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In Tepid Defense of Population Health: Physicians and Antibiotic Resistance

Published online by Cambridge University Press:  06 January 2021

Richard S. Saver
Richard S. Saver*
Affiliation:
Health Law and Policy Institute, University of Houston Law Center, Stanford Law School, Harvard University
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Abstract

Antibiotic resistance menaces the population as a dire public health threat and costly social problem. Recent proposals to combat antibiotic resistance focus to a large degree on supply side approaches. Suggestions include tinkering with patent rights so that pharmaceutical companies have greater incentives to discover novel antibiotics as well as to resist overselling their newer drugs already on market. This Article argues that a primarily supply side emphasis unfortunately detracts attention from physicians' important demand side influences. Physicians have a vital and unavoidably necessary role to play in ensuring socially optimal access to antibiotics. Dismayingly, physicians' management of the antibiotic supply has been poor and their defense of population health tepid at best. Acting as a prudent steward of the antibiotic supply often seems to be at odds with a physician's commonly understood fiduciary duties, ethical obligations, and professional norms, all of which traditionally emphasize the individual health paradigm as opposed to population health responsibilities. Meanwhile, physicians face limited incentives for antibiotic conservation from other sources, such as malpractice liability, regulatory standards, and reimbursement systems. While multi-faceted efforts are needed to combat antibiotic resistance effectively, physician gatekeeping behavior should become a priority area of focus. This Article considers how health law and policy tools could favorably change the incentives physicians face for antibiotic conservation. A clear lesson from the managed care reform battles of the recent past is that interventions, to have the best chance of success, need to respect physician interest in clinical autonomy and individualized medicine even if, somewhat paradoxically, vigorously promoting population health perspectives. Also, physicians' legal and ethical obligations need to be reconceptualized in the antibiotic context in order to better support gatekeeping in defense of population health. The principal recommendation is for increased use of financial incentives to reward physicians for compliance with recommended guidelines on antibiotic prescribing. Although not a panacea, greater experimentation with financial incentives can provide a much needed jump-start to physician interest in antibiotic conservation and likely best address physicians' legitimate clinical autonomy concerns.

Type
Article
Information
American Journal of Law & Medicine , Volume 34 , Issue 4 , December 2008 , pp. 431 - 491
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2008

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References

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)Google Scholar.

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 America, supra note 1, at 10-11.

5 See Institute of Medicine, supra note 3; Infectious Diseases Soc’y of America, supra note 1, at 10-11 (2004).

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7 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. Parmet, Wendy E., Legal Power and Legal Rights – Isolation and Quarantine in the Case of Drug-Resistant Tuberculosis, 357 New Eng. J. Med. 433, 433 (2007)CrossRefGoogle ScholarPubMed; Lawrence K. Altman, Traveler's TB Not As Severe As Officials Thought, N.Y. Times, July 4, 2007, at A11.

8 See infra Part I.A; Outterson, Kevin, The Vanishing Public Domain: Antibiotic Resistance, Pharmaceutical Innovation and Intellectual Property Law, 67 U. Pitt. L. Rev. 67, 73 n. 29 (2005)Google Scholar.

9 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.

10 See Food and Drug Administration, Task Force on Antimicrobial Resistance: Key Recommendations and Report (Dec. 2000), www.fda.gov/oc/antimicrobial/taskforce2000.html.

11 For example, the FDA recently reprimanded pharmaceutical company Pfizer for aggressively promoting linezolid, 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 linezolid 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. Antibiotic resistance considerations caution that a powerful new medication such as linezolid should be prescribed judiciously, in order to avoid exacerbating new resistance problems for the class of oxazolidinones. Ament, Paul W. et al., Linezolid: Its Role in the Treatment of Gram-Positive, Drug-Resistant Bacterial Infections, 65 Am. Fam. Physician 663, 669 (2002)Google ScholarPubMed.

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13 See infra Part III.F.

14 See infra Part II.A.

15 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.

16 See Infectious Diseases Soc’y of Am., supra note 1, at 14-19.

17 Id. 24-25. See also infra Part I.D.

18 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) and (b) the Protecting America in the War on Terror Act of 2005, S.3, 109th Cong. (2005). See also Outterson, Kevin et al., Will Longer Antimicrobial Patents Improve Global Public Health?, 7 Lancet Infectious Disease 559, 561-562 (2007)CrossRefGoogle ScholarPubMed.

19 It is estimated that physicians influence or control between seventy to ninety percent of overall health care expenditures. Agrawal, Gail B., Resuscitating Professionalism: Self- Regulation in the Medical Marketplace, 66 Mo L. Rev. 341, 356 (2001)Google Scholar (discussing various estimates); Hall, Mark, Institutional Control of Physician Behavior: Legal Barriers to Health Care Cost Containment, 137 U. PA. L. Rev. 431, 434 (1988)CrossRefGoogle Scholar (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. See e.g., Graber, Alan, The U.S. Physician Workforce: Serious Questions Raised, Answers Needed, 141 Annals Internal Med. 732, 733 (2004)CrossRefGoogle Scholar. 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. Wilensky, Gail R. & Rossiter, Louis F., The Relative Importance of Physician- Induced Demand in the Demand for Medical Care, 61 The Milbank Q. 252, 260-66 (1983)CrossRefGoogle ScholarPubMed. 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. See Stensland, Jeffery & Winter, Ariel, Do Physician-Owned Cardiac Hospitals Increase Utilization?, 25 Health Affairs 119, 120-122 (2006)CrossRefGoogle ScholarPubMed.

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23 Stuart B. Levy, The Antibiotic Paradox: How the Misuse of Antibiotics Destroys their Curative Powers xii-xiv (2002).

24 World Health Org., supra note 9, at ch. 3.

25 See infra Part II.A.

26 See Centers for Disease Control and Prevention, Campaign for Appropriate Antibiotic Use in the Community, http://www.cdc.gov/drugresistance/community/anitbioticresistance-faqs.htm.

27 See e.g., Labeling Requirements for Systematic Antibacterial Drug Products Intended for Human Use, 68 Fed. Reg. 6062, 6068 (Feb. 6, 2003) (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. 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).

28 Contopoulos-Iannidis, Despina G. 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)CrossRefGoogle Scholar; Steinman, Michael A. et al., Predictors of Broad-Spectrum Antibiotic Prescribing for Acute Respiratory Tract Infections in Adult Primary Care, 289 JAMA 719, 722 (2003)CrossRefGoogle ScholarPubMed.

