My husband likes one particular kind of toothpaste. It’s not available at all stores, so he tends to stockpile four or five tubes at a time. Aquafresh Extreme Clean® is a matter of taste. But what if the hospital runs out of the drug you need for your next cancer treatment? At least 200 medicines critical for treating diseases such as childhood leukemia, breast cancer, and infectious diseases, along with drugs to treat heart attack patients and accident victims, have been in short supply this year.[1] Doctors are scrambling to find the drugs, or devise an alternate treatment. Many of these substituted drugs are less effective or cause unpleasant side effects. In the last 15 months, 15 people have died because of the drug shortages.[2]
This public health crisis is unprecedented, and is reverberating across the medical industry. But because it happens in the hospital, rather than at the pharmacy, most people are unaware. In many cases hospitals have been forced to purchase drugs from “gray market vendors” instead of their usual wholesalers. One study found that on average these secondary vendors mark-up the price of the medication by 650%. In one case a blood pressure drug normally priced at $26 per dose was priced at $1,200.[3] Who pays for this? You and your insurance company. Additionally, the quality control of these drugs cannot always be verified, putting patient safety at risk.
I’m sure many of you are wondering why the U.S is facing these serious shortages. More than half of drug shortages are caused by quality or manufacturing problems. Contamination of one cancer drug shuts down the entire line of drugs. Others shortages are due to delays and capacity problems. There is a consolidation of generic drug manufacturers, often overseas where FDA inspectors are scarce, increasing the shortage. There is also a significant problem with theft of prescription medications in warehouses and on their way to hospitals. Patients who eventually received stolen drugs have had adverse reactions, probably due to improper storage.[4]
Many companies have stopped making a number of older generic drugs due to low profit margins, sometimes without any advance warning. This prevents the FDA from preparing for the shortage. Another company would not have the time to start a new manufacturing process before the drug runs out.
With fewer drug manufacturers and also fewer purchasers, competition and production are stifled. It’s a multi-layered public health crisis, with no easy fix.[5] President Obama issued an executive order instructing the FDA to increase its reporting of potential drug shortages and to give the Department of Justice more information about suspected price gouging.[6] Congress is considering a bill that would require manufacturers to give six months notice before discontinuing a prescription drug. But more needs to be done.
This is a public health issue we should pay attention to. It’s not just a matter of toothpaste preference. It could be a matter of life or death.
[1] Gardiner Harris, “U.S. Scrambling to Ease Shortage of Vital Medicine,” New York Times August 19, 2011 http://www.nytimes.com/2011/08/20/health/policy/20drug.html?partner=rss&emc=rss (accessed September 26, 2011).
[2] Associated Press, “AP Impact: Drug Shortages Endanger Patients, Disrupt Hospital Operations, Raise Cost of Care,” Washington Post September 23, 2011, http://www.washingtonpost.com/national/health-science/ap-impact-drug-shortages-endanger-patients-disrupt-hospital-operations-raise-cost-of-care/2011/09/23/gIQAjP4fpK_story.html (accessed September 26, 2011).
[3] Associated Press.
[4] Angela Atkinson, “Could Organized Crime Be Partially to Blame for US Drug Shortages?” Scrubs & Suits October 25, 201, http://scrubsandsuits.com/news/could-organized-crime-be-partially-to-blame-for-us-drug-shortages (accessed November 13, 2011).
[5] Joyce Frieden, “No Easy Fix for Drug Shortage Crisis,” MedPage Today Sep. 26, 2011, http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/28749 (accessed November 13, 2011).
[6] “Obama Orders FDA to Help Ease Drug Shortages,” MSNBC, http://www.msnbc.msn.com/id/45102150/ns/health/ (accessed October 31, 2011).