Don't Be Fooled by Counterfeit Drugs
April Fool's Day is traditionally celebrated with harmless jokes and pranks among friends. At the end of the day, everyone usually has a good laugh. But as Rick Roberts can tell you, getting fooled by counterfeit drugs is no laughing matter. As he shared in a recent news article, twice, Roberts picked up expensive prescriptions from a reputable pharmacy only to find fake drug.
A few years ago, I helped the Partnership for Safe Medicines develop SAFE DRUG, a checklist guide to help consumers identify and protect against counterfeit medicines. This checklist helps consumers evaluate their medications to make sure they are safe, and provides tips on what to do if they believe there is a problem.
Sample: Request samples of your medications from your physician when first having a medication prescribed in order to compare the appearance, taste, texture and reaction later to medications filled through the doctor's prescription.
Appearance: Compare the prescription medicine you receive with what it is supposed to look like by taking pictures of the original manufacturer's drug and all associated packaging.
Feel: Take note of the prescription drug's taste and any associated feelings once you take it. Is there anything unusual in your body's reaction compared to previous experiences?
Evaluate: Ask your doctor or pharmacist what you should expect to feel and when you should expect to begin feeling relief or improvement.
Doctor: If your drugs do not seem to have the same taste or if you feel different than usual, immediately write down your symptoms and contact your doctor and pharmacist.
Report: If you have any concerns about your drugs, or have confirmed there is a difference in its packaging, labeling or pills, you should immediately contact the pharmacy where you purchased them.
Unavailable: If you confirm that your medicine has been compromised, immediately remove it from your medicine cabinet, mark the packaging with a red pen and put tape around the top of the drug container so that it will be unavailable to you or others in your family.
Gather: Gather all the information you can find related to how you got the counterfeit medication and how long you have been taking it.
We need to be on alert and aware of the real risks associated with online drug sellers and counterfeit medicines. Patients have usually been the first to detect counterfeit medicines, so everyone can help in promoting safe drugs. To learn more about how we can protect ourselves from counterfeit drugs, visit SafeMedicines.org.
Regulating Online Pharmacies
Bryan A. Liang, MD, PhD, JD
According to some sources, there are at least 1,000 Web sites selling prescription drugs. Of course, not all of which are legitimate. Considering the sheer number of hits an Internet search for "online pharmacy" returns, it's not surprising that the U.S. Senate has put the Online Pharmacy Consumer Protection Act of 2007 on its legislative calendar.
One provision in the Act will prohibit an online pharmacy from selling a controlled substance over the Internet without a valid prescription. This is not an isolated concern. In fact, recently a Utah couple was in the news for their role in an international counterfeit drug operation in which they received and distributed shipments of hundreds of drugs, sometimes thousands of tablets, without a license or doctor's supervision.
As I've noted elsewhere, by confronting the safety issues associated with online drug access, requiring a prescription is step in the right direction. But it needs to go much further. It should require online pharmacies to be certified so customers can recognize which pharmacies are legitimate.
Stories of people who've died after purchasing controlled substances through online pharmacies are tragic. For example, Ryan Haight, a straight-A, talented high school scholar and athlete died because of an overdose of Vicodin, a powerful painkiller that he'd purchased without a prescription through an unregulated Internet seller.
Unfortunately, online drug peddlers prey upon an increasing demand: the National Survey of Drug Use and Health found that 6 million Americans aged 12 or older had used prescription psychotherapeutic drugs nonmedically in the previous month, and 3.1 million had abused OxyContin in their short lives. The bulk of new abusers are in the 12- to 17-year-old age group.
Further, beyond selling drugs of abuse to children, unregulated online pharmacies also maim and injure patients by passing off fakes.
Patients who access drugs through the Internet, who often represent some of the most vulnerable patients including the elderly and minorities, don't know they are not getting the real thing because many diseases are "silent."
Drugs treating high blood pressure, elevated cholesterol, cancer, and other illnesses don't provide immediate or obvious clinical changes after being taken.
Unregulated online sellers represent a lose-lose situation—patients getting the drugs of abuse they want; and patients not getting the drugs of treatment they need.