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30 See Solomon, Daniel H. et al., Academic Detailing to Improve Use of Broad-Spectrum Antibiotics at an Academic Medical Center, 161 Archives Internal Medicine 1897, 1898 (2001)CrossRefGoogle ScholarPubMed.

31 Avorn & Solomon, supra note 22, at 128.

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33 See Orentlicher, David, Paying Physicians More to Do Less: Financial Incentives to Limit Care, 30 U. Rich. L. Rev. 155, 158-60 (1996)Google Scholar.

34 Rosoff, Arnold J., Policy Challenges in Modern Health Care, 26 J. LEGAL MEDICINE 523, 525 (2005)CrossRefGoogle Scholar (book review).

35 See Lawrence O. Gostin, Public Health Law: Power, Duty, Restraint 11-14 (2000); Alvin R. Tarlov, Introduction, in Policy Challenges in Modern Health Care vii (David Mechanic et al. eds., 2005).

36 See generally Neu, Harold C., The Crisis in Antibiotic Resistance, 257 Science 1064 (1992)CrossRefGoogle ScholarPubMed.

37 See infra Part III.A.

38 See infra Part II.B.

39 For example, soon after the use of penicillin, outbreaks of resistant staphylococci appeared in the 1940s. See Stuart B. Levy, supra note 23, at 11-12. Further antibioticresistant staphylocci problems resulted from widespread use of antibiotics in the 1950s and 1960s. See generally Parrino, Thomas A., Controlled Trials To Improve Antibiotic Utilization: A Systematic Review of Experience, 1984-2004, 25 Pharmacotherapy 289 (2005)CrossRefGoogle ScholarPubMed.

40 Ricki Lewis, The Rise of Antibiotic-Resistant Infections (Sept. 1995), http://www.fda.gov/Fdac/features/795_antibio.html.

41 See World Health Organization, supra note 9, at ch. 3.

42 Shlaes, David 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)CrossRefGoogle Scholar.

43 Centers for Disease Control and Prevention, supra note 2.

44 Livermore, David M., Bacterial Resistance: Origins, Epidemiology, and Impact, 36 Clinical Infectious Diseases S11, S12-S13 (2003)CrossRefGoogle Scholar.

45 See Colgan, Richard & Powers, John H., Appropriate Antimicrobial Prescribing: Approaches That Limit Antibiotic Resistance, 64 Am. Fam. Physician 999, 999-1000 (2001)Google ScholarPubMed; Institute of Medicine, supra note 3, at 37-38.

46 See Institute of Medicine, supra note 3, at 37.

47 McGowan, John E., Economic Impact of Antimicrobial Resistance, 7 Emerging Infectious Diseases 286, 290 (2001)CrossRefGoogle ScholarPubMed.

48 Institute of Medicine, supra note 3, at 37.

49 Id. at 38.

50 See Livermore, supra note 44, at S15-S16.

51 Institute of Medicine, supra note 3, at 37.

52 See id.

53 See Livermore, supra note 44, at S11.

54 See Sanchirico, James N., To Take Or Not To Take The Antibiotic?, in Battling Resistance to Antibiotics and Pesticides: An Economic Approach, 76, 76-77 (Laxminarayan, Ramanan, ed., Resources for the Future 2003)Google Scholar.

55 Labeling Requirements, supra note 27, at 6076.

56 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); R. Monica Klevens et al., supra note 6, at 1769 (estimating over 18,000 deaths due to MRSA infections alone); World Health Organization Report on Infectious Diseases 2000 supra note 9, ch. 4 (estimating 14,000 annual deaths).

57 See Livermore, supra note 44, at S17.

58 Labeling Requirements, supra note 27, at 6075.

59 Infectious Diseases Soc’y of America, supra note 1, at 4-5; Labeling Requirements, supra note 27, at 6075.

60 Labeling Requirements, supra note 27, at 6075.

61 See World Health Organization, supra note 9, at Ch. 3.

62 See Livermore, supra note 44, at S17-S18.

63 Ramanan Laxminarayan, Battling Resistance to Antibiotics and Pesticides: An Economic Approach 3 (Ramanan Laxminarayan ed., 2003).

64 See Labeling Requirements, supra note 27, at 6076 (2003).

65 See Laxminarayan, supra note 63.

66 See Avorn & Solomon, supra note 22, at 128 (stating that 15% of the $100 billion spent annually in the United States for medications is for antibiotics); infra Part II.A (discussing studies of inappropriate antibiotic prescribing).

67 See Institute Of Medicine, supra note 3, at 1. 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).

68 Kades, Eric, Preserving a Precious Resource: Rationalizing the Use of Antibiotics, 99 Nw. U. L. Rev. 611, 672 (2005)Google Scholar.

69 Id. at 634.

70 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.

71 See Kades, supra note 68, at 627-28.

72 See generally, Hardin, Garrett, The Tragedy of the Commons, 162 Science 1243 (1968)Google ScholarPubMed. For a recent, intriguing application of tragedy of the commons-type analysis to health law and policy problems, see generally Avraham, Ronen & Camara, K.A.D., The Tragedy of the Human Commons, 29 Cardozo L. Rev. 479 (2007)Google Scholar (discussing insurers’ failure to cover prospectively efficient medical care, such as noncoverage of bariatric surgery to combat morbid obesity).

73 Id.

74 Compare Laxminarayan, Ramanan & Brown, Gardner M., Economics of Antibiotic Resistance: A Theory of Optimal Use, 42 J. of Envtl. Econ. and Mgmt. 183 (2001)CrossRefGoogle Scholar (considering antibiotic effectiveness as a nonrenewable resource) with Kades, supra note 68, at 660-62 (distinguishing circumstances in which antibiotics would be renewable resources).

75 Eventually resistance will develop as an expected biological occurrence and make the antibiotic useless even if additional units of the drug can be made and are available for prescription. See Kades, supra note 68, at 629-635.

76 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. Wilen, James E. & Msangi, Siwa, 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 (Laxminarayan, Ramanan, ed., Resources for the Future 2003)Google Scholar. 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. Kades, supra note 68, at 662-64.

77 See e.g., Outterson, supra note 8, at 100-101 & n.192.

78 Infectious Disease Soc’y of America, supra note 1, at 24-25.

79 Protecting America in the War on Terror Act of 2005, S.3, 109th Cong. (2005); Biological, Chemical, and Radiological Weapons Countermeasures Research Act (BioShield II), S.666, 108th Cong. (2003).

