Regulatory and Legal Issues with the SNS Several issues related to legal and regulatory requirements impact the SNS, including liability and labeling practices, distribution of controlled substances, and the likelihood that the United States military will become engaged during the medical emergency. Liability and Indemnification Almost without exception, the use of any medical product can produce unintended side effects that may cause injury or harm to the patient. By extension, the SNS has the potential not only to do great good but also to cause unintended harm. This is even more likely to be the case if the SNS is deployed on the basis of its use in prophylaxis of persons who may or may not have been exposed to a harmful agent. In the anthrax attacks of 2001, the use of antibiotics for prophylaxis was extended to over 35,000 people through the use of VMI. The vast majority of these people had probably not been exposed to anthrax, but because exposure could not be ruled out in most cases, the decision was made to provide antibiotics. As noted above, the use of antibiotics by otherwise healthy persons led to discussion of the side effects, which in turn led to examination of the legal liability issues that may result from any harm done to the antibiotic recipients. 18 One of the key issues under discussion was the question of whether or not, in deploying the SNS and advising on its use, the Federal government or its agents were exposed to legal liability and the attendant possibility of being sued for damages by persons who had experienced side effects from the use of antibiotics. In a comprehensive review of vaccine liability, J.S. Mair and M. Mair explored legal issues that may impact use of antibiotics or other medical materiel from the SNS.19 They noted, “under the historic legal doctrine that ‘the king can do no wrong,’ the Federal government is immune from all liability and cannot be sued without its consent. Recognizing the inherent inequities that resulted from such sweeping protection, the Federal government has waived its sovereign immunity in some circumstances. With the enactment of the Federal Tort Claims Act (FTCA) in 1946, the Federal government agreed to substitute itself as defendant when Federal employees, who were acting within the scope of their office or employment, are sued in tort. Tort has been defined as a ‘private or civil wrong or injury, including action for bad faith breach of contract, for which the court will provide a remedy in the form of an action for damages.’ When the government substitutes itself as defendant under the FTCA, Federal employees cannot be sued in tort and special rules govern the lawsuit.” Mair and Mair identified several precedents that relate to handling vaccine liability that may also be applied to other SNS materiel. They noted that these are not always mutually exclusive. The government can 1) substitute itself as defendant and accept liability on behalf of the participants in the vaccination program, 2) decide that no one needs to be held liable and establish a no-fault compensation program, 3) indemnify (i.e., reimburse) vaccine manufacturers and distributors, providers, and other participants after they have been sued and a judgment issued against them, or 4) alter the normal rules of litigation and/or compensation. Of particular note, given the current legal status of the SNS within the DHS, is the language in the Homeland Security Act that speaks to liability following administration of medical products. Government liability is expressly addressed by Section 304 of the Act, which applies only to “covered countermeasures against smallpox.” If the same vaccines and treatments are used for a pathogen other than smallpox—for example, monkeypox—Section 304 does not apply. Moreover, if vaccines or treatments are developed or used for other possible bioterrorism agents (e.g., bacteria such as plague, toxins such as botulinum, viruses such as ebola, etc.), the Act must be amended or a new law enacted. Labeling State and Federal regulations specify the information that must be provided on a drug label and the information sheet that will be provided to patients or the public if drugs are to be used as prophylactics. For example, the Food and Drug Administration (FDA) requires that the label include drug name, strength, and quantity, directions for use, location of dispensing facility, serial number of the prescription, date, and the name of the prescriber. The information on the labels of the products in the SNS can vary greatly. Most are limited to the drug name, strength, quantity, lot number, and unique prescription number. The local sites must provide the additional data that is required to conform to Federal and state law. 20 When bulk drugs in the SNS are repackaged on-site, the labeling machines that accompany each of the push packs can be programmed to provide the required labeling. However, even under these circumstances, the dispensing site will have to annotate the patient’s name on the label. According to the planner’s guide, maximum repackaging of a push package requires 300 volunteers for 8-10 hours. 21 This would produce 27,800 individual regimens per hour and provide the capacity needed to dispense the SNS bulk products to the public in appropriate unit doses. Clearly, handling the SNS is a formidable logistic challenge. Distribution of Controlled Substances The three controlled substances in push packs (morphine, diazepam, and lorazepam) not only require special, secure storage conditions, but also legal considerations during delivery, storage, and dispensing. The Drug Enforcement Administration (DEA) provides a system of registration for all persons who must handle specific classes of controlled substances, and this applies to the SNS. A detailed chain-of-custody must be kept, and transfer of materials from registrant to registrant must be carefully documented. It also is suggested that these materials be transferred in coordination with law enforcement agencies to provide security for the products and the dispensing personnel. IND and Off-Label Use of Strategic National Stockpile Materiel According to the CDC, all drugs in the SNS have long-established safety and efficacy records. However, some are not FDA-labeled (that is, licensed) to treat specific agents that may be released in a biological incident. 22 The CDC is working with the FDA to establish a process that will qualify these drugs, but until the specific labeling is approved, they may have to be used under the auspices of an Investigational New Drug (IND) application. The use of SNS materiel under an IND presents some interesting and potentially problematic logistical and legal issues. One issue is whether the U.S. government can legally stockpile medical
countermeasures for purposes that are not identified on the label of the
product. This was a significant point of contention between the CDC and
the FDA before and after the 9/11 attacks . The standard treatment for
some diseases in ordinary medical practice is off-label (i.e., the drug
is being used to treat a disease for which it is not specifically licensed
by the FDA). For example, for plague the drug of choice is a generic antibiotic.