However, mandating prescriptions alone is not enough. Unscrupulous online businesses will sell whatever to whomever, as long as they are paid. Just as they've embraced counterfeit drugs, they'll also sell fake prescriptions.
Regulating these pharmacies should include verification that consumers have a valid prescription. But these sellers should also be licensed in the state where they sell drugs just like normal pharmacies, and be subject to rigorous oversight standards, such as the VIPPS program--the Verified Internet Pharmacy Practice Site accreditation program created by the National Association of Boards of Pharmacy.
The idea of ensuring that pharmacies verify prescriptions is a good one. But it is only a start. Oversight must include assurances that they are legitimate, have a license, and verify the need for the medications they dispense.
For more information about buying safely online, go to SafeMedicines.org.
Safe Alternatives for Reducing Healthcare Spending
Bryan A. Liang, MD, PhD, JD
Healthcare spending and prices are on the rise—again. The Centers for Medicare and Medicaid Services estimates that overall healthcare spending in America will reach $4.3 trillion annually by 2017. Given that healthcare costs are increasing at nearly three times the rate of inflation, it's no wonder Americans are seeking ways to keep their healthcare costs low.
Some are turning to the Internet, where thousands of Web sites promise big savings on prescription drugs. But Internet-based sales of pharmaceuticals are a major source of counterfeit medicines in industrial countries according to the World Health Organization. In fact, again according to WHO, Internet "pharmacies" ship fakes in more than 50 percent of cases.
Patients don't have to turn to questionable online sellers to get the medications they need. The Partnership for Prescription Assistance (PPA) is a safe alternative for patients who cannot afford to fill their prescriptions and get medicine they need.
The PPA is a clearinghouse of information that is a single point of access to more than 475 public and private patient assistance programs. The program offers language assistance and can provide information in over 100 different languages. Patients only need to answer a few short eligibility questions, which they can do online or by phone (1-888-477-2669) to find out if they quality for assistance programs.
It's always a good idea to save money - but patient safety should never be sacrificed. Being left untreated, injured, or killed is not a good tradeoff for purchasing from risky Internet sellers.
Heparin Havoc Continues
It looks as though the problems from China-sourced heparin are far from over. An unknown substance, similar in chemical makeup to heparin, has been found in batches of the blood thinner produced by U.S.-based Baxter International and Germany-based Rotexmedica.
In some cases, this mystery component comprised as much as 20 percent of the contaminated heparin. Unfortunately, we don't whether this was introduced into the product, whether it was a natural reaction resulting in a byproduct, or if there is some other explanation for the dozens of adverse reactions and at least 19 deaths associated with the product. In any event, it's worrying for patients and providers who rely on this common drug.
Beyond US and German recalls, three Japanese firms have also announced earlier this week a precautionary heparin recall linked to Scientific Protein Laboratories, which processed the raw materials from China used to make active ingredient in Baxter's heparin.
At this time, we don't know source of the heparin problem. But we do know that in the past, there have been dangerous substitutions made when supply shortages for the raw product have occurred. Unscrupulous suppliers don't hesitate to use foreign, possibly toxic, materials into a drug's raw materials if it will save them money. And as I said back in November, it's easier than ever for counterfeiters to use materials of questionable quality to penetrate the U.S. market since pharmaceutical supply chains are becoming increasingly global-and vulnerable.
If contaminates can penetrate and cause injury in heparin's legitimate supply chain, just imagine the possibility of them being used in contraband drugs from rogue online sellers.
If you order medicines online, make sure the Web site is part of the Verified Internet Pharmacy Practice Sites (VIPPS) program. The VIPPS identifies online pharmacy sites that are appropriately licensed, are legitimately operating via the Internet, and that have successfully completed a rigorous criteria review and inspection.
It is important to use all the tools and information at our disposal to protect ourselves. Remember, counterfeit drugs are unsafe at any cost.
An Easy Prescription to Follow
If you're looking to purchase drugs online, here are a couple of simple ways to increase the possibility the website you're considering buying drugs from is a legitimate website, and to protect yourself from receiving counterfeit or contraband drugs.
