportive. In fact, I remember my first month back from maternity leave working in the pediatric ICU. I quickly discovered that nearly every floor of the hospital has a lactation room, including the ICU. One time I was in the middle of pumping when my attending paged me with a nonurgent issue. Once finished, I called back and apologized, explaining the reason for my late response. In return, I received an even bigger apology from my attending, who felt bad for disturbing my pumping session. I was moved.
The American Academy of Pediatrics recommends exclusive breastfeeding of healthy term infants for about 6 months.1 Healthy People 2020 set goals of 82% breastfeeding at birth and 61% at 6 months.2 How do we as trainees do? A study published in 1996 looked at 60 female residents who delivered a child during residency. They found that even though 80% initiated breastfeeding, only 15% were still breastfeeding at 6 months. Only 54% of these residents who were breastfeeding after returning to work felt supported by their attending, and 67% felt supported by their colleagues.3 A more recent study published in 2013 looked at breastfeeding during obstetrics residency. Of 89 female residents who had personal experience with breastfeeding, 73% felt supported by their program directors and faculty; and 84% felt supported by colleagues. The rate of breastfeeding at 6 months was now 52%.4
Compared with 1996, breastfeeding practices during residency appear to have improved with much higher rates at 6 months. However, we are slightly below the Healthy People 2020 goals. For the most part, residents feel supported by their attendings and colleagues. With continued support and attention, these goals are well within reach. When it comes to breastfeeding during training, be your own advocate!
References
1. Pediatrics. 2012 Mar;129(3):e827-41.
3. Pediatrics. 1996 Sep;98(3 Pt 1):434-7.
4. Breastfeed Med. 2013 Aug;8(4):394-400.
Dr. Burek is a third-year pediatric resident at the Medical College of Wisconsin and the Children’s Hospital of Wisconsin, both in Milwaukee.
I had my first child during my third year of medical school, and I remember being embarrassed to tell my attending and residents that I needed to pump. I was at the bottom of the training hierarchy and I didn’t want to ask for “special accommodations.” I remember racing to a separate wing of the hospital to pump during my lunch break (if not taken up by lectures), while devouring a sandwich. It quickly became overwhelming, and by the time my daughter was 3 months old, I started supplementing.
I am currently breastfeeding my second child now as a third year pediatric resident. The experience has been much better. My son is 6 months old and is still breastfed! As a resident, I felt more comfortable making everyone aware of my need to pump periodically during work hours. My coresidents and faculty have been very supportive. In fact, I remember my first month back from maternity leave working in the pediatric ICU. I quickly discovered that nearly every floor of the hospital has a lactation room, including the ICU. One time I was in the middle of pumping when my attending paged me with a nonurgent issue. Once finished, I called back and apologized, explaining the reason for my late response. In return, I received an even bigger apology from my attending, who felt bad for disturbing my pumping session. I was moved.
The American Academy of Pediatrics recommends exclusive breastfeeding of healthy term infants for about 6 months.1 Healthy People 2020 set goals of 82% breastfeeding at birth and 61% at 6 months.2 How do we as trainees do? A study published in 1996 looked at 60 female residents who delivered a child during residency. They found that even though 80% initiated breastfeeding, only 15% were still breastfeeding at 6 months. Only 54% of these residents who were breastfeeding after returning to work felt supported by their attending, and 67% felt supported by their colleagues.3 A more recent study published in 2013 looked at breastfeeding during obstetrics residency. Of 89 female residents who had personal experience with breastfeeding, 73% felt supported by their program directors and faculty; and 84% felt supported by colleagues. The rate of breastfeeding at 6 months was now 52%.4
Compared with 1996, breastfeeding practices during residency appear to have improved with much higher rates at 6 months. However, we are slightly below the Healthy People 2020 goals. For the most part, residents feel supported by their attendings and colleagues. With continued support and attention, these goals are well within reach. When it comes to breastfeeding during training, be your own advocate!
References
1. Pediatrics. 2012 Mar;129(3):e827-41.
3. Pediatrics. 1996 Sep;98(3 Pt 1):434-7.
4. Breastfeed Med. 2013 Aug;8(4):394-400.
Dr. Burek is a third-year pediatric resident at the Medical College of Wisconsin and the Children’s Hospital of Wisconsin, both in Milwaukee.
I had my first child during my third year of medical school, and I remember being embarrassed to tell my attending and residents that I needed to pump. I was at the bottom of the training hierarchy and I didn’t want to ask for “special accommodations.” I remember racing to a separate wing of the hospital to pump during my lunch break (if not taken up by lectures), while devouring a sandwich. It quickly became overwhelming, and by the time my daughter was 3 months old, I started supplementing.
I am currently breastfeeding my second child now as a third year pediatric resident. The experience has been much better. My son is 6 months old and is still breastfed! As a resident, I felt more comfortable making everyone aware of my need to pump periodically during work hours. My coresidents and faculty have been very supportive. In fact, I remember my first month back from maternity leave working in the pediatric ICU. I quickly discovered that nearly every floor of the hospital has a lactation room, including the ICU. One time I was in the middle of pumping when my attending paged me with a nonurgent issue. Once finished, I called back and apologized, explaining the reason for my late response. In return, I received an even bigger apology from my attending, who felt bad for disturbing my pumping session. I was moved.
The American Academy of Pediatrics recommends exclusive breastfeeding of healthy term infants for about 6 months.1 Healthy People 2020 set goals of 82% breastfeeding at birth and 61% at 6 months.2 How do we as trainees do? A study published in 1996 looked at 60 female residents who delivered a child during residency. They found that even though 80% initiated breastfeeding, only 15% were still breastfeeding at 6 months. Only 54% of these residents who were breastfeeding after returning to work felt supported by their attending, and 67% felt supported by their colleagues.3 A more recent study published in 2013 looked at breastfeeding during obstetrics residency. Of 89 female residents who had personal experience with breastfeeding, 73% felt supported by their program directors and faculty; and 84% felt supported by colleagues. The rate of breastfeeding at 6 months was now 52%.4
Compared with 1996, breastfeeding practices during residency appear to have improved with much higher rates at 6 months. However, we are slightly below the Healthy People 2020 goals. For the most part, residents feel supported by their attendings and colleagues. With continued support and attention, these goals are well within reach. When it comes to breastfeeding during training, be your own advocate!
References
1. Pediatrics. 2012 Mar;129(3):e827-41.
3. Pediatrics. 1996 Sep;98(3 Pt 1):434-7.
4. Breastfeed Med. 2013 Aug;8(4):394-400.
Dr. Burek is a third-year pediatric resident at the Medical College of Wisconsin and the Children’s Hospital of Wisconsin, both in Milwaukee.
Don’t forget about OSHA
Given the bewildering array of new bureaucracies that private practices have been forced to contend with in recent years, it’s easy to forget about the older ones – especially OSHA (Occupational Safety and Health Administration).
Now would be a good time – before the new year begins, and you’re forced to take on the MACRA meshugas, which I’ll discuss next month – to get out your OSHA logs, walk through your office, and confirm that you remain in compliance with all the applicable regulations. Even if you hold regular safety meetings (which all too often is not the case), the occasional comprehensive review is always a good idea, and could save you a bundle in fines.
I’m always amazed at how many offices lack an official OSHA poster, enumerating employee rights and explaining how to file complaints; it’s the first thing an OSHA inspector looks for. You can download one from OSHA’s website, or order it at no charge by calling 800-321-OSHA.
Next, check out your building’s exits. Everyone must be able to evacuate your office quickly in case of fire or other emergencies. At minimum, you (or the owner of the building) are expected to establish exit routes to accommodate all employees and to post easily visible evacuation diagrams.
Examine all electrical devices and their power sources. All electrically powered equipment – medical, clerical, or anything else in the office – must operate safely. Pay particular attention to the way wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it and that circuit breakers are present and functioning. And beware the common situation of too many gadgets running off a single circuit.
Now, review your list of hazardous chemicals, which all employees have a right to know about. Keep in mind that OSHA’s list contains many substances – alcohol, disinfectants, even hydrogen peroxide – that you might not consider particularly dangerous but must nevertheless be on your written list of hazardous chemicals. For each of these, your employees must also have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific substance and for handling and containing it in a spill or other emergency.
How old is your written exposure control plan for blood-borne pathogens? It should document your use of such protective equipment as gloves, face and eye protection, and gowns, and your implementation of universal precautions – and it’s supposed to be updated annually, to reflect changes in technology. You need not adopt every new safety device as it comes on the market, but you should document which ones you are using, and why.
For example, you and your employees may decide not to purchase a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it’s worth; but you should document how you arrived at your decision and what you plan to use instead.
You must provide all at-risk employees with hepatitis B vaccine, at no cost to them. You also must provide and pay for appropriate medical treatment and follow-up after any exposure to a dangerous pathogen.
Other components of the rule include proper containment of regulated medical waste, identification of regulated waste containers, sharps disposal boxes, and periodic employee training regarding all of those things.
Federal OSHA regulations do not require medical and dental offices to keep an injury and illness log, as other businesses must; but your state may have such a requirement that supersedes the federal law. Check with your state, or with your local OSHA office, regarding any such requirements.
It is a mistake to take OSHA regulations lightly; failure to comply with them can result in stiff penalties running into many thousands of dollars.
How can you be certain you are complying with all the rules? The easiest and cheapest way is to call your local OSHA office and request an inspection. Why would you want to do that? Because in return for agreeing to have your office inspected, OSHA will agree not to cite you for any violations they find, as long as you fix them.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
Given the bewildering array of new bureaucracies that private practices have been forced to contend with in recent years, it’s easy to forget about the older ones – especially OSHA (Occupational Safety and Health Administration).
Now would be a good time – before the new year begins, and you’re forced to take on the MACRA meshugas, which I’ll discuss next month – to get out your OSHA logs, walk through your office, and confirm that you remain in compliance with all the applicable regulations. Even if you hold regular safety meetings (which all too often is not the case), the occasional comprehensive review is always a good idea, and could save you a bundle in fines.
I’m always amazed at how many offices lack an official OSHA poster, enumerating employee rights and explaining how to file complaints; it’s the first thing an OSHA inspector looks for. You can download one from OSHA’s website, or order it at no charge by calling 800-321-OSHA.
Next, check out your building’s exits. Everyone must be able to evacuate your office quickly in case of fire or other emergencies. At minimum, you (or the owner of the building) are expected to establish exit routes to accommodate all employees and to post easily visible evacuation diagrams.
Examine all electrical devices and their power sources. All electrically powered equipment – medical, clerical, or anything else in the office – must operate safely. Pay particular attention to the way wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it and that circuit breakers are present and functioning. And beware the common situation of too many gadgets running off a single circuit.
Now, review your list of hazardous chemicals, which all employees have a right to know about. Keep in mind that OSHA’s list contains many substances – alcohol, disinfectants, even hydrogen peroxide – that you might not consider particularly dangerous but must nevertheless be on your written list of hazardous chemicals. For each of these, your employees must also have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific substance and for handling and containing it in a spill or other emergency.
How old is your written exposure control plan for blood-borne pathogens? It should document your use of such protective equipment as gloves, face and eye protection, and gowns, and your implementation of universal precautions – and it’s supposed to be updated annually, to reflect changes in technology. You need not adopt every new safety device as it comes on the market, but you should document which ones you are using, and why.
For example, you and your employees may decide not to purchase a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it’s worth; but you should document how you arrived at your decision and what you plan to use instead.
You must provide all at-risk employees with hepatitis B vaccine, at no cost to them. You also must provide and pay for appropriate medical treatment and follow-up after any exposure to a dangerous pathogen.
Other components of the rule include proper containment of regulated medical waste, identification of regulated waste containers, sharps disposal boxes, and periodic employee training regarding all of those things.
Federal OSHA regulations do not require medical and dental offices to keep an injury and illness log, as other businesses must; but your state may have such a requirement that supersedes the federal law. Check with your state, or with your local OSHA office, regarding any such requirements.
It is a mistake to take OSHA regulations lightly; failure to comply with them can result in stiff penalties running into many thousands of dollars.
How can you be certain you are complying with all the rules? The easiest and cheapest way is to call your local OSHA office and request an inspection. Why would you want to do that? Because in return for agreeing to have your office inspected, OSHA will agree not to cite you for any violations they find, as long as you fix them.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
Given the bewildering array of new bureaucracies that private practices have been forced to contend with in recent years, it’s easy to forget about the older ones – especially OSHA (Occupational Safety and Health Administration).
Now would be a good time – before the new year begins, and you’re forced to take on the MACRA meshugas, which I’ll discuss next month – to get out your OSHA logs, walk through your office, and confirm that you remain in compliance with all the applicable regulations. Even if you hold regular safety meetings (which all too often is not the case), the occasional comprehensive review is always a good idea, and could save you a bundle in fines.
I’m always amazed at how many offices lack an official OSHA poster, enumerating employee rights and explaining how to file complaints; it’s the first thing an OSHA inspector looks for. You can download one from OSHA’s website, or order it at no charge by calling 800-321-OSHA.
Next, check out your building’s exits. Everyone must be able to evacuate your office quickly in case of fire or other emergencies. At minimum, you (or the owner of the building) are expected to establish exit routes to accommodate all employees and to post easily visible evacuation diagrams.
Examine all electrical devices and their power sources. All electrically powered equipment – medical, clerical, or anything else in the office – must operate safely. Pay particular attention to the way wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it and that circuit breakers are present and functioning. And beware the common situation of too many gadgets running off a single circuit.
Now, review your list of hazardous chemicals, which all employees have a right to know about. Keep in mind that OSHA’s list contains many substances – alcohol, disinfectants, even hydrogen peroxide – that you might not consider particularly dangerous but must nevertheless be on your written list of hazardous chemicals. For each of these, your employees must also have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific substance and for handling and containing it in a spill or other emergency.
How old is your written exposure control plan for blood-borne pathogens? It should document your use of such protective equipment as gloves, face and eye protection, and gowns, and your implementation of universal precautions – and it’s supposed to be updated annually, to reflect changes in technology. You need not adopt every new safety device as it comes on the market, but you should document which ones you are using, and why.
For example, you and your employees may decide not to purchase a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it’s worth; but you should document how you arrived at your decision and what you plan to use instead.
You must provide all at-risk employees with hepatitis B vaccine, at no cost to them. You also must provide and pay for appropriate medical treatment and follow-up after any exposure to a dangerous pathogen.
Other components of the rule include proper containment of regulated medical waste, identification of regulated waste containers, sharps disposal boxes, and periodic employee training regarding all of those things.
Federal OSHA regulations do not require medical and dental offices to keep an injury and illness log, as other businesses must; but your state may have such a requirement that supersedes the federal law. Check with your state, or with your local OSHA office, regarding any such requirements.
It is a mistake to take OSHA regulations lightly; failure to comply with them can result in stiff penalties running into many thousands of dollars.
How can you be certain you are complying with all the rules? The easiest and cheapest way is to call your local OSHA office and request an inspection. Why would you want to do that? Because in return for agreeing to have your office inspected, OSHA will agree not to cite you for any violations they find, as long as you fix them.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
Should I throw out my expired medications?
A 55-year-old patient requests new prescriptions at a routine appointment. She will be traveling internationally next month and wants to replace her emergency medication kit, as the medications in it (ciprofloxacin, loperamide, and oxycodone) have all expired.
What do you do?
A) Replace the prescription for ciprofloxacin.
B) Replace all three medications.
C) Tell the patient that all the meds should still be fine.
This is a common concern brought up by patients. Many patients discard medications when they pass the expiration date on the package. Is this necessary? Is there a health risk to taking expired medications, and is it okay from a therapeutic standpoint to use medications past their expiration date?
The expiration date is not a date that the drug stops being effective or potentially becomes toxic. It is a date, required by law, that the manufacturer can guarantee greater than 90% original potency of the medication. There really isn’t incentive for pharmaceutical companies to extend the expiration dates, as it is profitable for patients to throw away expired medications and replace them with new prescriptions.
The U.S. military purchases a large stockpile of drugs and has the potential for having a great deal of expired medications. To help reduce this problem, the Food and Drug Administration administers the shelf-life extension program (SLEP) for the U.S. military as a testing and evaluation program designed to justify an extension of the shelf life of stockpiled drug products.1
Robbe Lyon, MD, and colleagues reported data from the SLEP.2 A total of 122 drugs were studied representing 3,005 lots, with 88% of these extended at least 1 year past the expiration date, with an average extension of more than 5 years. Several antibiotics were studied, including ciprofloxacin (mean extension, 55 months), amoxicillin (mean extension, 23 months), and doxycycline (mean extension, 50 months).
