- Email: [email protected]
FDA advisory panel assesses hydrocodone prescription writing
COMMENTARY
GUEST
EDITORIAL
Editorials represent the opinions of the authors and not necessarily those of the American Dental Association.
GUEST EDITORIAL
FDA advisory panel assesses hydrocodone prescription writing Every dentist’s responsibility
The U.S. Food and Drug Administration Patient Provider Agreement initiative should help us inform our patients of the risks and side effects of taking an opioid.
Frederick A. Curro, DMD, PhD
T
he issue of drug diversion is a national problem with a high incidence of morbidity and even mortality. Defined by the National Association of Drug Diversion Investigators,1 drug diversion is any criminal act involving a prescription drug. The U.S. Drug Enforcement Agency’s (DEA’s) Diversion Control Program mission is to prevent, detect and investigate the redirection from legitimate channels controlled pharmaceuticals and certain listed chemicals. In 2007, approximately 27,000 unintended drug overdose deaths occurred in the United States, one death every 19 minutes. Prescription drug abuse is the fastest growing drug problem in the United States.2 Roughly 100 people die each day from drug overdoses primarily driven by prescription drugs. The death rate of 11.8 per 100,000 population in 2007 was roughly three times the rate in 1991.3 The number of prescriptions filled for opioid pain relievers has increased dramatically in recent years. From 1997 to 2007, the milligram-per-person use of prescription opioids in the United States rose from 96 mg of morphine to approximately 700 mg, an increase of more than 600 percent.2 In 2000, retail pharmacies dispensed 174 million prescriptions for opioids; in 2009, 257 million prescriptions were dispensed, an increase of 48 percent.4 The United States consumes 99 percent of the world’s hydrocodone.5 The National Institute of Drug Abuse identified this problem in a publication describing the use of opioids by a number of health care disciplines.6 Dentists were among the contributors in the number of prescriptions written per year. Two years ago, the U.S. Food and Drug Administration (FDA) formed the Safe Use Drug Initiative to develop a Patient Provider Agreement to be used when opiates are to be prescribed. The Patient Provider Agreement has been completed and is being fieldtested for its acceptability among health care professionals. This shared decision is meant to educate patients on the side effects of opioids, the risks involved and the proper disposal of the drug after its use. The agreement also is meant to remind providers of the side effects and risks of prescribing such a drug. The FDA Center for Drug Evaluation and Research met Jan. 24-25, 2013, for its Drug Safety and Risk Management Advisory Committee to assess public health benefits and risks, including the potential for abuse of drugs containing hydrocodone, either used with other analgesics or as an antitussive. The meeting was the result of a request from the U.S. Department of Health and Human Services, responding to a request from the DEA for a scientific and medical
