In tepid defense of population health: Physicians and antibiotic resistance

American Journal of Law and Medicine

Volumn 34, Issue 4, 2008, Pages 431-491

  Saver, Richard S ^a,b  

^a Department of Law ^*  (United States)

^b UNIVERSITY OF HOUSTON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PRESCRIPTION DRUG;

ANTIBIOTIC RESISTANCE; ARTICLE; CLINICAL PRACTICE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HUMAN; LEGAL ASPECT; PATIENT REFERRAL; PHYSICIAN; PROFESSIONAL PRACTICE; PUBLIC HEALTH; REIMBURSEMENT; UNITED STATES;

DRUG RESISTANCE, BACTERIAL; GATEKEEPING; HEALTH POLICY; HUMANS; PHYSICIAN'S PRACTICE PATTERNS; PHYSICIANS; PRESCRIPTION DRUGS; PROFESSIONAL AUTONOMY; PUBLIC HEALTH; REIMBURSEMENT MECHANISMS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 63249095614     PISSN: 00988588     EISSN: None     Source Type: Journal    
DOI: 10.1177/009885880803400401     Document Type: Article

References (248)

1. This Article refers to "antibiotic" in the broad sense of the term as an antimicrobial that inhibits the growth of microorganisms, especially bacteria. INFECTIOUS DISEASES SOC'Y OF AMERICA, BAD BUGS, NO DRUGS: AS ANTIBIOTIC CRISES STAGNATES A PUBLIC HEALTH CRISES BREWS 9 (2004).
2. The Centers for Disease Control and Prevention defines antibiotic resistance as "the ability of bacteria or other microbes to resist the effects of an antibiotic", which can occur "when bacteria change in some way that reduces or eliminates the effectiveness of drugs, chemicals, or other agents designed to cure or prevent infections." CENTERS FOR DISEASE CONTROL AND PREVENTION, About Antibiotic Resistance, http://www.cdc.gov/ drugresistance/community/anitbiotic-resistance-faqs.htm.
3. INSTITUTE OF MEDICINE, ANTIMICROBIAL RESISTANCE: ISSUES AND OPTIONS 1 (Polly F. Harrison & Joshua Lederberg eds., 1998).
4. INFECTIOUS DISEASES SOC'Y OF AM., supra note 1, at 10-11.
5. See INST. OF MED., supra note 3;
6. INFECTIOUS DISEASES SOC'Y OF AM., supra note 1, at 10-11 (2004).
7. R. Monica Klevens et al., Invasive Methicillin-Resistant Staphylococcus Aureus Infections in the United States, 298 JAMA 1763, 1767 (2007);
8. Kevin Sack, Deadly Bacteria Found to Be More Common, N. Y. TIMES, October 17, 2007, at A14.
9. XDR tuberculosis has the potential to become a public health menace because it has a cure rate of only thirty to forty percent. The recent case of Andrew Speaker, extensively reported in the media, raised public anxiety about the spread of XDR tuberculosis. Speaker traveled abroad and back into the United States against public health authorities' recommendations while allegedly infected with XDR tuberculosis. Later testing indicated that he had multi-drug resistant tuberculosis, but not XDR tuberculosis. Wendy E. Parmet, Legal Power and Legal Rights - Isolation and Quarantine in the Case of Drug-Resistant Tuberculosis, 357 NEW ENG. J. MED. 433, 433 (2007);
10. Lawrence K. Altman, Traveler's TB Not As Severe As Officials Thought, N. Y. TIMES, July 4, 2007, at A11.
11. See infra Part LA; Kevin Outterson, The Vanishing Public Domain: Antibiotic Resistance, Pharmaceutical Innovation and Intellectual Property Law, 67 U. PITT. L. REV. 67, 73 n. 29 (2005).
12. The World Health Organization warns ominously that "resistance to treatment could bring the world back to a pre-antibiotic stage... as [t]he window of opportunity is closing." WORLD HEALTH ORGANIZATION, Preface to REPORT ON INFECTIOUS DISEASES 2000: OVERCOMING ANTIMICROBIAL RESISTANCE, http://www.who.int/infectious-dieasereport/2000.
13. See FOOD AND DRUG ADMINISTRATION, TASK FORCE ON ANTIMICROBIAL RESISTANCE: KEY RECOMMENDATIONS AND REPORT (Dec. 2000), www.fda.gov/oc/antimicrobial/ taskforce2000.html.
14. For example, the FDA recently reprimanded pharmaceutical company Pfizer for aggressively promoting Iinezolid, a synthetic antibiotic belonging to a new class of antibiotics called the oxazolidinones, including promoting the drug for all types of MRSA infections even though Iinezolid has been approved for only limited MRSA indications. Letter from Thomas W. Abrams R. Ph., MBA, Dir., Division of Drug Marketing, Advertising and Communications, FDA, to Henry McKinnell, Jr., Ph. D., Chief Executive Officer, Pfizer, Inc. (July 20, 2005), available at http://www.fda.gov/cder/warn/2005/Zyvox-wl.pdf.
15. Antibiotic resistance considerations caution that a powerful new medication such as Iinezolid should be prescribed judiciously, in order to avoid exacerbating new resistance problems for the class of oxazolidinones. Paul W. Ament et al., Linezolid: Its Role in the Treatment of Gram-Positive, Drug-Resistant Bacterial Infections, 65 AM. FAM. PHYSICIAN 663, 669 (2002).
16. Rekha Murthy, Implementation of Strategies To Control Antimicrobial Resistance, 119 CHEST 406 (S) (2001).
17. See Antibiotic Resistance in Livestock, USDA/HHS Response to the House and Senate Reports: Agricultural, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bills (2000), http://www.fda.gov/cvm/Documents/jtrpt091400.pdf.
18. See INFECTIOUS DISEASES SOC'Y OF AM., supra note 1, at 14-19.
19. Recent legislative proposals seeking to expand patent rights in the manner suggested by IDSA and other supply side advocates, such as extended patent terms and wildcard patents that could be applied to antimicrobial drugs, include: (a) Biological, Chemical, and Radiological Weapons Countermeasures Research Act (BioShield II), S.666, 108th Cong. (2003)
20. and (b) the Protecting America in the War on Terror Act of 2005, S. 3, 109th Cong. (2005).
21. See also Kevin Outterson et al., Will Longer Antimicrobial Patents Improve Global Public Health?, 7 LANCET INFECTIOUS DISEASE 559, 561-562 (2007).
22. It is estimated that physicians influence or control between seventy to ninety percent of overall health care expenditures. Gail B. Agrawal, Resuscitating Professionalism: Self-Regulation in the Medical Marketplace, 66 MO L. REV. 341, 356 (2001) (discussing various estimates);
23. Mark Hall, Institutional Control of Physician Behavior: Legal Barriers to Health Care Cost Containment, 137 U. PA. L. REV. 431, 434 (1988) (same). Patients and third-party payors may be unable to discern very beneficial, necessary services from services that are of limited marginal benefit or even wasteful. Economic analysis of the health care market suggests that because of such information problems and agency relationships, patients and payors may be heavily dependent upon what the physician directs, putting physicians in a position to induce or heavily influence utilization of services, including services of limited marginal benefit.
24. See e.g., Alan Graber, The U. S. Physician Workforce: Serious Questions Raised, Answers Needed, 141 ANNALS INTERNAL MED. 732, 733 (2004).
