Are ASPs a form of bedside rationing?

The first claim to be proved is that ASPs are in fact a form of bedside rationing. I adopt the definition of bedside rationing from Ubel and Goold, which includes three criteria:10

1. Clinicians must withhold, withdraw or fail to recommend a service that, in their clinical judgment, is in the patient’s best medical interests.

2. They must do so primarily to promote the interests of someone other than the individual patient.

3. The clinician must have control over the use of the medically beneficial service.

The first condition is required for an action to be considered an act of rationing: an individual patient's immediate interests must be compromised. The second and third criteria are required for such rationing to be considered of the ‘bedside’ variety, as opposed to a form of rationing imposed on clinicians by external forces. I address each of these three criteria in turn.

To meet the first criterion requires the demonstration that ASPs result in the withholding or withdrawal of care that is in the patient's best medical interest. For critically ill patients, failure to initiate appropriate broad-spectrum antibiotics is associated with an increase in mortality. But even in the most severe infections, a positive culture result indicating which organism is causing the infection occurs in less than two-thirds of cases.11 In the remainder, the use of antimicrobials remains ‘empirical’, that is, the ‘best guess’ of which organism is causing the illness. By narrowing the spectrum and decreasing the dose or duration of antimicrobial therapy, ASPs theoretically put individual patients, especially those being treated empirically, at risk of treatment failure or infectious relapse. Although all patients, including those currently receiving antibiotics, may benefit in the long term from the continued effectiveness of antimicrobials, this assumes the individual will survive long enough to enjoy this benefit. Although critically ill patients are generally too sick to make their immediate interests known, it is reasonable to assume that for most people, an increased likelihood of short-term survival would likely be of higher priority than theoretical future benefits of antimicrobial effectiveness. Thus, for the clinicians and families making decisions on the patient's behalf, when ASPs recommend that a physician narrows the spectrum or shortens the duration of antibiotics, this seems to be rationing, on balance, against the patient's immediate best interests, thereby fulfilling criterion.1 Further emphasising the concept of ASPs as rationing is the recognition of physician concerns about rationing as a potential barrier to the implementation of ASPs.12 However, as I note below, this rationing may be ethically justified.

The second two criteria are more straightforward to demonstrate. ASPs have been shown to result in lower costs for hospitals13 ,14 and to result in lower rates of AROs,14 ,15 both of these are clearly of benefit for hospitals, and future patients. Neither directly promotes the interests of the individual patient whose care is being managed by the ASP (although if the patient is fortunate enough to survive the current illness, and unfortunate enough to get another infection, he/she stands a chance of benefitting from reduced rates of AROs). Finally, as to the third criterion, ASPs are distinct from other forms of antimicrobial rationing because they are meant to be a part of the bedside decision-making of individual clinicians. According to the IDSA guidelines, the first core strategy of ASPs is the ‘audit of antimicrobial use with direct interaction and feedback to the prescriber, performed by either an ID physician or a clinical pharmacist with infectious diseases training’. The second core strategy is formulary preauthorisation, where the approval of the ID physician or pharmacist is required to gain access to an antimicrobial. In both cases, the treating physicians jointly have the discretion to prescribe or limit the therapies used, and decide in what cases rationing is to be used, thus fulfilling the third criterion.

In summary, the core strategies of ASPs are a form of bedside rationing, where clinicians limit the antimicrobials that are used, in order to lower costs and prevent the development of AROs. Although many clinicians are wary of bedside rationing, it has been argued that such rationing is a necessary part of modern healthcare.16 The progressive acceptance of ASPs since their introduction in the 1980s5 may be due to the fact that despite clinician reluctance to participate in bedside rationing, ASPs are a fair, ethically sound example of the practice. In the next section, I will explore how ASPs meet many of the ideal qualities of healthcare rationing.

