PRACTICE CHANGER
Ensure that antibiotics are administered to surgical patients when their urinary catheter is removed to reduce the risk for urinary tract infections (UTIs).¹

STRENGTH OF RECOMMENDATION
B: Based on a meta-analysis.¹

ILLUSTRATIVE CASE
A 49-year-old man was admitted to the hospital for resection of a vertebral mass. He is almost ready for discharge, and soon his urinary catheter will be removed. Should he be given an antibiotic when his catheter is removed to prevent a UTI?

Approximately 15% to 25% of hospitalized patients receive a urinary catheter, typically during the perioperative period.² UTIs are the most common hospital-acquired infections, and virtually all of these UTIs are caused by instrumentation of the urinary tract, primarily by catheters.²

Although the mortality rate among patients with catheter-associated UTIs (CAUTIs) is just 2.3%, CAUTIs are the leading cause of hospital-acquired bacteremia, which increases morbidity and length of stay.² The most ­common pathogens for CAUTIs are Escherichia coli (21.4%), Candida species (21%), and Enterococcus species (14.9%).²Pseudomonas aeruginosa, Klebsiella, and Enterobacter species comprise the bulk of the remainder.²

Support for antibiotic prophylaxis has historically been equivocal
Until now, no data clearly supported routine use of prophylactic antibiotics after urinary catheterization. CDC guidelines published in 2009 outline which patients are appropriate candidates for catheterization but do not recommend routine use of antibiotics to prevent CAUTIs.² A 2014 Infectious Diseases Society of America practice recommendation, which was published after the study reported on here, states the benefit of antibiotics at the time of catheter removal is an unresolved issue.³

STUDY SUMMARY
Analysis shows prophylactic antibiotics reduce UTIs
Marschall et al¹ searched multiple databases for studies published between 1947 and 2012 that evaluated prophylactic use of antibiotics at the time of urinary catheter removal. The endpoint for their analysis was symptomatic UTI, which they defined as bacteriuria plus at least one clinical symptom. Trials were excluded if patients had suprapubic catheters or if antibiotics were started shortly after the catheter was inserted.

The authors analyzed seven studies. Six were randomized controlled trials, of which one was unpublished. The seventh trial was a nonrandomized study that compared outcomes of patients of two surgeons, one of whom used prophylactic antibiotics and one who did not. Five studies enrolled surgical patients exclusively, including two that focused on urology patients. In all of the studies, patients had a urinary catheter in place for fewer than 15 days. The duration of antibiotic treatment varied from a single dose to three days. The antibiotics used included trimethoprim/sulfamethoxazole, nitrofurantoin, ciprofloxacin, and a cephalosporin.

Antibiotic prophylaxis significantly reduced the rate of ­CAUTIs. The absolute risk reduction was 5.8%; the rate of CAUTIs was 4.7% in the group treated with antibiotics and 10.5% in the control group. The number needed to treat to prevent one CAUTI was 17, with a risk ratio (RR) of .45. The RR varied only slightly (.36) when the researchers repeated their analysis but excluded the unpublished trial and remained at .45 when they analyzed only studies of surgical patients.

The reduction in CAUTIs remained consistent despite varying lengths of antibiotic administration and choice of antimicrobial agents. However, when the authors looked at pooled results just from the two studies that included both surgical and medical patients, they found no decrease in CAUTIs.

WHAT’S NEW
We now have an effective way to reduce CAUTIs
Prophylactic use of antibiotics when a urinary catheter is removed appears to reduce the rate of CAUTIs by more than 50% in surgical patients. The 2009 CDC guidelines on CAUTI prevention emphasize the use of appropriate infection control measures and limiting the duration of urinary catheter use.² Now there are data showing a reduction in the incidence of CAUTIs when prophylactic antibiotics are given during catheter removal.

Continue for caveats and challenges >>

CAVEATS
Results may not apply to ­nonsurgical patients
This meta-analysis does not provide enough information to identify which patients are most likely to benefit from antibiotic prophylaxis. Most patients (92%) in this analysis had undergone surgery, but urinary catheterization is common among medically hospitalized patients. Studies of antibiotic prophylaxis at the time of catheter removal in nonsurgical patients are needed to strengthen the recommendation of this practice for all patients.

Some of the studies analyzed may have been biased. The authors determined that most of the studies in their meta-analysis were at high risk for attrition bias because there was potential for systematic differences in withdrawals between the treatment and control groups. In addition, in most studies, the randomization and allocation appeared to be inadequate, which increased the risk for selection bias.

CHALLENGES TO IMPLEMENTATION
Which antibiotics to use—and for how long—remains unclear
Antibiotic choice depends upon institutional policies and local resistance patterns, which complicates making universal recommendations. The optimal duration of treatment also is unknown, although this meta-analysis suggests that prophylaxis for three days or less can reduce CAUTI risk.

Catheters impregnated with antimicrobials or with microbial resistance barriers may be an alternative to administration of antibiotics at catheter removal, but in preliminary studies, these devices have not been shown to reduce the incidence of CAUTIs.^4,5 Increasing antimicrobial resistance also complicates the widespread use of prophylaxis.

REFERENCES
1. Marschall J, Carpenter CR, Fowler S, et al; CDC Prevention Epicenters Program. Antibiotic prophylaxis for urinary tract infections after removal of urinary catheter: meta-analysis. BMJ. 2013;346:f3147.

2. Gould CV, Umscheid CA, Agarwal RK, et al. Guideline for prevention of catheter-associated urinary tract infections 2009. www.cdc.gov/hicpac/pdf/cauti/cautiguideline2009final.pdf. Accessed November 12, 2014.  

3. Lo E, Nicolle LE, Coffin SE, et al. Strategies to prevent catheter-associated urinary tract infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014;35:464-479.

4. Pickard R, Lam T, Maclennan G, et al. Types of urethral catheter for reducing symptomatic urinary tract infections in hospitalised adults requiring short-term catheterisation: multicentre randomised controlled trial and economic evaluation of antimicrobial- and antiseptic-impregnated urethral catheters (the CATHETER trial). Health Technol Assess. 2012;16:1-197.

5. Pickard R, Lam T, MacLennan G, et al. Antimicrobial catheters for reduction of symptomatic urinary tract infection in adults requiring short-term catheterisation in hospital: a multicentre randomised controlled trial. Lancet. 2012;380:1927-1935.

ACKNOWLEDGEMENT
The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2014. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice. 2014;63(5):E10-E12.

PRACTICE CHANGER
Ensure that antibiotics are administered to surgical patients when their urinary catheter is removed to reduce the risk for urinary tract infections (UTIs).¹

STRENGTH OF RECOMMENDATION
B: Based on a meta-analysis.¹

ILLUSTRATIVE CASE
A 49-year-old man was admitted to the hospital for resection of a vertebral mass. He is almost ready for discharge, and soon his urinary catheter will be removed. Should he be given an antibiotic when his catheter is removed to prevent a UTI?

Approximately 15% to 25% of hospitalized patients receive a urinary catheter, typically during the perioperative period.² UTIs are the most common hospital-acquired infections, and virtually all of these UTIs are caused by instrumentation of the urinary tract, primarily by catheters.²

Although the mortality rate among patients with catheter-associated UTIs (CAUTIs) is just 2.3%, CAUTIs are the leading cause of hospital-acquired bacteremia, which increases morbidity and length of stay.² The most ­common pathogens for CAUTIs are Escherichia coli (21.4%), Candida species (21%), and Enterococcus species (14.9%).²Pseudomonas aeruginosa, Klebsiella, and Enterobacter species comprise the bulk of the remainder.²

Support for antibiotic prophylaxis has historically been equivocal
Until now, no data clearly supported routine use of prophylactic antibiotics after urinary catheterization. CDC guidelines published in 2009 outline which patients are appropriate candidates for catheterization but do not recommend routine use of antibiotics to prevent CAUTIs.² A 2014 Infectious Diseases Society of America practice recommendation, which was published after the study reported on here, states the benefit of antibiotics at the time of catheter removal is an unresolved issue.³

STUDY SUMMARY
Analysis shows prophylactic antibiotics reduce UTIs
Marschall et al¹ searched multiple databases for studies published between 1947 and 2012 that evaluated prophylactic use of antibiotics at the time of urinary catheter removal. The endpoint for their analysis was symptomatic UTI, which they defined as bacteriuria plus at least one clinical symptom. Trials were excluded if patients had suprapubic catheters or if antibiotics were started shortly after the catheter was inserted.

The authors analyzed seven studies. Six were randomized controlled trials, of which one was unpublished. The seventh trial was a nonrandomized study that compared outcomes of patients of two surgeons, one of whom used prophylactic antibiotics and one who did not. Five studies enrolled surgical patients exclusively, including two that focused on urology patients. In all of the studies, patients had a urinary catheter in place for fewer than 15 days. The duration of antibiotic treatment varied from a single dose to three days. The antibiotics used included trimethoprim/sulfamethoxazole, nitrofurantoin, ciprofloxacin, and a cephalosporin.

Antibiotic prophylaxis significantly reduced the rate of ­CAUTIs. The absolute risk reduction was 5.8%; the rate of CAUTIs was 4.7% in the group treated with antibiotics and 10.5% in the control group. The number needed to treat to prevent one CAUTI was 17, with a risk ratio (RR) of .45. The RR varied only slightly (.36) when the researchers repeated their analysis but excluded the unpublished trial and remained at .45 when they analyzed only studies of surgical patients.

The reduction in CAUTIs remained consistent despite varying lengths of antibiotic administration and choice of antimicrobial agents. However, when the authors looked at pooled results just from the two studies that included both surgical and medical patients, they found no decrease in CAUTIs.

WHAT’S NEW
We now have an effective way to reduce CAUTIs
Prophylactic use of antibiotics when a urinary catheter is removed appears to reduce the rate of CAUTIs by more than 50% in surgical patients. The 2009 CDC guidelines on CAUTI prevention emphasize the use of appropriate infection control measures and limiting the duration of urinary catheter use.² Now there are data showing a reduction in the incidence of CAUTIs when prophylactic antibiotics are given during catheter removal.

Continue for caveats and challenges >>

CAVEATS
Results may not apply to ­nonsurgical patients
This meta-analysis does not provide enough information to identify which patients are most likely to benefit from antibiotic prophylaxis. Most patients (92%) in this analysis had undergone surgery, but urinary catheterization is common among medically hospitalized patients. Studies of antibiotic prophylaxis at the time of catheter removal in nonsurgical patients are needed to strengthen the recommendation of this practice for all patients.

Some of the studies analyzed may have been biased. The authors determined that most of the studies in their meta-analysis were at high risk for attrition bias because there was potential for systematic differences in withdrawals between the treatment and control groups. In addition, in most studies, the randomization and allocation appeared to be inadequate, which increased the risk for selection bias.

CHALLENGES TO IMPLEMENTATION
Which antibiotics to use—and for how long—remains unclear
Antibiotic choice depends upon institutional policies and local resistance patterns, which complicates making universal recommendations. The optimal duration of treatment also is unknown, although this meta-analysis suggests that prophylaxis for three days or less can reduce CAUTI risk.

Catheters impregnated with antimicrobials or with microbial resistance barriers may be an alternative to administration of antibiotics at catheter removal, but in preliminary studies, these devices have not been shown to reduce the incidence of CAUTIs.^4,5 Increasing antimicrobial resistance also complicates the widespread use of prophylaxis.

REFERENCES
1. Marschall J, Carpenter CR, Fowler S, et al; CDC Prevention Epicenters Program. Antibiotic prophylaxis for urinary tract infections after removal of urinary catheter: meta-analysis. BMJ. 2013;346:f3147.

2. Gould CV, Umscheid CA, Agarwal RK, et al. Guideline for prevention of catheter-associated urinary tract infections 2009. www.cdc.gov/hicpac/pdf/cauti/cautiguideline2009final.pdf. Accessed November 12, 2014.  

3. Lo E, Nicolle LE, Coffin SE, et al. Strategies to prevent catheter-associated urinary tract infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014;35:464-479.

4. Pickard R, Lam T, Maclennan G, et al. Types of urethral catheter for reducing symptomatic urinary tract infections in hospitalised adults requiring short-term catheterisation: multicentre randomised controlled trial and economic evaluation of antimicrobial- and antiseptic-impregnated urethral catheters (the CATHETER trial). Health Technol Assess. 2012;16:1-197.

5. Pickard R, Lam T, MacLennan G, et al. Antimicrobial catheters for reduction of symptomatic urinary tract infection in adults requiring short-term catheterisation in hospital: a multicentre randomised controlled trial. Lancet. 2012;380:1927-1935.

ACKNOWLEDGEMENT
The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2014. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice. 2014;63(5):E10-E12.

PRACTICE CHANGER
Ensure that antibiotics are administered to surgical patients when their urinary catheter is removed to reduce the risk for urinary tract infections (UTIs).¹

STRENGTH OF RECOMMENDATION
B: Based on a meta-analysis.¹

ILLUSTRATIVE CASE
A 49-year-old man was admitted to the hospital for resection of a vertebral mass. He is almost ready for discharge, and soon his urinary catheter will be removed. Should he be given an antibiotic when his catheter is removed to prevent a UTI?

Approximately 15% to 25% of hospitalized patients receive a urinary catheter, typically during the perioperative period.² UTIs are the most common hospital-acquired infections, and virtually all of these UTIs are caused by instrumentation of the urinary tract, primarily by catheters.²

Although the mortality rate among patients with catheter-associated UTIs (CAUTIs) is just 2.3%, CAUTIs are the leading cause of hospital-acquired bacteremia, which increases morbidity and length of stay.² The most ­common pathogens for CAUTIs are Escherichia coli (21.4%), Candida species (21%), and Enterococcus species (14.9%).²Pseudomonas aeruginosa, Klebsiella, and Enterobacter species comprise the bulk of the remainder.²

Support for antibiotic prophylaxis has historically been equivocal
Until now, no data clearly supported routine use of prophylactic antibiotics after urinary catheterization. CDC guidelines published in 2009 outline which patients are appropriate candidates for catheterization but do not recommend routine use of antibiotics to prevent CAUTIs.² A 2014 Infectious Diseases Society of America practice recommendation, which was published after the study reported on here, states the benefit of antibiotics at the time of catheter removal is an unresolved issue.³

STUDY SUMMARY
Analysis shows prophylactic antibiotics reduce UTIs
Marschall et al¹ searched multiple databases for studies published between 1947 and 2012 that evaluated prophylactic use of antibiotics at the time of urinary catheter removal. The endpoint for their analysis was symptomatic UTI, which they defined as bacteriuria plus at least one clinical symptom. Trials were excluded if patients had suprapubic catheters or if antibiotics were started shortly after the catheter was inserted.

