What does the data actually show about the safety of buying medication online? Is it really dangerous to buy lower cost medication from a pharmacy in another country over the Internet? Do drug companies fund research in this area?
This week, in our continuing quest to get the truth out and for our elected leaders in Congress to take bold action to protect online access to safe and affordable medication, we’re publishing the next section of our report called Online Pharmacies, Personal Drug Importation, and Public Health…
Research and Data about Online Pharmacy Safety
There are only two peer-reviewed studies of foreign and domestic online pharmacies that test drug and online pharmacy safety by comparing those that are members of online pharmacy credentialing programs with others. Their combined findings are published by the B.E Journal of Economic Analysis and Policy in an article called “In Whom We Trust: The Role of Certification Agencies In Online Drug Markets” [“BEJEAP Study”]. Its lead author is Roger Bate, an economist and expert on counterfeit drugs with the American Enterprise Institute. The studies strongly indicate that credentialed international online pharmacies are equally as safe as domestic ones: the results showed that they only sell genuine medication, as well as require valid prescriptions.
In the BEJEAP study, through ‘mystery shopping’ – meaning posing as a consumer making actual purchases from domestic and international online pharmacies – and testing the prescription drugs ordered using a Raman Spectrometer, the authors found that all credentialed U.S. and international online pharmacies sell genuine and safe medication and require prescriptions. In contrast, some non-credentialed sites sent counterfeit drugs and/or did not require a prescription. The credentialing programs tested were those operated by NABP, LegitScript, PharmacyChecker.com and the Canadian International Pharmacy Association (CIPA). The study classified U.S. online pharmacies with approval by NABP and/or LegitScript as tier 1 sites (8 online pharmacies); non-U.S. online pharmacies with approval by PharmacyChecker.com and/or CIPA as tier 2 sites (22 online pharmacies, all approved by PharmacyChecker.com; 12 of the 22 approved by CIPA); and non-credentialed online pharmacies as tier 3 sites (49 online pharmacies).
Three hundred and seventy-eight orders of five medications were purchased from credentialed and non-credentialed online pharmacies. All medications ordered from credentialed online pharmacies, foreign and domestic, were genuine and dispensed pursuant to a valid prescription. Many orders from non-credentialed online pharmacies did not require a valid prescription; however, surprisingly, all products from non-credentialed sites were genuine, too, except Viagra, in which case 23% were not genuine and some contained dangerous ingredients.
The 22 international online pharmacies (tier 2 websites) shown to operate safely in the BEJEAP study – those verified by PharmacyChecker.com – are designated as “unapproved” by LegitScript and “rogue” by NABP.1 The authors of the BEJEAP study concluded: “If some foreign websites sell safe prescription drugs with substantial price discounts but American consumers are guided to buy from U.S. websites only, the FDA could potentially discourage price competition between U.S. and foreign pharmacies and therefore reduce drug affordability within the U.S.” A corollary conclusion is that by discouraging Americans never to use credentialed international online pharmacies, the FDA increases incidents of cost-related prescription non-adherence when U.S. pharmacy prices are the barrier to access.
The BEJEAP report’s data was not mentioned in the GAO report and its lead author, Mr. Bate, was not consulted, despite his well-known expertise in this area. Mr. Bate published a book on counterfeit and substandard pharmaceuticals called “Phake: The Deadly World of Falsified and Substandard Medicines”. He has consulted the FDA on drug safety, including directly with FDA Commissioner Margaret Hamburg and FDA is aware of Mr. Bate’s online pharmacy research.
The lead author of the GAO report participated with Mr. Bate in a series of expert panels organized by the Pew Charitable Trusts Drug Safety Project. Mr. Bate articulated his findings about online pharmacies for the Pew project, specifically noting that pharmacy websites approved by NABP and PharmacyChecker.com, including foreign pharmacies sent only genuine medications.
Unlike GAO’s recent report, the 2004 report by GAO also tested products and prescription requirements of online pharmacies. In “Internet Pharmacies: Some Pose Safety Risks for Consumers and are Unreliable in Their Business Practices,” the GAO found that Canadian online pharmacies all required a prescription, included proper pharmacy labeling and sold genuine medication. One of that report’s authors was Marcia Crosse.