80 Id.

81 Kades, supra note 68, at 672.

82 Id. at 650-52.

83 Kades suggests it may be necessary to “repatent” key antibiotics already off patent back to private bidders, in order to provide the proper incentives for stockpiling and extending the useful life of the medications. Id. at 652-53. This approach, taking drugs supposedly already in the public domain and reinstating an exclusivity term so that the drugs will be priced higher with more limited access, seems fraught with practical difficulties.

84 See Outterson, supra note 8, at 94-98.

85 See id. at 77 & n.53 (“Some biologists believe that we have already harvested the lowhanging fruit of easily discoverable antibiotics.”).

86 Metlay, Joshua P. et al., Tensions in Antibiotics Prescribing: Pitting Social Concerns Against the Interest of Individual Patients, 17 J. Gen. Internal Med. 87, 87 (2002)CrossRefGoogle Scholar.

87 See generally Colgan & Powers, supra note 45; Murthy, supra note 12; Shlaes et al., supra note 42; Solomon et al., supra note 30.

88 See Steinman et al., supra note 28, at 722 (finding “wide variation in prescribing of broad-spectrum agents among different groups of patients and physicians, even after controlling for diagnosis and comorbidities.”).

89 Antibiotic prescribing by physicians varies significantly across different geographic regions. Metlay, supra note 86, tbl.1, 92 (2002). It can also differ between physicians within the same region. For example, studies report that physicians in the Northeast and South prescribed broad-spectrum antibiotics for upper respiratory tract infections at higher rates than in other geographic regions. Id. at 721. And even within the same geographic region, internists prescribe broad spectrum antibiotics for these clinical conditions at particularly higher rates than other specialist physicians. Id.

90 See World Health Organization, supra note 9, at ch. 3.

91 Colgan & Powers, supra note 45, at 999.

92 Id. at 1000.

93 Gonzalez, Ralph et al., Excessive Antibiotic Use for Acute Respiratory Infections in the United States, 33 Clinical Infectious Diseases 757, 757 (2001)CrossRefGoogle Scholar.

94 Id.

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99 Id. at 86.

100 Id.

101 Id. at 85. In the same study, even the physicians who did seek validation of diagnosis through additional tests nonetheless showed a high degree of discomfort of going along with results indicating the absence of strep infection. Patients with negative strep tests under throat cultures and/or RADTs nonetheless received an antibiotic 25% of the time. Id.

102 Roumie, Christianne L. et al., Trends in Antibiotic Prescribing For Adults in the United States - 1995 to 2002, 20 J. Gen. Internal Med. 697, 699-700 (2005)CrossRefGoogle ScholarPubMed.

103 Id. at 701.

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105 Id. at 605; moreover, apart from resistance concerns, broad spectrum antibiotics tend to cost more. 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. Linder, Jeffrey et al., Antibiotic Treatment of Adults With Sore Throat By Community Primary Care Physicians: A National Survey, 1989-1999, 286 JAMA 1181, 1185 (2001)CrossRefGoogle Scholar.

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107 Roumie et al., supra note 102, at 697, 699.

108 Linder, Jeffrey et al., Antibiotic Treatment of Children With Sore Throat, 294 JAMA 2315, 2315 (2005)CrossRefGoogle ScholarPubMed.

109 Linder et al., supra note 105, at 1181-83.

110 Id. at 1184.

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112 Id. at 549.

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116 See id. at 10.

117 See id. at 9-10.

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119 See Linder et al., supra note 108.

120 Id.

121 Id. at 2317-18.

122 Nicholas Bakalar, Practices: One Simple Ailment, Many Wrong Prescriptions, N.Y. Times, Nov. 15, 2005, at F1.

123 Finkelstein, supra note 121, at 620; Linder, supra note 108, at 2318.

124 World Health Organization, supra note 9, at ch. 3.

125 Linder, supra note 108, at 2319; Stille, Christopher J. et al., Increased Use of Second- Generation Macrolide Antibiotics for Children in Nine Health Plans in the United States, 114 Pediatrics 1206, 1206 (2004)CrossRefGoogle ScholarPubMed (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).

126 See, e.g., Dellinger, E. Patchen et al., Quality Standard for Antimicrobial Prophylaxis in Surgical Procedures, 18 Clinical Infectious Diseases 422, 422 (1994)CrossRefGoogle ScholarPubMed (emphasizing the need to determine optimal timing, dose and duration for drug therapy).

127 Bratzler, Dale W. et al., Use of Antimicrobial Prophylaxis For Major Surgery, 140 Archives of Surgery 174, 176-78 (2005)CrossRefGoogle ScholarPubMed.

128 Id. at 179-80.

129 Id. at 179.

130 Id. at 180.

131 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)Google Scholar.

132 See Simpson, Ross J. Jr., Challenges for Improving Medication Adherence, 296 JAMA 2614, 2614 (2006)CrossRefGoogle ScholarPubMed (arguing that patient non-adherence is partially the result of some physicians’ negative attitudes and inadequate attention to guideline-recommended care).

133 Deborah Franklin, Antibiotics: How Long is Long Enough?, N.Y. Times, June 20, 2006, at F5.

134 See Metlay, supra note 86.

135 Id. at 88.

136 Id.

137 See Hooper, David C., Expanding Uses of Fluoroquinolones: Opportunities and Challenges, 129 Annals of Internal Medicine 908, 910 (1998)CrossRefGoogle ScholarPubMed (“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.”).

138 Metlay, supra note 86, at 88.

139 See id. at 92.

140 See supra Part II.A.2.

141 See Metlay, supra note 86, at 88.

142 Id.

143 See id.

144 Id. at 92.

145 See id. at 93.

146 See id. at 92.

147 See, e.g., Cabana, Michael et al., Why Don't Physicians Follow Clinical Practice Guidelines? A Framework For Improvement, 282 JAMA 1458, 1462 (1999)CrossRefGoogle ScholarPubMed (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); Pierluissi, Edgar et al., Discussion of Medical Errors in Morbidity and Mortality Conferences, 290 JAMA 2838, 2839-41 (2003)CrossRefGoogle ScholarPubMed (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).

148 Wester, C. William et al., Antibiotic Resistance: A Survey of Physician Perceptions, 162 Archives of Internal Med. 2210, 2211 (2002)CrossRefGoogle ScholarPubMed.

149 Id.

150 Id.

151 Id.

152 Id. at 2211-12.

153 Id.

154 Parmet, Wendy E., Unprepared: Why Health Law Fails to Prepare Us For A Pandemic, 2 J. Health & Biomedical Law 157, 176 (2006)Google Scholar.

