Wednesday, January 29, 2014

Critical IV solution shortage affecting US hospitals

The country is experiencing a serious shortage of certain IV fluids, mainly involving sodium chloride injection 0.9% (IV saline) in 1,000 mL bags. Some hospitals have also been short of Lactated Ringer’s solution.  Smaller size bags are available right now but we’re hearing that those supplies are dwindling.

This latest drug shortage seems to have started back in November but has gotten progressively worse in the past couple of weeks and now hospitals are scrambling. The market in the US is served by Baxter (45%), Hospira (45%) and B. Braun (10%). Apparently the acute situation is related to increased demand (patients with influenza who are hospitalized) combined with a planned shutdown at Baxter for maintenance in December.  All of the manufacturers have communicated about supplies with their customers. The shortage is such that they’re allocating solutions to customers already under contract. It’s unclear how long this shortage situation will last but everything we’re hearing is that it’s going to be several weeks at least, and for some solutions it will be into March.  I’ve spoken to all three companies and they tell me they are working hard to get supplies back up to normal.

There are other IV solutions available such as 5% dextrose in water, 5% dextrose with smaller concentrations of sodium chloride than 0.9%, and many others, but they may not always be appropriate for a particular patient.  How long supplies of the various solutions will last is not known but we could very well see shortages with these too. Although it should be a last resort, it’s possible for hospital pharmacists to compound sodium chloride IV solutions using small volumes from very high concentration sodium chloride injection vials to bring solutions of lesser concentration up to 0.9%. But doing so can increase the potential for compounding errors so this should be a last resort. Compounding requires strict quality control checks to prevent accidentally adding too much or too little sodium chloride, either of which can be harmful.  Also, if compounding became routine it could lead to shortages of the high concentration sodium chloride vials, which happened last year due to production issues at one of the generic injectable companies.

Hospitals are being advised to use oral hydration as much as possible, or use smaller bags, at least while they last, along with more frequent bag changes. IV sodium chloride solutions are often used in surgical patients or patients with diabetes who must restrict dextrose intake since it is a sugar. So far we haven’t heard of delays in elective surgery but that is a possibility if things don’t turn around soon.

The sodium chloride shortage is the latest in a series of drug shortages that peaked in 2010. In October, FDA published a strategic plan to address drug shortages and legislation was passed in 2012 that requires manufacturers to notify FDA at least 6 months in advance when they are considering production shutdowns. FDA has also established a drug shortage section staffed by 11 individuals. My take is that there has been improvement overall but shortages remain of great concern, sometimes forcing less than adequate therapy and increasing the risk of medication errors when caregivers must break routines or use unfamiliar replacement products. 

FDA has sometimes worked with foreign manufacturers and allowed products to be imported to help alleviate the problem here. But that also presents problems because of differences in the way imported products are labeled, sometimes in a foreign language, and there can also be a variance in the exact ingredients and the strength per dosage unit. Although the option may exist to import IV solutions, it doesn’t seem likely because of the size and weight of the heavy cartons, the fact that millions of solutions are used every week in the US, and the likely enormous shipping costs.  


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