Antivirals for Pandemic Influenza Guidance on Developing a Distribution and Dispensing Program (2008) / Chapter Skim
Currently Skimming:
4 Who Should Get Antivirals and Where?
4 Who Should Get Antivirals and Where?
Pages 53-86
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 53... ...
. However, the committee notes that if program goals for the current antiviral supply include both�������������������������������������������������������� treatment and some level of p�������������������������� ����������������������������������������� rophylaxis���������������� ,��������������� it may become �������������� necessary to p������������������������������������������������������������� rioritiz����������������������������������������������������� e���������������������������������������������������� groups for treatment������������������������������� ��������������������������������������������������� �������������������������������������������� in addition to prophylaxis on the basis of the national ethical framework and the recommendations of the advisory body described in Chapter 3, as well as the characteristics of the pandemic�� .� A number of tests are available to diagnose seasonal influenza but few are sufficiently accurate (i.e., high sensitivity and specificity)
|
From page 54... ...
of any laboratory or clinical diagnostic tool depend on the prevalence of influenza in the population, which influences the predictive value. For example, the positive predictive value of rapid tests is fairly good (i.e., most positives are true positives)
|
From page 55... ...
In this setting where the prevalence of influenza was 66 percent, the positive predictive value was 79 percent and the negative predictive value was 49 percent. Clinical diagnosis in children may be even more difficult because the symptoms vary by age, and many respiratory viral infections mimic influenza.
|
From page 56... ...
Later in this chapter, dispensing sites are discussed, some of which could function as sites for diagnosis. Remote Diagnosis: Telephone- or Website-Based Triage The National Health System in the United Kingdom is planning to use the National FluLine as its main mechanism for providing information, and for diagnosing, triaging, and referring individuals to dispensing locations (Alcock, 2007; UK Department of Health, 2007)
|
From page 57... ...
of phone personnel and contingency planning for pandemic-related attrition in regional or international call centers. Existing state- or local-level call centers may be a more realistic mechanism for diagnosis and referral, although they would experience human resource demands similar to those of dispensing sites (perhaps minus the risk of infection)
|
From page 58... ...
national in scope, inclusive of diverse populations and viewpoints, and in keeping with a shared ethical framework -- to discuss and develop a prioritization scheme for antiviral treatment and prophy laxis that is capable of adjustments in real-time in response to the influenza pandemic. The national dialogue and public engagement activities will ideally include a discussion of the goals of an antiviral dispensing program, for example, maintaining the functioning of society or mitigating death and hospitalizations, and whether the program can address some or all potential goals.
|
From page 59... ...
The most basic level of prioritization requires deciding whether a limited antiviral supply (beyond that needed for treatment) would be provided to household contacts of infected individuals, or to certain groups of front-line workers, either as prolonged or post-exposure prophylaxis, depending on the amount of drugs available.
|
From page 60... ...
In a public health crisis when supplies are short, ���������������������� those who voluntar���� ������������ ily� assume risk on behalf of others������������������������������������������ ������������������������������������������������������������� both need and deserve first-priority status������������������������������������������������������������������������ . With an indeterminate supply of antivirals, primarily����������������� �������������������������� prioritized for treatment in the first wave, ������������������������������������������� offering prophylaxis from a limited supply to household contacts of ill individuals and to family members of those ��������������������������������������������������������������������� ����������������������������������������������� with occupational���������������������������������������������������� risk would likely undermine capacity for treatment and protection of �������������������������������������������������� health care workers and emergency response personnel��������������������������������������������������������������������� .
|
From page 61... ...
The committee affirms that notwithstanding limited supplies of antiviral stockpiles, some antiviral medication will need to be used for prophylaxis to protect essential health care workers who are providing care directly to severely ill patients in both the inpatient and outpatient settings. Antiviral use in this situation will best be done as an adjunct to other infection control measures in hospitals and clinics and within the broader community.
|
From page 62... ...
