- Email: [email protected]
Veterans Administration-National Surgical Quality Improvement Program
Letters to the Editor ● 1B). In this situation, the specific color clearly indicates the type of the drug that is being injected. We emphasize the need to use well-labeled and colored syringes to prevent syringe swap. Yoshihiro Hirabayashi, M.D. Norimasa Seo, M.D. Department of Anesthesiology and Critical Care Medicine Jichi Medical School Tochigi, Japan References 1. Fuzier R, Singelyn F. Unintentional neuromuscular blocking agent injection during an axillary brachial plexus nerve block. Reg Anesth Pain Med 2005;30:104-107. 2. Hirabayashi Y, Seo N. A sheet for preparing anesthetic drugs. Rinsho Masui (J Clin Anesth Japan) 2004;28:1100-1101.
Accepted for publication March 17, 2005. doi:10.1016/j.rapm.2005.03.008
cits, miscalculations, and transcription errors). Accordingly, the report by Drs. Fuzier and Singelyn1 recommended some steps to improve their daily practice, such as reducing workload, strengthening the anesthesia staff, the use of regional anesthesia cart, preparing drugs at the patient bedside, color labeling, and double checking. However, this report also highlighted the need for labeling modifications by the pharmaceutical industry and by health professionals. In my opinion, one immediate measure could be the use of colored printed labels instead of handwritten labels on the syringes. Drug packaging could include colored adhesive printed labels with the name of the drug and its dosage and administration section. Another measure is the use of color-coded polypropylene containers, vials, or ampules. In conclusion, drug safety should motivate the different anesthesia societies, the pharmaceutical industry, and health-care authorities to decrease drug-related errors and complications in anesthesia practice. Simple and inexpensive measures such as color labeling may improve daily practice conditions and increase patient safety. Bassam Al-Nasser, M.D. Department of Anesthesia and Intensive Care Clinique du Parc Saint Lazare Beauvais, France
Labeling as a Tool to Reduce Drug Error in Anesthesia Practice To the Editor: I read with interest the article by Drs. Fuzier and Singelyn,1 in which the authors describe a case of unintentional atracurium injection instead of local-anesthetic agent during an axillary brachial plexus block. Drugrelated errors are a major factor associated with iatrogenic injury in hospitalized patients.2 Two studies highlight the potential harm associated with drug administration errors.3,4 Critical incident reporting is an important tool in identifying system-based errors2 and helps in finding solutions to limit and decrease incidents that could affect patient care. In a recent study Abysekera et al.2 reported from the Australian Incident Monitoring database that between 1988 and 2001, syringe or drug-preparation error accounted for 50% of the total number of drug errors and included syringe swaps (34%), wrong ampules or preparation error (11%), and labeling errors (28%). The authors also reported that a large number of errors involved syringes of similar size. Although I agree with Drs. Fuzier and Singelyn1 that fatigue, haste, and inattention were probably contributing factors to their error, I find some issues in this case still confusing. Preparing drugs during a preceding surgery could be a major source of error, as could moving syringes from the operating room to the preanesthesia care area during a preceding surgery. Fontaine5 reported that labeling and packaging design have been identified as factors that cause or contribute to medication errors and as instruments to reduce the likelihood of medication errors. He also reported that an analysis in 2001 by the FDA on drug errors attributed 20% to labels, 3% to packaging, and 13% to name confusion, and the remaining 64% were attributed to other factors, such as communication in 19% of errors and human factors in 42% (knowledge or performance defi-
311
References 1. Fuzier R, Singelyn F. Unintentional neuromuscular blocking agent injection during an axillary brachial plexus nerve block. Reg Anesth Pain Med 2005;30:104-107. 2. Abeysekera A, Bergman IJ, Kluger MT, Short TG. Drug error in anaesthetic practice: A review of 896 reports from the Australian Incident Monitoring Study database Anaesthesia 2005;60:220-227. 3. Brennan TA, Leape LL, Laird NM, Hebert L, Localio AR, Lawthers AG, Newhouse JP, Weiler PC, Hiatt HH. Incidence of adverse events and negligence in hospitalized patients: Results of the Harvard Medical Practice Study I. N Engl J Med 1991;324:370-376. 4. Currie M, Mackay P, Morgan C, Runciman WB, Russell WJ, Sellen A, Webb RK, Williamson JA. The Australian Incident Monitoring Study. The “wrong drug” problem in anaesthesia: An analysis of 2000 incident reports. Anaesth Intensive Care 1993;21:596-601. 5. Fontaine AL. Current requirements and emerging trends for labeling as a tool for communicating pharmacovigilance findings. Drug Saf 2004;27:579-589.
