Health Letter, March 2013
At first glance, the Internet may appear to be an attractive source for prescription drugs, and sales have continued to grow as more and more Americans fill their prescriptions online. The reasons for this trend may be understandable: Online pharmacies offer the prospect of convenience and reduced prices on prescription drugs. But these appealing promises may come at a price, as online pharmacies present a number of dangers to consumers. Many pharmacies use the Internet to skirt the law, and some customers are cajoled into taking risks shopping online that can lead to serious harm.
Any pharmacy can break regulations protecting consumers from dangerous drugs, but online pharmacies are far more likely to do so. In fact, a recent review by the National Association of Boards of Pharmacy (NABP) found that a staggering 97 percent of these websites violate pharmacy laws and practice standards. Prosecuting those that violate the law can be difficult, as online sellers of drugs may evade authorities by either concealing their location or moving it outside the U.S. Likewise, consumers who use these websites engage in a high-risk behavior, often knowing that some online pharmacies break laws but choosing to shop anyway.
Customers who shop online for drugs can reduce some of the risks by only visiting the very few websites that have been approved by trustworthy sources (see box below). Even after careful research, it may be difficult to guarantee that drugs purchased online are identical to the drugs being sold at the local pharmacy.
Flaunting safety laws
All pharmacies in the U.S. are regulated under a system of state and federal laws designed to ensure that the drugs they sell are safe, effective and appropriately labeled with instructions and warnings to prevent misuse and injury. Pharmacies must receive licenses from state boards, comply with safety standards, undergo inspections and obtain specialized training. Pharmacists cannot dispense prescription drugs without a valid prescription from a licensed health care professional, and they must take additional steps to prevent fraud or abuse when dispensing controlled substances.
With a few exceptions, pharmacies also must only sell drugs approved by the Food and Drug Administration (FDA) that are made in manufacturing facilities registered by that agency. The FDA inspects these facilities and imposes strict manufacturing and quality-control standards that require all makers of a given approved drug, brand name or generic, to ensure the same purity, potency (amount of active ingredient) and labeling. The FDA also routinely double-checks manufacturers’ quality-control practices by independently testing the products the agency approves. This system seems to be generally working: Fewer than 2 percent of products fail the FDA’s tests, and fewer than 0.1 percent fail the tests because they contain the wrong amount of active ingredient.
However, even some brick-and-mortar pharmacies break federal, state and local regulations. For example, a compounding pharmacy, a type of pharmacy specializing in individually tailored medicine, recently made headlines for manufacturing and distributing contaminated steroid injections that had not been approved by the FDA. These incidents are limited to a particular kind of pharmacy practice, however, and most traditional brick-and-mortar pharmacies abide by the applicable laws and sell FDA-approved products made by registered drug manufacturers.
In contrast, the vast majority of online pharmacies make evading the laws part of their business models by selling expensive, high-risk or addictive drugs without prescriptions and without complying with regulatory standards. These dangerous practices allow them to offer drugs at artificially low prices. When the NABP recently reviewed more than 10,000 online pharmacies, it found that 97 percent of these websites violate pharmacy laws and practice standards. Half offered drugs that were foreign or not FDA-approved, and approximately 87 percent did not require a valid prescription from a health care provider. Some online pharmacies pretend to offer medical services by asking patients to fill out a questionnaire prior to dispensing a prescription drug, a practice that is illegal and allows the website to collect confidential personal and health information about its customers.
Organizations that help mitigate consumer risk
It is hard to guarantee that drugs purchased online will be the same as those dispensed in your local pharmacy, but the websites of the following organizations can help you avoid the most serious risks if you choose to purchase drugs online.
National Association of Boards of Pharmacy (NABP)
The NABP’s Verified Internet Pharmacy Practice Sites (VIPPS) accreditation program works to ensure and consistently monitor, on an ongoing basis, the legitimacy of the few businesses it approves. For a list of VIPPS-accredited online pharmacies, visit www.nabp.net/programs/accreditation/vipps/find-a-vipps-online-pharmacy.
LegitScript is recommended by the NABP because it applies evaluation standards comparable to NABP’s standards. On its home page, LegitScript states that only .6 percent of the websites it monitors have been deemed legitimate.
Risky consumer behavior
Some consumers use websites in the same way they would use an ordinary brick-and-mortar pharmacy. They visit a doctor, obtain a diagnosis and a prescription to treat it, and place an order at a trusted website. People who engage in this type of online shopping can reduce their risks by taking steps to identify whether the website is operating legally and selling FDA-approved drugs (see box above).
Other online shopping behaviors are far riskier in that they involve websites that do not comply with state and federal laws; for example, they dispense drugs without a doctor’s prescription, or they sell a controlled substance without the usual safeguards. Online shoppers sometimes know or suspect that the websites operate in a legal gray area, but they choose to take the risk because they feel that the laws are expensive, unnecessary or overly restrictive.
Customers’ motivations for risky online shopping are reflected in the sales figures of the top illegal online retailers: Many illegal online pharmacy purchases are for drugs that are easy to abuse, such as painkillers, weight-loss drugs, sleeping pills or controlled substances. Others are for drugs that people may be reluctant to discuss with their doctor, such as male enhancement products or drugs to treat mental illness. A small but troubling number of illegal online pharmacy sales are for drugs to treat serious acute or chronic illness, such as HIV or other infections, diabetes, or heart disease. Cost — and lack of adequate health insurance — is probably the main factor driving some of these questionable website purchases.