Although the committee was not charged with examining dimensions of pandemic influenza planning outside antiviral distribution and dispensing, the committee notes that given the likely use of antiviral prophylaxis in conjunction with other strategies to reduce the risk of health care personnel and emergency responders, greater clarity is needed on official recommendations for the use of masks and respirators in health care settings, workplaces, and homes. To the extent that the lack of clarity relates to inadequate scientific evidence, it will be important to conduct studies of the efficacy of infection control methods that could be used with antiviral prophylaxis and in order to decrease the need for prophylaxis in groups with occupational exposure.
|
From page 63... ...
They will be able to work safely without prophylaxis or personal protective equipment. Identifying priority groups among emergency responders may be made more complex by the fact that other personnel and trained volunteers may play emergency response roles in a pandemic.
|
From page 64... ...
For example, there could be variation in the manifestations of the pandemic and variations in the populations served, which might potentially lead to minor differences in public health response. The committee believes that provision of prophylaxis to health care personnel and other relevant workers during a pandemic would rely on their health care facilities' plans and existing information systems, distribution mechanisms, and procedures.
|
From page 65... ...
There may be other means of preventing exposure of family members of health care workers, including meticulous and comprehensive infection control measures, but in-depth examination of these issues is beyond the scope of this report. Post-Exposure Prophylaxis for Household Contacts The ability to provide post-exposure prophylaxis for household contacts of cases is dependent on decisions made about the size of stockpiles (see scenario C, described in Chapter 2)
|
From page 66... ...
. Legal Considerations During an influenza pandemic, declarations of emergency, disaster, or public health emergency at federal, state, or local levels alter the existing legal environment to allow government public health and safety officials and others sufficient flexibility and powers to respond.
|
From page 67... ...
or other dispensing sites to begin functioning. In the context of diagnosis for initiating empiric treatment, voluntary isolation of cases and household prophylaxis, there are tradeoffs to remote diagnosis (e.g., via a telephone or web-based algorithm, see discussion earlier in this chapter)
|
From page 68... ...
the prescription for treatment of the infected individual and for post-exposure prophylaxis for household contacts to the POD, pharmacy, or other dispensing site that will be accessible to the respective household. This will require careful planning and decision making by each jurisdiction to ensure optimal placement of dispensing sites to ensure the most rapid and equitable process for giving antiviral courses to those who meet dispensing criteria.
|
From page 69... ...
If distribution mechanisms other than the SNS mechanism are considered to disperse some or all of a jurisdiction's antiviral supply, the respective public health agencies and their partners would benefit from considering private sector and Department of Defense expertise in supply chain science: efficiently moving product or material from point A to point B. After the declaration of a pandemic, drugs need to be moved to dispensing sites smoothly and quickly to address treatment needs and, if appropriate, prophylaxis needs. To facilitate prompt dispensing, the CDC supplemental guidance for pandemic influenza asked grantees to identify sites where antivirals may be pre-positioned when a pandemic is judged to be imminent (DHHS and CDC, 2006)
|
From page 70... ...
Sites that could be considered, and many of which are already considered by jurisdictions around the country, include the following: • Public health agency POD • Hospitals • Physicians' offices or other primary care settings • Pharmacies • Businesses • Schools • Drive-through pharmacies or other stores • Parking lots • Parish nurses or visiting nurses • Homes, through mail or parcel delivery service, either pre distributed or just-in-time • Other private-sector delivery mechanisms employing a mail or parcel delivery service (e.g., Netflix-like system) • Health maintenance organization systems • Nursing homes or other long-term care facilities Other dispensing sites could be used depending on local circumstances and needs.
|
From page 71... ...
) • Issues related to using private distributors to deliver antiviral medications to private homes A major consideration in selecting dispensing sites is suitability for vulnerable or special-needs populations (e.g., ease of access, linguistic and cultural competence, geographic proximity so transportation does not become a barrier, perceived safety of the site, hours of operation)
|
From page 72... ...
In a pandemic, many people may try to avoid the hospital believing it to be a locus of infection. Hospitals may have security problems -- including securing the antiviral supply, other hospital assets, and patient information -- if they were used as community dispensing sites with large numbers of non-patients streaming through.
|
From page 73... ...
