What Causes Drug Shortages?

While Washington wrestles with the mind-numbing details of implementing the new health overhaul law, there is a growing problem in the health sector that could seriously compromise patient care: drug shortages.

America has faced drug shortages in the past. But recently, these shortages have reached unprecedented levels. This is a real threat to public health, yet it remains under the radar.

Reports recently submitted to the Institute for Safe Medication Practices (ISMP) indicate that there’s widespread alarm among doctors and nurses that shortages of medically necessary pharmaceuticals are harming patient health.

In September alone, nearly 50 pharmaceuticals were on the Food and Drug Administration’s drug shortage list. And this list doesn’t even tell the full story since it only reports on drugs that treat or prevent serious medical conditions for which no alternative treatments are available.

Drug shortages jeopardize quality of care. For instance, there currently is a shortage of prefilled epinephrine syringes — a hormone and neurotransmitter that is used in emergency rooms to treat heart attacks and shock. These prefilled syringes are only produced by one manufacturer. So in many hospitals, emergency room professionals report having to dilute a concentrated form of epinephrine before treating patients. Such a process is inherently inexact — and risky.

Having the right drugs available can be a matter of life and death, especially in an emergency.

Consider what this shortage could mean in practice. After a serious car accident, for example, a paramedic may reach the scene and begin treating a patient thrown from the vehicle into a dark, wooded area. If the medic determines that epinephrine is critical and a prefilled syringe is not available, he would be forced to improvise. As the ISMP itself has explained, “instead of just grabbing a well-labeled syringe after starting an IV line, the EMT now must pull together various components — syringe, needle, diluent, drug ampul [vial] — to prepare the injection.”

This is a serious problem for that patient and for anyone facing an emergency situation.

There is not one cause of drug shortages but rather a confluence of circumstances.

More than 80 percent of the materials used to make drugs come from outside the United States so problems with availability of materials abroad affect the availability of drugs here.

Sometimes manufacturers just don’t foresee the demand for a particular medication, particularly those that are newly approved or if there’s an unexpected outbreak of disease. Alternatively, if a drug’s patent expires, manufactures tend to scale back its production, leaving them unprepared for a sudden rush of demand.

The FDA also bears some responsibility for these shortages. The agency often imposes a labyrinthine of legal requirements on drug manufactures that unnecessarily slow down — or, sometimes, halt entirely — the production process. Bureaucratic meddling in the drug industry can cause real problems.

The FDA, pharmaceutical companies, medical practitioners, and other experts need to join forces to analyze the sources of drug shortages and develop a plan to solve them. Without coordinated, determined action, drug shortages could soon become one of our most critical public health problems.

Published in The Morning Journal, Feb. 14, 2011.

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