Lee Cantrell, PharmD, and coinvestigators looked at sealed drugs from a retail pharmacy that were 28-40 years past their expiration date.3 Amazingly, 12 of the 14 compounds tested were in concentrations that were at least 90% of the labeled amount. Among the drugs that were tested that maintained greater than 90% of the labeled amount were acetaminophen, codeine, hydrocodone, and barbiturates. Aspirin and amphetamine were the two drugs that did not have greater than 90% of the labeled amount. The aspirin amounts were very low, about 1% of the listed amount on the package.
The major myth surrounding expired medications is that taking an expired medication could be toxic.
There is one case report of toxicity from the use of expired tetracycline.4 This was a case series of three patients who developed reversible Fanconi syndrome linked to using an expired tetracycline preparation. That preparation of tetracycline is no longer available.
There are no other reports of toxicity due to use of expired medications.5,6 There appears to be no direct risk of toxicity to the patient by using medication past the expiration date.
The risk that isn’t answered is the risk of using medications that may not be effective if potency isn’t guaranteed beyond the expiration date. It appears that most drugs are effective for years past the expiration date.
This isn’t an issue for medications for treatment of chronic conditions, as patients take the medications every day, and the medications will be used up long before they expire. For medications that are used infrequently – analgesics, antihistamines, and medications for traveler’s diarrhea – they appear to be stable for years past expiration, and there is little risk to the patient if the medications are not fully effective.
I think aspirin should not be used past expiration, given the data showing that it breaks down more so than other medications. For the case at the start of this article, I think having the patient use the expired medications should be fine.
References
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
A 55-year-old patient requests new prescriptions at a routine appointment. She will be traveling internationally next month and wants to replace her emergency medication kit, as the medications in it (ciprofloxacin, loperamide, and oxycodone) have all expired.
What do you do?
A) Replace the prescription for ciprofloxacin.
B) Replace all three medications.
C) Tell the patient that all the meds should still be fine.
This is a common concern brought up by patients. Many patients discard medications when they pass the expiration date on the package. Is this necessary? Is there a health risk to taking expired medications, and is it okay from a therapeutic standpoint to use medications past their expiration date?
The expiration date is not a date that the drug stops being effective or potentially becomes toxic. It is a date, required by law, that the manufacturer can guarantee greater than 90% original potency of the medication. There really isn’t incentive for pharmaceutical companies to extend the expiration dates, as it is profitable for patients to throw away expired medications and replace them with new prescriptions.
The U.S. military purchases a large stockpile of drugs and has the potential for having a great deal of expired medications. To help reduce this problem, the Food and Drug Administration administers the shelf-life extension program (SLEP) for the U.S. military as a testing and evaluation program designed to justify an extension of the shelf life of stockpiled drug products.1
Robbe Lyon, MD, and colleagues reported data from the SLEP.2 A total of 122 drugs were studied representing 3,005 lots, with 88% of these extended at least 1 year past the expiration date, with an average extension of more than 5 years. Several antibiotics were studied, including ciprofloxacin (mean extension, 55 months), amoxicillin (mean extension, 23 months), and doxycycline (mean extension, 50 months).
Lee Cantrell, PharmD, and coinvestigators looked at sealed drugs from a retail pharmacy that were 28-40 years past their expiration date.3 Amazingly, 12 of the 14 compounds tested were in concentrations that were at least 90% of the labeled amount. Among the drugs that were tested that maintained greater than 90% of the labeled amount were acetaminophen, codeine, hydrocodone, and barbiturates. Aspirin and amphetamine were the two drugs that did not have greater than 90% of the labeled amount. The aspirin amounts were very low, about 1% of the listed amount on the package.
The major myth surrounding expired medications is that taking an expired medication could be toxic.
There is one case report of toxicity from the use of expired tetracycline.4 This was a case series of three patients who developed reversible Fanconi syndrome linked to using an expired tetracycline preparation. That preparation of tetracycline is no longer available.
There are no other reports of toxicity due to use of expired medications.5,6 There appears to be no direct risk of toxicity to the patient by using medication past the expiration date.
The risk that isn’t answered is the risk of using medications that may not be effective if potency isn’t guaranteed beyond the expiration date. It appears that most drugs are effective for years past the expiration date.
This isn’t an issue for medications for treatment of chronic conditions, as patients take the medications every day, and the medications will be used up long before they expire. For medications that are used infrequently – analgesics, antihistamines, and medications for traveler’s diarrhea – they appear to be stable for years past expiration, and there is little risk to the patient if the medications are not fully effective.
I think aspirin should not be used past expiration, given the data showing that it breaks down more so than other medications. For the case at the start of this article, I think having the patient use the expired medications should be fine.
References
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
A 55-year-old patient requests new prescriptions at a routine appointment. She will be traveling internationally next month and wants to replace her emergency medication kit, as the medications in it (ciprofloxacin, loperamide, and oxycodone) have all expired.
What do you do?
A) Replace the prescription for ciprofloxacin.
B) Replace all three medications.
C) Tell the patient that all the meds should still be fine.
This is a common concern brought up by patients. Many patients discard medications when they pass the expiration date on the package. Is this necessary? Is there a health risk to taking expired medications, and is it okay from a therapeutic standpoint to use medications past their expiration date?
The expiration date is not a date that the drug stops being effective or potentially becomes toxic. It is a date, required by law, that the manufacturer can guarantee greater than 90% original potency of the medication. There really isn’t incentive for pharmaceutical companies to extend the expiration dates, as it is profitable for patients to throw away expired medications and replace them with new prescriptions.
The U.S. military purchases a large stockpile of drugs and has the potential for having a great deal of expired medications. To help reduce this problem, the Food and Drug Administration administers the shelf-life extension program (SLEP) for the U.S. military as a testing and evaluation program designed to justify an extension of the shelf life of stockpiled drug products.1
Robbe Lyon, MD, and colleagues reported data from the SLEP.2 A total of 122 drugs were studied representing 3,005 lots, with 88% of these extended at least 1 year past the expiration date, with an average extension of more than 5 years. Several antibiotics were studied, including ciprofloxacin (mean extension, 55 months), amoxicillin (mean extension, 23 months), and doxycycline (mean extension, 50 months).
Lee Cantrell, PharmD, and coinvestigators looked at sealed drugs from a retail pharmacy that were 28-40 years past their expiration date.3 Amazingly, 12 of the 14 compounds tested were in concentrations that were at least 90% of the labeled amount. Among the drugs that were tested that maintained greater than 90% of the labeled amount were acetaminophen, codeine, hydrocodone, and barbiturates. Aspirin and amphetamine were the two drugs that did not have greater than 90% of the labeled amount. The aspirin amounts were very low, about 1% of the listed amount on the package.
The major myth surrounding expired medications is that taking an expired medication could be toxic.
There is one case report of toxicity from the use of expired tetracycline.4 This was a case series of three patients who developed reversible Fanconi syndrome linked to using an expired tetracycline preparation. That preparation of tetracycline is no longer available.
There are no other reports of toxicity due to use of expired medications.5,6 There appears to be no direct risk of toxicity to the patient by using medication past the expiration date.
The risk that isn’t answered is the risk of using medications that may not be effective if potency isn’t guaranteed beyond the expiration date. It appears that most drugs are effective for years past the expiration date.
This isn’t an issue for medications for treatment of chronic conditions, as patients take the medications every day, and the medications will be used up long before they expire. For medications that are used infrequently – analgesics, antihistamines, and medications for traveler’s diarrhea – they appear to be stable for years past expiration, and there is little risk to the patient if the medications are not fully effective.
I think aspirin should not be used past expiration, given the data showing that it breaks down more so than other medications. For the case at the start of this article, I think having the patient use the expired medications should be fine.
References
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
Should we pursue board certification in Mohs micrographic surgery?
The medical director was direct and blunt: “You’ve got a problem with two very different levels of training in Mohs surgery. This is a big problem for your specialty.”
The remarks came at a medical director summit that I was attending to speak on the value of dermatology. I was explaining to medical directors how including small dermatology practices in their plans would realize cost savings when treating skin cancer in the office setting. An awkward silence followed the medical director’s remarks. Then I uttered a lame “we may have a board certification someday.”
My interview with the New York Times reporter before the meeting quickly became adversarial. “What about these guys who do Mohs after a 3-day course?” I explained that there is more involved than just the 3-day course, that there is a preceptorship and case reviews. Plus, some of “those guys” wrote some of the best Mohs textbooks. The reporter wasn’t buying it, and the rest of the interview went downhill.
And the training issues surrounding Mohs surgery are playing out in practice. One dermatologist wrote me complaining that an insurer will no longer let him bill for Mohs because “he can’t document his residency training in Mohs and did not do a fellowship.” Another wrote me saying he can no longer teach Mohs surgery at the VA or the medical school “because he didn’t do a formal Mohs fellowship.”
The issue of who is qualified to perform Mohs surgery is coming to a head. There are more than 2,500 dermatologists billing Medicare for Mohs, and insurers are groaning at the expense. They are looking for any possible reason to exclude dermatologists from billing for Mohs surgery.
A possible solution is a board certification in Mohs surgery. Osteopathic dermatologists have had this option for 20 years. Unfortunately, allopathic dermatologists cannot sit for the osteopathic exam. A new certification exam for allopathic dermatologists who have successfully completed a dermatology residency accredited by the Accreditation Council for Graduate Medical Education (ACGME) seems worthy of a discussion.
Downsides of certification include the likely $1,000 or more cost of a test, the costs of preparing for the test, and the risk of failing a test. A new certification would give the Maintenance of Certification (MOC) haters another reason to complain, since about 600 lifetime certified, board-exempt dermatologists would be dragged back into MOC to maintain a Mohs surgery subspecialty certification. Some of the current fellowship-trained Mohs surgeons will not like being grouped with the nonfellowship-trained surgeons, whom they consider their inferiors and who will now have the opportunity to be board certified.
The name of the fellowship, which is “micrographic surgery and dermatologic oncology,” also has some paranoid types fearing that they will lose the right to treat skin cancer if such a subspecialty is created. That shouldn’t be an issue, since all dermatologists are trained in residency to treat skin cancer. The formal fellowships already exist. There are already 1,600 fellowship-trained Mohs surgeons out there, and they have not cornered the market on skin cancer. The situation should not change since general dermatologists remain the gatekeepers – and entry point – for most skin cancer patients. Certification exams in dermatopathology and pediatric dermatology have not had a negative impact on general dermatologists, who still read their own slides and see kids for skin disease. In fact, having dermatopathology as a certified part of dermatology has been a huge benefit in our struggle to maintain the right to read our own slides.
Developing a certification exam would take at least 2 years if the American Board of Dermatology decided to do it. There would be no “grandfathering” automatic certification. Everyone would have to take the same exam – young, old, formally trained, or not.
Members of the American Board of Dermatology explained the qualifiers to sit for an exam (if there was an exam) at a summit I held in Cincinnati in 2015. They are interested in including all ABD dermatologists who currently practice Mohs surgery, fellowship trained or not. Suggested parameters included any ABD fellow whose practice is 20% Mohs and reconstructive surgery (by volume or income), or anyone who performs Mohs once a week. Fellowship-trained micrographic surgeons could be eligible, and this would be a self-attestation! There would be no case log reviews, no visits by inspectors, no secret questions or passwords. This pathway would remain open for 5 years as were the exams for dermatopathology and pediatric dermatology. After that point, only ACGME fellowship–trained Mohs surgeons would be eligible to take the exam.
Upsides to this approach include decreasing divisiveness in the specialty, creating a better brand, and elevating the specialty. A board certification will help in obtaining a Medicare specialty designation, which will help stop the delisting of Mohs surgeons from insurance networks based on their average charges compared with general dermatologists. This action would particularly help small practices.
The American Academy of Dermatology board of directors sent this issue to the education committee to inform and poll the membership. You should expect to hear more about the proposed process. As an AAD member, you will get to express your opinion so make sure you are well informed. The AAD membership opinion will be important in whether or not the American Board of Dermatology decides to pursue this. Remember, this is an American Board of Dermatology decision, not an AAD decision.
More reasons for a board certification include that the ACGME expects its fellowships to develop a board exam at some point (although not all have). The 1,000 ACGME fellowship–trained micrographic surgeons deserve a chance to be board certified, which is the medical profession’s way to demonstrate competence to the public.
Having all Mohs surgeons board certified would heal a huge rift in the house of dermatology, and give us a united, consistent face to present to other specialties, the Congress, and the media. Physicians are judged by their training and credentials. Love them or hate them, the ACGME is the gold standard. Perhaps the greatest beneficiaries would be those practicing Mohs who did not complete a formal fellowship. I think a board exam is overdue, and will be a boon to all of dermatology.
Dr. Coldiron is a past president of the American Academy of Dermatology. He is currently in private practice, but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics.
The medical director was direct and blunt: “You’ve got a problem with two very different levels of training in Mohs surgery. This is a big problem for your specialty.”
The remarks came at a medical director summit that I was attending to speak on the value of dermatology. I was explaining to medical directors how including small dermatology practices in their plans would realize cost savings when treating skin cancer in the office setting. An awkward silence followed the medical director’s remarks. Then I uttered a lame “we may have a board certification someday.”
My interview with the New York Times reporter before the meeting quickly became adversarial. “What about these guys who do Mohs after a 3-day course?” I explained that there is more involved than just the 3-day course, that there is a preceptorship and case reviews. Plus, some of “those guys” wrote some of the best Mohs textbooks. The reporter wasn’t buying it, and the rest of the interview went downhill.
And the training issues surrounding Mohs surgery are playing out in practice. One dermatologist wrote me complaining that an insurer will no longer let him bill for Mohs because “he can’t document his residency training in Mohs and did not do a fellowship.” Another wrote me saying he can no longer teach Mohs surgery at the VA or the medical school “because he didn’t do a formal Mohs fellowship.”
The issue of who is qualified to perform Mohs surgery is coming to a head. There are more than 2,500 dermatologists billing Medicare for Mohs, and insurers are groaning at the expense. They are looking for any possible reason to exclude dermatologists from billing for Mohs surgery.
A possible solution is a board certification in Mohs surgery. Osteopathic dermatologists have had this option for 20 years. Unfortunately, allopathic dermatologists cannot sit for the osteopathic exam. A new certification exam for allopathic dermatologists who have successfully completed a dermatology residency accredited by the Accreditation Council for Graduate Medical Education (ACGME) seems worthy of a discussion.
Downsides of certification include the likely $1,000 or more cost of a test, the costs of preparing for the test, and the risk of failing a test. A new certification would give the Maintenance of Certification (MOC) haters another reason to complain, since about 600 lifetime certified, board-exempt dermatologists would be dragged back into MOC to maintain a Mohs surgery subspecialty certification. Some of the current fellowship-trained Mohs surgeons will not like being grouped with the nonfellowship-trained surgeons, whom they consider their inferiors and who will now have the opportunity to be board certified.
The name of the fellowship, which is “micrographic surgery and dermatologic oncology,” also has some paranoid types fearing that they will lose the right to treat skin cancer if such a subspecialty is created. That shouldn’t be an issue, since all dermatologists are trained in residency to treat skin cancer. The formal fellowships already exist. There are already 1,600 fellowship-trained Mohs surgeons out there, and they have not cornered the market on skin cancer. The situation should not change since general dermatologists remain the gatekeepers – and entry point – for most skin cancer patients. Certification exams in dermatopathology and pediatric dermatology have not had a negative impact on general dermatologists, who still read their own slides and see kids for skin disease. In fact, having dermatopathology as a certified part of dermatology has been a huge benefit in our struggle to maintain the right to read our own slides.
Developing a certification exam would take at least 2 years if the American Board of Dermatology decided to do it. There would be no “grandfathering” automatic certification. Everyone would have to take the same exam – young, old, formally trained, or not.
Members of the American Board of Dermatology explained the qualifiers to sit for an exam (if there was an exam) at a summit I held in Cincinnati in 2015. They are interested in including all ABD dermatologists who currently practice Mohs surgery, fellowship trained or not. Suggested parameters included any ABD fellow whose practice is 20% Mohs and reconstructive surgery (by volume or income), or anyone who performs Mohs once a week. Fellowship-trained micrographic surgeons could be eligible, and this would be a self-attestation! There would be no case log reviews, no visits by inspectors, no secret questions or passwords. This pathway would remain open for 5 years as were the exams for dermatopathology and pediatric dermatology. After that point, only ACGME fellowship–trained Mohs surgeons would be eligible to take the exam.
Upsides to this approach include decreasing divisiveness in the specialty, creating a better brand, and elevating the specialty. A board certification will help in obtaining a Medicare specialty designation, which will help stop the delisting of Mohs surgeons from insurance networks based on their average charges compared with general dermatologists. This action would particularly help small practices.
