Stopping Counterfeit Drugs at the Source
Here at the Partnership for Safe Medicines, one of our core principles for drug safety is the need to unify in the fight against counterfeit drugs. This week, we saw progress.
Recently, U.S. Secretary of Health and Human Services Michael Leavitt said the agency will station as many as 15 inspectors in three Chinese cities to scrutinize exports to the United States. Unfortunately, it took more than 80 deaths from compromised heparin (the drug was produced with counterfeit drug ingredients from China) to get the FDA, Congress and Chinese authorities to take action.
Getting the inspectors in the country is an important first step. But it’s important that we don’t stop there. In order to stop counterfeit drugs and other unsafe products from pouring out of China and into the U.S., the FDA needs staff those foreign offices with inspectors and criminal investigators armed with the same authority as their State-side colleagues. Additionally, the FDA needs to be granted the authority to enter and inspect foreign manufacturing facilities without previous notice.
Finally, we need both a carrot and a stick. The carrot: cooperation with FDA activities by Chinese factories and authorities will allow these drug sources to be treated like US factories that have undergone inspection, and hence pass into our distribution system. The stick: lack of cooperation (such as limiting the ability of FDA authorities to make surprise inspections) will result in an FDA import alert to all such products at our borders and delay for detailed inspections before allowing such products to be distributed. This will cost time and money and even result in rejection of these imports. In this way, we can reward safety efforts while simultaneously deter suspect factories and their products from reaching us on our shores.
The Warning Signs of Illegal Online “Pharmacies”
Why buy from a store when you can shop on the Internet? Unfortunately, there are numerous illegal Web sites that will sell you contaminated or counterfeit drugs, unapproved products, the wrong product, or simply take your money and never deliver anything in return.
The situation is very much "buyer beware." Patients can protect themselves by looking for suspicious characteristics that indicate thee "online pharmacies" may be selling illicit or counterfeit drugs. For example:
The site does not have a physical address or telephone number is listed.
The site does not have a licensed pharmacist available to answer questions.
There is no way to talk to a person if problems arise regarding suspect contraband or counterfeit medication.
The site does not ask for the name, address, or phone number of your current doctor.
The site does not require that a valid prescription issued by a physician be provided before filling the order.
The site offers to sell drugs without a prescription or only requires a buyer to fill out a questionnaire to receive drugs.
The site does not accept any insurance and requires that all payments be made with a credit card.
The site requires that you waive some rights before sending the drugs.
The site "advises" consumers about drug importation laws and why it is "permissible" to obtain prescription drugs from foreign countries via the Internet.
The site encourages buyers to have the drugs sent to post office boxes.
If you suspect a Web site is making illegal online drug sales or selling counterfeit drugs, report it to the FDA by sending an email to a webcomplaints@ora.fda.gov. This is just one of the 10 ways the Partnership for Safe Medicines recommends you can fight counterfeit drugs. Visit SafeMedicines.org to learn more about how you can help combat counterfeit drugs.
Out of Time
Last week, the Food and Drug Administration (FDA) issued a consumer alert warning patients that two Baltimore pharmacies may have received either expired or possibly counterfeit drugs. Earlier this year, New York Attorney General Andrew M. Cuomo initiated legal action against CVS and Rite Aid pharmacies after a statewide investigation found it had sold expired products, including over-the-counter medications.
From a medical point of view, expiration dates are important. Over time, prescription and over-the-counter drugs lose potency and degrade as their chemical ingredients break down. This loss can be anywhere from five to 50 percent of the drug's original strength. Any reduction in can lead to clinically important complications if the drug is used to treat serious conditions.
The expiration date specifies the date that the manufacturer guarantees the full potency and safety of a drug. As my colleague, Professor Marv Shepherd, shared with MarketWatch, "To be safe, the pharmaceutical companies will put maybe a 12-months or 24-months expiration date on [a drug] when they know it's probably good for 36 months, but they don't want to take any chances because they don't know where the person's going to store it. If you put it in a glove compartment in the southern United States, it won't last very long at all."
This raises another important medical issue: drug storage. Because along with time, another important factor that affects a drug's potency is how it's stored. Sunlight, heat and humidity accelerate a drug's breakdown. Unfortunately, common places such as bathrooms, kitchens, and cars are some of the worst sites to store medicines since they are exposed to extreme changes in temperature and humidity. The best places to store medications are in dry, dark places at either reasonable room temperature or, if required, in a refrigerator.
