A study published in the scientific journal Academic Emergency Medicine (AEM) reports the number of drug shortages related to emergency care have grown significantly since 2008.
The drugs most affected by the shortage are used for “life-saving interventions or high-acuity conditions” for which no substitute is available, the report stated.
Emergency medicine shortages increased by 435 percent between 2008 and 2014, write the authors of Longitudinal Trends in U.S. Drug Shortages for Medications Used in Emergency Departments (2001–2014). The most common shortages were of drugs for treatment of infectious diseases, analgesia, and toxins.
Drug manufacturers consulted for the study said the causes for the increase in shortages include manufacturing delays (25.6 percent), supply and demand (14.9 percent), economic factors— such as availability of raw materials, discontinuations, and other business decisions—and regulation (12.9 percent). Manufacturers did not give a reason in 46.6 percent of responses.
No Shortage of Skepticism
John Graham, a senior fellow at the Independent Institute and adjunct scholar at the Mackinac Center for Public Policy, says although drug shortages do occur, the database AEM consulted for its study may not be reliable.
“Even the quality of information on this topic is jeopardized by conflict,” Graham said. “Last April, it was reported that the number of drug shortages reported by the [Food and Drug Administration] and the number reported by the University of Utah Drug Information Service, the leading private source of this data, are diverging dramatically.”
Dr. John Dale Dunn, a policy advisor for The Heartland Institute, which publishes Health Care News, says the alarm over widespread drug shortages “is another crisis identified by people who are convinced that more money, more government control, and more regulations for health care are the answer. Sure, there have been special categories of injectable and boutique, but important, drugs that have run out.
“[The drug shortages] have to do with the nature of the resuscitation, infrequently used, and critical care drugs,” said Dunn. “It is a market phenomenon based on demand and the value of producing these drugs, which is not attractive to manufacturers. There are many drugs in circulation that produce incomes that dwarf the returns on these specialty items, so manufacturing resources are often withdrawn from some drugs. Don’t worry, if they were profitable and popular, the manufacturers would find the resources.”
Devon Herrick, a senior fellow at the National Center for Policy Analysis, says the cure for U.S. drug shortages is the utilization of free-market forces and less government intervention.
“One solution that is occasionally used is to temporarily import drugs that are in short supply when they are available around the globe,” Herrick said. “Another is granting manufacturers a temporary reprieve when the [Food and Drug Administration] finds problems with the production line.”
Without such a reprieve from the U.S. Food and Drug Administration (FDA), supplies of needed drugs could indeed dry up, Graham says.
“Many of these drugs have only one, two, or a few production lines globally,” Graham said. “The FDA can and has shut them down. New competitors cannot enter, because getting a manufacturing facility certified by the FDA takes a very long time. Just imposing another burden on manufacturers, to report when they think a shortage is looming, does nothing to solve the shortage.”
Graham says FDA tightened regulations during a scare over contaminated Heparin in 2008. Heparin is blood thinner made partly from pig intestines.
“The FDA closed down a supply of pig intestines from a Chinese supplier,” Graham said. “Fair enough, but the risk aversion has gone way overboard since then.
“The U.S. government’s measures to mitigate this problem have failed because it has ignored the conclusion that shortages result from too much … control over the market for these drugs,” Graham said.
Darren Nelson ([email protected]) writes from Washington, DC. Michael Hamilton ([email protected]) is The Heartland Institute’s research fellow for health care issues and managing editor of Health Care News.
Jonathan D. Alpern, William M. Stauffer, and Aaron S. Kesselheim, “High-Cost Generic Drugs–Implications for Patients and Policymakers,” New England Journal of Medicine, November 13, 2014: https://heartland.org/policy-documents/high-cost-generic-drugs-implications-patients-and-policymakers