Proliferation of Counterfeit Prescription Drugs

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Americans face a new and widely overlooked threat. Counterfeit prescription drugs are being unknowingly consumed across our nation. Without changes in policy, this issue will continue to grow at an already alarming pace. The World Health Organization (WHO) has estimated that between 5% and 8% of the worldwide trade in pharmaceuticals is in counterfeits. Almost half of American prescription drugs are imported. Further, many of the raw ingredients used to produce prescription drugs made in the U.S. come from overseas.

Traditional drug traffickers are beginning to turn to counterfeit prescription drugs as a low risk method of turning a profit. Producing a counterfeit prescription drug can be a fairly simple process at a marginal cost. Often manufactured in squalid conditions, the main ingredients in these bogus drugs can be sugar and chalk or other “filler” substances such as ground up aspirin or household chemicals. From antibiotics to medication to control blood pressure or diabetes, almost any prescription drug can be imitated. These imitations are ending up in medicine cabinets across the country and putting many Americans at risk.

Fake replicas are often sold through “rogue” internet websites which pretend to be legitimate. Even more alarming is that one of the methods of transport is the reliable postal service. Frequently, counterfeit prescription drugs are simply sent out via U.S. mail. A recent 60 Minutes piece showed the jaw dropping volume of questionable packages pulled aside at inspection centers. Each piece is examined and those that do not pass inspection by U.S. customs agents are simply returned to the sender. Shockingly, the Food and Drug Administration (FDA) does not grant customs agents the authority to destroy packages containing counterfeit prescription drugs. Instead, bogus pharmaceuticals are sent back to their origin where often, they are repackaged and shipped again. Eventually, due to lack of dedicated enforcement personnel, agents miss the counterfeit products and they make their way into the country.

Currently, the U.S. has 300 customs ports, but the FDA has only 200 port inspectors and a mere 17 inspectors to cover all international mail centers. This is a staggering figure in comparison to the number of illicit pharmaceuticals being sent to the U.S.

A comprehensive approach is needed to solve this patient safety problem. The United States needs to be a leader in the global fight against counterfeit drugs. We need to strengthen accountability within the drug distribution system through tougher enforcement and consequences for those who send counterfeit prescription drugs. However, one of the most obvious methods of addressing this problem is to destroy identified counterfeit prescription drugs being sent through U.S. mail. The FDA should grant authority to authorized personnel to destroy bogus pharmaceuticals on site and consequences for the producers of counterfeit medicines should reflect the magnitude of their offenses. Any American who takes any form of prescription drugs could be at risk for death or serious injury and this problem should be dealt with accordingly and aggressively.

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