In April 2016, the Centers for Disease Control and Prevention (CDC) released new Emergency Use Instructions (EUIs) for Doxycycline and Ciprofloxacin for post-exposure prophylaxis following anthrax emergency. Released EUIs include the following documents:

• Revised Doxycycline & Ciprofloxacin Post-Exposure Prophylaxis Instructions for Healthcare Providers
• Revised Doxycycline & Ciprofloxacin Emergency Use Instructions for Drug Recipients
• An Updated Pamphlet and New One-Pager for Doxycycline Pill Crushing Instructions
• A Video entitled: How to Crush Doxycycline for Children & Adults Who Cannot Swallow Pills

Of note, these newly issued EUIs contain new weight-based dosing table information that is different from prior versions of pill crushing instructions. Local health departments may consider pre-emergency review of relevant locally-developed MCM screening forms and protocols to ensure consistency with these new EUI documents.

Accessing the Emergency Use Instructions

These new EUIs are currently uploaded on CDC’s secure MCM Sharepoint Site (CDC Join Account is needed to access). During an emergency, these documents will also be posted on CDC’s public facing website.

Background on Emergency Use Instructions

Under the 2013 Pandemic and All-Hazards Preparedness Re-Authorization Act (PAHPRA), the Department of Health and Human Services (HHS) Seceratary (or designee) may issue EUIs for providers and drug recipients before and during emergencies. HHS delegated the authority to issue new EUIs to CDC.

“EUIs provide information regarding event-driven prevention and treatment of a disease or condition for which the MCM has been approved, licensed, or cleared by FDA in the face of an emergency.”* EUIs allow for the legal protection for MCMs use in a non-traditional way or in non-medical model.* EUIs cannot be used for products not approved by the FDA nor for unapproved usage of approved products.* The following document provides additional clarifying information surrounding EUIs, Emergency Use Authorizations, and other provisions of PAHPRA that are relevant to MCMs for emergencies.

References

*Medical Countermeasure Link Workshop, CDC, 2016 Preparedness Summit, April 19, 2016.