New England Journal of Medicine on saline shortage....
https://www.nejm.org/doi/full/10.1056/NEJMp1800347
"Most drug shortages occur with older, generic, injectable medications that are produced by a small number of suppliers — typically three or fewer. The United States gets its saline from just three companies: Baxter International, B. Braun Medical, and ICU Medical. Most shortages are caused by a quality or production problem at the manufacturing facility — causes that apply to the current saline shortage as well.
2,3 In addition, when one supplier experiences a shortage, other suppliers often have insufficient manufacturing capacity to make up the difference. Drug manufacturers are not required to have redundancy in their facilities or even a business contingency plan in case of a disaster, no matter how essential or lifesaving the medication they are producing.
1
Saline is an inexpensive product — it’s simply salt water — but proper manufacturing practices are required to keep it sterile, pyrogen-free, and free from particulate matter. Production demands are challenging, since very large quantities are needed: more than 40 million bags per month. Saline is required for virtually all hospitalized patients, whether as a component of a medication infusion or as a hydration, resuscitation, or irrigation fluid.
2 Unfortunately, shortages of saline have become commonplace in recent years (see
table).
Most drug shortages occur with older, generic, injectable medications that are produced by a small number of suppliers — typically three or fewer. The United States gets its saline from just three companies: Baxter International, B. Braun Medical, and ICU Medical. Most shortages are caused by a quality or production problem at the manufacturing facility — causes that apply to the current saline shortage as well.
2,3 In addition, when one supplier experiences a shortage, other suppliers often have insufficient manufacturing capacity to make up the difference. Drug manufacturers are not required to have redundancy in their facilities or even a business contingency plan in case of a disaster, no matter how essential or lifesaving the medication they are producing.
1
The shortage of small-volume saline bags (250 ml or less) became dire almost immediately after Baxter’s Puerto Rico manufacturing plant was hit by Hurricane Maria.
2 Baxter supplies approximately 50% of U.S. hospitals with this product, which is used as a diluent to deliver a variety of parenteral medications. Despite this tremendous need, Baxter has no redundancy in manufacturing capacity for small-volume saline bags. The other two saline suppliers have not been able to increase their production enough to make up for the shortage.
2,3 In fact, saline produced by B. Braun was already in short supply before the hurricane, as the company worked to correct manufacturing-quality problems.
3
The saline shortage had actually begun in 2014, affecting large- as well as small-volume products.
4 Large-volume saline products (>500 ml) are typically used as maintenance or resuscitation fluids or for irrigation. Although some shortages of large-volume saline solutions are attributable to problems at manufacturing facilities, increased demand for intravenous fluids due to a severe influenza season has also contributed to the current short supply.
2