The authors analyzed seven studies. Six were randomized controlled trials, of which one was unpublished. The seventh trial was a nonrandomized study that compared outcomes of patients of two surgeons, one of whom used prophylactic antibiotics and one who did not. Five studies enrolled surgical patients exclusively, including two that focused on urology patients. In all of the studies, patients had a urinary catheter in place for fewer than 15 days. The duration of antibiotic treatment varied from a single dose to three days. The antibiotics used included trimethoprim/sulfamethoxazole, nitrofurantoin, ciprofloxacin, and a cephalosporin.

Antibiotic prophylaxis significantly reduced the rate of ­CAUTIs. The absolute risk reduction was 5.8%; the rate of CAUTIs was 4.7% in the group treated with antibiotics and 10.5% in the control group. The number needed to treat to prevent one CAUTI was 17, with a risk ratio (RR) of .45. The RR varied only slightly (.36) when the researchers repeated their analysis but excluded the unpublished trial and remained at .45 when they analyzed only studies of surgical patients.

The reduction in CAUTIs remained consistent despite varying lengths of antibiotic administration and choice of antimicrobial agents. However, when the authors looked at pooled results just from the two studies that included both surgical and medical patients, they found no decrease in CAUTIs.

WHAT’S NEW
We now have an effective way to reduce CAUTIs
Prophylactic use of antibiotics when a urinary catheter is removed appears to reduce the rate of CAUTIs by more than 50% in surgical patients. The 2009 CDC guidelines on CAUTI prevention emphasize the use of appropriate infection control measures and limiting the duration of urinary catheter use.² Now there are data showing a reduction in the incidence of CAUTIs when prophylactic antibiotics are given during catheter removal.

Continue for caveats and challenges >>

CAVEATS
Results may not apply to ­nonsurgical patients
This meta-analysis does not provide enough information to identify which patients are most likely to benefit from antibiotic prophylaxis. Most patients (92%) in this analysis had undergone surgery, but urinary catheterization is common among medically hospitalized patients. Studies of antibiotic prophylaxis at the time of catheter removal in nonsurgical patients are needed to strengthen the recommendation of this practice for all patients.

Some of the studies analyzed may have been biased. The authors determined that most of the studies in their meta-analysis were at high risk for attrition bias because there was potential for systematic differences in withdrawals between the treatment and control groups. In addition, in most studies, the randomization and allocation appeared to be inadequate, which increased the risk for selection bias.

CHALLENGES TO IMPLEMENTATION
Which antibiotics to use—and for how long—remains unclear
Antibiotic choice depends upon institutional policies and local resistance patterns, which complicates making universal recommendations. The optimal duration of treatment also is unknown, although this meta-analysis suggests that prophylaxis for three days or less can reduce CAUTI risk.

Catheters impregnated with antimicrobials or with microbial resistance barriers may be an alternative to administration of antibiotics at catheter removal, but in preliminary studies, these devices have not been shown to reduce the incidence of CAUTIs.^4,5 Increasing antimicrobial resistance also complicates the widespread use of prophylaxis.

REFERENCES
1. Marschall J, Carpenter CR, Fowler S, et al; CDC Prevention Epicenters Program. Antibiotic prophylaxis for urinary tract infections after removal of urinary catheter: meta-analysis. BMJ. 2013;346:f3147.

2. Gould CV, Umscheid CA, Agarwal RK, et al. Guideline for prevention of catheter-associated urinary tract infections 2009. www.cdc.gov/hicpac/pdf/cauti/cautiguideline2009final.pdf. Accessed November 12, 2014.  

3. Lo E, Nicolle LE, Coffin SE, et al. Strategies to prevent catheter-associated urinary tract infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014;35:464-479.

4. Pickard R, Lam T, Maclennan G, et al. Types of urethral catheter for reducing symptomatic urinary tract infections in hospitalised adults requiring short-term catheterisation: multicentre randomised controlled trial and economic evaluation of antimicrobial- and antiseptic-impregnated urethral catheters (the CATHETER trial). Health Technol Assess. 2012;16:1-197.

5. Pickard R, Lam T, MacLennan G, et al. Antimicrobial catheters for reduction of symptomatic urinary tract infection in adults requiring short-term catheterisation in hospital: a multicentre randomised controlled trial. Lancet. 2012;380:1927-1935.

ACKNOWLEDGEMENT
The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2014. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice. 2014;63(5):E10-E12.

A 17-year-old girl underwent a routine tonsillectomy without complications at a surgical center. Following the procedure, she was taken to the recovery room and administered fentanyl for pain. 

The recovery room nurse assigned to monitor the patient spent 20 minutes treating another patient and then went on break, signing out to a second recovery room nurse. On receiving the sign­out, the second recovery room nurse discovered that the patient was in respiratory distress and began resuscitation efforts. The patient was resuscitated but died 15 days later.

The plaintiff claimed that the girl was left unmonitored by nurses assigned to the unit and that the monitoring equipment was not used, not set properly, or muted.
During her deposition, the second recovery room nurse admitted under oath that the first recovery room nurse falsified the patient’s chart; the first nurse claimed that she had assessed the patient during an important time period when she had not.  

Continue for the outcome and commentary >>

OUTCOME
The case was settled for $6 million: $1 million against the surgical center’s primary policy and $5 million against its excess policy.

COMMENT
Cases such as this one are unfortunate and avoidable—and tragically, too common. On any medical malpractice lawyer’s desk is a teetering stack of potential cases; much of that stack involves narcotics. This case raises two important areas to discuss: the dangers of parenteral narcotics and the perils of falsifying medical records.

First, when parenteral narcotics are given, proper monitoring safeguards must be in place. Malpractice cases frequently involve a scenario in which patients are given parenteral narcotics and left alone, out of sight, and unmonitored. This simply can’t be done. Close supervision and monitoring—with both equipment and eyes—are required to safeguard your patients and avoid malpractice risk. 

Other malpractice scenarios involve the ambulatory patient who is given parenteral narcotics in a clinic setting and discharged after a 10-minute “observation” period—a period during which peak drug effect is probably not realized. The patient is unsafely discharged before that peak is reached and suffers potentially fatal adverse effects. Even when direct fatal effects are not realized, the patient is discharged with impaired motor coordination and cognitive judgment, placing the patient at risk in his/her surroundings.

If a clinician commits to giving parenteral narcotics, he or she commits to providing “real-time” monitoring until the narcotic effects have safely diminished and the patient’s condition is thoroughly documented in the record. Generally speaking, the patient must be reasonably clear of the effects of narcotics before discharge. (Remember the special case of naloxone, administered for opiate excesses, in which naloxone is metabolized before the opiate; the patient can relapse into a coma/apnea if the naloxone fully metabolizes before the opiate.)

Here, this young woman was probably opiate naïve. While the amount she was given was certain, her response to the drug was not. She was left alone for at least 20 minutes and did not have a functioning SaO₂ monitor. Close monitoring of this patient was required but not provided.

As a result of this case, the surgical center changed several policies: Nurses must be on a one-to-one ratio with patients who have received narcotics during anesthesia. Furthermore, nurses must have line-of-sight to see patients at all times and, importantly, may not mute monitors (eg, oximetry monitors). 

The second salient point of this case is never, ever alter or falsify patient records! It will be discovered, and your credibility will be irretrievably damaged. Plaintiff lawyers live for this, and yet clinicians continue to do it. Don’t.

When altered medical records are discovered, the plaintiff’s theory of the case will be “cover up,” and jurors will be invited to punish the clinician for it. The jurors will do so. 

Also problematic is an otherwise defensible case that becomes much more difficult to defend because a clinician has altered the records. Remember, the plaintiff must prove all aspects of negligence, including causation and damages. In some cases, the clinician knows an obvious mistake was made but does not know that the eventual damages may be minimal or attributable to another cause. By altering the medical record, the clinician may enhance the damages value of a case by introducing a punitive element. Altering records may result in a lawsuit being filed when it otherwise wouldn’t have, or maintained when it would have been dropped before trial. In sum, don’t create a case against yourself by altering the medical records. 

Here, the falsification of records came to light during the deposition of the second nurse—who, being under oath, probably had little choice but to testify that the first nurse falsified the records. No doubt, this falsification made a bad case worse and gave the plaintiff leverage in securing more favorable settlement terms. 

You can’t make it right by rewriting history, but you can make it right by showing concern for the patient in your actions following a problem. You can also make it right by troubleshooting problems in a closed-door, formal peer review conference. Peer review conferences are designed for full and frank communication between clinicians and staff to solve problems, and as such they are protected from plaintiff disclosure.

This is an unfortunate case and a tragic loss of life. As clinicians, we must respect the potential life-ending power of parenteral narcotics. —DML

A 17-year-old girl underwent a routine tonsillectomy without complications at a surgical center. Following the procedure, she was taken to the recovery room and administered fentanyl for pain. 

The recovery room nurse assigned to monitor the patient spent 20 minutes treating another patient and then went on break, signing out to a second recovery room nurse. On receiving the sign­out, the second recovery room nurse discovered that the patient was in respiratory distress and began resuscitation efforts. The patient was resuscitated but died 15 days later.

The plaintiff claimed that the girl was left unmonitored by nurses assigned to the unit and that the monitoring equipment was not used, not set properly, or muted.
During her deposition, the second recovery room nurse admitted under oath that the first recovery room nurse falsified the patient’s chart; the first nurse claimed that she had assessed the patient during an important time period when she had not.  

Continue for the outcome and commentary >>

OUTCOME
The case was settled for $6 million: $1 million against the surgical center’s primary policy and $5 million against its excess policy.

COMMENT
Cases such as this one are unfortunate and avoidable—and tragically, too common. On any medical malpractice lawyer’s desk is a teetering stack of potential cases; much of that stack involves narcotics. This case raises two important areas to discuss: the dangers of parenteral narcotics and the perils of falsifying medical records.

First, when parenteral narcotics are given, proper monitoring safeguards must be in place. Malpractice cases frequently involve a scenario in which patients are given parenteral narcotics and left alone, out of sight, and unmonitored. This simply can’t be done. Close supervision and monitoring—with both equipment and eyes—are required to safeguard your patients and avoid malpractice risk. 

Other malpractice scenarios involve the ambulatory patient who is given parenteral narcotics in a clinic setting and discharged after a 10-minute “observation” period—a period during which peak drug effect is probably not realized. The patient is unsafely discharged before that peak is reached and suffers potentially fatal adverse effects. Even when direct fatal effects are not realized, the patient is discharged with impaired motor coordination and cognitive judgment, placing the patient at risk in his/her surroundings.

If a clinician commits to giving parenteral narcotics, he or she commits to providing “real-time” monitoring until the narcotic effects have safely diminished and the patient’s condition is thoroughly documented in the record. Generally speaking, the patient must be reasonably clear of the effects of narcotics before discharge. (Remember the special case of naloxone, administered for opiate excesses, in which naloxone is metabolized before the opiate; the patient can relapse into a coma/apnea if the naloxone fully metabolizes before the opiate.)

Here, this young woman was probably opiate naïve. While the amount she was given was certain, her response to the drug was not. She was left alone for at least 20 minutes and did not have a functioning SaO₂ monitor. Close monitoring of this patient was required but not provided.

As a result of this case, the surgical center changed several policies: Nurses must be on a one-to-one ratio with patients who have received narcotics during anesthesia. Furthermore, nurses must have line-of-sight to see patients at all times and, importantly, may not mute monitors (eg, oximetry monitors). 

The second salient point of this case is never, ever alter or falsify patient records! It will be discovered, and your credibility will be irretrievably damaged. Plaintiff lawyers live for this, and yet clinicians continue to do it. Don’t.

When altered medical records are discovered, the plaintiff’s theory of the case will be “cover up,” and jurors will be invited to punish the clinician for it. The jurors will do so. 

Also problematic is an otherwise defensible case that becomes much more difficult to defend because a clinician has altered the records. Remember, the plaintiff must prove all aspects of negligence, including causation and damages. In some cases, the clinician knows an obvious mistake was made but does not know that the eventual damages may be minimal or attributable to another cause. By altering the medical record, the clinician may enhance the damages value of a case by introducing a punitive element. Altering records may result in a lawsuit being filed when it otherwise wouldn’t have, or maintained when it would have been dropped before trial. In sum, don’t create a case against yourself by altering the medical records. 

Here, the falsification of records came to light during the deposition of the second nurse—who, being under oath, probably had little choice but to testify that the first nurse falsified the records. No doubt, this falsification made a bad case worse and gave the plaintiff leverage in securing more favorable settlement terms. 

You can’t make it right by rewriting history, but you can make it right by showing concern for the patient in your actions following a problem. You can also make it right by troubleshooting problems in a closed-door, formal peer review conference. Peer review conferences are designed for full and frank communication between clinicians and staff to solve problems, and as such they are protected from plaintiff disclosure.

This is an unfortunate case and a tragic loss of life. As clinicians, we must respect the potential life-ending power of parenteral narcotics. —DML

A 17-year-old girl underwent a routine tonsillectomy without complications at a surgical center. Following the procedure, she was taken to the recovery room and administered fentanyl for pain. 

The recovery room nurse assigned to monitor the patient spent 20 minutes treating another patient and then went on break, signing out to a second recovery room nurse. On receiving the sign­out, the second recovery room nurse discovered that the patient was in respiratory distress and began resuscitation efforts. The patient was resuscitated but died 15 days later.

The plaintiff claimed that the girl was left unmonitored by nurses assigned to the unit and that the monitoring equipment was not used, not set properly, or muted.
During her deposition, the second recovery room nurse admitted under oath that the first recovery room nurse falsified the patient’s chart; the first nurse claimed that she had assessed the patient during an important time period when she had not.  

Continue for the outcome and commentary >>

OUTCOME
The case was settled for $6 million: $1 million against the surgical center’s primary policy and $5 million against its excess policy.

COMMENT
Cases such as this one are unfortunate and avoidable—and tragically, too common. On any medical malpractice lawyer’s desk is a teetering stack of potential cases; much of that stack involves narcotics. This case raises two important areas to discuss: the dangers of parenteral narcotics and the perils of falsifying medical records.

First, when parenteral narcotics are given, proper monitoring safeguards must be in place. Malpractice cases frequently involve a scenario in which patients are given parenteral narcotics and left alone, out of sight, and unmonitored. This simply can’t be done. Close supervision and monitoring—with both equipment and eyes—are required to safeguard your patients and avoid malpractice risk. 

Other malpractice scenarios involve the ambulatory patient who is given parenteral narcotics in a clinic setting and discharged after a 10-minute “observation” period—a period during which peak drug effect is probably not realized. The patient is unsafely discharged before that peak is reached and suffers potentially fatal adverse effects. Even when direct fatal effects are not realized, the patient is discharged with impaired motor coordination and cognitive judgment, placing the patient at risk in his/her surroundings.

