Prepositioning Antibiotics for Anthrax (2012) / Chapter Skim
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4 Prepositioning Strategies
4 Prepositioning Strategies
Pages 93-152
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From page 93... ...
Antibiotics may be prepositioned in many different venues using many different strategies, including: • forward-deployed MCM -- MCM stored near the locations from which they will be dispensed, • cached MCM -- MCM stored at the locations from which they will be dispensed,1 and 1 The term cache often is used broadly to describe stockpiles of MCM held by state or local jurisdictions, health care facilities, and private-sector organizations, among others.
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From page 94... ...
For each category, several example strategies, the potential roles for those strategies within a jurisdiction's overall dispensing strategy, and potential health risks, if any, are discussed. Also discussed for each category are practical considerations, including logistics, communication needs, expected behavior and adherence, and legal and regulatory issues.
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From page 95... ...
; stockpiles public health open state/local/tribal public PODs health authorities Commercial forward- Commercial pharma deployed to supply ceutical distributor(s) ; private-sector closed private-sector entities PODs with closed PODs Cached MCM Caches in hospitals and – Protect health care – Health systems, Infrastructure and staff other health care facili- workers expected hospitals, and other needed to store and ties -- for example, com- to work during the health care facilities*
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From page 96... ...
Infrastructure and staff Pharmacies may caches expected to work dur- to store and dispense serve as open PODs ing the response and MCM already exist in dispensing MCM their families retail pharmacies delivered postevent General private-sector – Enhance dispensing Private-sector entities* Most workplaces do Private-sector work workplace caches capability for the not already have the places may serve as general population by infrastructure and staff closed PODs dispens off-loading demand to store and dispense ing MCM delivered from the public health MCM; this capacity postevent distribution and would have to be de dispensing system veloped or alternative arrangements made – Help ensure business continuity and the well-being of employ ees and their families Workplace caches Protect first responders, Private and public Predispensed MCM for those who will critical infrastructure employers with could be used for be expected to work workers, and other employees who are those for whom during a response groups of workers expected to work workplace caches expected to work during a response*
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From page 97... ...
; with their health plan workers' families may administrator to assess also be included whether the medica tion will be covered – Help ensure business continuity and the well-being of employ ees and their families continued 97
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From page 98... ...
Private and other nongovernmental entities could implement prepositioning and Response; CDC = Centers for Disease Control and Prevention; strategies independently, but in many cases, federal, state, local, and tribal DOD = Department of Defense; MCM = medical countermeasures; governments will play a key role in facilitating the adoption of such strategies POD = point of dispensing; SNS = Strategic National Stockpile; through initiatives, planning assistance, financial and other incentives, and/or VA = Department of Veterans Affairs. efforts to address legal and other barriers.
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From page 99... ...
Decreasing the transportation time from SNS warehouses to state RSS sites will be effective, however, only if the RSS sites and PODs can be set up and staffed quickly enough to take advantage of the reduced delivery time (Burel, 2011)
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From page 100... ...
. The most significant difference between an attack with B OX 4-1 C HEMPACK: Forward-Deployed Strategic National Stockpile (SNS)
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From page 101... ...
. In 2005, the New York State Department of Health's Office of Health Emergency Preparedness established all-hazard medical emergency response caches (MERCs)
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From page 102... ...
. Commercial pharmaceutical distributors could forward-deploy MCM on behalf of either public health authorities to supply open PODs or private-sector entities to supply closed PODs for employees and their families.
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From page 103... ...
CACHED MEDICAL COUNTERMEASURES Cached MCM are positioned in the locations from which they will be dispensed. The caches may be located in health care facilities (e.g., hospitals and pharmacies)
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From page 104... ...
. Caches in Hospitals and Acute Care Medical Facilities Hospitals and acute care medical facilities are part of the critical infrastructure for combating an anthrax attack and maintaining the health status of a community.
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From page 105... ...
Caches in Nonhospital Health Care Facilities Antibiotics may also be cached in nonhospital health care facilities, such as community health centers, clinics, skilled nursing facilities, and 3 Personalcommunication, John Hick, medical director for emergency preparedness, Hennepin County Medical Center, MN, June 15, 2011.
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From page 106... ...
Prepositioning MCM for health care workers in a range of institutional facilities outside of hospitals and acute care facilities not only would help ensure that those workers could continue to care for patients and residents, but also would expand the pool of health care workers available to engage in a broader community response should an emergency overwhelm the internal surge capacity of hospitals. MCM caches in locations such as skilled nursing facilities also would provide protection for the patients and long-term residents, many of whom would be unable to stand in line at open PODs to receive their antibiotics.
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From page 107... ...
Finally, the section examines the specific case of workplace caches, in which private-sector entities preposition MCM on-site. As discussed in more detail below, although many companies have expressed willingness to dispense SNS or state antibiotics via closed PODs, many have significant concerns about caching the MCM on-site.
