Expired Medication Found in US-Based Pharmacy Chains
It is important to remember that unsafe drugs are not confined to overseas and online pharmacies. Expired medications could be for sale at your corner drugstore.
On Dec. 5, the State of New York sued CVS and Rite Aid over sales of expired products, including over-the-counter (OTC) drugs and baby food. According to state investigators, expired goods were found in 60 percent of the state’s CVS stores and 43 percent of Rite Aid stores.
This is not the first time CVS has been found selling expired over-the-counter drugs. After a 2003 lawsuit filed against CVS by the State of New York, the drugstore agreed to stop selling expired drugs and implement safeguards for the future. However, it seems those safeguards haven’t improved the company’s inventory practices so New York officials are now calling for harsher checks and penalties for those distributing unsafe medicines.
According to the petition issued by the State, CVS must allow an independent monitor to conduct monthly checks, post signs that inform consumers about the health risks associated with expired medication and that they are entitled to refunds for expired products and pay a penalty of $500 for every violation. Expired products have also been found in CVS stores in California and Pennsylvania.
Rite-Aid’s settlement requires the company to conduct weekly inspections of its New York stores to ensure that all expired over-the-counter drugs, infant formula, milk and eggs are no longer sold in stores. Rite Aid faces a $1 million civil penalty.
These examples illustrate why we must be proactive about the safety of our prescription and OTC medicines. Double check the expiration date and inspect the packaging and safety features of any prescription or OTC drug before you purchase it because expired and improperly stored drugs can lose up to 50 percent of its original potency.
Visit SafeMedicines.org to learn more about how you can help combat counterfeit drugs and ways to safeguard the safety of your prescription and OTC medicines.
Counterfeit Drugs and Baby Formula
Four infants are dead and more than 54,000 children in China have suffered from kidney stones and kidney failure this past year as a result of baby formula and powdered milk tainted with melamine, an industrial chemical used to make plastics, glue and is found in pesticides. The toxin found its way into the milk products from more than 30 Chinese companies because of its ability to make the milk appear high in protein.
According to the Wall Street Journal, around two dozen countries and the 27-member European Union have banned or recalled Chinese milk and other products made with it. Among the products involved are those made in China by major multinational firms for sale around Asia—including Nestle milk, Heinz baby cereal, Nabisco Oreos and Ritz, Cadbury chocolate, M&Ms and Snickers from Mars and several batches of Lipton powdered teas made by Unilever.
In the United States, the FDA has issued alerts warning consumer not to consume White Rabbit Creamy Candy or the Mr. Brown instant coffee and milk tea products found in many ethnic stores. However, one of the more disturbing elements of the story is that Chinese government and corporate officials tried to conceal the contamination after receiving their first complaint in December 2007.
As incidents of food, drug and other household product contamination become increasingly apparent across the globe, the Partnership for Safe Medicines is leading the effort to educate the public of the dangers of contaminated or counterfeit drugs. This type of health-threatening behavior exemplifies why consumers need to take an active role in the fight against counterfeit drugs and contaminated products that we may purchase – especially those from foreign markets or online vendors as products produced abroad aren’t necessary regulated in the same fashion as those under the umbrella of the U.S. Food and Drug Administration. To find out more about how to protect yourself from contaminated products and counterfeit drugs, visit SafeMedicines.org.
Politics and Counterfeit Drugs
The only constant in politics is change. This is evident on the campaign trail as presidential candidates Barack Obama and John McCain are reconsidering their support of prescription drug importation. In fact, earlier this week, the Partnership for Safe Medicines met with McCain’s campaign to discuss the dangers of counterfeit drugs.
Currently, the United States has one of the safest drug supplies in the world because its pharmaceutical supply system is "closed" to importation. Once a drug is outside the strictly regulated distribution channel, there is no guarantee of its authenticity, effectiveness, or safety. We know from the recent incident in China of the deliberately contaminated milk and baby formula. This tragedy caused thousands of babies to be sick and so far has caused four deaths. Poorly regulated environments allow counterfeiters and unscrupulous sellers to thrive.