155 Rodwin, Marc A., 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)Google Scholar.

156 See Mehlman, Maxwell, Fiduciary Contracting Limitations on Bargaining Between Patients and Health Care Providers, 51 U. Pitt. L. Rev. 365, 389-90 (1990)Google Scholar (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. 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. See Marc A. Rodwin, supra note 155, at 247-48. See also Oberman, Michelle, Mothers and Doctors’ Orders: Unmasking the Doctor's Fiduciary Role in Maternal-Fetal Conflicts, 94 Nw. U. L. Rev. 451, 459 (2000)Google ScholarPubMed (noting limited application of fiduciary principles to the physicianpatient relationship).

157 Crossley, Mary, Infected Judgment: Legal Responses to Physician Bias, 48 Vill. L. Rev. 195, 251-52 (2003)Google ScholarPubMed.

158 For more on antibiotic cycling, see supra Part II.A.2.

159 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).

160 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. Vernacchio, Louis 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)CrossRefGoogle Scholar.

161 For further discussion of how fiduciary duty problems arising from antibiotic conservation could be somewhat ameliorated, see infra Part IV.A.

162 See generally Public Health Leadership society, Principles of the Ethical Practice of Public Health (2002), available at http://www.apha.org/NR/rdonlyres/1CED3CEA-287E-4185-9CBDBD405FC60856/0/ethicsbrochure.pdf. See also infra Part IV.A.

163 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.” Public Health Leadership society, 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 … .” Id. at 5.

164 American Med. Ass’n, Code of Medical Ethics, xiv, ¶ VII (2004-2005 ed.).

165 American Med. Ass’n, supra note 164, at xiv, ¶VIII.

166 American Med. Ass’n, supra note 164, §2.09.

167 American Med. Ass’n, supra note 164, §10.015. See also Mossman, Douglas, Critique of Pure Risk Assessment or, Kant Meets Tarasoff, 75 U. Cin. L. Rev. 523, 578 (2006)Google Scholar (“In traditional medical ethics, doctors serve individual patients and have fiduciary obligations to them, not those around them.”).

168 See American Med. Ass’n, supra note 172, § 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. See Council on Ethical and Judicial Affairs, American Medical Association, Ethical Issues in Managed Care, 273 JAMA 330, 330-35 (1995)CrossRefGoogle Scholar; Orentlicher, supra note 33, at 167.

169 Sage, William M., Physicians as Advocates, 35 Hous. L. Rev. 1529, 1555 (1999)Google ScholarPubMed (discussing the views regarding doctor's decision-making expressed in Evans, Roger W., Health Care Technology and the Inevitability of Resource Allocation and Rationing Decisions: Part II, 249 JAMA 2208 (1983)CrossRefGoogle ScholarPubMed).

170 Rosoff, supra note 34, at 524-525 (2005).

171 Callahan, Daniel & Jennings, Bruce, Ethics and Public Health: Forging A Strong Relationship, 92 Am. J. Pub. Health 169, 170 (2002)CrossRefGoogle ScholarPubMed.

172 Jerome Groopman, How Doctors Think 82 (2007)Google Scholar (“Alas, serving as a gatekeeper to limit access is not what most doctors envisioned when they chose primary care.”).

173 See Chernew, Michael et al., Barriers to Constraining Health Care Cost Growth, 23 Health Aff. 122, 124 (2004)CrossRefGoogle ScholarPubMed (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); Gillick, Muriel R., The Technological Imperative and the Battle for the Hearts of America, 50 Persp. Biology & Med. 276 (2007)CrossRefGoogle ScholarPubMed (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). See also Noah, Lars, Informed Consent and the Elusive Dichotomy Between Standard and Experimental Therapy, 28 Am. J.L. & Med. 361, 401 (2002)Google ScholarPubMed (”… 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.”).

174 McGowan, supra note 47, at 287. See also Wax, Amy L., Technology Assessment and the Doctor-Patient Relationship, 82 Va. L. Rev. 1641, 1642-43 (1996)CrossRefGoogle ScholarPubMed (“[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.”).

175 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).

176 See Redelmeirer, Donald A. & Twersky, Amos, Discrepancy Between Medical Decisions for Individual Patients and for Groups, 322 New Eng. J. Med. 1162, 1163-64 (1990)CrossRefGoogle Scholar.

177 Id. at 1163; Sage, William M., Physicians as Advocates, 35 Hous. L. Rev. 1529, 1556 (1999)Google ScholarPubMed.

178 See, e.g., Williams, Rosamund J., Biomedicine: Containment of Antibiotic Resistance, 279 Sci. 1153 (1998)CrossRefGoogle Scholar (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).

179 See World Health Organization, supra note 9, at Chapter 3.

180 See supra Part IIB.2.

181 See e.g., Sage, William M., Relational Duties, Regulatory Duties, and the Widening Gap Between Individual Health Law and Collective Health Policy, 96 Geo. L. J. 497, 499-501 (2008)Google Scholar (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.” Id.

182 Id. at 500-01, 519-22.

183 See Arnold, supra note 175, at 494-95.

184 Id. (emphasis added).

185 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.

186 See id.

187 See Finkelstein, Jonathan A. et al., Watchful Waiting For Acute Otitis Media: Are Parents and Physicians Ready?, 115 Pediatrics 1466, 1468-1472 (2005)CrossRefGoogle ScholarPubMed.

188 Id. at 1472.

189 See Vernacchio, supra note 160, at 285.

190 See id.

191 St. Lawrence, Janet S. 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)CrossRefGoogle Scholar (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).

192 Id. at 1786; see also Bowser, Rene & Gostin, Lawrence, Managed Care and the Health of a Nation, 72 S Cal. L. Rev. 1209, 1259 (1999)Google ScholarPubMed (noting physicians have historically failed to comply with mandatory reporting of communicable diseases).

193 Outterson, Kevin et al., Will Longer Antimicrobial Patents Improve Global Public Health?, 7 Lancet Infectious Disease 559, 563 (2007)CrossRefGoogle Scholar.

194 See Barlam, Tamar, Antibiotic-Stewardship Practices at Top Academic Centers Throughout the United States and at Hospitals Throughout Massachusetts, 27 Infection Control & Hosp. Epidemiology 695, 697 (2006)CrossRefGoogle ScholarPubMed (noting that “Doctors tend to believe that the goal of [antibiotic control] programs is to save costs rather than to improve patient outcomes … .”); Avorn and Solomon, supra note 22, at 133 (“Overuse of costly antibiotics attracts notice and perhaps reprimand, whereas massive overuse of amoxicillin or trimethoprim-sulfamethoxasole [which introduces resistance pressures] often attracts no notice at all.”).

