HIV and the Blood Supply An Analysis of Crisis Decisionmaking (1995) / Chapter Skim
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8 Conclusions and Recommendations
8 Conclusions and Recommendations
Pages 207-236
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From page 207... ...
The events of the early 1980s, however, revealed an important weakness in the system in its ability to deal with a new threat that was characterized by substantial uncertainty. The potential for recurring threats to the blood supply led this Committee to reappraise the processes, policies, and resources through which our society attempts to preserve its supply of safe blood and blood products.
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From page 208... ...
Public Health Service agencies such as the CDC, the FDA, and the National Institutes of Health (NIH) , and private-sector organizations such as community blood banks and the American Red Cross, blood and plasma collection agencies, blood product manufacturers, groups such as the National Hemophilia Foundation (NHF)
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From page 209... ...
Decisionmaking Under Uncertainty The management of a public health risk requires an evolving process of decisionmaking under uncertainty. It includes interpretive judgment in the presence of scientific uncertainty and disagreement about values.
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From page 210... ...
If the CDC had made numeric estimates of the risk, and the blood banks, blood product manufacturers, or the FDA had used these estimates in a formal analysis of the decision problem, they might have reached different conclusions about, for example, surrogate testing for AIDS. Consider the Full Range of Possibilities When there is uncertainty about the facts that will determine the consequences of a decision, a systematic approach is usually best (NRC 1994~.
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From page 211... ...
The failure to adopt risk-reduction strategies can be seen in the resistance of blood banks to screening for homosexual activity or using surrogate tests for AIDS (Chapter 5) and in FDA's limited approach to product recall decisions (Chapter 6~.
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From page 212... ...
These actions are the responsibilities of the highest levels of the public health establishment. The Public Health Service failed to bring these leadership functions to bear when CDC scientists raised concerns about the blood supply at the January 4, 1983 meeting but received no public support from the director of the CDC or the office of the Assistant Secretary for Health.
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From page 213... ...
In addition, there did not seem to be any focus within the Public Health Service prepared to, or charged to, analyze the options, costs, and benefits of the options for protecting the blood supply that were discussed at the January 4, 1983, meeting convened by CDC. In addition, agencies need to monitor more systematically the long-term outcomes of blood transfusion and blood product infusion and to think far ahead
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From page 214... ...
Presumptive Regulatory and Public Health Triggers The Committee believes that the Public Health Service should prepare for future threats to the blood supply by specifying in advance the types of actions that should occur once the level of concern passes a threshold. In the face of scientific uncertainty, the PHS needs a series of criteria or triggers for taking regulatory or other public health actions to protect the safety of blood and blood products.
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From page 215... ...
CONCL USIONS AND RECOMMENDA TIONS Table 8.1. Triggers for Taking Actions in Response to Uncertain Risks Trigger Action Product Treatment Proposal to increase safen,r Initiation of risk-benefit or cost-benefit analysis Donor Screening Identification of a high-risk population Public sector to assume responsibility for thorough analysis and development Ensure that the analysis takes into account possible secondary and other benefits Self-deferral and segregation of lots Plasma fractionators' action to increase All companies consider why they screening should not follow suit and set In motion a consensus development mechanism Availability of a surrogate test or other Use the test/intervention unless it is partially effective interventions that certain to be redundant prior to have minimal risks realizing its benefits Recall Implementation of a new test or treatment process Beginning of a recall action Communication of Risk New information relevant to a public health agency's actions Recall untested or untreated products as expeditiously as possible Provide clear guidance and monitoring Tell affected communities what they need to know to make an informed choice among listed options: the facts, the gaps in knowledge, and He implications Hereof 215 When performing a cost-effectiveness analysis of new treatments for blood products, the potential to protect against other threats should always be a part of the analysis.
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From page 216... ...
Blood banks should use a partially effective intervention that has little or no risk unless they can show that a better method will rapidly supersede it. In this case the trigger is the availability of an inherently risk-free, partially effective intervention, and the response to use that test/intervention unless it is certain to become redundant prior to realizing its full benefits.
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From page 217... ...
In this case, the trigger is new information relevant to the public health, and the action is to tell affected individuals what they need to make an informed choice: the facts, the gaps in knowledge, and the implications thereof. RECOMMENDATIONS The Comm~ttee's charge was to learn from the events of the early 1980s the lessons that would help the nation prepare for future threats to the blood supply.
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From page 218... ...
In the event of a threat to the blood supply, the PHS must, as in any public health crisis, insist upon coordinated action. The Secretary of Health and Human Services is responsible for all the agencies of the Public Health Service, and therefore the Committee makes Recommendation 1: The Secretary of Health and Human Services should designate a Blood Safety Director, at the level of a deputy assistant secretary or higher, to be responsible for the federal government's efforts to maintain the safety of the nation's blood supply.