25. For example, physicians may be able to counter supply increases, ordinarily expected to lead to price reductions in a competitive market, by inducing or influencing patient and/or payor demand for more, different, and/or more intense services to maintain physician income. Indeed, studies suggest regions with greater physician-to-population ratios are associated with higher use of certain types of care, such as physician-initiated ambulatory visits, suggesting some physician-induced demand may be at work to offset competitive, supply-expansion pressures to reduce fees. Gail R. Wilensky & Louis F. Rossiter, The Relative Importance of Physician-Induced Demand in the Demand for Medical Care, 61 THE MILBANK Q. 252, 260-66 (1983). On the other hand, evidence of physician-induced demand is difficult to measure, given the many factors at play, and several previous studies on physician-induced demand have been criticized for faulty methodology.
26. See Jeffery Stensland & Ariel Winter, Do Physician-Owned Cardiac Hospitals Increase Utilization?, 25 HEALTH AFFAIRS 119, 120-122 (2006).
27. See Christopher B. Forrest, Primary Care Gatekeeping and Referrals: Effective Filter or Failed Experiment, 326 BRIT. MED. J. 692, 694-95 (2003) (discussing physician gatekeeping in the United States and the United Kingdom).
28. See e.g., James C. Robinson, The End of Managed Care, 285 JAMA 2622, 2622-23 (2001);
29. Gail B. Agrawal & Mark A. Hall, What If You Could Sue Your HMO? Managed Care Liability Beyond the ERISA Shield, 47 ST. LOUIS U. L. J. 235, 264-71 (2003).
30. Jerry Avorn & Daniel H. Solomon, Cultural and Economic Factors That (Mis) Shape Antibiotic Use: The Nonpharmacologic Basis of Therapeutics, 133 ANNALS OF INTERNAL MED. 128, 128 (2000).
31. STUART B. LEVY, THE ANTIBIOTIC PARADOX: HOW THE MISUSE OF ANTIBIOTICS DESTROYS THEIR CURATIVE POWERS xii-xiv (2002).
32. WORLD HEALTH ORG., supra note 9, at ch. 3.
33. See Centers for Disease Control and Prevention, Campaign for Appropriate Antibiotic Use in the Community, http://www.cdc.gov/drugresistance/community/ anitbioticresistance-faqs.htm.
34. See e.g., Labeling Requirements for Systematic Antibacterial Drug Products Intended for Human Use, 68 Fed. Reg. 6062, 6068 (Feb. 6, 2003)
35. (to be codified at 21 C. F. R. pt. 201) [hereinafter Labeling Requirements]. Broad-spectrum antibiotics are effective against multiple forms of bacteria. Alliance for the Prudent Use of Antibiotics, Glossary, Narrowspectrum vs. broad-spectrum antibiotics, http://www.tufts.edu/med/apua/ Miscellaneous/Glossary.html. Resistance concerns would tend to counsel against using broad-spectrum antibiotics indiscriminately and as a first-order response when narrow spectrum drugs, targeted to smaller numbers of bacteria, could also be effective. Labeling Requirements, supra. Overuse of broad-spectrum antibiotics can encourage development of resistance in many groups of bacteria, not just the bacteria targeted for immediate treatment.
36. A. Tomasz, New Strategies Against Multi-Drug-Resistant Bacterial Pathogens, in THE RESISTANCE PHENOMENON IN MICROBES AND INFECTIOUS DISEASE VECTORS IMPLICATIONS FOR HUMAN HEALTH AND STRATEGIES FOR CONTAINMENT - WORKSHOP SUMMARY 46, 47 (S. L. Knoblre et al., eds., 2003).
37. Despina G. Contopoulos-Iannidis et al., Meta-analysis of Randomized Controlled Trials on the Comparative Efficacy and Safety of Azithromycin Against Other Antibiotics for Lower Respiratory Tract Infections, 48 J. ANTIMICROBIAL CHEMOTHERAPY, 691, 698 (2001);
38. Michael A. Steinman et al., Predictors of Broad-Spectrum Antibiotic Prescribing for Acute Respiratory Tract Infections in Adult Primary Care, 289 JAMA 719, 722 (2003).
39. See Daniel H. Solomon et al., Academic Detailing to Improve Use of Broad-Spectrum Antibiotics at an Academic Medical Center, 161 ARCHIVES INTERNAL MEDICINE 1897, 1898 (2001).
40. See, e.g., Valerie Weber & Maulik S. Joshi, Effecting and Leading Change in Health Care Organizations, 26 J. ON QUALITY IMPROVEMENT 388, 389-92 (2000) (discussing the problems encountered by hospitals in trying to apply Total Quality Management (TQM) and Quality Improvement (QI) initiatives in the 1990s, when TQM/QI programs were viewed with much enthusiasm by management, due to lack of staff physician participation and even physician resistance).
41. See David Orentlicher, Paying Physicians More to Do Less: Financial Incentives to Limit Care, 30 U. RICH. L. REV. 155, 158-60 (1996).
42. Arnold J. Rosoff, Policy Challenges in Modern Health Care, 26 J. LEGAL MEDICINE 523, 525 (2005) (book review).
43. See LAWRENCE O. GOSTIN, PUBLIC HEALTH LAW: POWER, DUTY, RESTRAINT 11-14 (2000);
44. Alvin R. Tarlov, Introduction, in POLICY CHALLENGES IN MODERN HEALTH CARE vii (David Mechanic et al. eds., 2005).
45. See generally Harold C. Neu, The Crisis in Antibiotic Resistance, 257 SCIENCE 1064 (1992).
46. See generally Thomas A. Parrino, Controlled Trials To Improve Antibiotic Utilization: A Systematic Review of Experience, 1984-2004, 25 PHARMACOTHERAPY 289 (2005).
47. Ricki Lewis, The Rise of Antibiotic-Resistant Infections (Sept. 1995), http://www.fda.gov/Fdac/features/795-antibio.html.
48. See WORLD HEALTH ORG., supra note 9, at ch. 3.
49. David Shlaes et al., Society for Healthcare Epidemiology of America and Infectious Diseases Society of America Joint Committee on the Prevention of Antimicrobial Resistance-Guidelines for the Prevention of Antimicrobial Resistance in Hospitals, 25 CLINICAL INFECTIOUS DISEASES 584, 585 (1997).
50. CENTERS FOR DISEASE CONTROL AND PREVENTION, supra note 2.
51. David M. Livermore, Bacterial Resistance: Origins, Epidemiology, and Impact, 36 CLINICAL INFECTIOUS DISEASES S11, S12-S13 (2003).
52. See Richard Colgan & John H. Powers, Appropriate Antimicrobial Prescribing: Approaches That Limit Antibiotic Resistance, 64 AM. FAM. PHYSICIAN 999, 999-1000 (2001);
53. INST. OF MED., supra note 3, at 37-38.
54. See INST. OF MED., supra note 3, at 37.
55. John E. McGowan, Economic Impact of Antimicrobial Resistance, 7 EMERGING INFECTIOUS DISEASES 286, 290 (2001).
56. INST. OF MED., supra note 3, at 37.
57. INST. OF MED., supra note 3, at 37.
58. See James N. Sanchirico, To Take Or Not To Take The Antibiotic?, in BATTLING RESISTANCE TO ANTIBIOTICS AND PESTICIDES: AN ECONOMIC APPROACH, 76, 76-77 (Ramanan Laxminarayan, ed., Resources for the Future 2003).
