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LOCAL ANESTHESIA AND INFORMED CONSENT
L E T T E R S
LETTERS ADA welcomes letters from readers on articles and other information that has appeared in The Journal. The Journal reserves the right to edit all communications and requires that all letters be signed. Letters must be no more than 550 words and must cite no more than five references. No illustrations will be accepted. You may submit your letter via e-mail to “[email protected]”; by fax to 1-312-440-3538; or by mail to 211 E. Chicago Ave., Chicago, Ill. 60611-2678. The views expressed are those of the letter writer and do not necessarily reflect the opinion or official policy of the Association. Brevity is appreciated.
J
LOCAL ANESTHESIA AND INFORMED CONSENT
The November JADA article by Dr. Daniel Orr II and William Curtis, “Obtaining Written Informed Consent for the Administration of Local Anesthetic in Dentistry” (JADA 2005;136:1568-71), is exactly the kind of information that, in the telling, makes it so—a selffulfilling prophecy. It is sort of an advertisement to lawyers on how to go about suing dentists. And since the warning about written informed consent is now published in JADA, it increases the credibility of it needing to be done or, at least, provides one more increment of credibility for the concept to be introduced in court. The article appears to be written by a lawyer [Dr. Orr has a law degree, as well as a DDS, a PhD and an MD] for lawyers. The conclusion, as quoted from the article, is “based on the 436
JADA, Vol. 137
results of our informal survey.” The conclusion reads, “All dentists may want to consider whether it would be beneficial to their patients and their practices to obtain written informed consent when administering local anesthetic.” What does that mean? Why, based on the article, would I perhaps want to consider obtaining written informed consent? Will it benefit me, my practice or my patients? Nothing in the article suggested it would, except the implied threat that I will be asked by a lawyer why I don’t have a written informed consent, if my patient ever has an untoward response to dental treatment, if a local anesthetic was used. (If an untoward response to dental treatment occurred and a local anesthetic was not used, I would still get sued, but the question of written informed consent for the local wouldn’t come up.) But would getting written informed consent change the outcome of the suit, or is it just one more way for a lawyer to make it appear that my dental practice wasn’t up to the standard of care? Especially now, since an article was published in JADA suggesting that I “may want to consider getting a written informed consent.” I live in California. Currently, I have to get patients to sign a state government-mandated acknowledgment that I have given them a dental materials fact sheet. Essentially, this document tells patients that there is silver and mercury in their silver fillings, quartz and binders in their composite fillings, gold in their gold crowns, etc. Soon we will all have to sign an acknowledgment that there is
gas in the gas pumps at filling stations. At some point, a person who comes to a dentist to get dental work done knows that the use of a local anesthetic will be necessary for some dental procedures. They also know that, as with any medical or dental procedure, untoward things can happen. They shouldn’t be required to sign a form that acknowledges that. Next, I will have to meet my new patients at the bottom of the stairs to my office and inform them that the office is at the top of the stairs, and that there is a risk that they may fall while climbing the stairs to the office or that they may have a heart attack. All of that is true, but there is no benefit or value to them in a signed informed consent. Actually, in the back of my mind, I can hear my liability insurance carrier’s lawyers saying, “Hey! The stair informed consent thing is a great idea.” Also, in California, as I understand it, if the risk of a side effect to a medication is less than 3 percent, then the patient doesn’t have to be informed. That is common sense. A patient doesn’t need to be burdened with information about something that is unlikely to happen. I suspect that problems associated with local anesthetic administration are less than 1 percent and, therefore, common sense, compassion for not burdening the patient and an extrapolation of the law would suggest that there is no benefit to me, my patient (the person I am most concerned about) or my office to have them sign a written informed consent. Though doing so may, in some small way, protect me
http://jada.ada.org April 2006 Copyright ©2005 American Dental Association. All rights reserved.
