Web drugstores: Prescription for disaster?
June 4, 1999
by Tom Spring
(IDG) -- As a spokesperson for the wonder drug Viagra, ex-Senator Bob Dole isn't shy about discussing erectile dysfunction. But millions of men are, and thanks to the anonymity of the Internet, thousands have sought help online without feeling embarrassed. By paying visits to online doctors and virtual pharmacies, men can easily obtain prescriptions for Viagra.
But experts warn that these patients are at risk, and so are many more patrons of online pharmacies that sell prescriptions and medicines. For example, Viagra can cause complications or death for people with certain heart or liver conditions. But a growing number of Web sites let you be your own doctor. They permit you essentially to write your own prescriptions, and then sell you the drugs sight unseen.
Purchasing prescription medication using a mail-order service or via the Internet isn't illegal if you have a prescription from your doctor. The tricky ethical and legal question is whether a doctor can prescribe drugs over the Internet without ever meeting the patient.
Prescription for disaster?
As the nascent online prescription-drug business booms, domestic Internet pharmacies are coming under scrutiny from state and federal health officials. Both worry that some online pharmacies are selling powerful prescription drugs such as Viagra, Propecia (a hair-loss treatment), and the weight-loss drug Xenical based on nothing more than a consultation with an online doctor.
More disturbing -- and difficult to control -- are pharmacies popping up overseas that allow anyone with a credit card to purchase drugs like the tranquilizer Xanax, anabolic steroids, Rohypnol (a sedative not available in the U.S.), and the narcotic Demerol.
Officials are struggling to battle online prescription-drug traffickers, but say there is little to do to stop them.
It's all pretty simple. If you're shopping for the allergy drug Claritin at Rx Leader, for example, you're asked to complete a short form that asks if you suffer from allergies, if you are taking any other medications, if have had any problems with your liver or kidneys, and if you are pregnant.
A few more clicks, and Rx Leader charges you $250 -- the cost of the "consultation" and a 30-day prescription of Claritin. Wait a couple more days and the drugs show up at your door.
"How can you possibly establish a solid doctor-patient relationship when you never meet the person you're treating?" asks Carmen Catizone, executive director of the National Association of Boards of Pharmacy. "We don't think it's ethical, and somebody is going to get killed."
Officials say that online pharmacies prosper by exploiting loopholes in import regulations, and the sheer number of the operations make them hard to control. For example, overseas pharmacies inform American buyers that U.S. Customs will not seize shipments of drugs because a "personal use" policy allows customers to import a limited supply of drugs.
Law enforcement agencies that try to manage online pharmacy abuse are finding it a challenging to do so. Authorities in Arizona have struggled to untangle jurisdictional issues and locate Web site proprietors. In one instance, an online pharmacy with an Arizona mailing address was being hosted in another state. The resident physician signing off on prescriptions was discovered to be a retired veterinarian living in Mexico.
"Is it illegal for a doctor in another country to approve a prescription that you buy online in the U.S.?" asks Gale Thackery, an attorney with the Cyber Crimes Unit of the Arizona Attorney General's office. The law doesn't clearly identify where the transaction took place and who can regulate the transaction, she says.
The Arizona State Attorney General has tried to stop out-of-state and overseas Internet doctors from doing business with state residents, but concedes the office lacks the power and enforcement muscle to stop them.
Feds: Our hands are tied
The Federal Trade Commission is also concerned but insists it's up to individual states to police their own doctors, says Richard Cleland, senior staff council at the FTC.
"From a public health standpoint," Cleland says, "We view online drugs as a serious concern." But in the absence of a federal law prohibiting doctors from prescribing drugs to patients they haven't examined in person, the FTC's hands are tied.
The Food and Drug Administration, which supervises individual state boards of medicine, is neither unconcerned nor unaware, but lacks the means to do battle. "There is a difference between caring and not having the legal authority," says Brad Stone, FDA spokesperson.
The Drug Enforcement Agency also pleads that it is ill-equipped to handle the onslaught of cases. Along with U.S. Customs agents, the DEA seizes inbound parcels of foreign pharmaceutical drugs at the U.S. border bound for people it suspects are abusing the personal use provision.
