The recent spike in drug product shortages, particularly regarding injectable products, has led to some severe rationing both by patients and institutions.


For example, hospitals often have to use a different size IV bag than normal, or give the medicine by a different route altogether (e.g. by mouth, a deeper needle through the muscle). Sometimes they can simply order empty bags as opposed to prefilled, and mix the ingredients themselves. Nonetheless, it is always a challenge allocating to the cases of greatest need[1].


In other instances, such as for patients like Alec Raeshawn that require injections of insulin, the lack of reasonably priced product has led to dangerous practices. Raeshawn died after he had been taking increasingly less than his prescribed doses each day because he simply could not afford the ludicrous prices that companies such as Eli Lilly are charging. Eli Lilly began issuing discount coupons last year, but it is uncertain how long the program will last[5]. For a more permanent fix, starting in 2020, FDA created new guidelines to adjust how it regulates insulin so as to allow more competition to diminish Eli Lilly’s stronghold[2].


Price is not always the culprit, however, as is the case with the overwhelming demand for normal saline. Since 2014, the top 3 IV bag manufacturers—Baxter, Hospira, and B Braun—have been operating 24/7 to bang out supplies. Furthermore, the many steps, both to make the saline sterile and comply with FDA, greatly limit the pool of qualified candidates to add to assist with the production line[3]. FDA has since found two additional foreign companies who began operations in the U.S. to assist in ramping up production. Furthermore, FDA is collecting data to possibly extend expiration dates[4].


It is our hope at Pharmate to become a successful competitor, assisting in spearheading these FDA initiatives.

References:

1. ASHP, University of Utah Drug Information Service. Small-Volume Parenteral Solutions Shortages Suggestions for Management and Conservation. fda.gov. https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM582461.pdf . Published October 18, 2017. Accessed April 16, 2019.

2. Florko N. FDA chief blasts insulin prices, touts far-off new rules for the market. STAT. https://www.statnews.com/2018/12/11/gottlieb-blasts-high-insulin-prices-touts-new-rules/ . Published December 11, 2018. Accessed April 17, 2019. 3. Fry E. There’s a national shortage of saline solution. Yeah, we’re talking salt water. Huh? Fortune. http://fortune.com/2015/02/05/theres-a-national-shortage-of-saline/. Published February 5, 2015. Accessed February 28, 2019.

3. Office of the Commissioner. Press Announcements – FDA Commissioner Scott Gottlieb, M.D., updates on some ongoing shortages related to IV fluids. US Food and Drug Administration Home Page.
4.https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm592617.htm. Published January 16, 2018. Accessed February 28, 2019.

5. Stanley T. What happens when a lifesaving drug becomes intolerably expensive? The Washington Post. https://www.washingtonpost.com/news/magazine/wp/2019/01/07/feature/insulin-is-a-lifesaving-drug-but-it-has-become-intolerably-expensive-and-the-consequences-can-be-tragic.?noredirect=on&utm+term=.33be2b7f8d63. Published January 6, 2019. Accessed April 15, 2019.