Life-threatening Reality of Generic Drug Shortages in the U.S.

Life-threatening Reality of Generic Drug Shortages in the U.S.

There is a myriad of challenges in practicing medicine from the intrusion of third parties to the declining number of medical professionals.  For the most part, these obstacles are a result of some well-intentioned but poorly executed effort, but there are some that arise out of ridiculous circumstances like the nationwide shortage of some medications.

In 2010, the Food and Drug Administration reported that 178 drugs were in short supply around the country.  Many of these were for critical care, cancer treatment or antibiotic use.  In 2011, this number rose to 250.   While this number declined in the following years, by May of 2015, the shortage had returned to 250.

The problem of life-saving drug shortages has become so pronounced that the U.S. Congress has convened hearings on the matter. The White House has even addressed the issue and labeled the “shortages of pharmaceutical drugs pose a serious and growing threat to public health.”

It is absolutely absurd that the wealthiest nation in the world is losing people because it can’t supply doctors and hospitals with essential medications like saline, vaccines or heart medicine, but that is the reality.  There is a simple reason why manufacturers are not churning these drugs out: profits.  There is little or no financial incentive for many of these companies to produce generic medications, especially since the 2003 Medicare Modernization Act cut drug reimbursement to the average selling price (plus a 6 percent administrative fee).

In addition to diminishing reimbursement from public insurers, there are other contributing factors like limited availability of raw materials, regulatory impediments and declining competition within the pharmaceutical industry. With fewer manufacturers in the market, any disruption in the pipeline can drastically diminish drug supplies.  However, the situation is unlikely to change until the financial rewards for drug production are high enough.

Until then, the medical community will need to wrestle with how to ration drugs.  Around the nation, hospitals are instituting triage systems to dole out medications to only the neediest.  Physicians and pharmacists continue to debate which patients merit precious medications.  Many organizations are cutting corners like shortening courses of treatment, alerting patients to drug shortages, and concocting drugs from raw ingredients.

Of course, the patients are the real victims in this crisis, but physicians and hospital administrators are burdened with the stress of refusing treatment to ailing patients. Many doctors are frustrated because they expect these drugs—many of which have been on the market for decades—to be stocked and must contend with panicked patients when they are suddenly unavailable.

Another frightening result of drug shortages is the greater utilization of the grey or black market.  In the grey market, unscrupulous hoarders may purchase drugs for a significant markup and resale. While these drugs may be authentic, those found in illegal markets can be diluted or completely counterfeit. Of the $900 billion global pharmaceutical market, almost $75 billion is generated from sales of counterfeit drugs.  While the current sales of fake drugs in the U.S. are miniscule, desperate patients are likely to fuel growth in the coming years. 

Article written by:
Robert Moghim, M.D.
CEO, Onyx M.D.

 

Disclaimer: The views expressed in this article are the personal views of Robert Moghim, M.D. and do not necessarily represent and are not intended to represent the views of the company or its employees.




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