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Uses of error: More chefs
ACADEME AND INDUSTRY
References 1
Bodenheimer T. Uneasy alliance: clinical investigators and the pharmaceutical industry. N Eng J Med 2000, 342: 1539–44. 2 US Department of Health and Human Service. Report of the National Commission on Orphan Diseases. Washington DC, 1989. 3 Di Masi JA. Trends in drug development costs, times, and risks. Drug Inf J 1995; 29: 375–84. 4 Di Masi JA, Hansen RW, Grabowski HG, Lasagna L. Research and development costs for new drugs by therapeutic class. Pharmacoeconomics 1995; 7: 152–69. 5 Peabody JW, Ruby A, Cannon P. The economics of orphan drug policy in the US. Pharmacoeconomics 1995; 8: 374–84. 6 Haffner ME. Orphan product: ongoings, progress, and prospects. Annu Rev Pharmacol 1991; 31: 603–20. 7 Orphan Drug Act. Pub. Law No. 97–414, 96 Stat. 2049, 1983. 8 Anon. The inauguration of a system for the promotion of orphan drug development. Jap Bioind Letters 1994; 11: 5–6. 9 Commonwealth Department of Health and Family Service. The Australian orphan drug programme. (January, 1998). Available at http://www.health.gov.au/tga/docs/html/orphan.htm, accessed May 2001. 10 Regulation (EC) No 141/2000 of the European Parliament and of the Council of December 16, 1999 concerning the orphan medicinal product. Off J Eur Comm 2000; 18: 1–5. 11 Médecins sans Frontières. Neglected disease, orphaned drug. MSF
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17 18 19 20 21 22
International Activity Report, 2000. Available at http://www.msf.org/publications/activ_rep/2000/access-orphan.htm, accessed July 11, 2001. ’t Hoen E. Industry and industry failing AIDS victims. Financial Times, July 21, 2000. Swarns RL. Drugmakers drop AIDS suit against South Africa. Int Herald Tribune, April 20, 2001. Editorial. South Africa moral victory. Lancet 2001 357: 1303. McNeil D. Medicine merchants: a special report. New York Times, May 21, 2000. Trouiller P, Battistella C, Pinel J, Pecoul B. Is orphan drug status beneficial to tropical diseases control? Comparison of the American and future European orphan drug acts. Trop Med Int Health 1999; 4: 412–20. Pecoul B, Chirac P, Trouiller P, Pinel J. Access to essential drugs in poor countries: a lost battle? JAMA 1999; 281: 361–37. Moore M. Yes, drugs for the poor—and patents as well. Int Herald Tribune, Feb 22, 2001. Pharmaceutical Research and Manufacturers of America. Health care in the developing world. Available at http://world.phrma.org/index.html, accessed May, 2001. Jones B, Jarvis P, Lewis JA, et al. Trials to assess equivalence: the importance of rigorous methods. BMJ 1996; 313: 36–39. Ware JH, Antam EM. Equivalence trials. N Engl J Med 1997; 337: 1159–61. Garattini S. Are me-too drugs justified? J Nephrol 1997; 33: 283–94.
Uses of error: More chefs There is a cliché that says, “Too many chefs spoil the broth.” While this may be true for chicken soup, it is not true for acute care medicine. When I was a second year house officer, covering the emergency ward without senior supervision, I saw an elderly man who complained of several hours of leg pain and fatigue. I found nothing on history and examination. I looked at his obligatory electrocardiogram and noted that he had a right bundle branch block and a left anterior hemiblock. However, I did not recognise his acute inferior wall myocardial infarction complicated by complete heart block. I sent him home with planned follow-up. The next day he had a cardiac arrest and died. Had another physician looked at the ECG or had we used a computerised ECG interpretation, his ultimately fatal infarct would not have been missed. When I was an attending physician in a coronary intensive care unit, I took care of a middle-aged woman who had cardiogenic shock and respiratory failure. She developed sepsis, and because she did not respond to the usual antibiotics, I added an aminoglycoside. I failed to note that she had a history of myasthenia gravis. Shortly after starting the aminoglycoside, she developed a neuromuscular block requiring an additional week of mechanical ventilation. I was very honest with her family and told them explicitly that I had made a mistake. Fortunately, she recovered and they forgave me. My most serious error occurred during the care of a middle-aged man who developed a rapidly progressive constrictive pericarditis. He was on digoxin for atrial fibrillation. I was very proud of myself as I quickly made the diagnosis, called up nationally-renowned experts for advice, and arranged urgent surgery. What I didn’t notice was his slowly increasing creatinine level. Sure enough, the night before surgery, he developed high-grade heart block and shock. I administered a digitalis antibody, which successfully restored sinus rhythm, but the episode threw him into multi-organ failure from which he did not recover. Learning something from these errors, I enthusiastically supported hiring a doctor of pharmacy to accompany us on rounds in the coronary intensive care unit. His services have been invaluable. Every day he uses his expertise to help us avoid these kinds of mistakes, while ensuring that we use correct drug doses and combinations. Interestingly, the more experienced I become, the more convinced I am that when dealing with acutely ill, complex patients, the more chefs the better. Michael S Lauer Department of Cardiology, Cleveland Clinic Foundation, Cleveland, OH 44195
THE LANCET • Vol 358 • November 10, 2001
1641
For personal use. Only reproduce with permission from The Lancet Publishing Group.