Accepted for publication March 7, 2005. doi:10.1016/j.rapm.2005.03.002
Veterans Administration–National Surgical Quality Improvement Program To the Editor: We read with interest the article by Wu et al.1 The authors analyzed a sample of Medicare claims data and found that the presence of epidural analgesia was associated with significantly lower odds of death at 7 and 30 days after surgery. They have acknowledged the limitations of this retrospective study. In addition, they state that it is expen-
312
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sive and impractical to do a randomized control trial. We would like to make mention of the prospective data collection (preoperative patient characteristics and 30-day postoperative outcomes for most major operations), which is being undertaken by over 120 Veterans Administration hospitals. This has been ongoing for over 10 years as the Veterans Administration–National Surgical Quality Improvement Program (VA-NSQIP). Under the NSQIP, validated models for risk adjustment of 30-day morbidity and mortality after major surgery were developed. Using this database, Best et al.2 showed that the sensitivity and positive predictive value of administrative data, in comparison to NSQIP data, were poor. The administrative data collection methods are similar to the Medicare claims data. They therefore recommended substitution of these retrospective data collection methods with NSQIP data methods. One of the reasons for NSQIP success is that data are collected by trained nurses in a prospective fashion with clearly defined outcome parameters. The other significant conclusion made by Wu et al.1 is the increased incidence of pneumonia after surgery in patients with epidural analgesia. This does not correspond to the studies published elsewhere or with those from the NSQIP database. Using the NSQIP database (n ⫽ 160,805), Arozullah et al.3 were able to show that the odds ratio of developing postoperative pneumonia was 1.56 with general anesthesia, whereas it was 1.0 in patients with regional anesthesia. This ambiguity between studies has significant implications. It has been estimated that hospital surgical costs escalate from $4,487 to $52,466 in patients with respiratory complications.4 Hence, more definitive data regarding the association between postoperative epidural analgesia and pneumonia are required. It has been argued that collecting data prospectively, as in the NSQIP model, is expensive. However, since the inception of the NSQIP data-collection process, the 30-day postoperative mortality and morbidity, after major surgery in the VA, has decreased by 27% and 45%,5 respectively. Therefore, investing in similar projects should potentially be cost-effective. Recognizing the benefits and the success of NSQIP at the VA, many private sector hospitals are implementing similar NSQIP data collection.6 Soon we should have enough prospective data to answer some of the “outcome questions” pertaining to the practice of anesthesiology. Venkatesh Srinivasa, M.D. Ian Kallmeyer, M.D. Amer Al-Tabbaa, M.D. Veterans Administration Hospital West Roxbury, MA References 1. Wu CL, Hurley RW, Anderson GF, Herbert R, Rowlingson AJ, Fleisher LA. Effect of postoperative epidural analgesia on morbidity and mortality following surgery in medicare patients. Reg Anesth Pain Med 2004;29:525-533. 2. Best WR, Khuri SF, Phelan M, Hur K, Henderson WG, Demakis JG, Daley J. Identifying patient preoperative risk factors and postoperative adverse events in administrative
3.
4.
5.