If a clinician commits to giving parenteral narcotics, he or she commits to providing “real-time” monitoring until the narcotic effects have safely diminished and the patient’s condition is thoroughly documented in the record. Generally speaking, the patient must be reasonably clear of the effects of narcotics before discharge. (Remember the special case of naloxone, administered for opiate excesses, in which naloxone is metabolized before the opiate; the patient can relapse into a coma/apnea if the naloxone fully metabolizes before the opiate.)

Here, this young woman was probably opiate naïve. While the amount she was given was certain, her response to the drug was not. She was left alone for at least 20 minutes and did not have a functioning SaO₂ monitor. Close monitoring of this patient was required but not provided.

As a result of this case, the surgical center changed several policies: Nurses must be on a one-to-one ratio with patients who have received narcotics during anesthesia. Furthermore, nurses must have line-of-sight to see patients at all times and, importantly, may not mute monitors (eg, oximetry monitors). 

The second salient point of this case is never, ever alter or falsify patient records! It will be discovered, and your credibility will be irretrievably damaged. Plaintiff lawyers live for this, and yet clinicians continue to do it. Don’t.

When altered medical records are discovered, the plaintiff’s theory of the case will be “cover up,” and jurors will be invited to punish the clinician for it. The jurors will do so. 

Also problematic is an otherwise defensible case that becomes much more difficult to defend because a clinician has altered the records. Remember, the plaintiff must prove all aspects of negligence, including causation and damages. In some cases, the clinician knows an obvious mistake was made but does not know that the eventual damages may be minimal or attributable to another cause. By altering the medical record, the clinician may enhance the damages value of a case by introducing a punitive element. Altering records may result in a lawsuit being filed when it otherwise wouldn’t have, or maintained when it would have been dropped before trial. In sum, don’t create a case against yourself by altering the medical records. 

Here, the falsification of records came to light during the deposition of the second nurse—who, being under oath, probably had little choice but to testify that the first nurse falsified the records. No doubt, this falsification made a bad case worse and gave the plaintiff leverage in securing more favorable settlement terms. 

You can’t make it right by rewriting history, but you can make it right by showing concern for the patient in your actions following a problem. You can also make it right by troubleshooting problems in a closed-door, formal peer review conference. Peer review conferences are designed for full and frank communication between clinicians and staff to solve problems, and as such they are protected from plaintiff disclosure.

This is an unfortunate case and a tragic loss of life. As clinicians, we must respect the potential life-ending power of parenteral narcotics. —DML

BOSTON – Treat to target in both early and established rheumatoid arthritis, recommended the authors of American College of Rheumatology draft guidelines on the management of RA.

The new ACR guidelines, expected to be finalized and published by the spring of 2015, also focus on the care of those patients whom most rheumatologists see in day-to-day practice, and they call for patience when trying a new therapy or new dose of an existing drug, Dr. Jasvinder Singh, of the division of clinical immunology and rheumatology at the University of Alabama, Birmingham, said to a standing-room-only crowd at the annual meeting of the American College of Rheumatology.

One of the guiding principles of the proposed recommendations is that “if a patient is doing well and the RA is under control, switching from one therapy to another should be done by a physician in consultation and agreement with the patient, and arbitrary switching between therapies should not be done,” he said.

Overall, the evidence-based guidelines emphasize several important aspects of RA care, including the following:

• Focus on the common patient and not exceptional cases.

• Give optimal doses of medications for 3 months before escalating or switching therapy.

• Assess disease activity using one of ACR’s recommended measures at a majority of encounters with RA patients.

• Consider methotrexate as the initial therapy in most RA patients.

• Methotrexate is the preferred monotherapy with a disease-modifying antirheumatic drug (DMARD), but other options include sulfasalazine, hydroxychloroquine, or leflunomide.

• A rheumatologist is the clinician of first choice for all patients with RA.

• Limit glucocorticoid treatment to the lowest possible dose for the shortest possible time to offer the best ratio of benefit to risk.

• Routinely assess patients’ functional status with standardized validated measures at least once yearly, or more frequently when RA is active.

The draft guidelines strongly recommend “using a treat-to-target strategy rather than a nontargeted approach” in both early and established RA.

Ideally, the target to be determined by the clinician and patient, should be remission or low disease activity. The guidelines acknowledge, however, that in some cases risk tolerance or comorbidities may require choice of a different and presumably less aggressive target.

Early RA

For early RA in treatment-naive patients, the guidelines offer an algorithm suggesting DMARD monotherapy for patients with low disease activity and, if the disease flares, recourse to short-term glucocorticoids.

For patients with moderately or highly active early RA, DMARD monotherapy can be followed with either short-term glucocorticoids, or in the case of DMARD failure, to either combination traditional DMARDs, a tumor necrosis factor inhibitor (TNFi) with or without methotrexate, or a non-TNF biologic agent with or without methotrexate, and with or without low-dose glucocorticoids. If the above therapies fail, the clinician and patient should consider a treatment course used for established RA.

Established RA

As with early RA, DMARD-naive patients with low disease activity may be started on DMARD monotherapy and proceed to traditional DMARD combinations, a TNFi with/without methotrexate, or non-TNF biologic with/without methotrexate, or tofacitinib with methotrexate. The guidelines offer a less robust recommendation about adding low-dose glucocorticoids, or short-term glucocorticoids for flares.

Patients who have not responded to treatment with single TNFi can move to a non-TNF biologic plus or minus methotrexate, or a different TNFi with/without methotrexate.

Patients who have not responded to treatment with multiple TNFi can try a non-TNF biologic plus/minus methotrexate, or tofacitinib with or without methotrexate.

Patients who have not responded to treatment with a single non-TNF biologic agent can try a different non-TNF biologic with/without methotrexate.

When both a TNFi and non-TNF biologic fail to help, the patient can try another non-TNF biologic plus/minus methotrexate, or tofacitinib plus/minus methotrexate.

Patients for whom multiple non-TNF biologic agents have failed can try either tofacitinib plus/minus methotrexate, or, if the patient is TNFi naive, a TNFi plus/minus methotrexate.

Special considerations

The guidelines make recommendations about treating patients with previously treated or untreated melanoma (TNFi preferable to tofacitinib) or nonmelanoma skin cancer (combination DMARD or non-TNF biologic preferable to TNFi) or a previously treated lymphoproliferative disorder (combination DMARD or non-TNF biologic such as abatacept, tocilizumab or rituximab over a TNFi). Patients with treated solid-organ malignancies, however, can be treated as other patients with RA are treated.

For patients with active hepatitis B or C virus infection who are receiving effective antiviral therapy, a DMARD, TNFi, non-TNF biologic, or tofacitinib can be prescribed, based on American Association for the Study of Liver Diseases case series and clinical experience, Dr. Singh said.

For patients with established RA and heart failure (HF), the guidelines recommend combination DMARD, non-TNF biologic, or tofacitinib over a TNFi, and if the patient has established or worsening HF on a TNFi, the three drug options above are preferable to switching the patient to another TNFi.

For patients with previous serious infections, however, there was less agreement on the optimal course. The guidelines, as currently planned, recommend a DMARD combination or abatacept over a TNFi in these patients, but there was no consensus about either rituximab or tocilizumab over a TNFi, Dr. Singh noted.

Tapering therapy

Finally, the proposed guidelines deal with therapeutic tapers. Specifically, for patients with established RA and low disease activity on maintenance methotrexate, the guidelines strongly recommend continuing on a traditional DMARD, TNFi, non-TNF biologic, or tofacitinib.

There is a conditional recommendation that patients with established RA in remission continuing on methotrexate can taper traditional DMARD therapy, TNFi, non-TNF biologic, or tofacitinib. But the guidelines strongly recommend against discontinuing all therapies in these patients, Dr. Singh emphasized.

“The strong recommendation is based on clinical experience that only a very small minority of patients are able to discontinue all therapies. Conditional recommendations here, supported by low-level evidence, are largely based upon expert opinion and clinical experience,” said Dr. Singh, who disclosed financial relationships with Allergan, Regeneron, Savient, and Takeda.

Join the queue

The proposed guidelines follow up on ACR’s 2012 guidelines, and will join an already crowded field of clinical practice recommendations, including those published in 2013 by the European League Against Rheumatism.

BOSTON – Treat to target in both early and established rheumatoid arthritis, recommended the authors of American College of Rheumatology draft guidelines on the management of RA.

The new ACR guidelines, expected to be finalized and published by the spring of 2015, also focus on the care of those patients whom most rheumatologists see in day-to-day practice, and they call for patience when trying a new therapy or new dose of an existing drug, Dr. Jasvinder Singh, of the division of clinical immunology and rheumatology at the University of Alabama, Birmingham, said to a standing-room-only crowd at the annual meeting of the American College of Rheumatology.

One of the guiding principles of the proposed recommendations is that “if a patient is doing well and the RA is under control, switching from one therapy to another should be done by a physician in consultation and agreement with the patient, and arbitrary switching between therapies should not be done,” he said.

Overall, the evidence-based guidelines emphasize several important aspects of RA care, including the following:

• Focus on the common patient and not exceptional cases.

• Give optimal doses of medications for 3 months before escalating or switching therapy.

• Assess disease activity using one of ACR’s recommended measures at a majority of encounters with RA patients.

• Consider methotrexate as the initial therapy in most RA patients.

• Methotrexate is the preferred monotherapy with a disease-modifying antirheumatic drug (DMARD), but other options include sulfasalazine, hydroxychloroquine, or leflunomide.

• A rheumatologist is the clinician of first choice for all patients with RA.

• Limit glucocorticoid treatment to the lowest possible dose for the shortest possible time to offer the best ratio of benefit to risk.

• Routinely assess patients’ functional status with standardized validated measures at least once yearly, or more frequently when RA is active.

The draft guidelines strongly recommend “using a treat-to-target strategy rather than a nontargeted approach” in both early and established RA.

Ideally, the target to be determined by the clinician and patient, should be remission or low disease activity. The guidelines acknowledge, however, that in some cases risk tolerance or comorbidities may require choice of a different and presumably less aggressive target.

Early RA

For early RA in treatment-naive patients, the guidelines offer an algorithm suggesting DMARD monotherapy for patients with low disease activity and, if the disease flares, recourse to short-term glucocorticoids.

For patients with moderately or highly active early RA, DMARD monotherapy can be followed with either short-term glucocorticoids, or in the case of DMARD failure, to either combination traditional DMARDs, a tumor necrosis factor inhibitor (TNFi) with or without methotrexate, or a non-TNF biologic agent with or without methotrexate, and with or without low-dose glucocorticoids. If the above therapies fail, the clinician and patient should consider a treatment course used for established RA.

Established RA

As with early RA, DMARD-naive patients with low disease activity may be started on DMARD monotherapy and proceed to traditional DMARD combinations, a TNFi with/without methotrexate, or non-TNF biologic with/without methotrexate, or tofacitinib with methotrexate. The guidelines offer a less robust recommendation about adding low-dose glucocorticoids, or short-term glucocorticoids for flares.

Patients who have not responded to treatment with single TNFi can move to a non-TNF biologic plus or minus methotrexate, or a different TNFi with/without methotrexate.

Patients who have not responded to treatment with multiple TNFi can try a non-TNF biologic plus/minus methotrexate, or tofacitinib with or without methotrexate.

Patients who have not responded to treatment with a single non-TNF biologic agent can try a different non-TNF biologic with/without methotrexate.

When both a TNFi and non-TNF biologic fail to help, the patient can try another non-TNF biologic plus/minus methotrexate, or tofacitinib plus/minus methotrexate.

Patients for whom multiple non-TNF biologic agents have failed can try either tofacitinib plus/minus methotrexate, or, if the patient is TNFi naive, a TNFi plus/minus methotrexate.

Special considerations

The guidelines make recommendations about treating patients with previously treated or untreated melanoma (TNFi preferable to tofacitinib) or nonmelanoma skin cancer (combination DMARD or non-TNF biologic preferable to TNFi) or a previously treated lymphoproliferative disorder (combination DMARD or non-TNF biologic such as abatacept, tocilizumab or rituximab over a TNFi). Patients with treated solid-organ malignancies, however, can be treated as other patients with RA are treated.

For patients with active hepatitis B or C virus infection who are receiving effective antiviral therapy, a DMARD, TNFi, non-TNF biologic, or tofacitinib can be prescribed, based on American Association for the Study of Liver Diseases case series and clinical experience, Dr. Singh said.

For patients with established RA and heart failure (HF), the guidelines recommend combination DMARD, non-TNF biologic, or tofacitinib over a TNFi, and if the patient has established or worsening HF on a TNFi, the three drug options above are preferable to switching the patient to another TNFi.

For patients with previous serious infections, however, there was less agreement on the optimal course. The guidelines, as currently planned, recommend a DMARD combination or abatacept over a TNFi in these patients, but there was no consensus about either rituximab or tocilizumab over a TNFi, Dr. Singh noted.

Tapering therapy

Finally, the proposed guidelines deal with therapeutic tapers. Specifically, for patients with established RA and low disease activity on maintenance methotrexate, the guidelines strongly recommend continuing on a traditional DMARD, TNFi, non-TNF biologic, or tofacitinib.

There is a conditional recommendation that patients with established RA in remission continuing on methotrexate can taper traditional DMARD therapy, TNFi, non-TNF biologic, or tofacitinib. But the guidelines strongly recommend against discontinuing all therapies in these patients, Dr. Singh emphasized.

“The strong recommendation is based on clinical experience that only a very small minority of patients are able to discontinue all therapies. Conditional recommendations here, supported by low-level evidence, are largely based upon expert opinion and clinical experience,” said Dr. Singh, who disclosed financial relationships with Allergan, Regeneron, Savient, and Takeda.

Join the queue

The proposed guidelines follow up on ACR’s 2012 guidelines, and will join an already crowded field of clinical practice recommendations, including those published in 2013 by the European League Against Rheumatism.

BOSTON – Treat to target in both early and established rheumatoid arthritis, recommended the authors of American College of Rheumatology draft guidelines on the management of RA.

The new ACR guidelines, expected to be finalized and published by the spring of 2015, also focus on the care of those patients whom most rheumatologists see in day-to-day practice, and they call for patience when trying a new therapy or new dose of an existing drug, Dr. Jasvinder Singh, of the division of clinical immunology and rheumatology at the University of Alabama, Birmingham, said to a standing-room-only crowd at the annual meeting of the American College of Rheumatology.

One of the guiding principles of the proposed recommendations is that “if a patient is doing well and the RA is under control, switching from one therapy to another should be done by a physician in consultation and agreement with the patient, and arbitrary switching between therapies should not be done,” he said.

Overall, the evidence-based guidelines emphasize several important aspects of RA care, including the following:

• Focus on the common patient and not exceptional cases.

• Give optimal doses of medications for 3 months before escalating or switching therapy.

