Public Health Emergency...
The purpose of the DSCSA, more formally known as the Drug Supply Chain Security Act, is to create a system that makes it easier to track and trace prescription medications along the drug supply chain in the United States. Initiated in 2013, the DSCSA regulates transactions along the supply chain, including manufacturers, repackager, distributors, pharmacies and other dispensers. The process of fully enacting the DSCSA is scheduled to take place over a 10 year period, illustrating that the requirements under the act are significant and complex.
With this in mind, one of the main questions surrounding full implementation of the DSCSA is what will happen in the event of a public health emergency. If we’re facing a situation where speed becomes crucial in the manufacture and distribution of pharmaceuticals, will the requirements of the DSCSA negatively impact our ability to navigate a public health crisis effectively? It’s important that anyone working within the drug supply chain understand if and how the DSCSA requirements will affect a public health crisis.
“Additionally, any entity that is engaged in distribution activities during a public health emergency should maintain all security aspects of the supply chain as medications are distributed to meet the pressing public health need. Once the expiration of the public health emergency is declared, any exceptions made under the DSCSA for the term also expire and standard requirements apply. ”
Defining a Public Health Crisis
The event of a true, serious public health crisis is relatively rare in the United States. We’re fortunate enough that advancements in technology have made it easier to recognize a significant public health threat so that it can be addressed before it becomes a widespread issue. However, we are not completely immune. In fact, we need not look much further than recent history to illustrate this point.
For example, the AIDS epidemic posed a significant public health crisis in parts of Africa during the 1980s. More recently, we’ve experienced close calls with threats to public health, such as MRSA, SARS, and H5N1, also known as the bird flu. The simple fact is that people are traveling around the world in massive numbers, and this exponentially increases the risk of a public health crisis. For reference, the Federal Aviation Administration claims that 2.5 million passengers fly daily in and out of United States airports alone.
While we’ve seen some smaller scale threats to public health in recent years, a true public health crisis can be defined as a health related event that has a geographically widespread effect on the general public with the potential to have devastating consequences on not only the health of the citizens but also on social and economical levels. A significant public health crisis has the capacity to destroy lives, communities and our economic structure. This means that the ability to respond quickly is key to managing a crisis and mitigating any potential damage.
The DSCSA and Public Health Emergencies
The implementation of serialization and tracing standards within the DSCSA is a time consuming process to say the least. Even once the final deadline is reached in 2023, we’re still looking at processes that could potentially slow down the ability to produce and supply the public with necessary medication in the event of a public health emergency.
Considering that this is a question that many people in the drug supply chain industries have asked, the FDA has included provisions about how the DSCSA requirements will be handled during the event of a public health crisis.
The Secretary of Health and Human Services has the ability to declare a public health emergency under section 319 o0f the Public Health Service Act. This can occur when it’s agreed upon that a disease presents a public health emergency or that a public health emergency, to include both infectious diseases or bioterrorist attacks, exists. In such an event, there may exist a need to expedite the production and distribution of pharmaceuticals as the emergency situation dictates. The FDA wants to assure both the public and members of the drug supply chain that no part of the DSCSA is designed to impede upon this process.
The DSCSA considers a public health emergency as sufficient reason to automatically exclude certain requirements for a period of time. According to the FDA, product distribution for public health emergencies is excluded from the act’s definition of wholesale distribution and transaction. Meaning, that any requirements related to tracing and wholesale distribution don’t apply to any trading partner that works to address a public health emergency. In such a case, the other requirements set forth in the DSCSA still apply.
Additionally, any entity that is engaged in distribution activities during a public health emergency should maintain all security aspects of the supply chain as medications are distributed to meet the pressing public health need. Once the expiration of the public health emergency is declared, any exceptions made under the DSCSA for the term also expire and standard requirements apply. Generally speaking, the term of the public health emergency will last until the Secretary states the emergency is no longer a threat to public health or 90 days after the declaration of the emergency was first issued, whichever of the two occurs first. If necessary, the Secretary may elect to extend the term beyond the initial 90 days.
It’s also important to note that there’s a designation between a true public health emergency and a general shortage of a particular medication. If a shortage of medication is not directly related to a public health emergency, then the manufacturer is expected to comply according to all stated guidelines.
Navigating Public Health Emergencies
While we all have the sincere hope that there won’t be the need to test the DSCSA requirements during a public health crisis, it’s important to acknowledge that the risk exists and to be prepared in the event that an emergency is issued by the Secretary. If we’re faced with a public health emergency, members of the drug supply chain will need to know how to react in accordance of the DSCSA requirements.