At one time or another, we may have gone to a doctor to receive help with a medical condition. More often than not the medical issue has been resolved when the physician writes a prescription for some wonder drug.
You take that order to your local pharmacy, get the medication filled and administer it as prescribed. In due time, the medical issue either goes away or at least becomes manageable.
But what would happen if you stopped at your local pharmacy and your pharmacist handed the prescription right back to you and said, “This drug is unavailable. There’s a severe shortage.” We, as patients, rarely give medication supply issues a thought. In our advanced medical system, the pharmaceuticals we require always seem available.
What if they weren’t? Pharmaceutical shortages in the United States are becoming a major medical issue. The number of new and long-term medication shortages has increased by almost 300% between 2007 and 2012, and the shortages are being viewed as a permanent part of the American medical system structure.
The drug categories most affected are those involved in treating severe medical conditions. The most common shortages were for generic sterile injectable pharmaceuticals, particularly IV fluids and chemotherapy drugs.
Other formulas in dangerous short supply include the heart medication nitroglycerin and cisatracurium, a drug that is used to paralyze muscles during surgery and for patients on ventilators. Without these medications, such life-saving procedures would not be possible.
Erin Fox, the director of the University of Utah’s Drug Information Service and a contributor of data for this analysis, stated, “We are at a public health crisis when we don’t have the medicines to treat acutely ill patients…” In some cases, doctors have had to ration chemotherapy drugs in their clinics or have been forced to use less effective alternatives.
There are several contributing factors that create drug shortages: 1) There are only three manufacturers that produce 71% of this country’s sterile injectable cancer drugs and any production issues (like raw material delays or quality control issues) result in production delays that become more difficult to eventually overcome, 2) many of the factories that make generic sterile injectable medications are aging and this makes the production lines prone to quality control problems that result in either temporary manufacturing shutdowns or closings of entire factories, 3) pharmaceutical companies that manufacture these drugs have not expanded production adequately to account to the increased need of these specific life-saving drugs, and 4) changes in Medicare reimbursements and group purchasing organization’s negotiated rates have driven down prices that pharmaceutical makers receive for their products, making production of these medications less profitable.
So, as a nation, what are we doing about this pharmaceutical shortage crisis? In 2012, the US Food and Drug Administration was given additional power to manage the shortages and the US Government Accountability Office was designated to evaluate the FDA’s response to this problem.
With this new law, drug manufacturers were then required to alert the FDA of potential shortages before they become critical so that the industry as a whole could react more effectively to increase production of a medication on the verge of being unavailable.
A recent Congressional hearing on this matter discovered that the number of new shortages actually declined in 2012 for the first time in several years. Additionally, it was shown that the 2013 data indicated similar downward trends in medication shortages.
Ultimately, the solution to this problem is to require that the various entities in the nation’s healthcare system be responsible for maintaining adequate pharmaceutical supplies, and the recent data analysis suggests that this is happening.
Thoughts? Comments? I’d love to hear them!