195 See Barlam, supra note 194, at 701.

196 See Jane E. Brody, Just What the Doctor Ordered? Not Exactly, N.Y. Times, May 9, 2006, at F8.

197 See Arnold, supra note 175, at 494.

198 See Avorn and Solomon, supra note 22, at 128.

199 See id. at 128-29.

200 See Bowser & Gostin, supra note 192, at 1260.

201 See Spivey, Bruce, The Relation Between Hospital Management and Medical Staff Under a Prospective Payment System, 310 New Eng. J. Med. 984, 984 (1984)CrossRefGoogle Scholar.

202 See id. at 984-85.

203 Medicare uses the Resource-Based Relative Value Scale (RBRVS) for determining physician payments under the fee-for-service system. See 42 U.S.C. §§ 1395w-4(a) to 4(j) (2000).

204 Avorn & Solomon, supra note 22, at 129.

205 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)Google Scholar.

206 See id. at 24,716.

207 See id.; Press Release, Centers for Medicare & Medicaid Services, Eliminating Serious, Preventable, and Costly Medical Errors – Never Events (May 18, 2006), available at http://www.cms.hhs.gov/apps/media/press/release.asp?Counter=1863.

208 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).

209 See supra Part II.A.

210 See, e.g., Hofmann v. Blackmon, 241 So. 2d 752, 753 (Fla. Dist. Ct. App. 1970), 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); Shepard v. Redford Community Hosp., 390 N.W.2d 239, 241 (Mich. Ct. App. 1986) 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).

211 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).

212 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).

213 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); 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).

214 See, e.g., Lawthers, Ann G. et al., Physicians’ Perception of The Risk of Being Sued, 17 J. Health Pol. Pol’y & L. 463, 463 (1992)CrossRefGoogle ScholarPubMed (finding that among physicians surveyed, their perception of the risk of facing a malpractice suit was three times the actual risk).

215 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.” Office of Tech. Assessment, supra note 96, at 75.

216 See Studdert, David et al., Claims, Errors and Compensation Payments in Medical Malpractice Litigation, 354 New Eng. J. Med. 2024, 2025, 2029-2030 (2006)CrossRefGoogle ScholarPubMed. 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. See generally Brennan, T.A. 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)CrossRefGoogle ScholarPubMed; Hyman, David, 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)Google Scholar (summarizing much of the empirical literature).

217 Id.

218 See Mello, Michelle M. & Brennan, Troyen A., Deterrence of Medical Errors: Theory and Evidence for Malpractice Reform, 80 Tex. L. Rev. 1595, 1623 (2002)Google Scholar.

219 See generally Labeling Requirements, supra note 27.

220 See 21 C.F.R. §201.24 (2008).

221 See id.

222 See id.

223 See supra Part II.A.1.

224 See Labeling Requirements, supra note 27, at 6068-69. By declining to require more forcefully that physicians regularly screen and test for bacterial agents before initiating antibiotic therapy, the FDA label rule essentially leaves much to the discretion of the treating physician, a result unlikely to counter the currently wide clinical variation in prescription patterns and frequent physician disregard for antibiotic conservation guidelines. Indeed, the language from the FDA label rule is so open-ended and vague, it is doubtful if, in a future malpractice claim against a physician asserting inappropriate antibiotic prescribing, the FDA rule could be relied upon to establish a definitive standard of care.

225 Under its enabling statute, the Food and Drug Administration has limited authority to restrict a physician's ability to prescribe an already approved medication, even when the prescription is not in accord with an FDA-recommended label instruction. 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.

226 See, e.g., Johnson, Sandra H., Polluting Medical Judgment? False Assumptions in the Pursuit of False Claims for Off-Label Prescribing, 9 Minn. J. L. Sci. & Tech. (forthcoming 2007)Google Scholar (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. See id. at 61.

227 Even the most dire “black box” warnings that the FDA occasionally issues with certain drugs due to newly discovered safety concerns often go unheeded by physicians. Many physicians prescribe drugs in a manner and for uses that evidence disregard of black box warnings. See, e.g., Gurwitz, Jerry H, Serious Adverse Drug Effects – Seeing The Trees Through the Forest, 354 New Eng. J. Med. 1413, 1414 (2006)CrossRefGoogle ScholarPubMed.

228 See, e.g., Johnson, supra note 226; Noah, Lars, Medicine's Epistemology: Mapping the Haphazard Diffusion of Knowledge in the Biomedical Community, 44 Ariz. L. Rev. 373, 393-94 (2002)Google Scholar; Soumerai, Stephen B. 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)CrossRefGoogle Scholar; 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).

229 See, e.g., Labeling Requirements, supra note 27, at 6068.

230 See id. at 6065.

231 See id.

232 “Licensure” refers to meeting the conditions required by state statutes and regulations in order to be legally authorized to practice a health care profession or to be able to operate a health care facility. “Accreditation” involves meeting on a voluntary basis standards imposed not by a governmental regulatory agency but developed by private, external, nongovernmental bodies that establish their own standards for quality. A typical accrediting body is the Joint Commission, which accredits most hospitals nationwide. 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. See Mark Hall et al., Health Care Law and Ethics 1073-74 (6th ed. 2003).

233 See supra Part III.C.

234 See, e.g., Misocky, Michael, 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)Google Scholar (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).

235 Although a trend in this direction may be underway as more states try to encourage hospitals to more aggressively address hospital-acquired infections. California, for example, is requiring licensed acute care hospitals to develop a process for evaluating the judicious use of antibiotics within each licensed institution. See Cal. Health & Safety Code §1288.8 (West 2007).

236 See generally Furrow, et al., supra note 232, at 122-24.

237 See id.

238 See Fidler, David, Legal Issues Associated With Antimicrobial Resistance, 4 Emerging Infectious Diseases (1998)CrossRefGoogle Scholar (discussing the danger of heavy handed prescription regulation). See also infra Part IV.B (discussing clinical autonomy concerns).

239 Accreditation by the Joint Commission can help a hospital meet the governmental certification conditions in order to participate in and receive funds from the Medicare and Medicaid programs. See Hall, supra note 232, at 1073-74.

240 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. See id. at 244 (discussing elements of performance for standard IC3.10, relating to establishing priorities and goals for preventing health-care associated infections).