• Assess disease activity using one of ACR’s recommended measures at a majority of encounters with RA patients.

• Consider methotrexate as the initial therapy in most RA patients.

• Methotrexate is the preferred monotherapy with a disease-modifying antirheumatic drug (DMARD), but other options include sulfasalazine, hydroxychloroquine, or leflunomide.

• A rheumatologist is the clinician of first choice for all patients with RA.

• Limit glucocorticoid treatment to the lowest possible dose for the shortest possible time to offer the best ratio of benefit to risk.

• Routinely assess patients’ functional status with standardized validated measures at least once yearly, or more frequently when RA is active.

The draft guidelines strongly recommend “using a treat-to-target strategy rather than a nontargeted approach” in both early and established RA.

Ideally, the target to be determined by the clinician and patient, should be remission or low disease activity. The guidelines acknowledge, however, that in some cases risk tolerance or comorbidities may require choice of a different and presumably less aggressive target.

Early RA

For early RA in treatment-naive patients, the guidelines offer an algorithm suggesting DMARD monotherapy for patients with low disease activity and, if the disease flares, recourse to short-term glucocorticoids.

For patients with moderately or highly active early RA, DMARD monotherapy can be followed with either short-term glucocorticoids, or in the case of DMARD failure, to either combination traditional DMARDs, a tumor necrosis factor inhibitor (TNFi) with or without methotrexate, or a non-TNF biologic agent with or without methotrexate, and with or without low-dose glucocorticoids. If the above therapies fail, the clinician and patient should consider a treatment course used for established RA.

Established RA

As with early RA, DMARD-naive patients with low disease activity may be started on DMARD monotherapy and proceed to traditional DMARD combinations, a TNFi with/without methotrexate, or non-TNF biologic with/without methotrexate, or tofacitinib with methotrexate. The guidelines offer a less robust recommendation about adding low-dose glucocorticoids, or short-term glucocorticoids for flares.

Patients who have not responded to treatment with single TNFi can move to a non-TNF biologic plus or minus methotrexate, or a different TNFi with/without methotrexate.

Patients who have not responded to treatment with multiple TNFi can try a non-TNF biologic plus/minus methotrexate, or tofacitinib with or without methotrexate.

Patients who have not responded to treatment with a single non-TNF biologic agent can try a different non-TNF biologic with/without methotrexate.

When both a TNFi and non-TNF biologic fail to help, the patient can try another non-TNF biologic plus/minus methotrexate, or tofacitinib plus/minus methotrexate.

Patients for whom multiple non-TNF biologic agents have failed can try either tofacitinib plus/minus methotrexate, or, if the patient is TNFi naive, a TNFi plus/minus methotrexate.

Special considerations

The guidelines make recommendations about treating patients with previously treated or untreated melanoma (TNFi preferable to tofacitinib) or nonmelanoma skin cancer (combination DMARD or non-TNF biologic preferable to TNFi) or a previously treated lymphoproliferative disorder (combination DMARD or non-TNF biologic such as abatacept, tocilizumab or rituximab over a TNFi). Patients with treated solid-organ malignancies, however, can be treated as other patients with RA are treated.

For patients with active hepatitis B or C virus infection who are receiving effective antiviral therapy, a DMARD, TNFi, non-TNF biologic, or tofacitinib can be prescribed, based on American Association for the Study of Liver Diseases case series and clinical experience, Dr. Singh said.

For patients with established RA and heart failure (HF), the guidelines recommend combination DMARD, non-TNF biologic, or tofacitinib over a TNFi, and if the patient has established or worsening HF on a TNFi, the three drug options above are preferable to switching the patient to another TNFi.

For patients with previous serious infections, however, there was less agreement on the optimal course. The guidelines, as currently planned, recommend a DMARD combination or abatacept over a TNFi in these patients, but there was no consensus about either rituximab or tocilizumab over a TNFi, Dr. Singh noted.

Tapering therapy

Finally, the proposed guidelines deal with therapeutic tapers. Specifically, for patients with established RA and low disease activity on maintenance methotrexate, the guidelines strongly recommend continuing on a traditional DMARD, TNFi, non-TNF biologic, or tofacitinib.

There is a conditional recommendation that patients with established RA in remission continuing on methotrexate can taper traditional DMARD therapy, TNFi, non-TNF biologic, or tofacitinib. But the guidelines strongly recommend against discontinuing all therapies in these patients, Dr. Singh emphasized.

“The strong recommendation is based on clinical experience that only a very small minority of patients are able to discontinue all therapies. Conditional recommendations here, supported by low-level evidence, are largely based upon expert opinion and clinical experience,” said Dr. Singh, who disclosed financial relationships with Allergan, Regeneron, Savient, and Takeda.

Join the queue

The proposed guidelines follow up on ACR’s 2012 guidelines, and will join an already crowded field of clinical practice recommendations, including those published in 2013 by the European League Against Rheumatism.

SAN FRANCISCO – Patients undergoing carotid endarterectomy and open abdominal aortic aneurysm repair are less likely to have complications and die if their surgeon is a vascular specialist, according to a study reported at the annual clinical congress of the American College of Surgeons.

“We feel that carotid endarterectomy and open triple-A repair performed by a vascular surgeon is an independent predictor of improved morbidity and mortality. Hospitals should consider utilizing this specialty-specific information to identify potential quality improvement initiatives,” recommended lead investigator Dr. Carla C. Moreira, a surgeon in the division of vascular and endovascular surgery, Boston Medical Center.

She and her colleagues analyzed data from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP), assessing outcomes for 94,029 patients who underwent open vascular procedures between 2006 and 2012. Some 8% had abdominal aneurysm repairs, 57% had carotid endarterectomies, and 35% had lower-extremity bypasses.

Overall, 94% of the procedures were performed by vascular surgeons, while the rest were performed by other types of surgeons (including cardiac surgeons because their numbers were too small to tease out, according to Dr. Moreira).

Results showed that for patients undergoing abdominal aneurysm repair, the unadjusted rate of 30-day mortality did not differ significantly by surgeon specialty. However, in multivariate, propensity-matched analysis, the odds of complications were reduced by half when the repair was done by a vascular surgeon as compared with some other type of surgeon (odds ratio, 0.50).

Patients undergoing carotid endarterectomy had a lower unadjusted mortality if the operation was performed by a vascular surgeon (0.7% vs. 1.0%), although the difference was no longer significant after multivariate adjustment. However, they had significantly lower adjusted odds of complications (odds ratio, 0.62).

For patients undergoing lower-extremity bypass, neither the rate of mortality nor the odds of complications differed significantly by surgeon specialty.

An analysis of temporal trends showed that the proportions of all eligible patients undergoing open abdominal aneurysm repair and lower-extremity bypass during the study period fell, regardless of surgeon type, whereas the proportion of eligible patients undergoing carotid endarterectomies remained stable. “I think this is reflective likely of the penetration of endovascular procedures when it comes to the treatment of abdominal aneurysm and lower-extremity peripheral arterial disease, as compared to carotid disease,” speculated Dr. Moreira, who disclosed that she had no relevant conflicts of interest.

Session moderator Dr. Peter K. Henke, associate chair of research, department of surgery, and Leland Ira Doan Professor of Vascular Surgery at the University of Michigan in Ann Arbor, asked whether the findings have implications for surgeon training.

“Our results were different from what has been previously published for open aneurysm repair. I think that open aneurysm repair is probably becoming more and more specialized in terms that more and more, you are going to see just vascular surgeons performing it as compared to other specialties, especially as I have shown that there is a decreasing number of general surgeons being exposed to open vascular procedures,” Dr. Moreira replied. “So I think this [speaks] to individual surgeons and their individual experience with triple-A repair. Our data does show that general surgeons who are performing these procedures are doing a good job because there is not a difference in outcome at least in terms of mortality. But as the easy triple-A repairs go away, I think it’s going to push the procedure to be done more by specialized surgeons.”

In an interview, Dr. Henke commented, “I think it has been alluded to in other studies and other reports in the literature, but this study brings to the forefront the fact that overall numbers of open vascular procedures are less and less, so the surgeons performing those procedures need to be specialists. And I’d say within the U.S. anyway, most practitioners who do vascular procedures are vascular surgeons or cardiovascularly trained, as compared with general surgeons. I suspect that some of the general surgeons who are still doing these procedures may be at a place where they are the only ones who can do it or there are no vascular specialists there.

“The other issue that this study may impact, as more of these reports come out, is hospital credentialing, because hospital credentialing of surgeons really determines what they can and cannot do at that hospital,” he added. “So as more hospital credentialing boards see this type of data, I think they will limit open vascular procedures to vascular specialists who have had training in vascular disease.”

SAN FRANCISCO – Patients undergoing carotid endarterectomy and open abdominal aortic aneurysm repair are less likely to have complications and die if their surgeon is a vascular specialist, according to a study reported at the annual clinical congress of the American College of Surgeons.

“We feel that carotid endarterectomy and open triple-A repair performed by a vascular surgeon is an independent predictor of improved morbidity and mortality. Hospitals should consider utilizing this specialty-specific information to identify potential quality improvement initiatives,” recommended lead investigator Dr. Carla C. Moreira, a surgeon in the division of vascular and endovascular surgery, Boston Medical Center.

She and her colleagues analyzed data from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP), assessing outcomes for 94,029 patients who underwent open vascular procedures between 2006 and 2012. Some 8% had abdominal aneurysm repairs, 57% had carotid endarterectomies, and 35% had lower-extremity bypasses.

Overall, 94% of the procedures were performed by vascular surgeons, while the rest were performed by other types of surgeons (including cardiac surgeons because their numbers were too small to tease out, according to Dr. Moreira).

Results showed that for patients undergoing abdominal aneurysm repair, the unadjusted rate of 30-day mortality did not differ significantly by surgeon specialty. However, in multivariate, propensity-matched analysis, the odds of complications were reduced by half when the repair was done by a vascular surgeon as compared with some other type of surgeon (odds ratio, 0.50).

Patients undergoing carotid endarterectomy had a lower unadjusted mortality if the operation was performed by a vascular surgeon (0.7% vs. 1.0%), although the difference was no longer significant after multivariate adjustment. However, they had significantly lower adjusted odds of complications (odds ratio, 0.62).

For patients undergoing lower-extremity bypass, neither the rate of mortality nor the odds of complications differed significantly by surgeon specialty.

An analysis of temporal trends showed that the proportions of all eligible patients undergoing open abdominal aneurysm repair and lower-extremity bypass during the study period fell, regardless of surgeon type, whereas the proportion of eligible patients undergoing carotid endarterectomies remained stable. “I think this is reflective likely of the penetration of endovascular procedures when it comes to the treatment of abdominal aneurysm and lower-extremity peripheral arterial disease, as compared to carotid disease,” speculated Dr. Moreira, who disclosed that she had no relevant conflicts of interest.

Session moderator Dr. Peter K. Henke, associate chair of research, department of surgery, and Leland Ira Doan Professor of Vascular Surgery at the University of Michigan in Ann Arbor, asked whether the findings have implications for surgeon training.

“Our results were different from what has been previously published for open aneurysm repair. I think that open aneurysm repair is probably becoming more and more specialized in terms that more and more, you are going to see just vascular surgeons performing it as compared to other specialties, especially as I have shown that there is a decreasing number of general surgeons being exposed to open vascular procedures,” Dr. Moreira replied. “So I think this [speaks] to individual surgeons and their individual experience with triple-A repair. Our data does show that general surgeons who are performing these procedures are doing a good job because there is not a difference in outcome at least in terms of mortality. But as the easy triple-A repairs go away, I think it’s going to push the procedure to be done more by specialized surgeons.”

In an interview, Dr. Henke commented, “I think it has been alluded to in other studies and other reports in the literature, but this study brings to the forefront the fact that overall numbers of open vascular procedures are less and less, so the surgeons performing those procedures need to be specialists. And I’d say within the U.S. anyway, most practitioners who do vascular procedures are vascular surgeons or cardiovascularly trained, as compared with general surgeons. I suspect that some of the general surgeons who are still doing these procedures may be at a place where they are the only ones who can do it or there are no vascular specialists there.

“The other issue that this study may impact, as more of these reports come out, is hospital credentialing, because hospital credentialing of surgeons really determines what they can and cannot do at that hospital,” he added. “So as more hospital credentialing boards see this type of data, I think they will limit open vascular procedures to vascular specialists who have had training in vascular disease.”

SAN FRANCISCO – Patients undergoing carotid endarterectomy and open abdominal aortic aneurysm repair are less likely to have complications and die if their surgeon is a vascular specialist, according to a study reported at the annual clinical congress of the American College of Surgeons.

“We feel that carotid endarterectomy and open triple-A repair performed by a vascular surgeon is an independent predictor of improved morbidity and mortality. Hospitals should consider utilizing this specialty-specific information to identify potential quality improvement initiatives,” recommended lead investigator Dr. Carla C. Moreira, a surgeon in the division of vascular and endovascular surgery, Boston Medical Center.

She and her colleagues analyzed data from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP), assessing outcomes for 94,029 patients who underwent open vascular procedures between 2006 and 2012. Some 8% had abdominal aneurysm repairs, 57% had carotid endarterectomies, and 35% had lower-extremity bypasses.

Overall, 94% of the procedures were performed by vascular surgeons, while the rest were performed by other types of surgeons (including cardiac surgeons because their numbers were too small to tease out, according to Dr. Moreira).

Results showed that for patients undergoing abdominal aneurysm repair, the unadjusted rate of 30-day mortality did not differ significantly by surgeon specialty. However, in multivariate, propensity-matched analysis, the odds of complications were reduced by half when the repair was done by a vascular surgeon as compared with some other type of surgeon (odds ratio, 0.50).

Patients undergoing carotid endarterectomy had a lower unadjusted mortality if the operation was performed by a vascular surgeon (0.7% vs. 1.0%), although the difference was no longer significant after multivariate adjustment. However, they had significantly lower adjusted odds of complications (odds ratio, 0.62).

For patients undergoing lower-extremity bypass, neither the rate of mortality nor the odds of complications differed significantly by surgeon specialty.

An analysis of temporal trends showed that the proportions of all eligible patients undergoing open abdominal aneurysm repair and lower-extremity bypass during the study period fell, regardless of surgeon type, whereas the proportion of eligible patients undergoing carotid endarterectomies remained stable. “I think this is reflective likely of the penetration of endovascular procedures when it comes to the treatment of abdominal aneurysm and lower-extremity peripheral arterial disease, as compared to carotid disease,” speculated Dr. Moreira, who disclosed that she had no relevant conflicts of interest.

Session moderator Dr. Peter K. Henke, associate chair of research, department of surgery, and Leland Ira Doan Professor of Vascular Surgery at the University of Michigan in Ann Arbor, asked whether the findings have implications for surgeon training.