References 1
Bodenheimer T. Uneasy alliance: clinical investigators and the pharmaceutical industry. N Eng J Med 2000, 342: 1539–44. 2 US Department of Health and Human Service. Report of the National Commission on Orphan Diseases. Washington DC, 1989. 3 Di Masi JA. Trends in drug development costs, times, and risks. Drug Inf J 1995; 29: 375–84. 4 Di Masi JA, Hansen RW, Grabowski HG, Lasagna L. Research and development costs for new drugs by therapeutic class. Pharmacoeconomics 1995; 7: 152–69. 5 Peabody JW, Ruby A, Cannon P. The economics of orphan drug policy in the US. Pharmacoeconomics 1995; 8: 374–84. 6 Haffner ME. Orphan product: ongoings, progress, and prospects. Annu Rev Pharmacol 1991; 31: 603–20. 7 Orphan Drug Act. Pub. Law No. 97–414, 96 Stat. 2049, 1983. 8 Anon. The inauguration of a system for the promotion of orphan drug development. Jap Bioind Letters 1994; 11: 5–6. 9 Commonwealth Department of Health and Family Service. The Australian orphan drug programme. (January, 1998). Available at http://www.health.gov.au/tga/docs/html/orphan.htm, accessed May 2001. 10 Regulation (EC) No 141/2000 of the European Parliament and of the Council of December 16, 1999 concerning the orphan medicinal product. Off J Eur Comm 2000; 18: 1–5. 11 Médecins sans Frontières. Neglected disease, orphaned drug. MSF
12 13 14 15 16
17 18 19 20 21 22
International Activity Report, 2000. Available at http://www.msf.org/publications/activ_rep/2000/access-orphan.htm, accessed July 11, 2001. ’t Hoen E. Industry and industry failing AIDS victims. Financial Times, July 21, 2000. Swarns RL. Drugmakers drop AIDS suit against South Africa. Int Herald Tribune, April 20, 2001. Editorial. South Africa moral victory. Lancet 2001 357: 1303. McNeil D. Medicine merchants: a special report. New York Times, May 21, 2000. Trouiller P, Battistella C, Pinel J, Pecoul B. Is orphan drug status beneficial to tropical diseases control? Comparison of the American and future European orphan drug acts. Trop Med Int Health 1999; 4: 412–20. Pecoul B, Chirac P, Trouiller P, Pinel J. Access to essential drugs in poor countries: a lost battle? JAMA 1999; 281: 361–37. Moore M. Yes, drugs for the poor—and patents as well. Int Herald Tribune, Feb 22, 2001. Pharmaceutical Research and Manufacturers of America. Health care in the developing world. Available at http://world.phrma.org/index.html, accessed May, 2001. Jones B, Jarvis P, Lewis JA, et al. Trials to assess equivalence: the importance of rigorous methods. BMJ 1996; 313: 36–39. Ware JH, Antam EM. Equivalence trials. N Engl J Med 1997; 337: 1159–61. Garattini S. Are me-too drugs justified? J Nephrol 1997; 33: 283–94.
Uses of error: More chefs There is a cliché that says, “Too many chefs spoil the broth.” While this may be true for chicken soup, it is not true for acute care medicine. When I was a second year house officer, covering the emergency ward without senior supervision, I saw an elderly man who complained of several hours of leg pain and fatigue. I found nothing on history and examination. I looked at his obligatory electrocardiogram and noted that he had a right bundle branch block and a left anterior hemiblock. However, I did not recognise his acute inferior wall myocardial infarction complicated by complete heart block. I sent him home with planned follow-up. The next day he had a cardiac arrest and died. Had another physician looked at the ECG or had we used a computerised ECG interpretation, his ultimately fatal infarct would not have been missed. When I was an attending physician in a coronary intensive care unit, I took care of a middle-aged woman who had cardiogenic shock and respiratory failure. She developed sepsis, and because she did not respond to the usual antibiotics, I added an aminoglycoside. I failed to note that she had a history of myasthenia gravis. Shortly after starting the aminoglycoside, she developed a neuromuscular block requiring an additional week of mechanical ventilation. I was very honest with her family and told them explicitly that I had made a mistake. Fortunately, she recovered and they forgave me. My most serious error occurred during the care of a middle-aged man who developed a rapidly progressive constrictive pericarditis. He was on digoxin for atrial fibrillation. I was very proud of myself as I quickly made the diagnosis, called up nationally-renowned experts for advice, and arranged urgent surgery. What I didn’t notice was his slowly increasing creatinine level. Sure enough, the night before surgery, he developed high-grade heart block and shock. I administered a digitalis antibody, which successfully restored sinus rhythm, but the episode threw him into multi-organ failure from which he did not recover. Learning something from these errors, I enthusiastically supported hiring a doctor of pharmacy to accompany us on rounds in the coronary intensive care unit. His services have been invaluable. Every day he uses his expertise to help us avoid these kinds of mistakes, while ensuring that we use correct drug doses and combinations. Interestingly, the more experienced I become, the more convinced I am that when dealing with acutely ill, complex patients, the more chefs the better. Michael S Lauer Department of Cardiology, Cleveland Clinic Foundation, Cleveland, OH 44195
THE LANCET • Vol 358 • November 10, 2001
1641
For personal use. Only reproduce with permission from The Lancet Publishing Group.