ORIGINAL ARTICLE
Triage in times of drug shortage Jennifer Flynn, PhD1; Katherine Chubbs, RN, BN, MHS, CHE2; Susan Gladney-Martin, MHS2; Rick Singleton, PhD2; and Daryl Pullman, PhD1
Healthcare Management Forum 2015, Vol. 28(5) 202-205 ª 2015 The Canadian College of Health Leaders. All rights reserved. Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0840470415588677 hmf.sagepub.com
Abstract This paper addresses the current drug shortage, and examines the ethics framework for dealing with drug shortages developed by our organization. That three-step allocation process and framework was published previously in this journal. Specifically, this paper offers a rationale and justification for the framework’s second step, which involves a triage process aimed to ensure that the available drug supply is utilized effectively and ethically.
Introduction In the fall of 2014, healthcare providers across Canada were ´ (BCG), informed of a short supply of Bacillus Calmette-Guerin a drug used to control the symptoms of bladder cancer. Without it some patients could require surgery to remove their bladders. The BCG shortage is one of the latest examples of a recurring problem in both Canada and the United States, as ongoing shortages of essential pharmaceuticals threaten the normal functioning of the healthcare system.1 When the plant that manufactures 80% to 90% of generic injectable drugs used in Canada massively slowed production in February 2012 (note 1),2 it was considered an extraordinary though hopefully temporary situation. However, that incident confirmed what reports from the Canadian Agency for Drugs and Technologies in Health,3 the Canadian Pharmacists Association, and the US Food and Drug Administration4,5 had been predicting, namely, an escalation in drug shortages and ongoing supply problems. Drug shortages are now the new normal for healthcare providers. In response to ongoing chronic shortages of essential drugs, healthcare institutions across the country have scrambled to devise policies and procedures to manage the allocation of these essential resources. The clinical ethics group at the Eastern Regional Health Authority in Newfoundland and Labrador (EH) has been working with clinical leaders within the organization to develop an ethics framework for dealing with drug shortages, including an allocation process for drugs in short supply. Historically, EH has utilized its ethics group widely at the organizational level, and it was instrumental in developing EH’s corporate values statement. Engaging the ethics service in broad policy issues on an ongoing basis ensures that the corporate values are operationalized in the day-to-day management of the organization. Resource allocation decisions are often emotionally and politically charged, and this is particularly so in times of crisis. Providing an ethically defensible framework for decision-making not only assists frontline staff in making difficult decisions under duress but it can also aid an organization in avoiding the perception that decisions are made in an ad hoc fashion.
The initial involvement of our ethics service in crisis allocation decisions occurred with regard to H1N1 planning.6 We have continued to develop and adapt our process as other allocation crises have arisen. In response to the ongoing drug shortage, EH developed a three-step allocation process and framework that was published previously in this journal (note 2).1 Briefly, the three-step allocation process includes: (1) an ‘‘efficient drug utilization’’ first step that involves efforts to procure alternate drugs and to redistribute available stock: and (2) an ‘‘optimization of therapeutic benefit’’ second step that triages patients to ensure that the available supply is utilized effectively and ethically based on available evidence. This process involves establishing a hierarchy of priority among relevant patients and a particular decision-making procedure. In the event the triage process fails to determine a clear ‘‘winner’’ in terms of which patient should receive the limited supply of a scarce drug (ie, two or more patients fulfill the triage priority criteria), we would move to (3) a ‘‘fair access’’ third step involving a random draw. In what follows, we offer a rationale and justification for some of the more controversial aspects of this model, particularly as it pertains to the second optimization of therapeutic benefit step.
The initial triage process: Our first priority list The triage process is initiated when efforts to conserve and/or reallocate the existing supply of drugs (our first ‘‘efficient drug utilization’’ step) fail to prevent the situation in which immediate demand for a particular drug is greater than the current and foreseeable supply. Our ethical responsibility in such a 1
2
Faculty of Medicine, Memorial University, St John’s, Newfoundland and Labrador, Canada. Eastern Health, Health Sciences Centre, St. John’s, Newfoundland and Labrador, Canada.