“Our results were different from what has been previously published for open aneurysm repair. I think that open aneurysm repair is probably becoming more and more specialized in terms that more and more, you are going to see just vascular surgeons performing it as compared to other specialties, especially as I have shown that there is a decreasing number of general surgeons being exposed to open vascular procedures,” Dr. Moreira replied. “So I think this [speaks] to individual surgeons and their individual experience with triple-A repair. Our data does show that general surgeons who are performing these procedures are doing a good job because there is not a difference in outcome at least in terms of mortality. But as the easy triple-A repairs go away, I think it’s going to push the procedure to be done more by specialized surgeons.”

In an interview, Dr. Henke commented, “I think it has been alluded to in other studies and other reports in the literature, but this study brings to the forefront the fact that overall numbers of open vascular procedures are less and less, so the surgeons performing those procedures need to be specialists. And I’d say within the U.S. anyway, most practitioners who do vascular procedures are vascular surgeons or cardiovascularly trained, as compared with general surgeons. I suspect that some of the general surgeons who are still doing these procedures may be at a place where they are the only ones who can do it or there are no vascular specialists there.

“The other issue that this study may impact, as more of these reports come out, is hospital credentialing, because hospital credentialing of surgeons really determines what they can and cannot do at that hospital,” he added. “So as more hospital credentialing boards see this type of data, I think they will limit open vascular procedures to vascular specialists who have had training in vascular disease.”

Prescription medications

Credit: CDC

The US Food and Drug Administration (FDA) is evaluating trial data suggesting that 30 months of dual antiplatelet therapy (DAPT), compared to 12 months of the therapy, can increase the overall risk of death among patients who have a drug-eluting coronary stent.

The trial, which was published in NEJM, also indicates that longer-term DAPT can decrease the risk of stent thrombosis and major cardiovascular and cerebrovascular events.

For this trial, researchers compared 12 months and 30 months of DAPT—aspirin plus either clopidogrel or prasugrel—in 9961 patients who had a drug-eluting stent. The team also enrolled patients with bare-metal stents, but those patients were not included in this publication.

All 9961 patients received aspirin and clopidogrel/prasugrel for 12 months. Then, they were randomized to continue DAPT for another 18 months or to receive aspirin and placebo during that period.

In the 30-month group, 65.2% of patients received clopidogrel, and 34.8% received prasugrel. In the 12-month group, 65.4% of patients received clopidogrel, and 34.6% received prasugrel.

The investigators followed all patients for 33 months. At that point, 4732 patients in the 30-month group and 4658 patients in the 12-month group were evaluable.

The researchers observed a significant reduction in stent thrombosis for patients who received DAPT for 30 months compared to 12 months—0.4% vs 1.4% (hazard ratio [HR]=0.29, P<0.001).

Patients who received DAPT for 30 months also saw a reduction in major cardiovascular and cerebrovascular events, a combined endpoint of all-cause death, myocardial infarction, and stroke. The rate was 4.3% for the 30-month group and 5.9% for the 12-month group (HR 0.71, P<0.001).

The reduction in the risk of major cardiovascular and cerebrovascular events was driven by a decrease in the rate of non-fatal myocardial infarction. There were no differences in the rates of cardiovascular death or stroke.

The investigators also found that the overall death rate was higher among patients receiving DAPT for a longer period. The rate was 2.0% in the 30-month group and 1.5% in the 12-month group (HR=1.36, P=0.05).

The researchers said this can be explained by an increase in non-cardiovascular deaths (1% vs 0.5%, HR 2.2, P=0.002). The most frequent causes of non-cardiovascular death were cancer (34 deaths vs 17 deaths) and trauma (8 deaths vs 2 deaths) for 30 months and 12 months of DAPT, respectively.

The increase in overall mortality was present in clopidogrel-treated patients (2.2% vs 1.5%, respectively) but not prasugrel-treated patients (1.6% vs 1.6%). The FDA noted that other large clopidogrel trials have not shown an increase in the risk of non-cardiovascular death.

The FDA said it plans to evaluate the results from this trial and other relevant data, then announce its conclusions and recommendations.

For now, the agency said healthcare professionals should not change the way they administer DAPT. And patients should not stop taking these drugs, as this may result in an increased risk of heart attacks, thrombosis, strokes, and other major cardiovascular problems.

Healthcare professionals and patients can report adverse events or side effects related to the aforementioned drugs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Prescription medications

Credit: CDC

The US Food and Drug Administration (FDA) is evaluating trial data suggesting that 30 months of dual antiplatelet therapy (DAPT), compared to 12 months of the therapy, can increase the overall risk of death among patients who have a drug-eluting coronary stent.

The trial, which was published in NEJM, also indicates that longer-term DAPT can decrease the risk of stent thrombosis and major cardiovascular and cerebrovascular events.

For this trial, researchers compared 12 months and 30 months of DAPT—aspirin plus either clopidogrel or prasugrel—in 9961 patients who had a drug-eluting stent. The team also enrolled patients with bare-metal stents, but those patients were not included in this publication.

All 9961 patients received aspirin and clopidogrel/prasugrel for 12 months. Then, they were randomized to continue DAPT for another 18 months or to receive aspirin and placebo during that period.

In the 30-month group, 65.2% of patients received clopidogrel, and 34.8% received prasugrel. In the 12-month group, 65.4% of patients received clopidogrel, and 34.6% received prasugrel.

The investigators followed all patients for 33 months. At that point, 4732 patients in the 30-month group and 4658 patients in the 12-month group were evaluable.

The researchers observed a significant reduction in stent thrombosis for patients who received DAPT for 30 months compared to 12 months—0.4% vs 1.4% (hazard ratio [HR]=0.29, P<0.001).

Patients who received DAPT for 30 months also saw a reduction in major cardiovascular and cerebrovascular events, a combined endpoint of all-cause death, myocardial infarction, and stroke. The rate was 4.3% for the 30-month group and 5.9% for the 12-month group (HR 0.71, P<0.001).

The reduction in the risk of major cardiovascular and cerebrovascular events was driven by a decrease in the rate of non-fatal myocardial infarction. There were no differences in the rates of cardiovascular death or stroke.

The investigators also found that the overall death rate was higher among patients receiving DAPT for a longer period. The rate was 2.0% in the 30-month group and 1.5% in the 12-month group (HR=1.36, P=0.05).

The researchers said this can be explained by an increase in non-cardiovascular deaths (1% vs 0.5%, HR 2.2, P=0.002). The most frequent causes of non-cardiovascular death were cancer (34 deaths vs 17 deaths) and trauma (8 deaths vs 2 deaths) for 30 months and 12 months of DAPT, respectively.

The increase in overall mortality was present in clopidogrel-treated patients (2.2% vs 1.5%, respectively) but not prasugrel-treated patients (1.6% vs 1.6%). The FDA noted that other large clopidogrel trials have not shown an increase in the risk of non-cardiovascular death.

The FDA said it plans to evaluate the results from this trial and other relevant data, then announce its conclusions and recommendations.

For now, the agency said healthcare professionals should not change the way they administer DAPT. And patients should not stop taking these drugs, as this may result in an increased risk of heart attacks, thrombosis, strokes, and other major cardiovascular problems.

Healthcare professionals and patients can report adverse events or side effects related to the aforementioned drugs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Prescription medications

Credit: CDC

The US Food and Drug Administration (FDA) is evaluating trial data suggesting that 30 months of dual antiplatelet therapy (DAPT), compared to 12 months of the therapy, can increase the overall risk of death among patients who have a drug-eluting coronary stent.

The trial, which was published in NEJM, also indicates that longer-term DAPT can decrease the risk of stent thrombosis and major cardiovascular and cerebrovascular events.

For this trial, researchers compared 12 months and 30 months of DAPT—aspirin plus either clopidogrel or prasugrel—in 9961 patients who had a drug-eluting stent. The team also enrolled patients with bare-metal stents, but those patients were not included in this publication.

All 9961 patients received aspirin and clopidogrel/prasugrel for 12 months. Then, they were randomized to continue DAPT for another 18 months or to receive aspirin and placebo during that period.

In the 30-month group, 65.2% of patients received clopidogrel, and 34.8% received prasugrel. In the 12-month group, 65.4% of patients received clopidogrel, and 34.6% received prasugrel.

The investigators followed all patients for 33 months. At that point, 4732 patients in the 30-month group and 4658 patients in the 12-month group were evaluable.

The researchers observed a significant reduction in stent thrombosis for patients who received DAPT for 30 months compared to 12 months—0.4% vs 1.4% (hazard ratio [HR]=0.29, P<0.001).

Patients who received DAPT for 30 months also saw a reduction in major cardiovascular and cerebrovascular events, a combined endpoint of all-cause death, myocardial infarction, and stroke. The rate was 4.3% for the 30-month group and 5.9% for the 12-month group (HR 0.71, P<0.001).

The reduction in the risk of major cardiovascular and cerebrovascular events was driven by a decrease in the rate of non-fatal myocardial infarction. There were no differences in the rates of cardiovascular death or stroke.

The investigators also found that the overall death rate was higher among patients receiving DAPT for a longer period. The rate was 2.0% in the 30-month group and 1.5% in the 12-month group (HR=1.36, P=0.05).

The researchers said this can be explained by an increase in non-cardiovascular deaths (1% vs 0.5%, HR 2.2, P=0.002). The most frequent causes of non-cardiovascular death were cancer (34 deaths vs 17 deaths) and trauma (8 deaths vs 2 deaths) for 30 months and 12 months of DAPT, respectively.

The increase in overall mortality was present in clopidogrel-treated patients (2.2% vs 1.5%, respectively) but not prasugrel-treated patients (1.6% vs 1.6%). The FDA noted that other large clopidogrel trials have not shown an increase in the risk of non-cardiovascular death.

The FDA said it plans to evaluate the results from this trial and other relevant data, then announce its conclusions and recommendations.

For now, the agency said healthcare professionals should not change the way they administer DAPT. And patients should not stop taking these drugs, as this may result in an increased risk of heart attacks, thrombosis, strokes, and other major cardiovascular problems.

Healthcare professionals and patients can report adverse events or side effects related to the aforementioned drugs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Not many health care leaders can transition smoothly from discussing the importance of walking 30 minutes per day to the need to send PHS officers to help control the Ebola epidemic in West Africa. The Surgeon General has to. As the most prominent public health official, the Surgeon General must offer a reassuring voice on health care issues big and small. With over 26 years at the PHS, Rear Admiral (RADM) Boris D. Lushniak, MD, MPH, is well equipped to handle the challenging role.

A year after assuming the role and just before delivering a plenary address at the 2014 AMSUS meeting, RADM Lushniak agreed to a wide-ranging conversation with Federal Practitioner. The following is condensed and edited, but the complete interview can be found at http://www.fedprac.com.

Rear Admiral (RADM) Boris D. Lushniak, MD, MPH, is the Acting United States Surgeon General and oversees the operations of the U.S. Public Health Service Commissioned Corps. He served as Deputy Surgeon General from November 2010 until July 17, 2013, when he assumed the duties of Acting Surgeon General. RADM Lushniak brings 26 years of experience in the PHS to the position. He has served with the Epidemic Intelligence Service and the National Institute for Occupational Safety and Health, both at the CDC. He also served at the FDA as the Chief Medical Officer of the Office of Counterterrorism and later the Assistant Commissioner, Counterterrorism Policy and Director of the Office of Counterterrorism and emerging Threats within the Office of the Commissioner. After Hurricane Katrina, RADM Lushniak served as the HHS representative in San Antonio, Texas.

---

The 50th anniversary of the Surgeon General’s report on smoking 

RADM Boris D. Lushniak, Acting Surgeon General. Go back to January 1964 and realize what a different world we lived in back then. In fact, that report, which came out after a year and a half of scientific deliberations, of looking at facts, of searching through the literature, came up with a very important conclusion. That conclusion, simply put was: Smoking is bad for you.

Now it really was a landmark report from that perspective, but when we look back 50 years, what did it prove? It proved that cigarette smoking was directly associated with only 1 cancer at that point, specifically lung cancer in men. The report had a very simple but beautiful conclusion. It said that cigarette smoking is a health hazard of significant importance in the U.S. to warrant appropriate remedial action....

A half-century later, the social norms of our society have changed. We don’t have ashtrays all around. We don’t smoke on airplanes anymore. We oftentimes can’t smoke in bars and restaurants and establishments like that. We’ve moved from 43% of our population that smoked in 1964 to 18% currently.

We’ve had 32 Surgeons’ General reports since that first one....We brought up the issue of secondhand smoke 25 years ago. We talked about the successes and failures over these years, but 50 years later smoking remains a major public health problem in this country....

When we look to the future, what’s the goal? Well we really want to get to a zero point. We reannounced with the 50th anniversary report, which was released in January 2014, that this is an endgame strategy. At some point we have to realize that it’s not good enough to get down to 18% because of the health impact. Cigarettes and tobacco use in this country bring no good; no good to the individual, no good to the individual who has to deal with secondhand smoke, and no good for the future of our nation. So we’re really talking about an endgame strategy....

Our 50th anniversary report wasn’t just looking backward....It contains current data that now show us that we’re up to 13 different cancers caused by tobacco use. We know the impact on the whole human body. In essence, it affects almost every single system of the human body now. Brand-new diseases, formerly not associated with smoking, are still being discovered.

Most recently, we’ve seen diabetes and colon and rectal cancers as some of those diseases. We’re talking about blindness associated with smoking. We’re talking about diseases such as erectile dysfunction, which are associated with smoking. This product has brought nothing but grief and sorrow into our society and continues to do so.

Now it’s not only an impact on the United States for the Office of the Surgeon General’s to speak, but also in essence we know that internationally people look at the Surgeon General reports that come out of this office as that stellar scientific information that then can be translated worldwide.

Not only do we see leadership of public health here within the United States, but we also see leadership on an international level by profiling some of the major public health issues.

The PHS response to Ebola in the U.S. and Africa

RADM Lushniak. As many of the readers may know, the Surgeon General is the commander of the U.S. Public Health Service Commissioned Corps. We have 6,800 public health professionals. These are officers working in 11 different categories working across the government, to protect, promote, and advance the health and safety of the nation.

[In October] I was in Anniston, Alabama, seeing about 70 of my officers being trained for deployment to Liberia. And in fact, in the next weeks, we will have a full team in Liberia who will be serving in the Monrovia Medical Unit and providing health care to both Liberian as well as foreign health care workers. I want to get that message out, because this battle against Ebola is occurring here in the U.S. and being done very well by the CDC and the NIH and elements of the Commissioned Corps who are working with the CDC.

At the same time, we know that the real success of eliminating Ebola and stopping the epidemic lies in Western Africa. Dr. Frieden has said that. We’re confident that there will not be an Ebola outbreak on U.S. soil; however, we need to be able to stop this outbreak. Therefore, I’m very proud of my officers who are heading off to Western Africa.

