If your computer has an Internet connection and you have access to a credit card number, a prescription for nearly any medication-from narcotic painkillers to Viagra-could soon be on its way to your home. In some cases, only the scrutiny of an online questionnaire stands in the way of a patient and potentially harmful medications. Almost anyone using the Internet-and especially those with Web-based e-mail-has witnessed this phenomenon. The barrage of pop-up ads soliciting one kind of medication or another begs the question: With a system like this, who needs a doctor?
For the past several years, many Internet prescription companies may have thought just that. They operate as if they were outside the scope of traditional state and federal laws and regulations. Yet, in recent months, these companies have begun to face a harsher reality. State and federal enforcement authorities are catching up with them, handing down hefty penalties, shutting down businesses, and revoking medical licenses.
Not all interactions between consumers and online pharmacies are improper, and there usually isn't a problem until the pharmacy skips the critical step of ensuring that a physician familiar with the patient has actually written the prescription.
"It's illegal [to distribute drugs without verification of a prescription] under federal law, because you have not visited a physician," says Dr. Bruce Levy, Texas State Board of Medical Examiners. "You're illegally obtaining drugs over the Internet" (Hillebrand, 2000).
"As a physician, you not only look at written information, but you also look at visual information," says Levy. "When someone comes to your office, you can make a diagnosis and evaluation first. On the Internet, you don't have that capability." And, indeed, there have been problems with Internet prescriptions over the last few years. Recently, the Texas State Board filed a complaint against a San Antonio doctor who worked with the now-defunct Web site, www.thepillbox.com. The Board alleged that the physician prescribed Viagra over the Internet to approximately 1,300 patients and did not obtain a medical history, take a physical exam, or even speak with patients. Prescribing in this manner put those patients at a very high risk. "Viagra could induce a hypertensive crisis during the sexual act or immediately after it," says Levy.
Some online pharmacies, namely those that have been accredited by the National Association of Boards of Pharmacy (NABP), require written authorization from a customer's physician before filling online prescriptions. However, for a fee, other sites have found a route around this safeguard by providing an online or telephone consultation with a physician. Other pharmacies, such as those based outside the United States, only require that customers check a box affirming they are at least 18 years old and don't plan to abuse the drugs. One such site, which claims to be affiliated with a pharmacy in Lima, Peru, contends it is legal to import medications as long as they are for personal use. In fact, according to the U.S. Drug Enforcement Administration (DEA), it is against the law for someone inside the United States to purchase or order controlled substances from a pharmacy that is outside the United States.
One site, www.kwikmed.com, for example, offers a "fast, discreet, and 100% private" way to start weight-loss treatment with Xenical, a prescription drug. The site requires customers to submit to a $65 consultation billed only if you are approved for the drug. After asking for the customer's mailing address, drug order, shipping preference, and credit card information, the consultation gets around to the "Customer Medical Declaration." The customer is then asked to provide medical information, including height, weight, history of illnesses, whether or not he or she has taken Xenical previously, allergies, what other medications he or she is now taking, and whether or not she has a history of breast cancer. Finally the customer is asked, "Are there are any reasons why you believe you may not be able to take Xenical?"
Because many online pharmacies offer a variety of medications, including addictive painkillers, and do not adhere to safeguards and ethical guidelines to protect patients, the potential for harm to consumers seems enormous. In spite of this risk, the rewards for unscrupulous pharmacies and physicians can be quite lucrative. One doctor in Texas admitted to writing 450 prescriptions a day. An Oklahoma doctor reportedly made $175,000 in six weeks. Unfortunately, federal enforcement of this Internet marketplace is minimal; individual states are largely responsible for determining what is legal or not in dispensing drugs over the Internet.
According to a study cited by the U.S. Department of Justice (DOJ) in its recent report on confronting online crime, in 1999 Internet pharmacies sold more than $1.9 billion worth of prescription and over-the-counter drugs, vitamins, and a host of other healthcare products. As the DOJ's report stresses, much of the new industry is legal (Hillebrand, 2000). One example of an apparently booming and legal dot.com pharmacy is www.drugstore.com, founded by former Microsoft executive Peter Neupert in February 1999. Neupert says his Web site has served nearly 700,000 customers since its inception, and predicts the online drug market will grow from what was almost nothing in 1998 to $15 billion a year by 2004.
In 1999 and 2000 there was increasing interest in regulating online pharmacies. Then-President Bill Clinton proposed a federal plan to penalize pharmacies that broke medical practice rules. While several bills have been introduced, none has been passed that provides the statutory framework for regulating this industry at the federal level. To date, the Federal Food, Drug, and Cosmetic Act of 2002 (HR 4990) requires making the location of the pharmacy explicit so they can be held accountable by State Boards of Pharmacy.
