In October of 2017, Supply Chain Matters alerted our readers to the initial pharmaceutical and drug supply chain disruption impacts due to the devastating effects of Hurricane Maria on the island of Puerto Rico. Readers will likely recall that the island’s total electrical supply infrastructure was literally destroyed by the hurricane which struck in September. Thousands of homes were destroyed and residents continue to feel the effects.
In early January, we provided an update in the light of a widespread outbreak of influenza that was underway across the United States, resulting in a critical nationwide shortage of small Saline IV solution bags. Baxter International was one of the first drug manufacturers to communicate to impacted customers that “multiple production delays” were hampering the producer’s ability to restore supply of two medicines that were already characterized as in a constrained supply condition. The products were noted as the intravenous fluids used to treat critical hospital patients. The drug manufacturer indicated that it was still assessing hurricane-related damage to its production facilities in Puerto Rico.
Last week, Reuters reported that Baxter has informed customers that the both of the drug maker’s small Saline IV bag production facilities in Puerto Rico have, with the restoration of supplies of electrical power from the island’s electrical utility, been able to ease supply shortages of U.S. hospitals. In our earlier update, we highlighted that the severe shortage of the smaller IV bags had forced hospitals to utilize supplies of the larger Saline bags, which is often the case, led to nationwide shortages of the latter bags. Baxter’s general manager of U.S. Hospital products indicated in his letter that overall progress is being made is resuming normal supply.
Baxter has also informed customers that it has been granted approval by U.S. drug regulators to import inventory of large saline bags form its manufacturing plant in Mexico in an effort to ease hospital shortages of the large bags as-well. Baxter also produces the large Saline IV bags at facilities in the United States. It turns out that production of the larger IV bags was an industry-wide problem prior to Hurricane Maria. The U.S. Food and Drug Administration had granted both B. Braun and Baxter, temporary approval to import supplies from their offshore production facilities. According to Reuters, two additional producers, Fresenius Kabi, a division of Germany based Fresenius, and Laboratories Grifols of Spain were approved to provide added supply of Saline. The FDA is also working with companies to extend expiration dates on existing supplies, if it can safely be done.
According to the Reuters report, there is still some concerns among hospital procurement teams that supplies of Saline bags have not been able to keep-up with existing demand given the current level of patient volumes related to flu cases. Supply Chain Matters has not been able to validate that situation, and we encourage feedback from our healthcare supply chain readership.
It is now four months since Hurricane Maria devastated the island of Puerto Rico and its electrical infrastructure. The subsequent disruption of drug supply from the island’s resident manufacturers has been compounded by an unusually large outbreak of flu cases across the United States. This situation will likely continue if and when normal drug production supply and replenishment cycles return to somewhat of a normal pattern.
In the meantime, thanks should be extended to all of the teams working on this supply disruption, with a special shout-out to drug production workers in Puerto Rico who have had to struggle with personal loss and trauma, while contributing to efforts to restore production under rather difficult challenges.