Making good policy decisions: a discipline we cannot afford to ignore

There is a growing discussion on blood safety decision making and on policy approaches designed to optimize value in health care generally. In this issue, Kramer and colleagues1 provide some degree of evidence regarding the broad set of qualitative factors that affect policy making in the domain of blood safety, with an emphasis on ethical considerations. They propose and apply a social science approach (based on Grounded Theory) that provides a mechanism for identifying a taxonomy of concerns that have not to date been systematically and explicitly acknowledged in the domain of blood safety. The authors effectively catalog and classify advantages and disadvantages of possible safety policies, uncertainties and risk assessment difficulties, principles, and practical obstacles to translating assessments into actual decisions. They illustrate that there are a wide variety of competing concerns, but found no universally applicable decision-making algorithms to process those concerns. The authors suggest that for realistic and productive policy making, we should have explicit awareness of the multiplicity of concerns which decision makers must confront.

These findings are strikingly consistent with the conclusions of the International Consensus Conference on Risk-Based Decision Making for Blood Safety (Toronto, 2010)2, 3 and the subsequent efforts by the Alliance of Blood Operators to produce a framework to integrate these concerns into an overall risk profile to inform the decision-making process. The notion of “framework” conveys a structured approach: a systematic methodology for setting the best course of action under uncertainty by identifying, assessing, communicating, and mitigating risk. The first purpose of the risk-based decision-making framework for blood safety (RBDM framework)4 is to optimize the safety of the blood supply by enabling the proportional allocation of finite resources to mitigate the most serious risks, recognizing that the elimination of all risk is not possible. The second purpose of the framework is to analyze and account for a series of contextual factors that affect decision making in the management of blood risks, such as social, economic, and significantly, ethical perspectives.

The central argument of the article by Kramer and coworkers is that a philosophical-ethical perspective can advance the quality of analysis; this contention has merit, especially for mesolevel and systemwide policy making. The study yielded several ethics-based decision factors: concern with safety, allocation of limited resources, opportunity cost that arises from forgoing some other morally valuable goal, considerations of justice, and potentially unique ethical duties owed to transfusion recipients. The study concludes that any systematic decision-making approach or framework should explicitly account for ethical reflection on 1) the reasonableness of the cost of a safety measure and 2) the value of transparency in public policy and that fundamental principles serve an important function in policy making. Whether viewed from a risk-based lens or an ethics-based lens, these considerations and the implications for our blood safety decision-making paradigm are remarkably similar. Kramer and colleagues suggest that it was at least in part our incapacity to address a variety of competing concerns, including political and economic ones, and weak policy-making practices that led to decision-making failures in the face of human immunodeficiency virus and hepatitis C virus. They cite various critiques of current policy-making practices and note controversy surrounding the precautionary principle and its application to blood safety issues. Such critiques also served as the genesis of the RBDM framework.

Turning first to the reasonableness of the cost of a safety measure, we have observed the evolution of decision making since the crises of the 1980s and 1990s as a movement to precautionary risk minimization through safety measures with high incremental cost-effectiveness ratios. The study yielded competing principles that assigned different (qualitative) priorities to safety and costs, but did not reveal risk or cost thresholds that were broadly recognized across or within countries. Similarly, it has been observed by Custer and Janssen5 that economic analyses of blood safety interventions in most countries have demonstrated that these interventions do not conform to broadly accepted cost-effectiveness thresholds. They show that threshold considerations need to be further developed specifically in the context of blood safety and transfusion medicine to appropriately inform the decision-making process. As noted by Custer and Janssen, there is an important link between blood safety decision making and the discipline of health economics, as a means to quantify the cost of a risk response at various levels of precaution. They assert that risk assessment, and the cost and benefits of mitigating risk, should serve as complementary evidence in the decision-making process and in the selection of risk management options for optimal patient outcomes. Their recommendation that both budget impact and cost utility be evaluated is premised on the notion that allocating finite resources to the most serious risks requires an understanding of the inherent opportunity cost. Herein lies a primary rationale for the contention that the discipline of ethics can make a significant contribution. While various areas of ethics literature are pertinent to blood safety decision making, particularly germane to the realm of cost-effectiveness is the growing interest in the ethical implications associated with allocation of limited health resources and the need to synthesize “evidence, economics, and ethics.”6-8