The American Academy of Dermatology board of directors sent this issue to the education committee to inform and poll the membership. You should expect to hear more about the proposed process. As an AAD member, you will get to express your opinion so make sure you are well informed. The AAD membership opinion will be important in whether or not the American Board of Dermatology decides to pursue this. Remember, this is an American Board of Dermatology decision, not an AAD decision.
More reasons for a board certification include that the ACGME expects its fellowships to develop a board exam at some point (although not all have). The 1,000 ACGME fellowship–trained micrographic surgeons deserve a chance to be board certified, which is the medical profession’s way to demonstrate competence to the public.
Having all Mohs surgeons board certified would heal a huge rift in the house of dermatology, and give us a united, consistent face to present to other specialties, the Congress, and the media. Physicians are judged by their training and credentials. Love them or hate them, the ACGME is the gold standard. Perhaps the greatest beneficiaries would be those practicing Mohs who did not complete a formal fellowship. I think a board exam is overdue, and will be a boon to all of dermatology.
Dr. Coldiron is a past president of the American Academy of Dermatology. He is currently in private practice, but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics.
The medical director was direct and blunt: “You’ve got a problem with two very different levels of training in Mohs surgery. This is a big problem for your specialty.”
The remarks came at a medical director summit that I was attending to speak on the value of dermatology. I was explaining to medical directors how including small dermatology practices in their plans would realize cost savings when treating skin cancer in the office setting. An awkward silence followed the medical director’s remarks. Then I uttered a lame “we may have a board certification someday.”
My interview with the New York Times reporter before the meeting quickly became adversarial. “What about these guys who do Mohs after a 3-day course?” I explained that there is more involved than just the 3-day course, that there is a preceptorship and case reviews. Plus, some of “those guys” wrote some of the best Mohs textbooks. The reporter wasn’t buying it, and the rest of the interview went downhill.
And the training issues surrounding Mohs surgery are playing out in practice. One dermatologist wrote me complaining that an insurer will no longer let him bill for Mohs because “he can’t document his residency training in Mohs and did not do a fellowship.” Another wrote me saying he can no longer teach Mohs surgery at the VA or the medical school “because he didn’t do a formal Mohs fellowship.”
The issue of who is qualified to perform Mohs surgery is coming to a head. There are more than 2,500 dermatologists billing Medicare for Mohs, and insurers are groaning at the expense. They are looking for any possible reason to exclude dermatologists from billing for Mohs surgery.
A possible solution is a board certification in Mohs surgery. Osteopathic dermatologists have had this option for 20 years. Unfortunately, allopathic dermatologists cannot sit for the osteopathic exam. A new certification exam for allopathic dermatologists who have successfully completed a dermatology residency accredited by the Accreditation Council for Graduate Medical Education (ACGME) seems worthy of a discussion.
Downsides of certification include the likely $1,000 or more cost of a test, the costs of preparing for the test, and the risk of failing a test. A new certification would give the Maintenance of Certification (MOC) haters another reason to complain, since about 600 lifetime certified, board-exempt dermatologists would be dragged back into MOC to maintain a Mohs surgery subspecialty certification. Some of the current fellowship-trained Mohs surgeons will not like being grouped with the nonfellowship-trained surgeons, whom they consider their inferiors and who will now have the opportunity to be board certified.
The name of the fellowship, which is “micrographic surgery and dermatologic oncology,” also has some paranoid types fearing that they will lose the right to treat skin cancer if such a subspecialty is created. That shouldn’t be an issue, since all dermatologists are trained in residency to treat skin cancer. The formal fellowships already exist. There are already 1,600 fellowship-trained Mohs surgeons out there, and they have not cornered the market on skin cancer. The situation should not change since general dermatologists remain the gatekeepers – and entry point – for most skin cancer patients. Certification exams in dermatopathology and pediatric dermatology have not had a negative impact on general dermatologists, who still read their own slides and see kids for skin disease. In fact, having dermatopathology as a certified part of dermatology has been a huge benefit in our struggle to maintain the right to read our own slides.
Developing a certification exam would take at least 2 years if the American Board of Dermatology decided to do it. There would be no “grandfathering” automatic certification. Everyone would have to take the same exam – young, old, formally trained, or not.
Members of the American Board of Dermatology explained the qualifiers to sit for an exam (if there was an exam) at a summit I held in Cincinnati in 2015. They are interested in including all ABD dermatologists who currently practice Mohs surgery, fellowship trained or not. Suggested parameters included any ABD fellow whose practice is 20% Mohs and reconstructive surgery (by volume or income), or anyone who performs Mohs once a week. Fellowship-trained micrographic surgeons could be eligible, and this would be a self-attestation! There would be no case log reviews, no visits by inspectors, no secret questions or passwords. This pathway would remain open for 5 years as were the exams for dermatopathology and pediatric dermatology. After that point, only ACGME fellowship–trained Mohs surgeons would be eligible to take the exam.
Upsides to this approach include decreasing divisiveness in the specialty, creating a better brand, and elevating the specialty. A board certification will help in obtaining a Medicare specialty designation, which will help stop the delisting of Mohs surgeons from insurance networks based on their average charges compared with general dermatologists. This action would particularly help small practices.
The American Academy of Dermatology board of directors sent this issue to the education committee to inform and poll the membership. You should expect to hear more about the proposed process. As an AAD member, you will get to express your opinion so make sure you are well informed. The AAD membership opinion will be important in whether or not the American Board of Dermatology decides to pursue this. Remember, this is an American Board of Dermatology decision, not an AAD decision.
More reasons for a board certification include that the ACGME expects its fellowships to develop a board exam at some point (although not all have). The 1,000 ACGME fellowship–trained micrographic surgeons deserve a chance to be board certified, which is the medical profession’s way to demonstrate competence to the public.
Having all Mohs surgeons board certified would heal a huge rift in the house of dermatology, and give us a united, consistent face to present to other specialties, the Congress, and the media. Physicians are judged by their training and credentials. Love them or hate them, the ACGME is the gold standard. Perhaps the greatest beneficiaries would be those practicing Mohs who did not complete a formal fellowship. I think a board exam is overdue, and will be a boon to all of dermatology.
Dr. Coldiron is a past president of the American Academy of Dermatology. He is currently in private practice, but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics.
Update on resveratrol
• Found abundantly in nature, this polyphenolic phytoalexin is believed to exhibit a wide range of biologic activity.
• Potent antioxidant, anti-inflammatory, and antiproliferative properties.
• Highly studied polyphenolic substance also considered a chemopreventive agent against skin cancer.
• In small studies, has contributed to antiaging, antiacne, antierythema, and skin-lightening results.
Resveratrol (trans-3,5,4’-trihydroxystilbene), a polyphenolic phytoalexin synthesized in nearly 70 plant species, is found to be particularly abundant in Vitis vinifera (grape vine) and its derivatives (e.g., red wine, purple grape juice), various berries, peanuts, jackfruit, pomegranate, eucalyptus, the roots of Polygonum cuspidatum (Japanese knotweed, which is used in traditional Chinese and Japanese medicine to treat dermatitis, among other conditions)1, Scots pine, spruce, corn lily, gnetum, and butterfly orchid.2-6 Several studies have demonstrated that resveratrol possesses potent antioxidant, anticarcinogenic, anti-inflammatory, as well as antimicrobial characteristics.7-11 Specifically, in vitro and in vivo studies have shown that resveratrol exerts chemopreventive and antiproliferative activity against various cancers, including skin cancer, by suppressing cellular events associated with tumor initiation, promotion, and progression, and triggering apoptosis in such tumor cells.12-14 It also is reputed to impart antiaging benefits.15 This column will focus on recent research findings pertaining to effects on the skin as well as topical uses of this botanical agent, the main source of which, V. vinifera, has been used since antiquity.
Resveratrol was first identified from the roots of Veratrum grandiflorum (white hellebore) in 1940,16-19 but research on the compound did not take root until after a 1997 report in Science suggested chemopreventive properties. In that study, purified resveratrol was found to exhibit major inhibitory activity against cancer initiation, promotion, and progression.20 Since then, copious research on this botanical compound has yielded a reputation as a strong antioxidant, anti-inflammatory, and antiproliferative agent.7,21,22 Most importantly, resveratrol is considered to act as a chemopreventive agent against skin cancer and antiproliferative influence on oral squamous, breast, colon, and prostate cancer cells.12,14 It is also one of the most studied polyphenolic compounds.
Skin cancer and photoprotection
In 2012, Osmond et al. conducted in vitro and in vivo experiments to assess the potential of resveratrol as a chemotherapy adjunct for melanoma treatment. Resveratrol significantly reduced melanoma cell viability in both melanoma cell lines tested, and selectively spared cells in the nonmalignant fibroblast lines, compared with its cytotoxic impact on melanoma cells. Further, cytotoxicity to malignant cells was greatly enhanced by 72 hours of treatment with resveratrol and temozolomide, compared with temozolomide treatment alone. No significant differences were seen in vivo. The researchers concluded that the in vitro antitumor activity of resveratrol suggested its potential as a therapeutic agent in melanoma management.23
Resveratrol has been shown to protect against UVB-mediated cutaneous damage in SKH-1 hairless mice. Afaq et al. demonstrated that UVB-induced skin edema was significantly suppressed by the topical application of resveratrol to SKH-1 hairless mice.7
In a different study by the same team, topically applied resveratrol significantly inhibited UVB-mediated increases in bifold skin thickness and edema and greatly diminished UVB-induced lipid peroxidation, cyclo-oxygenase and ornithine decarboxylase (ODC) activities, as well as protein expression of the ODC enzyme in SKH-1 hairless mice.24 In an experiment by some of the same researchers, resveratrol was topically applied to SKH-1 hairless mice 30 minutes before exposure to UVB; 24 hours later, significant decreases were observed in bifold skin thickness, hyperplasia, and leukocyte infiltration. Critical cell cycle regulatory proteins, the target of the investigation, were substantially down-regulated because of the resveratrol. The investigators concluded that resveratrol might have the potential to play a significant role in preventing UVB-mediated photodamage and carcinogenesis.25
More recently, in 2015, Sirerol et al. found that the topical treatment with pterostilbene, a natural dimethoxy analog of resveratrol, effectively shielded SKH-1 hairless mice from UVB-induced photodamage and carcinogenesis.26
Interestingly, recent in vitro studies by Sticozzi and colleagues have shown that topical resveratrol dose-dependently protected human keratinocytes from cigarette smoke–induced reduction of scavenger receptor B1 protein expression27 and can lower cigarette smoke–induced reactive oxygen species and carbonyl formation in human keratinocytes.28
Antiaging activity
In 2010, Giardina et al. performed an in vitro study to evaluate the tonic-trophic characteristics of resveratrol alone and resveratrol plus N-acetyl-cysteine on cultured skin fibroblasts. Both formulations dose-dependently increased cell proliferation and inhibition of collagenase activity.29
In 2012, Wu et al. investigated the protective effects of resveratrate, a stable derivative of resveratrol, against damage to human skin caused by repetitive solar simulator UV radiation (ssUVR) in 15 healthy human volunteers. Six sites on nonexposed dorsal skin of each participant were assessed, with four sites exposed to ssUVR and the remaining sites serving as positive control (ssUVR only) and baseline control (no treatment or exposure). The researchers noted minimal erythema on areas treated with resveratrate and the resveratrol derivative significantly inhibited sunburn cell formation. They concluded that resveratrate protects the skin against sunburn and suntan caused by repetitive ssUVR.4
Also that year, Buonocore et al. conducted a placebo-controlled, double-blind study in 50 subjects that revealed the antiaging efficacy of a dietary nutraceutical blend of resveratrol and procyanidin. Specifically, skin moisturization and elasticity improved while wrinkle depth and skin roughness lessened after 60 days of treatment.30
In a 2013 in vitro study of the skin permeation kinetics of polyphenols using diffusion cells via ex vivo pig skin and a cellulose membrane, Zillich et al. showed that several polyphenols, including resveratrol, epigallocatechin gallate, quercetin, rutin, and protocatechuic acid formulated in oil-in-water emulsions could permeate the stratum corneum and were identified in the epidermis and dermis. The team concluded that their findings validate the use of polyphenols as active ingredients in antiaging products.31
In 2014, Farris et al. found that the topical application of resveratrol in a proprietary blend (1% resveratrol, 0.5% baicalin, 1% vitamin E) yielded a statistically significant amelioration of fine lines and wrinkles, hyperpigmentation, radiance, as well as skin roughness, firmness, elasticity, and laxity in a small study over 12 weeks.32
Skin lightening
Resveratrol has also been used as a promising topical treatment for hyperpigmentation disorders.33 The compound has been shown to work synergistically with 4-n-butylresorcinol (a derivative of resorcinol, one of the main phenols found in argan oil) to reduce tyrosinase levels and significantly diminish melanin synthesis, more effectively than either compound alone.34 In 2012, Franco et al. observed that resveratrol can inhibit tyrosinase but it does not sufficiently suppress melanin production to justify its use as a lone skin-whitening agent in pharmaceutical formulations, but warrants attention as a coadjuvant for treating hyperpigmentation.35 The skin-lightening capacity of resveratrol supported by a 2013 study in which 52 medicinal plants grown in Korea were tested for human tyrosinase activity and the dried stems of the grape tree V. vinifera were found to potently suppress human tyrosinase, and more effectively than arbutin.36 It is worth noting that resveratrol, through its antioxidant activity and possible inhibitory effect on cytochrome P450 2E1 expression, has been shown to protect mouse primary hepatocytes from hydroquinone-induced cytotoxicity.37 Also, J.M. Galgut and S.A. Ali, noted the gathering of pigment cells and resultant skin lightening from the effects of topical ethanolic extract of Arachis hypogaea (peanuts, which contain half the resveratrol of red wine) on the tail melanophores of tadpole Bufo melanostictus, concluding that resveratrol merits attention for potential clinical use as a nontoxic melanolytic agent to treat hyperpigmentation.38,34
Acne
Resveratrol is considered an emerging agent in the topical armamentarium for treating acne.39 In a single-blind pilot study in 2011, Fabbrocini et al. investigated the potential therapeutic impact of resveratrol on 20 patients with acne. A resveratrol-containing hydrogel was applied daily on the right side of the face for 60 days, with the left side receiving the hydrogel vehicle as control. No adverse effects were reported and all patients were satisfied with the treatment. Researchers reported a 53.75 % mean reduction in the Global Acne Grading System score on the resveratrol-treated sides and a 6.10 % decrease on the control sides. Histologic analysis revealed a statistically significant reduction of lesions in areas treated with resveratrol (66.7 % mean reduction in the average area of microcomedones on the resveratrol-treated sides vs. 9.7% reduction on the control sides).40
A 2015 comprehensive literature review of randomized clinical trials and controlled trials by Dall’oglio et al. found that cosmetics with antimicrobial and anti-inflammatory ingredients, including resveratrol, may accelerate acne resolution.41
Significantly, resveratrol is one of the novel acne treatments considered to have little potential for susceptibility to antibiotic resistance to Propionibacterium acnes.42
Erythema
In a small 2013 study by Ferzli et al., 16 subjects with erythema applied a formulation containing resveratrol, green tea polyphenols, and caffeine twice daily to the whole face. Clinical photographs and spectrally enhanced images taken before treatment and every 2 weeks through 3 months were assessed. The investigators reported that improvement was seen in 16 of 16 clinical images and 13 of 16 spectrally enhanced images. Erythema reduction was observable by 6 weeks of treatment, and no adverse effects were observed.43
Conclusion
Resveratrol is emerging as a compound with the potential to deliver significant health benefits, particularly in terms of photoprotective, cancer preventive, and cardioprotective activity. While there are 2 strong decades of research, more is necessary to elucidate the full potential of resveratrol as a first-line dermatologic therapy. Preclinical data do support the use of resveratrol in various product types (e.g., emollients, patches, sunscreens, and additional skin care products) intended to prevent skin cancer or to prevent or treat other conditions caused or exacerbated by solar exposure, such as photoaging. I look forward to seeing clinical evidence of the efficacy of topically applied resveratrol.
Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and a book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Her latest book, “Cosmeceuticals and Cosmetic Ingredients,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera Biopharmaceuticals, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. She also developed and owns the Baumann Skin Type Solution skin-typing systems and related products.
References
1. Toxicol Appl Pharmacol. 2003 Jan 1;186(1):28-37.
2. Science. 1997 Jan 10;275(5297):218-20.
3. Cancer Res. 2001 Feb 15;61(4):1604-10.
4. J Eur Acad Dermatol Venereol. 2013 Mar;27(3):345-50.
5. Photochem Photobiol. 2008 Mar-Apr;84(2):415-21.
6. Dose Response. 2010 Mar 18;8(4):478-500.
7. Toxicol Appl Pharmacol. 2003 Jan 1;186(1):28-37.
8. Neoplasia. 2003 Jan-Feb;5(1):74-82.
9. An Illustrated Guide to 101 Medicinal Herbs: Their History, Use, Recommended Dosages, and Cautions (Loveland, Colo.: Interweave Press, 1998, pp. 108-9.)
