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Forget your family doctor and the pharmacist that you’ve visited down the street for the last 15 years. You can now pop pills with the click of your mouse and a credit card and without so much as a physical exam. No joke. The consequences of easy access to drugs are extremely serious. Self-prescribing medication can make you sicker if you’re already sick and sick if you’re healthy. I know I can’t tell the difference in appearance between a blood pressure pill and an aspirin. That’s why I rely on my family doctor. On the Internet, consumers don’t have that luxury. Online health care generally can provide a host of benefits to consumers. One benefit is easy access to loads of information — some reliable, some not so reliable. Online research for doctors is another. The pharmaceutical companies see the Internet as having great marketing potential. The ability of the sick, frail, and elderly to order (or have their health care assistants order) their drugs online is a plus too. THE ‘EMBARRASSMENT’ DRUGS ePrescribe.com is an online pharmacy whose “physicians specialize in consulting with privacy-minded individuals and prescribing popular medications,” including what it calls “embarrassment” drugs like Viagra. In the privacy of our own homes, we can now self-diagnose and self-medicate. Great, right? It may be the blind treating the blind. Basically, there are three types of online pharmacies. The more traditional online pharmacies require consumers to obtain a prescription from a licensed physician before ordering a drug. The “patient” must submit the doctor’s prescription before obtaining the drug. Another category of online pharmacies offers a two-part service. First, an online doctor diagnoses a patient online using a medical questionnaire to obtain the patient’s health profile, current medications that he takes, and a medical history. Based on this “e-diagnosis,” a doctor determines the cause of the illness and prescribes a medication that the patient can purchase on the Web site. Frankly, I have enough problems telling the truth to my current family doctor: “Nope. There’s absolutely, positively, no cholesterol in my current diet. I just can’t understand why my cholesterol count is so high. And yes, I exercise religiously four times a week. Both strength training and cardiovascular conditioning.” I can just imagine how I would fill out my online questionnaire. Some of these sites charge a patient for both the consultation and the prescription. Others charge only for the consultation if the patient fills a prescription at the site based on the doctor’s recommendation. (Can we say “conflict of interest”?) The most alarming type of online pharmacy, however, is the online drugstore that only requires a credit card to issue prescription drugs. Online pharmacies must familiarize themselves with and operate under the rules that govern them, and potentially, there are several. While the prescription drug laws as applied online are still in their infancy, don’t throw caution to the wind. You could find yourself subject to civil and criminal penalties if you do. It hasn’t taken long for the U.S. Food and Drug Administration to raise an eyebrow. The FDA has issued “cyberletters” to a dozen operators of foreign-based Internet sites that offer to sell prescription drugs online. The letters warn Web site operators that they may be engaging in activities that violate U.S. laws aimed at prescription drug sales. This effort is a first step by the FDA to reach out to potential violators of the federal Food, Drug, and Cosmetic Act. The FDA claims that its efforts will continue and will escalate to protect the public against illegal and potentially dangerous products sold through Web sites. The Department of Justice, through its Civil and Criminal Divisions, local U.S. attorney’s offices, the FBI, and other governmental entities, is also focusing on stopping illegal drug sales online. DRUG LAWS The Food, Drug, and Cosmetic Act (FDCA) generally prohibits the manufacture and distribution of misbranded and adulterated drugs and requires that drugs are accurately labeled and handled in ways that prevent them from being contaminated and misused. Accordingly, the FDCA generally requires that only physicians prescribe certain drugs and that only pharmacists distribute those drugs to someone with a valid prescription, one a doctor has prescribed under his professional supervision. The FDCA considers any prescription drug dispensed without a valid prescription “misbranded.” Therefore, an online pharmacy that fills a prescription with merely an “online flash” of an American Express card would violate this act. For those online pharmacies that offer “check-ups” and diagnoses in addition to drugs, the legal issue becomes whether the e-check-up results in a valid prescription or whether the online pharmacy that distributes medication pursuant to an online checkup and prescription has, in fact, misbranded the medication in violation of the FDCA. Several states, including Kansas, Maryland, and Washington, have already taken legal action against doctors, Web sites, and pharmacies that dispense prescription drugs over the Internet in violation of state law. The Controlled Substances Act prohibits the dispensing of a controlled substance without a valid prescription. Based on a regulation that the Drug Enforcement Agency issued, some interpret the definition of prescription under the CSA to exclude a prescription written by a physician based on information obtained from merely an online questionnaire. This should raise concern for online pharmacies offering diagnostic services as a means to ensure that prescriptions are valid and issued by a licensed physician. Online pharmacies also need to be aware of Federal Trade Commission provisions and ensure that they post only true and fair representations on their Web sites. If you state that the drugs from your Web site are safe and effective, they better be. Otherwise, you may receive a knock on the door from the feds. Federal mail- and wire-fraud statutes may also make up part of the regulatory jigsaw puzzle. Schemes the FTC deems as fraudulent, such as improperly billing an insurance company for an e-physician consultation or for the drug itself, may be violations of these laws, too. So what about taking your e-pharmacy offshore? Can you get away with it then? Not necessarily. The FDA is working with its counterparts in foreign countries and with foreign online prescription businesses to prevent the shipping of illegal drugs into the United States. While I don’t expect to see workable international standards for online pharmacies in the immediate future, international cooperation on the issue is growing. PENDING LEGISLATION Congress has addressed the issue of easy online access to prescription drugs in several pieces of legislation. For example, the Pharmaceutical Freedom Act of 2000 validates the online sale of prescription drugs. This act would require that the sale comply with the FDCA, with all applicable state laws, and that the Web site post accurate information regarding its compliance to such laws. Congress also addressed the issue in the Internet Pharmacy Consumer Protection Act. This act sets forth minimum requirements for an online pharmacy site. These requirements include that a Web site post accurate contact information; a list of states in which the Web site is authorized by law to dispense prescription drugs; the names of the pharmacists for the site and the states which those pharmacists are authorized in; and, if the Web site offers medical consultations, the name of the consulting doctors, the states in which they’re licensed or otherwise authorized by law to provide consultations, and their licensed specialties. Online pharmacies can sure come in handy, and as the regulations develop, so will my comfort level. But let’s not forget that the self-medicating patient is probably as foolish as the lawyer who represents himself at his own trial. Mark Grossman leads the computer and Internet law department of Becker & Poliakoff in Miami. Allison K. Hift is an associate with the firm. Your questions and comments are welcome. E-mail them to [email protected] Also, visit his home page at www. mgrossmanlaw.com. Online research for this column is provided by Lexis-Nexis.

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