Anytime consumers venture outside of the U.S. supply system, they take on a very real risk of getting counterfeit drugs. All political leaders need to understand that drug importation programs, including state-government sponsored programs, encourage Americans-especially vulnerable patient populations such as minorities, seniors, and fixed income patients-to gamble with their health.
We urge both candidates to adhere to the Principles for Drug Safety. This invaluable resource can help to form the basis for a national strategy to strengthen the U.S. distribution system and curtail the criminal counterfeit drug trade. Specifically, the Partnership's principles addresses ways to protect the pharmaceutical supply chain, regulate online drug sellers, and fight counterfeit drugs.
All Americans should feel secure the medicines upon which they rely are safe, untainted and regulated to ensure the highest quality. The Partnership encourages Congress to enact stronger safety measures and enable law enforcement to deal with counterfeit drugs.
To join us in our stand against counterfeit drugs or obtain your own copy of the Principles for Drug Safety, please visit SafeMedicines.org.
Online Pharmacies and Prescriptions
Marv Shepherd, PhD
Earlier this week, the House Committee on Energy and Commerce finished the mark up of the “Ryan Haight Online Pharmacy Consumer Protection Act of 2008” (H.R. 6353). The bill addresses a major safety issue associated with online pharmacies—the sale of controlled substances over the Internet without a valid prescription.
One of the Partnership’s core principles for drugs safety is that we must regulate online pharmacies. We believe that no one should be able to purchase any type of prescription drug, not just controlled substances, over the Internet without a valid prescription. Prescription drugs are not safe for use without the supervision of a licensed healthcare practitioner—that is why these drugs should only be dispensed with a valid prescription.
Before a healthcare practitioner issues a prescription, he or she examines the patient to determine the appropriate treatment. Online pharmacies that don’t require a prescription or only ask customers to fill out a questionnaire before getting a prescription drug deny consumers the protection of an in-person meeting and provided by a licensed healthcare practitioner.
Consumers—such as the bill’s namesake—have died from purchasing drugs from online pharmacies that sold them without a prescription or through an online survey. These deaths may have been avoided if they had gone to their doctor to get a prescription for the drug instead of an online pharmacy.
Unfortunately, mandating prescriptions for drugs purchased online will not be enough to stop this public health threat. Internet drug peddlers will simply bridge the gap by creating and selling fake prescriptions. These unscrupulous online businesses will continue to sell whatever to whomever, as long as they are paid. If we truly want to avoid another deadly incident of failed online pharmacy safety, Congress needs to take this opportunity to further address the vulnerabilities threatening the safety of our prescription drugs.
Visit SafeMedicines.org to learn more about the dangers of unregulated online pharmacies.
GAO Report Weighs in on Federal Efforts Against Counterfeit Products
Protecting the American public against counterfeit drugs is unarguably a daunting task. One of the ways our government combats the sale of unsafe or substandard products—like counterfeit pharmaceuticals—is through the enforcement of intellectual property (IP) laws. So, how are the five key agencies that play a role in IP enforcement faring? Well, it turns out that’s an excellent question that we can’t really answer right now.
According to a March U.S. Government Accountability Office (GAO) report on IP enforcement, the Food and Drug Administration (FDA), Customs and Border Protection, Immigration and Customs Enforcement (ICE), Federal Bureau of Investigation and Department of Justice have not taken key steps to assess their achievements even though their efforts against counterfeit drugs generally increased from 2001-2006.
The good news is that the report offers specific recommendations about how they can improve—such as collected data on their efforts to address IP crimes that affect public health and safety, systematically analyzing their IP enforcement statistics to inform management and resource allocation decisions, and establishing IP-related performance measures or targets to assess their achievements. Also, since counterfeit drugs are an increasingly high priority for the FDA, the agency will permanently assign staff at the new ICE center to help achieve the GAO’s recommendations and improve interagency enforcement efforts.