Corresponding author: Jennifer Flynn, Faculty of Medicine, Memorial University, Newfoundland and Labrador, Canada. E-mail: [email protected]
Flynn, Chubbs, Gladney-Martin, Singleton and Pullman circumstance is to maximize the therapeutic benefit of the drug in question using evidence-based rationing. Thus, our first priority patients are those the evidence indicates have the greatest likelihood of benefiting from the drug and for whom there are no other therapeutic options. Available evidence would also indicate that not receiving the drug could have severe and adverse health consequences. Patients who are considered second priority in our triage process fulfill the criteria of first priority patients except that they have other therapeutic options, even though available evidence indicates that such options would be considered suboptimal. Third priority patients also have urgent or emergent medical needs, but they differ from second priority patients in two important respects. First, unlike second priority patients, patients in this category do not have other therapeutic options. It is the second difference, however, that is particularly relevant to this triage process. For this group of patients the available evidence on the effectiveness of the drug in question for their medical condition is equivocal at best. We provide a rationale for how we arrived at this prioritization ordering in the discussion to follow. While we expect this initial triage process will be adequate for the majority of cases, a situation could arise in which there is still an inadequate supply of a drug for two or more patients at the same stage on this priority list. In such cases, the goals of treatment would need to be considered and a second priority list consulted.
203 possible that two or more patients will need a drug in short supply as a life-saving treatment or intervention. All other things being equal, our framework suggests that should such a situation arise, an allocation decision can be based on age. The broader rationale in support of this decision is discussed in the next section as well. Second priority patients under goals of treatment are those for whom treatment is intended to manage pain. Triage decisions regarding patients who require drugs in short supply for pain and symptom management should consider the severity of patients’ pain, the patients’ ability to cope with pain, the potential of the drug to manage patients’ pain, and that some treatments falling into this category involve terminal patients with severe pain. Triage decisions regarding allocation of pain and symptom management require consideration of the physical, spiritual, and psychosocial needs and resources of the individuals as well as balanced and fair processes to compare the needs of two or more patients. One can only imagine the challenges in deciding between a child with severe postorthopedic surgery pain and a terminally ill senior with bone cancer. The third priority in this goals of treatment supplemental triage process are patients for whom treatment is intended to manage an illness. As always, decisions about which patients should receive a drug in short supply should be evidence based. Evidence-based drug usage ought to take priority over off-label usages. Not surprisingly, drug allocation decisions should anticipate that drug treatment will likely result in improvement of quality of life and/or long-term life expectancy.
Our supplemental priority list: Considering goals of treatment
Discussion
Consider the case in which a particular drug is in short supply and there are two patients in need of it but only enough for one. Further, assume that both are first priority patients, according to our initial triage process. That is, the evidence suggests that both would benefit from the drug, not getting the drug could have severe consequences, and there are no therapeutic alternatives for either patient. In such an instance, we would move to a second priority list that considers the goals of treatment. The supplementary ‘‘goals of treatment’’ triage process applies to multi-purpose drugs that can be used for a range of therapeutic purposes. Various drugs fit into this category. Consider, for example, propofol, which functions in a lifesaving capacity when it keeps a patient sedated through lifesaving surgery. In a less acute circumstance, propofol might be used to consciously sedate a patient, making a patient comfortable yet responsive, crucial for the administration of certain sorts of treatments. In the latter case, propofol’s use would be considered maintenance (ie, illness treatment) rather than acute (ie, life-saving). Heparin is another example of a multi-purpose drug that can be life-saving when used as a thrombolytic to breakup a blood clot but might also be used in another instance for pain management. When we consider goals of treatment, first priority goes to patients for whom treatment is intended to be life-saving. It is
As noted at the outset, the purpose for developing an allocation process is to provide a rational basis for ethical decisionmaking under conditions of duress. Inasmuch as ready access to pharmaceuticals is considered the standard of care across the healthcare spectrum, any decision to allocate drugs in short supply to some patients while denying them to others requires some justification. Developing our two-stage triage process involved extensive discussions about how to justify prioritization decisions at various key junctures in the process. Here we offer the rationale and justification for some of the more sensitive and controversial decision points in that process. As it pertains to the initial triage process, some might question why patients with other therapeutic options (our second priority patients) would be given priority over patients who have no other options (our third priority group). Here we emphasize again the importance of evidence-based rationing in the triage process. According to the available evidence, both first and second priority patients in the initial triage would benefit from the drug in question, but the evidence of therapeutic benefit for the third priority patients is equivocal at best. Evidence-based rationing requires that the scarce resource in question be allocated where it is judged to be most effective. Thus, although our second priority patients have other suboptimal options available, the evidence suggests the scarce