L E T T E R S
from being made to look clueless by some lawyer intent on impugning my character, implying that my not having done so suggests that my dental practice is not up to the standard of care. Peter L. Jacobsen, PhD, DDS Professor, Department of Pathology and Medicine University of the Pacific Arthur A. Dugoni School of Dentistry San Francisco
MORE ABOUT INFORMED CONSENT
We commend Dr. Daniel Orr II and William Curtis’ November JADA article, “Obtaining Written Informed Consent for the Administration of Local Anesthetic in Dentistry” (JADA 2005;136:1568-71), for addressing the challenging issue of informed consent as it relates to local anesthesia. We agree that the informing duty involved in “informed consent” can be stated as “the process by which a patient is apprised (informed) of the nature and risks of a proposed treatment … .” We also assert that informed consent includes the relative “pros” and “cons” of potential treatments. This would include information about the relative risks associated with the products typically used to achieve anesthesia. Empirical evidence1-4 indicates that some local anesthetics have a significantly higher rate of paresthesia associated with their use than others, and we believe it is important to inform the patient of the relative risks associated with various anesthetic products to be used by the doctor. When using a higher-risk agent, the added risk should be described, along with the bene-
fit of its use. The product insert for Septocaine 5 indicates that the Septodont-sponsored U.S. Food and Drug Administration study on Septocaine reported 11 cases of paresthesia with 882 patient treatments. This equates to one paresthesia in every 80 patient treatments. The insert also lists other adverse events experienced by less than 1 percent of the patients in the study. The list includes other nervous system problems, such as facial paralysis, hyperesthesia, neuropathy and paresthesia. The reader is referred to two examples from the literature.1,2 One of the articles, “A 21 Year Retrospective Study of Reports of Paresthesia Following Local Anesthetic Administration,” includes a graph and tables on paresthesias associated with the local anesthetics available in Canada. The article reported that in 1993 there were 10 paresthesias with articaine, four with prilocaine and zero paresthesias with any other local anesthetic. Where the local anesthetic agent was known, the authors indicated articaine was associated with 50 paresthesias, bupivacaine with zero, lidocaine with five, mepivacaine with four and prilocaine with 43 paresthesias. The authors concluded that there was a significantly higher paresthesia rate with articaine and prilocaine, compared with the other local anesthetic agents. Two other studies3,4 in Ontario, Canada, subsequently substantiated those findings. The use of product inserts, practitioner experience, the references we have cited here and other literature on the subject would be useful in providing patients with the information nec-
essary for an informed decision related to the use of local anesthetics. Information about the provider’s experiences with each of the local anesthetics should not overshadow a frank discussion of the information contained in the product insert. While practitioners and patients both may be reluctant to have such discussions, good ethics and prudence call for them, in our view. Although paresthesias associated with local anesthesia were once a rare phenomenon, such has not been the case since the introduction of 4 percent local anesthetics, such as articaine and prilocaine.2 The ethics of good practice is not a static thing. As technology changes, practice must change with it. Patients deserve the full story, even if it includes uncomfortable information, and doctors themselves will benefit from an open discussion in the long run, as thorough informed consent tends to buffer them from the negative impact of litigation. James S. Dower Jr., DDS, MA Associate Professor of Restorative Dentistry Director of Local Anesthesia Curriculum
A. Thomas Indresano, DMD Chairperson and Professor of Oral and Maxillofacial Surgery
Bruce Peltier, PhD, MBA Professor of Psychology and Ethics Director of Ethics Education University of the Pacific Arthur A. Dugoni School of Dentistry San Francisco 1. Haas DA, Lennon D. A 21 year retrospective study of reports of paresthesia following local anesthetic administration. J Can Dent Assoc 1995;61(4):319-30. 2. Dower JS. A review of paresthesia in association with the administration of local anesthesia. Dent Today 2003;Feb:64-9.
JADA, Vol. 137 http://jada.ada.org Copyright ©2005 American Dental Association. All rights reserved.