6.
databases: Results from the Department of Veterans Affairs National Surgical Quality Improvement Program. J Am Coll Surg 2002;194:257-266. Arozullah AM, Khuri SF, Henderson WG, Daley J. Development and validation of a multifactorial risk index for predicting postoperative pneumonia after major noncardiac surgery. Ann Intern Med 2001;135:847-857. Dimick JB, Chen SL, Taheri PA, Henderson WG, Khuri SF, Campbell DA, Jr. Hospital costs associated with surgical complications: A report from the private-sector National Surgical Quality Improvement Program. J Am Coll Surg 2004;199:531-537. Khuri SF, Daley J, Henderson WG. The comparative assessment and improvement of quality of surgical care in the Department of Veterans Affairs. Arch Surg 2002;137:20-27. Fink AS, Campbell DA, Jr, Mentzer RM, Jr, Henderson WG, Daley J, Bannister J, Hur K, Khuri SF. The National Surgical Quality Improvement Program in nonveterans administration hospitals: Initial demonstration of feasibility. Ann Surg 2002;236:344-353.
Accepted for publication February 11, 2005. doi:10.1016/j.rapm.2005.02.002
Reply to Dr. Srinivasa To the Editor: We appreciate the interest of Drs. Srinivasa, Kallmeyer, and Al-Tabbaa in our most recent article, which demonstrates, in a Medicare claims database, an association between the presence of postoperative epidural analgesia and a decreased odds of death.1 As noted in our article, database analysis has many limitations in evaluation of this issue. However, each type of study design (including randomized controlled trials) has limitations in examination of the “regional versus general anesthesia-analgesia” issue.2 We agree with Drs. Srinivasa, Kallmeyer, and Al-Tabbaa about difficulty of reconciling our finding of an increased incidence of pneumonia in those who received postoperative epidural analgesia with the available literature that shows a decreased incidence with epidural analgesia.2 Use of other databases, such as the Veterans Administration National Surgical Quality Improvement Program (NSQIP), to examine the effect of various interventions on uncommon outcomes, including major morbidity and death, would be valuable to confirm (or refute) available randomized controlled trials and cohort trials on this issue. The NSQIP database would provide at least equivalent, if not more robust, results if the data are analyzed in a similar fashion to our study,1 although the applicability of a Veterans Hospital population and care model may be the same as the population in the Medicare data set. To examine whether postoperative analgesia per se is associated with a difference in morbidity and mortality, however, the NSQIP database (or any other database) ideally would need to provide information on the location of epidural catheter placement, the type of analgesic regimen used, and the duration of epidural analgesia.2 In addition, the effect of epidural analgesia on other outcomes, such as patient satisfaction, quality of life, and recovery, may necessitate the availability of certain data, such as pain scores, incidence and severity of side effects,
Accepted for publication March 17, 2005. doi:10.1016/j.rapm.2005.03.008
cits, miscalculations, and transcription errors). Accordingly, the report by Drs. Fuzier and Singelyn1 recommended some steps to improve their daily practice, such as reducing workload, strengthening the anesthesia staff, the use of regional anesthesia cart, preparing drugs at the patient bedside, color labeling, and double checking. However, this report also highlighted the need for labeling modifications by the pharmaceutical industry and by health professionals. In my opinion, one immediate measure could be the use of colored printed labels instead of handwritten labels on the syringes. Drug packaging could include colored adhesive printed labels with the name of the drug and its dosage and administration section. Another measure is the use of color-coded polypropylene containers, vials, or ampules. In conclusion, drug safety should motivate the different anesthesia societies, the pharmaceutical industry, and health-care authorities to decrease drug-related errors and complications in anesthesia practice. Simple and inexpensive measures such as color labeling may improve daily practice conditions and increase patient safety. Bassam Al-Nasser, M.D. Department of Anesthesia and Intensive Care Clinique du Parc Saint Lazare Beauvais, France