204 resource is better utilized for them than it would be for patients in our third priority group. Our initial triage process prioritizes patients on the basis of the evidence of a drug’s effectiveness in treating a patient’s condition irrespective of the goals of treatment. That is, if there is strong evidence (ie, evidence acquired through randomized controlled trials) indicating that a drug in short supply was very effective in pain and symptom management, but only anecdotal evidence suggesting it might also be disease modifying such that it could extend a patient’s life, our initial evidence-based triage process would prioritize pain management over life extension in that case. That is, evidence-based rationing suggests it would be unethical to allocate a scarce drug on the basis of anecdotal evidence that it could possibly extend a patient’s life when there was solid evidence that it would almost certainly be effective in managing pain. However, if the initial triage process fails to distinguish between two or more patients based on the available evidence of a drug’s effectiveness, our second priority list invokes goals of treatment to help resolve the issue. Perhaps the most controversial aspect of our supplemental goals of treatment triage process involves age-based rationing in instances where two or more patients are triaged to the same level in the process but where there is only an adequate supply of medication for one of them. In the hypothetical scenario we described earlier, the initial triage process has identified two patients for whom the drug in question would be life-saving and for whom there are no alternative interventions available. ‘‘All things being equal,’’ we state, age can be used as a criterion. The age rationale is often described in the literature as ‘‘the fair innings principle’’ or ‘‘the life cycle principle.’’ The established and acceptable rationale is that death seems more tragic when a child or young adult dies than when an elderly person dies. This is because children and young adults have not had the chance to live and develop through all of life’s stages and not because the lives of older people are somehow less valuable (note 3).7 The fair innings principle supports allocating resources to those who are at an earlier stage in the life cycle. It does not favour younger persons over older persons in absolute terms, but rather those in an earlier phase in the life cycle relative to other patients with the same prognosis. The general moral intuition that suggests we should favour children over adults in life-threatening crisis situations was borne out in a community consultation process we undertook while developing this framework. Participants voiced support of the high priority to protect and rescue children and youth. Although we begin our description of age-based rationing with the statement all things being equal, all things are seldom equal in the healthcare context, particularly when it comes to comparing the relative health of individuals at various stages in the life process. Elderly patients, for example, generally suffer from more co-morbidities than do children or younger adults. This will affect their ability to respond to any medical intervention. Again, evidence-based rationing would suggest that the patient most likely to benefit from the intervention should receive the drug. In the hypothetical scenario described earlier, both patients are ostensibly at the same priority in the triage
Healthcare Management Forum process; both require the drug in question and not getting it could have severe health consequences, and there are no other options. Our second goals of treatment has also failed to settle the issue, as the drug is considered to be life-saving for both patients. It is only in such a rare situation that age might serve to break the tie for both the evidentiary (eg, younger patient has less co-morbidities; children may need a smaller dose of the drug in short supply) and conceptual (eg, ‘‘fair innings’’) considerations discussed earlier. We should emphasize that according to our framework, age alone will never be the determining allocation factor. Further, age would be considered only in a crisis situation, and it appears in our triage process only at a point where our first process has failed. The likelihood of the triage process reaching this second stage, and of the patients in question requiring the drug for the same treatment goal, is slim at best.
Conclusion We have described the way our organization plans to handle situations in which the need for particular drugs outstrips the supply. In particular, we have discussed our two-stage triage allocation process for drugs in short supply and offered some of the ethical rationale underlying those processes. Our organization is utilizing this framework in dealing with the a BCG shortage and has decided that for the time being the available supply will be used only for initial treatment of newly diagnosed patients, while maintenance doses of the drug will no longer be offered. Although not a drug allocation issue per se, our evidence-based criterion for resource allocation decisions is forcing us to reflect as well on the resources currently being diverted into Ebola preparedness, as we question whether the degree of the response is disproportionate to the current risk. Having an ethics framework and a triage process will not resolve every difficult resource allocation decision we face in the years to come. These are only tools to aid in sorting through some of the complexities, not algorithms that replace the sensitive and nuanced discussion that must occur in each critical situation. Nevertheless, developing these tools allows us the luxury of thinking through such complexities and considering appropriate rationales and justifications in advance. As drug shortages continue to be a challenge not only within our region but across North America, we hope others in the position of dealing with the challenge can learn from our work. The work we have done and continue to do on scarce drug allocation has far-reaching implications. Our work is relevant not only across healthcare organizations but across a variety of challenges that involve difficult crisis allocation decisions. Notes 1. See Kaposy’s article for a description of the events leading up to the shortage as well as an argument regarding the ethical problems with generic drug shortages.