The role of the PHS Commissioned Corps

RADM Lushniak. Most of my officers are dedicated to who? To serving the underserved and vulnerable populations. Many of my clinical officers are assigned, for example, to the Indian Health Service and are providing care to that important population of our nation. They’re assigned to the Federal Bureau of Prisons and, therefore, working with the Department of Justice in getting health care to, again, a vulnerable and underserved population. They’re working at the NIH in a clinical perspective. They’re treating the Coast Guard as the main medical and dental and environment health officers. So I have officers scattered all around, and in essence, they see everything that any other practitioner sees in this country.

The emphasis certainly from the Office of the Surgeon General has been on prevention. It’s prevention of preventable diseases; many of them are chronic diseases. And certainly, my officers not only are out there treating those individual patients, but at the same time are implementing and taking to task on the importance of prevention as a general theme. We make sure that the word of the Surgeon General’s office gets spread to local communities through our practitioners.

Raising the Commissioned Corps profile

RADM Lushniak. We need to get the word out. Part of our issue, I’ll be honest with you, is that oftentimes people don’t even know the U.S. Public Health Service Commissioned Corps exists. Therefore, even when my officers are part of a Centers for Disease Control and Prevention response, they’re embedded with other facets of CDC.

What I want to proudly say is that right now this Monrovia Medical Unit will be run by U.S. Public Health Service Commissioned Corps. This is the only entity of the U.S. government that will actually have direct patient care responsibilities in Western Africa. That being said, we’re also proud that this year is the 125th anniversary of the Commissioned Corps as a uniformed service in this country. So 125 years ago an act was passed by Congress to be able to establish this uniformed service.

Finally, I’d like to say that no other nation has a uniformed service like this. I keep saying that I love my sister services. I love the Army, the Navy, the Air Force, the Marines, the Coast Guard; but many other nations have similar type entities.

The reality of the situation is that no other nation on this planet has a uniformed service purely dedicated to public health. We are an unarmed service, and we are part of the Department of Health and Human Services, but we are just as proud to be officers. We are just as proud to be serving our nation in uniform on a slightly different mission but one that has, again, a noble cause associated with it.

Reaching the top of the PHS

RADM Lushniak. I’m honored and humbled to be in this position at this stage of my career. I came in 26, almost 27 years ago into the United States Public Health Service as a young lieutenant. My goal at that time was to be an Epidemic Intelligence Service Officer at the Centers for Disease Control and Prevention. That’s how I started my career, doing what’s deemed to be shoe leather epidemiology, going out there and getting my hands dirty and being able to try to make this nation a better place and to protect the public’s health.

It’s been a great ride from the CDC to the FDA, and then ultimately, to the Office of the Secretary here within the Office of the Surgeon General as the Deputy and now as the Acting Surgeon General. The message is everyone should, first of all, acknowledge the fact that we have an incredible mission to undertake. The mission of the Commissioned Corps of the PHS is to protect, promote, and advance the health and safety of our nation. And I dare say although we captured that as our mission, that mission is translatable to almost every federal practitioner that is out there.

The burden of that is apparent—to protect, promote, and advance the health and safety of our nation. And yet it’s a bold and noble mission, one that is achievable. We’ve had incredible successes. We still have a lot of work ahead of us.

So first and foremost, I tell my young officers and I tell everyone who may be exposed to this conversation is the sense that do your job and do it well. That’s really the prime thing I’m asking my officers to do: Be dedicated to the mission and realize that incredible things are still achievable.

The National Prevention Strategy

The goal is for us to have a healthy population at every stage of life. And so 20 federal partners...came up with a National Prevention Strategy, which is a focus of priming our nation towards prevention and wellness. It’s based on 4 strategic aims, which includes the importance of healthy and safe communities. It also entails the idea of clinical community preventive services. It talks about the empowerment of people, which is a key component of change in this nation, and the elimination of health disparities throughout the nation. It focuses on the really important preventable diseases. And among them, include the elimination of tobacco use, the importance of our really looking at alcohol and substance use in general. It’s looking at the concept of active living, the importance that we move our bodies, and the importance of healthy eating.

Office of the Surgeon General initiatives

RADM Lushniak. First and foremost, the smoking issue still continues, and there will be more on tobacco use and smoking from us. We won’t give up that fight until we’re zeroed out.

In addition, recently we released a call to action on skin cancer prevention. That’s, I think, an important issue as well because we have over 5 million people in the United States each and every year who are treated for skin cancers. We have over 60,000 people who are diagnosed with the most deadly form of skin cancer, melanoma, and 9,000 people, that’s 1 person every hour, dying of melanoma. It has an incredible impact on our country, and it is, again, one of those preventable diseases. So we look at the idea of getting the message out that we, in the Office of Surgeon General, want people to live an active lifestyle. That’s an important part of the National Prevention Strategy.

I want people to be outdoors, I want them to be runners and walkers and enjoying nature; but at the same time, I need to get the message out that we need to be wary of ultraviolet radiation from sunlight, that we can protect ourselves, seek shade when possible, put on a big hat that produces shade on your face and neck and ears. Wear glasses, put on protective clothing, and then use sunscreens, broad-spectrum sunscreens of a UV protective factor of at least 15. That’s one of the initiatives that we recently released.

In the future, where we’re priming, we’re really getting back into the fitness mode. One of the things that we’re working on, and it really simplifies, I think, what has become too complex a message—the idea of how do we have a healthy and fit nation?...

I want people to start walking 30 minutes a day, 5 days a week. Do you realize just by that simple act of walking how good our nation could do in the future? How healthy we can be as a people. So we’re really looking at an emphasis on walking and walkable communities, because not every community is walkable at this stage.

Speaking at the AMSUS Continuing Education Meeting in Washington, D.C.

RADM Lushniak. AMSUS has always provided an excellent forum for the United States Public Health Service Commissioned Corps, of which I am the commander, to be able to share our information with other federal practitioners, with other parties within the federal family that are interested in health care, in public health, in contact with patients on the clinical side and the scientific side....

I’ve been a member over many years, and I’ve been a regular attendee at the meetings. It allows us to cross-fertilize, to have that ability to sit down with our sister services, to be able to sit down with nonuniformed professionals who serve in the federal system under the flag of health care or under the flag of medical care or under the big flag of science, medical science.

Not many health care leaders can transition smoothly from discussing the importance of walking 30 minutes per day to the need to send PHS officers to help control the Ebola epidemic in West Africa. The Surgeon General has to. As the most prominent public health official, the Surgeon General must offer a reassuring voice on health care issues big and small. With over 26 years at the PHS, Rear Admiral (RADM) Boris D. Lushniak, MD, MPH, is well equipped to handle the challenging role.

A year after assuming the role and just before delivering a plenary address at the 2014 AMSUS meeting, RADM Lushniak agreed to a wide-ranging conversation with Federal Practitioner. The following is condensed and edited, but the complete interview can be found at http://www.fedprac.com.

Rear Admiral (RADM) Boris D. Lushniak, MD, MPH, is the Acting United States Surgeon General and oversees the operations of the U.S. Public Health Service Commissioned Corps. He served as Deputy Surgeon General from November 2010 until July 17, 2013, when he assumed the duties of Acting Surgeon General. RADM Lushniak brings 26 years of experience in the PHS to the position. He has served with the Epidemic Intelligence Service and the National Institute for Occupational Safety and Health, both at the CDC. He also served at the FDA as the Chief Medical Officer of the Office of Counterterrorism and later the Assistant Commissioner, Counterterrorism Policy and Director of the Office of Counterterrorism and emerging Threats within the Office of the Commissioner. After Hurricane Katrina, RADM Lushniak served as the HHS representative in San Antonio, Texas.

---

The 50th anniversary of the Surgeon General’s report on smoking 

RADM Boris D. Lushniak, Acting Surgeon General. Go back to January 1964 and realize what a different world we lived in back then. In fact, that report, which came out after a year and a half of scientific deliberations, of looking at facts, of searching through the literature, came up with a very important conclusion. That conclusion, simply put was: Smoking is bad for you.

Now it really was a landmark report from that perspective, but when we look back 50 years, what did it prove? It proved that cigarette smoking was directly associated with only 1 cancer at that point, specifically lung cancer in men. The report had a very simple but beautiful conclusion. It said that cigarette smoking is a health hazard of significant importance in the U.S. to warrant appropriate remedial action....

A half-century later, the social norms of our society have changed. We don’t have ashtrays all around. We don’t smoke on airplanes anymore. We oftentimes can’t smoke in bars and restaurants and establishments like that. We’ve moved from 43% of our population that smoked in 1964 to 18% currently.

We’ve had 32 Surgeons’ General reports since that first one....We brought up the issue of secondhand smoke 25 years ago. We talked about the successes and failures over these years, but 50 years later smoking remains a major public health problem in this country....

When we look to the future, what’s the goal? Well we really want to get to a zero point. We reannounced with the 50th anniversary report, which was released in January 2014, that this is an endgame strategy. At some point we have to realize that it’s not good enough to get down to 18% because of the health impact. Cigarettes and tobacco use in this country bring no good; no good to the individual, no good to the individual who has to deal with secondhand smoke, and no good for the future of our nation. So we’re really talking about an endgame strategy....

Our 50th anniversary report wasn’t just looking backward....It contains current data that now show us that we’re up to 13 different cancers caused by tobacco use. We know the impact on the whole human body. In essence, it affects almost every single system of the human body now. Brand-new diseases, formerly not associated with smoking, are still being discovered.

Most recently, we’ve seen diabetes and colon and rectal cancers as some of those diseases. We’re talking about blindness associated with smoking. We’re talking about diseases such as erectile dysfunction, which are associated with smoking. This product has brought nothing but grief and sorrow into our society and continues to do so.

Now it’s not only an impact on the United States for the Office of the Surgeon General’s to speak, but also in essence we know that internationally people look at the Surgeon General reports that come out of this office as that stellar scientific information that then can be translated worldwide.

Not only do we see leadership of public health here within the United States, but we also see leadership on an international level by profiling some of the major public health issues.

The PHS response to Ebola in the U.S. and Africa

RADM Lushniak. As many of the readers may know, the Surgeon General is the commander of the U.S. Public Health Service Commissioned Corps. We have 6,800 public health professionals. These are officers working in 11 different categories working across the government, to protect, promote, and advance the health and safety of the nation.

[In October] I was in Anniston, Alabama, seeing about 70 of my officers being trained for deployment to Liberia. And in fact, in the next weeks, we will have a full team in Liberia who will be serving in the Monrovia Medical Unit and providing health care to both Liberian as well as foreign health care workers. I want to get that message out, because this battle against Ebola is occurring here in the U.S. and being done very well by the CDC and the NIH and elements of the Commissioned Corps who are working with the CDC.

At the same time, we know that the real success of eliminating Ebola and stopping the epidemic lies in Western Africa. Dr. Frieden has said that. We’re confident that there will not be an Ebola outbreak on U.S. soil; however, we need to be able to stop this outbreak. Therefore, I’m very proud of my officers who are heading off to Western Africa.

The role of the PHS Commissioned Corps

RADM Lushniak. Most of my officers are dedicated to who? To serving the underserved and vulnerable populations. Many of my clinical officers are assigned, for example, to the Indian Health Service and are providing care to that important population of our nation. They’re assigned to the Federal Bureau of Prisons and, therefore, working with the Department of Justice in getting health care to, again, a vulnerable and underserved population. They’re working at the NIH in a clinical perspective. They’re treating the Coast Guard as the main medical and dental and environment health officers. So I have officers scattered all around, and in essence, they see everything that any other practitioner sees in this country.

The emphasis certainly from the Office of the Surgeon General has been on prevention. It’s prevention of preventable diseases; many of them are chronic diseases. And certainly, my officers not only are out there treating those individual patients, but at the same time are implementing and taking to task on the importance of prevention as a general theme. We make sure that the word of the Surgeon General’s office gets spread to local communities through our practitioners.

Raising the Commissioned Corps profile

RADM Lushniak. We need to get the word out. Part of our issue, I’ll be honest with you, is that oftentimes people don’t even know the U.S. Public Health Service Commissioned Corps exists. Therefore, even when my officers are part of a Centers for Disease Control and Prevention response, they’re embedded with other facets of CDC.

What I want to proudly say is that right now this Monrovia Medical Unit will be run by U.S. Public Health Service Commissioned Corps. This is the only entity of the U.S. government that will actually have direct patient care responsibilities in Western Africa. That being said, we’re also proud that this year is the 125th anniversary of the Commissioned Corps as a uniformed service in this country. So 125 years ago an act was passed by Congress to be able to establish this uniformed service.

Finally, I’d like to say that no other nation has a uniformed service like this. I keep saying that I love my sister services. I love the Army, the Navy, the Air Force, the Marines, the Coast Guard; but many other nations have similar type entities.

The reality of the situation is that no other nation on this planet has a uniformed service purely dedicated to public health. We are an unarmed service, and we are part of the Department of Health and Human Services, but we are just as proud to be officers. We are just as proud to be serving our nation in uniform on a slightly different mission but one that has, again, a noble cause associated with it.

Reaching the top of the PHS

RADM Lushniak. I’m honored and humbled to be in this position at this stage of my career. I came in 26, almost 27 years ago into the United States Public Health Service as a young lieutenant. My goal at that time was to be an Epidemic Intelligence Service Officer at the Centers for Disease Control and Prevention. That’s how I started my career, doing what’s deemed to be shoe leather epidemiology, going out there and getting my hands dirty and being able to try to make this nation a better place and to protect the public’s health.

It’s been a great ride from the CDC to the FDA, and then ultimately, to the Office of the Secretary here within the Office of the Surgeon General as the Deputy and now as the Acting Surgeon General. The message is everyone should, first of all, acknowledge the fact that we have an incredible mission to undertake. The mission of the Commissioned Corps of the PHS is to protect, promote, and advance the health and safety of our nation. And I dare say although we captured that as our mission, that mission is translatable to almost every federal practitioner that is out there.

The burden of that is apparent—to protect, promote, and advance the health and safety of our nation. And yet it’s a bold and noble mission, one that is achievable. We’ve had incredible successes. We still have a lot of work ahead of us.

So first and foremost, I tell my young officers and I tell everyone who may be exposed to this conversation is the sense that do your job and do it well. That’s really the prime thing I’m asking my officers to do: Be dedicated to the mission and realize that incredible things are still achievable.

The National Prevention Strategy

The goal is for us to have a healthy population at every stage of life. And so 20 federal partners...came up with a National Prevention Strategy, which is a focus of priming our nation towards prevention and wellness. It’s based on 4 strategic aims, which includes the importance of healthy and safe communities. It also entails the idea of clinical community preventive services. It talks about the empowerment of people, which is a key component of change in this nation, and the elimination of health disparities throughout the nation. It focuses on the really important preventable diseases. And among them, include the elimination of tobacco use, the importance of our really looking at alcohol and substance use in general. It’s looking at the concept of active living, the importance that we move our bodies, and the importance of healthy eating.

