REBECCA S BUSCHSo why is it consumers are willing to toss the dice and order from non-reputable online pharmacies? The bottom line is our prescription drugs are simply too expensive for the average American. That, coupled with the fact that other country’s citizens can get the same drugs for less, garners attention and concern from politicians, pharmaceutical manufacturers and the FDA to name a few.
Addressing Drug Safety
The Pharmaceutical Market Access and Drug Safety Act of 2011 currently proposed in Congress hopes to address this problem with the legalization of drug importation. And this is where the waters get murky. As it stands today, Congress and the FDA have created and maintained a drug safety net that is the best in the world. While not perfect, it is estimated that as much as 10% of our supply is contaminated or counterfeit, while in other countries that number jumps between 30-50%. Many opposed to legalizing drug importation maintain that allowing foreign drug companies to dispense within our borders increases our risk to counterfeit, adulterated and mislabeled drugs.
Interesting when you consider that, according to FDA Commissioner Margaret A. Hamburg, 40% of our drugs currently come from other countries and 80% of the ingredients for our medications are also imported. Therefore, only 20% of our drugs are 100% ‘made in America’.
We Need More Drug Control
I have to ask myself, what are we afraid of and what are we trying to prevent? Pharmaceutical companies are already participating in global exchange. We are already importing as shown by the numbers above, so what is the difference? The main issue is once the floodgates are opened, we lose control. As it is now, the FDA can only annually inspect 8% of the foreign manufacturing establishments. It would take 13 years to inspect all the facilities we do business with today.
What we need, regardless of whether we legalize importation or not, is more internal drug control. The FDA needs to be able to follow the chain of custody (pedigree disclosure) from the ingredient’s manufacturer to the dispensing pharmacy, identifying each prior sale, purchase or trade. Companies, as well as the government, are working on tracking the medications that we buy. However, “tracking” may be simply pulling a piece of paper out of a file cabinet to verify the source of purchases. This system is easily penetrable. Tracking may also be done by putting a GPS device on a truck that is delivering and or moving the medication. This lackluster drug control is not good enough either. What we need is the ability to open up inventory records electronically throughout the supply chain and run a report that says exactly who handled that product from the day it was manufactured. This mechanism does not exist today. We track our medications in bits and pieces. Again, this is not stopping the introduction of bad products. We need more drug regulation.
We can’t stop the ethically challenged from making drugs – but what we can do is stop them from introducing them into our supply chain. What we need are real, concrete pedigree laws that require tracking of all movements of a medication. If not, how much are we willing to roll the dice on lives?
Thanks for reading!
Healthcare Advocate
Rebecca Busch