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From page 219... ...
The Blood Safety Council should take the lead to ensure the education of public health officials, clinicians, and the public about the nature of threats to our nation's blood supply and the public health strategies for dealing with these threats. Supplying safe blood and blood products to the nation a public good- requires the cooperation of public and private institutions.
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From page 220... ...
Blood Safety Council relationships. ~Acade m ia '| Blood Banks l | Blood Product | | Manufacturers | Pu blic
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From page 221... ...
Drawing on its members' knowledge about blood and blood product safety concerns, and about clinical alternatives, the Blood Safety Council could establish a panel of experts to provide the public and providers of care with information about risks and benefits, alternatives to using blood products, and recommended best practices, as described in more detail in Recommendation 13 below. Investigate Methods to Make Blood Products Safer.
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From page 222... ...
CDC created a forum on its own by convening the January 4, 1983, meeting in Atlanta, but as the Committee's analysis indicates, the follow-up on this meeting was insufficient. If a standing Blood Safety Council had existed, the CDC scientists who had concerns about the safety of blood and blood products would have had an opportunity to hold blood collection organizations accountable for their decisions regarding donor deferral and surrogate testing.
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From page 223... ...
The Blood Safety Council could have insisted that the FDA commission a formal decision analysis of the options for surrogate testing, or the Council might have performed such an analysis itself. The FDA would retain its regulatory authority, and continue to get advice from the BPAC, but the Council would have provided critical information relevant to the agency's decision.
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From page 224... ...
The Centers for Disease Control and Prevention The CDC has an indispensable role to play in protecting our nation's health: to detect potential public health risks and sound the alert. Because of its expertise in detecting and evaluating possible infectious disease outbreaks, the Committee believes that the CDC should take responsibility for a surveillance system to detect adverse outcomes from blood and blood products.
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From page 225... ...
The CDC plays this role in the Public Health Service. The CDC appears to have been prescient in raising the possibility that the blood supply was contaminated early in the AIDS epidemic, but it was relatively ineffective in convincing other agencies of the potential gravity of the situation.
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From page 226... ...
The Committee found cause for concern when it evaluated the FDA's actions in protecting the public from HIV in the nation's blood supply during the 1980s. The record reveals many opportunities to improve the agency's capacity to deal with crises involving the blood supply, most notably with respect to the safety of AHF concentrate.
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From page 227... ...
Requiring all blood banks to adopt this policy would not have compromised the nation's blood supply, and it would have prevented at least a few instances in which a patient received an infected unit of blood. Example: Destruction of Potentially Contaminated Cryoprecipitate.
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From page 228... ...
Lookback required blood banks to contact recipients of blood from infected donors and notify them that they might be a HIV carrier and should be tested for HIV antibodies. Earlier action on lookback might have reduced secondary transmission of HIV.
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From page 229... ...
While most regulated industries might have interpreted these letters as mandatory, that question should not have been left to the judgment of individual entities. Talcing this into account, the Committee makes Recommendation 8: Because regulators must rely heavily on the performance of the industry to accomplish blood safety goals, the FDA must articulate its requests or requirements in forms that are understandable and implementable by regulated entities.
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From page 230... ...
Chapter 6 also contains a discussion of the December 15, 1983, BPAC meeting, which effectively curtailed actions on surrogate testing of blood for months. The Committee's analysis of the EDA's management of its advisory committee leads to the following three recommendations: Recommendation 9: The FDA should ensure that the composition of the Blood Products Advisory Committee reflects a proper balance between members who are connected with the blood and blood products industry and members who are independent of industry.
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From page 231... ...
The FDA's lack of independent information and its own analytic capacity meant that it had little choice but to incorporate the advice of the BPAC into its policy recommendations. To ensure the proper degree of independence between the FDA and the blood products industry, the Committee makes Recommendation 11: The FDA should develop reliable sources of the information that it needs to make decisions about the blood supply.
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From page 232... ...
The Blood Safety Council called for in Recommendation 2 would deal primarily with risk assessment and in the public health domain, actions that would reduce the chance that blood products could be vectors of infectious agents. The primary responsibility of the expert panel on best practices called for in Recommendation 13 would be to provide the clinical information that
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From page 233... ...
1994~. Experience in developing practice guidelines for hemophilia treatment and blood transfusion is an important element of preparedness for future threats to the blood supply.
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From page 234... ...
Financial conflicts of interest influence organizations as well as individuals. As indicated in Chapter 7 arid above, the financial relationships between the NHF and the blood products industry seriously compromised the NHF's credibility.
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From page 235... ...
94-0592. Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, U.S.
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