MEDICAL COUNTERMEASURES

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5.1 Summary

In the event of a major disaster or emergency, critical medical supplies will be needed across the District. These items, often referred to as medical countermeasures (MCM), may come from many sources, including District stockpiles, hospital and health system stockpiles, privately owned stockpiles, neighboring jurisdictions through mutual aid, and federal stockpiles. MCM include both pharmaceutical interventions, such as vaccines, antimicrobials, antidotes, and antitoxins, and non-pharmaceutical interventions, such as ventilators, diagnostics, personal protective equipment (PPE), and patient decontamination, that may be used to prevent, mitigate, or treat the adverse health effects of an intentional, accidental or naturally occurring public health emergency. A terrorist attack employing biological or chemical weapons may cause mass casualties that require rapid distribution and dispensing of MCM to minimize morbidity and mortality. Similarly, disease outbreaks and natural disasters may cause serious health impacts for entire populations that require MCM to mitigate impacts. Both federal and District laws authorize or guide the use of MCM, including liability exemptions. In some cases, special United States Food and Drug Administration (FDA) emergency use authorities may need to be utilized in order to use the best MCMs available for response in impacted populations.      

5.2 Mayor’s Authority

The Mayor has the authority to declare a state of public emergency, D.C. Official Code § 7-2304, and a subsequent state of public health emergency, D.C. Official Code § 7-2304.01. In both of these situations, the Mayor’s declaration could implement a wide range of measures designed to respond to and mitigate the emergency, including the deployment of medical countermeasures (MCM). For example, the terms of the declaration could include a temporary overriding of the District law so as to establish a grant of authority to the DC Health Director (or the District’s Chief Health Officer or Chief Medical Officer, or a similarly qualified official) to issue one or more “standing medical orders” or “blanket prescriptions” to enable the distribution, dispensing, and administration of prophylactic medications and/or other pharmaceuticals as a means of combating the emergency and protecting potentially exposed individuals.

See section 4.5 of the Manual regarding the mayor’s authority to declare emergencies.

5.3 Strategic National Stockpile

The Strategic National Stockpile (SNS), which includes drugs, vaccines, biological products, medical devices, and other supplies, is maintained by the United States Secretary of Health and Human Services (HHS Secretary) to provide for the emergency health security of the U.S. The HHS Secretary may deploy the SNS to respond to an actual or potential public health emergency or to otherwise protect the public health or safety, or as required by the Secretary of the United States Department of Homeland Security (DHS Secretary) to respond to an actual or potential emergency. The federal government established the SNS, which is managed by the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the United States Department of Health and Human Services (HHS), to augment local supplies of critical medical items. See 42 U.S.C. § 247d-6b.

One component included in the SNS is “Push Packs,” which are caches of large quantities of medicines, antidotes, and medical supplies that are responsive to a wide range of threats. Push Packs include MCMs that may be useful in biological attacks (using agents such as anthrax, plague, and tularemia), nuclear attacks, radiological events, and explosive events, as well as natural disasters and other human caused incidents. Another component of the SNS is CHEMPACKS that are prepositioned and stored locally to provide chemoprophylaxis to nerve agents released during a large-scale chemical event. Having these items forward deployed allows for their immediate use in suspected or confirmed victims. This is essential since any delay in treatment could gravely affect patient outcomes.

Section 402: Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPIA) codifies the PHEMCE into law. The PHEMCE is designed to inform the direction of research, development, stockpiling, utilization, and procurement of MCMs for the SNS, including considerations for deployment and distribution of MCMs.

Section 403: Strategic National Stockpile of the PAHPIA requires collaboration between the ASPR Secretary and the Centers for Disease Control and Prevention (CDC) regarding management of the SNS, while reauthorizing the SNS through 2023.

5.4 Chemical, Biological, Radioactive, Nuclear, or Explosive Event

Human casualties are the highest priority for emergency responders in disasters and emergencies, especially acts of terrorism involving Chemical, Biological, Radioactive, Nuclear, or Explosive (CBRNE) weapons. A terrorist attack may be localized or widespread and multiple CBRNE events may occur simultaneously over a short span of time, or in combination with another hazard. The effects may be immediate (e.g., due to chemical agents) or delayed (e.g., due to biological agents). Persons who are not symptomatic but are known or believed to have been exposed will receive MCM as prophylaxis in accordance with the District’s emergency medical plans.

