The Centers for Disease Control and Prevention (CDC) launched in 2003 the CHEMPACK program, which “forward places” caches of nerve agent antidotes and symptomatic treatments at the local level “to provide a sustainable resource to respond quickly to a nerve agent incident.” Since then, the program has had no fundamental renewal, even with the introduction of new monitoring technologies and products over the past decade.
On 23 January 2014, the Emergency Services Coalition for Medical Preparedness – a coalition supported by private and public organizations to help protect providers in the event of a large-scale biological event – held its first public strategic review of the program in Washington, D.C. This review was part of a larger project to develop policies and operational capacities to ensure the health of emergency services personnel when faced with various public health threats. Responders who have adequate protection are better able to protect the communities they serve. On 3 February 2014, the House of Representatives passed – with a vote of 391 to 2 – the Medical Preparedness Allowable Use Act (H.R. 1791), which would help enhance medical preparedness, medical surge capacity, and mass prophylaxis capabilities. Conditions are favorable for a broader examination of national emergency services protection and preparedness.
The Existing CHEMPACK Program The CHEMPACK program is a critical asset to the hospital and emergency services communities that support the long-term sustainment and further development of this response asset. Funding constraints should not hinder efforts to derive administrative savings, increase local engagement, and introduce proven technology.
Historically, the management of the program has depended on federal staff members remotely monitoring caches and traveling nationwide to and from localities to replenish expiring drug products. This is an unnecessarily costly process. To achieve the stated goal of a sustainable strategy, the Emergency Services Coalition for Medical Preparedness recommends a significant shift of management responsibility to localities and private sector partners, along with sustained funding for expanding the formulary, which is the official list of drug products in the program.
Local pharmacists – with the support of CDC CHEMPACK staff and product manufacturers/distributors – are capable of managing the rotation of “soon-to-expire” stock as needed. Vendor management of pharmaceuticals has proved to provide superior timeliness, cost effectiveness, and efficiency, given this is a core competency of these firms. Local pharmacists are able to make determinations of needs specific to their own communities. The Internet-based remote monitoring capacity has overcome the rationale for in-person federal inspections.
Recommendation 1 – Local Management
- Transfer select routine CHEMPACK sustainment activities to local pharmacists and use resultant cost savings – via reduced federal staff administrative overhead – to further develop a CHEMPACK quality assurance program, enhance exercises, and expand the CHEMPACK formulary to address additional threats.
- Allow localities to determine the appropriate formulary for local conditions and add products to a defined core CHEMPACK cache – for example, cyanide antidotes and potassium iodide.
- Update current CHEMPACK monitoring systems with cost-effective online systems.
Chemical agent antidote and treatment development has not kept up with initial projections. This also has been true of the larger countermeasure development enterprise. Among reasons cited are lack of incentives for private sector research and manufacture, changes in threat analysis, and time since previous intentional events. Nonetheless, there are important new products awaiting introduction into the CHEMPACK.
Recommendation 2 – Renew & Replenish the Formulary
- Use administrative savings to update the protections provided by the CHEMPACK.
- Use advanced purchase commitments and other modern financing options to provide incentives for enhanced and new product lines.
Repackaging concerns have delayed the expansion of the Shelf Life Extension Program (SLEP) beyond the U.S. Department of Defense to include state and local membership. The current SLEP process requires that extended product be turned over to a “state-licensed, drug-repackaging firm” to have the product relabeled with new expiration dates. If repackaging and associated shipping costs can be avoided, the CHEMPACK annual maintenance costs would be greatly reduced.
Recommendation 3 – Simplify Shelf-Life Management
- Work with manufacturers toentify a “CHEMPACK-Only” version of products. Such versions will have longer initial shelf-life dates and accommodate simplified labeling for SLEP administration.
- Propose to the U.S. Food and Drug Administration that “CHEMPACK-Only” products do not include expiration date data on their immediate containers and packaging. Instead, data would be contained in a pouch affixed to the outside of each CHEMPACK container. At the time of activation, pharmacies would fix expiration date adhesive labels to products before releasing them. When new product expiration dates occur due to SLEP, pharmacies would provide new sets of labels. This approach would greatly reduce repackaging overhead costs.
The CHEMPACK program has not changed in the years since it was developed. In the meantime, the nation has added 30 million residents, 70 percent of them in the southern and western United States. Locally maintained CHEMPACK caches must include periodic threat and hazard assessments taking into account shifts in population and chemical industry expansion. To be the sustainable local asset close enough to population centers, CHEMPACK must continuously improve and expand.
Recommendation 4 – Pilot Change Process
- Fund two or more pilot projects toentify innovative practices for the development of the next generation of locally managed CHEMPACK.
- Establish a practitioner-led Board to oversee a continuous quality improvement process.
The CHEMPACK program is an essential part of national resilience required across the whole community to protect emergency responders as well as the residents they serve. It is time to build a second-generation program via local management, engagement of the private sector, implementation of SLEP efficiencies, and improved use of technology to ensure the efficacy and security of the installations. These four recommendations of the Emergency Services Coalition for Medical Preparedness are a starting point.
_________________________ Timothy Stephens is an advisor to the Emergency Services Coalition for Medical Preparedness. He owns an independent public health and risk management consulting practice, where he has provided strategic advice to numerous organizations and businesses, including Unither Virology, the Centers for Disease Control and Prevention, Association of State and Territorial Health Officials, National Association of County and City Health Officials, and the National Sheriffs Association. He conducts leadership seminars and is certified in numerous educational assessment instruments including Change Style Indicator and the Paper Planes simulation. He is an adjunct instructor at the Vanderbilt University School of Nursing, and has a master’s degree in communications from the University of North Carolina at Chapel Hill.