Flynn, Chubbs, Gladney-Martin, Singleton and Pullman 2. The article by Singleton et al. provides a general description of our framework. The introduction offers a description of the drug shortage situation. 3. In Emanuel and Wertheimer’s 2006 discussion of vaccine allocation, the authors suggest the life cycle principle as a way of allocating vaccine in short supply.
References 1. Singleton R, Chubbs K, Flynn J, et al. From framework to the frontline: designing a structure and process for drug supply shortage planning. Healthcare Management Forum. 2013; 26(1):41-5. 2. Kaposy C. Drugs, money, and power: the Canadian drug shortage. J Bioeth Inq. 2014;11(1):85-89. 3. Canadian Agency for Drugs and Technologies in Health (2011). Drug Supply Disruptions: Environmental Scan.
205
4.
5.
6.
7.
Available at: http://cadth.ca/prodcuts/environmental-scanning/ environmental-scans/environmental-scans-18. Accessed October 12, 2012. Canadian Pharmacists Association (2010). Canadian Drug Shortages Final Report. Available at: http://www.pharmacists.ca/ cpha-ca/assets/File/cpha-on-the-issues/DrugShortagesReport.pdf. Accessed 14 October 2012. US Food and Drug Administration (2011). A Review of FDA’s Approach to Medical Product Shortages. Available at: http:// www.fda.gov/downloads/aboutfda/reportsmanualsforms/reports/ ucm277755.pdf. Accessed 8 October 2012. Kaposy C, Bandrauk N, Pullman D, Singleton R, Brunger F. Adapting the Hamilton Health Sciences critical care pandemic triage protocol. Healthc Q. 2010;13(2):60-63. Emanuel E, Wertheimer A. Who should get influenza vaccine when not all can? Science. 2006;312(5775):854-855.
Triage in times of drug shortage Jennifer Flynn, PhD1; Katherine Chubbs, RN, BN, MHS, CHE2; Susan Gladney-Martin, MHS2; Rick Singleton, PhD2; and Daryl Pullman, PhD1
Healthcare Management Forum 2015, Vol. 28(5) 202-205 ª 2015 The Canadian College of Health Leaders. All rights reserved. Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0840470415588677 hmf.sagepub.com
Abstract This paper addresses the current drug shortage, and examines the ethics framework for dealing with drug shortages developed by our organization. That three-step allocation process and framework was published previously in this journal. Specifically, this paper offers a rationale and justification for the framework’s second step, which involves a triage process aimed to ensure that the available drug supply is utilized effectively and ethically.
Introduction In the fall of 2014, healthcare providers across Canada were ´ (BCG), informed of a short supply of Bacillus Calmette-Guerin a drug used to control the symptoms of bladder cancer. Without it some patients could require surgery to remove their bladders. The BCG shortage is one of the latest examples of a recurring problem in both Canada and the United States, as ongoing shortages of essential pharmaceuticals threaten the normal functioning of the healthcare system.1 When the plant that manufactures 80% to 90% of generic injectable drugs used in Canada massively slowed production in February 2012 (note 1),2 it was considered an extraordinary though hopefully temporary situation. However, that incident confirmed what reports from the Canadian Agency for Drugs and Technologies in Health,3 the Canadian Pharmacists Association, and the US Food and Drug Administration4,5 had been predicting, namely, an escalation in drug shortages and ongoing supply problems. Drug shortages are now the new normal for healthcare providers. In response to ongoing chronic shortages of essential drugs, healthcare institutions across the country have scrambled to devise policies and procedures to manage the allocation of these essential resources. The clinical ethics group at the Eastern Regional Health Authority in Newfoundland and Labrador (EH) has been working with clinical leaders within the organization to develop an ethics framework for dealing with drug shortages, including an allocation process for drugs in short supply. Historically, EH has utilized its ethics group widely at the organizational level, and it was instrumental in developing EH’s corporate values statement. Engaging the ethics service in broad policy issues on an ongoing basis ensures that the corporate values are operationalized in the day-to-day management of the organization. Resource allocation decisions are often emotionally and politically charged, and this is particularly so in times of crisis. Providing an ethically defensible framework for decision-making not only assists frontline staff in making difficult decisions under duress but it can also aid an organization in avoiding the perception that decisions are made in an ad hoc fashion.