462 JADA 144(5) http://jada.ada.org May 2013 Copyright © 2013 American Dental Association. All Rights Reserved.
COMMENTARY
evaluation and scheduling recommendation for these drugs in light of continuing reports of misuse, abuse and addiction related to these products. In addition, the committee discussed the impact of rescheduling hydrocodone products from Schedule III to Schedule II. The schedule of a substance dictates the requirements regarding physical security, quotas, prescription and registration. The main difference between Schedules II and III lies in the degree of abuse potential and psychological dependence. At the Advisory Committee meeting, an open public hearing session was conducted with parents of children who had become addicted to hydrocodone. The parents described how their children obtained the drug from relatives or friends or were prescribed the drug without any controls or follow-up visits. As a consistent theme, parents said they had not been told of the side effects and/or risks of taking opioid medications. One constant throughout the public hearing was a lack of education among both providers and patients. There was no doubt from the presentations that providers were overprescribing opioids beyond the temporal management of pain. Also discussed at the meeting were the issues of third-party reimbursement for large amounts of medication, the convenience of multiple refills, how to avoid having patients return for follow-up visits and all the costs involved. Hydrocodone is a Schedule III drug, and its potency places it between codeine and oxycodone. Oxycodone is a Schedule II drug, and codeine is a moderate opioid with an identified genetic impact on metabolism. Dentists mainly treat acute pain, and an opioid prescribed for a procedure should provide relief for three to five days. Considering
the consequences, prescribing opioids beyond this time without a follow-up visit is not appropriate. Dentists frequently use combination drugs, as pain often is associated with an inflammatory process. Providers are not maximizing their use of nonsteroidal anti-inflammatory drugs as substitutes to reduce the use of opioids, indicating that more in-depth pharmacology education is needed. During the open public hearing, a representative of the organization Physicians for Responsible Opioid Prescribing suggested in a presentation that rescheduling hydrocodone would reduce the number of people addicted,7 but data about oxycodone use do not support that position. Listening to parents describe the deaths of their children from opiate addiction was emotional and suggested that hydrocodone should be made more difficult to acquire as a basis for rescheduling. However, the knowledge and education of providers and the ease with which they prescribe these drugs must be addressed. This came through clearly when physicians themselves admitted that they were unaware of the unintended consequences of prescribing opioids, a fact that only reinforces the need for increasing the knowledge base in pharmacology in both medical and dental schools. Near the end of the session, the Advisory Committee voted 19 to 10 to reschedule hydrocodone to Schedule II. This decision affects people in nursing homes, where physicians will have to increase their number of visits. It also affects people being treated for chronic pain (also represented at the meeting) and whose care is managed responsibly by their providers. Ultimately, the cost of hydrocodone will rise as the storage and maintenance of a Schedule II drug is
GUEST
EDITORIAL
more labor-intensive, limiting the number of pharmacists who will carry the drug. At one point in the proceedings, two patients who had a collagen syndrome being managed with hydrocodone argued that health care was retreating from personalized medicine by adopting a one-class-ofdrug-fits-all approach. Pain is the one symptom that brings even the most reluctant patient to seek dental care. Acute pain management is essential for a successful practice. Managing acute pain to prevent a more chronic condition should be the goal of every dentist. As providers, we are only as good as our knowledge base. The message from this meeting was that improvements are needed in both medical and dental school curricula in pharmacology and in the continuing education courses required of practitioners. With more than 30 new drugs approved by the FDA each year in the United States, pharmacology is the one area of science that is dynamic and continually bridges both the basic and clinical sciences. The FDA Patient Provider Agreement initiative should help us inform our patients of the risks and side effects of taking an opioid. If the FDA accepts the panel’s recommendation, it will be sent to the U.S. Department of Health and Human Services, which will make the final determination. n Dr. Curro is a clinical professor, oral and maxillofacial pathology, radiology and medicine, and the director, Practitioners Engaged in Applied Research and Learning (PEARL) Practice-Based Research Network, Bluestone Center for Research, College of Dentistry, New York University, New York City. He also represented the American Dental Association and the American Association of Oral and Maxillofacial Surgeons at the Drug Safety and Risk Management Advisory Committee meeting and chairs the working group on opiate use for the U.S. Food and Drug Administration’s Safe Use Initiative. Address reprint requests to Dr. Curro at the PEARL Network, College of Dentistry, New York University, 380 Second Ave., Suite 302, New York, N.Y. 10010-4086, e-mail [email protected].
JADA 144(5) http://jada.ada.org May 2013 463 Copyright © 2013 American Dental Association. All Rights Reserved.