Office of the Surgeon General initiatives

RADM Lushniak. First and foremost, the smoking issue still continues, and there will be more on tobacco use and smoking from us. We won’t give up that fight until we’re zeroed out.

In addition, recently we released a call to action on skin cancer prevention. That’s, I think, an important issue as well because we have over 5 million people in the United States each and every year who are treated for skin cancers. We have over 60,000 people who are diagnosed with the most deadly form of skin cancer, melanoma, and 9,000 people, that’s 1 person every hour, dying of melanoma. It has an incredible impact on our country, and it is, again, one of those preventable diseases. So we look at the idea of getting the message out that we, in the Office of Surgeon General, want people to live an active lifestyle. That’s an important part of the National Prevention Strategy.

I want people to be outdoors, I want them to be runners and walkers and enjoying nature; but at the same time, I need to get the message out that we need to be wary of ultraviolet radiation from sunlight, that we can protect ourselves, seek shade when possible, put on a big hat that produces shade on your face and neck and ears. Wear glasses, put on protective clothing, and then use sunscreens, broad-spectrum sunscreens of a UV protective factor of at least 15. That’s one of the initiatives that we recently released.

In the future, where we’re priming, we’re really getting back into the fitness mode. One of the things that we’re working on, and it really simplifies, I think, what has become too complex a message—the idea of how do we have a healthy and fit nation?...

I want people to start walking 30 minutes a day, 5 days a week. Do you realize just by that simple act of walking how good our nation could do in the future? How healthy we can be as a people. So we’re really looking at an emphasis on walking and walkable communities, because not every community is walkable at this stage.

Speaking at the AMSUS Continuing Education Meeting in Washington, D.C.

RADM Lushniak. AMSUS has always provided an excellent forum for the United States Public Health Service Commissioned Corps, of which I am the commander, to be able to share our information with other federal practitioners, with other parties within the federal family that are interested in health care, in public health, in contact with patients on the clinical side and the scientific side....

I’ve been a member over many years, and I’ve been a regular attendee at the meetings. It allows us to cross-fertilize, to have that ability to sit down with our sister services, to be able to sit down with nonuniformed professionals who serve in the federal system under the flag of health care or under the flag of medical care or under the big flag of science, medical science.

Not many health care leaders can transition smoothly from discussing the importance of walking 30 minutes per day to the need to send PHS officers to help control the Ebola epidemic in West Africa. The Surgeon General has to. As the most prominent public health official, the Surgeon General must offer a reassuring voice on health care issues big and small. With over 26 years at the PHS, Rear Admiral (RADM) Boris D. Lushniak, MD, MPH, is well equipped to handle the challenging role.

A year after assuming the role and just before delivering a plenary address at the 2014 AMSUS meeting, RADM Lushniak agreed to a wide-ranging conversation with Federal Practitioner. The following is condensed and edited, but the complete interview can be found at http://www.fedprac.com.

Rear Admiral (RADM) Boris D. Lushniak, MD, MPH, is the Acting United States Surgeon General and oversees the operations of the U.S. Public Health Service Commissioned Corps. He served as Deputy Surgeon General from November 2010 until July 17, 2013, when he assumed the duties of Acting Surgeon General. RADM Lushniak brings 26 years of experience in the PHS to the position. He has served with the Epidemic Intelligence Service and the National Institute for Occupational Safety and Health, both at the CDC. He also served at the FDA as the Chief Medical Officer of the Office of Counterterrorism and later the Assistant Commissioner, Counterterrorism Policy and Director of the Office of Counterterrorism and emerging Threats within the Office of the Commissioner. After Hurricane Katrina, RADM Lushniak served as the HHS representative in San Antonio, Texas.

---

The 50th anniversary of the Surgeon General’s report on smoking 

RADM Boris D. Lushniak, Acting Surgeon General. Go back to January 1964 and realize what a different world we lived in back then. In fact, that report, which came out after a year and a half of scientific deliberations, of looking at facts, of searching through the literature, came up with a very important conclusion. That conclusion, simply put was: Smoking is bad for you.

Now it really was a landmark report from that perspective, but when we look back 50 years, what did it prove? It proved that cigarette smoking was directly associated with only 1 cancer at that point, specifically lung cancer in men. The report had a very simple but beautiful conclusion. It said that cigarette smoking is a health hazard of significant importance in the U.S. to warrant appropriate remedial action....

A half-century later, the social norms of our society have changed. We don’t have ashtrays all around. We don’t smoke on airplanes anymore. We oftentimes can’t smoke in bars and restaurants and establishments like that. We’ve moved from 43% of our population that smoked in 1964 to 18% currently.

We’ve had 32 Surgeons’ General reports since that first one....We brought up the issue of secondhand smoke 25 years ago. We talked about the successes and failures over these years, but 50 years later smoking remains a major public health problem in this country....

When we look to the future, what’s the goal? Well we really want to get to a zero point. We reannounced with the 50th anniversary report, which was released in January 2014, that this is an endgame strategy. At some point we have to realize that it’s not good enough to get down to 18% because of the health impact. Cigarettes and tobacco use in this country bring no good; no good to the individual, no good to the individual who has to deal with secondhand smoke, and no good for the future of our nation. So we’re really talking about an endgame strategy....

Our 50th anniversary report wasn’t just looking backward....It contains current data that now show us that we’re up to 13 different cancers caused by tobacco use. We know the impact on the whole human body. In essence, it affects almost every single system of the human body now. Brand-new diseases, formerly not associated with smoking, are still being discovered.

Most recently, we’ve seen diabetes and colon and rectal cancers as some of those diseases. We’re talking about blindness associated with smoking. We’re talking about diseases such as erectile dysfunction, which are associated with smoking. This product has brought nothing but grief and sorrow into our society and continues to do so.

Now it’s not only an impact on the United States for the Office of the Surgeon General’s to speak, but also in essence we know that internationally people look at the Surgeon General reports that come out of this office as that stellar scientific information that then can be translated worldwide.

Not only do we see leadership of public health here within the United States, but we also see leadership on an international level by profiling some of the major public health issues.

The PHS response to Ebola in the U.S. and Africa

RADM Lushniak. As many of the readers may know, the Surgeon General is the commander of the U.S. Public Health Service Commissioned Corps. We have 6,800 public health professionals. These are officers working in 11 different categories working across the government, to protect, promote, and advance the health and safety of the nation.

[In October] I was in Anniston, Alabama, seeing about 70 of my officers being trained for deployment to Liberia. And in fact, in the next weeks, we will have a full team in Liberia who will be serving in the Monrovia Medical Unit and providing health care to both Liberian as well as foreign health care workers. I want to get that message out, because this battle against Ebola is occurring here in the U.S. and being done very well by the CDC and the NIH and elements of the Commissioned Corps who are working with the CDC.

At the same time, we know that the real success of eliminating Ebola and stopping the epidemic lies in Western Africa. Dr. Frieden has said that. We’re confident that there will not be an Ebola outbreak on U.S. soil; however, we need to be able to stop this outbreak. Therefore, I’m very proud of my officers who are heading off to Western Africa.

The role of the PHS Commissioned Corps

RADM Lushniak. Most of my officers are dedicated to who? To serving the underserved and vulnerable populations. Many of my clinical officers are assigned, for example, to the Indian Health Service and are providing care to that important population of our nation. They’re assigned to the Federal Bureau of Prisons and, therefore, working with the Department of Justice in getting health care to, again, a vulnerable and underserved population. They’re working at the NIH in a clinical perspective. They’re treating the Coast Guard as the main medical and dental and environment health officers. So I have officers scattered all around, and in essence, they see everything that any other practitioner sees in this country.

The emphasis certainly from the Office of the Surgeon General has been on prevention. It’s prevention of preventable diseases; many of them are chronic diseases. And certainly, my officers not only are out there treating those individual patients, but at the same time are implementing and taking to task on the importance of prevention as a general theme. We make sure that the word of the Surgeon General’s office gets spread to local communities through our practitioners.

Raising the Commissioned Corps profile

RADM Lushniak. We need to get the word out. Part of our issue, I’ll be honest with you, is that oftentimes people don’t even know the U.S. Public Health Service Commissioned Corps exists. Therefore, even when my officers are part of a Centers for Disease Control and Prevention response, they’re embedded with other facets of CDC.

What I want to proudly say is that right now this Monrovia Medical Unit will be run by U.S. Public Health Service Commissioned Corps. This is the only entity of the U.S. government that will actually have direct patient care responsibilities in Western Africa. That being said, we’re also proud that this year is the 125th anniversary of the Commissioned Corps as a uniformed service in this country. So 125 years ago an act was passed by Congress to be able to establish this uniformed service.

Finally, I’d like to say that no other nation has a uniformed service like this. I keep saying that I love my sister services. I love the Army, the Navy, the Air Force, the Marines, the Coast Guard; but many other nations have similar type entities.

The reality of the situation is that no other nation on this planet has a uniformed service purely dedicated to public health. We are an unarmed service, and we are part of the Department of Health and Human Services, but we are just as proud to be officers. We are just as proud to be serving our nation in uniform on a slightly different mission but one that has, again, a noble cause associated with it.

Reaching the top of the PHS

RADM Lushniak. I’m honored and humbled to be in this position at this stage of my career. I came in 26, almost 27 years ago into the United States Public Health Service as a young lieutenant. My goal at that time was to be an Epidemic Intelligence Service Officer at the Centers for Disease Control and Prevention. That’s how I started my career, doing what’s deemed to be shoe leather epidemiology, going out there and getting my hands dirty and being able to try to make this nation a better place and to protect the public’s health.

It’s been a great ride from the CDC to the FDA, and then ultimately, to the Office of the Secretary here within the Office of the Surgeon General as the Deputy and now as the Acting Surgeon General. The message is everyone should, first of all, acknowledge the fact that we have an incredible mission to undertake. The mission of the Commissioned Corps of the PHS is to protect, promote, and advance the health and safety of our nation. And I dare say although we captured that as our mission, that mission is translatable to almost every federal practitioner that is out there.

The burden of that is apparent—to protect, promote, and advance the health and safety of our nation. And yet it’s a bold and noble mission, one that is achievable. We’ve had incredible successes. We still have a lot of work ahead of us.

So first and foremost, I tell my young officers and I tell everyone who may be exposed to this conversation is the sense that do your job and do it well. That’s really the prime thing I’m asking my officers to do: Be dedicated to the mission and realize that incredible things are still achievable.

The National Prevention Strategy

The goal is for us to have a healthy population at every stage of life. And so 20 federal partners...came up with a National Prevention Strategy, which is a focus of priming our nation towards prevention and wellness. It’s based on 4 strategic aims, which includes the importance of healthy and safe communities. It also entails the idea of clinical community preventive services. It talks about the empowerment of people, which is a key component of change in this nation, and the elimination of health disparities throughout the nation. It focuses on the really important preventable diseases. And among them, include the elimination of tobacco use, the importance of our really looking at alcohol and substance use in general. It’s looking at the concept of active living, the importance that we move our bodies, and the importance of healthy eating.

Office of the Surgeon General initiatives

RADM Lushniak. First and foremost, the smoking issue still continues, and there will be more on tobacco use and smoking from us. We won’t give up that fight until we’re zeroed out.

In addition, recently we released a call to action on skin cancer prevention. That’s, I think, an important issue as well because we have over 5 million people in the United States each and every year who are treated for skin cancers. We have over 60,000 people who are diagnosed with the most deadly form of skin cancer, melanoma, and 9,000 people, that’s 1 person every hour, dying of melanoma. It has an incredible impact on our country, and it is, again, one of those preventable diseases. So we look at the idea of getting the message out that we, in the Office of Surgeon General, want people to live an active lifestyle. That’s an important part of the National Prevention Strategy.

I want people to be outdoors, I want them to be runners and walkers and enjoying nature; but at the same time, I need to get the message out that we need to be wary of ultraviolet radiation from sunlight, that we can protect ourselves, seek shade when possible, put on a big hat that produces shade on your face and neck and ears. Wear glasses, put on protective clothing, and then use sunscreens, broad-spectrum sunscreens of a UV protective factor of at least 15. That’s one of the initiatives that we recently released.

In the future, where we’re priming, we’re really getting back into the fitness mode. One of the things that we’re working on, and it really simplifies, I think, what has become too complex a message—the idea of how do we have a healthy and fit nation?...

I want people to start walking 30 minutes a day, 5 days a week. Do you realize just by that simple act of walking how good our nation could do in the future? How healthy we can be as a people. So we’re really looking at an emphasis on walking and walkable communities, because not every community is walkable at this stage.

Speaking at the AMSUS Continuing Education Meeting in Washington, D.C.

RADM Lushniak. AMSUS has always provided an excellent forum for the United States Public Health Service Commissioned Corps, of which I am the commander, to be able to share our information with other federal practitioners, with other parties within the federal family that are interested in health care, in public health, in contact with patients on the clinical side and the scientific side....

I’ve been a member over many years, and I’ve been a regular attendee at the meetings. It allows us to cross-fertilize, to have that ability to sit down with our sister services, to be able to sit down with nonuniformed professionals who serve in the federal system under the flag of health care or under the flag of medical care or under the big flag of science, medical science.

Warfarin tablets

CHICAGO—Long-term overtreatment with warfarin given in combination with antiplatelet therapy may increase the risk of dementia in patients with atrial fibrillation, a new study suggests.

Researchers retrospectively analyzed patients who received warfarin plus aspirin or clopidogrel for up to 10 years.

And patients who had an international normalized ratio (INR) above the acceptable range more than 25% of the time had an increased risk of dementia.

T. Jared Bunch, MD, of the Intermountain Medical Center Heart Institute in Murray, Utah, presented these findings at the American Heart Association’s Scientific Sessions 2014 (abstract 13426).

“[W]e have to consider that long-term exposure to anticlotting drugs such as warfarin, if not well controlled, can significantly increase bleeding risk,” Dr Bunch said. “This may result in micro bleeds in the brain that don’t cause symptoms right away but accumulate over time, raising the risk of dementia.”

Dr Bunch and his colleagues studied 1031 patients with no previous history of stroke or dementia for up to 10 years while they received warfarin plus aspirin or clopidogrel.

Among patients who had an INR higher than 3 more than 25% of the time, 2.7% developed dementia.

The researchers adjusted their analysis for traditional stroke and bleeding risk factors and found that patients with supratherapeutic INR levels more than 25% of the time had more than double the risk of dementia compared to patients with supratherapeutic INR levels less than 10% of the time. The hazard ratio was 2.40 (P=0.04).

This increase is higher than what researchers found in a previous study of warfarin alone.