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From page 108... ...
For these same reasons, this model also could be highly effective for dispensing antibiotics in response to an anthrax attack. However, it is critical that a framework for cooperation among public health officials and
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From page 109... ...
The committee is unaware of data on how many private-sector entities have developed plans to serve as closed PODs after an anthrax attack, but this is a major component of the overall dispensing strategy in some jurisdictions. Speaking at a 2008 IOM workshop, Pamela Blackwell, Director of the Center for Emergency Preparedness and Response for the Cobb and Douglas Boards of Health, estimated that the closed PODs planned at that time for the metropolitan Atlanta area would serve enough people to reduce demand on the open POD system by 40 to 50 percent (IOM, 2008)
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From page 110... ...
The latter group should include representatives of businesses of different sizes, from different geographic locations, from both critical infrastructure and noncritical infrastructure industries, and from both health care and non–health care sectors. The federal government should also ensure that the plans developed in the national guidance include Public Readiness and Emergency Preparedness (PREP)
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From page 111... ...
BOX 4-2 Key Components of National Guidance for Public-Private Coordination in Prepositioning, Distribution, and D ispensing of Medical Countermeasures The national guidance might include (but should not be limited to) : • m echanisms for sharing threat assessments among all partners; • a model memorandum of understanding; • s ecurity requirements; • r oles and responsibilities of each partner; • p rocesses for communication both between public and private enti ties and within the participating private-sector entity; • g uidance on who would have authority to initiate dispensing; • p rocesses for inventory control and liability protection; • p rocesses for implementing workplace caches; • s trategies to reduce the costs associated with obtaining, maintain ing, and replacing expired product; and • m echanisms to encourage a uniform state approach to reduc ng i legal and regulatory barriers to prepositioning, distribution, and dispensing.
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From page 112... ...
The Department of Health and Human Services should convene state, local, and tribal governments and private-sector organizations to develop national guidance that will facilitate and ensure consis tency for public-private cooperation in the prepositioning, distribution, and dispensing of medical countermeasures and help leverage existing private-sector systems and networks. Workplace Caches As discussed above, workplace caches are one potential way in which private-sector entities could participate in MCM distribution and dispensing.
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From page 113... ...
. Especially in the case of large companies with many employees, closed PODs served by prepositioned caches could therefore alleviate the burden on the entire public health distribution and dispensing system and enhance the overall dispensing capacity in a jurisdiction while also potentially reducing costs by relying on private-sector efficiencies.
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From page 114... ...
Businesses that employ medical professionals or that have occupational health programs may be particularly well suited to developing workplace caches since the required staffing already exists. Appropriate security measures would be needed to safeguard the cached MCM and to ensure their secure transportation if storage and dispensing were carried out at different locations.
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From page 115... ...
Legal considerations Private-sector entities serving as closed PODs would have to consider many applicable federal and state laws and regulations. The Public Health Law Network has outlined the following legal issues relevant to private-sector entities that serve as closed PODs: • impact of an official declaration of emergency, disaster, or public health emergency; • MOU between a public health agency and an entity; • ownership of medical supplies; • medical personnel; • authorization to dispense medications; • EUAs; • liability; • workers' compensation; • privacy (Health Insurance Portability and Accountability Act [HIPAA]
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From page 116... ...
During a federally declared emergency, however, the provisions of the PREP Act extend liability protections to all entities and individuals involved in the distribution and/or dispensing of approved MCM -- including nongovernmental entities and persons (see Chapter 3 for further discussion; Public Health Law Network, 2011b)
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From page 117... ...
Caches in Other Non–Health Care Settings Caches also could be established in community- and faith-based organizations and educational institutions. Community- and Faith-Based Organizations Service networks that serve vulnerable populations could play an important role in enhancing access to MCM for vulnerable populations, including people with low incomes and/or limited transportation, people with no or limited English proficiency, historically underserved ethnic/racial groups, people with disabilities, people who are homeless, and people who are homebound.
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From page 118... ...
These organizations may be better suited to serve as PODs or use other existing service delivery systems to dispense MCM delivered postevent. Some agencies -- for example, food banks with their climate-controlled warehouses -- may already have the capacity to provide appropriate storage conditions (Smith, 2011)
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From page 119... ...
Predispensing MCM is unique relative to other potential prepositioning strategies because it puts the MCM directly into the hands of the intended end-users. This introduces potential health risks to both individuals and the community that do not exist for prepositioning strategies such as forward-deployed and cached MCM.
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From page 120... ...
anthrax attack and the 2011 nuclear accident in Fukushima, Japan. Some examples of predispensing MCM exist in other countries, such as a previous program to preposition antidotes for nerve agents in homes in Israel (suspended because of a lack of cost-effectiveness)
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From page 121... ...
