Letters
Matthew Miller, MD, MPH, ScD Catherine W. Barber, MPA Sarah Leatherman, PhD
into the intestine, leading to rapid absorption and a potentially fatal overdose.3,4 Such overdose events may have less to do with an opioid’s duration of action and more to do with the disrupted controlled-delivery system.
Author Affiliations: Department of Health Sciences, Northeastern University, Boston, Massachusetts (Miller); Department of Health Policy and Management, Harvard School of Public Health, Harvard University, Boston, Massachusetts (Barber); Massachusetts Veterans Epidemiology Research and Information Center, Veterans Affairs Boston Healthcare System, Boston (Leatherman).
Xiulu Ruan, MD Jiang Wu, MD Alan David Kaye, MD, PhD
Corresponding Author: Matthew Miller, MD, MPH, ScD, Department of Health Sciences, Northeastern University, 360 Huntington Ave, Rm 316 RB, Boston, MA 02115 ([email protected]).
Author Affiliations: Department of Anesthesiology, Louisiana State University Health Science Center, New Orleans (Ruan, Kaye); Department of Anesthesiology and Pain Medicine, University of Washington Medical Center, Seattle (Wu).
Additional Contributions: We would like to acknowledge our coauthor John Hermos, MD, from the Massachusetts Veterans Epidemiology Research and Information Center, Veterans Affairs Boston Healthcare System, Boston, Massachusetts, for his input into our response.
Corresponding Author: Xiulu Ruan, MD, Department of Anesthesiology, Louisiana State University Health Science Center, 1542 Tulane Ave, New Orleans, LA 70112 ([email protected]).
Conflict of Interest Disclosures: None reported.
Conflict of Interest Disclosures: None reported.
1. Miller M, Barber CW, Leatherman S, et al. Prescription opioid duration of action and the risk of unintentional overdose among patients receiving opioid therapy. JAMA Intern Med. 2015;175(4):608-615.
1. Miller M, Barber CW, Leatherman S, et al. Prescription opioid duration of action and the risk of unintentional overdose among patients receiving opioid therapy. JAMA Intern Med. 2015;175(4):608-615. 2. DURAGESIC (Fentanyl Transdermal System) for transdermal administration [package insert]. Titusville, NJ: Janssen Pharmaceuticals; 2014.
Problems Assessing Indoor Tanning-Related Injuries
3. Medscape. Drug & Disease. http://reference.medscape.com/drug/ms-continavinza-morphine-343319. Accessed April 14, 2015.
To the Editor There were numerous problems related to a recently published Research Letter about indoor tanningrelated injuries.1 The research documented 405 emergency department visits related to tanning beds and sun lamps over a decade span. Correspondence with the author and analysis using the Consumer Product Safety Commission (CPSC) National Electronic Injury Surveillance System (NEISS) database reveal several disconcerting factors not addressed in the research: (1) questions about causality, (2) lack of access to data for verification, and (3) failure to discuss the absolute risk of the injuries. The author’s team selected cases that they determined were related to an indoor tanning device. In the NEISS database, there are cases that may have been deemed related to tanning beds, but any practical person might conclude otherwise. For example, a narrative reads: “(Patient) awoke to take dog out. Felt dizzy & fell back against bathtub. Had seizure. Also had (seizure yesterday) in tanning bed.”2 While this narrative contains the “tanning bed” keywords, only further inquiry could confirm causality. While NEISS data generally are made available to the public, the NEISS-All Injury Program (AIP) set of patient records used here was not made available. It is impossible for independent researchers to verify medical cases that were described as related to indoor tanning. This reader’s correspondence with the Centers for Disease Control and Prevention (CDC) and the CPSC returned contradictory information about the inclusion of tanning-related injuries in NEISS databases. The research seems to sensationalize what amounts to only 1 indoor tanning-related emergency department visit per hospital every 20 months. Other studies of the NEISS-AIP data set have determined that approximately 13.3 million annual nonfatal injuries related to consumer products are treated in emergency medical departments every year, so tanning bed injuries account for only 0.0243% of all such visits.3 Dancing accounts for 16 times more emergency department visits than tanning beds; monkey bars cause at least 24 times more inju-
