By: Jim Dahl, Board Member, Partnership for Safe Medicines (PSM)
Almost since there were HIV/AIDS treatments, unlicensed distributors have been selling dangerous black market medications to American pharmacies, unscrupulous secondary wholesale distributors, and patients. Since 2006 at least 86 individuals have been charged with distributing HIV and AIDS medicines in the United States. These cases are just the tip of the iceberg.
The United States has the safest drug supply in the world. The FDA and licensing programs in individual states ensure that every entity in the American drug supply chain is answerable to a regulator. Companies that sell drugs outside of the FDA-approved drug supply are not accountable to the FDA, state licensing boards or anyone. Counterfeiters substitute cheap ingredients, offer medicines in unfamiliar doses and omit instructions and safety warnings. Their medicine may contain harmful chemicals or contaminants; it may contain no active ingredients at all. Counterfeiters are canny marketers. Their websites are very convincing, but they sell medicines that may be expired, contaminated, diluted or damaged during shipping. Patients who buy these drugs risk taking substandard medicines, and substandard medicines lead to higher viral loads, poor health and drug resistance, even if patients are conscientious about their drug regimen.
These aren't hypothetical risks.
In 2000, university professor Rick Roberts learned that the Serostim he had been taking to treat HIV wasting syndrome was counterfeit. The fake Serostim had made its way to his pharmacy via unlicensed distributors that had forged documentation to make it look legitimate. Roberts eventually recovered his health, but one child—a brain cancer survivor—suffered developmental and growth delays after being treated with another growth hormone being sold by these groups.
Since 2012, investigators have uncovered diversion of HIV/AIDS medicines on a massive scale. Customers of New York branches of MOMS Pharmacy were prescribed $274 million in second hand, stolen or expired HIV treatments. The FBI seized more than 33,000 bottles of second hand AIDS, asthma and schizophrenia drugs and 250,000 loose pills from drug diverters in New York. A Texas-based company called Cumberland Distribution sold $58 million in HIV/AIDS, antipsychotics and diabetes treatments to pharmacies. Their sources had acquired the drugs from “street level drug diverters.”
In late 2005 after just retiring as Assistant Director of FDA’s Office of Criminal Investigation (OCI), I testified before a House Subcommittee that in my time at the agency I hadn’t seen a counterfeit drug get into the otherwise legitimate supply chain without the aid of a pre-existing diversion infrastructure. I’m confident the same can be said today. Diverted drugs are not only unreliable but drug diversion poses an additional risk. Addicts who resell their medication are often selling vials they have already used. It is standard practice to take a dose of an IV drug and replace the missing contents with water using the same syringe. As many as 30,000 have been exposed to hepatitis C as a result of diversion in hospital settings since 2004; who knows what the exposure rate has been from black market injectables?
In the face of this threat, we must give patients the tools to be safe.
Patients need strategies to save money safely. Counsel them to adopt generics when they are appropriate. Let them know that they can comparison shop online for the lowest prices for safe, licensed online pharmacies at Pharmahelper.com and compare prices at their neighborhood pharmacies on websites such as WeRx.com, LowestMeds.com and GoodRX.com. If they are un- or under-insured, be sure they know about cards like the NeedyMeds Drug Discount Card, and direct them to prescription assistance program resources at NeedyMeds and the Partnership for Prescription Assistance.
Patients need to know how to spot questionable drugs. In medical settings, they should examine drug packaging to verify that it is in good condition and that its labeling is accurate and in English, and keep a record of the medicine lot number. At home, they should verify that their medicine's packaging is clean and correctly sealed, with instructions in English, and that new medication has the same packaging as past medication, with no differences in paper, printing, color or fonts. Patients should also examine the appearance of medicine; if it looks chipped or cracked, or different from earlier prescriptions, it may be fake.
Finally, patients and medical professionals should be alert to the possibility that a patient's treatment may not be working because the medication itself is compromised. Changes to the way a medicine tastes, new side effects or adverse effects and failure of treatment might signal changes to a drug.
If there's any question about whether a drug is counterfeit, patients should contact the pharmacy where they purchased their medicine. Patients and medical professionals can contact the FDA and the manufacturer of the medication to report concerns. The FDA can be contacted by calling toll-free 1-800-FDA-1088 (800-332-1088), or on the Web at www.fda.gov/medwatch.