11. Eur J Pharm Sci. 2015 Oct 12;78:204-13.
12. Pancreas. 2002 Nov;25(4):e71-6.
13. Toxicol Appl Pharmacol. 2007 Nov 1;224(3):274-83.
14. J Biol Chem. 2003 Oct 17;278(42):41482-90.
15. J Drugs Dermatol. 2014 Dec;13(12):1467-72.
16. Fitoterapia. 2013 Apr;86:84-91.
17. Ann N Y Acad Sci. 2011 Jan;1215:60-71.
18. Recent Pat Cardiovasc Drug Discov. 2007 Jun;2(2):133-8.
19. Anticancer Res. 2004 Sep-Oct;24(5A):2783-840.
20. Science. 1997 Jan 10;275(5297):218-20.
21. Biochem Pharmacol. 2002 Jan 15:63(2):99-104.
22. Biomed Pap Med Fac univ Palacky Olomouc Czech Repub. 2003 Dec;147(2):137-45.
23. J Surg Res. 2012 Jan;172(1):109-15.
24. Front Biosci. 2002 Apr 1;7:d784-92.
25. Oncogene. 2004 Jul 1;23(30):5151-60.
26. Free Radic Biol Med. 2015 Aug;85:1-11.
27. Free Radic Biol Med. 2014 Apr;69:50-7.
28. Food Funct. 2014 Sep;5(9):2348-56.
29. Minerva Ginecol. 2010 Jun;62(3):195-201.
30. Clin Cosmet Investig Dermatol. 2012;5:159-65.
31. Int J Cosmet Sci. 2013 Oct;35(5):491-501.
32. J Drugs Dermatol. 2014 Dec;13(12):1467-72.
33. Semin Cutan Med Surg. 2012 Jun;31(2):133-9.
34. Pharmazie. 2012 Jun;67(6):542-6.
35. Molecules. 2012 Oct 9;17(10):11816-25.
36. Evid Based Complement Alternat Med. 2013;2013:645257.
37. Int J Environ Res Public Health. 2012 Sep 19;9(9):3354-64.
38. J Recept Signal Transduct Res. 2011 Oct;31(5):374-80.
39. Am J Clin Dermatol. 2012 Dec 1;13(6):357-64.
40. Am J Clin Dermatol. 2011 Apr 1;12(2):133-41.
41. G Ital Dermatol Venereol. 2015 Feb;150(1):1-11.
• Found abundantly in nature, this polyphenolic phytoalexin is believed to exhibit a wide range of biologic activity.
• Potent antioxidant, anti-inflammatory, and antiproliferative properties.
• Highly studied polyphenolic substance also considered a chemopreventive agent against skin cancer.
• In small studies, has contributed to antiaging, antiacne, antierythema, and skin-lightening results.
Resveratrol (trans-3,5,4’-trihydroxystilbene), a polyphenolic phytoalexin synthesized in nearly 70 plant species, is found to be particularly abundant in Vitis vinifera (grape vine) and its derivatives (e.g., red wine, purple grape juice), various berries, peanuts, jackfruit, pomegranate, eucalyptus, the roots of Polygonum cuspidatum (Japanese knotweed, which is used in traditional Chinese and Japanese medicine to treat dermatitis, among other conditions)1, Scots pine, spruce, corn lily, gnetum, and butterfly orchid.2-6 Several studies have demonstrated that resveratrol possesses potent antioxidant, anticarcinogenic, anti-inflammatory, as well as antimicrobial characteristics.7-11 Specifically, in vitro and in vivo studies have shown that resveratrol exerts chemopreventive and antiproliferative activity against various cancers, including skin cancer, by suppressing cellular events associated with tumor initiation, promotion, and progression, and triggering apoptosis in such tumor cells.12-14 It also is reputed to impart antiaging benefits.15 This column will focus on recent research findings pertaining to effects on the skin as well as topical uses of this botanical agent, the main source of which, V. vinifera, has been used since antiquity.
Resveratrol was first identified from the roots of Veratrum grandiflorum (white hellebore) in 1940,16-19 but research on the compound did not take root until after a 1997 report in Science suggested chemopreventive properties. In that study, purified resveratrol was found to exhibit major inhibitory activity against cancer initiation, promotion, and progression.20 Since then, copious research on this botanical compound has yielded a reputation as a strong antioxidant, anti-inflammatory, and antiproliferative agent.7,21,22 Most importantly, resveratrol is considered to act as a chemopreventive agent against skin cancer and antiproliferative influence on oral squamous, breast, colon, and prostate cancer cells.12,14 It is also one of the most studied polyphenolic compounds.
Skin cancer and photoprotection
In 2012, Osmond et al. conducted in vitro and in vivo experiments to assess the potential of resveratrol as a chemotherapy adjunct for melanoma treatment. Resveratrol significantly reduced melanoma cell viability in both melanoma cell lines tested, and selectively spared cells in the nonmalignant fibroblast lines, compared with its cytotoxic impact on melanoma cells. Further, cytotoxicity to malignant cells was greatly enhanced by 72 hours of treatment with resveratrol and temozolomide, compared with temozolomide treatment alone. No significant differences were seen in vivo. The researchers concluded that the in vitro antitumor activity of resveratrol suggested its potential as a therapeutic agent in melanoma management.23
Resveratrol has been shown to protect against UVB-mediated cutaneous damage in SKH-1 hairless mice. Afaq et al. demonstrated that UVB-induced skin edema was significantly suppressed by the topical application of resveratrol to SKH-1 hairless mice.7
In a different study by the same team, topically applied resveratrol significantly inhibited UVB-mediated increases in bifold skin thickness and edema and greatly diminished UVB-induced lipid peroxidation, cyclo-oxygenase and ornithine decarboxylase (ODC) activities, as well as protein expression of the ODC enzyme in SKH-1 hairless mice.24 In an experiment by some of the same researchers, resveratrol was topically applied to SKH-1 hairless mice 30 minutes before exposure to UVB; 24 hours later, significant decreases were observed in bifold skin thickness, hyperplasia, and leukocyte infiltration. Critical cell cycle regulatory proteins, the target of the investigation, were substantially down-regulated because of the resveratrol. The investigators concluded that resveratrol might have the potential to play a significant role in preventing UVB-mediated photodamage and carcinogenesis.25
More recently, in 2015, Sirerol et al. found that the topical treatment with pterostilbene, a natural dimethoxy analog of resveratrol, effectively shielded SKH-1 hairless mice from UVB-induced photodamage and carcinogenesis.26
Interestingly, recent in vitro studies by Sticozzi and colleagues have shown that topical resveratrol dose-dependently protected human keratinocytes from cigarette smoke–induced reduction of scavenger receptor B1 protein expression27 and can lower cigarette smoke–induced reactive oxygen species and carbonyl formation in human keratinocytes.28
Antiaging activity
In 2010, Giardina et al. performed an in vitro study to evaluate the tonic-trophic characteristics of resveratrol alone and resveratrol plus N-acetyl-cysteine on cultured skin fibroblasts. Both formulations dose-dependently increased cell proliferation and inhibition of collagenase activity.29
In 2012, Wu et al. investigated the protective effects of resveratrate, a stable derivative of resveratrol, against damage to human skin caused by repetitive solar simulator UV radiation (ssUVR) in 15 healthy human volunteers. Six sites on nonexposed dorsal skin of each participant were assessed, with four sites exposed to ssUVR and the remaining sites serving as positive control (ssUVR only) and baseline control (no treatment or exposure). The researchers noted minimal erythema on areas treated with resveratrate and the resveratrol derivative significantly inhibited sunburn cell formation. They concluded that resveratrate protects the skin against sunburn and suntan caused by repetitive ssUVR.4
Also that year, Buonocore et al. conducted a placebo-controlled, double-blind study in 50 subjects that revealed the antiaging efficacy of a dietary nutraceutical blend of resveratrol and procyanidin. Specifically, skin moisturization and elasticity improved while wrinkle depth and skin roughness lessened after 60 days of treatment.30
In a 2013 in vitro study of the skin permeation kinetics of polyphenols using diffusion cells via ex vivo pig skin and a cellulose membrane, Zillich et al. showed that several polyphenols, including resveratrol, epigallocatechin gallate, quercetin, rutin, and protocatechuic acid formulated in oil-in-water emulsions could permeate the stratum corneum and were identified in the epidermis and dermis. The team concluded that their findings validate the use of polyphenols as active ingredients in antiaging products.31
In 2014, Farris et al. found that the topical application of resveratrol in a proprietary blend (1% resveratrol, 0.5% baicalin, 1% vitamin E) yielded a statistically significant amelioration of fine lines and wrinkles, hyperpigmentation, radiance, as well as skin roughness, firmness, elasticity, and laxity in a small study over 12 weeks.32
Skin lightening
Resveratrol has also been used as a promising topical treatment for hyperpigmentation disorders.33 The compound has been shown to work synergistically with 4-n-butylresorcinol (a derivative of resorcinol, one of the main phenols found in argan oil) to reduce tyrosinase levels and significantly diminish melanin synthesis, more effectively than either compound alone.34 In 2012, Franco et al. observed that resveratrol can inhibit tyrosinase but it does not sufficiently suppress melanin production to justify its use as a lone skin-whitening agent in pharmaceutical formulations, but warrants attention as a coadjuvant for treating hyperpigmentation.35 The skin-lightening capacity of resveratrol supported by a 2013 study in which 52 medicinal plants grown in Korea were tested for human tyrosinase activity and the dried stems of the grape tree V. vinifera were found to potently suppress human tyrosinase, and more effectively than arbutin.36 It is worth noting that resveratrol, through its antioxidant activity and possible inhibitory effect on cytochrome P450 2E1 expression, has been shown to protect mouse primary hepatocytes from hydroquinone-induced cytotoxicity.37 Also, J.M. Galgut and S.A. Ali, noted the gathering of pigment cells and resultant skin lightening from the effects of topical ethanolic extract of Arachis hypogaea (peanuts, which contain half the resveratrol of red wine) on the tail melanophores of tadpole Bufo melanostictus, concluding that resveratrol merits attention for potential clinical use as a nontoxic melanolytic agent to treat hyperpigmentation.38,34
Acne
Resveratrol is considered an emerging agent in the topical armamentarium for treating acne.39 In a single-blind pilot study in 2011, Fabbrocini et al. investigated the potential therapeutic impact of resveratrol on 20 patients with acne. A resveratrol-containing hydrogel was applied daily on the right side of the face for 60 days, with the left side receiving the hydrogel vehicle as control. No adverse effects were reported and all patients were satisfied with the treatment. Researchers reported a 53.75 % mean reduction in the Global Acne Grading System score on the resveratrol-treated sides and a 6.10 % decrease on the control sides. Histologic analysis revealed a statistically significant reduction of lesions in areas treated with resveratrol (66.7 % mean reduction in the average area of microcomedones on the resveratrol-treated sides vs. 9.7% reduction on the control sides).40
A 2015 comprehensive literature review of randomized clinical trials and controlled trials by Dall’oglio et al. found that cosmetics with antimicrobial and anti-inflammatory ingredients, including resveratrol, may accelerate acne resolution.41
Significantly, resveratrol is one of the novel acne treatments considered to have little potential for susceptibility to antibiotic resistance to Propionibacterium acnes.42
Erythema
In a small 2013 study by Ferzli et al., 16 subjects with erythema applied a formulation containing resveratrol, green tea polyphenols, and caffeine twice daily to the whole face. Clinical photographs and spectrally enhanced images taken before treatment and every 2 weeks through 3 months were assessed. The investigators reported that improvement was seen in 16 of 16 clinical images and 13 of 16 spectrally enhanced images. Erythema reduction was observable by 6 weeks of treatment, and no adverse effects were observed.43
Conclusion
Resveratrol is emerging as a compound with the potential to deliver significant health benefits, particularly in terms of photoprotective, cancer preventive, and cardioprotective activity. While there are 2 strong decades of research, more is necessary to elucidate the full potential of resveratrol as a first-line dermatologic therapy. Preclinical data do support the use of resveratrol in various product types (e.g., emollients, patches, sunscreens, and additional skin care products) intended to prevent skin cancer or to prevent or treat other conditions caused or exacerbated by solar exposure, such as photoaging. I look forward to seeing clinical evidence of the efficacy of topically applied resveratrol.
Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and a book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Her latest book, “Cosmeceuticals and Cosmetic Ingredients,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera Biopharmaceuticals, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. She also developed and owns the Baumann Skin Type Solution skin-typing systems and related products.
References
1. Toxicol Appl Pharmacol. 2003 Jan 1;186(1):28-37.
2. Science. 1997 Jan 10;275(5297):218-20.
3. Cancer Res. 2001 Feb 15;61(4):1604-10.
4. J Eur Acad Dermatol Venereol. 2013 Mar;27(3):345-50.
5. Photochem Photobiol. 2008 Mar-Apr;84(2):415-21.
6. Dose Response. 2010 Mar 18;8(4):478-500.
7. Toxicol Appl Pharmacol. 2003 Jan 1;186(1):28-37.
8. Neoplasia. 2003 Jan-Feb;5(1):74-82.
9. An Illustrated Guide to 101 Medicinal Herbs: Their History, Use, Recommended Dosages, and Cautions (Loveland, Colo.: Interweave Press, 1998, pp. 108-9.)
11. Eur J Pharm Sci. 2015 Oct 12;78:204-13.
12. Pancreas. 2002 Nov;25(4):e71-6.
13. Toxicol Appl Pharmacol. 2007 Nov 1;224(3):274-83.
14. J Biol Chem. 2003 Oct 17;278(42):41482-90.
15. J Drugs Dermatol. 2014 Dec;13(12):1467-72.
16. Fitoterapia. 2013 Apr;86:84-91.
17. Ann N Y Acad Sci. 2011 Jan;1215:60-71.
18. Recent Pat Cardiovasc Drug Discov. 2007 Jun;2(2):133-8.
19. Anticancer Res. 2004 Sep-Oct;24(5A):2783-840.
20. Science. 1997 Jan 10;275(5297):218-20.
21. Biochem Pharmacol. 2002 Jan 15:63(2):99-104.
22. Biomed Pap Med Fac univ Palacky Olomouc Czech Repub. 2003 Dec;147(2):137-45.
23. J Surg Res. 2012 Jan;172(1):109-15.
24. Front Biosci. 2002 Apr 1;7:d784-92.
25. Oncogene. 2004 Jul 1;23(30):5151-60.
26. Free Radic Biol Med. 2015 Aug;85:1-11.
27. Free Radic Biol Med. 2014 Apr;69:50-7.
28. Food Funct. 2014 Sep;5(9):2348-56.
29. Minerva Ginecol. 2010 Jun;62(3):195-201.
30. Clin Cosmet Investig Dermatol. 2012;5:159-65.
31. Int J Cosmet Sci. 2013 Oct;35(5):491-501.
32. J Drugs Dermatol. 2014 Dec;13(12):1467-72.
33. Semin Cutan Med Surg. 2012 Jun;31(2):133-9.
34. Pharmazie. 2012 Jun;67(6):542-6.
35. Molecules. 2012 Oct 9;17(10):11816-25.
36. Evid Based Complement Alternat Med. 2013;2013:645257.
37. Int J Environ Res Public Health. 2012 Sep 19;9(9):3354-64.
38. J Recept Signal Transduct Res. 2011 Oct;31(5):374-80.
39. Am J Clin Dermatol. 2012 Dec 1;13(6):357-64.
40. Am J Clin Dermatol. 2011 Apr 1;12(2):133-41.
41. G Ital Dermatol Venereol. 2015 Feb;150(1):1-11.
• Found abundantly in nature, this polyphenolic phytoalexin is believed to exhibit a wide range of biologic activity.
• Potent antioxidant, anti-inflammatory, and antiproliferative properties.
• Highly studied polyphenolic substance also considered a chemopreventive agent against skin cancer.
• In small studies, has contributed to antiaging, antiacne, antierythema, and skin-lightening results.