COMMENTARY
GUEST
1. National Association of Drug Diversion Investigators. [Website home page.] www. naddi.org/aws/NADDI/pt/sp/home_page. Accessed April 8, 2013. 2. Paulozzi L. CDC Grand rounds: prescription drug overdoses—a U.S. epidemic. MMWR Morb Mortal Wkly Rep 2012;61(1);10-13. 3. Paulozzi LJ, Jones CM, Mack KA, Rudd RA. Vital signs: overdoses of prescription opioid pain relievers—United States, 1999-2008. MMWR Morb Mortal Wkly Rep
LETTERS
J
ADA welcomes letters from readers on articles that have 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. A letter concerning a recent JADA article will have the best chance of acceptance if it is received within two months of the article’s publication. For instance, a letter about an article that appeared in April JADA usually will be considered for acceptance only until the end of June. You may submit your letter via e-mail to jadaletters@ada. org; by fax to 1-312-440-3538; or by mail to 211 E. Chicago Ave., Chicago, Ill. 60611-2678. By sending a letter to the editor, the author acknowledges and agrees that the letter and all rights of the author in the letter sent become the property of The Journal. Letter writers are asked to disclose any personal or professional affiliations or conflicts of interest that readers may wish to take into consideration in assessing their stated opinions. 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. MIDLEVEL PROVIDERS
I am moved to respond to the January JADA article by Dr. J. Timothy Wright and colleagues, “A Systematic Review of Oral Health Outcomes Produced by Dental Teams Incorporating Midlevel Providers” (Wright JT, Graham F, Hayes C,
EDITORIAL 2011;60(43);1487-1492. 4. The White House, Office of National Drug Control Policy. Prescription drug abuse. www.whitehouse.gov/ondcp/prescriptiondrug-abuse. Accessed March 20, 2013. 5. Wolfe S. Hydrocodone: testimony for the Health Research Group of Public Citizen before the U.S. Food and Drug Administration Drug Safety and Risk Management Advisory Committee, January 25, 2013. www.citizen. org/documents/2092.pdf. Accessed March 20, 2013.
6. Compton WM, Volkow ND. Major increases in opioid analgesic abuse in the United States: concerns and strategies. Drug Alcohol Depend 2006;81(2):103-107. 7. Kolodny A. Opioids for chronic pain: addiction is not rare—comments on behalf of Physicians for Responsible Opioid Prescribing in open hearings before the U.S. Food and Drug Administration Drug Safety and Risk Management Advisory Committee, January 25, 2013.
et al. JADA 2013;144[1]: 75-91). The emphasis on methodological rigor in the laudable pursuit of evidence-based health care produces the occasional incongruity. Sometimes, in an effort to collect analyzable data that applies to clearly defined populations, a constricted view of a clinical problem is adopted that may fail to address a relevant larger issue. Whether or not the inclusion of so-called midlevel providers in dental teams affects the outcomes of treatment may have some relevance to those who bear the responsibility for guaranteeing a satisfactory level of care in a given community. Let it also be acknowledged that the inclusion of such providers is perceived as an economic threat by more than a few dentists. I would argue that, when dental care fails to reach underserved segments of our population, it matters not a whit whether it is a dentist or a midlevel provider who is not providing that care. The impact of the inclusion of midlevel providers on the quality of care that fails to be delivered is moot. A blinded comparative study of care provided by cohorts of midlevel providers and cohorts of dentists would be a more effective way of coming to grips with the quality issue. Edward B. Seldin, DMD, MD
Senior Oral and Maxillofacial Surgeon Massachusetts General Hospital Boston
COST OF EDUCATION
I was disappointed, but not surprised, to see that the American Dental Association has chosen to fight the wrong battle in the emerging war against midlevel providers. The article by Dr. J. Timothy Wright and colleagues1 and the accompanying comments by Dr. Wright2 and Dr. Robert Faiella3 only highlight how shortsighted our profession has become. The irrefutable fact is that dentistry is not properly serving large segments of our population. The poor, the near poor, the uninsured and the elderly, who constitute the greatest number of uninsured, desperately need dental care, but their options are limited. If these underserved groups cannot obtain dental care from traditional providers, other kinds of providers will emerge and will almost certainly divide our profession. The real problem lies with the dental schools. Over the past decade, many dental schools have embarked on expensive expansion projects.4 In order to service their debt, they have increased their class sizes and tuition and are now graduating large numbers of highly trained but heavily indebted dentists. Average U.S. dental school total resident costs for all four years went
464 JADA 144(5) http://jada.ada.org May 2013 Copyright © 2013 American Dental Association. All Rights Reserved.
GUEST
EDITORIAL
Editorials represent the opinions of the authors and not necessarily those of the American Dental Association.
