In February 5th, 2014, the U.S. Food and Drug Administration (FDA) released an official report concerning shortages of common injectable drugs used to treat a plethora of patient needs. The shortages include, but are not limited to, injectable drugs, cancer drugs, anesthetics, emergency medicine, and electrolytes. The official statement cites that the amount of shortages decreased over the last few years, yet there is facilities and agencies are still unsure when they are going to receive their next shipment.
Among reasons for the shortages on injectable drugs, the FDA has cited a few potential causes:
- Quality control in the manufacturing process
- Shortages of raw materials
- Decreased production of lower cost injectables
However, spokespeople from the manufacturers are expressing alternative theories in production including delayed FDA inspection processes and the genericization of medications.
In the last few years, the FDA has made more significant efforts to decrease the number of drug shortages, and has made significant headway. The use of common injectables quadrupled from 2005 to 2010 calling for an increase in production. Though this has occurred, there has been a significant need for updating of facilities and processes by manufacturers to keep pace with demand. The FDA continues to make significant strides to support manufacturers in updates and inspection that even include allowing drugs to be filtered instead of refusing a lot.
Unfortunately, this shortage of injectable drugs is affecting health care providers and individuals more than anyone else. An article in the San Diego Union-Tribune on February 11 speaks to the need for saline for blood donations. Saline is a mix of salt and water, but to a process like blood donation, it is essential to supporting donors. As a result of the shortage, surgeons are concerned they may have to start rescheduling procedures and turning away patients.
As a medical supply distributor, we have felt the sting of the injectable shortage as well. Manufacturers are limiting availability and increasing the cost of products such as
bacteriostatic water,
bacteriostatic sodium chloride, and common I.V. solutions. Despite these limits, a well structured supply chain has allowed us to continue providing these injectables to our customers at lower than average prices.
Manufacturers have cited a variety of reasons for shortages including access to resources, declining profit margins from healthcare reform, genericization of medications, and FDA delays. Companies like Hospira have reported lower earnings on their Fourth-Quarter and Full-Year Results indicating the ship-hold on their inventories as a primary cause of the availability of these injectables.
A February 10th article in the New York Times indicates that as these manufacturers lose the ability to profit from the manufacture of more common injectables, they are increasing production on more profitable items. In the FDA's report, they cannot force the manufacturers to keep manufacturing drugs they deem to be unprofitable, or require them to choose to update equipment and processes in lieu of alternate business strategies.
It is currently unclear how much longer the shortage of injectable drugs will go on. Referenced in the FDA report was an increased need for these items, especially during flu season when many have trouble keeping liquids down.
While manufacturers are producing lower quantities of these medications, individuals and care providers are sourcing injectable drugs as they are able and rationing any stores they may have.
Products Affected
Sodium Chloride 0.9%, Baxter
150 mL bag (NDC 00338-0049-01)
250 mL bag (NDC 00338-0049-02)
500 mL bag (NDC 00338-0049-03)
500 mL bag, PVC/DEHP-free (NDC 00338-6304-03)
250 mL bag, PVC/DEHP-free (NDC 00338-6304-02)
1000 mL bag (NDC 00338-0049-04)
Sodium Chloride 0.9%, BBraun
250 mL bag, PVC/DEHP-free (NDC 00264-7800-20)
500 mL bag, PVC/DEHP-free (NDC 00264-7800-10)
1000 mL bag, PVC/DEHP-free (NDC 00264-7800-00)
Sodium Chloride 0.9%, Hospira
150 mL bag (NDC 00409-7983-61)
250 mL bag, PVC/DEHP-free (NDC 00409-7983-25)
500 mL bag (NDC 00409-7983-03)
1000 mL bag (NDC 00409-7983-09)
Estimated Resupply Dates
- Baxter has all sodium chloride 0.9% injection presentations on allocation
- BBraun is allocating all sodium chloride 0.9% PVC/DEHP-free bags
- Hospira has sodium chloride 0.9% 250 mL bags PVC/DEHP-free on back order with an estimated release date of late-March 2014. The 150 mL bags are available in limited supply
http://www.medicaldaily.com/fda-issues-first-ever-drug-shortage-annual-report-down-2011-peak-shortages-still-pose-challenge
http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM384892.pdf
http://www.nytimes.com/2014/02/11/health/shortages-of-critical-drugs-continue-to-vex-doctors-study-finds.html?_r=0
http://www.utsandiego.com/news/2014/feb/11/blood-bank-saline-shortage/
http://phx.corporate-ir.net/phoenix.zhtml?c=175550&p=irol-newsArticle&ID=1899279&highlight=
http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=993
Leave a comment