Labeling as a Tool to Reduce Drug Error in Anesthesia Practice To the Editor: I read with interest the article by Drs. Fuzier and Singelyn,1 in which the authors describe a case of unintentional atracurium injection instead of local-anesthetic agent during an axillary brachial plexus block. Drugrelated errors are a major factor associated with iatrogenic injury in hospitalized patients.2 Two studies highlight the potential harm associated with drug administration errors.3,4 Critical incident reporting is an important tool in identifying system-based errors2 and helps in finding solutions to limit and decrease incidents that could affect patient care. In a recent study Abysekera et al.2 reported from the Australian Incident Monitoring database that between 1988 and 2001, syringe or drug-preparation error accounted for 50% of the total number of drug errors and included syringe swaps (34%), wrong ampules or preparation error (11%), and labeling errors (28%). The authors also reported that a large number of errors involved syringes of similar size. Although I agree with Drs. Fuzier and Singelyn1 that fatigue, haste, and inattention were probably contributing factors to their error, I find some issues in this case still confusing. Preparing drugs during a preceding surgery could be a major source of error, as could moving syringes from the operating room to the preanesthesia care area during a preceding surgery. Fontaine5 reported that labeling and packaging design have been identified as factors that cause or contribute to medication errors and as instruments to reduce the likelihood of medication errors. He also reported that an analysis in 2001 by the FDA on drug errors attributed 20% to labels, 3% to packaging, and 13% to name confusion, and the remaining 64% were attributed to other factors, such as communication in 19% of errors and human factors in 42% (knowledge or performance defi-
311
References 1. Fuzier R, Singelyn F. Unintentional neuromuscular blocking agent injection during an axillary brachial plexus nerve block. Reg Anesth Pain Med 2005;30:104-107. 2. Abeysekera A, Bergman IJ, Kluger MT, Short TG. Drug error in anaesthetic practice: A review of 896 reports from the Australian Incident Monitoring Study database Anaesthesia 2005;60:220-227. 3. Brennan TA, Leape LL, Laird NM, Hebert L, Localio AR, Lawthers AG, Newhouse JP, Weiler PC, Hiatt HH. Incidence of adverse events and negligence in hospitalized patients: Results of the Harvard Medical Practice Study I. N Engl J Med 1991;324:370-376. 4. Currie M, Mackay P, Morgan C, Runciman WB, Russell WJ, Sellen A, Webb RK, Williamson JA. The Australian Incident Monitoring Study. The “wrong drug” problem in anaesthesia: An analysis of 2000 incident reports. Anaesth Intensive Care 1993;21:596-601. 5. Fontaine AL. Current requirements and emerging trends for labeling as a tool for communicating pharmacovigilance findings. Drug Saf 2004;27:579-589.
Accepted for publication March 7, 2005. doi:10.1016/j.rapm.2005.03.002
Veterans Administration–National Surgical Quality Improvement Program To the Editor: We read with interest the article by Wu et al.1 The authors analyzed a sample of Medicare claims data and found that the presence of epidural analgesia was associated with significantly lower odds of death at 7 and 30 days after surgery. They have acknowledged the limitations of this retrospective study. In addition, they state that it is expen-
312
Regional Anesthesia and Pain Medicine Vol. 30 No. 3 May–June 2005
sive and impractical to do a randomized control trial. We would like to make mention of the prospective data collection (preoperative patient characteristics and 30-day postoperative outcomes for most major operations), which is being undertaken by over 120 Veterans Administration hospitals. This has been ongoing for over 10 years as the Veterans Administration–National Surgical Quality Improvement Program (VA-NSQIP). Under the NSQIP, validated models for risk adjustment of 30-day morbidity and mortality after major surgery were developed. Using this database, Best et al.2 showed that the sensitivity and positive predictive value of administrative data, in comparison to NSQIP data, were poor. The administrative data collection methods are similar to the Medicare claims data. They therefore recommended substitution of these retrospective data collection methods with NSQIP data methods. One of the reasons for NSQIP success is that data are collected by trained nurses in a prospective fashion with clearly defined outcome parameters. The other significant conclusion made by Wu et al.1 is the increased incidence of pneumonia after surgery in patients with epidural analgesia. This does not correspond to the studies published elsewhere or with those from the NSQIP database. Using the NSQIP database (n ⫽ 160,805), Arozullah et al.3 were able to show that the odds ratio of developing postoperative