4. Sloan P. Review of oral oxymorphone in the management of pain. Ther Clin Risk Manag. 2008;4(4):777-787.
In Reply We appreciate the opportunity to address the questions that Ruan et al raise with respect to whether the 4802 users of fentanyl patches drove our finding that opioid-naïve patients who initiate long-acting opioid formulations (n = 18 887) appear to be at increased risk of unintentional overdose compared with patients initiating short-acting formulations. Of the 37 overdose events observed in our original cohort of long-acting opioid formulation initiators, 4 events occurred among those initiating fentanyl patches (1 event in the first 14 days after initiation and 3 events after 60 days of therapy). Exclusion of fentanyl initiators from analysis did not materially change our findings. After adjustment for age, sex, opioid dose, and other clinical characteristics, patients receiving long-acting opioid formulations other than fentanyl still had a significantly higher rate of overdose injury than did those receiving short-acting opioid formulations (hazard ratio [HR], 2.24; 95% CI, 1.21-4.14), with risk particularly marked during the first 2 weeks after treatment initiation (HR, 4.97; 95% CI, 1.77-13.96).1 Ruan et al speculate that alcohol and high-fat diets might influence our findings by disrupting the drug delivery systems for opioid formulations, such as sustained-release morphine, where duration of anticipated analgesia is based on a drug delivery system engineered to result in a sustained release of a short-acting opioid. Although we find this speculation plausible, our article was not designed to elucidate underlying mechanisms and, moreover, made no claims about the mechanisms responsible for the associations we observed. Future work informed by the kind of thoughtful speculation that Ruan et al posit seems like one of several good next steps, as does examining whether the associations we observed can be replicated in other populations. jamainternalmedicine.com
(Reprinted) JAMA Internal Medicine September 2015 Volume 175, Number 9
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: by a UNIVERSITY OF ADELAIDE LIBRARY User on 10/13/2017
1583
Letters
ries; everyday interactions with chairs produce 95 times more hospital visits; and injuries from unintentional bites and stings are over 380 times more prevalent in emergency departments than tanning bed mishaps.4 These comparisons to traumas caused by physical objects are relevant because many of the reported tanning bed injuries were not related to UV light but to physical equipment. It is disappointing that the CDC will not release its data when all appearances suggest that the research may not have been accurately portrayed. Gregory Kohs, MA Author Affiliation: MyWikiBiz, West Chester, Pennsylvania. Corresponding Author: Gregory Kohs, MA, Founder, MyWikiBiz, 489 Lake George Circle, West Chester, PA 19382 ([email protected]). Conflict of Interest Disclosures: Mr Kohs was a paid consultant in 2007-2008 for research studies related to consumer attitudes about indoor tanning. No other conflicts are reported. 1. Guy GP Jr, Watson M, Haileyesus T, Annest JL. Indoor tanning-related injuries treated in a national sample of US hospital emergency departments. JAMA Intern Med. 2015;175(2):309-311. 2. National Electronic Injury Surveillance System (NEISS). NEISS Estimates Query Builder CPSC Case #70452756, recorded April 27, 2007. http://www.cpsc .gov/cgibin/NEISSQuery/home.aspx. Accessed July 15, 2015. 3. Lawrence BA, Spicer RS, Miller TR. A fresh look at the costs of non-fatal consumer product injuries. Inj Prev. 2015;21(1):23-29. 4. Centers for Disease Control and Prevention. National Estimates of the 10 Leading Causes of Nonfatal Injuries Treated In Hospital Emergency Departments, United States. 2011. http://www.cdc.gov/injury/wisqars/pdf/10lci _nonfatal_injurytreated_in_hospital-emergency_dept_2011-a.pdf. Accessed April 30, 2015.