April 2006
437
LETTERS ADA welcomes letters from readers on articles and other information that has appeared in The Journal. The Journal reserves the right to edit all communications and requires that all letters be signed. Letters must be no more than 550 words and must cite no more than five references. No illustrations will be accepted. You may submit your letter via e-mail to “[email protected]”; by fax to 1-312-440-3538; or by mail to 211 E. Chicago Ave., Chicago, Ill. 60611-2678. The views expressed are those of the letter writer and do not necessarily reflect the opinion or official policy of the Association. Brevity is appreciated.
J
LOCAL ANESTHESIA AND INFORMED CONSENT
The November JADA article by Dr. Daniel Orr II and William Curtis, “Obtaining Written Informed Consent for the Administration of Local Anesthetic in Dentistry” (JADA 2005;136:1568-71), is exactly the kind of information that, in the telling, makes it so—a selffulfilling prophecy. It is sort of an advertisement to lawyers on how to go about suing dentists. And since the warning about written informed consent is now published in JADA, it increases the credibility of it needing to be done or, at least, provides one more increment of credibility for the concept to be introduced in court. The article appears to be written by a lawyer [Dr. Orr has a law degree, as well as a DDS, a PhD and an MD] for lawyers. The conclusion, as quoted from the article, is “based on the 436
JADA, Vol. 137
results of our informal survey.” The conclusion reads, “All dentists may want to consider whether it would be beneficial to their patients and their practices to obtain written informed consent when administering local anesthetic.” What does that mean? Why, based on the article, would I perhaps want to consider obtaining written informed consent? Will it benefit me, my practice or my patients? Nothing in the article suggested it would, except the implied threat that I will be asked by a lawyer why I don’t have a written informed consent, if my patient ever has an untoward response to dental treatment, if a local anesthetic was used. (If an untoward response to dental treatment occurred and a local anesthetic was not used, I would still get sued, but the question of written informed consent for the local wouldn’t come up.) But would getting written informed consent change the outcome of the suit, or is it just one more way for a lawyer to make it appear that my dental practice wasn’t up to the standard of care? Especially now, since an article was published in JADA suggesting that I “may want to consider getting a written informed consent.” I live in California. Currently, I have to get patients to sign a state government-mandated acknowledgment that I have given them a dental materials fact sheet. Essentially, this document tells patients that there is silver and mercury in their silver fillings, quartz and binders in their composite fillings, gold in their gold crowns, etc. Soon we will all have to sign an acknowledgment that there is
gas in the gas pumps at filling stations. At some point, a person who comes to a dentist to get dental work done knows that the use of a local anesthetic will be necessary for some dental procedures. They also know that, as with any medical or dental procedure, untoward things can happen. They shouldn’t be required to sign a form that acknowledges that. Next, I will have to meet my new patients at the bottom of the stairs to my office and inform them that the office is at the top of the stairs, and that there is a risk that they may fall while climbing the stairs to the office or that they may have a heart attack. All of that is true, but there is no benefit or value to them in a signed informed consent. Actually, in the back of my mind, I can hear my liability insurance carrier’s lawyers saying, “Hey! The stair informed consent thing is a great idea.” Also, in California, as I understand it, if the risk of a side effect to a medication is less than 3 percent, then the patient doesn’t have to be informed. That is common sense. A patient doesn’t need to be burdened with information about something that is unlikely to happen. I suspect that problems associated with local anesthetic administration are less than 1 percent and, therefore, common sense, compassion for not burdening the patient and an extrapolation of the law would suggest that there is no benefit to me, my patient (the person I am most concerned about) or my office to have them sign a written informed consent. Though doing so may, in some small way, protect me
http://jada.ada.org April 2006 Copyright ©2005 American Dental Association. All rights reserved.
