Who Is Responsible For The 10-Month Morphine Shortage?

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Who Is Responsible For The 10-Month Morphine Shortage?

By John Lavitt 10/18/16

A recently resolved shortage of morphine sulfate injection has left drug manufacturers and the DEA playing the blame game.

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Who Is Responsible For The 10-Month Morphine Shortage?
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According to the U.S. Food and Drug Administration (FDA), a shortage of morphine sulfate injection, an essential opioid prescription medication for relieving pain in hospitals and clinics, was resolved as of Oct. 11, 2016.

The shortage began on Dec. 14, 2015. For 10 whole months, an essential pain-relieving drug for patients with cancer and other painful medical conditions was not readily available. Why was such a shortage allowed to happen in the first place?

The initial knee-jerk response would be to blame the opioid epidemic. Given the recent surge in excessive fentanyl use nationwide—another drug typically seen only in clinical settings in the past—wouldn't it make sense that the extended shortage of morphine sulfate injections would be caused by diversion of the drug to street usage? However, it seems the factors behind the shortage are more complex than expected.

According to official government and reporting websites, the shortage was caused by problems with the drug makers. But this response seems more like a smokescreen than an answer.

For instance, the Astramorph injection made by the international pharmaceutical giant Fresenius Kabi has not been available since 2012. According to the American Society of Health-System Pharmacists, Fresenius Kabi "changed manufacturing sites." With the change, there is no estimate if the Astramorph injection will return to their production line. Acquired by Pfizer, another manufacturer, Hospira, stated that the shortage was due to manufacturing delays.

Then there's West-Ward Pharmaceuticals, a company owned by international pharmaceutical giant Hikma. It launched several new morphine sulfate products in late September 2015, but oddly decided not to actively market the 15 mg/mL 1mL vials. Given the shortage and the financial opportunities, isn’t it strange that none of these pharmaceutical powerhouses chose to step in and offer their supplies to fulfill the heavy U.S. demand?

According to The Fiscal Times, a conservative online economic site, the reason behind the shortage is not due to problems with the pharmaceutical giants suddenly not wanting to make money, but the ongoing incompetence of the Drug Enforcement Administration (DEA). According to what they describe as a “scathing 80-page report from the Government Accountability Office (GAO),” the DEA is directly responsible for the shortage.

By intensifying regulations and ignoring quotas in regards to controlled substances that pose risks for potential addiction and abuse, the DEA is creating the shortages, says the GAO report.

The DEA is required to set quotas for drugs like morphine sulfate injection. Pharmaceutical companies and drug manufacturers utilize these quotas to determine how much of the drug they should produce. Incredibly, the DEA wasn’t providing the quotas on time, and this has been an ongoing problem for years.

According to GAO auditors, between 2001 and 2014, the DEA consistently failed to report morphine sulfate injection quotas to manufacturers on time. The drug makers claim these failures delayed their production process, directly resulting in the shortages. Moreover, some of the drug makers, not wanting to deal with the headache of interacting with the DEA, decided to halt production altogether. 

In addition, the GAO auditors concluded, “Given such barriers to coordination, DEA and FDA cannot effectively act to prevent or alleviate shortages.”

In light of the importance of opioid pain relievers like morphine sulfate injection, one can only hope that the DEA will resolve its internal issues so that this type of preventable shortage ceases to be an issue for the American public.

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