. The committee considered available data on misuse of routinely prescribed antibiotics to inform conclusions about the likelihood that the general public will use predispensed antibiotics -- intended for use during an anthrax attack -- outside of a declared emergency.
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From page 122... ...
122 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX mechanism) , nor did the study test how the medication was impacted by actual storage conditions in participants' households (a significant challenge for predispensing as therapeutic effectiveness can be affected by improper storage)
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From page 123... ...
Paul As discussed in Chapter 3, postal carriers who volunteered to participate in the Minneapolis-St. Paul pilot of the postal model for MCM distribution were provided with MedKits to keep in their homes, containing sufficient quantities of antibiotic for themselves and their families.
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From page 124... ...
However, postal workers' family members likely have a financial and social incentive to comply with instructions of the workers' employer regarding adherence and saving the kit for emergency use. Therefore, the committee judged that the evidence from the postal pilot informs primarily predispensing to targeted subpopulations.
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From page 125... ...
anthrax attack and the reaction in the United States following the nuclear accident in Fukushima, Japan, in March 2011 (for an overview of the former, see Jernigan et al., 2002, and of the latter, see IAEA, 2011)
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From page 126... ...
Extremely limited No available evidence evidence: U.S. public response to the nuclear accident in Japan a For example, first responders, critical infrastructure workers, postal workers, and their families; patient populations.
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From page 127... ...
Chapter 2 raises the possibility of a shortened time window for effective prophylaxis delivery due to the uncertainties inherent in the available scientific data on the incubation period for anthrax and the concern that detection of an anthrax attack could be delayed. In addition, the committee acknowledges that risk data could be available at the classified level that would indicate a shorter time frame for prophylaxis.
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From page 128... ...
and the potential for widespread inappropriate use in response to a distant anthrax attack, a false alarm caused by a nonanthrax white-powder event, or some other public health emergency for which antibiotics are not indicated. In her testimony to the IOM committee, Nadine Shehab of CDC outlined several potential areas of concern: misuse, which could result in adverse reactions and increased antibiotic resistance; unintentional ingestion; dosing and dose delivery; drug interactions; stability and storage; and adherence (Shehab, 2011)
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From page 129... ...
Given that the emergency occurred on the other side of the world, it appears likely that misuse of predispensed antibiotics would rise across the nation following a localized anthrax attack somewhere within the United States. In contrast to the above two sources of evidence, misuse among participants in the St.
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From page 130... ...
These uncertainties call for a larger, more comprehensive study to test the impact of the form of predispensed MCM on rates of inappropriate use and to better test the feasibility of predispensing by omitting features that could artificially increase the rate of adherence to instructions, such as financial incentives for participation. Finding 4-2: The most extensive body of relevant evidence (statistics on the misuse of antibiotics prescribed for routine medical care)
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From page 131... ...
. Of 5,343 people who took at least one dose of antibiotics following the 2001 anthrax attack, 57 percent (N = 3,032)
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From page 132... ...
Contraindications and warnings Some people are allergic to doxycycline and other antibiotics; of the estimated 140,000 emergency department visits for ADEs attributed to antibiotics, approximately 80 percent were due to an allergic reaction (Shehab et al., 2008)
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From page 133... ...
Stability and storage conditions Prepositioning antibiotics in homes raises a number of concerns about storage conditions. First, are the products stable under home conditions?
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From page 134... ...
If predispensed MCM were available solely through an individual purchase and maintain system, they likely would frequently be stored long past their expiration date or disposed of improperly. Impact of form of predispensing No data are available comparing how individuals would store and dispose of MedKits versus personal stockpiles and the effect on the stability of the MCM.
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From page 135... ...
Moreover, while any dispensing strategy carries the risk that exposed individuals will commute outside of areas in which they will be able to receive timely prophylaxis, predispensing MCM may convey a false presumption of lower demand at public PODs, which will not be the case if many or most individuals are unable to reach their MedKits. As discussed above, postal carriers who volunteered to participate in the Minneapolis-St.
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From page 136... ...
Finding 4-3: Predispensing provides no flexibility to dispense alternative MCM in case of an attack using a strain of anthrax that is resistant to the predispensed antibiotic. In addition, unlike POD strategies, the development and implementation of a predispensing strategy for the general public would be unlikely to strengthen public health infrastructure and the capability to accomplish other public health goals beyond dispensing antibiotics for anthrax.11 Communications, Behavior, and Adherence Predispensing MCM to the general public raises many issues related to communications, behavior, and adherence -- both outside of an emergency situation and during a public health emergency.
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From page 137... ...
Finally, MedKits would likely contain only a 10-day supply, so communications would still be needed about how to obtain the remaining doses. Instructions, health literacy, and limited English proficiency Comprehensible instructions would be necessary to explain how to take predispensed antibiotics for both children and adults who cannot swallow pills.