Resveratrol (trans-3,5,4’-trihydroxystilbene), a polyphenolic phytoalexin synthesized in nearly 70 plant species, is found to be particularly abundant in Vitis vinifera (grape vine) and its derivatives (e.g., red wine, purple grape juice), various berries, peanuts, jackfruit, pomegranate, eucalyptus, the roots of Polygonum cuspidatum (Japanese knotweed, which is used in traditional Chinese and Japanese medicine to treat dermatitis, among other conditions)1, Scots pine, spruce, corn lily, gnetum, and butterfly orchid.2-6 Several studies have demonstrated that resveratrol possesses potent antioxidant, anticarcinogenic, anti-inflammatory, as well as antimicrobial characteristics.7-11 Specifically, in vitro and in vivo studies have shown that resveratrol exerts chemopreventive and antiproliferative activity against various cancers, including skin cancer, by suppressing cellular events associated with tumor initiation, promotion, and progression, and triggering apoptosis in such tumor cells.12-14 It also is reputed to impart antiaging benefits.15 This column will focus on recent research findings pertaining to effects on the skin as well as topical uses of this botanical agent, the main source of which, V. vinifera, has been used since antiquity.
Resveratrol was first identified from the roots of Veratrum grandiflorum (white hellebore) in 1940,16-19 but research on the compound did not take root until after a 1997 report in Science suggested chemopreventive properties. In that study, purified resveratrol was found to exhibit major inhibitory activity against cancer initiation, promotion, and progression.20 Since then, copious research on this botanical compound has yielded a reputation as a strong antioxidant, anti-inflammatory, and antiproliferative agent.7,21,22 Most importantly, resveratrol is considered to act as a chemopreventive agent against skin cancer and antiproliferative influence on oral squamous, breast, colon, and prostate cancer cells.12,14 It is also one of the most studied polyphenolic compounds.
Skin cancer and photoprotection
In 2012, Osmond et al. conducted in vitro and in vivo experiments to assess the potential of resveratrol as a chemotherapy adjunct for melanoma treatment. Resveratrol significantly reduced melanoma cell viability in both melanoma cell lines tested, and selectively spared cells in the nonmalignant fibroblast lines, compared with its cytotoxic impact on melanoma cells. Further, cytotoxicity to malignant cells was greatly enhanced by 72 hours of treatment with resveratrol and temozolomide, compared with temozolomide treatment alone. No significant differences were seen in vivo. The researchers concluded that the in vitro antitumor activity of resveratrol suggested its potential as a therapeutic agent in melanoma management.23
Resveratrol has been shown to protect against UVB-mediated cutaneous damage in SKH-1 hairless mice. Afaq et al. demonstrated that UVB-induced skin edema was significantly suppressed by the topical application of resveratrol to SKH-1 hairless mice.7
In a different study by the same team, topically applied resveratrol significantly inhibited UVB-mediated increases in bifold skin thickness and edema and greatly diminished UVB-induced lipid peroxidation, cyclo-oxygenase and ornithine decarboxylase (ODC) activities, as well as protein expression of the ODC enzyme in SKH-1 hairless mice.24 In an experiment by some of the same researchers, resveratrol was topically applied to SKH-1 hairless mice 30 minutes before exposure to UVB; 24 hours later, significant decreases were observed in bifold skin thickness, hyperplasia, and leukocyte infiltration. Critical cell cycle regulatory proteins, the target of the investigation, were substantially down-regulated because of the resveratrol. The investigators concluded that resveratrol might have the potential to play a significant role in preventing UVB-mediated photodamage and carcinogenesis.25
More recently, in 2015, Sirerol et al. found that the topical treatment with pterostilbene, a natural dimethoxy analog of resveratrol, effectively shielded SKH-1 hairless mice from UVB-induced photodamage and carcinogenesis.26
Interestingly, recent in vitro studies by Sticozzi and colleagues have shown that topical resveratrol dose-dependently protected human keratinocytes from cigarette smoke–induced reduction of scavenger receptor B1 protein expression27 and can lower cigarette smoke–induced reactive oxygen species and carbonyl formation in human keratinocytes.28
Antiaging activity
In 2010, Giardina et al. performed an in vitro study to evaluate the tonic-trophic characteristics of resveratrol alone and resveratrol plus N-acetyl-cysteine on cultured skin fibroblasts. Both formulations dose-dependently increased cell proliferation and inhibition of collagenase activity.29
In 2012, Wu et al. investigated the protective effects of resveratrate, a stable derivative of resveratrol, against damage to human skin caused by repetitive solar simulator UV radiation (ssUVR) in 15 healthy human volunteers. Six sites on nonexposed dorsal skin of each participant were assessed, with four sites exposed to ssUVR and the remaining sites serving as positive control (ssUVR only) and baseline control (no treatment or exposure). The researchers noted minimal erythema on areas treated with resveratrate and the resveratrol derivative significantly inhibited sunburn cell formation. They concluded that resveratrate protects the skin against sunburn and suntan caused by repetitive ssUVR.4
Also that year, Buonocore et al. conducted a placebo-controlled, double-blind study in 50 subjects that revealed the antiaging efficacy of a dietary nutraceutical blend of resveratrol and procyanidin. Specifically, skin moisturization and elasticity improved while wrinkle depth and skin roughness lessened after 60 days of treatment.30
In a 2013 in vitro study of the skin permeation kinetics of polyphenols using diffusion cells via ex vivo pig skin and a cellulose membrane, Zillich et al. showed that several polyphenols, including resveratrol, epigallocatechin gallate, quercetin, rutin, and protocatechuic acid formulated in oil-in-water emulsions could permeate the stratum corneum and were identified in the epidermis and dermis. The team concluded that their findings validate the use of polyphenols as active ingredients in antiaging products.31
In 2014, Farris et al. found that the topical application of resveratrol in a proprietary blend (1% resveratrol, 0.5% baicalin, 1% vitamin E) yielded a statistically significant amelioration of fine lines and wrinkles, hyperpigmentation, radiance, as well as skin roughness, firmness, elasticity, and laxity in a small study over 12 weeks.32
Skin lightening
Resveratrol has also been used as a promising topical treatment for hyperpigmentation disorders.33 The compound has been shown to work synergistically with 4-n-butylresorcinol (a derivative of resorcinol, one of the main phenols found in argan oil) to reduce tyrosinase levels and significantly diminish melanin synthesis, more effectively than either compound alone.34 In 2012, Franco et al. observed that resveratrol can inhibit tyrosinase but it does not sufficiently suppress melanin production to justify its use as a lone skin-whitening agent in pharmaceutical formulations, but warrants attention as a coadjuvant for treating hyperpigmentation.35 The skin-lightening capacity of resveratrol supported by a 2013 study in which 52 medicinal plants grown in Korea were tested for human tyrosinase activity and the dried stems of the grape tree V. vinifera were found to potently suppress human tyrosinase, and more effectively than arbutin.36 It is worth noting that resveratrol, through its antioxidant activity and possible inhibitory effect on cytochrome P450 2E1 expression, has been shown to protect mouse primary hepatocytes from hydroquinone-induced cytotoxicity.37 Also, J.M. Galgut and S.A. Ali, noted the gathering of pigment cells and resultant skin lightening from the effects of topical ethanolic extract of Arachis hypogaea (peanuts, which contain half the resveratrol of red wine) on the tail melanophores of tadpole Bufo melanostictus, concluding that resveratrol merits attention for potential clinical use as a nontoxic melanolytic agent to treat hyperpigmentation.38,34
Acne
Resveratrol is considered an emerging agent in the topical armamentarium for treating acne.39 In a single-blind pilot study in 2011, Fabbrocini et al. investigated the potential therapeutic impact of resveratrol on 20 patients with acne. A resveratrol-containing hydrogel was applied daily on the right side of the face for 60 days, with the left side receiving the hydrogel vehicle as control. No adverse effects were reported and all patients were satisfied with the treatment. Researchers reported a 53.75 % mean reduction in the Global Acne Grading System score on the resveratrol-treated sides and a 6.10 % decrease on the control sides. Histologic analysis revealed a statistically significant reduction of lesions in areas treated with resveratrol (66.7 % mean reduction in the average area of microcomedones on the resveratrol-treated sides vs. 9.7% reduction on the control sides).40
A 2015 comprehensive literature review of randomized clinical trials and controlled trials by Dall’oglio et al. found that cosmetics with antimicrobial and anti-inflammatory ingredients, including resveratrol, may accelerate acne resolution.41
Significantly, resveratrol is one of the novel acne treatments considered to have little potential for susceptibility to antibiotic resistance to Propionibacterium acnes.42
Erythema
In a small 2013 study by Ferzli et al., 16 subjects with erythema applied a formulation containing resveratrol, green tea polyphenols, and caffeine twice daily to the whole face. Clinical photographs and spectrally enhanced images taken before treatment and every 2 weeks through 3 months were assessed. The investigators reported that improvement was seen in 16 of 16 clinical images and 13 of 16 spectrally enhanced images. Erythema reduction was observable by 6 weeks of treatment, and no adverse effects were observed.43
Conclusion
Resveratrol is emerging as a compound with the potential to deliver significant health benefits, particularly in terms of photoprotective, cancer preventive, and cardioprotective activity. While there are 2 strong decades of research, more is necessary to elucidate the full potential of resveratrol as a first-line dermatologic therapy. Preclinical data do support the use of resveratrol in various product types (e.g., emollients, patches, sunscreens, and additional skin care products) intended to prevent skin cancer or to prevent or treat other conditions caused or exacerbated by solar exposure, such as photoaging. I look forward to seeing clinical evidence of the efficacy of topically applied resveratrol.
Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and a book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Her latest book, “Cosmeceuticals and Cosmetic Ingredients,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera Biopharmaceuticals, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. She also developed and owns the Baumann Skin Type Solution skin-typing systems and related products.
References
1. Toxicol Appl Pharmacol. 2003 Jan 1;186(1):28-37.
2. Science. 1997 Jan 10;275(5297):218-20.
3. Cancer Res. 2001 Feb 15;61(4):1604-10.
4. J Eur Acad Dermatol Venereol. 2013 Mar;27(3):345-50.
5. Photochem Photobiol. 2008 Mar-Apr;84(2):415-21.
6. Dose Response. 2010 Mar 18;8(4):478-500.
7. Toxicol Appl Pharmacol. 2003 Jan 1;186(1):28-37.
8. Neoplasia. 2003 Jan-Feb;5(1):74-82.
9. An Illustrated Guide to 101 Medicinal Herbs: Their History, Use, Recommended Dosages, and Cautions (Loveland, Colo.: Interweave Press, 1998, pp. 108-9.)
11. Eur J Pharm Sci. 2015 Oct 12;78:204-13.
12. Pancreas. 2002 Nov;25(4):e71-6.
13. Toxicol Appl Pharmacol. 2007 Nov 1;224(3):274-83.
14. J Biol Chem. 2003 Oct 17;278(42):41482-90.
15. J Drugs Dermatol. 2014 Dec;13(12):1467-72.
16. Fitoterapia. 2013 Apr;86:84-91.
17. Ann N Y Acad Sci. 2011 Jan;1215:60-71.
18. Recent Pat Cardiovasc Drug Discov. 2007 Jun;2(2):133-8.
19. Anticancer Res. 2004 Sep-Oct;24(5A):2783-840.
20. Science. 1997 Jan 10;275(5297):218-20.
21. Biochem Pharmacol. 2002 Jan 15:63(2):99-104.
22. Biomed Pap Med Fac univ Palacky Olomouc Czech Repub. 2003 Dec;147(2):137-45.
23. J Surg Res. 2012 Jan;172(1):109-15.
24. Front Biosci. 2002 Apr 1;7:d784-92.
25. Oncogene. 2004 Jul 1;23(30):5151-60.
26. Free Radic Biol Med. 2015 Aug;85:1-11.
27. Free Radic Biol Med. 2014 Apr;69:50-7.
28. Food Funct. 2014 Sep;5(9):2348-56.
29. Minerva Ginecol. 2010 Jun;62(3):195-201.
30. Clin Cosmet Investig Dermatol. 2012;5:159-65.
31. Int J Cosmet Sci. 2013 Oct;35(5):491-501.
32. J Drugs Dermatol. 2014 Dec;13(12):1467-72.
33. Semin Cutan Med Surg. 2012 Jun;31(2):133-9.
34. Pharmazie. 2012 Jun;67(6):542-6.
35. Molecules. 2012 Oct 9;17(10):11816-25.
36. Evid Based Complement Alternat Med. 2013;2013:645257.
37. Int J Environ Res Public Health. 2012 Sep 19;9(9):3354-64.
38. J Recept Signal Transduct Res. 2011 Oct;31(5):374-80.
39. Am J Clin Dermatol. 2012 Dec 1;13(6):357-64.
40. Am J Clin Dermatol. 2011 Apr 1;12(2):133-41.
41. G Ital Dermatol Venereol. 2015 Feb;150(1):1-11.
Aesthetic dermatology: What do we know so far about Volbella?
On May 31, 2016, the Food and Drug Administration approved Juvéderm Volbella XC for use in the lips for lip augmentation and for correction of perioral rhytids, in adults over the age of 21. In the U.S. pivotal clinical trial of 168 patients, Juvederm Volbella XC was found to increase lip fullness and soften the appearance of perioral rhytids in two-thirds through 1 year.
Like its previously approved predecessor Juvéderm Voluma XC, approved for the mid-face/cheek area, Juvéderm Volbella XC is composed of hyaluronic acid (HA) using Vycross technology. Vycross technology blends different molecular weights of hyaluronic acid together, allowing for longer duration of the product. Unlike Juvéderm Voluma XC (20 mg/mL), Juvéderm Volbella XC is a lower-concentration HA (15 mg/mL) and has a lower G prime and cohesivity, allowing more horizontal spread as opposed to a lift, which makes it more appropriate for injection into the lips and superficial perioral lines.1
Juvéderm Volbella XC will not be available for use in the United States until October 2016. However, the product was first approved in Europe in 2011, and subsequently in Latin America, the Middle East, Asia Pacific, and Canada. What has been the experience of our neighboring colleagues?
In a randomized, prospective, 12-month controlled European study of 280 patients comparing Volbella to a nonanimal stabilized hyaluronic acid (NASHA), Volbella was found to be noninferior to NASHA at 3 months.2 Improvements in lip fullness, perioral lines, and oral commissures for Volbella were statistically significant at 6 and 12 months. Acute swelling was also noted to be less.
In a German 62-patient study with primary endpoints of satisfaction with improvement and look and feel of the lips, a high degree of subject satisfaction with aesthetic improvement in the lips, as well as with their natural look and feel, was noted among 83.6% and 75%-93%, respectively.3
In a retrospective chart review of 400 patients in Israel, where Volbella was injected into tear troughs (disclaimer: not approved for tear troughs in the United States) and/or lips, 17 patients (4.25%) developed prolonged inflammatory cutaneous reactions, lasting up to 11 months, which recurred (with an average number of 3.17 episodes) and occurred late (with an average onset of 8.41 weeks after the injection).4 The reactions were treated with antibiotics and hyaluronidase injections. The finding in this published report is higher than the 0.02% of delayed-onset inflammatory reaction previously reported with HA fillers.
With a full armamentarium of HA and non-HA fillers on the market, we are lucky to have many options to select from to treat aesthetic concerns of patients. For lip and perioral enhancement in the United States, Restylane, Juvéderm, Belotero, and now Volbella are all excellent options. As the dermal filler portfolio available internationally is larger than that in the United States, much can be learned from the experience of our international colleagues.
References
1. Plast Reconstr Surg. 2015 Nov;136(5 Suppl):139S-48S.
2. J Drugs Dermatol. 2015 Dec;14(12):1444-52.
3. J Cosmet Dermatol. 2014 Jun;13(2):125-34.
4. Dermatol Surg. 2016 Jan;42(1):31-7.
Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. Dr. Wesley has no disclosures with regard to Volbella; she participated in clinical trials for Juvéderm Voluma. Dr. Talakoub is a national trainer for Juvéderm manufacturer Allergan for all its injectables.
On May 31, 2016, the Food and Drug Administration approved Juvéderm Volbella XC for use in the lips for lip augmentation and for correction of perioral rhytids, in adults over the age of 21. In the U.S. pivotal clinical trial of 168 patients, Juvederm Volbella XC was found to increase lip fullness and soften the appearance of perioral rhytids in two-thirds through 1 year.
Like its previously approved predecessor Juvéderm Voluma XC, approved for the mid-face/cheek area, Juvéderm Volbella XC is composed of hyaluronic acid (HA) using Vycross technology. Vycross technology blends different molecular weights of hyaluronic acid together, allowing for longer duration of the product. Unlike Juvéderm Voluma XC (20 mg/mL), Juvéderm Volbella XC is a lower-concentration HA (15 mg/mL) and has a lower G prime and cohesivity, allowing more horizontal spread as opposed to a lift, which makes it more appropriate for injection into the lips and superficial perioral lines.1
Juvéderm Volbella XC will not be available for use in the United States until October 2016. However, the product was first approved in Europe in 2011, and subsequently in Latin America, the Middle East, Asia Pacific, and Canada. What has been the experience of our neighboring colleagues?
