The Precautionary Principle Has No Role In Infection Control
In April 2000, a paper in the Journal of the Canadian Dental Association advocated "overkill" when performing infection control in the dental office. 1 The article was based on the premise that, although the risks of acquiring infections are unknown, strict infection control does not demand proof of success but simply the incorporation of an uncertain amount of non-defined "overkill" into current recommendations. The moralistic theme of the article concluded by the author stating that, "It is better to be safe than sorry."1 The concept proposed by the author is a prime example of the Precautionary Principle.
The purpose of this article is to refute the role of the Precautionary Principle in infection control.
The Precautionary Principle
The Precautionary Principle (PP) has numerous definitions. They tend to be variations of the "Wingspread Consensus Statement" drafted in 1998. It states that, "When an activity raises threats of harm to human health or environment precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically."2 Governments and similar authorities use the PP to regulate risks. This occurs despite the fact that all scientific conclusions are subject to revisions and that not one is ever fully established. 3
At first blush, the PP appears to be a sensible approach. After all the "Better safe than sorry" or "Look before you leap" catchphrases are commonly applied to everyday occurrences. However, an analysis of the PP's underlying philosophy reveals numerous inherent faults. One of the Principle's major detractors is Cass R Sunstein -- the most cited law professor in the United States. In his article, "The Paralyzing Principle" and in his 2005 book, "Laws of Fear: Beyond the Precautionary Principle" he effectively eviscerates the PP. 4,5 His thesis is that the PP offers no guidance because it either endorses taking no action (because to do so would incur worse risks) or, especially in worse case possibilities, adopting wide-ranging usually limitless actions. The latter occurs because of the assumption that we are able to identify safe and effective options even though we are profoundly ignorant of their probable outcomes.
As a consequence, the outcomes invariably create risks or unfavourable results that necessitate further precautions. In turn, these produce an increasingly complex maze of recommendations and regulations that have little relationship to the original risk. Sunstein is of the opinion that, "The problem with the Precautionary Principle is not that it leads in the wrong direction, but that -- if taken for all it is worth -- it leads in no direction at all."4
In other words, since all policies and actions generate risks the PP fails because precautions against some risks almost always create other risks. 5 Employing the PP to develop policies or solve problems is meaningless since it is of no help whatsoever. Whyte is of the opinion that, "Those who invoke it in support of their favoured policies do not display their prudence; they reveal groundless biases."6
The fundamental fault with the PP is that it justifies action without evidence. It permits those without evidence to shape and influence policy decisions by introducing moral and ethical elements into what should be a scientific decision making process. 7 As will be demonstrated the use of "overkill" to justify infection control regulations is a prime example of all that is wrong with the Precautionary Principle.
Infection Control
In their 1991 landmark study Goodman and Soloman demonstrated the rarity of the transmissions of infectious diseases in outpatient health settings including dental offices. 8 In 1997 Lee emphatically stated that, "for some settings, such as most ambulatory care and behavioural health settings the theoretic risks of the most common nosocomial infections found in acute care settings are almost nonexistent."9
These investigators do not believe that the transmission of an infectious disease from a dental environment is a frequent or common occurrence -- an idea supported by the Administrator of the Cochrane Collaboration: Oral Health Group.
In a recent personal communication he admitted that the transmission of infection during dental treatment is at such a low level of frequency that it is not possible to conduct evidence-based systematic reviews of the effectiveness of the precautions advocated in dental infection control.10 (This opinion questions the validity of the combined statement made in September 1996 by the CDA, the ODA and the RCDSO that they had, "some time ago developed evidenced-based guidelines on the use of universal infection control precautions."11)
Most critics of the PP agree that it has some merit if the probability of a problem occurring is high and the proposed preventative measures have been proven to be appropriate, accurate and effective. 7 The above examples demonstrate that the Precautionary Principle has no application to infection control in dentistry. However, there are other reasons for arriving at this conclusion.
The author of the "overkill" paper states that since, "we do not have strong evidence to support all of the recommendations for infection control" we must rely on data that, "establishes some degree of potential for cross-infection."1 He contends that the potential for cross-contamination is resisted by introducing "overkill" into infection control recommendations thus making them, "too safe."1 The fallacy of this approach is that it is not possible to determine if the "overkill" practices are safe and effective since they are being taken against unknown perhaps non-existent risks. In such an environment it is impossible to determine when "safe" levels have been reached.
Nevertheless, the Precautionary Principle demands that more and more precautions are adopted against more and more potential infectious risks without knowing if the actions will reduce the risks to safe levels (whatever these are since they have not been defined) or create, as yet, unforeseen and unintended consequences.
According to Sunstein's view of the PP these consequences could force the adoption of an escalating number of precautions until the ability to conduct dentistry in an efficient, effective and economically viable environment is severely compromised. For example, implementing extensive and time-consuming infection control recommendations will increase practice overheads.
Unless dentists are prepared to absorb these costs the necessary fee increases may deprive patients of treatment. Alternatively, if fees are not increased the inevitable decrease in income levels may reduce the intake to dental schools again limiting access to dental care. Indeed, if the PP is taken to its logical conclusion the only way to achieve the exalted goal of absolute safety is to avoid practicing dentistry!
Another reason for doubting the validity of the PP is the failure by the author of the 2000 article to place any limits on the extent of "overkill" or to define what is meant by "too safe."1 This absence permits the "overkill" philosophy to be applied freely to all perceived or theoretical risks since presumably it is the only way of obtaining patient safety. However, since there are no criteria to assess the achievement of "safety" it is a flawed concept but one that may be attractive to regulatory agencies charged with preventing infectious disease transmission from dental offices.
