Articles

Online Pharmacies: Are They Safe?

By Rita H. Boone, R.Ph., J.D.

Purchasing goods and services on-line has become a way of life for many consumers around the world. Increasingly, the relationship between physicians, patients, and pharmacists is being conducted on the internet. The reasons most often cited for the increasing use of online pharmacies are cost, convenience, and privacy. The privacy issue is implicated with prescriptions for the so-called "lifestyle drugs" such as Viagra for erectile dysfunction, Propecia for hair loss and Xenical (now available OTC in a lower dose) for weight loss. The convenience issue resonates most with the elderly and with persons in remote areas who can avoid the inconvenience of traveling to a store to purchase medications. The cost issue may be most significant for the under-insured or the uninsured that cannot afford to buy their prescriptions drugs in the United States and, therefore, may use the internet as an alternative source to find drugs in other countries where the cost is often lower. The Canadian Drugstore, for instance, advertises that "it brings Canadian drug prices to consumers around the world at a savings of up to 50%".

Monitoring online domestic and foreign pharmacies has been a persistent source of concern regarding illegal sale of drugs. The concerns in question relate to the sale of medications that are fake (counterfeit or "copycat" medicines), that are too strong or too weak, that contain dangerous ingredients, that are expired (out-of-date), that are not approved for safety and effectiveness, that are not made using safe chemicals, that have not been made using safe standards, or that are not safe to use with other medicines, or that are not labeled, stored, or shipped correctly.

Traditional regulation of drug sales falls to individual states. Internet technology, due to its interstate and international nature, requires the federal government to take on a more active role in regulating the practice of online pharmacy. Both the Food and Drug Administration ("FDA") and the Federal Trade Commission ("FTC") have oversight functions. The FDA enforces laws related to importation, sale, or distribution of adulterated, misbranded, or unapproved drugs. Additionally, the FDA regulates illegal promotion of drugs, the sale or dispensing of prescription drugs without a valid prescription, and counterfeit drugs. The FTC enforces consumer protection laws regarding unfair or deceptive acts such as websites that make false or misleading claims about the products or services it provides, including medical consultation in connection with prescribing and dispensing of a drug.

There are two (2) types of online pharmacies: those that dispense drugs and those that prescribe and dispense drugs. Those that dispense drugs usually require the following:

1. Users open an account with the pharmacy, submitting credit and insurance information.
   
2. The pharmacy is licensed to sell prescription drugs by the state in which it operates and in those states to which it sells, if an out-of-state license is required.
   
3. After establishing an account, users must submit a valid prescription. Doctors either fax or mail the prescription to the pharmacy. This authenticates the existence of the physician-patient relationship. The pharmacy then verifies each prescription before dispensing the medication and a written verification policy is usually posted on the site.
   
4. Sites typically have a mechanism for users to ask questions of the pharmacist, either through email or a toll free number.
   
5. Finally, the medication is delivered within 3 days with no shipping charge or overnight for an extra fee.
   

Online pharmacies that prescribe drugs are the primary source of concern. Typically, consumers can obtain medication by answering only a questionnaire. These sites bypass the physician-patient relationship and rely on self-diagnosis. This creates a dangerous environment in which drugs are dispensed based on little (possibly inaccurate) medical information, poor health status information, and incomplete past medical history. At best, the medication dispensed may be inappropriate for the consumer’s condition or it may interact adversely with other medications that the consumer may be taking. Some foreign sites, those most often targeted by the FDA, go so far as to dispense drugs without a prescription and without a questionnaire. When a consumer purchases from these sites, the health and safety risks increase substantially.

The FDA polices on-line pharmacies primarily under the Internet Drug Sales Action Plan of 1999. This plan focuses on unapproved new drugs, health fraud, and prescription drugs sold without a valid prescription. The FTC has used its power to block prescriptions being sold on-line using false and misleading claims; such as unwarranted claims about Viagra.

The National Association of Boards of Pharmacy ("NABP") has established its own oversight program for on-line pharmacies called the Verified Internet Pharmacy Practice Sites ("VIPPS") program. VIPPS certifies an on-line pharmacy's credentials, including maintenance of state licenses and inspections by NABP-sanctioned teams. The VIPPS program gives consumers assurance that the on-line pharmacist is reputable. The impact of VIPPS is limited because it is a voluntary program and it does not apply to foreign operations.

In sum, "safe" on-line pharmacies are available to consumers. However, because it is voluntary, as of 2001, very few on-line sites were registered on the VIPPS. Also, to date, there is no enforcement or certification mechanism to provide consumers with assurances regarding foreign on-line pharmacies. When making online drug purchases, the consumer is left to balance the benefits of lower international drug prices and anonymity against the health and safety risks associated with possibly receiving counterfeit drugs, drugs that are untested as to safety and efficacy or drugs that contain dangerous ingredients.

References:

1. http://www.fda.gov/oc/buyonline/faqs.html
   
2. http://www.nabp.net
   
3. http://www.meds.com/onlinemeds.html
   
4. http://www.law.duke.edu/journals/dltr/articles/2001dltr0041.html