Persons who experience symptoms resulting from any hazard will be referred to a designated facility for care and/or treatment. For example, during the 2014 Ebola outbreak, there were a number of hospitals designated nationally as treating facilities, including Children’s National Medical Center, Medstar Washington Hospital Center, and George Washington University Hospital in the District. See https://dc.gov/release/dc-based-hospitals-among-35-nationally-recognized-treatment-centers-ready-handle-ebola.

5.5 Personnel Authorized to Dispense Medications During a State of Public Health Emergency

The Mayor has the authority, as part of a public health emergency order, to implement emergency measures regarding the dispensing of medication. D.C. Official Code § 7-2304.01(c)(4), (d)(1), (d)(2), (d)(4). The Mayor’s authority in this regard may be delegated to the Chief Public Health Officer/DC Health Director.

For example, the order may include a provision to expand the types of healthcare providers authorized to dispense medications.

5.6 Procurement or Taking of Private Property

The Mayor has the authority, as part of a public health emergency order, to procure property, supplies, and equipment as necessary to respond to the emergency. D.C. Official Code § 7-2304(b).

The District’s procurement laws and regulations provide procedures for emergency procurements when there is an imminent threat to the public health, welfare, property, or safety, or to minimize disruption in District services when an emergency condition exists. See D.C. Official Code § 2-354.05; 27 DCMR § 1702.

5.7 Medical Countermeasures Emergency Use Authorities

Under most circumstances, drugs, medical devices, and biologics may only be introduced into interstate commerce if they have been approved, cleared, or licensed by the United States Food and Drug Administration (FDA). In certain situations, the best MCMs available for response are unapproved by the FDA or may need to be used in unapproved ways. The FDA has special authorization to allow for the use of such MCMs in impacted populations during or in anticipation of emergencies. Mechanisms the FDA can use to allow the emergency use of MCMs include the emergency use authorization (EUA) authority and several authorities related to the emergency use of approved MCMs. See  https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/mcm-related-counterterrorism-legislation.

The FDA-issued Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders provides useful information regarding MCM emergency use authorities.

5.7.1    Emergency Use Authorization Authority

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA may authorize (1) the use of an unapproved medical product, or (2) an unapproved use of an approved medical product, in certain situations through an EUA to make available an MCM for use in an emergency without violating provisions of the FD&C Act. Before the FDA may issue an EUA, the HHS Secretary must declare that circumstances exist justifying the authorization. The HHS EUA declaration is based on one of four types of determinations issued by the HHS Secretary, the DHS Secretary, or the United States Department of Defense Secretary. The FDA also must ensure that certain criteria for issuance are met, such as that the known and potential benefits of the product outweigh its known and potential risks and that there is no adequate, approved, and available alternative to the product.

Each EUA includes specific conditions for the various stakeholders involved (e.g., HHS, state and local stakeholders, and healthcare providers) and fact sheets about the product and its emergency use for healthcare providers and recipients. The FDA has issued over 60 EUAs. Generally, an EUA remains in effect for the duration of the emergency declaration made by the HHS Secretary unless revoked at an earlier date.

5.7.2    Other Medical Countermeasure Emergency Use Authorities (limited to approved medical products)

Emergency activities involving eligible FDA-approved products without the FDA needing to issue an EUA are also possible through actions under section 564A of the FD&C Act, including the issuance of an emergency dispensing order (EDO), waiver of Current Good Manufacturing Practice (CGMP) requirements, waiver of Risk Evaluation and Mitigation Strategies (REMS) requirements, extension of labeled expiration dating, and/or issuance of emergency use instructions (EUI) for specific MCMs.

These authorities are delegated from HHS to the FDA. However, the EUI authority was delegated from HHS to CDC in 2013. For additional information about the FDA and CDC coordination on the EUI authority, refer to the FDA-CDC memorandum of understanding.

The EDO authority allows the FDA to facilitate the availability and use of eligible, approved MCMs needed during public health emergencies by allowing emergency dispensing of approved MCMs without requiring an individual prescription for each recipient of the MCM. The FDA intends to issue orders to allow emergency dispensing when, based on available information about the MCM, emergency response plans, and operational needs, the FDA concludes that it is reasonable to permit emergency dispensing of eligible FDA-approved products. The FDA may allow emergency dispensing (including mass dispensing at a point of dispensing (POD)) of approved MCMs during an actual Chemical, Biological, Radioactive, or Nuclear (CBRN) emergency, without requiring an individual prescription for each recipient of the MCM, if (1) permitted by state law or (2) in accordance with an order issued by the FDA. EDOs issued by the FDA also may include waivers of CGMP requirements, such as storage or handling when appropriate to accommodate emergency response needs.