Although there are sometimes signs that signal significant deterioration, many drugs do not display any visual signs of degradation.
As a patient safety matter, patients should go through their prescription and over-the-counter medicines at least once a year and remove expired drugs and move all drugs into appropriate storage areas. To learn more about how to safely dispose of expired medications, download the FDA's guide to "How to Dispose of Unused Medicines.”
An Unexpected Fake in Los Angeles
Botox treatment is one of the fastest-growing cosmetic procedures on the market today. With the promise to eliminate wrinkles and fine lines, more and more baby boomers are turning to this product to fight the signs of aging. However, in addition to battling wrinkles, the makers of Botox now find themselves fighting the illicit business of counterfeit drugs.
Last week, Ms. Rana J. Hunter appeared in federal court facing criminal charges for her alleged role in a scheme to sell human growth hormone (HGH), and counterfeit Botox to spas across the country via the Internet. Ms. Hunter’s arrest came after an undercover U.S. Immigration and Customs Enforcement (ICE) agent, posing as a supplier for clinics and spas, purchased vials of the counterfeit drug and multiple vials of real HGH.
It was over a year ago when U.S. Customs and Border Protection (CBP) officers began intercepting packages from a China address to Ms. Hunter’s company, Westgate Distributors, claiming to contain synthetic hair pieces, plastic molds and "sample iron oxide" (better known as rust). In reality, the packages contained vials of HGH and counterfeit Botox.
Unfortunately, this is not the first instance of tainted or fake Botox. Several years ago, a physician was supplied with a research version of Botox, which is much more concentrated than that utilized for anti-wrinkle treatment and not intended for human use. It resulted in respiratory paralysis and near death for several patients, including the physician who was using it himself.
The take away message is clear – counterfeit drugs can show up everywhere and are dangerous. Keep visiting SafeMedicines.org to learn how you can protect your family from contraband and counterfeit drugs.
Getting Back to Basics: Use the Standard VIPPS Categories
When it comes to shopping, no retailer is as accessible to consumers as the Internet. With a few clicks of the mouse, this remarkable tool can connect you with almost anything you want—from rare collectables to inexpensive trinkets—and have it delivered to your doorstep. But it is a double edged-sword-the anonymity of the Internet allows the good and the bad to sell, including counterfeit drugs via online “pharmacies.” And, as my colleagues and I have warned, for prescription drugs, the Internet can be a prescription for disaster, since these drug pushers are anything but legitimate pharmacies.
Since the late 1990s, the National Association of Boards of Pharmacy (NABP) in its Verified Internet Pharmacy Practice Site (VIPPS) program have reviewed online drug sellers and placed them into two categories: recommended or not recommended. The "Recommended" sellers are legitimate online pharmacies. They are the 15 pharmacy Web sites that carry the VIPPS seal, have gone through rigorous assessment and inspection, and represent more than 12,000 actually verified pharmacies. The "Not Recommended Sites" are online drug sellers that do not appear to comply with state and federal laws, or NABP's patient safety and pharmacy practice standards—which indicates that they represent a greater risk of selling counterfeit drugs.
But recently, NABP began using a new category: "Reviewed Internet Pharmacy Practice Sites." Here, NABP reviews "public information" available for these online drug sellers and determine that they appear to or may comply with state and federal laws and NABP patient safety and online pharmacy practice standards.
This new "reviewed" category is not helpful. It is important to remember that these online drug sellers have not demonstrated compliance with the stringent set of criteria necessary for legitimate online pharmacies to qualify for VIPPS accreditation, and therefore could be distributing counterfeit drugs to buyers. Even NABP advises patients to use the "reviewed" sites with caution since the information needed to conclusively determine the legitimacy and legality of these sites isn't available.
That's why we at the Partnership for Safe Medicines continue to recommend that you only use full, "Recommended" VIPPS accreditation online pharmacies to avoid receiving counterfeit drugs.
Remember, you are the last barrier to harm. So keep visiting SafeMedicines.org to learn how to protect yourself and your family from contraband and counterfeit drugs.