In Reply In our study in the February issue of JAMA Internal Medicine,1 we found that an average of 3234 indoor tanning– related injuries were treated annually in hospital emergency departments in the United States from 2003-2012. The majority of injuries were directly related to ultraviolet radiation (UV) from indoor tanning devices: skin burns comprised 79.5% of injuries; and injuries to the eye, primarily burns, 5.8%. Additional injuries (eg, lacerations and broken bones) often related to fainting during or directly following indoor tanning, or being hit by a device’s lid or door, were reported. In his letter, Mr Kohs mentions a narrative from the Consumer Product Safety Commission (CPSC) National Electronic Injury Surveillance System (NEISS) data set. This is not the data set that we used. Instead, we used the NEISS-All Injury Program (NEISS-AIP). The data set that Mr Kohs mentions, the NEISS, only retains records for consumer products. Since indoor tanning devices are classified as medical devices, not consumer products, indoor tanning device injuries are not included in the NEISS data. The CPSC removes the tanning bed product code from cases with more than 1 product code and removes the case completely if the tanning bed product code was the only code used. The data set we used, the NEISS-AIP, collects information on all injuries rather than just consumer product–related injuries.2 Mr Kohs mentions concerns related to public access to the data included in our analysis. The NEISS-AIP public use data 1584
set, and related documentation, is available to the general public.3 The patient case narratives we used are not available on the public use data set because of preexisting rules of nondisclosure and confidentiality provisions agreed upon by all federal participants funding the NEISS-AIP. As noted in our article, we used a text mining process on the patient case narratives with explicit and objective inclusion and exclusion criteria to ensure that included cases represented injuries attributable to indoor tanning. Cases were initially selected using a keyword search. Each case narrative was reviewed and classified by 3 study researchers to confirm that the injuries were attributable to indoor tanning, with classification differences resolved by consensus. Cases not involving the use of an indoor tanning device were excluded, such as injuries resulting from sun exposure, moving or cleaning an indoor tanning device, and working at a tanning salon. Thus, the narrative provided by Mr Kohs would have been initially selected based on the keyword search but excluded upon case narrative review since the injury was not directly related to the use of an indoor tanning device. Our study provides national estimates of indoor tanning– related injuries treated in emergency departments in the United States. Although indoor tanning–related injuries might account for a small portion of the total injuries treated in US hospital departments, it is clear that these are avoidable injuries that result in harm to the injured person and cost to treat the injuries. In addition to causing acute injuries, indoor tanning, a known carcinogen, increases the risk of skin cancer.4 Gery P. Guy Jr, PhD, MPH Meg Watson, MPH Tadesse Haileyesus, MS Author Affiliations: Centers for Disease Control and Prevention, Atlanta, Georgia. Corresponding Author: Gery P. Guy Jr, PhD, MPH, Division of Cancer Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Hwy, Mail Stop K-76, Atlanta, GA 30341 ([email protected]). Conflict of Interest Disclosures: None reported. 1. Guy GP Jr, Watson M, Haileyesus T, Annest JL. Indoor tanning-related injuries treated in a national sample of US hospital emergency departments. JAMA Intern Med. 2015;175(2):309-311. 2. NEISS. The National Electronic Injury Surveillance System: A Tool for Researchers. http://www.cpsc.gov/PageFiles/106626/2000d015.pdf. Accessed May 14, 2015. 3. National Electronic Injury Surveillance System All Injury Program, 2011 (ICPSR 35233). Inter-university Consortium for Political and Social Research [distributor]; Ann Arbor, MI. 2014. http://www.icpsr.umich.edu/icpsrweb/NACJD /studies/35233/version/1. Accessed July 10, 2015. 4. US Department of Health and Human Services. The Surgeon General’s Call to Action to Prevent Skin Cancer. Washington, DC: US Dept of Health and Human Services, Office of the Surgeon General; 2014.
In Defense of Documentary Cameras To The Editor Neal Baer and I have sparred before on the issue of documentary cameras being allowed into emergent settings.1,2 Alas, I find this latest jeremiad3 shows him to be just as willfully subjective about which facts he includes this time as last. As a viewer, Dr Baer is entitled to his opinion. How-
JAMA Internal Medicine September 2015 Volume 175, Number 9 (Reprinted)
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: by a UNIVERSITY OF ADELAIDE LIBRARY User on 10/13/2017
jamainternalmedicine.com
Matthew Miller, MD, MPH, ScD Catherine W. Barber, MPA Sarah Leatherman, PhD
into the intestine, leading to rapid absorption and a potentially fatal overdose.3,4 Such overdose events may have less to do with an opioid’s duration of action and more to do with the disrupted controlled-delivery system.