The FDA license for such drugs does not contain specific reference to
its use in treatment of plague; thus, use in treatment of plague is off-label.
The FDA contended that the CDC could not stockpile products for such off-label
uses. An example of an innovative solution to off-label use is cited by the CDC in the guide for receiving, distributing, and dispensing the NPS. 23 It relates to the issue of expiration dates for SNS drugs. Before the fall 2001 attacks, bulk drugs could not be repackaged and retain their original manufacturer’s expiration date. This meant that repackaged bulk drugs had a much shorter lifespan. After the attacks, the CDC “located firms that operated under a special FDA license and were able to create unit-of-use regimens that keep their original manufacturer’s expiration date.” Recently, the FDA has coordinated with the CDC to ensure that gentamicin (an antimicrobial drug) has a swifter IND process.24 In an effort to have SNS stocks adequately labeled, the FDA and CDC have worked to identify those requiring an IND application and have created the concept of the "streamlined" IND, which meets regulatory requirements and allows access to SNS resources in the event of a terrorist attack. Other drugs identified and relabeled by the FDA for emergency non-IND use include ciprofloxacin, another antibiotic long used for inhalation anthrax. 25 Shortly after the anthrax attacks, the Center for Drug Evaluation and Research (CDER) worked to relabel doxycycline and procaine penicillin for post-exposure management of anthrax. Military Use of the Strategic National Stockpile The Department of Defense (DOD) has no formal role in the storage, deployment, or utilization of the SNS. However, it is likely that, in the event of SNS deployment, some elements of the DOD will become engaged. As noted above, although military bases seem to provide secure landing sites and facilities for the initial delivery of the SNS, they should be used only as a last resort. 26 There are two principal reasons for this. First, during a crisis that requires SNS deployment, most nearby military facilities will be operating under heightened levels of security and will not be freely accessible to civilians. Second, most military airfields are unable to offload a wide-bodied commercial jetliner, and the use of alternative means of offload would delay deployment of stocks. If the military does not receive the SNS, the first DOD engagement with the SNS is likely to be when National Guard units, under the control of the governor, play their part in a local or state response plan. The use of Guard units in state and local responses to an emerging incident is an essential part of most state plans for crisis and consequence management. This is true whether the incident is man-made or naturally occurring. The role of the Guard with respect to the SNS will vary from state to state but might include support to civil authorities in law enforcement, security, logistics, or the use of DOD-specific skills or resources. Regardless of the role that the Guard plays, it is likely that the Guard units will include personnel requiring access to the SNS. For example, if antibiotic prophylaxis is being used in the civilian population, the Guard probably will share SNS stocks with civilians. However, it is worth noting that unlike their civilian counterparts, Guard personnel will likely have been vaccinated against some of the possible biological agents, such as smallpox and anthrax. They also will be well versed in the use of individual protective equipment (IPE), such as masks, respirators, and suits; collective protective equipment (ColPro), such as shelters and over-pressure vehicles; and military detection equipment, such as the Chemical Agent Monitor (CAM). Clearly, the role of the Guard in incidents involving weapons of mass destruction (WMD) will be critically important. The deployment of DOD assets other than the National Guard for homeland defense operations is the responsibility of U.S. Northern Command (USNORTHCOM).27 These DOD components probably would be deployed according to the DOD directive on military assistance to civil authorities (MACA).28 This would occur when a state requests support from Federal authorities under the auspices of legislative authority, such as the Stafford Act, which operates in the event of a Federal emergency or some other form of declared disaster. MACA can provide a wide range of resources and assets, from unskilled manpower to skilled and qualified personnel and specialized equipment. In this case, the DOD anticipates that operating MACA will grant military access to the SNS materiel. The alternative would be that the DOD might consider establishing its own, scaled-down version of the SNS with materiel that is tailored to the specific requirements of a DOD deployment. Current DOD assets include:
Selected military-specific supplies, such as MARK 1 kits and field dressings items, are kept in a few Defense Logistics Agency warehouses around the country. Also, the Army relies on Installation Support Packages (ISP) at each installation and at Regional Medical Centers. An ISP contains a 30-day supply of doxycycline and ciprofloxacin. The Army has enough for 25 percent of the total catchment population (meaning 25 percent of active duty soldiers, their family members, and Army civilian employees) for that installation. A 15-day supply is kept at the installation, and the other 15-day supply is kept in reserve at the Regional Medical Center. 29 It is possible that the use of the SNS by the DOD will create some real challenges for military. For instance, the DOD will use different criteria for starting forces on antibiotics if military personnel have to enter a contaminated environment or if they might be exposed to a contagious biological agent. The DOD comprises a younger, healthier population that is required to work long hours with no time-off, and, of course, the DOD doesn’t have the same liability concerns that exist in the civilian population. Given their preeminent expertise in response to such threats as WMD, and the likelihood that they will be required to be in close proximity to the incident focus, the DOD may choose to put young, healthy soldiers on antibiotics when they are at very low risk, while civilians at much higher risk are not being treated, thus ensuring military personnel availability during all phases of incident response.
18. This issue is addressed in “Antimicrobial
Post-exposure Prophylaxis for Anthrax: Adverse Events and Adherence,”
C.W. Shepard et al. Emerging Infectious Diseases, Vol. 8 No.
10, October 2002.
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