In its 2013 report, the GAO appears to criticize state drug importation programs that, despite FDA warnings that “the agency could not ensure the safety of drugs not approved for sale in the United States,” contributed “to a perception among U.S. consumers that they can readily save money and obtain safe prescription drugs by purchasing them from Canada.” In this section the GAO seems to indicate that Americans are not able to obtain more affordable and safe medication from Canada when GAO’s own data from 2004, which was derived from mystery shopping and independent analysis, concludes that Americans can and do save money safely when purchasing medication online from Canada. Ironically, it’s reasonable to assume that state drug importation programs were pursued in earnest based on findings similar to those of the earlier GAO report or even the actual GAO report itself.
In contrast to the aforementioned peer-reviewed studies and the earlier GAO report, other studies about purchasing medication from online pharmacies focus only on rogue websites, such as those selling prescription drugs without requiring valid prescriptions and/or that don’t publish contact information. Not surprisingly, such studies conclude that rogue online pharmacies are dangerous. Those studies may help to understand and demonstrate the dangers presented by Internet drug sales, but do not help in determining which online pharmacies are safe and a clear benefit to consumers.
One such study is called “Internet-Ordered Viagra (Sildenafil Citrate) Is Rarely Genuine.” The study is financed and conducted by drug company Pfizer. None of the websites Pfizer assessed required consumers to submit a valid prescription based on a physical exam (but two did require online or “remote” consultations, which is legal in some states). Not surprisingly, the prescription requirement assessment concluded that no websites required a valid prescription, meaning based on a physical exam. The costs per pill were between $3.28 and $33.00. The products were shipped from Hong Kong (11 sites), United States (6 sites), United Kingdom (2 sites), Canada (1 site), China (1 site), and India (1 site). Seventy-seven percent of the products received were counterfeit; 18% authentic; 5% foreign generics (generic version approved in another country) that are not approved in the U.S.
The Pfizer study concludes “Internet sites claiming to sell authentic Viagra shipped counterfeit medication 77% of the time; counterfeits usually came from non-U.S. addresses and had 30%-50% of the labeled API [active pharmaceutical ingredients] claim. Caution is warranted when purchasing Viagra via the Internet.” While most of these sites were foreign-based, none were credentialed or required a prescription based on an in-person consultation with a licensed prescriber. The incidence of counterfeits received in Pfizer’s study appears very high, even compared to other studies that procure medications from non-credentialed online pharmacies. This research, and other studies like it, shows there are many rogue online pharmacies that sell counterfeit Viagra, but it does not negate the existence of safe international online pharmacies.
Prescription Drug Abuse; Controlled Drugs and the Internet
As reported above, the most severe reports of adverse health outcomes associated with the use of online pharmacies relate to orders placed on foreign and domestic rogue pharmacy websites that sell controlled drugs without a valid prescription. Safe and properly credentialed international online pharmacies do not sell controlled drugs into the U.S. at all, even pursuant to a prescription, and cannot be considered a cause of prescription drug abuse. To highlight this point, Senator Charles E. Schumer (D-NY) made the distinction clear in discussing a bill introduced in 2006 to combat rogue pharmacy sites selling prescription narcotics: “The bill is geared to domestic Internet pharmacies that sell drugs without a valid prescription, not international pharmacies that sell drugs at a low cost to individuals who have a valid prescription from their U.S. doctors.”
According to the DEA, the Internet is a very minor source of illegally distributed controlled prescription narcotics and it informed GAO authors that online pharmacies are a low agency priority. The DEA told GAO that the Ryan Haight Act was successful at deterring illegal sales of controlled drugs over the Internet. The GAO report appears to take issue with DEA’s position by citing data from the DEA as evidence that the Internet is a big threat for illegal and dangerous sales of controlled drugs. GAO identified that DEA mystery shopped 10 Internet pharmacies that offered controlled drugs and was able to obtain them without a valid prescription in four out of 10 instances. A selection of only 10 websites that offer to sell controlled drugs without a prescription shows the existence of a problem, but it is insufficient to determine the scope of that problem.