Previous research also suggested that patients with atrial fibrillation taking warfarin were more likely to develop dementia if their INRs were too high or too low.

From those results, the researchers concluded that brain injury from both small bleeds and blood clots is likely important in the development of dementia in patients with atrial fibrillation.

“Even at skilled centers, it’s very common to have INR outside the ideal range up to 40% of the time,” Dr Bunch noted. “And, over the years, there may be an accumulative negative impact on cognitive ability.”

Warfarin tablets

CHICAGO—Long-term overtreatment with warfarin given in combination with antiplatelet therapy may increase the risk of dementia in patients with atrial fibrillation, a new study suggests.

Researchers retrospectively analyzed patients who received warfarin plus aspirin or clopidogrel for up to 10 years.

And patients who had an international normalized ratio (INR) above the acceptable range more than 25% of the time had an increased risk of dementia.

T. Jared Bunch, MD, of the Intermountain Medical Center Heart Institute in Murray, Utah, presented these findings at the American Heart Association’s Scientific Sessions 2014 (abstract 13426).

“[W]e have to consider that long-term exposure to anticlotting drugs such as warfarin, if not well controlled, can significantly increase bleeding risk,” Dr Bunch said. “This may result in micro bleeds in the brain that don’t cause symptoms right away but accumulate over time, raising the risk of dementia.”

Dr Bunch and his colleagues studied 1031 patients with no previous history of stroke or dementia for up to 10 years while they received warfarin plus aspirin or clopidogrel.

Among patients who had an INR higher than 3 more than 25% of the time, 2.7% developed dementia.

The researchers adjusted their analysis for traditional stroke and bleeding risk factors and found that patients with supratherapeutic INR levels more than 25% of the time had more than double the risk of dementia compared to patients with supratherapeutic INR levels less than 10% of the time. The hazard ratio was 2.40 (P=0.04).

This increase is higher than what researchers found in a previous study of warfarin alone.

Previous research also suggested that patients with atrial fibrillation taking warfarin were more likely to develop dementia if their INRs were too high or too low.

From those results, the researchers concluded that brain injury from both small bleeds and blood clots is likely important in the development of dementia in patients with atrial fibrillation.

“Even at skilled centers, it’s very common to have INR outside the ideal range up to 40% of the time,” Dr Bunch noted. “And, over the years, there may be an accumulative negative impact on cognitive ability.”

Warfarin tablets

CHICAGO—Long-term overtreatment with warfarin given in combination with antiplatelet therapy may increase the risk of dementia in patients with atrial fibrillation, a new study suggests.

Researchers retrospectively analyzed patients who received warfarin plus aspirin or clopidogrel for up to 10 years.

And patients who had an international normalized ratio (INR) above the acceptable range more than 25% of the time had an increased risk of dementia.

T. Jared Bunch, MD, of the Intermountain Medical Center Heart Institute in Murray, Utah, presented these findings at the American Heart Association’s Scientific Sessions 2014 (abstract 13426).

“[W]e have to consider that long-term exposure to anticlotting drugs such as warfarin, if not well controlled, can significantly increase bleeding risk,” Dr Bunch said. “This may result in micro bleeds in the brain that don’t cause symptoms right away but accumulate over time, raising the risk of dementia.”

Dr Bunch and his colleagues studied 1031 patients with no previous history of stroke or dementia for up to 10 years while they received warfarin plus aspirin or clopidogrel.

Among patients who had an INR higher than 3 more than 25% of the time, 2.7% developed dementia.

The researchers adjusted their analysis for traditional stroke and bleeding risk factors and found that patients with supratherapeutic INR levels more than 25% of the time had more than double the risk of dementia compared to patients with supratherapeutic INR levels less than 10% of the time. The hazard ratio was 2.40 (P=0.04).

This increase is higher than what researchers found in a previous study of warfarin alone.

Previous research also suggested that patients with atrial fibrillation taking warfarin were more likely to develop dementia if their INRs were too high or too low.

From those results, the researchers concluded that brain injury from both small bleeds and blood clots is likely important in the development of dementia in patients with atrial fibrillation.

“Even at skilled centers, it’s very common to have INR outside the ideal range up to 40% of the time,” Dr Bunch noted. “And, over the years, there may be an accumulative negative impact on cognitive ability.”

The contemporary management of differentiated thyroid cancer includes posttreatment monitoring for recurrence or metastasis.¹ This monitoring includes clinical, biochemical, and imaging evaluation. Follow-up treatment can then be tailored based on the results of this monitoring.

Our patient was a 61-year-old man with a history of papillary thyroid carcinoma, including lymph node involvement and an extension of the primary focus into skeletal muscle (pT3N1bMX, stage IVa). The patient’s status was posttotal thyroidectomy and radioiodine ablation therapy (196.2 mCi iodine-131) in April 2009. The patient underwent follow-up thyrotropin alpha stimulated whole-body radioiodine surveillance scanning in May 2010.

Images demonstrated residual thyroid tissue/carcinoma regional to the thyroid bed, corresponding to prior posttherapy images. Whole body scintiphotos also demonstrated abnormal iodine localization that raised the possibility of distant bony metastasis in the region of the right hip (see Figures 1A and 1B). Current treatment standards for isolated bony metastases recommend repeated radioactive iodine therapy and potential external beam radiation. Imaging is required for accurate verification.¹ This abnormal osseous finding was questionable on initial review, as it was present on the posterior, not anterior, view. The patient was instructed to continue hydration and return for additional delayed scintiphotos for further evaluation.

The patient returned 4 days later for delayed scintiphotos, which again demonstrated abnormal iodine localization near the right hip. However, iodine distribution was different, including now being visible on both the anterior and posterior views (see Figures 2A and 2B on the next page).

• What is your diagnosis?
• How would you treat this patient? 

[Click through to the next page to see the answer.]

Our Treatment

The patient had no pain in the area and, upon further questioning, reported that he returned wearing the same athletic shorts. Given that radioiodine is excreted in the urine, this atypical distribution was thought to reflect urinary contamination. When images were taken again with the shorts removed, no abnormal radioiodine activity was present (see Figures 2C and 2D). Additional findings with thyrotropin alfa stimulation included increased quantitative thyroglobulin values of 20.2 ng/mL with antithyroglobulin antibody < 20.0 U/mL. Radioiodine ablation therapy using thyrotropin alfa was repeated. Iodine localization also was not present in the hip on posttherapy imaging (not shown).

Despite advances in imaging techniques, radioiodine scanning remains an imperfect science. Artifacts and pitfalls have been identified; in part, these are related to the accumulation of iodide in organs other than the thyroid, such as the nasopharynx and stomach, as well as the apparent accumulation due to excretion in the gut and bladder.^2-4 These variations can be divided into ectopic normal thyroid tissue, physiologic accumulation in nonthyroidal tissue, and contamination by physiologic secretions. Recent case reports have confirmed this classification. Abnormal radioiodine uptake has been described in vertebral hemangioma,⁵ liver abscess⁶ and hydatid cyst,⁷ bronchiectasis,⁸ bronchogenic cyst and mucinous cystadenoma (2 fluid-filled cavities),⁹ chronic submandibular sialadenitis,¹⁰ esophageal diverticulum,¹¹ hiatal hernia,¹² appendix,¹³ indwelling Hickman catheter,¹⁴ renal cyst,¹⁵ and, similar to this case, contamination of the hair.¹⁶

Contaminated clothing is not uncommon; however, a persistent abnormality from contaminated clothing on repeat follow-up is unusual and could easily be misinterpreted.² It would be valuable for all providers to be aware of the pitfalls of imaging before embarking on an unnecessary and potentially hazardous—not to mention costly—treatment course.

Acknowledgments
The authors acknowledge the assistance of Richard Cacciato, MLIS, Medical Librarian, who assisted in the literature review.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

The contemporary management of differentiated thyroid cancer includes posttreatment monitoring for recurrence or metastasis.¹ This monitoring includes clinical, biochemical, and imaging evaluation. Follow-up treatment can then be tailored based on the results of this monitoring.

Our patient was a 61-year-old man with a history of papillary thyroid carcinoma, including lymph node involvement and an extension of the primary focus into skeletal muscle (pT3N1bMX, stage IVa). The patient’s status was posttotal thyroidectomy and radioiodine ablation therapy (196.2 mCi iodine-131) in April 2009. The patient underwent follow-up thyrotropin alpha stimulated whole-body radioiodine surveillance scanning in May 2010.

Images demonstrated residual thyroid tissue/carcinoma regional to the thyroid bed, corresponding to prior posttherapy images. Whole body scintiphotos also demonstrated abnormal iodine localization that raised the possibility of distant bony metastasis in the region of the right hip (see Figures 1A and 1B). Current treatment standards for isolated bony metastases recommend repeated radioactive iodine therapy and potential external beam radiation. Imaging is required for accurate verification.¹ This abnormal osseous finding was questionable on initial review, as it was present on the posterior, not anterior, view. The patient was instructed to continue hydration and return for additional delayed scintiphotos for further evaluation.

The patient returned 4 days later for delayed scintiphotos, which again demonstrated abnormal iodine localization near the right hip. However, iodine distribution was different, including now being visible on both the anterior and posterior views (see Figures 2A and 2B on the next page).

• What is your diagnosis?
• How would you treat this patient? 

[Click through to the next page to see the answer.]

Our Treatment

The patient had no pain in the area and, upon further questioning, reported that he returned wearing the same athletic shorts. Given that radioiodine is excreted in the urine, this atypical distribution was thought to reflect urinary contamination. When images were taken again with the shorts removed, no abnormal radioiodine activity was present (see Figures 2C and 2D). Additional findings with thyrotropin alfa stimulation included increased quantitative thyroglobulin values of 20.2 ng/mL with antithyroglobulin antibody < 20.0 U/mL. Radioiodine ablation therapy using thyrotropin alfa was repeated. Iodine localization also was not present in the hip on posttherapy imaging (not shown).

Despite advances in imaging techniques, radioiodine scanning remains an imperfect science. Artifacts and pitfalls have been identified; in part, these are related to the accumulation of iodide in organs other than the thyroid, such as the nasopharynx and stomach, as well as the apparent accumulation due to excretion in the gut and bladder.^2-4 These variations can be divided into ectopic normal thyroid tissue, physiologic accumulation in nonthyroidal tissue, and contamination by physiologic secretions. Recent case reports have confirmed this classification. Abnormal radioiodine uptake has been described in vertebral hemangioma,⁵ liver abscess⁶ and hydatid cyst,⁷ bronchiectasis,⁸ bronchogenic cyst and mucinous cystadenoma (2 fluid-filled cavities),⁹ chronic submandibular sialadenitis,¹⁰ esophageal diverticulum,¹¹ hiatal hernia,¹² appendix,¹³ indwelling Hickman catheter,¹⁴ renal cyst,¹⁵ and, similar to this case, contamination of the hair.¹⁶

Contaminated clothing is not uncommon; however, a persistent abnormality from contaminated clothing on repeat follow-up is unusual and could easily be misinterpreted.² It would be valuable for all providers to be aware of the pitfalls of imaging before embarking on an unnecessary and potentially hazardous—not to mention costly—treatment course.

Acknowledgments
The authors acknowledge the assistance of Richard Cacciato, MLIS, Medical Librarian, who assisted in the literature review.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

The contemporary management of differentiated thyroid cancer includes posttreatment monitoring for recurrence or metastasis.¹ This monitoring includes clinical, biochemical, and imaging evaluation. Follow-up treatment can then be tailored based on the results of this monitoring.

Our patient was a 61-year-old man with a history of papillary thyroid carcinoma, including lymph node involvement and an extension of the primary focus into skeletal muscle (pT3N1bMX, stage IVa). The patient’s status was posttotal thyroidectomy and radioiodine ablation therapy (196.2 mCi iodine-131) in April 2009. The patient underwent follow-up thyrotropin alpha stimulated whole-body radioiodine surveillance scanning in May 2010.

Images demonstrated residual thyroid tissue/carcinoma regional to the thyroid bed, corresponding to prior posttherapy images. Whole body scintiphotos also demonstrated abnormal iodine localization that raised the possibility of distant bony metastasis in the region of the right hip (see Figures 1A and 1B). Current treatment standards for isolated bony metastases recommend repeated radioactive iodine therapy and potential external beam radiation. Imaging is required for accurate verification.¹ This abnormal osseous finding was questionable on initial review, as it was present on the posterior, not anterior, view. The patient was instructed to continue hydration and return for additional delayed scintiphotos for further evaluation.

The patient returned 4 days later for delayed scintiphotos, which again demonstrated abnormal iodine localization near the right hip. However, iodine distribution was different, including now being visible on both the anterior and posterior views (see Figures 2A and 2B on the next page).

• What is your diagnosis?
• How would you treat this patient? 

[Click through to the next page to see the answer.]

Our Treatment

The patient had no pain in the area and, upon further questioning, reported that he returned wearing the same athletic shorts. Given that radioiodine is excreted in the urine, this atypical distribution was thought to reflect urinary contamination. When images were taken again with the shorts removed, no abnormal radioiodine activity was present (see Figures 2C and 2D). Additional findings with thyrotropin alfa stimulation included increased quantitative thyroglobulin values of 20.2 ng/mL with antithyroglobulin antibody < 20.0 U/mL. Radioiodine ablation therapy using thyrotropin alfa was repeated. Iodine localization also was not present in the hip on posttherapy imaging (not shown).

Despite advances in imaging techniques, radioiodine scanning remains an imperfect science. Artifacts and pitfalls have been identified; in part, these are related to the accumulation of iodide in organs other than the thyroid, such as the nasopharynx and stomach, as well as the apparent accumulation due to excretion in the gut and bladder.^2-4 These variations can be divided into ectopic normal thyroid tissue, physiologic accumulation in nonthyroidal tissue, and contamination by physiologic secretions. Recent case reports have confirmed this classification. Abnormal radioiodine uptake has been described in vertebral hemangioma,⁵ liver abscess⁶ and hydatid cyst,⁷ bronchiectasis,⁸ bronchogenic cyst and mucinous cystadenoma (2 fluid-filled cavities),⁹ chronic submandibular sialadenitis,¹⁰ esophageal diverticulum,¹¹ hiatal hernia,¹² appendix,¹³ indwelling Hickman catheter,¹⁴ renal cyst,¹⁵ and, similar to this case, contamination of the hair.¹⁶

Contaminated clothing is not uncommon; however, a persistent abnormality from contaminated clothing on repeat follow-up is unusual and could easily be misinterpreted.² It would be valuable for all providers to be aware of the pitfalls of imaging before embarking on an unnecessary and potentially hazardous—not to mention costly—treatment course.

Acknowledgments
The authors acknowledge the assistance of Richard Cacciato, MLIS, Medical Librarian, who assisted in the literature review.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.