CHARLOTTE, N.C. — Premier Inc. (NASDAQ: PINC), through its ProvideGx™ program, and Exela Pharma Sciences, LLC, have successfully resolved the multi-year, national shortage of cysteine hydrochloride injection.
Cysteine hydrochloride, a critical drug for pediatric and adult patients who require parenteral nutrition (PN), was officially delisted from the U.S. Food and Drug Administration’s drug shortage website on Sept. 4, 2019, just two months after it entered the market via a supply deal with ProvideGx. The drug had previously been in continual shortage since 2015.
Exela Pharma Sciences is currently the only FDA-approved manufacturer of cysteine hydrochloride injection. Its new formulation is labeled to contain no more than 120 parts per billion (ppb) or mcg/L of aluminum. Patients with renal impairment, including preterm infants, who receive greater than 4 to 5 mcg/kg/day of parenteral aluminum can accumulate aluminum to levels associated with central nervous system and bone toxicity.
“Creating permanent solutions that put an end to drug shortages has been the mission of ProvideGx since day one,” said Premier’s President, Michael J. Alkire. “Not only have we helped stabilize this market and ensured a reliable supply for patients nationwide, we did so with an FDA-approved, U.S. manufactured product labeled with the lowest aluminum content to date. We have always had the utmost confidence that our approach to tackling drug shortages would produce real, tangible results. This is a model that works, and we are proud of our collaboration with Exela. We hope to replicate this success for many other drugs currently in shortage.”
Premier’s ProvideGx program identifies safe, high-quality supply sources for drugs that are or may be at risk of being added to the national drug shortage list. Guided by health systems with more than 1,000 hospitals across the nation, Premier’s ProvideGx program has directly led to the reliable supply of multiple critical shortage drugs in 2019, including metoprolol, sodium bicarbonate, diphenhydramine, hydromorphone, lidocaine, morphine and thiamine, with plans to introduce additional drugs from a target list of more than 60 products in months to come.
ProvideGx is part of Premier’s ongoing effort to help facilitate the availability of hundreds of high-quality products, including drugs for which there may be supply challenges. In doing so, Premier is working to insulate its members from supply fluctuations that may affect the market at large.
“At Exela, our mission is to expedite the availability of affordable medicines,” said Exela Pharma Sciences President and CEO, Phanesh Koneru, Ph.D., LL.M. “Through the process of bringing cysteine hydrochloride injection to the market, we worked collaboratively with the FDA to secure our approval, and with ProvideGx to ensure we had a viable sales channel once we were cleared for production. Introducing this drug is one of the high points of our company history.”
After a period of decline, drug shortages in America increased significantly in 2018, with an estimated 113 drugs currently at risk or not readily available for U.S. hospitals, according to the FDA’s drug shortage list. With wide-ranging effects on patient care, drug shortages can add time and expense as providers search for therapeutic alternatives and manage supplies, potentially delaying certain elective hospital procedures.
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