The second ethics-based element noted as relevant is the value of transparency in public policy. Decisions about blood safety risks and the allocation of resources directed to mitigation are inherently societal in nature, leading to a clear requirement for transparency in decision making. Those of us who are entrusted with the operation of the blood system are accountable for safe, efficient, transparent, and ethical decision making. Credibility in these areas requires that stakeholders understand and contribute to decisions that affect them. In addition, like all managers of public risks, we stand to benefit from stakeholder input that enhances the information base for decision making. As a result of genuine engagement, mutual trust can emerge that strengthens the decision and its implementation and lays the groundwork for future decisions as well. A decision framework can help to navigate stakeholder identification, assessment, and engagement on considerations such as risks, opportunities, alternate solutions, unintended consequences, resources, and implementation implications.

Transparency and optimal input also play into determinations of overall risk acceptability or tolerability in the context of patient and donor safety. Taking a principled approach to risk tolerability, it is recognized that 1) each individual has a legitimate expectation of protection from the high risks of societal activity; 2) individuals are expected to tolerate reasonable risks for societal benefits of an activity; and 3) individuals and society should be provided with information on the risks to which they are exposed, for their own and broader societal benefit. Therefore, a tolerable risk is one that is justified by the benefits gained, managed at a level that is proportional to the risk and the benefits that accompany it, fairly distributed to the extent possible, and borne knowingly. While these principles are relatively easy to understand and accept at a conceptual level, they are challenging to implement in real-time decision making. Decision frameworks can assist by proposing the relevant questions and processes that can move us closer to articulating the tolerability of any given risk or set of competing risks. The contribution that an ethics-based approach can provide is to help structure the public discourse9 about a blood safety risk or policy issue. For example, ethical rationales for risk communication are based not only on the effectiveness of the decision making at the system level but also on obligations at the individual level such as the principle of informed consent.10

Even if we accept as relevant the principles surrounding the reasonableness of the cost of a safety measure and the value of transparency in public policy, it is often challenging to determine the precise function of fundamental principles in policy making. Kramer and colleagues hold that principles should not be decision rules. Rather, they suggest that key ethical principles should inform the exercise of the decision maker's judgment in a specific context, “serving primarily to elucidate normative dimensions of candidate decisions rather than to dictate outcomes.” Similarly, the RBDM framework articulates a series of risk management principles (several of which are ethics based) to inform the risk-based decision-making process: beneficence, fairness, transparency, consultation, evidence and judgment, practicality and proportionality, continuous improvement, and vigilance. To apply these principles and concepts in day-to-day decision making, we must be able to account for the complexity of our decision-making environment: emerging risks, evolving technology, societal shifts, economic constraints, and risk trade-offs across competing risks.11 Whether ethics based or risk based, it is of course not enough to articulate the principles alone. Any systematic decision-making approach for blood safety must offer scalable, practical tools for the evaluation of interventions from the perspectives of individual patient safety, population health, and the broader health care system and its sustainability.

Regardless of one's vantage point, the rationale for a course correction in blood safety decision making continues to become more compelling, given various market, policy, and demographic forces: changes in blood product demand; successful patient blood management efforts;12 an aging population with increased medical care needs and associated costs;13 fewer resources available for innovation, continuous improvement, and risk mitigation; and the need to align to a more holistic view of health care value, across the domains of patient outcomes, population health, and cost-effectiveness.14 Budget challenges that limit our ability to mitigate all possible risk are not new. But in an environment where overall health care costs are viewed as unsustainable, a clear pathway, based on patient outcomes, is necessary for choosing between alternative ways of expending limited resources to achieve the greatest societal benefit.15 It is therefore timely to discuss and debate the questions that can lead us to improved decision making for blood safety.

CONFLICT OF INTEREST

The author has disclosed no conflicts of interest.