- Make sure the website carries a VIPPS® Seal, which signals that the online pharmacy has the seal of approval by The National Association of Boards of Pharmacy.
- Check that the site requires a valid prescription by a licensed healthcare provider.
- Check to see if there's a licensed pharmacist available to answer questions about your medicine or your order, and valid contact information.
If any of the above isn't true for the website, be suspicious! There's a strong chance that the website is not legitimate, nor are the drugs that come from it. This is even the case for websites that appear to be American or Canadian.
Unfortunately, an FDA study released last month concluded that many purchasers of drugs online are people specifically trying to avoid needing a valid prescription. Others were trying to find drugs at cheaper prices. Here, too, the FDA found that people were misguided, since more than half of the prescription drugs the FDA looked at for its study had FDA-approved generic versions, likely sold at lower prices.
Taking medicines without a valid prescription presents inherent risks, which are then compounded when the drugs are bought from illegitimate websites. While the need to save money is understandable, no amount of cost savings is worth risking your family's health and possibly their lives.
This website offers tools to help you make sure the prescription drugs you're buying come from a legitimate, safe source. Click here. It also has a guide for ways to find safe drugs at cheaper prices. Click here.
Remember protect yourself and your family! You are the last barrier to harm!
They’re Not Going to Take It
Recognizing the growing threat of the availability of counterfeit drugs worldwide, the Medicines and Healthcare Regulatory Products Agency (MHRA) - Britain's version of the FDA - last week published its first Anti-Counterfeiting Strategy. The strategy sets out the MHRA's approach to combating this threat for the next three years, including the launch of a new 24-hour hotline for reporting suspected counterfeit medicines and devices.Recognizing the growing threat of the availability of counterfeit drugs worldwide, the Medicines and Healthcare Regulatory Products Agency (MHRA) - Britain's version of the FDA - last week published its first Anti-Counterfeiting Strategy. The strategy sets out the MHRA's approach to combating this threat for the next three years, including the launch of a new 24-hour hotline for reporting suspected counterfeit medicines and devices.
Overall, the MHRA's strategy sets out to tackle four major problems of counterfeiting in the UK:
- the availability of counterfeit medicines (and medical devices) there;
- the fact that the UK is an attractive market for counterfeiters because of the high prices of drugs, a large market, and very complex supply chain;
- the need to raise awareness of the counterfeit drug threat to the public and stakeholders; and,
- the problem of counterfeiters using the UK as a transit point and distribution hub.
So it's clear that the UK isn't going to tolerate counterfeiters, typically from Asia, using the UK as "cover" for sending fake drugs ordered online from the U.S. Part of its strategy is looking to increase criminal prosecutions in these cases.
I applaud the MHRA for drawing the line in the sand and effectively telling counterfeiters "we're not going to take it". I congratulate the British public for having a drug regulatory authority that is actively addressing this important patient safety issue.
Unfortunately, the problems with counterfeiting aren't confined to the UK. Many of the problems noted by the MHRA are common in the U.S. as well.
As I've noted before, patients are the last barrier to harm. Here in the U.S., the FDA has had a counterfeit-watch program for a couple of years now, whereby consumers are encouraged to report suspicions of counterfeit drugs. To do so, consumers can call MedWatch at 1-800-322-1088. Let the FDA know if you suspect fakes! The worst you can be is wrong; the best you can do is save lives.
Other ways that you can protect yourself include tools you can find on this website:
- Download the SAFE DRUG checklist to learn how to avoid, deter, and report suspected counterfeit drugs.
- Sign up for the SAFEMEDS EMAIL ALERT SYSTEM, which broadcasts FDA Counterfeit Alert Network notices as soon as they come out.
- If you do buy drugs online, only use Verified Internet Pharmacy Practice Sites (click here), that are accredited by The National Association of Boards of Pharmacy's (NABP) as legitimate pharmacies.
Remember protect yourself and your family! You are the last barrier to harm!
Between a Rock and Hard Place
There's no question that prescription drugs save lives, relieve suffering, and promote the quality of life for those with access to them. There's also no question that, to be helped by these drugs, patients have to be able to afford drugs that are safe and effective.