The pharmacy industry is also regulating its practices. In the spring of 1999, the NABP responded to public concern and developed the Verified Internet Pharmacy Practice Sites (VIPPS) program. A coalition of state and federal regulatory associations, professional associations, and consumer advocacy groups provided their expertise in developing the criteria that VIPPS-certified pharmacies follow. To be VIPPS-certified, a pharmacy must comply with the licensing and inspection requirements of its state and each state to which it dispenses pharmaceuticals. In addition, pharmacies displaying the VIPPS seal have demonstrated to NABP compliance with VIPPS criteria, including patient rights to privacy, authentication and security of prescription orders, adherence to a recognized quality assurance policy, and provision of meaningful consultation between patients and pharmacists (National Association of Boards of Pharmacy, Park Ridge, Illinois).
Other efforts for self regulation have sprung up in recent months as well. The Council for Responsible Telemedicine (CRT), based in Washington, D.C., has emerged to make clear the difference between their membership and those online pharmacies with fewer scruples (Chin, 2002). However, while trying to make some line of demarcation, CRT does not require its members and their affiliated physicians to establish physician-patient relationships with their online patients prior to prescribing medications-a fact that has the medical establishment questioning the purpose of even forming this coalition.
Even without explicit legislative mandate, federal agencies, such as the DOJ, are now investigating e-health and Internet pharmacy transactions that take place in 'brick-and-mortar' pharmacies (Arent Fox Health Group (DOJ), 2001). This approach has been discussed by DOJ Deputy Associate Attorney General Ethan M. Posner at a recent American Health Lawyers Association conference. "Laws should be applied in the same manner, whether it takes place in an Internet or traditional brick-and-mortar operation," he remarked. Posner also noted that state and federal officials have focused their attention on the use of questionnaires without verification of a customer's answers or a proper physical examination by a physician, as well as the failure of Internet pharmacies to comply with state licensure and disclosure laws (Arent Fox Health Group (DOJ), 2001). On April 27, 2001, the DEA also weighed in by issuing policy guidance on dispensing and purchasing controlled substances over the Internet, and provides an interesting overview of the issues surrounding Internet pharmacy sites.
Besides the DOJ, the Food and Drug Administration (FDA) and the DEA have taken a closer look at online pharmacy activities and are taking steps to enforce existing laws and protect consumers.
State medical and pharmacy boards are also getting involved. State attorneys general are warning consumers of the risks of online pharmacies and cracking down on fraudulent Internet marketing and sales of prescription drugs. In the wake of the 2001 anthrax attacks there has been an increase in online marketing of Cipro and other antibiotics. But, state officials caution consumers to watch for overpricing and substandard quality, and to be sure and have valid prescriptions and a medical consultation.
Besides enforcing existing state practice laws for pharmacists and physicians, some states are making new laws. The California Legislature approved a bill that went into effect in 2001 that specifically banned filling prescriptions via the Internet unless there was first a 'good faith examination' by a qualified physician. A hefty fine of $25,000 was established for each prescription illegally approved by a California physician or filled by a California-based Web site. (Arent Fox Health Group (Hammer), 2002).
In 2001, Kansas became the first state to sue an Internet site for alleged illegal marketing of prescription drugs. Later that year, New Jersey followed suit for alleged illegal sales of prescription drugs (Arent Fox Health Group (DOJ), 2001).
The Pennsylvania Attorney General's Bureau of Consumer Protection charged three online pharmacies with violating Pennsylvania law by selling Viagra, Propecia, and Xenical without obtaining a state medical license or pharmacy permit. The pharmacies, 4-Health-Drugs.com, Kwikmed, Inc., and Cyber Health Services, Inc., were charged for violating Pennsylvania Consumer Protection Law, the Pharmacy Act, and the state's medical practices act. The attorney general reached a settlement agreement with 4-Health-Drugs.com, barring the company from advertising, selling, or delivering any prescription drug over the Internet to consumers in Pennsylvania. On its Web site, 4-Health-Drugs.com must now clearly and conspicuously disclose that prescription drugs are not available for sale to Pennsylvania consumers. The owner, Henry Eugene Jones, agreed to refund the $50 consultation fees it charged to consumers, and to pay Pennsylvania $4,000 in civil penalties and $4,000 for investigation costs (Arent Fox Health Group (Pennsylvannia), 2001).
On May 28, 2001, California Governor Gray Davis announced that the California State Board of Pharmacy (under the new law described above) had fined Total Remedy and Prescription Center II, a Los Angeles-based pharmacy-approximately $88 million, and charged two of its pharmacists for alleged violations of a California Internet prescription law that prohibits Internet pharmacies from filling prescriptions without a prior 'good faith medical examination' by a licensed California physician. The fines and allegations are the result of an eight-month investigation by the Board of Pharmacy. The state alleges that the pharmacy and its pharmacists filled more than 3,500 prescriptions for drugs, such as Viagra, Propecia, and Xenical. In contravention of the new California law, the state alleges that no California licensed physicians provided prescriptions for these drugs (Arent Fox Health Group (State), 2001).
