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    Pharmacy Supply Lines Are Still Shaking After Storm Passes

    Two hurricanes devastated the U.S. supply chain, affecting pharmacies all over—and leaving many to wonder what’s next.

     

    The FDA is allowing Baxter to redirect supplies from facilities in Ireland and Australia. “While these actions will help mitigate some of the projected shortfall in supply, they will not be adequate to fully bridge the gap in the near term,” Baxter stated on the company website.3 “Baxter will continue to do everything it can to ramp up production in Puerto Rico in the weeks ahead and, with the support of special importation granting from FDA, continue to utilize its other facilities to help address product demand in the United States.”

    With no word on what might go into short supply, the only recourse for pharmacists is to be aware that shortages may occur. “The concern of potential drug shortages has always been a priority for emergency managers and public health officials,” said Nicolette Louissaint, PhD, Executive Director of Healthcare Ready, formed by trade groups in the biopharmaceutical supply chain after Hurricane Katrina. “As of now, no significant long-term threats have been reported by the FDA.” she told Drug Topics in an email.

    The Fragility of the Supply Chain

    The concentration of pharmaceutical production in Puerto Rico came about because of tax breaks that were offered by the federal government in the 1970s to companies that set up factories there. These tax breaks were phased out in 2006, but most companies have kept their factories in place.

    Hurricane Maria laid bare two main issues with the pharmaceutical and medical device supply chain, said Friend. “Problem 1 is that the supply chain has not been managed for these kind of disasters. Problem 2 is that these products require a reliable power supply.”

    A drug company cannot easily move production from one factory to another, Friend said. “It is not easy to say ‘We can’t build something in Puerto Rico, so we will move [production] to Philadelphia.’ Regulations make it difficult.”

    The industry has set up a system where important drugs and products are single source and that source is in a location with a history of major storms, Friend said. “They did not understand the risks that they had taken and now we are faced with inability to supply products,” he stated.

    The risks of supply-chain disruption from any large-scale disaster may need to be evaluated by regulatory agencies. “As part of the FDA approval process of manufacturing facilities, one of the questions that should be asked is ‘Is this area safe from disasters and if not, how much of the company’s manufacturing is done there, and if it goes down, what will the impact be on patient care and the supply chain?’” said Pane.  

    Related article: Plan ahead: Best practices in an era of drug shortages

    Natural disasters can happen anywhere. Blizzards have disrupted deliveries to pharmacies for days, for example. “In our area, we provide adequate staffing before a predicted storm hits to handle the up to 50% increase,” said Peter Kreckel, RPh, a community pharmacist in Altoona, PA. “Ideally, the major PBMs should lift any early refill edits—within reason, say 10 days—in areas that are impacted by a potential storm to allow our patients to flee to safety,” he added.

    Newer practices with inventory and delivery also play a part. Pharmacies in hospitals and other health-care facilities once kept larger inventories of products they needed, but have moved to keeping less stock and depending on “just-in-time” deliveries, Friend said. A just-in-time system may almost always work well, but it means there is little or no buffer when the supply chain breaks for any reason. “This is a ubiquitous problem and it is just that it is magnified in pharma,” he said.

    Valerie DeBenedette
    Valerie DeBenedette is Managing Editor of Drug Topics.

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