Unfortunately, current public policy puts patients in a Catch 22 by not effectively addressing either the issues of safe drug availability or affordability. Policymakers focused on drug prices fail to address safety and, on the other hand, those focused on safety fail to address high prices.
According to a recent GAO report and hearings we've talked about in this blog, the FDA isn't able to address the vulnerabilities that allow counterfeits and diverted drugs to enter into the supply chain. Technology focuses on tracking the cardboard packaging of our medicines, not the product. And patients who cannot afford legitimate drugs are increasingly being driven to questionable and unsafe medication sources that expose them to the dangers of counterfeits.
The combination of high prices and limited protections makes the U.S. an attractive market to counterfeiters who can produce fakes at virtually no cost and little risk of being held accountable. This results in huge profits compared to other activities available to the counterfeiter with virtually no chance of being caught.
With growing incidents of counterfeit drugs making their way into the worldwide drug distribution and increasing access to the anonymous and unregulated world of Internet pharmacies, what can be done to help patients avoid being in between a rock and a hard place when it comes to their health?
Some ideas I have include:
• creating a low cost/no cost drug program that segregates needy patients from private markets, with participation by both brand name and generic companies;
• identification and registration of legitimate drug wholesalers;
• banning Internet drug sales unless pharmacies are accredited by the National Association of Boards of Pharmacy;
• prohibiting drug importation;
• directing the Centers for Disease Control and Prevention to create aggressive public and provider education on counterfeit drugs;
• and,
• significantly increase increasing penalties for counterfeiters to fit the crime of cheating the hopes of the sick and vulnerable.
We have a ways to go before we get to these solutions because we need policymakers to think about both price and authenticity when they think of access. But I hope that as more people become aware of our vulnerabilities, the more they'll want policymakers to do something
about it.
In the meantime, consumers can protect themselves and their families by
• Subscribing to the Partnership for Safe Medicines free email alerts. (Link here)
• Downloading our simple SAFEDRUG guide. (Link here)
• If you have to buy drugs online, buying them only from verified online pharmacies. (Link here)
Click here and sign up for the SafeMeds email alerts of government counterfeit drug warnings. We'll talk about other tools in future discussions.
A Scary Tale on Halloween
A front-page article in today's (10/31/07) New York Times exposed the scary reality about pharmaceutical ingredients exported from China: these ingredients "are often made by chemical companies that are neither certified nor inspected by Chinese drug regulators."
The frightful story doesn't end there.
The potentially harmful ingredients were being openly peddled by Chinese chemical companies at a major pharmaceutical convention this month in Milan, Italy. According to the New York Times' investigation, one third of the over 1,300 companies exhibiting at the convention were from China. Of these, several companies had been involved in recent government investigations and have a history of selling fake and, in some cases, lethal drugs. One scheduled company wasn't there -- it's owner is currently in a Houston jail after trying to sell drugs to customs agents (he was successful in getting his drugs into the European market).
The lack of regulation in China means that these chemical companies don't have to meet any drug-manufacturing standards and are easily able to export unapproved and counterfeit ingredients.
And now for the part that's really alarming:
"The substandard formulations made from those ingredients often end up in pharmacies in developing countries and for sale on the Internet, where more Americans are turning for cheap medicine," according to the Times. And unfortunately, the Times also reports that the FDA simply cannot inspect even a small fraction of the 700 or more Chinese manufacturers that may be sending drugs to the United States.
The Times' front page exposé is another chilling example of how more and more unsafe Chinese chemicals are finding their way into drug ingredients that make up the medicines bought by unsuspecting consumers. Unfortunately, consumers are buying these drugs from illegitimate sources, including many online sellers posing as Canadian pharmacies.
Kudos to the New York Times and its reporters for its great work revealing the extent to which counterfeit drugs are a serious patient safety problem that U.S. health experts believe "pose a greater threat to a broader segment of the American public," especially those buying their drugs on the Internet.
Click here to read the full investigative piece.
Click here to help protect yourself and your family by signing up for the SafeMeds email alerts of government counterfeit drug warnings.