Meanwhile, the GAO report omits any mention of the main source of data on which DEA bases its view that the Internet is an exceedingly minor part of the prescription drug abuse problem. The source is the most extensive survey data relating to the nation’s prescription abuse problem administered by the Substance Abuse and Mental Health Services Administration (SAMHSA), a part of the Department of Health and Human Services. Its data shows that .2% of illegal prescription narcotic purchases are made online. This is a decrease from .4% in 2010.
This author agrees that the Internet remains a threat to people who might seek to obtain controlled drugs online without a valid prescription and the DEA and FDA should remain vigilant. However, future legislation that may address the sale of controlled prescription drugs over the Internet should conspicuously avoid provisions that may affect access to or delegitimize safe international online pharmacies.
Fake Canadian Online Pharmacies
The GAO report correctly identifies the problem of rogue online pharmacies purporting to be Canadian, “when they are actually located elsewhere or selling drugs sourced from other countries.” Many rogue pharmacy sites include pictures of the Canadian flag, use the word Canada, publish logos and graphics associated with Canada, such as the maple leaf, and even display fake pharmacy licenses with photographs of a fake bricks-and-mortar location. Many such sites are not based in Canada. They are often based in Russia and Eastern European countries and sometimes have ties to organized crime.
In contrast, there are credentialed international online pharmacies, based in Canada, that fill orders through pharmacies in other countries that are not fake Canadian online pharmacies. For example, the oldest and most safe Canadian online pharmacies are actually based in Canada and operate Canadian pharmacies. However, their prescription services have become more global over the past decade by forming prescription fulfillment arrangements with licensed pharmacies in many other countries. Some Canadian pharmacies made these changes because pharmaceutical companies cut off their supplies in an attempt to stop their sales of lower priced medication to Americans. The drug quality tests conducted in the BEJEAP study included prescription drugs ordered from credentialed Canadian online pharmacies that were filled by partner pharmacies in several countries, including Australia, India, New Zealand, Turkey and the United Kingdom.
As presented in this report, the safe international online pharmacies are relatively equal in safety to domestic pharmacies. The fact that the medications are dispensed from pharmacies in several countries does not show lack of safety. After all, the pharmaceuticals sold on U.S. pharmacy shelves are manufactured in about 150 countries. When “American” medications are purchased from Walgreens, CVS, or other U.S. pharmacies, in-store or online, about 80% of the active pharmaceutical ingredients in those medications are foreign; about 40% of the finished medicine products are imported, and about 34% of the medications come from India.
Are Most “Rogue” Online Pharmacies Really Foreign?
Potentially, the majority of rogue online pharmacies are domestic, yet the GAO report asserts that most rogue online pharmacies “operate from abroad.” According to the NABP, of the over 10,181 sites that it calls “rogue”:
- 23% have a physical address located outside of the U.S. (though most rogue sites do not post any address)
- 88% do not require a valid prescription
- 60% issue prescriptions per online consultation or questionnaire only
- 49% offer foreign or non-Food and Drug Administration (FDA-) approved drugs
- 16% do not have secure sites
- 41% have server locations in foreign countries
- 12% dispense controlled substances
If 49% of rogue online pharmacies are offering foreign or non-FDA approved drugs then it appears that over half (51%) are selling FDA-approved drugs, which indicates they are based in the U.S. Forty-one percent have server locations in foreign countries, which indicates a clear majority locate their servers in the U.S. Overemphasizing the threat of foreign versus domestic online pharmacies can lead to a misappropriation of resources that does not best serve the public health. For example, as we’ve identified above, some online pharmacies sell safe and effective medications even when those medications, often due to their packaging, are not technically approved by the FDA. A clear cut example of a safe “foreign” online pharmacy is a licensed Canadian pharmacy selling medication online that requires a prescription from, and does not sell controlled drugs to, Americans. It is not a threat to the public health. In contrast, a U.S.-based website that only sells FDA-approved controlled drugs without requiring a valid prescription is very dangerous. As mentioned in this report, most reported deaths are attributed to online domestic pharmacies selling controlled drugs.