The initial involvement of our ethics service in crisis allocation decisions occurred with regard to H1N1 planning.6 We have continued to develop and adapt our process as other allocation crises have arisen. In response to the ongoing drug shortage, EH developed a three-step allocation process and framework that was published previously in this journal (note 2).1 Briefly, the three-step allocation process includes: (1) an ‘‘efficient drug utilization’’ first step that involves efforts to procure alternate drugs and to redistribute available stock: and (2) an ‘‘optimization of therapeutic benefit’’ second step that triages patients to ensure that the available supply is utilized effectively and ethically based on available evidence. This process involves establishing a hierarchy of priority among relevant patients and a particular decision-making procedure. In the event the triage process fails to determine a clear ‘‘winner’’ in terms of which patient should receive the limited supply of a scarce drug (ie, two or more patients fulfill the triage priority criteria), we would move to (3) a ‘‘fair access’’ third step involving a random draw. In what follows, we offer a rationale and justification for some of the more controversial aspects of this model, particularly as it pertains to the second optimization of therapeutic benefit step.
The initial triage process: Our first priority list The triage process is initiated when efforts to conserve and/or reallocate the existing supply of drugs (our first ‘‘efficient drug utilization’’ step) fail to prevent the situation in which immediate demand for a particular drug is greater than the current and foreseeable supply. Our ethical responsibility in such a 1
2
Faculty of Medicine, Memorial University, St John’s, Newfoundland and Labrador, Canada. Eastern Health, Health Sciences Centre, St. John’s, Newfoundland and Labrador, Canada.
Corresponding author: Jennifer Flynn, Faculty of Medicine, Memorial University, Newfoundland and Labrador, Canada. E-mail: [email protected]
Flynn, Chubbs, Gladney-Martin, Singleton and Pullman circumstance is to maximize the therapeutic benefit of the drug in question using evidence-based rationing. Thus, our first priority patients are those the evidence indicates have the greatest likelihood of benefiting from the drug and for whom there are no other therapeutic options. Available evidence would also indicate that not receiving the drug could have severe and adverse health consequences. Patients who are considered second priority in our triage process fulfill the criteria of first priority patients except that they have other therapeutic options, even though available evidence indicates that such options would be considered suboptimal. Third priority patients also have urgent or emergent medical needs, but they differ from second priority patients in two important respects. First, unlike second priority patients, patients in this category do not have other therapeutic options. It is the second difference, however, that is particularly relevant to this triage process. For this group of patients the available evidence on the effectiveness of the drug in question for their medical condition is equivocal at best. We provide a rationale for how we arrived at this prioritization ordering in the discussion to follow. While we expect this initial triage process will be adequate for the majority of cases, a situation could arise in which there is still an inadequate supply of a drug for two or more patients at the same stage on this priority list. In such cases, the goals of treatment would need to be considered and a second priority list consulted.
203 possible that two or more patients will need a drug in short supply as a life-saving treatment or intervention. All other things being equal, our framework suggests that should such a situation arise, an allocation decision can be based on age. The broader rationale in support of this decision is discussed in the next section as well. Second priority patients under goals of treatment are those for whom treatment is intended to manage pain. Triage decisions regarding patients who require drugs in short supply for pain and symptom management should consider the severity of patients’ pain, the patients’ ability to cope with pain, the potential of the drug to manage patients’ pain, and that some treatments falling into this category involve terminal patients with severe pain. Triage decisions regarding allocation of pain and symptom management require consideration of the physical, spiritual, and psychosocial needs and resources of the individuals as well as balanced and fair processes to compare the needs of two or more patients. One can only imagine the challenges in deciding between a child with severe postorthopedic surgery pain and a terminally ill senior with bone cancer. The third priority in this goals of treatment supplemental triage process are patients for whom treatment is intended to manage an illness. As always, decisions about which patients should receive a drug in short supply should be evidence based. Evidence-based drug usage ought to take priority over off-label usages. Not surprisingly, drug allocation decisions should anticipate that drug treatment will likely result in improvement of quality of life and/or long-term life expectancy.