In a randomized, prospective, 12-month controlled European study of 280 patients comparing Volbella to a nonanimal stabilized hyaluronic acid (NASHA), Volbella was found to be noninferior to NASHA at 3 months.2 Improvements in lip fullness, perioral lines, and oral commissures for Volbella were statistically significant at 6 and 12 months. Acute swelling was also noted to be less.
In a German 62-patient study with primary endpoints of satisfaction with improvement and look and feel of the lips, a high degree of subject satisfaction with aesthetic improvement in the lips, as well as with their natural look and feel, was noted among 83.6% and 75%-93%, respectively.3
In a retrospective chart review of 400 patients in Israel, where Volbella was injected into tear troughs (disclaimer: not approved for tear troughs in the United States) and/or lips, 17 patients (4.25%) developed prolonged inflammatory cutaneous reactions, lasting up to 11 months, which recurred (with an average number of 3.17 episodes) and occurred late (with an average onset of 8.41 weeks after the injection).4 The reactions were treated with antibiotics and hyaluronidase injections. The finding in this published report is higher than the 0.02% of delayed-onset inflammatory reaction previously reported with HA fillers.
With a full armamentarium of HA and non-HA fillers on the market, we are lucky to have many options to select from to treat aesthetic concerns of patients. For lip and perioral enhancement in the United States, Restylane, Juvéderm, Belotero, and now Volbella are all excellent options. As the dermal filler portfolio available internationally is larger than that in the United States, much can be learned from the experience of our international colleagues.
References
1. Plast Reconstr Surg. 2015 Nov;136(5 Suppl):139S-48S.
2. J Drugs Dermatol. 2015 Dec;14(12):1444-52.
3. J Cosmet Dermatol. 2014 Jun;13(2):125-34.
4. Dermatol Surg. 2016 Jan;42(1):31-7.
Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. Dr. Wesley has no disclosures with regard to Volbella; she participated in clinical trials for Juvéderm Voluma. Dr. Talakoub is a national trainer for Juvéderm manufacturer Allergan for all its injectables.
On May 31, 2016, the Food and Drug Administration approved Juvéderm Volbella XC for use in the lips for lip augmentation and for correction of perioral rhytids, in adults over the age of 21. In the U.S. pivotal clinical trial of 168 patients, Juvederm Volbella XC was found to increase lip fullness and soften the appearance of perioral rhytids in two-thirds through 1 year.
Like its previously approved predecessor Juvéderm Voluma XC, approved for the mid-face/cheek area, Juvéderm Volbella XC is composed of hyaluronic acid (HA) using Vycross technology. Vycross technology blends different molecular weights of hyaluronic acid together, allowing for longer duration of the product. Unlike Juvéderm Voluma XC (20 mg/mL), Juvéderm Volbella XC is a lower-concentration HA (15 mg/mL) and has a lower G prime and cohesivity, allowing more horizontal spread as opposed to a lift, which makes it more appropriate for injection into the lips and superficial perioral lines.1
Juvéderm Volbella XC will not be available for use in the United States until October 2016. However, the product was first approved in Europe in 2011, and subsequently in Latin America, the Middle East, Asia Pacific, and Canada. What has been the experience of our neighboring colleagues?
In a randomized, prospective, 12-month controlled European study of 280 patients comparing Volbella to a nonanimal stabilized hyaluronic acid (NASHA), Volbella was found to be noninferior to NASHA at 3 months.2 Improvements in lip fullness, perioral lines, and oral commissures for Volbella were statistically significant at 6 and 12 months. Acute swelling was also noted to be less.
In a German 62-patient study with primary endpoints of satisfaction with improvement and look and feel of the lips, a high degree of subject satisfaction with aesthetic improvement in the lips, as well as with their natural look and feel, was noted among 83.6% and 75%-93%, respectively.3
In a retrospective chart review of 400 patients in Israel, where Volbella was injected into tear troughs (disclaimer: not approved for tear troughs in the United States) and/or lips, 17 patients (4.25%) developed prolonged inflammatory cutaneous reactions, lasting up to 11 months, which recurred (with an average number of 3.17 episodes) and occurred late (with an average onset of 8.41 weeks after the injection).4 The reactions were treated with antibiotics and hyaluronidase injections. The finding in this published report is higher than the 0.02% of delayed-onset inflammatory reaction previously reported with HA fillers.
With a full armamentarium of HA and non-HA fillers on the market, we are lucky to have many options to select from to treat aesthetic concerns of patients. For lip and perioral enhancement in the United States, Restylane, Juvéderm, Belotero, and now Volbella are all excellent options. As the dermal filler portfolio available internationally is larger than that in the United States, much can be learned from the experience of our international colleagues.
References
1. Plast Reconstr Surg. 2015 Nov;136(5 Suppl):139S-48S.
2. J Drugs Dermatol. 2015 Dec;14(12):1444-52.
3. J Cosmet Dermatol. 2014 Jun;13(2):125-34.
4. Dermatol Surg. 2016 Jan;42(1):31-7.
Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. Dr. Wesley has no disclosures with regard to Volbella; she participated in clinical trials for Juvéderm Voluma. Dr. Talakoub is a national trainer for Juvéderm manufacturer Allergan for all its injectables.
It does get better ... with your help: Preventing suicide
Suicide continues to be a major public health problem in the United States. It is the second leading cause of death in young people aged 10-24 years, according to 2010 injury data from the Centers from Disease Control and Prevention.1 This problem disproportionately affects lesbian, gay, bisexual, and transgender (LGBT) youth. Compared to their heterosexual peers, LGBT youth are four times as likely to attempt suicide.2 In addition, almost 50% of transgender youth have attempted suicide.3
Why are LGBT youth at high risk for suicide? Antigay and antitrans stigma and discrimination against LGBT youth create a very stressful environment. For example, LGBT youth are two times more likely than are heterosexual youth to experience bullying4 because of their sexual orientation, and half of transgender youth have reported bullying because of their gender identity.3 LGBT youth tend to perceive lower levels of parental support than do heterosexual youth.5-8 A combination of harassment from peers and decreased perceived support from families increases the risk for suicide in LGBT youth.
However, there are factors that can reduce this risk. LGBT youth whose parents reject their sexual orientation or gender identity are eight times as likely to be suicidal,3,9 while in contrast, LGBT youth whose parents are more accepting are less likely to be suicidal.10 These studies underscore the importance of social support in reducing the stress from antigay and antitrans discrimination, and therefore, play a role in preventing suicide.
Health care providers are another source of support for LGBT youth. They can play a role in providing education and preventing suicide in this population because many victims of suicide have visited a health care provider before attempting to kill themselves.11 It is important for providers to screen for suicide in their patients. Although there is no lab test for suicidal ideation, suicidal adolescents tend to have certain risk factors. In addition to being LGBT, being bullied, and having a lack of social support, other risk factors are psychiatric illness, a history of being impulsive, alcohol and substance abuse, and most important of all, a previous suicide attempt.12
When screening for suicide risk, always remember that at the beginning of any visit with an adolescent, remind them about confidentiality and its limits (e.g., breaking confidentiality if the patient is suicidal). Although this appears counterintuitive, it actually builds rapport between you and the patient. If you don’t discuss the limits of confidentiality beforehand and have to break it because the patient is suicidal, the patient is less likely to tell you again in the future. Once you suspect suicidal ideation based on the above risk factors, you can ask:
• Have you thought about ending your own life or would you rather be dead?
• Have you done something to harm yourself or to end your life?
• Have you considered ways to end your own life?12
Some clinicians have expressed concern over asking about suicide in their adolescent patients, but doing so does not induce suicidal thoughts.13 If a patient does express any of the above, the clinician must then inquire about other risk factors that increase the individual’s chances of completing suicide. The American Association of Suicidology has listed several warning signs of imminent suicide, which can be remembered with the acronym IS PATH WARM. This stands for Ideation, Substance use, Purposelessness, heightened Anxiety, feeling Trapped, feeling Hopeless, Withdrawal from friends and family, uncontrollable Anger, engaging in Reckless behavior, and dramatic Mood changes.14
If a patient threatens to kill him/herself, has a specific plan to do so, or speaks about death and suicide, then the clinician must act immediately. Although sending a patient to the emergency department is the safest option, it is not the only option. If a good support system is present, and the patient lives in an environment where he or she does not have the means to carry out a suicide (e.g., there are no guns in the home), then the clinician can create a safety plan for the patient. A safety plan is different from a “no suicide contract.” A no suicide contract is a written commitment that the patient does not engage in suicidal behavior. Many experts caution against a no suicide contract because it can create a false sense of security for the clinician and does not address the strategies needed to combat feelings of suicidality.15,16
Usually with a safety plan, the clinician and the patient identify several people the patient can contact if the patient feels suicidal. In addition, the clinician and the patient can discuss ways the patient can cope with his/her feelings or distract himself/herself from suicidal thoughts (e.g., going out for a walk, watching a movie, etc.). Finally, if these methods fail, patients are provided with emergency hotlines or directed to the emergency department. The Suicide Prevention Resource Center has a template of a patient safety plan.
Finally, clinicians should be proactive in preventing suicide, especially for LGBT youth. Because bullying is a risk factor for suicide, and because LGBT youth are disproportionately affected by bullying, clinicians should advocate for antibullying school policies and advocate for schools to be more LGBT friendly. Clinicians also should speak to the community about suicide, its warning signs, and how to address it. Just like with any disease, prevention is the most effective form of treatment.
As clinicians, we should always be on the lookout for suicide in our young patients, especially LGBT youth. For many LGBT youth, we may be the only source of support. If patients are suicidal, we should work with them to determine how to keep the them safe. We have a powerful voice in the community. We can advocate for making schools safe for LGBT youth and educate the community in suicide prevention. Such a powerful voice proclaiming that it gets better can save a life.
Resources
• The Trevor Project: A non-profit organization dedicated to prevent suicide in LGBT Youth (www.thetrevorproject.org)
• It Gets Better Project: Another website dedicated to preventing suicide in LGBT youth by promoting the message that life will improve for LGBT teens (www.itgetsbetter.org)
• Patient Safety Plan Template from the Suicide Prevention Resource Center (www.sprc.org)
References
1. CDC. NCIPC. Web-based Injury Statistics Query and Reporting System (WISQARS). 2010.
2. MMWR Surveill Summ. 2011 Jun 10;60(7):1-133.
3. Injustice at Every Turn: A Report of the National Transgender Discrimination Survey. (Washington: National Center for Transgender Equality and National Gay and Lesbian Task Force, 2011).
4. J Adolesc Health. 2014 Sep;55(3):432-8.
5. J Youth Adolesc. 2013 Mar;42(3):376-93.
6. J Youth Adolesc. 2010 Oct;39(10):1189-98.
7. School Psychology Review. 2008;37(2):202-16.
8. J Homosex. 2010;57(2):287-309.
9. Pediatrics. 2009 Jan;123(1):346-52.
10. J Child Adolesc Psychiatr Nurs. 2010 Nov;23(4):205-13.
11. Mayo Clin Proc. 2011 Aug;86(8):792-800.
12. Ital J Pediatr. 2015 Jul 7;41:49.
13. Ment Health Fam Med. 2008 Dec;5(4):229-35.
14. Know the Warning Signs of Suicide. American Association of Suicidology.
15. J Psychiatr Ment Health Nurs. 2008 Aug;15(6):512-22.
16. J Amer Acad Psych Law. 1999;27(3):445-50.
Dr. Montano is a physician at Children’s Hospital of Pittsburgh of UPMC and a clinical instructor of pediatrics at the University of Pittsburgh School of Medicine.
Suicide continues to be a major public health problem in the United States. It is the second leading cause of death in young people aged 10-24 years, according to 2010 injury data from the Centers from Disease Control and Prevention.1 This problem disproportionately affects lesbian, gay, bisexual, and transgender (LGBT) youth. Compared to their heterosexual peers, LGBT youth are four times as likely to attempt suicide.2 In addition, almost 50% of transgender youth have attempted suicide.3
Why are LGBT youth at high risk for suicide? Antigay and antitrans stigma and discrimination against LGBT youth create a very stressful environment. For example, LGBT youth are two times more likely than are heterosexual youth to experience bullying4 because of their sexual orientation, and half of transgender youth have reported bullying because of their gender identity.3 LGBT youth tend to perceive lower levels of parental support than do heterosexual youth.5-8 A combination of harassment from peers and decreased perceived support from families increases the risk for suicide in LGBT youth.
However, there are factors that can reduce this risk. LGBT youth whose parents reject their sexual orientation or gender identity are eight times as likely to be suicidal,3,9 while in contrast, LGBT youth whose parents are more accepting are less likely to be suicidal.10 These studies underscore the importance of social support in reducing the stress from antigay and antitrans discrimination, and therefore, play a role in preventing suicide.
Health care providers are another source of support for LGBT youth. They can play a role in providing education and preventing suicide in this population because many victims of suicide have visited a health care provider before attempting to kill themselves.11 It is important for providers to screen for suicide in their patients. Although there is no lab test for suicidal ideation, suicidal adolescents tend to have certain risk factors. In addition to being LGBT, being bullied, and having a lack of social support, other risk factors are psychiatric illness, a history of being impulsive, alcohol and substance abuse, and most important of all, a previous suicide attempt.12
When screening for suicide risk, always remember that at the beginning of any visit with an adolescent, remind them about confidentiality and its limits (e.g., breaking confidentiality if the patient is suicidal). Although this appears counterintuitive, it actually builds rapport between you and the patient. If you don’t discuss the limits of confidentiality beforehand and have to break it because the patient is suicidal, the patient is less likely to tell you again in the future. Once you suspect suicidal ideation based on the above risk factors, you can ask:
• Have you thought about ending your own life or would you rather be dead?
• Have you done something to harm yourself or to end your life?
• Have you considered ways to end your own life?12
Some clinicians have expressed concern over asking about suicide in their adolescent patients, but doing so does not induce suicidal thoughts.13 If a patient does express any of the above, the clinician must then inquire about other risk factors that increase the individual’s chances of completing suicide. The American Association of Suicidology has listed several warning signs of imminent suicide, which can be remembered with the acronym IS PATH WARM. This stands for Ideation, Substance use, Purposelessness, heightened Anxiety, feeling Trapped, feeling Hopeless, Withdrawal from friends and family, uncontrollable Anger, engaging in Reckless behavior, and dramatic Mood changes.14
If a patient threatens to kill him/herself, has a specific plan to do so, or speaks about death and suicide, then the clinician must act immediately. Although sending a patient to the emergency department is the safest option, it is not the only option. If a good support system is present, and the patient lives in an environment where he or she does not have the means to carry out a suicide (e.g., there are no guns in the home), then the clinician can create a safety plan for the patient. A safety plan is different from a “no suicide contract.” A no suicide contract is a written commitment that the patient does not engage in suicidal behavior. Many experts caution against a no suicide contract because it can create a false sense of security for the clinician and does not address the strategies needed to combat feelings of suicidality.15,16
Usually with a safety plan, the clinician and the patient identify several people the patient can contact if the patient feels suicidal. In addition, the clinician and the patient can discuss ways the patient can cope with his/her feelings or distract himself/herself from suicidal thoughts (e.g., going out for a walk, watching a movie, etc.). Finally, if these methods fail, patients are provided with emergency hotlines or directed to the emergency department. The Suicide Prevention Resource Center has a template of a patient safety plan.
Finally, clinicians should be proactive in preventing suicide, especially for LGBT youth. Because bullying is a risk factor for suicide, and because LGBT youth are disproportionately affected by bullying, clinicians should advocate for antibullying school policies and advocate for schools to be more LGBT friendly. Clinicians also should speak to the community about suicide, its warning signs, and how to address it. Just like with any disease, prevention is the most effective form of treatment.
As clinicians, we should always be on the lookout for suicide in our young patients, especially LGBT youth. For many LGBT youth, we may be the only source of support. If patients are suicidal, we should work with them to determine how to keep the them safe. We have a powerful voice in the community. We can advocate for making schools safe for LGBT youth and educate the community in suicide prevention. Such a powerful voice proclaiming that it gets better can save a life.
Resources
• The Trevor Project: A non-profit organization dedicated to prevent suicide in LGBT Youth (www.thetrevorproject.org)
• It Gets Better Project: Another website dedicated to preventing suicide in LGBT youth by promoting the message that life will improve for LGBT teens (www.itgetsbetter.org)
• Patient Safety Plan Template from the Suicide Prevention Resource Center (www.sprc.org)
References
1. CDC. NCIPC. Web-based Injury Statistics Query and Reporting System (WISQARS). 2010.
2. MMWR Surveill Summ. 2011 Jun 10;60(7):1-133.
3. Injustice at Every Turn: A Report of the National Transgender Discrimination Survey. (Washington: National Center for Transgender Equality and National Gay and Lesbian Task Force, 2011).