59. See J. Gerberding, The Centers for Disease Control and Prevention's Campaign To Prevent Antimicrobial Resistance in Health Care Settings, in THE RESISTANCE PHENOMENON IN MICROBES AND INFECTIOUS DISEASE VECTORS IMPLICATIONS FOR HUMAN HEALTH AND STRATEGIES FOR CONTAINMENT - WORKSHOP SUMMARY 210, 210 (S. L. Knoblre et al., eds., 2003) (estimating 90, 000 annual deaths due to infections acquired while in the hospital and that 70% of hospital-acquired infections involve drug resistant bacteria);
60. WORLD HEALTH ORG., supra note 9, ch. 4 (estimating 14, 000 annual deaths).
61. INFECTIOUS DISEASES SOC'Y OF AM., supra note 1, at 4-5;
62. See WORLD HEALTH ORG., supra note 9, at Ch. 3.
63. RAMANAN LAXMINARAYAN, BATTLING RESISTANCE TO ANTIBIOTICS AND PESTICIDES: AN ECONOMIC APPROACH 3 (Ramanan Laxminarayan ed.).
64. See INST. OF MED., supra note 3, at 1.
65. Meanwhile, antibiotic control advocacy groups, such as ReAct: Action on Antibiotic Resistance, suggest the annual costs run even higher, at over $7 billion per year. ReAct: Action on Antibiotic Resistance, Economical Aspects of Antibiotic Resistance (June 10, 2008), www.reactgroup.org (follow "ReAct Publications" hyperlink; then follow "Fact sheets on burden of resistance" hyperlink; then follow "Economical aspects of Antibiotic Resistance (pdf 121 KB) hyperlink).
66. Eric Kades, Preserving a Precious Resource: Rationalizing the Use of Antibiotics, 99 NW. U. L. REV. 611, 672 (2005).
67. Even an "unnecessary" antibiotic prescription may have certain value to the patient. Opting to take an antibiotic, in the face of uncertainty as to the cause of the underling illness, may be of high benefit to the patient even if the drug proves unnecessary because the patient avoids further time and expense for additional physician office visits and follow-up testing to determine the underlying cause of the illness. It may be of high value to the patient to take the antibiotic now and follow a wait and see attitude as to whether the antibiotic does any good. Paul H. Rubin, The FDA and Antibiotic Resistance, Emory University Law and Economics Research Paper Series No. 04-07(2004), http://ssrn. com/abstract=556997.
68. See generally, Garrett Hardin, The Tragedy of the Commons, 162 SCIENCE 1243 (1968).
69. For a recent, intriguing application of tragedy of the commons-type analysis to health law and policy problems, see generally Ronen Avraham & K. A. D. Camara, The Tragedy of the Human Commons, 29 CARDOZO L. REV. 479 (2007) (discussing insurers' failure to cover prospectively efficient medical care, such as noncoverage of bariatric surgery to combat morbid obesity).
70. Compare Ramanan Laxminarayan & Gardner M. Brown, Economics of Antibiotic Resistance: A Theory of Optimal Use, 42 J. OF ENVTL. ECON. AND MGMT. 183 (2001) (considering antibiotic effectiveness as a nonrenewable resource)
71. In some environments, prudent usage strategies may contain resistance rates at possibly manageable levels by maintaining resistant and susceptible strains of bacteria in a delicate competition equilibrium, so that resistant strains do not spread out of control. In such situations, antibiotics could be treated as a renewable resource. Their effectiveness could be preserved by proper management akin to ecological conservation techniques used with renewable resources like fisheries. James E. Wilen & Siwa Msangi, Dynamics of Antibiotic Use: Ecological Versus Interventionists Strategies to Manage Resistance to Antibiotics, in BATTLING RESISTANCE TO ANTIBIOTICS AND PESTICIDES: AN ECONOMIC APPROACH 17, 32-34 (Ramanan Laxminarayan, ed., Resources for the Future 2003).
72. On the other hand, some studies demonstrate that resistance effects can persist in a community long after the source antibiotic is removed from use. Richard E. Lenski, The Cost of Antibiotic Resistance - From the Perspective of a Bacterium, in ANTIBIOTIC RESTISTANCE: ORIGIN, EVOLUTION, SELECTION AND SPREAD 131, 133-34 (Derek J. Chadwick & Jamie Goode eds., 1997). This underscores the finiteness problem, which would suggest the importance of focusing on supply side solutions to increase the supply of entirely new antibiotics.
73. INFECTIOUS DISEASE SOC'Y OF AM., supra note 1, at 24-25.
74. Protecting America in the War on Terror Act of 2005, S. 3, 109th Cong. (2005);
75. Biological, Chemical, and Radiological Weapons Countermeasures Research Act (BioShield II), S. 666, 108th Cong. (2003).
76. Joshua P. Metlay et al., Tensions in Antibiotics Prescribing: Pitting Social Concerns Against the Interest of Individual Patients, 17 J. GEN. INTERNAL MED. 87, 87 (2002).
77. See WORLD HEALTH ORG., supra note 9, at ch. 3.
78. Ralph Gonzalez et al., Excessive Antibiotic Use for Acute Respiratory Infections in the United States, 33 CLINICAL INFECTIOUS DISEASES 757, 757 (2001).
79. Karen Gilberg et al., Analysis of Medication Use Patterns: Apparent Overuse of Antibiotics and Underuse of Prescription Drugs for Asthma, Depression, and CHF, 9 J. OF MANAGED CARE PHARMACY 232, 234 (2003).
80. See OFFICE OF TECH. ASSESSMENT, IMPACTS OF ANTIBIOTIC-RESISTANT BACTERIA 22 (1995).
81. See generally Mohamad G. Fakih, Compliance of Resident and Staff Physicians With IDSA Guidelines For the Diagnosis and Treatment of Streptococcal Pharyngitis, 14 INFECTIOUS DISEASES IN CLINICAL PRAC. 84 (2006).
82. Christianne L. Roumie et al., Trends in Antibiotic Prescribing For Adults in the United States-1995 to 2002, 20 J. GEN. INTERNAL MED. 697, 699-700 (2005).
83. Richard Besser, Antimicrobial Prescribing in the United States: Good News, Bad News, 138 ANNALS INTERNAL MED. 605, 605 (2003).
84. Treatment with a broad spectrum drug such as azithromycin is about 20 times more expensive than treatment with front-line, older antibiotics such as penicillin. Jeffrey Linder et al., Antibiotic Treatment of Adults With Sore Throat By Community Primary Care Physicians: A National Survey, 1989-1999, 286 JAMA 1181, 1185 (2001).
85. Arch G. Mainous III, et al., Trends in Antimicrobial Prescribing for Bronchitis and Upper Respiratory Infections Among Adults and Children, 93 AM J. PUB. HEALTH 1910, 1910 (2003) (estimating that use of broad spectrum antibiotics with children for bronchitis visits increased from 10.6% to 40.5% of visits during 1993-1999).
86. Jeffrey Linder et al., Antibiotic Treatment of Children With Sore Throat, 294 JAMA 2315, 2315 (2005).
87. Patrick G. P. Charles et al., The Dearth of New Antibiotic Development: Why We Should Be Worried and What We Can Do About It, 181 MED. J. AUSTL. 549, 549 (2004).
88. Joseph F. John, Jr., Editorial, Antibiotic Cycling: Is It Ready For Prime Time?, 21 INFECTION CONTROL & HOSP. EPIDEMIOLOGY 9, 9 (2000).
89. Erwin M. Brown & Dilip Nathwani, Antibiotic Cycling Or Rotation: A Systematic Review of the Evidence of Efficacy, 55 J. ANTIMICROBIAL CHEMOTHERAPY 6, 6-7 (2005).