The "overkill" concept fails to acknowledge the advice offered in 1995 by Epstein and Mathias. 12,13 They identified that one of the principles of infection control is that, "precautionary procedures must be based on a demonstrated risk of infectious disease transmission, and not on a theoretical risk alone." In addition, they noted that the precautionary procedures must be demonstrated to be effective in a clinical environment.
The "overkill" concept is based entirely on theoretical assumptions. Indeed, the author admits that, "All of these unknowns tend to foster a certain level of "overkill" at all stages of infection control."1 In addition, since "too safe" is not defined there is no way to determine if the "overkill" procedures are clinically effective. According to Epstein and Mathias the "overkill" philosophy, i. e., the Precautionary Principle, is not one on which to build a rational infection control policy.
The "Better safe than sorry" approach to infection control might appeal to those adopting the moral high ground. However, in practical terms it is doomed to failure. In attempting to attain the elusive quality of patient safety it forces the creation of an infinite number of precautions with no definable end point.
The mass of recommendations produced by this approach might be attractive to regulators but completely frustrating to the dentists forced to implement them and of limited value to their patients. Indeed it could be argued that the potential environmental hazards stemming from the recommendations will create yet another escalating series of precautions. Since the Precautionary Principle provides no useful direction it is no wonder that Sunstein and others believe that it is useless since it provides no guidance when making difficult decisions.
According to Sunstein, "a rational system of risk regulation certainly takes precautions. But it does not adopt the Precautionary Principle."4 The low risk of disease transmission in dentistry warrants a few simple but clinically effective precautions.
Conclusion
To err on the side of caution has a simplistic sensible appeal infused with overtones of political correctness and moral certitude. Unfortunately, the Precautionary Principle is neither simple nor sensible. It is not simple because regulating risk is a complicated affair that includes cost-benefit analyses, inevitable trade-offs and some evidence beyond mere speculation.
It is not sensible because all actions create risks thus it is impossible to achieve zero risk or a safe environment. Therefore, the "overkill" philosophy will not produce a "too safe" haven. Instead it illustrates that its advocate is recommending an action to be morally and scientifically correct when he is ignorant of its likely effects.
Proponents of using the Precautionary Principle to develop infection control recommendations should be aware of the warning made by Professor Frank Cross of the University of Texas, "The truly fatal flaw of the precautionary principle, ignored by almost all commentators, is the unsupported presumption that an action aimed at public health protection cannot possibly have negative effects on public health."2
With this in mind it would be prudent for those developing infection control recommendations to base their decisions on the advice offered by Epstein and Mathias. This needs to be tempered by the knowledge that according to the Cochrane Collaboration there are no systematic reviews of the clinical effectiveness of infection control procedures. Policy makers should not ignore the valuable practical experience that clinical dentists bring to the decision making process. However, all should ig nore the "overkill" philosophy that will produce a surfeit of never ending recommendations, time-consuming procedures and unlimited expenses. "Overkill," which dentists and their patients can do well without.
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Dr. John Hardie, an oral pathologist, has been the Head of Dentistry at major teaching hospitals in Ottawa, Vancouver and Riyadh, Saudi Arabia. Most recently he was the Director of Dental Services for a large health trust in Northern Ireland.
Oral Health welcomes this original article.
References
1. Petty, T. Accepting the Need for "Overkill" in Infection Control. J Can Dent Assoc 2000; 66(4): 186-187
2. Adler, JH. Dangerous Precautions. National Review Online, September 13th, 2002. Available: www.nationalreview.com/script/printpage. p?ref=/adler/ adler091302.asp
3. Bailey, R. Precautionary Tale. Reasononline, April 1999. Available:www.reason.com/news/printer/30977.html
4. Sunstein, CR. The Paralyzing Principle. Regulation Winter 2002-2003. 5. Sunstein, CR. Laws of Fear:Beyond the Precautionary Principle. Cambridge University Press, New York, 2005.
6. Whyte, J. Only a reckless mind could believe in safety first. Timesonline, July 27th, 2007. Available: www.timesonline.co.uk/tol/comment/columnists/guest_contributors/article2148188
7. Durodie, B. The Precautionary Principle Assumes That Prevention Is Better Than Cure. Spiked March 16th, 2004. Available:www.durodie.net/articles/spiked/20040316precautionaryprinciple.htm
8. Goodman, RA, Soloman SL. Transmission of Infectious Diseases in Outpatient Health Settings. JAMA 1991; 265(18): 2377-2381.
9. Lee, TB. Surveillance in Acute Care and Non Acute Care Settings: Current issues and concepts. Am J Infect Cont 1997; 25(2): 121-124.
10. Personal communication from Philip Riley, July 9th, 2008.
11. CDA, ODA and RCDSO Clarify Guidelines on Universal Precautions and the Application of the Human Rights Code. RCDS Dispatch 1996; 10(3).
12. Epstein, JB, Mathias RG, Gibson GB. Survey to Assess Dental Practitioner's Knowledge of Infectious Disease. J Can Dent Assoc 1995; 61(6): 519-525.
13. Gibson, GB, Mathias RG, Epstein JB. Compliance to Recommended Infection Control Procedures: Changes Over Six Years Among British Columbia Dentists. J Can Dent Assoc 1995; 61(6): 526-532.
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ABSTRACT
The Precautionary Principle is one that mandates erring on the side of caution. This "better safe than sorry" approach has been recommended as the foundation on which infection control protocols are developed. However, the numerous faults in the Principle are such that it should be avoided when making policy decisions. This article will describe these shortcomings in relationship to infection control in the dental office.
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Employing the Precautionary Principle to develop policies or solve problems is meaningless since it is of no help whatsoever
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If the Precautionary Principle is taken to its logical conclusion the only way to achieve the exalted goal of absolute safety is to avoid practicing dentistry!
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Therefore, the "overkill" philosophy will not produce a "too safe" haven