Author Affiliations: Department of Health Sciences, Northeastern University, Boston, Massachusetts (Miller); Department of Health Policy and Management, Harvard School of Public Health, Harvard University, Boston, Massachusetts (Barber); Massachusetts Veterans Epidemiology Research and Information Center, Veterans Affairs Boston Healthcare System, Boston (Leatherman).
Xiulu Ruan, MD Jiang Wu, MD Alan David Kaye, MD, PhD
Corresponding Author: Matthew Miller, MD, MPH, ScD, Department of Health Sciences, Northeastern University, 360 Huntington Ave, Rm 316 RB, Boston, MA 02115 ([email protected]).
Author Affiliations: Department of Anesthesiology, Louisiana State University Health Science Center, New Orleans (Ruan, Kaye); Department of Anesthesiology and Pain Medicine, University of Washington Medical Center, Seattle (Wu).
Additional Contributions: We would like to acknowledge our coauthor John Hermos, MD, from the Massachusetts Veterans Epidemiology Research and Information Center, Veterans Affairs Boston Healthcare System, Boston, Massachusetts, for his input into our response.
Corresponding Author: Xiulu Ruan, MD, Department of Anesthesiology, Louisiana State University Health Science Center, 1542 Tulane Ave, New Orleans, LA 70112 ([email protected]).
Conflict of Interest Disclosures: None reported.
Conflict of Interest Disclosures: None reported.
1. Miller M, Barber CW, Leatherman S, et al. Prescription opioid duration of action and the risk of unintentional overdose among patients receiving opioid therapy. JAMA Intern Med. 2015;175(4):608-615.
1. Miller M, Barber CW, Leatherman S, et al. Prescription opioid duration of action and the risk of unintentional overdose among patients receiving opioid therapy. JAMA Intern Med. 2015;175(4):608-615. 2. DURAGESIC (Fentanyl Transdermal System) for transdermal administration [package insert]. Titusville, NJ: Janssen Pharmaceuticals; 2014.
Problems Assessing Indoor Tanning-Related Injuries
3. Medscape. Drug & Disease. http://reference.medscape.com/drug/ms-continavinza-morphine-343319. Accessed April 14, 2015.
To the Editor There were numerous problems related to a recently published Research Letter about indoor tanningrelated injuries.1 The research documented 405 emergency department visits related to tanning beds and sun lamps over a decade span. Correspondence with the author and analysis using the Consumer Product Safety Commission (CPSC) National Electronic Injury Surveillance System (NEISS) database reveal several disconcerting factors not addressed in the research: (1) questions about causality, (2) lack of access to data for verification, and (3) failure to discuss the absolute risk of the injuries. The author’s team selected cases that they determined were related to an indoor tanning device. In the NEISS database, there are cases that may have been deemed related to tanning beds, but any practical person might conclude otherwise. For example, a narrative reads: “(Patient) awoke to take dog out. Felt dizzy & fell back against bathtub. Had seizure. Also had (seizure yesterday) in tanning bed.”2 While this narrative contains the “tanning bed” keywords, only further inquiry could confirm causality. While NEISS data generally are made available to the public, the NEISS-All Injury Program (AIP) set of patient records used here was not made available. It is impossible for independent researchers to verify medical cases that were described as related to indoor tanning. This reader’s correspondence with the Centers for Disease Control and Prevention (CDC) and the CPSC returned contradictory information about the inclusion of tanning-related injuries in NEISS databases. The research seems to sensationalize what amounts to only 1 indoor tanning-related emergency department visit per hospital every 20 months. Other studies of the NEISS-AIP data set have determined that approximately 13.3 million annual nonfatal injuries related to consumer products are treated in emergency medical departments every year, so tanning bed injuries account for only 0.0243% of all such visits.3 Dancing accounts for 16 times more emergency department visits than tanning beds; monkey bars cause at least 24 times more inju-
