Issue link: https://beckershealthcare.uberflip.com/i/1117375
78 Executive Briefing: Nephron has launched around 50 new products since its outsourcing division opened, and all of them are candidates for abbreviated new drug applications, according to Ms. Kennedy. It has already submitted three — sodium bicarbonate, water for injections and saline — to the FDA. The timeline for generic approval is promising under President Donald Trump's administration, according to Ms. Kennedy. Nephron hopes to get generic approval within nine months, whereas in the past, FDA approval could take three to five years. However, in its efforts to address drug shortages, Nephron still faces certain hurdles, such as FDA regulations requiring manufacturers to package generic medications in glass containers. If regulators begin allowing plastic packaging — which is the norm for the rest of the world, Ms. Kennedy said — companies like Nephron could speed up production. With Blow-Fill-Seal packaging, Nephron could produce 18 million doses of a medication in the same amount of time it would take to make around 200,000 doses using glass. Plastic packaging, known as BFS, would cost about 25 cents, compared to 75 cents for a glass vial. Glass also has unique handling requirements because it's fragile, must be sterilized before being filled and requires needles to use — plus, it's in short supply, according to Ms. Kennedy. "Back in the day, milk always came in a glass bottle and later came in plastic jugs. We can do the same thing with medications," she said. "Utilizing plastic packaging containers, instead of glass, would speed up production. Small changes can make a big difference for companies like ours — and for patients in need." The opioid shortage and alternatives One particular need Nephron aims to satisfy as quickly as possible is the demand for pain management solutions. In the past, when big manufacturers aggressively marketed highly addictive substances, "bad actors" decided to get in on the action, Ms. Kennedy said. They began supplying laced or poor-quality fentanyl, contributing to a rash number of deaths and an even bigger crisis. In response, controlled substance manufacturers decided to halt production of those lines and focus on other drugs. At the same time, the Drug Enforcement Administration began to allocate the quantity of materials available to produce controlled substances. The consequence was "self-inflicted" shortage of those products, according to Ms. Kennedy. Nephron's approach to the opioid shortage mirrors its approach to other drug shortages: center efforts on delivering alternatives as quickly as possible. The manufacturer has partnered with providers to hear their ideas for opioid-free treatments and uses the input to customize production. The collaborative approach led Nephron to release a new opioid-free product, which combines bupivacaine, ketamine and ketorolac for managing pain. According to Ms. Kennedy, the company recognized that some older drugs have the potential to deliver good patient outcomes with fewer risks than opioids. The concept is supported by researchers at St. Louis- based Washington University School of Medicine. In three randomized, controlled trials involving 261 patients, researchers discovered intravenous ketamine was on par with intravenous morphine for pain reduction. Ketamine is just one alternative Nephron has turned to in its efforts to address the opioid shortage. Others include ketorolac, epinephrine and clonidine. "As much as we can, and as fast as we safely can, we are producing more of those products for clinicians to use in hospitals and surgery centers across America," Ms. Kennedy said. A model for drug manufacturing The effects of drug shortages are pervasive across healthcare organizations' pharmacy departments, according to Ms. Kennedy. Nurses and physicians track the dire shortages they're facing on whiteboards and giant spreadsheets, and each deficiency has a domino effect. When a drug is unavailable, clinicians are unable to follow the protocols built into EMRs and medication delivery systems. Providers are pulled away from patient care and forced to place phone call after phone call in search of critical medications. "Dialing for doses," as Ms. Kennedy called it, has become far too common. "There could be plenty of other things you could do in a pharmacy department that would be better served than working the telephones to try to find medication opportunities," she said. "We have high expectations for pharmacists and all clinicians — we expect the right dose to the right patient at the right time — and that all depends on ample supply and ample quality supply." Although there have been fewer drug shortages in recent years than there were earlier in the decade, according to data from ASHP, shortages remain a critical factor in soaring healthcare costs and patient safety. If you ask Ms. Kennedy, the solution to the seemingly ever-present issue lies in rigorous quality standards and long-term investment. "What we represent is what I think the true model for America should be, and that is a manufacturer looking to assist hospitals and surgery centers, but most importantly, patients," Ms. Kennedy said. n Nephron 503B Outsourcing is a division of Nephron Pharmaceuticals Corporation. This division produces pre-filled sterile syringes and IV bags for hospitals and surgery centers across America, in an effort to alleviate their drug shortage needs. In accordance with the DQSA draft guidance, the company follows cGMP, GDP and all quality expectations. The company has been licensed by the Food and Drug Administration as a sterile manufacturer of generic respiratory medications along with an Outsourcing Facility providing equal sterility and quality. Nephron received a 2017 ISPE/FOYA innovation award for the high level of automation present throughout the facility. For more information, please visit www.nephronpharm.com.