Our supplemental priority list: Considering goals of treatment
Discussion
Consider the case in which a particular drug is in short supply and there are two patients in need of it but only enough for one. Further, assume that both are first priority patients, according to our initial triage process. That is, the evidence suggests that both would benefit from the drug, not getting the drug could have severe consequences, and there are no therapeutic alternatives for either patient. In such an instance, we would move to a second priority list that considers the goals of treatment. The supplementary ‘‘goals of treatment’’ triage process applies to multi-purpose drugs that can be used for a range of therapeutic purposes. Various drugs fit into this category. Consider, for example, propofol, which functions in a lifesaving capacity when it keeps a patient sedated through lifesaving surgery. In a less acute circumstance, propofol might be used to consciously sedate a patient, making a patient comfortable yet responsive, crucial for the administration of certain sorts of treatments. In the latter case, propofol’s use would be considered maintenance (ie, illness treatment) rather than acute (ie, life-saving). Heparin is another example of a multi-purpose drug that can be life-saving when used as a thrombolytic to breakup a blood clot but might also be used in another instance for pain management. When we consider goals of treatment, first priority goes to patients for whom treatment is intended to be life-saving. It is
As noted at the outset, the purpose for developing an allocation process is to provide a rational basis for ethical decisionmaking under conditions of duress. Inasmuch as ready access to pharmaceuticals is considered the standard of care across the healthcare spectrum, any decision to allocate drugs in short supply to some patients while denying them to others requires some justification. Developing our two-stage triage process involved extensive discussions about how to justify prioritization decisions at various key junctures in the process. Here we offer the rationale and justification for some of the more sensitive and controversial decision points in that process. As it pertains to the initial triage process, some might question why patients with other therapeutic options (our second priority patients) would be given priority over patients who have no other options (our third priority group). Here we emphasize again the importance of evidence-based rationing in the triage process. According to the available evidence, both first and second priority patients in the initial triage would benefit from the drug in question, but the evidence of therapeutic benefit for the third priority patients is equivocal at best. Evidence-based rationing requires that the scarce resource in question be allocated where it is judged to be most effective. Thus, although our second priority patients have other suboptimal options available, the evidence suggests the scarce
204 resource is better utilized for them than it would be for patients in our third priority group. Our initial triage process prioritizes patients on the basis of the evidence of a drug’s effectiveness in treating a patient’s condition irrespective of the goals of treatment. That is, if there is strong evidence (ie, evidence acquired through randomized controlled trials) indicating that a drug in short supply was very effective in pain and symptom management, but only anecdotal evidence suggesting it might also be disease modifying such that it could extend a patient’s life, our initial evidence-based triage process would prioritize pain management over life extension in that case. That is, evidence-based rationing suggests it would be unethical to allocate a scarce drug on the basis of anecdotal evidence that it could possibly extend a patient’s life when there was solid evidence that it would almost certainly be effective in managing pain. However, if the initial triage process fails to distinguish between two or more patients based on the available evidence of a drug’s effectiveness, our second priority list invokes goals of treatment to help resolve the issue. Perhaps the most controversial aspect of our supplemental goals of treatment triage process involves age-based rationing in instances where two or more patients are triaged to the same level in the process but where there is only an adequate supply of medication for one of them. In the hypothetical scenario we described earlier, the initial triage process has identified two patients for whom the drug in question would be life-saving and for whom there are no alternative interventions available. ‘‘All things being equal,’’ we state, age can be used as a criterion. The age rationale is often described in the literature as ‘‘the fair innings principle’’ or ‘‘the life cycle principle.’’ The established and acceptable rationale is that death seems more tragic when a child or young adult dies than when an elderly person dies. This is because children and young adults have not had the chance to live and develop through all of life’s stages and not because the lives of older people are somehow less valuable (note 3).7 The fair innings principle supports allocating resources to those who are at an earlier stage in the life cycle. It does not favour younger persons over older persons in absolute terms, but rather those in an earlier phase in the life cycle relative to other patients with the same prognosis. The general moral intuition that suggests we should favour children over adults in life-threatening crisis situations was borne out in a community consultation process we undertook while developing this framework. Participants voiced support of the high priority to protect and rescue children and youth. Although we begin our description of age-based rationing with the statement all things being equal, all things are seldom equal in the healthcare context, particularly when it comes to comparing the relative health of individuals at various stages in the life process. Elderly patients, for example, generally suffer from more co-morbidities than do children or younger adults. This will affect their ability to respond to any medical intervention. Again, evidence-based rationing would suggest that the patient most likely to benefit from the intervention should receive the drug. In the hypothetical scenario described earlier, both patients are ostensibly at the same priority in the triage
Healthcare Management Forum process; both require the drug in question and not getting it could have severe health consequences, and there are no other options. Our second goals of treatment has also failed to settle the issue, as the drug is considered to be life-saving for both patients. It is only in such a rare situation that age might serve to break the tie for both the evidentiary (eg, younger patient has less co-morbidities; children may need a smaller dose of the drug in short supply) and conceptual (eg, ‘‘fair innings’’) considerations discussed earlier. We should emphasize that according to our framework, age alone will never be the determining allocation factor. Further, age would be considered only in a crisis situation, and it appears in our triage process only at a point where our first process has failed. The likelihood of the triage process reaching this second stage, and of the patients in question requiring the drug for the same treatment goal, is slim at best.