GUEST EDITORIAL
FDA advisory panel assesses hydrocodone prescription writing Every dentist’s responsibility
The U.S. Food and Drug Administration Patient Provider Agreement initiative should help us inform our patients of the risks and side effects of taking an opioid.
Frederick A. Curro, DMD, PhD
T
he issue of drug diversion is a national problem with a high incidence of morbidity and even mortality. Defined by the National Association of Drug Diversion Investigators,1 drug diversion is any criminal act involving a prescription drug. The U.S. Drug Enforcement Agency’s (DEA’s) Diversion Control Program mission is to prevent, detect and investigate the redirection from legitimate channels controlled pharmaceuticals and certain listed chemicals. In 2007, approximately 27,000 unintended drug overdose deaths occurred in the United States, one death every 19 minutes. Prescription drug abuse is the fastest growing drug problem in the United States.2 Roughly 100 people die each day from drug overdoses primarily driven by prescription drugs. The death rate of 11.8 per 100,000 population in 2007 was roughly three times the rate in 1991.3 The number of prescriptions filled for opioid pain relievers has increased dramatically in recent years. From 1997 to 2007, the milligram-per-person use of prescription opioids in the United States rose from 96 mg of morphine to approximately 700 mg, an increase of more than 600 percent.2 In 2000, retail pharmacies dispensed 174 million prescriptions for opioids; in 2009, 257 million prescriptions were dispensed, an increase of 48 percent.4 The United States consumes 99 percent of the world’s hydrocodone.5 The National Institute of Drug Abuse identified this problem in a publication describing the use of opioids by a number of health care disciplines.6 Dentists were among the contributors in the number of prescriptions written per year. Two years ago, the U.S. Food and Drug Administration (FDA) formed the Safe Use Drug Initiative to develop a Patient Provider Agreement to be used when opiates are to be prescribed. The Patient Provider Agreement has been completed and is being fieldtested for its acceptability among health care professionals. This shared decision is meant to educate patients on the side effects of opioids, the risks involved and the proper disposal of the drug after its use. The agreement also is meant to remind providers of the side effects and risks of prescribing such a drug. The FDA Center for Drug Evaluation and Research met Jan. 24-25, 2013, for its Drug Safety and Risk Management Advisory Committee to assess public health benefits and risks, including the potential for abuse of drugs containing hydrocodone, either used with other analgesics or as an antitussive. The meeting was the result of a request from the U.S. Department of Health and Human Services, responding to a request from the DEA for a scientific and medical