A model for rationing healthcare resources

One of the most widely accepted models for healthcare rationing is that described by Norman Daniels, called ‘AFR’, the premise of which is that the moral legitimacy of healthcare rationing decisions depends on the process that is used to set them as much as the identity of the decision-maker or the rationing outcomes.9 According to AFR, there are four requirements for a rationing process to be considered fair:17

1. Publicity condition: decisions and rationales must be publicly accessible.

2. Relevance condition: must appeal to reasons and principles which can be generally agreed on are relevant.

3. Appeals/revision condition: provision of a mechanism for dispute resolution or revision of decision.

4. Enforcement condition: regulation of the process to ensure that criteria 1–3 are met.

As laid out in the IDSA guidelines, ASPs fulfil all of the AFR criteria, and can thereby serve as a model bedside rationing. I will address each criterion below.

Are ASPs an effective form of rationing?

The AFR criteria are not merely conditions for fair rationing, but they also prerequisite for an ASP to be a clinically effective form of bedside rationing. An ASP which is not public in its decisions, does not value the relevance of individual patient care, and provides no mechanism for clinicians to appeal rationing decisions on behalf of individual patients is unlikely to succeed, as clinicians ‘game’ the system. Ubel identifies this concern as one of the reasons why rationing decisions must be made at the bedside rather than be imposed on clinicians.16 Hence, the real test of whether or not the AFR criteria are effectively and appropriately met can be determined in part by determining whether ASPs effectively meet their desired clinical goals. For instance, an ASP where the HCPs refuse to limit antimicrobials and increasing rates of AROs signifies that the process itself may not be perceived by HCPs as fair and its methods re-evaluated. Perhaps the HCPs require education on the long-term benefits of the ASP, or a clearer appeals mechanism to decide when to not restrict antibiotics. For these reasons, I would argue that other incentives (financial, administrative, etc) not be routinely used to encourage HCPs or ASPs to meet targets. The potential for conflict of interest in bedside rationing is too great, and the stakes too high to further conflate the interests of the HCP and the patient for whom decisions are being made. Such incentives effectively destroy the ‘veil of ignorance’ and violate the relevance criterion—remuneration of HCPs is not relevant to the interests of the patient.

Thankfully, there have been many studies of the implementation of ASPs which can address concerns about their use.24 ASPs appear to be effective in reducing costs in the long term13 and in preventing the development of AROs without resulting in worse clinical outcomes.14 This success has been shown to translate into multiple centres,14 ,15 ,23 and ASPs are gradually becoming part of the standard of care in ICUs.6 Hence, ASPs are likely one of the most effective models of bedside rationing, demonstrating both fair process as described by AFR, and excellent outcomes as a result of well-monitored rationing, with a minimal impact on the care of individual patients. Potential compromise of individual patient care in the short term can pay off over time with improved outcomes for the critically ill population in general.

Rejecting ASPs as a form of bedside rationing

There are a few concerns some may have with this interpretation of ASPs. Some may dispute that ASPs are really a form of bedside rationing at all, given that the emerging data from ASPs finds that patient outcomes are no worse following the implementation of an ASP—according to Ubel's first criterion, bedside rationing must be a decision to withhold or withdraw care that is in an individual patient's best interest. In fact, in some cases ASPs have resulted in improvements in patient outcomes, such as a lower risk of Clostridium difficile infections secondary to inappropriate antibiotic use.25 ,26 However, we must distinguish between the effects of ASPs on populations of critically ill patients and on individual critically ill patients. The purpose of ASPs is to improve the health of the entire critically ill population. The failure to demonstrate such improvements would be a failure of ASPs. The benefits ASP demonstrate for the health of populations does not diminish the risk that they pose to individual patients within that population—they are the ones who carry the burden of risk, by receiving a shorter dose or narrow-spectrum antibiotic with uncertain effects on their personal health—such patients need to survive their initial illness before they could possibly benefit from the reduced risk of AROs or secondary infections which ASPs can provide. Hence, ASPs withhold or withdraw care that is in the individual patient's best interest and puts them at short-term risk, although there is a theoretical long-term benefit if those risks are well managed and the patient survives. The success of ASPs does not discredit the claim that they are a form of bedside rationing, but rather indicates that they are a successful form of bedside rationing.