While the world is watching the ever-quickening spread of COVID-19, we need to be aware of the potential disruptions in the drug supply chain. These disruptions can prevent drug manufacturers from producing life-saving medications for patients around the world. With some countries on total lockdown, this will become a national security issue unless the Food and Drug Administration (FDA) and State Boards of Pharmacy untie the hands of the compounding industry.

The United States needs a plan to provide timely, transparent information and increase patient access to medically necessary drugs during shortages. Traditional compounding pharmacies and outsourcing facilities have filled this role in the past by working from the FDA’s drug shortage list, but it is often delayed and can result in gaps causing patient harm. However, allowing the compounding and manufacturing of drug shortages listed by the American Society of Health-System Pharmacists (ASHP) will quicken the response and reduce the gap in patients' access to medications. 

We are asking the FDA to allow our industry to use both the FDA’s and the ASHP lists. Traditional compounding pharmacies have been compounding for shortages for decades using the FDA shortage list. This led to the creation of outsourcing facilities by congress (and regulated by the FDA)  by federal statute, to ease the burden of the shortages by manufacturing drugs to the same cGMP standards of the original pharmaceutical manufacturers. 

According to the FDA, 40% of all manufactured drugs are imported to the United States, and 70% of the top 40 drugs in the U.S. are imported. Hurricane Maria, and the year-long market disruption that followed, is a perfect example of what happens when we are too dependent on a single geographical location to supply of our finished drugs and essential raw materials.  This is the time for action. We need to put a plan in place before supply chain issues greatly diminish patient care. 

After several requests to State Boards of Pharmacy and the FDA, hand sanitizer was allowed to be produced at local compounding pharmacies to fill the gap in the first line of defense of COVID-19. This is what our industry was made for: to fill the gaps where large pharmaceutical companies can't provide for patients' needs. There are thousands of traditional compounding pharmacies around the country and around 70 large outsourcing facilities that are working around the clock to meet the needs of these patients. All we need is more timely, transparent information about drug shortages and the needs of the industry. 

We are starting a discussion, and we are asking for health care professionals to let the FDA know that although we are ready and willing to help during this crisis, there needs to be better access to information. Two hundred forty-two drugs on the ASHP shortage list is too many when you have high-quality products and professionals available to help during this pandemic. Compounding is #HeretoHelp.

About MEDISCA

Medisca is a global corporation with locations throughout North America, Australia, and Europe, that contributes to healthcare by leveraging strong partnerships that deliver customized solutions with an unwavering commitment to quality and innovation. Backed by 30+ years and a strong foundation in pharmaceutical compounding supply, Medisca is a business-to-business company that delivers comprehensive offerings by providing value, consistency, responsiveness, and loyalty. As Partners in Wellness, Medisca offers an unfailing devotion to improving lives across a multitude of needs and people. For more information visit www.medisca.com and follow us on LinkedIn, Facebook, Twitter, and YouTube.

Contact:

Adam Pinsky