90. See Jonathan Finkelstein et al., Reduction in Antibiotic Use Among US Children, 1996-2000, 112 PEDIATRICS 620, 620 (2003).
91. Nicholas Bakalar, Practices: One Simple Ailment, Many Wrong Prescriptions, N. Y. TIMES, Nov. 15, 2005, at F1.
92. WORLD HEALTH ORG., supra note 9, at ch. 3.
93. Christopher J. Stille et al., Increased Use of Second-Generation Macrolide Antibiotics for Children in Nine Health Plans in the United States, 114 PEDIATRICS 1206, 1206 (2004) (noting a dramatically increased use of second-generation macrolides among children, even among younger children, despite recommendations not to use such drugs for initial treatment of illness).
94. See, e.g., E. Patchen Dellinger et al., Quality Standard for Antimicrobial Prophylaxis in Surgical Procedures, 18 CLINICAL INFECTIOUS DISEASES 422, 422 (1994) (emphasizing the need to determine optimal timing, dose and duration for drug therapy).
95. Dale W. Bratzler et al., Use of Antimicrobial Prophylaxis For Major Surgery, 140 ARCHIVES OF SURGERY 174, 176-78 (2005).
96. Noncompliant patients may become infected and/or re-infected with resistant bacteria that spread, creating resistance pressures within the environment. However, one must be careful not to overstate patient noncompliance effects. Patient noncompliance can lead to spread of bacteria. But in some cases, resistance in the environment develops when resistant genetic material is spread, as opposed to spread of bacteria. In such situations, outbreaks of resistance cannot simply be explained as chiefly due to patient noncompliance. In these instances, patient noncompliance does not necessarily speed the onset of resistance. RAMANAN LAXMINARAYAN & ANUP MALANI, EXTENDING THE CURE: POLICY RESPONSES TO THE GROWING THREAT OF ANTIBIOTIC RESISTANCE 50 (2007).
97. See Ross J. Simpson, Jr., Challenges for Improving Medication Adherence, 296 JAMA 2614, 2614 (2006) (arguing that patient non-adherence is partially the result of some physicians' negative attitudes and inadequate attention to guideline-recommended care).
98. Deborah Franklin, Antibiotics: How Long is Long Enough?, N. Y. TIMES, June 20, 2006, at F5.
99. See David C. Hooper, Expanding Uses of Fluoroquinolones: Opportunities and Challenges, 129 ANNALS OF INTERNAL MEDICINE 908, 910 (1998) ("Fluoroquinolones should be chosen for indications in which they offer a clear therapeutic advantage over other classes of antibiotics rather than as agents whose broad spectrum prompts routine empirical use.").
100. See, e.g., Michael Cabana et al., Why Don't Physicians Follow Clinical Practice Guidelines? A Framework For Improvement, 282 JAMA 1458, 1462 (1999) (noting physicians often fail to follow clinical practice guidelines based on controlled studies and that, "inertia of previous practice", the powerful reluctance of physicians to readily change practice patterns they already believe in and have been accustomed to, represents one of the significant barriers to guideline adoption);
101. Edgar Pierluissi et al., Discussion of Medical Errors in Morbidity and Mortality Conferences, 290 JAMA 2838, 2839-41 (2003) (noting that physician leaders of morbidity and mortality conferences infrequently used explicit language to signal that an error was being discussed and infrequently acknowledged having made an error).
102. C. William Wester et al., Antibiotic Resistance: A Survey of Physician Perceptions, 162 ARCHIVES OF INTERNAL MED. 2210, 2211 (2002).
103. Wendy E. Parmet, Unprepared: Why Health Law Fails to Prepare Us For A Pandemic, 2 J. HEALTH & BIOMEDICAL LAW 157, 176 (2006).
104. Marc A. Rodwin, Strains in the Fiduciary Metaphor: Divided Physician Loyalties and Obligation in a Changing Health Care System, 21 Am. J. L. & Med. 241, 241-42 (1995).
105. See Maxwell Mehlman, Fiduciary Contracting Limitations on Bargaining Between Patients and Health Care Providers, 51 U. PITT. L. REV. 365, 389-90 (1990) (finding that the primary reason the law treats the physician-patient relationship as fiduciary in nature is because of the asymmetry of information between doctors and patients). However, not all physician-patient relationships are automatically fiduciary, and not all aspects of the doctorpatient relationship are fiduciary in nature. For example, courts have been reluctant to impose exacting fiduciary standards upon physicians with regard to disclosure of financial conflicts of interest.
106. See Neades v. Portes, 739 N. E.2d 496, 502 (Ill. 2000) (rejecting fiduciary duty claims in a case involving managed care incentives). Courts determine the fiduciary aspects of the doctor-patient relationship on a case by case basis, responding to factors such as expertise of the physician, the patient's vulnerability and dependency, and some aspects of entrustment.
107. See also Michelle Oberman, Mothers and Doctors' Orders: Unmasking the Doctor's Fiduciary Role in Maternal-Fetal Conflicts, 94 NW. U. L. REV. 451, 459 (2000) (noting limited application of fiduciary principles to the physicianpatient relationship).
108. Mary Crossley, Infected Judgment: Legal Responses to Physician Bias, 48 VILL. L. REV. 195, 251-52 (2003).
109. Stephen W. Salant, Same Infection, Same Time, Same Antibiotic?, in BATTLING RESISTANCE TO ANTIBIOTICS AND PESTICIDES: AN ECONOMIC APPROACH 84-93 (Ramanan Laxminarayan ed., 2003).
110. When treating ear infections, pediatricians sometimes prescribe cefdinir or amoxicillin-clavulanate as second-line agents after treatment with regular amoxicillin fails. Guidelines from the American Academy of Pediatrics and the American Academy of Family Physicians recommend amoxicillin-clavulanate in these situations. Nonetheless, a preference has been emerging among some physicians (and perhaps parents) to use cefdinir because although both drugs have roughly equivalent efficacy, cefdinir has more convenient dosing options and poses less risk of diarrhea. Louis Vernacchio et al., Management of Acute Otitis Media By Primary Care Physicians: Trends Since The Release of the 2004 American Academy of Pediatrics/American Academy of Family Physicians Clinical Practice Guideline, 120 PEDIATRICS 281, 285 (2007).
111. See generally PUBLIC HEALTH LEADERSHIP SOCIETY, PRINCIPLES OF THE ETHICAL PRACTICE OF PUBLIC HEALTH (2002), available at http://www.apha.org/NR/ rdonlyres/lCED3CEA-287E-4185-9CBD-BD405FC60856/0/ethicsbrochure.pdf.
112. For example, the Public Health Leadership Society's Principles of the Ethical Practice of Public Health are intended primarily for "public and other institutions... that have an explicit public health mission", whereas individuals, such as physicians practicing in more typical clinical settings, are merely advised that they "may also find the Code relevant and useful." PUB. HEALTH LEADERSHIP SOC'Y, supra note 162, at 1. This code of ethics further acknowledges the individual health/population health divide, noting that "the concerns of public health are not fully consonant with those of medicine... thus we cannot simply translate the [traditional] principles of medical ethics to public health. For example, in contrast to medicine, public health is concerned more with populations than with individuals...."
113. AMERICAN MED. ASS'N, CODE OF MEDICAL ETHICS, xiv, ¶ VII (2004-2005 ed.).
114. See also Douglas Mossman, Critique of Pure Risk Assessment or, Kant Meets Tarasoff, 75 U. CIN. L. REV. 523, 578 (2006) ("In traditional medical ethics, doctors serve individual patients and have fiduciary obligations to them, not those around them.").