The primary care setting has at least in principle the advantages of familiarity, ability to screen for contraindications and prescribe the proper dose for each individual patient, ability and duty to follow patients and refer in the event of adverse events, and so on. However, in a moderateto-severe pandemic, primary care providers may be rapidly overwhelmed with demand.
|
From page 74... ...
Legal issues may include assessing responsibility for maintaining the premises, determining compensation for its use, providing adequate security to ensure public safety, and resolving liability concerns. On the other hand, state and local governments may not typically use federal properties for dispensing sites without federal approval, even during emergencies.
|
From page 75... ...
In terms of the types of personnel that will be used, 36 states intend to use hospital staff for dispensing, 35 plan to use public health staff, 17 intend to use medical reserve corps, 15 will use other emergency response personnel, 12 will use emergency systems for the advance registration of volunteer health professionals (ESAR-VHPs) , 14 intend to use pharmacy personnel, and 15 plan to dispense via local health departments, primary care providers, and community health centers (ASTHO, 2007)
|
From page 76... ...
. To discourage spontaneity and promote organization of volunteer health practitioners during emergencies, Congress (PL 107-188, 42 U.S.C.A.
|
From page 77... ...
. Other states have recently passed or are currently considering passage of a 2007 model law, the Uniform Emergency Volunteer Health Practitioners Act (UEVHPA)
|
From page 78... ...
The liability protections of Alternative B, on the other hand, are more comparable to existing liability protections found in the federal Volunteer Protection Act, which provides liability protections to largely uncompensated volunteer health practitioners. As of January 2008, four states (Colorado, Kentucky, New Mexico, and Tennessee)
|
From page 79... ...
. The Uniform Emergency Volunteer Health Practitioners Act, which is under consideration in multiple jurisdictions, seeks to provide workers' compensation benefits to registered volunteers as if they were state employees (Carpenter et al., 2008)
|
From page 80... ...
. To remedy this issue, many existing state emergency laws and the Uniform Emergency Volunteer Health Practitioners Act allow states to view out-of-state volunteer health practitioners as licensed in the jurisdiction for which they provide services during the duration of the emergency (Hodge et al., 2007)
|
From page 81... ...
The volume of data entered in a pandemic mass dispensing setting would be likely to place unprecedented demands on most existing public health information systems, such as registries. Finally, some jurisdictions have extremely limited information technology resources that do not meet existing public health practice needs, let alone those of an emergent pandemic response.
|
From page 82... ...
AERS does not address the need of state and local jurisdictions to monitor and respond to adverse events, so public health agencies and their partners may need some additional measures to prepare and plan 10 This would be needed in the event of power failure and other critical infrastructure failures. 11 Information about the initiative is available at http://www.bt.cdc.gov/cri/.
|
From page 83... ...
Also, planning could focus on systems to capture only serious and unexpected adverse events. Recommendation 4-5: The committee recommends that the Depart ment of Health and Human Services consider options in addition to the Food and Drug Administration Adverse Event Reporting System to capture adverse events resulting from use of antiviral drugs to ensure active and timely reporting.
|
From page 84... ...
. Still, personnel at dispensing sites may need to be sensitive to the privacy expectations of individuals seeking antivirals during pandemic influenza.
|
From page 85... ...
Some jurisdictions have used actual disease outbreaks or other emergencies as opportunities to practice their pandemic influenza or public health emergency response plans. A number of local public health agencies have used seasonal influenza immunization clinics to test their preparedness for mass dispensing in the event of an influenza pandemic.
|
From page 86... ...
86 ANTIVIRALS FOR PANDEMIC INFLUENZA of the final shape of the pandemic, it is clear to the committee that many of these issues need to be addressed in advance and provide a foundation for later decision making. Several overarching goals need to be kept in the forefront: developing in advance an ethical framework, communication and education of the public with clear and consistent messages, the need to reconcile actual supply and antiviral program goals, and flexibility on the one hand to react to the changes in the course of the pandemic and on the other hand to address the diverse needs of localities.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.