241 “High-risk” medications according to the Joint Commission rules include drugs involved in a high percentage of medical errors, medications that carry a high risk of abuse or adverse outcomes, and investigational drugs. See id. at 236 (discussing standard MM.6.20, regarding medication management) & at 237 (discussing standard MM.7.10., regarding processes for ordering and dispensing high-risk medications). Antibiotics per se are not necessarily considered high-risk medications under these standards.

242 See 42 C.F.R. § 482.42 (2007); see also Office of Tech. Assessment, supra note 96, at 80; Markow, Scott B., Penetrating the Walls of Drug Resistant Bacteria: A Statutory Prescription to Combat Antibiotic Misuse, 87 Geo. L. J. 531, 537-38 (1998)Google Scholar (calling for amendments to the Medicare and Medicaid statutes so that the programs’ conditions of participation require more express antibiotic control responsibilities from hospitals).

243 See 42 C.F.R. § 482.42 (2007).

244 See Barlam, Tamar & DiVall, Margarita, Antibiotic-Stewardship Practices at top Academic Centers Throughout the United States and at Hospitals Throughout Massachusetts, 27 Infection Control & Hosp. Epidemiology 695, 702 (2006)CrossRefGoogle ScholarPubMed.

245 See, e.g., Levy, supra note 23, at 115-17.

246 See Colgan & Powers, supra note 45, at 1000.

247 See Avorn & Solomon, supra note 22, at 129.

248 See Hamm, RM et al., Antibiotics and Respiratory Infections: Are Patients More Satisfied When Expectations Are Met?, 43 J. Fam. Prac. 56, 57 (1996)Google Scholar; see also Vernacchio, Louis 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)CrossRefGoogle Scholar (“[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.”).

249 See Colgan & Powers, supra note 45, at 1001.

250 See Finkelstein, supra note 187, at 1472. A patient's racial status may cut many different ways in terms of being a predictor for their expectation for, and their likelihood of receiving, antibiotic therapy. For example, other studies indicate that being African American is a factor associated with lower rates of broad-spectrum antibiotic prescribing; see also Steinman, supra note 28, at 721.

251 With “wait and see prescriptions”, patients are given a prescription but not asked to fill it unless there is no improvement or symptoms worsen over a designated time interval, such as 48 hours. See Spiro, David M. et al., Wait-and-See Prescription For the Treatment of Acute Otitis Media: A Randomized Controlled Trial, 296 JAMA 1235 (2006)CrossRefGoogle ScholarPubMed (discussing an evaluation of the wait and see approach with children suffering from ear aches).

252 See Sage, Advocates, supra note 169, at 1583.

253 Id. at 1583.

254 Rubin, supra note 70.

255 See Sage, Advocates, supra note 169, at 1579.

256 This observation, of course, applies not only to antibiotic prescribing, but to many aspects of physician practice that have a population health dimension.

257 Norms theory suggests that social norms and conventions largely influence how parties act, regardless of what a particular law or regulation says. Concerns about violating socially understood standards of behavior, which can lead to loss of reputation, censure, ostracism, and disruption of important relationships, can motive an individual's choices to a large degree, perhaps even more than any law or regulation. See, e.g., Ellickson, Robert C., Law and Economics Discovers Social Norms, 27 J. Legal Stud. 537, 539-41 (1998)CrossRefGoogle Scholar; Posner, Eric A., The Regulation of Groups: The Influence of Legal and Nonlegal Sanctions on Collective Action, 63 U. Chi. L. Rev. 133 (1996)CrossRefGoogle Scholar; Sunstein, Cass R., Social Norms and Social Roles, 96 Colum. L. Rev. 903 (1996)CrossRefGoogle Scholar.

258 See supra Part III.A.

259 See Groopman, supra note 172, at 219-20 (noting physician marketing studies indicate most physicians routinely prescribe only around two dozen drugs and the majority were adopted during the physicians’ medical training or shortly after); see also Johnson, supra note 241; Noah, Medicine's Epistemology, supra note 228, at 393-94.

260 See infra Part IV.D.

261 See supra Part III.A.

262 See Sage, Relational Duties, supra note 181, at 519-22.

263 See supra Part III.C.

264 See Saver, Richard S., Squandering the Gain: Gainsharing and the Continuing Dilemma of Physician Financial Incentives, 98 Nw. U. L. Rev. 145, 220-21 (2003)Google ScholarPubMed.

265 See Orentlicher, David, Paying Physicians More To Do Less: Financial Incentives To Limit Care, 30 U. Rich. L. Rev. 155, 167 (1996)Google Scholar (making a similar argument regarding the appropriateness of physicians’ conserving limited care health resources for the greater good).

266 See Wax, Amy L., Technology Assessment and the Doctor-Patient Relationship, 82 Va. L. Rev. 1641, 1644-46 (1996)CrossRefGoogle ScholarPubMed; see generally Hall, Mark A., Rationing Health Care at the Bedside, 69 N.Y.U. L. Rev. 693 (1994)Google ScholarPubMed.

267 See generally Minogue, Brendan, The Two Fundamental Duties of the Physician, 75 Acad. Med. 431 (2000)CrossRefGoogle ScholarPubMed; Bloche, M. Gregg, Clinical Loyalties and The Social Purpose of Medicine, 281 JAMA 268 (1999)CrossRefGoogle Scholar.

268 See Lawrence O. Gostin, Public Health Law: Power, Duty, Restraint 18-21 (2000).

269 See Public Health Law And Ethics: A Reader 67-68, 93 (Lawrence O. Gostin ed., 2002).

270 See Dan Beauchamp. Community: The Neglected Tradition of Public Health, reprinted in Public Health Law And Ethics: A Reader, supra note 288, at 79-81.

271 See id.

272 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).

273 Gostin, supra note 268, at 13.

274 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).

275 See Bloche, M. Gregg & Jacobson, Peter, The Supreme Court and Bedside Rationing, 284 JAMA 2776, 2778 (2000)CrossRefGoogle ScholarPubMed.

276 See Callahan, Daniel & Jennings, Bruce, Ethics and Public Health: Forging A Strong Relationship, 92 Am. J. Pub. Health 169, 169 (2002)CrossRefGoogle ScholarPubMed; Gostin, supra note 268, at 10-13 (2002) (describing Public Health Leadership Society's ethical guidelines and other public health subdisciplines’ ethical codes).

