By Institute of Medicine, Board on Health Sciences Policy, Forum on Medical and Public Health Preparedness for Catastrophic Events, Bruce M. Altevogt, Lori Nadig, Clare Stroud
In the course of public well-being emergencies reminiscent of terrorist assaults or influenza outbreaks, the general public overall healthiness system's skill to save lots of lives may perhaps depend upon shelling out clinical countermeasures equivalent to antibiotics, antiviral drugs, and vaccines to a lot of humans in a quick period of time. The IOM's discussion board on scientific and Public healthiness Preparedness for Catastrophic occasions held a workshop on November 18, 2009, to supply an summary of present threats, contemporary development made within the public health and wellbeing procedure for allotting and meting out countermeasures, and ultimate vulnerabilities.
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Extra resources for Medical Countermeasures Dispensing: Emergency Use Authorization and the Postal Model: Workshop Summary
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Payment Who pays for medical countermeasures dispensing? The government provides the product, but providers, such as pharmacists, are responsible for compounding the medication. Healthcare providers spend staff time and resources administering vaccinations. ” Communication Consistent messaging between partners is essential to keeping the public and providers informed. When conflicting information is generated, many problems can occur. Rothholz shared an example of one such misfire. “[The] Centers for Medicare & Medicaid Services did a great flyer to the elderly population that talked about getting vaccinated against H1N1,” Rothholz explained.
Because of this, the conditions of authorization for that EUA are not known in advance, and these conditions specify the information that must be provided to healthcare practitioners, authorized dispensers, and recipients, as well as requirements for recordkeeping and data collection. Therefore, it is impossible to fully produce fact sheets and recordkeeping documentation before the emergency and issuance of the EUA. Kevin Sell, pharmacist consultant to the Minnesota Department of Health’s Office of Emergency Preparedness, illustrated that point using the example of the state of Minnesota.
An EUA is issued separately from a PREP Act declaration. “It’s not automatic that an EUA will have a PREP Act declaration,” Courtney said. It is also not a requirement that a PREP Act declaration be made for an EUA to be issued. ” The PREP Act itself has sometimes been an additional motivating factor for requesting an EUA. The statute states that coverage is only available for medical countermeasures that are approved and licensed by the FDA under an IND, investigational device exemption (IDE), or EUA.