462 JADA 144(5) http://jada.ada.org May 2013 Copyright © 2013 American Dental Association. All Rights Reserved.
COMMENTARY
evaluation and scheduling recommendation for these drugs in light of continuing reports of misuse, abuse and addiction related to these products. In addition, the committee discussed the impact of rescheduling hydrocodone products from Schedule III to Schedule II. The schedule of a substance dictates the requirements regarding physical security, quotas, prescription and registration. The main difference between Schedules II and III lies in the degree of abuse potential and psychological dependence. At the Advisory Committee meeting, an open public hearing session was conducted with parents of children who had become addicted to hydrocodone. The parents described how their children obtained the drug from relatives or friends or were prescribed the drug without any controls or follow-up visits. As a consistent theme, parents said they had not been told of the side effects and/or risks of taking opioid medications. One constant throughout the public hearing was a lack of education among both providers and patients. There was no doubt from the presentations that providers were overprescribing opioids beyond the temporal management of pain. Also discussed at the meeting were the issues of third-party reimbursement for large amounts of medication, the convenience of multiple refills, how to avoid having patients return for follow-up visits and all the costs involved. Hydrocodone is a Schedule III drug, and its potency places it between codeine and oxycodone. Oxycodone is a Schedule II drug, and codeine is a moderate opioid with an identified genetic impact on metabolism. Dentists mainly treat acute pain, and an opioid prescribed for a procedure should provide relief for three to five days. Considering
the consequences, prescribing opioids beyond this time without a follow-up visit is not appropriate. Dentists frequently use combination drugs, as pain often is associated with an inflammatory process. Providers are not maximizing their use of nonsteroidal anti-inflammatory drugs as substitutes to reduce the use of opioids, indicating that more in-depth pharmacology education is needed. During the open public hearing, a representative of the organization Physicians for Responsible Opioid Prescribing suggested in a presentation that rescheduling hydrocodone would reduce the number of people addicted,7 but data about oxycodone use do not support that position. Listening to parents describe the deaths of their children from opiate addiction was emotional and suggested that hydrocodone should be made more difficult to acquire as a basis for rescheduling. However, the knowledge and education of providers and the ease with which they prescribe these drugs must be addressed. This came through clearly when physicians themselves admitted that they were unaware of the unintended consequences of prescribing opioids, a fact that only reinforces the need for increasing the knowledge base in pharmacology in both medical and dental schools. Near the end of the session, the Advisory Committee voted 19 to 10 to reschedule hydrocodone to Schedule II. This decision affects people in nursing homes, where physicians will have to increase their number of visits. It also affects people being treated for chronic pain (also represented at the meeting) and whose care is managed responsibly by their providers. Ultimately, the cost of hydrocodone will rise as the storage and maintenance of a Schedule II drug is
GUEST
EDITORIAL
more labor-intensive, limiting the number of pharmacists who will carry the drug. At one point in the proceedings, two patients who had a collagen syndrome being managed with hydrocodone argued that health care was retreating from personalized medicine by adopting a one-class-ofdrug-fits-all approach. Pain is the one symptom that brings even the most reluctant patient to seek dental care. Acute pain management is essential for a successful practice. Managing acute pain to prevent a more chronic condition should be the goal of every dentist. As providers, we are only as good as our knowledge base. The message from this meeting was that improvements are needed in both medical and dental school curricula in pharmacology and in the continuing education courses required of practitioners. With more than 30 new drugs approved by the FDA each year in the United States, pharmacology is the one area of science that is dynamic and continually bridges both the basic and clinical sciences. The FDA Patient Provider Agreement initiative should help us inform our patients of the risks and side effects of taking an opioid. If the FDA accepts the panel’s recommendation, it will be sent to the U.S. Department of Health and Human Services, which will make the final determination. n Dr. Curro is a clinical professor, oral and maxillofacial pathology, radiology and medicine, and the director, Practitioners Engaged in Applied Research and Learning (PEARL) Practice-Based Research Network, Bluestone Center for Research, College of Dentistry, New York University, New York City. He also represented the American Dental Association and the American Association of Oral and Maxillofacial Surgeons at the Drug Safety and Risk Management Advisory Committee meeting and chairs the working group on opiate use for the U.S. Food and Drug Administration’s Safe Use Initiative. Address reprint requests to Dr. Curro at the PEARL Network, College of Dentistry, New York University, 380 Second Ave., Suite 302, New York, N.Y. 10010-4086, e-mail [email protected].
JADA 144(5) http://jada.ada.org May 2013 463 Copyright © 2013 American Dental Association. All Rights Reserved.