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From page 138... ...
A strategy of predispensing MCM for the general public could be government sponsored or could rely on individuals to obtain and own the MCM. The form of the predispensed MCM (e.g., personal stockpile or MedKit)
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From page 139... ...
For these groups and individuals, the risk of not obtaining prophylactic antibiotics following an anthrax attack may outweigh the potential health risks associated with inappropriate use. In addition, with a more limited, targeted strategy, it may be easier to institute systems to decrease inappropriate use, manage costs, and/or develop an alternative dispensing mechanism in the case of an attack with antibioticresistant anthrax.
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From page 140... ...
(2011) proposal for implementing the postal model includes providing prophylaxis to postal workers' families as well as the workers themselves based on the assumption that workers may not report to work until their family members have been taken care of.
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From page 141... ...
Louis study and postal pilot program. Although the data suggest that these groups may not misuse the MCM in nonemergency situations, no data are available on whether these groups would misuse them in an emergency situation in which antibiotics were not indicated -- for example, a nonanthrax public health emergency, a false alarm caused by a nonanthrax white-powder event, or an anthrax attack far away.
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From page 142... ...
For patients without access via these mechanisms, the potential risk of not having antibiotics following an anthrax attack may outweigh concerns about health risks from inappropriate use, lack of flexibility, and cost. Kent Sepkowitz, Vice Chairman of Clinical Affairs at Memorial SloanKettering Cancer Center, suggested to the committee that oncology patients and possibly HIV patients might appropriately receive predispensed antibiotics.
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From page 143... ...
Specifically, the committee is not recommending predispensing for those who are anxious about an anthrax attack but who could, for example, obtain MCM at a POD, although the committee recognizes that this is currently allowed legally under normal prescription laws. The committee acknowledges that public health officials have not done a very good job at communicating what plans are in place, and therefore it may be challenging for physicians and their patients to determine whether and how a patient would access antibiotics in case of an anthrax attack.
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From page 144... ...
Personal Physician screening for Misuse is likely to be high Unknown whether they Baseline for predispensed Stockpile contraindications, allergies, differ from general MCM and drug interactions population a EUA MedKit Include screening out of Extremely limited data Two studies, with substan- Administrative costs at FDA; people allergic to the MCM; restricted to families of tial limitations, that used cost to assemble packages specific instructions and postal workers suggest target subpopulations show (customized to household) ; tamper-evident packaging; that misuse is decreased decreased misuse relative to limited economies of scale provision of instructions relative to historical historical prescription data on how to prepare for prescription data (no head-to-head com children and adults who parison)
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From page 145... ...
Slides presented at the Institute of Medicine Public Workshop for the Committee on Prepositioned Medical Countermeasures for the Public, Washington, D.C, http://iom.edu/~/media/Session%20 8-%20Anderson_Vulnerable%20Populations.pdf (accessed July 21, 2011)
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From page 146... ...
Slides presented at the Institute of Medicine Public Workshop for the Committee on Prepositioned Medical Countermeasures for the Public, Washington, DC, http://www. iom.edu/~/media/Session%201-%20Burel_Federal%20Perspective.pdf (accessed March 30, 2011)
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From page 147... ...
Slides pre sented at the Institute of Medicine Public Workshop for the Committee on Prepositioned Medical Countermeasures for the Public, Washington, DC, http://iom.edu/~/media/ Session%204-%20Griffith_Other%20Examples%20of%20Prepositioning.pdf (accessed March 23, 2011)
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From page 148... ...
Slides presented at the Insti tute of Medicine Committee on Prepositioned Medical Countermeasures for the Public Meeting Three, Irvine, CA, http://iom.edu/~/media/Files/Activity%20Files/PublicHealth/ PrepositionedCountermeasures/Meeting%203/2%20-%20Janis%20-%20At-Risk%20 Populations.pdf (accessed September 15, 2011)
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From page 149... ...
Slides presented at the Institute of Medicine Public Workshop for the Committee on Prepositioned Medical Countermeasures for the Public, Wash ington, DC, http://www.iom.edu/~/media/Session%2010%20MuccioHospital%20%20 CHC%20Caches.pdf (accessed June 18, 2011)
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From page 150... ...
drug resistance. Slides presented at the Institute of Medicine Public Workshop for the Committee on Preposi tioned Medical Countermeasures for the Public, Washington, DC, http://www.iom.edu/~/ media/Session%207-%20Sepkowitz_Safety%20Issues.pdf (accessed June 19, 2011)
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From page 151... ...
Slides presented at the Institute of Medicine Public Workshop for the Committee on Prepositioned Medical Countermeasures for the Public, Washington, DC, http://iom.edu/~/media/Session%20 11B-%20Turner_Colleges%20-%20Other%20Strategies.pdf (accessed July 21, 2011)
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