In early 2002, an Oklahoma doctor involved with the now-defunct www.nationpharmacy.com was sentenced to a fifty-one month prison sentence for improperly selling prescription medication over the Internet. Ricky Joe Nelson, MD had been convicted by a jury in January of the federal crime of conspiracy to distribute controlled drugs. The Department of Justice alleged that Nelson had been giving prescriptions for controlled drugs (including highly addictive painkillers) over the Internet to patients who had not undergone physical examinations. On May 29, 2002, despite Nelson's remorseful statements to the court, the U.S. District Judge sentenced him to the lengthy prison term and also ordered the forfeiture of $660,000 in illegal gains. The Oklahoma Board of Medical Examiner's Web site states that Nelson surrendered his license to practice medicine in Oklahoma on July 18, 2002. Similarly, in Alabama, the Medical Licensure Commission moved somewhat quicker, dropping their complaint on April 8, 2002 after Nelson surrendered his license to practice in Alabama (Alabama Board of Medical Examiners, 2002).
The cases mentioned above are only a few of hundreds of other cases under investigation across the country, and long-overdue enforcement appears to be well underway. Equipping the boards of medicine and pharmacy with explicit language to regulate online pharmacies will aid such agencies, but much can be done in its absence. Responsible enforcement of existing laws clearly benefits consumers since their health and safety are at stake. The 'brick-and-mortar' pharmacies who have established their niche in the market, such as Walgreens and CVS, are also benefiting. The federal government also wins with stiffer accountability for online pharmacies. Fines can be assessed and collected for state boards of pharmacy and medicine, of course, but the legitimacy of their existence is solidified when they have an increased burden to protect the state from external virtual threats.
Those who are engaged in or planning future activity in telemedicine ought to pay close attention to this trend of increasingly vigorous enforcement of medical practice statutes. The parallels between evaluation/delivery of online prescriptions and the online evaluation/diagnosis of a skin lesion are obvious. As states garner experience in taking healthcare practitioners to task over illegal activity over the Internet, professionals endeavoring to practice telemedicine in multiple states without full licensure would likely become targets as well.
It is uncertain whether federal regulations will succeed or even be necessary to protect consumers from the illegal practices of online pharmacies. It is clear, however, that there are many legitimate concerns about the substantial health risks involved. This awareness has prompted private industry, state government, and select federal agencies to take action against illegal Web sites. Although some form of regulation is needed, the lack of resources necessary to effectively monitor illegal Web sites still poses a problem. Once a Web site is shut down in one state, it only takes minimal effort to relocate to another state. While recent state actions may not completely eliminate the prevalence of illegal online prescription sales, it provides necessary monitoring as a first step in helping to curb the problem.
With enforcement action against Internet-based prescription companies on the rise, it would appear that illegally selling highly desirable 'lifestyle' medications may be coming to a grinding halt. Vigorous enforcement must continue, but another avenue to consider is education of consumers on the dangers of taking medications without proper medical supervision. At the very least, heightened scrutiny and consumer education could change the rules of the game, not to mention the consequences.
Alabama Board of Medical Examiners. Medical Licensure Commission Public Action Report Alabama Board of Medical Examiner Newsletter, Summer, 2002, 17(3): 2. (Link last checked on December 15, 2004).
Chin T. Questions linger over group's 'responsible' prescribing. American Medical News, October 14, 2002, 45(38). (Link last checked on December 15, 2004).
Arent Fox Health Group. DOJ Policing Internet Pharmacies Arent Fox Developments in E-Health and Telemedicine, May 2001. (Link last checked on December 15, 2004).
Hillebrand M. Clinton Cracks Down on Net Pharmacies. E-Commerce Times, March 22, 2000. (Link last checked on December 15, 2004).
National Association of Boards of Pharmacy. Introduction to VIPPS Program. National Association of Boards of Pharmacy, Last Modified: October 1, 2004. (Link last checked on December 15, 2004).
Arent Fox Health Group. JCAHO Recommends Move to Electronic Prescriptions. Arent Fox Developments in E-Health and Telemedicine, November, 2001. (Link last checked on December 15, 2004).
Arent Fox Health Group. Pennsylvania Bars Online Pharmacy From Doing Business With State Residents. Arent Fox Developments in E-Health and Telemedicine, June, 2001. (Link last checked on December 15, 2004).
State Enforcement Actions Against On-line Pharmacies Continue. Arent Fox Developments in E-Health and Telemedicine, June, 2001.
Arent Fox Health Group. The Hammer Begins to Fall: Civil and Criminal Actions Against Internet Pharmacists and Physicians. Arent Fox Alerts, June 4, 2002. (Link last checked on December 15, 2004).