4. Sloan P. Review of oral oxymorphone in the management of pain. Ther Clin Risk Manag. 2008;4(4):777-787.
In Reply We appreciate the opportunity to address the questions that Ruan et al raise with respect to whether the 4802 users of fentanyl patches drove our finding that opioid-naïve patients who initiate long-acting opioid formulations (n = 18 887) appear to be at increased risk of unintentional overdose compared with patients initiating short-acting formulations. Of the 37 overdose events observed in our original cohort of long-acting opioid formulation initiators, 4 events occurred among those initiating fentanyl patches (1 event in the first 14 days after initiation and 3 events after 60 days of therapy). Exclusion of fentanyl initiators from analysis did not materially change our findings. After adjustment for age, sex, opioid dose, and other clinical characteristics, patients receiving long-acting opioid formulations other than fentanyl still had a significantly higher rate of overdose injury than did those receiving short-acting opioid formulations (hazard ratio [HR], 2.24; 95% CI, 1.21-4.14), with risk particularly marked during the first 2 weeks after treatment initiation (HR, 4.97; 95% CI, 1.77-13.96).1 Ruan et al speculate that alcohol and high-fat diets might influence our findings by disrupting the drug delivery systems for opioid formulations, such as sustained-release morphine, where duration of anticipated analgesia is based on a drug delivery system engineered to result in a sustained release of a short-acting opioid. Although we find this speculation plausible, our article was not designed to elucidate underlying mechanisms and, moreover, made no claims about the mechanisms responsible for the associations we observed. Future work informed by the kind of thoughtful speculation that Ruan et al posit seems like one of several good next steps, as does examining whether the associations we observed can be replicated in other populations. jamainternalmedicine.com
(Reprinted) JAMA Internal Medicine September 2015 Volume 175, Number 9
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: by a UNIVERSITY OF ADELAIDE LIBRARY User on 10/13/2017
1583
Letters
ries; everyday interactions with chairs produce 95 times more hospital visits; and injuries from unintentional bites and stings are over 380 times more prevalent in emergency departments than tanning bed mishaps.4 These comparisons to traumas caused by physical objects are relevant because many of the reported tanning bed injuries were not related to UV light but to physical equipment. It is disappointing that the CDC will not release its data when all appearances suggest that the research may not have been accurately portrayed. Gregory Kohs, MA Author Affiliation: MyWikiBiz, West Chester, Pennsylvania. Corresponding Author: Gregory Kohs, MA, Founder, MyWikiBiz, 489 Lake George Circle, West Chester, PA 19382 ([email protected]). Conflict of Interest Disclosures: Mr Kohs was a paid consultant in 2007-2008 for research studies related to consumer attitudes about indoor tanning. No other conflicts are reported. 1. Guy GP Jr, Watson M, Haileyesus T, Annest JL. Indoor tanning-related injuries treated in a national sample of US hospital emergency departments. JAMA Intern Med. 2015;175(2):309-311. 2. National Electronic Injury Surveillance System (NEISS). NEISS Estimates Query Builder CPSC Case #70452756, recorded April 27, 2007. http://www.cpsc .gov/cgibin/NEISSQuery/home.aspx. Accessed July 15, 2015. 3. Lawrence BA, Spicer RS, Miller TR. A fresh look at the costs of non-fatal consumer product injuries. Inj Prev. 2015;21(1):23-29. 4. Centers for Disease Control and Prevention. National Estimates of the 10 Leading Causes of Nonfatal Injuries Treated In Hospital Emergency Departments, United States. 2011. http://www.cdc.gov/injury/wisqars/pdf/10lci _nonfatal_injurytreated_in_hospital-emergency_dept_2011-a.pdf. Accessed April 30, 2015.
