Q: Counterfeit drugs making their way across pharmacy counters and into hospitals? How is it possible that this has happened in the USA, of all places, and where did it all go wrong?

Counterfeits enter the food and drug supply through two channels, sometimes in concert: manufacturing and distribution. Set against this background, I think the reason we are finding so many counterfeit foods and drugs in the US supply is a perfect storm of three problems:

First, as the US economy has participated more and more in the global economy, it naively has not prepared for the unintended consequences. When we yield our manufacturing to China, we are at the mercy of China; we no longer control the quality of what’s being produced, nor do we control the way it’s brought back into this country.

Second, the FDA, like the rest of the US government, is unprepared, and not funded well enough to handle the work that needs to be done to oversee how drugs are being manufactured, then transported and distributed. In 2007, only 15 of the hundreds of pharma manufacturing plants in China were inspected. They just can’t keep up.

Finally, there will always be people who can figure out clever ways to take advantage of a broken system. Think prohibition and corn liquor or speak-easys. With loss of control over manufacturing, almost no oversight on the part of the FDA, and a lack of interest on the part of the pharma companies in the United States to rein in on the problems (too expensive, it cuts into their profits, etc.), there are so many wide gaps in the system for counterfeiters to walk through. This is true no matter where in the world the counterfeiters are located; China, the US or any other country. It’s just so easy.

Q: In your online article How do drug counterfeiters make their money you end by highlighting the necessity for the FDA to implement a ‘Pedigree system’. How would this function and how close is it to being achieved?

One way to maintain some control over the quality of the manufacturing and the safety of the distribution system is to have each drug, as its manufactured, packaged, transported and distributed, come with a set of credentials that have following it from the moment it was ordered. Originally that idea was a paper-based idea, and pharmaceutical manufacturers fought it, saying it was too expensive. In the past several years, an ‘e-pedigree system’ has been proposed, meaning, for example, each packaged drug might have a computer chip in it that could prove it was the bona fide drug, and could prove itself to be that drug. The information on the chip would be updated as the drug went through each stage of the manufacturing and distribution process.

But pedigree systems, including e-pedigree systems remain elusive. Once again, big pharma continues to fight it because it’s too expensive. Profits are more important to them than the possibility of people being harmed.

The implementation of a pedigree system is stalled. The FDA wanted to go through with it, but pharma talked them out of it. The technology is available and inexpensive, but until the pharmaceutical companies are ready to comply, it probably will not be implemented.

Q: If you are contacted by a patient who suspects they have received counterfeit drugs, what is the first piece of advice you would give them?

Few of us will suspect we have received counterfeit drugs because, like car accidents or house fires, we think those things only happen to other people.

What we are more likely to notice is that a drug we have taken for months or years suddenly seems no longer to be effective. Or that the packaging seems off-kilter, like the blister pack has split, or the plastic cover on a liquid medication is missing or sticky. Or that an injectable we’ve used for ages begins to sting for the first time.

While none of those problems necessarily means the drug was counterfeit, it does indicate a problem. It may have been manufactured incorrectly, and has possibly been recalled. Regardless, it’s wise to take steps to make your local pharmacist and the FDA aware of the problem.

Here are some steps to take:

• Don’t take any of the medication.

• Look on the FDA website’s MedWatch (or if you are not in the USA, your local drug regulatory authority such as the Medicines and Healthcare Products Regulatory Agency in the UK) to see if the drug has already been reported. You can check by manufacturer or by the name of the drug.

• Whether or not you see the drug listed, go ahead and report your problem. The FDA won’t take action until they begin to see a trend, and someone needs to be the first to report it. Don’t expect to hear back from the FDA, but know you’ve done a smart thing by reporting it.

• Whether or not the drug is listed at MedWatch, plan to return it, with its packaging, to your pharmacist. You’ll need a replacement so you can continue taking the right drug, so you’ll need to see him anyway. But you’ll want the pharmacist to know that there was a problem so he can remove any remaining stock from his shelf.
  
  However – before you return it, write down the manufacturer’s name, the lot numbers, any dates you find on the packaging, or any other identifying information you can find. Even better, take photos of the packaging, the pills, the inserts, and any other aspect of the product in case you want to be able to identify it later – or even compare it to the new product you’re given to replace it. You may even want to keep a sample.

• When you get the replacement drug, inspect it carefully, and make sure it does not come from the same lot number as the problem drug.

Q: Would you ever buy drugs online? Is it possible to create a safe Internet purchasing experience for pharmaceuticals?

Yes, I would buy drugs online. Actually, I get my daily dose of omeprazole from a mail order source. Certainly, there are online pharmacies that are more credible than others, and I would be very wary of where I purchased a drug from.

The real problem is our profit-focused American health system. Since we have to purchase our drugs, and since they are so horribly expensive, Americans are always looking for ways to save money on them. And then, of course, that just creates yet another opening for a counterfeiter to walk through.

That said, I think there are ways to approach the purchase of drugs from sources that could be credentialed in some way. As far as I know, this isn’t being done anywhere. For example, the government could certify an online pharmacy, and it might be accessible only through a Medicare website interface, or some approach like that. Individual health insurance companies could provide access to online pharmacies as a service to their insured customers, perhaps negotiating lower prices their insured patients could pay for drugs that aren’t covered.

Q: What are your views on other kinds of fakes? Would you ever buy a fake handbag for example?

NO. I would never knowingly purchase anything fake, nor would I condone someone else buying products or ideas that are fake.

There are two kinds of fakes – those which end up causing harm, and those which cause more harm.

Harm can be anything from actual death from a fake drug, to harming someone’s income or expertise because an idea, such as intellectual property, has been stolen.

I am both a creative and an ideas person. I find places on the Internet, for example, where people have stolen my articles or blog posts and try to pass off my ideas as their own. So while I’ve never suffered from a dose of a counterfeit drug, I do have an understanding of the frustration and anger that goes along with having had something stolen from me.

Are there fake products that don’t hurt anyone? I’m sure some could argue that imitation is the sincerest form of flattery and use that as an excuse to steal from someone else. I would suggest they have never had anything stolen from them. If that happened, it might change their perspective.

Trisha Torrey is a newspaper columnist, radio talk show host, blogger, author and speaker. At About.com she acts as ‘Every Patient’s Advocate’, helping patients navigate their way through the complexities of the American healthcare system.

In 2004 Trisha was diagnosed with a rare, deadly lymphoma and told she needed chemotherapy immediately or would die within six months. Thankfully this turned out to be a misdiagnosis but it was the catalyst that led her to her current role as a patient advocate.

At About.com Trisha provides information and practical suggestions to help people take responsibility for their own medical decisions, and work with their doctors to attain the best outcomes possible for their medical situation. She teaches people to be good health care consumers, how to stay safe in the health care environment and how to advocate for themselves.

At About.com you can read Trisha’s important and informative articles on counterfeit drugs.