While government funding and bureaucracy catches up with the extensive needs to combat counterfeit drugs, it’s important we continue to take steps to protect ourselves from counterfeit drugs. The Partnership for Safe Medicines recommends 10 ways you can fight counterfeit drugs:
Follow the news: Learn about what's happening here in the U.S. and other parts of the world with our comprehensive news archive. SafeMedicines.org maintains lists all relevant news stories from around the globe and is great way to see the global dimensions of this problem.
Subscribe to the SafeMeds Weekly News Update: Our free weekly email provides readers with a weekly roundup of what's happening around the world regarding counterfeit drugs, as well as the latest blog entry from our experts.
Learn how to protect your family: Download our simple SAFEDRUG guide and keep your family safe.
Check the list of verified online pharmacies: WHO warns that half of rogue online drugstores sell counterfeits. Go to the VIPPS list to ensure you use reputable Internet pharmacies.
Sign up for the SafeMeds Email Alert System: As part of the FDA's Alert Network, this free service sends official alerts from the FDA and other government agencies around the world to anyone—private citizens, public groups, corporations, associations—when specific counterfeit drug incidents occur.
Test your ability to spot fakes: Can you tell the difference? Check out the FDA archive to see examples of counterfeits.
Become an expert: SafeMedicines.org has a virtual library of testimony, studies, and more.
Use safe channels if you need help paying for medicines: The Partnership for Prescription Assistance (PPA) is a clearinghouse of information that is a single point of access to more than 475 public and private patient assistance programs for anyone who cannot afford to fill their prescriptions and get medicine they need.
Join the Partnership for Safe Medicines: Help us protect consumers from counterfeit or contraband medicines.
Learn how to spot rogue websites. Do you want to help put fight counterfeiters? Become a virtual volunteer. Write us for more information.
Posted by safemedicines2 at 09:30 AM
Partnership for Safe Medicines Issues Statements on Series of Drug Safety Hearings
Recently, the heparin contamination and drug safety in general have taken center stage on Capitol Hill. In the past two weeks, there has been three hearings in the House and one in the Senate examining issues affecting the safety of our prescription medicines.
As part of our commitment to protecting consumers from counterfeit and contraband medicines, the Partnership issued statements to the media and Congress for each hearing about the government’s role in drug safety and suggestions for protecting Americans moving forward.
Although I applaud the members of Congress who initiated these hearings, their findings shouldn’t come as a surprise. Here at the Partnership for Safe Medicines, we have been saying for months that the FDA’s ability to safeguard America’s food and drug supplies is being compromised by numerous challenges and obstacles.
In our statements, we reiterated our call for strict, rigorous regulatory oversight of imported drugs to keep situations such as the recent heparin contamination from repeating in the future. But more importantly, progress in the fight against counterfeit and contaminated medications is unforeseeable unless we give the FDA all the tools it truly needs to fix the problems.
These hearings were a step in the right direction. But we can’t stop there. It’s essential that Congress and the FDA view the ideas and legislation coming out of these hearings as the beginning of drug safety efforts in our country, not the end.
While the government works to develop a plan to protect Americans, it’s more important than ever before that everyone learns how they can take steps to protect themselves from contraband and potentially counterfeit medicines—because counterfeit drugs are unsafe at any cost. Visit SafeMedicines.org and join us in our stand against counterfeit drugs.
Heparin Update: 62 Suspected U.S. Fatalities, 2 Upcoming Hearings
Marv Shepherd, PhD
The heparin fallout continues. As an update to our March 13 post, the Food and Drug Administration (FDA) now reports 62, not 19, suspicious deaths in the United States linked to the blood thinner heparin, most of which occurred in December, January and February. According to an article in the New York Times, investigations continue into whether the deaths were caused by the Chinese contaminant.
Recognizing the importance and urgency of eliminating contaminated drugs, the Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations will hold two hearings in the coming weeks on this issue. The first hearing, tentatively scheduled for Tuesday, April 22 at 11 a.m., will ask FDA Commissioner Andrew von Eschenbach to explain how to address the many concerns raised by the Committee regarding FDA’s efforts to inspect foreign drug plants making products for the U.S. market. The second hearing, tentatively scheduled for Tuesday, April 29 at 10 a.m., will examine the events leading up to the distribution of a contaminated batch of heparin imported from China.