pneumonia was 1.56 with general anesthesia, whereas it was 1.0 in patients with regional anesthesia. This ambiguity between studies has significant implications. It has been estimated that hospital surgical costs escalate from $4,487 to $52,466 in patients with respiratory complications.4 Hence, more definitive data regarding the association between postoperative epidural analgesia and pneumonia are required. It has been argued that collecting data prospectively, as in the NSQIP model, is expensive. However, since the inception of the NSQIP data-collection process, the 30-day postoperative mortality and morbidity, after major surgery in the VA, has decreased by 27% and 45%,5 respectively. Therefore, investing in similar projects should potentially be cost-effective. Recognizing the benefits and the success of NSQIP at the VA, many private sector hospitals are implementing similar NSQIP data collection.6 Soon we should have enough prospective data to answer some of the “outcome questions” pertaining to the practice of anesthesiology. Venkatesh Srinivasa, M.D. Ian Kallmeyer, M.D. Amer Al-Tabbaa, M.D. Veterans Administration Hospital West Roxbury, MA References 1. Wu CL, Hurley RW, Anderson GF, Herbert R, Rowlingson AJ, Fleisher LA. Effect of postoperative epidural analgesia on morbidity and mortality following surgery in medicare patients. Reg Anesth Pain Med 2004;29:525-533. 2. Best WR, Khuri SF, Phelan M, Hur K, Henderson WG, Demakis JG, Daley J. Identifying patient preoperative risk factors and postoperative adverse events in administrative
3.
4.
5.
6.
databases: Results from the Department of Veterans Affairs National Surgical Quality Improvement Program. J Am Coll Surg 2002;194:257-266. Arozullah AM, Khuri SF, Henderson WG, Daley J. Development and validation of a multifactorial risk index for predicting postoperative pneumonia after major noncardiac surgery. Ann Intern Med 2001;135:847-857. Dimick JB, Chen SL, Taheri PA, Henderson WG, Khuri SF, Campbell DA, Jr. Hospital costs associated with surgical complications: A report from the private-sector National Surgical Quality Improvement Program. J Am Coll Surg 2004;199:531-537. Khuri SF, Daley J, Henderson WG. The comparative assessment and improvement of quality of surgical care in the Department of Veterans Affairs. Arch Surg 2002;137:20-27. Fink AS, Campbell DA, Jr, Mentzer RM, Jr, Henderson WG, Daley J, Bannister J, Hur K, Khuri SF. The National Surgical Quality Improvement Program in nonveterans administration hospitals: Initial demonstration of feasibility. Ann Surg 2002;236:344-353.
Accepted for publication February 11, 2005. doi:10.1016/j.rapm.2005.02.002
Reply to Dr. Srinivasa To the Editor: We appreciate the interest of Drs. Srinivasa, Kallmeyer, and Al-Tabbaa in our most recent article, which demonstrates, in a Medicare claims database, an association between the presence of postoperative epidural analgesia and a decreased odds of death.1 As noted in our article, database analysis has many limitations in evaluation of this issue. However, each type of study design (including randomized controlled trials) has limitations in examination of the “regional versus general anesthesia-analgesia” issue.2 We agree with Drs. Srinivasa, Kallmeyer, and Al-Tabbaa about difficulty of reconciling our finding of an increased incidence of pneumonia in those who received postoperative epidural analgesia with the available literature that shows a decreased incidence with epidural analgesia.2 Use of other databases, such as the Veterans Administration National Surgical Quality Improvement Program (NSQIP), to examine the effect of various interventions on uncommon outcomes, including major morbidity and death, would be valuable to confirm (or refute) available randomized controlled trials and cohort trials on this issue. The NSQIP database would provide at least equivalent, if not more robust, results if the data are analyzed in a similar fashion to our study,1 although the applicability of a Veterans Hospital population and care model may be the same as the population in the Medicare data set. To examine whether postoperative analgesia per se is associated with a difference in morbidity and mortality, however, the NSQIP database (or any other database) ideally would need to provide information on the location of epidural catheter placement, the type of analgesic regimen used, and the duration of epidural analgesia.2 In addition, the effect of epidural analgesia on other outcomes, such as patient satisfaction, quality of life, and recovery, may necessitate the availability of certain data, such as pain scores, incidence and severity of side effects,