Premier Inc. Moves Forward With Efforts to End Drug Shortages That Impact Patient Care Delivery
The Charlotte-based Premier Inc. has been moving forward to address very difficult drug shortages that have been impacting patient care. Using the power of its group purchasing operations and influence, the alliance on October 8 made two announcements in that area.
In the first announcement, the alliance stated that “Premier Inc., through its ProvideGx™ program, has partnered with Amphastar Pharmaceuticals, Inc. to supply to healthcare providers phytonadione injection, and emergency, pre-filled syringes of calcium chloride, epinephrine, sodium bicarbonate, atropine sulfate, dextrose and lidocaine. Clinicians use emergency syringes in hospital crash carts and emergency departments because they are pre-measured in the precise adult dose and ready to use for immediate injection, speeding response times and minimizing the potential for dosing errors,” the Oct. 8 press release noted. “According to research published in the Journal of Patient Safety, emergency syringes halve the time it takes to dose and prepare medications for injection with compared to vials. The research also found that medication error rates as high as 75 percent fell to the single digits when clinicians administered the medicine through emergency syringes.”
And it quoted Premier President Michael J. Alkire, who stated in the press release, “Emergency syringes for several medications have been in shortage for a number of years and are completely unavailable in some parts of the country. In an urgent response situation, seconds count, and these shortages compromise providers’ rapid response capabilities, as well as patient safety. We are proud to partner with Amphastar to help ensure these life-saving syringes are once again back in the hands of providers across the nation. With this deal, we are not only closing a major gap, but simultaneously raising the bar for the entire drug supply chain.”
As the press release continued, “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 critical shortage drugs in 2019, including metoprolol, cystine hydrochloride, 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.”
“Offering more precise dosing and ease of use, we’ve come to rely heavily on emergency syringes to respond to a number of serious medical events, including heart attacks, allergic reactions, hemorrhages and poisonings,” said Julio Viola, B.S., M.S., PharmD, R.Ph, and Director, Centralized Pharmacy Services of Northwell Health, an 18-hospital academic medical system in the metro New York City/Long Island area. “Without access to these syringes, we’ve had to take a step backward and use vials, if we have access to the drugs at all. The one thing that is critical during an emergency is consistency among the products we use. This helps avoid confusion and wasting precious time. Having a reliable supply of emergency syringes is truly a life-saving development that will better enable us to provide the right drug, at the right time, for the right urgent situation.”
Meanwhile, also on Oct. 8, the alliance announced that “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.”
Shortly after the two announcements were made, Blair Childs, senior vice president for public affairs at Premier, spoke with Healthcare Innovation Editor-in-Chief Mark Hagland, regarding their significance. Below are excerpts from that interview.
Can you explain the significance of these announcements for the healthcare delivery system?
It used to be that it took four to five years for a new ANDA—an Abbreviated New Drug Application—to get through the FDA [Food and Drug Administration]. So you had barriers to entry to new products; if you wanted to reduce the drug shortage, you were encumbered. FDA has now sped up this process, in part because of the legislation we authored and got passed. And as a consequence, the time it takes us to work with manufacturers, and it’s causing manufacturers to say, we can’t hide behind the barriers to entry. We’re going to have more competitors. So we’ve been able to leverage that and bring more competitors to market; and we’re going to eliminate drug shortages—that’s our mission and goal in that space. There are parts of the problem that can’t address without a national policy. We’re raising the bar, and it’s forcing everyone else to react, so it’s exciting.
What made the announcements important?
They represent incredible progress. We’ve got well over 120 of the drug shortage products that we’re making fully available to our members. That has huge implications for health systems and anyone providing care, because of disruptions that undermine care delivery. Also, there are huge price spikes when shortages occur. So the fact that we’re making this much progress, and specifically taking a product off the shortage list, and continuing to raise the bar has forced all the other GPOs [group purchasing organizations] to scramble and forced the manufacturers to respond. When there have been barriers to entry, they’ve been able to raise prices. So it’s a cost issue and a reliability of care issue. And you have to keep all the NDCs [National Drug Codes] and EHRs [electronic health records] and so there’s a lot of coding and management from that vantage point that been a problem in terms of the stability of the supply chain.