When MCMs are needed during public health emergencies, information about the emergency use of the product is also needed. The EUI authority allows CDC to provide streamlined information (also referred to as fact sheets for recipients of an MCM and for healthcare professionals) about the use of eligible, approved MCMs. Under section 564A(e) of the FD&C Act, CDC may create and issue, and government stakeholders may disseminate, EUI about the FDA-approved conditions of use for such MCMs before or during a CBRN event. EUI are intended to be similar to “fact sheets” that have been authorized in past EUAs, and may be directed to healthcare professionals and authorized dispensers or to recipients of an eligible MCM. The EUI authority offers enhanced flexibility for CDC to prepare and disseminate EUI concerning a disease or condition for which an MCM is FDA-approved, licensed, or cleared without further limitation.

The FDA and CDC interpret this provision as permitting the creation of EUI that describe how the approved drug may be used, for the disease or condition for which it is approved, but in ways that may deviate from or extend beyond the FDA-approved labeling. When feasible, the FDA and CDC will coordinate issuance of an EDO and EUI for a specific approved MCM together as a “package.” Such packages also may include waivers of certain CGMP requirements (e.g., temporary deviations from the labeled storage conditions) and expiration dating extensions.

Under section 564B of the FD&C Act, government entities and their agents may preposition or stockpile an unapproved medical product intended for emergency use in anticipation of the FDA approval or clearance, or issuance of an EUA to enable them to better prepare for potential rapid deployment during an actual CBRN emergency.

Currently, there are EDOs for doxycycline and ciprofloxacin for post-exposure prophylaxis of inhalational anthrax during an anthrax emergency, with accompanying EUI.

Information about expiration dating extensions by the FDA can be found at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/expiration-dating-extension.

5.8 Liability Protection

The Mayor has the authority, as part of a public health emergency order, to appoint healthcare providers as agents of the District, and to specifically exempt healthcare providers from civil liability, except in instances of gross negligence, and solely for the duration of the public health emergency. D.C. Official Code § 7-2304.01(d)(2), (d)(3).

The Advanced Life Support Act of 1977 (D.C. Official Code § 7-401) provides a blanket exemption from civil liability for any person who renders medical care in good faith in an emergency situation on a volunteer basis. This law limits liability for rendering medical care or assistance during any emergency event with or without a public health emergency order. It protects any non-licensed individual rendering emergency care as a Good Samaritan. This law also covers any emergency medical technician (paramedic, intermediate or basic) certified in any state or the District who is providing assistance under the direction of a licensed physician, as well as the licensed physician who is providing the emergency medical instruction as long as the care is provided in good faith and does not constitute gross negligence. During a declared emergency pursuant to D.C. Official Code § 7-2304, this protection is also extended to the employer of the emergency medical technician, provided that the care is rendered in good faith and does not constitute gross negligence.

See section 11.3.1 of the Manual for information regarding liability protections for volunteer health practitioners who provide services under D.C. Official Code § 7-2361.01 to-2361.12.

The Public Readiness and Emergency Preparedness Act (PREP Act) of 2005 Pub. L. No. 109-148; 42 U.S.C. §§ 247d-6d, 247d-6e authorizes the HHS Secretary to issue a declaration (called a “PREP ACT declaration”) that provides immunity (except for willful misconduct) for claims related to administration or use of countermeasures against CBRN agents to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures. A PREP Act declaration includes, among other provisions:

  • The countermeasures covered by the declaration;
  • The category of diseases, health conditions, or health threats for which administration and use of the countermeasures are recommended;
  • The effective time period of the declaration;
  • The population of individuals receiving the countermeasure;
  • Limitations, if any, on the geographic area for which immunity is in effect;
  • Limitations, if any, on the means of distribution of the countermeasure; and
  • Any additional persons identified by the HHS Secretary as qualified to prescribe, dispense, or administer the countermeasures.

The PREP Act also authorizes a fund in the United States Treasury to provide compensation for injuries directly caused by administration or use of countermeasures covered by the Secretary's declaration.

Additional information about the PREP Act and current PREP Act declarations are available at https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx.



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