Becker's ASC Review

77 Executive Briefing: Sponsored by: T he 224 drug shortages that plagued U.S. healthcare providers between January 1996 and June 2002 were just the tip of the iceberg for medication scarcities. In 2010 alone, the number of U.S. drug shortages climbed to 211 — just 13 short of the total in the prior six-year span, according to the American Society of Health-System Pharmacists. More than a decade later, drug shortages remain prevalent, and shortages related to drug quality issues wreak the most havoc. With 37 percent of traceable drug shortages linked to manufacturing quality issues, the FDA has doubled down on oversight and numerous plants have been shuttered, including ones owned by Pfizer, Baxter and Johnson & Johnson. In some instances, companies have shut down drug lines for reasons unrelated to quality, according to Nephron Pharmaceuticals CEO Lou Kennedy. Production of certain drugs may be halted simply because it's less profitable, and suppliers will appease shareholders by shifting their focus to the money-making products. Due to a concentrated marketplace and the widespread offshoring of manufacturing, the drug supply chain is also vulnerable to crises such as natural disasters. Storms like Hurricanes Maria and Irma in late 2017 devastated facilities in Puerto Rico that produced most of the supply for certain drugs, such as saline, causing far-reaching, ongoing problems. "Drug shortages caused by natural disasters is an ongoing problem for the FDA, large companies — and, ultimately, patients," Ms. Kennedy said. "Drug companies have an invaluable opportunity to work together with the FDA and plan ahead before the next natural disaster strikes. We can make sure that contingencies are in place to deliver healthcare and critical drugs to patients in the aftermath of natural disasters. This kind of help can go a long way for those who are suffering." Almost two years later, saline — also known as sodium chloride — remains scarce. A critical, basic component of nearly any injectable drug treatment, sodium chloride was among the 123 drugs in shortage as of April 8, 2019, according to the FDA. Approaches to boosting supply Despite these recent issues, the government and industry stakeholders can look to the past for proven strategies to help prevent drug shortages. In 2008, contaminated heparin from China contributed to the deaths of 81 people. The crisis spurred an international recall of the drug, which resulted in a massive heparin shortage. In 2013, U.S. regulators took action to prevent the occurrence of similar crises. The FDA signed the Drug Quality and Security Act into law in 2013, allowing a compounder to become an outsourcing facility under section 503B. Designated 503B compounding facilities can prepare medications in bulk without patient-specific prescriptions, making it easier for healthcare providers to find medications amid shortages and price gouging. At the time, Nephron already had a new 503B facility underway in South Carolina. By the end of 2017, the company opened its outsourcing division to supply compounded drugs that were badly needed. The new, 408,000-square-foot facility was a natural step for Nephron, according to Ms. Kennedy, because of the company's 20-plus years of experience complying with current good manufacturing practices in the respiratory medication business. The space also gave the company an advantage over manufacturers operating in smaller, decades-old buildings, and inexperienced market entrants looking to make a quick buck. "We made a serious long-term investment in our facilities and our team because that's what it takes to deliver quality products that help patients," Ms. Kennedy said. Unlike newer manufacturers, Nephron doesn't have to hope for fast results from an outside lab; the company uses in-house microbiology and chemistry labs that were already established for its respiratory business. Its 1,000-plus employees also have an understanding of the level of testing required for a sterile manufacturer, according to Ms. Kennedy. While Nephron's infrastructure, manpower and two decades of knowledge make the company well-positioned to help alleviate drug shortages, the problem is a massive one to tackle. Nephron had to undergo changes in mindset and strategy to achieve its goal of delivering drugs to facilities as quickly as possible. The challenges of fast manufacturing Nephron's challenges included adapting to producing small batches for 503B requests, in addition to the large batches it was accustomed to making. Whereas the large batches could take around four days to fill, a small batch — tailored to an individual facility's needs — could be filled in as few as four hours. In the long run, Nephron's plan is to make the medications it produces on a smaller scale a permanent part of its company pipeline. The company's large-scale manufacturing capabilities make that an attainable goal, Ms. Kennedy said. How experience & opioid alternatives help combat crippling drug shortages

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