Researchers report that half of the online pharmacies are rogue operations that may operate without a license or have other serious shortcomings.
The high cost of chemotherapy drugs is leading some leukemia patients to buy medications online from rogue web sites, a new study found.
Gleevec (imatinib), the first-line treatment option for chronic myeloid leukemia (CML), is cost-prohibitive for many patients because it needs to be taken indefinitely, wrote co-author Sachiko Ozawa, Ph.D., M.H.S., an associate professor at the University of North Carolina Eshelman School of Pharmacy in the Journal of the National Comprehensive Cancer Network.
While generic imatinib was approved in the US in 2016 and lowered average retail prices by 30%, patient assistance programs from pharmaceutical manufacturers have declined in response to the availability of generics, according to Ozawa and colleagues. That increased out-of-pocket payments for some U.S. patients taking generic imatinib; many pay as much as $700 monthly at brick-and-mortar pharmacies.
As a result, more CML patients are turning to online pharmacies. The authors of this study say that the vast majority (96%) of online pharmacies failed to adhere to US legal standards, the author.
“Online access to treatment for CML is a significant concern if medicines are dispensed without a prescription or proper clinical oversight,” Ozawa wrote. “With imatinib, contact with a medical team is critical because patients must be frequently monitored for treatment response and must receive medication adjustments as necessary.”
Gleevec requires an adherence rate greater than 85% to 90% to achieve optimal clinical outcomes, but patients with higher copayments have been found to be more likely to discontinue or be nonadherent to drugs in the tyrosine kinase inhibitor class.
In their survey of online pharmacies that sell imatinib, only 3 of the 44 identified English-language sites that shipped within the U.S. were certified through the LegitScript online pharmacy monitoring service, according to a news release about this study. Half (52%)were classified as “rogue” pharmacies that might operate without a license, sell counterfeit or expired products, stealpayment information, or reject important safety precautions, such as requiring a prescription for potentially hazardous medications, the researchers found.
Notably, 13 of the online pharmacies sold Gleevec without a prescription, and more than three-quarters did not offer a way for patients to speak with a pharmacist, according to Ozawa.
“This is a significant concern for patient safety,” Ozawa said. “We were struck by just how easy it is to buy an oral chemotherapy medication online, as imatinib is not a benign drug.”
“Taking imatinib requires monitoring and frequent dosage adjustments. Even if an online pharmacy provides the medication as ordered, “patients bypassing provider interactions are likely to face much greater risks of nonadherence, discontinuation, treatment failures, and adverse events,” Ozawa added.
In addition, rogue or unclassified pharmacies may not be providing patients with the real medication, and could be stealing patients’ medical or payment information, according to the authors.
Unfortunately, the rogue sites are difficult to regulate, as they often originate abroad. “We also found it deceiving how well some illegitimate websites mimic legitimate sites,” Ozawa said.
“The exorbitant price of oncology drugs is a major barrier to optimal therapy of many malignancies, including CML,” said Bernard Marini, Pharm.D., B.C.O.P., a clinical pharmacist specialist at Michigan Medicine who treats patients with leukemias and other hematologic malignancies but was not involved in the research. “…The problem has become so bad that there is a major illegitimate online marketplace for generic oral oncology drugs. Healthcare providers need to be aware that many of these rogue and unapproved pharmacies do not even require a prescription or have access to pharmacist consultations, putting patients at high risk for adverse drug events.”
The study reminds healthcare professionals about “the need to fully recognize the dangers of illegitimate online pharmacies and ensure our patients have appropriate financial support when prescribing high-cost medications,” Marini added.
Patients should be encouraged to speak with their pharmacist, financial counselor, or other members of their healthcare team if they can’t afford their medications, added study co-author Benyam Muluneh, Pharm.D., B.C.O.P., assistant professor at the University of North Carolina Eshelman School of Pharmacy.
“Cancer drugs are very expensive; however, there are some resources such as third party foundation grants that may be able to help. If a medication is not affordable through regular channels, patients could also discuss alternative medication options with their providers rather than look for discounts online,” Muluneh said.