by Georgina Lee, PharmD 2011
How many times have you heard, “Drugs are too expensive in the U.S., just buy them from Canada!” Nowadays, all you have to do is Google “Canadian medications” and you’ll have access to over a million online pharmacies at your fingertips. Yet, how many of them are legitimate (and not located in a dilapidated one-bedroom cabin in a remote part of northern Canada)? Not only are the same medications you’d find in America available, they are also much cheaper, especially for those without insurance (such as the 15 million unemployed people out there). The question remains, however: Do we really know how reliable these online pharmacies are? Do we know where and how they are getting their medications?
Who regulates these drugs?
In 2005, a U.S. Food and Drug Administration (FDA) operation called “Operation Bait and Switch” revealed that almost 50% of imported drugs shipped from “Canadian” pharmacies were actually from four other countries – India, Israel, Costa Rica, and Vanuatu (an island northeast of Australia in case you were curious). The report also noted that of the drugs being promoted as “Canadian,” 85% actually came from 27 other countries and a number of them were found to be counterfeit (hmm…those look a lot like LifeSavers to us). The FDA is currently working closely with the Canadian Drug Regulatory and Law Enforcement authorities to take appropriate action in order to keep these counterfeit products out of the U.S. and to pursue legal action against those responsible (sounds serious, doesn’t it?).
What should I know about buying my drugs outside of the U.S.?
Unfortunately, the FDA cannot guarantee the safety and effectiveness of any medications that are purchased outside the U.S. Therefore, here are some issues to keep in mind (courtesy of the FDA) before you click the “Add to cart” button at your favorite online pharmacy:
- Quality assurance concerns – Medicines that have not been approved for sale in the U.S. may not have been manufactured under quality assurance procedures designed to produce a safe and effective product. By quality assurance, we mean a laundry list of hefty standards enforced by various government agencies such as the Institute Review Board (IRB), the FDA, and the U.S. Pharmacopeia.
- Counterfeit potential – Some imported medicines may bear the name of a U.S. approved product but may be fake versions that are unsafe or ineffective (you may be taking jelly beans instead of an antibiotic or a hallucinogen instead of an allergy medication).
- Presence of untested substances – Some drugs may already be legal in other countries but may not have been evaluated for safety or effectiveness in the U.S. All approved drugs in the U.S. undergo extensive clinical trials in order to be considered safe and effective (on average, it takes a drug about 7 years to be approved!). As a result, they may possess addictive or other dangerous ingredients that you, as the consumer, may not be aware of and would prohibit the FDA from approving them for use in the United States. Keep this in mind before you accidentally send grandma on a medication-induced hallucinogenic roller coaster to save a few dollars.
- Risks of unsupervised use – Some medicines are unsafe when taken without proper medical supervision, especially when frequent lab tests and physical evaluations are required (Warfarin and Lithium are excellent examples). Also, it can be difficult to report and treat a side effect of a medication you purchased internationally because of the unknown origin and composition of the drug.
- Labeling and language issues – If someone doesn’t understand the directions and side effects written on the medication’s label, it can put the patient using it in harm’s way (and unfortunately Google is not a suitable substitute for a healthcare professional’s advice). This is why your pharmacist always explains how to use your medication when you pick up your prescription.
Lack of information – An imported medicine may not have sufficient information about the drug on their label (which is required for approved products in the U.S.). The FDA works with the manufacturer to ensure that all important and relevant information is placed on the label for both the consumer and the health care professional.
Ok this all sounds very dandy, but how serious is this issue?
According to the Food, Drug, and Cosmetic Act, all drugs must be approved by the FDA before they can be marketed to the public in the U.S. This means that these drug approvals have to be manufacturer-specific, product-specific and have to be made in FDA-inspected facilities (so you know you’re not getting drugs from Uncle Bob’s garage). While investigating drugs imported from Canada, an FDA laboratory analysis of generic medications all showed failing marks in terms of potency, dissolution (how well it dissolves), and impurities in three of the most commonly ordered drugs:
- Lipitor (cholesterol-lowering agent)
- Viagra (primarily used for erectile dysfunction)
Ambien (used for insomnia)
In addition, a survey conducted in 2006-2007 from an International Mail Facility (IMF) demonstrated that many purchases of foreign drug appear to offer little or no savings to the consumer. The survey revealed that 55% of foreign drugs had FDA approved generics or OTC versions available in the U.S. In addition, 47% of drugs purchased internationally were available in the U.S. through national retail chain programs that offered $4 co-pays for a month supply of generic drugs. Some examples of the drugs from the IMF survey included:
- Warfarin (a blood thinner that requires careful monitoring of your blood clotting capabilities)
- Amoxicillin (an antibiotic whose misuse can cause drug resistance)
- Dipyrone (an analgesic removed from the U.S. market in 1977 due to adverse events)
Methotrexate (an anti-inflammatory and cancer drug that requires careful monitoring for potential serious toxicities)
Many foreign brand names may be the same or similar to U.S. brand names but contain a different active ingredient. Several hundred foreign brand names are so similar to U.S. brand names that they are not allowed in the U.S. because they contain different active ingredients and are commonly confused with their similarly named counterpart. For example, Flomax is the brand name for the medication tamsulosin in the U.S. and is used to treat benign prostate hypertrophy (BPH). In Italy, Flomax is the brand name for momiflumate, which is indicated for pain and inflammation. Starting to see the problem?
Your Take Home Message: How can you avoid ordering counterfeit drugs?
Logic has it that the main reasons consumers order drugs from other countries is to lower costs and gain easy access. Who doesn’t want to save money? Keep in mind, however, that there are really only a handful of legitimate online pharmacies that order their drugs from licensed wholesalers in the U.S. This means that the rest of the online pharmacies are getting their drugs from undocumented sources and unverified personnel! Scary stuff. Before they lure you in with their enticing prices and flashy website, talk with your health care provider to see if the medications you need come in generic form. Not only are generics proven to be bioequivalent (meaning they contain the same amount of active ingredient as the brand), they are also significantly cheaper. WalMart, Target, Walgreens and a number of local supermarkets offer a month’s supply of any generic medication for $4. Pretty amazing stuff (and hard to beat in terms of cost). In addition, many pharmaceutical companies offer a Patient Assistance Program, which enables consumers with financial difficulty to access their brand name medications at discounted prices (to learn more go to http://www.rxassist.org). There is also a push to increase the number of US-based online pharmacies offering certified prescriptions, some of which also offer online physician consultations included with your prescription for basic medications. KwikMed, based in Salt Lake City, Utah, is the only company granted regulatory approval to prescribe FDA-approved and domestically manufactured medications online. Lastly, the FDA MedWatch program allows you to report adverse events associated with a medication or unlawful sales of medical products your stumble across on the internet. MedWatch is a voluntary report that is available to the public and can be accessed online or via telephone (not to mention that it is free and confidential). For more information, refer to the FDA website at www.fda.gov. As always, don’t start any medication without consulting a healthcare provider, especially if you’re buying the medication online. Google is no substitute for professional medical advice and if the deal is too good to be true, it probably is.
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