115. See AM. MED. ASS'N, supra note 164, § 2.03. Instead, the traditional medical ethics position is that if physicians work within restraints due to limited resources, it is better that individual physicians not directly become involved in allocation conflicts, but instead implement allocation limitations imposed by others, such as special committees or administrative persons not treating the patients.
116. See Council on Ethical and Judicial Affairs, American Medical Association, Ethical Issues in Managed Care, 273 JAMA 330, 330-35 (1995);
117. William M. Sage, Physicians as Advocates, 35 HOUS. L. REV. 1529, 1555 (1999)
118. (discussing the views regarding doctor's decision-making expressed in Roger W. Evans, Health Care Technology and the Inevitability of Resource Allocation and Rationing Decisions: Part II, 249 JAMA 2208 (1983)).
119. Daniel Callahan & Bruce Jennings, Ethics and Public Health: Forging A Strong Relationship, 92 AM. J. PUB. HEALTH 169, 170 (2002).
120. JEROME GROOPMAN, HOW DOCTORS THINK 82 (2007) ("Alas, serving as a gatekeeper to limit access is not what most doctors envisioned when they chose primary care.").
121. See Michael Chernew et al., Barriers to Constraining Health Care Cost Growth, 23 HEALTH AFF. 122, 124 (2004) (noting a physician bias for action over inaction and that certain physicians act as "early adopters" and actively seek out and apply new technologies in the clinic);
122. Muriel R. Gillick, The Technological Imperative and the Battle for the Hearts of America, 50 PERSP. BIOLOGY & MED. 276 (2007) (discussing the diffusion of left ventricular assist device (LVAD) for treatment of advanced heart failure as an example of the technological imperative at work and calling for a reassessment of the device's current use).
123. See also Lars Noah, Informed Consent and the Elusive Dichotomy Between Standard and Experimental Therapy, 28 AM. J. L. & MED. 361, 401 (2002) ("... physicians may embrace new procedures and technologies prematurely, before much evidence exists to support their enthusiasm, only belatedly discovering that these innovations do no good or worse.").
124. See also Amy L. Wax, Technology Assessment and the Doctor-Patient Relationship, 82 VA. L. REV. 1641, 1642-43 (1996) ("[T]he absolutist mindset - which opposes planned limits on individuals' access to treatment that is believed to present some chance of medical benefit, however remote - holds considerable sway in the health care community."). (Pubitemid 126408601)
125. Under this orientation, physicians may be reluctant to conserve broad spectrum antibiotics recommended as a second-line agents because "physicians want to prescribe what they think are the best medications for the individual patient which often means a broadspectrum agent to protect against potentially resistant organisms regardless of the... [resistance] consequences." Sandra Arnold, Interventions to Improve Antibiotic Prescribing in the Community, in ANTIBIOTIC POLICIES: THEORY AND PRACTICE 494, 522 (Ian M. Gould & Jos W. M. van der Meer, eds., 2005) (emphasis added).
126. See Donald A. Redelmeirer & Amos Twersky, Discrepancy Between Medical Decisions for Individual Patients and for Groups, 322 NEW ENG. J. MED. 1162, 1163-64 (1990).
127. William M. Sage, Physicians as Advocates, 35 HOUS. L. REV. 1529, 1556 (1999).
128. See, e.g., Rosamund J. Williams, Biomedicine: Containment of Antibiotic Resistance, 279 SCI. 1153 (1998) (arguing for more education on antibiotic resistance in medical training institutions to counter the perception that antibiotics are "magic bullets" and to provide balance to information put out by pharmaceutical companies).
129. See WORLD HEALTH ORG., supra note 9, at Chapter 3.
130. See e.g., William M. Sage, Relational Duties, Regulatory Duties, and the Widening Gap Between Individual Health Law and Collective Health Policy, 96 GEO. L. J. 497, 499-501 (2008) (describing the obligation of physician to patient as "the paradigm case of relational duty", in contrast to "duties rooted in concern for society as a whole" - or "relational duties."). Sage observes that "far more legal issues in health care are approached as relational than as regulatory problems, making it very difficult for the law to serve truly 'public' policy."
131. See American Academy of Pediatrics & American Academy of Family Physicians, Questions and Answers on Acute Otitis Media, (Mar. 9, 2004), http://www.aap.org/advocacy/releases/aomqa.htm.
132. See Jonathan A. Finkelstein et al., Watchful Waiting For Acute Otitis Media: Are Parents and Physicians Ready?, 115 PEDIATRICS 1466, 1468-1472 (2005).
133. Janet S. St. Lawrence et al., STD Screening, Testing, Case Reporting, and Clinical and Partner Notification Practices: A National Survey of U. S. Physicians, 92 AM. J. P. HEALTH 1784, 1787 (2002) (indicating that only slightly more than half of physicians make required case reports for sexually transmitted diseases such as syphilis and HIV and that many physicians prefer to rely on their patients for partner notification).
134. see also Rene Bowser & Lawrence Gostin, Managed Care and the Health of a Nation, 72 S CAL. L. REV. 1209, 1259 (1999) (noting physicians have historically failed to comply with mandatory reporting of communicable diseases).
135. Kevin Outterson et al., Will Longer Antimicrobial Patents Improve Global Public Health?, 7 LANCET INFECTIOUS DISEASE 559, 563 (2007).
136. See Tamar Barlam, Antibiotic-Stewardship Practices at Top Academic Centers Throughout the United States and at Hospitals Throughout Massachusetts, 27 INFECTION CONTROL & HOSP. EPIDEMIOLOGY 695, 697 (2006) (noting that "Doctors tend to believe that the goal of [antibiotic control] programs is to save costs rather than to improve patient outcomes....");
137. See Jane E. Brody, Just What the Doctor Ordered? Not Exactly, N. Y. TIMES, May 9, 2006, at F8.
138. See Bruce Spivey, The Relation Between Hospital Management and Medical Staff Under a Prospective Payment System, 310 NEW ENG. J. MED. 984, 984 (1984).
139. See 42 U. S. C. §§ 1395w-4 (a) to 4 (j) (2000).
140. See Department of Health and Human Services, Centers for Medicare and Medicaid Services, Medicare Program: Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2008 Rates, 72 Fed. Reg. 24, 680, 24, 716 (proposed May 3, 2007).
141. Press Release, Centers for Medicare & Medicaid Services, Eliminating Serious, Preventable, and Costly Medical Errors - Never Events (May 18, 2006),
142. See 72 Fed. Reg., at 24, 718-19 (explaining that not all hospital-acquired infections meet the criteria for the new payment approach, meaning they are not clearly preventable by evidence-based guidelines and/or they do not currently result in high cost to the Medicare program).
143. See, e.g., Hofmann v. Blackmon, 241 So. 2d 752, 753 (Fla. Dist. Ct. App. 1970)
144. cert. denied, 245 So. 2d 257 (Fla. 1971) (physician treating a patient infected with tuberculosis has a duty to use reasonable care to advise a patient's family members of the existence of the disease and dangers of exposure to the patient);
145. Shepard v. Redford Community Hosp., 390 N. W.2d 239, 241 (Mich. Ct. App. 1986)
146. appeal denied, 430 N. W.2d 458 (Mich. 1988) (physician treating a patient with spinal meningitis has a duty to protect the patient's son).