277 Public Health Leadership Society, supra note 162.

278 Id. at 7; see also id. at 4 (“Public health should achieve community health in a way that respects the rights of individuals in the community.”).

279 See id. at 1 (discussing the primary audience for the Public Health Leadership Society's ethical code as public and other institutions that have an explicit public health mission).

280 Cf. Agrawal, Gail B., Resuscitating Professionalism: Self-Regulation in the Medical Marketplace, 66 Mo. L. Rev. 341, 405-07 (2001)Google Scholar; Hall, Mark, Arrow on Trust, 26 J. Health Pol. Pol’y & L. 1131, 1138 (2001)CrossRefGoogle ScholarPubMed. 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.

281 See, e.g., Furrow, Barry R., Incentivizing Medical Practice: What (If Anything) Happens to Professionalism?, 1 Widener L. Symp. J. 1, 5 (1996)Google Scholar.

282 See, e.g., Hall, Mark, Institutional Control of Physician Behavior: Legal Barriers to Health Care Cost Containment, 137 U. Pa. L. Rev. 431, 451 (1988)CrossRefGoogle Scholar.

283 The same considerations, as well as enforcement concerns, suggest that changing the Medicare and Medicaid conditions of participation might also have limited effect. Physicians need to be engaged through alternative means other than top-down commands. For a proposal to change the Medicare and Medicaid conditions of participation to include more express antibiotic control programs, including restricting prescribing ability of physicians for certain antibiotics, see Markow, supra note 242, at 554-62; see also supra Part III.E.

284 See Weber, Valerie & Joshi, Maulik S., Effecting and Leading Change in Health Care Organizations, 26 Joint Comm. J. on Quality Improvement 388, 389-92 (2000)CrossRefGoogle ScholarPubMed. 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. See, e.g., Furrow, supra note 281 at 36-37.

285 See supra Part III.C.

286 See Mello, Michelle M., Of Swords and Shields: The Role of Clinical Practice Guidelines in Medical Malpractice Litigation, 149 U. Pa. L. Rev. 645, 692-93 (2001)CrossRefGoogle Scholar.

287 Barlam, supra note 194, at 697.

288 Id.

289 See supra Part II.B.2.

290 See Wester, C. William, Antibiotic Resistance: A Survey of Physician Perceptions, 162 Archives Intern. Med. 2210, 2212, 2214-15 (2002)CrossRefGoogle ScholarPubMed. 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. See Hirschman, Salom Z. et al., Use of Antimicrobial Agents in a University Teaching Hospital, 148 Archives of Intern. Med. 2001, 2001-07 (1988)CrossRefGoogle Scholar.

291 For example, even audits of physicians’ antibiotic prescribing patterns may yield little change in behavior. One medical center reviewed antibiotic utilization and sent monthly letters to the staff physicians in the top 50% of antibiotic use, notifying them of their high prescribing patterns as compared to their peers. The intervention tried to leverage physicians’ respect for professional peers to encourage self-examination of possible inappropriate prescribing. Yet the new audit program failed to produce any measurable change in prescribing habits of the targeted physicians. See Parrino, Thomas A., The No Value of Retrospective Peer Comparison Feedback in Containing Hospital Antibiotic Costs, 86 Am. J. Med. 442 (1989)CrossRefGoogle Scholar. 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.

292 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, see Hoffman, Sharona & Podgurski, Andy, Finding a Cure: The Case For Regulation and Oversight of Electronic Health Record Systems, 22 Harv. J. L. & Tech.Google Scholar (forthcoming).

293 Inst. of Med., supra note 292, at 1, 26-36.

294 See, e.g., Inst. of Med., supra note 292, at 2; Havighurt, Clark C., Practice Guidelines As Legal Standards Governing Physician Liability, 54 Law & Contemporary Problems 87, 87-88 (1991)CrossRefGoogle Scholar; Mello, supra note 286, at 645; Daly, Michael, 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)CrossRefGoogle ScholarPubMed.

295 See Parrino, supra note 39, at 289 (“Guidelines for antibiotic use were proposed as early as the 1960s … .”).

296 See Vernacchio, supra note 160, at 285; American Academy of Pediatrics & American Academy of Family Physicians, supra note 185.

297 See Snow, Vicenza 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)CrossRefGoogle ScholarPubMed.

298 See, e.g., Levy, supra note 23, at 306-10; American Academy of Pediatrics & American Academy of Family Physicians, supra note 185.

299 See Dowell, Scott F. et al., Principles of Judicious Use of Antimicrobial Agents for Pediatric Upper Respiratory Tract Infections, 101 Pediatrics 163 (Supp. 1998)Google Scholar.

300 See Grilli, Roberto & Lomas, Jonathan, Evaluating the Message: The Relationship Between Compliance Rate and the Subject of a Practice Guideline, 32 Med. Care 202, 202 (1994)CrossRefGoogle ScholarPubMed.

301 See Mello, supra note 286, at 681-91; Orentlicher, David, Paying Physicians More To Do Less: Financial Incentives to Limit Care, 30 U. Rich L. Rev. 155, 169-71 (1996)Google Scholar.

302 See Ducharme, James, Clinical Guidelines and Policies: Can They Improve Emergency Department Pain Management?, 33 J. L. Med. & Ethics 783, 787 (2005)CrossRefGoogle ScholarPubMed.

303 See, e.g., Johnson, supra note 226, at 73-74; Noah, supra note 173, at 393-94; Soumerai, Stephen B. 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)CrossRefGoogle ScholarPubMed; Office of Tech. Assessment, supra note 228, at 73.

304 Cabana, Michael et al., Why Don't Physicians Follow Clinical Practice Guidelines?, 282 JAMA 1458, 1461-62 (1999)CrossRefGoogle ScholarPubMed (discussing limited effects of CPGs on changing physician behavior and the many barriers that can interfere with physician adherence); Office of Tech Assessment, supra note 228, at 73.

305 Erwin M. Brown, Interventions to Optimise Antibiotic Prescribing in Hospitals: The UK Approach, in Antibiotic Policies, supra note 175, at 159 & 163; see also Peter Gross, Guideline Implementation: It Is Not Impossible, in Antibiotic Policies, supra note 175, at 15-17.

306 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; Gonzales, Ralph 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)CrossRefGoogle ScholarPubMed (discussing CDC-initiated guidelines).

307 CDC: Campaign To Prevent Antimicrobial Resistance in Healthcare Settings, www.cdc.gov/drugresistance/healthcare (last visited Oct. 18, 2008).

