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Biosecurity Briefing
Study: MedKits Show Promise as a Countermeasure Distribution Strategy By Brooke Courtney, March 14, 2008 A study of the U.S. Centers for Disease Control and Prevention’s (CDC) MedKit concept demonstrated that pre-positioning caches of antibiotics in individual households could be an effective strategy to ensure that the public has access to medical countermeasures after a release of anthrax.1 The CDC collaborated with the U.S. Food and Drug Administration (FDA) to design the MedKit prototype, a five-day supply of antibiotics in a four-fold cardboard blister pack.1 The pack, which is sealed in a clear plastic bag, includes instructions for use in an outside open pouch. The prototype has been evaluated as an investigational new drug (IND), and is being considered by the CDC as one of several modalities, including points of dispensing (PODs) and direct residential delivery by postal carriers, to distribute countermeasures to the public in response to large-scale public health emergencies.1 In 2006, the CDC partnered with the Missouri Department of Health and Senior Services to conduct an eight-month evaluation of placing MedKits in individual households in the St. Louis metro area.1 The objectives of the study were to determine the ability of households to maintain MedKits in their homes as directed; explore attitudes, perceptions, and other social factors that could influence storage and proper use of the kits; and assess the acceptability of the MedKit prototype. Participants were compensated and included corporation employees, first responders, and clients and staff of a community health clinic. One member of each household was responsible for the kit and was the survey responder for that household.1 Of the 4,076 households (12,040 persons) for which data was complete, the CDC reported that 97% (3,946) of respondents returned the kits at the end of the study; no statistical difference among cohorts was found. Of the 130 (3%) households that did not return their MedKits, 125 (96%) reported not being able to locate their kits, while 5 (4%) households refused to return them. The four households that reported using their kits were in the clinic cohort. Only 34 of the MedKit bags were returned opened (more than 99% had no missing pills), with “curiosity about the contents” being the most frequently cited reason for opening the bag.1 In addition to increasing awareness about preparing for a public health emergency, the majority of respondents reported that, based on the study experience, they would like to have a MedKit in their home and would pay an average of $23 per person for the kits.1 According to the CDC, the MedKit prototype, currently under development in the U.S. Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA), still needs FDA approval.1 To facilitate a New Drug Application (NDA) of the prototype, FDA is requiring additional testing on the comprehension among different literacy levels of the kit’s labeling and instructions, understanding of the correct use of the medications, palatability of the antibiotics when mixed with several common food substances, and ability of participants to understand and implement home preparation instructions to administer the medicine to children. Approval of the MedKit is estimated to take at least three years.1 In a February 19, 2008, Flu Wiki forum, William F. Raub, Science Advisor to the HHS Secretary, stated that HHS seeks “to encourage commercialization of antibiotic MedKits.” He also said that “[h]ousehold stockpiling of pharmaceuticals for use during public health emergencies could be an important modality of personal preparedness if we can develop products and approaches that are affordable; easy to obtain, maintain, and use; and consistent with medical and public health principles.”2 References
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