June 16, 2016 at 5:00 am ET
Counterfeit drugs entering the U.S. from alleged Canadian online pharmacies pose a significant threat to the safety of American patients and to the integrity of the U.S. prescription drug supply.
How do I know? I’m a pharmacist, and I see it first-hand in Maine.
In the fall of 2013, Maine began a public health experiment. Maine was the first state to pass a prescription drug importation law (LD 171, Public Law chapter 373) which circumvented the federal drug-supply regulations and authorized retail pharmacies in Canada, the United Kingdom, Australia or New Zealand to export prescription drugs to residents of Maine. This state law was passed despite the FDA’s findings that up to 69 percent of prescription drugs in mail shipments from foreign countries are substandard and warnings that sites claiming to be Canadian or distribute Canadian-manufactured medications could be part of organized criminal networks.
Despite these risks, LD-171 also offered no recourse or protections for the patients. So if the patient used one of these online pharmacies and received counterfeit medications and was injured or died as a result, there was no legal recourse or protection for that patient or their family here in the U.S.
Soon after Maine’s new prescription drug importation ordinance took effect, an investigative journalist at the CBS news affiliate in Portland, Maine, contacted me to inquire if a prescription drug they had ordered from an online “Canadian pharmacy” could be analyzed. The journalist ordered a generic of Viagra 50 mg. The parcel he received contained a product labeled “Fildena Sildenafil Citrate Tablets 50 mg”. The laboratory analysis verified that the tablet in fact contained Sildenafil Citrate, the active ingredient of Viagra; however, a quantitative analysis measured only 7 mg of active ingredient rather than the 50 mg labeled strength.
One may argue, “What’s the harm if a generic prescription drug for erectile dysfunction only contains 7 mg rather than 50 mg?” But, think about the big picture. What if this had been a prescription medication to prevent harmful blood clots? Or, imagine your loved one having a heart attack and the emergency room personnel assumes the Plavix he or she is taking is legitimate, when in fact it is a counterfeit drug of the wrong dosage with contaminants and other active ingredients. Counterfeiters have gotten very good at making their drugs look, on the outside, exactly like what’s FDA-approved here in the States. In fact, these drugs don’t have the proper level of active ingredients, and some have been found to have carcinogens in them.
Regardless of the medical indication, substandard prescription drugs are unacceptable because they cause harm, and they’re not what your doctor prescribed for you. Compelled by these results, I decided to investigate further. I contacted another purported Canadian pharmacy that had advertised services in the Portland Press Herald newspaper in November of 2013 (which I cannot name publicly for fear of legal action).
Despite the false Canadian certifications prominently displayed on their website, I was to learn that the company does not provide services to Canadians, but only mail prescriptions to Americans. Further inspection of the client agreement, which I had to sign before the medications would be dispensed, revealed they were not actually a licensed Canadian pharmacy. The client agreement also forced me to waive any liability for “…claim, loss, damage or expense of any kind or nature caused directly or indirectly by any inadequacy, deficiency or unsuitability of any prescription…”
I ordered three prescription drugs from this online retailer, generics of Plavix, Nexium, and Celebrex. I received a parcel in the mail which contained “Clopivas-75”, “Izra-20” and “Cobix-200”, respectively. None of the products received in the four tests conducted (Fildena, Clopivas-75, Izra-20, Cobix-200) are actually approved for use in Canada, therefore nullifying the argument that opening the U.S. to importation from only select countries would provide any protection from drugs manufactured anywhere across the globe.
In short, we cannot simply open our borders to importation from one or a few select countries. The reality is that we would be opening ourselves up to foreign companies that are not licensed, established solely to supply Americans by mail, and exporting medications that have not been approved here or in the countries in which they supposedly reside.
In 2013, the Maine Pharmacy Association (MPA) along with other co-plaintiffs filed a lawsuit to overturn Maine’s prescription drug importation law on the grounds that it violated federal laws which were established to protect the public from substandard, counterfeit, and adulterated medications. In February of 2015, Maine’s federal court ruled in favor of MPA’s case against the state of Maine (Ouellette, et al vs Mills) regarding the importation of medications from foreign countries. We believe that the court ruled correctly. All along, MPA warned that Maine’s law was unconstitutional and put the safety of Maine people at risk.
Around the time that the Maine drug importation law was passed, I sat down with a 73-year-old woman (whom I’ll refer to as “Judy”) to review all of her medications. She relied on a dozen prescription medications in addition to over-the-counters and vitamins. She was concerned about having to pay the full cost of her prescription meds if she reached the “donut-hole” on her Medicare plan and was considering ordering from a Canadian pharmacy.
I cautioned her that ordering prescription drugs from these websites puts her at risk and assured her that this was not the only recourse she had to solve this problem. Working with her doctor, we were able to discontinue two of her medications; one medication that was a duplication and another that was no longer indicated. We verified that her current medications were being filled with the least expensive generic option. I also offered to help her during the Medicare Part D re-enrollment to select a plan with the least out-of-pocket expense (deductible, copayments, and donut-hole).
Judy is not the only patient with additional options. There are many safe, affordable alternatives available to patients. For example, the Partnership for Prescription Assistance (PPA) offers a single point of access to more than 475 public and private patient assistance programs, including more than 200 programs offered by pharmaceutical companies, to qualifying patients who lack prescription coverage. Since the launch of the PPA in 2005, American biopharmaceutical companies have helped millions of patients fill their prescriptions.
There are several potential ways consumers can save including generic medicines, shopping around to various pharmacies to get the best deal, state prescription assistance programs, and enrollment in the Medicare prescription drug program, for those who qualify.
While consumers assume they get a better deal by ordering their drugs online from another country, evidence suggests otherwise in many cases. The FDA has found that nearly 45 percent of the drugs that consumers buy online have generic versions that are available in the U.S., and about 50 percent of these generic drugs are available through national pharmacy chain programs that offer generic prescriptions at a cost of $4 each. This is significantly less than the cost of drugs charged by internet “pharmacies”.
We’ve had a safe, secure drug supply system in the U.S. for so long, that patients who order their prescriptions online may never stop to think about the trustworthiness of the source of those medications. There are several things national and state policymakers must consider.
Legislators and healthcare providers must broaden the definition of medication reconciliation to include asking patients where they have their prescriptions filled, and whether or not those medications are FDA approved. We must educate members of the healthcare team on this issue, and the risks and threats to patients if the source of their medication is outside the U.S. Everyone involved in patient care needs to ask about the source and origin of all medications a patient takes.
We need to ensure state laws and regulations are in alignment with the federal Drug Security Act. We need to ensure that this federal “track and trace” law put into place a few years ago can be implemented and enforced at the state as well as federal level.
In the meantime, my colleagues and I in Maine will continue to do all that we can to help each patient find safe and affordable medication options and to promote public health policy that first and foremost ensures patient safety.
Kenneth McCall BSPharm, PharmD, RPh is a pharmacist and the immediate past president of the Maine Pharmacy Association.