L E T T E R S
from being made to look clueless by some lawyer intent on impugning my character, implying that my not having done so suggests that my dental practice is not up to the standard of care. Peter L. Jacobsen, PhD, DDS Professor, Department of Pathology and Medicine University of the Pacific Arthur A. Dugoni School of Dentistry San Francisco
MORE ABOUT INFORMED CONSENT
We commend Dr. Daniel Orr II and William Curtis’ November JADA article, “Obtaining Written Informed Consent for the Administration of Local Anesthetic in Dentistry” (JADA 2005;136:1568-71), for addressing the challenging issue of informed consent as it relates to local anesthesia. We agree that the informing duty involved in “informed consent” can be stated as “the process by which a patient is apprised (informed) of the nature and risks of a proposed treatment … .” We also assert that informed consent includes the relative “pros” and “cons” of potential treatments. This would include information about the relative risks associated with the products typically used to achieve anesthesia. Empirical evidence1-4 indicates that some local anesthetics have a significantly higher rate of paresthesia associated with their use than others, and we believe it is important to inform the patient of the relative risks associated with various anesthetic products to be used by the doctor. When using a higher-risk agent, the added risk should be described, along with the bene-
fit of its use. The product insert for Septocaine 5 indicates that the Septodont-sponsored U.S. Food and Drug Administration study on Septocaine reported 11 cases of paresthesia with 882 patient treatments. This equates to one paresthesia in every 80 patient treatments. The insert also lists other adverse events experienced by less than 1 percent of the patients in the study. The list includes other nervous system problems, such as facial paralysis, hyperesthesia, neuropathy and paresthesia. The reader is referred to two examples from the literature.1,2 One of the articles, “A 21 Year Retrospective Study of Reports of Paresthesia Following Local Anesthetic Administration,” includes a graph and tables on paresthesias associated with the local anesthetics available in Canada. The article reported that in 1993 there were 10 paresthesias with articaine, four with prilocaine and zero paresthesias with any other local anesthetic. Where the local anesthetic agent was known, the authors indicated articaine was associated with 50 paresthesias, bupivacaine with zero, lidocaine with five, mepivacaine with four and prilocaine with 43 paresthesias. The authors concluded that there was a significantly higher paresthesia rate with articaine and prilocaine, compared with the other local anesthetic agents. Two other studies3,4 in Ontario, Canada, subsequently substantiated those findings. The use of product inserts, practitioner experience, the references we have cited here and other literature on the subject would be useful in providing patients with the information nec-
essary for an informed decision related to the use of local anesthetics. Information about the provider’s experiences with each of the local anesthetics should not overshadow a frank discussion of the information contained in the product insert. While practitioners and patients both may be reluctant to have such discussions, good ethics and prudence call for them, in our view. Although paresthesias associated with local anesthesia were once a rare phenomenon, such has not been the case since the introduction of 4 percent local anesthetics, such as articaine and prilocaine.2 The ethics of good practice is not a static thing. As technology changes, practice must change with it. Patients deserve the full story, even if it includes uncomfortable information, and doctors themselves will benefit from an open discussion in the long run, as thorough informed consent tends to buffer them from the negative impact of litigation. James S. Dower Jr., DDS, MA Associate Professor of Restorative Dentistry Director of Local Anesthesia Curriculum
A. Thomas Indresano, DMD Chairperson and Professor of Oral and Maxillofacial Surgery
Bruce Peltier, PhD, MBA Professor of Psychology and Ethics Director of Ethics Education University of the Pacific Arthur A. Dugoni School of Dentistry San Francisco 1. Haas DA, Lennon D. A 21 year retrospective study of reports of paresthesia following local anesthetic administration. J Can Dent Assoc 1995;61(4):319-30. 2. Dower JS. A review of paresthesia in association with the administration of local anesthesia. Dent Today 2003;Feb:64-9.
JADA, Vol. 137 http://jada.ada.org Copyright ©2005 American Dental Association. All rights reserved.
April 2006
437