147. For a rare case alleging antibiotic overuse, see Neumeyer v. Terral, 478 So.2d 1281, 1284 (La. Ct. App. 1985) (jury found that physician breached duty of care by prescribing too many antibiotics, but breach of duty did not result in injury).
148. See, e.g., Babcock v. Bridgeport Hospital, 742 A.2d 322 (Conn. 1999) (patients brought malpractice action against hospital for harms arising from spread of MRSA infection due to hospital's alleged failure to follow recommended infection control practices such as surveillance through regular measurement of bacteria colonization rates).
149. See, e.g., Nelson v. Hammon, 802 P.2d 452 (Colo. 1990) (finding that a surgeon breached a duty to prescribe antibiotics to prevent spread of harmful bacteria even after the surgeon introduced American Heart Association guidelines as evidence);
150. Hellwig v. Potluri, No. 90-C-55, 1991 WL 285712 (Ohio Ct. App. Dec. 27, 1991) (physician's failure to prescribe antibiotics for patient that stepped on rusty nail).
151. See, e.g., Ann G. Lawthers et al., Physicians' Perception of The Risk of Being Sued, 17 J. HEALTH POL. POL'Y & L. 463, 463 (1992) (finding that among physicians surveyed, their perception of the risk of facing a malpractice suit was three times the actual risk).
152. As the Office of Technology Assessment observed, "[i]t is reasonable to speculate that fear of malpractice litigation may contribute to prescription of overly broad spectrum antibiotics or of antibiotic usage where the chance of bacterial infection is small." OFF. OF TECH. ASSESSMENT, supra note 96, at 75.
153. See David Studdert et al., Claims, Errors and Compensation Payments in Medical Malpractice Litigation, 354 NEW ENG. J. MED. 2024, 2025, 2029-2030 (2006). Indeed, empirical investigations dating back to the famous Harvard Medical Practice Study from the 1980s suggest that the tort system performs rather poorly and at high cost in identifying true instances of medical error.
154. See generally T. A. Brennan et al., Incidence of Adverse Events and Negligence in Hospitalized Patients. Results from the Harvard Medical Practice Study I, 324 NEW ENG. J. MED. 370 (1991);
155. David Hyman, Medical Malpractice and the Tort System: What Do We Know and What (If Anything) Should We Do About It?, 80 TEX. L. REV. 1639, 1641-45 (2002) (summarizing much of the empirical literature).
156. See Michelle M. Mello & Troyen A. Brennan, Deterrence of Medical Errors: Theory and Evidence for Malpractice Reform, 80 TEX. L. REV. 1595, 1623 (2002).
157. See 21 C. F. R. § 201.24 (2008).
158. See 21 U. S. C. § 396 (1997) ("Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. "). Also, drugs already approved have been tested through the FDA review process for general safety, even if not for efficacy as to all possible uses. Accordingly, the FDA has historically declined to interfere with or police individual physicians' off-label prescriptions.
159. See, e.g., Sandra H. Johnson, Polluting MedicalJudgment? False Assumptions in the Pursuit of False Claims for Off-Label Prescribing, 9 MINN. J. L. SCI. & TECH. (forthcoming 2008) (summarizing various off-label studies). By some estimates, over half the prescriptions in the U. S. may be "off-label" in at least some respects, such as intended use, intended population, and recommended dosage.
160. See, e.g., Jerry H Gurwitz, Serious Adverse Drug Effects - Seeing The Trees Through the Forest, 354 NEW ENG. J. MED. 1413, 1414 (2006).
161. Lars Noah, Medicine's Epistemology: Mapping the Haphazard Diffusion of Knowledge in the Biomedical Community, 44 ARIZ. L. REV. 373, 393-94 (2002);
162. Stephen B. Soumerai et al., Effect of Local Medical Opinion Leaders on Quality of Care For Acute Myocardial Infarction: A Randomized Controlled Clinical Trial, 279 JAMA 1358 (1998);
163. OFFICE OF TECH. ASSESSMENT, STRATEGIES FOR MED. TECH. ASSESSMENT 73(1982), available at http://www.fas.org/ota/reports/8227.pdf (last visited Oct. 18, 2008).
164. See generally, BARRY FURROW ET AL., HEALTH LAW: CASES, MATERIALS AND PROBLEMS 181-84 (5th ed. 2004). "Certification" refers to meeting the conditions established by the government to participate voluntarily in the governmental health care programs, such as Medicare and Medicaid, in order for the provider to be eligible for reimbursement under such programs.
165. See MARK HALL ET AL., HEALTH CARE LAW AND ETHICS 1073-74 (6th ed. 2003).
166. See, e.g., Michael Misocky, The Epidemic of Antibiotic Resistance: A Legal Remedy To Eradicate The "Bugs" in the Treatment of Infectious Diseases, 30 AKRON L. REV. 733, 746 (1997) (noting that physicians "are virtually unrestricted when it comes to prescribing antibiotics" under Ohio licensure laws and calling for more regulatory controls on when certain antibiotics can be prescribed).
167. See CAL. HEALTH & SAFETY CODE § 1288.8 (West 2007).
168. See David Fidler, Legal Issues Associated With Antimicrobial Resistance, 4 EMERGING INFECTIOUS DISEASES (1998) (discussing the danger of heavy handed prescription regulation).
169. See JOINT COMMISSION ON ACCREDITATION OF HEALTHCARE ORGANIZATIONS, HOSPITAL ACCREDITATION STANDARDS 239-52 (2007) (discussing standards IC1.10 to IC9.10 on surveillance, prevention, and control of infection). For example, hospitals are encouraged to develop goals such as enhancing hand hygiene and minimizing risk of transmission of infection associated with use of medical equipment or devices.
170. See 42 C. F. R. § 482.42 (2007);
171. see also OFF. OF TECH. ASSESSMENT, supra note 96, at 80;
172. Scott B. Markow, Penetrating the Walls of Drug Resistant Bacteria: A Statutory Prescription to Combat Antibiotic Misuse, 87 GEO. L. J. 531, 537-38 (1998) (calling for amendments to the Medicare and Medicaid statutes so that the programs' conditions of participation require more express antibiotic control responsibilities from hospitals). (Pubitemid 128429268)
173. See 42 C. F. R. § 482.42 (2007).
174. See Tamar Barlam & Margarita DiVall, Antibiotic-Stewardship Practices at top Academic Centers Throughout the United States and at Hospitals Throughout Massachusetts, 27 INFECTION CONTROL & HOSP. EPIDEMIOLOGY 695, 702 (2006).
175. See RM Hamm et al., Antibiotics and Respiratory Infections: Are Patients More Satisfied When Expectations Are Met?, 43 J. FAM. PRAC, 56, 57 (1996);
176. see also Louis Vernacchio et al., Management of Acute Otitis Media By Primary Care Physicians: Trends Since the Release of the 2004 American Academy of Pediatrics/American Academy of Family Physicians Clinical Practice Guideline, 120 PEDIATRICS 281, 285 (2007) ("[T]here is a disconnect between what studies show parents will accept [regarding observation, not antibiotic treatment, for their children] and what physicians think parents will accept.").
177. See David M. Spiro et al., Wait-and-See Prescription For the Treatment of Acute Otitis Media: A Randomized Controlled Trial, 296 JAMA 1235 (2006) (discussing an evaluation of the wait and see approach with children suffering from ear aches).