Hidden health risks
Unfortunately, it is almost impossible for consumers to assess the risk of purchasing from an online pharmacy. Qualified federal and state regulators do not test the drugs dispensed from online pharmacies. Studies addressing the quality of these drugs have tended to use crude techniques designed to pick up blatant counterfeits but not to evaluate handling or labeling or to detect impurities, degraded products, potency issues or the potential for drug abuse.
In 2004, the U.S. General Accounting Office (GAO, now called the Government Accountability Office) ordered 68 samples of 11 different drugs from online pharmacies and tested them for authenticity, appropriate handling and labeling, and FDA approval status. The GAO found that 4 of the 68 samples, close to 6 percent, were either total counterfeits or had “significantly different chemical composition” than the product that had been ordered. The GAO also identified handling errors: Several samples of a drug requiring temperature-controlled handling arrived in envelopes without insulation.
The GAO report also showed that many drugs sold online did not have adequate instructions for use or safety warnings. For example, 2 out of 3 orders of isotretinoin (Accutane), obtained without a prescription, included no warning labels informing patients of serious safety risks. Accutane is a prescription acne medication that can cause severe side effects, including birth defects and serious mental disturbances leading to suicide among some users. The FDA requires doctors prescribing this drug to participate in a special program to help ensure that patients know about the risks, take appropriate birth control, avoid giving blood and have access to psychiatric help should side effects arise. Accutane is an expensive drug, and numerous websites tempt patients with low-cost versions that do not require a prescription.
When patients obtain a drug without a prescription, they also run the risk of taking an inappropriate dosage that will lead to side effects. This is particularly true with addictive drugs. A recent study compared those who obtained a prescription for their pain medication to those who purchased it on the web without a prescription. More than half of patients who bought their drugs online did so to obtain higher doses of the drug than their physicians would allow. That freedom came at a price: The online shoppers were significantly more likely to report severe side effects, including life-threatening seizures, than those who bought painkillers after obtaining a prescription from a doctor.
A final prominent risk for many online shoppers, especially those using sites that are not accredited, is getting scammed. Often the scam is simple: The ordered drugs never arrive. Yet the risk of a financial scam does not end when drugs are delivered. Illegal businesses may also be less careful with a customer’s private information, which can remain in databases for years and be vulnerable for use in future scams.
The FDA recently warned consumers of a scam by criminals who had obtained the records of hundreds of people who since 2008 had made purchases of drugs online or over the phone. The perpetrators were making phone calls pretending to be FDA agents, threatening prosecution and seeking bribes.
More such scams may be on the way. Leaked information has recently revealed several large-scale hacking incidents involving prominent online pharmacies GlavMed, SpamIt and RX-Promotion. Hackers broke into the sales databases of these companies and stole customers’ private information, potentially including credit card numbers, Social Security numbers, dates of birth and contact information. The hackers shared data from more than a million orders on various underground forums and file-sharing sites, and it remains to be seen how the data may be used for criminal purposes over the next several years.
Consumers can identify the very few legitimate online pharmacies by first visiting the websites of trustworthy groups that vet such businesses to identify the ones that comply with local laws (see box on page 7). One of the best is the NABP website, which accredits those online pharmacies that comply with U.S. laws and pharmacy-practice standards. The NABP requires an application and charges a fee for accreditation, and only a small fraction of online pharmacies have been accredited through this process. Consumers looking for more options also can visit www.LegitScript.com, which is recommended by the NABP because it applies similar standards in evaluating websites.
It remains risky to buy drugs from online pharmacies claiming to be based in Canada. Foreign businesses commonly pose as “Canadian” pharmacies while actually being based in other countries, and they dispense drugs manufactured in India or South America under dubious quality standards. Unfortunately, there is no legal, risk-free way to buy Canadian drugs, because the FDA has been reluctant to develop a legal framework for importing Canadian drugs into the U.S., despite pressures from consumers and members of Congress to encourage this type of competitive importation. Drug companies have worked to prevent such importation by lobbying to keep Canadian drugs out of U.S. markets and threatening to raise Canadian prices or stop selling to Canada if importation were to be legalized.
The laws preventing re-importation prevent the NABP and LegitScript from accrediting or verifying pharmacies located in Canada. However, the Canadian International Pharmacy Association, a trade association of Canadian pharmacies, does provide a list of certified websites that comply with Canadian drug safety laws. Although these drugs all meet Canadian standards — in some cases being identical copies of FDA-approved drugs — patients must still exercise caution when buying Canadian drugs, because there is no system to ensure bioequivalency with FDA-approved products. As a result, there will always be a risk that people who switch from an FDA-approved drug to a Canadian drug will not experience the same effects.
Ultimately, the Internet presents many tempting opportunities to shop for drugs that would be more expensive or harder to obtain through traditional channels. Yet these opportunities come with a hidden price tag, as unpredictable risks force some shoppers to pay more than they bargained for in terms of damage to their health and finances. You can reduce these risks by going to your doctor for a prescription and shopping only at the websites that have been verified by a trustworthy source. Ultimately, however, the surest and simplest way to buy safe, quality drugs is to shop at your local pharmacy.