308 See Brown, supra note 305, at 163-64.

309 See Mello, supra note 286, at 682-83.

310 For a discussion of various types of managed care financial incentives, see Greely, Henry, Direct Financial Incentives in Managed Care: Unanswered Questions, 6 Health Matrix 53, 57-59 (1996)Google ScholarPubMed; see generally Mark Hall, , Making Medical Spending Decisions 171-92 (Oxford University Press 1997)Google Scholar (concerning the ethical dilemmas of giving financial incentives to doctors); Marc Rodwin, Medicine, Money & Morals (1993); Orentlicher, supra note 33 (arguing opposition to financial incentives is “ultimately misguided”); Magnus, Stephen, Physicians’ Financial Incentives in Five Dimensions: A Conceptual Framework For HMO Managers, 24 Health Care Mngt. Rev. 57 (1999)Google ScholarPubMed (establishing a framework for HMOs to develop financial incentive systems).

311 See, e.g., Rodwin, supra note 310; Angell, Marcia, The Doctor As Double Agent, 3 Kennedy Instit. Ethics J. 279 (1993)CrossRefGoogle ScholarPubMed; Bloche, M. Gregg, Trust and Betrayal in the Medical Marketplace, 55 Stan. L. Rev. 919 (2002)CrossRefGoogle ScholarPubMed; Saver, supra note 264, at 150-52.

312 See Hillinger, Fred J., The Impact of Financial Incentives on Physician Behavior in Managed Care Plans: A Review of the Evidence, 53 Med. Care Res. & Rev. 294 (1996)CrossRefGoogle Scholar; Hillman, Alan L., Financial Incentives for Physicians in HMOs: Is There a Conflict of Interest?, 317 New Eng. J. Med. 1743, 1747 (1987)CrossRefGoogle Scholar (“It is human nature [for physicians] to respond to financial incentives.”).

313 See Hillinger, supra note 312.

314 Barlam, supra note 194, at 697.

315 See supra Part III.B.

316 See Latham, Stephen R., Regulation of Managed Care Incentive Payments to Physicians, 22 Am. J. L. & Med. 399, 408 (1996)Google Scholar.

317 See Hall, Mark A., Institutional Control of Physician Behavior: Legal Barriers to Health Care Cost Containment, 137 U. Pa. L. Rev. 431, 479-80 (1988)CrossRefGoogle Scholar.

318 See Magnus, supra note 310.

319 Cf. Orentlicher, supra note 33, at 174-77 (explaining the relative advantages of financial incentives compared to other cost control measures in terms of preserving the ability of physicians to provide individualized care).

320 Cf. id. at 174-76 (explaining the similar advantage of financial incentives as a cost control measure compared to payment caps on specific services).

321 See Brown, supra note 305, at 172-73.

322 See Hall, supra note 19, at 478-79.

323 See Arnold, supra note 175, at 524.

324 See generally Kahn, Charles N. III et al., Snapshot of Hospital Quality Reporting and Pay-For-Performance Under Medicare, 25 Health Affairs 148 (2006)CrossRefGoogle ScholarPubMed (discussing the Pay For Performance recommendations of the Medicare Payment Advisory Commission and the Premier Hospital Quality Incentive Demonstration rules).

325 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).

326 See Laxminarayan & Malani, supra note 131, at 115.

327 See id. at 126.

328 See Gonzalez et al., supra note 93, at 757.

329 See Laxminarayan & Malani, supra note 131, at 77 (describing such potential manipulation problems in paying physicians bonuses for appropriate antibiotic prescribing).

330 See supra Part III.B.

331 See Saver, supra note 264, at 207-10.

332 Medicare reimburses most hospitals on a prospective basis under the complicated prospective payment system. See supra Part III.B. Financial incentives for guideline compliance would need to be well coordinated with the other incentives already expressed through Medicare's prospective payment system to avoid unintended effects, such as encouraging hospitals to underreport and/or not actively combat hospital-acquired infections. Cf. Laxminarayan, Extending the Cure, supra note 131, at 125 (describing related moral hazard problems that can arise in adjusting the Medicare prospective payment system to separately code for resistant bacterial infections).

333 See, e.g., Grilli, Roberto et al., Practice Guidelines Developed by Specialty Societies: The Need for a Critical Appraisal, 355 Lancet 103 (2000)CrossRefGoogle ScholarPubMed.

334 See, e.g., Eichacker, Peter Q. et al., Surviving Sepsis – Practice Guidelines, Marketing Campaigns, and Eli Lilly, 355 New Eng. J. Med. 1640 (2006)CrossRefGoogle ScholarPubMed (sepsis guidelines criticized because a product recommended in the guidelines was manufactured by the same drug company that financially supported the guideline development); Noah, Medicine's Epistemology, supra note 228, at 423.

335 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). See Agency for Healthcare Research and Quality, NGC Disclaimer, http://www.guideline.gov/about/disclaimer.aspx; cf. Rosoff, Arnold, Evidence-Based Medicine and the Law: The Courts Confront Clinical Practice Guidelines, 26 J. Health Pol. Pol’y & L. 327, 346 (2001)CrossRefGoogle ScholarPubMed (proposing agency certification of guidelines to improve the use of guidelines in malpractice litigation).

336 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).

337 Reminders generated through electronic health record systems can help improve the quality of prescribing. See Hoffman & Podgurski, supra note 292.

338 See Bowser & Gostin, supra note 192, at 1261.

339 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); 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); Bowser & Gostin, supra note 205, at 1261.

340 See, e.g., Solomon, supra note 30, at 1901.

341 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).

342 See Ducharme, supra note 302, at 787 (2005) (discussing the related concept of “outreach visits,” a form of academic detailing, for encouraging physician compliance with pain management guidelines).

343 See, e.g., Solomon, supra note 30, at 1900 (reviewing an academic detailing study targeting unnecessary use of broad spectrum drugs levofloxacin and ceftazidime at a major reaching hospital and finding, during the detailing intervention, the risk of prescribing a day of unnecessary antibiotics was reduced by 41% for the intervention services compared with controls).

344 See, e.g., Young, Jane M. et al., Role of Opinion Leaders in Promoting Evidence-Based Surgery, 138 Archives of Surgery 785, 789 (2003)CrossRefGoogle ScholarPubMed (surgeons reported that the opinions and practices of professional peers were more likely to change their practice patterns than audits or clinical practice guidelines); Johnson, supra note 226; Soumerai, supra note 228, at 363.

345 See, e.g., St. Lawrence, supra note 191.