While it's hard to prosecute the overseas pharmacies, the DEA says, U.S. buyers can be prosecuted for smuggling illegal drugs into the country. However, DEA representatives acknowledge that they have been slow to fine, jail, or penalize anyone for such violations. In fact, a DEA representative could cite only one instance. Last year, a Texas man was sentenced to a year in jail for having prescription drugs shipped to him and later reselling them.
States show inconsistent efforts
States are grappling with their concerns about online pharmacies on a case-by-case basis.
They have the support of the American Medical Association, which says online physicians who write prescriptions without patient contact are in direct violation of AMA policy. The organization wants states to penalize doctors for prescribing drugs sight unseen.
Washington State health officials are among the first to take disciplinary action against physicians. Last month, the state board of health filed charges against Leandro Pasos, accusing him of "unprofessional conduct." The state alleges Pasos agreed to write Viagra prescriptions for patients without "performing a complete physical examination."
In May, the Illinois State Department of Professional Regulation suspended Robert Filice, a physician, for prescribing Viagra via an Internet pharmacy for patients he'd never seen. Filice was working as a consultant for The Pill Box, a San Antonio, Texas-based pharmacy chain that sells online.
The state suspended Filice's license immediately because his actions put people in danger, says Tony Sanders, Illinois DPR spokesperson. The agency later reinstated Filice's license when he admitted that his conduct was "unprofessional." The physician was fined $1000, put on a two-year probation, and ordered to not prescribe medication to patients without personally interviewing and examining them.
Patients who wanted a prescription drug like Viagra logged onto The Pill Box's site and filled out a questionnaire that included health questions. The completed form went to the company's medical consultants, including Filice, Sanders says.
Filice reviewed the forms and, if he found no health conditions that would make the drugs dangerous, would write a prescription for the drug, which The Pill Box would fill.
The Pill Box's president, Bill Stallknecht, says there's nothing inherently dangerous about writing a prescription for a patient a doctor has never seen.
"These prescriptions are not illegal," Stallknecht says. "They're bona fide prescriptions with bona fide doctor-patient relationships."
Although The Pill Box is based in Texas, it used an Illinois physician, which complicates agency oversight. "We have found no reason for disciplinary action," says Jill Wiggins, of the Texas State Board of Medical Examiners, which licenses doctors.
"One out of three prescriptions written are prescribed by doctors who've never seen their patients," Stallknecht claims. He says the pharmaceutical drugs he sells online -- primarily Viagra, Propecia, Claritin, and Xenical -- are safe. These drugs require a prescription because manufacturers are "milking their patents" before they expire and the drugs become available over the counter, he says.
In the meantime, Illinois legislators are considering a bill to regulate online and mail-order pharmacies that sell products in the state. The bill would require Internet pharmacies to register with the state annually.
Loopholes to be filled
The federal government is also taking a closer look at some of the loopholes that allow online pharmacies to operate as they do.
But federal agencies say those policies are being misinterpreted and exploited by overseas businesses that ship drugs into the U.S. Both provisions were never intended to apply to drugs shipped into the U.S. for resale.
Ordering prescription drugs over the Internet for anything but legitimate medical purposes is illegal under both state and federal laws, say DEA representatives.
While regulatory agencies at several levels are developing solutions, getting a handle on the international aspects remains daunting.
"Within a year or two, we will be able to get a handle on the domestic online pharmacies," says the NABP's Caltizone. "But we aren't even at the embryonic stages of controlling the growing international problem."
One professional association is taking a cue from the voluntary regulation some electronic commerce sites provide. Just as the Better Business Bureau and other agencies issue seals of approval for display on Web sites that meet criteria as responsible businesses, the NABP is organizing a voluntary seal program. The organization will endorse sites that meet its criteria for dispensing drugs online.
The plan has the endorsement and cooperation of the DEA, the FDA, the AMA, and the online industry itself. And while the seal of approval may protect consumers, it may not deter the sites -- or patients -- that don't care about a regulatory agency's endorsement.
New York clears way for electronic medication transactions
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