178. See, e.g., Robert C. Ellickson, Law and Economics Discovers Social Norms, 27 J. LEGAL STUD. 537, 539-41 (1998); (Pubitemid 128429242)
179. Eric A. Posner, The Regulation of Groups: The Influence of Legal and Nonlegal Sanctions on Collective Action, 63 U. CHI. L. REV. 133 (1996); (Pubitemid 126408713)
180. Cass R. Sunstein, Social Norms and Social Roles, 96 COLUM. L. REV. 903 (1996). (Pubitemid 126406323)
181. Noah, Medicine's Epistemology, supra note 228, at 393-94.
182. See Richard S. Saver, Squandering the Gain: Gainsharing and the Continuing Dilemma of Physician Financial Incentives, 98 NW. U. L. REV. 145, 220-21 (2003).
183. See David Orentlicher, Paying Physicians More To Do Less: Financial Incentives To Limit Care, 30 U. RICH. L. REV. 155, 167 (1996) (making a similar argument regarding the appropriateness of physicians' conserving limited care health resources for the greater good).
184. See Amy L. Wax, Technology Assessment and the Doctor-Patient Relationship, 82 VA. L. REV. 1641, 1644-46 (1996); (Pubitemid 126408601)
185. see generally Mark A. Hall, Rationing Health Care at the Bedside, 69 N. Y. U. L. REV. 693 (1994).
186. See generally Brendan Minogue, The Two Fundamental Duties of the Physician, 75 ACAD. MED. 431 (2000);
187. M. Gregg Bloche, Clinical Loyalties and The Social Purpose of Medicine, 281 JAMA 268 (1999).
188. See LAWRENCE O. GOSTIN, PUBLIC HEALTH LAW: POWER, DUTY, RESTRAINT 18-21 (2000).
189. See PUBLIC HEALTH LAW AND ETHICS: A READER 67-68, 93 (Lawrence O. Gostin ed., 2002).
190. See Dan Beauchamp. Community: The Neglected Tradition of Public Health, reprinted in PUBLIC HEALTH LAW AND ETHICS: A READER, supra note 269, at 79-81.
191. Cf. Howard Brody, Managed Care, The Marketplace, and the Future of the Physician-Patient Relationship, in SOCIAL RESPONSIBILITY: BUSINESS, JOURNALISM, LAW, MEDICINE 53, 61 (Louis W. Hodges ed., 1997) (arguing that the ethical concerns may be overstated about whether physicians participating in managed care programs can ethically ration care that is not cost effective; because most medical interventions offer reasonable benefit at reasonable cost, physician gatekeeping in this manner should still work to the benefit of individual patients most of the time).
192. See Stephan W. Salant, Same Infection, Same Time, Same Antibiotic? in BATTLING RESISTANCE TO ANTIBIOTICS AND PESTICIDES: AN ECONOMIC APPROACH 84 (Ramanan Laxminarayan ed., 2003) (discussing various models suggesting that in certain situations with multiple antibiotics available for an infection, it would be socially optimal to treat same infections in different individuals at the same time with different antibiotics, in order to minimize resistance problems for the population at large).
193. See M. Gregg Bloche & Peter Jacobson, The Supreme Court and Bedside Rationing, 284 JAMA 2776, 2778 (2000).
194. See Daniel Callahan & Bruce Jennings, Ethics and Public Health: Forging A Strong Relationship, 92 AM. J. PUB. HEALTH 169, 169 (2002);
195. PUB. HEALTH LEADERSHIP SOC'Y, supra note 162.
196. Cf. Gail B. Agrawal, Resuscitating Professionalism: Self-Regulation in the Medical Marketplace, 66 MO. L. REV. 341, 405-07 (2001);
197. Mark Hall, Arrow on Trust, 26 J. HEALTH POL. POL'Y & L. 1131, 1138 (2001). Both articles discuss similar concerns regarding the need for better ethical guidelines for helping physicians allocate limited health care resources as part of health care cost control.
198. See, e.g., Barry R. Furrow, Incentivizing Medical Practice: What (If Anything) Happens to Professionalism?, 1 WIDENER L. SYMP. J. 1, 5 (1996).
199. See, e.g., Mark Hall, Institutional Control of Physician Behavior: Legal Barriers to Health Care Cost Containment, 137 U. PA. L. REV. 431, 451 (1988).
200. See Valerie Weber & Maulik S. Joshi, Effecting and Leading Change in Health Care Organizations, 26 JOINT COMM. J. ON QUALITY IMPROVEMENT 388, 389-92 (2000). The general track record has been that even changes sought in physician practice patterns motivated chiefly because of quality concerns, not cost control, nonetheless fail unless physicians perceive the changes as reflecting their professional perspectives and sufficiently preserving their ability to exercise clinical independence. For example, health care systems that have organizational cultures that foster greater physician input in policy development and institutional decision-making are linked to better quality of care.
201. See Michelle M. Mello, Of Swords and Shields: The Role of Clinical Practice Guidelines in Medical Malpractice Litigation, 149 U. PA. L. REV. 645, 692-93 (2001). (Pubitemid 33656781)
202. See C. William Wester, Antibiotic Resistance: A Survey of Physician Perceptions, 162 ARCHIVES INTERN. MED. 2210, 2212, 2214-15 (2002). Nonetheless, a few studies report success in implementing antibiotic control through prescription restrictions. At Mt. Sinai Hospital in New York City, an antibiotic control program involving surveillance, prescription restrictions, and education involved in part a requirement that staff physicians could not prescribe restricted antibiotics without approval from a physician in the medical center's infectious disease department. The study, of course now somewhat old, reported success in reducing antibiotic misuse without a negative effect on patients' health.
203. See Salom Z. Hirschman et al., Use of Antimicrobial Agents in a University Teaching Hospital, 148 ARCHIVES OF INTERN. MED. 2001, 2001-07 (1988).
204. See Thomas A. Parrino, The No Value of Retrospective Peer Comparison Feedback in Containing Hospital Antibiotic Costs, 86 AM. J. MED. 442 (1989). As this study was designed to chiefly address cost control concerns, not antibiotic resistance, it is possible that physicians were less inclined to change because they perceived the audits as merely part of a cost cutting initiative.
205. The Institute of Medicine defines clinical practice guidelines as "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances." INST, OF MED. GUIDELINES FOR CLINICAL PRACTICE 2 (Marilyn J. Field & Kathleen N. Lohr eds., 1992). For a recent discussion of how clinical practice guidelines might be used effectively in coordination with electronic health record systems to improve quality of care
206. see Sharona Hoffman & Andy Podgurski, Finding a Cure: The Case For Regulation and Oversight of Electronic Health Record Systems, 22 HARV. J. L. & TECH. (forthcoming).
207. INST, OF MED., supra note 292, at 1, 26-36.
208. See, e.g., INST, OF MED., supra note 292, at 2;
209. Clark C. Havighurt, Practice Guidelines As Legal Standards Governing Physician Liability, 54 LAW & CONTEMPORARY PROBLEMS 87, 87-88 (1991);
210. Michael Daly, Comment, Attacking Defensive Medicine Through the Utilization of Practice Parameters: Panacea or Placebo for the Health Care Reform Movement?, 16 J. LEGAL MED. 101, 101 (1995).
211. AM. ACAD, OF PEDIATRICS & AM. ACAD. OF FAM. PHYSICIANS, supra note 185.
212. See Vicenza Snow et al., Principles of Appropriate Antibiotic Use for Treatment of Nonspecific Upper Respiratory Tract Infections in Adults, 134 ANNALS INTERNAL MED. 487, 488-89 (2001).
213. AM. ACAD. OF PEDIATRICS & AM. ACAD. OF FAM. PHYSICIANS, supra note 185.
214. See Scott F. Dowell et al., Principles of Judicious Use of Antimicrobial Agents for Pediatric Upper Respiratory Tract Infections, 101 PEDIATRICS 163 (Supp. 1998).
