The growing and dangerous counterfeit drug problem is a troubling, global epidemic that can — and does — harm patients who are merely trying to get well. Efforts to address the problem are hamstrung for a variety of reasons: Americans don’t see the immediate threat, this global public health problem needs a coordinated global response, and too many stakeholders are more focused on self-interest than on working together to find a solution. The Partnership for Safe Medicines (PSM) is a public–private–community organization bringing people together to fight this global health concern. PSM involves more than 60 nonprofit organizations that are committed to the safety of prescription drugs and protecting consumers against counterfeit, substandard, and otherwise unsafe medicines. Its message is simple: Counterfeit medicines do exist, they are not safe, and we can take action to avoid them.
Medications are increasingly a key component of every physician’s arsenal against disease. Recently developed drugs can send many cancers into remission, extend HIV/AIDS patients’ lives indefinitely, treat depression, and help manage diabetes and heart disease. A typical American family fills twice as many prescriptions now than 20 years ago. Strictly regulated drugs have contributed significantly to improving the quality of life in the United States and Europe.
That isn’t true everywhere. In many countries, “medicines” get sold that are too weak or strong, are past their expiration dates, that lack active ingredients, and/or contain harmful and potentially deadly “fillers.” In 2009 alone, the Pharmaceutical Security Institute (PSI) reported ~1,700 counterfeiting incidents worldwide. In 531 of those incidents, fakes reached licensed wholesale distributors or pharmacies in 48 different countries. In some developing countries, up to 30% of the drug supply is counterfeit. And counterfeited drugs are not merely “lifestyle” drugs; they include life-saving biologics as well.
Unfortunately, the developed world is not immune from this epidemic. Even with the high standards of the US FDA and EMA, counterfeit drugs still get through both online and (perhaps surprisingly to patients) even brick-and-mortar neighborhood pharmacies. For example, one of my colleagues suffers from AIDS and needs daily injections of a biologic drug for treatment. He purchased two different counterfeit versions of that drug from his regular pharmacy. More frightening: He did not recognize the counterfeits immediately and continued to inject them (they turned out to be female hormones). It took months of investigation for him to determine what the counterfeits contained and their potential effects on his health.
Online problems are just as bad. Unregulated, excessive active ingredients have killed children whose parents obtained those poisons from online sellers without a prescription.
Diverted drugs are often expired and unregulated. Some fakes contain heavy metals that have led directly to patient deaths. Such stories aren’t headline news, so average Americans don’t see the problem.
For biologics, the battle against counterfeits is growing. For the 2008–2009 review period, PSI found that 3.5% of all reported counterfeit drugs were biologics, compared with 1.23% for 2005–2006. With 3.7 billion US prescriptions written annually, and biologics representing the top drugs by expenditures provided to Medicare patients, the rapid rise in light of serious and unique threats posed by counterfeit biologics is of great present and future concern.
Because manufacturing biologics is a complex, exacting procedure, changes can affect effectiveness and safety profiles. Erythropoietin illustrates these difficulties. Despite cooperative licensing, in the European Union it caused life-threatening immune reactions whereas the US form did not. The problem was traced to a different rubber stopper on the vials. So the ability of counterfeiters to successfully create safe biologics is remote.
Counterfeit biologics are a challenging public health issue because they are extremely difficult to detect. Most often, biologics are administered as injections. They generally appear as clear or white liquids or powders. Many are administered as preventive measures (e.g., influenza vaccines) or for treating diseases that manifest no clinical changes after dosing (e.g., some cancer drugs). So counterfeiters can simply use tap water, knowing that fakes will not be detected for months — if ever.
There are more alarming statistics, more terrifying and tragic stories, and more examples of how counterfeiters are becoming increasingly sophisticated. Counterfeit medicines are a growing global public health threat that requires a coordinated response. PSM is working globally to raise awareness of this issue. Together, we can identify effective ways to join together and ensure that no patient ever has to bet his or her life on the safety of the drug supply.
Bryan A. Liang, MD, PhD, JD, is director of the San Diego Center for Patient Safety (University of California San Diego School of Medicine) and executive director of the Institute of Health Law Studies (California Western School of Law), 350 Cedar Street, San Diego, CA 92101; 1-619-515-1568; firstname.lastname@example.org. He also serves on the board of the Partnership for Safe Medicines (www.safemedicines.org).