The Partnership for Safe Medications applauds the efforts of Committee Chairman John D. Dingell, Committee Ranking Member Joe Barton, Subcommittee Chairman Bart Stupak and Subcommittee Ranking Member John Shimkus in arranging these hearings. Every step taken to ensure the safety of consumers is an important one.
Contaminated heparin is just one example of the increasingly global problem of counterfeit and contraband medications sold to an unknowing public. It is important to educate yourself on this topic and SafeMedicines.org has many resources available on how to keep your family safe, verifying online pharmacies are legitimate, how to spot fake drugs and the safe channels available to pay for prescription medications. Don’t become a victim—or a statistic—of counterfeit drugs.
Federal Efforts to Combat Fake Meds
Marv Shepherd, PhD
Counterfeit drugs, tainted medicines, rogue online pharmacies – inarguably a growing problem around the world. But what can our federal government do to help protect us here in the United States?
One of our government’s best weapons in the battle against counterfeit drugs is the Food and Drug Administration’s (FDA) Alert Network, a coalition of health professional and consumer groups. The Alert Network disseminates alert messages about counterfeit drug incidents in the U.S. and develops educational information about the roles and responsibilities consumers and professionals should play to identify and report counterfeit drugs.
And recently, it played a role in helping indict Georgios Xydeas, a Greek national, for selling counterfeit, misbranded and unapproved prescription drugs to online pharmacies and undercover agents.
In February 2007, the FDA issued an alert saying some Internet pharmacy customers were receiving a powerful anti-psychotic drug identified as Haloperidol, the active pharmaceutical ingredient found in Haldol, instead of the medication they ordered. The misbranded drugs were shipped from Greece and further investigation led agents to Xydeas.
Although the foreign-based aspect of this crime makes U.S. investigation and prosecution especially difficult (this single counterfeit drug case was investigated for three years by agents from the U.S. Department of Homeland Security’s Immigration and Customs Enforcement, the Food and Drug Administration’s Office of Criminal Investigations, DOJ’s U.S. Attorney’s Office and the Chinese government, with support from the U.S. State Department and Panamanian officials and assistance from the Eli Lilly Pharmaceutical Co., the Sanofi-Aventis Pharmaceutical Co., the British Medicines and Health Care Regulatory Agency), Xydeas is facing 43 criminal counts for his role as a suppler of these misbranded and counterfeit drugs from China.
As counterfeiters have grown more sophisticated and set-up deceptive online pharmacies to con patients, we can use some of that same technology to fight back against fake drugs. I’m proud the Partnership for Safe Medicines’ SafeMeds Email Alert System is part of the FDA’s Alert Network. Our email alert system sends official alerts from the FDA and other government agencies around the world to anyone—private citizens, public groups, corporations, associations. To learn more about the SafeMeds Email Alert System and sign up for this free service, please visit SafeMedicines.org.
Marvin D. Shepherd, PhD
Dr. Marv Shepherd is the Director of the Center for Pharmacoeconomic Studies and Chairman of the Pharmacy Administration Division at the University of Texas at Austin’s College of Pharmacy. He also serves as the President of the Partnership for Safe Medicines.
Among his many research interests, Dr. Shepherd examines the policies related to drug importation and re-importation—especially from Mexico—the use of drug anti-counterfeiting strategies, and techniques for monitoring prescription drug diversion. His research and expertise on drug importation and drug counterfeiting has been featured on CNN News, NPR Radio: First Edition, Newsweek, Wall Street Journal, Money Magazine, Time Magazine, Prevention Magazine, US News and World Report, New York Times, USAToday, Washington Post, plus many other national newspapers, magazines, and television and radio news broadcasts.
He earned a Bachelor of Science in biology from Michigan Technological University, Bachelor of Science in pharmacy from Ferris State University, Master of Science from the University of Rhode Island, and PhD from Purdue University.