COMMENTARY
GUEST
1. National Association of Drug Diversion Investigators. [Website home page.] www. naddi.org/aws/NADDI/pt/sp/home_page. Accessed April 8, 2013. 2. Paulozzi L. CDC Grand rounds: prescription drug overdoses—a U.S. epidemic. MMWR Morb Mortal Wkly Rep 2012;61(1);10-13. 3. Paulozzi LJ, Jones CM, Mack KA, Rudd RA. Vital signs: overdoses of prescription opioid pain relievers—United States, 1999-2008. MMWR Morb Mortal Wkly Rep
LETTERS
J
ADA welcomes letters from readers on articles that have 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. A letter concerning a recent JADA article will have the best chance of acceptance if it is received within two months of the article’s publication. For instance, a letter about an article that appeared in April JADA usually will be considered for acceptance only until the end of June. You may submit your letter via e-mail to jadaletters@ada. org; by fax to 1-312-440-3538; or by mail to 211 E. Chicago Ave., Chicago, Ill. 60611-2678. By sending a letter to the editor, the author acknowledges and agrees that the letter and all rights of the author in the letter sent become the property of The Journal. Letter writers are asked to disclose any personal or professional affiliations or conflicts of interest that readers may wish to take into consideration in assessing their stated opinions. 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. MIDLEVEL PROVIDERS
I am moved to respond to the January JADA article by Dr. J. Timothy Wright and colleagues, “A Systematic Review of Oral Health Outcomes Produced by Dental Teams Incorporating Midlevel Providers” (Wright JT, Graham F, Hayes C,
EDITORIAL 2011;60(43);1487-1492. 4. The White House, Office of National Drug Control Policy. Prescription drug abuse. www.whitehouse.gov/ondcp/prescriptiondrug-abuse. Accessed March 20, 2013. 5. Wolfe S. Hydrocodone: testimony for the Health Research Group of Public Citizen before the U.S. Food and Drug Administration Drug Safety and Risk Management Advisory Committee, January 25, 2013. www.citizen. org/documents/2092.pdf. Accessed March 20, 2013.
6. Compton WM, Volkow ND. Major increases in opioid analgesic abuse in the United States: concerns and strategies. Drug Alcohol Depend 2006;81(2):103-107. 7. Kolodny A. Opioids for chronic pain: addiction is not rare—comments on behalf of Physicians for Responsible Opioid Prescribing in open hearings before the U.S. Food and Drug Administration Drug Safety and Risk Management Advisory Committee, January 25, 2013.
et al. JADA 2013;144[1]: 75-91). The emphasis on methodological rigor in the laudable pursuit of evidence-based health care produces the occasional incongruity. Sometimes, in an effort to collect analyzable data that applies to clearly defined populations, a constricted view of a clinical problem is adopted that may fail to address a relevant larger issue. Whether or not the inclusion of so-called midlevel providers in dental teams affects the outcomes of treatment may have some relevance to those who bear the responsibility for guaranteeing a satisfactory level of care in a given community. Let it also be acknowledged that the inclusion of such providers is perceived as an economic threat by more than a few dentists. I would argue that, when dental care fails to reach underserved segments of our population, it matters not a whit whether it is a dentist or a midlevel provider who is not providing that care. The impact of the inclusion of midlevel providers on the quality of care that fails to be delivered is moot. A blinded comparative study of care provided by cohorts of midlevel providers and cohorts of dentists would be a more effective way of coming to grips with the quality issue. Edward B. Seldin, DMD, MD
Senior Oral and Maxillofacial Surgeon Massachusetts General Hospital Boston
COST OF EDUCATION
I was disappointed, but not surprised, to see that the American Dental Association has chosen to fight the wrong battle in the emerging war against midlevel providers. The article by Dr. J. Timothy Wright and colleagues1 and the accompanying comments by Dr. Wright2 and Dr. Robert Faiella3 only highlight how shortsighted our profession has become. The irrefutable fact is that dentistry is not properly serving large segments of our population. The poor, the near poor, the uninsured and the elderly, who constitute the greatest number of uninsured, desperately need dental care, but their options are limited. If these underserved groups cannot obtain dental care from traditional providers, other kinds of providers will emerge and will almost certainly divide our profession. The real problem lies with the dental schools. Over the past decade, many dental schools have embarked on expensive expansion projects.4 In order to service their debt, they have increased their class sizes and tuition and are now graduating large numbers of highly trained but heavily indebted dentists. Average U.S. dental school total resident costs for all four years went
464 JADA 144(5) http://jada.ada.org May 2013 Copyright © 2013 American Dental Association. All Rights Reserved.