215. See Roberto Grilli & Jonathan Lomas, Evaluating the Message: The Relationship Between Compliance Rate and the Subject of a Practice Guideline, 32 MED. CARE 202, 202 (1994).
216. David Orentlicher, Paying Physicians More To Do Less: Financial Incentives to Limit Care, 30 U. RICH L. REV. 155, 169-71 (1996).
217. See James Ducharme, Clinical Guidelines and Policies: Can They Improve Emergency Department Pain Management?, 33 J. L. MED. & ETHICS 783, 787 (2005).
218. Stephen B. Soumerai et al., Effect of Local Medical Opinion Leaders on Quality of Care For Acute Myocardial Infarction: A Randomized Controlled Trial, 279 JAMA 1358, 1358 (1998);
219. OFF. OF TECH. ASSESSMENT, supra note 228, at 73.
220. Michael Cabana et al., Why Don't Physicians Follow Clinical Practice Guidelines?, 282 JAMA 1458, 1461-62 (1999) (discussing limited effects of CPGs on changing physician behavior and the many barriers that can interfere with physician adherence);
221. OFF. OF TECH. ASSESSMENT, supra note 228, at 73.
222. Erwin M. Brown, Interventions to Optimise Antibiotic Prescribing in Hospitals: The UK Approach, in ANTIBIOTIC POLICIES, supra note 175, at 159 & 163;
223. see also Peter Gross, Guideline Implementation: It Is Not Impossible, in ANTIBIOTIC POLICIES, supra note 175, at 15-17.
224. See Jane D. Siegel et al., MANAGEMENT OF MULTIDRUG RESISTANT ORGANISMS IN HEALTHCARE SETTINGS, 2006 16(2006), http://www.cdc.gov/ncidod/dhqp/pdf/ar/ mdroguideline2006.pdf;
225. Ralph Gonzales et al., Principles of Appropriate Antibiotic Use For Treatment of Acute Respiratory Tract Infections in Adults: Background, Specific Aims, and Methods, 134 ANNALS INTERN. MED. 479, 481-82 (2001) (discussing CDC-initiated guidelines).
226. CDC: Campaign To Prevent Antimicrobial Resistance in Healthcare Settings, www.cdc.gov/drugresistance/healthcare (last visited Oct. 18, 2008).
227. For a discussion of various types of managed care financial incentives, see Henry Greely, Direct Financial Incentives in Managed Care: Unanswered Questions, 6 HEALTH MATRIX 53, 57-59 (1996);
228. see generally MARK HALL, MAKING MEDICAL SPENDING DECISIONS 171-92 (Oxford University Press 1997) (concerning the ethical dilemmas of giving financial incentives to doctors);
229. MARC RODWIN, MEDICINE, MONEY & MORALS (1993);
230. Stephen Magnus, Physicians' Financial Incentives in Five Dimensions: A Conceptual Framework For HMO Managers, 24 HEALTH CARE MNGT. REV. 57 (1999) (establishing a framework for HMOs to develop financial incentive systems).
231. Marcia Angell, The Doctor As Double Agent, 3 KENNEDY INSTIT. ETHICS J. 279 (1993);
232. M. Gregg Bloche, Trust and Betrayal in the Medical Marketplace, 55 STAN. L. REV. 919 (2002);
233. See Fred J. Hillinger, The Impact of Financial Incentives on Physician Behavior in Managed Care Plans: A Review of the Evidence, 53 MED. CARE RES. & REV. 294 (1996);
234. Alan L. Hillman, Financial Incentives for Physicians in HMOs: Is There a Conflict of Interest?, 317 NEW ENG. J. MED. 1743, 1747 (1987) ("It is human nature [for physicians] to respond to financial incentives.").
235. See Stephen R. Latham, Regulation of Managed Care Incentive Payments to Physicians, 22 AM. J. L. & MED. 399, 408 (1996).
236. See Mark A. Hall, Institutional Control of Physician Behavior: Legal Barriers to Health Care Cost Containment, 137 U. PA. L. REV. 431, 479-80 (1988).
237. See generally Charles N. Kahn III et al., Snapshot of Hospital Quality Reporting and Pay-For-Performance Under Medicare, 25 HEALTH AFFAIRS 148 (2006) (discussing the Pay For Performance recommendations of the Medicare Payment Advisory Commission and the Premier Hospital Quality Incentive Demonstration rules).
238. See U. S. DEP'T OF HEALTH & HUMAN SERVS., 2007 CMS STATISTICS 10, 15(2007), available at http://www.cms.hhs.gov/CapMarketUpdates/Downloads/ 2007CMSstat.pdf (showing approximately 30% of the United States population enrolled in Medicare, Medicaid, or SCHIP in an average month in 2007).
239. See, e.g., Roberto Grilli et al., Practice Guidelines Developed by Specialty Societies: The Need for a Critical Appraisal, 355 LANCET 103 (2000).
240. See, e.g., Peter Q. Eichacker et al., Surviving Sepsis - Practice Guidelines, Marketing Campaigns, and Eli Lilly, 355 NEW ENG. J. MED. 1640 (2006) (sepsis guidelines criticized because a product recommended in the guidelines was manufactured by the same drug company that financially supported the guideline development);
241. See Agency for Healthcare Research and Quality, National Guideline Clearinghouse, http://www.guideline.gov. The National Guideline Clearinghouse website contains a disclaimer noting that the inclusion of a guideline "does not constitute or imply an endorsement" of the guideline by AHRC and that "while AHRC verifies each guideline posted meets minimum criteria for inclusion, the agency "does not verify or evaluate accuracy of the individual guideline content" and does "not make judgments regarding the comparative quality" of included guidelines).
242. See Agency for Healthcare Research and Quality, NGC Disclaimer, http://www.guideline.gov/about/disclaimer.aspx;
243. cf. Arnold Rosoff, Evidence-Based Medicine and the Law: The Courts Confront Clinical Practice Guidelines, 26 J. HEALTH POL. POL'Y & L. 327, 346 (2001) (proposing agency certification of guidelines to improve the use of guidelines in malpractice litigation).
244. See Sandra L. Arnold, Interventions To Improve Antibiotic Prescribing in the Community, in ANTIBIOTIC POLICIES: THEORY AND PRACTICE 520-21 (Ian M. Gould & Jos W. M. van der Meer eds., 2005).
245. See Erwin M. Brown, Interventions To Optimise Antibiotic Prescribing in Hospitals: The UK Approach, in ANTIBIOTIC POLICIES: THEORY AND PRACTICE 165-168 (Ian M. Gould & Jos W. M. van der Meer eds., 2005);
246. Peter Gross, Guideline Implementation: It Is Not Impossible, in ANTIBIOTIC POLICIES: THEORY AND PRACTICE 16-18 (Ian M. Gould & Jos W. M. van der Meer eds., 2005);
247. See, e.g., Peter Gross, Guideline Implementation: It Is Not Impossible, in ANTIBIOTIC POLICIES: THEORY AND PRACTICE 17-18 (Ian M. Gould & Jos W. M. van der Meer eds., 2005).
248. See, e.g., Jane M. Young et al., Role of Opinion Leaders in Promoting Evidence-Based Surgery, 138 ARCHIVES OF SURGERY 785, 789 (2003) (surgeons reported that the opinions and practices of professional peers were more likely to change their practice patterns than audits or clinical practice guidelines);