Conclusion We have described the way our organization plans to handle situations in which the need for particular drugs outstrips the supply. In particular, we have discussed our two-stage triage allocation process for drugs in short supply and offered some of the ethical rationale underlying those processes. Our organization is utilizing this framework in dealing with the a BCG shortage and has decided that for the time being the available supply will be used only for initial treatment of newly diagnosed patients, while maintenance doses of the drug will no longer be offered. Although not a drug allocation issue per se, our evidence-based criterion for resource allocation decisions is forcing us to reflect as well on the resources currently being diverted into Ebola preparedness, as we question whether the degree of the response is disproportionate to the current risk. Having an ethics framework and a triage process will not resolve every difficult resource allocation decision we face in the years to come. These are only tools to aid in sorting through some of the complexities, not algorithms that replace the sensitive and nuanced discussion that must occur in each critical situation. Nevertheless, developing these tools allows us the luxury of thinking through such complexities and considering appropriate rationales and justifications in advance. As drug shortages continue to be a challenge not only within our region but across North America, we hope others in the position of dealing with the challenge can learn from our work. The work we have done and continue to do on scarce drug allocation has far-reaching implications. Our work is relevant not only across healthcare organizations but across a variety of challenges that involve difficult crisis allocation decisions. Notes 1. See Kaposy’s article for a description of the events leading up to the shortage as well as an argument regarding the ethical problems with generic drug shortages.
Flynn, Chubbs, Gladney-Martin, Singleton and Pullman 2. The article by Singleton et al. provides a general description of our framework. The introduction offers a description of the drug shortage situation. 3. In Emanuel and Wertheimer’s 2006 discussion of vaccine allocation, the authors suggest the life cycle principle as a way of allocating vaccine in short supply.
References 1. Singleton R, Chubbs K, Flynn J, et al. From framework to the frontline: designing a structure and process for drug supply shortage planning. Healthcare Management Forum. 2013; 26(1):41-5. 2. Kaposy C. Drugs, money, and power: the Canadian drug shortage. J Bioeth Inq. 2014;11(1):85-89. 3. Canadian Agency for Drugs and Technologies in Health (2011). Drug Supply Disruptions: Environmental Scan.
205
4.
5.
6.
7.
Available at: http://cadth.ca/prodcuts/environmental-scanning/ environmental-scans/environmental-scans-18. Accessed October 12, 2012. Canadian Pharmacists Association (2010). Canadian Drug Shortages Final Report. Available at: http://www.pharmacists.ca/ cpha-ca/assets/File/cpha-on-the-issues/DrugShortagesReport.pdf. Accessed 14 October 2012. US Food and Drug Administration (2011). A Review of FDA’s Approach to Medical Product Shortages. Available at: http:// www.fda.gov/downloads/aboutfda/reportsmanualsforms/reports/ ucm277755.pdf. Accessed 8 October 2012. Kaposy C, Bandrauk N, Pullman D, Singleton R, Brunger F. Adapting the Hamilton Health Sciences critical care pandemic triage protocol. Healthc Q. 2010;13(2):60-63. Emanuel E, Wertheimer A. Who should get influenza vaccine when not all can? Science. 2006;312(5775):854-855.