4. J Adolesc Health. 2014 Sep;55(3):432-8.
5. J Youth Adolesc. 2013 Mar;42(3):376-93.
6. J Youth Adolesc. 2010 Oct;39(10):1189-98.
7. School Psychology Review. 2008;37(2):202-16.
8. J Homosex. 2010;57(2):287-309.
9. Pediatrics. 2009 Jan;123(1):346-52.
10. J Child Adolesc Psychiatr Nurs. 2010 Nov;23(4):205-13.
11. Mayo Clin Proc. 2011 Aug;86(8):792-800.
12. Ital J Pediatr. 2015 Jul 7;41:49.
13. Ment Health Fam Med. 2008 Dec;5(4):229-35.
14. Know the Warning Signs of Suicide. American Association of Suicidology.
15. J Psychiatr Ment Health Nurs. 2008 Aug;15(6):512-22.
16. J Amer Acad Psych Law. 1999;27(3):445-50.
Dr. Montano is a physician at Children’s Hospital of Pittsburgh of UPMC and a clinical instructor of pediatrics at the University of Pittsburgh School of Medicine.
Suicide continues to be a major public health problem in the United States. It is the second leading cause of death in young people aged 10-24 years, according to 2010 injury data from the Centers from Disease Control and Prevention.1 This problem disproportionately affects lesbian, gay, bisexual, and transgender (LGBT) youth. Compared to their heterosexual peers, LGBT youth are four times as likely to attempt suicide.2 In addition, almost 50% of transgender youth have attempted suicide.3
Why are LGBT youth at high risk for suicide? Antigay and antitrans stigma and discrimination against LGBT youth create a very stressful environment. For example, LGBT youth are two times more likely than are heterosexual youth to experience bullying4 because of their sexual orientation, and half of transgender youth have reported bullying because of their gender identity.3 LGBT youth tend to perceive lower levels of parental support than do heterosexual youth.5-8 A combination of harassment from peers and decreased perceived support from families increases the risk for suicide in LGBT youth.
However, there are factors that can reduce this risk. LGBT youth whose parents reject their sexual orientation or gender identity are eight times as likely to be suicidal,3,9 while in contrast, LGBT youth whose parents are more accepting are less likely to be suicidal.10 These studies underscore the importance of social support in reducing the stress from antigay and antitrans discrimination, and therefore, play a role in preventing suicide.
Health care providers are another source of support for LGBT youth. They can play a role in providing education and preventing suicide in this population because many victims of suicide have visited a health care provider before attempting to kill themselves.11 It is important for providers to screen for suicide in their patients. Although there is no lab test for suicidal ideation, suicidal adolescents tend to have certain risk factors. In addition to being LGBT, being bullied, and having a lack of social support, other risk factors are psychiatric illness, a history of being impulsive, alcohol and substance abuse, and most important of all, a previous suicide attempt.12
When screening for suicide risk, always remember that at the beginning of any visit with an adolescent, remind them about confidentiality and its limits (e.g., breaking confidentiality if the patient is suicidal). Although this appears counterintuitive, it actually builds rapport between you and the patient. If you don’t discuss the limits of confidentiality beforehand and have to break it because the patient is suicidal, the patient is less likely to tell you again in the future. Once you suspect suicidal ideation based on the above risk factors, you can ask:
• Have you thought about ending your own life or would you rather be dead?
• Have you done something to harm yourself or to end your life?
• Have you considered ways to end your own life?12
Some clinicians have expressed concern over asking about suicide in their adolescent patients, but doing so does not induce suicidal thoughts.13 If a patient does express any of the above, the clinician must then inquire about other risk factors that increase the individual’s chances of completing suicide. The American Association of Suicidology has listed several warning signs of imminent suicide, which can be remembered with the acronym IS PATH WARM. This stands for Ideation, Substance use, Purposelessness, heightened Anxiety, feeling Trapped, feeling Hopeless, Withdrawal from friends and family, uncontrollable Anger, engaging in Reckless behavior, and dramatic Mood changes.14
If a patient threatens to kill him/herself, has a specific plan to do so, or speaks about death and suicide, then the clinician must act immediately. Although sending a patient to the emergency department is the safest option, it is not the only option. If a good support system is present, and the patient lives in an environment where he or she does not have the means to carry out a suicide (e.g., there are no guns in the home), then the clinician can create a safety plan for the patient. A safety plan is different from a “no suicide contract.” A no suicide contract is a written commitment that the patient does not engage in suicidal behavior. Many experts caution against a no suicide contract because it can create a false sense of security for the clinician and does not address the strategies needed to combat feelings of suicidality.15,16
Usually with a safety plan, the clinician and the patient identify several people the patient can contact if the patient feels suicidal. In addition, the clinician and the patient can discuss ways the patient can cope with his/her feelings or distract himself/herself from suicidal thoughts (e.g., going out for a walk, watching a movie, etc.). Finally, if these methods fail, patients are provided with emergency hotlines or directed to the emergency department. The Suicide Prevention Resource Center has a template of a patient safety plan.
Finally, clinicians should be proactive in preventing suicide, especially for LGBT youth. Because bullying is a risk factor for suicide, and because LGBT youth are disproportionately affected by bullying, clinicians should advocate for antibullying school policies and advocate for schools to be more LGBT friendly. Clinicians also should speak to the community about suicide, its warning signs, and how to address it. Just like with any disease, prevention is the most effective form of treatment.
As clinicians, we should always be on the lookout for suicide in our young patients, especially LGBT youth. For many LGBT youth, we may be the only source of support. If patients are suicidal, we should work with them to determine how to keep the them safe. We have a powerful voice in the community. We can advocate for making schools safe for LGBT youth and educate the community in suicide prevention. Such a powerful voice proclaiming that it gets better can save a life.
Resources
• The Trevor Project: A non-profit organization dedicated to prevent suicide in LGBT Youth (www.thetrevorproject.org)
• It Gets Better Project: Another website dedicated to preventing suicide in LGBT youth by promoting the message that life will improve for LGBT teens (www.itgetsbetter.org)
• Patient Safety Plan Template from the Suicide Prevention Resource Center (www.sprc.org)
References
1. CDC. NCIPC. Web-based Injury Statistics Query and Reporting System (WISQARS). 2010.
2. MMWR Surveill Summ. 2011 Jun 10;60(7):1-133.
3. Injustice at Every Turn: A Report of the National Transgender Discrimination Survey. (Washington: National Center for Transgender Equality and National Gay and Lesbian Task Force, 2011).
4. J Adolesc Health. 2014 Sep;55(3):432-8.
5. J Youth Adolesc. 2013 Mar;42(3):376-93.
6. J Youth Adolesc. 2010 Oct;39(10):1189-98.
7. School Psychology Review. 2008;37(2):202-16.
8. J Homosex. 2010;57(2):287-309.
9. Pediatrics. 2009 Jan;123(1):346-52.
10. J Child Adolesc Psychiatr Nurs. 2010 Nov;23(4):205-13.
11. Mayo Clin Proc. 2011 Aug;86(8):792-800.
12. Ital J Pediatr. 2015 Jul 7;41:49.
13. Ment Health Fam Med. 2008 Dec;5(4):229-35.
14. Know the Warning Signs of Suicide. American Association of Suicidology.
15. J Psychiatr Ment Health Nurs. 2008 Aug;15(6):512-22.
16. J Amer Acad Psych Law. 1999;27(3):445-50.
Dr. Montano is a physician at Children’s Hospital of Pittsburgh of UPMC and a clinical instructor of pediatrics at the University of Pittsburgh School of Medicine.
Medical boards investigating negligence
(This column is the second in a three-part series.)
Question: A penicillin-allergic patient died from massive hemolysis after receiving the antibiotic ceftriaxone (Rocephin). The plaintiff alleged that the defendant was grossly negligent in administering the drug and subsequently refusing to treat or to readmit the decedent.
If this case is referred to the state’s medical board, which of the following statements is best?
A. The outcome depends on the jurisdiction.
B. Substandard medical care is not part of professional misconduct, which is what a medical board is supposed to look at.
C. Disciplinary action requires a simple showing of ordinary negligence.
D. Disciplinary action requires more than one act of ordinary negligence.
E. Disciplinary action requires proof of gross negligence.
Answer: A. Under the Medical Practice Act, each state authorizes its medical board to issue licenses and regulate physician practice. Professional misconduct is about unprofessional behavior, and covers both ethical breach and substandard care.
Medical boards do not typically adjudicate single acts of ordinary negligence, leaving them instead to the tort system and civil lawsuits. However, grossly culpable misconduct – even in a single instance – or a recurring pattern of ordinary negligence can come under medical board review. And it is common practice for boards to use malpractice data as a tool to trigger further investigations, such as a certain number of malpractice settlements over a given span of time.
States vary somewhat over when to investigate a complaint of alleged substandard practice. In California, the term “unprofessional conduct” is codified under section 2234 of the California Business and Professions Code, and the errant doctor is subject to disciplinary sanction if there is gross negligence, repeated negligent acts (defined as two or more negligent acts or omissions), or incompetence.
In Hawaii, the disciplinary law is set up under Hawaii Revised Statutes section 453-8, which lists 15 situations of wrongdoing. In the malpractice category, Hawaii’s law uses the terms hazardous misconduct, hazardous negligence, incompetence, or multiple instances of negligence.
The state of New York defines professional misconduct by reference to a comprehensive list of 49 categories under section 6530, which include gross incompetence or gross negligence on a single occasion, or negligence or incompetence on more than one occasion.
However, Maryland is an example of a jurisdiction that does not require gross or repeated negligence; the state considers any failure to meet the appropriate medical standards as professional misconduct.1
But what constitutes gross negligence?
The vast majority of medical malpractice lawsuits allege ordinary, not gross negligence. Ordinary negligence is a well-defined legal term, as illustrated in Prosser’s Textbook on Torts: “The formula under which this usually is put to the jury is that the doctor must have and use the knowledge, skill, and care ordinarily possessed and employed by members of the profession in good standing.”2
In contrast, there is no universal definition for the term gross negligence. Everyone recognizes it denotes a greater degree of culpability than ordinary negligence, but how much greater?
According to the California Supreme Court, gross negligence may be said to be “the want of even scant care or an extreme departure from the ordinary standard of conduct.”3 The law in Texas stipulates: “Gross negligence means more than momentary thoughtlessness, inadvertence, or error of judgment. It means an entire want of care as to establish that the act or omission was the result of actual, conscious indifference to the rights, safety, and welfare of the person affected.”4
Examples in case law of gross negligence (or where punitive damages were awarded, which usually signify egregious conduct) include a doctor’s wanton failure to provide follow-up care for a child who developed fever and gangrenous toes following foot surgery,5 the prescription of an excessive number of birth control pills (more than 1,000 pills within a time period when less than 200 were sufficient) with resulting liver complications,6 and leaving behind a 6.5-inch clamp in a surgical incision.7
On the other hand, a Connecticut court (which decided the case in the hypothetical above) ruled that, under the facts, the defendant’s conduct did not meet the high threshold of egregiousness that defines gross negligence.8
As in any malpractice lawsuit, a medical board investigation involves determining whether the accused physician has met the standard of care in his or her specialty, and boards usually look to expert community physicians to articulate that requisite standard.
Compared with a civil lawsuit, a disciplinary hearing has the physician at a disadvantage. Medical board complaints are easier to file; the complaining party does not need an attorney; impartial expert witnesses are the responsibility of the board, not the complainant; and no patient injury needs to be shown.
Furthermore, a settlement is rarely reached or negotiated, and penalties are potentially far more serious, such as public posting of an adverse decision and restriction or actual loss of licensure.
Reputational loss also is arguably more devastating with board censure, because an adverse action taken by a medical board indicates a violation of the Medical Practice Act. In contrast, malpractice settlements or verdicts are regularly viewed as unreliable measures of a physician’s competence.
Still, two features work in favor of the doctor facing a board hearing. First, the misconduct typically has to be recurrent or grossly negligent, rather than an isolated case of carelessness. And second, some boards (only a small minority) require evidentiary proof of fault to be “clear and convincing,” instead of the familiar “more probable than not” standard that is used in a civil negligence suit. This makes it theoretically harder to reach a finding of culpability against the doctor.
References
1. Md. Code Ann. Health Occ. section 14-404.
2. Prosser and Keeton on Torts, 5th ed., 1984.
3. Van Meter v. Bent Construction Co., 297 P.2d 644 (Cal. 1956).
4. Texas Civil Practice & Remedies Code section 41.001(7).
5. Dempsey v. Phelps, 700 So.2d 1340 (Ala. 1997).
6. Jackson v. Taylor, 912 F.2d 795 (5th Cir. 1990).
7. Fox v. Oklahoma Memorial Hospital, 774 P.2d 459 (Ok. 1989).
8. Boone v. William W. Backus Hospital, 864 A.2d 1 (Conn. 2005).
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].
(This column is the second in a three-part series.)
Question: A penicillin-allergic patient died from massive hemolysis after receiving the antibiotic ceftriaxone (Rocephin). The plaintiff alleged that the defendant was grossly negligent in administering the drug and subsequently refusing to treat or to readmit the decedent.
If this case is referred to the state’s medical board, which of the following statements is best?
A. The outcome depends on the jurisdiction.
B. Substandard medical care is not part of professional misconduct, which is what a medical board is supposed to look at.
C. Disciplinary action requires a simple showing of ordinary negligence.
D. Disciplinary action requires more than one act of ordinary negligence.
E. Disciplinary action requires proof of gross negligence.
Answer: A. Under the Medical Practice Act, each state authorizes its medical board to issue licenses and regulate physician practice. Professional misconduct is about unprofessional behavior, and covers both ethical breach and substandard care.
Medical boards do not typically adjudicate single acts of ordinary negligence, leaving them instead to the tort system and civil lawsuits. However, grossly culpable misconduct – even in a single instance – or a recurring pattern of ordinary negligence can come under medical board review. And it is common practice for boards to use malpractice data as a tool to trigger further investigations, such as a certain number of malpractice settlements over a given span of time.
States vary somewhat over when to investigate a complaint of alleged substandard practice. In California, the term “unprofessional conduct” is codified under section 2234 of the California Business and Professions Code, and the errant doctor is subject to disciplinary sanction if there is gross negligence, repeated negligent acts (defined as two or more negligent acts or omissions), or incompetence.
In Hawaii, the disciplinary law is set up under Hawaii Revised Statutes section 453-8, which lists 15 situations of wrongdoing. In the malpractice category, Hawaii’s law uses the terms hazardous misconduct, hazardous negligence, incompetence, or multiple instances of negligence.
The state of New York defines professional misconduct by reference to a comprehensive list of 49 categories under section 6530, which include gross incompetence or gross negligence on a single occasion, or negligence or incompetence on more than one occasion.
However, Maryland is an example of a jurisdiction that does not require gross or repeated negligence; the state considers any failure to meet the appropriate medical standards as professional misconduct.1
But what constitutes gross negligence?
The vast majority of medical malpractice lawsuits allege ordinary, not gross negligence. Ordinary negligence is a well-defined legal term, as illustrated in Prosser’s Textbook on Torts: “The formula under which this usually is put to the jury is that the doctor must have and use the knowledge, skill, and care ordinarily possessed and employed by members of the profession in good standing.”2
In contrast, there is no universal definition for the term gross negligence. Everyone recognizes it denotes a greater degree of culpability than ordinary negligence, but how much greater?
According to the California Supreme Court, gross negligence may be said to be “the want of even scant care or an extreme departure from the ordinary standard of conduct.”3 The law in Texas stipulates: “Gross negligence means more than momentary thoughtlessness, inadvertence, or error of judgment. It means an entire want of care as to establish that the act or omission was the result of actual, conscious indifference to the rights, safety, and welfare of the person affected.”4
Examples in case law of gross negligence (or where punitive damages were awarded, which usually signify egregious conduct) include a doctor’s wanton failure to provide follow-up care for a child who developed fever and gangrenous toes following foot surgery,5 the prescription of an excessive number of birth control pills (more than 1,000 pills within a time period when less than 200 were sufficient) with resulting liver complications,6 and leaving behind a 6.5-inch clamp in a surgical incision.7
On the other hand, a Connecticut court (which decided the case in the hypothetical above) ruled that, under the facts, the defendant’s conduct did not meet the high threshold of egregiousness that defines gross negligence.8
As in any malpractice lawsuit, a medical board investigation involves determining whether the accused physician has met the standard of care in his or her specialty, and boards usually look to expert community physicians to articulate that requisite standard.