In Reply In our study in the February issue of JAMA Internal Medicine,1 we found that an average of 3234 indoor tanning– related injuries were treated annually in hospital emergency departments in the United States from 2003-2012. The majority of injuries were directly related to ultraviolet radiation (UV) from indoor tanning devices: skin burns comprised 79.5% of injuries; and injuries to the eye, primarily burns, 5.8%. Additional injuries (eg, lacerations and broken bones) often related to fainting during or directly following indoor tanning, or being hit by a device’s lid or door, were reported. In his letter, Mr Kohs mentions a narrative from the Consumer Product Safety Commission (CPSC) National Electronic Injury Surveillance System (NEISS) data set. This is not the data set that we used. Instead, we used the NEISS-All Injury Program (NEISS-AIP). The data set that Mr Kohs mentions, the NEISS, only retains records for consumer products. Since indoor tanning devices are classified as medical devices, not consumer products, indoor tanning device injuries are not included in the NEISS data. The CPSC removes the tanning bed product code from cases with more than 1 product code and removes the case completely if the tanning bed product code was the only code used. The data set we used, the NEISS-AIP, collects information on all injuries rather than just consumer product–related injuries.2 Mr Kohs mentions concerns related to public access to the data included in our analysis. The NEISS-AIP public use data 1584
set, and related documentation, is available to the general public.3 The patient case narratives we used are not available on the public use data set because of preexisting rules of nondisclosure and confidentiality provisions agreed upon by all federal participants funding the NEISS-AIP. As noted in our article, we used a text mining process on the patient case narratives with explicit and objective inclusion and exclusion criteria to ensure that included cases represented injuries attributable to indoor tanning. Cases were initially selected using a keyword search. Each case narrative was reviewed and classified by 3 study researchers to confirm that the injuries were attributable to indoor tanning, with classification differences resolved by consensus. Cases not involving the use of an indoor tanning device were excluded, such as injuries resulting from sun exposure, moving or cleaning an indoor tanning device, and working at a tanning salon. Thus, the narrative provided by Mr Kohs would have been initially selected based on the keyword search but excluded upon case narrative review since the injury was not directly related to the use of an indoor tanning device. Our study provides national estimates of indoor tanning– related injuries treated in emergency departments in the United States. Although indoor tanning–related injuries might account for a small portion of the total injuries treated in US hospital departments, it is clear that these are avoidable injuries that result in harm to the injured person and cost to treat the injuries. In addition to causing acute injuries, indoor tanning, a known carcinogen, increases the risk of skin cancer.4 Gery P. Guy Jr, PhD, MPH Meg Watson, MPH Tadesse Haileyesus, MS Author Affiliations: Centers for Disease Control and Prevention, Atlanta, Georgia. Corresponding Author: Gery P. Guy Jr, PhD, MPH, Division of Cancer Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Hwy, Mail Stop K-76, Atlanta, GA 30341 ([email protected]). Conflict of Interest Disclosures: None reported. 1. Guy GP Jr, Watson M, Haileyesus T, Annest JL. Indoor tanning-related injuries treated in a national sample of US hospital emergency departments. JAMA Intern Med. 2015;175(2):309-311. 2. NEISS. The National Electronic Injury Surveillance System: A Tool for Researchers. http://www.cpsc.gov/PageFiles/106626/2000d015.pdf. Accessed May 14, 2015. 3. National Electronic Injury Surveillance System All Injury Program, 2011 (ICPSR 35233). Inter-university Consortium for Political and Social Research [distributor]; Ann Arbor, MI. 2014. http://www.icpsr.umich.edu/icpsrweb/NACJD /studies/35233/version/1. Accessed July 10, 2015. 4. US Department of Health and Human Services. The Surgeon General’s Call to Action to Prevent Skin Cancer. Washington, DC: US Dept of Health and Human Services, Office of the Surgeon General; 2014.
In Defense of Documentary Cameras To The Editor Neal Baer and I have sparred before on the issue of documentary cameras being allowed into emergent settings.1,2 Alas, I find this latest jeremiad3 shows him to be just as willfully subjective about which facts he includes this time as last. As a viewer, Dr Baer is entitled to his opinion. How-
JAMA Internal Medicine September 2015 Volume 175, Number 9 (Reprinted)
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: by a UNIVERSITY OF ADELAIDE LIBRARY User on 10/13/2017
jamainternalmedicine.com