Compared with a civil lawsuit, a disciplinary hearing has the physician at a disadvantage. Medical board complaints are easier to file; the complaining party does not need an attorney; impartial expert witnesses are the responsibility of the board, not the complainant; and no patient injury needs to be shown.
Furthermore, a settlement is rarely reached or negotiated, and penalties are potentially far more serious, such as public posting of an adverse decision and restriction or actual loss of licensure.
Reputational loss also is arguably more devastating with board censure, because an adverse action taken by a medical board indicates a violation of the Medical Practice Act. In contrast, malpractice settlements or verdicts are regularly viewed as unreliable measures of a physician’s competence.
Still, two features work in favor of the doctor facing a board hearing. First, the misconduct typically has to be recurrent or grossly negligent, rather than an isolated case of carelessness. And second, some boards (only a small minority) require evidentiary proof of fault to be “clear and convincing,” instead of the familiar “more probable than not” standard that is used in a civil negligence suit. This makes it theoretically harder to reach a finding of culpability against the doctor.
References
1. Md. Code Ann. Health Occ. section 14-404.
2. Prosser and Keeton on Torts, 5th ed., 1984.
3. Van Meter v. Bent Construction Co., 297 P.2d 644 (Cal. 1956).
4. Texas Civil Practice & Remedies Code section 41.001(7).
5. Dempsey v. Phelps, 700 So.2d 1340 (Ala. 1997).
6. Jackson v. Taylor, 912 F.2d 795 (5th Cir. 1990).
7. Fox v. Oklahoma Memorial Hospital, 774 P.2d 459 (Ok. 1989).
8. Boone v. William W. Backus Hospital, 864 A.2d 1 (Conn. 2005).
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].
(This column is the second in a three-part series.)
Question: A penicillin-allergic patient died from massive hemolysis after receiving the antibiotic ceftriaxone (Rocephin). The plaintiff alleged that the defendant was grossly negligent in administering the drug and subsequently refusing to treat or to readmit the decedent.
If this case is referred to the state’s medical board, which of the following statements is best?
A. The outcome depends on the jurisdiction.
B. Substandard medical care is not part of professional misconduct, which is what a medical board is supposed to look at.
C. Disciplinary action requires a simple showing of ordinary negligence.
D. Disciplinary action requires more than one act of ordinary negligence.
E. Disciplinary action requires proof of gross negligence.
Answer: A. Under the Medical Practice Act, each state authorizes its medical board to issue licenses and regulate physician practice. Professional misconduct is about unprofessional behavior, and covers both ethical breach and substandard care.
Medical boards do not typically adjudicate single acts of ordinary negligence, leaving them instead to the tort system and civil lawsuits. However, grossly culpable misconduct – even in a single instance – or a recurring pattern of ordinary negligence can come under medical board review. And it is common practice for boards to use malpractice data as a tool to trigger further investigations, such as a certain number of malpractice settlements over a given span of time.
States vary somewhat over when to investigate a complaint of alleged substandard practice. In California, the term “unprofessional conduct” is codified under section 2234 of the California Business and Professions Code, and the errant doctor is subject to disciplinary sanction if there is gross negligence, repeated negligent acts (defined as two or more negligent acts or omissions), or incompetence.
In Hawaii, the disciplinary law is set up under Hawaii Revised Statutes section 453-8, which lists 15 situations of wrongdoing. In the malpractice category, Hawaii’s law uses the terms hazardous misconduct, hazardous negligence, incompetence, or multiple instances of negligence.
The state of New York defines professional misconduct by reference to a comprehensive list of 49 categories under section 6530, which include gross incompetence or gross negligence on a single occasion, or negligence or incompetence on more than one occasion.
However, Maryland is an example of a jurisdiction that does not require gross or repeated negligence; the state considers any failure to meet the appropriate medical standards as professional misconduct.1
But what constitutes gross negligence?
The vast majority of medical malpractice lawsuits allege ordinary, not gross negligence. Ordinary negligence is a well-defined legal term, as illustrated in Prosser’s Textbook on Torts: “The formula under which this usually is put to the jury is that the doctor must have and use the knowledge, skill, and care ordinarily possessed and employed by members of the profession in good standing.”2
In contrast, there is no universal definition for the term gross negligence. Everyone recognizes it denotes a greater degree of culpability than ordinary negligence, but how much greater?
According to the California Supreme Court, gross negligence may be said to be “the want of even scant care or an extreme departure from the ordinary standard of conduct.”3 The law in Texas stipulates: “Gross negligence means more than momentary thoughtlessness, inadvertence, or error of judgment. It means an entire want of care as to establish that the act or omission was the result of actual, conscious indifference to the rights, safety, and welfare of the person affected.”4
Examples in case law of gross negligence (or where punitive damages were awarded, which usually signify egregious conduct) include a doctor’s wanton failure to provide follow-up care for a child who developed fever and gangrenous toes following foot surgery,5 the prescription of an excessive number of birth control pills (more than 1,000 pills within a time period when less than 200 were sufficient) with resulting liver complications,6 and leaving behind a 6.5-inch clamp in a surgical incision.7
On the other hand, a Connecticut court (which decided the case in the hypothetical above) ruled that, under the facts, the defendant’s conduct did not meet the high threshold of egregiousness that defines gross negligence.8
As in any malpractice lawsuit, a medical board investigation involves determining whether the accused physician has met the standard of care in his or her specialty, and boards usually look to expert community physicians to articulate that requisite standard.
Compared with a civil lawsuit, a disciplinary hearing has the physician at a disadvantage. Medical board complaints are easier to file; the complaining party does not need an attorney; impartial expert witnesses are the responsibility of the board, not the complainant; and no patient injury needs to be shown.
Furthermore, a settlement is rarely reached or negotiated, and penalties are potentially far more serious, such as public posting of an adverse decision and restriction or actual loss of licensure.
Reputational loss also is arguably more devastating with board censure, because an adverse action taken by a medical board indicates a violation of the Medical Practice Act. In contrast, malpractice settlements or verdicts are regularly viewed as unreliable measures of a physician’s competence.
Still, two features work in favor of the doctor facing a board hearing. First, the misconduct typically has to be recurrent or grossly negligent, rather than an isolated case of carelessness. And second, some boards (only a small minority) require evidentiary proof of fault to be “clear and convincing,” instead of the familiar “more probable than not” standard that is used in a civil negligence suit. This makes it theoretically harder to reach a finding of culpability against the doctor.
References
1. Md. Code Ann. Health Occ. section 14-404.
2. Prosser and Keeton on Torts, 5th ed., 1984.
3. Van Meter v. Bent Construction Co., 297 P.2d 644 (Cal. 1956).
4. Texas Civil Practice & Remedies Code section 41.001(7).
5. Dempsey v. Phelps, 700 So.2d 1340 (Ala. 1997).
6. Jackson v. Taylor, 912 F.2d 795 (5th Cir. 1990).
7. Fox v. Oklahoma Memorial Hospital, 774 P.2d 459 (Ok. 1989).
8. Boone v. William W. Backus Hospital, 864 A.2d 1 (Conn. 2005).
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].
Quality or convenience: Pick one
A 35-year-old male with a 5-year-history of a changing mole on his back sends a picture of the lesion to a telemedicine website for advice. The photo reveals a black nodule. The clinician replies, advising the patient that the lesion is benign.
To most dermatologists, the above scenario would occur only in a bizarre nightmare, never in real life. In real life, if the words “black” and “nodule” are used to describe a lesion, they are followed by the verb “biopsy.” Most dermatologists would recognize this as a high-risk growth and recommend additional investigation.
Unfortunately, a recent study of direct-to-consumer (DTC) telemedicine in JAMA Dermatology showed that 21% of the time, the patient was wrongfully reassured that a lesion was benign (JAMA Dermatol. 2016;152[7]:768-75). The study examined how 16 DTC telemedicine websites and apps handled six standardized dermatology cases designed to test the quality of the services. While some provided good care, others missed important diagnoses such as syphilis, eczema herpeticum, and melanoma. If these cases had been actual patients, the consequences for such mistakes could have been dire.
“The services failed to ask simple, relevant questions of patients about their symptoms, leading them to repeatedly miss important diagnoses,” Jack Resneck Jr., MD, a dermatologist at the University of California, San Francisco, and lead author of the study, told the Wall Street Journal.
The study is timely, as telemedicine is accelerating explosively. The low cost of connectivity, viable business models, and changing consumer behaviors are fueling its rocket growth. Startups in digital health and telemedicine have raised over $700 million already this year, indicating that there is more fuel to be burned and more money to be made.
DTC telemedicine describes the model when a patient sends photos directly to a clinician without a prior history with that provider. A teleconsultation, in contrast, is an interaction between two doctors. In DTC, the episode of care is usually isolated from the patient’s record, and the information is not transferred to the primary care physician. Patients pay a fee, which can range from $1.59 to $250.
Advocates of DTC cite its low cost and extraordinary convenience as arguments for its adoption. However, these disconnected visits are notable exceptions to the current trend toward better care coordination and information sharing among providers.
Quality is also a concern. Although consumers were often promised answers from board-certified physicians, the JAMA Dermatology study was unable to verify this in many cases. The researchers also found that nondermatologists, physician extenders, and physicians practicing in India were often the providers, facts that were not obvious to users.
Worse, the study found both the quality of the diagnoses and the recommendations were poor. All the providers missed the cases of syphilis and most missed eczema herpeticum. Risks of prescription medications were not disclosed two-thirds of the time. Worse yet, three services mistakenly advised that a nodular melanoma did not need further treatment. Had these been real patients, such wrongful recommendations could have resulted in deaths.
In an effort to ensure safety and reliability for consumers, the American Telemedicine Association has begun credentialing telemedicine providers. Such credentials are not required, however, and consumers are likely to be unaware of which providers have or have not met this standard. The American Academy of Dermatology addresses DTC teledermatology in its position statement, updated in 2016: “Dermatologists providing direct-to-patient teledermatology must make every effort to collect accurate, complete, and quality clinical information. When appropriate, the dermatologist may wish to contact the primary care providers or other specialists to obtain additional corroborating information.”
Currently, patients remain on their own in choosing telemedicine and other digital health services: caveat emptor. Do they want quality and convenient care? For now, it seems, they must pick only one.
Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego. He is @Dermdoc on Twitter. Write to him at [email protected].
A 35-year-old male with a 5-year-history of a changing mole on his back sends a picture of the lesion to a telemedicine website for advice. The photo reveals a black nodule. The clinician replies, advising the patient that the lesion is benign.
To most dermatologists, the above scenario would occur only in a bizarre nightmare, never in real life. In real life, if the words “black” and “nodule” are used to describe a lesion, they are followed by the verb “biopsy.” Most dermatologists would recognize this as a high-risk growth and recommend additional investigation.
Unfortunately, a recent study of direct-to-consumer (DTC) telemedicine in JAMA Dermatology showed that 21% of the time, the patient was wrongfully reassured that a lesion was benign (JAMA Dermatol. 2016;152[7]:768-75). The study examined how 16 DTC telemedicine websites and apps handled six standardized dermatology cases designed to test the quality of the services. While some provided good care, others missed important diagnoses such as syphilis, eczema herpeticum, and melanoma. If these cases had been actual patients, the consequences for such mistakes could have been dire.
“The services failed to ask simple, relevant questions of patients about their symptoms, leading them to repeatedly miss important diagnoses,” Jack Resneck Jr., MD, a dermatologist at the University of California, San Francisco, and lead author of the study, told the Wall Street Journal.
The study is timely, as telemedicine is accelerating explosively. The low cost of connectivity, viable business models, and changing consumer behaviors are fueling its rocket growth. Startups in digital health and telemedicine have raised over $700 million already this year, indicating that there is more fuel to be burned and more money to be made.
DTC telemedicine describes the model when a patient sends photos directly to a clinician without a prior history with that provider. A teleconsultation, in contrast, is an interaction between two doctors. In DTC, the episode of care is usually isolated from the patient’s record, and the information is not transferred to the primary care physician. Patients pay a fee, which can range from $1.59 to $250.
Advocates of DTC cite its low cost and extraordinary convenience as arguments for its adoption. However, these disconnected visits are notable exceptions to the current trend toward better care coordination and information sharing among providers.
Quality is also a concern. Although consumers were often promised answers from board-certified physicians, the JAMA Dermatology study was unable to verify this in many cases. The researchers also found that nondermatologists, physician extenders, and physicians practicing in India were often the providers, facts that were not obvious to users.
Worse, the study found both the quality of the diagnoses and the recommendations were poor. All the providers missed the cases of syphilis and most missed eczema herpeticum. Risks of prescription medications were not disclosed two-thirds of the time. Worse yet, three services mistakenly advised that a nodular melanoma did not need further treatment. Had these been real patients, such wrongful recommendations could have resulted in deaths.
In an effort to ensure safety and reliability for consumers, the American Telemedicine Association has begun credentialing telemedicine providers. Such credentials are not required, however, and consumers are likely to be unaware of which providers have or have not met this standard. The American Academy of Dermatology addresses DTC teledermatology in its position statement, updated in 2016: “Dermatologists providing direct-to-patient teledermatology must make every effort to collect accurate, complete, and quality clinical information. When appropriate, the dermatologist may wish to contact the primary care providers or other specialists to obtain additional corroborating information.”
Currently, patients remain on their own in choosing telemedicine and other digital health services: caveat emptor. Do they want quality and convenient care? For now, it seems, they must pick only one.
Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego. He is @Dermdoc on Twitter. Write to him at [email protected].
A 35-year-old male with a 5-year-history of a changing mole on his back sends a picture of the lesion to a telemedicine website for advice. The photo reveals a black nodule. The clinician replies, advising the patient that the lesion is benign.
To most dermatologists, the above scenario would occur only in a bizarre nightmare, never in real life. In real life, if the words “black” and “nodule” are used to describe a lesion, they are followed by the verb “biopsy.” Most dermatologists would recognize this as a high-risk growth and recommend additional investigation.
Unfortunately, a recent study of direct-to-consumer (DTC) telemedicine in JAMA Dermatology showed that 21% of the time, the patient was wrongfully reassured that a lesion was benign (JAMA Dermatol. 2016;152[7]:768-75). The study examined how 16 DTC telemedicine websites and apps handled six standardized dermatology cases designed to test the quality of the services. While some provided good care, others missed important diagnoses such as syphilis, eczema herpeticum, and melanoma. If these cases had been actual patients, the consequences for such mistakes could have been dire.
“The services failed to ask simple, relevant questions of patients about their symptoms, leading them to repeatedly miss important diagnoses,” Jack Resneck Jr., MD, a dermatologist at the University of California, San Francisco, and lead author of the study, told the Wall Street Journal.
The study is timely, as telemedicine is accelerating explosively. The low cost of connectivity, viable business models, and changing consumer behaviors are fueling its rocket growth. Startups in digital health and telemedicine have raised over $700 million already this year, indicating that there is more fuel to be burned and more money to be made.
DTC telemedicine describes the model when a patient sends photos directly to a clinician without a prior history with that provider. A teleconsultation, in contrast, is an interaction between two doctors. In DTC, the episode of care is usually isolated from the patient’s record, and the information is not transferred to the primary care physician. Patients pay a fee, which can range from $1.59 to $250.
Advocates of DTC cite its low cost and extraordinary convenience as arguments for its adoption. However, these disconnected visits are notable exceptions to the current trend toward better care coordination and information sharing among providers.
Quality is also a concern. Although consumers were often promised answers from board-certified physicians, the JAMA Dermatology study was unable to verify this in many cases. The researchers also found that nondermatologists, physician extenders, and physicians practicing in India were often the providers, facts that were not obvious to users.
Worse, the study found both the quality of the diagnoses and the recommendations were poor. All the providers missed the cases of syphilis and most missed eczema herpeticum. Risks of prescription medications were not disclosed two-thirds of the time. Worse yet, three services mistakenly advised that a nodular melanoma did not need further treatment. Had these been real patients, such wrongful recommendations could have resulted in deaths.
In an effort to ensure safety and reliability for consumers, the American Telemedicine Association has begun credentialing telemedicine providers. Such credentials are not required, however, and consumers are likely to be unaware of which providers have or have not met this standard. The American Academy of Dermatology addresses DTC teledermatology in its position statement, updated in 2016: “Dermatologists providing direct-to-patient teledermatology must make every effort to collect accurate, complete, and quality clinical information. When appropriate, the dermatologist may wish to contact the primary care providers or other specialists to obtain additional corroborating information.”
Currently, patients remain on their own in choosing telemedicine and other digital health services: caveat emptor. Do they want quality and convenient care? For now, it seems, they must pick only one.
Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego. He is @Dermdoc on Twitter. Write to him at [email protected].
